The development quality of generic sleep questionnaires: A systematic review and call for action

This systematic review summarizes the scope, structure, and quality of the development process of generic sleep patient-reported outcome measures (PROMs). A literature search identified 24 articles reporting on the development of 27 generic sleep PROMs. Using the consensus-based standards for the selection of health measurement instruments (COSMIN) as guiding framework, the overall quality of the development was found doubtful for 4 PROMs and inadequate for 23 PROMs. For 20 PROMs no concept elicitation study and/or cognitive interview or other pilot study was reported. Common concerns were unclear construct definitions, unclear origin of the constructs, unclear target populations, and the observation that patients were not consulted in the development process. These concerns are interpreted in light of evolving standards and situated in ongoing scientific debates concerning: 1) increasing input from patients and the broader public, 2) multitude of guidelines, 3) lack of conceptual clarity, and 4) challenges in applying COSMIN criteria. While appreciating the substantial methodological progress achieved in recent decades, we advocate for retrospective improvements to existing generic sleep PROMs and encourage future developments to adhere to current best practices, thereby further strengthening sleep research and clinical care.