Professor Ian Harris | International Research Integrity Conference

A practicing orthopaedic surgeon and Professor of Orthopaedics at UNSW. HIs research interests include research integrity, methodological studies and clinical trials of surgical effectiveness.

ABSTRACT:

The varying use of randomisation in “randomised” trials included in systematic reviews in orthopaedic surgery

Harris IA [1], Tang M [1], Lun KK [1], Lewin A[1]

1. South Western Sydney Campuses, School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney

Aim
This study aims to describe the quality of randomisation in randomised trials (RCTs) included in systematic reviews in orthopaedic surgery.

Methods
Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 reviews was selected, and all included RCTs retrieved. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as ‘adequate’, ‘inadequate’, ‘no information’ or ‘observational study’; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews.

Results
We included 917 unique RCTs. We found that 374 RCTs (40.8%) reported adequate sequence generation, 410 (44.7%) lacked information, 61 (6.7%) were inadequately randomized (non-random), and 72 (7.9%) were observational studies incorrectly included as RCTs within the systematic review. Publication year, an author with statistical or epidemiological qualifications, and journal impact factor were each associated with adequate randomization. We found that 45 systematic reviews (45%) included at least one inadequately randomized RCT or an observational study incorrectly treated as a RCT.

Conclusion
There is evidence of a lack of random allocation in RCTs included in systematic reviews in orthopaedic surgery. The conduct of RCTs and systematic reviews should be improved to minimize the risk of bias from inadequate randomization in RCTs and mislabelling of non-randomized studies as RCTs.