Research waste in randomized clinical trials of degenerative spinal diseases: a cross-sectional study

Résumé fourni par la source

Evidence-based medicine continues to face the challenge of research waste (i.e., nonpublication, reporting limitations, high risk of bias) in randomized clinical trials (RCTs) of degenerative spinal diseases (DSDs). A search was conducted on ClinicalTrials.gov for RCTs registered before July 27, 2024 using the keywords DSDs and related terms. The major outcome was the percentage of trials exhibiting the characteristics of research waste on DSD RCTs. A total of 335 DSD RCTs were eligible, with a lower percentage of multicenter trials outside North America than in North America (33 [14.7%] vs. 53 [47.7%]; P < .001). A total of 224 trials were included. Of the 176 (78.6%) published RCTs, 126 (71.5%) had reporting limitations and 71 (40.3%) were at high risk of bias. RCTs with implementing blinding (single vs. none/open-label: OR 0.10, 95% CI 0.03-0.35, P < .001; double/more vs. none/open-label: 0.14, 95% CI 0.04-0.52, P = .003), non-industry funding (0.13; 95% CI, 0.04-0.42; P < .001), and multicenter (0.22; 95% CI, 0.08-0.56; P = .002) have lower odds of research waste. In conclusion, we provide the first description of DSD RCTs over the past 30 years and find significant research waste that is out of proportion to the magnitude of the disease burden.

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