A systematic review of outcomes measured in interventional trials in people with diabetic sensorimotor polyneuropathy

IF 3.4 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Diabetic Medicine Pub Date : 2025-09-12 DOI:10.1111/dme.70134

Galvin Chiam, Sasha Smith, Tony Tu, Amaan Din, Pasha Normahani, Alun Davies

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Abstract

Aims

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.

Methods

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.

Results

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.

Conclusions

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.

Abstract Image

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对糖尿病感觉运动多神经病变患者介入试验结果的系统回顾。

目的：糖尿病感觉运动多发性神经病（DSPN）是糖尿病最常见的慢性并发症。DSPN试验结果测量的异质性可能阻碍了新疗法的发展。没有核心结局集（COS）来标准化DSPN试验结果。本系统综述旨在识别和综合在DSPN干预性试验中报道的结果。方法：该方案在PROSPERO （CRD42023408403）上预先注册，并按照系统评价和荟萃分析（PRISMA）指南的首选报告项目进行报告。使用预定义的策略检索自2018年以来的前瞻性DSPN干预性试验，并使用有效性试验核心结果测量（COMET）推荐的分类提取、合并和组织主要和次要逐字结果。结果测量工具进行描述性总结。结果：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，已完成的试验，n = 11；已发表的试验，n = 101）。疼痛是最常见的主要结局（n = 127）和次要结局（n = 64）。通过分类学，神经系统预后是最常见的主要（n = 174）和次要（n = 89）指标。最常用的测量工具是视觉模拟量表（n = 37）、数值评定量表（n = 37）和神经传导研究（n = 34）。超过30种不同的测量工具被用来测量神经系统的结果。结论：尽管结果报告一致，但测量工具的可变性突出了使用标准化工具进行COS的必要性。患者报告的结果比评估者报告的结果更常见；然而，两者同时使用可以减少反应的变异性和偏倚。这些发现将为未来的德尔福过程提供信息，以开发DSPN的COS。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetic Medicine 医学-内分泌学与代谢

CiteScore

7.20

自引率

5.70%

发文量

229

审稿时长

3-6 weeks

期刊介绍： Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions. The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed. We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services. Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”