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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Self-citation
Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement
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Self-citation
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Self-citation
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Self-citation
Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative
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“…information about the clinical context and the cohort because the accuracy of an index test is not constant Downloaded from: https://pubs.asha.org Laura Moorer on 08/26/2020, T but varies across different clinical contexts, disease spectrums, and even patient subgroups (Bossuyt et al., 2015).”
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“A diagnostic accuracy study was conducted, in accordance with the STARD guidelines [18].”
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“Precision and accuracy are critical in diverse arenas, and in the medical community the STAndards for the Reporting of Diagnostic accuracy studies (STARD) [44] aims to improve the accuracy and completeness of reporting of studies of diagnostic accuracy.”
Background
Recommendations for designing and conducting veterinary clinical pathology biologic variation studies
Freeman, K. P., Baral, R. M., Dhand, N. K., Nielsen, S. S., & Jensen, A. L. (2017) · Veterinary Clinical Pathology · doi:10.1111/vcp.12475 · Cited by 43
Forced oscillation technique for early detection of the effects of smoking and COPD: contribution of fractional-order modeling
Ribeiro, C. O., Faria, Á. C. D., Lopes, A. J., & de Melo, P. L. (2018) · International Journal of COPD · doi:10.2147/copd.s173686 · Cited by 44
Feasibility of Training Clinical Officers in Point-of-Care Ultrasound for Pediatric Respiratory Diseases in Aweil, South Sudan
Nadimpalli, A., Tsung, J. W., Sanchez, R., Shah, S. P., Zelikova, E., Umphrey, L., Hurtado, N., Gonzalez, A., & Teicher, C. L. (2019) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.18-0745 · Cited by 43
Use of the MyProstateScore Test to Rule Out Clinically Significant Cancer: Validation of a Straightforward Clinical Testing Approach
Tosoian, J. J., Trock, B. J., Morgan, T. M., Salami, S. S., Tomlins, S. A., Spratt, D. E., Siddiqui, J., Kunju, L. P., Botbyl, R., Chopra, Z., et al. (2020) · The Journal of Urology · doi:10.1097/ju.0000000000001430 · Cited by 43
MR Imaging Features to Differentiate Retinoblastoma from Coats’ Disease and Persistent Fetal Vasculature
Jansen, R. W., de Bloeme, C. M., Brisse, H. J., Galluzzi, P., Cardoen, L., Göricke, S. L., Maeder, P. P., Cassoux, N., Gauthier, A., Schlüter, S., et al. (2020) · Cancers · doi:10.3390/cancers12123592 · Cited by 43
Fluorescence devices for the detection of dental caries
Macey, R., Walsh, T., Riley, P., Glenny, A., Worthington, H. V., Fee, P. A., Clarkson, J., & Ricketts, D. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013811 · Cited by 47
Systematic analysis and comparison of commercial seizure‐detection software
Koren, J. P., Hafner, S., Feigl, M., & Baumgartner, C. (2021) · Epilepsia · doi:10.1111/epi.16812 · Cited by 46
Evaluation of the sensitivity and specificity of basal plasma adrenocorticotrophic hormone concentration for diagnosing pituitary pars intermedia dysfunction in horses: A systematic review
Tatum, R. C., McGowan, C. M., & Ireland, J. L. (2021) · The Veterinary Journal · doi:10.1016/j.tvjl.2021.105695 · Cited by 44
Risk-prediction models in postmenopausal patients with symptoms of suspected ovarian cancer in the UK (ROCkeTS): a multicentre, prospective diagnostic accuracy study
Sundar, S. S., Agarwal, R., Davenport, C. F., Scandrett, K., Johnson, S., Sengupta, P. P., Vikram, R., Kwong, F. L., Mallett, S., Rick, C., et al. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(24)00406-6 · Cited by 41
Suggested guidelines for validation of real-time PCR assays in veterinary diagnostic laboratories
Toohey-Kurth, K. L., Reising, M. M., Tallmadge, R. L., Goodman, L. B., Bai, J., Bolin, S. R., Pedersen, J. C., Bounpheng, M. A., Pogranichniy, R. M., Christopher‐Hennings, J., et al. (2020) · Journal of Veterinary Diagnostic Investigation · doi:10.1177/1040638720960829 · Cited by 43
Clinical Relevance of Immersive Virtual Reality in the Assessment and Treatment of Addictive Disorders: A Systematic Review and Future Perspective
Langener, S., Nagel, J. V. D., van Manen, J. G., Markus, W., Dijkstra, B. A. G., DeFuentes-Merillas, L., Klaassen, R., Heitmann, J., Heylen, D., & Schellekens, A. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10163658 · Cited by 44
“Therefore, a systematic quality appraisal with standardized clinical frameworks or meta-analysis of data was not possible [73,74].”
