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Co-producing Progression Criteria for Feasibility Studies: A Partnership between Patient Contributors, Clinicians and Researchers

Author

Listed:
  • Hannah M. L. Young

    (Department of Respiratory Sciences, University of Leicester, Leicester LE1 7RH, UK
    John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK)

  • Samantha Goodliffe

    (Department of Respiratory Sciences, University of Leicester, Leicester LE1 7RH, UK
    John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK)

  • Meeta Madhani

    (Leicester Kidney Lifestyle Haemodialysis Patient Involvement Group, University of Leicester and University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK)

  • Kay Phelps

    (Department of Health Sciences, University of Leicester, Leicester LE1 7RH, UK)

  • Emma Regen

    (Department of Health Sciences, University of Leicester, Leicester LE1 7RH, UK)

  • Anthony Locke

    (Aging Related Research Patient and Public Involvement Group, University of Leicester, Leicester LE1 7RH, UK)

  • James O. Burton

    (National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough LE11 3TU, UK
    Department of Cardiovascular Science, University of Leicester, Leicester LE1 7RH, UK)

  • Sally J. Singh

    (Department of Respiratory Sciences, University of Leicester, Leicester LE1 7RH, UK
    National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough LE11 3TU, UK
    Department of Respiratory Medicine, Glenfield Hospital, University Hospitals of Leicester, Leicester LE1 5WW, UK)

  • Alice C. Smith

    (Aging Related Research Patient and Public Involvement Group, University of Leicester, Leicester LE1 7RH, UK
    joint senior authors.)

  • Simon Conroy

    (Department of Health Sciences, University of Leicester, Leicester LE1 7RH, UK
    joint senior authors.)

Abstract

There is a lack of guidance for developing progression criteria (PC) within feasibility studies. We describe a process for co-producing PC for an ongoing feasibility study. Patient contributors, clinicians and researchers participated in discussions facilitated using the modified Nominal Group Technique (NGT). Stage one involved individual discussion groups used to develop and rank PC for aspects of the trial key to feasibility. A second stage involving representatives from each of the individual groups then discussed and ranked these PC. The highest ranking PC became the criteria used. At each stage all members were provided with a brief education session to aid understanding and decision-making. Fifty members (15 (29%) patients, 13 (25%) researchers and 24 (46%) clinicians) were involved in eight initial groups, and eight (two (25%) patients, five (62%) clinicians, one (13%) researcher) in one final group. PC relating to eligibility, recruitment, intervention and outcome acceptability and loss to follow-up were co-produced. Groups highlighted numerous means of adapting intervention and trial procedures should ‘change’ criteria be met. Modified NGT enabled the equal inclusion of patients, clinician and researcher in the co-production of PC. The structure and processes provided a transparent mechanism for setting PC that could be replicated in other feasibility studies.

Suggested Citation

  • Hannah M. L. Young & Samantha Goodliffe & Meeta Madhani & Kay Phelps & Emma Regen & Anthony Locke & James O. Burton & Sally J. Singh & Alice C. Smith & Simon Conroy, 2019. "Co-producing Progression Criteria for Feasibility Studies: A Partnership between Patient Contributors, Clinicians and Researchers," IJERPH, MDPI, vol. 16(19), pages 1-17, October.
    • Handle: RePEc:gam:jijerp:v:16:y:2019:i:19:p:3756-:d:273818
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    Cited by:

    1. Alex Molassiotis & Yao Jie Xie & Angela Y. M. Leung & Grace W. K. Ho & Yan Li & Polly Hang-Mei Leung & Hua Li Wang & Catherine Xiao Rui Chen & Danny W. K. Tong & Judy Yuen-man Siu & Joseph T. F. Lau, 2022. "A Community-Based Participatory Research Approach to Developing and Testing Social and Behavioural Interventions to Reduce the Spread of SARS-CoV-2: A Protocol for the ‘ COPAR for COVID ’ Programme of," IJERPH, MDPI, vol. 19(20), pages 1-29, October.

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