building an evidence base for chronic illness management: the example of chronic wounds nicky cullum...
TRANSCRIPT
Building an evidence base for chronic illness management: the
example of chronic woundsNicky Cullum RGN
Department of Health Sciences
Context
Ageing western population Increasing numbers of people living with
chronic illness Increasing demand for health care Meeting demand huge challenge from
financial and workforce perspectives
Huge contribution of nursing and nurses to chronic illness management
Nurses play a key role in the care and management of the care of people with chronic ill health
Can be role substitution (see Temmink et al, JAN 2000)
Can be a new role – care coordination, case management etc
Often combination with the emphasis on care rather than cure; living with …
Examples of nursing roles in chronic illness management
Nurse specialists in diabetes, Parkinson’s disease, COPD, rheumatology, asthma, wound care etc etc
Increasing emphasis on role of nurse specialists in implementing evidence based health care/evidence based decision making
Key Question
Does research evidence, relevant for the nursing role in chronic illness management, exist?
Is there an evidence base?
What is evidence based health care?
The consideration of relevant, valid, research evidence when making health care decisions NOT evidence driven or dictated but
evidence informed The nature of the research evidence
depends on the nature of the decision/uncertainty NOT solely concerned with RCTs though it
is for questions of effectiveness
Is the evidence base “fit for purpose”?
Evidence in context
Chronic disease research historically under-funded
Complexity (interventions and co-morbidities) methodologically challenging
Nursing research still “young”, under-developed and under-resourced
Nurses less likely to have research training in epidemiological and health services research methods
Exemplar of chronic wounds…
Chronic wounds
Leg ulcers (mainly venous disease, also arterial and mixed aetiology)
Diabetic foot ulcers Pressure ulcers Chronic, non-healing surgical wounds
In many parts of the world management of people with chronic wounds almost wholly a nursing responsibility
Common and costly
Imagine it is 1990 …
Thatcher resigns!
Ninja Turtles
Baywatch was big! Nelson Mandela released
Problem of leg ulcers
The UK Department of Health knew that the management of people with leg ulcers was a major proportion of community nurse workload
They did not know how much They did not know what care nurses were
delivering They did not know if it was effective Commissioned a systematic review
Traditional reviews not fit for purpose Mulrow reviewed 50 reviews in 4 major
medical journals from 1985 – 1986
used 8 explicit quality criteria to assess the reviews
no review met 8 criteria one met 6; 32 met 4/5; 17 met 3/8 only one review had clear methods Mulrow concluded that “current medical
reviews do not routinely use scientific methods to identify, assess and synthesise information”
Mulrow CD. The medical review article: state of the science. Ann Intern Med 1987; 106:485-8.
Death after heart attack
CumulativeYear RCTs Pts1960
1965
1970
1975
1980
1985
1990
1 20.5
1 232 653 1494 3167 179310 254411 265115 331117 392923 576727 612533 657143 21059 54 2205170 48154
Odds Ratio
Favours treatment Favours control
p < 0.01
p < 0.001
p < 0.00001
Death after heart attack
CumulativeYear RCTs Pts1960
1965
1970
1975
1980
1985
1990
1 20.5
1 232 653 1494 3167 179310 254411 265115 331117 392923 576727 612533 657143 21059 54 2205170 48154
Odds Ratio
Favours treatment Favours control
p < 0.01
p < 0.001
p < 0.00001
Textbook Recommendations
Rout Specif Exp NOT
21 510 2 8 7 812 4 3 1 1
112
872
111281
515 6
Systematic reviews
Are driven by a focused, answerable question
Have a pre-specified, scientific method Strive to minimise bias at all stages Aim to be comprehensive (all relevant
research included) Base their conclusions on the amount and
validity of the evidence
UK Department of Health commissioned a systematic review of leg ulcer care in March 1990
Objectives:
to critically review the research underpinning the nursing management of leg ulcers in the community and
develop a research agenda to inform and improve nursing practice
Clinical question driven review
What is the underlying pathology of leg ulceration?
How many people affected? Do we know risk factors and
early warning signs? Effective prevention? Recurrence rates? Interventions to reduce
recurrence? What methods of treatment are
used? Which treatments are effective? What are the adverse effects of
leg ulcer treatment?
Can adverse effects be reduced?
What is a nursing assessment of a leg ulcer patient?
How is care delivered and where?
What proportion of community nursing workload is leg ulcer management?
What is the impact of leg ulceration on the patient?
What outcomes should be measured?
Clinical question driven review
What is the underlying pathology of leg ulceration?
How many people affected? Do we know risk factors and
early warning signs? Effective prevention? Recurrence rates? Interventions to reduce
recurrence? What methods of treatment
are used? Which treatments are
effective? What are the adverse effects
of leg ulcer treatment?
Can adverse effects be reduced?
What is a nursing assessment of a leg ulcer patient?
How is care delivered and where?
What proportion of community nursing workload is leg ulcer management?
What is the impact of leg ulceration on the patient?
