Amy Price1,2, Loai Albarqouni3, Jo Kirkpatrick2, Mike Clarke4, Su May Liew5, Nia Roberts6, Amanda Burls7. 1. University of Oxford, UK. 2. Empower-2-Go, UK and USA. 3. Bond University, Faculty of Health Sciences and Medicine, Gold Coast Australia, Australia. 4. Northern Ireland Methodology Hub, Centre for Public Health, Queen's University Belfast, Belfast, UK. 5. University of Malaya, Malaysia. 6. Bodleian Health Care Libraries, University of Oxford, UK. 7. City, University of London, UK.
Abstract
BACKGROUND: Funders encourage lay-volunteer inclusion in research. There are controversy and resistance, given concerns of role confusion, exploratory methods, and limited evidence about what value lay-volunteers bring to research. This overview explores these areas. METHODS: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis. RESULTS: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report 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 for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
BACKGROUND: Funders encourage lay-volunteer inclusion in research. There are controversy and resistance, given concerns of role confusion, exploratory methods, and limited evidence about what value lay-volunteers bring to research. This overview explores these areas. METHODS: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis. RESULTS: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report 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 for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
Authors: Simon A Carter; Talia Gutman; Charlotte Logeman; Dan Cattran; Liz Lightstone; Arvind Bagga; Sean J Barbour; Jonathan Barratt; John Boletis; Dawn Caster; Rosanna Coppo; Fernando C Fervenza; Jürgen Floege; Michelle Hladunewich; Jonathan J Hogan; A Richard Kitching; Richard A Lafayette; Ana Malvar; Jai Radhakrishnan; Brad H Rovin; Nicole Scholes-Robertson; Hérnan Trimarchi; Hong Zhang; Karolis Azukaitis; Yeoungjee Cho; Andrea K Viecelli; Louese Dunn; David Harris; David W Johnson; Peter G Kerr; Paul Laboi; Jessica Ryan; Jenny I Shen; Lorena Ruiz; Angela Yee-Moon Wang; Achilles Hoi Kan Lee; Samuel Fung; Matthew Ka-Hang Tong; Armando Teixeira-Pinto; Martin Wilkie; Stephen I Alexander; Jonathan C Craig; Allison Tong Journal: Clin J Am Soc Nephrol Date: 2020-04-30 Impact factor: 8.237
Authors: K D Coulman; A Nicholson; A Shaw; A Daykin; L E Selman; R Macefield; G W Shorter; H Cramer; M R Sydes; C Gamble; M E Pick; G Taylor; J A Lane Journal: Trials Date: 2020-06-18 Impact factor: 2.279
Authors: Julia Jones; Marion Cowe; Sue Marks; Tony McAllister; Alex Mendoza; Carole Ponniah; Helena Wythe; Elspeth Mathie Journal: Res Involv Engagem Date: 2021-07-22