Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Research

Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences

Authors: Joanna C. Crocker, Keira Pratt-Boyden, Jenny Hislop, Sian Rees, Louise Locock, Sophie Olszowski, Alan Chant, Shaun Treweek, Jonathan A. Cook, Kerry Woolfall, Nicola Farrar, Jennifer Bostock, Richard Bulbulia

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background and aims

Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We aimed to identify and describe current PPI practice in surgical trials in the United Kingdom, and to explore the views and experiences of surgical trial staff and patient or public contributors in relation to these practices. This was part of a larger study to inform development of a robust PPI intervention aimed at improving recruitment and retention in surgical trials.

Methods

Our study had two stages: 1) an online survey to identify current PPI practice in active UK-led, adult surgical trials; and 2) focus groups and interviews with key stakeholders (surgical trial investigators, administrators, and patient or public contributors) to explore their views and experiences of PPI.

Results

Of 129 eligible surgical trial teams identified, 71 (55%) took part in the survey. In addition, 54 stakeholders subsequently took part in focus groups or interviews. Sixty-five (92%) survey respondents reported some kind of PPI, most commonly at the design and dissemination stages and in oversight or advisory roles. The single most common PPI activity was developing participant information sheets (72%). Participants reported mixed practice and views on a variety of issues including the involvement of patients versus lay members of the public, recruitment methods, use of role descriptions and payment for the time of PPI contributors. They suggested some solutions, including the use of written role descriptions and databases of potential PPI contributors to aid recruitment.

