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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Result
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Method
Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm
Koechlin, L., Boeddinghaus, J., López‐Ayala, P., Nestelberger, T., Wussler, D. N., Mais, F., Twerenbold, R., Zimmermann, T., Wildi, K. S., Köppen, A. M., et al. (2022) · American Heart Journal · doi:10.1016/j.ahj.2022.10.007 · Cited by 12
Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols
Revéiz, L., Haby, M. M., Martínez-Vega, R. A., Pinzón-Flores, C. E., Elias, V. M., Smith, E., Pinart, M., Broutet, N. J. N., Becerra-Posada, F., Aldighieri, S., et al. (2017) · PLoS ONE · doi:10.1371/journal.pone.0180220 · Cited by 12
Simultaneous inter-arm and inter-leg systolic blood pressure differences to diagnose peripheral artery disease: a diagnostic accuracy study
Herráiz-Adillo, Á., Soriano‐Cano, A., Martínez‐Hortelano, J. A., Garrido‐Miguel, M., Mariana-Herráiz, J. Á., Martínez‐Vizcaíno, V., & Notario‐Pacheco, B. (2017) · Blood Pressure · doi:10.1080/08037051.2017.1400903 · Cited by 12
Salivary Cortisol Determination in ACTH Stimulation Test to Diagnose Adrenal Insufficiency in Patients with Liver Cirrhosis
Albert, L., Profitós, J., Sánchez‐Delgado, J., Capel, I., González-Clemente, J. M., Subías, D., Cano, A., Berlanga, E., Espinal, A., Hurtado, M., et al. (2019) · International Journal of Endocrinology · doi:10.1155/2019/7251010 · Cited by 12
“Other studies derived cutoffs from findings in patients with suspected AI, and that design could influence the spectrum of disease in included patients [41].”
Background
The SPaCE diagnostic: a pilot study to test the accuracy of a novel point of care sensor for point of care detection of burn wound infection
Young, A. E., Naing, T., Mercer-Chalmers, J. D., Greenwood, R., Coy, K., Booth, S. P., Sack, A., & Jenkins, A. T. A. (2020) · Journal of Hospital Infection · doi:10.1016/j.jhin.2020.09.033 · Cited by 12
“A reference standard provides the best available method for establishing the presence or absence of the target condition [19,20].”
Evaluation of the Diagnostic Accuracy of a New Biosensors-Based Rapid Diagnostic Test for the Point-Of-Care Diagnosis of Previous and Recent Dengue Infections in Malaysia
Chong, Z. L., Soe, H. J., Ismail, A. A., Mahboob, T., Samudi, C., & Sekaran, S. D. (2021) · Biosensors · doi:10.3390/bios11050129 · Cited by 13
Thrombospondin-2 as a diagnostic biomarker for distal cholangiocarcinoma and pancreatic ductal adenocarcinoma
Byrling, J., Hilmersson, K. S., Ansari, D., Andersson, R. E., & Andersson, B. (2021) · Clinical & Translational Oncology · doi:10.1007/s12094-021-02685-8 · Cited by 12
Validity and reliability of the fatigue impact scale in stroke
Batur, E. B., Taşkıran, Ö. Ö., Yüksel, S., Cengiz, M., & Karataş, G. K. (2021) · Topics in Stroke Rehabilitation · doi:10.1080/10749357.2021.1978629 · Cited by 12
“414), and the study adheres to the STARD 2015 items.(35) All the participants gave their written informed consent.”
Background
Serum carbohydrate sulfotransferase 7 in lung cancer and non-malignant pulmonary inflammations
Debeljak, Ž., Dundović, S., Badovinac, S., Mandić, S., Samaržija, M., Dmitrović, B., Miloš, M., Maričić, L., Šerić, V., & Buljanović, V. (2018) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2017-1157 · Cited by 12
“Where applicable, REMARK and STARD guidelines [26, 27] were followed.”
Method
Modifying and validating the social responsiveness scale edition 2 for use with deaf children and young people
Wright, B., Phillips, H., Couteur, A. S. L., Sweetman, J., Hodkinson, R., Ralph‐Lewis, A., Hayward, E., Brennan, A., Mulloy, J., Day, N., et al. (2020) · PLoS ONE · doi:10.1371/journal.pone.0243162 · Cited by 11
“The STARD (STAndards of Reporting Diagnostic accuracy studies) 2015 flow diagram [41] is presented.”
