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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Multicenter validation of a machine learning phase space electro-mechanical pulse wave analysis to predict elevated left ventricular end diastolic pressure at the point-of-care
Bhavnani, S. P., Khedraki, R., Cohoon, T. J., Meine, F. J., Stuckey, T., McMinn, T. R., Depta, J. P., Bennett, B. A., Mcgarry, T. F., Carroll, W. S., et al. (2022) · PLoS ONE · doi:10.1371/journal.pone.0277300 · Cited by 9
“The present results are reported according to STARD guidelines [23] (S6 File).”
Result
The clinical significance of computed tomography texture features of renal cell carcinoma in predicting pathological T1–3 staging
Li, T. X., Li, Z., Wu, K. M., Dong, P., Liu, H., Wu, S., & Zhou, F. (2023) · Quantitative Imaging in Medicine and Surgery · doi:10.21037/qims-22-1043 · Cited by 8
Agreement between cardiac output measurements by pulse wave analysis using the Pressure Recording Analytical Method and transthoracic echocardiography in patients with veno-venous extracorporeal membrane oxygenation therapy
Greiwe, G., Flick, M., Hapfelmeier, A., Winkler, M. S., Nitzschke, R., Frings, D. P., & Saugel, B. (2023) · European Journal of Anaesthesiology · doi:10.1097/eja.0000000000001828 · Cited by 8
Analytical and diagnostic performance characteristics of reverse-transcriptase loop-mediated isothermal amplification assays for dengue virus serotypes 1–4: A scoping review to inform potential use in portable molecular diagnostic devices
Arkell, P., Mairiang, D., Songjaeng, A., Malpartida-Cardenas, K., Hill-Cawthorne, K., Avirutnan, P., Georgiou, P., Holmes, A. H., & Rodríguez-Manzano, J. (2023) · PLOS Global Public Health · doi:10.1371/journal.pgph.0002169 · Cited by 8
Real-World Diagnostic Accuracy of the On-Site Cytopathology Advance Report (OSCAR) Procedure Performed in a Multidisciplinary One-Stop Breast Clinic
Suciu, V., Chamieh, C. E., Soufan, R., Mathieu, M., Balleyguier, C., Delaloge, S., Balogh, Z., Scoazec, J., Chevret, S., & Vielh, P. R. (2023) · Cancers · doi:10.3390/cancers15204967 · Cited by 8
“These strengths included the large consecutive series of patients analyzed and its reporting, which was conducted according to published guidelines and speciﬁcations [122,218–222].”
Background
Improving diagnostic accuracy in clinically ambiguous paediatric appendicitis: a retrospective review of ultrasound and pathology findings with focus on the non-visualised appendix
Kelly, B. S., Bollard, S. M., Weir, A., O’Brien, C., Mullen, D., Kerin, M. J., & McCarthy, P. (2018) · British Journal of Radiology · doi:10.1259/bjr.20180585 · Cited by 8
Physical examination to screen for peripheral artery disease in a defined Primary Care population: A diagnostic accuracy study
Herráiz-Adillo, Á., Piñar-Serrano, O., Mariana-Herráiz, J. Á., Martínez‐Vizcaíno, V., Pozuelo‐Carrascosa, D. P., & Notario‐Pacheco, B. (2018) · International Journal of Clinical Practice · doi:10.1111/ijcp.13253 · Cited by 8
Higher predictability of the lipid accumulation product than commonly used anthropometric parameters partly due to its definition
Tian, S., Xu, Y., & Han, F. (2017) · Clinical Nutrition · doi:10.1016/j.clnu.2017.03.001 · Cited by 8
Comparative performance of commercial Amies transport media with and without charcoal for Neisseria gonorrhoeae culture for gonococcal isolation and antimicrobial resistance monitoring in Ukraine
Boiko, I., & Krynytska, І. (2021) · GERMS · doi:10.18683/germs.2021.1261 · Cited by 7
A Deep Learning Model for Identifying the Risk of Mesenteric Malperfusion in Acute Aortic Dissection Using Initial Diagnostic Data: Algorithm Development and Validation
Jin, Z., Dong, J., Li, C., Jiang, Y., Yang, J., Xu, L., Li, P., Xie, Z., Li, Y., Wang, D., et al. (2025) · Journal of Medical Internet Research · doi:10.2196/72649 · Cited by 7
“This report is written in accordance with the standards for reporting of diagnostic accuracy principles [26].”
