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MET : REevaluation for Perioperative cArdIac Risk – Frailty study

Appendix 5A

MET-REPAIR: Screening - Inclusion Form


Inclusion criteria

- Enrolment in MET-REPAIR study Yes No

- Consent Mandatory?  Yes  No


Mandatory unless the centre has an explicit and written exemption from IRB
If consent mandatory - Consent obtained Yes No

Exclusion criteria

- Unable to consent or unwilling to participate No Yes

- Previous enrolment in MET-REPAIR Frailty No Yes

IF all items confirm patient can be included,


THEN, Paper CRF and electronic CRF should be completed.
IF patient does not comply with any inclusion criteria,
THEN, DO NOT INCLUDE patient in the study
Paper CRF and electronic CRF should NOT be completed.

MET-REPAIR Frailty Screening / Inclusion form –Version 1.0 dated 19 Apr 2017
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Appendix 5B

MET-REPAIR Frailty: Patient Confidential


Identification CRF Coversheet
This coversheet is intended to help site staff and local investigator link local patient data to the study-specific
study patient code. This sheet is used to facilitate this task for investigators; it can be filled to your
convenience. After completing follow-up, this coversheet should be saved separately from the CRF and
filed in a secure place. The information on this coversheet will NOT be collected in the CRF. It is for local
use ONLY.

IDENTIFYING DATA

A Date paper CRF created


|__|__| / |__|__|__| / |__|__|__|__| (dd/Mmm/YYYY)

B Date of birth
|__|__| / |__|__|__| / |__|__|__|__| (dd/Mmm/YYYY)

Patient Code (OpenClinica eCRF


C1 |__|__|__|-|__|__|__|-|__|__|__| (xxx-xxx-xxx 3 digit code for the
ID number) for MET-REPAIR
country, 3 digit code for the hospital and 3 digit individual patient number)

Patient Hospital/local Identification Number (handwritten or


sticker):
Identification
C2 fill in with available data – only for First name:
local follow-up use:

Last name:

Completion progress of the study forms: Paper CRF OpenClinica


electronic CRF

CRF1: PATIENT CONSENT


- MET-REPAIR Frailty consent (1.2)

CRF2: FRAILTY INDICES


- Clinical Frail Scale (2.1)
- Edmonton (2.2)
- Electronic Frailty Index (2.3)

MET-REPAIR Frailty CRF Confidential Identification Coversheet –version 1.0 dated 19 Apr 2017
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MET : REevaluation for Perioperative cArdIac Risk – Frailty study

Appendix 5C

MET-REPAIR Case Report Form


CRF 1: PATIENT DETAILS

PATIENT IDENTIFICATION AND CONSENT

MET-REPAIR Study |__|__|__|-|__|__|__|-|__|__|__|


1.1 Subject ID: Enter Study Subject ID in this format xxx-xxx-xxx 3 digit code for the country, 3
digit code for the hospital and 3 digit individual patient number

Informed consent applicable? 1.2.1 If yes, was consent for MET-REPAIR Frailty
Yes No obtained?
choose no only if consent process has been Yes No
confirmed in writing as not needed by local Ethics
1.2
1.2.1.1 If obtained, date of informed consent for MET-
REPAIR Frailty
|__|__|- |__|__|__| -|__|__|__|__|
in this format dd-Mmm-YYYY (Month in English
starting with capital letter)

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CRF 2: FRAILTY INDICES

Clinical Frail Scale

Clinical Frail Scale score:

1. Very fit
People who are robust, active, energetic and motivated. These
people commonly exercise regularly. They are among the fittest
for their age.

2. Well
People who have no active disease symptoms but are less fit
than category 1. Often, they exercise or are very active
occasionally, e.g. seasonally.

3. Managing well
People whose medical problems are well controlled, but are not
regularly active beyond routine walking

4. Vulnerable
While not dependent on others for daily help, often symptoms
limit activities. A common complaint is being “slowed up”, and/or
being tired during the day.

5. Mildly Frail
These people often have more evident slowing, and need help in 1 (Very Fit)
high order IADLs (finances, transportation, heavy housework, 2 (Well)
medications). Typically, mild frailty progressively impairs 3 (Managing Well)
2.1.1
shopping and walking outside alone, meal preparation and 4 (Vulnerable)
housework. 5 (Mildly frail)
6 (Moderately frail)
6. Moderately Frail 7 (Severely frail)
Moderately Frail – People need help with all outside activities 8 (Very severely frail)
and with keeping house. Inside, they often have problems with 9 (Terminally ill)
stairs and need help with bathing and might need minimal
assistance (cuing, standby) with dressing.

7. Severely Frail
Severely Frail – Completely dependent for personal care, from .
whatever cause (physical or cognitive). Even so, they seem
stable and not at high risk of dying (within ~ 6 months).

8. Very severely Frail


Very Severely Frail – Completely dependent, approaching the
end of life. Typically, they could not recover even from a minor
illness.

