Cited by 985Meta-analysis and systematic reviewsStatistical Methods in EpidemiologyClinical practice guidelines implementation

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STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies

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Bossuyt, Patrick M, Reitsma, Johannes B, Bruns, David E, Gatsonis, Constantine A, Glasziou, Paul P, Irwig, Les, Lijmer, Jeroen G, Moher, David, Rennie, Drummond, de Vet, Henrica C W, Kressel, Herbert Y, Rifai, Nader, Golub, Robert M, Altman, Douglas G, Hooft, Lotty, Korevaar, Daniël A, Cohen, Jérémie F·2015·Clinical Chemistry

DOI 10.1373/clinchem.2015.246280

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Abstract

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

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Vetrugno, L., Boero, E., Berchialla, P., Forfori, F., Bernardinetti, M., Spadaro, S., Cammarota, G., Bruni, A., Garofalo, E., Tescione, M., et al. (2024) · Anaesthesia Critical Care & Pain Medicine · doi:10.1016/j.accpm.2024.101432 · Cited by 2
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Navarro, I. J. R. L., Pacheco, F. P., Parent, É., & Candotti, C. T. (2025) · Journal of Bodywork and Movement Therapies · doi:10.1016/j.jbmt.2025.01.043 · Cited by 2
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Yang, Q., Cha, S., Niu, Y., Wen, J.-X., Yan, L., Hai, L., Wang, Y., Gao, W., Zhou, F., Zhou, Q., et al. (2025) · Infection and Drug Resistance · doi:10.2147/idr.s493610 · Cited by 2
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Song, T., Yin, L., Zhou, X., Tao, X., Tie, D., Zhang, J., & Jiang, L. (2025) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2025.1567981 · Cited by 2
The Estimand Framework in Diagnostic Accuracy Studies
Fierenz, A., Akacha, M., Benda, N., Badpa, M., Bossuyt, P. M., Dendukuri, N., Rackow, B., & Zapf, A. (2025) · Statistics in Medicine · doi:10.1002/sim.70248 · Cited by 1
“To identify pertinent parts of the estimand framework for diagnostic studies, the STARD (Standards for Reporting Studies of Diagnostic Accuracy) [15] and QUADAS (Quality Assessment of Diagnostic Accuracy Studies) [16] tools were consulted.”
Self-citation
Elastic fusion biopsy versus systematic biopsy for prostate cancer detection: Results of a multicentric study on 1119 patients
Oderda, M., Marra, G., Albisinni, S., Altobelli, E., Baco, E., Beatrici, V., Dellabella, M., Descotes, J., Eldred‐Evans, D., Fasolis, G., et al. (2019) · Actas Urológicas Españolas (English Edition) · doi:10.1016/j.acuroe.2019.01.011 · Cited by 2
Estudio de precisión diagnóstica de la velocidad de sedimentación globular y la proteína C reactiva en pacientes con lupus eritematoso sistémico y fiebre admitidos en un hospital de la Seguridad Social en Lima, Perú, 2010-2019
León, G. R., Menacho-Alvarado, A., Cieza-Calderón, J., & Segura, E. R. (2022) · Revista Colombiana de Reumatología · doi:10.1016/j.rcreu.2021.12.003 · Cited by 2
Translation of Biomarkers into Clinical Practice
McShane, L. M., Lively, T., & Makhlouf, H. R. (2016) · Springer eBooks · doi:10.1007/978-3-319-41761-5_1 · Cited by 2
Unfounded conclusions of equivalence in diagnostic accuracy studies: a pervasive fallacy of inference in pediatric radiology scientific abstracts
May, L. A., Guillerman, R. P., Zhang, W., & Orth, R. C. (2018) · Pediatric Radiology · doi:10.1007/s00247-018-4222-9 · Cited by 2
Discriminatory power of Stroke Specific Quality of Life questionnaire items to evaluate the participation component of the International Classification of Functioning, Disability and Health
Silva, S. M., Corrêa, F. I., Faria, C. D. C. D. M., & Corrêa, J. C. F. (2020) · International Journal of Therapy and Rehabilitation · doi:10.12968/ijtr.2018.0077 · Cited by 2
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Mantese, C. E. A., Medeiros, M., Schuh, A. F. S., & Rieder, C. R. D. M. (2020) · Arquivos de Neuro-Psiquiatria · doi:10.1590/0004-282x20200045 · Cited by 2
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Silvestre, R. A., Lafuente, A. A., Mendiguchía, L. J., Cano, A. M. G., López, R. R., Izquierdo, B. G., de Santayana, C. P., Iglesias, P., Díez, J. J., Arribas, I., et al. (2020) · Advances in Laboratory Medicine / Avances en Medicina de Laboratorio · doi:10.1515/almed-2020-0053 · Cited by 2
