Development of a persian version of the BREAST-Q and validity and reliability of the reconstruction module for the assessment of the quality of life and patient satisfaction following breast surgery

Background: Breast cancer is the most common cancer in women and its treatment includes various surgeries. Breast-Q is a new patient-reported outcome instrument for breast surgery and it should be validated appropriately for clinical research. This study aimed to develop the Persian version of the Breast-Q and validate the reconstruction module to evaluate the quality of life and satisfaction of Iranian women with a previous history of breast reconstruction. Methods: This study was descriptive and analytical cross-sectional. The study population consisted of women with a previous history of breast cancer and various breast surgeries referred to the outpatient clinic of Cancer Institute, Imam Khomeini Hospital from September 2017 to October 2019, using convenience sampling. After obtaining permission from the MAPI institute and translating all questionnaires into Persian, the validity, and reliability of the breast reconstruction module were evaluated. To confirm face validity, a questionnaire was given to patients to judge each item. To confirm the content validity of the questionnaire, two qualitative and quantitative methods were used. Content validity ratio (CVR) was calculated based on the expert opinion (Lawshe formula). Waltz & Bausell’s method was used to examine the content validity index (CVI). Finally, a new version of the questionnaire was assessed in 20 women who had undergone TRAM flap breast reconstruction at least 6 months ago. Results: After translation of the questionnaire into Persian, and face and content validation process, the 116 items of the first questionnaire converted to 72 with an acceptable impact score greater than 1.5 and CVR and CVI. The internal validity of the breast reconstruction module was approved by Cronbach's alpha value of 0.94. Conclusion: Considering the limitation of the specific questionnaires for various breast surgery procedures, the Breast-Q questionnaire can be an efficient tool for the evaluation of the quality of life and satisfaction in patients. Since the translation of the questionnaire has become valid and reliable, it can be used for future research by other researchers.