epr - data collection form · 2014-12-15 · confidential page 1 23/07/2012 /login page/ login...

Confidential 23/07/2012

/Login page/

LOGIN

Username* (i.e., email address) [ ]

Password* [ ]

Can’t access your account?1

Login

Don’t have an EPR account. Note that you first have to acquire a Specialist Porphyria Centre ID no from

your participating Porphyria Specialist Centre. Click here for further details

Sign up

1 Reset password protocol


/Sign up page /

SIGN UP

S1 Specialist Porphyria Centre ID no.2 * [ ]

� (View only) Your associated Porphyria

Specialist Centre is located here3*

Brussels (Belgium)

Leuven (Belgium)

Sofia (Bulgaria)

Prague (Czech Republic)

Viborg (Denmark)

Helsinki (Finland)

Bordeaux (France)

Paris (France)

Chemnitz (Germany)

Düsseldorf (Germany)

Karlsruhe (Germany)

Munich (Germany)

Budapest (Hungary)

Szeged (Hungary)

Dublin (Ireland)

Tel Aviv (Israel)

Milan (Italy)

Modena (Italy)

Rome (Italy)

San Giovanni Rotondo (Italy)

Rotterdam (The Netherlands)

Bergen (Norway)

Warsaw (Poland)

Moscow (Russia)

Barcelona (Spain)

Madrid (Spain)

Stockholm (Sweden)

Zürich (Switzerland)

Ankara (Turkey)

Cardiff (Wales, United Kingdom)

Leeds (United Kingdom)

London (United Kingdom)

Salford (United Kingdom)

� Language 4 Czech

Danish

Dutch

English

2 Supplied by the porphyria centre and required before first time entry into the EPR. Possibly the first two numbers could

indicate country? 3 This is connected to the Specialist Porphyria Centre ID and is view only

4 Drop-down list. Should default to the official language of the country based on specialist centre ID. This will not appear in

the first draft as there is currently no multilingual support. But this is likely to change so we must prepare for this. Maybe

default to the language corresponding to location based on IP address?


SIGN UP

Hungarian

Hebrew

Italian

Finnish

French

German

Norwegian

Polish

Russian

Spanish

Swedish

Turkish

Please enter your personal details below to register for a password

S2 First name* [ ]

S3 Middle name [ ]

S4 Surname* [ ]

S5 Professional role (tick all that apply) porphyria specialist (physician)

genetic counsellor

researcher/ site coordinator

general practitioner/ primary care physician

gastroenterologist

haematologist

dermatologist

psychiatrist

neurologist

surgeon

other specialist

allied health professional/ nurse

other

S6 Working place (please edit if different form

the porphyria specialist centre)*

[default to specialist porphyria centre ]*

S7 Institution* [ ]

S8 Address street

suburb/town

state/province

[ ]

[ ] postcode [ ]

[ ] country* [autocomplete]5

S9 Phone number [ ]

5 Defaults to country based on specialist centre ID. The list is autocomplete. Source for country code: UN's Standard country

or area codes and geographical regions for statistical use http://unstats.un.org/unsd/methods/m49/m49.htm. Note Also

available in 6 other languages. Three-digit numerical codes used for statistical processing purposes by the Statistics Division

of the United Nations Secretariat and three-digit alphabetical codes assigned by the International Organization for

Standardization (ISO).


SIGN UP

S10 Email address6* (username) [ ]

SPAM Filtering software notice7

S11 Password* [ ]

See password requirements8

S12 Password confirmation* [ ]

Sign up

6 The users email address is their username

7 EPR-related information communicated through e-mail may be affected by any e-mail filtering “SPAM” software you have

installed on your computer. EPR uses your e-mail address during the Web-based password request process and for

subsequent communication. To ensure that you receive your password confirmation and other important EPR-related

correspondence, you may want to do one of the following:

- Add the mail ___ domain to your e-mail “safe list”.

- If your settings do not allow you to add e-mail addresses to a “safe list,” use the Help section or contact your e-

mail/internet provider's Customer Support to research your configuration options.

- Disable your e-mail filtering “SPAM” software.

- Choose an e-mail account with the least restrictive spam filters, security settings, etc. 8 Passwords contain at least 8 characters. They must have at least one upper-case letter and one number.


/Homepage/

<username> I Log out

HOMEPAGE

<Display real time statistics here regarding EPR recruitment rates>

General inclusion criteria

Patients with porphyria, with present or previous symptoms and with a confirmed diagnosis

either by DNA-analysis, or if not tested confirmed by standardised biochemical criteria:

Written informed consent

General exclusion criteria

Participants who are unable to understand the study protocol or unable to give informed

consent and have no legal representative.

Patients without a confirmed diagnosis of porphyria either by standardised biochemical criteria

or by DNA-analysis.

Disease specific inclusion criteria: AIP9 I VP I HCP I ADP I PCT I EPP I XLDPP I CEP I HEP

Quick links to Participant Information and Consent forms10

Children (< 12 years)

Adolescents (12 to 16/18)

Adults (>16/18)

About the EPR I Technical difficulties I Contact us I Disclaimer

9 AIP specific inclusion criteria:

Patients with porphyria, with present or previous symptoms and with a confirmed diagnosis either by DNA-analysis, or if

not tested confirmed by standardised biochemical criteria:

- a urine or plasma PBG value greater than the PBG upper reference limit (URL)

- and a negative plasma fluorescence scanning or wavelength less than 623 nm

- and a fecal coproporphyrin isomer III:I ratio less than 2.0, or if not available, the fecal coproporphyrin less than the

corresponding URL.

Presymptomatic mutation carriers confirmed by DNA-analysis demonstrating inheritance of a disease-related sequence

variant in the hydroxymethylbilane gene. 10

The participant info consent forms are country specific – and routed by help of specialist centre code

Enrolment of a new EPR

participant

Enter data (enrol)

Access or enter new data for

existing EPR participant

Enter data

Enter a new event

View/ edit previous entries

Complete previous entry

Reports

Statistical reports of the EPR

Go To

EPR Protocol (Synopsis)

Overview of your participants


/Enrolment page/

HOMEPAGE I ENROLMENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT I LAB I

FAMILY11

ENROLMENT OF A NEW EPR PARTICIPANT

Patient information and consent form

E1 Register the patient’s date of birth to obtain

an age related print out of the consent

form*12

[dd/mm/yyyy] 13

E2 Written consent given* yes

no14 (the patient cannot be registered)

Previous Next – Creation of an EPR ID No.

