Shao Taihang, Li Xia, Zhou Chengchao, Zang Xiao, Malone Daniel C, Zhang Liang, Zhou Jifang, Tang Wenxi
Department of Pharmacoeconomics, School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.
Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing, China.
Front Med (Lausanne). 2021 Feb 25;8:651559. doi: 10.3389/fmed.2021.651559. eCollection 2021.
The Chinese government has established a nationwide community-based chronic disease management program since 2009 with hypertension a vital part of it. Though drugs have been proven effective with hypertensive patients, they bring economic burden as well, especially for those who with elevated blood pressure and are potentially eligible for national programs. When the effectiveness of pharmacotherapy-only interventions remains uncertain on these patients, non-pharmacological interventions have demonstrated non-inferior effectiveness and may have economic advantages. To date, there rarely are evidences on the effectiveness and cost-effectiveness of non-pharmacological treatment in comparison with pharmacological interventions for patients with varying severity of blood pressure. This study aims to propose a study for a network meta-analysis and cost-effectiveness analysis to explore what kind of intervention is potentially effective and cost-effective to four specific patient groups, stage I-III hypertensive patients and patients with elevated blood pressure, and to provide recommendations for hypertensive management to Chinese decision makers. We will systematically search databases (MEDLINE, PubMed, Cochrane Library, etc.,) for randomized controlled trials and observational studies with qualified study design in recent decade that assess the effectiveness of non-pharmacological, pharmacological, or combined intervention aimed at adult populations who are diagnosed with the above four types of hypertension in China. The effectiveness outcomes will include changes in SBP/DBP, rate of comorbidities, mortality, and health related quality of life. We will use network meta-analysis to compare and rank effectiveness of different interventions. Subgroup analyses and meta-regression analyses will be performed to analyze and explain heterogeneity. The economic outcome will include cost-effectiveness based on simulation results from Markov models. Under study perspective of Chinese health system, life-time direct cost will be included. This study aims to compare and rank the effectiveness and cost-effectiveness of pharmacological, non-pharmacological and combined interventions for stage I-III hypertensive patients and those who with elevated blood pressure. Compared to existing studies, this comprehensive synthesis of relevant evidences will influence future practice with better efficiency and generalizability for community-based hypertensive management programs in China. The study might also be valuable for other low- and middle-income countries to find their own solutions. CRD42020151518.
自2009年以来,中国政府建立了一项全国性的社区慢性病管理计划,高血压是其中的重要组成部分。尽管药物已被证明对高血压患者有效,但它们也带来了经济负担,特别是对于那些血压升高且可能符合国家计划条件的患者。当仅采用药物治疗干预对这些患者的有效性仍不确定时,非药物干预已显示出非劣效性,并且可能具有经济优势。迄今为止,与针对不同血压严重程度患者的药物干预相比,关于非药物治疗的有效性和成本效益的证据很少。本研究旨在提出一项网络荟萃分析和成本效益分析研究,以探索哪种干预措施对四个特定患者群体(I-III期高血压患者和血压升高患者)可能有效且具有成本效益,并为中国决策者提供高血压管理建议。我们将系统地检索数据库(MEDLINE、PubMed、Cochrane图书馆等),以查找近十年内具有合格研究设计的随机对照试验和观察性研究,这些研究评估了针对在中国被诊断为上述四种高血压类型的成年人群的非药物、药物或联合干预的有效性。有效性结果将包括收缩压/舒张压的变化、合并症发生率、死亡率以及与健康相关的生活质量。我们将使用网络荟萃分析来比较和排名不同干预措施的有效性。将进行亚组分析和荟萃回归分析以分析和解释异质性。经济结果将包括基于马尔可夫模型模拟结果的成本效益。在中国卫生系统的研究视角下,将纳入终身直接成本。本研究旨在比较和排名药物、非药物和联合干预措施对I-III期高血压患者和血压升高患者的有效性和成本效益。与现有研究相比,这种对相关证据的综合汇总将以更高的效率和可推广性影响中国社区高血压管理计划的未来实践。该研究对于其他低收入和中等收入国家寻找自身解决方案可能也具有价值。CRD42020151518