Abstract

Background

A recent study of older men participating in the Testosterone Trials (TTrials) defined a clinically meaningful change in the Psychosexual Daily Questionnaire (PDQ) question 4 in hypogonadal men age ≥65 years. This study defines clinically meaningful change in the same population for sexual desire assessed by PDQ question 1.

Aim

To determine a clinically meaningful change in the answers to question 1 of the PDQ in hypogonadal older men.

Methods

Participants in the Sexual Function Trial of the TTrials were randomly divided into a training and test set. Anchor-based methods, including regression analysis, receiver operating characteristic curves, and empirical cumulative distribution functions, were used to determine a clinically meaningful change on question 1 in the training set, and the selected threshold was evaluated in the test set for an effect of testosterone treatment.

Results

A clinically meaningful increase in question 1 of the PDQ was determined to be ≥0.7 points.

Clinical Implications

Question 1 of the PDQ can be used to assess sexual desire in response to testosterone treatment.

Strengths & Limitations

Data were obtained from a single large study of older hypogonadal men.

Conclusion

Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ.

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