“Hay que destacar, por otra parte, que en el estudio de validez diagnóstica se utilizó un gold standard robusto y consolidado en la comunidad científica, así como que se aplicó a la totalidad de los pacientes incluidos en el estudio [28].”
Background
Comparison of imaging modalities in the diagnosis of external cervical resorption (ECR): an in-vitro study
Cunliffe, J., AlHadidi, A., Sawair, F., & Mahasneh, S. A. (2021) · Odontology · doi:10.1007/s10266-021-00651-y · Cited by 2
It was not easy to identify the study design from the title and abstract of articles indexed as diagnostic (test) accuracy studies in EMBASE in 2012 and 2019
Thompson, G., Zhelev, Z., Hunt, H. A., & Hyde, C. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.12.014 · Cited by 2
Magnetic resonance radiographic features which might lead to misdiagnosis of muscle-invasive bladder cancer based on vesical imaging reporting and data system: the application experience of a single center
Li, B., Li, X., Li, Z., Yang, P., Pan, C., Tian, L., & Xie, C. (2023) · Quantitative Imaging in Medicine and Surgery · doi:10.21037/qims-23-356 · Cited by 2
CD276 is a promising biomarker for the prognosis of clear cell renal cell carcinoma
Yu, Y., Xu, J., Chen, H., Lin, Y.-X., Ou‐Yang, J., & Zhang, Z. (2024) · The Kaohsiung Journal of Medical Sciences · doi:10.1002/kjm2.12891 · Cited by 2
“15”
Objective image analysis of non-magnifying image-enhanced endoscopy for diagnosis of small depressed early gastric cancers
Watari, J., Kobayashi, M., Nakai, K., Ito, C., Tamura, A., Ogawa, T., Yamasaki, T., Okugawa, T., Kondo, T., Kono, T., et al. (2018) · Endoscopy International Open · doi:10.1055/a-0735-9317 · Cited by 2
Evaluación de la biopsia de fusión elástica vs. biopsia sistemática para la detección del cáncer de próstata: resultados de un estudio multicéntrico en 1.119 pacientes
Oderda, M., Marra, G., Albisinni, S., Altobelli, E., Baco, E., Beatrici, V., Dellabella, M., Descotes, J., Eldred‐Evans, D., Fasolis, G., et al. (2019) · Actas Urológicas Españolas · doi:10.1016/j.acuro.2019.01.009 · Cited by 2
Quantitative Diagnostic Test Validation
Flatland, B. (2022) · Wiley eBooks · doi:10.1002/9781119500537.ch139 · Cited by 2
A Multi-Center Clinical Diagnostic Accuracy Study of Surestatus - an Affordable, WHO Emergency-Use-Listed, Rapid, Point-of-Care, Antigen-Detecting Diagnostic Test for SARS-CoV-2Preprint
Krüger, L. J., Lindner, A. K., Gaeddert, M., Tobian, F., Klein, J., Steinke, S., Lainati, F., Schnitzler, P., Nikolai, O., Mockenhaupt, F. P., et al. (2022) · SSRN Electronic Journal · doi:10.2139/ssrn.4072491 · Cited by 2
Clinical Trials and Evidence‐Based Research in the Clinical Laboratory
Wolk, D. M., & Whitfield, N. N. (2024) · Wiley eBooks · doi:10.1002/9781683673941.ch42 · Cited by 2
Test evaluation trials present different challenges for trial managers compared to intervention trials
Rick, C., Mallett, S., Brown, J. C., Ottridge, R. S., Palmer, A., Parker, V., Priest, L., & Deeks, J. J. (2020) · Trials · doi:10.1186/s13063-020-04861-7 · Cited by 1
Protocol for the development of a reporting guideline for clinical trials with integrated Chinese and western medicine interventions: the CONSORT extension for ICWM
Wang, J., Zhang, X., Wang, P., Han, F., Li, J., Ma, Y., Lü, A., & Bian, Z. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2023.1190560 · Cited by 1
Predictive abilities comparison from multiple dynamic prediction models
Moreau, C., Riou, J., & Roux, M. (2023) · Statistical Methods in Medical Research · doi:10.1177/09622802231188521 · Cited by 1
“Such models should be rigorously evaluated using international guidelines 4,5 before being used in clinical practice.”
Method
Exploring the potential of cell-free tumor DNA in bronchoscopic diagnosis of peripheral lung lesions—the DRILL study
Juul, A. D., Arshad, A., Christophersen, A., Larsen, J. G., Pulga, A., Kristiansen, P., Rasmussen, T. R., Skaarup, S. H., Hilberg, O., & Laursen, C. B. (2025) · European Clinical Respiratory Journal · doi:10.1080/20018525.2025.2474277 · Cited by 1
“The DRILL study was conducted as a prospective, multicenter, diagnostic accuracy study in accordance with the STARD guidelines [18].”
Dual energy CT-based Radiomics for identification of myocardial focal scar and artificial beam-hardening
Zeng, L., Hu, F., Qin, P., Jia, T., Lu, L., Yang, Z., Zhou, X., Qiu, Y., Luo, L., Chen, B., et al. (2025) · International Journal of Cardiology · doi:10.1016/j.ijcard.2025.133482 · Cited by 1
