Dataset Information

Assessing the Impact of Decision Aid Use on Post Prostatectomy Patient Reported Outcomes.

ABSTRACT:

Objective

To evaluate whether completing a decision aid, Personal Patient Profile - Prostate (P3P), prior to prostatectomy, affects self-reported bother from post-prostatectomy urinary incontinence and erectile dysfunction.

Materials and methods

This retrospective analysis included data from men with newly diagnosed clinically localized, very low to intermediate risk prostate cancer who elected for prostatectomy within the Michigan Urological Surgery Improvement Collaborative between 2018-2021. Multivariable logistic regression models were used to estimate the association between P3P use and bother from post prostatectomy erectile dysfunction and urinary incontinence as measured by the Expanded Prostate Cancer Index Composite (EPIC-26).

Results

Among the 3987 patients included, 7% used P3P (n = 266). Men who used P3P reported significantly less bother from erectile dysfunction at 6 months vs non-users (aOR 0.42 [95% CI 0.27-0.66]). At 12 months, the effect of P3P on bother from erectile dysfunction was not statistically significant (aOR 0.62 [95% CI 0.37-1.03]). Men who used P3P did not have a statistically significant difference in bother from urinary incontinence (3-month: aOR 0.56 [95% CI 0.30-1.06]; 6-month; aOR 0.79 [95% CI 0.31-1.97]).

Conclusion

Within the stated limitations of this study, we find that use of a decision aid for localized prostate cancer was associated with decreased odds of men being bothered from sexual dysfunction but not urinary incontinence at 6 months post prostatectomy.

SUBMITTER: Lane GI

PROVIDER: S-EPMC9296586 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Assessing the Impact of Decision Aid Use on Post Prostatectomy Patient Reported Outcomes.

Lane Giulia I GI Qi Ji J Dupati Ajith A Ferrante Stephanie S Dunn Rodney L RL Paudel Roshan R Wittmann Daniela D Wallner Lauren P LP Berry Donna L DL Ellimoottil Chad C Montie James E JE Clemens J Quentin JQ

Urology 20220224

<h4>Objective</h4>To evaluate whether completing a decision aid, Personal Patient Profile - Prostate (P3P), prior to prostatectomy, affects self-reported bother from post-prostatectomy urinary incontinence and erectile dysfunction.<h4>Materials and methods</h4>This retrospective analysis included data from men with newly diagnosed clinically localized, very low to intermediate risk prostate cancer who elected for prostatectomy within the Michigan Urological Surgery Improvement Collaborative betw ...[more]

PMID: 35219768

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Project description:BackgroundKnowledge of treatment assignment may affect patient-reported outcomes (PROs), which is of concern in oncology, where open-label trials are common. This study measured the magnitude of open-label bias by comparing PROs for similar patient groups in oncology trials with different degrees of concealment.MethodsIndividual patient data from ipilimumab arms of 2 melanoma and docetaxel arms of 2 non-small cell lung cancer (NSCLC) trials were adjusted for differences using propensity score weighting. Patients were aware of treatment assignment in CA184-022 and CheckMate 057 (open-label) but not in MDX010-20 and VITAL (blinded). Overall survival (OS) and mean changes from baseline to week 12 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (melanoma) and Lung Cancer Symptom Scale (NSCLC) scores were compared between open-label and blinded groups.ResultsAfter adjustment, baseline characteristics were balanced between blinded (melanoma, n = 125; NSCLC, n = 424) and open-label (melanoma, n = 69; NSCLC, n = 205) groups. Study discontinuation and PRO completion rates at week 12 and OS were similar. There was no clear direction in differences in change scores between groups. In the melanoma trials, role functioning (mean = -5.2, 95% confidence interval [CI] = -15.4 to 5.0), global health status (mean = -1.3, 95% CI = -8.7 to 6.1), and pain (mean = 6.2 , 95% CI = -1.8 to 14.2) favored the blinded, whereas emotional functioning (mean = 2.2, 95% CI = -5.8 to 10.2) and diarrhea (mean = -8.3, 95% CI = -17.3 to 0.7) favored the open-label group. In the NSCLC trials, changes in dyspnea (mean = 5.4, 95% CI = -0.7 to 11.5) favored the blinded and changes in appetite (mean = -1.2, 95% CI = -8.1 to 5.7) favored the open-label group. None were clinically or statistically significant.ConclusionsThis study adds to the growing evidence demonstrating that concerns regarding open-label bias should not prohibit the interpretation of large and meaningful treatment effects on PROs.

Dataset Information

Assessing the Impact of Decision Aid Use on Post Prostatectomy Patient Reported Outcomes.

Objective

Materials and methods

Results

Conclusion

Publications

Assessing the Impact of Decision Aid Use on Post Prostatectomy Patient Reported Outcomes.

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