In the United States and Australia retrospective case record analysis has provided the foundation and driving force for initiatives to reduce harm to patients and to make more efficient use of expensive hospital resources. Our findings indicate that a full national study would be justified in the United Kingdom, as indicated in the chief medical officer's recent report. 8 We believe that the investigation should cover at least 20 general hospitals (of varying size and type) and include 500 representative case records from each hospital. This would yield around 1000 adverse events for detailed analysis. Such a study would provide reliable information on the numbers, types, and costs of adverse events occurring in NHS hospitals. This would allow the principal causes to be explored and specific risk reduction strategies to be identified and costed. The total cost of such a study would probably be equivalent to the money lost through preventable adverse events in less than eight hours in the NHS.We thank our international colleagues Bob Gibberd, John Hamilton, Bernie Harrison, Eric Thomas, and Ross Wilson for their time and support, and Alastair Gray for advice on economic aspects of the study. We also thank the clinical reviewers: Justice U-Lois, Sebastian Borges, Aubyn Marath, Deirdre Murphy, and Robert Downes; the nurse/midwife screeners: Jayne Moore, Jane Weaver, Sinéad Trainor, Marcia Persaud, and Katie Major; and the staff at the two trusts.Contributors: CV designed and wrote the original research proposal. GN was lead clinician for the review. MW managed the project and was responsible for data analysis. All authors contributed equally to the final report. CV and GN are guarantors.Funding AbstractObjective To assess the extent to which consumers are involved in the work of clinical trial coordinating centres in the United Kingdom and the nature of consumers' involvement in randomised trials coordinated by these centres. Design National surveys using structured questionnaires with some open ended sections. Setting 103 clinical trial coordinating centres in the United Kingdom identified through a database assembled in 1997 by the NHS clinical trials adviser. Participants Named contacts at 62 coordinating centres and investigators in 60 trials that were identified as involving consumers. Main outcome measures Number of coordinating centres and number of trials in which consumers were involved and the nature of consumers' involvement.Results Of the 62 eligible centres, 23 reported that consumers had already been involved in their work, and most respondents were positive about this involvement. 17 centres planned to involve consumers. 15 centres had no plans to involve consumers, but only four of these considered such involvement irrelevant. Responses from investigators about the 48 individual trials were mostly positive, with respondents commenting that input from consumers had helped refine research questions, improve the quality of patient information, and make the trial more relevant to the needs of patients....

Background Service user involvement is embedded in the United KingdomÕs National Health Service, but knowledge about the impact of involvement on service users, such as the benefits and challenges of involvement, is scant. Our research addresses this gap.

BackgroundPatient and public involvement (PPI) is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.MethodsSemi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.ResultsWe interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups) and managerial (e.g. trial management groups) roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees).ConclusionThose seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited.ObjectiveInform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams.MethodsWe compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers’ and PPI contributors’ interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique.ResultsOf 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors’ lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding ‘the right’ PPI contributors, and advised caution when involving investigators’ current patients.ConclusionsEngaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI before, during and after trials will help the research community to optimise PPI, although the need for ongoing flexibility in implementing PPI should also be recognised.

BackgroundIn April 2005, researchers based at the Medical Research Council Clinical Trials Unit, set out to involve women affected by cervical cancer in a systematic review and meta-analysis of individual patient data to evaluate treatments for this disease. Each of the women had previously been treated for cervical cancer. Following completion of the meta-analysis, we aimed to evaluate the process of involvement from the researcher and research partner perspective.MethodsAn advisory group was first established to give advice on recruiting, supporting and involving women and led to efforts to recruit women to take part in the systematic review using different approaches. Evaluation of the process and outcomes of the partnership between the systematic reviewers and the patients, in respect to what the partnership achieved; what worked well and what were the difficulties; what was learned and the resource requirements, took place during the conduct of the meta-analysis and again after completion of the project.ResultsSix women, each of whom had received treatments for cervical cancer, were recruited as Patient Research Partners and five of these women subsequently took part in a variety of activities around the systematic review. They attended progress meetings and all but one attended a meeting at which the first results of the review were presented to all collaborators and gave feedback. Three of the women also became involved in a further related research project which led to an editorial publication from the patient perspective and also participated, along with two lead researchers, in the evaluation of the process and outcomes. While they were generally positive about the experience, one Patient Research Partner questioned the extent of the impact patients could make to the systematic review process.ConclusionsIn general, researchers and patient research partners felt that they had learned a lot from the process and considered it to have been a positive experience. The researchers felt that because of resource implications, patient involvement in future systematic reviews would probably have to be prioritized to those in which the greatest impacts could be achieved.

