Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised controlled trial
Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised controlled trial
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加强对南亚裔患者的糖尿病护理（英国亚裔糖尿病研究）：分组随机对照试验
DOI：
10.1016/s0140-6736(08)60764-3
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发表时间：
2008-05-24
期刊：
影响因子：
168.9
通讯作者：
Barnett, A. H.
中科院分区：
文献类型：
--
作者：
Bellary, S.;O'Hare, J. P.;Barnett, A. H.
向社区贫困阶层提供高质量的循证卫生保健是社会的一个主要目标。我们调查了英国全科实践中文化敏感的强化护理方案对改善南亚2型糖尿病患者心血管危险因素的有效性。方法：在本整群随机对照试验中，通过简单随机化将英国21个市中心诊所分配到干预组（强化护理，包括与执业护士的额外时间以及一名联络员和糖尿病专科护士的支持[9个诊所；n=8681]）或对照组（标准护理[12个诊所；n=618]）。所有南亚裔2型糖尿病成年患者均入选。为所有实践提供了具有明确目标的处方算法。主要结局是2年后血压、总胆固醇和血糖控制（血红蛋白A(1c)）的变化。分析的目的是治疗。本试验已注册，编号为ISRCTN 38297969。我们记录了两组舒张压的显著差异（1 ~ 91）[95% CI -2.88 ~ -0]。[14][参考文献]0001)和平均动脉压（0.01）。[-2.49到-0]23] mm Hg, p=0.0180)，校正混杂因素和聚类。我们注意到两组之间总胆固醇（0.03[-0.04至0.11]mmol/L）、收缩压（-0.33[-2.41至1.75]mm Hg）或HbA(1c)（-0.15%[-0.33至0.03]）无显著差异。经济分析表明，护士主导的干预并不具有成本效益（每获得QALY的增量成本效益比为28英镑933）。在2年的试验中，在整个研究人群中，收缩压、舒张压和胆固醇分别显著降低了4.9 (95% CI 4.0-5.9) mm Hg、3.8 (3.2-4.4)mm Hg和0.45 (0.40-0.51)mmol/L，我们记录到血红蛋白a (1c)（0 - 0.04%[-0.04 -0.04]）有小幅且不显著的升高。131), p = 0。290)。我们从我们的文化量身定制的护理方案中获得了额外的好处，尽管很小，但比英国近年来取得的长期变化更大。需要在一般实践中制定更严格的目标，并采取进一步措施激励患者，以便在南亚糖尿病患者中实现可能的最佳保健结果。资助辉瑞、赛诺菲-安万特、英国施维雅实验室、默克夏普多明/先灵葆雅、英国武田、罗氏、默克制药、英国第一三共、勃林格殷格翰、礼来、诺和诺德、百时美施贵宝、索尔维医疗保健和英国保险医学协会。
Background Delivery of high-quality, evidence-based health care to deprived sectors of the community is a major goal for society. We investigated the effectiveness of a culturally sensitive, enhanced care package in UK general practices for improvement of cardiovasular risk factors in patients of south Asian origin with type 2 diabetes.Methods In this cluster randomised controlled trial, 21 inner-city practices in the UK were assigned by simple randomisation to intervention (enhanced care including additional time with practice nurse and support from a link worker and diabetes-specialist nurse [nine practices; n=8681) or control (standard care [12 practices; n=618]) groups. All adult patients of south Asian origin with type 2 diabetes were eligible. Prescribing algorithms with clearly defined targets were provided for all practices. Primary outcomes were changes in blood pressure, total cholesterol, and glycaemic control (haemoglobin A(1c)) after 2 years. Analysis was by intention to treat. This trial is registered, number ISRCTN 38297969.Findings We recorded significant differences between treatment groups in diastolic blood pressure (1-91 [95% CI -2.88 to -0 . 94] Turn Hg, p=0. 0001) and mean arterial pressure (1 . 36 [-2.49 to -0 . 23] mm Hg, p=0.0180), after adjustment for confounders and clustering. We noted no significant differences between groups for total cholesterol (0.03 [-0.04 to 0.11] mmol/L), systolic blood pressure (-0.33 [-2.41 to 1.75] mm Hg), or HbA(1c) (-0.15% [-0.33 to 0.03]). Economic analysis suggests that the nurse-led intervention was not cost effective (incremental cost-effectiveness ratio 28 pound 933 per QALY gained). Across the whole study population over the 2 years of the trial, systolic blood pressure, diastolic blood pressure, and cholesterol decreased significantly by 4.9 (95% CI 4.0-5.9) mm Hg, 3.8 (3.2-4.4) mm Hg, and 0.45 (0.40-0.51) mmol/L, respectively, and we recorded a small and non-significant increase for haernoglobin A(1c) (0 - 04% [-0.04 to 0. 131), p=0. 290).Interpretation We recorded additional, although small, benefits from our culturally tailored care package that were greater than the secular changes achieved in the UK in recent years. Stricter targets in general practice and further measures to motivate patients are needed to achieve best possible health-care outcomes in south Asian patients with diabetes.Funding Pfizer, Sanofi-Aventis, Servier Laboratories UK, Merck Sharp & Dohme/ Schering-Plough, Takeda UK, Roche, Merck Pharma, Daiichi-Sankyo UK, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Bristol-Myers Squibb, Solvay Health Care, and Assurance Medical Society UK.