Patient-Reported Quality-of-Life Outcomes of Breast Reduction Evaluated with Generic Questionnaires and the Breast Reduction Assessed Severity Scale

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1 Breast Surgery Patient-Reported Quality-of-Life Outcomes of Breast Reduction Evaluated with Generic Questionnaires and the Breast Reduction Assessed Severity Scale Aesthetic Surgery Journal 2015, Vol 35(1) The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: DOI: /asj/sju017 Yavuz Kececi, MD; Emin Sir, MD; and Melike Gungor, MD Abstract Background: The effects of breast reduction on quality of life (QOL) have been evaluated in patients with macromastia, but few investigators have performed condition-specific assessments. Objectives: The authors employed generic and condition-specific questionnaires to examine the QOL of patients with macromastia and determined the responsiveness of the Turkish version of Breast Reduction Assessed Severity Scale (BRASS). Methods: This prospective cohort study included patients with breast hypertrophy who underwent breast reduction (n = 94). Patients completed the Turkish versions of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), the BRASS, and the Rosenberg Self-Esteem Scale preoperatively and 4 months postoperatively. Differences in responses were evaluated by paired t-test and by comparing change effect sizes. Multiple regression analyses were performed to evaluate improvements in QOL in response to adjustments in baseline differences across patients. Results: Preoperative and postoperative questionnaires were completed by 78 patients (83%). Significant postoperative improvements in self-esteem (Rosenberg Self-Esteem Scale; P <.001) and in all domains of the BRASS (P <.001) were noted. Mean preoperative scores for 5 of 8 domains in the SF- 36 were lower than those of a normative population. Postoperatively, all 5 mean scores improved significantly, but the score for bodily pain remained less than that of a normative population. Conclusions: The results of this study indicate significant improvements in health-related QOL at 4 months after breast reduction in a population of patients with macromastia. The authors also demonstrate excellent responsiveness of the BRASS. Level of Evidence: 3 Accepted for publication May 13, Therapeutic Breast hypertrophy is associated with physical symptoms, including back, neck, shoulder, and breast pain; shoulder grooving; intertrigo; poor posture; difficulty dressing; and discomfort during sleep. Patients with macromastia also experience psychological symptoms, such as decreased selfesteem, increased self-consciousness, unwanted attention, and difficulties finding appropriate clothing and participating in certain social functions. 1-4 Recognizing the importance of patient experiences in the evaluation of breast surgery, investigators in recent years have included patient-reported outcomes in studies of the effects of breast hypertrophy. Initially, most questionnaires addressing breast hypertrophy were prepared by and for physicians, forcing patients to communicate through a tool that was designed without their insight. Moreover, these questionnaires were developed and validated without considering established psychometric criteria. 1,5 These instruments were considered ad hoc measures Department of Plastic and Reconstructive Surgery, Izmir Education and Research Hospital, Izmir, Turkey. Corresponding Author: Dr Yavuz Kececi, 119/3 sokak 1/1 Zeytinpark evleri C blok D:8, Evka 3, Bornova, Izmir, Turkey. yavuz.kececi@gmail.com

2 Kececi et al 49 of patient-reported outcomes that contained clinically reasonable questions but that lacked established levels of reliability (ie, the ability to produce consistent and reproducible scores) and validity (ie, the ability to measure that which is intended). 5 More recently, investigators have employed validated, but generic, questionnaires, such as the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), 4,6,7 intended to evaluate a patient s overall health status and to compare the relative burdens of various disease states with each other and with a normative population. The SF-36 has been applied to determine the change in health status after an intervention and whether patients indicate a poorer quality of life (QOL) than the general population before an intervention. 8 Although generic instruments may be reliable, they may lack sufficient sensitivity to measure changes in health status after surgical intervention or to capture all outcomes specific to breast surgery. 9 To meet this need, questionnaires intended to capture all meaningful symptoms experienced by patients with breast hypertrophy have been developed and validated. 10,11 Because condition-specific instruments, by definition, pertain to the disorder being investigated, these tools are more responsive than generic instruments to changes resulting from an intervention. 5 However, few authors have applied validated, condition-specific questionnaires to outcome assessments of reduction mammaplasty. 12 In the present study, we applied the validated Turkish versions of the SF-36, the Rosenberg Self-Esteem Scale, and the Breast Reduction Assessed Severity Scale (BRASS) to evaluate changes in QOL resulting from reduction mammaplasty The SF-36 includes scales for 8 health-related QOL domains: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, bodily pain, energy and vitality, and general perception of health. Each scale ranges from 0 to 100 such that higher scores indicate better health. 