BackgroundTraining in patient and public involvement (PPI) is recommended, yet little is known about what training is needed. We explored researchers’ and PPI contributors’ accounts of PPI activity and training to inform the design of PPI training for both parties.MethodsWe used semi-structured qualitative interviews with researchers (chief investigators and trial managers) and PPI contributors, accessed through a cohort of clinical trials, which had been funded between 2006 and 2010. An analysis of transcripts of audio-recorded interviews drew on the constant comparative method.ResultsWe interviewed 31 researchers and 17 PPI contributors from 28 trials. Most researchers could see some value in PPI training for researchers, although just under half had received such training themselves, and some had concerns about the purpose and evidence base for PPI training. PPI contributors were evenly split in their perceptions of whether researchers needed training in PPI. Few PPI contributors had themselves received training for their roles. Many informants across all groups felt that training PPI contributors was unnecessary because they already possessed the skills needed. Informants were also concerned that training would professionalise PPI contributors, limiting their ability to provide an authentic patient perspective. However, informants welcomed informal induction ‘conversations’ to help contributors understand their roles and support them in voicing their opinions. Informants believed that PPI contributors should be confident, motivated, intelligent, focussed on helping others and have relevant experience. Researchers looked for these qualities when selecting contributors, and spoke of how finding ‘the right’ contributor was more important than accessing ‘the right’ training.ConclusionsWhile informants were broadly receptive to PPI training for researchers, they expressed considerable reluctance to training PPI contributors. Providers of training will need to address these reservations. Our findings point to the importance of reconsidering how training is conceptualised, designed and promoted and of providing flexible, learning opportunities in ways that flow from researchers’ and contributors’ needs and preferences. We also identify some areas of training content and the need for further consideration to be given to the selection of PPI contributors and models for implementing PPI to ensure clinical trials benefit from a diversity of patient perspectives.

BackgroundPatient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a series of case studies of PPI to document and share good practice.MethodsWe used purposive sampling to identify studies representing the scope of research at the MRC CTU and different approaches to PPI. We carried out semi-structured interviews with staff and patient representatives. Interview notes were analysed descriptively to categorise the main aims and motivations for involvement; activities undertaken; their impact on the studies and lessons learned.ResultsWe conducted 19 interviews about ten case studies, comprising one systematic review, one observational study and 8 randomised controlled trials in HIV and cancer. Studies were either open or completed, with start dates between 2003 and 2011. Interviews took place between March and November 2014 and were updated in summer 2015 where there had been significant developments in the study (i.e. if the study had presented results subsequent to the interview taking place). A wide range of PPI models, including representation on trial committees or management groups, community engagement, one-off task-focused activities, patient research partners and participant involvement had been used. Overall, interviewees felt that PPI had a positive impact, leading to improvements, for example in the research question; study design; communication with potential participants; study recruitment; confidence to carry out or complete a study; interpretation and communication of results; and influence on future research.ConclusionsA range of models of PPI can benefit clinical studies. Researchers should consider different approaches to PPI, based on the desired impact and the people they want to involve. Use of multiple models may increase the potential impacts of PPI in clinical research.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1488-9) contains supplementary material, which is available to authorized users.

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.