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.
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.
Authors: Paula R Williamson; Douglas G Altman; Heather Bagley; Karen L Barnes; Jane M Blazeby; Sara T Brookes; Mike Clarke; Elizabeth Gargon; Sarah Gorst; Nicola Harman; Jamie J Kirkham; Angus McNair; Cecilia A C Prinsen; Jochen Schmitt; Caroline B Terwee; Bridget Young Journal: Trials Date: 2017-06-20 Impact factor: 2.279
Authors: Jean-Baptiste Beuscart; Lisa G Pont; Stefanie Thevelin; Benoit Boland; Olivia Dalleur; Anne W S Rutjes; Johanna I Westbrook; Anne Spinewine Journal: Br J Clin Pharmacol Date: 2017-01-18 Impact factor: 4.335
Authors: Nicola Rocco; Corrado Rispoli; Lorenzo Moja; Bruno Amato; Loredana Iannone; Serena Testa; Andrea Spano; Giuseppe Catanuto; Antonello Accurso; Maurizio B Nava Journal: Cochrane Database Syst Rev Date: 2016-05-16
Authors: Paula R Williamson; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; Peter Tugwell Journal: Trials Date: 2012-08-06 Impact factor: 2.279
Authors: Delphine Héquet; Kevin Zarca; Sylvie Dolbeault; Benoît Couturaud; Charlotte Ngô; Virgine Fourchotte; Anne De La Rochefordière; Jean-Guillaume Féron; Alfred Fitoussi; Catherine Bélichard; Fabien Reyal; Fatima Laki; David Hajage; Brigitte Sigal; Bernard Asselain; Séverine Alran Journal: Springerplus Date: 2013-07-18
Authors: Caroline Miller; Jane Cross; Joel O'Sullivan; Dominic M Power; Derek Kyte; Christina Jerosch-Herold Journal: BMJ Open Date: 2021-07-30 Impact factor: 2.692