Abstract
Background
To assess the impact of animation deformity on health-related quality of life, a content-specific, valid, and reliable patient-reported outcome measure is needed. This report describes the development and validation of the BREAST-Q Animation Deformity scale.
Methods
Women with breast cancer who had an implant-based reconstruction provided data. In phase 1 (January 2017 and December 2018), qualitive and cognitive patient interviews and expert input were used to develop and refine scale content. In phase 2 (March to June 2019), a field test study with members of the Love Research Army (LRA) was conducted. Rasch Measurement Theory (RMT) analysis was used to examine psychometric properties.
Results
In phase 1 of the study, qualitative (n = 11) and cognitive (n = 4) interview data and expert input (n = 9) led to the development of a 12-item scale measuring animation deformity. In phase 2, 651 LRA members provided data and 349 participated in a test-retest study. In the RMT analysis, the data fit the Rasch model (X2(96) = 104.06; p = 0.27). The scale’s reliability was high, with person separation index and Cronbach alpha values with/without extremes of ≥ 0.84 and ≥ 0.92 respectively, and an intraclass correlation coefficient of 0.92 (95% confidence interval, 0.90–0.94). Mean scores on the Animation Deformity scale varied as predicted across subgroups of participants who reported differing amounts of change in breast appearance when their arms were lifted overhead or when they lifted something heavy, and for increasing happiness with the overall outcome of their breast reconstruction.
Conclusion
The 12-item Animation Deformity scale forms a new scale in the BREAST-Q Reconstruction Module that can be used in comparative effectiveness research or to inform clinical care.
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Acknowledgment
Phase 1 of this study was supported by the Canadian Breast Cancer Foundation Project Grant (now integrated into Canadian Cancer Society)—Grant number 319371. Phase 2 of this study was supported by the Plastic Surgery Foundation.
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The Animation Deformity scale is owned by Memorial Sloan-Kettering Cancer Center, McMaster University, and Mass General Brigham, and Drs Pusic and Klassen are co-developers. The remaining authors have no conflicts of interest. A number of authors have received, and are grateful for, funding from the Canadian Institutes of Health Research (CIHR). Dr. Klassen holds a CIHR Foundation Grant. She also receives research project grant funds from the Canadian Breast Cancer Foundation (CBCF) and Canadian Cancer Society (CCS). Dr. Zhong holds the inaugural Belinda Stronach Chair in Breast Cancer Reconstructive Surgery at the University Health Network and is the recipient of a CIHR New Investigator Award and Foundation Grant. Dr. Kaur holds a CIHR Training Award. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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Tsangaris, E., Pusic, A.L., Kaur, M.N. et al. Development and Psychometric Validation of the BREAST-Q Animation Deformity Scale for Women Undergoing an Implant-Based Breast Reconstruction After Mastectomy. Ann Surg Oncol 28, 5183–5193 (2021). https://doi.org/10.1245/s10434-021-09619-2
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DOI: https://doi.org/10.1245/s10434-021-09619-2