Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT™ Toolbox initiative

Christelle Chrea, Catherine Acquadro, Esther F Afolalu, Erica Spies, Thomas Salzberger, Linda Abetz-Webb, Stefan Cano, Benoit Arnould, Nelly Mainy, Jed Rose, Rolf Weitkunat, Christelle Chrea, Catherine Acquadro, Esther F Afolalu, Erica Spies, Thomas Salzberger, Linda Abetz-Webb, Stefan Cano, Benoit Arnould, Nelly Mainy, Jed Rose, Rolf Weitkunat

Abstract

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers' responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration's "Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims," scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox ( Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.

Keywords: Behavior; Best measurement practices; Consumer perception; Modified risk tobacco products; Reduced risk products; Self-report instruments.

Conflict of interest statement

Competing interests: CC, ES, EA, NM, and RW are employees of Philip Morris International. All other authors are contracted by Philip Morris International for consulting services on the work presented in this communication.

Figures

Figure 1.. Iterative process for the development…
Figure 1.. Iterative process for the development of an ABOUT™ instrument.
Figure 2.. Linguistic validation process for the…
Figure 2.. Linguistic validation process for the development of an ABOUT™ instrument.

References

    1. Abrams DB, Glasser AM, Pearson JL, et al. : Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine Use to Rapidly Save Lives. Annu Rev Public Health. 2018;39:193–213. 10.1146/annurev-publhealth-040617-013849
    1. Berman ML, Connolly G, Cummings KM, et al. : Providing a Science Base for the Evaluation of Tobacco Products. Tob Regul Sci. 2015;1(1):76–93. 10.18001/TRS.1.1.8
    1. U.S. Department of Health and Human Services: The Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health,2014; Last Accessed 2 October 2018.
    1. U.S. Department of Health and Human Services: The Health Benefits of Smoking Cessation. A Report of the Surgeon General.Rockville (MD): U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Center for Chronic Disease Prevention and Health Promotion Office on Smoking and Health. DHHS Publication No. (CDC) YO-K-116. 1990; Last accessed 2 October 2018.
    1. Zeller M, Hatsukami D, Strategic Dialogue on Tobacco Harm Reduction Group: The Strategic Dialogue on Tobacco Harm Reduction: a vision and blueprint for action in the US. Tob Control. 2009;18(4):324–332. 10.1136/tc.2008.027318
    1. Institute of Medicine: Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction.Washington, DC: The National Academies Press,2001; Last accessed 2 October 2018. 10.17226/10029
    1. World Health Organization: Monograph: Advancing Knowledge on Regulating Tobacco Products.Geneva: World Health Organization,2009; Last accessed 2 October 2018.
    1. U.S. Department of Health and Human Services: Guidance for industry - Modified Risk Tobacco Product Applications - Draft Guidance.Silver Spring (MD): U.S. Department of Health and Human Services, FDA, Center for Tobacco Products,2012; Last accessed 2 October 2018.
    1. Institute of Medicine: Scientific standards for studies on modified risk tobacco products.Washington, DC: The National Academies Press,2012; Last accessed 2 October 2018. 10.17226/13294
    1. Rees VW, Kreslake JM, Cummings KM, et al. : Assessing consumer responses to potential reduced-exposure tobacco products: a review of tobacco industry and independent research methods. Cancer Epidemiol Biomarkers Prev. 2009;18(12):3225–3240. 10.1158/1055-9965.EPI-09-0946
