City Research Online

Abstract

Background
Funders encourage lay-volunteer inclusion in research but this is not without controversy or resistance, given concerns of role confusion, exploratory methods and limited evidence about what value this brings to research. This overview explores these elements.

Methods
Eleven databases and gray literature were searched without date or language restrictions for systematic reviews of public involvement in clinical trials design. This systematic overview of patient and public involvement (PPI) included 27 reviews from which areas of good and bad practice were identified. PPI strengths, weaknesses, opportunities and threats were explored through use of meta-narrative analysis.

Results
Inclusion criteria was met by 27 reviews. Confidence in the findings was assessed using Cerqual, Nice-H, CASP for qualitative research and CASP systematic reviews. Quality ranged from high (n=7), medium (n=14) to low (n=6) in the reviews. Four reviews report the risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation and dissemination. Challenges identified include lack of clarity within common language, roles and research boundaries; while logistical needs include extra time, training and funding, Researchers report struggling to report involvement and avoid tokenism.

Conclusions
Involving patients and the public in clinical trials design, can be beneficial but requires resources, preparation, training, flexibility and time. Issues to address include reporting deficits in the areas of risk of bias, study quality and conflicts of interests. There is a need for improved dissemination strategies to increase public involvement and health literacy. Improvements in funding, training, and reporting of PPI are needed to facilitate meaningful and effective PPI.

Publication Type:	Article
Additional Information:	This is the peer reviewed version of the following article: Price, A., Albarqouni, L., Kirkpatrick, J., Clarke, M., Liew, S. M., Roberts, N. & Burls, A. (2017). Patient and Public Involvement in the Design of Clinical Trials: An Overview of Systematic Reviews. Journal of Evaluation in Clinical Practice, which is published in final form at http://dx.doi.org/10.1111/jep.12805. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
Departments:	School of Health & Psychological Sciences
SWORD Depositor:	Symplectic Administrator

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