Background
High referral accuracy for oral cancers and oral potentially malignant disorders using telemedicine
Haron, N., Rajendran, S., Kallarakkal, T. G., Zain, R. B., Ramanathan, A., Abraham, M. T., Lau, S. H., Cheng, L. C., Chong, S. M. Y., Azahar, F. A. M., et al. (2021) · Oral Diseases · doi:10.1111/odi.13892 · Cited by 41
Poor Sensitivity of Commercial Rapid Diagnostic Tests for Hepatitis B e Antigen in Senegal, West Africa
Seck, A., Ndiaye, F., Maylin, S., Ndiaye, B., Simon, F., Funk, A. L., Fontanet, A. L., Takahashi, K., Akbar, S. M. F., Mishiro, S., et al. (2018) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.18-0116 · Cited by 41
Deep learning to diagnose pouch of Douglas obliteration with ultrasound sliding sign
Maicas, G., Leonardi, M., Avery, J., Panuccio, C., Carneiro, G., Hull, M. L., & Condous, G. (2021) · Reproduction and Fertility · doi:10.1530/raf-21-0031 · Cited by 41
Decision Criteria for Large Vessel Occlusion Using Transcranial Doppler Waveform Morphology
Thorpe, S., Thibeault, C. M., Canac, N., Wilk, S. J., Devlin, T. G., & Hamilton, R. (2018) · Frontiers in Neurology · doi:10.3389/fneur.2018.00847 · Cited by 40
The predictive value of variables measurable in the ambulance and the development of the Predict Sepsis screening tools: a prospective cohort study
Wallgren, U. M., Sjölin, J., Järnbert‐Pettersson, H., & Kurland, L. (2020) · Scandinavian Journal of Trauma Resuscitation and Emergency Medicine · doi:10.1186/s13049-020-00745-6 · Cited by 40
The Performance of Computer-Aided Detection Digital Chest X-ray Reading Technologies for Triage of Active Tuberculosis Among Persons With a History of Previous Tuberculosis
Kagujje, M., Kerkhoff, A. D., Nteeni, M. S., Dunn, I., Mateyo, K. J., & Muyoyeta, M. (2022) · Clinical Infectious Diseases · doi:10.1093/cid/ciac679 · Cited by 39
Diagnostic performance of a CT-based scoring system for diagnosis of anastomotic leakage after esophagectomy: comparison with subjective CT assessment
Goense, L., Stassen, P. M. C., Wessels, F. J., van Rossum, P. S. N., Ruurda, J. P. H., van Leeuwen, M. S., & van Hillegersberg, R. (2017) · European Radiology · doi:10.1007/s00330-017-4802-3 · Cited by 39
Follicle Stimulating Hormone is an accurate predictor of azoospermia in childhood cancer survivors
Kelsey, T., McConville, L., Edgar, A. B., Ungurianu, A. I., Mitchell, R. T., Anderson, R. A., & Wallace, W. H. (2017) · PLoS ONE · doi:10.1371/journal.pone.0181377 · Cited by 40
“conclude that they are at low risk of bias and have low concern about applicability, as specified by the QUODAS-2 and STARD frameworks for reporting diagnostic accuracy [34, 35].”
Development and validation of a nomogram predicting the overall survival of stage IV breast cancer patients
Li, S., Zhao, J., Zhu, L., Su, F., & Chen, K. (2017) · Cancer Medicine · doi:10.1002/cam4.1224 · Cited by 39
Staging with computed tomography of patients with colon cancer
Malmstrøm, M. L., Brisling, S. K., Klausen, T., Săftoiu, A., Perner, T., Vilmann, P., & Gögenür, I. (2017) · International Journal of Colorectal Disease · doi:10.1007/s00384-017-2932-3 · Cited by 39
A Laboratory Medicine Best Practices Systematic Review and Meta-analysis of Nucleic Acid Amplification Tests (NAATs) and Algorithms Including NAATs for the Diagnosis of Clostridioides ( Clostridium ) difficile in Adults
Kraft, C. S., Parrott, J. S., Cornish, N. E., Rubinstein, M. L., Weissfeld, A. S., McNult, P., Nachamkin, I., Humphries, R. M., Kirn, T. J., Bard, J. D., et al. (2019) · Clinical Microbiology Reviews · doi:10.1128/cmr.00032-18 · Cited by 40
“racy Studies (STARD) provides a list of minimum essential reporting items (113).”
