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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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Demidova, A., Drewitz, K. P., Kimkool, P., Banjanin, N., Барзилович, В. Д., Botjes, E., Capper, I., Castor, M. A. R., Comberiati, P., Cook, E. E., et al. (2024) · Allergy · doi:10.1111/all.16023 · Cited by 34
“10,11 The unique outcomes were categorized into domains via Dodd et al. 12 taxonomy, initially reviewed by a core group through email and Zoom discussions.”
Alkhaffaf, B. H., Blazeby, J. M., Metryka, A., Glenny, A., Adeyeye, A. A., Costa, P., del Val, I. D., Gisbertz, S. S., Güner, A., Law, S. Y.-K., et al. (2021) · Trials · doi:10.1186/s13063-021-05338-x · Cited by 31
Self-citationBachmann, K. F., Jenkins, B., Asrani, V. M., Bear, D. E., Bolondi, G., Boraso, S., Casaer, M. P., Chang, Z., Coopersmith, C. M., Cotoia, A., et al. (2024) · Critical Care · doi:10.1186/s13054-024-05192-8 · Cited by 32
Patel, J., Tolppa, T., Biccard, B. M., Fazzini, B., Haniffa, R., Marletta, D., Moonesinghe, R., Pearse, R. M., Sutharshan, V., Stephens, T., et al. (2022) · World Journal of Surgery · doi:10.1007/s00268-022-06621-x · Cited by 31
“…(ERIC) taxonomy [21, 22], outcome measures were categorized using the COMET (Core Outcome Measures in Effectiveness Trials) Initiative taxonomy [23], and facilitators and barriers to pathway implementation were aggregated using the Consolidated Framework for Implementation Research (CFIR) [24].”
Waugh, M., Youdan, G., Casale, C. E., Balaban, R., Cross, E. S., & Merom, D. (2024) · PLoS ONE · doi:10.1371/journal.pone.0311889 · Cited by 33
Connolly, B. A., Barclay, M., Davies, C., Hart, N., Pattison, N. A., Sturmey, G., Williamson, P. R., Needham, D. M., Denehy, L., & Blackwood, B. (2024) · Annals of the American Thoracic Society · doi:10.1513/annalsats.202406-581oc · Cited by 32
“…trials through parallel health economic analyses — for example, (36, 37) — or outcomes related to hospital admission (e.g., ICU and hospital length of stay, or mechanical ventilation duration) and/or the need for concomitant interventions such as other organ support or medications (35).”
InfluentialSelf-citationOutcomes in prevention and management of miscarriage trials: a systematic review
Smith, P., Dhillon‐Smith, R. K., O’Toole, E., Cooper, N., Coomarasamy, A., & Clark, T. J. (2018) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.15528 · Cited by 28
Beyer, K., Moris, L., Lardas, M., Omar, M. I., Healey, J., Tripathee, S., Gandaglia, G., Venderbos, L. D. F., Vradi, E., den Broeck, T. V., et al. (2022) · European Urology · doi:10.1016/j.eururo.2022.01.042 · Cited by 28
Self-citationKearney, A., Gargon, E., Mitchell, J., Callaghan, S., Yameen, F., Williamson, P. R., & Dodd, S. R. (2023) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2023.03.011 · Cited by 29
Self-citationOutcome reporting from protocols of clinical trials of Coronavirus Disease 2019 (COVID-19): a reviewPreprint
Qiu, R., Wei, X., Zhao, M., Zhong, C., Zhao, C., Hu, J., Li, M., Huang, Y., Han, S., He, T., et al. (2020) · medRxiv · doi:10.1101/2020.03.04.20031401 · Cited by 28
“The taxonomy of outcome domains were developed by the researchers from COMET initiative [7].”
AFCOS: The Development of a Cryptoglandular Anal Fistula Core Outcome Set
Iqbal, N., Machielsen, A. J. H. M., Kimman, M., Gillian, K., Rebecca, W., Grossi, U., Tozer, P. J., & Breukink, S. O. (2022) · Annals of Surgery · doi:10.1097/sla.0000000000005462 · Cited by 27
Murphy, R., Elsayed, H., Singh, S., Dumville, J. C., Wong, J. K. F., & Reid, A. J. (2021) · Neurosurgery · doi:10.1093/neuros/nyab060 · Cited by 28
AVERY, K. N. L., Wilson, N. M., Macefield, R. C., McNair, A., Hoffmann, C., Blazeby, J. M., Potter, S., & On behalf of the Core Outcomes for early pHasE Surgical Innovation and deVicEs (COHESIVE) study steering group (2021) · Annals of Surgery · doi:10.1097/sla.0000000000004975 · Cited by 28
Tellum, T., Omtvedt, M., Naftalin, J., Hirsch, M., & Jurkovic, D. (2021) · Human Reproduction Open · doi:10.1093/hropen/hoab030 · Cited by 27
“The outcomes were classified to core areas and domains according to a taxonomy recommended by COMET (Dodd et al., 2018).”
