Hofer A, Hummer M, Huber R, Kurz M, Walch T, Fleischhacker W W
Department of Biological Psychiatry, University Clinics Innsbruck, Austria.
J Clin Psychopharmacol. 2000 Dec;20(6):699-702. doi: 10.1097/00004714-200012000-00019.
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.
尽管已知患者的选择是影响临床试验结果的一个重要因素，但对于招募问题却知之甚少。许多接受抗精神病药物临床试验筛查的精神分裂症患者最终并未纳入研究。因此，对一组选定患者进行研究所获得的结果是否真的能代表精神分裂症患者总体人群这一问题便产生了。作者对33个月内连续入住因斯布鲁克精神病学系住院部、诊断为精神分裂症样或精神分裂症障碍的200名患者进行了选择性抽样的可能原因研究。除了人口统计学数据和精神病理学评分（使用简明精神病评定量表）外，作者还记录了患者是否被纳入III期研究，以及那些未被纳入的患者理论上是否符合此类研究的条件。最终有27名患者被招募参加临床试验。这些患者平均年龄较小，发病时间更近，且过去经历的精神病发作较少。既往治疗不依从史和拒绝同意是理论上符合条件的患者未被纳入临床试验的最常见原因。
