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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Lee, J., Mulder, F. I., Leeflang, M., Wolff, R. F., Whiting, P. F., & Bossuyt, P. M. (2022) · Annals of Internal Medicine · doi:10.7326/m22-0276 · Cited by 102
Self-citation
Recommendations for Cell-Free DNA Assay Validations
Lockwood, C. M., Borsu, L., Cankovic, M., Earle, J. S. L., Gocke, C. D., Hameed, M., Jordan, D., Lopategui, J. R., Pullambhatla, M., Reuther, J., et al. (2023) · The Journal of Molecular Diagnostics · doi:10.1016/j.jmoldx.2023.09.004 · Cited by 96
Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay
Sörensen, N. A., Neumann, F., Ojeda, F., Giannitsis, E., Spanuth, E., Blankenberg, S., Westermann, D., & Zeller, T. (2019) · Clinical Chemistry · doi:10.1373/clinchem.2019.307405 · Cited by 92
“The STARD Checklist (10) for reports of studies on diagnostic accuracy is available in the online Data Supplement (see Table 1 in the online Data Supplement).”
Background
Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024
Elsman, E. B. M., Mokkink, L. B., Terwee, C. B., Beaton, D., Gagnier, J. J., Tricco, A. C., Baba, A., Butcher, N. J., Smith, M., Hofstetter, C., et al. (2024) · Quality of Life Research · doi:10.1007/s11136-024-03634-y · Cited by 103
Self-citation
The CRESS checklist for reporting stability studies: on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)
Cornes, M. P., Šimundić, A.-M., Cadamuro, J., Costelloe, S. J., Baird, G. S., Kristensen, G. B. B., Meyer, A., Nybo, M., Rioja, R. G., & on behalf of the Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) (2020) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2020-0061 · Cited by 92
“The checklist follows the recommendations of the European Federation for Laboratory Medicine (EFLM) Biological Variation Working Group (BVWG) [6] and STARD (Standard for Reporting of Diagnostic Accuracy Guidelines), both of which have an aim of improving the quality of reporting the studies in their respective areas […”
Method
A methodological checklist for fMRI drug cue reactivity studies: development and expert consensus
Ekhtiari, H., Zare-Bidoky, M., Sangchooli, A., Janes, A. C., Kaufman, M. J., Oliver, J. A., Prisciandaro, J. J., Wüstenberg, T., Anton, R. F., Bach, P., et al. (2022) · Nature Protocols · doi:10.1038/s41596-021-00649-4 · Cited by 89
68Ga-PSMA-PET/CT in comparison with 18F-fluoride-PET/CT and whole-body MRI for the detection of bone metastases in patients with prostate cancer: a prospective diagnostic accuracy study
Dyrberg, E., Hendel, H. W., Huynh, T. H. V., Klausen, T. W., Løgager, V., Madsen, C., Pedersen, E. M., Pedersen, M., & Thomsen, H. S. (2018) · European Radiology · doi:10.1007/s00330-018-5682-x · Cited by 90
Recognising Bias in Studies of Diagnostic Tests Part 1: Patient Selection
Hall, M. K., Kea, B., & Wang, R. C. (2019) · Emergency Medicine Journal · doi:10.1136/emermed-2019-208446 · Cited by 87
Novel high-sensitivity cardiac troponin I assay in patients with suspected acute coronary syndrome
Chapman, A. R., Fujisawa, T., Lee, K. K., Andrews, J. P. M., Anand, A., Sandeman, D., Ferry, A. V., Stewart, S., Marshall, L., Strachan, F. E., et al. (2018) · Heart · doi:10.1136/heartjnl-2018-314093 · Cited by 86
A targeted proteomics approach reveals a serum protein signature as diagnostic biomarker for resectable gastric cancer
Shen, Q., Połom, K., Williams, C., de Oliveira, F. M. S., Guergova-Kuras, M., Lisacek, F., Karlsson, N. G., Roviello, F., & Kamali‐Moghaddam, M. (2019) · EBioMedicine · doi:10.1016/j.ebiom.2019.05.044 · Cited by 86
“This retrospective study was followed the Standards for the Reporting of Diagnosis Accuracy studies (STARD) statement [14].”
Method
Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients
Kortela, E., Kirjavainen, V., Ahava, M. J., Jokiranta, S. T., But, A., Lindahl, A. L., Jääskeläinen, A., Jääskeläinen, A. J., Järvinen, A., Jokela, P., et al. (2021) · PLoS ONE · doi:10.1371/journal.pone.0251661 · Cited by 89
“The study complies with the STARD reporting guidelines [15], and it was approved by the review board of the Helsinki University Hospital, Finland (HUS/157/2020-29), which waived the requirement for informed consent.”
