Arch Suicide Res. 2020 Apr-Jun;24(2):285-300. doi: 10.1080/13811118.2019.1632232. Epub 2019 Jul 18.
During a trial, standardization can lock in a treatment that researchers learn is flawed and may be ineffective. In such cases, researchers typically decide between two options, continue the trial and monitor for iatrogenic effects or stop the trial. When faced with this dilemma while testing an adaptation of motivational interviewing to address suicidal ideation, our research team considered a third option, to correct the flaws in the intervention and study the effect on outcome. We explored the rationale for and against changing an intervention mid-trial and progressed through a series of steps to determine whether we should change the intervention, ultimately deciding to make changes and examine their impact. We developed a procedure that researchers can use to determine whether they should change an intervention during a trial, how to implement the changes, and how to redesign their study. When faced with evidence that a treatment is ineffective, researchers should consider changing the intervention and examining the effects of the changes on outcome. Such decisions may be particularly relevant in trials examining life-threatening outcomes. Making and studying these changes may increase the potential for the study to identify a treatment that produces a desired outcome.
在试验过程中，标准化可能会锁定一种治疗方法，而研究人员后来发现这种方法存在缺陷且可能无效。在这种情况下，研究人员通常会在两种选择之间做出决定，是继续试验并监测医源性影响，还是停止试验。在测试一项针对自杀意念的动机性访谈改编版时，我们的研究团队在面临这一两难困境时，考虑了第三种选择，即纠正干预措施中的缺陷，并研究其对结果的影响。我们探讨了在试验中途改变干预措施的理由和依据，并通过一系列步骤来确定是否应该改变干预措施，最终决定做出改变并检查其影响。我们制定了一个程序，研究人员可以使用该程序来确定他们是否应该在试验中改变干预措施，如何实施这些改变，以及如何重新设计研究。当有证据表明一种治疗方法无效时，研究人员应该考虑改变干预措施并检查这些改变对结果的影响。在针对危及生命的结果进行的试验中，这些决策可能特别重要。做出这些改变并对其进行研究可能会增加研究确定产生所需结果的治疗方法的可能性。
