A METHODOLOGICAL SURVEY ON REPORTING OF PILOT AND FEASIBILITY TRIALS FOR PHYSIOTHERAPY INTERVENTIONS

ABSTRACT Background: Pilot and feasibility studies are exploratory studies aimed to test whether the key steps on a randomized controlled trial are feasible. Pilot and feasibility studies must have a good reporting quality in order to encourage the transparency and good interpretation of the data to readers. Aims: The main aims of this study are: 1) describe percentage of pilot and feasibility studies indexed on Physiotherapy Evidence Database (PEDro); 2) describe the reporting quality of intervention pilot and feasibility studies on physiotherapy field; 3) describe whether the main aims of intervention pilot and feasibility studies as linked to feasibility and 4) describe associated factor with better completeness of reporting of pilot and feasibility studies of physiotherapy interventions. Methods and analysis: We included pilot and feasibility studies indexed on PEDro through a search with key words “Pilot*”, “Feasibilit*”, “Vangard” and “Dress rehearsal” on titles and abstracts. Also, we fill the methods field with “clinical trials” since 01/01/17 to 06/02/17. Two reviewers identified the number and percentage of all studies that claim to be pilot and feasibility trials. To included studies we evaluated the reporting quality through CONSORT extension for pilot and feasibility trials (range 0-16) being higher the score better the reporting quality. At statistical analysis we described the reporting quality of pilot and feasibility trials and whether the main aims were linked with feasibility. Also, we described factors associated with better reporting quality. Results: Through our search 1.361 pilot and feasibility studies of physiotherapy intervention were identified. 36 trials were removed (N=5 were proof of concept studies and N=31 do not claim to be pilot or feasibility studies). The mean score of reporting quality were 3,54 (SD 1,78). 42% of included studies stated feasibility as primary aim. We identified statistically significant improvement in reporting quality in studies that were published in a periodic that endorse the CONSORT statement, studies that stated funding, studies that described registry, studies with a better methodological quality and studies that stated allocation concealment. Conclusion: Pilot and feasibility studies of physiotherapy interventions have low reporting quality and five factors were associated with a better reporting quality. Keywords: feasibility studies; pilot projects