Deborah A. Zarin

Challenges to evidence-based medicine: a comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network.

The practice of evidence-based medicine depends on the availability of clinically relevant research, yet questions have been raised about the generalizability of findings from randomized controlled trials (RCTs). The aim of this study was to quantify differences between RCT patients and treatments and those in day-to-day clinical practice. Data from published reports of two key RCTs underlying recent treatment advances in psychiatry were compared with data on routine psychiatric practice collected through a Practice Research Network (PRN). Hospital inpatient units (RCT) and the full range of psychiatric practice settings in the United States (PRN). Adults with bipolar I disorder and adults with schizophrenia. Demographic (age, gender, race), clinical (principal diagnoses, comorbid conditions, psychosocial functioning, and histories of hospitalization), and treatment (medication name and dosage) characteristics. PRN patients had more comorbid conditions and were more likely to be white, female, and older than RCT patients. In all, 38% of PRN patients with schizophrenia and 55% of PRN patients with bipolar I disorder would have been ineligible for the corresponding RCT. Most PRN patients receiving an RCT study medication were also receiving other medications not allowed by the RCT protocol. Findings support the assertion that RCT patients and treatments are not typical of those in clinical practice, and most patients in clinical practice are receiving treatments that do not have direct empirical support. Research is needed to determine the extent to which RCT findings should be used to guide routine clinical decisions.

Is gender a factor in psychiatrists' evaluation and treatment of patients with major depression?

BACKGROUND Gender differences in clinical assessment and treatment have been reported in several areas of medicine. We examine whether differences exist in the routine outpatient psychiatric management of men and women with major depression. METHODS Psychiatrists practicing in the community completed case forms on a systematic sample of their adult outpatients with major depression. Comparisons are presented between male (n=261) and female (n=472) patients focusing on their background characteristics, clinical presentation, assessment, and treatment. Significant gender disparities in assessment and treatment are also examined with respect to the gender of the treating psychiatrist. RESULTS Although male and female patients had generally similar clinical profiles, a significantly greater proportion of males than females had psychomotor retardation and substance use disorders. No significant gender differences were observed in the assessment of depressive symptoms, psychiatric comorbidities, and treatment with antidepressant medications or psychotherapy. However, a significantly smaller percentage of depressed women than men received assessments of sexual function and medication-related sexual side effects. Female patients were also less likely to have discussed their treatment preferences with their psychiatrists. LIMITATIONS Only a minority (33.2%) of psychiatrists invited to participate contributed patients to this study. The results are based on structured assessments completed by practicing psychiatrists rather than patient self-assessments or independent research assessments. CONCLUSIONS Although we find overall little evidence of gender bias in the clinical management of major depression, both male and female psychiatrists need to further explore sexual function and treatment preferences in female patients.

Bridging the gap between psychiatry and primary care: The DSM-IV-PC

To facilitate recognition of psychiatric and addictive disorders within primary care settings, the development of a primary care manual to diagnose mental disorders is described. The manual, DSM-IV-PC, is compatible with the full DSM-IV and was developed by both psychiatrists and primary care physicians. Symptom-based clinical algorithms are described to demonstrate the format of the manual, which the authors hope will promote educational, clinical, and research collaboration between psychiatrists and primary care physicians.

Health Plan Characteristics and Conformance with Key Practice Guideline Psychopharmacologic Treatment Recommendations for Major Depression

Our objective was to assess whether specific health plan, patient, setting, and psychiatrist characteristics are associated with conformance with key evidence-based practice guideline psychopharmacologic treatment recommendations for major depressive disorder (MDD). Nationally generalizable data from the APA Practice Research Network 1997 Study of Psychiatric Patients and Treatments on 406 adult patients of psychiatrists with MDD were used. This observational study used logistic regression to assess factors associated with guideline conformance. Existing data from a psychiatric practice research network were analyzed. Ninety-one and seven-tenths percent of patients received treatment consistent with the recommendations. Conformance with specific recommendations was as follows: (1) an antidepressant or ECT for moderate, severe, or recurrent depression (92.3%); (2) an antidepressant and an antipsychotic or ECT for psychotic depression (80.9%); (3) an antidepressant and/or psychotherapy for mild depression (97.6%); and (4) no antianxiety medications alone without an antidepressant (96.0%). Variables most strongly associated with nonconformance were (1) lack of psychiatrist financial incentives (OR = 9.6; 95% CI = 1.2, 75.4), (2) psychiatrists with low proportions of public patients (OR = 7.8; 95% CI = 1.9, 32.1), (3) nonmanaged plans (OR = 3.8; 95% CI = 1.4, 10.4), and (4) psychiatrists 62 years or older (OR = 2.9; 95% CI = 1.2, 7.3). Although overall conformance was high, findings have implications for targeting quality improvement initiatives. Research is needed to distinguish clinically appropriate from inappropriate reasons for nonconformance and assess conformance with other recommendations.

Practice Guidelines and Psychiatric Education

The American Psychiatric Association’s practice guidelines provide authoritative guidance for assessing and treating major clinical problems that psychiatrists face. This article reviews the social context in which practice guidelines have emerged, opportunities they afford educators, and limitations in their educational and practice applications. Practice guidelines should be used in residents’ and medical students’ seminars and in continuing medical education activities. The incentive to study guidelines may increase as their likely use as information sources for questions on in-service and specialty board certification examinations as well as in clinical quality-assurance activities becomes more widely recognized.

Evidence-Based Psychiatry in the United States

In this report, we will discuss: (1) several programmes undertaken by the American Psychiatric Association to develop evidence-based systems for defining, guiding, and monitoring aspects of psychiatric care in the US, (2) some of the limitations in these approaches (i.e., we should not get too overconfident about our capacities), and (3) provide some recommendations about how to deal with some of these limitations — and particularly the role of a practice-based research network.