16 Results of the SF-36 are represented as physical and mental health component summaries. The difference in SF-36 scale values that corresponds to a clinically meaningful difference in health-related QOL has not been established scientifically. The Turkish version of the Rosenberg Self-Esteem Scale includes 10 questions, each with 4 possible responses, that address self-esteem. Scores for this short scale range from 10 to 40 such that higher scores indicate higher self-esteem. 14 The original version of the BRASS was developed by Sigurdson et al, 11 and the Turkish version was validated previously. 13 (English and Turkish versions of the BRASS [Supplementary material online, Appendices A and B, respectively] are available online at journal.com). The BRASS is a self-administered scale designed to address QOL issues in patients with mammary hypertrophy. The scale pertains to 5 conceptual domains of QOL: physical implications, poor self-concept, body pain, negative social interactions, and physical appearance. Responses are scored on a 5-point Likert scale, with 1 corresponding to very little and 5 corresponding to very much. Although the reliability and validity of the Turkish version of the BRASS have been demonstrated, 13 the responsiveness of this tool for detecting clinically meaningful changes in health status has not been determined. Responsiveness is an important psychometric feature for evaluating changes resulting from a healthcare intervention and for monitoring patients over time. Responsiveness usually is measured by comparing standardized preintervention and postintervention indicators of change magnitude, such as effect sizes The aims of this study were to evaluate the effects of breast reduction on QOL among patients with breast hypertrophy by means of condition-specific and generic validated questionnaires and to determine the predictive factors with the greatest effects on the outcome of breast reduction. In addition, the responsiveness of the Turkish version of the BRASS was assessed in this study. We previously demonstrated the reliability and validity of the BRASS. 13 METHODS Study Design and Patient Population This prospective cohort study was approved by the Ethical Review Committee of the Izmir Bozyaka Education and Research Hospital, Turkey. This study was conducted in accordance with the principles of Declaration of Helsinki. Patients with breast hypertrophy who presented for breast reduction at the Izmir Bozyaka Education and Research Hospital between July 2010 and December 2011 were included. All study participants (N = 94) were approved for breast reduction. Exclusion criteria included unilateral mammary hypertrophy, mammary hypertrophy with severe asymmetry, a history of mammary surgery, and illiteracy. Patients were informed that their responses to the questionnaires would not influence their medical care. All participants gave written informed consent. Demographic information, including age, body mass index (BMI), and education level, was recorded preoperatively. Surgical Procedure Reduction mammaplasty was performed under general anesthesia. The breasts were marked preoperatively for preservation of the nipple-areola complex by means of an inferior pedicle created with an inverted T incision. Breast tissues resected from each patient were weighed. Data Analysis Preoperatively and 4 months postoperatively, participants completed the Turkish versions of the SF-36, the Rosenberg

3 50 Aesthetic Surgery Journal 35(1) Self-Esteem Scale, and the BRASS questionnaires. Patients were characterized in terms of descriptive statistics, numerical variables (represented as means ± SDs), and categorical variables ( proportions). Preoperative and postoperative differences in the scored responses to the questionnaires were compared by the paired t-test. SF-36 scores were compared with previously published normative data from a population of Turkish women 20 by the 1-sample t-test. Normality was assessed with the Kolmogorov-Smirnov test. The responsiveness of the Turkish BRASS was represented as change effect sizes, computed as the mean difference between preoperative and postoperative scores divided by the standard deviation (SD) of the preoperative score. Change effect sizes were interpreted according to the thresholds established by Cohen, 21 as follows: <0.20, trivial; 0.20 to 0.50, small; >0.50 to 0.80, moderate; and >0.80, large. Multiple regression models were utilized to ascertain postoperative improvements in QOL and were adjusted for baseline differences across patients. Potential variables, including age, breast resection weight, and BMI were adjusted as independent variables, and questionnaire responses scored as improvements in QOL were regarded as dependent variables. A regression model designating improvement in the physical health component summary as the dependent variable and preoperative scores from the 5 BRASS domains as independent variables was analyzed to identify preoperative patient characteristics that were predictive of improvement in physical health after breast reduction. RESULTS Of 94 patients enrolled in the study, 78 (83%) completed postoperative assessments and were included in the analysis. Patient demographics are presented in Table 1. The mean age of the 78 patients was 41.6 ± 14.1 years (range, years), and the mean BMI was 29.6 ± 3.6 kg/m 2.The averageamountofbreasttissueremovedwas759±247g per breast. The 