CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation

Sally Hopewell¹, An-Wen Chan², Gary S Collins³, Asbjørn Hróbjartsson^{4

5}, David Moher⁶, Kenneth F Schulz⁷, Ruth Tunn¹, Rakesh Aggarwal⁸, Michael Berkwits⁹, Jesse A Berlin^{10

11}, Nita Bhandari¹², Nancy J Butcher^{13

14}, Marion K Campbell¹⁵, Runcie C W Chidebe^{16

17}, Diana Elbourne¹⁸, Andrew Farmer¹⁹, Dean A Fergusson²⁰, Robert M Golub²¹, Steven N Goodman²², Tammy C Hoffmann²³, John P A Ioannidis²⁴, Brennan C Kahan²⁵, Rachel L Knowles²⁶, Sarah E Lamb²⁷, Steff Lewis²⁸, Elizabeth Loder^{29

30}, Martin Offringa¹³, Philippe Ravaud³¹, Dawn P Richards³², Frank W Rockhold³³, David L Schriger³⁴, Nandi L Siegried³⁵, Sophie Staniszewska³⁶, Rod S Taylor³⁷, Lehana Thabane^{38

39}, David Torgerson⁴⁰, Sunita Vohra⁴¹, Ian R White²⁵, Isabelle Boutron⁴²

Affiliations

¹ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
² Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
³ United Kingdom EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁴ Department of Clinical Research, Centre for Evidence-Based Medicine Odense and Cochrane Denmark, University of Southern Denmark, Odense, Denmark.
⁵ Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
⁶ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
⁷ Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
⁹ Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
¹⁰ Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
¹¹ JAMA Network Open, Chicago, IL, USA.
¹² Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
¹³ Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.
¹⁴ Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
¹⁵ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
¹⁶ Project PINK BLUE-Health & Psychological Trust Centre, Abuja, Nigeria.
¹⁷ Department of Sociology and Gerontology, Miami University, Oxford, OH, USA.
¹⁸ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
¹⁹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
²⁰ Ottawa Hospital Research Institute, Ottawa, ON, Canada.
²¹ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
²² Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
²³ Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, QLD, Australia.
²⁴ Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
²⁵ MRC Clinical Trials Unit at University College London, London, UK.
²⁶ University College London, UCL Great Ormond Street Institute of Child Health, London, UK.
²⁷ NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
²⁸ Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh, UK.
²⁹ The BMJ, BMA House, London, UK.
³⁰ Harvard Medical School, Boston, MA, USA.
³¹ Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.
³² Clinical Trials Ontario, MaRS Centre, Toronto, ON, Canada.
³³ Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
³⁴ Department of Emergency Medicine, University of California, Los Angeles, CA, USA.
³⁵ South African Medical Research Council, Cape Town, South Africa.
³⁶ Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.
³⁷ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
³⁸ Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.
³⁹ St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
⁴⁰ York Trials Unit, Department of Health Sciences, University of York, York, UK.
⁴¹ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
⁴² Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.

PMID: 40739975
PMCID: PMC12362289
DOI: 10.12771/emj.2025.00409

Guideline

CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation

Sally Hopewell et al. Ewha Med J. 2025 Jul.

. 2025 Jul;48(3):e50.

doi: 10.12771/emj.2025.00409. Epub 2025 Jul 2.

Authors

Affiliations

¹ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
² Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
³ United Kingdom EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁴ Department of Clinical Research, Centre for Evidence-Based Medicine Odense and Cochrane Denmark, University of Southern Denmark, Odense, Denmark.
⁵ Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
⁶ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
⁷ Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
⁹ Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
¹⁰ Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
¹¹ JAMA Network Open, Chicago, IL, USA.
¹² Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
¹³ Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.
¹⁴ Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
¹⁵ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
¹⁶ Project PINK BLUE-Health & Psychological Trust Centre, Abuja, Nigeria.
¹⁷ Department of Sociology and Gerontology, Miami University, Oxford, OH, USA.
¹⁸ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
¹⁹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
²⁰ Ottawa Hospital Research Institute, Ottawa, ON, Canada.
²¹ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
²² Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
²³ Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, QLD, Australia.
²⁴ Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
²⁵ MRC Clinical Trials Unit at University College London, London, UK.
²⁶ University College London, UCL Great Ormond Street Institute of Child Health, London, UK.
²⁷ NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
²⁸ Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh, UK.
²⁹ The BMJ, BMA House, London, UK.
³⁰ Harvard Medical School, Boston, MA, USA.
³¹ Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.
³² Clinical Trials Ontario, MaRS Centre, Toronto, ON, Canada.
³³ Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
³⁴ Department of Emergency Medicine, University of California, Los Angeles, CA, USA.
³⁵ South African Medical Research Council, Cape Town, South Africa.
³⁶ Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.
³⁷ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
³⁸ Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.
³⁹ St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
⁴⁰ York Trials Unit, Department of Health Sciences, University of York, York, UK.
⁴¹ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
⁴² Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.

