Consumer Influences of Treatment of Depression

描述（由申请人提供）：到2005年，制药业每年将花费75亿美元用于处方药的直接面向消费者广告（DTCA）。DTCA的支持者说，它鼓励了病人和医生之间富有成效的讨论，而批评者则指责它增加了不必要的处方，提高了成本，并使医患关系变得紧张。这方面的政策制定缺乏经验证据。本研究将通过对标准化患者（SPs）进行实验来检验DTCA的临床影响，这些患者表现出抑郁症状（代表严重抑郁症或适应障碍），并提出：1)广告驱动的品牌抗抑郁药请求，2)一般治疗请求，或3)没有请求。我们对抑郁症的关注是合理的，因为这种疾病的高患病率和高成本，它与一般医疗实践的相关性，广播和印刷媒体上无处不在的抑郁症相关的DTC广告，以及使用抗抑郁药物的适应症的扩大。该应用程序有三个具体目的：1)估计DTC广告驱动的请求对医生为抑郁症状患者开抗抑郁药处方的影响；2)确定DTC广告驱动的请求是否与初级保健机构的护理质量好坏相关；3)描述医生在面对患者提出广告驱动请求、一般性请求和无特定请求时的沟通行为差异。在这项随机试验中，美国3个城市的144名初级保健医生每人将看到2名未通知的SPs。SPs将被训练来扮演6个不同的角色，这些角色是通过交叉2种临床表现（重度抑郁症和适应障碍）和3种请求条件（DTCA激活、一般激活和无请求）而产生的。访问将被录音，SPs将记录医生的临床行为。采用多层次混合效应模型分析数据，评估DTCA对抗抑郁药处方及临床护理过程的影响。这些分析将通过对实验条件下医生沟通行为的定性和定量分析来补充。研究结果将解决一个紧迫的政策问题（即，是否应该进一步规范DTCA ?），同时也有助于我们了解初级保健机构中抑郁症诊断和治疗的社会影响。

DESCRIPTION (provided by applicant): By 2005, the pharmaceutical industry will spend $7.5 billion annually on direct-to-consumer advertising (DTCA) of prescription drugs. Proponents of DTCA say it encourages productive discussions between patients and physicians, while critics charge that it increases unnecessary prescribing, raises costs, and strains the patient-clinician relationship. Empirical evidence for policymaking in this area is lacking. This study will examine the clinical impact of DTCA by conducting an experiment using standardized patients (SPs) who present with depressive symptoms (representing either major depression or adjustment disorder) and make either: 1) an ad-driven request for a brand-name antidepressant, 2) a generic request for treatment, or 3) no request. Our focus on depression is justified by the high prevalence and costs of this condition, its relevance to general medical practice, the ubiquity of depression-related DTC ads in both broadcast and print media, and the broadening indications for the use of antidepressant medications. The application has 3 specific aims: 1) to estimate the effects of DTC ad-driven requests on physicians' prescribing of antidepressants for patients with depressive symptoms; 2) to determine whether DTC ad-driven requests are associated with better or worse quality of care in primary care settings; and 3) to describe differences in physicians' communication behaviors when they are confronted by patients making ad-driven requests, generic requests, and no specific requests. In this randomized trial, 144 primary care physicians in 3 U.S. cities will each see 2 unannounced SPs. The SPs will be trained to portray 6 different roles, generated by crossing 2 clinical presentations (major depression and adjustment disorder) with 3 request conditions (DTCA activated, generically activated, and no request). Visits will be audio-recorded, and SPs will record physicians' clinical behaviors. Using multi-level mixed effects models, data will be analyzed to assess the influence of DTCA on antidepressant prescribing and the clinical process of care. These analyses will be supplemented by qualitative and quantitative analyses of physician communication behaviors across experimental conditions. The results will address a pressing policy question (i.e., should DTCA be further regulated?) while also contributing to our understanding of the social influences on diagnosis and treatment of depression in primary care settings.