A systematic review of core outcome set development studies demonstrates difficulties in defining unique outcomes
Open accessAbstract
OBJECTIVES: Core outcome set (COS) development often begins with a systematic review to identify outcomes. Reviews frequently show heterogeneity in numbers of outcomes reported across trials. Contributing to this is a lack of a uniform definition for an outcome. This study proposes a first working definition for a unique trial outcome to support reporting a quantitative assessment of outcome reporting heterogeneity (ORH). STUDY DESIGN AND SETTING: Eligible COS literature (development papers, protocols, and reviews) were identified using the COMET database, Ovid MEDLINE, and PubMed. Outcome numbers, definitions, timing, and grouping methodology were examined. RESULTS: One hundred and thirty two studies were included. 82 (88.1%) studies (excluding protocols) reported a total number of unique outcomes (median, 82; range, 12-5776; IQR, 261). Timing of assessment was reported in 32 (31.4%) studies. Methods to group similar outcomes were reported in 8 (7.8%) articles. No study defined how outcomes were agreed as different and how final numbers of unique outcomes were determined. It is proposed that a unique outcome requires original meaning and context. Thus ORH is suggested to be the reporting of multiple unique outcomes across trials related to one health care condition. CONCLUSION: This review identified inconsistencies in how authors define, extract, group, and count trial outcomes. Further work is needed to refine our proposed definitions to optimize COS development and allow a quantifiable measure of ORH.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
This distribution limits the ability to capture changes over time, as outcomes recorded only after treatment lack the context provided by earlier measurements.
“This distribution limits the ability to capture changes over time, as outcomes recorded only after treatment lack the context provided by earlier measurements (Young et al. 2019).”
From 1st Global Consensus for Clinical Guidelines: Identifying a Core Outcome Set for Implant Dentistry in Edentulous Maxilla Rehabilitation (2026) · cites this paper as Young et al. 2019
Cites
The COMET Handbook: version 1.0
Williamson, P. R., Altman, D. G., Bagley, H., Barnes, K. L., Blazeby, J. M., Brookes, S. T., Clarke, M., Gargon, E., Gorst, S., Harman, N., et al. (2017) · Trials · doi:10.1186/s13063-017-1978-4 · Cited by 2,011 · see citing works
Self-citationDeveloping core outcome sets for clinical trials: issues to consider
Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012) · Trials · doi:10.1186/1745-6215-13-132 · Cited by 1,661 · see citing works
Self-citationBetter Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
Ioannidis, J. P. A., Evans, S. J. W., Gøtzsche, P. C., O'Neill, R. T., Altman, D. G., Schulz, K., Moher, D., & for the CONSORT Group* (2004) · Annals of Internal Medicine · doi:10.7326/0003-4819-141-10-200411160-00009 · Cited by 1,593 · see citing works
The ClinicalTrials.gov Results Database — Update and Key Issues
Zarin, D. A., Tse, T., Williams, R. J., Califf, R. M., & Ide, N. C. (2011) · New England Journal of Medicine · doi:10.1056/nejmsa1012065 · Cited by 838 · see citing works
Core Outcome Set-STAndards for Development: The COS-STAD recommendations
Kirkham, J. J., Davis, K., Altman, D. G., Blazeby, J. M., Clarke, M., Tunis, S., & Williamson, P. R. (2017) · PLOS Medicine · doi:10.1371/journal.pmed.1002447 · Cited by 792 · see citing works
Self-citationGuidance on the conduct of narrative synthesis in sytematic reviews
Popay, J., Roberts, H. M., Sowden, A. J., Petticrew, M. P., Arai, L., Rodgers, M., & Britten, N. (2006) · Cited by 690 · see citing works
Core outcome set–STAndards for reporting: the COS-STAR statement
Kirkham, J. J., Gorst, S., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., Moher, D., Schmitt, J., Tugwell, P., et al. (2016) · PLOS Medicine · doi:10.1371/journal.pmed.1002148 · Cited by 650 · see citing works
