Chiam Galvin, Smith Sasha, Tu Tony, Din Amaan, Normahani Pasha, Davies Alun
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.
Imperial Vascular Unit, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
Diabet Med. 2025 Nov;42(11):e70134. doi: 10.1111/dme.70134. Epub 2025 Sep 12.
Diabetic sensorimotor polyneuropathy (DSPN) is the most common chronic complication of diabetes. Heterogeneity in outcome measures across DSPN trials may have hindered the development of novel therapies. No core outcome set (COS) exists to standardise DSPN trial outcomes. This systematic review aims to identify and synthesise outcomes reported in DSPN interventional trials.
The protocol was pre-registered on PROSPERO (CRD42023408403) and reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Prospective DSPN interventional trials since 2018 were searched with a predefined strategy, and primary and secondary verbatim outcomes were extracted, merged and organised using a taxonomy recommended by Core Outcome Measures in Effectiveness Trials (COMET). Outcome measuring tools were summarised descriptively.
Of the 4851 abstracts screened, 184 were eligible (protocols, n = 24; ongoing trials, n = 48 completed trials without published results, n = 11; published trials with results, n = 101). Pain was the most common primary (n = 127) and secondary (n = 64) unique outcome. By taxonomy, nervous system outcomes were the most common primary (n = 174) and secondary (n = 89) measure. The most common measuring tools were the visual analogue scale (n = 37), numerical rating scale (n = 37) and nerve conduction study (n = 34). Over 30 distinct measuring tools were utilised to measure nervous system outcomes.
Despite consistent outcome reporting, variability in measuring tools highlights the need for a COS with standardised tools. Patient-reported outcomes were more common than assessor-reported outcomes; however, using both may reduce response variability and bias. These findings will inform a future Delphi process to develop a COS for DSPN.
糖尿病感觉运动性多发性神经病变（DSPN）是糖尿病最常见的慢性并发症。DSPN试验中结局指标的异质性可能阻碍了新疗法的开发。目前尚无核心结局集（COS）来规范DSPN试验的结局。本系统评价旨在识别和综合DSPN干预试验中报告的结局。
该方案已在PROSPERO（CRD42023408403）上预先注册，并按照系统评价和Meta分析的首选报告项目（PRISMA）指南进行报告。使用预定义策略检索了自2018年以来的前瞻性DSPN干预试验，并提取了主要和次要的逐字记录结局，使用有效性试验核心结局指标（COMET）推荐的分类法进行合并和整理。对结局测量工具进行了描述性总结。
在筛选的4851篇摘要中，184篇符合条件（方案，n = 24；正在进行的试验，n = 48；未发表结果的完成试验，n = 11；已发表有结果的试验，n = 101）。疼痛是最常见的主要（n = 127）和次要（n = 64）独特结局。按分类法，神经系统结局是最常见的主要（n = 174）和次要（n = 89）测量指标。最常用的测量工具是视觉模拟量表（n = 37）、数字评定量表（n = 37）和神经传导研究（n = 34）。超过30种不同的测量工具被用于测量神经系统结局。
尽管结局报告一致，但测量工具的变异性凸显了使用标准化工具制定COS的必要性。患者报告的结局比评估者报告的结局更常见；然而，同时使用两者可能会降低反应变异性和偏倚。这些发现将为未来制定DSPN的COS的德尔菲过程提供参考。