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Li, Y., Chen, C., Zhang, Y., Yu, J., Xu, F. Z., Liu, F., Wang, T., Li, J., Wang, L., Lu, J., et al. (2025) · npj Precision Oncology · doi:10.1038/s41698-025-01032-2 · Cited by 1
Diagnostic model for COPD patients with nocardia infection: a study based on clinical features and risk factors
Zhang, K., Yang, K., & Wang, H. (2025) · Therapeutic Advances in Respiratory Disease · doi:10.1177/17534666251359139 · Cited by 1
Telehealth physical examinations show comparable accuracy and results to clinical exams for MRI confirmed shoulder pathologies
Glover, M. A., Bradley, K. E., Casey, P., Cook, C. E., Reinke, E. K., Vinson, E. N., Mather, R. C. “., Riboh, J. C., Lassiter, T., & Wittstein, J. R. (2025) · Journal of Telemedicine and Telecare · doi:10.1177/1357633x251375155 · Cited by 1
“13 A signi ﬁ cant portion of the data used in this study was previously collected and published prior to completion due to the COVID-19 pandemic as seen in the publication by Bradley et al. 12 Following international review board approval (IRB # Pro00101866, Duke University Health System), all…”
Influence of Complex Disease on the Accuracy of Transvaginal Ultrasound Diagnosis of Uterosacral Ligament Endometriosis
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Gold Nano-Rod (AuNR)-mediated plasmonic photothermal therapy in feline mammary carcinoma: assessing metastatic and nonmetastatic outcomes
Elsabagh, R. H., Farghali, H. A. M. A., Emam, I. A., Abdelrahman, H., Ragab, E. A., Nada, A. A., & Selim, S. A. K. (2025) · Veterinary oncology. · doi:10.1186/s44356-025-00035-2 · Cited by 1
Accuracy of seven criteria based on cholesterol and lactate dehydrogenase for differentiating exudative and transudative pleural effusions
Cha, S., Niu, Y., Wen, J.-X., Yan, C., Li, Y., Zhang, L., Wang, M.-Y., Jiao, W., Zheng, W., Porcel, J. M., et al. (2025) · Scientific Reports · doi:10.1038/s41598-025-30258-0 · Cited by 1
“This study followed the Standards for Reporting of Diagnostic Accuracy Studies (STARD) guidelines 23 .”
Unveiling the Benefits of Artificial Intelligence in Individual, Organizational Management, and the Health/Sector System
Gebremeskel, T. G., & Romeo, F. (2025) · Health Science Reports · doi:10.1002/hsr2.71536 · Cited by 1
Prognostic value of serum vitamin D level for renal scarring in childhood acute pyelonephritis
Mahzoon, M., Yousefi, J., Azarfar, A., & Khazaei, M. R. (2025) · The Turkish Journal of Pediatrics · doi:10.24953/turkjpediatr.2025.5599 · Cited by 1
α-Synuclein seed amplification assay methodology and performance in Parkinson’s disease, lewy body dementia, and multiple system atrophy: A meta-analysis
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Comparison of the diagnostic accuracy of interleukin-27 and adenosine deaminase for tuberculous pleural effusion: A systematic review and meta-analysis with head-to-head design
Gao, Y., Hai, L., Niu, Y., Zhu, H.-Z., Niu, R., Tian, Q.-F., Wang, Q.-J., Hao, Y.-L., Wen, J.-X., Xu, Y., et al. (2026) · Cytokine · doi:10.1016/j.cyto.2026.157131 · Cited by 1
Evaluating the feasibility of using digital Brix refractometry to determine the passive immune status of lambs
Akköse, M., Özbeyaz, C., Buczinski, S., & Gündoğar, U. C. (2026) · Veterinary Record · doi:10.1002/vetr.70497 · Cited by 1
Risk stratification of MASLD-related advanced fibrosis using a novel point-of-care device: the Hepatoscope
Caussy, C., Vergès, B. L., Subtil, F., Klich, A., Hervieu, V., Leleu, D., Milot, L. M., Segrestin, B., Bin, S., Berthiller, J., et al. (2026) · Diabetes & Metabolism · doi:10.1016/j.diabet.2026.101766 · Cited by 1
Computer-assisted and unassisted optical diagnosis of colorectal polyps: results from a prospective pragmatic implementation study
Medawar, E., Oleksiw, M., Rex, D. K., Hassan, C., Djinbachian, R., Michal, V., Battat, R. J., Deslandres, É., Bouin, M., Kiow, J. L. C., et al. (2026) · Endoscopy · doi:10.1055/a-2882-7665 · Cited by 1
Artificial intelligence–based ECG as a triage tool for acute myocardial infarction: a diagnostic systematic review and meta-analysis
Gaelzer, G. C., Batista, P. K. A., Montenegro, M. V., Silva, R. R. A. D. S., Malik, M., Tebet, M. L. C., Bacca, C. D. O. F., Giorgi, J. M., & Marques, G. L. (2026) · European Heart Journal - Digital Health · doi:10.1093/ehjdh/ztag075 · Cited by 1
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“The study was reported according to the Standards for Reporting of Diagnostic Accuracy (STARD) [36].”