Method
STARD 2015: updated reporting guidelines for all diagnostic accuracy studies.
Bossuyt, P. M., Cohen, J. F., Gatsonis, C., & Korevaar, D. A. (2016) · Europe PMC (PubMed Central) · doi:10.3978/j.issn.2305-5839.2016.02.06 · Cited by 85
Self-citation
Imaging for the exclusion of pulmonary embolism in pregnancy
van Mens, T. E., Scheres, L. J. J., de Jong, P. G., Leeflang, M., Nijkeuter, M., & Middeldorp, S. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011053.pub2 · Cited by 88
Comparison of humans versus mobile phone-powered artificial intelligence for the diagnosis and management of pigmented skin cancer in secondary care: a multicentre, prospective, diagnostic, clinical trial
Menzies, S. W., Sinz, C., Menzies, M., Lo, S., Yolland, W., Lingohr, J., Razmara, M., Tschandl, P., Guitera, P., Scolyer, R. A., et al. (2023) · The Lancet Digital Health · doi:10.1016/s2589-7500(23)00130-9 · Cited by 92
ECMO PAL: using deep neural networks for survival prediction in venoarterial extracorporeal membrane oxygenation
Stephens, A. F., Šeman, M., Diehl, A., Pilcher, D. V., Barbaro, R. P., Brodie, D., Pellegrino, V. A., Kaye, D. M., Gregory, S. D., & Hodgson, C. L. (2023) · Intensive Care Medicine · doi:10.1007/s00134-023-07157-x · Cited by 81
Diagnostic accuracy of a novel tuberculosis point-of-care urine lipoarabinomannan assay for people living with HIV: A meta-analysis of individual in- and outpatient data
Broger, T., Nicol, M. P., Székely, R., Bjerrum, S., Sossen, B., Schutz, C., Opintan, J. A., Johansen, I. S., Mitarai, S., Chikamatsu, K., et al. (2020) · PLoS Medicine · doi:10.1371/journal.pmed.1003113 · Cited by 80
Significances of spirometry and impulse oscillometry for detecting small airway disorders assessed with endobronchial optical coherence tomography in COPD
Su, Z., Guan, W., Li, S., Ding, M., Chen, Y., Jiang, M., Chen, X., Zhong, C., Tang, C., & Zhong, N. (2018) · International Journal of COPD · doi:10.2147/copd.s172639 · Cited by 79
Preclinical evaluation of a TEX101 protein ELISA test for the differential diagnosis of male infertility
Korbakis, D., Schiza, C., Brinc, D., Soosaipillai, A. R., Karakosta, T. D., Légaré, C., Sullivan, R., Mullen, B. M., Jarvi, K. A., Diamandis, E. P., et al. (2017) · BMC Medicine · doi:10.1186/s12916-017-0817-5 · Cited by 78
Diagnostic Accuracy of Holotranscobalamin, Vitamin B12, Methylmalonic Acid, and Homocysteine in Detecting B12 Deficiency in a Large, Mixed Patient Population
Campos, A. J., Risch, L., Nydegger, U. E., Wiesner, J., Dyck, M. V. V., Renz, H. E., Stanga, Z. G., & Risch, M. (2020) · Disease Markers · doi:10.1155/2020/7468506 · Cited by 79
“The Standards for Reporting Diagnostic Accuracy Studies (STARD) 2015 guidelines were adopted for the present report [39].”
