Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process

Anna Kearney, Paula Williamson, Bridget Young, Heather Bagley, Carrol Gamble, Simon Denegri, Delia Muir, Natalie A Simon, Stephen Thomas, Jim T Elliot, Helen Bulbeck, Joanna C Crocker, Claire Planner, Claire Vale, Mike Clarke, Tim Sprosen, Kerry Woolfall, Anna Kearney, Paula Williamson, Bridget Young, Heather Bagley, Carrol Gamble, Simon Denegri, Delia Muir, Natalie A Simon, Stephen Thomas, Jim T Elliot, Helen Bulbeck, Joanna C Crocker, Claire Planner, Claire Vale, Mike Clarke, Tim Sprosen, Kerry Woolfall

Abstract

Background: Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials.

Objective: To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.

Design: A modified Delphi process including a two round online survey and a stakeholder consensus meeting.

Participants: In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting.

Results: Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants.

Conclusions: The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

Keywords: Delphi; clinical trials; patient and public involvement; research priorities.

© 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Overview of the Delphi process

References

    1. Ioannidis JPA. Why most clinical research is not useful. PLoS Med. 2016;13:e1002049.
    1. Mullins CD, Vandigo JE, Zheng J, Wicks P. Patient‐centeredness in the design of clinical trials. Value Health. 2014;17:471‐475.
    1. Frank L, Basch E, Selby JV. For the Patient‐Centered Outcomes Research I. THe pcori perspective on patient‐centered outcomes research. JAMA. 2014;312:1513‐1514.
    1. Sacristán JA, Aguarón A, Avendaño‐Solá C, et al. Patient involvement in clinical research: why, when, and how. Patient Prefer Adherence. 2016;10:631‐640.
    1. INVOLVE . INVOLVE Strategy 2012‐2015. Putting people first in research. 2012.
    1. Boote JD, Twiddy M, Baird W, Birks Y, Clarke C, Beever D. Supporting public involvement in research design and grant development: a case study of a public involvement award scheme managed by a National Institute for Health Research (NIHR) Research Design Service (RDS). Health Expect. 2015;18:1481‐1493.
    1. Health Research Authority . INVOLVE. Public involvement in research: impact on ethical research. 2016;.Accessed 02 September, 2016.
    1. Salman RA‐S, Beller E, Kagan J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383:176‐185.
    1. Ioannidis JPA, Greenland S, Hlatky MA, et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet. 2014;383:166‐175.
    1. Staniszewska S, Thomas V, Seers K. Patient and public involvement in the implementation of evidence into practice. Evid Based Nurs. 2013;16:97.
    1. Woolfall K, Young B, Frith L, et al. Doing challenging research studies in a patient‐centred way: a qualitative study to inform a randomised controlled trial in the pediatric emergency care setting. BMJ Open. 2014;4:e005045.
    1. Robinson L, Newton J, Dawson P. Professionals and the public: power or partnership in health research? J Eval Clin Pract. 2012;18:276‐282.
    1. Trust W . Top Tips for Success. 2014.
    1. NIHR . Preparing for a full application for the Clinical Trials and Evaluation Board. 2014;.Accessed 20 November, 2014.
    1. Brett J, Staniszewska S, Mockford C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect. 2014;17:637‐650.
    1. Snape D, Kirkham J, Preston J, et al. Exploring areas of consensus and conflict around values underpinning public involvement in health and social care research: a modified Delphi study. BMJ Open. 2014;4:e004217.
    1. Barber R, Boote JD, Parry GD, Cooper CL, Yeeles P, Cook S. Can the impact of public involvement on research be evaluated? A mixed methods study. Health Expect. 2012;15:229‐241.
    1. El Enany N, Currie G, Lockett A. A paradox in healthcare service development: professionalization of service users. Soc Sci Med. 1982;2013:24‐30.
    1. Boote JD, Dalgleish M, Freeman J, Jones Z, Miles M, Rodgers H. ‘But is it a question worth asking?’ A reflective case study describing how public involvement can lead to researchers’ ideas being abandoned. Health Expect. 2014;17:440‐451.
    1. Staley K. Exploring Impact: Public Involvement in the NHS, public health and social care research. Involve: Eastleigh; 2009.
    1. Staniszewska S, Adebajo A, Barber R, et al. Developing the evidence base of patient and public involvement in health and social care research: the case for measuring impact. Int J Consum Stud. 2011;35:628‐632.
    1. Buck D, Gamble C, Dudley L, et al. 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:e006400.
