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The Unknown Prevalence of Postrandomization Bias in 15 Physical Therapy Journals: A Methods Review
Objectives:
To determine the prevalence of prospective clinical trial registration and postrandomization bias in published musculoskeletal physical therapy randomized clinical trials (RCTs).
Design:
A methods review.
Literature Search:
Articles indexed in MEDLINE and published between January 2016 and July 2020 were included.
Study Selection Criteria:
Two independent blinded reviewers identified the RCTs using Covidence. We included RCTs related to musculoskeletal interventions that were published in International Society of Physiotherapy Journal Editors member journals.
Data Synthesis:
Data were extracted independently for the variables of interest from the identified RCTs by 2 blinded reviewers. The data were presented descriptively or in frequency tables.
Results:
One hundred thirty-eight RCTs were identified. One third of RCTs were consistent with their prospectively registered intent (49/138); consistency with prospectively registered intent could not be determined for two thirds (89/138) of the RCTs. Four RCTs (8%)reported inconsistent results with the primary aims and 7 (14%) with the outcomes from the prospective clinical trial registry, despite high methodological quality (Physiotherapy Evidence Database [PEDro] scale score). Differences between prospectively registered and non-prospectively registered RCTs for PEDro scale scores had a medium effect size (r = 0.30). Two of 15 journals followed their clinical trial registration policy 100% of the time; in 1 journal, the published RCTs were consistent with the clinical trial registration.
Conclusion:
Postrandomization bias in musculoskeletal physical therapy RCTs could not be ruled out, due to the lack of prospective clinical trial registration and detailed data analysis plans. J Orthop Sports Phys Ther 2021;51(11):542-550. Epub 21 Sep 2021. doi:10.2519/jospt.2021.10491.
Insights
Prospective clinical trial registration is inconsistent in musculoskeletal physical therapy randomized clinical trials (RCTs), raising concerns about potential postrandomization bias. Further adherence to registration policies is needed to ensure trial integrity.
Area of Science:
- Clinical Trials
- Physical Therapy
- Biomedical Research
Background:
- Prospective clinical trial registration is crucial for transparency and minimizing bias in research.
- Musculoskeletal physical therapy randomized clinical trials (RCTs) are essential for evidence-based practice.
- Assessing the adherence to registration protocols and potential biases in published RCTs is vital for scientific integrity.
Purpose of the Study:
- To determine the prevalence of prospective clinical trial registration in musculoskeletal physical therapy RCTs.
- To investigate the occurrence of postrandomization bias in these trials.
- To evaluate the consistency between registered trial information and published results.
Main Methods:
- A methods review was conducted on articles published between January 2016 and July 2020, indexed in MEDLINE.
- Two independent blinded reviewers identified relevant musculoskeletal physical therapy RCTs from International Society of Physiotherapy Journal Editors member journals.
- Data on prospective registration and outcome reporting were extracted and descriptively analyzed.
Main Results:
- Out of 138 identified RCTs, only one-third (49/138) were consistent with their prospective registration.
- Consistency could not be determined for two-thirds (89/138) of the RCTs.
- Eight percent (4/138) of RCTs reported inconsistent primary aims, and 14% (7/138) reported inconsistent outcomes compared to their registry, despite high methodological quality (PEDro scores).
Conclusions:
- The lack of consistent prospective clinical trial registration and detailed data analysis plans in musculoskeletal physical therapy RCTs prevents ruling out postrandomization bias.
- Adherence to clinical trial registration policies by journals and researchers needs improvement.
- Ensuring prospective registration and transparent reporting is critical for the reliability of physical therapy research.
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