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ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2018

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

C B Terwee, C A C Prinsen, A Chiarotto, M J Westerman, D L Patrick, J Alonso, L M Bouter, H C W de Vet, L B Mokkink

4 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 1,080 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,080citing papers in PubMed, 23 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06317831 recruitingnot on this mapstarted 2024, after this paper: background citation

LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease - the SUNSET Study

Typeobservational_patient_registrySponsorAveiro UniversityRan2024 to 2028Enrolled150ConditionsInterstitial Lung Diseases
NCT06459011 recruitingnot on this mapstarted 2024, after this paper: background citation

TAKINGCARE - TAcKlING the Needs of Carers of People With Chronic respirAtoRy disEases

TypeobservationalSponsorAveiro UniversityRan2024 to 2028Enrolled250ConditionsChronic Respiratory Disease
NCT06568029 completednot on this mapstarted 2024, after this paper: background citation

Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease

TypeobservationalSponsorKarolinska InstitutetRan2024 to 2024Enrolled77,651ConditionsRheumatoid Arthritis, Polyarthritis, Psoriatic Arthritis, Ankylosing SpondylitisArmsQuestionnaire
NCT06850857 enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)

TypeobservationalSponsorUniversity of TennesseeRan2025 to 2026Enrolled500ConditionsFacial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex FractureArmsIMPACT-G Module, IMPACT-N Module, IMPACT-O Module, IMPACT-J Module, 15D Control Survey
3 · Its place in the literature

Who cites it

1,080 citing papers in PubMed, 23 syntheses or guidelines pooled it.

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  2. Instruments for measuring body image in breast cancer patients: a systematic review of measurement properties.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
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1,020 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

C B TerweeDepartment of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands. cb.terwee@vumc.nl.
C A C PrinsenDepartment of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.
A ChiarottoDepartment of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.
M J WestermanDepartment of Health Sciences and Amsterdam Public Health Research Institute, VU University, Amsterdam, The Netherlands.
D L PatrickDepartment of Health Services, University of Washington, Seattle, WA, USA.
J AlonsoIMIM (Hospital del Mar Medical Research Institute), Department of Experimental and Health Sciences, Pompeu Fabra University (UPF), Barcelona, Spain.
L M BouterDepartment of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.
H C W de VetDepartment of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.
L B MokkinkDepartment of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundContent 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.

methodsAn 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.

resultsDiscussion 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.

Indexed as

Delphi TechniquePatient Reported Outcome MeasuresSurveys and QuestionnairesValidation Studies as TopicConsensusHumansQualitative ResearchQuality of LifeContent validityCOSMINPatient outcome assessmentPatient-reported outcomeSystematic reviewValidation studies

Identifiers

PMID29550964
PMCPMC5891557

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.