Kravitz Richard L, Epstein Ronald M, Feldman Mitchell D, Franz Carol E, Azari Rahman, Wilkes Michael S, Hinton Ladson, Franks Peter
Center for Health Services Research in Primary Care, University of California, Davis, Sacramento, CA 95817, USA.
JAMA. 2005 Apr 27;293(16):1995-2002. doi: 10.1001/jama.293.16.1995.
Direct-to-consumer (DTC) advertising of prescription drugs in the United States is both ubiquitous and controversial. Critics charge that it leads to overprescribing, while proponents counter that it helps avert underuse of effective treatments, especially for conditions that are poorly recognized or stigmatized.
To ascertain the effects of patients' DTC-related requests on physicians' initial treatment decisions in patients with depressive symptoms.
Randomized trial using standardized patients (SPs). Six SP roles were created by crossing 2 conditions (major depression or adjustment disorder with depressed mood) with 3 request types (brand-specific, general, or none).
Offices of primary care physicians in Sacramento, Calif; San Francisco, Calif; and Rochester, NY, between May 2003 and May 2004.
One hundred fifty-two family physicians and general internists recruited from solo and group practices and health maintenance organizations; cooperation rates ranged from 53% to 61%.
The SPs were randomly assigned to make 298 unannounced visits, with assignments constrained so physicians saw 1 SP with major depression and 1 with adjustment disorder. The SPs made a brand-specific drug request, a general drug request, or no request (control condition) in approximately one third of visits.
Data on prescribing, mental health referral, and primary care follow-up obtained from SP written reports, visit audiorecordings, chart review, and analysis of written prescriptions and drug samples. The effects of request type on prescribing were evaluated using contingency tables and confirmed in generalized linear mixed models that accounted for clustering and adjusted for site, physician, and visit characteristics.
Standardized patient role fidelity was excellent, and the suspicion rate that physicians had seen an SP was 13%. In major depression, rates of antidepressant prescribing were 53%, 76%, and 31% for SPs making brand-specific, general, and no requests, respectively (P<.001). In adjustment disorder, antidepressant prescribing rates were 55%, 39%, and 10%, respectively (P<.001). The results were confirmed in multivariate models. Minimally acceptable initial care (any combination of an antidepressant, mental health referral, or follow-up within 2 weeks) was offered to 98% of SPs in the major depression role making a general request, 90% of those making a brand-specific request, and 56% of those making no request (P<.001).
Patients' requests have a profound effect on physician prescribing in major depression and adjustment disorder. Direct-to-consumer advertising may have competing effects on quality, potentially both averting underuse and promoting overuse.
在美国，处方药的直接面向消费者（DTC）广告既普遍存在又颇具争议。批评者指责其导致过度开药，而支持者则反驳称，它有助于避免有效治疗的使用不足，尤其是对于那些未得到充分认识或带有污名化的病症。
确定患者与DTC相关的请求对有抑郁症状患者的医生初始治疗决策的影响。
使用标准化患者（SP）的随机试验。通过将2种病症（重度抑郁症或伴有抑郁情绪的适应障碍）与3种请求类型（特定品牌、一般或无请求）交叉，创建了6种SP角色。
2003年5月至2004年5月期间，加利福尼亚州萨克拉门托、加利福尼亚州旧金山和纽约州罗切斯特的初级保健医生办公室。
从个体诊所、团体诊所和健康维护组织招募的152名家庭医生和普通内科医生；合作率在53%至61%之间。
将SP随机分配进行298次未提前通知的就诊，分配时加以限制，以便医生能见到1名患有重度抑郁症的SP和1名患有适应障碍的SP。在大约三分之一的就诊中，SP提出特定品牌药物请求、一般药物请求或不提出请求（对照条件）。
从SP书面报告、就诊录音、病历审查以及书面处方和药物样本分析中获取的关于开药、心理健康转诊和初级保健随访的数据。使用列联表评估请求类型对开药的影响，并在考虑聚类因素并针对地点、医生和就诊特征进行调整的广义线性混合模型中得到证实。
标准化患者角色的逼真度极佳，医生察觉见过SP的怀疑率为13%。在重度抑郁症中，提出特定品牌请求、一般请求和无请求的SP的抗抑郁药开药率分别为53%、76%和31%（P<0.001）。在适应障碍中，抗抑郁药开药率分别为55%、39%和10%（P<0.001）。这些结果在多变量模型中得到证实。对于重度抑郁症角色中提出一般请求的SP，98%得到了最低限度可接受的初始治疗（抗抑郁药、心理健康转诊或2周内随访的任何组合）；提出特定品牌请求的为90%；无请求的为56%（P<0.001）。
患者的请求对重度抑郁症和适应障碍患者的医生开药有深远影响。直接面向消费者广告可能对质量产生相互矛盾的影响，有可能既避免使用不足又促进过度使用。
