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A Test Method for Identifying Selection Bias Risk in Prospective Controlled Clinical Therapy Trials Using the I2
Steffen Mickenautsch1,2, Veerasamy Yengopal1
1Dentistry, University of the Western Cape, Cape Town, ZAF.
Objectives:
A test method is proposed for identifying potential selection bias risk in single prospective controlled clinical therapy trials that can be applied by trial reviewers.
Methods:
The method is described in detail and was tested on eight randomised controlled trials (RCTs) with reported negative Berger-Exner test results as negative and on eight prospective, controlled cohort studies as positive controls. All 16 studies were identified by systematic literature search.
Results:
The test method yielded negative results for all RCTs and positive results for six out of the eight cohort studies.
Conclusion:
All test results remained within the expected limits for both study types, suggesting a reasonably high accuracy for correctly identifying selection bias risk. However, the method does not provide the possibility to establish whether such bias risk has actually altered trial outcomes. Instead, a positive test result may provide an empirical basis for rating a trial as of high selection bias risk during trial appraisal.
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