Colin Tysall

Mapping the impact of patient and public involvement on health and social care research: a systematic review

There is an increasing international interest in patient and public involvement (PPI) in research, yet relatively little robust evidence exists about its impact on health and social care research.

A Systematic Review of the Impact of Patient and Public Involvement on Service Users, Researchers and Communities

ObjectivePatient and public involvement (PPI) in research has expanded nationally and internationally over the last decade, and recently there has been significant attention given to understanding its impact on research. Less attention has been given to the impact of PPI on the people involved, yet it has been shown that the success of PPI in research can be reliant on the processes of engagement between these individuals and communities. This paper therefore critically explores the impact of PPI on service users, researchers and communities involved in health and social care research.Data SourcesSearches were undertaken from 1995 to April 2012 in the electronic databases MEDLINE, EMBASE, PsycINFO, Cochrane library, CINAHL, HMIC and HELMIS. Searches were undertaken for grey literature using the databases InvoNet and NHS Evidence.Study SelectionStudies were included if they included the impact of PPI on individual service users, researchers or communities under research. Studies were excluded if they were in a foreign language (unless they were deemed critical to the systematic review) or were in children and adolescent services.Study AppraisalData were extracted using a narrative synthesis, and quality was assessed using the Critical Appraisal Skills Programme.Main ResultsService users reported feeling empowered and valued, gaining confidence and life skills. Researchers developed a greater understanding and insight into their research area, gaining respect and a good rapport with the community. The community involved in research became more aware and knowledgeable about their condition. However, lack of preparation and training led some service users to feel unable to contribute to the research, while other service users and communities reported feeling overburdened with the work involved. Researchers reported difficulties in incorporating PPI in meaningful ways due to lack of money and time.ConclusionThis is the first international systematic review to focus on the impact of PPI on the people involved in the process. The beneficial and challenging impacts reported highlight the importance of optimising the context and processes of involvement, so creating the potential for PPI to impact positively on the research itself.

GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research

BackgroundWhile the patient and public involvement (PPI) evidence base has expanded over the past decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom, and why.ObjectiveTo develop international consensus on the key items to report to enhance the quality, transparency, and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP2.MethodsThe EQUATOR method for developing reporting guidelines was used. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process.ResultsOne hundred forty-three participants agreed to participate in round one, with an 86% (123/143) response for round two and a 78% (112/143) response for round three. The Delphi survey identified the need for long form (LF) and short form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment, and reflections and is suitable for studies where the main focus is PPI. GRIPP2-SF includes five items on aims, methods, results, outcomes, and critical perspective and is suitable for studies where PPI is a secondary focus.ConclusionsGRIPP2-LF and GRIPP2-SF represent the first international evidence based, consensus informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency, and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. In order to encourage its wide dissemination this article is freely accessible on The BMJ and Research Involvement and Engagement journal websites.

Primum non nocere: shared informed decision making in low back pain – a pilot cluster randomised trial

BackgroundLow back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments.MethodsThis was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into “satisfaction” (very satisfied or somewhat satisfied) and “non-satisfaction” (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied).ResultsWe recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%.ConclusionWe did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation.Trial registrationCurrent Controlled Trials ISRCTN46035546 registered on 11/02/10.

Study protocol: improving patient choice in treating low back pain (IMPACT-LBP): a randomised controlled trial of a decision support package for use in physical therapy.

After publication of this protocol a change in study design was needed.1 Due to changes in the service configuration in the host physiotherapy department individual randomisation as originally planned could not be implemented. It was necessary to change to cluster randomisation with the unit of randomisation being the treating physiotherapist. Potential participants are given outpatient appointments by booking staff unaware of the physiotherapists randomisation. Trial recruitment is also done blind to physiotherapist allocation. In this manner we have ensured allocation concealment prior to participants joining the study. Cluster randomised trials need to inflate their sample size to account for clustering. Typically primary care trials use an intra-cluster correlation coefficient (ICC) of 0.05 in this calculation.2 Our past experience is that clustering effects by therapist in trials of this nature may be very small.3 To account for this we developed a provisional revised sample size using an ICC of 0.05 and did an interim analysis of pooled data, just for ICC of the primary outcome, after the first 40 participants had completed the three month follow-up questionnaire. The ICC was close to zero, suggesting that using an ICC of 0.05 was too conservative. We therefore assumed an ICC of 0.01 to estimate the design effect due to clustering. Based on an average cluster size of nine this results in a revised final sample size of 158.

Design and Development of a Decision Support Package for Low Back Pain

To develop a decision support package for people with low back pain (LBP) referred for physiotherapy.

Reaching consensus on reporting patient and public involvement (PPI) in research: methods and lessons learned from the development of reporting guidelines

Introduction Patient and public involvement (PPI) is inconsistently reported in health and social care research. Improving the quality of how PPI is reported is critical in developing a higher quality evidence base to gain a better insight into the methods and impact of PPI. This paper describes the methods used to develop and gain consensus on guidelines for reporting PPI in research studies (updated version of the Guidance for Reporting Patient and Public Involvement (GRIPP2)). Methods There were three key stages in the development of GRIPP2: identification of key items for the guideline from systematic review evidence of the impact of PPI on health research and health services, a three-phase online Delphi survey with a diverse sample of experts in PPI to gain consensus on included items and a face-to-face consensus meeting to finalise and reach definitive agreement on GRIPP2. Challenges and lessons learnt during the development of the reporting guidelines are reported. Discussion The process of reaching consensus is vital within the development of guidelines and policy directions, although debate around how best to reach consensus is still needed. This paper discusses the critical stages of consensus development as applied to the development of consensus for GRIPP2 and discusses the benefits and challenges of consensus development.