A systematic review of randomised controlled trials in breast reconstruction.

BACKGROUND: For preference sensitive treatments, such as breast reconstructions, there are barriers to conducting randomised controlled trials (RCTs). The primary aims of this systematic review were to investigate what type of research questions are explored by RCTs in breast reconstruction, where have they been performed and where have they been published, and to thematise the research questions and thus create an overview of the state of the research field. METHODS: Randomised controlled trials investigating any aspect of breast reconstructions were included. The PubMed database was searched with a pre-defined search string. Inclusion and data abstraction was performed in a pre-defined standardised fashion. For the purpose of this study, we defined key issues as comparison of categories of breast reconstruction and comparison of immediate and delayed breast reconstruction, when the thematisation was done. RESULTS: A total of 419 abstracts were retrieved from the search. Of the 419, 310 were excluded as they were not RCTs concerning some aspect of breast reconstruction, which left us with 110 abstracts to be included in the study. The research questions of the included studies could more or less be divided into seven different themes inclusive of 2 key issues: Other issues - comparison of different categories of breast reconstruction, comparison of immediate and delayed breast reconstruction, surgical details within a category of breast reconstruction, surgical details valid for several categories of breast reconstruction, donor site management, anaesthetics, and non-surgical details. Only five studies compared key issues, and they all illustrate the challenges with RCTs in breast reconstruction. CONCLUSIONS: A total of 110 publications based on RCTs in breast reconstruction have been published. Seven themes of research questions could be identified. Only five studies have explored the key issues. Better scientific evidence is needed for the key issues in breast reconstruction, for example by implementing a new study design in the field.

Swedish Normative Scores for the BREAST-Q Reduction/Mastopexy Module.

BACKGROUND: Norm values for patient reported outcomes, that is knowledge about how the general population of women rate their breast-related satisfaction and quality of life, are necessary to interpret the meaning of scores. The aims of this study were to create Swedish normative values for the BREAST-Q reduction/mastopexy module and to describe what healthy women are most satisfied/dissatisfied with regarding their breasts. METHODS: A random sample of 400 women aged 18-80, currently living in Region Västra Götaland, were sent BREAST-Q reduction/mastopexy. Descriptive data are presented. RESULTS: One hundred and forty-six women answered the questionnaire (36.5%). Mean total scores ranged from 48 to 78. No clear changes in scores could be seen with age and women with a high BMI seem to be less satisfied with their breasts. The participants were most satisfied with the appearance of the breasts when dressed, the appearance in the mirror dressed, the shape of the breasts with bra, and symmetry of size and most dissatisfied with appearance in the mirror naked and the shape of the breasts without a bra. Thirty to forty-five per cent of healthy women never or almost never feel sexually attractive. Among physical symptoms often described in breast hypertrophy, the most common among healthy women were lack of energy, pain in the neck, arms and shoulders, headache and difficulty performing intense physical activity. CONCLUSION: The norms for BREAST-Q reduction/mastopexy add another piece to the puzzle to what constitutes normal breast satisfaction and how surgical outcomes can be evaluated. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors   www.springer.com/00266 .

A systematic review and meta-analysis of risks and benefits with breast reduction in the public healthcare system: priorities for further research.

BACKGROUND: There is no consensus for when publicly funded breast reduction is indicated and recommendations in guidelines vary greatly, indicating a lack of evidence and unequal access. The primary aim of this review was to examine risks and benefits of breast reduction to treat breast hypertrophy. Secondary aims were to examine how the studies defined breast hypertrophy and indications for a breast reduction. METHODS: A systematic literature search was conducted in PubMed, MEDLINE All, Embase, the Cochrane Library, and PsycInfo. The included articles were critically appraised, and certainty of evidence was assessed using the GRADE approach. Meta-analyses were performed when possible. RESULTS: Fifteen articles were included; eight reporting findings from four randomised controlled trials, three non-randomised controlled studies, three case series, and one qualitative study. Most studies had serious study limitations and problems with directness. Few of the studies defined breast hypertrophy. The studies showed significantly improved health-related quality of life and sexuality-related outcomes in patients who had undergone breast reduction compared with controls, as well as reduced depressive symptoms, levels of anxiety and pain. Most effect sizes exceeded the reported minimal important difference for the scale. Certainty of evidence for the outcomes above is low (GRADE ⊕ ⊕). Although four studies reported significantly improved physical function, the effect is uncertain (very low certainty of evidence, GRADE ⊕). None of the included studies reported data regarding work ability or sick leave. Three case series reported a 30-day mortality of zero. Reported major complications after breast reduction ranged from 2.4 to 14% and minor complications from 2.4 to 69%. CONCLUSION: There is a lack of high-quality studies evaluating the results of breast reduction. A breast reduction may have positive psychological and physical effects for women, but it is unclear which women benefit the most and which women should be offered a breast reduction in the public healthcare system. Several priorities for further research have been identified. PRE-REGISTRATION: The study is based on a Health Technology Assessment report, pre-registered and then published on the website of The Regional HTA Centre of Region Västra Götaland, Sweden.

Objective evaluation of nipple position after 336 breast reductions.

Throughout different eras and cultures what is considered the cosmetically ideal breast has varied greatly. There is no broadly accepted standardised method that objectively evaluates aesthetic outcome after breast reduction mammoplasty. The primary aim of this study was to evaluate the result of breast reduction regarding nipple position, comparing it to an objective previously described standard. Secondary aims were to determine symmetry and examine predictors for achieving an aesthetically pleasing breast. The position of the nipple was measured in postoperative pictures and compared to a previously described standard. Three-hundred and thirty-six breast were included in the study. Compared with the previously described standard, 26% (89/336) of the nipples were within the optimal position in mediolateral direction, and 44% (147/336) in craniocaudal direction. The majority of women had the nipple in the same position in the two breasts. Age at surgery seems to significantly influence the possibility of achieving an optimal nipple position. No other predictors were found. Improvements can be made in placement of the nipple during reduction mammoplasty. Further studies are needed on how knowledge of the ideal nipple position can be used to optimize surgical planning and technique, and reduce variability in outcomes, in breast reduction mammoplasties.