Self-citationCarroll, R., Metcalfe, C., & Gunnell, D. (2014) · PLoS ONE · doi:10.1371/journal.pone.0089944 · Cited by 586 · see citing works
Self-citationLewin, S. A., Bohren, M. A., Rashidian, A., Munthe‐Kaas, H. M., Glenton, C., Colvin, C. J., Garside, R., Noyes, J., Booth, A., Tunçalp, Ö., et al. (2018) · Implementation Science · doi:10.1186/s13012-017-0689-2 · Cited by 570 · see citing works
OMERACT: An international initiative to improve outcome measurement in rheumatology
Tugwell, P., Boers, M., Brooks, P., Simon, L. S., Strand, V., & Idzerda, L. (2007) · Trials · doi:10.1186/1745-6215-8-38 · Cited by 536 · see citing works
The Role of Outcomes in Quality Assessment and Assurance
Donabedian, A. (1992) · QRB - Quality Review Bulletin · doi:10.1016/s0097-5990(16)30560-7 · Cited by 508 · see citing works
Noyes, J., Booth, A., Flemming, K., Garside, R., Harden, A., Lewin, S., Pantoja, T., Hannes, K., Cargo, M., & Thomas, J. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.06.020 · Cited by 480 · see citing works
Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research
Chan, A.-W. (2004) · Canadian Medical Association Journal · doi:10.1503/cmaj.1041086 · Cited by 444 · see citing works
Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review
Gargon, E., Gurung, B., Medley, N., Altman, D. G., Blazeby, J. M., Clarke, M. J., & Williamson, P. R. (2014) · PLoS ONE · doi:10.1371/journal.pone.0099111 · Cited by 333 · see citing works
Self-citationPage, M. J., McKenzie, J. E., Kirkham, J., Dwan, K., Kramer, S., Green, S., & Forbes, A. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000035.pub2 · Cited by 281 · see citing works
(1993) · PubMed · Cited by 198 · see citing works
Gorst, S. L., Gargon, E., Clarke, M. J., Blazeby, J. M., Altman, D. G., & Williamson, P. R. (2016) · PLoS ONE · doi:10.1371/journal.pone.0146444 · Cited by 148 · see citing works
Self-citationIssues in methodological research: perspectives from researchers and commissioners
Lilford, R. J., Richardson, A., Stevens, A., Fitzpatrick, R., Edwards, S., Rock, F., & Hutton, J. L. (2001) · Health Technology Assessment · doi:10.3310/hta5080 · Cited by 132 · cited 1× · see citing works
“A limitation of the study is that we did not undertake a full systematic review but rather focused our attention on studies identified through the COMET database from September 2015, with related articles identified through two other search engines, as per the published advice on methodological systematic reviews [49,…”
MethodSaldanha, I. J., Dickersin, K., Wang, X., & Li, T. (2014) · PLoS ONE · doi:10.1371/journal.pone.0109400 · Cited by 120 · see citing works
Shahzad, M. N., & Ahmed, N. (2013) · PubMed · Cited by 112 · see citing works
The COMET Initiative database: progress and activities from 2011 to 2013
Gargon, E., Williamson, P. R., Altman, D. G., Blazeby, J. M., & Clarke, M. J. (2014) · Trials · doi:10.1186/1745-6215-15-279 · Cited by 104 · see citing works
Self-citationVariation in outcome reporting in endometriosis trials: a systematic review
Hirsch, M., Duffy, J. M., Kusznir, J. O., Davis, C., Plana, N., Khan, K. S., Duffy, J. M. N., Farquhar, C. M., Hirsch, M., Johnson, N., et al. (2016) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2015.12.039 · Cited by 99 · see citing works
Developing a core outcome set for fistulising perianal Crohn’s disease
Sahnan, K., Tozer, P. J., Adegbola, S. O., Lee, M. J., Heywood, N., McNair, A., Hind, D., Yassin, N., Lobo, A., Brown, S. R., et al. (2018) · Gut · doi:10.1136/gutjnl-2017-315503 · Cited by 92 · see citing works
COS-STAR: a reporting guideline for studies developing core outcome sets (protocol)
on behalf of the COS-STAR Group, Kirkham, J. J., Gorst, S. L., Altman, D. G., Blazeby, J. M., Clarke, M. J., Devane, D., Gargon, E., & Williamson, P. R. (2015) · Trials · doi:10.1186/s13063-015-0913-9 · Cited by 89 · see citing works
