Ann A. Hohmann

How the new NIH Guidelines on Inclusion of Women and Minorities apply: efficacy trials, effectiveness trials, and validity.

The NIH (National Institutes of Health) Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research requires investigators applying for NIH research funds to develop and, if funded, implement plans for the inclusion of women and minority populations in their research, when that research involves human participants. It is the purpose of this article to help investigators understand (a) the scientific context and rationale behind the NIH Guidelines; (b) the NIH-defined concepts and the specific content of the NIH Guidelines; and (c) how the intent of the NIH Guidelines is related to mental health services research, the most applied area of mental health research. The article also discusses where investigators can find additional information as they work to implement the NIH Guidelines.

A Contextual Model for Clinical Mental Health Effectiveness Research

Clinical effectiveness research, like clinical efficacy research, is designed to establish a causal relationship between an intervention and an outcome. But instead of focusing on the intervention technology, clinical effectiveness research must focus on the rest of the “real-world” picture. To do that well, the research must be designed to answer complex questions about why the intervention “worked,” for whom, and under what circumstances. It must also incorporate the theory and methods available from the social and behavioral sciences. A model is proposed to help clinical effectiveness researchers accomplish this.

Enhancing measurement in health outcomes research supported by Agencies within the US Department of Health and Human Services

Many of the Institutes, Agencies and Centers that make up the US Department of Health and Human Services (DHHS) have recognized the need for better instrumentation in health outcomes research, and provide support, both internally and externally, for research utilizing advances in measurement theory and computer technology (informatics). In this paper, representatives from several DHHS agencies and institutes will discuss their need for better instruments within their discipline and describe current or future initiatives for exploring the benefits of these technologies. Together, the perspectives underscore the importance of developing valid, precise, and efficient measures to capture the full burden of disease and treatment on patients. Initiatives, like the Patient-Reported Outcomes Measurement Information System (PROMIS) to create health-related quality of life item banks, represent a trans-DHHS effort to develop a standard set of measures for informing decision making in clinical research, practice, and health policy.

Psychotropic Medication Prescription in U.S. Ambulatory Medical Care

Because of the pharmacologic power of psychotropic medications, the potential for adverse effects, and the changing popularity of particular psychotropic drugs, it is vital for pharmacoepidemiologists to monitor the prescribing patterns of these medications. Using data from the 1985 National Ambulatory Medical Care Survey (NAMCS), this article assesses psychotropic medication prescribing by U.S. ambulatory care physicians. Psychotropic medications are classified into three categories: Minor tranquilizers (i.e., anxiolytics and sedative-hypnotics), antidepressants, and antipsychotics. The prescribing patterns of psychiatrists, primary care clinicians, and all other physicians are compared. Differences in psychotropic prescribing patterns by psychiatric diagnosis are examined as well. The excessive use of minor tranquilizers, the continuing use of first-generation psychotropic medications (particularly minor tranquilizers), and the lack of concordance between diagnoses and prescribed psychotropic medications are discussed.