Are PROMs used adequately in sports research? An analysis of 54 randomized controlled trials with PROMs as endpoint
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
Are PROMs used adequately in sports research? An analysis of 54 randomized controlled trials with PROMs as endpoint. / Jensen, Jonas; Hansen, Christian Fugl; Brodersen, John; Comins, Jonathan D.; Krogsgaard, Michael Rindom.
In: Scandinavian Journal of Medicine & Science in Sports, Vol. 31, No. 5, 2021, p. 982-990.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
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‐
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 -
ID: 253729692