Conclusions

UK surgical trials involve patients and members of the public in a variety of different ways, most commonly at the beginning and end of the trial lifecycle and in oversight or advisory roles. These are not without challenges and there remain uncertainties about who best to involve, why, and how. Future research should aim to address these issues.
Appendix
Available only for authorised users
Literature
1.
2.
3.
Kearney A, Williamson P, Young B, Bagley H, Gamble C, Denegri S, Muir D, Simon NA, Thomas S, Elliot JT, et al. Priorities for methodological research on patient and public involvement in clinical trials: a modified Delphi process. Health Expect. 2017;20:1401–10.CrossRef
4.
Staniszewska S, Brett J, Simera I, Seers K, Mockford C, Goodlad S, Altman DG, Moher D, Barber R, Denegri S, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. Res Involve Engage. 2017;3(1):13.CrossRef
5.
6.
Bagley HJ, Short H, Harman NL, Hickey HR, Gamble CL, Woolfall K, Young B, Williamson PR. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials—a work in progress. Res Involve Engage. 2016;2(1):1–14.CrossRef
7.
Gamble C, Dudley L, Allam A, Bell P, Goodare H, Hanley B, Preston J, Walker A, Williamson P, Young B. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open. 2014;4(7):e005234.CrossRef
8.
Jones EL, Williams-Yesson BA, Hackett RC, Staniszewska SH, Evans D, Francis NK. Quality of reporting on patient and public involvement within surgical research: a systematic review. Ann Surg. 2015;261(2):243–50.CrossRef
9.
Crocker J, Rees S, Locock L, Petit-Zeman S, Chant A, Treweek S, Cook J, Farrar N, Woolfall K, Bulbulia R. Developing a patient and public involvement intervention to enhance recruitment and retention in surgical trials (PIRRIST): study protocol. Trials. 2015;16(2):P89.CrossRef
10.
Oliver S, Liabo K, Stewart R, Rees R. Public involvement in research: making sense of the diversity. J Health Serv Res Policy. 2014;20:45-51.
11.
12.
Crocker JC, Boylan A-M, Bostock J, Locock L. Is it worth it? Patient and public views on the impact of their involvement in health research and its assessment: a UK-based qualitative interview study. Health Expect. 2017;20(3):519–28.CrossRef
13.
Locock L, Boylan A-M, Snow R, Staniszewska S. The power of symbolic capital in patient and public involvement in health research. Health Expect. 2017;20(5):836–44.
14.
Dudley L, Gamble C, Allam A, Bell P, Buck D, Goodare H, Hanley B, Preston J, Walker A, Williamson P, et al. A little more conversation please? Qualitative study of researchers' and patients' interview accounts of training for patient and public involvement in clinical trials. Trials. 2015;16(1):190.CrossRef
15.
Blackburn S, McLachlan S, Jowett S, et al. The extent, quality and impact of patient and public involvement in primary care research: a mixed methods study. Research Involvement and Engagement. 2018;4(1):16.
16.
Mathie E, Wilson P, Poland F, McNeilly E, Howe A, Staniszewska S, Cowe M, Munday D, Goodman C. Consumer involvement in health research: a UK scoping and survey. Int J Consum Stud. 2014;38(1):35–44.CrossRef
17.
Vale CL, Thompson LC, Murphy C, Forcat S, Hanley B. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: results of a survey. Trials. 2012;13:9.
18.
Johns T, Crossfield S, Whibley C. Closed study evaluation: measuring impacts of patient and public involvement and research quality and performance. NIHR Clinical Research Network; 2015.
19.
Tarpey M, Bite S. Public involvement in research applications to the National Research Ethics Service: comparative analysis of 2010 and 2012 data. Eastleigh: INVOLVE; 2014.
20.
21.
Knapp P, Raynor DK, Silcock J, Parkinson B. Can user testing of a clinical trial patient information sheet make it fit-for-purpose?—a randomized controlled trial. BMC Med. 2011;9:89.CrossRef
22.
23.
Crocker J, Bostock J, Bulbulia R. PPI: calling all surgical researchers…. Bull R Coll Surg Engl. 2016;98(1):30–3.CrossRef
24.
Green J, Thorogood N. Thematic content analysis. In: Qualitative methods for health research. London: SAGE Publications Ltd; 2014. p. 209–18.
25.
Crocker JC, Ricci-Cabello I, Parker A, Hirst JA, Chant A, Petit-Zeman S, Evans D, Rees S. Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. BMJ. 2018;363:k4738.
26.
Wilson P, Mathie E, Keenan J, McNeilly E, Goodman C, Howe A, Poland F, Staniszewska S, Kendall S, Munday D, et al. ReseArch with Patient and Public invOlvement: a RealisT evaluation—the RAPPORT study. Health Serv Deliv Res. 2015;3:38.
27.
Vale CL, Cragg WJ, Cromarty B, Hanley B, South A, Stephens R, Sturgeon K, Gafos M. When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL. Trials. 2018;19(1):95.CrossRef
28.
Buck D, Gamble C, Dudley L, Preston J, Hanley B, Williamson PR, Young B, Group EPA. From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials. BMJ Open. 2014;4(12):e006400.CrossRef
29.
Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, Burls A. Patient and public involvement in the design of clinical trials: an overview of systematic reviews. J Eval Clin Pract. 2018;24:240–53.CrossRef
30.
31.
Snape D, Kirkham J, Britten N, Froggatt K, Gradinger F, Lobban F, Popay J, Wyatt K, Jacoby A. Exploring perceived barriers, drivers, impacts and the need for evaluation of public involvement in health and social care research: a modified Delphi study. BMJ Open. 2014;4(6):e004943.CrossRef
32.
Evans D, Coad J, Cottrell K, Dalrymple J, Davies R, Donald C, Laterza V, Long A, Longley A, Moule P, et al. Public involvement in research: assessing impact through a realist evaluation. Health Serv Deliv Res. 2014;2:36.
Metadata
Title
Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences
Authors
Joanna C. Crocker
Keira Pratt-Boyden
Jenny Hislop
Sian Rees
Louise Locock
Sophie Olszowski
Alan Chant
Shaun Treweek
Jonathan A. Cook
Kerry Woolfall
Nicola Farrar
Jennifer Bostock
Richard Bulbulia
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3183-0

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

RADIATE – Radial Dysplasia Assessment, Treatment and Aetiology: protocol for the development of a core outcome set using a Delphi survey

Study protocol

A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey

Study protocol

Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder

Study protocol

The effect of Baduanjin exercise on health-related physical fitness of college students: study protocol for a randomized controlled trial

Study protocol

The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial

Study protocol

Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial