Division of Endocrinology, Department of Medicine, Harbor-University of California, Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.
Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
J Sex Med. 2018 Jul;15(7):997-1009. doi: 10.1016/j.jsxm.2018.05.008.
Limited information is available on the performance characteristics of 2 questionnaires commonly used in clinical research, the Psychosexual Daily Questionnaire (PDQ) and the Derogatis Interview for Sexual Function (DISF)-II Assessment, especially in older men with low testosterone (T) and impaired sexual function.
To determine reliability of PDQ and DISF-II by assessing the correlation within and between domains in the questionnaires and to define clinically meaningful changes in sexual activity (PDQ question 4 [Q4]) and desire (DISF-II sexual desire domain [SDD]) domains.
Data from 470 men participating in the T Trials were used to calculate Spearman correlation coefficients of individual items and total score among questionnaires to determine convergent and construct validity. Clinically meaningful changes for sexual desire and activity were determined by randomly dividing the sample into training and validation sets. Anchor- and distribution-based clinically meaningful change criteria were defined in the training set, and selected changes were evaluated in the validation set.
Validity of the PDQ and DISF-II and clinically meaningful changes in sexual desire and activity were determined in older men in T Trials.
Moderate to strong correlations were shown within and between domains from different questionnaires. Using Patient Global Impression of Change as an anchor, clinically meaningful change in PDQ sexual activity was ≥0.6, and in DISF-SDD was ≥5.0. Applying these change cut-points to the validation set, a greater proportion of T-treated men achieved clinically meaningful improvement in their sexual desire and activity compared to placebo-treated men.
The PDQ-Q4 and DISF-II-SDD can be used to reliably assess clinically meaningful changes in sexual activity and sexual desire in hypogonadal men treated with T.
STRENGTHS & LIMITATIONS: Strengths of this study include a large sample size, long trial duration, and inclusion of men with low libido and unequivocally low T levels. Limitations include using data from a single study that enrolled only older hypogonadal men, and only 1 anchor for both sexual desire and activity.
Moderate to strong correlations were demonstrated within and between different sexual domains of the PDQ and DISF-II confirming construct and convergent validity. Clinically meaningful improvement in elderly hypogonadal men was change of ≥0.6 score in the PDQ-Q4 and ≥5.0 in the DISF-SDD. Improvements in sexual activity and desire in the T Trials were modest but clinically meaningful. Wang C, Stephens-Shields AJ, DeRogatis LR, et al. Validity and Clinically Meaningful Changes in the Psychosexual Daily Questionnaire and Derogatis Interview for Sexual Function Assessment: Results From the Testosterone Trials. J Sex Med 2018;15:997-1009.
在临床研究中，常用的两种问卷，即性心理日常问卷（PDQ）和性功能德罗氏访谈评估（DISF）-II，其性能特征的信息有限，尤其是在伴有低睾酮（T）和性功能障碍的老年男性中。
通过评估问卷中各领域内和各领域之间的相关性，确定 PDQ 和 DISF-II 的可靠性，并确定性行为（PDQ 问题 4 [Q4]）和欲望（DISF-II 性欲望领域 [SDD]）领域的临床有意义的变化。
使用参加 T 试验的 470 名男性的数据，计算问卷中各项目和总分的斯皮尔曼相关系数，以确定收敛性和结构效度。通过随机将样本分为训练集和验证集，确定性欲望和活动的临床有意义变化。在训练集中定义基于锚点和分布的临床有意义变化标准，并在验证集中评估选定的变化。
在 T 试验中，确定了 PDQ 和 DISF-II 的有效性以及性欲望和活动的临床有意义变化。
PDQ-Q4 和 DISF-II-SDD 可用于可靠地评估接受 T 治疗的低促性腺激素男性的性行为和性欲望的临床有意义变化。
本研究的局限性包括仅使用来自一项研究的数据，该研究仅招募了年龄较大的低性欲和明确低 T 水平的男性，且仅有一个用于性欲望和活动的锚点。
