Deviations from adequate use and reporting of PROMs may be problematic and misleading. The aim of this study was to investigate the extent of such problems in randomized clinical trials (RCTs). RCTs involving sports medicine research that used PROMs as primary outcomes were identified in 13 preselected journals. The articles were reviewed for nine potential problems related to how the PROM was used and how the data had been reported. The potential problems were as follows: aggregating subscale scores; combining patient-reported scores with physical, clinical, or para-clinical measures; using a PROM to diagnose or evaluate the individual patient; using a PROM for one leg or arm; selectively excluding domains or items; constructing a PROM for the specific occasion; mixing PROM formats (ie, digital, paper, telephone, e-mail, in person); ambiguous instructions for how the PROM should be completed; and recall bias. As covariates, we registered journal impact factor, year of publication, and existence of a registered protocol. In 29 (53.7%) of 54 identified RCTs, at least one potential problem was identified, the most common being aggregation of domain scores. This was not different with a published protocol or dependent on journal rankings, except for exclusion of domains, which was most common in high-ranking journals. Aggregation of domain scores was significantly less common in recently published articles compared with older articles (P = .03). Potential problematic use of PROMs and reporting of PROM data are common in RCTs, also in high-ranking journals, but less so in more recent articles.
|Scandinavian Journal of Medicine and Science in Sports
|17 nov. 2020
|Udgivet - maj 2021