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STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies
Open accessAbstract
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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“This study’s design and methods are reported in line with the Standards for Reporting Diagnostic accuracy studies (STARD) checklist [13].”
From Abstract screening using the automated tool Rayyan: results of effectiveness in three diagnostic test accuracy systematic reviews (2022) · cites this paper as [13]
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“QUADAS-2 assesses for risk of bias and applicability where STARD provides a checklist of information that should ideally be presented in a diagnostic accuracy study (9,10).”
BackgroundMethodKarregat, E. P. M., Himmelreich, J. C. L., Lucassen, W. A. M., Busschers, W. B., van Weert, H. C. P. M., & Harskamp, R. E. (2020) · Family Practice · doi:10.1093/fampra/cmaa076 · Cited by 17
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“Analytical Performance of RT-qPCR Assays According to the MIQE guidelines [76] and also to the “Standards for Reporting of Diagnostic Accuracy Studies” (STARD) [79], the repeatability (intra-assay variation) and reproducibility (inter-assay variation) of the measurements should be used decisive criteria for the perfor…”
MethodInfluentialWittwer, M. R., Ruknuddeen, M. I., Thorrowgood, M., Zeitz, C. J., Beltrame, J. F., & Arstall, M. A. (2021) · Resuscitation Plus · doi:10.1016/j.resplu.2021.100136 · Cited by 16
Diagnostic performance evaluation of hepatitis B e antigen rapid diagnostic tests in Malawi
Stockdale, A. J., Silungwe, N., Shawa, I. T., Kreuels, B., Gordon, M. A., & Geretti, A. M. (2021) · BMC Infectious Diseases · doi:10.1186/s12879-021-06134-3 · Cited by 17
Dudognon, D., Lévy, C., Chalumeau, M., Biscardi, S., Dommergues, M., Dubos, F., Levieux, K., Aurel, M., Minodier, P., Zenkhri, F., et al. (2021) · Frontiers in Pediatrics · doi:10.3389/fped.2021.684628 · Cited by 16
Self-citationAn, R., Huang, Y., Rocheleau, A. D., Avanaki, A., Thota, P., Zhang, Q., Man, Y., Sekyonda, Z., Segbefia, C. I., Dei‐Adomakoh, Y., et al. (2022) · Heliyon · doi:10.1016/j.heliyon.2022.e11778 · Cited by 17
Chao, J. H., Lin, R. C., Marneni, S., Pandya, S., Alhajri, S., & Sinert, R. H. (2016) · Academic Emergency Medicine · doi:10.1111/acem.13052 · Cited by 17
Cui, Y., Luo, R., Wang, R., Liu, H., Zhang, C., Zhang, Z., & Wang, D. (2017) · European Radiology · doi:10.1007/s00330-017-4993-7 · Cited by 16
Mick, I., Freger, S., Marien, M., Gholiof, M., & Leonardi, M. (2025) · O&G Open · doi:10.1097/og9.0000000000000061 · Cited by 19
“This study is performed and reported according to STARD (Standards for Reporting Diagnostic Accuracy) guidelines 19 to assist in standardization and transparency of reporting diagnostic accuracy.”
Janssen, H., Dias, P., Ahuja, S., Alharbi, S., Hiller, L., Khan, K., Iyer, K., Sundar, A., Abousharkh, I., Thomas, C., et al. (2025) · British Journal of Anaesthesia · doi:10.1016/j.bja.2025.05.057 · Cited by 15
Biomarkers for Early Cancer Diagnosis: Prospects for Success through the Lens of Tumor Genetics
Dragani, T. A., Matarese, V., & Colombo, F. (2020) · BioEssays · doi:10.1002/bies.201900122 · Cited by 15
Graglia, S., Shokoohi, H., Loesche, M. A., Yeh, D. D., Haney, R. M., Huang, C. K., Morone, C. C., Springer, C., Kimberly, H. H., & Liteplo, A. S. (2021) · The American Journal of Emergency Medicine · doi:10.1016/j.ajem.2020.12.085 · Cited by 15
Clark, A., Cannings-John, R. L., Blyth, M. H., Hay, A. D., Butler, C., & Hughes, K. (2022) · British Journal of General Practice · doi:10.3399/bjgp.2021.0633 · Cited by 15
Oderda, M., Albisinni, S., Benamran, D. A., Calleris, G., Ciccariello, M., Dematteis, A., Diamand, R., Descotes, J., Fiard, G., Forte, V., et al. (2022) · The Prostate · doi:10.1002/pros.24449 · Cited by 15
“The study was performed according to the Standard for Reporting Diagnostic accuracy studies.(13)”
MethodReliability and validity of physical examination tests for the assessment of ankle instability
Beynon, A. M., May, S. L., & Théroux, J. (2022) · Chiropractic & Manual Therapies · doi:10.1186/s12998-022-00470-0 · Cited by 21
“Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies.”