InfluentialKirkevang, L., Karim, I. A. E., Duncan, H. F., Nagendrababu, V., & Kruse, C. (2022) · International Endodontic Journal · doi:10.1111/iej.13812 · Cited by 28
Ciani, O., Salcher‐Konrad, M., Meregaglia, M., Smith, K., Gorst, S. L., Dodd, S. R., Williamson, P. R., & Fattore, G. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.03.003 · Cited by 28
Self-citationMachielsen, A. J. H. M., Iqbal, N., Kimman, M., Sahnan, K., Adegbola, S. O., Kane, G., Woodcock, R., Kleijnen, J., Grossi, U., Breukink, S. O., et al. (2021) · Techniques in Coloproctology · doi:10.1007/s10151-021-02452-5 · Cited by 28
“Outcomes belonging to the core area of ‘physiological or clinical’ were placed in domains according to their underlying cause or affected body system [13].”
InfluentialMitchell, J., Noble, A. J., Baker, G. A., Batchelor, R., Brigo, F., Christensen, J., French, J. A., Gil‐Nagel, A., Guekht, A. B., Jetté, N., et al. (2022) · Trials · doi:10.1186/s13063-022-06729-4 · Cited by 24
“Consolidation of outcomes into a ‘short list’ The candidate verbatim outcome terms from Review A and Review B will be categorised in line with the COMET outcome domain taxonomy to aid the conceptualisation of the outcomes [12].”
InfluentialSelf-citationWhich outcomes have been measured in hand eczema trials? A systematic review
Rönsch, H., Apfelbacher, C., Brans, R., Matterne, U., Molin, S., Ofenloch, R. F., Oosterhaven, J. A. F., Schuttelaar, M. L. A., Weißhaar, E., Yew, Y. W., et al. (2019) · Contact Dermatitis · doi:10.1111/cod.13212 · Cited by 26
“The identified efficacy outcomes were mapped according to the taxonomy developed by the COMET initiative.(13) In accordance with this taxonomy, both clinical signs and symptoms were classified within the “physiological or clinical” core area.”
Alkhaffaf, B. H., Metryka, A., Blazeby, J. M., Glenny, A., Adeyeye, A. A., Costa, P., del Val, I. D., Gisbertz, S. S., Güner, A., Law, S. Y.-K., et al. (2021) · British journal of surgery · doi:10.1093/bjs/znab192 · Cited by 25
Self-citationAddressing the gaps in nutritional care before and during pregnancy
Killeen, S. L., Geraghty, A. A., O’Brien, E. C., O'Reilly, S. L., Yelverton, C. A., & McAuliffe, F. M. (2021) · Proceedings of The Nutrition Society · doi:10.1017/s0029665121003724 · Cited by 30
DENTAL PATIENT-REPORTED OUTCOMES IN ENDODONTICS - A NARRATIVE REVIEW
Nagendrababu, V., Vinothkumar, T. S., Karim, I. A. E., Rossi‐Fedele, G., Doğramacı, E. J., Dummer, P. M. H., & Duncan, H. F. (2022) · Journal of Evidence Based Dental Practice · doi:10.1016/j.jebdp.2022.101805 · Cited by 26
“96 In this regard Dodd et al. 96 developed a comprehensive 38-item taxonomy for reporting outcomes in heath research.”
Srikandarajah, N., Noble, A. J., Clark, S., Wilby, M. J., Freeman, B. J. C., Fehlings, M. G., Williamson, P. R., & Marson, A. G. (2020) · PLoS ONE · doi:10.1371/journal.pone.0225907 · Cited by 24
“These were categorised into five higher order categories as per the taxonomy recommended by COMET (Clinical Outcomes, Life Impact, Resources Use, Death and Adverse Events) [15].”
