Comparing participants from a randomized trial and screened non-participants: Implications for generalizability of surgery and exercise therapy in young adults with meniscal tears.
case_control · Level III
Where this comes from
- Record sourced from PubMed, PMID 42255407.
- Also identified by DOI 10.1002/jeo2.70791 and PMC identifier 13239727.
- Licence recorded as CC BY.
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Abstract
To investigate the generalizability of the study population and treatment effects observed in a randomized controlled trial comparing a strategy of early surgery to a strategy of exercise therapy and patient education (with the option of later surgery) for young adults with meniscal tears, through comparison with a parallel clinical cohort. We compared patient characteristics of patients (<i>n</i> = 121) from the Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) to patients (<i>n</i> = 182) aged 18-40 years with a meniscal tear participating in a parallel clinical cohort (i.e., those who were screened for the RCT, but not participating for various reasons), to assess the generalizability of the DREAM study population. In addition, we compared observed treatment effects between the trial and cohort (Knee injury and Osteoarthritis Outcome Score, mean of 4/5 subscales-KOOS<sub>4</sub>) of surgery (trial [<i>n</i> = 60] vs. cohort [<i>n</i> = 52]) and exercise (trial [<i>n</i> = 61] vs. cohort [<i>n</i> = 51]). Patients participating in the DREAM trial and the clinical cohort were, on average, similar in most patient characteristics and level of patient-reported symptoms at baseline, except for symptom duration, symptom onset and KOOS symptom subscale scores, where statistically significant differences were observed. Similar baseline to 12-month average KOOS<sub>4</sub> trajectories were observed for trial and cohort patients following surgery (time × group <i>p</i> = 0.98; adjusted mean difference in change 0.7, 95% confidence interval [CI] -7.1 to 8.5) and exercise therapy (time × group <i>p</i> = 0.62; adjusted mean difference in change 3.2, 95% CI -4.3 to 10.7). Overall, both baseline characteristics and observed improvements of surgery and exercise therapy observed in the DREAM trial were largely comparable to those observed in the clinical cohort, suggesting that the DREAM trial results were generalizable to patients aged 18-40 years with meniscal tears observed in daily clinical practice. Level II.