Validation of the European Society of Cardiology 0/1-hour algorithm for chest pain triage in Asian emergency departments: a multinational stepped-wedge cluster-randomised trial
Inoue, K., Twerenbold, R., Kasim, S. S., Salleh, F. M., Mohamed, A. S., Tan, J. W. C., Lim, X. Y., Ping, T. B., Ahmad, B., Idrose, A. M., et al. (2025) · Heart · doi:10.1136/heartjnl-2025-326594 · Cited by 8
“Reporting followed the STARD (Standards for Reporting of Diagnostic Accuracy Studies) guidelines 23 and the Declaration of Helsinki.”
Does the SUVmax of FDG-PET/CT Correlate with the ADC Values of DWI in Musculoskeletal Malignancies?
Öztürk, M., Polat, A. V., Tosun, F. C., & Selçuk, M. B. (2021) · Journal of the Belgian Society of Radiology · doi:10.5334/jbsr.2378 · Cited by 7
Performance differences among commercially available antigen rapid tests for COVID-19 in Brazil
Freire, M. L., Alves, L. L., de Souza, C. S., Saliba, J. W., de Faria, V. C. S., Pedras, M. J., Carvalho, N. D. O., de Andrade, G. Q., Rabello, A., de Avelar, D. M., et al. (2022) · PLoS ONE · doi:10.1371/journal.pone.0269997 · Cited by 7
“This study was performed according to the Standards for Reporting of Diagnostic Accuracy (STARD) statement [13].”
Method
MRI-Targeted Prostate Fusion Biopsy: What Are We Missing outside the Target? Implications for Treatment Planning
Oderda, M., Dematteis, A., Calleris, G., Diamand, R., Gatti, M., Marra, G., Adans-Dester, G., Salhi, Y. A., Pastore, A. L., Faletti, R., et al. (2024) · Current Oncology · doi:10.3390/curroncol31070308 · Cited by 7
“This study was performed according to the Standard for Reporting Diagnostic Accuracy Studies [7].”
Method
Tumor markers determination in malignant pleural effusion: pearls and pitfalls
Zheng, W., Porcel, J. M., & Hu, Z.-D. (2024) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2024-0542 · Cited by 7
“The number of these patients should be indicated in the research report, preferably in a ﬂ owchart, according to the STARD (Standards for Reporting of Diagnostic Accuracy Studies) guideline [59].”
A loop-mediated isothermal amplification test for yaws: a multi-country diagnostic accuracy evaluation
Handley, B. L., González-Beiras, C., Tchatchouang, S., Hugues, K. A., Basing, L. A., Sylla, A., Kouamé-Sina, M. S., Amanor, I., Ndzomo, P., Aloumba, A., et al. (2024) · The Lancet Global Health · doi:10.1016/s2214-109x(24)00324-3 · Cited by 7
Accuracy and utility of using administrative healthcare databases to identify people with epilepsy: a protocol for a systematic review and meta-analysis
Mbizvo, G. K., Bennett, K., Simpson, C. R., Duncan, S., & Chin, R. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-020824 · Cited by 7
Development and validation of a case definition to identify hemophilia in administrative data
Alam, A. U., Karkhaneh, M., Wu, C. M., & Sun, H. (2021) · Thrombosis Research · doi:10.1016/j.thromres.2021.05.013 · Cited by 7
A new dynamic deep learning noise elimination method for chip-based real-time PCR
Zhang, B., Liu, Y., Song, Q., Li, B., Chen, X., Luo, X., & Wen, W. (2022) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-022-03950-7 · Cited by 7
“In Table 1, the sensitivity represents the probability that positive samples are correctly predicted, and specificity represents the probability that negative samples are correctly predicted [35].”
Background
Diagnostic accuracy of the World Health Organization Disability Assessment Schedule (WHODAS 2.0) to estimate disability after stroke
dos Santos, H. M., Pereira, G. S., de Oliveira, L. C., da Silva, P. K., Lima, M. G., Feliz, V. H. A. D. A., Faria, C. D. C. D. M., & Silva, S. M. (2022) · Disability and Rehabilitation · doi:10.1080/09638288.2022.2080876 · Cited by 7
Which Morphological Features of Facet Diastasis Predict Thoracolumbar Posterior Ligamentous Complex Injury as Defined by Magnetic Resonance Imaging?
