Abstract
Psychometric consumer reported outcome measures (CROM), which aim to infer latent variables (e.g., psychological dependence) from self-report measurement instruments, play a key role in data collection in research on tobacco- and nicotine-containing products (TNPs). While guidelines are available for patient reported outcomes (PRO) to be used in health studies, no comprehensive guidelines exist for Psychometric CROM which consider specifics in the field of TNP research. The proposed guidelines aim to fill the current gap with the objective of enhancing the quality of empirical research on TNPs. The objective is to develop guidelines for researchers with respect to the selection, development, modification, and implementation of Psychometric CROM in TNP research. The guidelines were developed by a working group comprised of CORESTA (Cooperation Centre for Scientific Research Relative to Tobacco) CROM Task Force members by adopting an iterative and consensus driven approach. This involved reviewing relevant peer-reviewed publications, publicly available guidelines, and best practices published by prominent organizations from related fields and seeking active collaboration with subject matter experts representing public health, academia, and the tobacco industry. The draft guidelines were presented and discussed at various health and tobacco research conferences. Based on feedback and suggestions provided, the guidelines were continuously updated and revised.
The resulting guidelines contain four sections, guiding the reader from construct definition to application and interpretation of Psychometric CROM. Emphasis is placed on crucial initial research stages, such as defining the ideal CROM characteristics based on the construct definition, the context of measurement, and the objectives of the study, to facilitate the researcher’s determination as to whether use of an existing CROM would be an appropriate choice for the study, or whether modifying an existing CROM or developing a new CROM would be warranted. While the guidelines provide direction for researchers who intend to use Psychometric CROM in their research, they also flag key measurement considerations and raise awareness of psychometric issues with the goal of advancing Psychometric CROM measurement science.
Grounded in psychometric principles, these guidelines present best practices and provide guidance on the appropriate identification, development, modification, and application of Psychometric CROM in TNP research in a way that is consistent with good measurement practices. With the dissemination of the guidelines, we expect a more informed selection of CROM, a better-founded modification of existing CROM and development of new CROM, improved integration of CROM into TNP research and ultimately a better harmonization of consumer-reported measurement in the field of TNP research.