Development and initial validation of a new self-report measure to assess perceived dependence on tobacco and nicotine products.

How nicotine is administered has evolved from cigarettes to various delivery systems. Assessing perceived dependence on nicotine-containing products now requires accounting for product specificity while allowing comparisons across products and users. This study aims to develop a new self-report measure to assess perceived dependence on tobacco and nicotine products (TNPs) among exclusive and poly-TNP users. A draft version of the new measure, the ABOUT-Dependence, was constructed based on literature review, qualitative research, and expert opinion. Data for scale formation and psychometric assessment was obtained through a US-based web survey (n = 2334) that included additional dependence measures for convergent validity assessment. Qualitative research confirmed a preliminary conceptual framework with seven sub-concepts. Following a cognitive debriefing, 19 items were considered to best represent the different sub-concepts. Psychometric findings supported a three-domain structure [i.e., behavioral impact (five items), signs and symptoms (five items), and extent/timing of use (two items)] and an overall total composite score. The data confirmed convergent and known-group validity, as well as test-retest reliability. The ABOUT-Dependence is a 12-item, psychometrically sound, self-report measure that may be used as a tool for research and further understanding of perceived dependence across the spectrum of TNP and TNP users.

Rasch Model of the COVID-19 Symptom Checklist-A Psychometric Validation Study.

While self-reported Coronavirus Disease 2019 (COVID-19) symptom checklists have been extensively used during the pandemic, they have not been sufficiently validated from a psychometric perspective. We, therefore, used advanced psychometric modelling to explore the construct validity and internal consistency of an online self-reported COVID-19 symptom checklist and suggested adaptations where necessary. Fit to the Rasch model was examined in a sample of 1638 Austrian citizens who completed the checklist on up to 20 days during a lockdown. The items' fatigue', 'headache' and 'sneezing' had the highest likelihood to be affirmed. The longitudinal application of the symptom checklist increased the fit to the Rasch model. The item 'cough' showed a significant misfit to the fundamental measurement model and an additional dependency to 'dry cough/no sputum production'. Several personal factors, such as gender, age group, educational status, COVID-19 test status, comorbidities, immunosuppressive medication, pregnancy and pollen allergy led to systematic differences in the patterns of how symptoms were affirmed. Raw scores' adjustments ranged from ±0.01 to ±0.25 on the metric scales (0 to 10). Except for some basic adaptations that increases the scale's construct validity and internal consistency, the present analysis supports the combination of items. More accurate item wordings co-created with laypersons would lead to a common understanding of what is meant by a specific symptom. Adjustments for personal factors and comorbidities would allow for better clinical interpretations of self-reported symptom data.

Improving the measurement of oral health-related quality of life: Rasch model of the oral health impact profile-14.

OBJECTIVES: The 14-item Oral Health Impact Profile (OHIP-14) is the most frequently used instrument to measure oral health-related quality-of-life (OHRQoL) in adults. Despite its popularity, its psychometric properties have been predominantly investigated based on the classical test theory while the fundamental principles of measurement have not been fully assessed. Therefore, our aim was to investigate to what extent the OHIP-14 meets the fundamental requirments of measurements. METHODS: We used the Rasch model to explore person-item-targeting, unidimensionality, local independence of items, invariance (differential-item-functioning, DIF), and the order of thresholds between response-options in the German version OHIP-14. We used data from osteoarthritis patients because hand disabilities and joint pain might influence oral hygiene. Furthermore, osteoarthritis in the temporomandibular-joint directly affects oral functioning. RESULTS: Five-hundred sixteen patients were included (mean age 66.5 years [±10.2; ranging from 34 to 89]; 71.3% [368] females). The OHIP-14 median total score was 0 (interquartile-range from 0 to 4), indicating a right-skewed distribution because many patients reported good OHRQoL. The instrument was found unidimensional. However, there was strong evidence of local dependency, disordered thresholds between response-options, and age-related DIF for item 5. A revised scoring scheme with three instead of five answer-options in all items and eliminating two items resolving local dependency, the newly adapted OHIP-12, showed better reliability and item-fit to the Rasch model than the original OHIP-14. CONCLUSIONS: This study assesses, for the first time, the OHIP-14 in terms of fundamental principles of measurement and proposes an item-reduced OHIP-12 as a psychometrically more accurate version of the instrument. CLINICAL SIGNIFICANCE: The Rasch model is essential to ensure instruments' precision and clinical meaningfulness when measuring OHRQoL in clinical practice and research. The OHIP-12, derived from the OHIP-14 by deleting two items due to local dependency, with a revised scoring scheme for all items distinguishing three answer-options instead of five, represents a psychometrically improved version of the instrument.

