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Patient-Perspective in AE Reporting (PPAR), a supplementary study, follows women enrolled into the ASPIRe clinical trial. The purpose of the PPAR study is to evaluate the patient’s perspective about adverse events and their role in patient decision-making outcomes. The aims of PPAR include comparing patient versus surgeon rankings of complication grade, outcome, expectedness and seriousness, to estimate the association between patient rankings of AEs with decision-making and quality of life outcomes, and to determine if their perspective about AEs changes over time.


STUDY RESULTS:

Sung VW, Menefee S, Dunivan G, Richter HE, Moalli P, Weidner A, Andy UU, Jelovsek E, Mazloomdoost D, Whitworth R, Thomas S, NICHD Pelvic Floor Disorders Network. Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial. Female Pelvic Med Reconstr Surg. 2020 Jun.

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