mette bach larsen - aarhus universitet · i also wish to thank bent hansen juel, csc scandihealth...

Diagnosing cancer in a time of change -from delay to fast track

Ph.D. dissertation

Mette Bach Larsen

The Research Unit and Section for General Practice

Faculty of Health Sciences

Aarhus University

2012

au

AARHUS UNIVERSITY

FACULTY OF HEALTH SCIENCES

II

Diagnosing cancer in a time of change - from delay to fast track

PhD thesis

Diagnosing cancer in a time of change -from delay to fast track

1st edition, 2012

©2012, Mette Bach Larsen

This thesis has been accepted for PhD defence by the Faculty of Health Sciences, Aarhus University and was defended on 27 Marts 2012.

Supervisors

Frede Olesen, Professor, GP, DrMedSci, The Research Unit for General Practice, Institute of Public Health, Aarhus University, Denmark

Peter Vedsted, Professor, MD, PhD, The Research Unit for General Practice, Danish Research Centre for Cancer Diagnosis in Primary Care, Institute of Public Health, Aarhus University, Denmark

Rikke Pilegaard Hansen, MD, PhD, The Research Unit for General Practice, Danish Research Centre for Cancer Diagnosis in Primary Care, Institute of Public Health, Aarhus University, Denmark

Dorte Gilså Hansen, MD, PhD, The Research Unit for General Practice, The National Research Centre for Cancer Rehabilitation, University of Southern Denmark, Denmark

Opponents

Bodil Hammer Bech, Associate Professor, MD, PhD (Chairman), Department of Epidemiology, Aarhus University, Denmark

Greg Rubin, Professor, GP, Department of General Practice and Primary Care, Durham University, UK

Dorte Ejg Jarbøl, MD, PhD, The Research Unit for General Practice, University of Southern Denmark, Denmark

Financial support

The Novo Nordic Foundation, the Danish Cancer Society and the Quality and Continuing Education Council for general practice in the Central Denmark Region and the Region of Southern Denmark.

ISBN 978-87-90004-17-0

Print: SUN-TRYK. Fællestrykkeriet for Sundhedsvidenskab og Humaniora, Aarhus Universitet

The Research Unit for General Practice, Aarhus University

Research Centre for Cancer Diagnosis in Primary Care

Bartholins Allé 2

DK-8000 Aarhus C.

Phone: +45 87167897

E-mail: [email protected]

All rights reserved. No parts of this publication may be reproduced, stored in retrieval systems, or transmitted in any form or by any means – electronic, mechanical, photocopying, recording or otherwise – without indication of source

III

Preface

Preface

IV


Motivation

“Cancer caught in time can wait” was the somewhat controversial heading of an editorial

in the Danish Medical Bulletin from 2004 (1) which concluded that the current status of

waits was humanly irresponsible and also on the verge of professional negligence. At

the time, individual anecdotes of cancer not being caught in time and long waits in the

diagnostic process repeatedly hit the media, which featured articles on consequences of

this approach in the form of the patients’ poor prognosis and poor quality of life. Further,

international studies showed that Danish cancer patients had poorer survival rates than

patients in the other Nordic countries and many European countries. Subsequent scientific

evidence of long time intervals in the diagnostic process sparked political initiatives to

change the course of the cancer care pathway. This thesis aims to provide knowledge on

how political decisions changed the intervals and how this influenced patients’ and health

professionals’ experience of the cancer care pathway.

Outline of the thesis

Chapter 1 offers a general introduction to issues related to cancer epidemiology and cancer

diagnosis in Denmark along with an introduction to the political initiatives relevant to the

thesis and the applied theoretical perspectives. The aims of the thesis are presented at the

end of the chapter. Chapter 2 describes the methods and materials of the study. Chapter 3

describes the inclusion and exclusion criteria and non-response and the chapter contains

the four articles forming the present thesis. In Chapter 4 and Chapter 5 methods and results

are discussed, respectively. Chapter 6 offers the main conclusions of the thesis and raises

perspectives relevant for future research. Finally, Chapters 7 to 9 give the references used

in the thesis and the English and Danish summaries. Appendices A to C provide a list of

cancer diagnoses included in the studies and the questionnaires sent to the GPs and the

patients.

V

Preface

THE FOUR PAPERS OF THE THESIS

Larsen MB, Jensen H, Hansen RP, Olesen F, Vedsted P. Identifying incident cancer patients

using administrative register data. (Submitted)

Larsen MB, Hansen RP, Hansen DG, Olesen F, Vedsted P. Urgent referral for suspected

cancer as a means of reducing delay in the diagnosis. A population-based observational

study in Denmark. (Submitted)

Larsen MB, Hansen RP, Hansen DG, Olesen F, Vedsted P. Patient evaluation of the cancer

care pathway before and after introduction of urgent referral for suspected cancer. Results

from a natural experiment in Denmark. (Submitted)

Larsen MB, Hansen RP, Hansen DG, Olesen F, Vedsted P. General practitioners’ evaluation

of the cancer care pathway before and after introduction of urgent referral for suspected

cancer, Results from a natural experiment in Denmark. (Submitted)

VI


ACKNOWLEDGEMENTS

This PhD thesis was carried out during my employment at the Research Unit for General

Practice, Aarhus University, Denmark.

First, I wish to extend my appreciation to my supervisors: Dorte Gilså Hansen for your

always valuable contributions when perspectives from outside the “Aarhus League”

were needed. Rikke Pilegaard Hansen, when I started out at the Research Unit, you were

finishing the forerunner of the present project devoting to the task serenity and proficiency

close to frightening, but also immensely inspiring. I deeply appreciate your contributions

to my project. Frede Olesen, under whom it has been an honour to work; your commitment

and insight has truly been an inspiration to me and I have enjoyed our fruitful battles.

Thank you for your never ending support. Last but not least, Peter Vedsted. No one could

possibly expect the amount of effort you have devoted to this project. I am deeply grateful

for your commitment and your qualified criticism in all phases of the project.

The technical and administrative staff at the Research Unit all deserves profound thanks,

especially Birthe Brauneiser and Eva Højmark. Thanks to Eva Munkholm for assisting with

logistics when conducting the survey. Without help from you and the students, especially

Lise Moth, I would have been lost. Statisticians are a strange race, Ineta Sokolowski and

Morten Fenger-Grøn being no exception. I am grateful for your existence.

Finally, my dear colleagues at the Research Unit: you made life a laugh. My true travelling

companion throughout the project deserves special thanks: Thomsen, among other things,

you are responsible for the impressive design of my questionnaires and your presence has

made the process a lot more fun. Thank you.

Thanks are also due to the Centre for Quality Development in Central Denmark Region;

especially Simone Witzel, Jens Thusgaard Hørlück, Torsten Munch-Hansen and now

late Peter Rohde. At the Department of Quality and Health Data in the Central Denmark

Region, special thanks are due to Bernhard Hansen, Jens Grønlund and Hans Peder

Graversen. In the Southern Denmark Region, thanks are due to Henrik Juul Andreasen

and Olaf Ingerslev, the Department of Health Documentation.

I also wish to thank Bent Hansen Juel, CSC Scandihealth and Thomas Randers Jensen, Opus

Consult for qualified working relationships. Further, I wish to thank Morten Pilegaard for

proofreading and editing my papers and this thesis, always receiving materials in the very

last moment, but never compromising on the quality.

Finally, the deepest gratitude goes to my family, friends and good neighbours for their

support and for broadening my perspectives. Else, for making everything easier; my in-

VII

Preface

laws and my parents for taking good care of Johanne and Jesper. Mom and dad, Morten

and Rasmus for your never failing support and encouragement. Finally, my deepest

appreciation goes to Jesper for always being there –and for showing me that you really can

run a household. And may the last word be dedicated to Johanne, the sweetest interruption

of my life.

VIII


ABBREVIATIONS

CI Confidence IntervalCQD Centre for Quality Development, Central Denmark Region CRN Civil Registration NumberDanPEP Danish Patients Evaluate PracticeDCR The Danish Cancer RegistryEORTC European Organisation for Research and Treatment of cancer EUROPEP European Patients Evaluate Practice GP General PractitionerICD-10 International Classification of Diseases version 10IQI Inter-quartile intervalMBL Mette Bach LarsenNPR The Danish National Patient RegistryPAS The Patient Administrative SystemPPV Positive Predictive ValuePRR Prevalence rate ratioQoL Quality of Life Questionnaire QLQ C-30 Quality of Life Questionnaire, 30 items RSA Rikke Sand Andersen

IX

Contents

contentschaPter 1

IntroductIon ��1

a tIme for change ��2

1.1.1 Danish cancer epiDemiology ............................................................................................................................ 2

1.1.2 Diagnosing cancer in Denmark ..................................................................................................................... 3

1.1.3 The cancer care paThway ................................................................................................................................ 3

1.1.4 Time as a facTor in cancer Diagnosis ............................................................................................................ 4

PolItIcal InItIatIves ��6

1.2.1 waiTing Time guaranTies .................................................................................................................................... 6

1.2.2 naTional cancer plans ...................................................................................................................................... 7

1.2.3 cancer as an acuTe conDiTion ....................................................................................................................... 7

1.2.4 urgenT referral for suspecTeD cancer........................................................................................................ 7

theoretIcal PersPectIves��10

1.3.1 healTh services research ............................................................................................................................... 10

1.3.2 healThcare reforms ......................................................................................................................................... 11

1.3.3 QualiTy of healTh care ................................................................................................................................... 11

1.3.4 assessing QualiTy improvemenT ..................................................................................................................... 13

aIm ��14

chaPter 2materIal and methods ��15

study desIgn ��16

2.1.1 seTTing ................................................................................................................................................................. 16

data from regIsters ��17

2.2.1 The Danish civil regisTraTion sysTem ........................................................................................................ 17

2.2.2 The paTienT aDminisTraTive sysTems ............................................................................................................. 17

2.2.3 The Danish naTional paTienT regisTry....................................................................................................... 18

2.2.4 The Danish cancer regisTry ........................................................................................................................ 18

data from questIonnaIres ��19

2.3.1 The gp QuesTionnaire ..................................................................................................................................... 19

2.3.2 The paTienT QuesTionnaire ............................................................................................................................... 20

2.3.3 piloT TesTing ....................................................................................................................................................... 20

2.3.4 DaTa collecTion ................................................................................................................................................ 21

2.3.5 DaTa enTry .......................................................................................................................................................... 21

samPlIng Procedure ��23

data analysIs ��25

2.5.1 ouTcome measures ........................................................................................................................................... 25

2.5.2 sTaTisTical analyses .......................................................................................................................................... 26

aPProvals ��27

2.6.1 eThical consiDeraTions .................................................................................................................................. 27

X


chaPter 3results ��29

exclusIon & non-resPonse ��30

3.1.2 paTienT QuesTionnaire ...................................................................................................................................... 31

3.1.3 seconDary care inTerval ................................................................................................................................ 33

artIcle I ��37

artIcle II ��53

artIcle III ��69

artIcle Iv��87

chaPter 4dIscussIon of methods �� 105

data valIdIty �� 106

4.1.1 Design ............................................................................................................................................................... 106

4.1.2 sampling proceDure...................................................................................................................................... 107

4.1.3 non-response ................................................................................................................................................. 107

4.1.4 QualiTy of regisTries..................................................................................................................................... 108

4.1.5 QualiTy of QuesTionnaires .......................................................................................................................... 109

4.1.6 processing QuesTionnaire DaTa ................................................................................................................ 110

4.1.7 alTernaTive meThoDs ..................................................................................................................................... 110

outcome measures �� 112

4.2.1 The seconDary care inTerval ..................................................................................................................... 112

4.2.2 paTienT evaluaTion ......................................................................................................................................... 112

4.2.3 gp evaluaTion................................................................................................................................................. 113

4.2.4 urgenT referral for suspecTeD cancer.................................................................................................. 113

4.2.5 Discharging hospiTal ................................................................................................................................... 114

4.2.6 sTaTisTical analyses anD precision ........................................................................................................... 115

bIas & generalIsabIlIty �� 116

4.3.1 selecTion bias ................................................................................................................................................. 116

4.3.2 informaTion bias ............................................................................................................................................. 116

4.3.3 confounDing .................................................................................................................................................. 117

4.3.4 generalisabiliTy .............................................................................................................................................. 118

chaPter 5dIscussIon of results �� 119

results In general �� 120

a PrerequIsIte for research In early cancer dIagnosIs �� 121

5.3.1 seconDary care inTerval ............................................................................................................................. 121

5.3.2 paTienT evaluaTion ......................................................................................................................................... 122

5.3.3 gp evaluaTion................................................................................................................................................. 124

XI

Contents

chaPter 6conclusIons and future research�� 125

conclusIons �� 126

6.1.1 The 2008 cohorT of inciDenT cancer paTienTs (aim 1) .................................................................... 126

6.1.2 The seconDary care inTerval (aim 2) ....................................................................................................... 126

6.1.3 paTienT evaluaTion (aim 3) ........................................................................................................................... 126

6.1.4 gp evaluaTion (aim 4) .................................................................................................................................. 127

future research �� 128

6.2.1 mechanisms of prolongeD seconDary care inTervals ....................................................................... 128

6.2.2 paTienT perspecTives on whaT consTiTuTes a coherenT cancer care paThway ............................ 128

6.2.3 paTienT evaluaTions as a preDicTor for oTher ouTcomes .................................................................. 128

6.2.4 The gp’s role in improving The cancer care paThway ....................................................................... 129

6.2.5 The “vejle effecT” .......................................................................................................................................... 129

6.2.6 urgenT referral for non-sympTomaTic cancer ................................................................................... 129

6.2.7 siDe effecTs of urgenT referrals ............................................................................................................. 130

6.2.8 seconDary care inTervals anD morTaliTy ............................................................................................... 130

chaPter 7references �� 131

chaPter 8englIsh summary �� 143

chaPter 9dansk resume �� 147

aPPendIx aIncluded cancer dIagnoses �� 151

aPPendIx bquestIonnaIre to the gP �� 153

aPPendIx cquestIonnaIre to the PatIent �� 163

1

Chapter 1 Introduction

chaPter 1IntroductIon

2


A TIME FOR CHANGE

1.1.1 Danish cancer epidemiology

The past ten years have seen a rise in the incidence of cancer in Denmark of 32% for men

and 28% for women. Thus, in 2009 approximately 35,500 new cancer cases were registered

in Denmark, and the prevalence had reached approximately 224,000 by the end of 2009 (2).

For men, the most frequent cancers are prostate, lung and colorectal cancers. For women,

the most frequent cancers are breast, lung and colorectal cancers. The elderly account for

the largest percentage of the new cancers. In 2009, men above 60 years accounted for 78%

of all male cancers, and women above 60 years accounted for 69% of all female cancers (2).

Since 2000, cancer has been the primary cause of death in Denmark, causing approx. 15,500

deaths per year (3). Finally, with a risk of 33% for getting cancer before the age of 75 (4),

cancer is one of the most prominent diseases in the Danish healthcare sector.

Studies have shown that Denmark has a lower relative survival rate from cancer than

the other Nordic countries and many European countries (5-8). Figure 1.1 shows that the

relative 5-year survival in Denmark is well below the European mean and more in line

with Eastern European countries than with the Nordic countries, especially for men.

Figure 1.1 5-year relative survival adjusted for age-mix and case-mix by country for all cancers combined, with area-weighted mean European survival (5)

Horizontal bars indicate 95% confidence intervals. Countries are ordered by total national health expenditure expressed as per capita purchasing power parity.

*Weighted mean of age-adjusted 5-year relative survival in the four UK regions.

3


Several studies have indicated that part of the explanation for Danish cancer patients’ lower

survival rates is that they seem to be at a more advanced stage of disease than patients in

the other Nordic countries when their treatment is initiated, which means that clinical

pathway may be delayed in Danish cancer patients (9-12).

1.1.2 Diagnosing cancer in Denmark

Denmark has a publicly funded healthcare system where patients have free access to

general practice, outpatient and hospital care. Carrying out initial diagnostic investigations

and referring to specialised healthcare when needed, the general practitioner (GP) serves

as gatekeeper to the secondary healthcare system. More than 98% of Danish citizens are

registered with a GP. The remaining patients have chosen a health insurance where they

can choose between all GPs, but have to pay a part of the consultation fee (13).

In Denmark, the diagnostic pathway is initiated in general practice for approximately 85% of

all cancer patients (14). Studies have shown that alarm symptoms of cancer are common in

the general population with approximately 15% of the population experiencing at least one

cancer alarm symptom within a year (15). Furthermore, positive predictive values (PPVs)

of cancer alarm symptoms have been proven to be relatively low, ranging from 2-10%

depending on age, gender and cancer type (16;17). The following eight alarm symptoms

of cancer are the only ones shown to have a PPV of 5% or higher: rectal bleeding, change

in bowel habit and iron deficiency anaemia in colorectal cancer; haematuria in urological

cancer; haemoptysis in lung cancer; dysphagia in oesophageal cancer; breast lump in breast

cancer; and postmenopausal bleeding in gynaecological cancers (18). A Danish study has

shown that the GP interpreted the initial symptoms as alarm symptoms in 50% of incident

cancer patients (19). Thus, many experience alarm symptoms, but only few of those who

choose to attend the GP with these alarm symptoms actually have cancer, and only half of

those with an incident cancer presented to the GP with alarm symptoms. Assuming that

cancer cases are randomly distributed in the population, a GP will see 8-10 new cancer

patients a year. Thus, diagnosing cancer is an act of identifying the few patients with cancer

among the many patients with symptoms that could indicate cancer (20).

1.1.3 The cancer care pathway

The clinical pathway from first symptom presentation to initiated treatment of cancer

is often divided into different time intervals. Delay was the term previously used for

describing these intervals. Methodologically, what was measured was not only undue

waiting time. Using the term diagnostic delay implies that delay should be reduced to

zero. However, some medically necessary waiting time will always exist, e.g. time required

4


to process test results, which differ greatly between cancer types and even within each

cancer type. Today’s preferred term is therefore intervals, which is the term used in this

thesis (21).

There has previously been no standardised definition of the time intervals, and recent

years have therefore seen many studies deploy various operational definitions (22-24).

An international consensus group therefore recently categorised the intervals as shown in

Figure 1.2.

Figure 1.2 Categorisation of intervals in the cancer care pathway (21)

This thesis focuses on the secondary care interval, defined as the interval from the first

referral to secondary care, from which time the GP has no further responsibility for the

diagnostic process, until start of treatment (21).

1.1.4 Time as a factor in cancer diagnosis

A Danish study found that the median interval from first symptom to treatment was 98

days, which means that half of the cancer patients waited more than three months. The

same study showed that the system interval accounted for most of that time (median 55

days), due partly to unavoidable factors like processing time for test results (14). For all

intervals, there was a “tail” of patients with very long waits (Figure 1.3).

First symptom

First presentation

in primary care

First investigation

in primary care

First referral to secondary

care

First visit in

secondary care

Diagnosis Start of treatment

Patient interval Doctor interval System interval

Diagnostic interval Treatment interval

Primary care interval Secondary care interval

5


Figure 1.3 Total delay and system delay for a Danish cohort of incident cancer patients (14)

It has been hypothesised that the longer the diagnostic and treatment intervals for cancer,

the more likely it is that the cancer will progress to advanced stages. For the same type and

degree of malignancy of a given cancer, a reduction of the time intervals until treatment

is anticipated to allow the cancer to be treated at earlier stages which will improve the

patient’s prognosis (25).

However, doubts have been raised about the benefits of expediting diagnosis because

diagnostic intervals measured in weeks or months might be negligible in light of the time it

takes for cancers to develop. Many studies even found counterintuitive results that showed

that patients with short diagnostic intervals had higher mortality than patients with long

intervals (referred to as the waiting time paradox) (26-28). However, a recent study showed

that the 3-year mortality risk for patients presenting with alarm symptoms decreased with

diagnostic intervals of up to five weeks and then increased. Thus, the counterintuitive

findings could be explained by the fact that the GPs are quickly expediting the ill patients,

but it remains indisputable that mortality rises the longer the diagnostic intervals (29).

Finally, it has been shown that tumour progression can happen within weeks, at least for

some cancers, indicating the negative impact of prolonged intervals (30).

The psychological distress on the patients caused by unwarranted waits is another important

issue that deserves attention. It is broadly accepted that prolonged diagnostic intervals

impose significant distress on patients and their relatives, even if this issue has only been

little studied. The risk of depression and even post-traumatic stress disorder after having

been treated for cancer is well-documented (31;32), whereas the psychological distress of

long diagnostic pathways is more commonly used as a pretext for shorter intervals when

effects on prognosis are doubtful (33). However, one study has reported that psychological

distress correlated positively with the actual length of total delay (34).

6


POLITICAL INITIATIVES

As a result of Danish cancer patients’ poor prognosis, political attention was drawn to

waiting lists in the Danish healthcare setting. As from the late 1990s, several initiatives

were taken in order to improve cancer survival. Initiatives relevant to the present thesis

will be reviewed below.

1.2.1 Waiting time guaranties

In 1999, the first waiting time guarantee specifically involving cancer was enacted by the

government. This guarantee was offered for lung, breast, gastrointestinal and cervical

cancers, and guaranties were specific for each of these cancers, typically two weeks to

the introductory examination after referral from the GP, two weeks from the patient

gave consent to treatment until treatment, and two weeks to further treatment after all

diagnostic investigations had been completed. The guarantee did not focus on the time

from the patient’s first encounter at the hospital until treatment (35).

By the end of 2000 and the beginning of 2001, criticism of the waiting times to treatment

of cancer reached new heights, leading to a new guarantee in 2001. This time all cancers

were included, except non-melanoma skin cancers and cancers in need of bone marrow

transplantation. The following maximum waiting times were guaranteed: two weeks

to introductory investigations after referral from primary care, two weeks from patient

consent to operation/medical treatment, four weeks to radiation therapy and finally, four

weeks to further treatment. The patients were guaranteed treatment in an out-of-county

hospital, private hospital or foreign hospital if the in-county hospitals could not live up to

the waiting time guarantees (36). Still, there was no focus on the length of the diagnostic

process at the hospital (the secondary care interval).

7


1.2.2 National cancer plans

The Danish government launched two comprehensive cancer plans in 2000 (37) and

2005 (38). The second cancer plan from 2005 focused on the secondary care interval and

recommended that the care pathway from the GP suspected cancer until diagnosis was

confirmed or rejected should be organised as standardised pathways. This recommendation

was based on experiences from a Danish hospital (Vejle) which had begun working with

urgent referrals already in the late 90s (38). However, the cancer plan did not take into

consideration the many cancers that do not present with alarm symptoms and therefore do

not benefit from urgent referral for suspected cancer.

1.2.3 Cancer as an acute condition

While problems of waiting times in the cancer care pathway did not improve significantly,

the risk of stage progression during the system interval were made evident (26;30). In 2007

the government and the five Danish regions (who own and run the hospitals) therefore

launched a new diagnostic strategy that classified cancer as an acute condition and allowed

only medically necessary waiting time in the care pathway. This initiative reinforced the

efforts to reorganise the cancer care pathway, but also eased access to pre-diagnostic

investigations, and a faster diagnostic process in hospitals was highlighted (39;40).

1.2.4 Urgent referral for suspected cancer

The implementation of the second national cancer plan and the classification of cancer as

an acute condition made the government introduce urgent referral for suspected cancer

nationally. In the fall of 2007, multidisciplinary working groups, chaired by the National

Board of Health, were established to describe the clinical pathway for each of the common

cancers (40). Urgent referrals were initiated for head and neck cancer, breast, colorectal and

lung cancer as from 1 April 2008. Gynaecological cancer followed 1 August 2008 and within

February 2010, urgent referral was implemented for 34 cancers (41). This was the first

initiative affording GPs with guidance while at the same time focusing on the diagnostic

process within the hospitals.

Urgent referral for suspected cancer is defined as a coherent care pathway based on clinical

guidelines.

8


Figure 1.4 The cancer care pathway following urgent referral for suspected cancer exemplified by breast cancer

Entr

ance

to

urge

nt re

ferr

al

Diag

nosti

c pr

oces

s

General practice

Reasonable suspicion

Clinical breast examination Mammography/ultrasound

Needle biopsy

Possibly chest x-ray

Consensus conference

Trea

tmen

t

Pre-examination

Operation/systemic treatment

Consensus conference

After

-trea

tmen

t Oncological pre-examination

Radiotherapy/chemotherapy/endocrinological treatment

Clos

ure

of

urge

nt re

ferr

al

Follow-up

Day 1

Day 4

Day 11

Referral received

15-20 days after ended treatment

Six months after ended treatment / after-treatment

Figure 1.4 depicts a simplified pathway for an urgently referred breast cancer patient. Whenever a

GP has reasonable suspicion of cancer, e.g. the patient presents with a certain set of symptoms, the

GP must use urgent referral. For each cancer, symptoms that must give rise to reasonable suspicion

are defined.

9


In the example of breast cancer, the GP must refer a patient if she has one or more of the

following symptoms:

• Suspicious, palpable tumour

• New papil retraction

• New skin retraction

• Papillary/areolar eczema /ulceration (obs Mb. Paget)

• Clinically suspicious axillary lymph nodes

• Suspicious changes found by mammography or examination at private radiologist

• Unknown primary tumour (axillary metastasis shown)

Apart from defined alarm symptoms of cancer, other factors may have to be present for

the GP to refer the patient urgently, e.g. the patient’s age (42). Once the GP has referred the

patient urgently, all diagnostic and treatment procedures are organised as temporally and

substantively well-defined processes where all relevant investigations and treatments are

pre-planned and pre-booked within a given number of days. The aim of the urgent referral

is to offer patients optimal diagnosis and treatment and thereby improve their prognosis

and quality of life and reduce the insecurity that accompanies unwarranted delays (43).

The rules of the waiting time guarantees apply to patients in whom there is no reasonable

suspicion of a definite cancer. However, diagnostic centres are now being set up in Denmark

to ensure timely treatment of the patients with unspecific cancer symptoms; yet, a further

discussion of this issue falls outside the scope of the present thesis.

Extant literature often uses urgent referral for suspected cancer and fast track diagnosis as

interchangeable terms. In the present thesis, the term urgent referral for suspected cancer

is used because emphasis is on the GP’s reaction, whereas fast track diagnosis relates more

closely to the diagnostic process after the GP has indicated suspected cancer.

10


THEORETICAL PERSPECTIVES

1.3.1 Health services research

“Health services research is the multidisciplinary field of scientific investigation that

studies how social factors, financing systems, organisational structures and processes,

health technologies, and personal behaviours affect access to health care, the quality and

cost of health care, and ultimately our health and well-being.”(44)

In general terms, health services research is the science of how to deliver health care.

Where clinical research focuses on the patient’s treatment, the focus in health services

research is on the organisation of care and how changes in the organisation of care impact

medical outcome, staff, costs or patient satisfaction (45). In contrast to laboratory-based

research, health services research often cannot be fully controlled by the researcher. Many

interventions are therefore based on events outside the researchers control, for instance

politically decided reforms, or on complex experimental interventions. Because changes

inevitably occur over time, the terms of the research can also be changed. At the same

time, there is often only one opportunity to observe what happened, since time cannot be

repeated as is the case in experiments (46).

This thesis is based on health services research and it explores how the organisation of

healthcare has an impact on selected outcome measures.

11


1.3.2 Healthcare reforms

Changes in the organisation of a healthcare system are often part of a continuing process

that involves minor adjustments and renewals. In contrast, healthcare reforms are structural

changes instituted by a government to achieve explicit political goals. The World Health

Organisation has defined healthcare reforms as follows:

“Health care reforms are a maintained process of fundamental change of political and

institutional factors listed by the government, designed to improve the health care function

and performance and ultimately improve health status of the population.” (47)

However, the outcome does not always have to be directly related to the aim of improving

health status. The outcome is often related to wishes of privatisation, freedom of choice or

reduced costs. In reality, the reform concept is used also when minor changes are being

introduced, and a series of minor changes can have the same fundamental effect as a

reform. It can be difficult to separate a continuing process of minor changes from an actual

reform (48). Thus, it seems fair to consider the mentioned introduction of urgent referral

for suspected cancer (Section 1.2.4) as a reform.

1.3.3 Quality of health care

Numerous definitions of quality of health care exist, and several of these definitions are

both possible and legitimate depending on the adopted research perspective. For example,

clinicians, patients, managers and authorities all have different perspectives. A single,

comprehensive definition of quality of health care will therefore hardly ever be feasible,

and no single criterion by which to measure quality of health care can be established (49;50).

Figure 1.5 shows the author’s depiction of different dimensions and criteria of quality

of health care. The figure is based on literature where Donabedian operationalised three

dimensions of quality of health care: outcome, process and structure (51). Outcome denotes

improvements in the health status of individuals and populations. Structure denotes the

attributes of the setting in which care occurs and, finally, process denotes what is actually

done in giving and receiving care.

12


Figure 1.5 Elements of quality of health care

Outcome

Quality of health care Process

Waiting time

Continuity

Health status

Coordination

Organisation

Informational continuity

Cross-sectional consistency

Structure

Management continuity

Relational continuity Interpersonal relations

Consistent core of staff

Written information

Undocumented information

Adequacy of equipment

Qualification of staff

Administration

As shown, one of the main elements of process quality is continuity. According to Haggerty

(52), informational continuity is the use of information on past events and personal

circumstances to assure current care. Relational continuity denotes the ongoing therapeutic

relationship between a patient and one or more health care providers. Management

continuity denotes a consistent and coherent approach to the management of a health

condition that is responsive to patients’ changing needs. This is especially important in

complex diseases, as for example cancer, which requires management involvement from

several providers across sectors. Experienced continuity is the patient’s experience of a

coordinated care pathway with smooth progression. This is achieved through the other

types of continuity (53).

Central to this thesis is management continuity which is achieved when care is delivered in

a complementary and timely manner that affords future care with a sense of predictability

and security (52). As mentioned in Section 1.2.4, these were some of the main reasons for

introducing urgent referral for suspected cancer in Denmark (39).

13


1.3.4 Assessing quality improvement

The outcome of any health care quality assessment is tied closely to the choice of dimensions

and elements of care to be evaluated. Likewise, the outcome of the assessment will also be

shaped by perspective adopted by those who assess the quality (51).

