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.
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.
Group Research and Development, British American Tobacco (Investments) Ltd, Southampton, United Kingdom; anuradha_kulasekaran@bat.com.
Anuradha
A
Kulasekaran
Group Research and Development, British American Tobacco (Investments) Ltd, Southampton, United Kingdom;
Christopher
C
Proctor
Group Research and Development, British American Tobacco (Investments) Ltd, Southampton, United Kingdom;
Ermioni
E
Papadopoulou
Group Research and Development, British American Tobacco (Investments) Ltd, Southampton, United Kingdom;
Christopher J
CJ
Shepperd
John Ware Research Group, Worcester, MA;
Rick
R
Guyer
John Ware Research Group, Worcester, MA; Department of Quantitative Health Sciences, UMass Medical School, Worcester, MA.
Barbara
B
Gandek
John Ware Research Group, Worcester, MA; Department of Quantitative Health Sciences, UMass Medical School, Worcester, MA.
John E
JE
Ware
D000328:Adult; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D016037:Single-Blind Method; D012907:Smoking / Q000453:epidemiology / Q000523:psychology*; D000074606:Smoking Prevention; D011795:Surveys and Questionnaires / Q000592:standards*; D062789:Tobacco Products / Q000633:toxicity; D061485:Tobacco Use Cessation Devices; D014175:Translating