Best Practices in PMCF Survey. Design and Execution: Learnings from 5000 patient case forms Introductions • PMCF Surveys – Pros and Cons • Learnings from 5000 patient forms collected in 2022 – Importance of Stakeholder identification – Managing Stakeholders’ expectations – Importance of good questionnaire design – 7 Steps to building a good questionnaire – How to identify the ‘right’ respondents • Strategies to enhance HCP engagement in PMCF surveys • Cheat Sheet 1: When do conduct PMCF Survey Studies in-house • Cheat Sheet 2: How to identify a good PMCF Survey partner

1. CONFIDENTIAL
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Best Practices in PMCF Survey
Design and Execution:
Learnings from 5000 patient case forms
Proactive Post-Market Surveillance Conference
Belgium (04-05 October 2022)
Presented by: Sumit Mehta, Chief Executive Officer
Organization: Cetas Healthcare Insights Pte Ltd
EU-MDR

2. CONFIDENTIAL
Agenda
• Introductions
• PMCF Surveys – Pros and Cons
• Learnings from 5000 patient forms collected in 2022
– Importance of Stakeholder identification
– Managing Stakeholders’ expectations
– Importance of good questionnaire design
– 7 Steps to building a good questionnaire
– How to identify the ‘right’ respondents
• Strategies to enhance HCP engagement in PMCF surveys
• Cheat Sheet 1: When do conduct PMCF Survey Studies in-house
• Cheat Sheet 2: How to identify a good PMCF Survey partner
2

3. CONFIDENTIAL 3
Planning | Design | Deployment | Analysis |NB Liaison

4. CONFIDENTIAL
PMCF Surveys are Cheaper, Faster, Better(?) (when applicable)
4
What could possibly go wrong?
HCP Participation Rate
Project Management
Platform learning curve
Internal costs
External costs
Opportunity costs
Data gaps/remedies
Primary endpoint failure
Secondary endpoint failure
QUALITY
COST
TIME
Everything!

5. CONFIDENTIAL 5

6. CONFIDENTIAL 6
Expectations from the survey to:
Fulfil the study objectives, make their decision
easy, fit their standards/style, be comparable
Expectations from the survey to:
Answer research objectives, yield as much
information as possible, with no errors
Notified Body
HCPs Biostatisticians
Medical Writing
PMCF Survey Design – Best Practices
Identify and Understand Your Stakeholders’ Expectations
Expectations from the survey to:
Easy to follow (knowing how to answer),
short, not difficult, interesting, not asking
confidential information
Expectations from the survey to:
Well laid out, clearly coded, efficient data
mapping, clear skip patterns, unambiguous,
unchanged to allow high quality raw data

7. CONFIDENTIAL 7
They need to see inputs to/output of CERs:
Question type: screening, consent, procedures,
indications, endpoints, AE, side-effects
Ensure reliable analysis to provide the
expected output - needs to uncover
information AND balance the needs of other
three groups of people.
Efficient programming and data
processing with minimum error
• Instructions, logics, codes, layout
Aim to get their cooperation and
ensure maximum relevant information
can be collected
• Avoid ambiguity, bias / leading, over
generalization, misunderstanding,
drop out, fatigue
Notified Body
HCPs Biostatisticians
Medical Writing
PMCF Survey Design – Best Practices
Survey Design should fulfill your stakeholders’ expectation

8. CONFIDENTIAL 8
Planning is Everything!
Defining WHO?
(HCPs)
Deciding HOW
(methodology)
Lock-in the key
objectives
Order the topics
from HCPs viewpoint
Address the level of
detail required for
each topic/objective
Plan the analysis
(biostatisticians/
medical writing)
Formulate the
questions
Questionnaire layout
Pilot the
questionnaire
Revise accordingly
PMCF Questionnaire Design Journey
Questionnaire writing is just 10% of the effort!

