Actively involving service users in health and social care research is encouraged as a way to improve research quality, relevance and accountability [1–3]. The Department of Health and devolved administrations, notably the Welsh Government, recommend it as good practice. Many health research funding bodies now require information on their application forms about the extent and methods of involving service users in designing and undertaking research [4–6] (http://www.hta.ac.uk/public/getinvolved/conductingresearch.shtml or http://www.sdo.nihr.ac.uk/getinvolved.html). The Central Commissioning Facility of the National Institute for Health Research states on its website that “applications that are technically excellent but have little patient or public involvement may be asked to address this before an offer of funding is made” (http://www.nihr-ccf.org.uk/site/consumerinvolvement/infoforresearchers/default.cfm).
Service users bring understanding and experience of conditions and interventions to the process of designing and conducting trials [5, 7]. We use the term ‘service user’ to refer to patients, carers and people eligible for a service, whether or not identified or diagnosed, and anyone else considered relevant to the study inclusion criteria .
Reports of impacts include influencing the development of research studies (e.g. shaping research questions); the choice of methods for trials (e.g. by helping to select the content of control arms); making the research more ethical and encouraging recruitment (e.g. by helping explain different concepts in patient information to enable informed consent); widening dissemination (e.g. by identifying non-academic routes and the best format for communicating findings) [3, 9–17]. Involving service users can increase public understanding of the purpose and process of science and can help make researchers more accountable to the people who may use services and contribute through taxes and donations .
Service users contribute to both the content and methods of research, including developing, reviewing and commissioning research proposals and undertaking research using a wide range of methods [13, 18–26]. Health Technology Assessment International (HTAi) has a Citizen and Patient Involvement group that aims to embed public and patient involvement across its membership of 59 countries (see http://www.htai.org/index.php?id=545) and public involvement in international Health Technology Assessment activities is growing . Work is underway to enhance the reporting of public and patient involvement in health research through GRIPP 2 with EQUATOR to strengthen the evidence base about service user involvement in research (see http://www.equator-network.org/resource-centre/library-of-health-research-reporting/reporting-guidelines/other-reporting-guidelines/). Although researchers are increasingly involving service users in planning and undertaking research, there is limited engagement with clinical trials [3, 28].
Guidance on how to involve service users in research mainly discusses general principles (e.g. ). Recent guidance by INVOLVE outlines benefits and challenges of engaging service users in trials . However, formal guidance about how to involve service users operationally in the conduct of trials is lacking although guidance for service users has recently been prepared (see http://www.trialsjournal.com/imedia/1292821605618248/supp1.doc). Recent evidence reports the importance of context and process on involvement, highlighting the need for researchers to understand their role in facilitating service user involvement and follow best practice [13, 31]. Researchers can be unsure how to involve people in research and need access to information and support in order to understand the potential opportunities and how to manage the involvement process with clarity and consensus . There is also a need to tackle misunderstood anxieties around who to involve, to explain the contribution of service users’ perspectives, so that researchers are not misled by anxieties about gaining representation, the so-called ‘red herring’ , in place of experience [32, 34, 35].
The West Wales Organisation for Rigorous Trials in Health (WWORTH) is a clinical trials unit based in Swansea University; it has recently received provisional UK Clinical Research Collaboration (UKCRC) registration following, among other things, the development of a suite of Standard Operating Procedures (SOPs). Although UKCRC did not require an SOP on involving service users before awarding registration, we judged that such an SOP would enhance researchers’ ability to involve service users throughout development and implementation of trials and other rigorous studies. We believed it would provide legitimacy for involving service users in trials and provide a starting point on which researchers could build. We considered it would also benefit the conduct and general quality of such studies. Other WWORTH SOPs, now numbering more than 30, cover project management, qualitative methods, the use of routine data and more familiar topics like randomisation, data management and statistical analysis.
Academics and service users together developed the SOP for involving service users to provide guidance to researchers. The authors have considered how to involve service users actively in trials and rigorous mixed-methods studies, and in developing research ideas through trial development groups. Using our experience, we aimed to ensure that the involvement of service users was in line with best practice and maximised opportunities to improve the design, conduct, analysis and dissemination of research [36, 37]. We adhered to elements of the GRIPP checklist where relevant to reporting guidance .