PMID: 40739975
PMCID: PMC12362289
DOI: 10.12771/emj.2025.00409

Abstract

배경: 잘 설계되고 적절하게 실행된 무작위 배정 임상시험은 의료 개입의 효과에 대한 가장 신뢰할 수 있는 증거라고 할 수 있다. 그러나 연구 보고의 질이 미흡하다는 많은 증거가 있다. CONSORT(통합 임상시험 보고 기준)는 이러한 보고의 질을 개선하기 위해 고안되었으며, 무작위 임상시험 보고서가 포함해야 할 최소한의 항목을 제시한다. CONSORT는 1996년에 처음 발표된 후 2001년과 2010년에 개정되었다. 여기에서는 최근의 방법론적 발전과 최종 사용자의 피드백을 반영하여 개정된 CONSORT 2025 statement를 소개한다.

방법: 문헌에 대해 범위를 검토하고 CONSORT와 관련된 경험과 이론에 바탕을 둔 프로젝트별 데이터베이스를 개발하여 점검표의 잠재적 변경 목록을 생성하였다. 이 목록은 기존 CONSORT 확장판(유해성, 결과, 비약물적 치료)의 주 저자들과, 관련 보고 지침들(TIDieR), 그리고 개인적인 의견 교환을 포함한 기타 출처에서 제공된 권고사항으로 보강되었다. 점검표의 잠재적 변경 목록은 317명이 참여한 대규모 국제 온라인 3 라운드 델파이 설문조사를 통해 평가되었으며, 초청된 30명의 국제 전문가가 참여한 이틀 간의 온라인 전문가 합의 회의에서 논의되었다.

결과: CONSORT 점검표를 대폭 변경하였다. 새로운 항목 7개를 추가하고, 3개 항목을 수정하고, 1개 항목은 삭제했으며, 주요 CONSORT 확장판의 여러 항목을 통합하였다. 또한 오픈 사이언스에 대한 새로운 섹션을 추가하여 CONSORT 점검표를 재구성하였다. CONSORT 2025 statement는 무작위 임상시험 결과를 보고할 때 반드시 포함해야 하는 30개 항목의 점검표와 임상시험 참여자의 흐름을 문서화하기 위한 다이어그램으로 구성되어 있다. 또한 각 항목의 핵심 요소를 도출하여 글머리 기호 형식으로 정리한 확장형 점검표도 개발하여 CONSORT 2025를 용이하게 이행할 수 있도록 하였다.

결론: 저자, 편집인, 심사자 및 기타 잠재적 사용자는 무작위 임상시험의 원고를 작성하고 평가할 때 CONSORT 2025를 사용하여 임상시험 보고서를 명확하고 투명하게 작성하도록 해야 한다.

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Conflict of interest statement

Conflict of interest

I have read the journal’s policy and the authors of this manuscript have the following competing interests: support from MRC-NIHR for the submitted work. SH, IB, AWC, AH, KFS, and DM are members of the SPIRIT-CONSORT executive group. SH, IB, AWC, AH, KFS, GSC, DM, MKC, NJB, MO, RST, and SV are involved in the development, update, implementation, and dissemination of several reporting guidelines. GSC is the director of the UK EQUATOR Centre, a statistical editor for The BMJ and NIHR Senior Investigator, DM is the director of the Canadian EQUATOR Centre, and member of The BMJ’s regional advisory board for North America, IB is deputy director and PR is director of the French EQUATOR Centre, TCH is director of the Australasian EQUATOR Centre, JPAI is director of the US EQUATOR Centre. RA is president of the World Association of Medical Editors. MKC is chair of the MRC-NIHR: Better Methods Better Research funding panel. RCWC is executive director of Project PINK-BLUE, which receives funding from Roche-Product. AF is director of the UK National Institute for Health and Care Research Health Technology Assessment Programme. DPR is a full time employee of Five02 Laboratories, which under contract to Clinical Trials Ontario provides services related to patient and public engagement; and is the volunteer vice president of the Canadian Arthritis Patient Alliance, which receives funding through independent grants from pharmaceutical companies. IRW was supported by the MRC Programmes MCUU00004/07 and MCUU00004/09. DLS is JAMA associate editor and receives editing stipends from JAMA and Annals of Emergency Medicine.

Figures

**그림 1.**
CONSORT 2025 흐름도. 두 그룹 무작위 배정 임상시험의 단계별 진행 상황(즉 등록, 중재 할당, 추적 관찰 및 데이터 분석)을 나타내는 흐름도. CONSORT, Consolidated Standards of Reporting Trials.

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CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation

Affiliations

CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation

Authors

Affiliations

Abstract

Conflict of interest statement

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