Researchers are developing promising new tools to improve the diagnosis of hypogonadism.
An established method of screening for hypogonadism is the Androgen Deficiency in the Aging Male (ADAM) questionnaire. The questionnaire, first devised in 2000, consists of 10 questions that require "yes" or "no" responses. However, in many cases, ADAM has proved inadequate for capturing the population of men with hypogonadism, and researchers are vying to find an evaluation instrument that more accurately identifies these men, allowing early treatment.
"Although the questionnaire has good sensitivity, up to 88%, the specificity can be as low as 60%," Mohit Khera, MD, MBA, MPH, assistant professor of urology at the Baylor College of Medicine in Houston, told Urology Times. "With the ADAM questionnaire, it is difficult to quantitatively assess any improvement in hypogonadal symptoms when patients are started on testosterone therapy."
In research by Dr. Khera's team, presented at the Sexual Medicine Society of North America Fall Scientific Meeting, Baylor patients who were scheduled to have a radical prostatectomy were administered the qADAM, the Sexual Health Inventory for Men (SHIM), and Expanded Prostate Cancer Index Composite (EPIC). In addition, patients also had their serum testosterone drawn.
In total, 58 patients completed the qADAM questionnaire. Of those, testosterone values were available for 34 patients. Investigators found 11 patients were hypogonadal, with testosterone levels measuring less than 300 ng/dL.
Researchers found that the qADAM questionnaire significantly correlated with serum testosterone measurements (r=.34, p=.023). It also correlated with SHIM questionnaire responses (r=.44, p=.005). Moreover, qADAM significantly correlated with patient responses within the sexual and hormonal domains of the EPIC questionnaire (r=.57, p≤.0001) and (r=.32, p=.008), respectively.
"The higher your qADAM score, the more likely you were to have better erections and the less likely you were to be hypogonadal," Dr. Khera said.
A limitation of the research is that an insufficient number of patients were available to validate the questionnaire, particularly since testosterone values were available for only 34 patients, Dr. Khera admitted.
Screening tool in development
Another new tool, a brief screening test for detecting hypogonadism, is being developed by scientists at the New England Research Institutes in Watertown, MA, including Andre Araujo, PhD, and Raymond Rosen, PhD.
"Current screening tests are not specific enough," said Dr. Araujo, director of epidemiology. "There is an unacceptably high rate of false positives. Men frequently test positive on the current screening tests when many of them have clinical depression, a sleep disorder, or chronic fatigue.
Increasingly, data are emerging linking low testosterone to comorbidities such as diabetes, metabolic syndrome, and cardiovascular illness, suggesting that the presence of low testosterone is not just a question of diminished quality of life, said Dr. Araujo.
In developing a new screening tool based on current FDA guidelines, Dr. Araujo's team has conducted extensive qualitative interviews with a group of carefully selected hypogonadal patients and age-matched controls. These interviews form the basis on which questionnaire items are developed and subsequently validated in a prospective, multicenter study. Results were presented at the SMSNA meeting.
Based on the results of the qualitative interviews and expert advice from a panel of urologists, endocrinologists, and primary care physicians, a draft of a screening instrument has been developed. It includes multiple questions in several domains of patient function, including physical health, bodily appearance, emotional experiences, sexual function, and cognitive function.
The draft questionnaire is expected to be completed in mid-2009. It will be available for use in clinical and research settings later in 2009.
Development of the screening test is funded by an unrestricted grant from Indevus Pharmaceuticals, Inc. Dr. Khera is a speaker for Auxilium. Dr. Rosen is a consultant to Bayer Schering, Eli Lilly, and Pfizer.