Patients with symptomatic macromastia (SM) frequently suffer from symptoms related to their breast volume, which negatively impact their quality of life (QoL)1–3. The most effective treatment for this disease is breast reduction, which provides an improvement in QoL2. In 2009, Pusic et al developed the BREAST-Q® questionnaire4, which is a patient-reported outcome (PRO) instrument specifically designed to measure QoL and satisfaction of patients undergoing surgery; one of the BREAST-Q® modules is dedicated to breast reduction. Although the modules have been linguistically adapted to many different languages and thoroughly evaluated using psychometric tests5–7, they have not been translated into Spanish for the Spanish population.
The objectives of this study are to develop a cross-cultural adaptation of the English version of the BREAST-Q® v.2.0 breast reduction module for the Spanish population and to test its reproducibility in our population. To this end, the study included patients with SM treated at our hospital between 2017 and 2018. The selection criteria were applied to patients requesting treatment who had: a body mass index (BMI) ≤30 kg/m2, estimated breast resection ≥500 g per breast, and age over 18 years. The remaining patients were excluded.
Development of the Spanish version of the BREAST-Q® breast reduction moduleThe study was approved by the regional ethics committee and authorized by the Memorial Sloan Kettering Cancer Center and Q-Portfolio. Validation was performed following the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)8. The linguistic validation process entailed the translation into Spanish of the original English version of the questionnaire by 2 independent translators. After a conciliation meeting, a definitive consensus translation was produced. This version was re-translated back into English by an independent native English-speaking translator. Both versions were assessed by the linguistic adaptation group, producing a final consensus version of the questionnaire translated into Spanish that was approved by Q-Portfolio. The definitive questionnaire was administered to 8 patients with SM during a cognitive interview to verify that it was easily understandable. In addition, the psychometric properties of the BREAST-Q© v.2.0 breast reduction module were analyzed in a sample of 37 patients and then compared with the original version to strengthen its validity. The questionnaire was administered by personal interview.
Regarding the results, the internal consistency of the questionnaire was studied with Cronbach’s alpha, with the same acceptance criteria as the original version: data loss <5%, Cronbach’s alpha for summary coefficients >0.70, total item correlation >0.30 and an intraclass correlation coefficient (ICC) >0.704,9. The results for the preoperative and postoperative versions are shown in Table 1. In the preoperative module, all the results were greater than 0.85. In the postoperative module, only one item did not reach a Cronbach’s alpha greater than 0.7 (satisfaction with the administrative staff). The medical team satisfaction scale obtained negative results (−0.091), probably because there were no differences in the answers and all the results were similar. Interobserver and intraobserver reproducibility is represented by the ICC. In addition, we wanted to compare the results of the traditional psychometric analysis with the results obtained in the original article4 (Table 2), obtaining similar results, which reinforces the consistency of the validation.
Psychometric analysis of the domains of the BREAST-Q®—Breast Reduction (mastopexy) Module (pre- and postoperative scales).
| No. of items | Cronbach’s alpha | ICC | 95% CI | |
|---|---|---|---|---|
| Preoperative n = 48 | ||||
| Satisfaction with breasts | 11 | 0.940 | 0.938 | 0.908−0.961 |
| Psychosocial wellbeing | 9 | 0.940 | 0.937 | 0.907−0.961 |
| Sexual wellbeing | 5 | 0.882 | 0.884 | 0.822−0.929 |
| Physical wellbeing | 14 | 0.888 | 0.884 | 0.830−0.927 |
| Postoperative n = 37 | ||||
| Satisfaction with breasts | 13 | 0.922 | 0.902 | 0.848−0.943 |
| Satisfaction with nipples | 4 | 0.895 | 0.843 | 0.745−0.912 |
| Psychosocial wellbeing | 9 | 0.957 | 0.957 | 0.932−0.975 |
| Sexual wellbeing | 5 | 0.950 | 0.944 | 0.908−0.969 |
| Physical wellbeing | 14 | 0.764 | 0.878 | 0.810−0.929 |
| Satisfaction with results | 8 | 0.765 | 0.783 | 0.656−0.875 |
| Satisfaction with information | 12 | 0.916 | 0.889 | 0.787−0.954 |
| Satisfaction with surgeon | 7 | 0.871 | 0.877 | 0.808−0.929 |
| Satisfaction with medical team | 7 | −0.091 | −0.091a | −0.738−0.377a |
| Satisfaction with administrative team | 7 | 0.466 | 0.687 | 0.501−0.821 |
CI: 95% confidence interval 95%; ICC: intraclass correlation coefficient.
Comparison of the Spanish version with the original article (Breast Reduction Module).
| Scales | No. of items | Cronbach’s alpha | |
|---|---|---|---|
| Our study | Pusic et al | ||
| Satisfaction with breasts | 13 | 0.922 | 0.91 |
| Satisfaction with results | 8 | 0.765 | 0.91 |
| Psychosocial wellbeing | 9 | 0.957 | 0.95 |
| Sexual wellbeing | 5 | 0.950 | 0.93 |
| Physical wellbeing | 14 | 0.764 | 0.83 |
| Satisfaction with information | 12 | 0.916 | 0.91 |
| Appearance of nipples and areolas | 4 | 0.895 | 0.89 |
The treatment of SM involves surgical breast reduction, which has a positive impact on both symptoms and QoL1–3. Despite this, there is no consensus on the selection criteria for this surgery10. Direct patient information (PRO) is an excellent tool for learning about the impact of the disease and its treatment on patients, which is particularly relevant when the disease causes psychosocial and functional sequelae that are difficult to measure with laboratory analyses or physical tests, like in SM. The BREAST-Q® is a questionnaire that measures PRO that was rigorously developed and designed to evaluate the results of different types of breast surgery4. Its advantage is that it includes 2 modules with pre- and postoperative evaluations, which allows us to quantify the baseline QoL of patients and variations in the effects of surgery. Currently, there is no linguistic adaptation of the BREAST-Q® v.2.0 breast reduction module for the Spanish population. The Spanish version of the BREAST-Q® questionnaire—Breast Reduction Module—that we have created meets international psychometric standards established and published in the original article by Pusic et al.4, which was confirmed by comparing our results with the original questionnaire.
We believe that the Spanish version of the BREAST-Q® v.2.0 —Breast Reduction Module—is valid for its use and application in the Spanish population. This instrument may be useful in the selection of patients in whom macromastia has a direct effect on QoL and who would benefit from surgical treatment, while also being able to identify opportunities to improve daily clinical practice.
