Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder.
Bremelanotide
Female sexual dysfunction
Hypoactive sexual desire disorder
Patient-reported outcomes
Validation
Journal
Journal of patient-reported outcomes
ISSN: 2509-8020
Titre abrégé: J Patient Rep Outcomes
Pays: Germany
ID NLM: 101722688
Informations de publication
Date de publication:
08 Oct 2020
08 Oct 2020
Historique:
received:
17
02
2020
accepted:
24
08
2020
entrez:
9
10
2020
pubmed:
10
10
2020
medline:
10
10
2020
Statut:
epublish
Résumé
The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an exploratory endpoint. The EDQ was developed based on a literature review, qualitative research with patients with hypoactive sexual desire disorder (HSDD), and input from clinical experts. This instrument is intended to be used to collect efficacy data in clinical trials evaluating potential treatments for HSDD. The objective of this study was to evaluate the measurement properties of both the monthly and daily recall versions of the EDQ during the RECONNECT trials. Participants completed the EDQ daily version for 7 consecutive days prior to selected monthly clinic visits. The monthly recall version was completed at each monthly clinic visit. The analysis population consisted of all subjects with Female Sexual Function Index (FSFI) data at baseline and ≥ 1 follow-up visit. At baseline, 1144 and 676 subjects completed the monthly and daily recall EDQs, respectively. The EDQ scores had good internal consistency and test-retest reliability. Monthly and daily recall EDQ scores were correlated with FSFI-desire domain scores at baseline and month 3. Scores from the monthly and daily recall versions were also correlated. After 6 months, there was a significantly greater improvement for bremelanotide versus placebo in both the monthly and daily recall versions (both P < 0.0001). The results demonstrated that EDQ exhibited good reliability, validity, and sensitivity to change. Consistent with other validated PRO measures of sexual desire, the EDQ provides additional insights into sexual desire. NCT02338960 and NCT02333071 (RECONNECT studies).
Sections du résumé
BACKGROUND
BACKGROUND
The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an exploratory endpoint. The EDQ was developed based on a literature review, qualitative research with patients with hypoactive sexual desire disorder (HSDD), and input from clinical experts. This instrument is intended to be used to collect efficacy data in clinical trials evaluating potential treatments for HSDD. The objective of this study was to evaluate the measurement properties of both the monthly and daily recall versions of the EDQ during the RECONNECT trials.
METHODS
METHODS
Participants completed the EDQ daily version for 7 consecutive days prior to selected monthly clinic visits. The monthly recall version was completed at each monthly clinic visit. The analysis population consisted of all subjects with Female Sexual Function Index (FSFI) data at baseline and ≥ 1 follow-up visit.
RESULTS
RESULTS
At baseline, 1144 and 676 subjects completed the monthly and daily recall EDQs, respectively. The EDQ scores had good internal consistency and test-retest reliability. Monthly and daily recall EDQ scores were correlated with FSFI-desire domain scores at baseline and month 3. Scores from the monthly and daily recall versions were also correlated. After 6 months, there was a significantly greater improvement for bremelanotide versus placebo in both the monthly and daily recall versions (both P < 0.0001).
CONCLUSIONS
CONCLUSIONS
The results demonstrated that EDQ exhibited good reliability, validity, and sensitivity to change. Consistent with other validated PRO measures of sexual desire, the EDQ provides additional insights into sexual desire.
TRIAL REGISTRATION
BACKGROUND
NCT02338960 and NCT02333071 (RECONNECT studies).
Identifiants
pubmed: 33033885
doi: 10.1186/s41687-020-00241-6
pii: 10.1186/s41687-020-00241-6
pmc: PMC7544783
doi:
Banques de données
ClinicalTrials.gov
['NCT02333071', 'NCT02338960']
Types de publication
Journal Article
Langues
eng
Pagination
82Subventions
Organisme : AMAG Pharmaceuticals
ID : N/A
Références
J Sex Med. 2008 Feb;5(2):357-64
pubmed: 18042215
Obstet Gynecol. 2019 Nov;134(5):909-917
pubmed: 31599847
J Sex Marital Ther. 2003 Jan-Feb;29(1):39-46
pubmed: 12519665
Menopause. 2014 Jun;21(6):633-40
pubmed: 24281236
Obstet Gynecol. 2019 Nov;134(5):899-908
pubmed: 31599840
J Sex Med. 2012 Mar;9(3):793-804
pubmed: 22239862
Sex Med Rev. 2018 Jul;6(3):367-383
pubmed: 29371145
J Urol. 2000 Mar;163(3):888-93
pubmed: 10688001
J Sex Med. 2011 Nov;8(11):3160-72
pubmed: 21933348
Womens Health (Lond). 2016 Jun;12(3):325-37
pubmed: 27181790
Health Qual Life Outcomes. 2006 Oct 11;4:79
pubmed: 17034633
J Sex Marital Ther. 2002;28 Suppl 1:77-83
pubmed: 11898712
Value Health. 2009 Jul-Aug;12(5):763-72
pubmed: 19192259
J Sex Med. 2012 Dec;9(12):3180-8
pubmed: 23057791
J Sex Med. 2016 Dec;13(12):1888-1906
pubmed: 27843072
Mayo Clin Proc. 2017 Jan;92(1):114-128
pubmed: 27916394
J Sex Med. 2007 Mar;4 Suppl 3:211-9
pubmed: 17394593
J Sex Med. 2013 Jul;10(7):1807-15
pubmed: 23672269
Obstet Gynecol. 2008 Nov;112(5):970-8
pubmed: 18978095
J Sex Med. 2011 Aug;8(8):2237-45
pubmed: 21595836
J Sex Med. 2011 Jan;8(1):148-57
pubmed: 20722778
J Sex Med. 2012 Apr;9(4):1074-85
pubmed: 22248038