Рекомендации по составлению отчетов о диагностических исследованиях (STARD 2015): разъяснения и уточнения

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Аннотация

Диагностические исследования (diagnostic accuracy studies), как и другие клинические исследования, подвержены риску систематических ошибок (bias) из-за недостатков дизайна и проведения, а их результаты могут оказаться неприменимыми к другим группам пациентов и в других условиях. Читатели должны быть достаточно подробно проинформированы о дизайне и проведении диагностического исследования, чтобы судить о надежности (trustworthiness) и применимости (applicability) его результатов. Руководство STARD (Standards for Reporting of Diagnostic Accuracy Studies) разработано с целью обеспечить полноту и прозрачность отчетов о диагностических исследованиях. Оно содержит перечень основных пунктов отчета, который может быть использован авторами, рецензентами и читателями как контрольный список (checklist) для отслеживания полноты представляемой информации. Здесь представлено обновленное руководство STARD, все материалы которого, включая контрольный список, доступны на http://www.equator-network.org/reporting-guidelines/stard. В данной статье приведены обоснования для 30 пунктов руководства и описание того, что требуется от авторов для составления достаточно информативных отчетов об исследованиях.

Настоящая статья является русскоязычным переводом оригинальной публикации [Cohen J.F., Korevaar D.A., Altman D.G. et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open 2016;6:e012799. doi: 10.1136/bmjopen-2016-012799 ] под редакцией д.м.н. Р.Т. Сайгитова.

Об авторах

Jérémie F. Cohen

University of Amsterdam; Paris Descartes University

Email: p.m.bossuyt@amc.uva.nl
ORCID iD: 0000-0003-3572-8985

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Department of Pediatrics

Нидерланды, Амстердам; Париж

Daniël A. Korevaar

University of Amsterdam

Email: p.m.bossuyt@amc.uva.nl
ORCID iD: 0000-0002-7979-7897

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre

Нидерланды, Амстердам

Douglas G. Altman

University of Oxford

Email: p.m.bossuyt@amc.uva.nl
ORCID iD: 0000-0002-7183-4083

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine

Великобритания, Оксфорд

David E. Bruns

University of Virginia School of Medicine

Email: p.m.bossuyt@amc.uva.nl

Department of Pathology, University of Virginia School of Medicine

США, Шарлотсвилл, Вирджиния

Constantine A. Gatsonis

Brown University School of Public Health

Email: p.m.bossuyt@amc.uva.nl

Department of Biostatistics, Brown University School of Public Health

США, Провиденс, Род-Айленд

Lotty Hooft

University of Utrecht

Email: p.m.bossuyt@amc.uva.nl

Cochrane Netherlands, Julius Center for Health Sciences and Primary Care

Нидерланды, Утрехт

Les Irwig

University of Sydney

Email: p.m.bossuyt@amc.uva.nl

Screening and Diagnostic Test Evaluation Program, School of Public Health

Австралия, Сидней, Новый Южный Уэльс

Deborah B. Levine

Beth Israel Deaconess Medical Center; Radiology Editorial Office

Email: p.m.bossuyt@amc.uva.nl
ORCID iD: 0000-0001-7761-6493

Department of Radiology, Beth Israel Deaconess Medical Center, Radiology Editorial Office

США, Бостон, Массачусетс

Henrica C. W. de Vet

VU University Medical Center

Email: p.m.bossuyt@amc.uva.nl
ORCID iD: 0000-0002-5454-2804

Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center

Нидерланды, Амстердам

Patrick M.M. Bossuyt

University of Amsterdam

Автор, ответственный за переписку.
Email: p.m.bossuyt@amc.uva.nl
ORCID iD: 0000-0003-4427-0128

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre

Нидерланды, Амстердам

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2. Рис. 1. Пример схемы исследования, в котором оценивалась точность иммунохимического анализа кала для диагностики рогрессирующей колоректальной неоплазии (адаптировано из работы M. Collins и соавт. [79]; публикуется с разрешения).

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