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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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Development of a core outcome set for neonatal septic shock management: a study protocol
Li, Y., Shi, J. C., Li, X., Li, Y., Guo, X., Lu, M., Wan, X., Tang, J., Luo, B., Fu, M. R., et al. (2024) · Trials · doi:10.1186/s13063-024-08422-0 · Cited by 3
Roijer, P. J., Vallinga, M. S., Jorna, M. M. F., Pidgeon, T. E., Ket, J. C. F., Bouman, M., & Mullender, M. G. (2024) · International Journal of Transgender Health · doi:10.1080/26895269.2024.2429490 · Cited by 3
“The taxonomy developed by Dodd et al. (2018) (Dodd et al., 2018) for the classification of outcomes included in trials is widely used in the development of COSs and endorsed by COMET (COMET Initiative, 2018).”
Li, X., Zhang, Y., Mao, Z., Chen, Q., Xiaoxue, L., Chen, H., Sun, Y., Yu, C., & Wang, X. (2025) · Patient Preference and Adherence · doi:10.2147/ppa.s501409 · Cited by 2
Developing a core outcome set for acetabular fractures: a systematic review (part I)
Schulz, D., Gaeth, C., Jordan, M. C., Herath, S. C., Spering, C., Bieler, D., Windolf, J., & Neubert, A. (2025) · Systematic Reviews · doi:10.1186/s13643-025-02824-0 · Cited by 4
“Afterwards, unique outcomes were categorized using the taxonomy of the COMET initiative [22].”
InfluentialZwetsloot, S. L. M., van Knippenberg, S. E. M., Ayyalasomayajula, V. S. R. K., Yeung, K. K., & Jongkind, V. (2025) · European Journal of Vascular and Endovascular Surgery · doi:10.1016/j.ejvs.2025.06.036 · Cited by 4
van Silfhout, N. Y., van Muilekom, M. M., van Karnebeek, C., Daams, J. G., Haverman, L., & van Eeghen, A. M. (2025) · Journal of Neurodevelopmental Disorders · doi:10.1186/s11689-025-09633-5 · Cited by 3
“This also accords with earlier studies, which showed that PROs often overlap across different conditions, such as cancer, congenital heart disease, and inflammatory bowel disease [35, 36].”
Heden, S. V., Chan, Y. M., Baoubbou, Z., Bruyère, O., Reginster, J., Surquin, M., Sánchez‐Rodríguez, D., & Beaudart, C. (2025) · European Geriatric Medicine · doi:10.1007/s41999-025-01285-x · Cited by 5
“Each outcome was systematically documented with the following details: the description of the outcome, how it was reported in the clinical trial, its classification based on the 38-outcome list from Dodd et al. (2018) [26], and the measurement tool used.”
McNally, E. H., Rudd, S., Mezes, P., Black, S. A., Hinchliffe, R. J., & Ozdemir, B. A. (2022) · Journal of Vascular Surgery Venous and Lymphatic Disorders · doi:10.1016/j.jvsv.2022.09.014 · Cited by 3
Hörold, M., Heytens, H., Debbeler, C. M., Ehrentreich, S., Rauwolf, T., Schmeißer, A., Gottschalk, M., Bitzer, E. M., Braun-Dullaeus, R. C., & Apfelbacher, C. (2023) · Systematic Reviews · doi:10.1186/s13643-023-02227-z · Cited by 5
“We categorised by the core areas: death, physiological or clinical, life impact, resource use and adverse events [23].”
InfluentialA pediatric virtual care evaluation framework and its evolution using consensus methods
Dulude, C., Sutherland, S., Vanderhout, S. M., King, W. J., Zuijdwijk, C., Major, N., Audcent, T. A., Howley, H. E. A., Cloutier, P., Buba, M., et al. (2023) · BMC Pediatrics · doi:10.1186/s12887-023-04229-1 · Cited by 3
“…and usable framework, members also used other healthcare evaluation frameworks, including: Ontario Health Quality, [18] COMET Outcomes Classification, [30] Canada Health Infoway Benefits Evaluation Framework (CHIBEF), [31] and other work on the evaluation of telehealth usability [18, 19, 32].”