16 of 94 patients (17%) who did not complete postoperative surveys were similar to the remaining 78 patients in terms of age, BMI, and tissue resection weight. Of 78 patients, 16 (21%) experienced a complication, including 12 patients (15%) who developed small areas of wound dehiscence, 2 (3%) who experienced partial nipple loss, and 2 (3%) who suffered from wound infection requiring antibiotic treatment. None of the patients required concurrent procedures. When compared with previously published normative data from a population of Turkish women, 20 mean SF-36 scores obtained preoperatively were significantly lower regarding the physical health component summary score and the following domains: physical functioning, social functioning, role limitations due to physical problems, bodily pain, and energy and vitality (P <.001, 1-sample t-test; Table 2). Postoperative SF-36 scores improved significantly Table 1. Patient Demographics (n = 78) Age, y Mean (SD) 41.6 (14.1) Range BMI, kg/m 2 Mean (SD) 29.6 (3.6) Range Tissue resection weight per breast, g Mean (SD) 759 (247) Range Duration of education, no. of patients (%) 5 y 33 (42) >5 y 45 (58) BMI, body mass index; SD, standard deviation. Table 2. SF-36 Scores vs Normative Data SF-36 Domain Physical functioning Normative Data, Mean (SD) Preoperative Score, Mean (SD) Postoperative Score, Mean (SD) 80.6 (21.7) 67.5 (22.4) a 79.3 (17.2) Social functioning 90.1 (12.9) 80.6 (18.3) a 87.7 (13.6) Role limitations, physical Role limitations, emotional 82.9 (28.6) 71.6 (22.8) a 80.9 (17.8) 89.0 (22.5) 83.6 (26.5) 90.7 (17.3) Mental health 70.1 (11.4) 68.8 (12.7) 69.7 (8.6) Bodily pain 81.0 (20.2) 56.7 (24.2) a 74.4 (15.5) a Energy and vitality 63.4 (13.7) 54.5 (18.7) a 64.1 (12.1) General perception of health Physical health component summary Mental health component summary 69.1 (16.9) 65.4 (19.8) 68.1 (17.9) 46.6 (9.9) 38.8 (13.6) a 45.3 (10.1) 47.3 (9.8) 45.1 (10.8) 46.6 (9.6) Normative data were obtained from Demiral et al. 20 SD, standard deviation; SF-36, Medical Outcomes Study 36-Item Short Form Health Survey. a P <.001 vs normative data; 1-sample t-test. vs preoperative scores (Table 3) and were comparable to normative values for physical functioning, social functioning, role limitations due to physical problems, and energy and vitality. Although the mean SF-36 score for postoperative

4 Kececi et al 51 Table 3. Preoperative vs Postoperative SF-36 Scores SF-36 Domain Preoperative Score, Mean (SD) Postoperative Score, Mean (SD) Change Effect Size P Value, Paired t-test Physical functioning 67.5 (22.4) 79.3 (17.2) 0.72 <.001 Social functioning 80.6 (18.3) 87.7 (13.6) 0.55 <.001 Role limitations, physical 71.6 (22.8) 80.9 (17.8) Role limitations, emotional 83.6 (26.5) 90.7 (17.3) Mental health 68.8 (12.7) 69.7 (8.6) Bodily pain 56.7 (24.2) 74.4 (15.5) 0.73 <.001 Energy and vitality 54.5 (18.7) 64.1 (12.1) 0.70 <.001 General perception of health 65.4 (19.8) 68.1 (17.9) Physical component summary 38.8 (13.6) 45.3 (10.1) Mental component summary 45.1 (10.8) 46.6 (9.6) Change effect sizes were computed as the mean difference between preoperative and postoperative scores, divided by the standard deviation of the preoperative score. bodily pain significantly improved vs the preoperative score (P <.001; Table 3), it remained significantly less than the normative value (P <.001; Table 2). Change effect sizes were computed to evaluate the responsiveness of the Turkish BRASS for detecting whether patients with breast hypertrophy who underwent breast reduction experienced clinically meaningful improvements in QOL. Moderate effect sizes were noted for physical functioning, social functioning, bodily pain, and energy and vitality. Small effect sizes were noted for role limitations due to physical or emotional problems, and for the physical health component summary (Table 3). The mean score calculated from the Rosenberg Self-Esteem Scale increased significantly after breast reduction (P <.001, paired t-test; Table 4). The change effect size was large for preoperative vs postoperative scores. Significant postoperative improvements were noted for all domains of the BRASS (P <.001, paired t-test; Table 5). Large change effect sizes were noted for all domains (range, 1.48 to 2.86), indicating excellent responsiveness of the questionnaire. The largest change effect size corresponded to bodily pain. Multiple regression analyses were performed to assess whether the observed improvements in factors affecting QOL persisted after adjusting for preoperative characteristics that might explain differences in the improvements. No associations were noted between improvements in SF-36 domains and age, weight of resected breast tissue, or BMI. However, age was positively correlated with the BRASS domain of physical implications (r =.302, P =.007) and was negatively correlated with improvements in negative social interactions (r =.272, P =.016) and poor selfconcept (r =.241, P =.034). Improvement in self-esteem scored by the Rosenberg Self-Esteem Scale was correlated Table 4. Results of Rosenberg Self-esteem Scale Mean preoperative score (SD) 28.7 (3.5) Mean postoperative score (SD) 32.4 (3.1) Mean change (95% CI) 3.7 ( ) P value, paired t-test <.001 Change effect size 1.06 CI, confidence interval; SD, standard deviation. Table 5. Preoperative vs Postoperative BRASS Scores BRASS Domain Preoperative Score, Mean (SD) Postoperative Score, Mean (SD) Change Effect Size Physical implications 14.3 (4.8) 4.5 (2.7) 2.03 Bodily pain 24 (5.1) 9.4 (4.4) 2.86 Physical appearance 13.9 (3.7) 4.5 (2.6) 2.54 Negative social interactions 7.6 (3.7) 2.1 (1.5) 1.48 Poor self-concept 10.7 (3.5) 3.2 (2.5) 2.14 BRASS, Breast Reduction Assessed Severity Scale; SD, standard deviation. negatively with BMI (r =.255, P =.024). In addition, improvement in the physical health component summary of the SF-36 was positively associated with preoperative scores for the physical implication domain of BRASS (P <.001, r =.457; Figure 1).