Delete and close Save I Save and close

11

Where the tabs feature on the page and how they look will require some thought in web design. The tabs are interactive

in that they show all pages that have been visited and the user will visit. This is dependent on the module. Users can click

backwards, but not forwards (???) 12

Following the registration of the patients DOB the browser’s print method is automatically invoked. Also display message:

“Please store the original consent form in the patient file and provide a copy to the participant. If required send a copy to

your porphyria specialist centre.” 13

After entering the age, the computer is prompted to print the age appropriate PICF. Age groups may change from country

to country according to local ethics regulations 14

Directed to E1


/EPR ID No. separate window/

CREATION OF THE PATIENT’S EPR ID NO.15

You are about to create the patient’s unique identifier/pseudonym, known as the patient EPR ID no. These

details have been written by the patients in the consent form. PLEASE TAKE GREAT CARE TO ENTER THIS

INFORMATION ACCURATELY, INCLUDING CORRECT SPELLING OF NAMES, as this will avoid the generation of

multiple EPR ID numbers for the same participant. Note that this personal data will never be stored within the

server database.

For more information about generating the EPR ID no, please see (link)16

Participant identification17

ID1 First name at birth* [ ]

ID2 Surname at birth*

OR

If the patient does not have a surname,

specify their patronym

[ ]

ID3 Current surname (if different from above) [ ]

ID4 Date of birth* [dd/mm/yyyy]

ID5 City of birth* [ ]

ID6 Country of birth* [ ]

Optional: you can choose to add the following for your own records

ID7 National ID no. [ ]

ID8 Address street

Suburb/town

postcode

country

[ ]

[ ]

[ ] state/province[ ]

[autocomplete ]18

You will be prompted to print this information after the creation of the EPR ID No. for your confidential records.

15

Appears when user indicates consent is given for a new subject or when a user indicates they have forgotten the

patient’s EPR ID No. This is a separate form opened in a separate window. 16

This links to a separate page. “From these personal data the EPR ID No. is calculated, consisting of a series of <8> digits.

The following personal data are used: first name at birth, surname at birth, date of birth, city of birth and country of birth.

Example: John Smith, born 21.04.1970 in Brighton, United Kingdom. This information results in the EPR ID No. 42-54-91-32.

Importantly, the pseudonym is created on the basis of a so-called ‘cryptographic hash function’. By this mathematical

operation a unique value is assigned during a complicated, one-way procedure. The mathematical algorithm used ensures

that nobody (not even the system programmer) can reconstruct from the result (the EPR ID No.) the information which was

used to generate the EPR ID No. in the first place. The personal data transmitted to generate the EPR ID No. are held only

for the calculation of the EPR ID No. in the working memory of a server. The calculation of the EPR ID No. requires only

milliseconds. Viewing personal data during this time is impossible. Thereafter all data used to create the EPR ID No. are

permanently erased from the working memory of the server so that no identifying details remain; data used to generate

the pseudonym are never stored in any form of permanent memory (e.g. on the hard drive). Following this, all database

entries and every use of data is exclusively carried out under the assigned EPR ID No. 17

To help avoid multiple entries, blanks, upper cases, and special characters are stripped 18

Autocomplete. Source for country code: UN's Standard country or area codes and geographical regions for statistical use

http://unstats.un.org/unsd/methods/m49/m49.htm.


CREATION OF THE PATIENT’S EPR ID NO.15

It is extremely important that you do not loose this as it is the easiest way to link the exact unique identifying

information to the participant’s EPR ID No. This information is to be kept securely with the patient consent form

in the patient’s personal file.

Create EPR ID No.

19

19 when a doctor clicks 'enter new event' under the 'access or enter new data for existing EPR participant' tile (from the

homepage) and then the 'I have forgotten the patient's EPR ID No.' on the Enter Event page, the EPR prevents them from

creating a new EPR ID No (ie., only allowed to match to a current participant EPR ID No). If they enter data that does not

match an existing EPR ID No. they receive the following error message: 'the participant cannot be found. Are you certain

the patient has been previously entered?'

- if yes, then 'please check for any errors in the above fields marked in red (note: fields are not case sensitive)', and if

incorrect again 'We are sorry, but we still cannot find the participant in the database, and the patient's visit cannot be

currently entered. Please either find the patient's <8> digit EPR ID No., which should be contained in a print out in the

patient's personal file, or contact your EPR coordinator at your local porphyria specialist centre for further assistance. It is

also possible the patient has a print out of their EPR ID No. What would you like to do: () enter the patient's EPR ID No., ()

go back to the homepage, or () leave the EPR.

- if no, then directed to the enrolment of a new EPR participant page.


/Enter event page/

HOMEPAGE I ENTER EVENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT I LAB I

FAMILY HISTORY

ENTER EVENT20

E3 Patient’s EPR ID No.* [ ]21

I have forgotten the participant’s EPR ID No.22

Dates of entry

Date of data entry [dd/mm/yyyy] 23

Dates of previous entries 1.

2.

[dd/mm/yyyy]24

[dd/mm/yyyy]

etc…

Back Next – Personal Characteristics


20

This is the first page to appear for those entering data for an existing EPR subject. 21

Pre-populated for physicians who have generated the EPR ID No. on the previous page. For physicians entering data for

an existing patient, if they enter data that does not match an existing EPR ID No. they receive an error message, telling

them 'the participant cannot be found. You can find the number in a print out in the patient's personal file. Either try

entering the number again, or click on ‘I have forgotten the participant’s EPR ID No.’ and re-enter their information as

written on their consent form. 22

This is only displayed if the EPR ID No. has not been prepopulated (i.e., only for users entering data for an existing EPR

subject). Users who have forgotten the EPR ID No. are directed to ‘Creation of the Patient’s EPR ID No.’ page. They are also

flagged in the database for quality assurance to ensure they have not made a mistake when re-entering the data.

If this is selected, the EPR prevents the user from creating a new EPR ID No (ie., only allowed to match to a current

participant EPR ID No). 23

Recorded automatically 24

If relevant


/Personal characteristics page/


FAMILY

PATIENT’S PERSONAL CHARACTERISTICS25

PC1 Date of birth* [dd/mm/yyyy]26

PC2 Sex* female

male

PC3 Country of residence [autocomplete ]27 unknown

Geographical region28 Europe

Eastern Europe

Northern Europe

Southern Europe

Western Europe

Africa

Eastern Africa

Middle Africa

Northern Africa

Southern Africa

Western Africa

Americas

Latin America and the Caribbean

Caribbean

Central America

South America

Northern America

Asia

Central Asia

Eastern Asia

Southern Asia

South-Eastern Asia

Western Asia

Oceania

Australia and New Zealand

Melanesia

Micronesia

Polynesia

unknown

PC4 Family history of porphyria known? yes

no

unknown

PC5 Number of children [ ]29 unknown

25

Administered consecutively, but details from the previous session are prepopulated and editable 26

Prepopulated from previous entry on enrolment page 27

Display default country based on specialist centre ID No. given 28

Not displayed but coded automatically from country (e.g., IF Greece THEN Southern Europe) 29

