Selection bias in clinical trials with antipsychotics
Selection bias in clinical trials with antipsychotics
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DOI：
10.1097/00004714-200012000-00019
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发表时间：
2000-12-01
影响因子：
2.9
通讯作者：
Fleischhacker, WW
中科院分区：
文献类型：
--
作者：
Hofer, A;Hummer, M;Fleischhacker, WW
虽然已知患者的选择是影响临床试验结果的一个重要因素，但对招募问题知之甚少。许多精神分裂症患者筛选了临床试验的研究性抗精神病药物，但最终没有被纳入研究。因此，问题出现了，通过研究一组选定的患者获得的结果是否真的代表精神分裂症患者的一般人群。作者研究了选择性抽样的可能原因，这些患者在33个月的时间里连续被诊断为精神分裂症或精神分裂症紊乱，住进因斯布鲁克精神科的住院病房。除了人口统计数据和精神病理评分（使用简短精神病学评定量表）外，作者还记录了患者是否被纳入III期研究，以及那些未被纳入III期研究的患者是否在理论上符合III期研究的条件。27名患者最终被招募参加临床试验。这些患者平均年龄更小，发病时间更近，过去精神病发作次数更少。不遵守先前治疗的历史和拒绝同意是不将理论上符合条件的患者纳入临床试验的最常见原因。
Although the selection of patients is known to be a powerful factor affecting the results of clinical trials, little is known about recruitment issues. Many patients with schizophrenia who are screened for a clinical trial of an investigational antipsychotic are ultimately not included in the study. Therefore, the question arises of whether the results obtained by studying a selected group of patients are really representative of the general population of patients with schizophrenia. The authors studied possible reasons for selective sampling in 200 patients who were consecutively admitted to inpatient units of Innsbruck's Department of Psychiatry with a diagnosis of schizophreniform or schizophrenic disorder over a time period of 33 months. Apart from demographic data and a psychopathologic rating (using the Brief Psychiatric Rating Scale), the authors recorded whether or not a patient was included in a phase III study and whether or not those were not included would have theoretically been eligible for such a study. Twenty-seven patients were finally recruited for a clinical trial. These patients were younger, on average, had a more recent onset of illness, and had experienced fewer psychotic episodes in the past. A history of noncompliance with previous treatment and the refusal of consent were the most common reasons for not including theoretically eligible patients in a clinical trial.