Next to outcomes such as mortality, morbidity, quality of life, and health care costs, patient

evaluations of care are increasingly seen by practitioners, administrators and policy makers

as a valuable outcome in itself (54;55). Patients have important insights about care provision

that care providers do not have or cannot assume. However, patient evaluation has proven

to be a multidimensional construct causing single global scores to possibly cover-up

divergent assessments of quality of care. Further, single global scores may not cover all

relevant aspects, or they may not allow comparison between different settings (56). Finally,

patient evaluations have been criticized for being subjective, and what satisfies one patient

may dissatisfy another. Still, it has been shown that patient evaluations of actually received

health care can be distinguished from their evaluation of their own health and from their

experiences with health or health care in general (57). Further, measures of patients’

perceptions have been shown to be as robust in terms of reliability and reproducibility as

physiological and other more specific medical outcomes (58).

Conceptualisation of patient satisfaction has typically been based on economic theory,

expectation theory, evaluations of health service attributes or a holistic approach attempting

to incorporate all influences and thereby to provide a comprehensive framework (59). The

evaluation of the health services attributes is often divided into structure, process and

outcome (see Figure 1.5). Finally, patient evaluations may reflect discrepancies between

the experienced utility and the expected utility (60;61).

Urgent referral for suspected cancer was introduced among others to give patients a sense

of coherence in the cancer care pathway; and the degree to which this purpose was reached

may be assessed from patient evaluations.

The health professionals’ evaluations of the patients’ care pathways is another issue that

should be raised. The GPs are required to keep detailed medical records of their patients and

they receive discharge letters for each hospital contact to make sure that they are informed

about their patients’ medical histories. The GP is therefore the only health professional

with knowledge of the entire cancer care pathway, even if he or she is not always directly

involved. Thus, the GP is an obvious source from which an overall, professional evaluation

of quality improvements in the entire cancer care pathway may be obtained. However, GP

evaluations are likely to be as multidimensional and subjective as the patient (62).

14


AIM

The overall aim of this thesis was to analyse how the introduction of urgent referral for

suspected cancer influenced 1) the performance of the healthcare system measured by

the length of the secondary care interval from first referral to secondary health care until

treatment, 2) patient evaluations of coherence in the cancer care pathways, and 3) GP

evaluations of coherence in the cancer care pathway.

The more detailed aims of the present thesis were the following:

1. To develop and validate a register-based algorithm for on-time sampling of incident

cancer patients as a target group for health services research in the clinical pathway

and to describe the completeness of a cohort of incident cancer patients using this

algorithm (Article I).

2. To analyse the changes in the secondary care interval over time, including changes

before and after the introduction of urgent referrals. Special emphasis was given

to specific types of cancer and patients treated at one specific hospital, Vejle, which

introduced urgent referrals years before they were introduced nationally (Article

II).

3. To analyse how patients evaluated the cancer care pathway during the introduction

of urgent referral for suspected cancer. Further to analyse possible association

between their evaluations and the secondary care interval and between patient

evaluations and discharging hospital, since Vejle Hospital had introduced urgent

referral years before the national introduction (Article III).

4. To analyse how GPs evaluated the cancer care pathway during the introduction

of urgent referral for suspected cancer. Further, to analyse possible associations

between GP evaluations and the secondary care interval and between GPs

evaluations and discharging hospitals, since Vejle Hospital had introduced urgent

referral years before the national introduction (Article IV).

15

Chapter 2 Material and methods

chaPter 2materIal and methods

16


STUDY DESIGN

The study was designed as a population-based observational study and it was conducted

among incident cancer patients in the Central Denmark Region and the Region of Southern

Denmark. Furthermore, the study was conducted as a comparative study of the time before

and after the national introduction of urgent referral for suspected cancer. Patients were

sampled based on administrative data, and questionnaires were sent to their GPs within

a month after their inclusion. Six months later, a questionnaire was sent to the patient.

Survey data were combined with register data.

2.1.1 Setting

The Central Denmark Region and the Region of Southern Denmark are two of five

Danish regions. The two regions have approx. 2.4 million inhabitants (44% of the Danish

population) (63) and approx. 14,000 new cancer cases pr. year (2).

Figure 2.1 Map of Denmark showing the Central Denmark Region and the Region of Southern Denmark (including Vejle)

Vejle Hospital is situated in the Region of Southern Denmark and its oncological ward is one of six Danish cancer centres. The oncological ward performs 38,000 outpatient consultations per year and in-patients consume 7,500 bed days per year (64).

Region of Southern Denmark

Vejle

Central Denmark Region

17


DATA FROM REGISTERS

As mentioned above, the study was based on data from Danish registries. The included

registries are described below.

2.2.1 The Danish Civil Registration System

Since 1968, all persons living in Denmark have been registered in the Danish Civil

Registration System. All Danish citizens are assigned a unique civil registration number

(CRN) identifying each individual throughout the public administration. The CRN

contains information on date of birth and gender, and if a person does not hold permanent

citizenship, this can be read directly from the CRN.

Apart from the CRN, the Civil Registration System holds individual information on name,

address, marital status (including spouse), kinship (parents/children) and profession and

it operates with a livelong updating process where old data are not deleted. The patients’

unique CRNs can be used to link individuals across all Danish registries (65).

2.2.2 The Patient Administrative Systems

All hospital contacts are registered in the Patient Administrative Systems (PASs). Its purpose

is to collect administrative information on hospital activities. PAS comprises variables like

the patient’s CRN, dates of admission and discharge, diagnoses classified according to

the International Classification of Diseases (ICD-10), codes for undertaken procedures,

the GP’s provider number and different additional codes. Of particular relevance for this

study, PAS comprises the additional code AZCA1. Certain diseases require a more detailed

reporting, e.g. cancer. The AZCA1 code is required by law whenever a hospital ward is

reporting a cancer diagnosis for the first time (66). PAS are regional systems providing data

for the Danish National Patient Registry (NPR). All hospitals are committed to report to the

NPR for the previous month by the 10th of each month (67). Patient registration is made in

accordance with a national guideline which ensures that PAS is used in the same manner

in all regions (66).

18


2.2.3 The Danish National Patient Registry

The NPR is a national database unifying information from the five regional PASs. When

data are entered into the NPR, not all information is transferred, e.g. the GP provider

number. PAS is regional, whereas the NPR is run by the National Board of Health who

carries out ongoing validation of the data from PAS. Thus, both PAS and the NPR are

continuously updated. Since 2000, the NPR has served as the basis for the payment of

public as well as private hospitals. Additionally, the NPR is used for medical research,

mainly epidemiological studies, quality improvement studies and for identifying patients

for various studies, even if this was not the main purpose of the NPR (67;68).

2.2.4 The Danish Cancer Registry

The Danish Cancer Registry (DCR) is a national research register designed to collect and

process data of incident cancer patients. The DCR was founded in 1942 and was run by the

Danish Cancer Society until 1996, when the Danish National Board of Health took over.

The DCR contains information on date of diagnosis, tumour topography, morphology and

tumour spreading, among others. Reporting to the DCR became mandatory in 1987. The

DCR went through a modernisation from 2004-2008 in order to ensure future data quality.

For several years, this caused considerable delay in data entry, and even today it is possible

to extract data from the DCR only for the previous calendar year due to comprehensive

quality control and validation (67;69;70).

2.2.5 The Danish National Health Service Registry

The Danish National Health Service Registry for Primary Care is a national register of

all health professionals contracted with the tax-funded healthcare system, e.g. GPs. The

register is run by the National Board of Health and based on the health professionals’

invoices to the regional health administrations. Among others, the Health Service Registry

holds information on name and addresses of every provider number. A provider number

may refer to several providers if, for example, several GPs form a medical practice

partnership (67;69-71).

19


DATA FROM QUESTIONNAIRES

Questionnaires to the GPs and the patients were developed in the period from February to

September 2007. Existing scales were used whenever possible; otherwise ad hoc questions

were constructed.

2.3.1 The GP questionnaire

The three main purposes served by the GP questionnaire were: 1) to validate the information

obtained from the registries, 2) to obtain information on important dates in the cancer care

pathway enabling us to calculate the secondary care interval for each patient, and 3) to get

a professional evaluation of the cancer care pathway.

First, the GP was asked to confirm the diagnosis and to describe his or her role in

diagnosing the cancer. Second, the questionnaire requested information on dates of first

symptom related to the cancer, first contact with the GP, initiation of diagnostic procedures

by the GP, first referral to secondary health care, first visit to secondary health care and the

dates of diagnosis and initiated treatment. The decision to ask these particular questions

was taken on the basis of prior, substantial experience in obtaining similar data from GPs

(72). Third, the questionnaire contained ad hoc questions on the GP’s satisfaction with

the care pathway (Appendix B). Ad hoc questions were informed by the discussion of

the theoretical perspectives on quality of health care offered in Chapter 1. Questions were

designed with a dual purpose: first to explore aspects of process quality as depicted in

Figure 1.5 and; second, to outline the problems in diagnosing cancer in Denmark caused

by the prevailing waiting lists. Special attention was drawn to factors related to the aims

of urgent referral for suspected cancer in general and to waits and lack of coherence in the

cancer care pathway in particular.

20


2.3.2 The patient questionnaire

The patient questionnaire focused on milestones in the cancer care pathway, its coherence

in the cancer care pathway, the patient’s self-perceived health status and quality of life

(QoL), the patient evaluation of the GP and the patient’s social network and socioeconomic

status.

Questions concerning dates in the cancer care pathway were limited to questions about

date of first cancer-related symptom, date of first presentation in primary care and date of

treatment start. A literature search identified no validated questionnaires covering patient

evaluation of the coherence in the cancer care pathway from their first contact with the

healthcare system to diagnosis and treatment. Ad hoc questions were therefore formulated

based on the literature and previously used questions within the research area (73-75). As

was the case with the GP questionnaire, these questions were designed to shed light on

aspects of process quality to reveal if the aims of the urgent referrals were met.

A patient’s self-perceived health status and QoL was measured using the European

Organisation for Research and Treatment of cancer (EORTC) Quality of Life Questionnaire

(QLQ C-30), which is a validated 30-item questionnaire (76).

The patient evaluation of the GP was measured using the standardised questionnaire

called Danish Patients Evaluate Practice (DanPEP), which is the Danish version of the

international European Patients Evaluate Practice (EUROPEP) questionnaire. Both are

standardised and validated instruments for measuring patient evaluation of general

practice (77-79). Questions on the patient’s socioeconomic position and social network

were adapted from questions used in national surveys on patient-experienced quality of

health care (80;81) (Appendix C).

2.3.3 Pilot testing

Because the GP questionnaire was adapted from a questionnaire that had already been

pilot-tested and successfully used for data collection (14), only a small pilot test of this

questionnaire was performed to ensure the data quality of the data in the areas where

the slight adjustments had been made. Thus, to secure reliability of the questionnaire, a

small number of medical doctors with research experience were first asked to fill out the

questionnaire on an incident cancer patient in their practice. Second, the questionnaire

was mailed to GPs with practical experience, but little or no research experience. A total

of 24 questionnaires were completed and analysis of these questionnaires gave rise to only

minor revisions.

In the spring of 2007, a qualitative pilot test of the patient questionnaire was performed by

21


MBL at the oncological ward at Vejle Hospital. During two days, patients were observed

while they were completing the questionnaire and they were interviewed afterwards. The

qualitative pilot test showed that patients evaluated the entire care pathway and rarely

regarded the diagnostic interval and the treatment intervals as separate intervals. Thus, the

first version of the questionnaire made a distinction that was not intuitive to the patients.

The questionnaire was changed accordingly, asking the patients to evaluate the entire

cancer care pathway as one. In the summer of 2007, a revised questionnaire was sent to

350 patients sampled by the algorithm used in the study, but in a month prior to the start

of the inclusion period of the study. Subsequent revisions primarily consisted of changes

in the phrasing of questions to avoid a ceiling effect. Phrases like I felt or In my experience

were added to underpin that the patients were asked to state their own experiences. All

patients in the quantitative pilot test were asked to participate in telephone interviews after

completing the questionnaire, and 80 telephone interviews were performed by a trained

researcher (RSA). The main purpose of the interviews was to quantify the patient interval.

In the questionnaire, patients were asked to assess the patient interval, and the response

categories were increased based on the interviews (Appendix C, question 1.4).

2.3.4 Data collection

Patients were sampled according to the procedure depicted in Figure 2.2. Immediately

following the sampling, questionnaires were sent to each patient’s general practise. In

practises with more than one GP, we requested the questionnaire to be completed by

the GP most familiar with the patient. Non-responders received a reminder after three

weeks. GPs received a minor financial reimbursement for each questionnaire completed

(approx. 16€). Patients were excluded if the GP had no knowledge of a cancer diagnosis.

If the GP contacted us with other reasons for excluding the patient, e.g. dementia, severity

of disease, langue skills or others, we followed their advice. If the GP did not exclude the

patient, (s)he received a questionnaire six months later if the patient was still alive. Also

non-responding patients received a reminder after three weeks if still alive. The patients

received no compensation for completing the questionnaire. Each questionnaire was

assigned a unique ID number enabling us to merge data from GPs, patients and registries

into one data file compiling all information on each patient.

2.3.5 Data entry

Both GP and patient questionnaires were coded by MBL and a trained assistant according

to a coding manual predefined by MBL. Thus, all questionnaires were checked to ensure

high quality of the answering marks. The GP questionnaire was designed and processed

using the computer programme Teleform Enterprise Version 8 (Cardiff software inc., San

22


Marcos, CA, USA) for data capture by optical scanning. The assistant performed the optical

scanning process and verified the scanning results for all the questionnaires. The high

accuracy of this processing has been documented (82). The patient questionnaires were

processed by a trained assistant using the computer program ABBYY FormReader 6.5. at

the Centre for Quality Development (CQD), Central Denmark Region. The project manager

at the CQD compiled a manual for scanning, verifying and validating data. Data from both

GPs and patients were transferred to the statistical program Stata (Stata software, version

11.2, StataCorp, College Station, Tex, USA) and further checked for errors. If errors were

encountered, the original questionnaire was inspected and the database entry corrected

according to standards predefined by MBL.

23


SAMPLING PROCEDURE

Incident cancer patients were included during a one-year period from 1 October 2007.

Incident cancer patients were defined by the following four characteristics: 1) cancer as

primary diagnosis, 2) no prior history of cancer, 3) only one cancer diagnosis present, and

4) the cancer was diagnosed within six months of inclusion (see Appendix A for a list of

included cancer diagnosis).

Figure 2.2 depicts the overall sampling procedure. A sampling algorithm to identify

incident cancer patients from PAS in the Central Denmark Region and the Region of

Southern Denmark was developed based on expert meetings with persons holding

administrative responsibility for registering cancer patients in the two regions, persons

in charge of handling output from registers and people with much research experience.

Patients were sampled from PAS based on discharge date, primary discharge diagnosis

and the additional code AZCA1, which specified that the cancer was reported for the first

time by the ward. Patients were sampled on the 15th of each month and data on all patients

registered during the preceding month were collected. The monthly sampling continued

for a 1-year period from 1 October 2007 to 30 September 2008. Patients with prior cancer

were excluded on the basis of a list of cancer cases from January 1994 to October 2007

extracted from the NPR. This list was updated monthly by adding the sampled patients.

GP addresses were identified using the Health Services Registry. Patients’ addresses

were found in the Civil Registration System. The patient’s unique CRN was used to link

individual data across all Danish registries.

24


Figure 2.2 Overall sampling procedure

Patient not at the NPR list of historical cancer cases

Incident cancer patients identified

Health Service Registry

GP address identified

GP questionnaire

GP confirmed diagnosis Patient questionnaire

Patient registered with cancer in PAS

Civil Registration System

Patient address identified

After the sampling period it became clear that the initial sampling algorithm had been

incomplete since fewer patients than expected had been included. Two main reasons for

this were identified: First, some patients were registered later than one month after their

diagnosis and were therefore missed because the algorithm only sampled one month back.

Second, the AZCA1 code was not used consistently for all incident cancer patients even

though its use is mandatory. Thus, eligible patients lacking the AZCA1 code were not

included. To ensure that all incident cancer patients were included, an additional sampling

was done in October 2009. Thus, the total sample consists of Samples 1 and 2. Patient

characteristics and non-response in the two samples are shown in Section 3.1.

25


DATA ANALYSIS

All data analyses were restricted to patients with a diagnostic pathway initiated in primary

care, since the pathway of interest was that where the GP refers the patient to further

diagnostic work-up in secondary care, which is the main route for cancer diagnosis in

Denmark (14).

2.5.1 Outcome measures

Based on register data, patients were categorised as diagnosed before or after introduction

of urgent referrals if they were admitted to hospital before or after 1 April 2008, respectively.

At this point, urgent referrals were implemented nationally for head and neck cancers,

breast, lung and colorectal cancers. Local differences in the rate at which urgent referrals

was introduced are not accounted for.

Using register data, we grouped patients according to discharging hospital with patients

from Vejle Hospital in one group and patients from other hospitals in another group.

Based on information from GP questionnaires, patients were further divided into groups

according to whether the GP interpreted their initial symptoms as alarm symptoms of

cancer. The GPs were not given a list of cancer-specific alarm symptoms, but were merely

asked if the patient presented with alarm symptoms (Appendix B, question 1.10). Their

answers therefore reflect their individual interpretation of the patients’ symptoms.

Patients were divided into two groups according to whether the GP gave clear indication of

cancer suspicion in the first referral to secondary healthcare or not (Appendix B, question

3.6). GPs were not asked whether they referred the patient urgently because at the time the

study was initiated, this was only an option in Vejle.

The patient evaluation of coherence in the cancer care pathway was measured on five

items (Appendix C, questions 1.35, 1.46, 1.47, 1.49 and 1.55). Answers were given on a five-

point Likert scale (strongly agree, agree, disagree, strongly disagree, and do not know/not

relevant separated into two categories). Answers were dichotomised into optimal evaluation

(strongly agree) or non-optimal evaluations (agree, disagree or strongly disagree). The GP

evaluation of the cancer care pathway was evaluated on five items (Appendix B, questions

4.10-4.14). Again, answers were dichotomised into optimal (strongly agree) or non-optimal

evaluation (agree, disagree or strongly disagree).

The secondary care interval was calculated based on information from the GP questionnaire.

According to the definition of the secondary care interval, it was calculated from the date

of the first referral to secondary healthcare (Appendix B, question 2.4,) and the date of

26


treatment start (Appendix B, question 2.7). Thus, the secondary care interval gave the

number of days from the first referral to secondary health care until treatment started as

reported by the GP. Patients were included into the study based on a hospital contacts

registered in PAS. If the GP did not report a date of treatment start, the date of admission

to this hospital contact was used to calculate the secondary care interval. In these cases,

the secondary care interval spanned the number of days from the GP-reported date of the

first referral until the PAS date of hospital admission. If the GP did not report a date of first

referral to secondary health care, the secondary care interval could not be calculated. The

effects of the imputation are shown in Section 3.1.3.

2.5.2 Statistical analyses

The secondary care interval was presented as medians with inter-quartile intervals (IQI)

because data were not normally distributed. Using the mean would allow for extremes to

affect the results to such an extent that the results would not be accurate.

Trends in monthly differences were tested by non-parametric trend tests across ordered

groups. Differences between groups were tested by Wilcoxon rank-sum test. Finally,

associations between optimal evaluations and the introduction of urgent referrals and

the association between optimal evaluation and discharging hospital were tested using a

generalized linear model with the log link for the binomial family. Clustering of patients

within each general practice was taken into account by using robust variance estimates.

Associations were measured as prevalence rate ratios (PRRs) since the odds ratios would

have overestimated the prevalence ratio due to the high proportion of optimal evaluations

(83). Three models were used: 1) unadjusted, 2) adjusted for patient age, gender, cancer

type and initial symptom presentation, and 3) adjusted as in Model 2 plus for secondary

care interval.

Throughout the thesis, estimates were given with 95% confidence intervals (95%CI) when

relevant. Analyses were made using Stata 11.2.

27


APPROVALS

According to the Scientific Ethics Committee for the Central Denmark Region, the

Biomedical Research Ethics Committee System Act does not apply to this project.

The study was approved by the Danish Data Protection Agency (J.no. 2007-41-0559) and

the National Board of Health (j.no. 7-604-04-2/22/EHE).

Furthermore, it was approved by the Multi-Practice Committee of the Danish Society of

General Practitioners and the Organisation of General Practitioners in Denmark (J.no.

MPU 23-2007).

2.6.1 Ethical considerations

Even though the Danish Scientific Ethics Committees do not assess survey studies, several

ethical considerations were made before this survey was conducted. How to approach

the patients in the accompanying letters was carefully considered as were the wording

of the questions in the questionnaire. Cancer is a serious condition, and we knew that

there was a small risk of registration errors in the registries. To reduce the risk of sending

a questionnaire to a patient who did not have cancer, we asked the GPs to verify the

diagnosis before contacting the patients. Furthermore, the wording of the accompanying

letter underpinned that there might be errors and if patients had any doubts, they should

contact their GP. The research group had previously ascertained the expediency of this

approach which was therefore adopted in the present study.

The timing of the questionnaire to the patients was also considered. With every consideration

there were pros and cons and the final decision of sending it six months after diagnosis was

a pragmatic counterbalance of anticipated consequences for the patient.

28


29

Chapter 3 Results

chaPter 3results

30


EXCLUSION & NON-RESPONSE

The inclusion criteria and sampling algorithm were described in Section 2.4. This section

describes exclusion and non-response.

3.1.1 GP questionnaire

A total of 12,669 patients were included into the study. GP questionnaires were completed

for 10,262 (81.0%) patients. The GPs validated the register-based inclusion criteria, and

on this basis 1,719 patients were excluded. Thus, 10,950 patients were included for data

analyses and GP questionnaires were completed for 8,543 (78.0%) patients. Figure 3.1

depicts the detailed flow chart for each of the two samples and the total sample.

Figure 3.1 Flow chart of exclusion and non-response for GP questionnaires

As shown in Table 3.1, there were differences between patients with a responding GP and

patients with a non-responding GP as well as between patients included in Sample 1 and

those included in Sample 2. The most important differences are that patients with a non-

responding GP were more likely to be older males. Patients included in Sample 2 were also

more likely to be older males and more likely to be discharged from other hospitals than

Vejle.

31

Chapter 3 Results

Table 3.1 Differences between patients with responding and non-responding GPs in the total sample and patients included in Sample 1 and Sample 2

3.1.2 Patient questionnaire

The patient survey included the 7,908 patients from Sample 1. Before questionnaires

were sent, the GP excluded 930 patients (see Figure 3.1) and advised against sending

questionnaires to eight patients which was respected. Finally, 906 patients died before

the patient survey. Thus, questionnaires were sent to 6,064 patients and returned by 3,861

(63.7%). Of those, 163 were excluded because they stated that their cancer was not incident.

The final number of patients included for analyses was therefore 5,901 of whom 3,698

(62.7%) had completed the questionnaire (Figure 3.2).

Patients whose GP were Patients included in

responding non-responding p-value*

Sample 1 Sample 2 p-value*

All n (%) 10,262 (81.0) 2,407 (19.0) 7,908 (62.4) 4,761 (37.6) Sex

Male 5,070 (49.4) 1,295 (53.8) <0.001

3,810 (48.2) 2,555 (53.7) <0.001 Female 5,192 (50.6) 1,112 (46.2) 4,098 (51.2) 2,206 (46.3)

Age 18-49 1,163 (11.3) 229 (9.5) <0.001 949 (12.0) 443 (9.3) <0.001

50-69 4,670 (45.5) 1,041 (43.3) 3,842 (48.6) 1,869 (39.3) 70+ 4,429 (43.2) 1,137 (47.2) 3,117 (39.4) 2,449 (51.4)

Cancer diagnosis Breast 1,653 (16.1) 308 (12.8) <0.001 1,496 (18.9) 465 (9.8) <0.001

Lung 1,225 (11.9) 259 (10.8) 0.106 893 (11.3) 591 (12.4) 0.057 Colorectal 1,296 (12.6) 296 (12.3) 0.659 1,048 (13.3) 544 (11.4) 0.003

Prostate 1,316 (12.8) 379 (15.8) <0.001 1,011 (12.8) 684 (14.4) 0.011 Melanoma 480 (4.7) 129 (5.4) 0.159 406 (5.1) 203 (4.3) 0.027

Other 4,292 (41.8) 1,036 (43.0) 0.276 3,054 (38.6) 2,274 (47.8) <0.001 Discharging hospital

Vejle 1,209 (11.8) 249 (10.3) <0.001 1,315 (16.6) 143 (3.0) <0.001 Other 9,053 (88.2) 2,158 (89.7) 6,593 (83.4) 4,618 (97.0)

*Differences between groups were tested by Pearson's chi-squared test

32


Figure 3.2 Flow chart of exclusion and non-response for patient questionnaires

*Patients whose GPs were non-responding received questionnaires without GP confirmation of diagnosis

A total of 906 patients died before the questionnaires were sent to the patients. They

were more likely to be older, males and diagnosed with lung cancer than those who were

still alive when the questionnaires were sent. Out of the 6,064 patients who received a

questionnaire, 3,861 (63.7%) completed it. Non-responding patients were more likely to be

older and males than responding patients (Table 3.2).

33

Chapter 3 Results

Table 3.2 Differences between patients who died before questionnaires were sent and those who were alive and responding vs. non-responding patients

3.1.3 Secondary care interval

A total of 1,326 (15.5%) of the 8,543 GP responses were excluded because the patient

pathway bypassed primary care. Furthermore, 665 (9.2%) were excluded because there

was no GP-reported date of first referral to secondary health care. Thus, the secondary

care interval could be calculated for 6,552 patients for whom there were complete GP-

reported intervals for 5,193 (79.3%) and dates of treatment were missing for 1,359 (20.7%).

Table 3.3 depicts the differences between patients with complete information and patients

with missing treatment date. The latter were more likely to older, males and diagnosed

with prostate cancer. Finally, they were less likely to be discharged from Vejle Hospital. It

should be noted that there were no differences in the proportion of missing treatment dates

before and after the introduction of urgent referrals for suspected cancer (Table 3.3)

Patient dead before questionnaire Patient completed the questionnaire Yes No p-value* Yes No p-value*

All n (%) 906 (13.0) 6,064 (87.0) 3,861 (63.7) 2,203 (36.3) Sex

Male 515 (56.8) 2,788 (46.0) <0.001

1,735 (44.9) 1,053 (47.8) 0.032 Female 391 (43.2) 3,276 (54.0) 2,126 (55.1) 1,150 (52.2)

Age 18-49 35 (3.9) 827 (13.6) <0.001 496 (12.9) 331 (15.0) <0.001

50-69 316 (34.9) 3,158 (52.1) 2,126 (55.1) 1,032 (46.9) 70+ 555 (61.3) 2,079 (34.3) 1,239 (32.1) 840 (38.1)

Cancer diagnosis Breast 15 (1.7) 1,353 (22.3) <0.001 954 (24.7) 399 (18.1) <0.001

Lung 264 (29.1) 576 (9.5) <0.001 334 (8.7) 242 (11.0) 0.003 Colorectal 85 (9.4) 874 (14.4) <0.001 560 (14.5) 314 (14.3) 0.789

Prostate 36 (4.0) 748 (12.3) <0.001 520 (13.5) 228 (10.4) <0.001 Melanoma 7 (0.8) 372 (6.1) <0.001 239 (6.2) 133 (6.0) 0.027

Other 499 (55.1) 2,141 (35.3) <0.001 1,254 (32.5) 887 (40.3) <0.001 Urgent referral

Before 481 (53.1) 3,279 (54.1) 0.580 2,137 (55.3) 1,623 (52.2) 0.010 After 425 (46.9) 2,785 (45.9) 1,725 (44.7) 1,485 (47.8)

Discharging hospital Vejle 130 (14.4) 1,016 (16.8) 0.068 664 (17.2) 352 (16.0) 0.221

Other 776 (85.7) 5,048 (83.3) 3,197 (82.8) 1,851 (84.0) *Differences between groups were tested by Pearson's chi-squared test

34


Table 3.3 Differences in patients with missing vs. complete GP-reported treatment date

Table 3.4 depicts differences in the median secondary care interval with the complete case

results given in italics below the imputed result. Overall, the median delay is underestimated

by the imputation. We observed no difference in the median secondary interval for 19.0%

of the patients and for 44.3% there is no difference within plus/minus one week. In 15.8%

of the patients, the interval is overestimated by more than seven days, and in 40.2% the

interval is underestimated by more than one week when imputating the admission date

instead of the treatment date (data not shown).

GP reported date of treatment

Missing Complete p-value*

All n (%) 1,359 (20.7) 5,193 (79.3) Sex

Male 813 (59.8) 2,391 (46.0) <0.001 Female 546 (40.2) 2,802 (54.0)

Age 18-49 101 (7.4) 716 (13.8) <0.001

50-69 567 (41.7) 2,500 (48.1) 70+ 691 (50.9) 1,977 (38.1)

Cancer diagnosis Breast 39 (2.9) 996 (19.2) <0.001

Lung 619 (11.9) 211 (15.5) <0.001 Colorectal 120 (8.8) 821 (15.8) <0.001

Prostate 236 (17.4) 531 (10.2) <0.001 Melanoma 71 (5.2) 313 (6.0) 0.262

Other 682 (50.2) 1,913 (36.8) <0.001 Urgent referral

Before 728 (53.6) 2,808 (54.1) 0.740 After 631 (46.4) 2,385 (45.9)

Discharging hospital Vejle 119 (8.8) 658 (12.7) <0.001

Other 1,240 (91.2) 4,535 (87.3) Alarm symptoms

Yes 763 (57.6) 3,324 (64.9) <0.001 No 561 (42.4) 1,797 (35.1)

Cancer suspicion Yes 712 (60.4) 2,899 (64.9) <0.001 No 467 (39.6) 1,571 (35.2)

35

Chapter 3 Results

Table 3.4 Differences in the median secondary care interval with imputed results and complete case results in italics below the imputed result

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36


37

Article I

ARTICLE I

Identifying incident cancer patients using administrative register data

Submitted for publication in Danish Medical Journal

1,2,3 Mette Bach Larsen, Research Fellow, MScPH

1,2,3Henry Jensen, Research Fellow, MHSc

1,3Rikke Pilegaard Hansen, MD, PhD

1,3Frede Olesen, Professor, DrMedSci

1,3Peter Vedsted, Professor, MD, PhD

1: The Research Unit for General Practice, Aarhus University, Bartholins Allé 2, DK-8000

Aarhus C, Denmark.

2: Section for General Practice, School of Public Health, Aarhus University, Bartholins Allé

2, DK-8000 Aarhus C, Denmark.

