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

Abstract

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.

Impact of tobacco and/or nicotine products on health and functioning: a scoping review and findings from the preparatory phase of the development of a new self-report measure

“…After applying the inclusion/exclusion criteria to the remaining 4,054 abstracts, 281 were identified as part of the rEM exercise. After additional manual screening and review of the abstracts and articles against the inclusion/exclusion criteria, 90 full-text articles were included for data extraction [ 20 , 37 – 125 ]. Seven additional full-text articles were also included on the basis of a manual search [ 126 – 132 ].…”

“…While generic health status measures, such as the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), have been used to evaluate the health status of people who smoke [ 16 , 17 ], comparisons have mainly been made between those who currently smoke, those who used to smoke, and those who never smoked [ 18 , 19 ]. Results from these studies strongly suggest that, in healthy populations, existing generic measures are not sensitive enough to detect change over time when stopping or switching from cigarettes to other TNPs, owing to high ceiling effects [ 20 ]. While a few smoking-specific quality of life measures have been developed, these measures have not been widely implemented or standardized [ 15 , 17 , 21 , 22 ], and the application of these smoking-specific measures to different TNP use across the risk continuum is scarce [ 20 ].…”

“…Results from these studies strongly suggest that, in healthy populations, existing generic measures are not sensitive enough to detect change over time when stopping or switching from cigarettes to other TNPs, owing to high ceiling effects [ 20 ]. While a few smoking-specific quality of life measures have been developed, these measures have not been widely implemented or standardized [ 15 , 17 , 21 , 22 ], and the application of these smoking-specific measures to different TNP use across the risk continuum is scarce [ 20 ].…”