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Abstract：
We examine recruitment processes for 71 pragmatic and comparative effectiveness trials identified in a systematic review, using path analysis to examine rates of refusal to screen, test, and consent to trial participation. Our analysis suggests that refusal rates might be on net slightly higher if potential subjects are screened or asked to undergo physical eligibility tests, but this was not significant in our sample of trials (p = .11 by Mann-Whitney test). We find that rates of refusing to provide informed consent are much lower for trials in which subjects have agreed to screening or testing (odds ratio = 0.40, Wilcoxon rank-sum z = 2.67, p = .008). We also observe that the overwhelming majority of trials examined secured consent after determining eligibility, even in trials involving screening or testing activities. The ethical implications and areas for future research are discussed.
摘要：
我们检查了系统回顾中确定的71项务实和比较有效性试验的招聘过程，使用路径分析来检查拒绝筛选的比率，test,并同意参与试验。我们的分析表明，如果对潜在受试者进行筛查或要求进行身体合格性测试，拒绝率可能会略高，但这在我们的试验样本中并不显著(Mann-Whitney检验p=.11)。我们发现，拒绝提供知情同意的比率对于受试者同意筛查或测试的试验要低得多（比值比=0.40，Wilcoxon秩和z=2.67，p=.008）。我们还观察到，绝大多数试验在确定资格后审查了安全同意，即使在涉及筛查或测试活动的试验中。讨论了伦理意义和未来研究的领域。
