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A Randomized Controlled Trial

Richard L. Kravitz, MD, MSPH; Ronald M. Epstein, MD; Mitchell D. Feldman, MD, MPhil; Carol E. Franz, PhD; Rahman Azari, PhD; Michael S. Wilkes, MD, PhD; Ladson Hinton, MD; Peter Franks, MD

JAMA. 2005;293:1995-2002.

Context  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.

Objective  To ascertain the effects of patients’ DTC-related requests on physicians’ initial treatment decisions in patients with depressive symptoms.

Design  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).

Setting  Offices of primary care physicians in Sacramento, Calif; San Francisco, Calif; and Rochester, NY, between May 2003 and May 2004.

Participants  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%.

Interventions  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.

Main Outcome Measures  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.

Results  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).

Conclusions  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.

Author Affiliations: Center for Health Services Research in Primary Care (Drs Kravitz, Franz, Azari, Wilkes, Hinton, and Franks) and Departments of Internal Medicine (Drs Kravitz and Wilkes), Statistics (Dr Azari), Psychiatry (Dr Hinton), and Family and Community Medicine (Dr Franks), University of California, Davis, Sacramento; Departments of Family Medicine and Psychiatry and Center to Improve Communication in Health Care, University of Rochester School of Medicine and Dentistry, Rochester, NY (Dr Epstein); Division of General Internal Medicine, Department of Medicine, University of California, San Francisco (Dr Feldman).

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