A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis
A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis
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DOI：
10.1186/s40814-019-0451-4
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发表时间：
2019-06-04
影响因子：
1.7
通讯作者：
McColl, Elaine
中科院分区：
文献类型：
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作者：
Holliday, Richard;Preshaw, Philip M.;McColl, Elaine
吸烟是包括牙周炎在内的几种口腔疾病的主要风险因素，电子烟（电子烟）越来越多地用于戒烟。本研究旨在评估在确定性研究之前，在牙科环境中提供和评估电子烟戒烟干预的可行性。方法在英国泰恩郡纽卡斯尔医院NHS牙科临床研究中心进行了一项为期22个月的可行性研究，包括随机对照试验和定性过程评价。初步试验包括一项双臂、平行组、个体随机、对照试验，分配比例为1：1。参与者的资格标准包括吸烟者，牙周炎和目前不使用电子烟。所有参与者都接受了标准的非手术牙周治疗和简短的戒烟建议。干预组还接受了电子烟入门套件和简短的培训。在6个月内收集了未来确定性试验的吸烟行为和牙周/口腔健康方面的拟议结果，以评估数据产量和质量以及参数估计值。分析为描述性分析，适当时提供95%置信区间。结果80名参与者成功地从一系列牙科设置。6个月时，参与者保留率为73%（n = 58; 95% CI 62-81%）。电子烟干预受到好评，戒烟时的使用率为90%（n = 36; 95%CI 77-96%）。对照组中有20%（n = 8; 95% CI 11-35%）的参与者在研究期间的某个时候使用了电子烟（违背建议）。除了每周一次的吸烟问卷调查（只有30%的参与者完成了>= 80%）外，大多数结果测量都被成功收集。在对照组和干预组中，观察到6个月内呼气一氧化碳分别减少6 ppm（95% CI 1-10 ppm）和12 ppm（95% CI 8-16 ppm）。两组的戒断率（经一氧化碳证实连续戒断6个月）分别为5%（n = 2; 95%CI 1-17%;对照组）和15%（n = 6; 95%CI 7-29%;干预组）。结论数据表明，一个明确的试验是可行的，干预可能会提高戒烟率。深入了解了如何最好地进行最终试验，并获得了为设计提供信息的参数估计。
Background Tobacco smoking is a major risk factor for several oral diseases, including periodontitis, and electronic cigarettes (e-cigarettes) are increasingly being used for smoking cessation. This study aimed to assess the viability of delivering and evaluating an e-cigarette intervention for smoking cessation within the dental setting, prior to a definitive study. Methods A feasibility study, comprising a pilot randomised controlled trial and qualitative process evaluation, was conducted over 22 months in the Newcastle upon Tyne Hospitals NHS Dental Clinical Research Facility, UK. The pilot trial comprised a two-armed, parallel group, individually randomised, controlled trial, with 1:1 allocation. Participant eligibility criteria included being a tobacco smoker, having periodontitis and not currently using an e-cigarette. All participants received standard non-surgical periodontal therapies and brief smoking cessation advice. The intervention group additionally received an e-cigarette starter kit with brief training. Proposed outcomes for a future definitive trial, in terms of smoking behaviour and periodontal/oral health, were collected over 6 months to assess data yield and quality and estimates of parameters. Analyses were descriptive, with 95% confidence intervals presented, where appropriate. Results Eighty participants were successfully recruited from a range of dental settings. Participant retention was 73% (n = 58; 95% CI 62-81%) at 6 months. The e-cigarette intervention was well received, with usage rates of 90% (n = 36; 95% CI 77-96%) at quit date. Twenty percent (n = 8; 95% CI 11-35%) of participants in the control group used an e-cigarette at some point during the study (against advice). The majority of the outcome measures were successfully collected, apart from a weekly smoking questionnaire (only 30% of participants achieved >= 80% completion). Reductions in expired air carbon monoxide over 6 months of 6 ppm (95% CI 1-10 ppm) and 12 ppm (95% CI 8-16 ppm) were observed in the control and intervention groups, respectively. Rates of abstinence (carbon monoxide-verified continuous abstinence for 6 months) for the two groups were 5% (n = 2; 95% CI 1-17%; control group) and 15% (n = 6; 95% CI 7-29%; intervention group). Conclusions Data suggest that a definitive trial is feasible and that the intervention may improve smoking quit rates. Insights were gained into how best to conduct the definitive trial and estimates of parameters to inform design were obtained.