OBJECTIVE Diabetes affects 537 million people globally, with 34% expected to develop foot ulceration in their lifetime. Diabetes-related foot ulceration causes strain on health care systems worldwide, necessitating provision of high-quality evidence to guide their management. Given heterogeneity of reported outcomes, a core outcome set (COS) was developed to standardize outcome measures in studies assessing treatments for diabetes-related foot ulceration. RESEARCH DESIGN AND METHODS The COS was developed using Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and patient interviews generated a long list of outcomes that were rated by patients and experts using a nine-point Likert scale (from 1 [not important] to 9 [critical]) in the first round of the Delphi survey. Based on predefined criteria, outcomes without consensus were reprioritized in a second Delphi round. Critical outcomes and those without consensus after two Delphi rounds were discussed in the consensus meeting where the COS was ratified. RESULTS The systematic review and patient interviews generated 103 candidate outcomes. The two consecutive Delphi rounds were completed by 336 and 176 respondents, resulting in an overall second round response rate of 52%. Of 37 outcomes discussed in the consensus meeting (22 critical and 15 without consensus after the second round), 8 formed the COS: wound healing, time to healing, new/recurrent ulceration, infection, major amputation, minor amputation, health-related quality of life, and mortality. CONCLUSIONS The proposed COS for studies assessing treatments for diabetes-related foot ulceration was developed using COMET methodology. Its adoption by the research community will facilitate assessment of comparative effectiveness of current and evolving interventions.

中文翻译：

---

为评估糖尿病相关足部溃疡干预措施的研究开发核心结局集


目的 糖尿病影响全球 5.37 亿人，预计 34% 的人在其一生中会出现足部溃疡。糖尿病相关的足部溃疡给全世界的医疗保健系统造成压力，需要提供高质量的证据来指导其管理。鉴于报告结局的异质性，开发了核心结局集 （COS） 来标准化评估糖尿病相关足部溃疡治疗研究的结局测量。研究设计和方法 COS 是使用有效性试验中的核心结局测量 （COMET） 方法开发的。在第一轮 Delphi 调查中，系统评价和患者访谈生成了一长串结果，这些结果由患者和专家使用 9 点李克特量表（从 1 [不重要] 到 9 [关键]）进行评分。根据预定义的标准，在第二轮 Delphi 中重新确定未达成共识的结果的优先级。关键结果和两轮 Delphi 后未达成共识的结果在批准 COS 的共识会议上进行了讨论。结果 系统评价和患者访谈产生了 103 个候选结果。连续两轮德尔菲轮次由 336 名和 176 名受访者完成，第二轮总体回复率为 52%。在共识会议讨论的 37 个结果中（第二轮后 22 个关键和 15 个未达成共识），8 个形成了 COS：伤口愈合、愈合时间、新发/复发性溃疡、感染、大截肢、小截肢、与健康相关的生活质量和死亡率。结论 拟议的用于评估糖尿病相关足部溃疡治疗的研究的 COS 是使用 COMET 方法开发的。 研究界采用它将有助于评估当前和不断发展的干预措施的比较有效性。