Principles of good practice for concept definition in the context of translation and linguistic validation of clinical outcome assessments (COAs)

Concept definitions guide stakeholders and ensure all parties align on the intended meaning of items being translated. While experts have made recommendations for best practices around translation and linguistic validation methodology, they have not clearly delineated the process of defining concepts. The Concept Definition Working Group of the ISOQOL TCA-SIG has therefore developed a set of recommendations for the process of defining concepts. With these recommendations the Working Group intends to standardize the development of concept definitions with the goal of enhancing conceptual equivalence across translations to support data pooling and provide confidence that clinical trial data are comparable, interpretable, and can be relied upon in evaluating clinical benefit of treatments.

Authors

Institutions

Publication Details

Journal
Journal of Patient-Reported Outcomes
Published
2025-07-14
DOI
https://doi.org/10.1186/s41687-025-00920-2
Primary Topic
Delphi Technique in Research
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Principles of good practice for concept definition in the context of translation and linguistic validation of clinical outcome assessments (COAs)

E. Parks-Vernizzi, Clayon B. Hamilton, Sonya Eremenco, John Eric Chaplin et al.
Journal of Patient-Reported Outcomes
Delphi Technique in Research
article

Principles of good practice for concept definition in the context of translation and linguistic validation of clinical outcome assessments (COAs)

E. Parks-Vernizzi, Clayon B. Hamilton, Sonya Eremenco, John Eric Chaplin, Holger Muehlan, B Brandt, Ana Popielnicki, Jussi P. Repo, Dana Weiß, Benjamin Arnold, Mark R. Wade, Beatrice Tedeschi
article en

Abstract

Concept definitions guide stakeholders and ensure all parties align on the intended meaning of items being translated. While experts have made recommendations for best practices around translation and linguistic validation methodology, they have not clearly delineated the process of defining concepts. The Concept Definition Working Group of the ISOQOL TCA-SIG has therefore developed a set of recommendations for the process of defining concepts. With these recommendations the Working Group intends to standardize the development of concept definitions with the goal of enhancing conceptual equivalence across translations to support data pooling and provide confidence that clinical trial data are comparable, interpretable, and can be relied upon in evaluating clinical benefit of treatments.

Journal of Patient-Reported OutcomesVol. 9(1)
Transparency International (CZ), Simon Fraser University (CA), University of Erfurt (DE), Critical Path Institute (US), Mapi Research Trust (FR), Research Complex at Harwell (GB), Fracture Analysis Consultants (United States) (US), GlaxoSmithKline (United States) (US), Tampere University Hospital (FI), Tampere University (FI), University of Gothenburg (SE)
Partnerships for the goals
Openalex Percentile: Top 77%
Delphi Technique in Research
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.