Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Department of Surgery, Section of Vascular Surgery, Södersjukhuset, Stockholm, Sweden.
Br J Surg. 2022 Aug 16;109(9):846-856. doi: 10.1093/bjs/znac241.
Management of intermittent claudication should include secondary prevention to reduce the risk of cardiocerebrovascular disease. Patient adherence to secondary prevention is a challenge. The aim of this study was to investigate whether a person-centred, nurse-led follow-up programme could improve adherence to medication compared with standard care.
A non-blinded RCT was conducted at two vascular surgery centres in Sweden. Patients with intermittent claudication and scheduled for revascularization were randomized to the intervention or control (standard care) follow-up programme. The primary outcome, adherence to prescribed secondary preventive medication, was based on registry data on dispensed medication and self-reported intake of medication. Secondary outcomes were risk factors for cardiocerebrovascular disease according to the Framingham risk score.
Some 214 patients were randomized and analysed on an intention-to-treat basis. The mean proportion of days covered (PDC) at 1 year for lipid-modifying agents was 79 per cent in the intervention and 82 per cent in the control group, whereas it was 92 versus 91 per cent for antiplatelet and/or anticoagulant agents. The groups did not differ in mean PDC (lipid-modifying P = 0.464; antiplatelets and/or anticoagulants P = 0.700) or in change in adherence over time. Self-reported adherence to prescribed medication was higher than registry-based adherence regardless of allocation or medication group (minimum P < 0.001, maximum P = 0.034). There was no difference in median Framingham risk score at 1 year between the groups.
Compared with the standard follow-up programme, a person-centred, nurse-led follow-up programme did not improve adherence to secondary preventive medication. Adherence was overestimated when self-reported compared with registry-reported.
间歇性跛行的管理应包括二级预防以降低心脑血管疾病的风险。患者对二级预防的依从性是一个挑战。本研究旨在调查以患者为中心、护士主导的随访方案是否可以提高与标准护理相比的药物依从性。
在瑞典的两个血管外科中心进行了一项非盲随机对照试验。患有间歇性跛行并计划进行血运重建的患者被随机分配到干预组或对照组（标准护理）随访方案。主要结局是根据配药登记数据和自我报告的药物摄入量评估的规定二级预防药物的依从性。次要结局是根据弗雷明汉风险评分评估心脑血管疾病的风险因素。
共有 214 名患者按意向治疗进行随机分组和分析。1 年内调脂药物的平均覆盖天数（PDC）在干预组为 79%，在对照组为 82%，而抗血小板和/或抗凝药物的 PDC 分别为 92%和 91%。两组的平均 PDC 无差异（调脂药物 P=0.464；抗血小板和/或抗凝药物 P=0.700）或随时间的药物依从性变化无差异。无论分配或药物组如何，自我报告的药物依从性均高于基于登记的依从性（最小 P<0.001，最大 P=0.034）。1 年内两组的弗雷明汉风险评分中位数无差异。
与标准随访方案相比，以患者为中心、护士主导的随访方案并未提高二级预防药物的依从性。与登记报告相比，自我报告的药物依从性过高。
