OBJECTIVES: The PICO (Population, Intervention, Comparator, Outcome) statement is the most widely accepted framework for defining the scope of systematic reviews. However, this framework mainly meets the requirements of clinical reviews, which do not fully consider the complexities of humanistic reviews. The objectives are to 1. Review existing guidelines for developing PICO statements for humanistic reviews and their application in practice; 2. Provide practical PICO considerations for humanistic reviews.

METHODS: A targeted search of health technology assessment websites and methodological bodies was performed to identify guidance frameworks. Additionally, we searched MEDLINE for humanistic reviews (all indications) published from 2017-present. Eligible reviews were assessed to determine how the PICO statement was developed and the inclusion rate based on screening criteria. Using this review and the authors’ experiences, guidance on developing PICO statements for burden reviews is presented.

RESULTS: A total of 27 humanistic reviews were included and all used the PICO framework. The proportion of eligible included studies ranged from 0.23%-8.05%, indicating low sensitivity of search strategies. To increase searches’ sensitivity and guide selection criteria, we propose: Identifying a distinct population (e.g., disease severity, subgroups, comorbidities); Explicitly outlining whether to prioritize generic, disease-specific scales, or different versions (e.g., EQ-5D-3L versus EQ-5D-5L); Avoiding vague outcomes (e.g., ‘functional status’); Limiting the type of respondent (e.g., patients, clinicians, caregivers); Creating an a priori list of effect estimates (e.g., mean scores, change from baseline) and time points based on clinical relevance; Implementing sample size, study design, and time restrictions.

CONCLUSIONS: Comprehensively understanding the humanistic disease burden through systematic reviews is fundamental when assessing the value of new health technologies. As the volume of evidence for humanistic reviews has increased drastically over recent years, specific guidance for developing PICO statements is required. Our practical considerations will guide researchers in this area and avoid unnecessary work during evidence selection and synthesis.