Development of a Japanese version of the BREAST-Q and the traditional psychometric test of the mastectomy module for the assessment of HRQOL and patient satisfaction following breast surgery
- 502 Downloads
An understanding of health-related quality of life (HRQOL) is of utmost importance in both oncological and esthetic breast surgery. The BREAST-Q is a patient-reported outcome (PRO) measure that investigates HRQOL and patient satisfaction before and after breast surgery. The aim of this study was to develop a Japanese version of the BREAST-Q including the mastectomy module, the reconstruction module, the augmentation module and the reduction/mastopexy module, and to assess the psychometric properties of the mastectomy module among Japanese women.
The Japanese version of the BREAST-Q was developed through forward translation, backward translation and patient testing. Traditional psychometric testing of the mastectomy module was administered to 45 post-mastectomy patients.
The mastectomy, reconstruction, augmentation and reduction/mastopexy modules were formally developed into Japanese. Despite cultural difference between Japanese women and original target population, the contents were considered to be valid among Japanese woman. With the exception of the sexual well-being subscale, good reliability and validity were evident for the mastectomy module (Test–retest reliability 0.76–0.95, Chronbach’s alpha coefficient 0.77–0.98).
The BREAST-Q Japanese version is a useful PRO measure for investigating the impact of breast surgery on HRQOL and patient satisfaction. Further validation in younger Japanese women is needed to determine the usefulness of the sexual well-being subscale.
KeywordsBREAST-Q Breast reconstruction Satisfaction Health-related quality of life Breast cancer
The authors are grateful to M. Yamashita, T. Waring and R. Waring for joining our project as translators. We appreciate the help of Y.Tsuyumu, S.Ogawa and K.Shimizu with the collection of data. This work was supported by JSPS KAKENHI Grant number 15k08713.
Complicance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
- 4.Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, et al. The European organization for research and treatment of cancer breast cancer-specific quality of life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996;14:2756–68.PubMedGoogle Scholar
- 11.Takei H, Ohsumi S, Shimozuma K, Takehara M, Suemasu K, Ohashi Y, et al. Health-related quality of life psychological distress, and adverse events in postmenopausal women with breast cancer who receive tamoxifen, exemestane, or anastrozole as adjuvant endocrine therapy: national surgical adjuvant study of breast cancer 04 (N-SAS BC 04). Breast Cancer Res Treat 2012;133:227–36.CrossRefPubMedGoogle Scholar
- 12.Shimozuma K, Ohashi Y, Takeuchi A, Aranishi T, Morita S, Kuroi K, et al. Feasibility and validity of the patient neurotoxicity questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer. 2009;17:1483–91.CrossRefPubMedGoogle Scholar
- 20.U.S. department of health and human services FDA center for drug evaluation and research, U.S. department of health and human services FDA center for biologics evaluation and research, U.S. department of health and human services FDA center for devices and radiological health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006;4:79. doi: 10.1186/1477-7525-4-79.CrossRefPubMedCentralGoogle Scholar
- 22.Rasch G. Probabilistic models for some intelligence and attainment tests. Copenhagen: The danish institute for educational research; 1960.Google Scholar
- 23.Acquadro C, Conway K, Giroudet C, Mear I. Linguistic validation manual for health outcome assessments. Lyon: MAPI institute; 2012.Google Scholar
- 28.Acquadro C, Conway K, Hareendran A, Aaronson N. European regulatory issues and quality of life assessment (ERIQA) group. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value Health. 2008;11:509–21.CrossRefPubMedGoogle Scholar
- 29.Wild D, Grove A, Mrtin M, Eremenco S, Verjee-Lorenz A, Erikson P. ISPOR task force for translation and cultural adaptation. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation. Value Health. 2005;8:94–104.CrossRefPubMedGoogle Scholar
- 38.Eltahir Y, Werners LL, Dreise MM, van Emmichoven IA, JansenL Werker PM, et al. Quality-of-life outcomes between mastectomy alone and breast reconstruction: comparison of patient-reported BREAST-Q and other health-related quality-of-life measures. Plast Reconstr Surg. 2013;132:201e–9e.CrossRefPubMedGoogle Scholar