Abstract
Background
Current hernia patient-reported outcome (PRO) measures were developed without patient input, greatly impairing their content validity.
Objective
The purpose of this study was to develop a conceptual model for PRO measures for ventral hernia (VH) patients.
Methods
Fifteen semi-structured, concept elicitation interviews and two focus groups employing nominal group technique were conducted with VH patients. Patients were recruited between November 2015 and July 2016 over the telephone from a five-surgeon patient cohort at our institution. Iterative thematic analysis identified domains. Reliability and validation were achieved using inter-rater reliability checks and triangulation.
Results
Seven framework domains were established: (1) expectations; (2) self and others; (3) surgeon and surgical team; (4) sensation; (5) function; (6) appearance; and (7) overall satisfaction. Overall patient satisfaction was associated with two themes: (1) provider–patient relationship; and (2) patient assessment of post-repair improvement.
Conclusions
VH patients experience a profoundly broad range of reactions to VH repair. A patient-informed PRO instrument that addresses the spectrum of patient-identified outcomes can guide practice, optimizing care targeting VH patients’ needs.
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Acknowledgements
We would like to thank the Penn Data Store for their assistance in assembling the information used in this study. Thank you to Rachel Russell from the Mixed Methods Research Lab at our institution for her support with data collection.
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MC, KG, JW, ML, AB, BC, FE, RB, FB, MS, and JF: substantial contributions to conception and design, review and interpretation of references, drafting the article critically for important intellectual content, final approval of the version to be published, and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors have given approval of the version to be published.
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Funding
This research received Grant funding from the Edwin and Fannie Gray Hall Center for Human Appearance (CHA).
Conflict of interest
MC, KG, JW, ML, AB, BC, FE, RB, FB, and MS declare no conflict of interest. JF declares a Grant from Edwin and Fannie Gray Hall Center for Human Appearance during the conduct of this study. He is also a paid speaker and consultant for Bard Davol, Integra Lifesciences, and Misonix.
Ethical approval
This study was approved by the Institutional Review Board at the University of Pennsylvania in the USA for all portions of consenting, surveying, and data analysis (protocol #823282).
Informed consent
All participants in the study were consented in an informed manner as dictated and approved by the Institutional Review Board at the University of Pennsylvania. Patients were given the option to opt out at any point in the study.
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Carney, M.J., Golden, K.E., Weissler, J.M. et al. Patient-Reported Outcomes Following Ventral Hernia Repair: Designing a Qualitative Assessment Tool. Patient 11, 225–234 (2018). https://doi.org/10.1007/s40271-017-0275-3
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DOI: https://doi.org/10.1007/s40271-017-0275-3