3: Centre for Cancer Diagnosis in Primary Care – CaP, Aarhus University, Bartholins Allé

2, DK-8000 Aarhus C, Denmark.

Correspondence

Mette Bach Larsen

The Research Unit for General Practice

Aarhus University

Bartholins Allé 2

DK-8000 Aarhus C Units in abstract: 1,587

Tel: +45 8716 7915 Units in main text: 14,000

E-mail: [email protected] Number of tables/figures: 4

mailto:[email protected]

38


Abstract

Introduction: In cancer research and quality assurance, on-time identification of incident cancer patients is often needed. Most cancer registries are typically not updated on a monthly or quarterly basis and no tested standardised algorithm exists to enable sampling from administrative data. The aim of this study was therefore to develop and validate a register-based algorithm for on-time sampling of incident cancer patients from administrative data.

Material and methods: The study was based on registry data and questionnaire data from incident cancer patients’ general practitioners (GPs) (2008 cohort; 12,669 patients, 2010 cohort: 7,996 patients). Two algorithms for on-time sampling of incident cancer patients were developed and tested using the GPs as the golden standard. For the 2008 cohort, the Danish Cancer Registry (DCR) was used as a golden standard, too. The completeness of the 2010 cohort over time was evaluated.

Results: The algorithms of the 2008 cohort and the 2010 cohort provided positive predictive values (PPVs) of 83.2% and 92.4%, respectively. Further, the 2010 algorithm displayed a completeness of 60% in the first month and a completeness of 95% after four months. The PPV of a patient from the 2008 cohort being registered in the DCR with cancer was 98.6%.

Conclusion: A valid and cost-saving algorithm for on-time sampling of incident cancer patients has been developed with great potential for research and quality assurance.

Funding: This work was funded by the Danish Cancer Society and the Novo Nordisk Foundation.

Trial registration: Not relevant.

39

Article I

IntroductionIn Denmark, cancer is a major health care burden with a life-time risk of 33%, approx. 35,500 new cases per year, 15,500 deaths per year and a prevalence of 224,000 by the end of 2009 (1;2).Many resources are consequently allocated to research and quality improvement of the cancer care pathway from early symptoms, diagnosis and treatment through rehabilitation and palliation. For many of these purposes, it is important to be able to collect data at the time of diagnosis or rapidly hereafter, e.g. if data from patients and health care professionals are needed facilitate the diagnostic pathway or to ensure timely and correct inclusion into scientific studies. Further, there is often a need for interventions at onset of the cancer pathway. Gathering such data and information has so far been too often been a laborious, ad hoc activity.

In Denmark, each citizen can be identified by a unique civil registration number, and a number of registries are collecting data on cancer patients from hospitals (private<5%), all using the civil registration number to identify each patient. For example, Denmark hosts the world’s oldest cancer registry, the Danish Cancer Registry (DCR), holding validated information on all incident cancer patients, but it is currently not possible to extract on-time data from the DCR. We therefore need to base on-time identification of incident cancer patients on administrative registries. However, no tested standardised algorithm exists to enable this.

The aim of the present paper was to develop and validate a register-based algorithm for on-time sampling of incident cancer patients and to describe the completeness of a cohort of incident cancer patients using this algorithm in relation to time since diagnosis.

40


Materials and methods

Data sources

Two regional patient administrative systems (PASs), the Danish National Patient Registry (NPR) and the DCR were used. Further, survey data from the individual cancer patient’s general practitioner (GP) was included.

The purpose of PAS is to collect administrative information on hospital activities. The PAS comprises information on every patient contact with the hospitals and includes variables like patients’ civil registration number, dates of admission and discharge, diagnoses classified according to the International Classification of Diseases (ICD-10) and codes for undertaken procedures. Patient registration is made in accordance with a national guideline (3). Providing data for the NPR, the hospitals are committed to up-date the PAS for the previous month by the 10th of each month and to report to the NPR (4).

The NPR is a national database run by the Danish National Board of Health. It comprises information from the five regional PASs. The NPR is an administrative register originally developed to monitor hospital activities, but since 2000 it has also served as the basis for the payment of public and private hospitals. The NPR is also being used for medical research in terms of epidemiological studies, quality improvement studies and for identifying patients for various studies. The validity of data in the NPR has been examined continuously since reporting became mandatory in the late 1970es. Several studies conclude that minor misclassifications do exist in the NPR, but they are unanimous that these misclassifications do not influence the overall validity of the NPR data (4-9).

The DCR is a national research register designed to collect and process data on incident cancer cases. The DCR contains information on date of diagnosis, tumour topography, morphology and spreading of the tumour, among others. Reporting to the DCR became mandatory in 1987. The DCR went through a modernisation from 2004-2008 in order to enhance future data quality. It is not possible to extract on-time information from the DCR due to comprehensive quality control and validation. Within a year, almost 90% of the tumours in the DCR are validated (4;10;11).

Definition of an incident cancer patient

An incident cancer patient was defined by the following four characteristics: 1) cancer as primary diagnosis, 2) no prior history of cancer, 3) only one cancer diagnosis present and 4) the cancer was diagnosed within six months of inclusion. Patients with non-melanoma

41

Article I

skin cancers (DC44) were excluded as were also patients younger than 18 years at the date of their admission to hospital.

Sampling algorithms

An initial sampling algorithm based on the PAS was developed in the spring of 2007 (sample 1, 2008 cohort). Patients were sampled from the PAS in the Central Denmark Region and the Region of Southern Denmark. They were sampled based on discharge date and diagnosis and the additional code AZCA1, which specified that the cancer was reported for the first time by the ward (3). Patients were sampled on the 15th of each month and data on all patients registered during the preceding months were then collected. The monthly sampling continued for a 1-year period from 1 October 2007 to 30 September 2008. To be certain that the cancer was incident, we checked whether the patients were on a national list of all cancer diagnoses from 1994 to 1 October 2007. The list was updated monthly.

This consecutive, monthly sampling proved to be incomplete for two major reasons. First, some patients were registered later than one month after their diagnosis and were therefore missed because the algorithm only sampled one month back. Second, the AZCA1 code was not used consistently for all incident cancer patients which meant that we did not include eligible patients lacking the AXCA1 code in the sample. An additional sampling was therefore performed 11 months after the sampling period ended (sample 2, 2008 cohort). This sampling procedure did not include the AZCA1 code as an inclusion criterion, and all patients were sampled simultaneously for the whole study period. The 2008 cohort consists of sample 1 and 2 combined (Figure 1).

Based on the experiences from the 2008 cohort, an improved algorithm was developed and tested for sampling of the 2010 cohort. The main differences between the two cohorts were that patients were sampled nationally based on hospital admission date from the NPR, monthly updates included the previous months’ patients to ensure incorporation of patients registered late and to the insurance of no prior history of cancer was based on the DCR until 31 December 2008 and the NPR for 2009. Finally, diagnoses classified D37-D48 were not included in this cohort (approx. 3% in the 2008 cohort) due to a relatively high proportion of misclassifications among these diagnoses. Patients were sampled from 1 January 2010 to 31 October 2011 (Figure 1).

42


Validating the sampling algorithms

The sampling algorithms of both the 2008 and the 2010 cohorts were validated using information on diagnosis and date of diagnosis obtained from the patients’ GPs, which served as a golden standard.

GPs in the 2008 cohort were sent a questionnaire requesting information on whether the patient had cancer, if the cancer was diagnosed within the previous six months and whether the register-based diagnosis was correct. The GPs were also asked to provide the date of diagnosis. For the 2008 cohort, non-responding GPs received a reminder after three weeks, and they received Euro 16 as remuneration for their participation. For the 2010 cohort, a similar questionnaire was sent to GPs. Non-responders received a reminder after five to six weeks. The GPs in the 2010 cohort received no remuneration for their participation.

Completeness of the 2010 cohort

We evaluated the completeness of the 2010 cohort over time stating how many months it would take to have a complete cohort of incident cancer patients from July 2010. Completeness was defined as the time when all sampled cancer patients were registered in the NPR. The level of completeness was measured as the cumulated monthly proportion of cancer patients sampled.

Analysis

For both cohorts, information from the GPs was used as a golden standard and positive predictive values (PPVs) for sampling an incident cancer patient based on the sampling algorithms were calculated. Further, the 2008 cohort was validated using the DCR as the golden standard by calculating the PPV of sampling a cancer patient and by testing differences between patients in the 2008 cohort and patients in the DCR.

The completeness of the sampling of the 2010 cohort was analysed by comparing the number of cancer patients sampled each month over time with the overall number of cancer patients sampled.

Results are given with 95% confidence intervals (CIs) when relevant.

43

Article I

Results

In the 2008 cohort, a total of 10,262 out of 12,669 GP questionnaires were answered (81.0%). In the 2010 cohort, a total of 5,711 out of 7,996 GPs answered the questionnaire (71.4%). For both cohorts, patients with a non-responding GP were more likely to be older men diagnosed with prostate cancer (data not shown).

Validating the cohorts using the GP as golden standard

Within the 2008 cohort, the PPV of sampling an incident cancer patient was higher in sample 1 than in the total sample (86.2 vs. 83.2%). However, only 62.7% of all the patients were included in sample 1. Sample 1 differed from the total sample with respect to sex, age and type of diagnosis (Table 1). After further developing the sampling algorithm in the 2010 cohort, the PPV of sampling an incident cancer patient increased to 92.4% (Table 1).

Validating the 2008 cohort using the DCR as golden standard

The PPV of a patient in the 2008 cohort being registered in the DCR was 98.6%. Out of 174 patients not registered in the DCR, the GP verified that the patient had cancer in 58 cases (33.3%). No statistically significant differences were observed between patients included in the study and patients registered in the DCR in the same period regarding gender, whereas patients in the DCR were older and more often diagnosed with lung and prostate cancer (Table 2).

Completeness over time (2010 cohort)

Overall, the completeness of registration of incident patients from June 2010 was 60.0% within the first month with variations between diagnoses, lowest for prostate cancer (49.0%) and highest for malignant melanoma (79.5%). After four months, the overall completeness exceeded 95%, again with variation from 90.5% (prostate cancer) to 98.1% (breast cancer). Completeness of minimum 95% was achieved within 2 to 5 months after admission except for prostate cancer. Completeness of 100% was achieved after maximum 12 months for all cancer diagnoses except prostate cancer (Figure 2).

44


Discussion

Main findings

Two sampling algorithms for on-time sampling of incident cancer patients were developed and tested. The algorithms’ overall PPVs ranged from 83.2% to 92.4% with the 2010 algorithm displaying the highest PPV. Further, the 2010 algorithm displayed a completeness of 60% in the first month and a completeness of 95% after four months. The PPV of a patient from the 2008 cohort being registered in the DCR was 98.6%. 33.3% of the patients not registered in the DCR had a cancer diagnosis when the GP was used as the golden standard.

Strengths and weaknesses

The PPV of 92.4% in the 2010 sampling algorithm is more acceptable than the PPV of 83.2% in the 2008 cohort because it testifies to a lower erroneous risk of sampling patients without cancer. The higher PPV in the 2010 sampling algorithm was partly achieved by excluding patients classified with the diagnoses D37-D48 (neoplasm of uncertain or unknown behaviour).

As sample 1 differed from the total sample in 2008 with respect to gender, age and type of diagnosis, sample 1 had a systematic selection bias compared with the full 2008 cohort sample. However, the second sample was collected a year after the inclusion ended in 2008, which means that it is hardly suitable for on-time sampling of incident cancer patients.

Regarding prostate cancer, both algorithms displayed relatively low PPVs for the sampling of incident cancer patients. This discrepancy could be rooted in the long diagnostic pathway for most prostate cancer patients, which may lead to delayed registration or misclassification.

45

Article I

The validation of the 2008 cohort against the DCR showed a high PPV. Surprisingly, we found that 58 patients were not registered in the DCR, but were verified to have cancer by their GPs. This could be explained by the validation procedures in the DCR, which determine that patients with discrepancies between the registration and the pathology report are put on hold before their data are entered into the DCR. The validation only showed minor differences in the distribution of age and cancer types, which indicates that there were no systematic differences in those included in the study and those registered in the DCR.

The considerable size of this study is a major strength because it enhances the statistical precision of our results. The use of registries minimised the risk of selection bias. GP-induced selection bias is possible if the proportion of patients misclassified with cancer in the registries was higher for non-responding than for responding GPs. With response rates of 71-81% and no reason to suspect systematic non-responding, the magnitude of this bias is considered minimal. A potential risk of information bias exists due to recall bias from the GPs. However, the GPs were asked to base their answers on their electronic medical records and discharge letters from the hospitals, so such bias is expected to play no significant role.

The use of completeness as a measure to estimate whether the sample incorporated all incident cancer patients in the samples could be questioned. Completeness is used to estimate whether a database can be used to recruit the eligible population (12).Completeness is therefore a measure that must be taken into account, and it has been argued that completeness should reach 90% to ensure that a sample is representative of the studied population (12). On this basis we argue that both the combined 2008 sample and the 2010 sample can be considered representative samples of all incident cancer patients.

Conclusion and implications

A valid and cost-saving algorithm for on-time sampling of incident cancer patients has been developed with much potential for future research and quality assurance. Using the algorithm, sampling 100 patients will include one person without cancer and seven patients who are not incident, which is acceptable, without GP validation of the patient’s diagnosis. Still, for prostate cancer, the researcher must expect a lower PPV and less completeness.

46


Acknowledgements

We wish to thank the involved persons from the Central Denmark Region and the

Region of Southern Denmark for assisting with the initial development of the sampling

algorithm for sample 1 in the 2008 cohort. Special thanks are due to Jens Grønlund from

the Central Denmark Region. Further, we wish to thank the Researchers’ Services at the

National Board of Health for help with data collection. Finally, we thank the participating

GPs for completing the questionnaires.

This work was funded by the Danish Cancer Society and the Novo Nordisk Foundation.

Conflict of interests

The funding sources had no involvement in the research process.

Ethics approval

According to the Committees on Biomedical Research Ethics in the Central Denmark

Region, the Act on the Biomedical Research Ethics Committee System and the act on

the Processing of Biomedical Research Projects do not apply to this project. The study

was approved by the Danish Data Protection Agency and the Danish National Board of

Health.

47

Article I

Reference List

(1) Engholm G, Ferlay J, Gjerstorff M, Christensen N, Johannesen TB, Klint A, et al. NORDCAN: Cancer Incidence, Mortality, Prevalence and Survival in the Nordic Countries, Version 4.0. Association of the Nordic Cancer Registries. Danish Cancer Society; 2011.

(2) The Danish National Board of Health. The Danish Register of Causes of Death [In Danish]. 2008.

(3) The Danish National Board of Health. Common content for regitration of hospital patients [In Danish]. http://www.sst.dk/Webudgivelser/FaellesIndhold/Forside.aspx . 21-12-2011.

(4) Sørensen HT, Christensen T, Schlosser HK, Pedersen L. Use of Medical Databases in clinical Epidemiology. Aarhus: Department of Clinical Epidemiology, Aarhus University Hospital; 2008.

(5) Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health 2011 Jul;39(7 Suppl):30-3.

(6) The Danish National Board of Health. Evaluation of the Danish National Patient Registry [In Danish]. Copenhagen: 1993.

(7) Lidegaard O, Hammerum MS. The National Patient Registry as a tool for continuous production and quality control. Ugeskr Laeger 2002 Sep 16;164(38):4420-3.

(8) Lidegaard O, Vestergaard CH, Hammerum MS. Quality monitoring based on data from the Danish National Patient Registry. Ugeskr Laeger 2009 Feb 2;171(6):412-5.

(9) Nørgaard M, Skriver MV, Gregersen H, Pedersen G, Schønheyder HC, Sørensen HT. The data quality of haematological malignancy ICD-10 diagnoses in a population-based hospital discharge registry. Eur J Cancer Prev 2005;14:201-6.

(10) The Danish National Board of Health. The modernised Cancer Registry [In Danish]. Copenhagen: 2009.

(11) Gjerstorff ML. The Danish Cancer Registry. Scand J Public Health 2011 Jul;39(7 Suppl):42-5.

(12) Black N, Payne M. Directory of clinical databases: improving and promoting their use. Qual Saf Health Care 2003 Oct;12(5):348-52.

48


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49

Article I

Table 1 Positive predictive values in percentage of sampling a cancer patient and an incident cancer patient

The 2008 cohortSample 1

The 2008 cohortTotal sample

The 2010 cohort

Cancer (all)* 97.9 97.0 98.8Included cancer (all)** 97.6 96.6 95.7

Lung cancer 99.5 99.1 96.3Colorectal cancer 98.9 98.7 95.3

Prostate cancer 99.3 98.9 96.5Malignant melanoma 97.4 97.3 95.8

Breast 99.6 99.6 97.2Other 95.1 93.4 94.5

Incident cancer (all)*** 86.2 83.2 92.4Lung cancer 93.2 91.8 95.4

Colorectal cancer 90.3 89.4 94.3Prostate cancer 72.8 68.8 83.4

Malignant melanoma 92.1 90.6 93.0Breast 90.2 88.7 96.4Other 84.2 80.5 92.0

*The GP confirms that the patient has the same cancer as stated in the register

**The GP confirms that the patient has a cancer included in the study

***The GP confirms that the patient has an incident cancer as defined in this study

50


Table 2 Validating the 2008 cohort based on the Danish Cancer Register

Total 2008 cohort DCR Test of no difference*

N=12,669 N=10,948 p-valueSex Male 6,365 (50.2) 5,514 (50.4) 0.849

Female 6,304 (49.8) 5,434 (49.6)Age 18-49 years 1,392 (11.0) 1,263 (11.4) 0.183

50-69 years 5,711 (45.1) 5,181 (47.3) <0.00170+ years 5,566 (43.9) 4,504 (41.1) <0.001

Diagnosis Breast cancer 1,961 (15.5) 1,680 (15.2) 0.777Lung cancer 1,484 (11.7) 1,452 (13.3) <0.001

Colorectal cancer 1,592 (12.6) 1,440 (13.2) 0.179Prostate cancer 1,695 (13.4) 1,370 (12.5) 0.048

Malignant melanoma 609 (4.8) 541 (4.9) 0.632Other 5,328 (42.1) 4,465 (40.8) 0.048

*Tested by Pearson’s chi-squared test

51

Article I

Figure 2 Completeness of included patients over time. Note: graph constrained to nine months, but analysis undertaken for all 14 months

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53

Article II

ARTICLE II

Urgent referral for suspected cancer as a means of reducing delay in the diagnosis.

A population-based observational study in Denmark

Submitted for publication in British Journal of Cancer

1, 2, 3Mette Bach Larsen, Research Fellow, MScPH


4Dorte Gilså Hansen, MD, PhD

1,3Frede Olesen, Professor, Research Director, DrMedSci


1: The Research Unit for General Practice, Aarhus University, Bartholins Allé 2, DK-8000 Aarhus C, Denmark.

2: Section for General Practice, School of Public Health, Aarhus University, Bartholins Allé 2, DK-8000 Aarhus C, Denmark.

3: Centre for Cancer Diagnosis in Primary Care – CaP, Aarhus University, Bartholins Allé 2, DK-8000 Aarhus C, Denmark.

4: The National Research Centre for Cancer Rehabilitation, Research Unit for General Practice, University of Southern Denmark, J.B. Winsløws vej 9, DK-5000 Odense C, Denmark.

Correspondence

Mette Bach Larsen


Aarhus University

Bartholins Allé 2

DK-8000 Aarhus C, Denmark Words in abstract: 200

Tel: +45 8716 7915 Words in main text: 3,241



54


Abstract

Background: Urgent referral for suspected cancer was implemented in Denmark 1 April 2008 to reduce the secondary care interval. However, knowledge about the association between the secondary care interval and urgent referral remains scarce. The aim of this study was to analyse how the secondary care interval changed before and after introduction of urgent referral at Vejle Hospital and other Danish hospitals.

Methods: This was a population-based observational study based on GP questionnaires. A total of 10,950 incident cancer patients were included and questionnaires completed on 8,543 (78%) patients.

Results: The median secondary care interval decreased after the introduction of urgent referral. Patients discharged from Vejle Hospital had a shorter secondary care intervals than those discharged from other hospitals. The strongest effect was seen in patients with alarm symptoms and those who were referred by their GP on suspicion of cancer. At other hospitals than Vejle, the secondary care interval started to decrease at the time the issue caught political attention, i.e. before the national implementation of the urgent referral.

Conclusion: Urgent referral had an effect on the secondary care interval which was achieved through standardized pathways and leadership. Thus, leadership, strategy and guidelines seem to have synergetic effect.

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Article II

Introduction

The lower cancer survival rates from cancer in Denmark than in the other Nordic countries and many European countries have been the focus of much attention since the beginning of this century (1-4). Studies have indicated that part of the explanation is that Danish cancer patients seem to be at a more advanced stage of disease than patients in the other Nordic countries when treatment is initiated. Their diagnosis and treatment may be delayed due to a prolonged diagnostic interval (5;6). The consequences of a prolonged diagnostic interval have long been controversial (7;8) but a recent study offered a plausible explanation for the disparity between previous results and showed that a longer diagnostic interval was associated with increased mortality among colorectal cancer patients (9).

The time interval from the first referral from primary care to treatment may be referred to as the secondary care interval (13). A long secondary care interval was documented in Denmark in 2007 (10-12), which directed political attention to the waiting lists in the Danish health care sector and made the Danish government and the Danish Regions (who own and run the hospitals) launch a new diagnostic strategy that classified cancer as an acute condition. This marked the beginning of a re-organisation of the cancer care pathway in Denmark (13).

The Danish government had launched its second cancer plan in 2005, which prescribed the use of a standardized pathway from cancer suspicion until treatment (14). In the summer of 2007, the government decided to implement at a national level the urgent referrals that had been successfully pursued at a regional level at Vejle Hospital since the late 90s. The principle of urgent referral was formally introduced for breast, lung, colorectal and head and neck cancers on a nation-wide basis on 1 April 2008. Gynaecological cancers followed 1 August 2008, haematological cancers 1 September 2008, and by 2010 urgent referral had been introduced for 34 different cancers (15). Urgent referral takes the form of a set of standardised procedures aiming at offering patients the optimal diagnostic process and rapid treatment (14). In Denmark, general practitioners (GPs) serve as gatekeepers to secondary health care, and for urgent referrals to work, the GP must suspect a specific cancer on the basis of a certain set of alarm symptoms. However, a study have shown that only approx. 50% of cancer patients presents with typical alarm symptoms in general practice (16).

Urgent referral was introduced nationally under the assumption that it would reduce the secondary care interval. However, knowledge about the actual association between the secondary care interval and urgent referrals is scarce. The aim of this study was therefore to analyse how the secondary care interval changed after the introduction of urgent referral for specific types of cancer in general and at Vejle Hospital in particular.

56


Method

Study design and setting

This population-based observational study was conducted among incident cancer patients in the Central Denmark Region and the Region of Southern Denmark. The two regions have approx. 2.4 million inhabitants (44% of the Danish population) and approx. 14,000 new cancer cases pr. year.

Vejle Hospital is situated in the Region of Southern Denmark and its oncological ward is one of six Danish cancer centres. The oncological ward performs 38,000 outpatient consultations per year and in-patients consume 7,500 bed days per year.

Denmark’s publicly funded healthcare system provides free access to general practice and hospital care. More than 98% of the Danish citizens are registered with a GP who acts as a gatekeeper to the rest of the healthcare system by referring patients to hospitals or outpatient clinics when necessary. Danish GPs keep medical records of their patients with discharge letters from hospitals.

Sampling procedure

In Denmark, each hospital admission and outpatient visit is coded and stored in regional patient-administrative systems (PAS) which feed the National Patient Register (17). Patients were sampled from PAS on the basis of their discharge date and diagnosis and the additional code AZCA1, which indicates that the cancer was reported for the first time by the ward (18). Patients were excluded if they were already registered on a national list of all cancer diagnoses from 1994 to 30 September 2007 extracted from the National Patient Registry. This list was updated monthly by adding included patients. The monthly sampling continued for one year from 1 October 2007 but some patients were registered later than the month after diagnosis and were missed as the algorithm only sampled one month back. Further, the AZCA1 code was used unsystematically inducing inaccuracies in the inclusion. Therefore, an additional sampling was performed in October 2009 covering the entire study period without the AZCA1 code as inclusion criterion.

Data collection

The GP questionnaire was developed based on the literature and research group experience from prior studies of patients’ diagnostic pathways (19). The GP provided information on the date of the patient’s first referral to the secondary health care, at which time the GP’s responsibility for the diagnostic process ended, and the date of treatment start. The GP also gave information stating whether the diagnostic pathway was initiated in general practice, whether the GP regarded the initial symptoms as alarm symptoms of cancer and whether the GP clearly indicated cancer suspicion in the first referral to secondary

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healthcare. Questionnaires were sent to the GPs within one month after patient inclusion. Reminders were sent after three weeks. The GPs were remunerated for their participation (approx. 16 €).

Outcome measures

Estimation of the secondary care interval was primarily based on data obtained from the GP questionnaires. However, for 2,024 (28.0%) patients, the GP did not provide complete information on the secondary care interval, mainly because the GP had received the questionnaire before obtaining information about treatment start. For those patients, we estimated the secondary care interval on the basis of the patient’s hospital admission date. This approximation systematically underestimated the interval as the median GP-reported secondary care interval was 40 days (IQI: 22; 74 days) compared with the 31-day (IQI: 14; 66 days) interval obtained when the interval was calculated on the basis of the patient’s date of admission.

Patients were categorised as diagnosed before or after the urgent referral if they were admitted to hospital before or after 1 April 2008, respectively. Patients were further divided into groups according whether the GP interpreted the initial symptoms as alarm symptoms of cancer and whether cancer suspicion was clearly mentioned in the first referral. Finally, patients were grouped according to discharging hospital with Vejle Hospital in one group and other hospitals in another.

Analyses

Data analyses were restricted to patients whose diagnostic pathway had been initiated in primary care, since the pathway of interest in the present study was that part where GPs refer patients to further diagnostic work-up in secondary care (main route of cancer diagnosis in Denmark (19)).

The secondary care interval is presented as medians with inter-quartile intervals (IQIs) because data was not normally distributed. Wilcoxon rank-sum test was used to test the differences between before and after the national introduction of urgent referral for suspected cancer. Trends in monthly differences in medians were tested by non-parametric trend test across ordered groups. To test for differences between groups, Wilcoxon rank-sum test was used. Estimates were given with 95% confidence intervals (95%CI) when relevant. Analyses were made using Stata 11.2.

58


Results

A total of 10,950 incident cancer patients were included in the study, and a GP questionnaire was completed for 8,543 (78.0%) of the patients. Patients with a non-responding GP were more likely to be older males, fewer had breast and lung cancers and more had prostate cancer. No statistically significant difference was observed in response rate from GPs with patients discharged from Vejle Hospital compared with other hospitals. Patients discharged from Vejle Hospital were statistically significantly more likely to be females, younger and diagnosed with breast cancer (Table 1).

The diagnostic pathway bypassed primary care in 1,326 (12.9%) patients. They were excluded together with 699 (9.7%) patients on whom we did not have information on the secondary care interval. The estimated secondary care interval was calculated for 2,024 (39.0%) patients. No differences were observed in the proportion of incomplete secondary care intervals before and after the introduction of urgent referral for suspected cancer (p=0.983). Secondary care intervals were statistically significantly more often incomplete in other hospitals than Vejle Hospital (p=0.001), in patients without alarm symptoms than with alarm symptoms (p<0.001) and in patients in whose secondary referral documents the GP did not indicate cancer suspicion than in documents where such suspicion was mentioned (p<0.001). A total of 6,518 patients were included in the analyses. Among these patients, 775 patients (11.9%) were discharged from Vejle Hospital.

The secondary care interval before and after introducing urgent referral for suspected cancer

The secondary care interval was statistically significantly shorter after the national introduction of urgent referral for suspected cancer at Vejle Hospital as well as at other hospitals than before its introduction (Table 2). In Vejle Hospital, the improvement was significant for breast cancer. Men had a longer secondary care interval than women, but both had a shorter interval after urgent referral had been introduced (Table 2).

GPs’ symptom interpretation

If the GP clearly indicated cancer suspicion in their referral documents, the median secondary care interval decreased statistically significantly from before to after the introduction of urgent referral in all hospitals. Note that if the GP did not indicate cancer suspicion, no statistically significant difference was observed in the secondary care interval before and after the introduction of urgent referral (Table 2).

At both Vejle Hospital and other hospitals, the secondary care interval was shorter if the GP categorised the patients’ symptoms as alarm symptoms. The secondary care interval did not improve significantly for cancer diagnosis without alarm symptoms (other).

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Article II

Differences between Vejle Hospital and other hospitals

The median secondary care interval for patients discharged from Vejle Hospital was shorter than for patients discharged from other hospitals irrespective of the GP’s symptom interpretation. Even so, at Vejle Hospital those patients whose symptoms were interpreted as alarm symptoms by their GPs had a significantly shorter secondary care interval than patients whose symptoms were not recognized as alarming (Table 2).

For all cancers, the secondary care interval was statistically significantly shorter at Vejle Hospital than at other hospitals both before and after the introduction of urgent referral. For the individual cancer types, the secondary care interval was shorter at Vejle Hospital than at other hospitals only before the introduction of urgent referral (Table 2). In general, it should be noted that especially the 75% percentile for secondary care interval in Vejle Hospital was lower than in other hospitals.

Monthly changes in the secondary care interval

For all cancers, the overall median secondary care interval for patients discharged from Vejle Hospital was 29 days (IQI: 18; 50 days) compared with 39 days (IQI: 20; 74 days) for patients discharged from other hospitals (p<0.001). For both Vejle Hospital and other hospitals, a statistically significantly decreasing trend was observed (Vejle: p=0.007, other: p<0.001). This was not the case for the 75% percentile or the 90% percentile of patients for any of the other hospitals. Stratified by diagnosis, the decreasing trend in the median secondary care interval was statistically significant for breast cancer (p<0.001), colorectal cancer (p<0.001) and lung cancer (p=0.009) at other hospitals and for breast cancer at Vejle Hospitals (p<0.001). No statistically significant decreasing trend was observed for other cancer diagnoses. Note that improvements had a tendency to diminish over time. Further, it should be noted that in other hospitals than Vejle Hospital, a tendency was seen towards a decrease in the secondary care interval before the introduction of urgent referral. This tendency was statistically significant for colorectal cancer (Figure 1).