Family module section will reflect the input given here



�30 PC5.1 (If yes) Year of birth – child one [yyyy] 31 unknown

PC6 Total number of pregnancies [ ]32 unknown

If the patient has died

PC7 Date of death* [dd/mm/yyyy]

� PC7.1 Was the death caused by porphyria

or complication of porphyria/

treatment for porphyria?*

yes

no

unknown

� � PC7.1.1 (If yes) Comment [ ]33

� PC7.2 Primary cause of death*34 cardiovascular diseases

hypertensive heart disease

Ischaemicischemic heart

disease

cerebrovascular disease

inflammatory heart disease

other cardiovascular

diseases

rheumatic heart disease

malignant neoplasms

colon and rectum cancers

breast cancer

prostate cancer

liver cancer

hepatocelluar

carcinoma

other primary liver

cancer

metastatic liver

cancer

trachea, bronchus, lung

cancers

melanoma and other skin

cancers

bladder cancer

lymphomas, multiple

myeloma

other malignant neoplasms

respiratory diseases

respiratory infections

unknown

30

Red arrows indicate branching questions 31

Field is expanded based on number of children 32

Field is only expanded if female (contingency question) 33

Text box is expanded according to the input 34

Drop-down list



diseases of the digestive system

cirrhosis of the liver

peptic ulcer disease

Other digestive diseases

unintentional injuries

intentional injuries

suicide

other intentional injuries

other, specify [ ]

� PC7.3 Additional comments about cause

of death

[ ]35

Back Next – to diagnosis


35

Text box is expanded according to the input


/Diagnosis page 1/


FAMILY

PORPHYRIA DIAGNOSIS I CLINICAL SETTING CRITERIA I PBG AT DIAGNOSIS I DNA ANALYSIS I

PORPHYRIA DIAGNOSIS 36

D1 Porphyria diagnosis* 37 Acute:

acute intermittent porphyria (AIP)

variegate porphyria (VP)

hereditary coproporphyria (HCP)

ALA dehydratase deficiency (ADP)

Non-acute porphyrias:

porphyria cutanea tarda (PCT)

erythropoietic protoporphyria (EPP)

x-linked dominant protoporphyria (XLDPP)

congenital erythropoietic (CEP)

hepatoerythropoietic porphyria (HEP)

Clinical Status38

D2 Does the patient have current symptoms consistent with

an acute attack of porphyria39 *

yes

no

D3 Has the patient previously had one or more diagnosed

acute porphyria attacks requiring hospitalisation? 40* yes

no

� D3.1 (If yes) Year of first episode [yyyy] unknown

� D3.2 Number of subsequent episodes [ ] unknown

� D3.3 Elevated u-PBG or pl-PBG concentrations

recorded in relation to at least one acute attack*

yes

no

� D3.4 (If yes to D2 or D3) Did the patient have any

acute illness of unknown cause consistent with

an acute attack of porphyria before the

diagnosis of <AIP>41 was made

yes

no

unknown

36

Baseline data. Details from the previous sessions are accessible if errors need to be corrected 37

Only AIP patients will initially be included in the study 38

Diagnosis algorithm: Patients with porphyria, with present or previous symptoms and with a confirmed diagnosis either

by DNA-analysis, or if not tested confirmed by standardised biochemical criteria:

- a urine or plasma PBG value greater than the PBG upper reference limit (URL)

- and a negative plasma fluorescence scanning or wavelength less than 623 nm

- and a fecal coproporphyrin isomer III:I ratio less than 2.0. Or if not available, the fecal coproporphyrinless than the

corresponding URL.

OR Presymptomatic mutation carriers confirmed by DNA-analysis demonstrating inheritance of a disease-related sequence

variant in the hydroxymethylbilane gene. 39

Not a baseline data element. Linked to G30 in the database (same variable). D2 is shown the first time a patient is

registered. However on subsequent data entries, doctors see and complete G30. Data is stored in the same variable. 40

Not a baseline data element. Linked to G30.1.1 in the database (same variable). D3 is shown the first time a patient is

registered. However on subsequent data entries, doctors see and complete G30.1.1. Data is stored in the same variable.

Thus this data element appears only for the first data entry. 41

This should be linked to D1 acute forms so that it corresponds to the input of the diagnosis.



� � D3.4.1 (If yes) Year of first episode [yyyy] unknown

� � D3.4.2 Total no. of episodes [ ] unknown

Back Next – Assessment



/Diagnosis page 2/


FAMILY

PORPHYRIA DIAGNOSIS I CLINICAL SETTING CRITERIA I PBG AT DIAGNOSIS I DNA ANALYSIS I


DNA Analysis

D4 HMBS mutation * 43 positive

negative

not tested

� D4.1 If positive, which mutation [autocomplete]* 44

� � D4.1.1 (If entered a

new mutation)

This mutation

is not listed in

our database,

please specify:

mutation:

evidence:

reference:

[ ] (*)

[ ]

[ ]

e.g. c.0003G>T

e.g. cDNA

amplification

e.g. Kauppinen

2002 Clin Chem,

1891

unknown

unknown

� � D4.1.2 Comment [ ]45

� � D4.1.3 If tested, date of analysis [dd/mm/yyyy] unknown

Biochemical data

PBG at time of porphyria diagnosis (or if not available, the earliest test result available – even if today)

D5 Urine PBG (*) concentration*

upper reference

limit*

date of

[ ]

[ ]

[dd/mm/yyyy]

μmol/mmol creatinine*

Other unit, choose46(*) ��

mmol/mol creatinine

µmol/g creatinine

mg/g creatinine

µmol/L

µg/L

mg/L

mg/dL

42

Baseline data. Details from the previous sessions are accessible if errors need to be corrected and/or to add missing data.

Otherwise this section only appears the first time for each participant. 43

If ‘no’ to D2 AND D3 AND ‘negative’ or ‘not tested’ to D4 then display the following message: ”The patient presently does

not fulfil the diagnostic criteria for registration in the EPR. You can continue to complete the form and your progress and

the patient’s data will be saved, which can be accessed and finalised when the inclusion criteria for the diagnosis of AIP is

fulfilled” 44

Linked to column of known mutations listing position, sequence and, if available, mutation (e.g., c.0003G>T). As this will

be updated over time, new entries are allowable 45


List is only expanded when other is nominated. A warning can be displayed suggesting that μmol/mmol creatinine is the

recommended unit for reporting



measurement

D6 Plasma PBG (*) concentration(*)

upper reference

limit(*)

date of

measurement

[ ]

[ ]

[dd/mm/yyyy]

µmol/L*

Other unit;

[ ](*)

� D6.1 (u-PBG or pl-PBG < URL)

Please report here if the

patient at a later stage has

presented with increased

PBG concentration (*)47

Concentration

upper reference

limit

date of

measurement

[ ]

[ ]

[dd/mm/yyyy]

u-PBG

μmol/mmol 48creatinine*

Other unit, choose49(*)

mmol/mol creatinine

µmol/g creatinine

mg/g creatinine

µmol/L

µg/L

mg/L

mg/dL

pl-PBG

µmol/L*

Other unit;

