A Test Method for Identifying Selection Bias Risk in Prospective Controlled Clinical Therapy Trials Using the I2 Point Estimate

Abstract

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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