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A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery
Open accessAbstract
OBJECTIVES: There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. STUDY DESIGN AND SETTING: A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. RESULTS: Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. CONCLUSIONS: This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes.
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“The Core Outcome Measures in Effectiveness Trials (COMET) initiative supports standardisation, providing a taxonomy 19 to classify outcomes used in trials.”
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“A strength of this review is the meticulous process of categorising and coding all measures with reference to literature, including the novel application of the COMET taxonomy to Acceptance and Commitment Therapy research. 19”
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“Outcomes will be presented using the order of the Taxonomy for Outcomes in Medical Research, with functional outcomes presented first.”
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“The revised Williamson and Clarke taxonomy [24] was used to categorise outcomes of relevance to AYAs into pre‐specified BOX 1 | Inclusion and exclusion criteria.”
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“Based on this taxonomy, we categorized the outcomes into the following domains: (a) mortality and survival, (b) physical health, (c) life impact, (d) resource use, and (e) adverse events [23].”
Hospital-to-home transitions for children with medical complexity: part 2—a core outcome set
Haspels, H. N., de Lange, A., Alsem, M. W., Sandbergen, B., Dulfer, K., de Hoog, M., Joosten, K., van Karnebeek, C., van Woensel, J. B. M., & Maaskant, J. M. (2023) · European Journal of Pediatrics · doi:10.1007/s00431-023-05049-2 · Cited by 13
“These outcomes were categorized into domains according to the taxonomy of Dodd et al. [30].”
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“We then categorized the outcome list using the COMET Outcome Classification Taxonomy domains to generate the Delphi round 1 questionnaire (26).”
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Protocol for the development of a core domain set for hand eczema trials
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Acute care models for older people living with frailty: a systematic review and taxonomy
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“Outcome measurements were classified using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy [12].”
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Variation in outcome reporting in studies on obesity in pregnancy—A systematic review
Dadouch, R., Faheim, M., Susini, O., Sedra, S., Showell, M. G., D'Souza, R. D., & on behalf of COSSOPP investigators (2019) · Clinical Obesity · doi:10.1111/cob.12341 · Cited by 12
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“Each outcome was reviewed and categorised using the COMET taxonomy [23] (Table 3).”
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“The COMET taxonomy was used as a high-level framework to group outcomes, with the hierarchy consisting of ‘COMET core areas’ followed by ‘COMET outcome domains’ [14].”
Core outcome sets in dermatology: next steps
Kottner, J., & Schmitt, J. M. (2018) · British Journal of Dermatology · doi:10.1111/bjd.16812 · Cited by 12
PREgnancy Nutrition: A protocol for the development of a Core Outcome Set (PRENCOS)
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“The use of such models has been limited due to inconsistent outcome description in trials and published corpora to support outcome detection [18, 19], however these models hold great promise for automatic detection of outcomes.”
Development of a core outcome set for traumatic brachial plexus injury
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“The outcomes extracted from the systematic review and identified from the interviews were grouped into domains and categorized into a taxonomy developed to support COS generation (Dodd et al., 2018) by the lead author (CM) and reviewed by the co-authors.”
Zarama, V., Arango-Granados, M. C., Manzano-Núñez, R., Sheppard, J. P., Roberts, N. W., & Plüddemann, A. (2024) · Scandinavian Journal of Trauma Resuscitation and Emergency Medicine · doi:10.1186/s13049-024-01192-3 · Cited by 13
“…powered to assess differences according to patient’s previous heart disease, considering the complete spectrum of myocardial ischemia (unstable angina as well as myocardial infarction), and providing evidence of its effect on relevant patient clinical outcomes, resource-use outcomes and costs [94].”
Kearney, A., Williamson, P. R., & Dodd, S. R. (2024) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2024.111440 · Cited by 11
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Outcome reporting in cardio-obstetrics studies: A systematic review
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Core Outcome Sets Relevant to Maternity Service Users: A Scoping Review
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Outcomes in intervention research on snakebite envenomation: a systematic review
Bhaumik, S., Beri, D., Tyagi, J., Clarke, M. J., Sharma, S. K., Williamson, P. R., & Jagnoor, J. (2022) · F1000Research · doi:10.12688/f1000research.122116.1 · Cited by 11
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Metadata
- Authors
- Dodd, S., Clarke, M., Becker, L., Mavergames, C., Fish, R., & Williamson, P. R.
- Affiliations
- University of Liverpool (GB)
- Queen's University Belfast (GB)
- SUNY Upstate Medical University (US)
- Cochrane (GB)
- University of Manchester (GB)
- Corresponding author
- Williamson, Paula R.
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2018-04
- Volume
- 96
- Pages
- 84-92
- ISSN
- 0895-4356 (ISSN-L)
- PMC
- PMC5854263
- OpenAlex
- W2778471389
- Cited by
- 625
- References
- 23
- Citations by year
- 2026: 63 · 2025: 97 · 2024: 124 · 2023: 74 · 2022: 84 · 2021: 82 · 2020: 51 · 2019: 34 · 2018: 14
- FWCI
- 69.79
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Journal of Clinical Epidemiology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion, cc-by)
- Research Portal (Queen's University Belfast) (publishedVersion, cc-by)
- Funders
- National Institute for Health and Care Research (NF-SI-0513-10025)
- Medical Research Council (MR/K025635/1)
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- clinical trial results, core outcome set, outcome standardization, knowledge discovery, clinical trial registries, adverse events, quality of life outcomes
- MeSH terms
- Clinical Trials as Topic, Humans, Health Knowledge, Attitudes, Practice, Quality of Life, Registries, Research Design, Databases, Factual, Outcome Assessment, Health Care, Data Curation
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