[ ](*)

Further Biochemical Diagnosis 50

D7 (If ‘yes’ to D2 or D3 AND ‘negative’ or ‘not

tested’ to D4), HCP and VP excluded? (*)

yes

no51

� D7.1 (If yes) Plasma scan: wavelength of fluorescence emission

peak if positive: [ ] (*)52

negative*

47

Displayed for all. However, If PBG concentration < URL AND ‘yes’ to D2 OR D3.3 AND ‘negative’ OR ‘not tested’ to D4 AND

age > 8yrs then this is required. 48

List to the left is expanded after selecting either u-PBG or pl-PBG. 49

List is only expanded when other is nominated. A warning can be displayed suggesting that μmol/mmol creatinine is the

recommended unit for reporting 50

Items D7 to D7.1.2.1 appear IF ‘not tested’ OR ‘negative’ to D6 and ‘yes’ to D2 AND/OR D3. 51

Display the following message: ”The patient presently does not fulfil the diagnostic criteria for registration in the EPR.

You can continue to complete the form and your progress and the patient’s data will be saved, which can be accessed and

finalised when the inclusion criteria for the diagnosis of AIP is fulfilled” 52

If reported positive value > 623 nm then display the following message: ”The patient presently does not fulfil the

diagnostic criteria for registration in the EPR. You can continue to complete the form and your progress and the patient’s

data will be saved, which can be accessed and finalised when the inclusion criteria for diagnosis of AIP is fulfilled”



date of measurement [dd/mm/yyyy]

� D7.1.1 Fecal coproporphyrin isomer III:I ratio

upper reference

limit

date of

measurement

[ ] (*) 53

[ ] (*)

[dd/mm/yyyy]

unknown

� � D7.1.1.1 (If total fecal CIII:I is

unknown) Fecal

coproporphyrin54

concentration

upper reference

limit

date of

measurement

[ ](*)55

[ ](*)

[dd/mm/yyyy]

nmol/g dry(*)

weight

other unit; (*)

[ ]

unknown

History of possible previous acute symptoms

D8 (If ‘no’ to D2 and D3) Has the patient ever

had acute abdominal pain of unknown

cause for two or more days requiring

hospitalisation?

yes

no

unknown

D9 (If ‘no’ to D3.3) Following diagnosis, has the

patient ever had acute abdominal pain for

two or more days requiring hospitalisation

that at the time was attributed to their

<AIP>56 57

yes

no

unknown

� D9.1 (If ‘no’ to D2 and D3 OR ‘yes to

D3.3 AND If ‘yes’ to D9) record

year of first/only episode

[yyyy] unknown


D3.3) Duration of first/only

episode

[ ], in days

unknown

� D9.3 (If ‘no’ to D2 and D3) Was a yes unknown

53

If reported a fecal coproporphyrin isomer III:I ratio > 2.0 display the following message: ” The patient presently does not

fulfil the diagnostic criteria for registration in the EPR. You can continue to complete the form and your progress and the

patient’s data will be saved, which can be accessed and finalised when the inclusion criteria for diagnosis of AIP is fulfilled” 54

Fecal coproporphyrin(TFP) only displayed if fecal CIII:I is not completed (i.e., detected when clicking ‘next’ or is unknown.

The CIII:I ratio is preferable, but since these are historical data, it may not be available for all patients. 55

If reported a fecal coproporphyrin< the corresponding URL display the following message: ” The patient presently does

not fulfil the diagnostic criteria for registration in the EPR. You can continue to complete the form and your progress and

the patient’s data will be saved, which can be accessed and finalised when the inclusion criteria for diagnosis of AIP is

fulfilled” 56

Link to D1 (acute forms only) 57

Prepopulated with a cross for ‘Yes’ and option to change



surgical intervention performed no

� � D9.3.1 (If yes) Record surgical

action

[autocomplete]58 unknown


D3.3) Pain episode associated with

(tick all that apply)

nausea and/or vomiting

muscle and back pain

sensory loss

motor paresis (including

impairment of bulbar or

respiratory function)

tachycardia

hypertension

hyponatremia

hypomagnesemia

behavioural changes

unknown

� D9.5 (If ‘no’ to D2 and D3 OR ‘yes’ to

D3.3) Was opiate analgesia

required

yes

no

unknown


D3.3) Total number of episodes

[ ], unknown


D3.3) Average duration of episodes

[ ], in days unknown

� D9.8 (If ‘no’ to D2 and D3) According to

these symptoms and sign

constellations, do you consider it

likely that the patient has

previously had an acute attack(s)? 59

yes, very confident

yes, moderately confident

uncertain

no, moderately confident

no, very confident

Back Next – Assessment60


58

List should be developed (e.g., Appendectomy/ Oophorectomy etc..) 59

Routed to General Assessment and then module 2 60

Error message for any mandatory fields that not completed according to the diagnostic algorithm (e.g., negative or not

tested to D4, age > 8 years, and urine (D4) or plasma (D5) PBG is not complete then display message: ‘Details of <__> must

be provided to register the patient in the EPR. You can continue filling out the form and your progress will be saved, but you

must provide this information at a later stage for the event to be included in the EPR”


/General Assessment page 1/

HOMEPAGE I ENROLMENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT I

LAB I FAMILY

GENERAL ASSESSMENT, LIVER AND KIDNEY FUNCTION I FUNCTIONAL CAPACITY I LIFESTYLE AND

DRUGS I ASSESSMENT MODULE

GENERAL ASSESSMENT61

G1 Date of visit/assessment* [dd/mm/yyyy] 62

G2 Reason for visit 63*

routine follow-up

treatment - current symptoms

treatment - chronic symptoms

prophylactic treatment - chronic symptoms/repeated

attacks

other, specify [ ]

G3 Did you personally attend to the patient? yes

no

� G3.1 (If no) Comment on how the data

was obtained

[ ]64

G4 Attendance/ Admission to health service* outpatient

inpatient

unknown

� G4.1 (If ‘inpatient’) Record length of stay [ ], in days

months

unknown

G5 (If the patient is female) Record menstrual

status 65

premenarche

regular menses

perimenopausal

postmenopausal

unknown

G6 (If patient is pregnant) Record month of

pregnancy 66

[ ] month unknown

Note: urine OR plasma PBG must be provided to register the visit

G7 Urine PBG (at present visit) (*) concentration

upper

reference limit

[ ]*

[ ]*

μmol/mmol creatinine (*)

Other, choose67 (*):

mmol/mol creatinine

µmol/g creatinine

mg/g creatinine

G8 Plasma PBG (at present visit) (*) concentration [ ](*) µmol/L(*)

61

Administered consecutively, but relevant baseline entries from the previous session are prepopulated and editable 62

