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A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery
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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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A systematic review of outcome reporting in laser treatments for dermatological diseases
Fransen, F., Tio, D., Prinsen, C. A. C., Hædersdal, M., Hedelund, L., Laubach, H., Marini, L., Paasch, U., Passeron, T., & Wolkerstorfer, A. (2019) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.15928 · Cited by 7
Berthelsen, D. B., WOODWORTH, T. G., Goel, N., Ioannidis, J. P. A., Tugwell, P., Devoe, D. J. A., Williamson, P. R., Terwee, C. B., Suarez-Almazor, M. E., Strand, V., et al. (2021) · Seminars in Arthritis and Rheumatism · doi:10.1016/j.semarthrit.2020.09.023 · Cited by 7
Self-citationOutcomes in intervention and management of multiple pregnancies trials: A systematic review
Farmer, N., Hillier, M., Kilby, M. D., Morton, V. H., & Morris, R. K. (2021) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2021.04.025 · Cited by 7
Synthesizing Core Outcome Sets for outcomes research in cohort studies: a systematic review
Musgrove, E., Gasparini, L., McBain, K., Clifford, S. A., Carter, S. A., Teede, H. J., & Wake, M. A. (2021) · Pediatric Research · doi:10.1038/s41390-021-01801-2 · Cited by 7
“Firstly, we identified an existing taxonomic framework for outcomes by Dodd et al.(20) to guide our synthesis process.”
InfluentialClinical law: what do clinicians want to know? The demography of clinical law
Wheeler, R. A., & Hall, N. J. (2022) · Journal of Medical Ethics · doi:10.1136/medethics-2022-108131 · Cited by 7
Wilson, N. M., Macefield, R. C., Hoffmann, C., Edmondson, M. J., Miller, R. L., Kirkham, E. N., Blencowe, N., McNair, A., Main, B., Blazeby, J. M., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-056003 · Cited by 7
Karim, I. A. E., Duncan, H. F., Nagendrababu, V., & Clarke, M. J. (2022) · International Endodontic Journal · doi:10.1111/iej.13862 · Cited by 8
Self-citationSabet, T. S., Anderson, D., Stubbs, P. W., Buchbinder, R., Terwee, C. B., Chiarotto, A., Gagnier, J. J., & Verhagen, A. P. (2022) · Systematic Reviews · doi:10.1186/s13643-022-02120-1 · Cited by 7
“Each domain will be mapped to the respective core area and outcome domain using the Williamson/Clarke (initial) taxonomy [30].”
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review
Verghis, R. M., Blackwood, B., McDowell, C., Toner, P. G., Hadfield, D., Gordon, A. C., Clarke, M. J., & McAuley, D. F. (2023) · Clinical Trials · doi:10.1177/17407745231151842 · Cited by 8
“This classification is similar to those proposed in the work of Dodd et al., 78 except for adverse events, given the exclusion of outcomes related to adverse events from this review.”
Self-citationJacobson, M. E., Rick, J. W., Gerbens, L. A. A., Baghoomian, W., Gould, L. J., Marzano, A. V., Chen, D. M., Oakes, D. L., Dissemond, J., Yamamoto, T., et al. (2023) · British Journal of Dermatology · doi:10.1093/bjd/ljad420 · Cited by 8
Kim, B. V., Aromataris, E., de Lint, W. B., Middleton, P., Townsent, R., Khalil, A. A., Duffy, J. M., Flenady, V., Thangaratinam, S., & Mol, B. W. (2020) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2020.12.036 · Cited by 7
Detect and Classify – Joint Span Detection and Classification for Health Outcomes
Abaho, M., Bollegala, D., Williamson, P. R., & Dodd, S. R. (2021) · Conference on Empirical Methods in Natural Language Processing (EMNLP) · doi:10.18653/v1/2021.emnlp-main.686 · Cited by 9
“Motivated by the taxonomy proposed by Dodd et al. (2018) to standardise outcome classifications in electronic databases and inspired the annotation of EBM-COMET dataset (Abaho et al., 2020), we attempt to align EBM-NLP’s arbitrary outcome classifications to standard outcome classifications that are…”
InfluentialSelf-citationAgar, M. R., Siddiqi, N., Hosie, A., Boland, J. W., Johnson, M. J., Featherstone, I., Lawlor, P. G., Bush, S. H., Page, V. J., Amgarth‐Duff, I., et al. (2021) · Palliative Medicine · doi:10.1177/02692163211040186 · Cited by 7
Constructing a finer-grained representation of clinical trial results from ClinicalTrials.gov
Shi, X., & Du, J. (2024) · Scientific Data · doi:10.1038/s41597-023-02869-7 · Cited by 6
“A study proposed categories of outcomes as Mortality/survival, Physiological/clinical, Life impact, Resource use, and adverse events 21 .”
