Department of Medicine, Rhode Island Hospital, Brown University, Providence, Rhode Island, USA.
Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong.
BMJ Evid Based Med. 2020 Jun;25(3):102-108. doi: 10.1136/bmjebm-2019-111197. Epub 2019 Aug 31.
To evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China.
We conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome.
Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes.
The EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians.
ChiCTR-TRC-14004169.
评估基于证据的个体化（EBI）咨询对高血压的治疗是否会影响中国轻度高血压参保患者的药物使用情况。
我们在中国深圳市的两个基层医疗中心进行了一项平行组、随机对照试验。招募了患有轻度原发性高血压、10 年心血管疾病（CVD）风险低于 20%且无 CVD 病史的患者，并将其随机分为两组。干预组接受 EBI 加一般咨询，对照组仅接受一般咨询。EBI 咨询包括每个个体估计的 10 年 CVD 风险和治疗获益的信息，以及降压药物的平均副作用和成本的信息。主要结局是 6 个月随访时的降压药物使用和治疗依从性，前者是主要结局。
共招募了 210 名患者，其中 103 名和 107 名患者分别被分配到干预组和对照组。基线时，62.4%的患者正在服用全部由健康保险覆盖的降压药物。在 6 个月随访结束时，干预组和对照组之间的药物使用率没有统计学上的显著差异（65.0% vs. 57.9%；OR=1.35，95%CI：0.77 至 2.36）。两组之间的治疗依从率差异也无统计学意义（43.7% vs. 40.2%；OR=1.15，95%CI 0.67 至 2.00]）。使用不同的截定点来定义这两个结局的敏感性分析结果稳健。
在本研究中，由保健教育工作者而不是主治医生进行的 EBI 咨询对轻度原发性高血压参保患者的治疗选择和服药行为影响不大。EBI 咨询是否会对未参保患者产生影响尚不清楚，特别是当由主治医生进行时。
ChiCTR-TRC-14004169。
