The comprehensibility continuum: a novel method for analysing comprehensibility of patient reported outcome measures.

Purpose: Evidence of comprehensibility is frequently required during the development of patient reported outcome measures (PROMs); the respondent's interpretation of PROM items needs to align with intended meanings. Cognitive interviews are recommended for investigating PROM comprehensibility, yet guidance for analysis is lacking. Consequently, the quality and trustworthiness of cognitive interview data and analysis is threatened, as there is no clear procedure detailing how analysts can systematically, and consistently, identify evidence that respondent interpretations align/misalign with intended meanings.

Including Young Children in the Development and Testing of Patient Reported Outcome (PRO) Instruments: A Scoping Review of Children's Involvement and Qualitative Methods.

Background: Qualitative research during the development/testing of Patient Reported Outcome Measures (PROMs) is recommended to support content validity. However, it is unclear if and how young children (≤ 7 years) can be involved in this research because of their unique cognitive needs.

Objectives: Here we investigate the involvement of children (≤ 7 years) in qualitative research for PROM development/testing.