Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

Abstract

BackgroundWe aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV.MethodsStaff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research.ResultsBetween October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers.ConclusionsWhilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future research conducted within the MRC Clinical Trials Unit and beyond.

ReseArch with Patient and Public invOlvement: a RealisT evaluation – the RAPPORT study

“…70,71 In particular, PPI is seen as being key to the development of plain English summaries as a requirement in many grant applications. 24,62 There are also claims that PPI improves the overall design in trials, 72 particularly by ensuring the design is acceptable for potential participants. 73 Contributing to the design of interventions is reported as being an important aspect of PPI; examples include stroke research interventions 74 and advising on the timing of interventions within Parkinson's disease research.…”

“…[88][89][90] Dissemination of research findings is also reported as gaining from PPI networks to increase access to peers 81 and relevant sections of the community, 15 and making information more broadly readable. 31,72 There are fewer published claims for PPI as playing a significant role in implementing findings, but, in a US public health research programme, Krieger et al 86 report PPI-related implementation of changes by increasing their cultural relevance. Several researchers have identified that PPI has helped them address ethical dilemmas, 17,71,78,85,91 for example ethically appropriate ways of contacting women with recently diagnosed breast cancer and the use of routine patient data.…”

“…Working with the public and service users is found to be a process whereby researchers learn to share control and develop facilitation skills. 88,97 PPI not only increases researchers' confidence in their studies 72 but perhaps most importantly fosters their greater understanding of the service user or patient perspective. 81,98 The evidence base for patient and public involvement in research…”

A nonsurgical permanent contraception stakeholder advisory committee: FHI 360's experience

“…Some HIV research had involved community engagement [10], and the Population Council had established a microbicide stakeholder advisory committee. In addition, in 1998 the United Kingdom (UK) Medical Research Council recommended consumer involvement in the conduct of clinical trials [11] as a means to more relevant research, more effective translation of research and more open communications [12]. Still, the use of committees composed of lay people (whether stakeholders or stakeholder subgroups such as consumers or community members) who had an interest in or were affected by research was in its early stages.…”

Pasienten som medvirker og kunnskapshåndterer

“…For å sikre at forskningen som utføres er relevant, for eksempel at utfallene som blir målt er pasientrelevante, kan pasienter delta som partnere i forskningsprosjekter (38,52,53). I kliniske forsøk kan pasienter vaere involvert i hele forsøksprosessen, både i planlegging, rekruttering og gjennomføring, og i arbeidet med å implementere og formidle resultatene fra forskningen (52,54). Det finnes eksempler på at pasienter har deltatt som intervjuere i forskningsprosjekter (55).…”