Manchester University NHS Foundation Trust, Manchester, UK
Northern Surgical Trainees Research Association, Newcastle, UK.
BMJ Open. 2022 Dec 6;12(12):e059463. doi: 10.1136/bmjopen-2021-059463.
Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous works have reported significant heterogeneity in outcome reporting for abdominal wall herniae, including ventral and inguinal hernia. This is coupled with under-reporting of important clinical and patient-reported outcomes. The lack of standardisation in outcome reporting contributes to reporting bias, hinders evidence synthesis and adequate data comparison between studies. This project aims to develop a core outcome set (COS) of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia.
This project has been designed as an international, multicentre, mixed-methods project. Phase I will be a systematic review of current literature to examine the current clinical and patient-reported outcomes for incisional hernia and abdominal wall reconstruction. Phase II will identify the outcomes of importance to all key stakeholders through in depth qualitative interviews. Phase III will achieve consensus on outcomes of most importance and for inclusion into a COS through a Delphi process. Phase IV will achieve consensus on the outcomes that should be included in a final COS.
The adoption of this COS into clinical and academic practice will be endorsed by the American, British and European Hernia Societies. Its utilisation in future clinical research will enable appropriate data synthesis and comparison and will enable better clinical interpretation and application of the current evidence base. This study has been registered with the Core Outcome Measures in Effectiveness Trials initiative.
CRD42018090084.
剖腹术后切口疝的发病率高达 20%，并伴有显著的发病率和生活质量受损。有多种手术策略可用于治疗切口疝患者，包括技术和网片类型。以前的工作已经报告了腹壁疝（包括腹侧和腹股沟疝）的结果报告存在显著的异质性。这与重要的临床和患者报告结果的报告不足有关。结果报告缺乏标准化导致报告偏倚，阻碍了证据综合和研究之间的充分数据比较。本项目旨在制定一套临床重要的、以患者为中心的核心结局集（COS），用于指导未来切口疝研究的报告。
本项目设计为一项国际、多中心、混合方法项目。第一阶段将对当前文献进行系统回顾，以检查切口疝和腹壁重建的当前临床和患者报告结果。第二阶段将通过深入的定性访谈确定所有主要利益相关者重视的结果。第三阶段将通过 Delphi 过程就最重要的结果达成共识，并将其纳入 COS。第四阶段将就应纳入最终 COS 的结果达成共识。
美国、英国和欧洲疝学会将认可该 COS 纳入临床和学术实践。它在未来临床研究中的应用将能够进行适当的数据综合和比较，并能够更好地对现有证据基础进行临床解释和应用。本研究已在核心结局测量在有效性试验倡议中注册。
PROSPERO 注册号：CRD42018090084。