60


Discussion

Main findings

The overall median secondary care interval decreased for cancers for which urgent referral had been introduced, both at Vejle Hospital and at other hospitals. Patients discharged from Vejle Hospital had a shorter secondary care interval than those discharged from other hospitals both before and after the introduction of urgent referral. The focus on early cancer diagnosis at Vejle Hospital had thus been effective already before the national introduction of urgent referral. Surprisingly, breast cancer patients from Vejle Hospital experienced an even shorter secondary care interval after the introduction of urgent referrals at the national level. This indicates that the introduction of standard pathways shortens the secondary care interval even where prior organizational initiatives to improve care pathways have already achieved some effect like at Vejle Hospital.

Patients had a shorter secondary care interval in those cases where the GPs had categorised initial symptoms as alarm symptoms or had indicated cancer suspicion in their referral documents; and the secondary care interval changed significantly after the introduction of urgent referral for suspected cancer. This supports the assumption that the GPs’ symptom interpretation and their action on suspicion of cancer are instrumental in shortening the secondary care interval for cancer patients.

An interesting finding was that the tendency towards a decrease in the secondary care interval at other hospitals began when the need for it was officially recognized, i.e. before the formal implementation of urgent referral. Furthermore, it should be noted that Vejle Hospital was able to even further reduce its secondary care intervals in light of the introduction of the urgent referral system at the national level. This indicates that urgent referral of cancer works through a combination of setting up standardised, well-operated and coordinated pathways and at the same time focus on leadership and reorganization to ensure that optimization of medical treatment lies at the heart of the organizational culture. Leadership, strategy and guidelines seem to have effect and to be synergetic. Moreover, the present study suggests that continued management is required to avoid that improvements decline over time.


The initial algorithm showed to be incomplete, causing us to make an additional sampling one year after the study period had expired. This, however, induced two problems in the form of, first, an increased risk of recall bias, second, an increased risk of selection bias. GP recall bias could influence the secondary care interval and the categorisation of patients according to initial symptom presentation and cancer suspicion in the first referral to secondary healthcare. As far as the initial symptom presentation is concerned, the mentioning of cancer suspicion in the referral and secondary care interval, recall bias

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are not considered to have much impact since GPs had the information in the patients’ electronic medical records. We did not specify which symptoms should be categorised as alarm symptoms and this may have introduced an information bias. Thus, the interpretation of the same symptom could differ between GPs. It is not possible to estimate the direction of this potential bias. GP-induced selection bias is possible if patients of non-responding GPs had a different secondary care interval than patients of responding GPs. If GPs with a longer doctor interval were more reluctant to respond, this could lead to shorter secondary care intervals due to a more obvious pathological picture. This bias may therefore lead estimates to go towards the null-hypothesis.

The considerable sample size ensures a high level of statistical precision. We did not have complete information on the secondary care interval for almost one third of the patients due to missing treatment date. We used the date of admission in these cases which introduced a systematic underestimation of the secondary care interval. As there were more patients with incomplete secondary care intervals in other hospitals than Vejle Hospital and among patients without alarm symptoms and without indication of cancer suspicion, we underestimated the secondary care interval for those with the longest secondary care interval, which caused the differences between Vejle Hospital and other hospitals to be absolute minimum differences. Despite this bias, we were able to detect considerable changes and differences and therefore conclude that this bias hardly alters our conclusions.

We had no information on who were actually referred urgently after the introduction of urgent referral, but this information could not have been used anyway as our aim was to make an ante-post comparison. The GP data detailing whether the patient presented with alarm symptoms and whether the GP clearly indicated cancer suspicion in his or her first referral are therefore the best source of information on whether the patient was regarded as an urgent case or not.

The ideal design for a study of the effect of urgent referral for suspected cancer would be a randomised controlled trial, but any study randomising patients to a longer delay would be deemed unethical. The natural experiment with Vejle Hospital serving as a control group is therefore the best alternative.

The conclusions of this study are considered generalisable to other regions in Denmark and to other healthcare systems with a primary care where GPs act as gatekeepers. The size of the possible effect of urgent referral will depend on the local context.

Findings in relation to other studies

The overall median secondary care interval of 42 days (IQI: 22; 80 days) for other hospitals than Vejle Hospital before the introduction of urgent referrals is fairly consistent with the results from another Danish study from 2005 which reported a secondary care interval

62


of 46 days (IQI: 26;78) (12). This study used the same definition of the secondary care interval and collected data by use of questionnaires sent to the GPs. A comparison of our results with those of a recent study by the Danish National Board of Health shows that the secondary care intervals reported in our study were shorter than those previously reported, except for colorectal cancer (11). The National Board of Health counted the days from the referral was received at the hospital, whereas we measured the day the referral was sent by the GP. Furthermore, the National Board of Health counted the days until the patients gave consent to treatment, whereas we included the time until treatment was actually initiated. We were able to detect the effect of the GP having suspected cancer and having noted so in his or her referral documents. The present study was hence able to demonstrate the importance of the referral process and the GPs’ knowledge, awareness and action. Further, we were able to compare Vejle Hospital with other hospitals and hence identify aspects highlighting how urgent referral may have an effect on time to treatment.

In other health care settings, studies have reported a direct, negative effect on non-urgent patients from the introduction of urgent referral for suspected cancer (20-23). However, we saw no indication of this serious adverse effect in our data.

Conclusion

The secondary care interval decreased significantly after the national introduction of urgent referrals for suspected cancer. Patients with alarm symptoms in general and those in whom the GP explicitly stated his or her suspicion of cancer in particular saw the most effect of the urgent referral. The one hospital, Vejle Hospital, that had developed and introduced urgent referral years before performed best both before and after the introduction of urgent referral at the national level, and it is remarkable that Vejle Hospital managed to shorten the intervals even further. The results suggest that the secondary care interval decreased prior to the formal implementation of urgent referral, indicating that political focus and leadership had an effect in itself. Thus, shortening the secondary care interval is the results of a concerted effort that involves both the design and implementation of clinical and organisational guidelines and administrative and political leadership.

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Acknowledgements

We wish to thank the participating GPs. Our thanks are also due to those from the Central Denmark Region and the Region of Southern Denmark who assisted with the initial development of the sampling algorithm. Thanks are also due to statistician Ineta Sokolowski. This work was funded by The Novo Nordic Foundation, the Danish Cancer Society and the Quality and Continuing Education Council for general practice in the Central Denmark Region and Region of Southern Denmark. National Research Centre for Cancer Rehabilitation is funded by The Danish Cancer Society.

Conflict of interests

The funding sources had no involvement in the research process.

Ethics approval

According to the Committees on Biomedical Research Ethics in the Central Denmark Region, the Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research Projects do not apply to this project. The study was approved by the Danish Data Protection Agency and the Danish National Board of Health.

64


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(8) Rupassara KS, Ponnusamy S, Withanage N, Milewski PJ. A paradox explained? Patients with delayed diagnosis of symptomatic colorectal cancer have good prognosis. Colorectal Dis 2006;8:423-9.

(9) Torring ML, Frydenberg M, Hansen RP, Olesen F, Hamilton W, Vedsted P. Time to diagnosis and mortality in colorectal cancer: a cohort study in primary care. Br J Cancer 2011;104(6):934-40.

(10) Hansen RP, Vedsted P, Sokolowski I, Sondergaard J, Olesen F. Time intervals from first symptom to treatment of cancer: a cohort study of 2,212 newly diagnosed cancer patients. BMC Health Serv Res 2011;11:284.

(11) Probst HB, Hussain ZB, Andersen O. Cancer patient pathways in Denmark as a joint effort between bureaucrats, health professionals and politicians -A national Danish project. Health Policy 2011 [epub ahead of print].

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(12) Olesen F, Hansen RP, Vedsted P. Delay in diagnosis: the experience in Denmark. Br J Cancer 2009;101(Suppl 2):5-8.

(13) Danish Regions. Danske Regioners syvpunktsplan på kræftområdet [In Danish]. Available from: http://www.regioner.dk/Aktuelt/Nyheder/2007/November/~/media/migration%20folder/upload/filer/sundhed/7punktsplan.pdf.ashx. (Accessed 5-1-2012).

(14) Danish National Board of Health. Kræftplan II [In Danish]. Copenhagen: Danish National Board of Health; 2005.

(15) Danish Regions. Status for pakkeforløb på kræftområdet april 2010 [In Danish]. Available from: http://www.regioner.dk/Aktuelt/Nyheder/2010/Maj/~/media/Filer/Sundhed/Kræftpakker/Status%20for%20pakkeforløb%20på%20kræftområdet_april%202010.ashx. (Accessed 5-1-2012).

(16) Nielsen TN, Hansen RP, Vedsted P. Symptom presentation in cancer patients in general practice. Ugeskr Laeger 2010;172(41):2827-31.


(18) Danish National Board of Health. Fællesindhold for basisregistrering af sygehuspatienter [In Danish]. Available from: http://www.sst.dk/Webudgivelser/FaellesIndhold/Forside.aspx. (Accessed 21-12-2011).

(19) Hansen RP. Delay in the diagnosis of cancer [PhD thesis]. 1 ed. Aarhus: Faculty of Health Sciences, Aarhus University; 2008.

(20) Hanna SJ, Muneer A, Khalil KH. The 2-week wait for suspected cancer: time for a rethink? Int J Clin Pract 2005;59(11):1334-9.

(21) Potter S, Govindarajulu S, Shere M, Braddon F, Curran G, Greenwood R, et al. Referral patterns, cancer diagnoses, and waiting times after introduction of two week wait rule for breast cancer: prospective cohort study. BMJ 2007;335(7614):288.

(22) Thorne K, Hutchings HA, Elwyn G. The effects of the Two-Week Rule on NHS colorectal cancer diagnostic services: a systematic literature review. BMC Health Serv Res 2006;6:43.:43.

(23) Lewis NR, Le J, I, Baldwin DR. Under utilisation of the 2-week wait initiative for lung cancer by primary care and its effect on the urgent referral pathway. Br J Cancer 2005;93(8):905-8.

http://www.regioner.dk/Aktuelt/Nyheder/2007/November/~/media/migration folder/upload/filer/sundhed/7punktsplan.pdf.ashx

http://www.regioner.dk/Aktuelt/Nyheder/2007/November/~/media/migration folder/upload/filer/sundhed/7punktsplan.pdf.ashx

http://www.regioner.dk/Aktuelt/Nyheder/2010/Maj/~/media/Filer/Sundhed/Kr�ftpakker/Status for pakkeforl�b p� kr�ftomr�det_april 2010.ashx



http://www.sst.dk/Webudgivelser/FaellesIndhold/Forside.aspx


66


Table 1 Patient characteristics of those discharged from Vejle Hospital and other hospitals, respectively

Other hospitals

n (%)

Vejle Hospital

n (%)

All 5,743 (88.1) 775 (11.9) p-value

SexMale 2,917 ( 50.8) 268 (34.6) <0.001

Female 2,826 (49.2) 507 (65.4)

Age (years)18-49 690 (12.0) 124 (16.0) <0.00150-69 2,656 (46.3) 294 (51.4)

70+ 2,397 (41.7) 253 (32.7)Cancer diagnosis

Breast 772 (13.4) 260 (33.6) <0.001Colorectal 842 (14.7) 96 (12.4) 0.090

Lung 712 (12.4) 113 (14.6) 0.086Head and Neck 165 (2.4) 9 (1.2) 0.006

Prostate 746 (13.0) 19 (2.5) <0.001Other 2,506 (43.6) 278 (35.9) <0.001

Alarm symptomsYes 3,541 (62.7) 519 (67.8) 0.007No 2,104 (37.3) 247 (32.3)

Cancer suspicionYes 3,156 (63.6) 435 (66.4) 0.154No 1,809 (36.4) 220 (33.6)

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Table 2 The median secondary care interval (days) before and after urgent referral for suspected cancer

*The number of cases at Vejle Hospital was too small to produce precise results on head and neck cancer (n=9) and prostate cancer (n=19)

Other hospitals Vejle Hospital Others vs. Vejle Before urgent

referral n=3,131

After urgent referral n=2,612

p-value

Before urgent referral n=387

Median (IQI)

After urgent referral n=388

Median (IQI)

p-value

No

difference before p-value

No

difference after

p-value

Median (IQI)

Median (IQI) All 42 (22; 80) 35 (18; 67) <0.001 30 (20; 50) 26 (15; 51) 0.020 <0.001 <0.001

Sex Male 46 (23; 90) 40 (20; 80) <0.001 32 (20; 63) 29 (17; 68) 0.362 <0.001 0.008

Female 39 (21; 69) 32 (16; 57) <0.001 29 (20; 45) 26 (15; 48) 0.036 <0.001 0.017 Age (years)

18-49 41 (21; 73) 29 (15; 61) 0.003 35 (18; 61) 25 (14; 39) 0.132 0.200 0.213 50-69 53 (30; 98) 45 (22; 81) <0.001 29 (20; 43) 26 (17; 50) 0.408 <0.001 0.002

70+ 41 (21; 77) 36 (18; 68) <0.001 33 (22; 56) 27 (15; 52) 0.062 0.041 0.022 Cancer diagnosis

Breast 33 (21; 56) 23 (15; 38) <0.001 28 (20; 40) 21 (13; 33) <0.001 0.029 0.139 Lung 37 (21;64) 33 (16; 53) 0.008 31 (20; 41) 29 (23; 65) 0.392 0.027 0.658

Colorectal 38 (22; 71) 30 (18; 53) <0.001 32 (23; 46) 26 (18; 37) 0.068 0.053 0.162 Head and neck* 39 (22; 64) 37 (17; 66) 0.443

Prostate* 72 (37; 141) 67 (31; 104) 0.028 Other 42 (19; 80) 40 (18; 76) 0.358 30 (17; 64) 31 (16; 70) 0.842 0.058 0.086

Alarm symptoms Yes 38 (21; 70) 33 (16; 58) <0.001 32 (22; 49) 27 (18; 44) 0.025 <0.001 <0.001 No 49 (26; 96) 42 (20; 86) <0.001 41 (27; 89) 36 (18; 77) 0.097 0.054 0.081

Cancer suspicion Yes 36 (20; 67) 30 (16; 56) <0.001 30 (21; 44) 22 (15; 37) 0.001 <0.001 <0.001 No 52 (27; 98) 46 (23; 89) 0.018 51 (30; 91) 43 (28; 84) 0.259 0.105 0.254

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Figure 1 Monthly secondary care intervals (median days with inter-quartile intervals). Urgent referral for suspected cancer was introduced April 2008

0

20

40

60

80

10 11 12 1 2 3 4 5 6 7 8 9

All cancers n=5,743

Before urgent referrals After urgent referrals

0

20

40

60

80

100

10 11 12 1 2 3 4 5 6 7 8 9

All cancers n=775


0

10

20

30

40

50

60

70

10 11 12 1 2 3 4 5 6 7 8 9

Breast cancer n=772


0

10

20

30

40

50

60

70

10 11 12 1 2 3 4 5 6 7 8

Breast cancer n=260


0102030405060708090

10 11 12 1 2 3 4 5 6 7 8 9

Colorectal cancer n= 842


0102030405060708090

10 11 12 1 2 3 4 5 6 7 8 9

Colorectal cancer n=96


0

20

40

60

80

100

10 11 12 1 2 3 4 5 6 7 8 9

Lung cancer n=712


0

20

40

60

80

100

10 11 12 1 2 3 4 5 6 7 8 9

Lung cancer n=113


0

20

40

60

80

100

120

10 11 12 1 2 3 4 5 6 7 8 9

Other cancers n=2,506


0

20

40

60

80

100

120

10 11 12 1 2 3 4 5 6 7 8 9

Other cancers n=278

Before urgent referrals After urgent referrals Before urgent referral After urgent referral

Test for trend: p(total)<0.001 p(before)=0.289 p(after=0.466) Test for trend: p(total)=0.007 p(before)=0.527 p(after=0.225)

Test for trend: p(total)<0.001 p(before)=0.073 p(after=0.238) Test for trend: p(total)<0.001 p(before)=0.011 p(after=0.251)

Test for trend: p(total)<0.001 p(before)=0.005 p(after=0.129) Test for trend: p(total)=0.304 p(before)=0.469 p(after=0.498)

Test for trend: p(total)=0.009 p(before)=0.956 p(after=0.262) Test for trend: p(total)=0.474 p(before)=0.555 p(after=0.503)

Test for trend: p(total)=0.182 p(before)=0.137 p(after=0.866) Test for trend: p(total)=0.727 p(before)=0.455 p(after=0.236)

Other hospitals Vejle Hospital 100

80

60

40

20

0

100

80

60

40

20

0

120

100

80

60

40

20

0

120

100

80

60

40

20

0

70605040302010

0

908070605040302010

0

908070605040302010

0

70605040302010

0

100

80

60

40

20

0

100

80

60

40

20

0

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

10 11 12 1 2 3 4 5 6 7 8 9

All cancers n=5,743

Breast cancer n=772

Colorectal cancer n=842 Colorectal cancer n=96

Lung cancer n=712

Other cancers n=2,506

All cancers n=775

Breast cancer n=260

Lung cancer n=113

Other cancers n=278

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ARTICLE III

Patient evaluation of the cancer care pathway before and after introduction of urgent referral for suspected cancer – results from a natural experiment in Denmark

Submitted for publication in BMJ Quality and Safety










Correspondence:

Mette Bach Larsen


Aarhus University

Bartholins Allé 2

DK-8000 Aarhus C

Denmark Words in abstract: 265




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Abstract

Introduction: Knowledge of how patients experience the secondary care interval in cancer diagnosis and the effect of introducing urgent referral for suspected cancer is sparse. The aim of this study was to analyse how the patient evaluates coherence in the care pathway before and after the introduction of urgent referral for suspected cancer and to analyse if there were associations between patient evaluations and the secondary care intervals.

Methods: During the study period, 6,978 patients were consecutively included in a population-based observational study. Data were collected from registries and questionnaires from patients and their GPs. Patients discharged from Vejle Hospital were regarded as a specific group as this hospital had implemented urgent referral years before the national implementation of urgent referral in April 2008. The patients’ evaluated the cancer care pathway in terms of five items describing the concept of patient-experienced coherence in the cancer care pathway. Responses were dichotomised into optimal evaluation (answered strongly agree) and non-optimal (answered agree, disagree or strongly disagree).

Results: For other hospitals than Vejle, the introduction of urgent referral entailed an increase in the proportion of optimal patient evaluations. Non-optimal patient evaluations of waits until diagnosis were significantly associated with longer secondary care interval for both Vejle Hospital and other hospitals.

Conclusion: The introduction of urgent referral was associated with an increase in the proportion of patients who evaluated coherence in the cancer care pathway as being optimal. The association found between the general practitioner-reported length of the secondary interval and the patients’ evaluation of the waiting time shows that patients are capable of evaluating their diagnostic pathway.

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Introduction

In 2007, a long time interval from the first referral from primary care until treatment (referred to as the secondary care interval (1)) was documented for Danish cancer patients (2-4). Further, patients felt a lack of continuity in the organisation of their care pathway and that transition from the primary to the secondary sector often was cumbersome (5). To reduce the secondary care interval and ease the patients’ care pathways, the Danish government therefore decided to introduce urgent referral for suspected cancer. This national decision was based on pioneer experience from a Danish hospital (Vejle), which had begun working with care pathways in 1995 and had introduced the first urgent referral pathway for lung cancer in 1999. The Vejle model proved suitable for care pathways under time pressure (6).

The importance of providing fast diagnosis and treatment of cancer to ensure optimal prognosis is intuitive, even though studies of the effects have produced contradictory results (7-9). The psychological distress the patients experience due to unwarranted waits is equally intuitive and has been shown to be an important factor in patients’ evaluation of health care services (10).

Next to outcomes such as mortality, morbidity, quality of life, and health care costs, patients’ evaluation of care is increasingly seen by practitioners, administrators and policy makers as an important outcome (11;12). Methodological and conceptual issues in patient evaluation are many. However, it has been shown that patients’ evaluation of health care can be distinguished from their evaluation of health and from their experiences with health or health care (13). Further, measures of patients’ perceptions have been shown to be as robust in terms of reliability and reproducibility as physiological and other medical outcomes (14). Finally, patients have important insights about care provision that can only be assessed by the patients themselves, and evidence has shown that besides being an important outcome measure related to improvements in health status, patient evaluations may be used to choose between alternative methods of organising or providing health care (14).

Urgent referral for suspected cancer was implemented nationally for breast, lung, colorectal and head and neck cancers 1 April 2008 (15). However, knowledge of how patients evaluate coherence in the care pathway and whether patient evaluations of the care pathway changed owing to the introduction of urgent referrals is sparse. The aim of this study was therefore to analyse how patients evaluated the cancer care pathway during the introduction of urgent referral for suspected cancer and if there was any association between their evaluations and the secondary care interval. Further, the study analysed if changes in patient evaluations differed between patients discharged from other hospitals and patients discharged from Vejle Hospital, which had introduced urgent referral years before urgent referral was introduced nationally.

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Method


The study was designed as a population-based observational study conducted among incident cancer patients in the Central Denmark Region and the Region of Southern Denmark. The two regions have approx. 2.4 million inhabitants (44% of the Danish population) and approx. 14,000 new cancer cases pr. year. Data were collected from several registers and comprehensive questionnaires sent to patients and their general practitioners (GPs).

Vejle hospital is situated in the Region of Southern Denmark and its oncological ward is one of six Danish cancer centres. The ward performs 38,000 outpatient consultations per year and in-patients consume 7,500 bed days per year.

Denmark’s publicly funded healthcare system provides free access to general practice and hospital care. More than 98% of the Danish citizens are registered with a GP who acts as a gatekeeper to the rest of the healthcare system by carrying out initial diagnostic investigations and referring patients to secondary care when necessary. All Danish GPs keep electronic medical records of their patients.

Sampling procedure

In Denmark, each hospital admission and outpatient visit is coded and stored in regional patient administrative systems (PAS), which feed the National Patient Register (16). Patients were sampled from PAS based on discharge date and diagnosis and the additional code AZCA1, which specifies that the cancer was reported for the first time by the ward (17). Patients were excluded if they were already registered on a national list of all cancer diagnoses from 1994 to 1 October 2007 which was extracted from the National Patient Registry. This list was updated monthly by adding the sampled patients. The monthly sampling continued for one year from 1 October 2007, but some patients were registered later than one month after their diagnosis and were therefore missed as the algorithm only sampled one month back. Further, the AZCA1 code was used ambiguously which induced inaccuracies in the inclusion. An additional sampling without the AZCA1 code as inclusion criterion was therefore performed in October 2009.

Data collection

The GP provided information on the date of first referral to the secondary health care, from which time the GP has no further responsibility for the diagnostic process, and on the date of treatment start. Furthermore, the GP provided information on whether the diagnostic pathway was initiated in general practice or not and whether the GP regarded the initial symptoms as alarm symptoms of cancer or not. The GPs were not invited to exclude patients, but we followed their recommendation if they advised against sending questionnaires to patients due to factors like dementia or severe illness. Questionnaires were sent to the GPs within one month after the patient’s inclusion. Reminders were sent after three weeks. The GPs were remunerated for their participation (approx. 16 €).

A literature search identified no validated questionnaires covering patients’ evaluation of the entire cancer care pathway. Ad hoc questions were therefore developed and used together with questions previously used within the research area (18-20). The questions

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were pilot-tested both qualitatively (interviews) and quantitatively (sent to 350 patients) to ensure feasibility and validity. The questionnaire was sent to the patients six months after their inclusion into the study. Non-responders received a reminder after three weeks. Patients received no remuneration.

Outcome measures

The secondary care interval was calculated from the GP-reported date of the first referral and the GP-reported date of treatment start. Where only the date of the first referral was reported by the GP, the interval was approximated by the GP-reported date of referral and the date of hospital admission as the date of treatment.

Patients evaluated the cancer care pathway on the basis of five items describing the concept of patient-experienced cancer care pathway coherence. The items covered the collaboration between GP and the hospital, information about the care pathway, satisfaction with the plans of the care pathway being followed, the overall organisation of the care pathway and waits until diagnosis. For each item, patients could respond strongly disagree, disagree, agree, strongly agree, do not know or not relevant. Responses were dichotomised into optimal evaluation if patients answered strongly agree and non-optimal if patients answered agree, disagree or strongly disagree (improvement possible).

Analyses

Data analyses were restricted to patients with a diagnostic pathway initiated in primary care, since the pathway of interest was that where the GP refers the patient to further diagnostic work-up in secondary care (the main route for cancer diagnosis in Denmark (2)).

Patients were categorised as diagnosed before or after introduction of the urgent referral if they were admitted to hospital before or after 1 April 2008, respectively. Further, patients were divided into groups according to whether they presented with alarm symptoms or not and whether they were discharged from Vejle Hospital or other hospitals.

The secondary care interval is presented as medians with inter-quartile intervals (IQI) because data were not normally distributed. Trends in monthly differences in optimal patient evaluations were tested by non-parametric trend tests across ordered groups. Associations were calculated with a generalized linear model with log link for the binomial family with robust variance that took the clustering of patients within each general practice into account. Associations are presented as prevalence rate ratios (PRRs) since the odds ratio would have overestimated the prevalence ratio due to the high proportion of optimal evaluations (21). Three models were used: 1) unadjusted, 2) adjusted for patient age, gender, cancer type and whether the patient presented with alarm symptoms or not, and 3) adjusted as in model 2 plus for secondary care interval. Differences in the secondary care interval between patient evaluations before and after the national introduction of urgent referral were tested by Wilcoxon rank-sum test. Estimates were given with 95% confidence intervals (95%CI) when relevant. Analyses were made using Stata 11.2.

74


Results

A total of 6,978 patients were sampled and GP questionnaires were returned for 5,816 (83.3%) of the patients. Patients of a non-responding GP were more likely to be older, male and diagnosed with prostate cancer than patients of responding GPs. Eight patients were excluded by the GP due to factors like dementia or severe illness. Further, 906 (15.6%) patients died before the questionnaires were sent. Thus, a total of 6,064 questionnaires were sent to patients, and 3,861 (63.7%) returned the questionnaire. Non-responding patients were more likely than responding patients to be males and more likely to have lung cancer with symptoms initially interpreted as alarm symptoms by the GP. No difference in response rate was observed between patients discharged from Vejle and patients discharged from other hospitals.

A total of 756 patients (13.0%) were excluded because their cancer care pathway bypassed primary care. Analyses of patient evaluations are thus based on 3,498 patients. Approximated secondary care intervals were calculated for 1,338 (26.4%) patients. The median secondary care interval was 39 days (IQI: 22; 72 days) when GP-reported and 32 days (IQI: 15; 67 days) when using the date of admission for the same patients.

Patient evaluation of coherence in the cancer care pathway

Overall, the proportion of optimal evaluations was higher for patients seen at Vejle Hospital than for patients admitted to other hospitals for all five coherence variables (GP-hospital collaboration: p=0.018; patient well-informed: p=0.015; plans were followed: p<0.001; pathway well-organised: p<0.001; wait until diagnosis: p<0.001). For patients discharged from other hospitals than Vejle, an increasing trend was observed in the proportion of optimal evaluations regarding feeling well-informed (p=0.038), feeling that the plans were being followed (p=0.025), feeling that the pathway was well-organised (p=0.034) and wait until diagnosis (p=0.004). For Vejle Hospital, no trends were observed in the proportion who gave optimal evaluation of the cancer care pathway (Figure 1).

Patient evaluation before and after introducing urgent referrals

At other hospitals than Vejle, a statistically significant association was observed for four of the five questions between optimal evaluations and the introduction of urgent referral (Table 2). Adjusted for patient and cancer characteristics, the association was strongest for “plans were followed” and “wait until diagnosis”. Adjusted for length of the secondary care interval, “plans were followed” was statistically significantly associated with urgent referral. These associations were not seen for patients discharged from Vejle Hospital where a tendency was seen towards an association between less optimal evaluation and the introduction of urgent referral (Table 2).

Before the introduction of urgent referrals, a statistically significant association between optimal patient evaluations and being discharged from Vejle Hospital prevailed for all five questions. When adjusted for patient characteristics and secondary care interval, the association remained significant for “pathway well-organised” and “plans were followed”. After the introduction of urgent referral, no statistically significant association between discharging hospital and patient evaluation was seen, except for waits until diagnosis (Table 3).

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Patient evaluation and length of the secondary care interval

Table 4 shows the median secondary care interval for patients with optimal patient evaluation compared with patients with non-optimal evaluation before and after the introduction of urgent referral for Vejle hospital and other hospitals. Note that for all groups, patients evaluating “wait until diagnosis” as optimal all had GP-reported shorter secondary care intervals (Table 4).

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Discussion

Main findings

The proportion of optimal evaluations rose over time at other hospital than Vejle for four of five coherence variables. Still, at all times the proportion of optimal patient evaluations was higher at Vejle Hospital for all five variables. Adjusting for the secondary care interval, we found that the likelihood that patients gave an optimal score to the item “plans were followed” remained significantly higher after introducing urgent referrals. This shows that introducing urgent referral also gave patients a feeling that the plans for their pathway were being followed.

Those patients from other hospitals than Vejle who gave non-optimal evaluations before the introduction of urgent referral for suspected cancer had significantly longer secondary care intervals (up to three weeks) than those who gave optimal evaluations. After the introduction of urgent referrals, this was still the case regarding GP-hospital collaboration and wait until diagnosis. Non-optimal patient evaluations of waits until diagnosis were significantly associated with longer secondary care interval. Thus, cancer patients are able to very precisely evaluate the status of their diagnostic pathway.


The study included a large population of cancer patients, and eligible patients were selected based on valid registries. The difficulties with the initial sampling algorithm may have caused selection bias because patients in the second sample did not receive a questionnaire because they were included up to two years after their diagnosis. Thus, the sample in this study included more females (52.6% vs. 47.2%) and more patients with breast cancer (19.6% vs. 10.2%) than the full sample. Combined with a higher response rate in these groups, the proportion of optimal patient evaluations in our study may be overestimated. However, this bias can be neglected in our comparative results because the same sampling algorithm was used both before and after introduction of urgent referrals. GP-induced selection bias is possible if patients of non-responding GPs had a different secondary care interval than patients of responding GPs. A greater reluctance to respond among GPs with a longer doctor interval could lead to shorter secondary care intervals because of a more obvious pathological picture. This bias may therefore lead estimates to go towards the null-hypothesis. The response rate among patients (63.7%) was satisfactory, but non-responders were mainly males and more likely to have lung cancer with symptoms initially interpreted as alarm symptoms by the GPs. We thus lack answers from patients who often have the shortest diagnostic interval due to severe illness.