Self-citationDeveloping, implementing and disseminating a core outcome set for neonatal medicine
Webbe, J., Brunton, G., Ali, S., Duffy, J. M., Modi, N., & Gale, C. (2017) · BMJ Paediatrics Open · doi:10.1136/bmjpo-2017-000048 · Cited by 84 · see citing works
A systematic review of the outcomes reported in multimodal pain therapy for chronic pain
Deckert, S., Kaiser, U., Kopkow, C., Trautmann, F., Sabatowski, R., & Schmitt, J. M. (2015) · European Journal of Pain · doi:10.1002/ejp.721 · Cited by 80 · see citing works
No common denominator: a review of outcome measures in IVF RCTs
Wilkinson, J., Roberts, S. A., Showell, M. G., Brison, D. R., & Vail, A. (2016) · Human Reproduction · doi:10.1093/humrep/dew227 · Cited by 73 · see citing works
Denniston, A. K., Holland, G. N., Kidess, A., Nussenblatt, R. B., Okada, A. A., Rosenbaum, J. T., & Dick, A. D. (2015) · Orphanet Journal of Rare Diseases · doi:10.1186/s13023-015-0318-6 · Cited by 68 · see citing works
Andersen, C. R., Fitzgerald, E., Delaney, A. P., & Finfer, S. R. (2018) · Neurocritical Care · doi:10.1007/s12028-018-0566-0 · Cited by 63 · see citing works
The COMET Initiative database: progress and activities update (2015)
Gargon, E., Williamson, P. R., Altman, D. G., Blazeby, J. M., Tunis, S., & Clarke, M. J. (2017) · Trials · doi:10.1186/s13063-017-1788-8 · Cited by 59 · see citing works
Self-citationTypes of outcomes in clinical research
Ferreira, J. C., & Patino, C. M. (2017) · Jornal Brasileiro de Pneumologia · doi:10.1590/s1806-37562017000000021 · Cited by 55 · see citing works
Ma, C., Hussein, I. M., Al-Abbar, Y. J., Panaccione, R., Fedorak, R. N., Parker, C. E., Nguyen, T. M., Khanna, R., Siegel, C. A., Peyrin‐Biroulet, L., et al. (2018) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.02.051 · Cited by 53 · see citing works
Béchir, M., Puhan, M. A., Fasshauer, M., Schuepbach, R. A., Stocker, R. A., & Neff, T. A. (2013) · Critical Care · doi:10.1186/cc13168 · Cited by 53 · see citing works
Range and Heterogeneity of Outcomes in Randomized Trials of Pediatric Chronic Kidney Disease
Chong, L. S. H., Sautenet, B., Tong, A., Hanson, C. S., Samuel, S. M., Zappitelli, M., Dart, A. B., Furth, S. L., Eddy, A. A., Groothoff, J. W., et al. (2017) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2017.03.034 · Cited by 52 · see citing works
Gonçalves, A., Cruz, J., Marques, A. S. P. D. D., Demain, S. H., & Samuel, D. (2017) · Age and Ageing · doi:10.1093/ageing/afx135 · Cited by 33 · see citing works
Tokarik, M., Sjöberg, F., Balík, M., Pafčuga, I., & Brož, L. (2013) · Journal of Burn Care & Research · doi:10.1097/bcr.0b013e318278197e · Cited by 33 · see citing works
Gargon, E., Williamson, P. R., & Clarke, M. J. (2015) · BMC Medical Research Methodology · doi:10.1186/s12874-015-0019-9 · Cited by 27 · see citing works
The NSW Health Outcomes program
Frommer, M. S., RUBIN, G. L., & Lyle, D. M. (1992) · New South Wales Public Health Bulletin · doi:10.1071/nb92067 · Cited by 26 · see citing works
&NA; (2014) · Journal of Burn Care & Research · doi:10.1097/01.bcr.0000446979.57498.e7 · Cited by 26 · see citing works
Fish, 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 · see citing works
Variability of outcome reporting in Hirschsprung’s Disease and gastroschisis: a systematic review
Allin, B. S. R., Irvine, A., Patni, N., & Knight, M. (2016) · Scientific Reports · doi:10.1038/srep38969 · Cited by 23 · see citing works
on behalf of the SCORE-IT study team, Harman, N., James, R., Wilding, J. P. H., & Williamson, P. R. (2017) · Trials · doi:10.1186/s13063-017-2317-5 · Cited by 22 · see citing works
A comparison between occlusive and exposure dressing in the management of burn wound
Dallal, M. M. S., Safdari, R., Koochak, H. E., Sharifi-Yazdi, S., Akhoondinasab, M.-R., Pourmand, M. R., Hadayatpour, A., & Yazdi, M. K. S. (2016) · Burns · doi:10.1016/j.burns.2015.05.001 · Cited by 21 · see citing works
