Assessing symptoms of hypogonadism by self-administered questionnaire: qualitative findings in patients and controls
RAYMOND C. ROSEN, ANDRE B. ARAUJO, MEGAN K. CONNOR, EMILY A. ELSTAD, SARAH A. MCGRAW, ANDRE T. GUAY, ABRAHAM MORGENTALER, &
MARTIN M. MINER4\. The Aging Male, June/September 2009; 12(2/3): 77–85

New England Research Institutes, Inc,.Watertown, Massachusetts, USA, Lahey Clinic Northshore, Center for Sexual Function, Peabody, Massachusetts, USA, Men’s Health Boston, Brookline, Massachusetts, USA and Department of Family Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA (Received 30 May 2009; revised 8 July 2009; accepted 13 July 2009)

Abstract

Background. Current screening instruments for hypogonadism lack adequate specificity and diagnostic accuracy. A new self-administered questionnaire of hypogonadism symptoms is being developed to address this need. The process for questionnaire development and results from the first (qualitative) phase are presented.
Methods. Qualitative interviews were conducted based on a new conceptual model of hypogonadism and according to standards for questionnaire development. An item pool was generated from focus groups and in-depth interviews with two groups of hypogonadal patients, treated (N 1⁄4 26) and untreated (N 1⁄4 26), and age-equivalent controls (N 1⁄4 28). Standardized scoring of the qualitative interviews was used to confirm conceptual domains in the model and to generate questionnaire items for further validation.

Results. Key domains identified in both patients and controls included: (a) physical function; (b) bodily signs and symptoms; (c) sexual function and libido; (d) sleep function; (e) mood and affective function; (f) memory and cognitive function. The final domain is distress or bother associated with hypogonadism symptoms. This domain was only relevant to the patient groups.

Conclusions. The first stage in the design of a new hypogonadism screener has been completed. Seven do- mains were identified and draft items were developed in each domain according to current standards of patient-reported outcomes.