What should inpatient psychological therapies be for? Qualitative views of service users on outcomes
Morgan, C., Clarkson, L., Hiscocks, R., Hopkins, I., Berry, K., Tyler, N., Wood, L., & Jacobsen, P. C. (2023) · Health Expectations · doi:10.1111/hex.13889 · Cited by 4
“27 Also, outcomes related to the delivery of care taxonomy domain 26 mapped to the intrapersonal, inter-personal, organisational levels of the socioecological framework.”
InfluentialGhosh, M., Mukherjee, S., Santra, P., Na, G., & Basuchowdhuri, P. (2024) · Joint International Conference on Data Science & Management of Data (CODS-COMAD) · doi:10.1145/3632410.3632442 · Cited by 3
“Additionally, the benefits of automated outcome recognition can be enhanced further if it is allowed to comprehend the categorization of outcomes by a relevant classification system [10].”
The logical differentiation between small data and big data
Nyikana, W., & Iyamu, T. (2023) · South African journal of information management · doi:10.4102/sajim.v25i1.1701 · Cited by 3
“Furthermore, in health research, taxonomy is used to categorise the results of clinical trials, to improve knowledge discovery, which makes it easier for trials in the registries and databases (Dodd et al. 2018).”
Raichurkar, P., Brown, K. G. M., Ansari, N., Koh, C., Ahmadi, N., Solomon, M. J., Moran, B. J., & Steffens, D. (2024) · Gastrointestinal Disorders · doi:10.3390/gidisord6010010 · Cited by 3
The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review
Millward, C. P., Keshwara, S. M., Armstrong, T. S., Barrington, H., Bell, S., Brodbelt, A. R., Bulbeck, H., Dirven, L., Grundy, P. L., Islim, A. I., et al. (2024) · Neuro-Oncology Advances · doi:10.1093/noajnl/vdae030 · Cited by 3
“24,29”
Self-citationShwan, A., Lamidi, S., Chan, C., Daniels, E., Song-Smith, C., Hanna, L., Sounderajah, V., Houghton, J. S. M., & Sayers, R. D. (2024) · BJS Open · doi:10.1093/bjsopen/zrae126 · Cited by 3
“18 .”
Jia, M., Lu, Y., Liang, X., Tong, C., Wang, J., Tang, J., Yang, J., Wang, M., Jiao, W., Du, W., et al. (2022) · Trials · doi:10.1186/s13063-022-06801-z · Cited by 3
“Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, et al. Core outcome set–STAndards for reporting: the COS-STAR statement.”
InfluentialThe key elements and application of a master protocol in the development of the core outcome set
Qiu, R., Wan, S., Guan, Z., Zhang, X., Han, S., Li, M., Hu, J., Zhao, C., Chen, Z., Liu, D., et al. (2022) · Journal of Evidence-Based Medicine · doi:10.1111/jebm.12500 · Cited by 3
Baldwin, C. E., Phillips, A., Edney, S. M., & Lewis, L. K. (2020) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2020.10.136 · Cited by 3
Gabes, M., Knüttel, H., & Apfelbacher, C. (2021) · Systematic Reviews · doi:10.1186/s13643-021-01701-w · Cited by 3
“[10] explored health research vocabularies and developed a pilot classification system of outcomes to prevent inconsistency and variation in how outcomes are described.”
Ashwal, E., Shehata, N., Kuo, K. H. M., Ryu, M., Ward, R. A., & Malinowski, A. K. (2022) · Blood Advances · doi:10.1182/bloodadvances.2022007089 · Cited by 3
Hamzeh, H., Spencer, S., Kelly, C. A., & Pilsworth, S. (2023) · PLoS ONE · doi:10.1371/journal.pone.0282393 · Cited by 4
“Death, survival, and mortality are important outcomes that are usually reported in effectiveness trials [32].”
