| An RCT may be blinded, (also called "masked") by "procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received." The 2010 CONSORT Statement specifies that authors and editors should not use the terms "single-blind", "double-blind", and "triple-blind"; instead, reports of blinded RCT should discuss "If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how." "open", or (if the intervention is a medication) "open-label". In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective; In pragmatic RCTs, although the participants and providers are often unblinded, it is "still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.") and other methods can be used. | | An RCT may be blinded, (also called "masked") by "procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received." The 2010 CONSORT Statement specifies that authors and editors should not use the terms "single-blind", "double-blind", and "triple-blind"; instead, reports of blinded RCT should discuss "If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how." "open", or (if the intervention is a medication) "open-label". In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective; In pragmatic RCTs, although the participants and providers are often unblinded, it is "still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.") and other methods can be used. |
− | RCT 可能会被“阻止研究参与者、照顾者或结果评估者知道哪些干预措施被接受的程序所蒙蔽”(也称“蒙面”)2010年 CONSORT 声明明确指出,作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语; 相反,关于盲性 RCT 的报告应讨论”如果完成了,干预分配后谁失明了(例如,参与者、护理提供者、评估结果的人员)以及如何完成”“开放”,或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论认为,只有当随机对照试验的结果是主观的而不是客观的时候,非盲性随机对照试验的结果往往偏向于有益的结果; 在实用的随机对照试验中,尽管参与者和提供者往往是非盲性的,但是”仍然需要并且往往可能使评估者失明,以获得评估结果的客观数据来源”以及其他方法。
| + | 一项RCT的盲法是指阻止研究参与者、照顾者或结果评估者知道哪些干预措施,这一程序也称“蒙面”。2010年 CONSORT 声明明确指出,作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语; 相反,关于盲法 RCT 的报告应讨论”如果完成了,干预分配后谁被“蒙面”了(例如,参与者、护理提供者、评估结果的人员)以及如何完成”“开放”,或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论认为,只有当随机对照试验的结果是主观的而不是客观的时候,非盲法随机对照试验的结果往往偏向于有益的结果; 在实用的随机对照试验中,尽管参与者和提供者往往是非盲的,但是”仍然需要并且往往可能使评估者“蒙面”,以获得评估结果的客观数据来源”以及其他方法。 |
| 分配给控制组和治疗组的治疗单位(受试者或受试者组)的数量影响 RCT 的可靠性。如果治疗的效果很小,任何一组的治疗单位的数量都可能不足以在各自的统计检验中拒绝无效假设。拒绝零假设的失败将意味着治疗在给定的测试中对治疗没有统计学意义上的显著影响。但是随着样本量的增加,相同的随机对照试验也许能够证明治疗的显著效果,即使这种效果很小。 | | 分配给控制组和治疗组的治疗单位(受试者或受试者组)的数量影响 RCT 的可靠性。如果治疗的效果很小,任何一组的治疗单位的数量都可能不足以在各自的统计检验中拒绝无效假设。拒绝零假设的失败将意味着治疗在给定的测试中对治疗没有统计学意义上的显著影响。但是随着样本量的增加,相同的随机对照试验也许能够证明治疗的显著效果,即使这种效果很小。 |