Determining scope of the TRR Host: Social/Cognitive Collection

The TRRP organised a series of WGs using the ‘HAVE Model’, an epidemiological framework that has been adapted for tobacco control surveillance.2 In this context, the terms ‘Host’, ‘Agent’, ‘Vector’ and ‘Environment’ derive from human epidemiological models of infectious disease where the Hosts (children and adults) are affected by disease-causing Agents (tobacco products) transmitted by the Vector (tobacco industry and retailers) within the context of the Environment. This WG was charged with identifying the intrapersonal factors that influence product use, including cognitive, affective, motivational and perceptive factors (ie, perceived norms and risk perceptions), from the list generated by the TRRP. In other words, this WG was asked to review several potential elements that, in its best judgement, could characterise the ‘host’ or person who does, or would, use tobacco products (table 1).

The initial scope outlined in table 1 was generated as a ‘working draft’ by the overarching TRRP to start the consensus process engaged in by the WG. The WG recognised that measures of some of the elements were included in the toolkit by previous, non-tobacco regulatory WGs (see table 2), while other measures were subsumed by other tobacco regulatory WGs. Discussion then focused on the selection of measures with supportive psychometric data, broad applicability, reasonable respondent burden, public availability and logistical feasibility. Following this discussion, the final list of measures (see table 3) was necessarily smaller in scope.

Expertise of the Host: Social/Cognitive WG

The Host: Social/Cognitive WG consisted of five experts with established research portfolios and expertise in the psychosocial risk factors for tobacco use and their impact on the tobacco regulatory environment. Two of the members served as co-chairs of the WG to lead the consensus process and provide guidance for the selection of standardised measures. The WG was supported by two liaisons from the TRRP, one special consultant and two federal agency (FDA and NIH) experts who provided input regarding the federal government’s perspective on tobacco regulatory priorities and how they meshed with current research on the social and cognitive measures used to examine tobacco use and inform prevention strategies.

The expertise of the WG members spanned several areas of inquiry, including racial, ethnic and cultural risk factors related to tobacco use; health disparities; trajectories of tobacco use; resilience and dependence; smoking cessation; addictive behaviours; risk perceptions and attitudes; and health messaging. In addition, several of the WG members had experience with special populations (eg, adolescents, young adults and marginalised populations). The expertise of the WG involving these special populations was used during the consensus process to prioritise and select measures for inclusion in the toolkit. This expertise also helped ensure adequate coverage of the most pressing areas for which standard measures and protocols to assess the social and cognitive elements of tobacco users were lacking in the current PhenX Toolkit. The breadth and depth of the expertise of the WG helped fulfil the aim of PhenX to expand the scope of the toolkit by establishing recommended measures in support of tobacco regulatory research (TRR) and, thereby, accelerating the integration of social/cognitive measures into new and ongoing TRR studies.

WG deliberations

The specific goal for the Host: Social/Cognitive WG was to identify validated measures that assessed the scope discussed below for inclusion in the PhenX Toolkit. The primary selection criteria were that the measures be (1) clearly defined, (2) well established, (3) broadly applicable and generally acceptable, (4) low burden to participants and investigators, (5) broadly validated with demonstrated utility, (6) reproducible, (7) specific, (8) reliable and (9) have a standard measurement protocol. The WG also considered other criteria, including the following: (1) cross-cutting relevance for population groups, (2) relevance to TRR, (3) use in major reference studies (eg, the National Health and Nutrition Examination Survey), (4) open-source software and non-proprietary instruments (preferred), (5) brevity and (6) expectation of acceptance by the research community.

During their introductory call on 7 March 2015, the WG started the process of selecting measures by reviewing what was already in the toolkit. This review provided insight into where the WG should focus their efforts to identify new measures that were not already addressed by the toolkit. The measures listed in table 2 were already in the toolkit when the WG was formed and were complementary to the group’s scope. PhenX identification numbers are provided in the table to facilitate reader access to the location of each measure in the toolkit.

The WG members then selected and researched the scope described in table 1 and identified extant measures not already included in the PhenX Toolkit. The WG members presented their findings (ie, measures that assessed the targeted element) at a 2-day, in-person meeting where various measures were reviewed and discussed using the selection criteria described above. The WG then conducted additional literature review and further examination of the extant PhenX measures. The findings were then discussed during two teleconferences and via numerous email exchanges. At the conclusion of this process, the WG came to a consensus that the following 11 measures should be considered for inclusion in the toolkit: (1) behaviour economics/purchase behaviour, (2) quality of communication about smoking, (3) attention, (4) peer and family influence on smoking, (5) hedonic tone or response to pleasurable situations, (6) susceptibility to smoking cigarettes, (7) multigroup ethnic identity, (8) frequency of communication about smoking, (9) motivation to quit―single and multi-item, (10) distress tolerance and (11) house rules about tobacco use.

A number of the elements in the Host: Social/Cognitive domain are multidimensional in nature and some overlap with other domains was unavoidable. For example, a child’s cognitive processing of parental monitoring (eg, permissive or restrictive) will influence the child’s smoking behaviour. Similarly, nicotine dependence is widely seen as having multiple components including those that are contextual and cognitive in nature. Thus, nicotine dependence, as an element, could occur within the scope of more than one WG.

The primary authors of the measurement protocols suggested for inclusion were contacted to seek permission for their potential inclusion in the PhenX Toolkit. Additionally, the proposed measures were shared with the research community as part of the Community Outreach, in which an email was sent to researchers in academia and government agencies and those affiliated with various professional societies and scientific journals to obtain their comments about the proposed PhenX Toolkit measures. This feedback aided in refining the selection of measures for the toolkit and building consensus and acceptance of the measures throughout the research community. Additionally, this outreach facilitated obtaining opinions regarding the priority and appropriateness of the proposed measures and the utility of the measurement protocols. All feedback was reviewed and considered, although the WG did not agree with all comments and subsequently not all feedback was incorporated. The feedback was used by the WG to make their final selection of measures to include in the PhenX Toolkit, which occurred on 9 July 2015. (See Swan et al, this issue, for additional details about this process.)

Community Outreach

Seventeen people responded to the Community Outreach email and 12 provided ratings on the value of the various measures recommended. Overall, the respondents rated the proposed measures as being valuable to TRR. However, some minor concerns were expressed about the following measures: multigroup ethnic identity (not consistent with Centers for Disease Control/Office of Management and BudgetDirective 15 on Race and Ethnicity), hedonic tone or response to pleasurable situations (may be tangential to tobacco regulation), frequency of communication about smoking (concerned about reliability), distress tolerance (measure may be too experimental) and attention (not relevant to tobacco regulation).

The WG discussed the feedback acquired via Community Outreach and decided on the final 11 measures to recommend for inclusion in the toolkit. These measures were subsequently approved by both the TRRP and the PhenX Steering Committee. The final 11 measures, which were the same 11 sent for Community Outreach, were released into the toolkit on 20 February 2015. Table 3 gives a brief description of each measure. The toolkit provides the measure, the populations and tobacco products it has been validated for use with and scoring procedures (if applicable) (http://www.phenxtoolkit.org). PhenX identification numbers are provided at the beginning of each section below to facilitate reader access to each recommended measure’s location within the PhenX Toolkit.

Final Host: Social/Cognitive measures included in the PhenX Toolkit

Quality of Communication about Smoking (PhenX ID=710101). This is a series of six self-administered questions geared towards asking an adolescent (12–17 years) about the quality of communication with his/her parent about smoking (ie, mutual interest in each other’s opinions, ease of discussion, comfort during discussion, perception of parent’s honesty and reasonableness, feeling of being understood and feeling of being taken seriously). The response options are on a 5-point Likert scale ranging from 1=completely not true to 5=completely true. The questions have shown predictive validity in numerous studies, are low burden and are freely available.3

Frequency of Communication about Smoking (PhenX ID=710201). This is a series of eight self-administered questions that ask an adolescent (12–17 years) about communication with his/her parent about smoking.3 The response options are on a 5-point Likert scale ranging from 0=never to 4=very often. Items assess communication about refraining from smoking, discouragement of friends who smoke, the dangers of smoking, possible actions concerning tobacco use, potential punishment for smoking, specific instructions to not smoke, the portrayal of smoking in movies and the importance of resisting peer pressure to smoke. The questions have shown predictive validity in numerous studies, are low burden and are freely available.4 5