Displays today’s date automatically but editable 63

Please select the reason that best describes the visit 64


Compound question: only asked IF “female” 66

Compound question: only asked IF “female” 67

List is only expanded when other is nominated. Maybe a warning is displayed suggesting that μmol/mmol creatinine is

the recommended measurement value



upper

reference limit

[ ](*)

other [ ](*)

G9 Urine ALA (at present visit) concentration

upper

reference limit

[ ]

[ ]

µmol/mmmol creatinine

Other, choose:68

mmol/mol creatinine

µmol/g creatinine

mg/g creatinine

G10 Plasma ALA (at present visit) concentration

upper

reference limit

[ ]

[ ]

µmol/L

other [ ]

G11 Blood pressure [sys/ dia] unknown

G12 Pulse rate [ ] per min unknown

G13 Height [ ] cm unknown

G14 Weight [ ] kg unknown

� BMI 69 [ ]

Kidney and liver function

G15 Serum creatinine [ ] μmol/L URL [ ] unknown

G16 Estimated GFR [ ] URL [ ] unknown

G17 Dialysis yes

no

unknown

G18 Post-kidney transplant yes

no

unknown

G19 Hepatoma screening performed regularly 70*

yes

no

unknown

(If yes) Record if the following procedures are performed and with what frequency

� G19.1 Alpha-foeto-protein (*) yes, every [ ]

no

month(s)

year(s)

unknown

� G19.2 Liver ultrasound (*) yes, every [ ]

no

month(s)

year(s)

unknown

� G19.3 Liver MRI (*) yes, every [ ]

no

month(s)

year(s)

unknown

� G19.4 Liver CT (*) yes, every [ ]

no

month(s)

year(s)

unknown

68

List is only expanded when other is nominated. Maybe a warning is displayed suggesting that μmol/mmol creatinine is

the recommended measurement value 69

Calculated automatically (calculate BMI: HEIGHT/ WEIGHT² (kg/m² ). 70

Sub data elements are only mandatory if hepatoma screen is carried out



G20 Has the patient had a hepatoma?* yes

no

unknown

� G20.1 (If yes) Record year of diagnosis* [yyyy] unknown

� G20.2 Year and modality of primary

treatment*

[yyyy] liver resection

radiofrequency ablation

liver transplantation

unknown

other, specify [ ]

� G20.3 Recurrence yes, when [yyyy]

no

unknown

Back Next71


71

If age > 8 years and urine or plasma PBG is not complete then display message: ‘Details of urine (G7) OR plasma (G8) PBG

must be provided to register the event in the EPR. You can continue filling out the form and your progress will be saved, but

you must provide this information at a later stage for the event to be included in the EPR”




LAB I FAMILY


DRUGS I


Functional Capacity

G21 Occupation normal

reduced capacity for usual job

marginal work only

unable to work

G22 Rate on a scale from 0 to 100% the patient’s performance status

normal no complaints; no evidence of health problems 100%

able to carry on normal activity; minor health problems 90%

normal activity with effort; some health problems 80%

cares for self; unable to carry on normal activity or to do active work 70%

requires occasional assistance, but is able to care for most of his personal needs 60%

requires considerable assistance and frequent medical care 50%

in bed more than 50% of the time 40%

almost completely bedfast 30%

totally bedfast and requiring extensive nursing care by professionals and/or family 20%

comatose or barely arousable 10%

dead 0% Back Next


72

Administered consecutively, but relevant details from the previous session are prepopulated and editable




LAB I FAMILY

GENERAL ASSESSMENT, LIVER AND KIDNEY FUNCTION I FUNCTIONAL CAPACITY I

LIFESTYLE AND DRUGS I


Lifestyle factors and drugs

G23 Alcohol use yes

no

unknown

� G23.1 Units per week (1 unit =

approx 10 grams of alcohol)74

< 1

1 – 5

6 – 10

11 – 20

> 20

unknown

G24 Smoking status (tobacco) never smoked

former smoker

current smoker

unknown

� G24.1 Cigarettes /day [ ] unknown

� G24.2 Age when smoking began [ ] unknown

� G24.3 Age when smoking finished75 [ ] unknown

� G24.4 Smoking duration76 [ ] unknown

G25 Snus use (Sweden and Norway only) yes

no

unknown

� G25.1 (If yes) Type loose snus

portion snus

unknown

� G25.2 Portions /day [ ] unknown

G26 Select all prescribed and over the counter medication the patient is taking 77

73

Relevant details from previous session are displayed and editable 74

For example: 1 small glass of beer = 1 unit, 1 medium glass of wine = 2 units, 1 shot of spirits = 1 unit, 1 bottle of wine = 9

units 75

Compound question: only asked if former smoker 76

Calculated automatically from previous two items. If the patient is a current smoker, calculated from date of visit. 77

Autocomplete. Linked to ATC drug codes. Expanded for multiple entries



Drug

(Generic name)

Strength78

Dose

(e.g. 150mg

Frequency

x 2)

Dose given

by

Route of

administrati

on

Started

(dd/mm/yyyy)

[autocomplete/drop-

down]79

[ ] [ x ] daily80

weekly

monthly

3 monthly

other

PO

IV

SC

topical

inhalation

other

[dd/mm/yyyy]

[autocomplete/drop-

down]

[ ] [ x ] daily81

weekly

monthly

3 monthly

other

PO

IV

SC

topical

inhalation

other

[dd/mm/yyyy]

[autocomplete/drop-

down]

[ ] [ x ] daily82

weekly

monthly

3 monthly

other

PO

IV

SC

topical

inhalation

other

[dd/mm/yyyy]

G27 Recreational/ Illicit drug use yes

no

unknown

� G27.1 (If yes) Which (tick all that apply)

78

Only complete for when dose is difficult to calculate 79

This is derived from The Drug database and coded by ATC code. Additional information from this database includes the

type of drug, e.g., Enprostil (code: A02BB02) is classified as ‘Drugs for acid related disorders’; and the classification of risk:

Not porphyrinogenic (NP), Probably not porphyrinogenic (PNP), Possibly porphyrinogenic (PSP), Probably porphyrinogenic

(PRP), Porphyrinogenic (P), and Not yet classified (NC). Further info at

http://www.whocc.no/atc/structure_and_principles/. 80

Drop-down list, but ‘day’ is the default value 81

Drop-down list, but ‘day’ is the default value 82

Drop-down list, but ‘day’ is the default value



Drug


Frequency83

Route of

administration84

Started

(dd/mm/yyyy)85

Cannabis/ marijuana (non-medical use)

MDMA ”ecstasy” (stimulant)

Amphetamines “speed”(stimulant)

GHB (stimulant)

Cocaine (stimulant)

Opiates (e.g, heroin or morphine)

Depressants “downers” (barbiturates)

LSD (hallucinogen)

Psychedelic mushrooms (hallucinogen)

Solvents (e.g., glue sniffing)

Other, specify [ ]

< monthly

monthly

weekly

daily

inhalation

PO

IV

SC

other

[mm/yyyy]

G28 Complementary or alternative

medicines

Yes

No

unknown

� G28.1 (If yes) Specify (tick all

that apply)

herbal medicine

vitamins and minerals

acupuncture

naturopathy

homeopathy

meditation

other, specify [ ]

� � G28.1.1 (If yes to herbal medicine or vitamins and minerals) List all herbal medicine/ non-

proprietary drugs the patient is taking now.