5 52 Aesthetic Surgery Journal 35(1) Figure 1. Relationship between the change in physical health component summary scores ( preoperative vs postoperative; Medical Outcomes Study 36-Item Short Form Health Survey [SF-36]) and the physical implication score ( preoperative; Breast Reduction Assessed Severity Scale [BRASS]). DISCUSSION The results of this study indicate that breast reduction alleviates symptoms associated with macromastia and improves QOL scores. In addition, we demonstrated the responsiveness of the Turkish BRASS, a validated questionnaire specific to breast hypertrophy. Preparation of the original BRASS was guided by patient interviews, focus groups, and expert panels, and the questionnaire was submitted to psychometric analysis. 22 The BREAST-Q is another validated, condition-specific, patient-reported measure that includes 6 domains and can be applied to patients undergoing breast reduction, reconstruction, or augmentation. 10,23 However, the BRASS is regarded as a comprehensive questionnaire for patients with breast hypertrophy and includes a domain addressing bodily pain, which the BREAST-Q lacks. Because our patients with macromastia often list pain as their primary complaint and because only the BRASS has a Turkish version, we selected the BRASS as the conditionspecific questionnaire for this study. When the responses to preoperative and postoperative assessments were compared, significant improvements and very large change effect sizes were detected in all domains of the BRASS, demonstrating excellent responsiveness of the questionnaire to the effects of breast reduction. To our knowledge, the present study is the first to employ this questionnaire outside of North America. The results of this study are consistent with those demonstrated by the authors who created the BRASS. 11 In a study of 49 patients undergoing breast reduction, Coriddi et al 12 found significant postoperative improvements in all dimensions of the BREAST-Q. In a 10-year retrospective analysis of 600 patients, Gonzalez et al 24 demonstrated positive outcomes of breast reduction with the BREAST-Q. However, these authors did not conduct a preoperative assessment and therefore could not determine any improvement related to breast reduction. 24 The BRASS and the BREAST-Q may enable plastic surgeons to compare surgical techniques and develop appropriate standards of breast reduction outcomes. 5 Validated versions of the BRASS translated into different languages would allow physicians to assess complaints related to macromastia in their patients cultural contexts and to reliably compare languages, cultural norms, and patient expectations. Although condition- or surgery-specific measures of patient outcomes are more responsive than generic measures, they generate insufficient data for comparing healthrelated QOL of patients with the normal population or for comparing relative burdens of various diseases. Participants in the present study completed generic and condition-specific questionnaires so that the investigators could evaluate major domains common to all diseases and domains specific to macromastia. 8 We assessed overall health status with the SF-36, a widely utilized generic instrument that has been applied to similar studies evaluating the health burden of macromastia and outcomes of breast surgery. 4,6,7 In addition, other authors have applied the SF-36 to collect normative data from a population of Turkish women. 20 When preoperative and postoperative responses to the SF-36 were compared in the present study, significant improvements were detected in mean scores corresponding to physical and social functioning, role limitations due to physical and emotional problems, energy and vitality, and bodily pain as well as in the physical health component summary. These findings are consistent with the results of similar studies and suggest prominent effects of breast reduction on QOL among women with macromastia. 6,25,26 Despite a significant postoperative improvement, the mean bodily pain score remained significantly less than the normative value. 20 Persistence of bodily pain in our study population could be related to long-term musculoskeletal effects of macromastia or could be complications of surgery. No significant changes in the mental health component summary were noted postoperatively, supporting the predominance of physical symptoms in our patient population. The results of the Rosenberg Self-Esteem Scale indicated low self-esteem in the study population preoperatively and a significant improvement postoperatively, consistent with the results of similar studies Changes in scores from the Rosenberg Self-Esteem Scale and BMI were negatively correlated in this study, suggesting that patients with low preoperative BMIs indicated greater postoperative improvements in self-esteem. Thin patients may perceive their hypertrophic breasts as disproportionate and may feel embarrassed in public and in social settings.