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Recall bias is inherent in the retrospective design, and patient evaluations may be influenced by the result of the treatment. Further, the questions chosen as proxy variables for patient evaluation of coherence in the cancer care pathway may have induced information bias. Since no validated questions were available, we developed ad hoc questions. Literature has shown that patient evaluation is a multidimensional construct causing single global scores to possibly cover up divergent assessments of the quality of care. Further, single global scores may not cover all relevant aspects or they may not allow comparison between different settings (22). We therefore used five item and established contents and construct validity by a qualitative pilot test interviewing patients, quantitative pilot test and thorough literature search (23).

Because of the presence of a ceiling effect, only patients who answered strongly agree were regarded as having an optimal evaluation. This is in accordance with other findings which indicate that patients are reluctant to give directly negative evaluations and that agree is more likely to express that nothing bad happened than that care, in fact, was good (12;24;25).

The use of hospital admission date for those with missing date of treatment underestimated the secondary care interval for those with the longest interval. This approximation thus allowed us to secure statistical precision without excluding patients with possibly longer treatment intervals; yet, the direction of the bias is still towards the null hypothesis.

The population-based approach and the homogeneous structure of general practice make the results generalisable to the rest of Denmark and other settings where GPs act as gatekeepers.


The literature suggests that patient evaluation is largely dependent upon patient expectations (26;27). Expectations were not included in our study, but we may reasonably believe that the patients’ expectations changed after the introduction of urgent referrals because of the media’s attention. This is likely to explain the decrease in the proportion of optimal evaluations at Vejle Hospital after the introduction of urgent referrals; expectations may simply have increased as the public focus on urgent referrals suddenly intensified (3).

Consistent with our result, a recently published report from the Danish Cancer Society revealed that 53.5% of incident cancer patients evaluated the pathway until diagnosis as excellent, which indicates that there is room for improvement. Furthermore, one in four patients felt that their GP was inadequately informed about their treatment, which indicates lack of collaboration between the GPs and the hospitals (28).

Another study found an independent hospital effect on patient satisfaction which indicates that the role and impact of managerial interventions deserve further investigation (29).

78


Conclusion

More patients at other hospitals than at the pioneering Hospital in Vejle gave optimal evaluations of the coherence in their cancer care pathway after the national introduction of urgent referral for suspected cancer. Overall, patients from Vejle Hospital had more optimal evaluations, even after a minor decrease following the introduction of urgent referrals. The association between GP-reported length of the secondary interval and patient evaluation of waiting time to diagnosis shows that patients are capable of evaluating the status of their diagnostic pathway.

AcknowledgementsWe thank the participating GPs. Also thanks to the involved persons from the Central Denmark Region and the Region of Southern Denmark for assisting with the sampling of the patients. Thanks are also due to statistician Morten Fenger-Grøn. This work was funded by The Novo Nordic Foundation, the Danish Cancer Society and the Quality and Continuing Education Council for general practice in the Central Denmark Region and Region of Southern Denmark. National Research Centre for Cancer Rehabilitation is funded by The Danish Cancer Society.

Conflict of interestsThe funding sources had no involvement in the research process.

Ethics approval According to the Committees on Biomedical Research Ethics in the Central Denmark Region, the Act on the Biomedical Research Ethics Committee System and the act on the Processing of Biomedical Research Projects do not apply to this project. The study was approved by the Danish Data Protection Agency and the Danish National Board of Health.

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(2) Hansen RP, Vedsted P, Sokolowski I, Sondergaard J, Olesen F. Time intervals from first symptom to treatment of cancer: a cohort study of 2,212 newly diagnosed cancer patients. BMC Health Serv Res 2011;11:284.:284.

(3) Probst HB, Hussain ZB, Andersen O. Cancer patient pathways in Denmark as a joint effort between bureaucrats, health professionals and politicians -A national Danish project. Health Policy 2011 [eoub ahead of print].

(4) Olesen F, Hansen RP, Vedsted P. Delay in diagnosis: the experience in Denmark. Br JCancer 2009;101(Suppl 2):5-8.

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(7) Rutqvist LE. Waiting times for cancer patients -a “slippery slope” in oncology. Acta Oncol 2006;45:121-3.

(8) Rupassara KS, Ponnusamy S, Withanage N, Milewski PJ. A paradox explained? Patients with delayed diagnosis of symptomatic colorectal cancer have good prognosis. Colorectal Dis 2006;8:423-9.

(9) Torring ML, Frydenberg M, Hansen RP, Olesen F, Hamilton W, Vedsted P. Time to diagnosis and mortality in colorectal cancer: a cohort study in primary care. Br J Cancer 2011;104(6):934-40.

(10) Robinson KM, Christensen KB, Ottesen B, Krasnik A. Diagnostic delay, quality of life and patient satisfaction among women diagnosed with endometrial or ovarian cancer: a nationwide Danish study. Qual Life Res 2011 [epub ahead of print].

(11) Grol R, Wensing M, Mainz J, Jung HP, Ferreira P, Hearnshaw H, et al. Patients in Europe evaluate general practice care: an international comparison. Br J Gen Pract 2000;50(460):882-7.

(12) Sitzia J, Wood N. Patient satisfaction: a review of issues and concepts. Soc Sci Med 1997;45(12):1829-43.

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(13) Wensing M. Patients evaluate general practice - A method for assessing and improving care. Nijmeegen: SSN Nijmeegen; 1997.

(14) Fitzpatrick R. Surveys of patients satisfaction: Important general considerations. BMJ 1991;302:887-9.

(15) Danish Regions. Status for pakkeforløb på kræftområdet april 2010 [In Danish]. Available from: http://www.regioner.dk/Aktuelt/Nyheder/2010/Maj/~/media/ Fi ler/Sundhed/Kræftpakker/Status%20for%20pakkeforløb%20på%20 kræftområdet_april%202010.ashx. (Accessed 5-1-2012).


(17) The Danish National Board of Health. Fællesindhold for basisregistrering af sygehuspatienter [In Danish].Available from: http://www.sst.dk/Webudgivelser/ FaellesIndhold/Forside.aspx. (Accessed 21-12-2011).

(18) Danish Cancer Society. Kræftpatientens verden [In Danish]. Copenhagen: Danish Cancer Society; 2006.

(19) Jenkinson C, Coulter A, Bruster S. The Picker Patient Experience Questionnaire: development and validation using data from in-patient surveys in five countries. Int J Qual Health Care 2002;14(5):353-8.

(20) Unit of Patient-Percieved Quality. Patienters oplevelser på landets sygehuse 2006 [In Danish]. Copenhagen: Unit for Patient-Percieved Quality; 2007.

(21) Barros AJ, Hirakata VN. Alternatives for logistic regression in cross-sectional studies: an empirical comparison of models that directly estimate the prevalence ratio. BMC Med Res Methodol 2003;3:21.

(22) Measurement of patients’ satisfaction with their care. 1 ed. London: Royal College of Physicians of London; 1993.

(23) Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 2010;63(7):737-45.

(24) Staniszewska S, Henderson L. Patients evaluations of their health care: the expression of negative evaluation and the role of adaptive strategies. Patient Educ Couns 2004 Nov;55(2):185-92.






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(25) Collins K, O’Cathain A. The continuum of patient satisfaction -from satisfied to very satisfied. Soc Sci Med 2003;57(12):2465-70.

(26) Pascoe GC. Patient satisfaction in primary health care: a literature review and analysis. Eval Program Plann 1983;6(3-4):185-210.

(27) Sofaer S, Firminger K. Patient perceptions of the quality of health services. Annu Rev Public Health 2005;26:513-59.

(28) Danish Cancer Society. Kræftpatienters oplevelse med sundhedsvæsnet gennem udredning og behandling [In Danish]. Copenhagen: Danish Cancer Society; 2011.

(29) Sherlaw-Johnson C, Datta P, McCarthy M. Hospital differences in patient satisfaction with care for breast, colorectal, lung and prostate cancers. Eur J Cancer 2008;44(11):1559-65.

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Hospitals other than Vejlen (%)

Vejle Hospitaln (%) p-value*

All 5,198 (83.5) 1,024 (16.5)Sex

Male 2,568 (49.4) 363 (35.5) <0.001Female 2,630 (50.6) 661 (64.6)

Age (years)18-49 622 (12.0) 155 (15.1) <0.00150-69 2,581 (49.7) 536 (52.3)



Lung 580 (11.2) 142 (13.9) 0.013Melanoma 228 (4.4) 126 (12.3) <0.001

Prostate 32 (3.1) 695 (13.4) <0.001Other 2,042 (39.3) 240(23.4) <0.001

Alarm symptomsYes 2,464 (59.3) 506 (64.2) 0.010No 1,691 (40.7) 282 (35.8)


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Article III

Figure 1 Changes in patient evaluation during introduction of urgent referrals for suspected cancer: monthly proportion of optimal evaluation in percentage

0

10

20

30

40

50

60

70

Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Mar-08 Apr-08 May-08 Jun-08 Jul-08 Aug-08 Sep-08

Hospitals other than Vejle

GP-hospital collaboration Patient well-informed Plans were followed

Pathway well-organised Wait until diagnosis

0

10

20

30

40

50

60

70


Vejle Hospital

GP-hospital collaboration Patient well-informed Plans were followed

Pathway well-organised Wait until diagnosis

Note: Urgent referral for suspected cancer was introduced April 2008

84


Tabl

e 2

Asso

ciati

ons (

prev

alen

ce ra

te ra

tio (P

RR) b

etw

een

optim

al p

atien

t eva

luati

ons a

nd in

trod

uctio

n of

urg

ent r

efer

rals

for s

uspe

cted

can

cer

* Ad

just

ed fo

r pati

ent a

ge, g

ende

r, ca

ncer

type

and

whe

ther

the

patie

nt p

rese

nted

with

ala

rm sy

mpt

oms o

r not

**

Adju

sted

for p

atien

t age

, gen

der,

canc

er ty

pe, w

heth

er th

e pa

tient

pre

sent

ed w

ith a

larm

sym

ptom

s or n

ot a

nd le

ngth

of s

econ

dary

car

e in

terv

al

Hosp

itals

oth

er th

an V

ejle

Ve

jle H

ospi

tal

Befo

re

urge

nt

refe

rral

n

(%)

After

ur

gent

re

ferr

al

n (%

)

Cr

ude

PRR

(95%

CI)

Ad

just

ed*

PRR

(95%

CI)

Ad

just

ed**

PR

R (9

5% C

I)

Befo

re

urge

nt

refe

rral

n

(%)

After

ur

gent

re

ferr

al

n (%

)

Cr

ude

PRR

(95%

CI)

Ad

just

ed*

PRR

(95%

CI)

Ad

just

ed**

PR

R (9

5% C

I) GP

-hos

pita

l col

labo

ratio

n 33

7 (3

3.1)

27

8 (3

6.1)

1.

09

(0.9

6; 1

.24)

1.

05

(0.9

2; 1

.21)

1.

02

(0.8

9; 1

.18)

82

(42.

5)

69 (3

9.0)

0.

92

(0.7

1; 1

.19)

0.

96

(0.7

3; 1

.27)

0.

98

(0.7

4; 1

.31)

Patie

nt w

ell-i

nfor

med

57

2 (3

9.4)

50

4 (4

4.7)

1.

14

(1.0

3; 1

.25)

1.

11

(1.0

0; 1

.23)

1.

09

(0.9

8; 1

.22)

14

7 (4

9.7)

12

2 (4

4.7)

0.

90

(0.7

5; 1

.07)

0.

94

(0.7

7; 1

.15)

0.

97

(0.7

9; 1

.19)

Plan

s wer

e fo

llow

ed

554

(38.

9)

502

(45.

1)

1.16

(1

.06;

1.2

7)

1.16

(1

.05;

1.2

9)

1.16

(1

.04;

1.2

9)

154

(52.

0)

126

(46.

8)

0.90

(0

.77;

1.0

6)

0.88

(0

.73;

1.0

6)

0.89

(0

.73;

1.0

8)

Path

way

wel

l-org

anise

d 57

2 (4

0.1)

50

3 (4

5.1)

1.

13

(1.0

3; 1

.23)

1.

09

(0.9

8; 1

.21)

1.

09

(0.9

8; 1

.21)

17

1 (5

8.8)

13

5 (5

0.9)

0.

87

(0.7

4; 1

.01)

0.

84

(0.7

0; 1

.00)

0.

86

(0.7

2; 1

.03)

Wai

t unti

l dia

gnos

is 46

4 (3

2.2)

42

3 (3

7.7)

1.

17

(1.0

5; 1

.30)

1.

13

(1.0

1; 1

.27)

1.

06

(0.9

3; 1

.20)

13

7 (4

6.3)

12

3 (4

5.7)

0.

99

(0.8

3; 1

.18)

1.

10

(0.9

1; 1

.34)

1.

07

(0.8

7; 1

.31)

85

Article III

Table 3 Associations (prevalence rate ratio (PRR)) between optimal patient evaluations and discharging hospital (Vejle vs. others). For numbers see Table 2

* Adjusted for patient age, gender, cancer type and whether the patient presented with alarm symptoms or not**Adjusted for patient age, gender, cancer type, whether the patient presented with alarm symptoms or not and length of secondary care interval

Other vs. Vejle Before urgent referral After urgent referral

Crude PRR

(95% CI)

Adjusted* PRR

(95% CI)

Adjusted** PRR

(95% CI)

Crude PRR

(95% CI)

Adjusted* PRR

(95% CI)

Adjusted** PRR

(95% CI) GP-hospital collaboration 1.28

(1.05; 1.57) 1.23

(0.96; 1.57) 1.17

(0.91; 1.52) 1.08

(0.87; 1.34) 1.16

(0.92; 1.46) 1.16

(0.91; 1.48) Patient well-informed 1.26

(1.10; 1.44) 1.21

(1.04; 1.42) 1.17

(1.00; 1.38) 1.00

(0.86; 1.16) 1.07

(0.91; 1.27) 1.06

(0.90; 1.26) Plans were followed 1.34

(1.18; 1.52) 1.31

(1.13; 1.51) 1.25

(1.08; 1.46) 1.04

(0.90; 1.20) 1.06

(0.89; 1.26) 1.01

(0.85; 1.20) Pathway well-organised 1.47

(1.30; 1.65) 1.44

(1.25; 1.65) 1.37

(1.19; 1.58) 1.13

(0.99; 1.30) 1.16

(0.99; 1.37) 1.11

(0.94; 1.31) Wait until diagnosis 1.44

(1.25; 1.65) 1.24

(1.06; 1.46) 1.15

(0.98; 1.36) 1.21

(1.04; 1.41) 1.20

(1.02; 1.42) 1.18

(0.98; 1.41)

86


Table 4 Comparison of the secondary care interval (median days with inter-quartile interval (IQI) between patient evaluations before and after the introduction of urgent referral for suspected cancer

Hospitals other than Vejle Vejle Hospital Before urgent

referrals After urgent

referrals

Before urgent referrals

After urgent referrals

Median

(IQI) p-value Median



(IQI) p-value

GP-hospital collaboration Optimal (n=583) 35 (20; 67) 0.001 29 (16; 55) 0.005 27 (19; 35) 0.180 22 (15; 33) 0.146

Non-optimal (n=1,080) 46 (25; 85) 39 (20; 75) 31 (17; 49) 27 (15; 54) Patient well-informed

Optimal (n=995) 41 (24; 75) 0.039 36 (23; 67) 0.692 30 (22; 40) 0.871 22 (15; 36) 0.086 Non-optimal (n=1,360) 47 (25; 89) 37 (18; 68) 30 (17; 49) 29 (15; 53)

Plans were followed optimal (n=1,582) 40 (23; 67) 0.001 37 (20; 69) 0.856 29 (22; 40) 0.587 22 (15; 36) 0.064

Non-optimal (n=86) 49 (25; 90) 36 (19; 68) 31 (17; 50) 29 (18; 52) Pathway well-organised

Optimal (n=1,567) 38 (22; 65) <0.001 35 (18; 66) 0.310 29 (21; 40) 0.213 23 (15; 36) 0.057 Non-optimal (n=92) 50 (27; 93) 37 (20; 72) 33 (20; 50) 29 (18; 55)

Waits until diagnosis Optimal (n=1,408) 31 (19; 55) <0.001 28 (16; 51) <0.001 27 (21; 35) 0.012 22 (14; 32) 0.002

Non-optimal (n=259) 52 (28; 95) 42 (22; 78) 33 (31; 57) 31 (16; 58)

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Article IV

ARTICLE IV

General practitioners’ evaluation of urgent referral for suspected cancer

– Results from a natural experiment in Denmark

Submitted for publication in Family Practice










Correspondence:

Mette Bach Larsen


Aarhus University

Bartholins Allé 2

DK-8000 Aarhus C, Denmark. Words in abstract: 279




88


AbstractBackground: To reduce the secondary care interval and increase coherence in the care pathway for Danish cancer patients, urgent referral for suspected cancer was introduced nationally in April 2008 based on experience from Vejle Hospital. However, knowledge on how health professionals evaluate urgent referral is scarce. Objective: To analyse how GPs evaluated their patients’ cancer care pathway and if there were any associations between 1) GP evaluations and the secondary care interval and 2) GP evaluations and discharging hospital (Vejle or not).Methods: The study was a population-based observational study of 6,518 incident cancer patients. The secondary care interval was calculated from the GP-reported date of the first referral and the reported date of treatment start. The GPs evaluated the cancer care pathway on the basis of five items where pathways were categorised as being optimal if GPs answered ‘strongly agree’. Data were analysed using non-parametric methods and a generalized linear model with log link for the binomial family.Results: Introduction of urgent referral for suspected cancer increased the proportion of optimal GP evaluations. GPs with patients discharged from Vejle Hospital had most optimal evaluations, also when data were adjusted for the length of the secondary interval. Patients with non-optimal GP evaluations had an up to three-week longer secondary care interval than patients with optimal GP evaluations.

Conclusion: The national introduction of urgent referral for suspected cancer increased the proportion of optimal GP evaluations. The GPs had distinct knowledge of their patients’ care pathways which was reflected in the association between the secondary care interval and the GPs’ evaluations. Further research is needed to determine how this knowledge can be used to further improve patients’ cancer care pathway.

89

Article IV

Introduction

The general practitioners (GPs) play an important role in the care pathway for Danish cancer patients. They are involved in diagnosing 85% of all cancers (1), and 90% of all cancer patients visit their GP within one year after treatment (2). Similar results are found in other countries where the GP serves as a gatekeeper to the specialised healthcare sector (3;4). Danish GPs are informed about discharge diagnosis and any procedures undertaken when a patient listed in the practice is discharged from hospital. So, even though the GP is not always directly involved in the entire pathway, (s)he is the only health professional with knowledge of the entire cancer care pathway.

The documentation of the existence of a long time interval from the first referral from the GP to secondary care until cancer treatment start (referred to as the secondary care interval (5)) in 2007 (1;6;7) made the Danish government decide to introduce urgent referral for suspected cancer at the national level. This decision was based on positive experience from the implementation of urgent referral at a regional hospital, Vejle Hospital, which started to work systematically with care pathways in 1995. In 1999, the hospital introduced its first urgent referral for lung cancer, and because the model proved suitable for care pathways under time pressure, it was extended to other types of cancer at Vejle Hospital (8).

Urgent referral for suspected cancer was implemented nationally for breast, lung, colorectal and head and neck cancers on 1 April 2008 (9). In a previous study, we showed that the introduction of urgent referral positively influenced the patient’s evaluation of coherence in the cancer care pathway. However, knowledge on how the introduction was evaluated by professionals is scarce. The aim of the present study was therefore to analyse how GPs evaluated the cancer care pathway during the introduction of urgent referral for suspected cancer. We also analysed possible associations between GP evaluations and the secondary care interval and between GPs evaluations and discharging hospitals, since Vejle Hospital had introduced urgent referral years before urgent referral was introduced nationally.

90


Material and methods


The study was a population-based observational study conducted among incident cancer patients in the Central Denmark Region and the Region of Southern Denmark. The two regions have approx. 2.4 million inhabitants (44% of the Danish population) and approx. 14,000 new cancer cases pr. year.

Vejle Hospital is situated in the Region of Southern Denmark and its oncological ward is one of six Danish cancer centres. The oncological ward performs 38,000 outpatient consultations per year and in-patients consume 7,500 bed days per year.

Denmark’s publicly funded healthcare system provides free access to general practice and hospital care. More than 98% of the Danish citizens are registered with a GP who acts as a gatekeeper to the rest of the healthcare system by referring patients to hospitals or outpatient clinics when necessary. Danish GPs keep medical records of their patients. The records also include information from discharge letters for each hospital stay their patients have had.

Sampling procedure

In Denmark, each hospital admission and outpatient visit is coded and stored in regional patient administrative systems (PASs), which feed the National Patient Register (10). Patients were sampled from PAS based on discharge date and diagnosis and the additional code AZCA1, which specifies that the cancer was reported for the first time by the ward (11). Patients were excluded if they were already registered on a national list of all cancer diagnoses from 1994 to 1 October 2007, which was extracted from the National Patient Registry. This list was updated monthly by adding the sampled patients. The monthly sampling continued for one year from 1 October 2007, but some patients were registered later than one month after their diagnosis and were therefore missed as the algorithm only sampled one month back. Furthermore, the AZCA1 code was used unsystematically, which induced inaccuracies in the inclusion. An additional sampling without the AZCA1 code as inclusion criterion was therefore performed in October 2009.

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Article IV

Data collection

A literature search identified no validated questionnaires that could be used for assessing GPs’ evaluation of patient care pathways and therefore ad hoc questions were developed based on the research group’s experience from prior studies of the cancer care pathway (12). The GP provided information on the date of first referral to the secondary health care, from which time the GP has no further responsibility for the diagnostic process, and on the date of treatment start. Furthermore, the GP provided information on whether the diagnostic pathway was initiated in general practice or not and whether the GP clearly indicated his or her cancer suspicion in the first referral to secondary healthcare or not. Reminders were sent after three weeks. The GPs were remunerated for their participation (approx. 16 €).

Outcome measures

The secondary care interval was calculated based on the GP-reported date of the first referral and the GP-reported date of treatment start. Where only the date of the first referral was reported by the GP, the interval was approximated by the GP-reported date of referral and the date of hospital admission as the date of treatment.

The GPs evaluated the cancer care pathway on the basis of five items covering the overall wait from the patients’ first symptoms until diagnosis, the overall wait from the diagnosis until treatment, the organisation of the care pathway, the inter-sectoral collaboration and the overall coherence in the care pathway. Questionnaires were sent to the GPs within one month after the patients’ inclusion.

For each item in the evaluation of the cancer care pathway, GPs could respond strongly disagree, disagree, agree, strongly agree, do not know or not relevant. Responses were dichotomised into optimal evaluation if GPs answered strongly agree or non-optimal evaluation (i.e. improvement was possible) if GPs answered agree, disagree or strongly disagree.

Analyses

Data analyses were restricted to patients with a diagnostic pathway initiated in primary care, since the pathway of interest was that where the GP refers the patient to further diagnostic work-up in secondary care.

Patients were categorised as diagnosed before or after the introduction of the urgent referral if they were admitted to hospital before or after 1 April 2008, respectively. Patients were further divided into groups according to whether the GP stated that (s)he clearly mentioned cancer suspicion in the first referral or not.

The secondary care intervals are presented as medians with inter-quartile intervals (IQI) because data were not normally distributed. Trends in monthly differences in optimal GP

92


evaluations were tested by non-parametric trend tests across ordered groups. Associations were estimated by a generalized linear model with log link for the binomial family with robust variance that took the clustering of patients within each general practice into account. Associations are presented as prevalence rate ratios (PRRs) since the odds ratio would have overestimated the prevalence ratio because of the high proportion of optimal evaluations (13). Three models were used: 1) unadjusted, 2) adjusted for patient age, gender, cancer type and whether the patient presented with alarm symptoms or not, and 3) adjusted as in Model 2 plus for the secondary care interval. Differences in the secondary care interval between GP evaluations before and after the national introduction of urgent referral were tested by Wilcoxon rank-sum test. Estimates were given with 95% confidence intervals (95%CI) when relevant. Analyses were made using Stata 11.2.

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Results

The dual sampling procedure identified 10,950 incident cancer patients during the study period, and a GP-questionnaire was completed for 8,543 (78.0%) of the patients. Patients with a non-responding GP were more likely to be older males, fewer had breast and lung cancers and more had prostate cancer compared with patients with a responding GP. No statistically significant difference in response rate was observed between GPs with patients discharged from Vejle Hospital and GPs with patients discharged from other hospitals. Patients discharged from Vejle Hospital were statistically significantly more likely to be females, younger at age, and diagnosed with breast cancer than patients discharged from other hospitals (Table 1).

The pathway bypassed primary care for 1,326 (12.9%) patients. They were excluded together with 699 (9.7%) patients for whom we had no information about the secondary care interval. A total of 6,518 patients were included in the analyses, 775 (11.9%) of whom were discharged from Vejle Hospital.

In 2,024 (31.1%) patients, the secondary care intervals were approximated by use of the date of hospital admission instead of the GP-reported date of treatment start. The percentage of patients in whom the secondary care interval was estimated in this way was the same before and after the introduction of urgent referral for suspected cancer (p=0.983). GP information on treatment start was missing more frequently for patients discharged from other hospitals than Vejle Hospital (p=0.001) and for patients in whose secondary care referral letters the GP had not indicated cancer suspicion (p<0.001).

GPs’ evaluation of coherence in the cancer care pathway

For GPs whose patients had been discharged from other hospitals, the introduction of urgent referral gave rise to a trend in the form of a larger proportion of optimal GP evaluations, except for waits until diagnosis and waits from diagnosis to treatment. For Vejle Hospital, no trends in the proportion of optimal evaluations of the cancer care pathway were seen following the introduction of urgent referral. Overall, the proportion of optimal evaluations was higher for Vejle Hospital than for others hospitals for all coherence variables (p<0.001 for all five variables).

94


Associations between GPs’ evaluation and national introduction of urgent referral for suspected cancer

At other hospitals than Vejle Hospital, the proportion of optimal evaluations rose by 10-14% after the introduction of urgent referrals (Table 2). Adjustment for the length of the secondary care interval yielded a more optimal GP evaluation of the overall organisation and the inter-sectoral collaboration. For Vejle Hospital, no association was seen between GPs’ evaluation and the national introduction of urgent referrals (Table 2).

Associations between GPs’ evaluation and discharging hospital

Both before and after the introduction of urgent referral for suspected cancer, the proportion of optimal GP evaluations was higher for patients discharged from Vejle Hospital than for patients discharged from other hospitals (Table 3). Following adjustment for the secondary care interval, this association was significant for waits from diagnosis to treatment and for the overall organisation of care before the introduction of urgent referrals (Table 3).

Associations between GPs’ evaluation and the secondary care interval

Patients whose pathway GPs evaluated as non-optimal had a significantly longer (i.e. more than three weeks) secondary care interval when discharged from other hospitals than Vejle Hospital (Table 4). Patients discharged from Vejle Hospital with a non-optimal GP evaluation had a longer secondary care interval (approx. one week) before the introduction of urgent referral, whereas it was two to three weeks longer after the introduction of urgent referral (Table 4).

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Article IV

Discussion

Main findings

Before the introduction of urgent referral, the proportion of optimal GP evaluations of the cancer care pathway was higher for GPs whose patients had been discharged from Vejle Hospital than among GPs whose patients had been discharged from other hospitals. The introduction of urgent referral spurred a rise in the proportion of optimal GP evaluations from hospitals other than Vejle Hospital. Still, GPs with patients discharged from Vejle Hospital had more optimal evaluations of the overall organisation and the waits from diagnosis to treatment than other hospitals, even when adjusted for the length of the secondary interval. An important finding of this study was that patients with non-optimal GP evaluations had an up to three-week longer secondary care interval than patients whose GPs gave an optimal evaluation.


The insufficiency of the first sampling algorithm invited two problems in the form of an increased risk of recall bias and an increased risk of selection bias. Recall bias could influence the secondary care interval and the categorisation of patients according to cancer suspicion in the first referral to secondary healthcare. We do, however, believe that recall bias was negligible since all information was available in the patients’ medical records. We have no reason to believe that GPs would tend not to respond if they considered the secondary care interval too long. Selection bias would also tend to underestimate the association. The items used to assess the GPs’ evaluation of coherence may also contain information bias. Since no validated questions were available, ad hoc questions were developed based on a literature search and previously used questionnaires in an effort to optimise contents validity. Construct validity was optimised by performing a qualitative pilot test.

The considerable size of our study sample ensures a high level of statistical precision. The use of the hospital admission date for those whose date of treatment was missing underestimated the secondary care interval for those with the longest interval. This approximation thus allowed us to secure statistical precision without excluding patients with possibly longer treatment intervals; yet, the direction of the bias is still towards the null hypothesis.

However, there might be residual confounding due, e.g., to GP characteristics about which we had no information. However, there is no reason to expect that GP characteristics would differ between patients discharged from Vejle Hospital and patients discharged other hospitals or before and after urgent referral was introduced. Thus, this could neither explain nor alter our conclusions.

The conclusions of this study are considered generalisable to other regions in Denmark and to other healthcare systems with a primary care where GPs act as gatekeepers. The

96


size of the possible effect of urgent referral will depend on the local context.


Other studies have also called upon GPs to assess organisational changes geared to improve the cancer care pathway. These studies found GP evaluation was more positive when they received tailored information from the hospitals than when no such information was received (14;15). This indicates that it takes relatively little to improve coherence and that this may be achieved by improving corporation and communication across sectors, which, in turn, would benefit the patients.

Other studies have found that the GPs are willing to engage in the entire cancer care pathway (16-18), and this study has documented that they are able to distinguish between coherent and non-coherent pathways. Further research is needed to determine how this knowledge can be utilized to further improve patients’ cancer care pathways.

Conclusion

The GPs had a distinct knowledge of their patients’ care pathway, which was reflected in the close association between the secondary care interval and the GPs’ evaluation. The national introduction of urgent referral increased the proportion of optimal GP evaluations at other hospitals than the pioneering one in Vejle, especially evaluations of the overall organisation of the cancer care pathway and the inter-sectoral collaboration. Further, the proportion of optimal evaluations was highest for Vejle Hospital, especially before introducing urgent referrals.