Ross, A. R., & Hall, N. J. (2016) · Journal of Pediatric Surgery · doi:10.1016/j.jpedsurg.2016.05.008 · Cited by 16 · see citing works
Variation in the reporting of outcomes among pregnant women with epilepsy: a systematic review
Wattar, B. H. A., Placzek, A., Troko, J., Pirie, A. M., Khan, K. S., McCorry, D., Zamora, J., & Thangaratinam, S. (2015) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2015.10.017 · Cited by 15 · see citing works
Kaufman, J., Ryan, R. E., Bosch‐Capblanch, X., Cartier, Y., Cliff, J., Glenton, C., Lewin, S. A., Gabriel Rada, G., Ames, H., Muloliwa, A. M., et al. (2015) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2015.10.003 · Cited by 14 · see citing works
The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction
Agha, R., Fowler, A. J., Pidgeon, T. E., Wellstead, G., & Orgill, D. P. (2015) · Annals of Plastic Surgery · doi:10.1097/sap.0000000000000645 · Cited by 14 · see citing works
Ross, A., Young, J., Hedin, R. J., Aran, G., Demand, A., Stafford, A., Worley, J. A., Moore, M., & Vassar, M. B. (2018) · Anaesthesia · doi:10.1111/anae.14211 · Cited by 13 · see citing works
Knight, S. R., & Hussain, S. (2016) · Clinical Transplantation · doi:10.1111/ctr.12861 · Cited by 6 · see citing works
Hallas, S., Nelson, E. A., O’Meara, S., & Gethin, G. (2017) · White Rose Research Online (University of Leeds, The University of Sheffield, University of York) · Cited by 1 · see citing works
Flagged first, then by citations
2 of the 52 references couldn’t be matched to a known paper.
Cited by
Sorted by citations
Kgosidialwa, O., Bogdanet, D., Egan, A. M., O’Shea, P. M., Newman, C., Griffin, T. P., McDonagh, C., O'Shea, C., Carmody, L. A., Cooray, S. D., et al. (2021) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.16825 · Cited by 29 · see citing works
Bigalke, S., Maeßen, T. V., Schnabel, K., Kaiser, U., Segelcke, D., Meyer‐Frießem, C. H., Liedgens, H., Macháček, P. A., Zahn, P. K., & Pogatzki-Zahn, E. M. (2021) · Pain · doi:10.1097/j.pain.0000000000002209 · Cited by 29 · see citing works
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 24 · see citing works
Reported outcomes in transsphenoidal surgery for pituitary adenomas: a systematic review
Horsfall, H. L., Lawrence, A. J., Venkatesh, A., Loh, R. T. S., Jayapalan, R. R., Koulouri, O., Sharma, R., Santarius, T., Gurnell, M., Dorward, N., et al. (2023) · Pituitary · doi:10.1007/s11102-023-01303-w · Cited by 22 · see citing works
Maxwell, L. J., Jones, C. M. P., Bingham, C. O., Boers, M., Boonen, A. E. R. C. H., Choy, E., Christensen, R., Conaghan, P. G., D’Agostino, M. A., Doria, A. S., et al. (2024) · Seminars in Arthritis and Rheumatism · doi:10.1016/j.semarthrit.2024.152423 · Cited by 22 · see citing works
Establishment of a core outcome set for burn care research: development and international consensus
Young, A. E., Davies, A. K., Tsang, C., Kirkham, J. J., Potokar, T. S., Gibran, N. S., Tyack, Z. F., Meirte, J., Harada, T., Dheansa, B. S., et al. (2022) · BMJ Medicine · doi:10.1136/bmjmed-2022-000183 · Cited by 20 · see citing works
Self-citationA core outcome set for airway management research
Hansel, J., Fuchs, A., Cornwell, B., Haynes, K., Tanna, V., Mohamed, A. A., Rivett, K., Radcliffe, G., Greif, R. T., Cook, T. M., et al. (2025) · Anaesthesia · doi:10.1111/anae.70026 · Cited by 19 · see citing works
Toilet training interventions for children with autism spectrum disorder: A systematic review
Simon, M., Wilkes‐Gillan, S., Chen, Y.-W. R., Cordier, R., Cantrill, A., Parsons, L., & Phua, J. J. (2022) · Research in Autism · doi:10.1016/j.rasd.2022.102049 · Cited by 19 · see citing works
Opportunities and challenges for the development of “core outcome sets” in neuro-oncology
Millward, C. P., Armstrong, T. S., Barrington, H., Brodbelt, A. R., Bulbeck, H., Byrne, A., Dirven, L., Gamble, C. L., Grundy, P. L., Islim, A. I., et al. (2022) · Neuro-Oncology · doi:10.1093/neuonc/noac062 · Cited by 18 · see citing works