9. Terminally Ill
Approaching the end of life. This category applies to people with
a life expectancy

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2.1.2 Yes
History of dementia?:
.1 No

Mild dementia
2.1.2
.2
Severity of dementia Moderate dementia
Severe dementia

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Edmonton Frail Scale

Cognition:
Ask patient to imagine a pre-drawn circle is a No errors
2.2.1 clock. Ask them to place the numbers in the Minor spacing errors
correct positions and place the hands to indicate Other errors
a time of ‘ten to eleven’

General health status: 0


2.2.2.1 “In the past year, how many times have you 1-2
been admitted to a hospital?”
>2

General health status: Excellent / Very good / Good


2.1.2.2 “In general how would you describe your Fair
health?” Poor

Functional independence:
“With how many of the following activities do you 0-1
2.2.3 require help? (meal preparation, shopping, 2-4
transportation, telephone, housekeeping,
5-8
laundry, managing money, taking medications)”

Social support: Always


“When you need help, can you count on
2.2.4
someone who is willing and able to meet your Sometime
needs?” Never

Medication use: No
2.2.5.1 “Do you use five or more different prescription Yes
medications on a regular basis?”

Medication use:
No
2.2.5.2 “At time do you forget to take your prescription
Yes
medications?”

Nutrition:
No
2.2.6 “Have you recently lost weight such that your
Yes
clothing has become looser?”

Mood: No
2.2.7
“Do you often feel sad or depressed?” Yes

Continence:
No
2.2.8 “Do you have a problem with losing control of
Yes
urine when you don't want to?”

Functional performance:
Ask patient to sit in chair with back and arms
0-10 s
resting. When you say ‘GO’ patient should stand
2.2.9 11-20 s
up and walk at safe and comfortable pace to
One of: >20s OR patient unwilling / requires assistance
mark on floor 3m away, return to chair and sit
down. Time taken to do so is measures.

Edmonton Frail Scale total score:


2.2.10
(SEE APPENDIX)

Not frail (0-5)


Vulnerable (6-7)
2.2.11 Assessment of frailty based on total score: Mild frailty (8-9)
Moderate Frailty (10-11)
Severe frallty (12-17)

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Electronic Frailty Index (eFI)

2.3.1 Electronic Frailty Index score

Fit
Category of frailty as measured by Mild frailty
2.3.2
Electronic Frailty Index Moderate Frailty
Severe Frailty

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MET-REPAIR: CRF INSTRUCTIONS


This document is intended to aid in the completion of the CRF. Should you have any questions or should
uncertainties arise, please do not hesitate to contact the ESA Secretariat at met-repair@esahq.org Frequently
Asked Questions and answers will be made available on esahq.org/met-repair

CONTENTS

1. General instructions: ................................................................................................................................6


2. Screening –Inclusion Form .....................................................................................................................8
2.1. Inclusion Criteria section .............................................................................................................8
2.2. Exclusion criteria Section: ...........................................................................................................8
3. Patient Confidential Identification CRF Coversheet ...............................................................................8
4. Case Report Form ...................................................................................................................................9
1.1 MET-REPAIR Study ID
1.2 Consent ........................................................................................... Error! Bookmark not defined.
2.1 Clinical Frail Scale in dementia patients ......................................... Error! Bookmark not defined.
2.2.10 Edmonton Frailty Score .............................................................. Error! Bookmark not defined.
5. Table of Abbreviations: ..........................................................................................................................12
6. References ............................................................................................................................................13

1. General instructions:

- The date format for all fields is dd-Mmm-YYYY (e.g. 06-Jan-1978)


- Data will be collected directly from source documents into the encoded paper CRF and secondarily
entered into the eCRF. A copy of the original source documents will be stored within a locked
cabinet/office accessible to authorised personnel only in accordance with local and national
regulations. The Patient Confidential Identification CRF Coversheet (page 2) and assigned patient
identification code will be stored separately also in a locked cabinet/office (accessible to authorised
personnel only) in order to record in-hospital outcomes, supply missing data points, and to allow
potential monitoring visits by National Coordinating Investigators, Sponsor, IRB, or regulatory
authorities. Signed ICF to document that written informed consent was obtained prior to enrolment
will be stored as described above. All study documents will be archived as required by local legislation.
- The paper CRF should be completed at patient inclusion. Data from the paper CRF should be entered
electronic CRF no more than 8 weeks after patient inclusion.

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- After the end of the study, if there are queries on data entered in the electronic CRF, centres may
receive a Data Clarification Form (DCF). The DCF must be completed, signed and returned within 1
week to the study team.

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2. Screening –Inclusion Form (App 5A)

2.1. Inclusion Criteria section

2.2. Exclusion criteria Section:

3. Patient Confidential Identification CRF Coversheet (App.5B)


Please note: this sheet is intended as an aid in local site organization and will help you keep track of CRF
still pending completion. The columns are not exclusive: one column tracks completion of the paper CRF,
the other of the eCRF.

The Patient Confidential Identification CRF Coversheet should be stored separately from the
CRF and data from this sheet is not collected in the eCRF.

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4. Case Report Form (CRF – App?5C)


Please note that numbering refers to CRF items.
1.1. MET-REPAIR Study ID

1.6. Consent

2.1.2. Clinical Frail Scale in patients with dementia: The degree of frailty corresponds to the degree of dementia.
Common symptoms in mild dementia include forgetting the details of a recent event, though still remembering the
event itself, repeating the same question/story and social withdrawal. In moderate dementia, recent memory is
very impaired, even though they seemingly can remember their past life events well. They can do personal care
with prompting. In severe dementia, they cannot do personal care without help.

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2.2.10 Edmonton Frail Scale: Score for the Edmonton Frail Scale is calculated based on 0-2 points allocated to each

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component

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5. Table of Abbreviations:

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6.
6. References

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