Reporting clinical outcomes of breast reconstruction: a systematic review.
BACKGROUND
Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered.


METHODS
We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided.


RESULTS
Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent.


CONCLUSIONS
The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.
Surgical Research Unit, School of Social and Community Medicine, University of Bristol, Bristol, UK. Shelley.Potter@bristol.ac.uk
S
S
Potter
A
A
Brigic
P F
PF
Whiting
S J
SJ
Cawthorn
K N L
KN
Avery
J L
JL
Donovan
J M
JM
Blazeby
D001943:Breast Neoplasms / Q000601:surgery*; D015331:Cohort Studies; D016208:Databases, Factual; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D018156:Journalism, Medical / Q000592:standards; D016462:Mammaplasty / Q000009:adverse effects; D015411:Mastectomy, Modified Radical; D009017:Morbidity; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic; D015983:Selection Bias; D016896:Treatment Outcome