Present: Levi Bonnell, Marianne Burke, Justine Dee,
Nancy Gell, Juvena Hitt, Jen Oshita, Gail Rose, Liliane Savard, Connie van
Eeghen, Adam Sprouse-Blum, Marian Wingood
1.
Warm Up: Happy new
year
2.
Review of Connie’s
Pragmatic Trial manuscript
a. What makes this
a methods paper: Example Annals methods paper title: practice approach to
qualitative research but not a systematic inquiry; more of a how to
i.
Not a qualitative research project, but relating the experience of
doing a pragmatic study with credentials of writers
b. This is not
about a solution; don’t go into your study thinking your protocol is finished
(punch line). You will be creating new
solutions; embrace it. Relax and pay
attention: what’s the research question and how do you answer it without
creating bias
c. Title: approach
to... recursive approach to... meta strategies... Problems and experiences in
two pragmatic trials (no); an approach to unanticipated problems in pragmatic
studies
d. Outline
i.
Pragmatic trials have challenges that are not easily anticipated
in the protocol (don’t compare to RCTs)
ii.
What do you do when faced with something not in the protocol,
here’s a list of 5 items and 1 sentence on how we responded to each
iii.
Largely successful; what do they have in common
1. You can’t plan
everything ahead of time – improvise and document
2. Rules: you can
change the protocol but any change made does not impair internal/external
validity
3. There are
situations where they can’t be fixed and the study fails (the data don’t answer
the question)
a. Many situations
where you can fix and succeed (data answers the question without loss of
internal/external validity)
b. Must be honest
with stakeholders about modifications to operations that differ from original
protocol and why and why it’s not a threat to validity
4. Bottom line:
defending research question is more important than defending the protocol
e. Lit review
i.
We identified the problem (describe), also found in (lit
sources). Other problems (more lit
sources)
ii.
Take out everything else; keep this short
f.
PREPARE team
i.
Ask PI how he does it – a parallel statement to what Ben expressed
this meeting: the system for surveillance, response, documenting, and reporting
these challenges
g. Framework
i.
Don’t talk about what is in the literature; talk about what isn’t
– in spite of our best efforts to anticipate everything, we were bombarded with
unanticipated problems (volcano – still in project; plus the earthquake, plus
the work stoppage...)
h. Co-authors
i.
Not reviewing the literature on complexity or reviewing all the
problems
ii.
Once there are problems with suggested solutions, they are no
longer complex – there’s a solution
iii.
All the ones you can’t anticipate are fundamentally complex: can’t
anticipate all the interactions; must make judgment calls based on protecting
the research question and managing: identifying, deciding, documenting,
reporting (four boxes)
iv.
Liliane’s process: describe the options and ask for feedback and
additional ideas
1. E.g. how to use
the lit review
i.
Other ideas: an article on “pragmatic trials are not pragmatic (as
in easy to fit into the clinical practice)”
j.
1/30: TBD
i.
Future: Marianne Burke on depositing original data in a repository
Recorded by CvE
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