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Pilot and feasibility studies in stroke rehabilitation: reporting quality, progression to trials, and barriers: a
Maria Tereza Mota Alvarenga1, Louise Ada2, Augusto Boening3
1Graduate Program in Rehabilitation Sciences, Discipline of Physiotherapy Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
Introduction:
Pilot and feasibility studies are designed to determine whether a future trial is warranted. In stroke rehabilitation, such studies have been increasingly published over the years. To clarify how well these studies support future trials, we aimed to: (1) assess the quality of reporting of pilot and feasibility studies aimed to improve mobility (ie, walking) after stroke; (2) examine whether they progress to randomized controlled trials (RCTs); and (3) explore the barriers in following up on these studies.
Design:
Scoping review.
Participants:
Adults (>18 years) after stroke.
Intervention:
Interventions to improve mobility (ie, walking).
Results:
28 papers were included. The quality of reporting of the studies was 6.1 out of 11 points. Only 3 out of 26 studies (12%) progressed to a definitive RCT. Of those authors who replied, the main reason for not proceeding to an RCT was lack of funding.
Conclusion:
The quality of reporting of pilot and feasibility studies still needs to improve, especially when describing the methods section. In addition, these studies should be designed a priori to provide transparency in reporting and enhance value in guiding future trials.Registration: 10.17605/OSF.IO/ENJ94.