83

Drop down lists, appears for each ticked drug 84

Drop down lists, appears for each ticked drug 85

appears for each ticked drug



Name herbal medicine / non-proprietary

drug(s) 86

Frequency87

Route of

administration88

Started

(mm/yyyy)

[ ] > yearly

yearly

monthly

weekly

daily

tablets/ capsules

powders

teas

extracts

fresh or dried

plants

topical

other

[mm/yyyy]

[ ] < yearly

yearly

monthly

weekly

daily

tablets/ capsules

powders

teas

extracts

fresh or dried

plants

topical

other

[mm/yyyy]

[ ] less often than

yearly

yearly

monthly

weekly

daily

tablets/ capsules

powders

teas

extracts

fresh or dried

plants

topical

other

[mm/yyyy]

G29 Does the patient have any ongoing

disorder with or without current

treatment?

yes

no

unknown

� G29.1 (If yes) Which? (tick all that

apply)

[drop-down list]89

� G29.2 Additional comments about the patient’s

comorbidities

[ ]90

Clinical status

G30 Does the patient have current symptoms consistent with an

acute attack of porphyria?91*

yes92

86

Appears if true to herbal medicines or vitamins and minerals, expands based on entry 87

Drop down lists 88

Drop down lists 89

Coding system to be developed 90




no

� G30.1 If no, is the patient under long term treatment for

repeated acute attacks (4 or more acute attacks

requiring hospitalisation per year) or preventive

treatment with or without acute episodes?*93

yes94

no

� � G30.1.1 If no, has the patient previously had one

or more acute porphyria attack(s)

requiring hospitalisation? 95*

yes

no96

� � � G30.1.1.1 (If yes) Elevated u or pl-PBG

concentrations recorded in

relation to at least one acute

attack*97

yes98

no99

Back Next


91

Linked to D2 in the database (same variable). D2 is shown the first time a patient is registered. However on subsequent

data entries, doctors see and complete this data element. Data is stored in the same variable. Note: G30.1 is always shown

here– independent of G30 being shown here or in the Diagnostics section. 92

Directed to Module 1 93

N.B., This is the same data element as A54, and should be coded into the same variable. 94


Linked to D3 in the database (same variable). D3 is shown the first time a patient is registered. However on subsequent

data entries, doctors see and complete this data element. Data is stored in the same variable. Note further: This variable

should not be displayed if acute attacks have previously been confirmed by

1) previous completion of the acute attack module (module 1)

2) previous completion of the chronic module (module 2)

3) previously responding yes to elevated u-PBG concentration to this variable (‘yes’ to D3.3)

IF a previous acute attack has been confirmed, then the doctor should be routed directly into Module 2 when having

responded No to G30 and G30.1. 96

Directed to module 2 97

Linked to D3.3 in the database (same variable). D3.3 is shown the first time a patient is registered. However on

subsequent data entries, doctors see and complete this data element. Data is stored in the same variable. Otherwise, same

criteria for displaying this item are as stated in the above footnote. 98


Directed to module 2


/Module 1 - web page 1/


LAB I FAMILY


DRUGS

SYMPTOMS AND FINDINGS I NEUROLOGICAL ASSESSMENT I PROVOKING FACTORS I OTHER

COMPLICATIONS I SEVERITY I TREATMENT I

MODULE 1

A1 Month and year of previous attack*100 [mm/yyyy] unknown

A2 Date of onset of current symptoms* [dd/mm/yyyy] unknown

Symptoms and findings

Pain

A3 Abdominal pain yes

no

unknown

A4 Back pain yes

no

unknown

A5 Lower limbs pain yes

no

unknown

A6 Other pain (1), specify [ ]101

A7 The patient reports no pain102 yes

no

unknown

Analgesia

A8 Non-opiate analgesia only yes

no

unknown

A9 Opiate analgesia yes

no

unknown

A10 No analgesia yes

no

unknown

Other symptoms

A11 Nausea Yes

No

unknown

A12 Vomiting Yes

No

unknown

A13 Constipation Yes

No

unknown

A14 Diarrhoea Yes

No

unknown

100

Appears if answered yes to previous attack asked previously in the diagnosis section 101

This list will be expanded one point at a time 102

Not possible IF selected ”Yes” to A2 to A5


MODULE 1

A15 Headache yes

no

unknown

A16 General malaise yes

no

unknown

A17 Fatigue yes

no

unknown

A18 Depressive symptoms yes

no

unknown

A19 Anxiety yes

no

unknown

A20 Insomnia yes

no

unknown

A21 Confusion yes

no

unknown

A22 Irritability yes

no

unknown

A23 Hallucinations yes

no

unknown

A24 Visual problems yes

no

unknown

A25 Other symptom (1), specify [ ]103

Back Next


103

This list will be expanded one point at a time




LAB I FAMILY

GENERAL ASSESSMENT AND KIDNEY FUNCTION I FUNCTIONAL CAPACITY I LIFESTYLE AND DRUGS

SYMPTOMS AND FINDINGS I NEUROLOGICAL ASSESSMENT I PROVOKING FACTORS I OTHER

COMPLICATIONS I SEVERITY I TREATMENT I

MODULE 1

Neurological assessment

A26 Sensory impairment yes

no

unknown

A27 Peripheral neuropathy yes

no

unknown

� A27.1 (If yes) Pain yes

no

unknown

� A27.2 Paresthesias yes

no

unknown

A28 Paresis yes

no

unknown

� A28.1 (If yes) Record where? (tick all that

apply)

upper extremities

lower extremities

respiratory muscle paresis

cranial nerve lesions

bulbar paresis

other, specify

unknown

[ ]

A29 Urinary retention yes

no

unknown

A30 Urinary incontinence yes

no

unknown

A31 Convulsions yes

no

unknown

A32 Decreased consciousness yes

no

unknown

A33 Psychosis yes

no

unknown

A34 Other neurological assessment (1) , specify [ ]104

A35 EMG normal

abnormal, comment [ ]105

not performed

104




MODULE 1

A36 EEG normal


not performed

A37 Cerebral CT normal


not performed

A38 Cerebral MRI normal


not performed

Back Next


106







LAB I FAMILY

GENERAL ASSESSMENT AND KIDNEY FUNCTION I FUNCTIONAL CAPACITY I LIFESTYLE AND DRUGS

SYMPTOMS AND FINDINGS I NEUROLOGICAL ASSESSMENT I PROVOKING FACTORS , OTHER

COMPLICATIONS AND SEVERITY I TREATMENT I

MODULE 1

Potential provoking factors (Note: other potentially provoking factors, such as drugs, have been

previously collected under the general assessment section)