Authors: Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L., Lijmer, J. G., Moher, D., Rennie, D., de Vet, H. C. W., Kressel, H. Y., Rifai, N., Golub, R. M., Altman, D. G., Hooft, L., Korevaar, D. A., & Cohen, J. F.
Affiliations: Amsterdam UMC Location University of Amsterdam (NL)
Utrecht University (NL)
University of Virginia (US)
Brown University (US)
Bond University (AU)
The University of Sydney (AU)
OLVG (NL)
University of Ottawa (CA)
University of California, San Francisco (US)
Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands
Beth Israel Deaconess Medical Center (US)
Boston Children's Hospital (US)
Northwestern University (US)
University of Oxford (GB)
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands
Inserm (FR)
Corresponding author: Bossuyt, Patrick M
ORCID: Bossuyt, Patrick M
Reitsma, Johannes B
Glasziou, Paul P
Lijmer, Jeroen G
Moher, David
Kressel, Herbert Y
Rifai, Nader
Altman, Douglas G
Hooft, Lotty
Cohen, Jérémie F
Venue: Clinical Chemistry
Publisher: Oxford University Press (OUP)
Published: 2015-12-01
Volume: 61
Issue: 12
Pages: 1446-1452
ISSN: 0009-9147 (ISSN-L)
1530-8561
DOI: 10.1373/clinchem.2015.246280
OpenAlex: W2188214922
Cited by: 984
References: 25
Citations by year: 2026: 54 · 2025: 64 · 2024: 124 · 2023: 110 · 2022: 100 · 2021: 134 · 2020: 124 · 2019: 81 · 2018: 96 · 2017: 67 · 2016: 28 · 2015: 2
FWCI: 58.69
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations: Clinical Chemistry (publishedVersion)
PubMed (publishedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
University of Birmingham Research Portal (University of Birmingham) (publishedVersion)
University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
Bond University Research Portal (Bond University) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
Pure Amsterdam UMC (submittedVersion, other-oa)
Pure (Coventry University) (submittedVersion)
Queen Mary Research Online (Queen Mary University of London) (submittedVersion)
University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
Funders: University of Amsterdam
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords: STARD 2015, diagnostic accuracy studies, reporting guidelines, reporting completeness, research transparency, critical appraisal
MeSH terms: Diagnostic Tests, Routine, Humans, Terminology as Topic, Quality Control, Research Design, Reproducibility of Results, Bias

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STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies

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