6 Kececi et al 53 Regression analyses were performed to control for covariate effects on the outcomes of breast reduction. BMI, age, and weight of resected tissue had no significant effect on improvements in SF-36 scores. However, changes in mean BRASS scores regarding negative social interactions and poor self-concept were negatively correlated with age, indicating larger improvements among younger patients for these domains. In contrast, age was positively correlated with improvements in mean scores for physical implications, suggesting that older patients improved more substantially in this domain. Breast resection weight had no significant effects on any breast reduction outcomes assessed, consistent with the results of other studies 24,30-33 and indicating that breast resection weight does not influence symptom relief. The change in the mean physical health component summary (SF-36) after breast reduction was positively correlated with the preoperative physical implication score (BRASS). If the change in the mean score for the physical health component summary is chosen as the primary marker of an improvement in QOL, scores pertaining to physical implications could be predictive of which women would benefit most from breast reduction. Patient questionnaires are applicable to everyday practice as well as research. During surgical consultations in our practice, patients overwhelmingly listed pain as their primary or sole complaint. Other symptoms related to physical implications, negative social interactions, poor selfconcept, and physical appearance were declared only after questioning. The BRASS can be a valuable tool for documenting symptoms related to macromastia in these patients, for surgical planning, and for managing patient expectations. Obese patients have been excluded from similar studies of QOL outcomes because of the higher operative risk and greater probability of postoperative complications in this patient population. 4,26 We included obese patients in the present study to investigate the effects of BMI on surgical outcomes. In addition, exclusion of obese patients from this study would have diminished the applicability of our findings because a considerable percentage of patients with macromastia are overweight or obese. This carefully designed prospective study enrolled consecutive patients to avoid selection bias and employed only validated questionnaires. However, this study has several limitations. Postoperative surveys were administered 4 months after breast reduction. Bodily pain reported after this duration could still be attributable to the surgery. Administering the postoperative survey after a longer duration could help characterize the persistence of the pain. We considered administering questionnaires at 1 or 2 years postoperatively to evaluate long-term effects of breast reduction, but it was unlikely that we would achieve sufficient patient participation after this duration. The mean educational level of our study population was low, and patients were not highly motivated to participate in the postoperative survey. Results of surveys administered 1 month after surgery indicate marked improvements in macromastia symptoms. 30 Another limitation of this study was the absence of a control group. The control group was omitted so that half of the patients would not have to wait 4 months before undergoing the indicated breast reduction. CONCLUSIONS Breast reduction alleviated all symptoms related to macromastia and improved health-related QOL in patients with breast hypertrophy. Patients with higher preoperative scores for the physical implication domain of BRASS showed more improved physical outcomes following breast reduction. Breast resection weight had no effects on surgical outcomes. Preoperative BMI affected improvements in symptoms related to psychological, but not physical, domains. The Turkish version of the BRASS has excellent responsiveness. Condition-specific and generic questionnaires should be administered together to capture important changes related to surgery and to enable comparisons of the health status of patients with that of the normal population. Supplementary Material A Supplementary Material that demonstrates placement of the cast may be viewed at or Disclosures The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Funding The authors received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Cano SJ, Browne JP, Lamping DL. Patient-based measures of outcome in plastic surgery: Current approaches and future directions. 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