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Article IV

AcknowledgementsWe thank the participating GPs. Also thanks to the involved persons from the Central Denmark Region and the Region of Southern Denmark for assisting with the sampling of the patients. This work was funded by The Novo Nordic Foundation, the Danish Cancer Society and the Quality and Continuing Education Council for general practice in the Central Denmark Region and Region of Southern Denmark. National Research Centre for Cancer Rehabilitation is funded by The Danish Cancer Society.

Conflict of interestsThe funding sources had no involvement in the research process.

Ethics approval According to the Committees on Biomedical Research Ethics in the Central Denmark Region, the Act on the Biomedical Research Ethics Committee System and the act on the Processing of Biomedical Research Projects do not apply to this project. The study was approved by the Danish Data Protection Agency and the Danish National Board of Health.

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(6) Probst HB, Hussain ZB, Andersen O. Cancer patient pathways in Denmark as a joint effort between bureaucrats, health professionals and politicians -A national Danish project. Health Policy 2011 [epub ahead of print].

(7) Olesen F, Hansen RP, Vedsted P. Delay in diagnosis: the experience in Denmark. Br J Cancer 2009;101(Suppl 2):5-8.


(9) Danish Regions. Status for pakkeforløb på kræftområdet april 2010 [In Danish]. Available from: http://www.regioner.dk/Aktuelt/Nyheder/2010/Maj/~/media/ Fi ler/Sundhed/Kræftpakker/Status%20for%20pakkeforløb%20på%20 kræftområdet_april%202010.ashx. (Accessed 5-1-2012).





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(11) The Danish National Board of Health. Fællesindhold for basisregistrering af sygehuspatienter [In Danish]. Available from: http://www.sst.dk/Webudgivelser/ FaellesIndhold/Forside.aspx. (Accessed 21-12-2011).

(12) Hansen RP. Delay in the diagnosis of cancer [PhD thesis]. 1 ed. Aarhus: Faculty of Health Sciences, Aarhus University; 2008.

(13) Barros AJ, Hirakata VN. Alternatives for logistic regression in cross-sectional studies: an empirical comparison of models that directly estimate the prevalence ratio. BMC Med Res Methodol 2003;3:21.

(14) Kousgaard KR, Nielsen JD, Olesen F, Jensen AB. General practitioner assessment of structured oncological information accompanying newly referred cancer patients. Scand J Prim Health Care 2003;21(2):110-4.

(15) Jefford M, Baravelli C, Dudgeon P, Dabscheck A, Evans M, Moloney M, et al. Tailored chemotherapy information faxed to general practitioners improves confidence in managing adverse effects and satisfaction with shared care: results from a randomized controlled trial. J Clin Oncol 2008;26(14):2272-7.

(16) Mitchell GK. The role of general practice in cancer care. Aust Fam Physician 2008;37(9):698-702.

(17) Anvik T, Holtedahl KA, Mikalsen H. “When patients have cancer, they stop seeing me” The role of the general practitioner in early follow-up of patients with cancer -a qualitative study. BMC Fam Pract 2006;7:19.

(18) Grunfeld E. Cancer survivorship: a challenge for primary care physicians. Br J Gen Pract 2005;55(519):741-2.



100




n (%)

Vejle Hospital

n (%) p-value*

All 5,743 (88.1) 775 (11.9)Sex

Male 2,917 ( 50.8) 268 (34.6) <0.001Female 2,826 (49.2) 507 (65.4)

Age (years)18-49 690 (12.0) 124 (16.0) <0.00150-69 2,656 (46.3) 294 (51.4)



Lung 712 (12.4) 113 (14.6) 0.086Head and Neck 165 (2.4) 9 (1.2) 0.006

Prostate 746 (13.0) 19 (2.5) <0.001Other 2,506 (43.6) 278 (35.9) <0.001

Cancer suspicionYes 3,156 (63.6) 435 (66.4) 0.154No 1,809 (36.4) 220 (33.6)


101

Article IV

Figure 1 Changes in GP evaluation during introduction of urgent referrals for suspected cancer: monthly proportion of optimal evaluation in percentage

0

10

20

30

40

50

60



Waits until diagnosis Waits from diagnosis to treatment Overall organisation

Cross-sectional collaboration Coherence in the care pathway

0

10

20

30

40

50

60


Vejle Hospital

Waits until diagnosis Waits from diagnosis to treatment Overall organisation

Cross-sectional collaboration Coherence in the care pathway

Note: Urgent referral for suspected cancer was introduced April 2008

102


Tabl

e 2

Asso

ciati

ons (

prev

alen

ce ra

te ra

tio (P

RR))

betw

een

optim

al G

P ev

alua

tions

and

intr

oduc

tion

of u

rgen

t ref

erra

l for

susp

ecte

d ca

ncer

Hosp

itals

oth

er th

an V

ejle

Vejle

Hos

pita

l

Befo

re

urge

nt

refe

rral

n (%

)

After

ur

gent

re

ferr

aln

(%)

Crud

ePR

R(9

5% C

I)

Adju

sted

*PR

R(9

5% C

I)

Adju

sted

**PR

R(9

5% C

I)

Befo

re

urge

nt

refe

rral

n (%

)

After

ur

gent

re

ferr

aln

(%)

Crud

ePR

R(9

5% C

I)

Adju

sted

*PR

R(9

5% C

I)

Adju

sted

**PR

R(9

5% C

I)

Wai

ts u

ntil d

iagn

osis

723

(26.

7)74

3 (2

9.7)

1.11

( 1.0

2; 1

.22)

1.12

(1.0

3; 1

.23)

1.06

(0.9

7; 1

.15)

129

(39.

9)13

7(3

6.3)

0.91

(0.7

5; 1

.10)

0.93

(0.7

7; 1

.11)

0.94

(0.7

9; 1

.12)

Wai

ts fr

om d

iagn

osis

to tr

eatm

ent

819

(32.

8)84

8(3

6.3)

1.11

(1.0

2; 1

.20)

1.11

(1.0

3; 1

.21)

1.06

(0.9

8; 1

.15)

147

(46.

2)17

1(4

8.0)

1.04

(0.8

9; 1

.21)

1.04

(0.8

9; 1

.22)

1.02

(0.8

8; 1

.18)

Ove

rall

orga

nisa

tion

928

(32.

6)95

8(3

7.1)

1.14

(1.0

5; 1

.23)

1.14

(1.0

5; 1

.22)

1.09

(1.0

1; 1

.17)

153

(46.

0)18

3(4

7.0)

1.02

(0.8

8; 1

.19)

1.02

(0.8

9; 1

.17)

1.00

(0.8

7; 1

.13)

Inte

r-se

ctor

al c

olla

bora

tion

988

(35.

9)1,

004

(39.

6)1.

10(1

.03;

1.1

8)1.

11(1

.03;

1.1

9)1.

07(1

.00;

1.1

6)15

3(4

8.0)

200

(51.

8)1.

08(0

.93;

1.2

6)1.

09(0

.94;

1.2

6)1.

08(0

.93;

1.2

4)

Cohe

renc

e in

the

care

pat

hway

928

(33.

2)94

9(3

6.9)

1.11

(1.0

3; 1

.20)

1.12

(1.0

4; 1

.21)

1.07

(1.0

0; 1

.15)

145

(44.

3)17

7(4

6.0)

1.04

(0.8

9; 1

.20)

1.06

(0.9

2; 1

.22)

1.02

(0.8

9; 1

.18)

* Ad

just

ed fo

r pati

ent a

ge, g

ende

r, ca

ncer

type

and

whe

ther

the

GP in

dica

ted

canc

er su

spic

ion

in th

e fir

st re

ferr

al to

seco

ndar

y ca

re o

r not

**Ad

just

ed fo

r pati

ent a

ge, g

ende

r, ca

ncer

type

, whe

ther

the

GP in

dica

ted

canc

er su

spic

ion

in th

e fir

st re

ferr

al to

seco

ndar

y ca

re o

r not

and

le

ngth

of s

econ

dary

car

e in

terv

al

103

Article IV

Table 3 Associations (prevalence rate ratio (PRR)) between optimal GP evaluations and discharging hospital (Vejle vs. others). For numbers see Table 2

* Adjusted for patient age, gender, cancer type and whether the GP indicated cancer suspicion in the first referral to secondary care or not **Adjusted for patient age, gender, cancer type, whether the GP indicated cancer suspicion in the first referral to secondary care or not and length of secondary care interval

Other vs. Vejle Before urgent referral After urgent referral

Crude PRR

(95% CI)

Adjusted* PRR

(95% CI)

Adjusted** PRR

(95% CI)

Crude PRR

(95% CI)

Adjusted* PRR

(95% CI)

Adjusted** PRR

(95% CI) GP-hospital collaboration 1.28

(1.05; 1.57) 1.23

(0.96; 1.57) 1.17

(0.91; 1.52) 1.08

(0.87; 1.34) 1.16

(0.92; 1.46) 1.16

(0.91; 1.48) Patient well-informed 1.26

(1.10; 1.44) 1.21

(1.04; 1.42) 1.17

(1.00; 1.38) 1.00

(0.86; 1.16) 1.07

(0.91; 1.27) 1.06

(0.90; 1.26) Plans were followed 1.34

(1.18; 1.52) 1.31

(1.13; 1.51) 1.25

(1.08; 1.46) 1.04

(0.90; 1.20) 1.06

(0.89; 1.26) 1.01

(0.85; 1.20) Pathway well-organised 1.47

(1.30; 1.65) 1.44

(1.25; 1.65) 1.37

(1.19; 1.58) 1.13

(0.99; 1.30) 1.16

(0.99; 1.37) 1.11

(0.94; 1.31) Wait until diagnosis 1.44

(1.25; 1.65) 1.24

(1.06; 1.46) 1.15

(0.98; 1.36) 1.21

(1.04; 1.41) 1.20

(1.02; 1.42) 1.18

(0.98; 1.41)

104


Table 4 Comparison of the secondary care interval (median days with inter-quartile interval (IQI)) between GP evaluations before and after the introduction of urgent referral for suspected cancer

Hospitals other than Vejle Vejle Hospital

Before urgent referrals After urgent referrals Before urgent referrals After urgent referrals

Median (IQI) p-value Median (IQI) p-value Median (IQI) p-value Median (IQI) p-value Waits until diagnosis

Optimal (n=1,658) 26 (13; 44) <0.001 21 (12; 38) <0.001 27 (19; 35) <0.001 20 (10; 28) <0.001 Non-optimal (n=4,000) 50 (28; 89) 43 (23; 80) 33 (21; 62) 34 (20; 76)

Waits from diagnosis to treatment Optimal (n=1,895) 27 (14; 49) <0.001 22 (13; 42) <0.001 25 (16; 34) <0.001 20 (12; 31) <0.001

Non-optimal (n=3,371) 53 (30; 90) 47 (27; 84) 35 (26; 62) 35 (23; 72) Overall organisation

optimal (n=2,113) 28 (14; 46) <0.001 23 (13; 42) <0.001 27 (17; 35) <0.001 21 (12; 30) <0.001 Non-optimal (n=3,718) 52 (28; 93) 45 (25; 84) 33 (22; 63) 38 (20; 84)

Inter-sectoral collaboration Optimal (n=2,255) 28 (15; 48) <0.001 24 (13; 43) <0.001 28 (17; 36) <0.001 21 (12; 32) <0.001

Non-optimal (n=3,471) 52 (28; 92) 45 (25; 84) 35 (22; 67) 39 (21; 85) Coherence in the care pathway

Optimal (n=2,096) 28 (15; 46) <0.001 32 (16; 57) <0.001 28 (18; 35) <0.001 21 (12; 31) <0.001 Non-optimal (n=3,679) 52 (28; 92) 76 (42; 140) 35 (22; 63) 36 (20; 77)

105

Chapter 4 Discussion of methods

chaPter 4dIscussIon of methods

106


DATA VALIDITY

4.1.1 Design

The study was a population-based observational study with a before-after design. We

established a large cohort of incident cancer patients with the possibility of follow-up.

Data were collected retrospectively. Baseline data were obtained on dates in the clinical

pathway, symptoms and clinical findings together with evaluations. In this study, data

were analysed in a cross-sectional design.

Cross-sectional studies are primarily descriptive because they can say nothing about

causality (84). In spite of their limitations, the cross-sectional design is increasingly used to

seek information on effects (85) because it may be nearly as informative as a longitudinal

design with respect to causal hypothesis when exposures remain constant (86). Keeping

the study limitations in mind, we may therefore argue that the associations found in this

study may be causal. General practices only encounter few new cancer patients every year

so it would hardly have been feasible to use a prospective design in which, for example,

patients were followed, important milestones registered and data on those who got cancer

were extracted for analysis once cancer was diagnosed. The best design for answering the

question whether the introduction of early referral had an effect on the secondary care

interval was hence one that allowed us to make a before-after analysis on the one hand,

and to compare a possible effect achieved in the intervention group with that obtained

in a reference group (Vejle Hospital) on the other hand, where, in theory, the effect, if

any, should already have been obtained. We initially planned to analyse the effect of the

introduction of urgent referral in a comparative study between Vejle Hospital and the

other hospitals, but because of the national introduction of urgent referral for suspected

cancer the design ended up having characteristics much like those of a natural experiment.

The unique possibility of analysing the immediate influence of the urgent referral added a

further dimension to this study.

107


4.1.2 Sampling procedure

We developed a sampling algorithm based on administrative registries to identify an

incident cancer patient as close to the date of diagnosis as possible (Article I). At the end

of the study period, it became clear that the algorithm was not sufficient as fewer patients

than expected were included. Two sources were identified and an additional sampling

was performed. This introduced an increased risk of recall bias, an increased risk of non-

response from GPs and the problem that no questionnaires could be distributed to patients

identified in the second sample.

The first problem is considered to have no major impact since GPs have the information in

the patients’ electronic medical records. But the risk of non-response from GPs is reflected

in the response rate for the two samples (85.3% vs. 73.9%, Figure 3.1). Even though the

medical records are electronic, it is time-consuming to find the requested information, and

it might not seem relevant to the GPs to provide the requested information as the patients

could have been cured or be dead at the time of data collection. The lower response rate in

Sample 2 demonstrates the advantage in terms of response rates of addressing the GP as

soon as possible in relation to the actual cancer case. Because patients in the second sample

were included up to two years after diagnosis, it was decided not to send these patients

a questionnaire. We decided that the risk of recall bias was too great and that it would be

unethical to send a questionnaire requesting information about the diagnostic pathway up

to two years after the diagnosis of the cancer.

4.1.3 Non-response

As discussed in Article I, the total cohort of cancer patients is valid and representative,

and it provides a solid base for research and follow-up in the future. However, important

issues regarding non-response emerge, especially in relation to the patient questionnaires

because they were sent only to patients from Sample 1. In Sample 1, women with breast

cancer were overrepresented compared with the total sample. Furthermore, in Sample 1,

39.4% of the patients were aged 70+ compared to 51.4% in Sample 2. Finally, only 3.0% of

the patients in Sample 2 were discharged from Vejle compared with 16.6% of the patients

in Sample 2. Thus, according to Article II (Table 2), patients included in Sample 1 were

typically patients with short secondary care interval. Thus, the secondary care interval may

be underestimated in Sample 1. However, the sampling procedure was the same throughout

the study period which ensures the absence of bias in relation to the observational before-

after design. Out of the patients eligible for questionnaires 906 (13.0%) died before the

questionnaires were sent. They were primarily older, males and diagnosed with lung

cancer. However, there were no differences either in the proportion of dead patients before

108


and after the introduction of urgent referrals or between discharging hospitals (Table 3.2).

Thus, our comparative results should not be biased due to this specific patient selection.

However, the actual length of the intervals may be biased. A recent study has shown that

the risk of dying decreases with diagnostic intervals of up to five weeks and then increases,

which reflects that seriously ill patients have short intervals (29). Thus, the bias in our data

would tend to overestimate the secondary care interval. The questionnaire was completed

by a total of 3,861 (63.7%) of those who received it. Responding patients were more likely to

be younger, females and diagnosed with breast cancer than non-responding patients. Thus,

those who completed the questionnaire were also those who were overrepresented in the

sample. Furthermore, more patients completed the questionnaires before the introduction

of urgent referrals than after their introduction. The underestimation of the secondary care

interval would therefore have been more pronounced before the urgent referrals, which

caused us to underestimate the effect of the urgent referrals.

4.1.4 Quality of registries

The validity of data in the National Patient Register (NPR) has been examined continuously

since reporting became mandatory in the late 1970s. The most recent overall evaluation of

the NPR by the Danish National Board of Health in 1993 showed that the validity of the

administrative data on discharge date and contact reason was high (91-97%). The validity

of factors related to specific diagnoses was lower, i.e. the correct diagnosis was indicated for

73% (65.5-82.7%) of the patients (87). Since 1993, several diagnosis-specific analyses on the

validity of NPR have been made and they have all concluded that minor misclassifications

do exist in the NPR, but these misclassifications are unanimous and do not influence the

overall validity of the NPR data (67;68;87-90).

In the research group, we knew that some risks could be associated with the inclusion of

patients based on administrative registries because patients might be incorrectly registered.

Balancing out the need for on-time data, we decided that with the GP as an intermediary

before sending questionnaires to patients, this risk could be minimised. As discussed

in Article I, the algorithm has been further developed and is now feasible without GP

validation.

109


4.1.5 Quality of questionnaires

The quality of the GP questionnaire was subject to only a minor pilot test since the main

part of the questionnaire had been used in prior studies. Adjustments were made in the

questions concerning the pre-hospital diagnostic process. Even so, these questions (3.1-3.5,

Appendix B) proved to be difficult for the GPs and they were therefore not included in the

analyses. The pilot test gave no indication of these problems and it should therefore have

been more thorough. Further, the pilot test should have been more detailed concerning the

evaluation of the coherence of the patient care pathway to guarantee the validity of these

questions.

The patient questionnaire was subject to a comprehensive pilot test where both qualitative

and quantitative measures were applied to establish its validity. Concerning the patient

questionnaire, the number of questions was discussed within the research group. We tried

to balance out the obvious opportunity of getting data on a large cohort of patients against

the risk of non-response due to overload. Questions 1.68-1.78 and 1.79-1.83 (Appendix

C) were collected to be used in three other studies. With a response rate of 62.9% in this

vulnerable population, a reasonable balance seems to have been reached. An earlier, similar

study in Aarhus County had a response rate of 53% (72).

110


4.1.6 Processing questionnaire data

To maximise the completeness and validity of the questionnaire data, only two experienced

persons coded the questionnaires before scanning. This was done according to a manual

and the inter-rater reliability for the two persons was checked throughout the study period.

The same two persons did the scanning and verification.

4.1.7 Alternative methods

A randomised controlled trial is often preferred to demonstrate effect. However, an

experiment in which patients were allocated to a longer secondary care interval would

not be ethical. The best design for analysing the effects of introducing urgent referral

for suspected cancer was therefore the observational study. A principal difficulty in any

observational study is to establish unbiased causality. The influence of other factors cannot

be eliminated, which is possible in an experiment (84;86). We compensated for this by

adjusting for known factors and by using patients discharged from Vejle Hospital as

“controls” since urgent referral had been introduced at Vejle Hospital years before urgent

referrals were introduced nationally.

In this study, patients were sampled from administrative registries. Alternatively, patients

could have been sampled directly from hospital wards. This could potentially have increased

the possibility of on-time inclusion of patients. However, this sampling approach would

have required massive personnel resources, e.g. project nurses, and its sampling success

would critically depend on individual hospitals’ willingness and ability to participate

which would have entailed a considerable risk of incomplete sampling. As described in

Article I, the sampling procedure was further developed based on experiences from the

study reported in this Article. The most important lesson from the sampling algorithm

of this study was that clinical practice does not always abide by existing administrative

guidelines. Thus, in the sampling algorithm of the 2010 cohort, the administrative code

AZCA1 was not consistently used to identify incident patients and monthly updates of the

cohort included the previous months’ patients to ensure inclusion of patients registered

later than by the 10th of each month. So despite these challenges, discussed in Article

I, a valid and cost-saving algorithm with much potential for future research has been

developed.

The GPs’ response rates in the two samples indicated that the timing of the questionnaires

had an impact on the problems of non-response. Thus, in order to avoid missing data due

to non-response, the GPs must receive the questionnaires as close to diagnosis as possible.

Further, the timing of the patient questionnaires should be reconsidered. The fact that 13%

of the patients died before questionnaires were sent could imply that we should have sent

111


the questionnaires closer to diagnosis. However, the response rate of 53% in a study who

sent the questionnaires within one month of diagnosis (14) suggests that it is difficult to

avoid some degree of missing data in this patient group. Sending the questionnaire within

a month increases non-response and sending it after six months increases the risk that the

patients will be dead. Research has shown that patient satisfaction increases as time passes

(91), which could be another argument for sending the questionnaires closer to the date of

diagnosis; an argument which is further supported by the size of the ceiling effect in our

data.

The information obtained from the GPs via questionnaires could also have been obtained

by external coding of their medical records. One advantage of such an approach would

have been that the GP could not have interpreted the information they offered in the

questionnaire in the light of his/her knowledge of the patient’s cancer diagnosis. In a study

that compared the diagnostic interval (from first presentation of symptoms until diagnosis)

in data collected via QP questionnaires with data coded by researchers blinded to cancer

status, the median diagnostic interval was 44 days (IQI: 23-76 days) in the questionnaire

data but 97 days (IQI: 44-218 days) in the data from audited medical records (92). This

indicates that the GPs interpret their medical records differently than a blinded researcher.

Yet, the true interval remains unknown and we do not know whether this difference would

also be found in regard to the secondary care interval. Furthermore, resort to external

coding of medical records would have been very costly and time-consuming because of

the size of the present study. Moreover, the costs of the questionnaires could not have been

saved because we also wished to obtain the GP evaluations of the cancer care pathway.

Alternatives to the patient questionnaires could be interviews. The advantages of this

approach could be that some patients would have found it easier to overcome an interview

than to complete a questionnaire. However, patient interviews also involve methodological

challenges (93;94) and they would have been costly and time-consuming given the size of

the present study.

Finally, only patients with a cancer diagnosis were included in this study. Optimally,

patients in whom the GP initially had cancer suspicion should have been included

since they are much more common in general practice than patients who are eventually

diagnosed with cancer and also among those referred urgently. However, this was not

feasible within the present study.

112


OUTCOME MEASURES

4.2.1 The secondary care interval

The time interval analysed in this thesis spanned the interval from the first referral

from general practice to secondary care until treatment. The validity of this interval is

considered to be high, because it is calculated on the basis of factual dates that can be

found in the patients’ medical records. However, information on the secondary interval

was incomplete for 20% of the patients. For the most part, the date of treatment was not

filled in, mainly so because patients had not started treatment at the time when GPs filled

out the questionnaire. For those patients, the secondary care interval was estimated from

the GP-reported date of referral and the register-based hospital admission date. Missing

data is a common problem in surveys and since they are rarely random, they tend to bias

the results if only complete-case analyses are performed. Several statistical methods may

be used for imputation of missing data (95-98). None of these methods were suitable in the

present study because the missing date was factual and could not be estimated based on

other factors. We instead used an available date as an approximation of the real date which

also appeared to be well-suited for this purpose as it systematically underestimated the

interval. Thus, statistical precision was ensured by not excluding patients with possibly

longer secondary care intervals. At the same time, the direction of the bias towards the null

hypothesis was clearly known.

4.2.2 Patient evaluation

Since every cancer type runs a unique disease course, patients were at different stages of

disease when they received the questionnaire. This does, of course, affect both response

rate and the evaluation, but we found it impossible to set a more unifying time since every

cancer type comes with much variation in the course of its progression to more advanced

stages.

We wanted to identify patients in whom there was a potential for improving their

evaluations. Pathways where patients answered strongly agree were therefore defined as

optimally evaluated. This was consistent with other findings that have found that patients

are reluctant to offer directly negative evaluations and that agree is more likely to express

that nothing extremely bad happened than that care, in fact, was good (55;99;100).

The literature suggests that patient evaluations are largely dependent upon patient

expectations (60;61). Expectations were not included in our study, but it is reasonable to

anticipate that the patients’ expectations changed after the introduction of urgent referral

113


owing to the media’s attention and the heightened public awareness. This is likely to explain

the decrease in the proportion of optimal evaluations at Vejle Hospital after the introduction

of urgent referral since expectations may be higher for patients at Vejle Hospital because

they were admitted to a hospital that had already optimized its procedures. However, with

the observational design of the present study, it was not possible to blind patients to the

hospital to which they were admitted. Furthermore, expectations could also be influenced

by the outcome of the disease and therefore be higher or lower at the time of completion of

the questionnaire than at the time of diagnosis.

Patients evaluated the coherence in the cancer care pathway on the basis of ad hoc

questions inspired by extant literature. As done in other studies, the basis for developing

these questions was Donabedian’s differentiation between structure, process and outcome

(50) and Haggerty’s definitions of continuity (52). However, further research is needed

to determine whether these concepts are useful in understanding the dimensionality of

patients’ perceptions of health care.

4.2.3 GP evaluation

Apart from the patient him- or herself and his or her relatives, the GP is the only person

involved in the entire cancer care pathway. The degree of GP involvement varies from

patient to patient, but as a minimum, the GP has discharge letters that indicate the course

of the pathway. Whereas the patient’s evaluation is subjective, the GP should be able to

provide a professional evaluation of the cancer care pathway that may serve as a very

valuable supplement to the patient evaluations.

Ad hoc questions also needed to be developed for the GP evaluation, since no validated

questionnaires were found in the literature. Other studies requesting GPs’ assessment of

managerial changes have also used ad hoc questions (101;102). The literature indicates that

GPs’ assessment of the quality of health care is as multidimensional as that of patients.

Thus, further research is needed to arrive at a precise understanding of GPs’ perception of

the quality of health care and how to precisely measure their perception.

4.2.4 Urgent referral for suspected cancer

No data are available to suggest which individuals were actually referred urgently and

which were not. Since urgent referral for suspected cancer was introduced in the middle of

the study period, no information could be obtained from the GP questionnaire to clarify this

question, and the intended national measurement failed (103). However, the scope of this

thesis was not to evaluate the direct effect of being urgently referred, but to analyse how the

profound change in the organisation affected the cancer care pathways. For this purpose,

114


it was useful to categorise patients as diagnosed before or after the introduction of urgent

referral, i.e. if they were admitted to hospital before or after 1 April 2008, respectively. To

assess whether the patient could be regarded as urgent at the time of referral to secondary

care, we used information from the GP questionnaire about whether the GP interpreted

the initial symptoms as alarm symptoms or not and whether the GP clearly indicated

cancer suspicion in the first referral or not. The fact that this information was provided

after the patients had been diagnosed may have influenced the answers; still, we consider

this information unique and very valuable for unanimously determining a patient’s status

both before and after the introduction of urgent referral.

4.2.5 Discharging hospital

We categorised patients according to whether they were discharged from Vejle Hospital or

from other hospitals on the basis of register data from PAS. This information is considered

to be valid. Still, we cannot determine whether the entire care pathway took place at Vejle

Hospital or not, but only that the patients were discharged from Vejle Hospital with an

incident cancer diagnosis.

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4.2.6 Statistical analyses and precision

Non-parametric analyses were used throughout this thesis because data were not normally

distributed. The use of non-parametric methods may also be necessary when data are

ranked, but no clear numerical interpretation is possible, such as when patients’ and GPs’

preferences are assessed. However, the non-parametric tests have less power wherefore

the sample must have a larger size to be able to draw conclusions with the same level

of confidence as is possible when parametric methods are used (104;105). However, the

sample size of this study was large enough to apply non-parametric methods with a 95%

confidence level.

Associations were estimated by a generalized linear model with log link for the binomial

family with robust variance that took the clustering of patients within each general practice

into account. Associations are presented as prevalence rate ratios (PRRs) since odds ratio

would have overestimated the prevalence ratio due to the high proportion of optimal

evaluations (83).

The study size had to be sufficiently large to accommodate random errors and sufficiently

small not to impose an unacceptable workload on the patients and the GPs or to involve

excessive costs from the processing of a large-scale survey. The number of included cancer

patients was high and our CIs relatively narrow, which reduced the risk of type II errors.

However, in our stratified analyses, we might lose power which may explain why overall

associations for all cancers could not be found for each cancer type (104).

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BIAS & GENERALISABILITY

4.3.1 Selection bias

Attempts to minimise the risk of selection bias were made by sampling patients from

valid registries independently of GPs and hospital wards. Despite the sampling problems

described in Article I, selection bias was minimal when the total sample was considered.

GP-induced selection bias was possible if patients of non-responding GPs had a different

secondary care interval than patients of responding GPs. If GPs with a longer doctor

interval were more reluctant to respond, this could lead to shorter secondary care intervals

due to a more obvious pathological picture. This bias may therefore lead estimates towards

the null hypothesis. In addition, the response rate from the GPs was 78.0% for the total

sample (Sample 1: 83.3, Sample 2: 68.7%), which reduced the risk of significant selection

bias.

A risk of selection bias was, however, inherent in the patient response rate of 62.7%. Since

non-responding patients were more likely to have lung cancer with symptoms initially

interpreted as alarm symptoms by their GPs, it is probable that the non-responding

patients were those most seriously ill and it is possible that their evaluation of the cancer

care pathway would have been different from other patients’. If this is the case, it is most

likely that we have underestimated the number of patients with a negative evaluation. We

were not able to estimate either the direction or the extent of this selection bias.

4.3.2 Information bias

The most pronounced risk of information bias is that of recall bias, especially in the patient

questionnaire. It was discussed within the research group when the right time for sending

the questionnaire to the patients would be. We decided on half a year after the diagnosis

because we wanted the patients to be well into the treatment of their cancer in order for

them to be able to evaluate the initial cancer care pathways as a whole. GP recall bias

could influence the secondary care interval and the categorisation of patients according

to initial symptom presentation and cancer suspicion in the first referral to secondary

healthcare. Regarding the initial symptom presentation, cancer suspicion in the referral

and secondary care interval recall bias are considered to have no major impact since GPs

extracted the information from the patients’ electronic medical records. Another source of

information bias is that we did not specify what should be categorised as alarm symptoms.

