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

Nicotine and Tobacco Research

Volumn 17, Issue 12, 2015, Pages 1456-1464

  Kulasekaran, Anuradha ^a   Proctor, Christopher ^a   Papadopoulou, Ermioni ^a   Shepperd, Christopher J ^a   Guyer, Rick ^b   Gandek, Barbara ^b,c   Ware, John E ^b,c  

^a BRITISH AMERICAN TOBACCO   (United Kingdom)

^b John Ware Research Group   (United States)

^c UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; EVALUATION STUDY; GERMAN (LANGUAGE); HUMAN; HUMAN EXPERIMENT; NORMAL HUMAN; PRIORITY JOURNAL; QUALITY OF LIFE ASSESSMENT; REDUCED TOXICANT PROTOTYPE; RELIABILITY; SHORT FORM 36; SINGLE BLIND PROCEDURE; SMOKING; SMOKING HABIT; TOBACCO QUALITY OF LIFE IMPACT TOOL; VALIDATION STUDY; EPIDEMIOLOGY; FEMALE; HEALTH STATUS INDICATOR; LONGITUDINAL STUDY; MALE; MIDDLE AGED; PREVENTION AND CONTROL; PSYCHOLOGY; PSYCHOMETRY; QUALITY OF LIFE; QUESTIONNAIRE; REPRODUCIBILITY; STANDARDS; TOBACCO; TOXICITY; TRANSLATING (LANGUAGE);

NICOTINE GUM;

ADULT; FEMALE; HEALTH STATUS INDICATORS; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; PSYCHOMETRICS; QUALITY OF LIFE; REPRODUCIBILITY OF RESULTS; SINGLE-BLIND METHOD; SMOKING; SURVEYS AND QUESTIONNAIRES; TOBACCO; TOBACCO PRODUCTS; TOBACCO USE CESSATION PRODUCTS; TRANSLATING;

EID: 84973091668     PISSN: 14622203     EISSN: 1469994X     Source Type: Journal    
DOI: 10.1093/ntr/ntv024     Document Type: Article

References (34)