Rasch model of the child perceptions questionnaire in multi-country data.

OBJECTIVE: To be fit-for-purpose, oral health-related quality of life instruments must possess a range of psychometric properties which had not been fully examined in the 16-item Short Form Child Perceptions Questionnaire for children aged 11 to 14 years (CPQ11-14 ISF-16). We used advanced statistical approaches to determine the CPQ's measurement accuracy, precision, invariance and dimensionality and analyzed whether age range could be extended from 8 to 15 years. METHODS: Fit to the Rasch model was examined in 6648 8-to-15-year-olds from Australia, New Zealand, Brunei, Cambodia, Hong Kong, Malaysia, Thailand, Germany, United Kingdom, Brazil and Mexico. RESULTS: In all but two items, the initial five answer options were reduced to three or four, to increase precision of the children's selection. Items 10 (Shy/embarrassed) and 11 (Concerned what others think) showed an 'extra' dependency between item scores beyond the relationship related to the underlying latent construct represented by the instrument, and so were deleted. Without these two items, the CPQ was unidimensional. The three oral symptoms items (4 Food stuck in teeth, 3 Bad breath and 1 Pain) were required for a sufficient person-item coverage. In three out of 14 items (21 %), Europe and South America showed regional differences in the patterns of how the answer options were selected. No differential item functioning was detected for age. CONCLUSION: Except for a few modifications, the present analysis supports the combination of items, the cross-cultural validity of the CPQ with 14 items and the extension of the age range from 8 to 15 years. CLINICAL SIGNIFICANCE: The valid, reliable, shortened and age-extended version of the CPQ resulting from this study should be used in routine care and clinical research. Less items and a wider age range increase its usability. Symptoms items are needed to precisely differentiate between children with higher and lower quality of life.

Rasch model of the Child Perceptions Questionnaire for oral health-related quality of life: A step forward toward accurate outcome measures.

BACKGROUND: Oral health is related to major chronic diseases and contributes to general health. Oral health-related quality of life (OHRQoL) is, therefore, an essential part of well-being. Measurement of OHRQoL over the lifetime requires accurate and comparable outcome measures that are suitable for different age groups. The most frequently used instrument for children aged 11 through 14 years is the Child Perceptions Questionnaire (CPQ-11-14). The authors aimed to examine the psychometric properties of the CPQ-11-14 using modern statistical approaches. METHODS: The authors carried out a psychometric analysis of 2 population-representative data sets from Germany (N = 2,658) and a randomly selected smaller sample (n = 300) on the basis of the Rasch model. RESULTS: The authors detected a right-skewed distribution of the CPQ-11-14 total scores. The instrument items did not match the level of OHRQoL of the study participants. Moreover, a large number of questionnaire items (range, 51.4%-94.3%) had so-called disordered thresholds, meaning that the answer categories did not work as intended. Unidimensionality was achieved via splitting the CPQ-11-14 into 2 subscales, namely socioemotional and oral symptoms and functioning. CONCLUSIONS: Despite its classic validation, the CPQ-11-14 needs adaptions for meaningful clinical use. More items on the better end of the scale are needed to better differentiate between children with higher and lower OHRQoL. PRACTICAL IMPLICATIONS: The Rasch model addresses psychometric properties of questionnaires on an item-based level, which were not detected via classic approaches. The results reported by the authors are needed to generate a well-calibrated outcome measure for accurate clinical and public health assessment of OHRQoL.

