Svendsen Karianne, Telle-Hansen Vibeke H, Mørch-Reiersen Lisa T, Garstad Kjersti W, Thyholt Kari, Granlund Linda, Henriksen Hege Berg, Gran Jon Michael, Jacobs David R, Retterstøl Kjetil
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046 Blindern, 0317 Oslo, Norway.
Mills AS, P.O. Box 4644 Sofienberg, 0506 Oslo, Norway.
Prev Med Rep. 2018 Aug 9;12:79-86. doi: 10.1016/j.pmedr.2018.08.004. eCollection 2018 Dec.
We investigated if alerting subjects to elevated total cholesterol (TC), hemoglobin A1c (HbA1c) and blood pressure (BP) (cardiovascular disease (CVD) risk factors that are usually asymptomatic), and if providing advice would result in reduced risk. We conducted a multicenter (50 community pharmacies) parallel three-arm 8-week randomized controlled trial (RCT) with a 52-week follow-up visit. During six days of screening, TC, HDL- and LDL-cholesterol, triglycerides, HbA1c, BP and body mass index (BMI) were assessed in 1318 individuals. Of these, 582 with a measured and predefined elevated ad hoc CVD risk score were randomized to either Alert/advice (n = 198) (immediately alerted of their screening result and received healthy lifestyle-advice), Advice-only (n = 185) (received only advice) or Control (n = 199) (not alert, no advice). Changes in risk score and self-reported health-related behaviors (diet, alcohol, physical activity) were assessed in pharmacies after 8 weeks (N = 543; 93%). Although the primary analysis showed no significant difference between groups, the Control group had the largest reduction in risk score of 14%. The total (uncontrolled) sample (N = 543) reduced the risk score by 3.2% beyond estimated regression towards the mean and improved their health-related behaviors. Among the 65% (n = 377) who returned 52 weeks after baseline, 14% reported started using CVD preventive medication after the screening. The study demonstrated that while assessing risk factors and behaviors in pharmacies proved efficient and possibly led to a small risk decrease, alerting people to their screening result did not seem to be more effective than a self-directed approach. ClinicalTrials.gov identifier: NCT02223793.
我们研究了向受试者告知总胆固醇（TC）、糖化血红蛋白（HbA1c）和血压（BP）升高（通常无症状的心血管疾病（CVD）风险因素）以及提供建议是否会降低风险。我们进行了一项多中心（50家社区药房）平行三臂8周随机对照试验（RCT），并进行了为期52周的随访。在6天的筛查期间，对1318名个体的TC、高密度脂蛋白和低密度脂蛋白胆固醇、甘油三酯、HbA1c、BP和体重指数（BMI）进行了评估。其中，582名测量并预先定义的临时CVD风险评分升高的个体被随机分为“提醒/建议”组（n = 198）（立即被告知其筛查结果并接受健康生活方式建议）、“仅建议”组（n = 185）（仅接受建议）或“对照组”（n = 199）（不提醒，不提供建议）。8周后在药房评估风险评分和自我报告的健康相关行为（饮食、饮酒、体育活动）的变化（N = 543；93%）。虽然初步分析显示各组之间无显著差异，但对照组的风险评分下降幅度最大，为14%。总（未控制）样本（N = 543）的风险评分比估计的向均值回归降低了3.2%，并改善了他们的健康相关行为。在基线后52周回访的65%（n = 377）中，14%报告在筛查后开始使用CVD预防药物。该研究表明，虽然在药房评估风险因素和行为被证明是有效的，并且可能导致风险略有降低，但提醒人们注意其筛查结果似乎并不比自我指导的方法更有效。ClinicalTrials.gov标识符：NCT02223793。