1. FDA. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009. www. fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Accessed January 20, 2014.
2. Frendl DM, Ware JE. Patient-reported functional health and well-being following drug therapy: a systematic review of randomized trials using the SF-36 Health Survey. Medical Care. 2014;52(5):439-445. doi:10.1097/MLR.000000000000010311.
3. Laaksonen M, Rahkonen O, Martikainen P, Karvonen S, Lahelma E. Smoking and SF-36 health functioning. Prev Med. 2006;42(3):206-209. doi.org/10.1016/j.ypmed.2005.12.003.
4. Olufade AO, Shaw JW, Foster SA, Leischow SJ, Hays RD, Coons SJ. Development of the Smoking Cessation Quality of Life questionnaire. Clin Ther. 1999;21(12):2113-2130. doi:10.1016/S0149-2918 (00)87242-2.
5. Tillmann M, Silcock J. A comparison of smokers' and ex-smokers' healthrelated quality of life. J Public Health Med. 1997;19(3):268-273. http://jpubhealth.oxfordjournals.org. Accessed January 20, 2014.
6. Wilson D, Parsons J, Wakefield M. The health-related quality-of-life of never smokers, ex-smokers, and light, moderate, and heavy smokers. Prev Med. 1999;29(3):139-144. doi.org/10.1006/pmed.1999.0523.
7. Hatsukami DK, Hanson K, Briggs A, et al. Clinical trials methods for evaluation of potential reduced exposure products. Cancer Epidemiol Biomarkers Prev. 2009;18(12):3143-3195.
8. Henney JE, Baker TB, Bascom R, Biswal S; Institute of Medicine. The Committee for Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: National Academies Press; 2012.
9. Stratton K, Shetty P, Wallace R, Bondurant S. Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. Washington, DC: National Academies Press; 2001.
10. Family Smoking Prevention and Tobacco Control Act, 21 USC. 2009. www. fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm237092.htm. Accessed January 20, 2014.
11. FDA. Draft Guidance. Modified Risk Tobacco Product Applications. Rockville, MD: US Food and Drug Administration; 2012. www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM297751.pdf. Accessed January 20, 2014.
12. EuroQol Group. EuroQol-a new facility for the measurement of healthrelated quality of life. Health Policy. 1990;16(3):199-208. www.healthpolicyjrnl. com. Accessed January 20, 2014.
13. Shepperd CJ, Eldridge A, Camacho OM, McAdam K, Proctor CJ, Meyer I. Changes in levels of biomarkers of exposure observed in a controlled study of smokers switched from conventional to reduced toxicant prototype cigarettes. Regul Toxicol Pharmacol. 2013;66(1):147-162. doi:10.1016/j. yrtph.2013.02.007.
14. Ware JE, Guyer R. How to Use the Tobacco Quality of Life Impact Test (TQOLIT®v1): User Manual. Worcester, MA: JWRG Incorporated; 2013.
15. Benowitz NL, Dains KM, Hall SM, et al. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012;21(5):761-769. doi:10.1158/1055-9965.EPI-11-0644.
16. Hatsukami DK, Lemmonds C, Zhang Y, et al. Evaluation of carcinogen exposure in people who used "reduced exposure" tobacco products. J Natl Cancer Inst. 2004;96(11):844-852. doi:10.1093/jnci/djh163.
17. Liu J, Liang Q, Frost-Pineda K, et al. Relationship between biomarkers of cigarette smoke exposure and biomarkers of inflammation, oxidative stress, and platelet activation in adult cigarette smokers. Cancer Epidemiol Biomarkers Prev. 2011;20(8):1-10. doi:10.1158/1055-9965. EPI-10-0987.
18. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995;273(1):59-65.
19. Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 2008;61(1):17-33.
20. Rose M, Bjorner JB, Gandek B, Bruce B, Fries JF, Ware JE. The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J Clin Epidemiol. 2014;67(5):516-526. doi:10.1016/j.jclinepi.2013.10.024.
21. Shepperd CJ, Newland N, Eldridge A, Graff D, Meyer I. A single-blinded, single-centre, controlled study in healthy adult smokers to identify the effects of a reduced toxicant prototype cigarette on biomarkers of exposure and of biological effect versus commercial cigarettes. BMC Public Health. 2013 July 29;13:690. doi:10.1186/1471-2458-13-690.
22. McHorney CA, Ware JE, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31(3):247-263.
23. Ware JE, Kosinski M, Bjorner JB, et al. Applications of computerized adaptive testing (CAT) to the assessment of headache impact. Qual Life Res. 2003;12(8):935-952.
24. Bullinger M. German translation and psychometric testing of the SF-36 Health Survey: preliminary results from the IQOLA Project. International Quality of Life Assessment. Soc Sci Med. 1995;41(10):1359-1366.
25. Bullinger M, Alonso J, Apolone G, et al. Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment. J Clin Epidemiol. 1998;51(11):913-923.
26. Acquadro C, Conway K, Hareendran A, Aaronson N; European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value Health. 2008;11(3):509-521. doi:10.1111/j.1524-4733.2007.00292.x.
27. Ware JE Jr, Kosinski M, Bjorner JB, Turner-Bowker DM, Gandek B, Maruish ME. User's manual for the SF-36® Health Survey (Version 2). 2nd ed. Lincoln, RI: QualityMetric Incorporated; 2007.
28. Guyatt GH, Naylor CD, Juniper E, Heyland DK, Jaeschke R, Cook DJ. Users' guides to the medical literature. XII. How to use articles about healthrelated quality of life. Evidence-Based Medicine Working Group. JAMA. 1997;277(15):1232-1237. doi:10.1001/jama.1997.03540390062037.
29. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77(4):371-383. doi:10.1016/S0025-6196(11)61793-X.
30. Norman G, Sloan J, Wyrwich K. Interpretation of changes in healthrelated quality of life the remarkable universality of half a standard deviation. Medical Care. 2003;41(5):582-592. http://journals.lww.com/lww-medicalcare/pages/default.aspx. Accessed January 20, 2014.
31. Nunnally JC. Psychometric Theory. 2nd ed. New York, NY: McGraw-Hill; 1978.
32. Cohen J. Statistical Power Analysis for the Behavioural Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
33. Ware JE, Kulasekaran A, Guyer R, Gandek B. Evaluation of the Tobacco Quality of Life Impact Tool (TQOLIT®v1) in current and former smokers in Germany and the United States. Health Qual Life Outcomes. In review.
34. Ware JE, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Medical Care. 1995;33(4 Suppl):AS264-AS279.