一种新的德语翻译版烟草对生活质量影响工具的初步评估，用于区分健康的当前吸烟者和既往吸烟者，并探讨吸烟者改用低毒原型卷烟的效果。
Preliminary Evaluation of a New German Translated Tobacco Quality of Life Impact Tool to Discriminate Between Healthy Current and Former Smokers and to Explore the Effect of Switching Smokers to a Reduced Toxicant Prototype Cigarette.
作者信息
Kulasekaran Anuradha, Proctor Christopher, Papadopoulou Ermioni, Shepperd Christopher J, Guyer Rick, Gandek Barbara, Ware John E
机构信息
Group Research and Development, British American Tobacco (Investments) Ltd, Southampton, United Kingdom;
John Ware Research Group, Worcester, MA;
出版信息
Nicotine Tob Res. 2015 Dec;17(12):1456-64. doi: 10.1093/ntr/ntv024. Epub 2015 Apr 26.
BACKGROUND
Assessment of health-related quality of life (HRQoL) is well established in clinical research, but ceiling effects in validated tools might prevent detection of changes in well respondents. Tobacco Quality of Life Impact Tool (TQOLITv1) uses conceptual and psychometric advances to enhance detection of HRQoL changes.
METHODS
In a 6-month, forced-switch study, the German TQOLITv1 was assessed in healthy adult (age 23-55 years) current and matched former-smokers. At baseline, smokers were switched to reduced toxicant prototype (RTP) or conventional cigarette for 6 months. TQOLITv1 responses were collected at baseline, 3 and 6 months from current smokers whilst former smokers completed it at the latter two time points. TQOLITv1 includes SF-36v2 and new smoking-specific, physical and general-health measures.
RESULTS
Reliability at baseline was good (Cronbach's coefficient alpha > 0.70) for all measures. The baseline percentage with the best possible score (ceiling effect) for former and current smokers was substantially better for the new physical function than SF-36 physical function measure (35% vs. 59% at ceiling, respectively). New smoking-specific measures discriminated current from former smokers better than general health measures. Smoking-specific symptoms (r = 0.73) were more stable from baseline to 6 months than other measures (r = 0.38-0.54) particularly more than the SF-36 mental component score (r = 0.24). Although both product smoking groups worsened in most HRQoL measures, changes in general and smoking-specific HRQoL impact measures favored RTP smokers.
CONCLUSIONS
The German TQOLITv1 is sufficiently reliable and valid to assess HRQoL and may be more useful than SF-36v2 in evaluation of interventions in well smoking populations including those consuming RTPs.
背景
健康相关生活质量（HRQoL）评估在临床研究中已得到广泛应用，但经过验证的工具中存在的天花板效应可能会妨碍对健康状况良好的受访者的变化进行检测。烟草生活质量影响工具（TQOLITv1）运用了概念和心理测量学方面的进展来增强对HRQoL变化的检测。
方法
在一项为期6个月的强制转换研究中，对德国版TQOLITv1在健康成年（年龄23 - 55岁）的当前吸烟者和匹配的既往吸烟者中进行了评估。在基线时，吸烟者被转换为低毒原型（RTP）香烟或传统香烟，为期6个月。当前吸烟者在基线、3个月和6个月时收集TQOLITv1的反应，而既往吸烟者在后面两个时间点完成该评估。TQOLITv1包括SF - 36v2以及新的针对吸烟的、身体和一般健康的测量指标。
结果
所有测量指标在基线时的信度良好（Cronbach's系数α>0.70）。对于新的身体功能指标，既往吸烟者和当前吸烟者获得最佳可能分数（天花板效应）的基线百分比显著优于SF - 36身体功能测量指标（分别为天花板效应时的35%对59%）。新的针对吸烟的测量指标比一般健康测量指标能更好地区分当前吸烟者和既往吸烟者。从基线到6个月，特定吸烟症状（r = 0.73）比其他测量指标（r = 0.38 - 0.54）更稳定，尤其比SF - 36心理成分得分（r = 0.24）更稳定。尽管两个产品吸烟组在大多数HRQoL测量指标上都有所恶化，但一般和特定吸烟的HRQoL影响测量指标的变化更有利于RTP吸烟者。
结论
德国版TQOLITv1在评估HRQoL方面具有足够的可靠性和有效性，在评估包括使用RTP香烟者在内的健康吸烟人群的干预措施时，可能比SF - 36v2更有用。
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