A39 Days since start of last menses 109 [ ] days unknown

Which of the following events occurred prior to the acute attack:

A40 Fasting in the previous 7 days yes

no

unknown

A41 Infection in the previous 7 days yes

no

unknown

A42 Excessive drinking during previous 7 days

preceding attack 110

yes

no

unknown

A43 Recent psychological stress (last 2 weeks)? yes

no

unknown

A44 Recent physical stress (last 2 weeks)? yes

no

unknown

� A44.1 (If yes) Specify which [ ]

A45 Other possible provoking factor 1, specify [ ]111

Other complications

A46 Lowest serum sodium recorded during

hospital stay

concentration* (µmol/L)

lower reference limit*

[ ]

[ ]

unknown

A47 Lowest serum magnesium recorded during

hospital stay

concentration (µmol/L)

lower reference limit

[ ]

[ ]

unknown

A48 Rhabdomyolysis yes

no

unknown

� A48.1 (If yes) Highest creatine kinase (CK)

concentration recorded during

hospital stay

concentration

upper reference

limit

[ ]

[ ]

U/L

other unit;

[ ]

109

Compound question: only asked IF “Pre-menopausal”. If “Unkown” then only asked IF “Female” 110

Compound question: only asked IF “Yes” to alcohol use 111



MODULE 1

date of

measurement

[dd/mm/yyyy]

unknown

Severity

A49 Admission to Intensive Care Unit ( ICU)* yes

no

unknown

� A49.1 (If yes) Record number of days in unit

(*)

[ ] days unknown

� A49.2 Mechanical ventilation(*) yes

no

unknown

� � A49.2.1 (If Yes) Record number of

days on ventilation(*)

[ ] days unknown

Back Next



/Module 1 web page 4/


DRUGS

SYMPTOMS AND FINDINGS I NEUROLOGICAL ASSESSMENT I PROVOKING FACTORS , OTHER

COMPLICATIONS AND SEVERITY I TREATMENT I

MODULE 1 (CURRENT ACUTE PORPHYRIA SYMPTOMS)

Treatment

A50 Oral carbohydrate yes

no

unknown

A51 High carbohydrate loading (i.v. glucose) (*) yes

no

unknown

� A51.1 Route of administration (tick all that

apply)

peripheral venous line

central venous line

other [ ]

unknown

� A51.2 Duration of treatment [ ] days unknown

� A51.3 Concentration [ ] % unknown

� A51.4 Average quantity per day [ ] grams glucose/day unknown

� A51.5 Insulin added yes

no

unknown

A52 Administered haem arginate(*) yes

no

unknown

� A52.1 (If yes) Duration of symptoms

before administration(*)

[ ]

hours

days

unknown

� A52.2 Initial dose (day 1) (*) [ ] mg/day unknown

� A52.3 Additional doses 1(*) [ ] mg/day

(*)

[ ] total no. of

days given (*)

unknown

� A52.4 Preparation(*) saline

[ ] % albumin

unknown

� A52.5 Route of administration (tick all that

apply)

peripheral venous line

central venous line

other [ ]

unknown

A53 Other IV fluids (tick all that apply) glucose

saline solutions

volume expanders

blood-based products

blood substitutes

parenteral nutrition

unknown

other, specify [ ]112

112



MODULE 1 (CURRENT ACUTE PORPHYRIA SYMPTOMS)

Clinical status

A54 Is the patient under long term treatment for

repeated acute attacks (4 or more acute

attacks requiring hospitalisation per year) or

preventive treatment with or without acute

attacks? (*)113

yes114

no115

Back Next


113

N.B., This is the same data element as G30.1, and should be coded into the same variable. 114


Directed to LAB section




LAB I FAMILY


DRUGS

CLINICAL HISTORY I CLINICAL ASSESSMENT I LONG TERM TREATMENT

MODULE 2

Clinical history

C1 (If yes to G30.1) Month and year of last

attack116

[mm/yyyy]

C2 (If yes to G30.1) Month and year of start of

repeated attacks117

[mm/yyyy] unknown

C3 (If yes to G30.1) Month and year of first

treatment with hemin arginate

[mm/yyyy] unknown

C4 (If yes to G30.1) Acute attacks in the last 12

months?

yes

no

unknown

� C4.1 (If yes) Record number [ ] unknown

C5 (If yes to G30.1) Outpatient treatment related

to acute attacks?

[ ] No. of attendances per year unknown

C6 (If yes to G30.1) Day case treatment [ ] No. of attendances per year unknown

C7 (If yes to G30.1) Inpatient treatment [ ] No. of admissions per year

[ ] Average length of stay

C8 (If yes to G30.1) Home care treatment/ self-

infusing

[ ] No. of attendances per year

C9 (If yes to G30.1.1) Month and year of last

attack requiring hospitalisation118

[mm/yyyy]

C10 (If yes to G30.1.1) Total number of acute

attacks during lifetime

[ ]

C11 (If yes to G30.1.1) Does the patient have

unspecific/chronic symptoms that may be

attributable to acute porphyria

yes, start [mm/yyyy]

no

Back Next


116

Administered consecutively, but details from the previous session are displayed and editable when relevant 117

Administered consecutively, but details from the previous session are displayed and editable 118

Administered consecutively, but details from the previous session are displayed and editable when relevant




LAB I FAMILY


DRUGS


MODULE 2

Clinical assessment

C12 Mobility status walks unaided

walks with support

requires wheelchair

C13 Other paresis present yes, specify [ ]119

No

C14 Contractures yes

no

unknown

C15 Muscle pain yes

no

unknown

C16 Chronic mild abdominal pain yes

no

unknown

C17 Opiate dependence yes

no

unknown

C18 Peripheral neuropathy yes

no

unknown

� C18.1 (If yes) Pain yes

no

unknown

� C18.2 Paresthesias yes

no

unknown

C19 Chronic fatigue yes

no

unknown

C20 Anxiety yes

no

unknown

C21 Depressive symptoms yes

no

unknown

C22 Other symptom/ finding (1), specify [ ]120

C23 (If yes to G30.1) Are repeated acute attacks

related to the menstrual cycle?121

yes

no

unknown

Back Next

119



Appears only if female and within the appropriate age range


MODULE 2




HOMEPAGE I ENROLMENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT

I LAB I FAMILY


DRUGS


MODULE 2

Long term treatments

C24 (If yes to G30.1) Is the patient under review for liver

transplantation?*

yes

no

unknown

� C24.1 (If yes) Comment [ ]122

C25 (If yes to G30.1.1) Liver transplant received* yes

no

unknown

� C25.1 (If yes) Record date of liver transplant(*) [dd/mm/yyyy] unknown

� C25.2 Combined liver and kidney transplant

performed? (*)

yes

no

� C25.3 Liver transplantation complications(*) yes

no

unknown

� � C25.4 (If yes) Record further details hepatic artery thrombosis

other, comment [ ]

unknown

� � C25.5 Further comments123 [

]124

C26 (If yes to G30.1) Administered haem arginate* yes

no

unknown

� C26.1 Frequency of administration* Regular treatment;

number

[ ] given per

At onset acute

attacks;

