Evidence map›Paper›PMID 33033885›Full record

ArticleJournal of patient-reported outcomes2020

Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder.

Dennis A Revicki, Stanley E Althof, Leonard R Derogatis, Sheryl A Kingsberg, Hilary Wilson, Amama Sadiq, Julie Krop, Robert Jordan, Johna Lucas

2 registry-linked trialsAbstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02333071 phase3completednot on this map

Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

TypeinterventionalSponsorPalatin Technologies, IncRan2014 to 2017Enrolled723ConditionsHypoactive Sexual Desire DisorderArmsBremelanotide, Placebo
NCT02338960 phase3completednot on this map

Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

TypeinterventionalSponsorPalatin Technologies, IncRan2015 to 2017Enrolled714ConditionsHypoactive Sexual Desire DisorderArmsBremelanotide, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Dennis A RevickiRevicki Outcomes Research Consulting, 5656 Eastwind Drive, Sarasota, FL, 34233, USA. dennis.revicki@gmail.com.ORCID http://orcid.org/0000-0001-6780-0019
Stanley E AlthofCase Western Reserve University School of Medicine, Cleveland, OH, USA.
Leonard R DerogatisMaryland Center for Sexual Health, Lutherville, MD, USA.
Sheryl A KingsbergUniversity Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Hilary WilsonEvidera, Bethesda, MD, USA.
Amama SadiqAMAG Pharmaceuticals, Inc., Waltham, MA, USA.
Julie KropAMAG Pharmaceuticals, Inc., Waltham, MA, USA.
Robert JordanPalatin Technologies, Inc., Cranbury, NJ, USA.
Johna LucasPalatin Technologies, Inc., Cranbury, NJ, USA.

Funding

AMAG Pharmaceuticals N/A
6 · The paper itself

Abstract

backgroundThe 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.

methodsParticipants 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.

resultsAt 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).

conclusionsThe 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 registrationNCT02338960 and NCT02333071 (RECONNECT studies).

Indexed as

BremelanotideFemale sexual dysfunctionHypoactive sexual desire disorderPatient-reported outcomesValidation

Identifiers

PMID33033885
PMCPMC7544783

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.