Freelance writer for Contemporary OB/GYN
In large part, clinicians and patients do not see eye to eye when it comes to what they consider important criteria for a rating scale assessing female sexual desire, according to a literature review
In large part, clinicians and patients do not see eye to eye when it comes to what they consider important criteria for a rating scale assessing female sexual desire, according to a literature review in Sexual Medicine Review.
The authors analyzed 12 validated ratings scales-five scales mostly derived from expert recommendations and seven scales with patient input-along with five sets of diagnostic criteria for sexual conditions like hypoactive sexual desire disorder (HSDD).
“The differences between what clinicians and patients thought important in a rating scale surprised me,” said lead author Robert Pyke, MD, PhD, president of Pykonsult LLC, a Connecticut-based consulting firm that has helped companies develop treatments for sexual dysfunction and has embarked on making nutritional supplement combinations for sexual function.
“Clinicians who created symptom sets and rating scales believed behaviors like receptivity, initiations and avoidance of sexual situations were important, but patients tended not to,” Dr. Pyke told Contemporary OB/GYN.
Conversely, patients creating rating scale items were of the opinion that the frequency of sexual activity was important, whereas clinicians did not. “I think this is mostly due to the fact, despite the FDA's insistence to the contrary, that the number of ‘satisfying’ sexual events per month has proven to be a very unreliable and an excessively variable endpoint that has torpedoed several clinical development projects, including the testosterone gel LibiGel (BioSante Pharmaceuticals),” Dr. Pyke says.
The other big surprise of the analysis for Dr. Pyke was that only one individual rating scale qualified by including items important to women with HSDD. “None of the scales developed in response to the FDA's guidance to industry on how to create patient-reported outcomes had all the important items,” Dr. Pyke said.
The sole rating scale to qualify was the clinician-created Elements of Desire Questionnaire (EDQ), which includes receptivity, initiations and sexual thoughts.
Dr. Pyke would like those sexual symptoms added to the Female Sexual Function Index (FSFI) for clinical trial endpoints.
“Also important, but underrepresented in scales is sexual avoidance,” Dr. Pyke said. “I think patients never reported it among symptoms important to HSDD because they feel so guilty about it. But psychiatrists know the burden it extracts in isolating partners and chilling marriages. We also know avoidance is how women cope with low desire over the long term instead of staying anxious and distressed about not being able to please their partner.”
Those additional diagnostic endpoints will be incorporated from the International Society for the Study of Women's Sexual Health (ISSWSH), according to Dr. Pyke. “And soon, by the vast majority of obstetricians and gynecologists who use the International Classification of Diseases (ICD) for diagnosis,” he said.
Adding the endpoints “will make a diagnosis of HSDD more meaningful,” Dr. Pyke said. “Further, monitoring these symptoms will make treatment gains far more relevant because these symptoms apply to the partnership relationship, not to the woman in isolation.”
For better comparisons across studies, Dr. Pyke recommended that trialists improve rating instruments and use the same measures for all studies, plus provide the percent of responders and remitters.