Biometrics Research

Robert L. Spitzer, M.D., Chief of Psychiatric Research
Janet B.W. Williams, D.S.W., Deputy Chief and Research Scientist VI
Michael B. First, M.D., Research Psychiatrist II
Miriam Gibbon, M.S.W., Research Scientist IV

OVERVIEW
The research of the department focuses on improving psychiatric classification and identification of mental disorders and the development of standardized assessment instruments.

CURRENT RESEARCH
Problems with the current DSM-IV categorical (present vs absent) approach to the classification of personality disorders have long been recognized by clinicians and researchers. An alternative to the categorical approach is a dimensional system in which the severity of a number of dimensions or domains is noted for each patient without any arbitrary cutoff indicating the presence of a disorder. Although the many advantages of a dimensional approach to personal disorder classification were recognized by the DSM-IV Personality Work Group, lack of consensus regarding any particular system and a lack of data supporting clinical utility and acceptability prevented a dimensional approach from being adopted.

Drs. Robert Spitzer and Michael First have completed data analysis for a study that compares the clinical utility of four dimensional systems: a dimensional implementation of the DSM-IV categorical system (Skodol and Oldham), the Five Factor Model (Widiger, et al), a Stepwise Psychobiological Classification (Cloninger), and a Prototype Matching Approach (Westen and Shedler). Over 400 psychiatrists and psychologists have completed the research forms in which they assessed one of their patients with personality disturbance using the four dimensional systems.

Dr. First has been centrally involved in a number of influential projects currently underway at the American Psychiatric Association. He is the liaison between the American Psychiatric Association and the National Center for Health Statistics, providing consultation to this government agency on issues related to coding of mental disorders in ICD-9-CM, the official coding system used for morbidity in the United States.

Dr. First was co-editor of the Research Agenda for DSM-V, which represents the first phase of the DSM-V planning process. The monograph includes six white papers developed under the auspices of the American Psychiatric Association and the NIMH with the purpose of stimulating a research agenda that might assist the ultimate development of an etiologically-based DSM in the future.

Dr. First is co-principal investigator and a member of the Steering Committee overseeing the NIMH/NIDA/NIAAA-funded DSM-V/ICD-11 diagnostic research conference co-operative agreement. This series of 10 diagnostic conferences over the next four years represents the second phase of the DSM-V research planning process. Dr. First will be involved in the planning and execution of each of these conferences.

Dr. First is Director of the DSM-V Prelude Web-Based project, which is establishing a web site for the purpose of soliciting suggestions and proposals about DSM-V from the general DSM community of clinicians, researchers, educators, administrators, and consumers. Suggestions submitted to the site will be reviewed and a dialogue will be initiated in order to encourage the empirical research necessary for the suggestion to be reviewed by the DSM-V work groups, once they are appointed in 2007.

Clinical trials are faced with important methodological challenges. For one, it is becoming more difficult to recruit research-naïve subjects in the community, whose results are more generalizable than research subjects at academic institutions. In addition, drug-placebo differences in clinical trials are often disappointing. One hypothesis to explain this is that the raters who make the judgments on the major outcome measures, are not well-trained and/or biased.

Dr. Williams conducted a study to examine the feasibility of using high-quality videoconferencing to identify and recruit primary care patients for clinical trials, and to examine patient comfort, satisfaction, and adherence in a mock clinical trial using high-quality videoconferencing for screening and evaluations by remote centralized raters. If this methodology is successful, it may provide us with a tool to recruit better patients, and to facilitate unbiased, more accurate ratings.
Forty-five patients with Major Depressive Disorder, Generalized Anxiety and Panic Disorder were identified in two primary care practices and interviewed remotely by well-trained raters using the telemedicine technology platform (high-quality videoconferencing). (Patients received treatment as usual from their primary care physician.) Patients completed a survey after their last remote assessment in which they were asked to rate their overall preferences for the videoconferencing process, their level of agreement with descriptions of various attributes of their experience, and to respond to three open-ended questions probing attitudes towards remote assessment.

Satisfaction and comfort levels of the participating patients using telemedicine were very high, indicating that they would participate again and would not hesitate to recommend to others participation in clinical studies using videoconferencing. More than three quarters (77%) preferred videoconferencing, indicating that patient acceptance of remote raters is high. The impact of remote centralized ratings on signal detection in clinical trials must now be tested.

BIBLIOGRAPHY
Desmond DW, Remien RH, Moroney JT, Stern Y, Sano M, Williams JBW: Ischemic stroke and depression. J Int Neuropsychol Soc. 9:429-439, 2003

Kovac SH, Klapow JC, Kroenke K, Spitzer RL, Williams, JBW: Differing symptoms of abused versus nonabused women in obstetric-gynecology settings. Am J Obstet Gynecol 188:707-713, 2003

Kobak KA, Engelhardt N, Williams JBW, Lipsitz JD: Rater training in multicenter clinical trials: Issues and recommendations. J Clin Psychopharm 24: 113-117, 2004

First MB, Gibbon M. The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and the Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II). In Comprehensive Handbook of Psychological Assessment, Volume 2 – Personality Assessment, Hilsenroth MJ (Ed) Segal DL (Ed). Hoboken New Jersey, John Wiley and Sons, 134-143, 2003.