What outcomes should be measured?
CLEAR ANSWERSOME ANSWERSUNCLEAR
Pressure ulcer systematic review 1995
Evidence for the accuracy of risk prediction scales is confusing; not clear whether better than clinical judgement
Effects of manual repositioning not adequately studied
Most available equipment not reliably evaluated
More RCTs and economic evaluations required
an evidence desert…
Implementation into Practice
Primary Research
Evidence Synthesis
Developing a research agenda for chronic wounds
UK NHS Research and Development Programme
Funded a suite of systematic reviews in wound care beginning in 1997
Cochrane Wounds Group
Cochrane Collaboration was established 1993 an international not-for-profit and independent
organization that produces and disseminates systematic reviews of healthcare interventions
the major product of the Collaboration is the Cochrane Database of Systematic Reviews which is published quarterly as part of The Cochrane Library.
The Cochrane Wounds Group was established 1995
56 systematic reviews published to date with a further 57 reviews in production
Examples of completed Cochrane reviews
Antibiotics and antiseptics for mammalian bites Antimicrobial drugs for treating MRSA colonisation Compression for venous leg ulcers Hyperbaric oxygen therapy for chronic wounds Patient education for preventing diabetic foot ulceration Pin site care for preventing infections associated with
external bone fixators and pins Support surfaces for pressure ulcer prevention Tissue adhesives for closure of surgical incisions Wound drainage after incisional hernia repair
The changing landscape: 1990 - 2008
1994: One systematic review in wound care 2008:
133 Cochrane Reviews 176 non-Cochrane systematic reviews
Huge amount of primary research completed in response to evidence gaps identified in Cochrane reviews
From evidence synthesis to evidence creation
Are cheaper alternating pressure overlays as effective as alternating pressure mattresses?
PRESSURE Trial
1972 participants
Mattresses more cost effective
Is the 4 layer compression bandage more effective than the short stretch bandage for healing venous leg ulcers?
VenUS I
387 participants
4 layer bandage more clinically and cost effective
Is larval therapy more effective than hydrogel in healing sloughy venous leg ulcers?
VenUS II
200+ participants
Is therapeutic ultrasound more effective than standard care alone in healing venous leg ulcers?
VenUS III
300+ participants
Is compression hosiery more effective than bandages in healing venous leg ulcers?
VenUS IV
RCTs only provide part of the picture …
We need to know more than “is treatment x effective?” – the patient perspective
How do patients feel about larval therapy? Are patients comfortable on alternating
pressure mattresses? What is the effect of pressure ulceration on
patients’ quality of life?
We need to know more than “is treatment x effective?” – the service perspective
How do nursing staff feel about using larval therapy?
Were alternating pressure mattresses and overlays used appropriately?
Would a costly trial of topical negative pressure be an efficient use of health service resources? (would the value of the information be greater than the cost?)
Do staff use the results of research in practice, and if not, why not?
Describing the Problemepidemiology; the patient experience; social determinants of health and health care
Methodological Research
Evidence Synthesis
Systematic reviewsMeta analysisMixed treatment comparisonsDecision analytic modellingValue of information analysis
Evaluating Interventions
Large, multi-centre RCTs with economic evaluations
Implementation into Practice
A schema for nursing research in chronic disease management
0
10
20
30
40
50
60
70
80
90
100
66-70 71-75 76-80 81-85 86-90 91-95 96-00 2001-2005
2006-2008(Aug)
RC
Ts
pu
bli
shed
Pressure ulcers
Leg ulcers
Real progress: RCTs Published by Year (PubMed Clinical Queries)
Long way to go
40 out of 42 (95%) recommendations in the UK national (NICE) pressure ulcer guidelines based on opinion, consensus or case reports
32 out of 45 (71%) recommendations in the UK leg ulcer guidelines based on level III evidence
Further improvements needed…
Ensuring the patient voice in establishing the research agenda
Research capacity shortage (eg, insufficient nurse researchers with epidemiological skills)
Research agenda based on the value of the information likely to accrue
Whose research questions? (Tallon et al, Lancet 2000)
Research funding does not reflect burden of disease
Funding sources; vested interests; publication bias; consumer pressure
When studied in osteoarthritis showed that evidence base dominated by pharmaceutical (59%) and surgical (26%) studies
Patients, doctors and physiotherapists want more research on knee replacement, physiotherapy, education and advice
The need for epidemiological methods
Epidemiology is the study of the distribution and determinants of health in the population
Answers questions about causes of ill health; prognosis; effects of treatments
Some education in epidemiological methods and the interpretation of epidemiological studies fundamental to evidence based health care
If nurses not epidemiologically literate they are not likely to ask important questions or answer them with the most appropriate methods
… and finally
Increasingly research funders are turning to health economics to help judgements of whether a particular research study is likely to be an efficient investment of funding
The value of the information that the study will provide is an important consideration (see work by Claxton and others)
Knowledge of the impact on quality of life of chronic disease and therapies essential