CORESTA Guidelines for Descriptive Consumer-Reported Outcome Measures in Tobacco and Nicotine Research

Evaluate FCTC policies at the level of the individual smoker

Identify the determinants of effective tobacco control policies

Disseminate research findings to the global tobacco control community, including researchers, policy makers, and advocates.”

Removing or introducing a response option of “I don’t know”

Changing the number of response categories (e.g., increasing the granularity of an item asking about household income)

Changing response category labels

Changing instructions and/or item content to reference a different product category (e.g., “Electronic Nicotine Delivery Systems (ENDS)” instead of “cigarettes”) or a specific brand

Changing language/terminology (e.g., changing “e-vapor” to “e-cigarettes”)

Adding product images to items asking about use of that product

Changing the recall period (e.g., “in the past 30 days” to “in the past 7 days”)

Administering a Descriptive Consumer-Reported Outcome Measure (CROM) developed for paper-and-pencil electronically

Changing the method of administration from self-completed to interviewer-administered

Changing the order of item administration (items asking about the use of different tobacco nicotine products (TNPs) are presented in a random order instead of fixed)

Modifying and applying measures of cigarette consumption to the consumption of a new TNP category ^a

Translating a Descriptive CROM into a different language and administering it to a new population (i.e., individuals whose primary language differs from languages the CROM has been validated for)

Administering a CROM to individuals from another culture (i.e., individuals whose cultural background differs from the background of individuals for whom the CROM was originally validated for)

Use simple language (be cognizant of reading level ^a,b) and avoid technical terminology, slang, idiomatic expressions, or colloquialisms (if possible)

Use direct, unambiguous language

Avoid leading questions and biasing language

Use of images can be helpful to aid comprehension/reduce confusion

Each item should communicate a single concept (no “double-barreled” items)

Avoid hypothetical questions

Recall period should be relevant and appropriate

Response option labels should be appropriately labeled and relevant

Response option labels should be appropriately granular (to meet the study’s needs, while also balancing limitations in participant’s memory, for example)

Response options should cover the full range of potential responses (a response of “another reason not listed” [or another similar response option] may be helpful)

Avoid response option labels that may bias the direction of the responses

Use of “not applicable” should be avoided when possible (items should be applicable for participants, and skip patterns can be used to avoid administering items to participants for whom they are truly not applicable)

“I don’t know” (or other similar response options) should be visually distinct from the other response options, and should be placed last in the response set

Making the text bold and underlining the recall period in the instructions (“In the past 7 days”) for visibility and emphasis

Changing font size or font style

Adding additional clarifying language to an item or instruction

Adding an image of the product being referenced

Adding an “I don’t know” response option

Administering a paper-and-pencil consumer-reported outcome measure (CROM) electronically without changing the presentation of the CROM

Changing the item to reference a different brand

Substantially changing the content of the CROM (e.g., changing the consumption measure of moist smokeless tobacco from times per day to cans per day)

Applying the CROM to tobacco nicotine products (TNPs) for which it was not developed

Modifying and administering the CROM to a population for which it was not developed

Translating a CROM into a new language and administering it to this new cultural population

Generally, no evidence is needed

In certain circumstances, qualitative evidence may be helpful (e.g., to ensure that new clarifying language added to instructions is clear)

Usability testing may be helpful in some circumstances, such as when modifying a paper-and-pencil CROM for electronic administration

If CROM content is substantially changed ^a

If responses from two versions of a CROM are being directly compared in a study

When administering a CROM to a new population and/or applying the CROM to a new product, and such changes could reasonably impact respondents’ interpretation of the CROM and response to the CROM.

When translating a CROM into a new language ^b