改善尼古丁替代疗法药物依从性以提高戒烟效果的智能手机应用（NRT2Quit）的实用随机试验：一项提前终止研究的结果。
Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study.
机构信息
Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, WC1E 6BT, London, UK.
Behavioural Science and Health, University College London, 1-19 Torrington Place, WC1E 6BT, London, UK.
出版信息
Trials. 2019 Sep 2;20(1):547. doi: 10.1186/s13063-019-3645-4.
BACKGROUND
Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2Quit smartphone app (for iOS) designed to improve quit attempts with OTC NRT by improving adherence to the medications.
METHODS
This study was a pragmatic double-blind randomised controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cigarettes per day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomly assigned within the app to the intervention (full) version of NRT2Quit or to its control (minimal) versions. The primary outcome was biochemically verified 4-week abstinence assessed at 8-week follow-up using Russell Standard criteria and intention to treat. Bayes factors were calculated for the cessation outcome. Secondary outcomes were self-reported abstinence, NRT use, app use and satisfaction with the app.
RESULTS
The study under-recruited. Only 41 participants (3.5% of the target sample) were randomly assigned to NRT2Quit (n = 16) or the control (n = 25) app versions between March 2015 and September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically verified quit rates (25.0% versus 8.0%, P = 0.19, odds ratio = 3.83, 0.61-24.02). The calculated Bayes factor, 1.92, showed that the data were insensitive to test for the hypothesis that the intervention app version aided cessation. The intervention participants had higher median logins (2.5 versus 0, P = 0.01) and were more likely to use NRT at follow-up (100.0% versus 28.6%, P = 0.03) and recommend NRT2Quit to others (100.0% versus 28.6%, P = 0.01).
CONCLUSIONS
Despite very low recruitment, there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using NRT. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.
TRIAL REGISTRATION
ISRCTN ISRCTN33423896 , prospectively registered on 22 March 2015.
背景
在柜台上购买的尼古丁替代疗法（NRT）似乎对戒烟效果不大，这可能部分解释了依从性差的原因。我们开发并评估了 NRT2Quit 智能手机应用程序（适用于 iOS），旨在通过提高对药物的依从性来改善使用 NRT 的戒烟尝试。
方法
这是一项实用的双盲随机对照试验，通过分发给 300 多家英国社区药店的传单进行远程招募。该研究招募了成年每日吸烟者（每天≥10 支香烟），他们购买了 NRT，希望戒烟，下载了 NTR2Quit 并在应用程序内完成了注册过程。参与者在应用程序内自动随机分配到干预（完整）版本的 NRT2Quit 或其对照（最小）版本。主要结果是使用 Russell 标准标准，通过 8 周随访时的生物化学验证，在 4 周时评估的戒烟率，并根据意向治疗进行评估。为戒烟结果计算了贝叶斯因子。次要结果是自我报告的戒烟、NRT 使用、应用程序使用和对应用程序的满意度。
结果
该研究的招募人数不足。2015 年 3 月至 2016 年 9 月期间，仅招募了 41 名参与者（目标样本的 3.5%）被随机分配到 NRT2Quit（n = 16）或对照（n = 25）应用程序版本。随访率为 51.2%。干预组参与者的生物化学验证戒烟率较高（25.0%对 8.0%，P = 0.19，优势比= 3.83，0.61-24.02）。计算的贝叶斯因子为 1.92，表明数据对干预应用程序版本有助于戒烟的假设不敏感。干预组参与者的中位数登录次数更高（2.5 对 0，P = 0.01），并且更有可能在随访时使用 NRT（100.0%对 28.6%，P = 0.03）并向他人推荐 NRT2Quit（100.0%对 28.6%，P = 0.01）。
结论
尽管招募人数非常少，但有初步但不确定的证据表明，NRT2Quit 可能会改善使用 NRT 的吸烟者的短期戒烟和依从性。需要对 NRT2Quit 进行更有力的研究，但需要采用不同的招募方法，通过社区药店或其他渠道吸引吸烟者。
试验注册
ISRCTN ISRCTN33423896，于 2015 年 3 月 22 日前瞻性注册。
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