Regan Susan, Reid Zachary Z, Kelley Jennifer H K, Reyen Michele, Korotkin Molly, Japuntich Sandra J, Viana Joseph C, Levy Douglas E, Rigotti Nancy A
Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA;
Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA;
Nicotine Tob Res. 2016 Jan;18(1):34-40. doi: 10.1093/ntr/ntv073. Epub 2015 Apr 6.
Biochemical confirmation (BC) of self-report is the gold standard of evidence for abstinence in smoking cessation research, but difficulty in obtaining samples may bias estimates of quit rates. Proxy confirmation (PC) has not been validated in cessation trials. We assessed the feasibility and validity of PC in a cessation trial for hospitalized smokers.
We enrolled 402 daily cigarette smokers during a hospital admission. At enrollment, participants provided demographics, smoking history, and named proxies to confirm their smoking status at follow-up. Participants provided self-reported (SR) 7-day tobacco abstinence by telephone at 6 months post-discharge. SR quitters were asked to mail a saliva sample for BC. Incentives were offered for survey completion ($20) and returned samples ($50). We called proxies for all those with SR to obtain PC. Quit rates were calculated with missing data indicating smoking. We assessed associations of nonresponse with baseline characteristics using chi-squared tests and logistic regression. We calculated the sensitivity and specificity of PC in detecting smokers as determined by BC.
All patients named at least one proxy. Response rates were 82% for SR, 84% for PC, and 69% for BC. Observed participant characteristics were unrelated to provision of sample for BC. Estimated quit rates were 35% for SR, 27% for SR + PC, 21% for SR + BC and 27% for SR + BC or PC. Sensitivity of PC was not higher than SR (73% vs. 77%); specificity was lower (84% vs. 100%).
PC was feasible but not superior to self-report in a cessation trial.
自我报告的生化确认（BC）是戒烟研究中禁欲证据的金标准，但获取样本的困难可能会使戒烟率的估计产生偏差。代理确认（PC）尚未在戒烟试验中得到验证。我们评估了PC在住院吸烟者戒烟试验中的可行性和有效性。
我们在医院入院期间招募了402名每日吸烟的患者。在入组时，参与者提供了人口统计学信息、吸烟史，并指定代理人在随访时确认他们的吸烟状态。参与者在出院后6个月通过电话提供自我报告的（SR）7天烟草戒断情况。SR戒烟者被要求邮寄一份唾液样本进行BC检测。完成调查（20美元）和返还样本（50美元）均有奖励。我们给所有有SR报告的人的代理人打电话以获得PC。计算缺失数据表明吸烟情况下的戒烟率。我们使用卡方检验和逻辑回归评估无应答与基线特征之间的关联。我们计算了PC在检测由BC确定的吸烟者方面的敏感性和特异性。
所有患者至少指定了一名代理人。SR的应答率为82%，PC的应答率为84%，BC的应答率为69%。观察到的参与者特征与提供BC样本无关。估计的戒烟率SR为35%，SR + PC为27%，SR + BC为21%，SR + BC或PC为27%。PC的敏感性不高于SR（73%对77%）；特异性较低（84%对100%）。
在戒烟试验中，PC是可行的，但并不优于自我报告。