Aly, M. M., Al-Shoaibi, A. M., Ali, S. A., Almutairi, H. M., Khormi, Y. H., Abdelaziz, M., & Eldawoody, H. A. F. (2022) · World Neurosurgery · doi:10.1016/j.wneu.2022.12.010 · Cited by 7
Quantification of mitochondrial cfDNA reveals new perspectives for early diagnosis of colorectal cancer
Linke, C., Hunger, R., Reinwald, M., Deckert, M., & Mantke, R. (2023) · BMC Cancer · doi:10.1186/s12885-023-10748-y · Cited by 7
Diagnostic performance of contrast-enhanced ultrasound combined with shear wave elastography in differentiating benign from malignant breast lesions: a systematic review and meta-analysis
Chen, X., Yu, H., Wei, N., Ozcan, B. B., An, G., Wu, Q., & Wang, N. (2023) · Gland Surgery · doi:10.21037/gs-23-333 · Cited by 7
Prediction Model for Choosing Needle Length to Minimize Risk of Median Nerve Puncture With Dry Needling of the Pronator Teres
Peña, R. F., Calvo‐Lobo, C., Gómez, M., & Muñoz‐García, D. (2019) · Journal of Manipulative and Physiological Therapeutics · doi:10.1016/j.jmpt.2018.11.020 · Cited by 7
Clinical evaluation of the molecular-based BD SARS-CoV-2/Flu for the BD MAX™ system
Paradis, S., Lockamy, E., Cooper, C. K., & Young, S. A. (2021) · Journal of Clinical Virology · doi:10.1016/j.jcv.2021.104946 · Cited by 7
Use of pooled serum samples to assess herd disease status using commercially available ELISAs
Hernandez-Medrano, J. H., Espinosa-Castillo, L. F., Rodríguez, A. D., Gutiérrez, C. G., & Wapenaar, W. (2021) · Tropical Animal Health and Production · doi:10.1007/s11250-021-02939-1 · Cited by 7
Sample size and precision of estimates in studies of depression screening tool accuracy: A meta‐research review of studies published in 2018–2021
Nassar, E., Levis, B., Neyer, M. A., Rice, D. B., Booij, L., Benedetti, A., & Thombs, B. D. (2022) · International Journal of Methods in Psychiatric Research · doi:10.1002/mpr.1910 · Cited by 7
“This points to the need for researchers to utilize STARD guidance in designing and reporting their studies and for peer reviewers and editors to insist on compliance.”
MethodInfluential
Studies of instrument/method comparison, as part of validation for use in veterinary species
Freeman, K. P., & Flatland, B. (2017) · Veterinary Clinical Pathology · doi:10.1111/vcp.12455 · Cited by 7
Laboratory Measurement's Contribution to the Replication and Application Crisis in Clinical Research
Bossuyt, P. M. (2019) · Clinical Chemistry · doi:10.1373/clinchem.2019.311605 · Cited by 7
Self-citation
To buy or not to buy - Evaluating commercial AI solutions in radiology (the ECLAIR guidelines)
Omoumi, P. (2021) · doi:10.26226/morressier.615e2a8f7c09fc044a9739af · Cited by 7
Does the Addition of Radial Endobronchial Ultrasound Improve the Diagnostic Yield of Electromagnetic Navigation Bronchoscopy? A Systematic Review
Juul, A. D., Falster, C., Rasmussen, T. R., Hilberg, O., Jacobsen, N., Arshad, A., & Laursen, C. B. (2022) · Respiration · doi:10.1159/000524671 · Cited by 8
Development and Clinical Validation of a Hook Effect-Based Lateral Flow Immunoassay Sensor for Cerebrospinal Fluid Leak Detection
Oh, H.-K., Park, J., Sonstein, W. J., Maher, S., & Kim, M. (2024) · Neurosurgery · doi:10.1227/neu.0000000000002914 · Cited by 6
Remote cutaneous confocal microscopy: A multicentric prospective study evaluating diagnostic accuracy for melanoma and keratinocyte carcinoma in tertiary settings
Ho, G., Collgros, H., Sinz, C., Gouveia, B. M., Gallo, B., Chew, C., Ip, K. H., Koutsis, J., Lo, S., Schwartz-Aldea, R., et al. (2024) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2024.09.051 · Cited by 6
Prospective Analysis of Confocal Laser Endomicroscopy for Assessment of the Resection Bed for Bladder Tumor
de Ruiter, B.-M., Freund, J. E., Savci-Heijink, C. D., van Hattum, J. W., Remmelink, M. J., de Reijke, T. M., Baard, J., Kamphuis, G. M., de Bruin, D. M., & Oddens, J. R. (2024) · European Urology Open Science · doi:10.1016/j.euros.2024.11.007 · Cited by 6
Systematic comparison of Commercial seizure detection Software: Update equals Upgrade?
