Jarl Gustav
University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden,
Department of Prosthetics and Orthotics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden,
Patient Prefer Adherence. 2018 Sep 12;12:1767-1775. doi: 10.2147/PPA.S175738. eCollection 2018.
Foot ulcers are a diabetic complication associated with significant morbidity, mortality, and amputation risk. Offloading devices prevent and heal foot ulcers, but adherence to using these devices is low. The reasons for nonadherence are unclear, and study results are difficult to compare due to methodological heterogeneity. This paper explores aspects of investigating adherence to using offloading devices among people with diabetes and provides recommendations for future studies, focusing on study designs, definitions of adherence, measurement methods, and conceptual frameworks. Most studies use a cross-sectional observational study design, limiting the potential to establish the temporal sequence between predictors and adherence, rule out confounding factors, and establish causality. Studies defining adherence as the length of time the device is worn have often used self-report to measure adherence, which may be unreliable. Studies using activity monitors to measure adherence have defined adherence as the number of steps taken with the device, which excludes weight-bearing activities where no steps are taken. Conceptual frameworks are not made explicit in the current quantitative research. It is concluded that future studies should use a longitudinal design with observational studies to identify patient groups prone to nonadherence and factors that influence adherence and experimental studies to evaluate interventions to improve adherence, focusing on these patient groups and factors. Furthermore, adherence should be defined in terms of relative adherence to using offloading devices during all weight-bearing activities, and objective measurement of adherence (using accelerometers and temperature monitors) should be used whenever possible. Clearly defined conceptual frameworks should guide the choice of factors to include in the study and the analysis of their interactions. By implementing these recommendations, research could provide a stronger evidence base in the future, supporting interventions to increase adherence and thereby improve outcomes for people with diabetic foot complications.
足部溃疡是一种糖尿病并发症，与较高的发病率、死亡率及截肢风险相关。减压装置可预防和治愈足部溃疡，但这些装置的使用依从性较低。不依从的原因尚不清楚，且由于方法学上的异质性，研究结果难以比较。本文探讨了调查糖尿病患者使用减压装置依从性的相关方面，并针对未来研究提出建议，重点关注研究设计、依从性定义、测量方法和概念框架。大多数研究采用横断面观察性研究设计，限制了确定预测因素与依从性之间的时间顺序、排除混杂因素以及确定因果关系的可能性。将依从性定义为佩戴装置时间长短的研究通常使用自我报告来测量依从性，这可能不可靠。使用活动监测器测量依从性的研究将依从性定义为佩戴装置时所走的步数，这排除了不产生步数的负重活动。在当前的定量研究中，概念框架并未明确阐述。得出的结论是，未来的研究应采用纵向设计，通过观察性研究确定易出现不依从情况的患者群体及影响依从性的因素，并通过实验性研究评估改善依从性的干预措施，重点关注这些患者群体和因素。此外，依从性应根据在所有负重活动中使用减压装置的相对依从性来定义，并且应尽可能采用客观的依从性测量方法（使用加速度计和温度监测器）。明确界定的概念框架应指导研究中纳入因素的选择及其相互作用的分析。通过实施这些建议，未来的研究可以提供更有力的证据基础，支持旨在提高依从性从而改善糖尿病足并发症患者结局的干预措施。
