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.
Highlights
Complex health interventions involve multiple context-dependent and inter-acting components [1,2].they can be challenging to evaluate and implement
We aimed to develop a robust and transparent method for co-producing progression criteria for frailty, falls and the role of exercise in haemodialysis patients: a mixed-methods randomised controlled feasibility study, which was inclusive of patient contributors, clinicians and researchers
The aim participants of the final discussion wasonly to bring contributors allprocess backgrounds to Nominal Group Technique (NGT) requires to generategroup ideas for one ortogether two questions, but as of our required review the progression criteria generated by the initial groups and decide upon the final preferred at least five aspects of the trial to be considered, the generation of ideas was time-limited [23]
Summary
Complex health interventions involve multiple context-dependent and inter-acting components [1,2]. They can be challenging to evaluate and implement. Feasibility studies explore the viability of a definitive randomised controlled trial (RCT) for complex interventions [2,3]. Res. Public Health 2019, 16, 3756; doi:10.3390/ijerph16193756 www.mdpi.com/journal/ijerph. Examples of progression criteria from other studies and analogies from everyday life.
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