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Review
. 2025 Nov;18(6):609-621.
doi: 10.1007/s40271-025-00752-8. Epub 2025 Jul 24.

Cognitive Interviews: Recommendations for Best Practices in Clinical Outcome Assessment (COA) Measure Development and Validation

Affiliations
Review

Cognitive Interviews: Recommendations for Best Practices in Clinical Outcome Assessment (COA) Measure Development and Validation

Keith A Meadows et al. Patient. 2025 Nov.

Abstract

Cognitive interviewing is a technique that can be used to improve and refine questionnaire items. Cognitive interviewing is now a commonly used method to improve the reliability and validity of clinical outcome assessment instruments by identifying problems respondents have in understanding and answering the draft questionnaire items, and then to revise the items to improve understanding and response accuracy. Although practitioners are in general agreement regarding the basic principles and aims of the cognitive interview, there is considerable variation in practitioners' approaches. The aim of this paper is to put forward a few recommendations regarding best practice in the application of cognitive interviews as part of the developmental process of clinical outcome assessment instruments. The paper is structured in order that each section addresses a discrete and key element of the cognitive interview process that ranges from selecting the appropriate methodology, development of the interview guide, interviewer recruitment and training, and determining sample size through to approaches for analysis and writing the cognitive interview report. Each element of the cognitive interview process is divided into (1) the rational underpinning the methodology; (2) the recommended procedural steps; and (3) an overview of lessons learnt from previous research.

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Conflict of interest statement

Declarations. Funding: No funding was received to assist with the preparation of this article. Conflicts of Interest/Competing Interests: Keith A. Meadows, Nur Ferrante and Tomislav Geršić have no conflicts of interest that are directly relevant to the content of this article. Ethics Approval: Not applicable. Consent to Participate: Not applicable. Consent for Publication: Not applicable. Availability of Data and Material: Not applicable. Code Availability: Not applicable. Authors’ Contributions: All authors contributed to the study conception and design. Original draft preparation (KAM); review and editing (KAM, NF and TG).

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