TY - JOUR

T1 - Are PROMs used adequately in sports research? An analysis of 54 randomized controlled trials with PROMs as endpoint

AU - Jensen, Jonas

AU - Hansen, Christian Fugl

AU - Brodersen, John

AU - Comins, Jonathan D.

AU - Krogsgaard, Michael Rindom

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - inadequate use

KW - patient&#8208

KW - reported outcome measures

KW - potential bias

KW - PROM

KW - sports medicine

KW - sports traumatology

KW - PLATELET-RICH PLASMA

KW - AUTOLOGOUS BLOOD INJECTIONS

KW - TOPICAL GLYCERYL TRINITRATE

KW - PHYSICAL-THERAPY

KW - DOUBLE-BLIND

KW - KNEE OSTEOARTHRITIS

KW - CLINICAL-OUTCOMES

KW - ACHILLES TENDINOPATHY

KW - PATELLAR TENDINOPATHY

KW - NONSURGICAL TREATMENT

U2 - 10.1111/sms.13880

DO - 10.1111/sms.13880

M3 - Journal article

C2 - 33202068

VL - 31

SP - 982

EP - 990

JO - Scandinavian Journal of Medicine & Science in Sports

JF - Scandinavian Journal of Medicine & Science in Sports

SN - 0905-7188

IS - 5

ER -