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 = 26) and untreated (N = 26), and age-equivalent controls (N = 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 domains were identified and draft items were developed in each domain according to current standards of patient-reported outcomes.
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 = 26) and untreated (N = 26), and age-equivalent controls (N = 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 domains were identified and draft items were developed in each domain according to current standards of patient-reported outcomes.
Authors: Heather L Gelhorn; Margaret K Vernon; Katie D Stewart; Michael G Miller; Meryl Brod; Stanley E Althof; Leonard R DeRogatis; Adrian Dobs; Allen D Seftel; Dennis A Revicki Journal: Patient Date: 2016-04 Impact factor: 3.883