    1. Kaufman AR, Persoskie A, Twesten J, et al. : A review of risk perception measurement in tobacco control research. Tob Control. 2018; pii: tobaccocontrol-2017-054005. 10.1136/tobaccocontrol-2017-054005
    1. Edelen MO: The PROMIS smoking assessment toolkit--background and introduction to supplement. Nicotine Tob Res. 2014;16 Suppl 3:S170–174. 10.1093/ntr/ntu086
    1. Hansen M, Cai L, Stucky BD, et al. : Methodology for developing and evaluating the PROMIS smoking item banks. Nicotine Tob Res. 2014;16 Suppl 3:S175–189. 10.1093/ntr/ntt123
    1. Edelen MO, Stucky BD, Hansen M, et al. : The PROMIS Smoking Initiative: initial validity evidence for six new smoking item banks. Nicotine Tob Res. 2014;16 Suppl 3:S250–260. 10.1093/ntr/ntu065
    1. Niaura R: Delivering on its promises: the PROMIS Smoking Initiative item banks. Nicotine Tob Res. 2014;16 Suppl 3:S261–262. 10.1093/ntr/ntu094
    1. Edelen MO, Huang W, Stucky BD: Additional validity evidence for the PROMIS Smoking Assessment Toolkit. Addict Behav. 2016;58:80–84. 10.1016/j.addbeh.2016.02.035
    1. Stucky BD, Huang W, Edelen MO: The Psychometric Performance of the PROMIS Smoking Assessment Toolkit: Comparisons of Real-Data Computer Adaptive Tests, Short Forms, and Mode of Administration. Nicotine Tob Res. 2016;18(3):361–365. 10.1093/ntr/ntv083
    1. U.S. Department of Health and Human Services: Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.Rockville (MD): U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health,2009; Last accessed 2 October 2018.
    1. Mokkink LB, Terwee CB, Knol DL, et al. : The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010;10:22. 10.1186/1471-2288-10-22
    1. Aaronson N, Alonso J, Burnam A, et al. : Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11(3):193–205. 10.1023/A:1015291021312
    1. Tashakkori A, Creswell JW: Editorial: Exploring the nature of research questions in mixed methods research. J Mix Methods Res. 2007;1(3):207–211. 10.1177/1558689807302814
    1. Morel T, Cano SJ: Measuring what matters to rare disease patients - reflections on the work by the IRDiRC taskforce on patient-centered outcome measures. Orphanet J Rare Dis. 2017;12(1):171. 10.1186/s13023-017-0718-x
    1. Patrick DL, Burke LB, Gwaltney CJ, et al. : Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health. 2011;14(8):978–988. 10.1016/j.jval.2011.06.013
    1. Patrick DL, Burke LB, Gwaltney CJ, et al. : Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967–977. 10.1016/j.jval.2011.06.014
    1. Salzberger T, Chrea C, Cano SJ, et al. : Perceived risks associated with the use of tobacco and nicotine-containing products: Findings from qualitative research. Tobacco Science and Technology. 2017;50(Suppl 1):32–42.
    1. Atkinson M, Chrea C, Salzberger T, et al. : Factors Influencing Consumers' Perceived Risk Of Tobacco Products. Value Health. 2015;18(7):A505. 10.1016/j.jval.2015.09.1439
    1. Chrea C, Salzberger T, Abetz-Webb L, et al. : Development of a tobacco and nicotine products dependence instrument. Poster presented at the Society for Research on Nicotine and Tobacco 2018 Annual Meeting, Baltimore, MD USA. Last accessed 2 October 2018.
    1. Andrich D: Rasch models for measurement.Beverly Hills: Sage Publications;1988.
    1. Cronbach LJ: Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297–334. 10.1007/BF02310555
    1. DeVellis RF: Scale development: theory and applications.USA: Sage Publications;2003.
    1. Andrich D: Rating scales and Rasch measurement. Expert Rev Pharmacoecon Outcomes Res. 2011;11(5):571–585. 10.1586/erp.11.59
    1. Andrich D: An elaboration of Guttman scaling with Rasch models for measurement. Sociol Methodol. 1985;15:33–80. 10.2307/270846