Method
Daily monitoring of vaginal interleukin 6 as a predictor of intraamniotic inflammation after preterm premature rupture of membranes – a new method of sampling studied in a prospective multicenter trial
Seliger, G., Bergner, M., Haase, R., Stepan, H., Schleußner, E., Zöllkau, J., Seeger, S., Kraus, F. B., Hiller, G. G. R., Wienke, A., et al. (2021) · Journal of Perinatal Medicine · doi:10.1515/jpm-2020-0406 · Cited by 11
Evaluation of the Marburg Heart Score and INTERCHEST score compared to current telephone triage for chest pain in out-of-hours primary care
Manten, A., Clercq, L. D., Rietveld, R. P., Lucassen, W. A. M., van Charante, E. P. M., & Harskamp, R. E. (2022) · Netherlands Heart Journal · doi:10.1007/s12471-022-01745-0 · Cited by 11
Minimal Hip Joint Space Width Measured on X-rays by an Artificial Intelligence Algorithm—A Study of Reliability and Agreement
Andersen, A. M., Rasmussen, B. S., Graumann, O., Overgaard, S., Lundemann, M. J., Haubro, M. H., Varnum, C., Rasmussen, J., & Jensen, J. (2023) · BioMedInformatics · doi:10.3390/biomedinformatics3030046 · Cited by 12
“All analyses were performed in accordance with the current Guidelines for Reporting Reliability and Agreement Studies [11,12].”
Method
Clinical applications of artificial intelligence in identification and management of bacterial infection: Systematic review and meta-analysis
Zubair, M. (2024) · Saudi Journal of Biological Sciences · doi:10.1016/j.sjbs.2024.103934 · Cited by 11
Video-assisted mediastinoscopic lymphadenectomy (VAMLA): Mature results for staging non–small cell lung cancer with normal mediastinum
Call, S., Reig-Oussedik, N., Obiols, C., Santos, J. S., Ochoa-Alba, J. M., Cabanillas-Paredes, L. R., Serra-Mitjans, M., & Rami–Porta, R. (2024) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2024.01.040 · Cited by 11
Textual Proficiency and Visual Deficiency: A Comparative Study of Large Language Models and Radiologists in MRI Artifact Detection and Correction
Güneş, Y. C., Cesur, T., Çamur, E., Çifçi, B. E., Kaya, T., Colakoglu, M. N., Koç, U., & Ökten, R. S. (2025) · Academic Radiology · doi:10.1016/j.acra.2025.01.004 · Cited by 11
Utility of pf/pan RDT for diagnosis in the prevention of re-establishment of malaria in Sri Lanka
Gunasekera, W. M. K. T. D. A. W., Premaratne, R. G., Weerasena, O. V. D. S. J., Premawansa, W. S., Handunnetti, S., & Fernando, S. D. (2018) · Pathogens and Global Health · doi:10.1080/20477724.2018.1536855 · Cited by 11
Simple and non-invasive screening method for diabetes based on myoinositol levels in urine samples collected at home
Takakado, M., Takata, Y., Yamagata, F., Yaguchi, M., Hiasa, G., Sato, S., Funada, J., Kawazu, S., & Osawa, H. (2020) · BMJ Open Diabetes Research & Care · doi:10.1136/bmjdrc-2019-000984 · Cited by 11
Efficacy of ascitic fluid cell block for diagnosing primary ovarian, peritoneal, and tubal cancer in patients with peritoneal carcinomatosis with ascites
Uehara, T., Yoshida, H., Fukuhara, M., Yoshida, M., Motoi, N., Sugawara, S., Sone, M., Arai, Y., Tamura, K., Uno, M., et al. (2020) · Gynecologic Oncology · doi:10.1016/j.ygyno.2020.02.004 · Cited by 11
Diagnostic Test Characteristics of Ultrasound Based Hydronephrosis in Identifying Low Kidney Function in Young Patients with Spina Bifida: A Retrospective Cohort Study
