National Clinical Research Centre for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital, National Centre for Cardiovascular Diseases, Beijing, China.
National Clinical Research Centre for Cardiovascular Diseases, Shenzhen, Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences, Shenzhen, China.
BMJ. 2024 Jul 23;386:e079143. doi: 10.1136/bmj-2023-079143.
To evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of guideline accordant antihypertensive treatment in primary care settings in China.
Pragmatic, open label, cluster randomised trial.
94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen (south China, including two regions).
94 practices were randomised (46 to CDSS, 48 to usual care). 12 137 participants with hypertension who used up to two classes of antihypertensives and had a systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg were included.
Primary care practices were randomised to use an electronic health record based CDSS, which recommended a specific guideline accordant regimen for initiation, titration, or switching of antihypertensive (the intervention), or to use the same electronic health record without CDSS and provide treatment as usual (control).
The primary outcome was the proportion of hypertension related visits during which an appropriate (guideline accordant) treatment was provided. Secondary outcomes were the average reduction in systolic blood pressure and proportion of participants with controlled blood pressure (<140/90 mm Hg) at the last scheduled follow-up. Safety outcomes were patient reported antihypertensive treatment related events, including syncope, injurious fall, symptomatic hypotension or systolic blood pressure <90 mm Hg, and bradycardia.
5755 participants with 23 113 visits in the intervention group and 6382 participants with 27 868 visits in the control group were included. Mean age was 61 (standard deviation 13) years and 42.5% were women. During a median 11.6 months of follow-up, the proportion of visits at which appropriate treatment was given was higher in the intervention group than in the control group (77.8% (17 975/23 113) 62.2% (17 328/27 868); absolute difference 15.2 percentage points (95% confidence interval (CI) 10.7 to 19.8); P<0.001; odds ratio 2.17 (95% CI 1.75 to 2.69); P<0.001). Compared with participants in the control group, those in the intervention group had a 1.6 mm Hg (95% CI -2.7 to -0.5) greater reduction in systolic blood pressure (-1.5 mm Hg 0.3 mm Hg; P=0.006) and a 4.4 percentage point (95% CI -0.7 to 9.5) improvement in blood pressure control rate (69.0% (3415/4952) 64.6% (3778/5845); P=0.07). Patient reported antihypertensive treatment related adverse effects were rare in both groups.
Use of a CDSS in primary care in China improved the provision of guideline accordant antihypertensive treatment and led to a modest reduction in blood pressure. The CDSS offers a promising approach to delivering better care for hypertension, both safely and efficiently.
ClinicalTrials.gov NCT03636334.
评估临床决策支持系统（CDSS）在改善中国基层医疗环境中遵循指南的降压治疗效果。
实用、开放标签、整群随机试验。
2019 年 8 月至 2022 年 7 月期间中国四个城市地区（中国中部的洛阳、中国东部的济宁和中国南部的深圳，包括两个地区）的 94 个基层医疗诊所。
94 个诊所被随机分配（46 个使用 CDSS，48 个使用常规护理）。纳入了 12137 名使用了最多两种降压药物且收缩压<180mmHg 且舒张压<110mmHg 的高血压患者。
基层医疗诊所被随机分配使用基于电子病历的 CDSS，该系统推荐特定的符合指南的方案来启动、滴定或转换降压药物（干预），或使用相同的电子病历而不使用 CDSS 并提供常规治疗（对照组）。
主要结局是在适当（符合指南）的治疗中提供的高血压相关就诊比例。次要结局是收缩压的平均降低和最后预约随访时血压控制良好（<140/90mmHg）的参与者比例。安全结局是患者报告的降压治疗相关不良事件，包括晕厥、伤害性跌倒、症状性低血压或收缩压<90mmHg 以及心动过缓。
干预组有 5755 名参与者和 23113 次就诊，对照组有 6382 名参与者和 27868 次就诊。平均年龄为 61（标准差 13）岁，42.5%为女性。在中位 11.6 个月的随访期间，干预组的就诊中给予适当治疗的比例高于对照组（77.8%（17975/23113）比 62.2%（17328/27868）；绝对差异 15.2 个百分点（95%置信区间（CI）为 10.7 至 19.8）；P<0.001；比值比（OR）2.17（95%CI 1.75 至 2.69）；P<0.001）。与对照组参与者相比，干预组参与者的收缩压降低了 1.6mmHg（95%CI-2.7 至-0.5）（-1.5mmHg 至 0.3mmHg；P=0.006），血压控制率提高了 4.4 个百分点（95%CI-0.7 至 9.5）（69.0%（3415/4952）比 64.6%（3778/5845）；P=0.07）。两组患者报告的降压治疗相关不良事件均很少见。
在中国基层医疗中使用 CDSS 提高了遵循指南的降压治疗效果，并导致血压适度降低。CDSS 提供了一种有前途的方法，可以安全有效地为高血压患者提供更好的护理。
ClinicalTrials.gov NCT03636334。