Background
Circular RNAs in Clear Cell Renal Cell Carcinoma: Their Microarray-Based Identification, Analytical Validation, and Potential Use in a Clinico-Genomic Model to Improve Prognostic Accuracy
Franz, A., Ralla, B., Weickmann, S., Jung, M., Rochow, H., Stephan, C., Erbersdobler, A., Kilic, E., Fendler, A., & Jung, K. (2019) · Cancers · doi:10.3390/cancers11101473 · Cited by 39
Clinical validation of S-DetectTM mode in semi-automated ultrasound classification of thyroid lesions in surgical office
Barczyński, M., Stopa-Barczyńska, M., Wojtczak, B., Czarniecka, A., & Konturek, A. J. (2020) · Gland Surgery · doi:10.21037/gs.2019.12.23 · Cited by 39
CYFRA 21-1 and MMP-9 as salivary biomarkers for the detection of oral squamous cell carcinoma: a systematic review of diagnostic test accuracy
AlAli, A. M., Walsh, T., & Maranzano, M. (2020) · International Journal of Oral and Maxillofacial Surgery · doi:10.1016/j.ijom.2020.01.020 · Cited by 44
Pituitary stalk thickening: the role of an innovative MRI imaging analysis which may assist in determining clinical management
Sbardella, E., Joseph, R. N., Jafar‐Mohammadi, B., Isidori, A. M., Cudlip, S., & Grossman, A. B. (2016) · European Journal of Endocrinology · doi:10.1530/eje-16-0455 · Cited by 38
Thromboelastography and rotational thromboelastometry for the surgical intensivist: A narrative review
Drumheller, B. C., Stein, D. M., Moore, L. J., Rizoli, S., & Cohen, M. J. M. (2019) · The Journal of Trauma: Injury, Infection, and Critical Care · doi:10.1097/ta.0000000000002206 · Cited by 38
Circulating mitochondrial DNA copy numbers represent a sensitive marker for diagnosis and monitoring of disease activity in systemic lupus erythematosus
Giaglis, S., Daoudlarian, D., Voll, R. E., Kyburz, D., Venhoff, N., & Walker, U. A. (2021) · RMD Open · doi:10.1136/rmdopen-2021-002010 · Cited by 38
Constipation screening in people taking clozapine: A diagnostic accuracy study
Every‐Palmer, S., Inns, S. J., & Ellis, P. (2020) · Schizophrenia Research · doi:10.1016/j.schres.2020.03.032 · Cited by 38
“The study was designed and reported in accordance with the Standards for Reporting of Diagnostic Accuracy Tests (STARD) (Bossuyt et al., 2015).”
Method
Visual or visual-tactile examination to detect and inform the diagnosis of enamel caries
Macey, R., Walsh, T., Riley, P., Glenny, A., Worthington, H. V., O'Malley, L. A., Clarkson, J., & Ricketts, D. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd014546 · Cited by 44
MR imaging in discriminating between benign and malignant paediatric ovarian masses: a systematic review
van Nimwegen, L. W. E., Mavinkurve‐Groothuis, A. M. C., de Krijger, R. R., Hulsker, C. C. C., Goverde, A. J., Zsíros, J., & Littooij, A. S. (2019) · European Radiology · doi:10.1007/s00330-019-06420-4 · Cited by 36
“Quality assessment The quality of the individual studies was judged using the “Standards for Reporting Diagnostic Accuracy 2015” (STARD 2015) checklist [18].”
Method
Benchmarking Deep Learning Models for Tooth Structure Segmentation
Schneider, L., Arsiwala-Scheppach, L. T., Krois, J., Meyer‐Lueckel, H., Bressem, K. K., Niehues, S. M., & Schwendicke, F. (2022) · Journal of Dental Research · doi:10.1177/00220345221100169 · Cited by 40
“Reporting of this study follows the Standards for Reporting Diagnostic Accuracy guideline (STARD) (Bossuyt et al. 2015) and the Checklist for Artificial Intelligence in Dental Research (Schwendicke et al. 2021).”
