Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Research

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

Authors: Cecilia A. C. Prinsen, Sunita Vohra, Michael R. Rose, Maarten Boers, Peter Tugwell, Mike Clarke, Paula R. Williamson, Caroline B. Terwee

Published in: Trials | Issue 1/2016

Login to get access

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.
Appendix
Available only for authorised users
Footnotes
1
Question: “The minimum standard for internal consistency of outcome measurement instruments to be included in a COS should be a Cronbach’s alpha of between 0.70 and 0.90.”
 
2
Question: “If no outcome measurement instrument exists that meets the requirements for adequate measurement properties, it can be included in a COS “conditionally.” What should be the minimum condition before an instrument can be included in a COS?”
 
3
“High quality evidence” is defined as consistent findings in multiple studies of at least good quality OR in one study of excellent quality AND a total sample size of 100 patients or more (Table 5)
 
4
“Good” is defined as a “+” rating according to the criteria for good measurement properties (Table 4)
 
Literature
1.
Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374:86–9.CrossRefPubMed
2.
Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.CrossRefPubMedPubMedCentral
3.
Gorst SL, Gargon E, Clarke M, Blazeby JM, Altman DG, Williamson PR. Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey. PLoS One. 2016;11:e0146444.
4.
5.
6.
Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010;63:737–45.CrossRefPubMed
7.
8.
Schmitt J, Apfelbacher C, Spuls PI, Thomas KS, Simpson EL, Furue M, et al. The Harmonizing Outcome Measures for Eczema (HOME) Roadmap: a methodological framework to develop core sets of outcome measurements in dermatology. J Invest Dermatol. 2014;135:24–30.CrossRefPubMed
9.
Prinsen CAC, Vohra S, Rose MR, King-Jones S, Ishaque S, Bhaloo Z, et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials. 2014;15:247.CrossRefPubMedPubMedCentral
10.
11.
Boers M, Kirwan JR, Wells GA, Beaton DE, Gossec L, D’Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014;67:745–53.CrossRefPubMed
12.
Adams D, Liu Y, Bhaloo Z, Hansraj N, Hartling L, Vohra S. Primary Outcomes Reporting in Trials (PORTal): a systematic review of pediatric randomized controlled trials. (accepted by J Clin Epidemiol, 2016). 2013. in press.
13.
Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19:539–49.CrossRefPubMedPubMedCentral
14.
Murphy MK, Black NA, Lamping DL, McKee CM, Sanderson CF, Askham J, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess. 1998;2:1–88.
15.
Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015;24:1127–42.CrossRefPubMed
16.
Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Bouter LM, et al. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol. 1998;51:1235–41.CrossRefPubMed
17.
18.
19.
Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60:34–42.CrossRefPubMed
20.
21.
Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014;9:e99111.CrossRefPubMedPubMedCentral
Metadata
Title
How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline
Authors
Cecilia A. C. Prinsen
Sunita Vohra
Michael R. Rose
Maarten Boers
Peter Tugwell
Mike Clarke
Paula R. Williamson
Caroline B. Terwee
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1555-2

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Study protocol

Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial

Study protocol

Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial

Study protocol

Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial

Methodology

Assessment of learning curves in complex surgical interventions: a consecutive case-series study

Study protocol

A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial

Review

A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials