Wells K B
UCLA Neuropsychiatric Institute, USA.
Soc Psychiatry Psychiatr Epidemiol. 1999 Jan;34(1):20-9. doi: 10.1007/s001270050107.
This paper describes a study design that blends health services and clinical research approaches to examine the cost-effectiveness of treatments and of quality improvement for depression in primary care, managed care practices. Six managed care organizations in Los Angeles (Calif.), San Antonio (Tex.), San Luis Valley (Colo.), Twin Cities (Minn.), and Columbia (Md.) participated. Primary care clinics were randomized to one of two quality improvement interventions or care as usual. Interventions included patient and provider education, nurse-assisted patient assessment, and resources to support appropriate medication management or access to cognitive behavioral therapy. Practices implemented the interventions with study support. Providers and patients selected treatment. Patients with depressive symptoms regardless of comorbidities were eligible. Over 27,000 primary care patients visiting the practices of 181 primary care clinicians were screened for depression, 14% were potentially eligible, and 1356 enrolled into the 2-year longitudinal study. Enrollees were similar to eligibles, but usual care clinic patients tended to be less severely depressed than intervention clinic patients, partly due to clinic staff enthusiasm. The result of the study showed that studying treatment effects and quality improvement in nonacademic settings is feasible, but requires relaxation of design features of experiments that protect internal validity. The trade-off between certainty of causal inference and generalizability to usual care conditions is discussed. The strengths and limitations of this study design are compared to those of clinical trials and recent clinical effectiveness studies.
本文描述了一种研究设计，该设计融合了卫生服务和临床研究方法，以检验在初级保健管理式医疗实践中治疗抑郁症及改善其质量的成本效益。加利福尼亚州洛杉矶、得克萨斯州圣安东尼奥、科罗拉多州圣路易斯谷、明尼苏达州双子城和马里兰州哥伦比亚的六个管理式医疗组织参与了研究。初级保健诊所被随机分配到两种质量改进干预措施之一或常规护理组。干预措施包括患者和提供者教育、护士协助的患者评估，以及支持适当药物管理或获得认知行为疗法的资源。各医疗机构在研究支持下实施干预措施。提供者和患者选择治疗方法。无论是否患有合并症，有抑郁症状的患者均符合条件。对在181名初级保健临床医生所在医疗机构就诊的超过27000名初级保健患者进行了抑郁症筛查，14%的患者可能符合条件，1356名患者被纳入为期两年的纵向研究。入组者与符合条件者相似，但常规护理诊所的患者抑郁程度往往低于干预诊所的患者，部分原因是诊所工作人员的积极性。研究结果表明，在非学术环境中研究治疗效果和质量改进是可行的，但需要放宽保护内部效度的实验设计特征。讨论了因果推断的确定性与常规护理条件下的可推广性之间的权衡。将该研究设计的优缺点与临床试验和近期临床疗效研究的优缺点进行了比较。
