Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Diabet Med. 2020 Aug;37(8):1256-1265. doi: 10.1111/dme.14326. Epub 2020 Jun 23.
To identify and synthesize the evidence for the effectiveness of psychosocial interventions to promote the healing, and/or reduce the occurrence of, foot ulceration in people with diabetes.
In March 2019 we searched CENTRAL, Medline, Embase and PsycInfo for randomized controlled trials of interventions with psychosocial components for people with diabetes. The primary outcomes of this review were foot ulceration and healing. We assessed studies using the Cochrane risk-of-bias tool, the TIDieR checklist and GRADE. We conducted narrative synthesis and random-effects meta-analysis.
We included 31 randomized controlled trials (4511 participants), of which most (24 randomized controlled trials, 4093 participants) were prevention studies. Most interventions were educational with a modest psychosocial component. Ulceration and healing were not reported in most studies; secondary outcomes varied. Evidence was of low or very low quality because of high risks of bias and imprecision, and few studies reported adherence or fidelity. In groups where participants had prior ulceration, educational interventions had no clear effect on new ulceration (low-quality evidence). Two treatment studies, assessing continuous pharmacist support and an intervention to promote understanding of well-being, reported healing but their evidence was also of very low quality.
Most psychosocial intervention randomized controlled trials assessing foot ulcer outcomes in people with diabetes were prevention studies, and most interventions were primarily educational. Ulcer healing and development were not well reported. There is a need for better understanding of psychological and behavioural influences on ulcer incidence, healing and recurrence in people with diabetes. Randomized controlled trials of theoretically informed interventions, which assess clinical outcomes, are urgently required. (PROSPERO registration: CRD42016052960).
确定和综合心理社会干预措施促进糖尿病患者足部溃疡愈合和/或减少足部溃疡发生的有效性证据。
2019 年 3 月，我们对具有心理社会干预内容的糖尿病患者干预措施的随机对照试验进行了 CENTRAL、Medline、Embase 和 PsycInfo 检索。本综述的主要结局是足部溃疡和愈合。我们使用 Cochrane 偏倚风险工具、TIDieR 清单和 GRADE 对研究进行评估。我们进行了叙述性综合和随机效应荟萃分析。
我们纳入了 31 项随机对照试验（4511 名参与者），其中大多数（24 项随机对照试验，4093 名参与者）是预防研究。大多数干预措施是教育性的，具有适度的心理社会成分。大多数研究未报告溃疡和愈合情况；次要结局也各不相同。由于偏倚风险高和不精确，以及很少有研究报告依从性或忠实性，证据质量为低或极低。在先前有溃疡的参与者组中，教育干预对新发溃疡没有明显效果（低质量证据）。两项治疗研究评估了持续的药剂师支持和促进对幸福感的理解的干预措施，报告了愈合情况，但证据质量也非常低。
大多数评估糖尿病患者足部溃疡结局的心理社会干预随机对照试验都是预防研究，大多数干预措施主要是教育性的。溃疡愈合和发展情况报告不佳。需要更好地了解心理和行为因素对糖尿病患者溃疡发生率、愈合和复发的影响。迫切需要进行理论指导的干预措施的随机对照试验，评估临床结局。（PROSPERO 注册：CRD42016052960）。