Method
STARD for Abstracts: essential items for reporting diagnostic accuracy studies in journal or conference abstracts
Cohen, J. F., Korevaar, D. A., Gatsonis, C., Glasziou, P., Hooft, L., Moher, D., Reitsma, J. B., de Vet, H. C. W., & Bossuyt, P. M. (2017) · BMJ · doi:10.1136/bmj.j3751 · Cited by 78
Self-citation
The potential role of exhaled breath analysis in the diagnostic process of pneumonia—a systematic review
van Oort, P. M. P., Póvoa, P. M. S. R., Schnabel, R. M., Dark, P. M., Artigas, A., Bergmans, D. C. J. J., Felton, T., Coelho, L., Schultz, M. J., Fowler, S. J., et al. (2018) · Journal of Breath Research · doi:10.1088/1752-7163/aaa499 · Cited by 77
A machine learning-based test for adult sleep apnoea screening at home using oximetry and airflow
Álvarez, D., Cerezo-Hernández, A., Crespo, A., Gutiérrez‐Tobal, G. C., Vaquerizo-Villar, F., Barroso-García, V., Moreno, F., Domingo, C. A. A., Albi, T. R., Hornero, R., et al. (2020) · Scientific Reports · doi:10.1038/s41598-020-62223-4 · Cited by 75
Deployment of Artificial Intelligence in Real-World Practice: Opportunity and Challenge
He, M., Li, Z., Liu, C., Shi, D., & Tan, Z. (2020) · Asia-Pacific Journal of Ophthalmology · doi:10.1097/apo.0000000000000301 · Cited by 77
“In this context, an AI algorithm developed for diagnosis or classification should comply with the Standards for Reporting Diagnostic Accuracy (STARD) statement, and an AI algorithm developed for prediction should follow the Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis…”
Method
Performance of the IOTA ADNEX model in preoperative discrimination of adnexal masses in a gynecological oncology center
Araújo, K. G., Jales, R. M., Pereira, P. N., Yoshida, A., Andrade, L. A. L. D. A., Sarian, L. O., & Derchain, S. (2016) · Ultrasound in Obstetrics and Gynecology · doi:10.1002/uog.15963 · Cited by 73
Design and validation of two measures to detect anxiety disorders in epilepsy: The Epilepsy Anxiety Survey Instrument and its brief counterpart
Scott, A. J., Sharpe, L., Thayer, Z. C., Miller, L. A., Hunt, C. J., MacCann, C., Parratt, K. L., Nikpour, A., Wong, T., & Gandy, M. (2019) · Epilepsia · doi:10.1111/epi.16348 · Cited by 72
Prospective Development and Validation of the Computerized Adaptive Screen for Suicidal Youth
King, C. A., Brent, D., Grupp-Phelan, J., Casper, T. C., Dean, J. M., Chernick, L. S., Fein, J. A., Mahabee-Gittens, E. M., Patel, S. J., Mistry, R. D., et al. (2021) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2020.4576 · Cited by 71
Diagnostic Accuracy of a Smartphone-Operated, Single-Lead Electrocardiography Device for Detection of Rhythm and Conduction Abnormalities in Primary Care
Himmelreich, J. C. L., Karregat, E. P. M., Lucassen, W. A. M., van Weert, H. C. P. M., de Groot, J. R., Handoko, M. L., Nijveldt, R., & Harskamp, R. E. (2019) · The Annals of Family Medicine · doi:10.1370/afm.2438 · Cited by 71
Coronary CT Angiography: Variability of CT Scanners and Readers in Measurement of Plaque Volume
Symons, R., Morris, J. Z., Wu, C. O., Pourmorteza, A., Ahlman, M. A., Lima, J. A. C., Chen, M. Y., Mallek, M., Sandfort, V., & Bluemke, D. A. (2016) · Radiology · doi:10.1148/radiol.2016161670 · Cited by 71
Commonly Used Screening Instruments to Identify Frailty Among Community-Dwelling Older People in a General Practice (Primary Care) Setting: A Study of Diagnostic Test Accuracy
Ambagtsheer, R. C., Visvanathan, R., Dent, E., Yu, S., Schultz, T., & Beilby, J. (2019) · The Journals of Gerontology Series A · doi:10.1093/gerona/glz260 · Cited by 74
Minimum standards for inpatient long-term video-EEG monitoring: A clinical practice guideline of the international league against epilepsy and international federation of clinical neurophysiology
Tatum, W. O., Mani, J., Jin, K., Halford, J. J., Gloss, D. S., Fahoum, F., Maillard, L. G., Mothersill, I. W., & Beniczky, S. (2021) · Clinical Neurophysiology · doi:10.1016/j.clinph.2021.07.016 · Cited by 76
“Studies had to specify key outcome metrics (diagnosis and management) according to the STARD (Standards for Reporting Diagnostic Accuracy Studies) criteria (Bossuyt et al., 2003; Bossuyt et al., 2015).”
Four human Plasmodium species quantification using droplet digital PCR
Srisutham, S., Saralamba, N., Malleret, B., Rénia, L., Dondorp, A. M., & Imwong, M. (2017) · PLoS ONE · doi:10.1371/journal.pone.0175771 · Cited by 73
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Study protocol for developing, piloting and disseminating the PRISMA-COSMIN guideline: a new reporting guideline for systematic reviews of outcome measurement instruments
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Self-citation
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Martín, A. J. M., Ay, C., Grilz, E., López, S., Font, C., Olmos, V. P., Rubio, V. E. C., Martínez-Marín, V., Salgado, M., Martínez, E., et al. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.22.00255 · Cited by 68
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Contrast-enhanced CT in determining resectability in patients with pancreatic carcinoma: a meta-analysis of the positive predictive values of CT
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Self-citation
Machine Learning in Laboratory Medicine: Recommendations of the IFCC Working Group
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Real-world big-data studies in laboratory medicine: Current status, application, and future considerations
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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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