Self-citationViau-Lapointe, J., D'Souza, R. D., Rose, L., & Lapinsky, S. E. (2018) · Obstetric Medicine · doi:10.1177/1753495x18772996 · Cited by 24
Hall, C., & D'Souza, R. D. (2020) · CJC Open · doi:10.1016/j.cjco.2020.05.010 · Cited by 24
“Mortality/survival (1) Maternal mortality (n 1⁄4 1) (1) Maternal mortality (n 1⁄4 8) (2) Short-term survival (n 1⁄4 1) (3) Shorter life expectancy (n 1⁄4 1) Physiological/clinical outcomes Cardiac (2) Arrhythmias (n 1⁄4 4) (3) Heart failure (n 1⁄4 2) (4) Deterioration of cardiac/general condition (n 1⁄4 2) (5) Appropr…”
Macefield, R. C., Wilson, N., Hoffmann, C., Blazeby, J. M., McNair, A., AVERY, K. N. L., & Potter, S. (2020) · BJS Open · doi:10.1002/bjs5.50358 · Cited by 24
International Core Outcome Set for Acute Simple Appendicitis in Children
Knaapen, M., Hall, N. J., Moulin, D., van der Lee, J. H., Butcher, N. J., Minneci, P. C., Svensson, J. F., Peter, S. D. S., Adams, S. E., Nah, S. A., et al. (2020) · Annals of Surgery · doi:10.1097/sla.0000000000004707 · Cited by 25
Rose, L., Burry, L. D., Agar, M. R., Blackwood, B., Campbell, N. L., Clarke, M. J., Devlin, J. W., Lee, J. S., Marshall, J. C., Needham, D. M., et al. (2021) · BMC Medicine · doi:10.1186/s12916-021-02015-3 · Cited by 25
Self-citationFish, R., Sanders, C., Ryan, N. A. J., van der Veer, S. N., Renehan, A. G., & Williamson, P. R. (2018) · Colorectal Disease · doi:10.1111/codi.14103 · Cited by 24
Self-citationTejwani, V., Chang, H.-Y., Tran, A. P., Naber, J. A., Gutzwiller, F. S., Winders, T. A., Khurana, S., Sumino, K., Mosnaim, G. S., & Moloney, R. (2021) · Annals of Allergy Asthma & Immunology · doi:10.1016/j.anai.2021.03.022 · Cited by 23
Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement
Simpson, R. C., Kirtschig, G., Selk, A., von Seitzberg, S., Vittrup, G., Bissonnette, I., Kottner, J., Lanthier, J., Stanton, C., Foster, D., et al. (2023) · British Journal of Dermatology · doi:10.1093/bjd/ljac145 · Cited by 24
Rose, L., Agar, M. R., Burry, L. D., Campbell, N. L., Clarke, M. J., Lee, J. S., Marshall, J., Siddiqi, N., Page, V. J., & for the Development of Core Outcome Sets for Effectiveness Trials of Interventions to Prevent and/or Treat Delirium (Del-COrS) Group (2020) · Critical Care Medicine · doi:10.1097/ccm.0000000000004238 · Cited by 22
“Non–deliriumspecific outcomes were grouped into outcome domains within the categories of the COMET taxonomy (21).”
Self-citationChowdhury, M. I., Turk-Adawi, K. I., Babu, A. S., Ghisi, G. L. D. M., Pamela Serón, S., Yeo, T. J., Uddin, J., Heine, M., García-Saldivia, M. A., Kouidi, E. J., et al. (2022) · Global Heart · doi:10.5334/gh.1091 · Cited by 22
Shah, P. K., Karim, I. A. E., Duncan, H. F., Nagendrababu, V., & CHONG, B. S. (2022) · International Endodontic Journal · doi:10.1111/iej.13763 · Cited by 22
Improvement was needed in the standards of development for cancer core outcome sets
Gargon, E., Williamson, P. R., Blazeby, J. M., & Kirkham, J. J. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2019.04.006 · Cited by 22
“With the publication of methodological evidence [13,14] and guidance [8,9,15], as well as reporting standards [12], improvement is expected over time.”
Self-citationKnaapen, M., Hall, N. J., van der Lee, J. H., Butcher, N. J., Offringa, M., van Heurn, E. L. W., Bakx, R., & Gorter, R. R. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-028861 · Cited by 35
Editor's Choice – A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair
Machin, M., Wanhainen, A., D’Oria, M., Koelemay, M. J. W., Kakkos, S. K., Grima, M. J., Powell, J. T., Loftus, I. M., Azhar, B., Bown, M. J., et al. (2024) · European Journal of Vascular and Endovascular Surgery · doi:10.1016/j.ejvs.2024.04.029 · Cited by 22
Alamrani, S. A., Rushton, A., Gardner, A. C., Falla, D., & Heneghan, N. R. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-034286 · Cited by 21
Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol
D'Souza, R. D., Villani, L. A., Hall, C., Seyoum, M., Kingdom, J. C., Krznaric, M., Donnolley, N. R., & Javid, N. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-034018 · Cited by 20
“While the development of a core outcome set will address the former, the latter is important to ensure inclusion of maternal and fetal outcomes representing all core outcome areas, 21 which include mortality/survival, clinical/physiological, life-impact/functioning, resource use and adverse events.”
Therapy outcome measures in temporomandibular disorder: a scoping review
Ooi, K., Aihara, M., Matsumura, H., Matsuda, S., Watanabe, Y., Yuasa, H., & Matsuka, Y. (2022) · BMJ Open · doi:10.1136/bmjopen-2022-061387 · Cited by 22
Swallowing outcomes in dysphagia interventions in Parkinson’s disease: a scoping review
Hirschwald, J., Hofacker, J., Duncan, S., & Walshe, M. (2022) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2022-112082 · Cited by 20
Korte, E. W. H., Welponer, T., Kottner, J., van der Werf, S., van den Akker, P. C., Horváth, B., Kiritsi, D., Laimer, M., Pasmooij, A. M. G., Wally, V., et al. (2023) · British Journal of Dermatology · doi:10.1093/bjd/ljad077 · Cited by 21
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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