Chu, D. I., Balmert, L. C., Chen, L., Arkin, C. M., Meyer, T., Rosoklija, I., Bowen, D. K., Hodgkins, K. S., Bowman, R. M., Cheng, E. Y., et al. (2020) · The Journal of Urology · doi:10.1097/ju.0000000000001411 · Cited by 11
Serum Neurofilament Light Chain: A Marker of Nervous System Damage in Myopathies
Saak, A., Benkert, P., Akgün, K., Willemse, E. A. J., Kühle, J., Ziemssen, T., Jackson, S., & Schaefer, J. (2021) · Frontiers in Neuroscience · doi:10.3389/fnins.2021.791670 · Cited by 11
Clinical performance and analytical accuracy of a C6 peptide-based point-of-care lateral flow immunoassay in Lyme borreliosis serology
Pietikäinen, A., Backman, I., Henningsson, A. J., & Hytönen, J. (2022) · Diagnostic Microbiology and Infectious Disease · doi:10.1016/j.diagmicrobio.2022.115657 · Cited by 11
Somatic, Genetic and Epigenetic Changes in Nephrogenic Rests and Their Role in the Transformation to Wilms Tumors, a Systematic Review
Bánki, T., Drost, J., van den Heuvel‐Eibrink, M. M., Mavinkurve‐Groothuis, A. M. C., & de Krijger, R. R. (2023) · Cancers · doi:10.3390/cancers15051363 · Cited by 11
“The “Standards for Reporting Diagnostic Accuracy 2015” (STARD 2015) checklist [20] was used to assess the quality of the included studies individually and is provided in Supplementary Table S2a.”
Method
Low Phase Angle Values Are Associated with Malnutrition according to the Global Leadership Initiative on Malnutrition Criteria in Kidney Transplant Candidates: Preliminary Assessment of Diagnostic Accuracy in the FRAILMar Study
Muñoz-Redondo, E., Morgado-Pérez, A., Pérez‐Sáez, M. J., Faura, A., Sánchez‐Rodríguez, D., Tejero-Sánchez, M., Meza-Valderrama, D., Muns, M. D., Pascual, J., & Marco, E. (2023) · Nutrients · doi:10.3390/nu15051084 · Cited by 11
Symptoms and signs of urogenital cancer in primary care
Holtedahl, K. A., Borgqúist, L., Donker, G., Buntinx, F., Weller, D., Campbell, C., Månsson, J., Hammersley, V., Braaten, T., & Parajuli, R. (2023) · BMC Family Practice · doi:10.1186/s12875-023-02063-z · Cited by 11
“We used the STARD checklist when generating study output [17].”
Method
Feasibility of in vivo magnetic resonance elastography of mesenteric adipose tissue in Crohn’s disease
Jensen, L. J., Loch, F. N., Kamphues, C., Shahryari, M., Garcia, S. R. M., Siegmund, B., Weidinger, C., Kühl, A. A., Hamm, B., Braun, J., et al. (2023) · Quantitative Imaging in Medicine and Surgery · doi:10.21037/qims-23-41 · Cited by 11
Reproducible Reporting of the Collection and Evaluation of Annotations for Artificial Intelligence Models
Elfer, K. N., Gardecki, E., Garcia, V. L., Ly, A., Hytopoulos, E., Wen, S., Hanna, M. G., Peeters, D. J. E., Saltz, J. H., Ehinger, A., et al. (2024) · Modern Pathology · doi:10.1016/j.modpat.2024.100439 · Cited by 15
Novel quantitative analysis of the S100P protein combined with endoscopic ultrasound-guided fine needle aspiration cytology in the diagnosis of pancreatic adenocarcinoma
Chiba, M., Imazu, H., Kato, M., Ikeda, K., Arakawa, H., Kato, T., Sumiyama, K., & Homma, S. (2017) · Oncology Reports · doi:10.3892/or.2017.5471 · Cited by 11
A novel metric that quantifies risk stratification for evaluating diagnostic tests: The example of evaluating cervical-cancer screening tests across populations
Katki, H. A., & SCHIFFMAN, M. H. (2018) · Preventive Medicine · doi:10.1016/j.ypmed.2018.02.013 · Cited by 11
Is gynecomastia related to the disease characteristics and prognosis in testicular germ cell tumor patients?