[ ] average no.

given per

week

month

year

month

year

Unknown

Unknown

� C26.2 Average dose* [ ] mg/day Unknown

� � C26.2.1 Preparation saline

[ ]% albumin

Unknown

� C26.3 Haem arginate therapy complications* yes unknown

122


Directed to “Laboratory Investigations” 124



MODULE 2 no

� � C26.3.1 Iron overload yes

no

unknown

� � � C26.3.1.1 Receiving

treatment for iron

overload

No treatment

Chelators

Phlebotomies

Other, specify

Deferoxamine

Deferasirox

Deferiprone

[ ]125

� � C26.3.2 Indwelling venous catheter yes

no

unknown

� � � C26.3.2.1 (If yes) Catheter

obstruction

yes

no

unknown

� � C26.3.3 Superficial venous thrombosis yes

no

unknown

� � C26.3.4 Deep venous thrombosis yes

no

unknown

C27 (If yes to G30.1) Administered GnRH (LHRH) agonist

treatment*

yes

no

unknown

Drug126

(Generic name)

Route of administration Started

(dd/mm/yyyy)

[prepopulated] 127 [prepopulated] [prepopulated] C27.1 If you have not previously entered GnRH agonist treatment, please describe below

GnRH (tick all that

apply) Average dose

(e.g. 0.9 mg)

Frequency

x 2)

Dose given by Route of

administration

Started

(dd/mm/yyyy)

buserelin

goserelin

other, specify

[ ]

[ mg x ] daily

weekly

monthly

3 monthly

other

nasal

subcutaneous

intramuscular

other

[dd/mm/yyyy]

� C27.2 GnRH related accelerated osteoporosis with

rapid bone loss present?

yes

no

unknown

� C27.3 Monitoring for loss of bone density yes

no

unknown

125


IF a LHRH drug has been entered previously, this section is pre-populated. 127

This is linked to G23 and prepopulated with any previously entered reference to LHRH, such as gonadorelin

hydrochloride(Factrel®) or gonadorelin diacetate tetrahydrate(Cystorelin®)


MODULE 2 � � C27.3.1 (If yes) How are you monitoring this

DEXA scan

Report on latest examination

normal

abnormal, comment

[ ]

Other procedure; specify

[ ]

Report on latest examination

normal

abnormal, comment

[ ]

unknown

� C27.4 Add back hormones given yes

no

unknown

C27.4.1 Add back hormone(s)


Average daily dose

(e.g. 0.9 mg) Route of administration Started

(dd/mm/yyyy)

oestrogen

progesterone

other, specify

[ ]

[ ] mg/day

[ ] mg/day

[ ] mg/day

oral

topical

vaginal

other

[dd/mm/yyyy]

� � C27.4.2 Undertaking endometrial monitoring? yes

no

unknown

� � � C27.4.2.1 (If yes) Ultrasound yes, frequency [ ]

other procedure

[ ],frequency [ ]

unknown

Back Next - Laboratory Investigations



/Lab page/


I LAB I FAMILY

LABORATORY INVESTIGATIONS MODULE – IF AVAILABLE (OPTIONAL SUPPLEMENTARY)

L1 Haemoglobin concentration (conc)

lower reference limit (LRL)

[ ]

[ ]

g/dl

g/L

mmol/L

Unknown

L2 Total WBC Conc

URL

[ ]

[ ]

x 10(9)/L

x 103/µL Unknown

L3 Platelets Conc

LRL

[ ]

[ ]

x 10(9)/L

x 103/µL Unknown

L4 Serum creatinine Conc

upper reference limit (URL)

[autofill]128

[autofill] 129

mmol/L Unknown

L5 Albumin creatinine

ratio

Conc

URL

[ ]

[autofill] 130

mg/mmol

creatinine Unknown

L6 Sodium Conc

LRL

[ ]

[autofill] 131

mmol/L

mg/dl Unknown

L7 Potassium Conc

LRL

[ ]

[ ]

mmol/L

mg/dl Unknown

L8 Calcium Conc

LRL

[ ]

[ ]

mmol/L

mg/dl Unknown

L9 Phosphate Conc

URL

[ ]

[ ]

mmol/L

mg/dl Unknown

L10 Magnesium Conc

LRL

[ ]

[ ]

mmol/L

mg/dl Unknown

L11 CK Conc

LRL

[autofill]132

[autofill]

U/L

mg/dl Unknown

L12 eGFR Conc [autofill]133

L13 ALT Conc

LRL

[ ]

[ ]

U/L

mg/dl Unknown

L14 CRP Conc

LRL

[ ]

[ ]

U/L

mg/L Unknown

Back Next - Family History


128

This is pre-populated from same data element from general assessment section (G13) 129



This is pre-populated from same data element from general assessment section (A46) 132

This is pre-populated from same data element from general assessment section 133

This is pre-populated from same data element from general assessment section


/Family page/


I LAB I FAMILY I

FAMILY HISTORY MODULE (OPTIONAL SUPPLEMENTARY) 134

F1 Family member135 mother

father

brother

sister

daughter

son

grandmother

grandfather

F2 Year of birth [yyyy] unknown

F3 Deceased Yes

No

unknown

� F3.1 Year of death [yyyy] unknown

� F3.2 Primary cause of death cardiovascular diseases

malignant neoplasms

respiratory diseases (e.g., chronic

obstructive pulmonary disease)

respiratory infections (e.g., lower

respiratory infections)

diseases of the digestive system (e.g.,

cirrhosis of the liver)

unintentional injuries (e.g., road

traffic accidents)

intentional injuries (e.g., self-inflicted

injuries)

other

unknown

� � F3.2.1 (If yes to malignant

neoplasms) Hepatocellular

cancer?*

Yes

No

Other primary liver cancer

unknown

� F3.3 Additional comments about cause of

death

[ ]

F4 <AIP>136 Yes

No

Suspected

unknown

� F4.1 (If yes or suspected) Attacks Yes

No

Suspected

unknown

134

Repeated for all family members: Mother, siblings, grandparents, children 135

Repeated until no additonal entries are included 136

Link to D1


FAMILY HISTORY MODULE (OPTIONAL SUPPLEMENTARY) 134 � F4.2 If known & available, enter their EPR

ID no.

[ ] unknown

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