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Record W4411919667 · doi:10.12771/emj.2025.00409

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

2025· article· en· W4411919667 on OpenAlexafffund
Sally Hopewell, An‐Wen Chan, Gary S. Collins, Asbjørn Hróbjartsson, David Moher, Kenneth F. Schulz, R. Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A. Berlin, Nita Bhandari, Nancy J. Butcher, Marion Campbell, Runcie C.W. Chidebe, Diana Elbourne, Andrew Farmer, Dean Fergusson, Robert M. Golub, Steven N. Goodman, Tammy Hoffmann, John P. A. Ioannidis, Brennan C Kahan, Rachel L Knowles, Sarah E Lamb, Steff Lewis, Elizabeth Loder, Martin Offringa, Philippe Ravaud, Dawn P. Richards, Frank W. Rockhold, David L. Schriger, Nandi Siegfried, Sophie Staniszewska, R. Taylor, Lehana Thabane, David Torgerson, Sunita Vohra, Ian R. White, Isabelle Boutron

Bibliographic record

VenueThe Ewha Medical Journal · 2025
Typearticle
Languageen
FieldDecision Sciences
TopicMeta-analysis and systematic reviews
Canadian institutionsImpactUniversity of AlbertaRobarts Clinical TrialsSt. Joseph’s Healthcare HamiltonHospital for Sick ChildrenOttawa HospitalMcMaster UniversityWomen's College HospitalUniversity of Toronto
FundersUniversity of North Carolina at Chapel HillUniversity of ExeterJawaharlal Institute Of Postgraduate Medical Education and ResearchSyddansk UniversitetCenters for Disease Control and PreventionUniversity of AberdeenUniversity of TorontoUniversity of GlasgowUniversity of WarwickUniversity of OxfordUniversity College LondonUniversity of OttawaMedical Research CouncilDepartment of Health and Social CareNational Institute for Health and Care ResearchSouth African Medical Research CouncilUniversity of AlbertaLondon School of Hygiene and Tropical MedicineMcMaster UniversityOttawa Hospital Research InstituteBond UniversityHospital for Sick ChildrenNorthwestern UniversityUniversity of Miami
KeywordsConsolidated Standards of Reporting TrialsGuidelineStatement (logic)Randomized controlled trialMedicineAccountingFamily medicineInternal medicineBusinessLinguisticsPathologyPhilosophy

Abstract

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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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.308
metaresearch head score (Gemma)0.617
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Reporting · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.692
Threshold uncertainty score0.854

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.3080.617
Meta-epidemiology (narrow)0.0050.005
Meta-epidemiology (broad)0.0100.021
Bibliometrics0.0260.024
Science and technology studies0.0030.006
Scholarly communication0.0120.010
Open science0.0080.008
Research integrity0.0100.022
Insufficient payload (model declined to judge)0.0290.021

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.829
GPT teacher head0.636
Teacher spread0.193 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designNot applicable
DomainReporting
GenreMethods

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations7
Published2025
Admission routes2
Has abstractyes

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