Surgical Research Unit, School of Social and Community Medicine, University of Bristol, Bristol, UK.
J Natl Cancer Inst. 2011 Jan 5;103(1):31-46. doi: 10.1093/jnci/djq438. Epub 2010 Dec 3.
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.
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.
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.
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.
乳腺癌根治术后的乳房重建需要准确评估，以便为循证参与式决策提供信息，但之前尚未考虑乳房重建后的结果报告标准。
我们广泛搜索了报告乳房重建手术结果的文章。我们使用已发表的并发症报告标准提取数据，并对其进行了修改，以反映重建实践。研究设计包括随机对照试验、队列研究和病例系列研究。使用 Cochrane 偏倚风险工具对所有研究设计进行严格评估。用于评估研究的其他标准包括选择和资金偏见、统计功效计算以及机构审查委员会批准。使用 Wilcoxon 符号秩检验比较研究结果的广度和频率，使用 χ²检验比较每组报告已发表标准中每项标准的研究数量。所有统计检验均为双侧。
在 134 项研究中评估了 42146 名女性乳房重建后的手术并发症。这些研究包括 11 项（8.2%）随机试验、74 项（55.2%）队列研究和 49 项（36.6%）病例系列研究。53%的研究在报告的并发症数量的方法和结果之间存在差异。87 项（64.9%）研究定义了并发症，78 项（58.2%）研究对其进行了分级。47 项（35.1%）研究分别遗漏了随访时间和不良结局的危险因素，58 项（43.3%）研究遗漏了这些内容。总体而言，这些研究对其报告的并发症的定义不足 20%，且这些定义在很大程度上不一致。
本系统评价的结果表明，乳房重建的结果报告不一致且缺乏方法学严谨性。建议制定标准化的核心结局集，以改善乳房重建的结果报告。
