Psychometric properties of disease-specific health-related quality of life (HRQoL) instruments for food allergy and food intolerance: protocol for a COSMIN-based systematic review

INTRODUCTION: Food allergies and food intolerances can bring burdens on patients and their caregivers and reduce health-related quality of life (HRQoL). An increasing number of disease-specific HRQoL instruments for food allergies and food intolerances has been developed, and some of them have been adapted for different cultures and languages. This report describes a protocol for a systematic review of the psychometric properties of these instruments. The aims of this systematic review are to: (1) formulate recommendations for the usage of existing validated disease-specific HRQoL instruments for patients with food allergies and/or food intolerances and their caregivers; and (2) identify knowledge gaps to inform future research relating to these instruments. METHODS AND ANALYSIS: This protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 checklist. The future review will follow the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guideline for systematic reviews of patient-reported outcome measures (PROMs) and PRISMA 2020 statement guideline. Six databases (PubMed, EMBASE, Web of Science, Scopus, CINAHL and ProQuest -Health & Medical Collection) will be searched to retrieve studies focusing on the development and psychometric properties of disease-specific HRQoL instruments for patients with food allergies and/or food intolerances and their caregivers between 1 December 2021 and 31 December 2021. Two researchers will be responsible for literature screening, data extraction and literature evaluation, independently. Disagreements will be addressed by discussion or the involvement of a third researcher. The methodological quality of the included studies and the quality of the identified instruments will be assessed based on the COSMIN guideline for systematic reviews of PROMs. ETHICS AND DISSEMINATION: Ethical approval is not applicable for this study. We will disseminate the findings through publication in peer-reviewed journals and/or academic conferences. PROSPERO REGISTRATION NUMBER: CRD42021252203.