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

Publication ,  Journal Article
Sung, VW; Menefee, S; Dunivan, G; Richter, HE; Moalli, P; Weidner, A; Andy, UU; Jelovsek, E; Mazloomdoost, D; Whitworth, R; Thomas, S ...
Published in: Female Pelvic Med Reconstr Surg
January 1, 2021

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.

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Published In

Female Pelvic Med Reconstr Surg

DOI

EISSN

2154-4212

Publication Date

January 1, 2021

Volume

27

Issue

1

Start / End Page

e112 / e117

Location

United States

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Postoperative Complications
  • Pelvic Organ Prolapse
  • Patient Reported Outcome Measures
  • Humans
  • Female
  • 3215 Reproductive medicine
  • 3202 Clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Sung, V. W., Menefee, S., Dunivan, G., Richter, H. E., Moalli, P., Weidner, A., … NICHD Pelvic Floor Disorders Network, . (2021). 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, 27(1), e112–e117. https://doi.org/10.1097/SPV.0000000000000845
Sung, Vivian W., Shawn Menefee, Gena Dunivan, Holly E. Richter, Pamela Moalli, Alison Weidner, Uduak Umoh Andy, et al. “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 27, no. 1 (January 1, 2021): e112–17. https://doi.org/10.1097/SPV.0000000000000845.
Sung VW, Menefee S, Dunivan G, Richter HE, Moalli P, Weidner A, et al. 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. 2021 Jan 1;27(1):e112–7.
Sung, Vivian W., et al. “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, vol. 27, no. 1, Jan. 2021, pp. e112–17. Pubmed, doi:10.1097/SPV.0000000000000845.
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. 2021 Jan 1;27(1):e112–e117.

Published In

Female Pelvic Med Reconstr Surg

DOI

EISSN

2154-4212

Publication Date

January 1, 2021

Volume

27

Issue

1

Start / End Page

e112 / e117

Location

United States

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Postoperative Complications
  • Pelvic Organ Prolapse
  • Patient Reported Outcome Measures
  • Humans
  • Female
  • 3215 Reproductive medicine
  • 3202 Clinical sciences