Nice to be involved in chat on potential new projects with the @MRCNIHRTMRP #retention group yesterday. While it’s on my mind...should we think of retention problems in trials differently depending on the amount of effort/engagement required of trial participants? 1/
Types of research vary in how much they ask of participants - in terms of time, risk, money, emotional investment and other aspects (combined here into the imperfect shorthand term ‘effort’, for simplicity). 2/
At one end of the spectrum is intensive involvement such as first-in-human studies, where participants have to give up weeks of their time to undergo close safety monitoring. It’s a big commitment, and as long as participants stay involved, they can hardly forget about it. 3/
At the other end is research involving only little ‘active’ effort, e.g. consenting to give samples for a biobank. Participation continues after consent, but participants may well forget about the research & that they are participants (e.g. ref here). 4/ journals.sagepub.com/doi/10.1177/20…
In the middle is research requiring some effort, or variable effort (e.g. more effort at the start but reduced effort as a possibility if the starting level proves too much to commit to - e.g. using routinely-collected health data instead) 5/
We should obviously aim in advance to make trials as low-effort as possible for everyone involved, including participants. This makes sense for various reasons - general efficiency, fairness & convenience for participants, more chance of successful trial & faster results. 6/
(Although there is a limit - putting a lot of work into making all elements of participation low-effort might affect generalisability if the effort-reducing mechanisms are not available in the non-trial setting.) 7/
Retention problems are a theoretical risk to lots of research, even where there isn’t long-term active involvement. But perhaps the potential mitigations/solutions are different depending on the amount of effort that participation involves? 8/
Maybe research priorities should be different, too? For high-effort research, we might focus on reducing effort involved & increasing participant willingness (including in under-served groups) to keep contributing (e.g. via behaviour change techniques) 9/ trialsjournal.biomedcentral.com/articles/10.11…
My reading of Priority II results is that they are mainly (/consciously?) aimed at these sorts of questions, & less about ‘low-effort’ research. (I may be wrong!) 10/ trialsjournal.biomedcentral.com/articles/10.11…
Lots of retention research focuses on questionnaire completion, i.e. high-effort research. Maybe it's logical - we might expect retention to be bigger challenge in that setting. But we shouldn’t assume low-effort research doesn’t have its own needs. 11/ pubmed.ncbi.nlm.nih.gov/24297482/
Starting suggestions for different retention research priorities in low-effort research: acceptability of ‘meta-consent’ (ref) and trial-within-cohort models, reducing (needless) duplication of effort between research activity and routine care… 12/ onlinelibrary.wiley.com/doi/full/10.11…
… and reducing/eliminating loss of outcome data arising from misunderstanding/miscommunication of the right to withdraw informed consent (as per our @UKCTUNetwork #persevere project) 13/
My views are informed by my experience as trial manager on a pragmatic trial at @mrcctu on the ‘low-effort’ end. Some participants definitely forgot they were in a trial, even among those who still went to their trial appointments (because it was so similar to routine care). 14/
Should we have tried to make them remember/engage, even if they were happy enough with the situation? We tried to increase engagement in the trial through a participant newsletter but uptake was very low. 15/
Participants in trials will of course vary in terms of the amount of engagement they bring. E.g. unpaid healthy volunteers might have less interest in staying involved than patients who are taking part in something potentially therapeutic that they feel is their last hope. 16/
If we design trials only for engaged people (i.e. ask them to make a big commitment to the trial because we think they will do it) might this affect generalisability and even act as a barrier to those ‘under-served groups’ that we are keen to include? 17/ trialsjournal.biomedcentral.com/articles/10.11…
Has this been thought about in this way already? I guess it’s similar to #precis2 but not quite the same. You could have a pragmatic trial that was high-effort or an explanatory trial that was low-effort (in theory, at least). 18/ bmj.com/content/350/bm…
There are some papers on measuring ‘burden’ of participation, which is a similar idea (/the same), though I'm not sure it’s been linked directly to the questions around retention & retention research 19/ bmcmedicine.biomedcentral.com/articles/10.11…
Phew… well done for getting to the end! Conclusion: I just wonder we might think of retention research (if we don't already) as addressing a group of related problems, not a single one. Would be interested to develop these ideas further if anyone’s interested to discuss! 20/end
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