Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17th St, Tulsa, OK, 74107, USA.
Department of Otolaryngology-Head and Neck Surgery, University of Texas Medical Branch, Galveston, TX, USA.
Eur Arch Otorhinolaryngol. 2023 Jun;280(6):2805-2819. doi: 10.1007/s00405-022-07803-y. Epub 2023 Jan 3.
To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS).
Using a cross-sectional study design, we performed a comprehensive search using MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and the Cochrane Database of Systematic Reviews databases for SRs regarding FESS on May 15th, 2022. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, we extracted general study characteristics, harms items, and overall methodological quality for each SR in our sample. Corrected covered area (CCA) was calculated for SR dyads. For data analysis, using Stata 16.1 we performed a bivariate analysis between variables.
Fifty-five SR's were included in our sample after excluding 375 studies that did not meet our inclusion criteria. Of the included SRs, 19 (19/55, 34.5%) did not report harms and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs had a balanced discussion of harms and benefits of FESS. Fifty-two SRs were appraised as "critically low" quality using AMSTAR-2. A significant association was found between completeness of harms reporting (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms.
Our study demonstrates gaps in harms reporting regarding FESS in SRs. We recommend future studies implement guidelines such as the STROCCS guidelines or the harms extension of the PRISMA guidelines to improve harms reporting. Accurate harms reporting may advance patient safety and promote a more objective risk-benefit analysis for physicians and patients.
评估与功能性内镜鼻窦手术（FESS）相关的系统评价（SR）中危害报告的完整性。
使用横断面研究设计，我们于 2022 年 5 月 15 日在 MEDLINE（PubMed 和 Ovid）、EMBASE、Epistemonikos 和 Cochrane 系统评价数据库中进行了全面搜索，以查找关于 FESS 的 SR。对检索结果进行筛选，并以盲法、重复的方式提取数据。根据既定方法，我们提取了样本中每个 SR 的一般研究特征、危害项目和整体方法学质量。计算了 SR 对子的校正涵盖面积（CCA）。对于数据分析，我们使用 Stata 16.1 在变量之间进行了双变量分析。
在排除了不符合纳入标准的 375 项研究后，我们的样本中包括 55 项 SR。在纳入的 SR 中，19 项（19/55，34.5%）未报告危害，39 项（39/55，70.9%）报告的危害项目少于一半。我们的研究发现，23 项（23/55，41.8%）SR 显示了危害数据收集方法，26 项（26/55，47.3%）SR 的结果中有患者可用于危害分析，25 项（25/55，45.5%）SR 对 FESS 的危害和益处进行了平衡讨论。使用 AMSTAR-2 对 52 项 SR 进行评估，结果均为“极低”质量。危害报告的完整性（Mahady）与危害是否被列为主要结局之间存在显著关联。其他关联均无统计学意义。有 2 对 SR 对子的 CCA 重叠在 20%至 50%之间，对其独特和共同的危害进行了比较。
我们的研究表明，SR 中关于 FESS 的危害报告存在差距。我们建议未来的研究实施 STROCCS 指南或 PRISMA 指南的危害扩展等指南，以改善危害报告。准确的危害报告可能会提高患者安全性，并为医生和患者促进更客观的风险效益分析。
