A Systematic Review of the Development and Psychometric Properties of Constipation-related Patient-reported Outcome Measures: Opportunities for Digital Health

BACKGROUND/AIMS: Constipation can be a chronic condition that impacts daily functioning and quality of life (QoL). To aid healthcare providers in accurately assessing patient symptoms and treatment outcomes, patient-related outcome measures (PROMs) have been increasingly adopted in clinical settings. This review aims to (1) evaluate the methodological quality and measurement properties of constipation-related PROMs, using the COnsensus-based Standards for the selection of health Measurement INtruments (COSMIN) criteria; and (2) assess the modes of digital dissemination of constipation-related PROMs. METHODS: PubMed, Embase, and PsycINFO databases were searched and 11 011 records ranging from 1989 to 2020 were screened by 2 independent reviewers. A total of 26 studies (23 PROMs; 18 measuring symptom-related items and 5 measuring constipation-related QoL items) were identified for the review and assessed. RESULTS: There were multiple variations between PROMs, including subtypes of constipation, methods of administration, length of PROM and recall period. While no PROM met all the COSMIN quality standards for development and measurement properties, 5 constipation-related PROMs received at least 4 (out of 7) sufficient ratings. Only 2 PROMs were developed in Asia. Five PROMs were administered through digital methods during the validation process but methods of adapting the PROMs into digital formats were not reported. CONCLUSIONS: The constipation-related PROMs identified in this review present varying quality of development and validation, with an overall need for improvement. Further considerations should be given towards more consistent methodology and reporting of PROM development, increase in culturally-specific PROMs, and better reporting of protocol for the digitization of PROMs.