Susceptibility to Smoking Cigarettes (PhenX ID=710301). This 3-item instrument is used to predict whether adolescents or young adults (12–22 years) who have never smoked are likely to start smoking. Item responses are on a 4-point scale—‘definitely yes’, ‘probably yes’, ‘probably not’ and ‘definitely not’—and include ‘refused’ and ‘don’t know’ options.6 A gateway question—‘Smoking Status’, an existing PhenX Toolkit measure—must be asked first. This protocol should only be used if the respondent has never smoked. Participants who are currently non-smokers and answer ‘definitely not’ to all four items are classified as non-susceptible; all remaining participants are considered susceptible to smoking. The protocol can be used across gender and race/ethnicity and requires no training or equipment to administer. This scale has also been used to predict smoking among young adults, including military recruits.

Behaviour Economics/Purchase Behaviour (PhenX ID=710401). The Cigarette Purchase Task (CPT)7 is a self-administered simulation procedure to assess the reinforcement value of cigarettes within a specific context in respondents 14 years and older. It is a time-efficient and cost-efficient assessment of the relative reinforcing efficacy of cigarettes that has good reliability and test–retest stability and is related to dependence and cigarettes per day.8 9 The CPT came from an adaptation of a progressive-ratio operant schedule.

Current smoking status must be ascertained before implementing this protocol, which is intended for use with current smokers. The CPT consists of both state (right now) and trait (a typical day) assessments of how many cigarettes the respondent would consume if they cost various amounts of money (ranging from US$0/pack to US$22 400/pack) and under a variety of assumptions. For adolescents, alternate prices can be considered from those used for adults.9 The data result in five demand indices.

Motivation to Quit (single (PhenX ID=710501) and multi-item (PhenX ID=710502)). The single-item version asks the respondent to indicate on a 10-point scale how motivated she/he is to quit smoking (1=not at all motivated to 10=extremely motivated). This item is only intended for use in current smokers and has been shown to be related to quit attempts in adults and quit attempts and cessation among adolescents (14 years and older) as an important indicator of validity.10 11 This item is also frequently used to screen smokers for smoking cessation trials.

For a multi-item motivation assessment, the WG recommended the Reasons for Quitting (RFQ)12 Questionnaire, which is a 20-item self-administered protocol developed to assess specific motivations for smoking cessation. The respondent is asked to rate the extent to which each motivation describes them (0=not at all true and 4=extremely true). The RFQ is based on an intrinsic–extrinsic model of motivation for smoking cessation with 10 intrinsic items (eg, health concerns and self-control) and 10 extrinsic items (eg, immediate reinforcement and social pressure). The RFQ has good psychometrics, is multidimensional and assesses motivations for quitting, such as short-term consequences, social disapproval and long-term consequences. An adolescent (aged 14–19 years) version has also been developed.13

This protocol should be used only if the subject is a current or former smoker. This questionnaire is most appropriate for tobacco users who are in some way motivated to quit smoking. With appropriate changes in the introductory wording, researchers could also administer this questionnaire to smokers who have either previously quit or are currently smoking but are not interested in quitting.14

Hedonic Tone or Response to Pleasurable Situations (PhenX ID=710601). Anhedonia, the inability to experience pleasure in normally pleasurable acts, is associated with smoking cessation outcomes.15 16 Emotional regulation, and specifically anhedonia, may be a core dimension of depression associated with cessation failure.15 17 The WG selected the Snaith-Hamilton Pleasure Scale (SHAPS),18 a self-administered, paper-and-pencil questionnaire with 14 items assessing four domains of pleasure response/hedonic experience: interest/pastimes, social interaction, sensory experience and food/drink in adults (18 years and older). The WG acknowledges that this protocol was developed in English as used in the UK and recommends adjusting for English as used in the USA as needed.

In this protocol, the respondent is asked to indicate the extent to which he/she agrees (‘agree’ or ‘strongly agree’) or disagrees (‘disagree’ or ‘strongly disagree’) to each of 14 potentially pleasurable situations. A higher total SHAPS score indicates a higher level of anhedonia.

