Involving service users in trials: developing a standard operating procedure

Abstract

BackgroundMany funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We aimed to develop a standard operating procedure (SOP) to support researchers to involve service users in trials and rigorous studies.MethodsResearchers with experience of involving service users and service users who were contributing to trials collaborated with the West Wales Organisation for Rigorous Trials in Health, a registered clinical trials unit, to develop the SOP. Drafts were prepared in a Task and Finish Group, reviewed by all co-authors and amendments made.ResultsWe articulated core principles, which defined equality of service users with all other research team members and collaborative processes underpinning the SOP, plus guidance on how to achieve these. We developed a framework for involving service users in research that defined minimum levels of collaboration plus additional consultation and decision-making opportunities. We recommended service users be involved throughout the life of a trial, including planning and development, data collection, analysis and dissemination, and listed tasks for collaboration. We listed people responsible for involving service users in studies and promoting an inclusive culture. We advocate actively involving service users as early as possible in the research process, with a minimum of two on all formal trial groups and committees. We propose that researchers protect at least 1% of their total research budget as a minimum resource to involve service users and allow enough time to facilitate active involvement.ConclusionsThis SOP provides guidance to researchers to involve service users successfully in developing and conducting clinical trials and creating a culture of actively involving service users in research at all stages. The UK Clinical Research Collaboration should encourage clinical trials units actively to involve service users and research funders should provide sufficient funds and time for this in research grants.

Predictive risk stratification model: a randomised stepped-wedge trial in primary care (PRISMATIC)

“…In accordance with STU's SOP for service user inclusion, 79 we recruited two service users who acted throughout the study as collaborators in our research partnership. 80,81 As members of the RMG, they attended the quarterly meetings responsible for strategic and operational decisions about the study.…”

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

“…In accordance with the relevant West Wales Organisation for Rigorous Trials in Health standard operating procedure, 95 we included service users as active contributors at all stages of this trial. They provided separate members of TSC, DMEC and TMG, contributed to the research process and provided valuable insights into UC.…”

“…20 NO. 44 works better (414) HP15 the good thing about infliximab is that you know fairly rapidly whether it is going to work and once it's worked and patients have a dramatic benefit (106) HP15 It's quite difficult to stop it and that's actually one of the biggest issues, the clinical decision is about when to stop the drug (108) HP16 you probably get patients out of hospital quicker with inflix (287) HPN18 I felt that when they were randomised to infliximab they has a greater chance of not going to surgery ... but that's my personal gut feeling (219, 224) HPN20 the patients that were on the trial, the vast majority of the inflix ones seemed to do better (179) HPN20 very beneficial (81) HPN23a I think those that are sensitive to it, it works very very well (57) HPN23a I think we definitely see much more progress with people on inflix (122) HPN24 it worked really well on that patient (33) HPN24 there's a quicker response with inflix...patients pass comments and they always tell me I feel much better after this one (118) HPN25a it seems like a very good drug because I've seen so many successful outcomes... but that's mainly with Chron's disease and my views about ulcerative colitis are slightly mixed because the outcomes haven't been as successful but I think perhaps they've been treated a little bit later (87,92,95) General comments about the effectiveness of ciclosporin & infliximab HP6 in terms of efficacy -sort of good similar experiences with both drugs (87) HP9 infliximab as safer and easier to manage but maybe not quite so effective and ciclosporin as a bit more sort of a fiddle, little bit more risky for the patient but perhaps a little bit more effective (91) HPN19 inflix was the new boy on the block as such and cicl was maybe seen as bit older, you know maybe less effective drug (26) HPN21 they all seem to do quite well on it (inflix) the same with cicl (84) HPN21 time consuming with regards to observation, particularly on a busy ward when you've got one nurse to 10 patients, it can take quite a huge part of your workload (16) HPN20 we're doing observations very, very frequently within a 30 minutes period over maybe 4-6 hours just to make sure that the individual is fine and comfortable (36) HPN20 your with that individual for up to 4 hours when you've got demands of other patients, that's when it becomes difficult, but that's more a time management issue and sort of staffing issue (51) HPN20 we kind of treat both as the same, we make sure the individual is monitored every 30 mins for a period of time.. The only difference with inflix is that the infusion only last 2 hours but you're observing that patient for 4 hours, so really when you put the two together they are very similar (66) HPN24 we have to monitor this patient closely for any side effects ... it takes 3 hrs because you've got to do obs for a couple of hours, but then sometimes we tend to forget because we get busy with other patients... so ideally it should be one to one..because we handle 9 patients (249, 255)…”

Support and Assessment for Fall Emergency Referrals (SAFER) 2: a cluster randomised trial and systematic review of clinical effectiveness and cost-effectiveness of new protocols for emergency ambulance paramedics to assess older people following a fall with referral to community-based care when appropriate

“…114-117 The SAFER 2 trial followed the principles and procedures outlined in the WWORTH SOP for user inclusion 118 to ensure that members of the public were actively involved throughout the research process. This SOP provided a starting point for developing a model of user involvement in the SAFER 2 trial.…”