Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial.
Journal
Female pelvic medicine & reconstructive surgery
ISSN: 2154-4212
Titre abrégé: Female Pelvic Med Reconstr Surg
Pays: United States
ID NLM: 101528690
Informations de publication
Date de publication:
01 01 2021
01 01 2021
Historique:
pubmed:
4
6
2020
medline:
15
12
2021
entrez:
4
6
2020
Statut:
ppublish
Résumé
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. 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. To date, the index trial has completed enrollment, and follow-up is ongoing. 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.
Identifiants
pubmed: 32487881
pii: 01436319-202101000-00032
doi: 10.1097/SPV.0000000000000845
pmc: PMC8087185
mid: NIHMS1695839
doi:
Banques de données
ClinicalTrials.gov
['NCT02676973']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e112-e117Subventions
Organisme : NICHD NIH HHS
ID : U10 HD041261
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069013
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD054215
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD054214
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069006
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069025
Pays : United States
Organisme : NICHD NIH HHS
ID : U01 HD069031
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD041267
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD041267
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069025
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069010
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069013
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD054214
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069006
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069010
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD041261
Pays : United States
Organisme : NICHD NIH HHS
ID : U24 HD069031
Pays : United States
Informations de copyright
Copyright © 2020 American Urogynecologic Society. All rights reserved.
Déclaration de conflit d'intérêts
The authors have declared they have no conflicts of interest.
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