Measuring and Predicting Prostate Cancer Related Quality of Life Changes Using EPIC for Clinical Practice

Abstract

Purpose To expand the clinical usefulness of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) by evaluating its responsiveness to health related quality of life (HRQOL) changes, defining the minimally important differences (MID) for an individual patient's change in each domain, and applying it to a sexual outcome prediction model. Methods In 1,201 subjects from a previously described multi-center, longitudinal cohort, we modeled each treatment group's EPIC-CP domain scores at pre-treatment, short-term, and long-term follow-up. We considered post-treatment domain score changes from pre-treatment ≥ 0.5 standard deviations (SD) clinically significant and with a p-value ≤ 0.01 as statistically significant. We determined domain MIDs using the 0.5 pooled SD of the 2, 6, 12, and 24 month post-treatment changes from pre-treatment. We recalibrated an EPIC-CP-based nomogram model predicting 2-year post-prostatectomy functional erections from that developed using EPIC-26. Results For every HRQOL domain, EPIC-CP was sensitive to similar post-treatment HRQOL changes over time as had been observed using EPIC-26. The EPIC-CP MIDs for changes in the urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal domains are 1.0, 1.3, 1.2, 1.6, and 1.0, respectively. The EPIC-CP-based sexual prediction model performs well (AUC=0.76) and shows robust agreement with its EPIC-26-based counterpart, with predicted probability differences between models of ≤10% for 95% of individuals and a mean difference of 0.0 (SD=0.05) across all individuals. Conclusions EPIC-CP is responsive to HRQOL changes during convalescence, and can be used to predict 2-year post-prostatectomy sexual outcomes. Its use can facilitate shared medical decision-making and patient-centered care.

Long-term Health-related Quality of Life After Primary Treatment for Localized Prostate Cancer: Results from the CaPSURE Registry

“…CaPSURE uses a one-half SD decline from baseline to represent a meaningful decline in HRQOL. Although there is literature to support this definition to assess HRQOL change among PCa patients [13], we acknowledge that this outcome relies heavily on the SD of scores within the cohort, thereby questioning the true clinical significance of this definition. CaPSURE does not differ between men undergoing WW versus AS.…”

“…Both instruments yield scores from 0 to 100, with higher scores denoting better function or less bother. A binary outcome was created denoting a clinically meaningful decline in function or bother, defined as a one-half standard deviation (SD) decrease from baseline [11][12][13]. Clinically meaningful declines were analyzed at 2, 5, and 10 yr after treatment.…”

Defining a Standard Set of Patient-centered Outcomes for Men with Localized Prostate Cancer

“…Other excellent PROMs related to the outcomes following PCa treatment exist [10,[18][19][20], and our recommendation for centers not yet ready to switch to the EPIC-26, or for centers with compelling reasons to use other validated PROMs, would be to collect the same domains at the same time points and develop cross-talk algorithms to allow meaningful comparisons with those tracking the set. We recognize that a 16-question version of EPIC designed for easy implementation clinically has now been validated [19], but due to the absence of a question on rectal bleeding, an important late toxicity from radiation, we continue to recommend the 26-item questionnaire at present.…”

“…We recognize that a 16-question version of EPIC designed for easy implementation clinically has now been validated [19], but due to the absence of a question on rectal bleeding, an important late toxicity from radiation, we continue to recommend the 26-item questionnaire at present. We also included three additional questions regarding sexual interest and the use of sexual medication and devices in the set to improve the interpretability of the sexual function domain from the EPIC-26 (Table 1).…”

Nightly sildenafil use after radical prostatectomy has adverse effects on urinary convalescence: Results from a randomized trial of nightly vs on-demand dosing regimens

“…These effects on EPIC urinary subscale scores were not only statistically, but clinically, significant, with mean differences of 2.5 and 4.9, well over the 1.0 to 1.6 threshold for clinical significance on the various subscales recently noted by the PROST-QA (Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment). 9 This deleterious effect persisted despite controlling for factors known to affect urinary con- Urinary function post rP and penile rehabilitation valescence, including age, nerve-sparing quality/quantity as captured by nerve-sparing score (NSS), and time after surgery. While the effects of better nerve-sparing on improving early urinary outcomes after RP in previously potent men have been suggested in the literature, [10][11][12] it has not been shown that early PDE5i use after RP may adversely affect early urinary health-related quality of life.…”