Criteria for use of composite end points for competing risks—a systematic survey of the literature with recommendations

摘要: Abstract Background Composite end points are frequently used in reports of clinical trials. One rationale for the use composite is to account competing risks. In presence risks, event rate a specific depends on rates other events. proposed solution include all important events one point. Clinical trialists require guidance regarding when this approach appropriate. Objectives To identify publications describing criteria risk and offer point appropriate basis Methods, Data Sources, Study Selection Extraction We searched MEDLINE, CINAHL, EMBASE, The Cochrane's Central & Systematic Review databases including Health Technology Assessment database, Methodology register from inception April 2015, candidate textbooks, articles providing issue. Eligible explicitly addressed issue outcome address Two reviewers independently screened titles abstracts full-text review; reviewed publications; abstracted authors offered Results Of 63,645 abstracts, 166 proved potentially relevant which 43 were included final review. Most note risks as reason using without further elaboration. None or textbook chapters provide risk. Some advocate avoid bias due others suggest that seldom never be purpose. recommend only if plausible it occurs with sufficiently high frequency influence interpretation effect intervention interest. These will met. heart failure trials published New England Journal Medicine revealed many them death hospitalization; none trials, however, satisfied our criteria. Conclusion existing literature fails clear often.