COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study

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Abstract

Background

Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM’s content validity and grading the quality of the evidence in systematic reviews of PROMs.

Methods

An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales (‘strongly disagree’ to ‘strongly agree’), and provided arguments for their ratings.

Results

Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM.

Discussion

The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.

Electronic supplementary material

The online version of this article (10.1007/s11136-018-1829-0) contains supplementary material, which is available to authorized users.

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How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Cecilia Prinsen, Sunita Vohra, Michael Rose … (2016)

Background In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Methods Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Results Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). Conclusions This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1555-2) contains supplementary material, which is available to authorized users.

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Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.

Margaret Rothman, Laurie Burke, Pennifer Erickson … (2009)

Patient-reported outcome (PRO) instruments are used to evaluate the effect of medical products on how patients feel or function. This article presents the results of an ISPOR task force convened to address good clinical research practices for the use of existing or modified PRO instruments to support medical product labeling claims. The focus of the article is on content validity, with specific reference to existing or modified PRO instruments, because of the importance of content validity in selecting or modifying an existing PRO instrument and the lack of consensus in the research community regarding best practices for establishing and documenting this measurement property. Topics addressed in the article include: definition and general description of content validity; PRO concept identification as the important first step in establishing content validity; instrument identification and the initial review process; key issues in qualitative methodology; and potential threats to content validity, with three case examples used to illustrate types of threats and how they might be resolved. A table of steps used to identify and evaluate an existing PRO instrument is provided, and figures are used to illustrate the meaning of content validity in relationship to instrument development and evaluation. RESULTS & RECOMMENDATIONS: Four important threats to content validity are identified: unclear conceptual match between the PRO instrument and the intended claim, lack of direct patient input into PRO item content from the target population in which the claim is desired, no evidence that the most relevant and important item content is contained in the instrument, and lack of documentation to support modifications to the PRO instrument. In some cases, careful review of the threats to content validity in a specific application may be reduced through additional well documented qualitative studies that specifically address the issue of concern. Published evidence of the content validity of a PRO instrument for an intended application is often limited. Such evidence is, however, important to evaluating the adequacy of a PRO instrument for the intended application. This article provides an overview of key issues involved in assessing and documenting content validity as it relates to using existing instruments in the drug approval process.

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Test validity and the ethics of assessment.

Samuel Messick (1980)

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Author and article information

Contributors

C. B. Terwee: cb.terwee@vumc.nl

Journal

Journal ID (nlm-ta): Qual Life Res

Journal ID (iso-abbrev): Qual Life Res

Title: Quality of Life Research

Publisher: Springer International Publishing (Cham )

ISSN (Print): 0962-9343

ISSN (Electronic): 1573-2649

Publication date (Electronic): 17 March 2018

Publication date PMC-release: 17 March 2018

Publication date (Print): 2018

Volume: 27

Issue: 5

Pages: 1159-1170

Affiliations

[1 ]ISNI 0000 0004 0435 165X, GRID grid.16872.3a, Department of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, , VU University Medical Center, ; P.O. Box 7057, 1007 MB Amsterdam, The Netherlands

[2 ]ISNI 0000 0004 1754 9227, GRID grid.12380.38, Department of Health Sciences and Amsterdam Public Health Research Institute, , VU University, ; Amsterdam, The Netherlands

[3 ]ISNI 0000000122986657, GRID grid.34477.33, Department of Health Services, , University of Washington, ; Seattle, WA USA

[4 ]ISNI 0000 0001 2172 2676, GRID grid.5612.0, IMIM (Hospital del Mar Medical Research Institute), Department of Experimental and Health Sciences, , Pompeu Fabra University (UPF), ; Barcelona, Spain

[5 ]ISNI 0000 0000 9314 1427, GRID grid.413448.e, CIBER en Epidemiología y Salud Pública (CIBERESP), ; Madrid, Spain

[6 ]ISNI 0000 0004 1754 9227, GRID grid.12380.38, Faculty of Humanities, Department of Philosophy, , VU University, ; Amsterdam, The Netherlands

Article

Publisher ID: 1829

DOI: 10.1007/s11136-018-1829-0

PMC ID: 5891557

PubMed ID: 29550964

SO-VID: 226efbaa-3f02-473e-a506-956a023f9718

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

History

Date accepted : 3 March 2018

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ScienceOpen disciplines: Public health

Keywords: patient outcome assessment,validation studies,content validity,patient-reported outcome,cosmin,systematic review

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ScienceOpen disciplines: Public health

Keywords: patient outcome assessment, validation studies, content validity, patient-reported outcome, cosmin, systematic review

COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study

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PLOS: COVID-19 pandemic

Most cited references 11

How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.

Test validity and the ethics of assessment.

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