Dovell, G., Staniszewska, A., Ramirez, J., Murray, I., Ambler, G. K., Twine, C. P., & Hinchliffe, R. J. (2021) · Diabetic Medicine · doi:10.1111/dme.14664 · Cited by 17 · see citing works
Millward, C. P., Armstrong, T. S., Barrington, H., Bell, S., Brodbelt, A. R., Bulbeck, H., Crofton, A., Dirven, L., Georgious, T., Grundy, P. L., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-057384 · Cited by 17 · see citing works
Tritschler, T., Cusano, E., Langlois, N., Mathieu, M., Hutton, B., Shea, B., Shorr, R., Skeith, L., Duffett, L. D., Cowley, L., et al. (2022) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.15787 · Cited by 16 · see citing works
Core outcomes for pressure ulcer prevention trials: results of an international consensus study
Lechner, A., Coleman, S. B., Balzer, K., Kirkham, J. J., Muir, D., Nixon, J., & Kottner, J. (2022) · British Journal of Dermatology · doi:10.1111/bjd.21741 · Cited by 16 · see citing works
Raepsaet, C., Alves, P. J. P., Cullen, B., Gefen, A., Lázaro‐Martínez, J. L., Lev‐Tov, H. A., Najafi, B., Santamaria, N., Sharpe, A., Swanson, T., et al. (2023) · Journal of Tissue Viability · doi:10.1016/j.jtv.2023.04.008 · Cited by 15 · see citing works
Core outcome set developers should consider and specify the level of granularity of outcome domains
Kottner, J., Beaton, D., Clarke, M. J., Dodd, S. R., Kirkham, J. J., Lange, T., Nieuwlaat, R., Schmitt, J. M., Tugwell, P., & Williamson, P. R. (2024) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2024.111307 · Cited by 15 · see citing works
Ernst, I. G., Torbahn, G., Schwingshackl, L., Knüttel, H., Kob, R., KEMMLER, W. K., Sieber, C. C., Batsis, J. A., Villareal, D. T., Stroebele‐Benschop, N., et al. (2022) · Obesity Reviews · doi:10.1111/obr.13497 · Cited by 14 · see citing works
Fearon, A., Grimaldi, A. M., Mellor, R., Nasser, A. M., Fitzpatrick, J., Ladurner, A., The COS-GT consensus group, & Vicenzino, B. (2024) · British Journal of Sports Medicine · doi:10.1136/bjsports-2023-107150 · Cited by 12 · see citing works
Rosenberger, D. C., Mennicken, E., Schmieg, I., Medkour, T., Péchard, M., Sachau, J., Fuchtmann, F., Birch, J. V., Schnabel, K., Vincent, K., et al. (2024) · Pain · doi:10.1097/j.pain.0000000000003290 · Cited by 13 · see citing works
Miller, C., Cross, J., O’Sullivan, J., Power, D., Kyte, D. G., & Jerosch‐Herold, C. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-044797 · Cited by 12 · see citing works
Methods used to assess outcome consistency in clinical studies: A literature-based evaluation
Rogozińska, E., Gargon, E., Olmedo‐Requena, R., Asour, A., Cooper, N. A. M., Vale, C. L., & Hooft, J. V. ’. (2020) · PLoS ONE · doi:10.1371/journal.pone.0235485 · Cited by 11 · see citing works
Maeßen, T. V., Austenfeld, E., Kaiser, U., Bigalke, S., Meyer‐Frießem, C. H., Liedgens, H., Zahn, P. K., & Pogatzki-Zahn, E. M. (2021) · Value in Health · doi:10.1016/j.jval.2021.01.016 · Cited by 9 · see citing works
Pregnancy Nutrition Core Outcome Set (PRENCOS): A core outcome set development study
Killeen, S. L., Callaghan, S. L., O'Reilly, S. L., & McAuliffe, F. M. (2023) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.17470 · Cited by 9 · see citing works
Beecher, C., Duane, S., Vellinga, A., Murphy, A. W., Cormican, M., Smyth, A., Healy, P., Moore, M. V., Little, P. S., Geoghegan, C., et al. (2022) · Antibiotics · doi:10.3390/antibiotics11121846 · Cited by 8 · see citing works
Outcomes 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 · see citing works
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 · see citing works
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 · see citing works
Protocol for development of a core outcome set for clinical trials in melasma
Ibrahim, S. A., Kang, B. Y., Schlessinger, D. I., Chiren, S. G., Tang, J. C., Kirkham, J. J., Schmitt, J. M., Poon, E., Maher, I. A., Sobanko, J. F., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2020-046953 · Cited by 6 · see citing works