Thus, the interpretation of the same symptom could differ between GPs. However, a GP’s

reaction is shaped by his or her own interpretation of the symptoms presented, and this

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interpretation will, in turn, determine whether he or she will decide on an urgent referral

or not. Inherent in the study design is that information from the GPs and the patients

was obtained retrospectively. Knowing that the patient was diagnosed with cancer may

have influenced the GPs’ answers both in stating the dates of the cancer care pathway,

in their recollection of the patient’s symptom presentation and in their evaluation of the

care pathway. Likewise, the patients’ answers may be influenced by factors like outcome

of the treatment. However, we were unable to estimate either the direction or the extent

of this information bias. Furthermore, the questions chosen as proxy variables for patient

and GP evaluation of coherence of the cancer care pathway may have induced information

bias. Since there were no validated questions, ad hoc questions were developed. Construct

validity was established by a qualitative pilot test. Content validity was established by a

thorough literature search (106).

4.3.3 Confounding

Analyses were adjusted for known confounders. For example, the associations between

patient and GP evaluations and the secondary care interval were adjusted for patient

and gender, cancer type, alarm symptoms and GP-indicated cancer suspicion in the first

referral to secondary care. However, there might be residual confounding due, e.g., to

GP characteristics about which we had no information. However, there is no reason to

speculate that GP characteristics should differ across parameters like discharge from Vejle

Hospital or from other hospitals, or before or after the introduction of urgent referrals.

Thus, this could neither explain nor alter our conclusions.

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4.3.4 Generalisability

The conclusions of this study are considered generalisable to other regions in Denmark

owing to the large sample size which was representative of the Danish population and

the Danish healthcare sector. The Danish healthcare system is organised almost uniformly

across regions and even though regional differences might exist, the study population is

sufficiently large to minimise the effect of any existing differences. The size of the possible

effect of urgent referral will obviously depend on the local context.

Extrapolation of our study results to other countries requires careful considerations of

differences in health care system, e.g. financing, levels of gatekeeping, levels of waiting

lists, etc. A prerequisite for such extrapolation is the presence of a primary healthcare sector

in which the GP is gatekeeper to specialised healthcare. Within this organisation of the

healthcare sector, effects of urgent referral for suspected cancer primarily depend on two

factors: 1) the GPs’ options as to referring the patient to diagnostic work-up and 2) how the

organisation of the diagnostic process is once the patient has been referred to specialised

health care. Further, our results suggest that apart from clinical and organisational

guidelines, administrative and political leadership has an influence. Thus, culture is an

important factor when extrapolating our results to other countries.

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Chapter 5 Discussion of results

chaPter 5dIscussIon of results

120


RESULTS IN GENERAL

The aim of this thesis was to analyse the influence of the national introduction of urgent

referral for suspected cancer on three different parameters. For any research in early

diagnosis of cancer to be meaningful, eligible patients must be identified in a valid and

consistent manner. Article I therefore describes the development and testing of a sampling

algorithm for timely identification of incident cancer patients based on administrative

registers. With a PPV of 92.4% and a completeness of 95% within two to four months

depending on cancer type, the sampling algorithm has much potential for future research.

In Article II, we showed that the introduction of urgent referral for suspected cancer did

decrease the secondary care interval, even at Vejle Hospital which had introduced the

concept of urgent referral years before it was introduced nationally. Patients with alarm

symptoms in general and those in whose referral letters the GP explicitly stated his or

her suspicion of cancer in particular achieved the most prominent effect of the urgent

referral. In Articles III and IV, we showed that the introduction of urgent referral positively

influenced both the patients’ and the GPs’ evaluation of coherence in the cancer care

pathway. Vejle Hospital outperformed other hospitals in terms of positive evaluations of

the cancer care pathway, especially before the national introduction of urgent referral for

suspected cancer.

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A PREREQUISITE FOR RESEARCH IN EARLY CANCER DIAGNOSIS

Identifying incident cancer patients at the time of diagnosis has previously been a costly

affair requiring considerable manpower at every hospital department. We developed and

tested a register-based sampling algorithm for timely identification of incident cancer

patients independently of cancer type, hospital ward or GP. The sampling algorithm has

acceptable PPVs of 98.8% for sampling a cancer patient and 92.4% for sampling an incident

cancer patient. Thus, we have met an important prerequisite for meaningful research into

the early diagnosis of cancer by enabling researchers to timely include patients in studies

and collect on-time data about the early diagnostic pathway.

The algorithm displayed a completeness of 60% within the first month and a completeness

of 95% after four months (two to five, depending on diagnosis). It has been argued that

completeness should reach 90% to ensure that a sample is representative of the studied

population (107).Even if an algorithm like ours is used, the researcher must remain attentive

towards the pros and cons of on-time patient inclusion.

Introduction of urgent referral for suspected cancer

5.3.1 Secondary care interval

The secondary care interval decreased significantly after the national introduction of

urgent referral for suspected cancer. Patients with alarm symptoms in general and those

in whom the GP explicitly stated his or her suspicion of cancer in particular saw the most

prominent effect of the urgent referral.

Overall, Vejle Hospital, which introduced the concept of urgent referrals years before its

national implementation, had a shorter secondary care interval than other hospitals. It is

remarkable that Vejle Hospital managed to shorten the intervals for breast cancer even

further.

The results for Vejle Hospital suggest that the secondary care interval decreased prior

to the formal implementation of urgent referral, which indicates that political focus and

leadership had an effect in itself. Furthermore, a tendency towards diminishing effect over

time is seen, even if the tendency fell short of reaching a level of statistical significance. Thus,

a shortened secondary care interval is the results of a concerted effort that involves both the

design and implementation of clinical and organisational guidelines and administrative

and political leadership.

Contrary to a study by the Danish National Board of Health (108), the present study was

able to quantify if patients were urgent owing to data from the GP questionnaires. The

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present study was hence able to demonstrate the importance of the referral process and

the GPs’ knowledge and action. We were also able to compare Vejle Hospital with other

hospitals and hence to identify aspects highlighting how urgent referral may have an effect

on time to treatment.

In the UK, urgent referral for suspected cancer was introduced in 2000 because Britain was

experiencing problems of poor survival from cancer comparable to those encountered in

Denmark (109). Several studies of the effect of urgent referrals in the UK have shown that

the overall number of referrals rose and that only few of those who were urgently referred

actually had cancer. For the majority of cancer patients referred outside the context of urgent

referrals, this meant that their waiting times grew longer. Other studies have reported

a direct, negative effect on non-urgent patients of the introduction of urgent referral for

suspected cancer (109-112). It has been suggested that inadequate GP referral guidelines

may partly explain this unfortunate effect and that the inadequacy is rooted mainly in a poor

definition and low PPVs of symptoms suggestive of caner (17;113). Furthermore, patients

eligible for urgent referral according to the guidelines may not be considered urgent by the

GP, whereas others who are not eligible may be considered urgent. It has therefore been

suggested that the GPs should rest a provisional diagnosis on the patient’s history and

the results of clinical examinations and that the lines of communication between GPs and

cancer specialists should be strengthened. Thus, innovations to facilitate this process may

be more successful than guidelines (114). We saw no indication of a prolonged secondary

care interval as a result of the introduction of urgent referral for suspected cancer in our

data. This may be due to the fact the Danish referral guidelines are more flexible than the

UK guidelines. Furthermore, based on the British experience and national research (14),

Danish attention was drawn to the large percentage of patients presenting without alarm

symptoms of cancer early in the process of reorganising the cancer care pathway.

5.3.2 Patient evaluation

The introduction of urgent referral at the national level was positively associated with a

stronger feeling among patients that the plans were being followed. This was evidenced

by a statistically significantly higher score on the relevant item after the introduction of

early referral than before its introduction. For patients discharged from Vejle Hospital, the

introduction of urgent referral did not alter the patient evaluation.

Before urgent referral was introduced nationally, more patients from Vejle Hospital than

from other hospitals gave optimal scores on the items “plans were followed” and “pathway

well-organised”, whereas no differences between Vejle Hospital and other hospitals could

be found after the introduction of urgent referral.

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Those patients from other hospitals than Vejle who gave non-optimal evaluations before

the introduction of urgent referral for suspected cancer had significantly longer secondary

care intervals (up to three weeks) than those who gave optimal evaluations After the

introduction of urgent referral, patients who gave non-optimal evaluation of the items GP-

hospital collaboration and wait until diagnosis had a longer secondary care interval. At Vejle

hospital, an association between non-optimal patient evaluation and longer secondary care

interval was only found for waits until diagnosis.

The rise of patient-centred care over the past 25 years has been accompanied by a growing

international use of patient evaluations as a quality measure (115). We found no studies

directly comparable to our study with respect to patient evaluations. However, results

from the Picker Institute support our finding by suggesting that institutional characteristics

and management are important in patient evaluations regardless of patient characteristics

(116). American research has shown that public reporting of patient surveys may focus

attention on improvement efforts (115). Likewise, the Danish National Survey of Patient

Experiences, which is being conducted every second year, has found improvements in

patient evaluations over the years (75). A Dutch study found no effect of feed-back on

patient evaluations to GPs (117) which may be explained by the general problem of ceiling

effect in patient evaluations. Thus, our findings of more optimal patient evaluations after

the introduction of urgent referrals and for patients discharged from Vejle Hospital may

testify to a rather substantial change in the patient evaluations.

The literature suggests that patient evaluations are largely dependent upon patient

expectations (60;61). This aspect was not explored in our study and further research is

needed to determine how patients’ experiences changed during the introduction of urgent

referrals. One study explored differences in cancer patients’ satisfaction between hospitals.

The items were different from ours as were the response categories. Still, the study found

an independent hospital effect on patient satisfaction which indicates that the role of

managerial interventions deserves further investigation (118).

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5.3.3 GP evaluation

Introducing urgent referral for suspected cancer significantly increased the proportion of

optimal GP evaluations. Even when data were adjusted for the length of the secondary care

interval, the GPs gave a more optimal evaluation on the overall organisation of the cancer

care pathway and the cross-sectional collaboration after the introduction of urgent referral

than before its introduction. For GPs with patients discharged from Vejle Hospital, the

introduction of urgent referral did not alter their evaluation.

Before urgent referrals, GPs with patients discharged from Vejle Hospital had more optimal

evaluations of the overall organisation and the waits from diagnosis to treatment than GPs

from other hospitals, even when adjusted for the length of the secondary interval. The

introduction of urgent referral meant no change in the evaluation for GPs with patients

discharged from Vejle Hospital.

A strong finding in this study was that patients with GPs who gave non-optimal evaluations

had up to three weeks longer secondary care intervals than patients whose GPs gave

optimal evaluations. The association between non-optimal GP evaluation and prolonged

secondary care interval was found both for GPs with patients discharged from Vejle

Hospital and for GPs with patients discharged from other hospitals, even if the secondary

care interval was shorter for the former.

We found no studies comparable to our in terms of results. However, other studies have

found that the GPs are willing to engage further in the cancer care pathway (119-121), and

the present study has documented that they are able to distinguish between coherent and

non-coherent pathways.

125

Chapter 6 Conclusions and future research

chaPter 6conclusIons and future research

126


CONCLUSIONS

Referring to the aims of this study stated in Section 1.4, the following conclusions can be

drawn.

6.1.1 The 2008 cohort of incident cancer patients (aim 1)

A valid register-based algorithm for on-time sampling of incident cancer patients was

successfully developed. The 2008 cohort is a representative sample of incident cancer

patients and served as a valuable step on the way to the final algorithm used to sample the

2010 cohort. The 2008 cohort and the data collected form a unique database with unlimited

potential for future research.

6.1.2 The secondary care interval (aim 2)

It seems fair to ascribe at least some of the reduction in the secondary care interval to the

concept of urgent referral. However, the secondary care interval began to decline almost

the moment the political decision was taken, i.e. before the formal implementation of

urgent referrals. This indicates that political focus and leadership had an effect in itself.

Thus, a shortening of the secondary care interval is the results of the concerted action of

clinical and organisational guidelines on the one hand and administrative and political

leadership on the other hand.

6.1.3 Patient evaluation (aim 3)

Urgent referral for suspected cancer seems to have had the intended effect of easing the

cancer care pathway for the patients. Patients were able to differentiate between prolonged

waiting time and coherence in the care pathway. Overall, patients from Vejle Hospital had

more optimal evaluation, even after a minor decrease following the introduction of urgent

referrals which may be due to a change in patients’ expectations.

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6.1.4 GP evaluation (aim 4)

Although the introduction of urgent referral was not directly aimed at the GPs, it did

improve their evaluation of the cancer care pathway, especially with regardto the overall

organisation of the cancer care pathway and the cross-sectional collaboration. Furthermore,

the GPs had distinct knowledge of their patients’ care pathways which was reflected in the

shorter secondary care interval for patients whose GPs evaluated the pathway as optimal.

The proportion of optimal evaluations was highest for Vejle Hospital, especially before

urgent referral was introduced nationally, which indicates that the introduction of urgent

referral was, in fact, the reason for the improvements in the GPs’ evaluations.

128


FUTURE RESEARCH

The aim of this section is to focus on the areas identified by the present thesis as candidates

for further research. This research can be performed with different methods and within the

realm of different professions, and the aim is not here to go into a deeper discussion on

methods and theories behind the proposed focus points for new research.

6.2.1 Mechanisms of prolonged secondary care intervals

This study indicates a need for further research into the mechanisms that prolong secondary

care intervals. Political and managerial leadership seem to play a role, which suggests

that organisational culture should be addressed. How to maintain cultural improvements

over time seems to be another focus area for future research. The urgent referral guideline

prescribes a fixed sequence of examinations for each known cancer type. Research is needed

to clarify the potential for further reducing the secondary care interval by rearranging

these sequences and by using more modern and/or facilitating faster access to the needed

imaging, ultrasound and endoscopic examinations (122). Finally, an enhanced information

flow and potential improvements achieved through better IT usage between different

actors within and across sectoral boundaries deserves future attention and documentation

of ways to obtain improvements.

6.2.2 Patient perspectives on what constitutes a coherent cancer care pathway

Part of the reasoning behind the introduction of urgent referral for suspected cancer was

that patients felt a lack of continuity in the organisation of their care pathway and found

that transition from the primary to the secondary sector was cumbersome. However,

patient perceptions on what constitutes a coherent cancer care pathway deserve attention

in future research.

6.2.3 Patient evaluations as a predictor for other outcomes

The association between patient evaluations of the diagnostic process and mortality has

been minimally studied and no conclusive results have so far been presented (34). Little

knowledge exists about the validity of patient evaluations of a pathway as a reliable

indicator for a good and timely diagnostic process. We also still lack deeper insight into the

possible associations between patient evaluations and how patients cope with their disease

and their rehabilitation after treatment.

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6.2.4 The GP’s role in improving the cancer care pathway

A significant finding was that the GPs had a distinct knowledge of their patients’ care

pathways. The GP is the only health professional who follows the patient throughout

the cancer care pathway, and future research should explore how the GP in his or her

capacity as a coordinator of the diagnostic pathway may further accelerate the diagnostic

process for patients with typical symptoms and signs of severe disease, including cancer.

Furthermore, one study found that depending of cancer type, up to half of the patients had

three or more GP consultations before being referred to secondary care (123). Thus, GP

guidelines on how to act on different symptoms are an important area for future research.

Finally, research has examined how the organizational structure of health care systems

may influence patients’ reflections on care seeking. Continuity in the doctor–patient

relationship may negatively influence patient reflections on access to health care, as the

focus shifts from the medical issues of the consultation to reflections on how to properly

interact with the GP (124).

6.2.5 The “Vejle effect”

It seems fair to ascribe some of the positive findings from Vejle Hospital to the concept of

urgent referral. However, a possible “Vejle effect” may deserve further unfolding to clarify

other aspects that may help explain the success in early diagnosis of cancer achieved at

Vejle Hospital. This research may focus on organisational aspects, e.g. faster and easier

access to pre-hospital diagnostic investigations, but we also need investigations to answer

if part of the Vejle effect is rooted in a culture of better and more informal and smooth inter-

professional collaboration than what is the case in larger organisational structures with

more rigid collaborative traditions.

6.2.6 Urgent referral for non-symptomatic cancer

This study documented that urgent referral for suspected cancer had the highest effect

in patients presenting with alarm symptoms of cancer and in whose referral letters for

further diagnostic work-up the GP had clearly indicated his or her cancer suspicion. Future

research must focus on how to improve the diagnostic pathway for patients without alarm

symptoms of a specific cancer, which is roughly 50% of all cancers (14). Scattered initiatives

have already been taken to introduce diagnostic centres and urgent referral for occult

cancers, but attention must also be paid to the fact that possible alarm symptoms of caner

are common in the general population (15) and their PPVs are relatively low (16;17), which

induces a risk of referral overload for which the system must be duly geared.

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6.2.7 Side effects of urgent referrals

Possible side effects of introducing urgent referral for suspected cancer remain unrevealed.

Future research should target the cost-effectiveness of urgent referral and any possible side

effects on cancer as well as non-cancer patients who are not referred urgently. Another side

effect of the urgent pathways may lie in the lack of time for the patient and the family to

reflect on ways to cope with the disease. We need better insight into methods that combine

fast access with the best possible patient experience.

6.2.8 Secondary care intervals and mortality

An improved prognosis for the Danish cancer patients, of course, remains the ultimate

goal of any effort at improving the cancer care pathway. This study holds interminable

potential for follow-up studies to clarify any associations between prolonged intervals

and mortality as well as any associations between the introduction of urgent referral and

mortality. Further, it has been hypothesised that gate-keeping may have an adverse effect

on survival from cancer (125); an issue that should also be addressed in future research.

A recent study has shown that mortality should be investigated in a continuous statistical

model to show the correct association between the time interval and mortality (29). The

data from this thesis call for further high-resolution research on associations between the

diagnostic interval and the prognosis for different types of cancer.

131

Chapter 7 References

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Chapter 8 English summary

chaPter 8englIsh summary

144


In Denmark, cancer is a major healthcare burden with a life-time risk of 33%, approx.

35,500 new cases per year, 15,500 deaths per year and a prevalence of 224,000 by the end

of 2009. Lower cancer survival rates in Denmark than in the other Nordic countries and

many European countries have been the focus of much attention since the beginning of

this century. The Danish government therefore decided to introduce urgent referral for

suspected cancer. This national decision was based on pioneer experience from a Danish

hospital (Vejle), which had begun working with care pathways in 1995 and introduced the

first urgent referral pathway for lung cancer in 1999. The principles of urgent referral were

formally introduced for breast, lung, colorectal and head and neck cancers on a nationwide

basis on 1 April 2008 under the assumption that it would reduce the secondary care interval

and ease the care pathway for the patients.

The aim of this study was to analyse how the introduction of urgent referral for suspected

cancer influenced the cancer care pathway measured by the length of the secondary

care interval, the patient evaluation of coherence in the cancer care pathway and the GP

evaluation of coherence in the cancer care pathway.

The study was conducted as a population-based observational study among incident cancer

patients in the Central Denmark Region and the Region of Southern Denmark. Patients

were sampled based on administrative data and questionnaires were sent to their GPs

within a month after inclusion. Six months later, questionnaires were sent to the patients.

Survey data were combined with register data. A total of 10,950 incident cancer patients

were included. GP questionnaires were completed for 8,543 (78%) patients and 3,698 (63%)

patients completed the patient questionnaire.

For any research in early diagnosis of cancer to be meaningful, eligible patients must be

identified in a valid, complete and consistent manner. Article I describes the development

and testing of a sampling algorithm for timely identification of incident cancer patients

based on administrative registers. Article I shows that the sampling algorithm used for

this study provides a solid cohort of incident cancer patients. Further development of the

sampling algorithm provided an algorithm with a positive predictive value of 92.4% using

the GP as the golden standard and a completeness of 95.0% within two to four months

depending on cancer type.

Article II showed that the introduction of urgent referral for suspected cancer did

decrease the secondary care interval, even at Vejle Hospital which had introduced

the concept of urgent referrals years before it was introduced nationally. Patients with

alarm symptoms in general and those in whom the GP explicitly stated his or her

suspicion of cancer in particular saw the most prominent effect of the urgent referral.

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Chapter 8 English summary

In Articles III and IV, we showed that the introduction of urgent referral positively

influenced both the patients’ and the GPs’ evaluation of coherence in the cancer care

pathway. Both patients and their GPs evaluated the cancer care pathway more positively

if patients were discharged from Vejle Hospital, especially before the national introduction

of urgent referral for suspected cancer.

In conclusion, this study provides evidence that the introduction of urgent referral for

suspected cancer had a positive effect on the length of the secondary care interval as well

as the GP and patient evaluation of coherence in the cancer care pathway.

Several areas for future research derive from this study. Research is needed into the

mechanisms of prolonged secondary care intervals. Vejle Hospital performed best on the

aspect included in this study, and more research could identify a possible “Vejle effect”

that, like urgent referral, may also be useful in other settings. Finally, important issues of

future research are early diagnosis of non-symptomatic cancer patients and possible side

effects of urgent referrals.

146


147

Chapter 9 Dansk resume

chaPter 9dansk resume

148


Kræft har udviklet sig til en af de største folkesygdomme i Danmark. Risikoen for at få

kræft inden 75-års alderen er 33%, der bliver konstateret ca. 35.500 nye tilfælde hvert år,

og ca. 15.500 dør af kræft hvert år. Ved udgangen af 2009 levede ca. 224.000 danskere med

kræft. Yderligere har danske kræftpatienter en dårligere overlevelse end kræftpatienter i de

øvrige nordiske lande og mange europæiske lande, hvilket har været genstand for megen

opmærksomhed siden begyndelsen af dette århundrede. Den danske regering indførte

derfor i samarbejde med Regionerne såkaldte pakkeforløb ved mistanke om kræft baseret

på positive erfaringer fra Vejle Sygehus, som begyndte at arbejde med patientforløb i 1995

og introducerede den første kræftpakke for lungekræft i 1999. Pakkeforløb blev således

indført nationalt for bryst-, lunge-, tyktarms- samt hoved- og halskræft den 1. april 2008

med forventning om, at det ville mindske tidsintervallet fra den praktiserende læges

henvisning til det specialiserede sundhedsvæsen frem til behandling (det sekundære

system interval) samt lette forløbet for patienterne.

Formålet med denne undersøgelse var at analysere, hvordan indførelsen af pakkeforløbene

har påvirket kræftpatienters forløb med hensyn til længden af det sekundære systeminterval

og med hensyn til patienters og praktiserende lægers vurdering af sammenhængen i

forløbet.

Undersøgelsen blev gennemført som et populationsbaseret observationelt studie af

incidente kræftpatienter i Region Midtjylland og Region Syddanmark i perioden oktober

2007 til oktober 2008. Patienterne blev inkluderet på baggrund af administrative data,

og der blev sendt spørgeskemaer til deres praktiserende læge inden for en måned efter

inklusionen. Seks måneder senere blev der sendt spørgeskemaer til patienterne. I alt

10.950 kræftpatienter blev inkluderet. De praktiserende læger udfyldte 8.543 (78%)

spørgeskemaer, og patienterne udfyldte 3.698 (63%) skemaer.

Forudsætningen for forskning i tidligere diagnostik af kræft er, at incidente patienter kan

inkluderes så tæt på diagnosetidspunktet som muligt. Artikel I beskriver derfor udviklingen

og valideringen af en algoritme til rettidig identifikation af incidente kræftpatienter

baseret på administrative registre. Artikel I viser, at den algoritme, der blev udviklet til

nærværende studie giver en solid kohorte af incidente kræftpatienter. Videreudvikling af

algoritmen gav en algoritme med en positiv prædiktiv værdi med egen læge som guld

standard på 92,4% for at inkludere en incident kræftpatient og en komplethed af kohorten

på 95,0% inden for to til fire måneder, afhængigt af kræfttype. Der er således udviklet en

algoritme, der giver et solidt grundlag for fremtidig forskning i tidlig diagnostik af kræft.

Artikel II viser, at det sekundære systeminterval blev kortere efter indførelsen af

pakkeforløb, selv på Vejle Sygehus, der indførte pakker, år før de blev indført på nationalt

plan. Pakkeforløbene har mest effekt for patienter med alarmsymptomer og dem, hvor den

praktiserende læge udtrykkeligt angiver mistanke om kræft. Endvidere tyder dette på, at

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Chapter 9 Dansk resume

det sekundære systeminterval begyndte at falde allerede før indførelsen af pakkerne.

Artikel III og IV viser, at indførelsen af pakkeforløbene havde positiv indvirkning på både

patienternes og lægernes vurdering af sammenhængen i forløbet. Både patienter og deres

læger vurderede forløbet mere positivt, hvis patienten blev udskrevet fra Vejle Sygehus,

især før den nationale indførelse af pakkerne. Både patienters og lægers evaluering af

sammenhængen var associeret med længden af det sekundære systeminterval.

Det tyder således på, at indførelsen af kræftpakkerne har haft en positiv effekt på længden

af det sekundære systeminterval samt på både praktiserende lægers og patienters

evaluering af sammenhængen af forløbet. Der er fortsat brug for forskning på området,

fx i de mekanismer, der skaber langvarige sekundære systemintervaller. Vejle klarer sig

bedre på de tre aspekter, der er målt på, og yderligere forskning kan klarlægge, om der kan

være tale om en eventuel “Vejle-effekt”, der består af mere end blot pakkerne, og som kan

implementeres i andre sammenhænge. Endelig er der behov for mere viden om, hvordan

vi sikrer kortest muligt sekundært systeminterval for den store del af kræftpatienterne,

der ikke debuterer med alarmsymptomer, samt om der er mulige negative effekter af

kræftpakkerne.

150


151

Appendix A Included cancer diagnoses

aPPendIx aIncluded cancer dIagnoses

152


Malignant neoplasms classified according to the International Classification of Disease

(ICD-10)*

* http://who.int/classifications/icd10/browse/2010/en#/II

C00-C14 Malignant neoplasms of lip, oral cavity and pharynx C15-C26 Malignant neoplasms of digestive organs C30-C39 Malignant neoplasms of respiratory and intrathoracic organs C40-C41 Malignant neoplasms of bone and articular cartilage C43 Malignant Melanoma C45-C49 Malignant neoplasms of mesothelial and soft tissue C50-C50 Malignant neoplasms of breast C51-C58 Malignant neoplasms of female genital organs C60-C63 Malignant neoplasms of male genital organs C64-C68 Malignant neoplasms of urinary tract C69-C72 Malignant neoplasms of eye, brain and other parts of central nervous system C73-C75 Malignant neoplasms of thyroid and other endocrine glands C76-C80 Malignant neoplasms of ill-defined, secondary and unspecified sites C81-C96 Malignant neoplasms, stated or presumed to be primary, of lymphoid,

haematopoietic and related tissue C97-C97 Malignant neoplasms of independent (primary) multiple sites D37-D48 Neoplasms of uncertain or unknown behaviour

153

Appendix B Questionnaire to the GP

aPPendIx bquestIonnaIre to the gP

154


Vejledning i udfyldelse af spørgeskemaet

Læs venligst nedenstående inden du går i gang.

Med dette spørgeskema ønsker vi bl.a. at blive i stand til at tegne følgende tidslinje for alle incidente cancerpatienter i Region Midtjylland og Region Syddanmark.

I nogle spørgsmål bliver du således bedt om at oplyse datoer. Det er meget vigtigt for os, at du opgiver datoer så korrekt som muligt, samt at du oplyser alle de datoer, der bedes om i spørgeskemaet. Skriv venligst så tydeligt som muligt og helst så tallene ligner nedenstående eksempler:

Vi beder dig om at benytte en sort eller blå kuglepen, da svarene aflæses maskinelt.

Vi beder dig besvare alle spørgsmålene medmindre andet er anført. Følg vejledningerne i spørgeskemaet og sæt et kryds i firkanten ud for det svar, som umiddelbart passer bedst for dig.

Hvis du laver en forkert afkrydsning, kan du blot strege det forkerte ud og sætte et nyt kryds. Eksempel:

Når du har besvaret spørgeskemaet, skal det sendes til Forskningsenheden for Almen Praksis i vedlagte frankerede svarkuvert.

Korrekt afkrydsning:Fortrudt afkrydsning:

5 6 7 8 9 0 4 3 2 1

Første symptom

Første læge-

kontakt

Specifik udredning indledes

Henvisning til hospital

Første besøg på hospital

Henvisning til

behandling

Behandling indledes

Patientdelay Lægedelay Systemdelay

Korrekt afkrydsning:

Fortrudt afkrydsning:

155


Hvad er dit navn? (Skriv venligst med blokbogstaver)

Generelle oplysninger

Sammenhæng for kræftpatienterLægespørgeskema

1

Spørgeskemaet bedes udfyldt af den læge i din/jeres praksis, der har haft flest kontakter medpatienten.

1.3

Hvilken stilling har du i praksis?

Fast læge i praksis med ydernummer (inkl. deleydernummer)

Uddannelseslæge

Aflastningsamanuensis eller vikar for praktiserende læge

År

Oplysninger om udfyldende læge

Hvilket køn er du?

Mand

Kvinde

Hvor mange års anciennitet har du som alment praktiserende læge?

1.6

Du bedes bekræfte, om patienten har cancer

Patienten har nævnte cancer

Patienten har cancer, men ikke nævnte

Patienten har ikke cancer

Hvis patienten har en anden type cancer, oplys venligst hvilken typeForbeholdt

kodning

Oplysninger om patienten

1.1

1.2

1.5

1.4

Gå til spørgsmål 1.3

Gå til spørgsmål 1.2Spørgeskemaet returneres

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1.7 Var du/praksis involveret i udredningen af patientens cancer?

Ja, jeg/praksis var helt eller delvist involveret

Nej, jeg/praksis var ikke involveret

Praksis' involvering i udredningen

Patienten blev indlagt akut uden forudgående kontakt til praksis

Patienten var tilknyttet anden praksis

Andet:

Forbeholdtkodning


2

Hvis nej, hvad var årsagen til, at du/praksis ikke var involveret i udredningen?

Var der praktiserende speciallæge(r) med sygesikringsoverenskomst involveret iudredningen af patientens cancer (fx øre-næse-halslæge, gynækolog eller dermatolog)?

Ja Nej Ved ikke

Hvilket speciale: Forbeholdtkodning

Var der privatklinik eller privathospital involveret i udredningen af patientens cancer?

Ja Nej Ved ikke

Andre instansers involvering i udredningen1.8

1.9

Patientens symptomdebut

Ja

Nej

Ved ikke

1.10 Debuterede patienten med alarmsymptomer (uventet vægttab, blødning,vedvarende hoste, knude mv.)?

Hvilke(t):Forbeholdt

kodning

(også hvis patienten er diagnosticeret vedscreening, blot blev henvist videre til sekundær sektor eller lignende)

(ingen kontakt med patienten i forbindelse medudredningen)

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Forløb fra første symptom til behandling

De følgende spørgsmål handler om forløbet, fra patienten første gang fik symptomer på cancer, tilbehandlingen blev påbegyndt. Hvis patienten ikke havde symptomer (fx diagnosticeret vedscreening uden symptomer), bedes du gå til spørgsmål 2.4

Vi vil bede dig besvare spørgsmålene så godt som muligt ud fra dine journalnotater, epikriser mv.

