Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment.

摘要: Background Ethical concern has been raised with critical care randomized controlled trials in which the standard of reflects a broad range clinical practices. Commentators have argued that without an unrestricted control group, practices are implemented at discretion attending physician, lack ability to redefine and might expose subjects excessive harms due inability stop early. Objective To develop framework for analyzing group selection trials. Method analysis. Results A key ethical variable trial design is extent adequately Such incorporate either "unrestricted" physicians or protocol specifies restricts parameters Control should be determined respect following objectives design: 1) value, 2) scientific validity, 3) efficiency feasibility, 4) protection human subjects. Because these may conflict, will involve trade-offs compromises. Trials using protocolized rather than likely enhanced validity. However, if lacks representativeness practices, then use such groups offer less value could provide assurance protecting compared groups. For evaluating contrasting strategies do not represent third more representative enhance increase early needed protect These advantages come expense feasibility. Conclusion Weighing balancing competing done each trial.