Development and validation of a new instrument to measure perceived risks associated with the use of tobacco and nicotine-containing products.

BACKGROUND: Making tobacco products associated with lower risks available to smokers who would otherwise continue smoking is recognized as an important strategy towards addressing smoking-related harm. Predicting use behavior is an important major component of product risk assessment. In this context, risk perception is a possible factor driving tobacco product uptake and use. As prior to market launch real-world actual product use cannot be observed, assessing risk perception can provide predictive information. Considering the lack of suitable validated self-report instruments, the development of a new instrument was undertaken to quantify perceived risks of tobacco and nicotine-containing products by adult smokers, former smokers and never-smokers. METHODS: Initial items were constructed based on a literature review, focus groups and expert opinion. Data for scale formation and assessment were obtained through two successive US-based web surveys (n = 2020 and 1640 completers, respectively). Psychometric evaluation was based on Rasch Measurement Theory and Classical Test Theory. RESULTS: Psychometric evaluation supported the formation of an 18-item Perceived Health Risk scale and a 7-item Perceived Addiction Risk scale: item response option thresholds were ordered correctly for all items; item locations in each scale were spread out (coverage range 75-87%); scale reliability was supported by high person separation indices > 0.93, Cronbach's alpha > 0.98 and Corrected Item-Total Correlations > 0.88; and no differential item functioning was present. Construct validity evaluations met expectations through inter-scale correlations and findings from known-group comparisons. CONCLUSIONS: The Perceived Risk Instrument is a psychometrically robust instrument applicable for general and personal risk perception measurement, for use in different types of products (including cigarettes, nicotine replacement therapy, potential Modified Risk Tobacco Products), and for different smoking status groups (i.e., current smokers with and without intention to quit, former smokers, never smokers).

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

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.

Attempting measurement of psychological attributes.

Measures of psychological attributes abound in the social sciences as much as measures of physical properties do in the physical sciences. However, there are crucial differences between the scientific underpinning of measurement. While measurement in the physical sciences is supported by empirical evidence that demonstrates the quantitative nature of the property assessed, measurement in the social sciences is, in large part, made possible only by a vague, discretionary definition of measurement that places hardly any restrictions on empirical data. Traditional psychometric analyses fail to address the requirements of measurement as defined more rigorously in the physical sciences. The construct definitions do not allow for testable predictions; and content validity becomes a matter of highly subjective judgment. In order to improve measurement of psychological attributes, it is suggested to, first, readopt the definition of measurement in the physical sciences; second, to devise an elaborate theory of the construct to be measured that includes the hypothesis of a quantitative attribute; and third, to test the data for the structure implied by the hypothesis of quantity as well as predictions derived from the theory of the construct.

Measuring functioning in people with fibromyalgia (FM) based on the international classification of functioning, disability and health (ICF)--a psychometric analysis.

OBJECTIVES: Instruments to assess functioning in patients with FM vary considerably in their content and are often symptom-specific. This study aimed to examine whether it is feasible to construct a psychometric-sound clinical instrument to measure functioning in FM based on the Brief ICF-Core-Set for chronic widespread pain (CWP). METHODS: Two hundred and fifty six people with FM completed the Brief ICF-Core-Set. The Rasch model was used for analysis. Once ordering of response options of ICF categories was ensured, the following properties were studied: fit of the ICF categories to the Rasch model, the targeting between ICF categories and a person's abilities, unidimensionality, and reliability. RESULTS: Six ICF categories were rescored due to disordered thresholds. Five ICF categories were removed due to high model-misfit and differential item functioning (DIF) for gender. Scores from 46 participants were excluded due to extreme scores. The ICF categories included display consistency with an underlying unidimensional construct, are free of DIF for age, disease duration and gender, display excellent overall reliability, and cover a range of functioning difficulties. CONCLUSIONS: This study illustrates that it is possible to measure functioning as a unidimensional construct based on selected ICF categories from the components body functions, as well as activities and participation of the Brief ICF-Core-Set for CWP in patients with FM.