Using What Patient Groups Prepare: What We Call It, What We Do with It,

and How We Can All Do Better

Frank GavinPublic Member, CDEC

CADTH SymposiumApril 2016

Declaration

• The views expressed in this presentation are mine alone.

Questions To Be Addressed• What is the content of patient-group submissions now called and

what do the names indicate?• What do I do with the submissions before and during CDEC meetings?• How does the Committee use them and what weight is given to

them? • How could the submissions be made more useful?• How could the process be improved to make it more transparent and

more accountable and responsive to patients and society?

What the content of the submissions is called

• Input / patient input• Information• Data• Anecdotal information / anecdotes• Stories• Opinion• Evidence / anecdotal evidence• Note: I cannot recall hearing it called qualitative evidence or expert opinion.• Are the terms descriptions of what we see in the submissions or reflections of

the attitudes, expertise, or expectations we bring to them?

What I do with submissions from patient groups• Read them before reading anything else• Ask CADTH staff to pass on clarifying questions, e.g. about # of respondents, # who

reported experience with drug, source of information about claims of safety, etc.• Write the first part of my report, while rereading the submissions and thinking

about what’s meant (e.g. “only unacceptable side effect is death”).• Read the Clinical Report with patient group submissions in mind, e.g. checking the

outcome data from QoL domains of most relevance to pts• Write last part of report about relation between 1) trial data, economic evidence,

and expert clinical opinion and 2) patients’ expectations, needs, and experiences• Present my report at the start of the deliberation and ask questions and offer

reminders, clarifications, and suggestions later, as appropriate.

How the whole committee uses the submissions• Some technical members read the submissions; all are interested in

patients’ needs, views, preferences, and experiences and sometimes question the public member about them or offer their own assessment or something from their own experience with patients.• Often during the deliberation clinical experts are asked questions

growing out of the submissions.• Weight given to submissions in making recommendations varies

widely and is not made explicit by members or the whole comm.• More explicit emphasis now in discussant templates and

recommendation documents on outcomes of importance to patients .

How submissions can be made more useful:Some suggestions (pt. 1)

• Focus on identifying, describing, and explaining unmet needs, especially of subpopulations, and why they are, in fact, needs and not conveniences.• Be specific about what patients need or expect, e.g. not “better QoL” but “at

least a 50% reduction in seizures so that I can …” or “faster walking speed so I can safely cross the street on a green light,” etc.• Try to capture, convey, and perhaps explain the variety of patients’ needs

and preferences; acknowledge known or possible differences between what you gathered and what trials, other surveys, etc. gathered and discuss possible reasons for these differences.• Fully identify the sources of information, e.g. not “published information,”

“literature searches,” “clinical experts,” etc.

How submissions can be made more useful:

Some suggestions (pt. 2)Apply what is known about effective advocacy:1. Know your audience. (CDEC members want to help patients, have emotions and

imaginations, but possess a healthy and necessary degree of skepticism and are focused on evidence and appreciative of nuance.)

2. Leave the reader room to interpret and respond. (John Keats: “We hate poetry that has a palpable design upon us.”)

3. Claims that aren’t or can’t be substantiated and that are not qualified, e.g. “The treatment will greatly improve adherence and eventually be cost-saving,” can reduce impact.

4. Demonstrating awareness of particular problems/barriers (e.g. very high cost, known serious side effects) and addressing them can strengthen case.

5. Unanimity and hyperbole can reduce credibility, eg. “All reported amazing results” or “The effect was miracle-like.”

How the process might be improved• More opportunities and time for questions and discussions between CDEC and

patient groups about submissions before CDEC meeting• Opportunities for groups to offer stories rather than just anecdotes• Opportunity for groups to respond to at least parts of Clinical Report, especially

section on tx’s potential place in therapy.• Opportunity for groups to speak to committee and respond to questions• Opportunity for groups to comment on draft recommendations• CDEC to be more explicit in its recommendations about how it used what it heard

from groups• Consideration of the content of the submissions as a potential source of insight,

illumination, and wisdom--as well as information or even evidence

Differences between “evidence” and “insights” from patients(Staley, 2016, It’s not evidence, it’s insight …)

The Nature of Evidence• Data obtained through systematic

enquiry• Objective• Rational• Written in scientific and technical

language• Mostly quantitative – stats• Apples

The Nature of Experiential Knowledge• Knowledge gained through

experience – insight• Subjective• Emotional• Written in the patients’ own

words• Mostly qualitative – stories• Pears

What should we call it?Whatever—after attending to it and considering its nature, value and use—best describes it.