Abstract

Patient Reported Outcome Measures (PROMs) are standardized surveys assessing functional status, health, and wellbeing. Contemporary movement towards the evaluation of services through consideration of the patient perspective is reflected in the development and use of PROMs. Cognitive Interviewing (CI) is a promising method of developing and refining PROMs, however, there is variability in the CI procedures implemented. The objectives of this study were to assess the methodological-reporting quality of studies using CI in the development of PROMs and examine the methodological processes used in studies using CI in the development of PROMs. A systematic literature search was carried out to identify studies using CI to develop PROMs. Quality assessment was carried out according to an appraisal framework. Data regarding CI processes were extracted and synthesized. A total of 19 studies were reviewed, which were assessed to be of high quality. Participant and study characteristics, CI processes, and method of reporting findings were presented. This systematic review found studies evaluating or developing PROMs using CI varied in terms of the processes used across all aspects of the methodology. CI studies of PROMs were more systematically reported when based upon a theoretical model, whether used to guide data collection, analysis, or both. The Cognitive Interviewing Reporting Framework provides a helpful structure for planning, conducting, and reporting CI studies. It is recommended that future research assesses the relative utility of different approaches to CI for identifying problems with PROMs, so as to enable more informed methodological choices.