9. CONFIDENTIAL
DNA of a good PMCF Questionnaire
Basics
Meeting the
propose
Short
Questionnaire
Specificity,
No ambiguity
Simplicity
Neutrality
• Easy to understand
• Can answer every question
• Willing to answer every question truthfully
• Addressing one or more of the pre-stated objectives to support identified claims
• Avoid nice-to-know information
• Keep the questionnaire as short as possible
• Long questionnaires may lead to refusal or boredom and poor data
• Language should have common meaning
• Avoid ambiguity e.g., often, sometimes, regularly
• Use familiar words
• Avoid complex or technical phrasing
• Use complete but short sentences
• Avoiding double negatives
• Avoid loaded / leading questions
• Avoid questions resulting in “socially accepted answers”
Compressive
response list
• Add options such as others (please specify), don’t know/not sure, etc.
• Add section breaks – section introduction

10. CONFIDENTIAL
7 Steps to a Robust Questionnaire Design
10
There are seven steps in the design of a questionnaire to satisfy all stakeholders:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
Finalize the layout of the questionnaire
Pretest and revise
Notified Body
HCPs Biostatisticians
Medical Writing

11. CONFIDENTIAL
Pretest and revise
Finalize the layout of the questionnaire
11
There are seven steps in the design of a questionnaire:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
Work backwards from CERs
• IFU ➔ guides your screening questions
• S&P endpoints, Claims ➔ guides your key metrics
• Clinical conditions for use ➔ safeguards your outcomes
• Clinical Evidence Matrix ➔ allows you to KISS
• Sample size calculations ➔ allows you to plan the execution
and document the questionnaire strawman!
7 Steps to a Robust Questionnaire Design (1)

12. CONFIDENTIAL
Pretest and revise
Finalize the layout of the questionnaire
7 Steps to a Robust Questionnaire Design (2)
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There are seven steps in the design of a questionnaire:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
• Make a list of all the questions that could go into the questionnaire
• The aim at this stage is to be as comprehensive as possible in the listing
to address all the objectives
• Identify the sections to be captured in the Questionnaire
• Bucket the questions in the sections identified
• Review it with the RA/consultants, if possible

13. CONFIDENTIAL
Pretest and revise
7 Steps to a Robust Questionnaire Design (3)
13
There are seven steps in the design of a questionnaire:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
Finalize the layout of the questionnaire
• Make it easy: KISS (Keep It Short and Simple)
• Short sentences or support with emphasizes
(with bold letters or emphasis with dashes etc.)
• Technical terms must be clear (known by respondents and by
interviewer)
• Be precise and make it comprehensible
• Wording must be clear, so that the answer is clear as well
• Tone must be friendly but firm as we want their knowledge-input,
looking for advise and it is no interrogation! Please USE PLEASE!
Time to walk the talk!

14. CONFIDENTIAL
Walking in the HCPs shoes
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Make-or-break for study outcomes
We need to ask ourselves:
• Will the respondent understand the question?
• Lookout for use of unfamiliar/incorrect/vague/technical words, abbreviations, etc. , use ‘HCP speak’
• Give a clear statement of the essence of the idea, split into basic elements, leverage the pilot surveys
• Will they be willing to answer? (confidential)
• Gently ‘leading in’ to suggest a range of answers, including less acceptable options
• Will they be able to answer?
• Too trivial/technical, irrelevant, stretching the memory; using the screener to avoid interviewing wrong person
• Is there a possibility of bias in the responses?
• Pre-empt by using question rotation, using specific boundaries, comprehensive answer options, avoid leading questions
• Is the flow logical/orderly?
• Warm-up>> introduction >> screener >> consent >> practice >> procedures >> end-points >> open-ends
• Do my questions satisfy all the study’s objectives to support the claims?
• Do we know how we will use the results of each question? (If you don’t, consider eliminating it.)
Remember: While all questions will elicit a response, not all responses will be valid!

15. CONFIDENTIAL
Pretest and revise
7 Steps to a Robust Questionnaire Design (4)
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There are seven steps in the design of a questionnaire:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
Finalize the layout of the questionnaire
Questionnaire Format
Close Ended (99%) Open Ended (1%)
• These are questions that
invite free ranging responses
– sometimes called verbatim
responses
• They are extremely useful for
obtaining a deep
understanding of the
respondents’ views and
behavior
• But are difficult to capture
precisely and time
consuming to analyze
• Minimize the open-ended
questions, ideally down to
one.
• These questions invite a response that
is fitted into a preordained answer
• There are multiple formats:
• Single Choice - Response strictly
limited to two alternatives
• Multiple Choice - Range of
possible answers
• Verbal/Numerical Rating Scales-
The phrase/scores are often out
of a number with 5, 7 and 10
(where the large number is best
and 1 is worst)
• Ranking – To identify the order
of importance of various factors
from a list

