title: Development of the Hypogonadism Impact of Symptoms Questionnaire Short Form: Qualitative Research.
abstract: BACKGROUND
  Hypogonadism in men is often associated with poor libido, erectile dysfunction, irritability, fatigue, and psychological and relationship problems. Many of these symptoms can be best assessed through patient report. The 28-item Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) was developed to evaluate hypogonadism symptoms in men with low testosterone in the context of clinical trials.
  
  
  OBJECTIVE
  To develop a briefer version of the HIS-Q that could be practical for use in treatment settings.
  
  
  METHODS
  Participants with low testosterone levels and symptoms consistent with hypogonadism were recruited through clinical sites. Focus groups and interviews were conducted to elicit symptom concepts and identify those that were most relevant to patients, including changes as a consequence of treatment.
  
  
  METHODS
  Systematic analysis of the qualitative data and expert clinician input were used to develop the HIS-Q short form (HIS-Q-SF). One-on-one cognitive interviews were conducted to confirm the content validity of the HIS-Q-SF.
  
  
  RESULTS
  Thirty-five men participated in this qualitative research. Concept elicitation was conducted through focus group discussions (n = 18) and telephone interviews (n = 2); then, the draft HIS-Q-SF was evaluated through cognitive interviews (n = 15). The mean age of total sample was 53.2 ± 6.8 years, and the mean serum total testosterone level was 184.9 ± 55.2 ng/dL. Results suggest that the HIS-Q-SF has demonstrated content validity, including the content coverage, comprehensibility, and the appropriateness of the response options and recall period. The final version of the HIS-Q-SF includes 17 items and is aligned with the original longer version of the instrument.
  
  
  CONCLUSIONS
  The HIS-Q-SF is a comprehensive measurement of hypogonadism symptom severity in men. Content coverage and content validity were confirmed. The instrument will be evaluated further to establish the psychometric characteristics and to assess the utility of the measurement in clinical treatment settings.
authors.affiliation: Evidera, Bethesda, MD, USA. Electronic address: heather.gelhorn@evidera.com.
authors.forename: Heather L
authors.initials: HL
authors.lastname: Gelhorn
authors.affiliation: AbbVie, North Chicago, IL, USA.
authors.forename: Amit R
authors.initials: AR
authors.lastname: Bodhani
authors.affiliation: Evidera, Bethesda, MD, USA.
authors.forename: Louisa S
authors.initials: LS
authors.lastname: Wahala
authors.affiliation: Evidera, Bethesda, MD, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Sexton
authors.affiliation: Evidera, Bethesda, MD, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: Landrian
authors.affiliation: AbbVie, North Chicago, IL, USA.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Miller
authors.affiliation: Maryland Center for Sexual Health, Lutherville, MD, USA.
authors.forename: Leonard
authors.initials: L
authors.lastname: Derogatis
authors.affiliation: Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Adrian
authors.initials: A
authors.lastname: Dobs
authors.affiliation: Evidera, Bethesda, MD, USA.
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D007172:Erectile Dysfunction / Q000150:complications / Q000523:psychology; D005221:Fatigue / Q000209:etiology; D017144:Focus Groups; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy / Q000523:psychology*; D007989:Libido / Q000502:physiology; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D036301:Qualitative Research; D011795:Surveys and Questionnaires / Q000592:standards*; D013739:Testosterone / Q000172:deficiency
chemical_list: D013739:Testosterone
keywords: Content Validity; Hypogonadism; Hypogonadism Impact of Symptoms Questionnaire; Instrument Development; Interviews; Low Testosterone; Patient-Reported Outcome; Qualitative Research; Symptoms