2.1 Hvilken dato fik patienten ifølge din/jeres anamnese førstegang symptomer, der med den viden du har i dag, varsymptomer på patientens aktuelle cancer?

- -dd mm åå

Hvis du ikke kan oplyse den præcise dato, vil vi bede diggive et skøn over, hvor længe du mener, at patienten havdesymptomer inden henvendelse hos dig/praksis

Under 1 uge

1 til 4 uger

5 til 8 uger

Mere end 8 uger

Ved ikke

2.2

dd- -

mm åå

2.3 Hvilken dato startede du/I specifik udredning for patientenscancer (blodprøver, biopsi, endoskopi eller billeddiagnostik),hvor du/praksis stadig havde ansvaret for det videre forløb? dd

- -mm åå

2.4

dd- -

mm åå

Hvilken dato blev patienten henvist til undersøgelser hospraktiserende speciallæge/på sygehus, hvor du/praksisvideregav ansvaret for det videre forløb?

Hvilken dato henvendte patienten sig første gang i praksis medsymptomer, der med den viden, du har i dag, var symptomer påpatientens aktuelle cancer?


3

Hvilken dato blev patienten vurderet første gang på sygehuseller hos praktiserende speciallæge, efter du/praksis havdevideregivet ansvaret for det videre forløb?

Hvilken dato blev den endelige cancerdiagnose stillet?

Hvis patienten får/har fået behandling, hvilken dato blevden påbegyndt?

2.5

2.6

2.7

- -

- -

- -

dd

dd

dd

mm

mm

mm

åå

åå

åå

Ikke relevant

Ikke relevant

Ikke relevant

Ikke relevant / ved ikke



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Udredning af patientens cancer

3.1Cancerrelateretblodprøve

dd- -

mm åå

Positiv* Negativ**Ja Nej

- -dd mm åå

Foretaget PrøvesvarFørste dato forhenvisning eller

rekvirering

Dato forprøvesvar

3.2Biopsi ellercytologiskundersøgelse

- -dd mm åå

- -dd mm åå

3.3Billeddiagnostikinkl. scanning - -

dd mm åå- -

dd mm åå

3.4Endoskopiskundersøgelse

- - - -ååmmddååmmdd

3.5 Er der foretaget andreprøver, oplys hvilke(n):

- - - -ååmmddååmmdd

Forbeholdt kode

De følgende spørgsmål handler om den præhospitale udredning af patientens cancer, altså denudredning, der ordineres i praksis, og hvor praksis stadig har ansvaret for den videre diagnostik ogopfølgning.

Hvis du svarede nej i spørgsmål 1.7, bedes du gå til spørgsmål 5.1.

Prøver under udredningen


Vi vil bede dig besvare spørgsmålene så godt som muligt ud fra dine journalnotater, epikriser mv.Hvis der er gennemført flere af samme type prøve, giv oplysningerne på den første

4

Var der i din første henvisning til sekundær sektor tydelig angivelse af cancermistanke?

Ja, cancer obs pro

Ja, specifik cancerdiagnose

Nej

Ved ikke

3.6

Krævede du/Iprøvenfremskyndet?Ja Nej

*Positivt prøvesvar betyder, at mistanken om cancer blev bestyrket eller bekræftet**Negativt prøvesvar betyder, at mistanken om cancer ikke blev bestyrket eller bekræftet

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Overordnet vurdering af forløbet

Megettilfreds Tilfreds Utilfreds

Megetutilfreds

Ved ikke/ikke

relevant

4.1 Længden af tiden fra patientensførste symptomer, til han/hunhenvendte sig hos dig/praksis

Hvor tilfreds er du med følgende?

4.2

Patientens compliance underudredningen (fremmøde vedplanlagte undersøgelser mv.)

4.3

4.4 Ventetid på klinisk biokemi/laboratoriediagnostik (ordineret afpraksis)

4.5 Ventetid på biopsisvar fra patolog(ordineret af praksis)

4.6 Ventetid på billeddiagnostik inkl.scanning (ordineret af praksis)

Ventetider

I det følgende bedes du vurdere forløbet fra patientens første sygdomstegn til behandlingsstart.

4.7 Ventetid på endoskopiskundersøgelse (ordineret af praksis)

Længden af tiden fra patientenførste gang henvendte sig i praksis,til du/praksis fik mistanke om cancer


5

4.8 Ventetid på undersøgelser vedpraktiserende speciallæge (tid frahenvisning til svar)

Ventetid på undersøgelser påsygehus (tid fra henvisning tilsvar)

Den samlede ventetid frapatientens første symptomer, tildiagnosen blev stillet

Den samlede ventetid fradiagnosen blev stillet, tilbehandlingen blev påbegyndt

4.9

4.10

4.11

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Megetenig Enig Uenig

Megetuenig

Ved ikke/ikke

relevant

4.12 Den samlede tilrettelæggelse afpatientforløbet var tilfredsstillende

Hvor enig er du i følgende udsagn?

4.13 Samarbejdet om patienten påtværs af sektorer fungeredetilfredsstillende

4.14 Sammenhængen i patientforløbetvar tilfredsstillende

4.15

Koordinering


6

Du/praksis var i stand til at udfylderollen som tovholder/koordinator påen tilfredsstillende måde

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Patientens helbredstilstand før aktuelle cancer

Anden cancersygdom end nuværende. Hvilken

Hypertension

Iskæmisk hjertesygdom

Apopleksi

Diabetes

KOL, bronkitis, emfysem eller astma

Allergi

Artrose eller anden reumatisk sygdom

Osteoporose

Lettere psykisk lidelse (let depression, angst mv.)

Psykisk sygdom (alvorlig depression, panikangst, skizofreni mv.)

Anden

Ingen

Ved ikke

Forbeholdtkodning

Forbeholdtkodning

5.1 Hvilke betydende sygdomme havde patienten før aktuelle cancer?(sæt evt. flere krydser)

5.2 Hvilke risikofaktorer for cancer havde du kendskab til hos patienten før aktuelle cancer?(sæt evt. flere krydser)

Forbeholdtkodning

Tobaksrygning (nuværende eller tidligere)

Alkohol (mænd >21 genstande/uge, kvinder >14 genstande/uge)

Arv (cancersygdom i familien, tidligere cancersygdom hos patienten)

Svær adipositas (BMI>30)

Arbejdsmiljø

Hormonbehandling

Anden

Ingen

Ved ikke


7

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Du er velkommen til at skrive her, hvis du har øvrige kommentarer.

Kontrollér venligst, at du ikke er kommet til at springe spørgsmål over i skemaet!

Det udfyldte skema bedes returneret til Forskningsenheden for Almen Praksis i vedlagtefrankerede svarkuvert.

Mange tak for hjælpen!


8

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163

Appendix C Questionnaire to the patient

aPPendIx cquestIonnaIre to the PatIent

164


Vejledning i udfyldelse af spørgeskemaet

Læs venligst nedenstående inden du går i gang.

Med dette spørgeskema ønsker vi at belyse dit sygdomsforløb, fra første gang du mærkede symptomer på din sygdom til der, hvor du er nu.

Når du besvarer spørgsmålene er der nogle ting, som vi vil bede dig tage hensyn til, da svarene aflæses maskinelt.

Vi beder dig om at benytte en sort eller blå kuglepen.

Enkelte spørgsmål skal du besvare med tal. Skriv venligst så tydeligt som muligt og helst så tallene ligner nedenstående eksempler:

Vi beder dig besvare alle spørgsmålene medmindre andet er anført. Følg vejledningerne i spørgeskemaet og sæt et kryds i firkanten ud for det svar, som umiddelbart passer bedst for dig.

Hvis du laver en forkert afkrydsning, kan du blot strege det forkerte ud og sætte et nyt kryds. Eksempel:

Når du har besvaret spørgeskemaet, skal det sendes til Forskningsenheden for Almen Praksis i vedlagte frankerede svarkuvert.

Korrekt afkrydsning:Fortrudt afkrydsning:

5 6 7 8 9 0 4 3 2 1

Korrekt afkrydsning:

Fortrudt afkrydsning:

165


Side 1

Korrekte oplysninger

1.1 Har du fået konstateret kræft inden for det sidste år? � Ja - Gå til spørgsmål 1.2 � Nej - Skemaet returneres. Portoen er betalt.

Fakta om dit kræftforløb 1.2 Hvordan blev din kræftsygdom opdaget?

� Jeg fortalte min egen læge om symptomer (fx træthed, vægttab, vandladningsproblemer, hoste, knude, blod i afføring mv.)

� Jeg var indlagt på sygehuset med anden sygdom � Jeg deltog i en befolkningsundersøgelse for kræft (screening) � Andet:

________________________________________________

1.3 Cirka hvilken dato oplevede du første gang de symptomer, som fik dig til at gå til læge? (Hvis du ikke husker datoen, kan du angive måned og år)

� Ved ikke

1.4 Cirka hvilken dato fortalte du første gang din læge om symptomerne? (Hvis du ikke husker datoen, kan du angive måned og år)

� Ved ikke

Hvis du ikke husker datoen, bedes du give et skøn over, hvor længe du ventede med at fortælle din læge om symptomerne:

� Under 1 uge � 1-4 uger � 5-8 uger � 2-3 måneder � 4-6 måneder � 7-12 måneder � Mere end 12 måneder � Ved ikke

1.5 Havde du overvejet, at det kunne være kræft, da du fortalte din egen læge om symptomerne? � Ja � Nej � Ved ikke

1.6 Er du startet i behandling for din kræftsygdom (fx operation, stråler eller kemo)? � Ja � Nej –Gå til spørgsmål 1.9 � Ved ikke

Hvis ja, cirka hvilken dato startede du i behandling? (Hvis du ikke husker datoen, kan du angive måned og år)

dd mm åååå

- -

dd mm åååå

- -

dd mm åååå

- -





166


Side 2

1.7 Er din behandling afsluttet? � Ja � Nej � Ved ikke

Hvis ja, cirka hvilken dato blev din behandling afsluttet? (Hvis du ikke husker datoen, kan du angive måned og år)

1.8 Hvilken behandling får/har du fået for din kræftsygdom? (sæt gerne flere krydser)

� Operation � Strålebehandling � Kemoterapi � Andet

1.9 Har du skiftet praktiserende læge under dit kræftforløb?

� Ja – gå til spørgsmål 1.10 � Nej – gå til spørgsmål 1.11

1.10 Hvad var den primære årsag til, at du skiftede praktiserende læge? � Min tidligere læge forlod praksis � Jeg flyttede til et andet område � Jeg var ikke tilfreds med min tidligere læge � Andet:

_______________________________________________________

Hvis du har skiftet praktiserende læge under dit forløb, beder vi dig tænke på din tidligere læge, når du udfylder følgende.

Dit forløb med kræft I det følgende spørger vi om din vurdering af det samlede forløb, fra du første gang mærkede, at du var syg og til i dag.

Information i dit forløb Hvor enig er du i følgende udsagn? M

eg

et

uen

ig

Uen

ig

En

ig

Meg

et

en

ig

Ved

ikke

Ikke r

ele

van

t

1.11 Jeg følte mig tilfreds med den mundtlige information, jeg modtog

1.12 Jeg følte mig tilfreds med den skriftlige information, jeg modtog

1.13 Jeg oplevede, at alle informationer blev givet på de rigtige tidspunkter

1.14 Jeg følte, at jeg manglede information undervejs i mit forløb

1.15 Jeg oplevede at få modstridende informationer på sygehuset

1.16 Jeg oplevede at få modstridende informationer fra min egen læge og sygehuset

1.17 Samlet set følte jeg, at der var sammenhæng i den information, jeg fik under hele forløbet

dd mm åååå

- -

Forbeholdt kodning

167


Side 3

Kommunikation i dit forløb Hvor enig er du i følgende udsagn? M

eg

et

uen

ig

Uen

ig

En

ig

Meg

et

en

ig

Ved

ikke

Ikke r

ele

van

t

1.18 Jeg oplevede, at min egen læge brugte et forståeligt sprog

1.19 Jeg oplevede, at min egen læge var god til at lytte til mig

1.20 Jeg følte tillid til min egen læges faglige dygtighed

1.21 Jeg oplevede, at sygehuslægerne brugte et forståeligt sprog

1.22 Jeg oplevede, at sygehuslægerne var gode til at lytte til mig

1.23 Jeg følte tillid til sygehuslægernes faglige dygtighed

1.24 Jeg oplevede, at sygeplejerskerne/plejepersonalet brugte et forståeligt sprog

1.25 Jeg oplevede, at sygeplejerskerne/plejepersonalet var gode til at lytte til mig

1.26 Jeg følte tillid til sygeplejerskernes/plejepersonalets faglige dygtighed

1.27 Jeg følte, at jeg vidste, hvem jeg skulle henvende mig til, hvis jeg havde spørgsmål

1.28 Jeg oplevede, at der var en fagperson tilgængelig, hvis jeg havde spørgsmål

Information til pårørende under dit forløb Hvor enig er du i følgende udsagn? M

eg

et

uen

ig

Uen

ig

En

ig

Meg

et

en

ig

Ved

ikke

Ikke r

ele

van

t

1.29 Jeg oplevede, at mine pårørende havde mulighed for at stille spørgsmål til min egen læge

1.30 Jeg oplevede, at min egen læge viste tilstrækkelig interesse for, hvordan mine pårørende havde det

1.31 Jeg oplevede, at mine pårørende havde mulighed for at stille spørgsmål til sygehuslægerne

1.32 Jeg oplevede, at sygehuslægerne viste tilstrækkelig interesse for, hvordan mine pårørende havde det

1.33 Jeg oplevede, at mine pårørende havde mulighed for at stille spørgsmål til sygeplejerskerne/plejepersonalet

1.34 Jeg oplevede, at sygeplejerskerne/plejepersonalet viste tilstrækkelig interesse for, hvordan mine pårørende havde det

168


Side 4

Sammenhæng i dit forløb Hvor enig er du i følgende udsagn? M

eg

et

uen

ig

Uen

ig

En

ig

Meg

et

en

ig

Ved

ikke

Ikke r

ele

van

t

1.35 Jeg oplevede, at samarbejdet mellem min egen læge og sygehuset fungerede tilfredsstillende

1.36 Jeg oplevede, at samarbejdet mellem min egen læge og hjemmepleje/hjemmesygeplejerske fungerede tilfredsstillende

1.37 Jeg oplevede, at samarbejdet mellem sygehuset og hjemmepleje/hjemmesygeplejerske fungerede tilfredsstillende

1.38 Jeg oplevede, at min egen læge havde kendskab til, hvad der skete på sygehuset

1.39 Jeg følte, at min egen læge var tilstrækkeligt involveret i mit forløb 1.40 Jeg havde en fast kontaktperson gennem hele sygehusforløbet 1.41 Jeg havde forskellige kontaktpersoner på hver afdeling, jeg var på under

sygehusforløbet

1.42 Jeg følte, at den/de faste kontaktperson(er) var en god støtte for mig 1.43 Jeg oplevede, at der var for mange forskellige læger involveret i mit forløb 1.44 Jeg oplevede, at der var for mange forskellige sygeplejersker/plejepersonale

involveret i mit forløb

1.45 Jeg følte mig tilstrækkeligt involveret i beslutninger, der skulle træffes 1.46 Jeg følte mig velinformeret om det forløb, jeg skulle igennem 1.47 Jeg oplevede, at de planer, der blev lagt for mit forløb, blev overholdt 1.48 Jeg oplevede, at mit forløb på sygehuset var veltilrettelagt 1.49 Jeg oplevede samlet set, at hele forløbet var veltilrettelagt

Ventetider i dit forløb Hvor enig er du i følgende udsagn? M

eg

et

uen

ig

Uen

ig

En

ig

Meg

et

en

ig

Ved

ikke

Ikke r

ele

van

t

1.50 Jeg følte, at den tid, jeg lod gå, fra første gang, jeg havde symptomer på min kræftsygdom, til jeg søgte læge første gang, var passende

1.51 Jeg oplevede, at ventetiden på at få den første tid hos min egen læge var tilfredsstillende

1.52 Jeg følte, at tiden fra jeg første gang henvendte mig til min egen læge, til han/hun fik mistanke om, at det kunne være kræft, var tilfredsstillende

1.53 Jeg oplevede, at ventetiden på undersøgelser, hvor jeg fik det endelige svar hos min egen læge (inkl. ventetid på at få svar), var tilfredsstillende

1.54 Jeg oplevede, at ventetiden på undersøgelser, hvor jeg fik det endelige svar på sygehuset (inkl. ventetid på at få svar), var tilfredsstillende

1.55 Jeg oplevede, at den samlede ventetid, til diagnosen blev stillet, var tilfredsstillende

1.56 Jeg oplevede, at ventetiden på at blive opereret var tilfredsstillende 1.57 Jeg oplevede, at ventetiden på strålebehandling var tilfredsstillende 1.58 Jeg oplevede, at ventetiden på kemoterapi var tilfredsstillende

169


Side 5

Fejl i dit forløb Hvor enig er du i følgende udsagn? M

eg

et

uen

ig

Uen

ig

En

ig

Meg

et

en

ig

Ved

ikke

Ikke r

ele

van

t

1.59 Jeg oplevede, at der skete fejl, da min egen læge skulle finde ud af, at det var kræft

1.60 Jeg oplevede, at der var problemer med henvisningen til sygehuset

1.61 Jeg oplevede, at der var problemer med henvisninger mellem forskellige afdelinger på sygehuset

1.62 Jeg oplevede, at oplysninger gik tabt (fx prøvesvar)

1.63 Jeg oplevede, at der skete fejl med min medicin

1.64 Jeg oplevede, at svar på undersøgelser kom senere end lovet

1.65 Jeg oplevede, at der kom svar på undersøgelser, som senere viste sig at være forkerte (fx røntgen)

1.66 Jeg oplevede, at der skete andre fejl

1.67 Jeg mener, at der er sket fejl, der har forlænget mit forløb unødigt

Støtte i dit forløb I hvilken grad gælder følgende udsagn? S

let

ikke

Lid

t

En

del

Meg

et

Ved

ikke

Ikke r

ele

van

t

1.68 Jeg har/har haft brug for fysisk genoptræning

1.69 Jeg har/har haft brug for professionel psykisk støtte

1.70 Jeg har/har haft brug for professionel hjælp til praktiske forhold (fx orlov, sygemelding og hjælpemidler)

1.71 Jeg har/har haft brug for professionel hjælp til at fastholde kontakten til arbejdsmarkedet

1.72 Jeg har/har haft brug for at søge alternativ behandling

1.73 Jeg har/har haft brug for at søge støtte i religion/tro

1.74 Jeg har benyttet støtte fra Kræftens Bekæmpelse (fx samtalegrupper og personlig rådgivning)

1.75 Jeg har benyttet støtte fra psykolog

1.76 Jeg har benyttet støtte fra socialrådgiver

1.77 Jeg har benyttet alternativ behandling

1.78 Jeg har benyttet religiøse/trosmæssige tilbud

170


Side 6

Symptomer, inden du gik til din egen læge I de følgende spørgsmål vil vi bede dig tænke tilbage på tiden, før du første gang gik til din egen læge med symptomerne. Hvis du ikke har været hos din egen læge med symptomerne, bedes du gå til spørgsmål 1.84 1.79 Inden jeg gik til læge med symptomerne, talte jeg med følgende personer om dem:

(sæt gerne flere krydser) Ingen Apoteker/materialist

Ægtefælle/samlever Hjemmehjælper

Datter Vagtlæge/speciallæge

Søn Hospitalspersonale

Forælder Tandlæge

Anden familie Zoneterapeut/kiropraktor

Kollega/klassekammerat Alternativ behandler

Ven Psykolog Nabo Andre:

1.80 Inden jeg gik til læge med symptomerne, var den første person jeg talte om dem med:

(sæt kun ét kryds) Ingen Apoteker/materialist

Ved ikke Hjemmehjælper

Ægtefælle/samlever Vagtlæge/speciallæge

Datter Hospitalspersonale

Søn Tandlæge

Forælder Zoneterapeut/Kiropraktor

Anden familie Alternativ behandler

Kollega/klassekammerat Psykolog

Ven Anden: Nabo

1.81 Nogle gange venter man med at gå til læge for ikke at gøre andre bekymrede, for at skåne nogen,

eller for ikke at aflyse en ferie eller stor familiebegivenhed. Af hensyn til følgende personer ventede jeg med at gå til læge med symptomerne: (sæt gerne flere krydser)

Ingen Anden familie

Ægtefælle/samlever Kollega/klassekammerat

Datter Ven

Søn Nabo Forælder Andre:

1.82 Følgende person, var særligt afgørende for min beslutning om at gå til læge med

symptomerne: (sæt kun ét kryds) Ingen Apoteker/materialist




Forælder Tandlæge



Ven Psykolog

Nabo Andre:

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Side 7

1.83 Følgende personer beroligede mig med, at det ikke var nødvendigt at gå til læge med

symptomerne: (sæt gerne flere krydser) Ingen Apoteker/materialist




Forælder Tandlæge



Ven Psykolog Nabo Andre:

Forhold til familie og venner De følgende spørgsmål handler om dit forhold til din familie og dine venner. 1.84 Hvor ofte træffer du venner og bekendte?

� Dagligt eller næsten dagligt � Et par gange om ugen � Et par gange om måneden � Sjældnere end et par gange om måneden � Aldrig � Ved ikke

1.85 Hvor ofte træffer du familie, som du ikke bor sammen med? � Dagligt eller næsten dagligt � Et par gange om ugen � Et par gange om måneden � Sjældnere end et par gange om måneden � Aldrig � Ved ikke

1.86 Hvis du har brug for hjælp til praktiske problemer, kan du da regne med at få hjælp fra andre? � Ja, helt sikkert � Ja, måske � Nej � Ved ikke

1.87 Sker det nogensinde, at du er alene, selvom du egentlig havde mest lyst til at være sammen med andre? � Ja, ofte � Ja, en gang imellem � Ja, sjældent � Nej � Ved ikke

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Side 8

Dit nuværende helbred De følgende spørgsmål handler om dit nuværende helbred.

Sle

t ik

ke

Lid

t

En

del

Meg

et

2.1 Har du nogen vanskeligheder ved at udføre anstrengende aktiviteter, som f.eks. at bære en tung indkøbstaske eller en kuffert?

2.2 Har du nogen vanskeligheder ved at gå en lang tur?

2.3 Har du nogen vanskeligheder ved at gå en kort tur udendørs?

2.4 Er du nødt til at ligge i sengen eller at sidde i en stol om dagen?

2.5 Har du brug for hjælp til at spise, tage tøj på, vaske dig eller gå på toilettet?

I den forløbne uge S

let

ikke

Lid

t

En

del

Meg

et

2.6 Var du begrænset i udførelsen af enten dit arbejde eller andre daglige aktiviteter?

2.7 Var du begrænset i at dyrke hobbyer eller andre fritidsaktiviteter?

2.8 Havde du åndenød?

2.9 Har du haft smerter?

2.10 Havde du brug for at hvile dig?

2.11 Har du haft svært ved at sove?

2.12 Har du følt dig svag?

2.13 Har du savnet appetit?

2.14 Har du haft kvalme?

2.15 Har du kastet op?

2.16 Har du haft forstoppelse?

2.17 Har du haft diarre (tynd mave)?

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Side 9

I den forløbne uge S

let

ikke

Lid

t

En

del

Meg

et

2.18 Var du træt?

2.19 Vanskeliggjorde smerter dine daglige aktiviteter?

2.20 Har du haft svært ved at koncentrere dig om ting - f.eks. læse avis eller se fjernsyn?

2.21 Følte du dig anspændt?

2.22 Var du bekymret?

2.23 Følte du dig irritabel?

2.24 Følte du dig deprimeret?

2.25 Har du haft svært ved at huske?

2.26 Har din fysiske tilstand eller medicinske behandling vanskeliggjort dit familieliv?

2.27 Har din fysiske tilstand eller medicinske behandling vanskeliggjort din omgang med andre mennesker?

2.28 Har din fysiske tilstand eller medicinske behandling medført økonomiske vanskeligheder for dig?

I de næste to spørgsmål bedes du sætte ring om det tal mellem 1 og 7, der passer bedst på dig. Hvordan vil du vurdere dit samlede helbred i den forløbne uge?

1 2 3 4 5 6 7

2.29

Meget dårligt Særdeles godt

Hvordan vil du vurdere din samlede livskvalitet i den forløbne uge?

1 2 3 4 5 6 7

2.30

Meget dårlig Særdeles god

Helbred før kræftsygdommen

2.31 Hvordan synes du alt i alt dit helbred var, før du oplevede de første symptomer på din nuværende kræftsygdom? � Fremragende � Vældig godt � Godt � Mindre godt � Dårligt

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Side 10

Evaluering af egen læge Vi spørger i det følgende om en række generelle forhold vedrørende din vurdering af din egen læge, når du ser tilbage på det sidste år. Hvis du har skiftet læge, beder vi dig tænke på din tidligere læge. Din egen læge får ikke kendskab til dine svar.

Hvad er din vurdering af din egen læge/lægepraksis i de seneste 12 måneder med hensyn til… D

årl

ig

No

gen

lun

de

Go

d

Meg

et

god

En

est

åen

de

Kan

ikke s

vare

3.1 at få dig til at føle, at der er tid til dig under konsultationen?

3.2 at vise interesse for din situation?

3.3 at gøre det let for dig at fortælle om dine problemer?

3.4 at inddrage dig i beslutninger?

3.5 at lytte til dig?

3.6 at overholde tavshedspligt og diskretion?

3.7 at sørge for hurtigt at lindre dine symptomer?

3.8 at hjælpe dig til at få det så godt, at du kan udføre dine normale aktiviteter?

3.9 at være omhyggelig ved behandlingen af dine problemer?

3.10 at undersøge dig?

3.11 at tilbyde dig samtaler om dit helbred, forebyggende undersøgelser og vaccinationer?

3.12 at forklare formålet med undersøgelser og behandlinger?

3.13 at tale med dig om dine symptomer og din sygdom, så du føler dig velinformeret?

3.14 at hjælpe dig til at håndtere dine følelser omkring dine helbredsproblemer?

3.15 at hjælpe dig til at forstå betydningen af at følge lægens råd?

3.16 at vide, hvad der er blevet sagt og gjort ved tidligere henvendelser til praksis?

3.17 at forberede dig på, hvad du kunne forvente af hospital, speciallæge eller andre behandlere?

3.18 det ikke-lægelige personales hjælpsomhed?

3.19 at få en tid, der passede dig?

3.20 at få kontakt med lægepraksis i telefonen?

3.21 at komme til at tale med lægen i telefonen?

3.22 ventetiden i venteværelset?

3.23 at yde hurtig hjælp ved presserende sygdom?

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Side 11

Personlige oplysninger Forløbet kan være afhængigt af en række personlige forhold, som vi gerne vil klarlægge. Derfor handler de følgende spørgsmål om dig. Når vi bruger oplysningerne kan de ikke føres tilbage til dig.

4.1 Hvad er din ægteskabelige status? � Gift � Samlevende � Enlig (ikke tidligere gift eller samlevende) � Enlig (skilt, separeret, afbrudt fast samlivsforhold) � Enlig (enke, enkemand)

4.2 Har du børn?

� Ja Antal drenge └─┴─┘ Antal piger └─┴─┘ � Nej

4.3 Hvilken skoleuddannelse har du? � 7 års skolegang eller mindre � 8-9 års skolegang � 10 års skolegang � Studentereksamen, HF, HH, HTX eller tilsvarende � Andet: _________________________________________________________

4.4 Hvilken erhvervsuddannelse har du?

� Ingen � Et eller flere kortere kurser (fx specialarbejderkurser, arbejdsmarkedskurser) � Faglært inden for håndværk, handel, kontor (fx lærlinge- eller efg-uddannelse) � Kort videregående uddannelse under 3 år (fx social- og sundhedsassistent, politibetjent,

tekniker, merkonom) � Mellemlang videregående uddannelse 3-4 år (fx folkeskolelærer, journalist, socialrådgiver,

fysioterapeut) � Lang videregående uddannelse på 5 år eller mere (fx civilingeniør, læge, psykolog) � Andet: _________________________________________________________

4.5 Hvad er din nuværende stilling? � Specialarbejder eller ufaglært arbejder � Faglært arbejder � Funktionær eller tjenestemand � Selvstændig erhvervsdrivende (inkl. medhjælpende ægtefælle) � Lærling, elev, studerende � Folkepensionist/førtidspensionist � På efterløn � Arbejdsløs med understøttelse � På kontanthjælp � Hjemmegående (uden andet arbejde) � På orlov (barselsorlov, uddannelsesorlov mv.) � Andet:

_______________________________________________________

4.6 Hvor stor var din husstands årsindkomst før skat sidste år? (Ved husstand forstås i denne sammenhæng dig og din eventuelle ægtefælle eller samlever)

� Under 99.000 kr. � 100.000 - 249.000 kr. � 250.000 – 449.000 kr. � 450.000 – 700.000 kr. � Over 700.000 kr. � Ved ikke

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Praktiske oplysninger Vi har for ca. seks måneder siden sendt et spørgeskema til din egen læge, som har oplyst nøgledatoer i dit forløb samt sin vurdering af forløbet. Når vi bruger oplysningerne, kan de ikke på nogen måde føres tilbage til dig personligt eller din egen læge. Vi beder dig give os tilladelse til at anvende disse oplysninger i undersøgelsen, da de er af stor værdi for os. 5.1 Hvis du ikke vil give tilladelse til, at oplysningerne fra din egen læge benyttes i

undersøgelsen, bedes du sætte kryds her.

Nej, oplysningerne fra min egen læge må ikke benyttes til forskning

Du er velkommen til at skrive her, hvis du har øvrige kommentarer til dit sygdomsforløb. _____________________________________________________________________________________

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Det vil være en stor hjælp, hvis du vil kontrollere, at du ikke er kommet til at springe spørgsmål over i skemaet! Det udfyldte skema bedes returneret til Forskningsenheden for Almen Praksis i vedlagte frankerede svarkuvert.

Mange tak for din hjælp!

mette bach larsen - aarhus universitet · i also wish to thank bent hansen juel, csc scandihealth...

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