John Ashis Samuel, Ganapathi Sanjay, Harikrishnan Sivadasanpillai, Lekha Thoniparambil Ravindranathanpillai, Stanley Antony, Soman Biju, Anish Thekkumkara Surendran, Hadaye Rujuta, Cherian Jerin Jose, Tandon Nikhil, Prabhakaran Dorairaj, Jeemon Panniyammakal
Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.
Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.
Glob Heart. 2025 Jul 31;20(1):65. doi: 10.5334/gh.1450. eCollection 2025.
We performed a within-trial cost-effectiveness analysis of a targeted family-based structured lifestyle modification intervention for cardiovascular risk reduction.
The PROLIFIC study was an open-label, cluster randomised controlled trial in the families (first-degree relatives and spouses older than age 18 years) of individuals with premature coronary heart disease. Families in the intervention group received a comprehensive package of interventions facilitated by non-physician health workers: screening for cardiovascular risk factors, structured lifestyle interventions, linkage to a primary healthcare facility for individuals with established chronic disease risk factors or conditions, and active follow-up for adherence. The usual care group received one-time counselling and annual screening for risk factors. The cost was estimated from a health system perspective, including intervention and treatment costs. Effectiveness was measured as changes in risk factors and quality-adjusted life years (QALYs) elicited using the EQ-5D-5 L instrument. The time horizon was two years, and we performed one-way and probabilistic sensitivity analyses.
Over two years, the incremental cost for the intervention compared to usual care was Int$ 157.5 per person (intervention group: Int$ 381.6, usual care group: Int$ 224.1), and the incremental QALY gain was 0.014 (0.0166 Vs 0.0027). The within-trial ICER was 11,352 Int$/QALY. Incremental cost per unit reduction in systolic blood pressure, fasting plasma glucose, HbA1c, total cholesterol, and waist circumference were Int$ 28.5, 26.9, 130.8, 178.7, and 39.8, respectively.
A family-based structured lifestyle modification program yields a net gain in quality of life and is cost-effective at a three times gross domestic product per capita threshold. The intervention is expected to be relatively more cost-effective when scaled up to larger populations over longer time horizons. The intervention has the potential for a substantial public health impact if adopted as a strategy at the state or national level.Trial Registration Number: Clinicaltrials.gov, NCT02771873.
我们对一项以家庭为基础的针对性结构化生活方式改变干预措施进行了试验内成本效益分析，以降低心血管疾病风险。
PROLIFIC研究是一项开放标签、整群随机对照试验，研究对象为早发性冠心病患者的家庭（18岁以上的一级亲属和配偶）。干预组家庭接受了由非医师卫生工作者提供的一揽子综合干预措施：心血管危险因素筛查、结构化生活方式干预、为有既定慢性病危险因素或疾病的个体与初级医疗保健机构建立联系，以及积极随访以确保依从性。常规护理组接受了一次性咨询和年度危险因素筛查。成本从卫生系统角度进行估算，包括干预和治疗成本。有效性通过使用EQ-5D-5L工具得出的危险因素变化和质量调整生命年（QALY）来衡量。时间跨度为两年，我们进行了单向和概率敏感性分析。
在两年时间里，与常规护理相比，干预措施的增量成本为每人157.5国际元（干预组：381.6国际元，常规护理组：224.1国际元），增量QALY增益为0.014（0.0166对0.0027）。试验内成本效果比为11,352国际元/QALY。收缩压、空腹血糖、糖化血红蛋白、总胆固醇和腰围每降低一个单位的增量成本分别为28.5国际元、26.9国际元、130.8国际元、178.7国际元和39.8国际元。
以家庭为基础的结构化生活方式改变项目可带来生活质量的净增益，并且在人均国内生产总值三倍的阈值下具有成本效益。预计在更长时间范围内扩大到更大人群时，该干预措施将相对更具成本效益。如果作为一项战略在州或国家层面采用，该干预措施有可能对公共卫生产生重大影响。试验注册号：Clinicaltrials.gov，NCT02771873。