MethodHaque, M. A., Gedara, M. L. B., Nickel, N. C., Turgeon, M., & Lix, L. M. (2024) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-024-02416-3 · Cited by 16
“Finally, we assessed whether the Standards for Reporting Diagnostic Accuracy (STARD) criterion [23] about the number of measures recommended for reporting were fulfilled.”
MethodPoint-of-Care Diagnostic Test for Beta-Thalassemia
An, R., Avanaki, A., Thota, P., Nemade, S., Mehta, A., & Gurkan, U. A. (2024) · Biosensors · doi:10.3390/bios14020083 · Cited by 15
Ultrasonographic characterization of parametrial endometriosis: a prospective study
Barra, F., Zorzi, C., Albanese, M., Mitri, P. D., Stepniewska, A. K., Roviglione, G., Giani, M., Albertini, G. C., Ferrero, S., & Ceccaroni, M. (2024) · Fertility and Sterility · doi:10.1016/j.fertnstert.2024.02.031 · Cited by 15
Dutton‐Regester, K. J., Barnes, T. S., Wright, J. D., Alawneh, J. I., & Rabiee, A. R. (2017) · Preventive Veterinary Medicine · doi:10.1016/j.prevetmed.2017.11.003 · Cited by 19
Gómez‐Moreno, M., Cuadrado, M. L., Cruz-Orduña, I., Martínez-Acebes, E. M., Mañas, R. G., Fernández, C., & García-Ramos, R. (2020) · Neurología · doi:10.1016/j.nrl.2019.11.006 · Cited by 15
Novosad, J., Krčmová, I., Bartoš, V., Drahošová, M., Vaník, P., Kirchnerová, O., Teřl, M., & Krejsek, J. (2020) · Advances in Dermatology and Allergology · doi:10.5114/ada.2020.94842 · Cited by 15
Reliability and validity of the incremental shuttle walking test in individuals after stroke
Quintino, L. F., Aguiar, L. T., de Brito, S. A. F., Pereira, A. S., Teixeira‐Salmela, L. F., & Faria, C. D. C. D. M. (2020) · Topics in Stroke Rehabilitation · doi:10.1080/10749357.2020.1818481 · Cited by 15
“This manuscript conforms to the Standards for Reporting Diagnostic Accuracy Studies (STARD) guidelines.(24) This prospective diagnostic accuracy study was approved by the university research ethical review board (number 51454115.”
MethodIs there a role for glycated albumin in the diagnosis of gestational diabetes mellitus?
Chume, F. C., Renz, P. B., Hernandez, M. K., Freitas, P. A. C., & Camargo, J. L. (2021) · Endocrine · doi:10.1007/s12020-021-02673-6 · Cited by 16
Mournet, S., Sené, T., Charbonneau, F., Poillon, G., Vignal‐Clermont, C., Clavel, G., Guillaume, J., Savatovsky, J., & Lecler, A. (2021) · European Radiology · doi:10.1007/s00330-021-08417-4 · Cited by 15
Yusuf, E., Herendael, B. V., & Schaeren, J. V. (2016) · Journal of Clinical Pathology · doi:10.1136/jclinpath-2016-204108 · Cited by 15
The problem of lack of normative data in paediatric EMG and possible solutions
Pitt, M. C., & Jabre, J. F. (2017) · Clinical Neurophysiology · doi:10.1016/j.clinph.2017.11.024 · Cited by 16
Predicting initial margin status in breast cancer patients during breast-conserving surgery
Pan, Z., Zhu, L., Li, Q., Lai, J., Peng, J., Su, F., Li, S., & Chen, K. (2018) · OncoTargets and Therapy · doi:10.2147/ott.s160433 · Cited by 15
Vazquez, N. P., Harding, S. P., Heimann, H., Czanner, G., & Knox, P. C. (2018) · PLoS ONE · doi:10.1371/journal.pone.0207342 · Cited by 16
Metadata
- 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
- 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
- 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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