Rodrigues, M., Syed, Z., Dufort, A., Sanger, N., Ghiassi, P., Sanger, S., Panesar, B., D’Elia, A., Parpia, S., Samaan, Z., et al. (2023) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2023.03.002 · Cited by 5 · see citing works
Delameillieure, A., Somogyi, V., Schenk, S., Töreyin, Z. N., Stenzel, N., Bulck, L. V., Breuls, S., Kreuter, M., Wuyts, W. A., Moğulkoç, N., et al. (2025) · European Respiratory Review · doi:10.1183/16000617.0133-2024 · Cited by 5 · see citing works
Tritschler, T., Langlois, N., Hutton, B., Shea, B., Shorr, R., Ng, S., Dubois, S., West, C., Iorio, A., Tugwell, P., et al. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-040122 · Cited by 5 · see citing works
Igarashi, M., Yamaguchi, S., Kawaguchi, T., Ogawa, M., Sato, S., & Fujii, C. (2021) · Neuropsychopharmacology Reports · doi:10.1002/npr2.12216 · Cited by 5 · see citing works
Pfisterer‐Heise, S., Scharfe, J., Kugler, C. M., Shehu, E., Wolf, T., Mathes, T., & Pieper, D. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-068138 · Cited by 4 · see citing works
A Core Outcome Set for Interventions to Prevent and/or Treat Delirium in Palliative Care
Bryans, A., Siddiqi, N., Burry, L. D., Clarke, M. J., Koffman, J., Agar, M. R., & Rose, L. (2023) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2023.05.013 · Cited by 4 · see citing works
HOW TO REPORT OUTCOMES IN CLINICAL DENTAL RESEARCH
Qin, D., Guo, F., & Hua, F. (2024) · Journal of Evidence Based Dental Practice · doi:10.1016/j.jebdp.2024.102053 · Cited by 4 · see citing works
Hansel, J., Fuchs, A., Radcliffe, G., Sotiriou, A., Rivett, K., Bohnenblust, V., Grimes, R., Fally, M., Greif, R. T., Cook, T. M., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-096886 · Cited by 4 · see citing works
Britton, E., Kobetić, M. D., McNally, E. H., Rudd, S., Potter, S., Hinchliffe, R. J., & Rees, J. R. E. (2025) · HPB · doi:10.1016/j.hpb.2025.02.008 · Cited by 3 · see citing works
Simons, G., Klepacz, N. A., & Baldwin, D. S. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-094973 · Cited by 3 · see citing works
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 · see citing works
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 · see citing works
Hamzeh, H., Spencer, S., Kelly, C. A., & Pilsworth, S. (2023) · PLoS ONE · doi:10.1371/journal.pone.0282393 · Cited by 3 · see citing works
Open challenges for the automatic synthesis of clinical trials
Sanchez-Graillet, O., Schmidt, D. M., Kullik, C., & Cimiano, P. (2025) · BMC Research Notes · doi:10.1186/s13104-025-07121-6 · Cited by 2 · see citing works
Forde, C. P., Mortimer, C., Smith, T. O., Costa, M. L., Cook, J. A., Tutton, E., Wistow, G., Minty, P., & Keene, D. J. (2025) · Bone & Joint Open · doi:10.1302/2633-1462.69.bjo-2025-0045.r1 · Cited by 2 · see citing works
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 · see citing works
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 · see citing works
Shen, Y., Hu, C., Li, L., Chen, Z., Chen, W., Lin, Z., Zhu, P., Tan, Q., Huang, W., Sun, X., et al. (2023) · BMJ Open · doi:10.1136/bmjopen-2023-075859 · Cited by 2 · see citing works
Millward, C. P., Islim, A. I., Armstrong, T. S., Barrington, H., Bell, S., Brodbelt, A. R., Bulbeck, H., Dirven, L., Grundy, P. L., Javadpour, M., et al. (2024) · Neuro-Oncology Advances · doi:10.1093/noajnl/vdae042 · Cited by 2 · see citing works
Guan, Z., Zhang, X., Jin, Y., Qiu, R., & Shang, H. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-083633 · Cited by 2 · see citing works
Brunello, G., Lin, G., Kopp, I., Carrasco‐Labra, A., Jung, R. E., Wang, H., Schwarz, F., & Strauss, F. J. (2026) · Clinical Oral Implants Research · doi:10.1111/clr.70075 · Cited by 1 · see citing works
“Although many outcomes were identified as relevant in the maintenance phase, determining the optimal timing and frequency of their assessment could be an important focus for future research to enhance their application in clinical practice and research (Young et al. 2019).”