Zanjir, M., Cardoso, E., Harman, N. L., Khansari, A., Jafarzadeh, H., Malkhassian, G., Sabeti, M., Aminoshariae, A., Kishen, A., Sale, J. E. M., et al. (2025) · Journal of Endodontics · doi:10.1016/j.joen.2025.01.011 · Cited by 6
Fang, G., Yu, W., Chen, D., Ding, X., Qiao, L., Zhang, L., Gao, X., Yan, Y., Huang, Q., Ma, J., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-083315 · Cited by 6
“Domain classification will be performed according to the functional attributes of the outcomes, 43 while retaining unclassifiable outcomes; (3) conduct an assessment by a steering committee to consider the appropriateness of the categorisation of outcomes and to produce a preliminary list of…”
Ferrara, L., Ardito, V., Tozzi, V. D., & Tarricone, R. (2025) · International Journal of Integrated Care · doi:10.5334/ijic.8623 · Cited by 7
Core Outcome Set and Reporting Checklist for Studies on Vasa Previa
Yeretsian, T., Javid, N., Hirschhorn-Edwards, N., Ashraf, R., Adams, A., Kingdom, J. C., & D'Souza, R. D. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.1000 · Cited by 6
Hiel, M. A. J., Korte, E. W. H., Tedbirt, B., Bolling, M. C., Meijer, J. M., Spuls, P. I., van der Werf, S., Yale, M., Horváth, B., & Joly, P. (2025) · British Journal of Dermatology · doi:10.1093/bjd/ljaf152 · Cited by 6
Ashraf, R., He, Y. Z., Silversides, C., Siu, S. C., Sermer, M., Keepanasseril, A., Seyoum, M., Malhamé, I., & D'Souza, R. D. (2025) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.124.011754 · Cited by 6
Mitchell, J., Doherty, J., Batchelor, R., Noble, A. J., & Marson, A. G. (2025) · Epilepsia · doi:10.1111/epi.18570 · Cited by 9
“66,67 The framework of domains and outcomes is outlined in Table 2.”
Chen, Y., Yang, W., Zhao, C., Wang, F., Ren, P., Liu, X., Cao, T., Ji, S., Chen, L., & Kang, D. (2025) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2025.1671405 · Cited by 6
Developing Core Outcome Sets for Vascular Conditions Across Europe, Not as Easy as It Sounds
Machin, M., & Powell, J. T. (2022) · EJVES Vascular Forum · doi:10.1016/j.ejvsvf.2022.11.003 · Cited by 6
Derouin, Y., Delhomme, T., Launey, Y., Bouras, M., Sautenet, B., Sebille, V., & Cinotti, R. (2024) · Journal of Neurotrauma · doi:10.1089/neu.2023.0417 · Cited by 6
“29 Because these broad domains may not provide a high degree of granularity, the third layer of classi fi cation proposes to organize outcomes as target domains.”