Method
Facilitating Prospective Registration of Diagnostic Accuracy Studies: A STARD Initiative
Korevaar, D. A., Hooft, L., Askie, L. M., Barbour, V., Faure, H., Gatsonis, C., Hunter, K. E., Kressel, H. Y., Lippman, H., McInnes, M. D. F., et al. (2017) · Clinical Chemistry · doi:10.1373/clinchem.2017.272765 · Cited by 33
Self-citation
Adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 Guidelines in Acute Point-of-Care Ultrasound Research
Prager, R. T., Bowdridge, J., Kareemi, H., Wright, C., McGrath, T. A., & McInnes, M. D. F. (2020) · JAMA Network Open · doi:10.1001/jamanetworkopen.2020.3871 · Cited by 36
Circular RNAs in prostate cancer: Biogenesis, biological functions, and clinical significance
Liu, X., Tong, Y., Ding, X., Peng, E., Yang, X., Liu, H., Ye, T., Wang, X., He, Y., Ye, Z., et al. (2021) · Molecular Therapy — Nucleic Acids · doi:10.1016/j.omtn.2021.10.017 · Cited by 35
Diagnostic accuracy of inflammatory markers in adults with suspected central nervous system infections
Olie, S. E., Staal, S. L., ter Horst, L., van Zeggeren, I. E., Man, W. K., Tanck, M. W. T., van de Beek, D., & Brouwer, M. C. (2024) · Journal of Infection · doi:10.1016/j.jinf.2024.01.016 · Cited by 40
miR‐199a‐3p and miR‐214‐3p improve the overall survival prediction of muscle‐invasive bladder cancer patients after radical cystectomy
Ecke, T., Stier, K., Weickmann, S., Zhao, Z., Buckendahl, L., Stephan, C., Kilic, E., & Jung, K. (2017) · Cancer Medicine · doi:10.1002/cam4.1161 · Cited by 34
The predictive value of T-tau and AB1-42 levels in idiopathic normal pressure hydrocephalus
Craven, C. L., Baudracco, I., Zetterberg, H., Lunn, M. P., Chapman, M. D., Lakdawala, N., Watkins, L. D., & Toma, A. K. (2017) · Acta Neurochirurgica · doi:10.1007/s00701-017-3314-x · Cited by 34
Biomarkers in Early-Phase Trials: Fundamental Issues
Yee, L. M., Lively, T., & McShane, L. M. (2018) · Bioanalysis · doi:10.4155/bio-2018-0006 · Cited by 34
Prospective evaluation of the performance of [68Ga]Ga-PSMA-11 PET/CT(MRI) for lymph node staging in patients undergoing superextended salvage lymph node dissection after radical prostatectomy
Abufaraj, M. M., Grubmüller, B., Zeitlinger, M. A., Kramer, G., Seitz, C., Haitel, A., Baltzer, P., Hacker, M., Wadsak, W., Pfaff, S., et al. (2019) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-019-04361-0 · Cited by 34
Anxiety screening tools in people with epilepsy: A systematic review of validated tools
Wang, Z., Luo, Z., Li, S., Luo, Z., & Wang, Z. (2019) · Epilepsy & Behavior · doi:10.1016/j.yebeh.2019.06.035 · Cited by 34
Comparison of the accuracy of telehealth examination versus clinical examination in the detection of shoulder pathology
Bradley, K. E., Cook, C. E., Reinke, E. K., Vinson, E. N., Mather, R. C. “., Riboh, J. C., Lassiter, T., & Wittstein, J. R. (2020) · Journal of Shoulder and Elbow Surgery · doi:10.1016/j.jse.2020.08.016 · Cited by 35
“We used the Standards for Reporting Diagnostic Accuracy Studies (STARD) reporting standards to guide this study.(3) All care in outpatient, orthopedic specialists’ practices was provided by 3 orthopedic surgeons (J.”
Method
Scope and challenges of machine learning-based diagnosis and prognosis in clinical dentistry: A literature review
Reyes, L. T., Knorst, J. K., Ortiz, F. R., & Ardenghi, T. M. (2021) · Journal of Clinical and Translational Research · doi:10.18053/jctres.07.202104.012 · Cited by 35
Minimum standards for inpatient long‐term video‐electroencephalographic 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) · Epilepsia · doi:10.1111/epi.16977 · Cited by 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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