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

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Abstract

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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Most cited references 15

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Quality criteria were proposed for measurement properties of health status questionnaires.

Caroline Terwee, Sandra D M Bot, Michael de Boer … (2007)

Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires. Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group. For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study. Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.

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The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes.

Lidwine B Mokkink, Caroline B Terwee, Donald L Patrick … (2010)

Lack of consensus on taxonomy, terminology, and definitions has led to confusion about which measurement properties are relevant and which concepts they represent. The aim was to clarify and standardize terminology and definitions of measurement properties by reaching consensus among a group of experts and to develop a taxonomy of measurement properties relevant for evaluating health instruments. An international Delphi study with four written rounds was performed. Participating experts had a background in epidemiology, statistics, psychology, and clinical medicine. The panel was asked to rate their (dis)agreement about proposals on a five-point scale. Consensus was considered to be reached when at least 67% of the panel agreed. Of 91 invited experts, 57 agreed to participate and 43 actually participated. Consensus was reached on positions of measurement properties in the taxonomy (68-84%), terminology (74-88%, except for structural validity [56%]), and definitions of measurement properties (68-88%). The panel extensively discussed the positions of internal consistency and responsiveness in the taxonomy, the terms "reliability" and "structural validity," and the definitions of internal consistency and reliability. Consensus on taxonomy, terminology, and definitions of measurement properties was reached. Hopefully, this will lead to a more uniform use of terms and definitions in the literature on measurement properties. Copyright 2010 Elsevier Inc. All rights reserved.

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The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study

Lidwine Mokkink, Caroline Terwee, Donald L Patrick … (2010)

Background Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. Methods A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated ‘agree’ or ‘strongly agree’. Results Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. Conclusions The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.

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Author and article information

Contributors

Cecilia A. C. Prinsen: +31 20 4445903 , c.prinsen@vumc.nl

Sunita Vohra: svohra@ualberta.ca

Michael R. Rose: m.r.rose@kcl.ac.uk

Maarten Boers: m.boers@vumc.nl

Peter Tugwell: Tugwell.BB@uOttawa.ca

Mike Clarke: m.clarke@qub.ac.uk

Paula R. Williamson: p.r.williamson@liverpool.ac.uk

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

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 13 September 2016

Publication date PMC-release: 13 September 2016

Publication date Collection: 2016

Volume: 17

Issue: 1

Electronic Location Identifier: 449

Affiliations

[1 ]Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, De Boelelaan 1089a, 1081 HV, Amsterdam, The Netherlands

[2 ]Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB Canada

[3 ]School of Public Health, University of Alberta, Edmonton, AB Canada

[4 ]Women’s and Children’s Health Research Institute, University of Alberta, Edmonton, AB Canada

[5 ]Department of Neurology, King’s College Hospital, London, UK

[6 ]Amsterdam Rheumatology & Immunology Center, Amsterdam, The Netherlands

[7 ]Department of Medicine, University of Ottawa, Ottawa, ON Canada

[8 ]Northern Ireland Network for Trials Methodology Research, Institute of Clinical Sciences, Royal Hospitals, Queen’s University Belfast, Belfast, UK

[9 ]Department of Biostatistics, University of Liverpool, Liverpool, UK

Article

Publisher ID: 1555

DOI: 10.1186/s13063-016-1555-2

PMC ID: 5020549

PubMed ID: 27618914

SO-VID: ab6bd92b-fc8c-4236-89bd-9c43e9e05dbb

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. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 1 September 2015

Date accepted : 9 July 2016

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004963, Seventh Framework Programme (BE);

Award ID: FP7/2007-2013; 305081

Award Recipient : Paula R. Williamson

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: comet,core outcome set,cosmin,delphi study,guideline,instrument selection,outcomes research,outcome measurement instrument

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ScienceOpen disciplines: Medicine

Keywords: comet, core outcome set, cosmin, delphi study, guideline, instrument selection, outcomes research, outcome measurement instrument

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

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Most cited references 15

Quality criteria were proposed for measurement properties of health status questionnaires.

The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes.

The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study

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