A Systematic Review of Outcome Measures in Orthopaedic Trauma Trials: What Are We Measuring?

Autor: Marcano-Fernández F; Orthopaedic Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc del Taulí, 1, 08208 Sabadell, Barcelona Spain., Camara-Cabrera J; Orthopaedic Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc del Taulí, 1, 08208 Sabadell, Barcelona Spain., Madden K; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON L8L 8E7 Canada.; Department of Health Research Methods, Evidence, and Impact, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON L8L 8E7 Canada., Johal H; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON L8L 8E7 Canada., Nadeem IM; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON L8P 1H6 Canada., Kapoor R; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON L8L 8E7 Canada., Shehata M; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON L8L 8E7 Canada., Prada C; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON L8L 8E7 Canada.
Jazyk: angličtina
Zdroj: Indian journal of orthopaedics [Indian J Orthop] 2022 Jun 18; Vol. 56 (8), pp. 1316-1326. Date of Electronic Publication: 2022 Jun 18 (Print Publication: 2022).
DOI: 10.1007/s43465-022-00667-8
Abstrakt: Purpose: The objectives of this study are to describe the outcome measures used in orthopaedic fracture care trials, with a particular focus on patient-reported outcome measures (PROMs), and to determine which study characteristics are associated with number of citations.
Methods: We retrieved randomized clinical trials on fracture care between 2012 and 2017 from Embase, Medline and CENTRAL databases. Data collected included study characteristics (e.g., region, design, setting, sample size) and outcome measures (e.g., primary variable, measurement perspective, use of PROMs, study results and number of citations).
Results: We identified a total of 8,580 articles in the initial search. After title screening, abstract screening and full-text review, we included 416 articles for analysis. 58.4% (243) of the studies clearly defined a primary outcome measure and 56.3% (234) reported sample size justifications for outcome selection. The most common primary outcome reported was a visual analogue scale for pain; used in 21 of the 243 (8.6%) studies that defined a primary outcome. At least one PROM was used in 68.5% (285) of the papers included.
Conclusions: A large proportion of studies reporting on PROMs for orthopaedic trauma patients do not provide key information on the outcome selection process; a step of utmost importance in and the designing and reporting of RCTs. There is substantial heterogeneity in the selection of PROMs for fracture care trials, which limits the ability to compare and summarize across studies. Future research in fracture care should strive towards improving the reporting of informative PROMs, with rationale that demonstrates understating of the injury, intervention and patient values.
Supplementary Information: The online version contains supplementary material available at 10.1007/s43465-022-00667-8.
Competing Interests: Conflict of InterestAll authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.
(© Indian Orthopaedics Association 2022.)
Databáze: MEDLINE
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