Ahmed, A., Koza, E., Shi, V. J., Ma, M. J., Haq, M., Kottner, J., Garg, A., Ingram, J. R., Ezzedine, K., Spuls, P. I., et al. (2024) · Archives of Dermatological Research · doi:10.1007/s00403-023-02812-1 · Cited by 1 · see citing works
Shah, N. M., Apps, C., Amin, R., Kaltsakas, G., Hart, N., Murphy, P. B., & Rose, L. (2025) · Respiratory Care · doi:10.1089/respcare.12608 · Cited by 1 · see citing works
Chiam, G., Smith, S., Tu, T., Din, A., Normahani, P., & Davies, A. H. (2025) · Diabetic Medicine · doi:10.1111/dme.70134 · Cited by 1 · see citing works
Self-citationVance, J. L., Man, R., Adeoye, A., Amaranathan, M. S., Massey, M. S., Gurney, L., Morris, R. K., & Morton, V. H. (2026) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2026.115122 · Cited by 1 · see citing works
Knowledge synthesis: How to improve the use of evidence from clinical trials?
Sarkis‐Onofre, R., & Agostini, B. A. (2020) · International Journal of Paediatric Dentistry · doi:10.1111/ipd.12744 · Cited by 1 · see citing works
Bova, G., Letzen, J. E., Anicich, A., Birch, J. V., Domenichiello, A. F., Kaiser, U., Nicholson, K., Rosenberger, D. C., Wandner, L. D., & Pogatzki-Zahn, E. M. (2025) · Pain Medicine · doi:10.1093/pm/pnaf008 · Cited by 1 · see citing works
Kgosidialwa, O., Bogdanet, D., Egan, A. M., Newman, C., O’Shea, P. M., Biesty, L., McDonagh, C., O'Shea, C., Devane, D., & Dunne, F. (2021) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.16842 · Cited by 1 · see citing works
What to measure in biliary atresia research: study protocol for developing a core outcome set
Maguire, C., Tyack, Z. F., Kimble, R. M., Griffin, B. R., Yesberg, H. J., Choo, F. M., & McBride, C. A. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-047224 · Cited by 1 · see citing works
Hu, T., Long, Y., Chen, R., Yang, Z., Liu, L., Huang, L., Huang, J., Liao, G., & Du, L. (2022) · Acupuncture in Medicine · doi:10.1177/09645284221108215 · Cited by 1 · see citing works
Bairagi, A., Griffin, B. R., Banani, T., McPhail, S., Kimble, R. M., & Tyack, Z. F. (2021) · Burns · doi:10.1016/j.burns.2021.07.013 · Cited by 1 · see citing works
Max, M. (2019) · Critical Care Medicine · doi:10.1097/ccm.0000000000003989
Patient Centered Outcome Research in the Field of Pain
Kaiser, U., Schnabel, K., & Pogatzki-Zahn, E. M. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-809324-5.24269-7
Core outcome domains for capillary malformations and current methodological challenges
Rönsch, H., & Kottner, J. (2022) · British Journal of Dermatology · doi:10.1111/bjd.21780
Protocol of a scoping review of outcome domains in dermatology
Nadir, U., Ahmed, A., Yi, M. D., Hisham, F. I., Dave, L., Kottner, J., Ezzedine, K., Garg, A., Ingram, J. R., Jemec, G. B. E., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-079632
Davies, A. K., Williams, C., Burden, C., Mullin, S., Moy, L., Redshaw, M., Patel, M., Fraser, A., Hinton, L., Lynch, M., et al. (2024) · Research Square · doi:10.21203/rs.3.rs-4353851/v1
Self-citationLv, Y., Lin, K., Zhou, F., Fan, Y., Mu, X., Yuan, T., & Wang, Y. (2025) · Journal of Advanced Nursing · doi:10.1111/jan.16714
Davies, A. K., Williams, C., Burden, C., Mullin, S., Moy, L., Redshaw, M., Patel, M., Fraser, A., Hinton, L., Lynch, M., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-088251