InfluentialInsomnia and its treatments—trend analysis and publication profile of randomized clinical trials
Kakazu, V. A., Assis, M., Bacelar, A., Bezerra, A. G., Ciutti, G. L. R., Conway, S. G., Galduróz, J. C. F., Drager, L. F., Khoury, M. P., Leite, I. P. A., et al. (2024) · npj Biological Timing and Sleep · doi:10.1038/s44323-024-00014-0 · Cited by 6
“When considering outcomes not related to sleep according to the COMET classi fi cation 25 , the most often reported were emotional functioning/well-being ( n = 50, 37.9%), physical functioning ( n = 18, 13.6%), cognitive functioning ( n = 16, 12.1”
InfluentialNijjar, S., Sandhar, S., Timor‐Tritsch, I. E., Agten, A. K., Jin, L., Chong, K. Y., Oza, M., Acklom, R., D’Antonio, F., Vuong, L. N., et al. (2024) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.17989 · Cited by 6
“Outcomes once extracted were classified into six pre-defined domains according to the taxonomy principles recommended by COMET [11]: treatment sequelae; complications and adverse effects; morbidity and mortality; future reproductive health; obstetric outcomes of expectantly managed CSEP and quality…”
Heterogeneity of outcomes for intraoperative music interventions: a scoping review and evidence map
Ambler, M., Springs, S., Garcia, D. R., & Born, C. T. (2020) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2020-111382 · Cited by 7
“35 This taxonomy—which includes economic, clinical and humanistic outcomes—was developed in order to address inadequate outcome reporting and classification.”
King, A., Leider, H., Herman, D., Malinowski, A. K., & D'Souza, R. D. (2021) · Thrombosis and Haemostasis · doi:10.1055/s-0041-1722855 · Cited by 6
Psychosocial Impact of 8 Weeks COVID-19 Quarantine on Italian Parents and their Children
Khoory, B. J., Keuning, M. W., Fledderus, A. C., Cicchelli, R., Fanos, V., Khoory, J., Nervi, D., Elyan, E., Vuttipittayamongkol, P., Oomen, M. W., et al. (2022) · Maternal and Child Health Journal · doi:10.1007/s10995-021-03311-3 · Cited by 6
Zhang, T., Li, X., Zhao, L., Zhang, J., Tian, J., & Zhang, J. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.753138 · Cited by 6
Nochaiwong, S., Chuamanochan, M., Ruengorn, C., & Thavorn, K. (2022) · Pharmaceuticals · doi:10.3390/ph15101246 · Cited by 6
“To better compare across-trial results, we recommend that standardized reporting in core outcome sets for people living with CSU (including efficacy, safety events, and patient-reported outcomes) be developed and applied to make trial evidence more useful [41].”
Mackey, D. C., Ekegren, C. L., Baldwin, C. E., Young, P. J., Gray, S. M., Ciok, A., & Wong, A. (2023) · International Journal of Behavioral Nutrition and Physical Activity · doi:10.1186/s12966-023-01431-3 · Cited by 6
“General outcomes referred to disorders and global measures and symptoms that affected the whole body and could not be attributed to a specific bodily system (see example outcomes in Table 3) [23].”
InfluentialSun, Y., An, Y., Weng, Z., Zhou, Y.-J., Wang, X., & Yu, C. (2023) · BMJ Open · doi:10.1136/bmjopen-2023-075856 · Cited by 6
Connolly, B. A., Milton-Cole, R., Blackwood, B., & Pattison, N. A. (2024) · Australian Critical Care · doi:10.1016/j.aucc.2024.05.005 · Cited by 6
Doelare, S. A. N., Oukrich, S., Yeung, K. K., Hinchliffe, R. J., Jongkind, V., Tran, B. L., Knaapen, M., Catarinella, F. S., & de Vries, R. (2024) · European Journal of Vascular and Endovascular Surgery · doi:10.1016/j.ejvs.2024.07.042 · Cited by 7
Chow, A. L., Soon, C. S., Smith, H. E., & Apfelbacher, C. (2019) · Acta Dermato Venereologica · doi:10.2340/00015555-3312 · Cited by 7
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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