Generalizability of clinical trial results for major depression to community samples: Results from the National Epidemiologic Survey on Alcohol and Related Conditions
Generalizability of clinical trial results for major depression to community samples: Results from the National Epidemiologic Survey on Alcohol and Related Conditions
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DOI：
10.4088/jcp.v69n0810
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发表时间：
2008-08-01
影响因子：
5.3
通讯作者：
Hasin, Deborah S.
中科院分区：
文献类型：
--
作者：
Blanco, Carlos;Olfson, Mark;Hasin, Deborah S.
目的：尽管新出现的数据表明样本组成可能会影响心理健康干预的有效性，但在临床试验中受试者在多大程度上代表了受影响的社区样本仍然未知。这项研究的目的是评估患有严重抑郁发作(MDE)的社区成年人符合MDE患者传统疗效试验的资格标准的比例。方法：我们将MDE患者临床试验中使用的一套标准排除标准应用于2001-2002年全国酒精及相关疾病流行病学调查(NESARC)，这是迄今为止美国最大的精神流行病学研究(N=43,093)。由于寻求疾病治疗的个体可能在系统上与没有寻求治疗的个体不同，我们首先将该标准应用于所有当前诊断为MDE的个体(N=3119)(根据DSM-IV诊断)，然后应用于寻求治疗的个体的子样本(N=1359)。结果：在全部MDE个体样本中，75.8%的个体被一个或多个研究资格标准排除在外。在寻求治疗的亚样本中，约三分之二(66.9%)被排除在外。被个别研究标准排除的受试者在总体样本中的百分比为2.4%至47.4%，在寻求治疗的样本中为0%至38.4%。对于这两组患者，共病、非抑郁、非物质使用的轴I障碍的存在和抑郁发作的持续时间排除了最大百分比的个体。结论：传统临床试验设计倾向于排除大多数患有MDE的个体。排除标准的选择可能对研究结果的概括性有很大的影响。临床试验应解释排除标准的基本原理，并评估合格标准对试验结果的概括性的影响。
Objective: Although emerging data indicate that sample composition may influence the effectiveness of mental health interventions, the extent to which subjects in clinical trials represent affected community samples remains unknown. The goal of this study was to assess the proportion of community-dwelling adults with major depressive episode (MDE) who would meet eligibility criteria for a traditional efficacy trial in patients with MDE.Method: We applied a standard set of exclusion criteria used in clinical trials in patients with MDE to the 2001-2002 National Epidemiologic Survey for Alcohol and Related Conditions (NESARC), the largest psychiatric epidemiologic study in the United States to date (N = 43,093). Because individuals who seek treatment for a disorder may systematically differ from those who do not, we applied the criteria first to all individuals with a Current diagnosis of MDE (N = 3119) (diagnosed according to DSM-IV) and then to the subsample of individuals who sought treatment (N = 1359).Results: Among the full sample of individuals with MDE, 75.8% were excluded by one or more study eligibility criteria. Approximately two thirds (66.9%) of the subsample of those who sought treatment were excluded. The percentage Of subjects excluded by individual study criteria ranged from 2.4% to 47.4% in the overall sample and 0% to 38.4% in the treatment-seeking sample. For both groups, the presence of comorbid, nondepressive, non-substance use Axis I disorders and the duration of the depressive episode excluded the largest percentage of individuals.Conclusion: The design of traditional clinical trials tends to exclude a majority of individuals with MDE. Selection of exclusion criteria may have a powerful influence on the generalizability of study results. Clinical trials should explain the rationale for their exclusion criteria and estimate the impact of eligibility criteria on the generalizability of trial results.