InfluentialVidyasagaran, A. L., Ayesha, R., Boehnke, J. R., Kirkham, J. J., Rose, L., Hurst, J. R., Miranda, J. J., Rana, R. Z., Vedanthan, R., Faisal, M. R., et al. (2024) · medRxiv · doi:10.1101/2024.01.29.24301589 · Cited by 3
Daniel, A. I., de Polnay, K., McCaul, M., Bendabenda, J., Prinzo, Z. W., & Naude, C. E. (2025) · BMJ Global Health · doi:10.1136/bmjgh-2024-017225 · Cited by 3
Šaler, F., Viđak, M., Tokalić, R., & Puljak, L. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111685 · Cited by 2
Connecting patients with clinical trials using patient navigation: a scoping review protocol
Hilal, O., Gupta, P., Luginaah, A., Moshref, L. H., Askin, N., Epp, C., Nassar, R., Hirmiz, R., Paunic, M., Hossami, M., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-088828 · Cited by 2
“22 COMET is a framework that establishes standardised outcome sets, known as the ‘core outcome sets’, which define the minimum outcomes that should be measured and reported for studies evaluating the effectiveness of interventions.”
Yalçınkaya, A., Tirta, M., Rahbek, O., Jepsen, J. F., Rathleff, M. S., Iobst, C., & Kold, S. (2025) · Journal of Orthopaedic Surgery and Research · doi:10.1186/s13018-025-06041-2 · Cited by 2
“The review employed a multi-tier classification structure drawing from COMET taxonomy with adaptations from Yalcinkaya et al. [18, 31] that consolidates all outcomes into five fundamental spheres: death, adverse events, life impact, physiological/clinical, and resource use [26, 27, 32].”
InfluentialShwan, A., Gonzalez-Aguado, M., Sayers, R. D., & Houghton, J. S. M. (2025) · PLoS ONE · doi:10.1371/journal.pone.0328453 · Cited by 2
“…of results will be undertaken with the full list of outcome measures identified in the reviews tabulated and presented by the taxonomy described by Dodd et al. [11] The systematic review of outcome measures used in studies of intermittent claudication has been completed and recently published.”
Li, Y. X., Hu, Y. L., Peng, H. M., Li, Y., Li, X., Su, W. Q., Li, X. W., Chen, Q., & Wan, X. L. (2025) · Journal of Nursing Management · doi:10.1155/jonm/5662163 · Cited by 2
“Furthermore, the COMET initiative has also recommended a comprehensive outcome taxonomy (a 38-category scale by Dodd et al.) that provides a standardized framework for outcome classifcation [14].”
InfluentialMurphy, L., Leckie, T., Harding, S., Gonçalves, A., & Hodgson, L. E. (2025) · BJA Open · doi:10.1016/j.bjao.2025.100501 · Cited by 4
Hiel, M. A. J., Tedbirt, B., Korte, E. W. H., Bolling, M. C., Meijer, J. M., Spuls, P. I., van der Werf, S., Yale, M., Joly, P., & Horváth, B. (2025) · British Journal of Dermatology · doi:10.1093/bjd/ljaf471 · Cited by 2
Yin, R., Soh, Z. L. H., Qin, V. M., Tasnim, S., Rohr, M., Apfelbacher, C., & Smith, H. E. (2026) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-025-09456-4 · Cited by 2
“The 38-category COMET outcome taxonomy [29] was used to classify the outcome measures used in the PROMs (Appendix B).”
Stallwood, E., Frey, B. N., Barrett, E. N., Markwell, A., Butcher, N. J., McCabe, R. E., & Green, S. M. (2026) · Journal of Affective Disorders Reports · doi:10.1016/j.jadr.2026.101039 · Cited by 1
Development Methodology, Availability, and Implementation of Core Outcome Sets in Pediatric Surgery
Allin, B. S. R., Bethell, G. S., & Hall, N. J. (2023) · European Journal of Pediatric Surgery · doi:10.1055/a-2196-1887 · Cited by 2
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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