Rating the Raters: Assessing the Quality of Hamilton Rating ... : Journal of Clinical Psychopharmacology (original) (raw)

Brief Reports

Assessing the Quality of Hamilton Rating Scale for Depression Clinical Interviews in Two Industry-sponsored Clinical Drug Trials

Engelhardt, Nina PhD*; Feiger, Alan D. MD†; Cogger, Kenneth O. PhD‡; Sikich, Dawn BA†; DeBrota, David J. MD§; Lipsitz, Joshua D. PhD∥; Kobak, Kenneth A. PhD*; Evans, Kenneth R. PhD¶; Potter, William Z. MD, PhD#

*MedAvante, Inc. MedAvante, Ewing, NJ †Research Training Associates of Colorado, Lakewood, CO; ‡Peak Consulting, Conifer, CO; §Eli Lilly and Company, Indiana University, Indianapolis, IN ∥New York State Psychiatric Institute, College of Physicians and Surgeons, Columbia University, New York, NY ¶Ontaro Cancer Biomaker Network, Toronto, Ontario, Canada and #Merck Research Laboratories, West Point, PA.

Received March 1, 2005; accepted after revision September 28, 2005.

Address correspondence and reprint requests to Nina Engelhardt, PhD, 7162 North Pennsylvania Street, Indianapolis, IN 46240. E-mail: [email protected].

Abstract

Objective:

The quality of clinical interviews conducted in industry-sponsored clinical drug trials is an important but frequently overlooked variable that may influence the outcome of a study. We evaluated the quality of Hamilton Rating Scale for Depression (HAM-D) clinical interviews performed at baseline in 2 similar multicenter, randomized, placebo-controlled depression trials sponsored by 2 pharmaceutical companies.

Methods:

A total of 104 audiotaped HAM-D clinical interviews were evaluated by a blinded expert reviewer for interview quality using the Rater Applied Performance Scale (RAPS). The RAPS assesses adherence to a structured interview guide, clarification of and follow-up to patient responses, neutrality, rapport, and adequacy of information obtained.

Results:

HAM-D interviews were brief and cursory and the quality of interviews was below what would be expected in a clinical drug trial. Thirty-nine percent of the interviews were conducted in 10 minutes or less, and most interviews were rated fair or unsatisfactory on most RAPS dimensions.

Conclusions:

Results from our small sample illustrate that the clinical interview skills of raters who administered the HAM-D were below what many would consider acceptable. Evaluation and training of clinical interview skills should be considered as part of a rater training program.