Koren, J. P., Colabrese, K., Hartmann, M., Feigl, M., Lang, C., Hafner, S., Nierenberg, N. C., Kluge, T., & Baumgartner, C. (2025) · Clinical Neurophysiology · doi:10.1016/j.clinph.2025.04.003 · Cited by 7
Sensitivity of SARS-CoV-2 RNA polymerase chain reaction using a clinical and radiological reference standard
Stockdale, A. J., Fyles, F., Farrell, C., Lewis, J., Barr, D. A., Haigh, K. A., Abouyannis, M., Hankinson, B., Penha, D., Fernando, R., et al. (2021) · Journal of Infection · doi:10.1016/j.jinf.2021.04.012 · Cited by 7
Placental α-microglobulin-1 in cervicovaginal fluid and cervical length to predict preterm birth by Thai women with symptoms of labor
Chawanpaiboon, S., Titapant, V., & Pooliam, J. (2021) · Asian Biomedicine · doi:10.2478/abm-2021-0015 · Cited by 6
Evaluation of the Advanta Dx SARS-CoV-2 RT-PCR Assay, a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva: A Diagnostic Accuracy Study
Balaska, S., Pilalas, D., Takardaki, A., Koutra, P., Parasidou, E., Gkeka, I., Tychala, A., Meletis, G., Fyntanidou, B., Metallidis, S., et al. (2021) · Diagnostics · doi:10.3390/diagnostics11101766 · Cited by 6
Multisystem Imaging Recommendations/Guidelines: In the Pursuit of Precision Oncology
Mahajan, A., Chakrabarty, N., Majithia, J., Ahuja, A., Agarwal, U., Suryavanshi, S., Biradar, M., Sharma, P., Raghavan, B., Arafath, R., et al. (2023) · Indian Journal of Medical and Paediatric Oncology · doi:10.1055/s-0043-1761266 · Cited by 6
MR Enterography Scores Correlate with Degree of Mucosal Healing in Pediatric Crohn’s Disease: A Pilot Study
Gladkikh, M., Benchimol, E. I., Mack, D. R., Mojaverian, N., Highmore, K., Miller, E., & Dávila, J. (2023) · Journal of the Canadian Association of Gastroenterology · doi:10.1093/jcag/gwad010 · Cited by 6
Evaluating Listening Performance for COVID-19 Detection by Clinicians and Machine Learning: Comparative Study
Han, J., Montagna, M., Grammenos, A., Xia, T., Bondareva, E., Brown, C., Chauhan, J., Dang, T., Spathis, D., Floto, R. A., et al. (2023) · Journal of Medical Internet Research · doi:10.2196/44804 · Cited by 6
“The Standards for Reporting of Diagnostic Accuracy (STARD) reporting guideline was followed [25].”
Development and validation of a model for measuring alcohol consumption from transdermal alcohol content data among college students
Kianersi, S., Ludema, C., Agley, J. D., Ahn, Y., Parker, M. A., Ideker, S., & Rosenberg, M. S. (2023) · Addiction · doi:10.1111/add.16228 · Cited by 7
Prediction of classical versus non classical papillary thyroid carcinoma subtypes from cytology of nodules classified according to TIRADS
Scappaticcio, L., Trimboli, P., Bellastella, G., Ferrazzano, P., Clery, E., Cozzolino, I., Montella, M., Fasano, M., Pirozzi, M., Ferrandes, S., et al. (2023) · Endocrine · doi:10.1007/s12020-023-03604-3 · Cited by 6
“In the current study the Standards for Reporting Diagnostic Accuracy (STARD) statement was followed [28].”
Method

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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