Wong Jessie J, Jones Nev, Timko Christine, Humphreys Keith
Center for Innovation to Implementation, VA Palo Alto Health Care System, Palo Alto, CA, USA.
Center for Health Policy/ Center for Primary Care and Outcomes Research, Stanford University, Stanford, CA, USA.
Contemp Clin Trials Commun. 2018 Jan 31;9:130-134. doi: 10.1016/j.conctc.2018.01.009. eCollection 2018 Mar.
The current paper reviews the English-language research on exclusion criteria in bipolar disorder treatment trials and discusses how study samples compare to the general bipolar patient population.
& Results: Across 8 identified studies of exclusion criteria and their impact, between 55% and 96% of people with bipolar disorder would be excluded from treatment research. The number of exclusion criteria varies across bipolar disorder treatment research, with one study estimate of a median of 7 criteria used across studies. The criteria that excluded the greatest number of potential participants were comorbid substance use disorder, suicidal risk, and comorbid medical conditions. Both studies that compared treatment responses among participants who met and did not meet exclusion criteria found no statistically significant differences.
Most potential participants are excluded from outcome research, which creates challenges for recruitment and limits generalizability of study findings. Common exclusionary practices lead to unrepresentative samples that limit generalizability and reduce the confidence of clinicians that findings can be translated to front-line practice with bipolar disorder patients.
本文回顾了关于双相情感障碍治疗试验中排除标准的英文研究，并讨论了研究样本与一般双相情感障碍患者群体的比较情况。
在8项已确定的关于排除标准及其影响的研究中，55%至96%的双相情感障碍患者会被排除在治疗研究之外。双相情感障碍治疗研究中的排除标准数量各不相同，一项研究估计各研究使用的排除标准中位数为7条。排除潜在参与者数量最多的标准是共病物质使用障碍、自杀风险和共病躯体疾病。两项比较符合和不符合排除标准的参与者治疗反应的研究均未发现统计学上的显著差异。
大多数潜在参与者被排除在疗效研究之外，这给招募工作带来了挑战，并限制了研究结果的普遍性。常见的排除做法导致样本缺乏代表性，限制了普遍性，并降低了临床医生对研究结果可转化为双相情感障碍患者一线治疗实践的信心。