    1. Andrich D, de Jong JHAL, Sheridan BE: Diagnostic opportunities with the Rasch model for ordered response Applications of latent trait and latent class models in the social sciences.Edited by Rost J, Langeheine R: Waxmann Publishing Co.;1997;59–70.
    1. Andrich D: A rating formulation for ordered response categories. Psychometrika. 1978;43(4):561–573. 10.1007/BF02293814
    1. Andrich D, Hagquist C: Real and artificial differential item functioning. J Educ Behav Stat. 2012;37(3):387–416. 10.3102/1076998611411913
    1. Chrea C, Cano S, Salzberger T, et al. : Using Rasch measurement to quantify the perceived risks associated with the use of tobacco and nicotine-containing products. Value Health. 2017;20(9):A765–A766. 10.1016/j.jval.2017.08.2180
    1. Cano S, Chrea C, Salzberger T, et al. : Development and validation of a new instrument to measure perceived risks associated with the use of tobacco and nicotine-containing products. Health Qual Life Outcomes. 2018;16(1):192. 10.1186/s12955-018-0997-5
    1. Herdman M, Fox-Rushby J, Badia X: 'Equivalence' and the translation and adaptation of health-related quality of life questionnaires. Qual Life Res. 1997;6(3):237–247. 10.1023/A:1026410721664
    1. Herdman M, Fox-Rushby J, Badia X: A model of equivalence in the cultural adaptation of HRQoL instruments: the universalist approach. Qual Life Res. 1998;7(4):323–335. 10.1023/A:1024985930536
    1. Regnault A, Hamel JF, Patrick DL: Pooling of cross-cultural PRO data in multinational clinical trials: how much can poor measurement affect statistical power? Qual Life Res. 2015;24(2):273–277. 10.1007/s11136-014-0765-x
    1. Wild D, Grove A, Martin M, et al. : Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005;8(2):94–104. 10.1111/j.1524-4733.2005.04054.x
    1. Wild D, Eremenco S, Mear I, et al. : Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force report. Value Health. 2009;12(4):430–440. 10.1111/j.1524-4733.2008.00471.x
    1. Acquadro C, Belay A, Popielnicki A, et al. : Linguistic validation of the Perceived Risk Instrument (PRI) into French, German, Italian, Japanese, Polish and Russian. Poster presented at the Society for Research on Nicotine and Tobacco 2018 Annual Meeting, Baltimore, MD, USA. Last accessed 2 October 2018.
    1. Mear I, Giroudet C: Chapter 1: Linguistic Validation Linguistic Validation Manual for Health Outcome Assessments.Edited by Acquadro C, Conway K, Giroudet C, et al.Lyon, France: Mapi Institute;2012;15–117.
    1. Salzberger T, Cano S, Mainy N, et al. : Psychometric evaluation of the mCEQ applied to cigarettes and heat-not-burn products in the US and Japan. Poster presented at the Society for Research on Nicotine and Tobacco 2018 Annual Meeting, Baltimore, MD, USA. Last accessed 2 October 2018.
    1. Regnault A, Herdman M: Using quantitative methods within the Universalist model framework to explore the cross-cultural equivalence of patient-reported outcome instruments. Qual Life Res. 2015;24(1):115–124. 10.1007/s11136-014-0722-8
    1. Acquadro C, Patrick DL, Eremenco S, et al. : Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures. J Patient Rep Outcomes. 2017;2(1):8. 10.1186/s41687-018-0035-8
    1. Anfray C, Emery MP, Conway K, et al. : The advantages of a centralized dissemination stratefy for health outcomes instruments and their translations: A case exemple with the Zarit Burden Interview (ZBI). Value Health. 2009;12(7):A399.
    1. Anfray C, Emery MP, Conway K, et al. : Questions of copyright. Health Qual Life Outcomes. 2012;10:16. 10.1186/1477-7525-10-16