Self-citationMillward, C. P., Armstrong, T. S., Bell, S., Brodbelt, A. R., Bulbeck, H., Dirven, L., Grundy, P. L., Islim, A. I., Javadpour, M., Keshwara, S. M., et al. (2025) · Neuro-Oncology Practice · doi:10.1093/nop/npaf023
COSSMaT Study: Protocol for Developing a Core Outcome Set for Severe Malaria Treatment TrialsPreprint
Asamoah, G. D., Love, S., Gibb, D. M., Maitland, K., & George, E. C. (2025) · medRxiv · doi:10.1101/2025.05.05.25326984
Byrne, C. J., Inglis, S. K., Radley, A., Beer, L. J. Z., Pham, M. D., Allardice, K., Palmer, N., Healy, B., Doyle, J., & Dillon, J. F. (2025) · Trials · doi:10.1186/s13063-025-09196-9
Rose, L., Burry, L. D., Agar, M., Blackwood, B., Campbell, N. L., Clarke, M. J., Devlin, J. W., Lee, J., Marshall, J. C., Needham, D. M., et al. (2021) · Figshare · doi:10.6084/m9.figshare.14803916
OSFCOS: A core outcome set for clinical trials on oral submucous fibrosis management
Gondivkar, S. M., Gadbail, A. R., Yuwanati, M. B., Lohe, V., & Sarode, S. C. (2026) · Journal of Oral Biology and Craniofacial Research · doi:10.1016/j.jobcr.2026.101421
Asamoah, G. D., Love, S., Gibb, D. M., Maitland, K., & George, E. C. (2026) · JMIR Research Protocols · doi:10.2196/78616 · Cited by 1 · see citing works
Livingston, M., Toomey, E., & Robinson, K. (2026) · Trials · doi:10.1186/s13063-026-09848-4
Purcell, S., Robinson, K., Morrissey, A., Ryan, S. M., O’Connor, M., Salsberg, J., & Hayes, S. (2026) · HRB Open Research · doi:10.12688/hrbopenres.14480.1
Li, D., Zhang, C., Jin, Y., Jin, X., Yang, F., 庞稳泰, & Zhang, J. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1872689
Gabb, V. G., Harding, S. A., Lemke, T., Alderman, S., Woodward, N., Clayton, J., McNair, A., Barrett‐Muir, W., Richardson, A., Dooley, J., et al. (2026) · Alzheimer s & Dementia · doi:10.1002/alz.71800
Yoo, S.-H., Park, M., & Kim, M. (2026) · BMJ Open · doi:10.1136/bmjopen-2026-124305
Li, D., Zhang, C., Jia, T., Jin, X., Yang, F., Pang, W., & Zhang, J. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1958608
PUMA tracheal extubation guidelines: towards clarity or complexity?
Ahmad, I., & Cook, T. M. (2026) · Anaesthesia · doi:10.1111/anae.70436
- Authors
- Young, A. E., Brookes, S. T., Avery, K. N. L., Davies, A., Metcalfe, C., & Blazeby, J. M.
- Affiliations
- University of Bristol (GB)
- Cancer Research UK Clinical Trials Unit (GB)
- Corresponding author
- Young, Amber E.
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2019-11
- Volume
- 115
- Pages
- 14-24
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2953844063
- Cited by
- 77
- References
- 52
- Citations by year
- 2026: 11 · 2025: 18 · 2024: 11 · 2023: 8 · 2022: 12 · 2021: 12 · 2020: 4 · 2019: 1
- FWCI
- 1.83
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Clinical Epidemiology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (publishedVersion, cc-by-nc-nd)
- Explore Bristol Research (submittedVersion, cc-by-nc-nd)
- Funders
- National Institute for Health Research (DRF-2016-09-031)
- Medical Research Council ConDuCT-II Hub
- NIHR Biomedical Research Centre
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- core outcome set, outcome reporting heterogeneity, outcome definitions
- MeSH terms
- Clinical Trials as Topic, Humans, Research Design, Databases, Factual, Outcome Assessment, Health Care, Evidence-Based Medicine
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