16. CONFIDENTIAL
Pretest and revise
7 Steps to a Robust Questionnaire Design (5)
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There are seven steps in the design of a questionnaire:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
Finalize the layout of the questionnaire
• Normally the respondent is eased into the task with relatively
straightforward questions while the more difficult or sensitive ones are left
until they are warmed up
From General
to
Specific
• The ordering of the questions is
important as it brings logic and
flow to the interview
• From General questions : guide
them step by step into the content
• Screening questions first
• Followed by consent screen
The Funnel Approach

17. CONFIDENTIAL
Pretest and revise
7 Steps to a Robust Questionnaire Design (6)
17
There are seven steps in the design of a questionnaire:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
Finalize the layout of the questionnaire
• The questionnaire now needs to be fully formatted with clear
instructions to the interviewer, including a powerful introduction to
each section, routings and probes
• Response codes against each options must be unique for each question
• Instructions to the Programmer on loop questions must be clear and not
too convoluted
• Run Grammar Checks
• Use professional translation agencies
• Always use back-translations services from a different agency

18. CONFIDENTIAL
7 Steps to a Robust Questionnaire Design (7)
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There are seven steps in the design of a questionnaire:
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Decide what information is required
Make sections of the questions
Refine the question phrasing
Develop the response format
Put questions in appropriate sequence
Finalize the layout of the questionnaire
Pretest and revise
• Unless the questionnaire has been used in interviews and with respondents, it is
impossible to say whether it is going to achieve the desired results
• The purpose of pretesting the questionnaire is to determine:
• Whether the questions as they are worded will achieve the desired results
• Whether the questions have been placed in the best order
• Whether the questions are understood by all classes of respondent
• Whether additional or specifying questions are needed or whether some
questions should be eliminated
• Whether the instructions to interviewers are adequate
• The small group of respondents selected for the pilot survey should be broadly
representative of the type of respondent to be interviewed in the main survey
Time to regroup and revise/approve the questionnaire!

19. CONFIDENTIAL
Optimal Screener Structure
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To identifying the right respondents for the PMCF surveys
Customized question as per
specific research objectives
Country
City/State
Facility Details
Respondent role/ job role
Procedure and Device related questions
Subject knowledge and study specific questions
Consent for data sharing
Conflict of interest
Experience (overall and in primary facility)
Professional Registration Number
Cheater Questions

20. CONFIDENTIAL
The Introduction to Survey
• Give a full and frank disclosure to put respondent at ease - first impressions count
• Keep it as short as possible, while still allowing for rapport
• A hook - we are very interested in the opinions of experts, like yourself
• It’s a good idea to include an indication of time
• Show them what is required (pen & paper or online platform-based survey approach)
The Incentive to participate in PMCF Survey
• Work with your compliance department for FMV based incentivization
• Think of other non-monetary incentive options to engage HCPs (CME?)
• Explore ‘community’ approach to ensure long term engagement (portfolio dependent)
The Execution of PMCF Survey
• Make it easy for HCP to submit data (think mobile phone/tablet friendly approach!), it’s NOT an RCT!
Motivating HCPs to Participate in PMCF Surveys

21. CONFIDENTIAL
Cheat Sheet 1: In-house Vs. External Vendor for PMCF Surveys
21
Time Constraint
Resources
Compliance
Access
Is enough time available for NB submission?
Necessary resources available (e.g. survey scripting,
biostatisticians, medical writers) internally?
Will your compliance allow to incentivize HCPs
meaningfully to participate in surveys?
Do you have access to the HCPs (especially in the indirect
markets) who could participate in the surveys?
Go for External
Agency Support
NO
NO
NO
NO
YES
YES
YES
YES
Do It In-house

22. CONFIDENTIAL
Cheat Sheet 2: External Vendor Selection for PMCF Surveys
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Domain Expertise
Scalability
Access
Compliance
Partner has experience in running surveys with HCPs in
medical devices domain?
Partner has enough team/bench strength to take on
multiple mandates?
Partner has a sufficient pool of HCPs who have pre-opted
in to participate in surveys?
Partner has the necessary GDPR, GCP, ISO certifications to
conduct PMCF surveys? Data Quality Policy?
Do NOT engage
NO
NO
NO
NO
YES
YES
YES
YES
Consider Engaging

23. Questions?
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