    1. Gamble C, Dudley L, Allam A, et al. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open. 2014;4:e005234.
    1. INVOLVE . Breaking Boundaries review of public involvement in the NIHR‐Update. 2014;.Accessed September 02, 2016.
    1. Oliver S, Armes D, Gyte G. Public involvement in setting a national research agenda. Patient. 2009;2:179‐190.
    1. Involve SD. NIHR Strategic Review of Public Involvement in research‐“Breaking Boundaries” Keynote speech. Paper presented at: INVOLVE 2014: Changing Landscapes Conference 2014; Birmingham, UK.
    1. Dudley L, Gamble C, Preston J, et al. What difference does patient and public involvement make and what are its pathways to impact? Qualitative study of patients and researchers from a cohort of randomised clinical trials. PLoS One. 2015;10:e0128817.
    1. Fleurence RL, Forsythe LP, Lauer M, et al. Engaging patients and stakeholders in research proposal review: the patient‐centered outcomes research institute engaging patients and stakeholders in research proposal review. Ann Intern Med. 2014;161:122‐130.
    1. Mathie E, Wilson P, Poland F, et al. Consumer involvement in health research: a UK scoping and survey. Int J Consum Stud. 2014;38:35‐44.
    1. South A, Hanley B, Gafos M, et al. Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies. Trials. 2016;17:1‐13.
    1. Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8:e1000393.
    1. Kouyoumdjian FG, Schuler A, McIsaac KE, et al. Using a Delphi process to define priorities for prison health research in Canada. BMJ Open. 2016;6:e010125.
    1. Keeney S, Hasson F, McKenna HP. A critical review of the delphi technique as a research methodology for nursing. Int J Nurs Stud. 2001;38:195‐200.
    1. Walker MA, Selfe MJ. The Delphi method: a useful tool for the allied health researcher. Br J Ther Rehabil. 1996;3:677‐681.
    1. Sadler GR, Lee H‐C, Lim RS‐H, Fullerton J. Research Article: Recruitment of hard‐to‐reach population subgroups via adaptations of the snowball sampling strategy. Nurs Health Sci. 2010;12:369‐374.
    1. Dudley L, Gamble C, Allam A, 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;16:1‐15.
    1. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64:395‐400.
    1. Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson P. The trials methodological research agenda: results from a priority setting exercise. Trials. 2014;15:32.
    1. Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:1‐8.
    1. Wilson P, Mathie E, Keenan J, et al. Research with patient and public involvement: a realist evaluation –the rapport study. Health Serv Deliv Res. 2015;38:1‐208.
    1. Evans D, Coad J, Cottrell K, et al. Public involvement in research: assessing impact through a realist evaluation. Health Serv Deliv Res. 2014;36:1‐158.
    1. Mockford C, Staniszewska S, Griffiths F, Herron‐Marx S. The impact of patient and public involvement on UK NHS health care: a systematic review. Int J Qual Health Care. 2012;24:28‐38.
    1. Bagley HJ, Short H, Harman NL, et al. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials – a work in progress. Res Involv Engage. 2016;2:1‐14.
    1. Pollard K, Donskoy AL, Moule P, Donald C, Lima M, Rice C. Developing and evaluating guidelines for patient and public involvement (PPI) in research. Int J Health Care Qual Assur. 2015;28:141‐155.
    1. INVOLVE . Public Involvement in Research: Values and Principles Framework. Eastleigh: INVOLVE; 2015.
    1. Shippee ND, Domecq Garces JP, Prutsky Lopez GJ, et al. Patient and service user engagement in research: a systematic review and synthesized framework. Health Expect. 2015;18:1151‐1166.
    1. Nilsen ES, Myrhaug HT, Johansen M, Oliver S, Oxman AD. Methods of consumer involvement in developing healthcare policy and research, clinical practice guidelines and patient information material. Cochrane Database Syst Rev. 2006;(3):CD004563.
    1. Domecq JP, Prutsky G, Elraiyah T, et al. Patient engagement in research: a systematic review. BMC Health Serv Res. 2014;14:89.
    1. Goodman CM. The delphi technique: a critique. J Adv Nurs. 1987;12:729‐734.
    1. Buck AJ, Meir G, Hakim S, Weinblatt J. Using the Delphi process to analyze social policy implementation: a post hoc case from vocational rehabilitation. Policy Sci. 1993;26:271‐288.
    1. Fink A, Kosecoff J, Chassin M, Brook RH. Consensus methods: characteristics and guidelines for use. Am J Public Health. 1984;74:979‐983.
    1. Sumsion T. The delphi technique: an adaptive research tool. Br J Occup Ther. 1998;61:153‐156.
    1. Hasson F, Keeney S, McKenna H. Research guidelines for the delphi survey technique. J Adv Nurs. 2000;32:1008‐1015.

Source: PubMed

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