TY - JOUR
T1 - Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire
AU - Gelhorn, Heather L.
AU - Dashiell-Aje, Ebony
AU - Miller, Michael G.
AU - DeRogatis, Leonard R.
AU - Dobs, Adrian
AU - Seftel, Allen D.
AU - Althof, Stanley E.
AU - Brod, Meryl
AU - Revicki, Dennis A.
N1 - Funding Information:
Conflicts of Interest: The work was funded by AbbVie who reviewed and approved the manuscript. Heather L. Gelhorn and Dennis A. Revicki are employees of Evidera; Ebony Dashiell-Aje is a former employee of Evidera. Evidera received research study support from AbbVie. Meryl Brod was a paid consultant to AbbVie on this project. Michael G. Miller is an employee and stockholder of AbbVie. Stanley E. Althof serves as an unpaid consultant to Eli Lilly. Adrian Dobs, Allen D. Seftel, and Leonard R. DeRogatis have no conflicts of interest to declare.
Funding Information:
Funding: This study was funded by AbbVie .
Publisher Copyright:
© 2016 The Authors
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Introduction The Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) is a patient-reported outcome measurement designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. Aim To conduct item analysis and reduction, evaluate the psychometric properties of the HIS-Q, and provide guidance on interpreting the instrument score. Methods A 12-week observational, longitudinal study of hypogonadal men was conducted. Participants completed the HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants also completed the Aging Male's Symptoms Scale, the International Index of Erectile Function, the Short Form-12 Health Survey, and the Patient-Reported Outcomes Measurement Information System Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (at baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change measurements and a clinical form. Main Outcome Measures Individual item performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed. Results In total, 177 men participated in the study (mean age = 54.1 years, range = 23–83). The original 53-item draft HIS-Q was reduced to 28 items; the final instrument included five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For all domains, test-retest reliability was acceptable (intraclass correlation coefficients > 0.70), construct validity was good (|r > 0.30| for all comparisons). Known-groups validity was demonstrated for all HIS-Q domain scores, subdomain scores, and the total score as measured by the Clinical Global Impression of Severity, and total testosterone level at baseline (P < .05 for all comparisons). All domains and subdomains were responsive to change based on patient-rated anchor questions (P < .05 for all comparisons). Conclusion The final 28-item HIS-Q is reliable, valid, and responsive. The HIS-Q is suitable for inclusion in future clinical trials to help characterize the effects of testosterone replacement therapy.
AB - Introduction The Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) is a patient-reported outcome measurement designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. Aim To conduct item analysis and reduction, evaluate the psychometric properties of the HIS-Q, and provide guidance on interpreting the instrument score. Methods A 12-week observational, longitudinal study of hypogonadal men was conducted. Participants completed the HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants also completed the Aging Male's Symptoms Scale, the International Index of Erectile Function, the Short Form-12 Health Survey, and the Patient-Reported Outcomes Measurement Information System Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (at baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change measurements and a clinical form. Main Outcome Measures Individual item performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed. Results In total, 177 men participated in the study (mean age = 54.1 years, range = 23–83). The original 53-item draft HIS-Q was reduced to 28 items; the final instrument included five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For all domains, test-retest reliability was acceptable (intraclass correlation coefficients > 0.70), construct validity was good (|r > 0.30| for all comparisons). Known-groups validity was demonstrated for all HIS-Q domain scores, subdomain scores, and the total score as measured by the Clinical Global Impression of Severity, and total testosterone level at baseline (P < .05 for all comparisons). All domains and subdomains were responsive to change based on patient-rated anchor questions (P < .05 for all comparisons). Conclusion The final 28-item HIS-Q is reliable, valid, and responsive. The HIS-Q is suitable for inclusion in future clinical trials to help characterize the effects of testosterone replacement therapy.
KW - Hypogonadism
KW - Hypogonadism Impact of Symptoms Questionnaire
KW - Patient-Reported Outcome
KW - Psychometric Properties
KW - Reliability
KW - Responsiveness
KW - Validity
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U2 - 10.1016/j.jsxm.2016.09.006
DO - 10.1016/j.jsxm.2016.09.006
M3 - Article
C2 - 27692845
AN - SCOPUS:84992397361
VL - 13
SP - 1737
EP - 1749
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
SN - 1743-6095
IS - 11
ER -