Distress Tolerance (PhenX ID=710701). Distress tolerance is the ability to persist in a goal-directed activity when experiencing psychological distress or the ability to tolerate psychological distress in general. One measurement approach is time spent on a frustrating behavioural task (ie, task persistence). Distress tolerance appears to be a relatively stable trait. Across measures, it has been found to be predictive of substance-use outcomes, including smoking cessation.19 20 Individuals who have low distress tolerance may experience greater difficulty in maintaining tobacco abstinence in the face of withdrawal and other challenges.21

The Mirror Tracing Persistence Task (MTPT) has been demonstrated to discriminate between adult smokers and non-smokers and predict smoking cessation outcomes.19 22 23 The original MTPT23 required the construction or purchase of a physical box with a slanted mirror on one side. The participant inserts his or her hand and traces geometric figures while only watching the hand in the mirror. This is extremely difficult and frustrating. Persistence is scored as the mean time spent on several trials prior to giving up. The predictive validity of task persistence as assessed by the MTPT has been published in the context of smoking cessation outcomes among adults19 22 but not among adolescents.

The Computerised MTPT (MTPT-C)24 was developed to make the test more accessible; indeed, the MTPT-C does not require tracking equipment to conduct the assessment. Thus, this test has potential as a screening instrument to identify individuals at high risk of smoking initiation or smoking cessation failure. To date, the MTPT-C has been used to predict treatment dropout among substance abusers and shown to be correlated with other distress tolerance tasks among smokers.25 Distress tolerance is measured by the latency in seconds to task termination. Several quantitative indices of tracing accuracy, duration and time to completion in each of the modes are provided.

Multigroup Ethnic Identity (PhenX ID=710801). The WG selected a general measure to assess both cognitive and affective components of a respondent’s sense of belonging and connectedness to a group of people with a common history, a clear understanding of the meaning of one’s group membership, positive attitudes towards the group, familiarity with its history and culture, and involvement in its practices.26 Ethnic identity development begins in childhood, and by young adulthood, identities have been reached; that is, people have a secure sense of themselves as members of a group. However, some evidence suggests that further development occurs during adulthood.27 28

The Ethnic Identity Scale is a 12-item multigroup ethnic identity measure used among adolescents and young adults (aged 14–34 years) to assess positive ethnic attitudes and sense of belonging (5 items); ethnic identity achievement, including exploration and resolution of identity issues (7 items) and ethnic behaviours and practices (2 items). In recent years, Phinney proposed the Multigroup Ethnic Identity Measure—Revised, which is a shorter, 10-item version29; however, it has not been well validated.

Peer and Family Influence on Smoking (PhenX ID=710901). The measure selected for this element assesses adolescent (12–17 years) and young adult (18–22 years) evaluation of the use of cigarettes by parents and siblings and perception (not actual use) of the number of friends who use tobacco in their best-friend social network. This measure focuses on the exposure of the respondent to smoking in their immediate social networks and can be either a self-administered or interviewer-administered questionnaire. The 5-item National Cancer Institute (NCI) measure consists of five questions about peer and family smoking.30 Although it has not been used with people over the age of 22 years, the WG recommended that scientists consider using this measure with participants up to the age of 26 years, as the most recent Surgeon General’s Report on young adult smokers, published in 2012, indicates that smoking initiation continues up to the age of 26 years.31

The WG recommends that these items be applied to other tobacco use (electronic cigarette (e-cigarette) and hookah), although the measure has only been validated in the context of cigarette use. Therefore, caution should be taken when applying it to other tobacco products.

Attention (PhenX ID=711001). Attention is the process of selecting specific aspects of the environment or ideas stored in memory for active cognitive processing. The WG selected the Attentional Control Scale (ACS),32 33 a 20-item self-report questionnaire developed to measure general individual differences in attentional focusing and shifting in adults 18 years and older who are known to be influenced by nicotine and other substances found in tobacco products. The ACS is brief and easy to administer and has solid psychometric properties and supportive validity information.

House Rules about Tobacco Use (PhenX ID=711101). This protocol includes questions from the Wave 1 Adult Population Assessment of Tobacco and Health (PATH) Study instrument (PATH Study Wave 1 Adult Extended Interview 7.5. Items AR1045 and AR1050).34 Two interviewer-administered questions ask whether or not smoking combustible (ie, cigarettes, cigars, pipes or hookah) and non-combustible tobacco products (ie, smokeless tobacco, dissolvable tobacco and e-cigarettes) is allowed inside the home (‘at no time and in no place’, ‘some places or times’ or ‘anywhere and anytime’). These two questions can be asked of both adult and adolescent populations (12 years and above).