Children Learning About Secondhand Smoke (CLASS II): A Pilot Cluster Randomized Controlled Trial.
Children Learning About Secondhand Smoke (CLASS II): A Pilot Cluster Randomized Controlled Trial.
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儿童学习二手烟（II类）：试点群集随机对照试验。
DOI：
10.1093/ntr/nty090
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发表时间：
2019-04-17
期刊：
影响因子：
--
通讯作者：
Sheikh A
中科院分区：
文献类型：
--
作者：
Siddiqi K;Huque R;Kanaan M;Ahmed F;Ferdous T;Shah S;Jackson C;Parrott S;Ahluwalia JS;Sheikh A
暴露于二手烟（SHS）的儿童患呼吸道疾病的风险增加。在调查其在小学儿童中的有效性和成本效益之前，我们试行了无烟干预（SFI）和试验方法。在孟加拉国进行的一项试点随机对照试验中，小学被分配到普通教育（对照）或SFI，使用最小化。5岁的孩子被招募。无法进行设盲治疗分配。“自立教育”由学校教师讲授，包括两次45分钟和四次15分钟的教育课。我们的主要结果是随机分组后两个月的SHS暴露，通过儿童唾液可替宁进行验证。该试验注册于ISRCTN.com; ISRCTN 68690577。2015年4月1日至2015年6月30日，我们招募了12所学校。在5年级的484名儿童中，有481人同意。六所学校被分配到SFI（n = 245）和普通教育（n = 236）。其中，450名儿童（SFI = 229;对照= 221）谁有可替宁水平指示SHS暴露进行了随访。所有学校均保留，91%（208/229）的SFI儿童和88%（194/221）的对照组儿童完成了主要结局评估。在聚类水平上，SFI组的平均可替宁为0.53 ng/ml（SD 0.36），对照组为1.84 ng/ml（SD 1.49），平均差异为-1.31 ng/ml（95%CI =-2.86至0.24）。在我们的试验中，招募、随机化和保留小学和儿童是可行的。我们的研究虽然不能检测两组之间平均可替宁的差异，但提供了估计值，为未来试验提供了可能的效应量。在吸烟率高的国家，儿童由于接触二手烟而仍然面临许多疾病的风险。几乎没有经验证据表明可以减少他们在家中接触二手烟的干预措施的有效性和成本效益。第二类试验发现，以学校为基础的干预（SFI）有可能减少儿童接触SHS的方法，很少使用，但在以学校为基础的情况下有相当大的价值。II类试验提供了在这一公共卫生领域进行未来确定性试验的关键信息，尽管其重要性迄今为止很少受到关注。
Children exposed to secondhand smoke (SHS) are at increased risk of respiratory illnesses. We piloted a Smoke Free Intervention (SFI) and trial methods before investigating its effectiveness and cost-effectiveness in primary school children. In a pilot cluster randomized controlled trial in Bangladesh, primary schools were allocated to usual education (control) or SFI, using minimization. Year-5 children were recruited. Masking treatment allocation was not possible. Delivered by schoolteachers, SFI consisted of two 45-min and four 15-min educational sessions. Our primary outcome was SHS exposure at two months post randomization, verified by children’s salivary cotinine. The trial is registered at ISRCTN.com; ISRCTN68690577. Between April 1, 2015 and June 30, 2015, we recruited 12 schools. Of the 484 children present in Year-5, 481 consented. Six schools were allocated to both SFI (n = 245) and to usual education only (n = 236). Of them, 450 children (SFI = 229; control = 221) who had cotinine levels indicative of SHS exposure were followed-up. All schools were retained, 91% children (208/229) in SFI and 88% (194/221) in the control arm completed primary outcome assessment. Their mean cotinine at the cluster level was 0.53 ng/ml (SD 0.36) in SFI and 1.84 ng/ml (SD 1.49) in the control arm—a mean difference of −1.31 ng/ml (95% CI = −2.86 to 0.24). It was feasible to recruit, randomize, and retain primary schools and children in our trial. Our study, though not powered to detect differences in mean cotinine between the two arms, provides estimates to inform the likely effect size for future trials. In countries with high smoking prevalence, children remain at risk of many conditions due to secondhand smoke exposure. There is little empirical evidence on the effectiveness and cost-effectiveness of interventions that can reduce their exposure to secondhand smoke at homes. CLASS II trial found that a school-based intervention (SFI) has the potential to reduce children’s exposure to SHS—an approach that has been rarely used, but has considerable merit in school-based contexts. CLASS II trial provides key information to conduct a future definitive trial in this area of public health, which despite its importance has so far received little attention.
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影响因子：
4.7
作者：
Huque, Rumana;Dogar, Omara;Siddiqi, Kamran
通讯作者：
Siddiqi, Kamran
影响因子：
168.9
作者：
Been, Jasper V.;Nurmatov, Ulugbek B.;Sheikh, Aziz
通讯作者：
Sheikh, Aziz
影响因子：
3.2
作者：
Huang, Christina Y.;Reisch, Lucia A.;Lissner, Lauren
通讯作者：
Lissner, Lauren
影响因子：
9.6
作者：
Gibbs, Kevin;Collaco, Joseph M.;McGrath-Morrow, Sharon A.
通讯作者：
McGrath-Morrow, Sharon A.
DOI：
10.3390/ijerph121215038
发表时间：
2015-12-01
影响因子：
--
作者：
Rosen, Laura J.;Myers, Vicki;Kott, Jeff
通讯作者：
Kott, Jeff