Daniel Umpierre,1,2,3 Lucas Helal,1 Patrícia Martins Bock,1,4 Lucas Porto Santos1
Physical activity trials are being published more often, but reports may not include randomized clinical trial reporting guideline items. We aimed to describe the completeness of guideline-recommended reporting in randomized clinical trials of supervised or unsupervised physical activity interventions.
We conducted MEDLINE searches to identify RCTs published in 5 leading journals in sports and exercise medicine (British Journal of Sports Medicine, Medicine and Science in Sports and Exercise, Scandinavian Journal of Medicine and Science in Sports, Journal of Applied Physiology, and International Journal of Sports Medicine) between January 2006 and December 2016. Eligible studies were primary reports having at least 1 intervention arm comprising structured physical activity (eg, tailored exercise programs) or unstructured physical activity programs (eg, general exercise recommendations). We excluded studies using a physical activity intervention arm as a comparator for a nonphysical activity active intervention. For each publication, 2 assessors independently reviewed full texts and abstracted data based on 9 items selected from Consolidated Standards of Reporting Trials (CONSORT) guidelines. The 9 items were chosen based on their applicability to physical activity trials and their relevance to readers (eg, title identification) and researchers (eg, numbers analyzed). Our review is ongoing; the findings reported here derive from a 25% random sample of retrieved articles for each journal.
Of 86 randomized clinical trials, 40 (47%) and 46 (53%) were published in the periods ranging from 2006 to 2016, respectively, 14 (16%) were identified as a randomized trial in the title; 65 (76%) provided details on trial design and allocation ratio; 50 (58%) mentioned specific hypotheses; 22 (26%) stated their primary outcome; 16 (19%) described sample size calculation; 23 (27%) mentioned examiners blinding; 14 (16%) explicitly indicated the number of participants analyzed; 20 (23%) mentioned trial registry; and only 6 (7%) cited an accessible full trial protocol. One trial reported all 9 items, 2 reported 8, and 7 did not report any item.
A low to modest proportion of trials published in 5 leading exercise science journals reported important CONSORT guideline items. Because careful trial description can enhance completeness, transparency, and reproducibility in exercise sciences, journal endorsement of standard reporting guidelines or checklists might be desirable.
1 Exercise Pathophysiology Research Laboratory, Federal University of Rio Grande do Sul, Porto Alegre, Brazil, email@example.com; 2 National Institute of Science and Technology for Health Technology Assessment (IATS)-CNPq, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; 3School of Nursing, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; 4 Faculdades Integradas de Taquara, Rio Grande do Sul, Brazil
Conflict of Interest Disclosures:
Daniel Umpierre receives research productivity grants from the National Council on Technology and Scientific Development (CNPq, Brazil). Patrícia Martins Bock receives postdoctoral scholarship from the Coordination for the Improvement of Higher Level Personnel (Capes). The other authors report no disclosures.
Role of the Funder/Sponsor:
The sponsors of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.
Datasets are publicly available at https://github.com/dumpierre/exsc-reporting.git