Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial.

OBJECTIVES: The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time. METHODS: This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months postoperatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient. RESULTS: To date, the index trial has completed enrollment, and follow-up is ongoing. CONCLUSIONS: The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making.

Urinary incontinence and other pelvic floor disorders after radiation therapy in endometrial cancer survivors.

OBJECTIVE: To investigate radiation therapy as a risk factor for urinary or fecal incontinence, pelvic organ prolapse, and sexual dysfunction in endometrial cancer survivors. STUDY DESIGN: We performed a retrospective cohort study of endometrial cancer survivors. Data were collected using a mailed survey and the medical record. Validated questionnaires were used to generate rates of urinary incontinence and other pelvic floor disorders. The incidence rates of pelvic floor disorders were compared across groups with different exposures to radiation. RESULTS: Of the 149 endometrial cancer survivors, 41% received radiation therapy. Fifty-one percent of women reported urine leakage. The rates of urinary incontinence in women exposed and not exposed to vaginal brachytherapy (VBT) or whole-pelvis radiation were 48% and 58%, respectively (p=0.47). The incidence of fecal incontinence did not differ between groups, but the score for overall sexual function was significantly higher in women who did not undergo radiation therapy. On multivariable analysis, significant risk factors for urinary incontinence were age (AOR 1.06 95% CI 1.02, 1.10) and BMI (AOR 1.07 95% CI 1.02, 1.11), but treatment with radiation was not significantly associated with urinary incontinence, or fecal incontinence (p>0.05). Age, BMI, and radiation exposure were independent predictors of decreased sexual function score (p<0.01). CONCLUSION: Local or regional radiation is not associated with urinary or fecal incontinence, but may contribute to sexual dysfunction in endometrial cancer survivors.