The Evolution of Self-Reported Urinary and Sexual Dysfunction over the Last Two Decades: Implications for Comparative Effectiveness Research

Abstract

Background Despite the paramount importance of patient-reported outcomes, little is known about the evolution of patient-reported urinary and sexual function over time. Objective To evaluate differences in pretreatment urinary and sexual function in two population-based cohorts of men with prostate cancer enrolled nearly 20 yr apart. Design, setting, and participants Patients were enrolled in the Prostate Cancer Outcomes Study (PCOS) or the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study, two population-based cohorts that enrolled patients with incident prostate cancer from 1994 to 1995 and from 2011 to 2012, respectively. Participants completed surveys at baseline and various time points thereafter. Outcome measurements and statistical analysis We performed multivariable logistic and linear regression analysis to investigate differences in pretreatment function between studies. Results and limitations The study comprised 5469 men of whom 2334 (43%) were enrolled in PCOS and 3135 (57%) were enrolled in CEASAR. Self-reported urinary incontinence was higher in CEASAR compared with PCOS (7.7% vs 4.7%; adjusted odds ratio [OR]: 1.83; 95% confidence interval [CI], 1.39–2.43). Similarly, self-reported erectile dysfunction was more common among CEASAR participants (44.7% vs 24.0%) with an adjusted OR of 3.12 (95% CI, 2.68–3.64). Multivariable linear regression models revealed less favorable self-reported baseline function among CEASAR participants in the urinary incontinence and sexual function domains. The study is limited by its observational design and possibility of unmeasured confounding. Conclusions Reporting of pretreatment urinary incontinence and erectile dysfunction has increased over the past two decades. These findings may reflect sociological changes including heightened media attention and direct-to-consumer marketing, among other potential explanations. Patient summary Patient reporting of urinary and sexual function has evolved and is likely contingent on continually changing societal norms. Recognizing the evolving nature of patient reporting is essential in efforts to conduct high-quality, impactful comparative effectiveness research.

The Comparative Harms of Open and Robotic Prostatectomy in Population Based Samples

“…23 To minimize bias from differences in the 2 PROM, we included 4 common measures of urinary incontinence and 3 common measures of sexual function, and derived modified domain summary scores scaled 0 to 100, with 100 representing optimal function. 24 …”

“…To account for documented differences in baseline function between PCOS and CEASAR subjects, 24 mean function was modeled with an interaction term between baseline function and surgical procedure (RRP vs RALP). Primary comparisons were assessed using these models, estimating the mean difference in function between patients undergoing the 2 procedures.…”

“…Sensitivity analyses were performed to evaluate differences attributable to the lack of availability of PD5 inhibitors during PCOS, and to mitigate possible confounding associated with differences in baseline reporting of baseline function. 24 This enabled the exploration of between-group differences in outcomes for 3 comparisons of 1) RRP in PCOS vs RRP in CEASAR, 2) RRP in CEASAR vs RALP and 3) RRP in PCOS vs RALP. If observed differences in primary outcomes were explained by differences in surgical technique, one would expect within-group differences between study cohorts not to be significant in comparison 1, but between-group differences to remain significant in comparisons 2 and 3.…”

Prostate Cancer Registries: Current Status and Future Directions

“…Understanding baseline sexual, urinary, and bowel function among contemporary men with newly diagnosed PCa [123] Differences in pretreatment urinary and sexual function in PCa patients enrolled nearly 20 yr apart [124] PCBaSe: Prostate Cancer data Base Sweden Patterns of ADT administration among patients diagnosed with PCa [65] Psychological distress following a prostate cancer diagnosis [125] Endocrine treatment and the risk of nonfatal and fatal cardiovascular diseases among PCa patients [126] Prostate Cancer Clinical Registry (part of the Cancer Registry of Norway)…”

With Patient-reported Health Changing, Is It Time to Retool Our Instruments?

“…As the authors noted in their conclusion [1], changes in urinary and sexual dysfunction over time have important implications for how we conduct and interpret comparative effectiveness research. As we ask stakeholders to consider evolving QoL trends when crafting policy, perhaps it is time we retool our instruments of choice.…”