Dovell George, Staniszewska Aleksandra, Ramirez Jozel, Murray Ines, Ambler Graeme K, Twine Christopher P, Hinchliffe Robert J
Centre for Surgical Research, University of Bristol, Bristol, UK.
Department of Vascular Surgery, North Bristol NHS Trust, Bristol, UK.
Diabet Med. 2021 Oct;38(10):e14664. doi: 10.1111/dme.14664. Epub 2021 Aug 9.
Diabetic foot ulceration (DFU) is a challenging clinical problem that affects up to a quarter of patients with diabetes in their lifetime. An agreed set of outcomes for assessing treatments or interventions for DFU has not previously been considered. The aim of this study was to identify outcomes that are reported in clinical studies assessing a treatment or intervention for DFU, to inform the development of a core outcome set (COS).
Systematic literature searches were performed between January 2016 and March 2019. The search strategy was pre-registered with PROSPERO (CRD42019128250). Two authors independently screened abstracts for full text review. Outcomes were extracted from selected papers verbatim and categorized into domains according to established taxonomy. Consistency of outcome reporting was assessed. Overlapping outcomes were merged independently to condense the extracted list of outcomes for use in forthcoming consensus processes.
Of 4645 abstracts identified, 114 studies met the inclusion criteria. There were 69 randomized studies, 40 prospective studies and 5 protocols. Some 948 outcomes were extracted verbatim. Outcome reporting was consistent for 474 (53%) outcomes. De-duplication left 714 unique verbatim outcomes across 33 domains. Merging of overlapping unique verbatim outcomes established 95 merged outcomes.
This study describes contemporary outcomes reported in studies assessing interventions for DFU. Outcome reporting is considered to be poor as it was consistent in just over half of outcomes extracted. Merging of outcomes has identified 95 outcomes that can be taken forward in the development of a COS.
糖尿病足溃疡（DFU）是一个具有挑战性的临床问题，一生中影响多达四分之一的糖尿病患者。此前尚未考虑过一套用于评估DFU治疗或干预措施的商定结果。本研究的目的是确定在评估DFU治疗或干预措施的临床研究中报告的结果，为核心结局集（COS）的制定提供信息。
于2016年1月至2019年3月进行了系统的文献检索。检索策略已在PROSPERO（CRD42019128250）上预先注册。两位作者独立筛选摘要以进行全文审查。从选定的论文中逐字提取结果，并根据既定分类法将其分类到各个领域。评估结果报告的一致性。对重叠的结果进行独立合并，以浓缩提取的结果列表，用于即将进行的共识过程。
在识别出的4645篇摘要中，114项研究符合纳入标准。其中有69项随机研究、40项前瞻性研究和5项方案。共逐字提取了约948个结果。474个（53%）结果的报告是一致的。去重后在33个领域留下了714个独特的逐字结果。重叠独特逐字结果的合并产生了95个合并结果。
本研究描述了评估DFU干预措施的研究中报告的当代结果。结果报告被认为较差，因为在提取的结果中只有略多于一半的结果是一致的。结果合并确定了95个结果，可用于COS的制定。
