2025 ISAKOS Biennial Congress ePoster
Are Patient Reported And Clinical Event Outcomes Appropriately Assessed In Randomized Trials Of Interventions For Acl Injury? A Scoping Review
Hana Marmura, MPT, PhD, Durham, NC UNITED STATES
Jenna Schulz, PT, PhD, London, ON CANADA
Chloe Hewitt, BSc, London, ON CANADA
Jill Neufeld, MSc, London, ON CANADA
Katelyn Inch, MSc, London, ON CANADA
Nicole Bryant, BMSc (Candidate), London, Ontario CANADA
Alan Getgood, MD, FRCS(Tr&Orth), DipSEM, Doha QATAR
Dianne M. Bryant, PhD, London, ON CANADA
Western University, London, ON, CANADA
FDA Status Not Applicable
Summary
Randomized trials conducted with patients after ACL injury might not be appropriately designed or conducted to assess both patient-reported outcomes and event outcomes.
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Abstract
Background
Patient reported outcome measures (PROMs) are a central feature of clinical research and frequently used as primary outcomes in studies investigating the treatment of ACL injuries. However, then are often no differences in PROMs reported between treatment groups despite potentially important differences in event outcomes which require large sample sizes to detect. Furthermore, we know that event outcomes, specifically re-injury and re-operation, are highly important to patients. Therefore, it is critical to understand the treatment effects of different interventions on these endpoints.
Purpose
To investigate how PROMs and event outcomes are being assessed in randomized clinical trials investigating interventions after ACL injury by synthesizing available evidence in a scoping review.
Methods
The PubMed/MEDLINE database was searched for any prospective randomized study investigating interventions for ACL injuries since the year 2000. Articles were screened in duplicate by seven reviewers. Studies were included if they reported both a PROM and any of the following event outcomes: graft failure/rupture, contralateral ACL injuries, ACL revision surgery, or re-operation for timepoints between one- and five-years post-injury/intervention. Studies that were conducted on cadavers/animals or that included participants with multi-ligament injuries were excluded. Data related to study details, sample size, methods, analysis, population, intervention, outcomes, and results were extracted from each of the included studies by one of six reviewers.
Results
A total of 4474 studies were included in title/abstract screening, of which 965 had full text assessed for eligibility, and 170 were included in the review. To date, data has been extracted from 82 of the 170 included studies and preliminary results are reported for this subset of trials. Almost three quarters (61/82, 74%) of studies included a sample size or power calculation, usually based on expected PROM or knee laxity results. However, only one study was designed to be adequately powered to detect differences in event outcomes after ACL injury. Importantly, 44% of studies (36/82) excluded participants who experienced graft failure, contralateral ACL injuries, ACL revision surgery, or re-operation from the follow-up analyses of PROM scores, meaning these participants who are likely to have worse outcomes were not represented in the results.
Conclusions
Randomized trials conducted with patients after ACL injury might not be appropriately designed or conducted to assess both patient-reported outcomes and event outcomes. Therefore, it is difficult to have confidence in recommendations based on individual study results. Additionally, patients who experience adverse events are being excluded from study analyses. Multi-center, adequately powered, and properly designed studies should be conducted to obtain the large samples required to accurately detect differences in event outcomes. Furthermore, all participants should be included in analyses of PROMs, regardless of clinical outcome.