Centre for Family Medicine, Faculty of Medicine, Ss. Cyril and Methodius University in Skopje, Skopje, Republic of North Macedonia.
Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
BMC Public Health. 2023 Sep 29;23(1):1887. doi: 10.1186/s12889-023-16644-1.
In 2019, smoking prevalence in North Macedonia was one of the world's highest at around 46% in adults. However, access to smoking cessation treatment is limited and no co-ordinated smoking cessation programmes are provided in primary care.
We conducted a three parallel-armed randomised controlled trial (n = 1368) to investigate effectiveness and cost-effectiveness of lung age (LA) or exhaled carbon monoxide (CO) feedback combined with very brief advice (VBA) to prompt smoking cessation compared with VBA alone, delivered by GPs in primary care in North Macedonia. All participants who decided to attempt to quit smoking were advised about accessing smoking cessation medications and were also offered behavioural support as part of the "ACT" component of VBA. Participants were aged ≥ 35 years, smoked ≥ 10 cigarettes per day, were recruited from 31 GP practices regardless of motivation to quit and were randomised (1:1:1) using a sequence generated before the start of recruitment. The primary outcome was biochemically validated 7-day point prevalence abstinence at 4 weeks (wks). Participants and GPs were not blinded to allocation after randomisation, however outcome assessors were blind to treatment allocation.
There was no evidence of a difference in biochemically confirmed quitting between intervention and control at 4wks (VBA + LA RR 0.90 (97.5%CI: 0.35, 2.27); VBA + CO RR 1.04 (97.5%CI: 0.44, 2.44)), however the absolute number of quitters was small (VBA + LA 1.6%, VBA + CO 1.8%, VBA 1.8%). A similar lack of effect was observed at 12 and 26wks, apart from in the VBA + LA arm where the point estimate was significant but the confidence intervals were very wide. In both treatment arms, a larger proportion reported a reduction in cigarettes smoked per day at 4wks (VBA + LA 1.30 (1.10, 1.54); VBA + CO 1.23 (1.03, 1.49)) compared with VBA. The point estimates indicated a similar direction of effect at 12wks and 26wks, but differences were not statistically significant. Quantitative process measures indicated high fidelity to the intervention delivery protocols, but low uptake of behavioural and pharmacological support. VBA was the dominant intervention in the health economic analyses.
Overall, there was no evidence that adding LA or CO to VBA increased quit rates. However, a small effect cannot be ruled out as the proportion quitting was low and therefore estimates were imprecise. There was some evidence that participants in the intervention arms were more likely to reduce the amount smoked, at least in the short term. More research is needed to find effective ways to support quitting in settings like North Macedonia where a strong smoking culture persists.
The trial was registered at http://www.isrctn.com (ISRCTN54228638) on the 07/09/2018.
2019 年，马其顿的吸烟率居世界首位之一，成年人中约有 46%的人吸烟。然而，戒烟治疗的可及性有限，初级保健中没有提供协调一致的戒烟计划。
我们进行了一项三臂平行随机对照试验（n=1368），以调查肺龄（LA）或呼出一氧化碳（CO）反馈与非常简短的建议（VBA）相结合，与单独使用 VBA 相比，在马其顿的初级保健中由全科医生提供戒烟治疗的有效性和成本效益。所有决定尝试戒烟的参与者都被建议如何获得戒烟药物，并作为 VBA 的“ACT”部分的一部分提供行为支持。参与者年龄≥35 岁，每天吸烟≥10 支，从 31 个全科医生诊所招募，无论戒烟动机如何，并使用在招募开始前生成的序列进行 1:1:1 随机分组。主要结局是在 4 周（wks）时通过生物化学验证的 7 天点戒烟率。在随机分组后，参与者和全科医生不能对分配情况进行盲法，但结果评估人员对治疗分配情况进行盲法。
在 4wks 时，干预组和对照组在生物化学确认的戒烟方面没有证据表明有差异（VBA+LA RR 0.90（97.5%CI：0.35, 2.27）；VBA+CO RR 1.04（97.5%CI：0.44, 2.44）），然而，戒烟者的绝对数量很少（VBA+LA 1.6%，VBA+CO 1.8%，VBA 1.8%）。在 12 周和 26 周时也观察到类似的缺乏效果，除了 VBA+LA 组，该组的点估计值显著，但置信区间非常宽。在两个治疗组中，在 4wks 时，更多的人报告每天吸烟量减少（VBA+LA 1.30（1.10, 1.54）；VBA+CO 1.23（1.03, 1.49））与 VBA 相比。点估计值表明，在 12 周和 26 周时，效果方向相似，但差异无统计学意义。定量过程测量表明，干预措施的实施协议具有很高的保真度，但行为和药物支持的使用率较低。VBA 是健康经济学分析中的主要干预措施。
总体而言，没有证据表明将 LA 或 CO 添加到 VBA 中会增加戒烟率。然而，由于戒烟者的比例较低，因此不能排除小的效果，因此估计不精确。有一些证据表明，干预组的参与者更有可能减少吸烟量，至少在短期内是这样。在像马其顿这样吸烟文化仍然很强的地方，需要更多的研究来寻找有效的戒烟方法。
该试验于 2018 年 9 月 7 日在 http://www.isrctn.com 上注册（ISRCTN54228638）。
