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Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating
Temitope E Adewuyi1, Graeme MacLennan2, Jonathan A Cook3
1Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, Scotland, UK. t.e.adewuyi.15@aberdeen.ac.uk.
Surgical trial reports often show suboptimal handling of non-compliance and missing data, impacting research validity. Improving transparency in reporting participant data is crucial for better evidence synthesis.
Area of Science:
- Medical research methodology
- Surgical clinical trials
- Evidence-based medicine
Background:
- Randomised controlled trials (RCTs) are crucial but vulnerable to non-compliance and missing data.
- Surgical trials present unique challenges to compliance and data collection due to intraoperative factors.
- Current reporting practices for these issues in surgical trials are unclear.
Purpose of the Study:
- To evaluate the reporting and handling of non-compliance and missing data in published surgical intervention trials.
- To identify common methods used to address missing data in surgical trial reports.
Main Methods:
- A systematic search of MEDLINE for surgical intervention trials published in 2010.
- Extraction of data on non-compliance, missing data, and data handling methods from full-text articles.
- Descriptive statistical analysis of the extracted data.
Main Results:
- Over half of the studies (55%) reported non-compliance, and 63% reported missing primary outcome data.
- Median non-compliance was 2% and median missing data was 6%.
- Complete case analysis was the predominant method for handling missing data (67%).
Conclusions:
- Reporting of treatment non-compliance and management of missing data in surgical trials are frequently inadequate.
- Adherence to CONSORT statement guidelines for participant accounting needs enhancement.
- Increased transparency in reporting is essential for robust evidence synthesis.
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