    1. Emery MP, Perrier LL, Acquadro C: Patient-reported outcome and quality of life instruments database (PROQOLID): frequently asked questions. Health Qual Life Outcomes. 2005;3:12. 10.1186/1477-7525-3-12
    1. World Health Organization: Monitoring tobacco Guidelines for Controlling and Monitoring the Tobacco Epidemic.World Health Organization;1998;76–101.
    1. Weitkunat R, Coggins CRE, Sponsiello-Wang Z, et al. : Assessment of cigarette smoking in epidemiologic studies. Beiträge zur Tabakforschung International/Contributions to Tobacco Research. 2013;25(7):638–648. 10.2478/cttr-2013-0940
    1. Sponsiello-Wang Z, de La Bourdonnaye G, David M, et al. : Accuracy of the smoking questionnaire. Beiträge zur Tabakforschung International/Contributions to Tobacco Research. 2017;27(8):224–239. 10.1515/cttr-2017-0023
    1. O'Connor RJ, Lindgren BR, Schneller LM, et al. : Evaluating the utility of subjective effects measures for predicting product sampling, enrollment, and retention in a clinical trial of a smokeless tobacco product. Addict Behav. 2018;76:95–99. 10.1016/j.addbeh.2017.07.025
    1. Hanson K, O'Connor R, Hatsukami D: Measures for assessing subjective effects of potential reduced-exposure products. Cancer Epidemiol Biomarkers Prev. 2009;18(12):3209–3224. 10.1158/1055-9965.EPI-09-0971
    1. Cappelleri JC, Bushmakin AG, Baker CL, et al. : Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addict Behav. 2007;32(5):912–923. 10.1016/j.addbeh.2006.06.028
    1. Hatsukami DK, Zhang Y, O'Connor RJ, et al. : Subjective responses to oral tobacco products: scale validation. Nicotine Tob Res. 2013;15(7):1259–1264. 10.1093/ntr/nts265
    1. National Academies of Sciences, Engineering, and Medicine: Public Health Consequences of E-Cigarettes.Washington, DC: The National Academies Press, 2018; Last accessed 2 October 2018.
    1. Fagerstrom K, Eissenberg T: Dependence on tobacco and nicotine products: a case for product-specific assessment. Nicotine Tob Res. 2012;14(11):1382–1390. 10.1093/ntr/nts007
    1. Strong DR, Messer K, Hartman SJ, et al. : Measurement of multiple nicotine dependence domains among cigarette, non-cigarette and poly-tobacco users: Insights from item response theory. Drug Alcohol Depend. 2015;152:185–193.
    1. Strong DR, Pearson J, Ehlke S, et al. : Indicators of dependence for different types of tobacco product users: Descriptive findings from Wave 1 (2013-2014) of the Population Assessment of Tobacco and Health (PATH) study. Drug Alcohol Depend. 2017;178:257–266.
    1. World Health Organization: International Classification of Functioning, Disability and Health: ICF. Geneva: World Health Organization,2001; Last accessed 2 October 2018.
    1. Ferrans CE, Zerwic JJ, Wilbur JE, et al. : Conceptual model of health-related quality of life. J Nurs Scholarsh. 2005;37(4):336–342. 10.1111/j.1547-5069.2005.00058.x
    1. Section 911 of the Federal Food, Drug, and Cosmetic Act - Modified Risk Tobacco Products. Last accessed 2 October 2018.
    1. Notice Announcing Availability of Common Data Elements for Tobacco Regulatory Research via the PhenX Toolkit. Last accessed 9 October 2018.
    1. Fong GT, Cummings KM, Borland R, et al. : The conceptual framework of the International Tobacco Control (ITC) Policy Evaluation Project. Tob Control. 2006;15 Suppl 3:iii3–11. 10.1136/tc.2005.015438
    1. Hyland A, Ambrose BK, Conway KP, et al. : Design and methods of the Population Assessment of Tobacco and Health (PATH) Study. Tob Control. 2017;26(4):371–378. 10.1136/tobaccocontrol-2016-052934
    1. McLeroy KR, Bibeau D, Steckler A, et al. : An ecological perspective on health promotion programs. Health Educ Q. 1988;15(4):351–377. 10.1177/109019818801500401

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