Polat, A. V., Öztürk, M., Çamlıdağ, İ., & Akyüz, B. (2019) · Diagnostic and Interventional Radiology · doi:10.5152/dir.2019.18297 · Cited by 11
Multiphoton microscopy in the diagnostic assessment of pediatric solid tissue in comparison to conventional histopathology: results of the first international online interobserver trial
Goedeke, J., Schreiber, P., Seidmann, L., Li, G., Birkenstock, J., Simon, F., König, J., & Muensterer, O. J. (2019) · Cancer Management and Research · doi:10.2147/cmar.s195470 · Cited by 10
Inconsistency in aortic stenosis severity between CT and echocardiography: prevalence and insights into mechanistic differences using computational fluid dynamics
Mittal, T. K., Reichmuth, L., Bhattacharyya, S., Jain, M., Baltabaeva, A., Haley, S. R., Mirsadraee, S., Panoulas, V. F., Kabir, T., Nicol, E. D., et al. (2019) · Open Heart · doi:10.1136/openhrt-2019-001044 · Cited by 11
Reporting Quality of Diagnostic Accuracy Studies in Laboratory Medicine: Adherence to Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015
Jang, M., Kim, B., & Lee, Y. K. (2019) · Annals of Laboratory Medicine · doi:10.3343/alm.2020.40.3.245 · Cited by 10
Impact of the Prevalence of Cognitive Impairment on the Accuracy of the Montreal Cognitive Assessment
Landsheer, J. A. (2020) · Alzheimer Disease & Associated Disorders · doi:10.1097/wad.0000000000000365 · Cited by 11
Polymorphic markers for identification of parasite population in Plasmodium malariae
Mathema, V. B., Nakeesathit, S., Pagornrat, W., Smithuis, F. M., White, N. J., Dondorp, A. M., & Imwong, M. (2020) · Malaria Journal · doi:10.1186/s12936-020-3122-2 · Cited by 11
Evaluating the validity, reliability and clinical utility of the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA): protocol of a validation study
Pool, J., Siegert, R. J., Taylor, S. M., Dunford, C., & Magee, W. L. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-039713 · Cited by 11
Deep learning of chest X-rays can predict mechanical ventilation outcome in ICU-admitted COVID-19 patients
Gourdeau, D., Potvin, O., Biem, J. H., Cloutier, F., Abrougui, L., Archambault, P. M., Chartrand‐Lefebvre, C., Dieumegarde, L., Gagné, C., Gagnon, L., et al. (2022) · Scientific Reports · doi:10.1038/s41598-022-10136-9 · Cited by 11
“This study is conducted and reported based on the STARD criteria 21 .”
Method
Review of Research Reporting Guidelines for Radiology Researchers
Cronin, P., & Rawson, J. V. (2016) · Academic Radiology · doi:10.1016/j.acra.2016.01.004 · Cited by 12
Fetal echocardiography (ECHO) in assessment of structural heart defects in congenital diaphragmatic hernia patients: Is early postnatal ECHO necessary for ECMO candidacy?
Style, C. C., Olutoye, O. O., Verla, M. A., Lopez, K. N., Vogel, A. M., Lau, P. E., Cruz, S. M., Espinoza, J., Fernandes, C. J., Keswani, S. G., et al. (2019) · Journal of Pediatric Surgery · doi:10.1016/j.jpedsurg.2019.01.022 · Cited by 11
Improving Detection of Multiple Sclerosis Lesions in the Posterior Fossa Using an Optimized 3D-FLAIR Sequence at 3T
Lecler, A., Sanharawi, I. E., Methni, J. E., Gout, O., Koskas, P., & Savatovsky, J. (2019) · American Journal of Neuroradiology · doi:10.3174/ajnr.a6107 · Cited by 12
Metabolic reprogramming in clear cell renal cell carcinoma: core pathways and targeted therapeutic strategies
Zhan, M., Zhao, B., Chen, H., Wu, J., Shi, R., Gao, F., Zhao, L., & Zhu, J. (2026) · Frontiers in Genetics · doi:10.3389/fgene.2025.1752384 · Cited by 10
“…the hospital” (Wilkinson et al., 2016; Sheller et al., 2020); at the same time, the study of tumor markers and diagnostic accuracy should follow REMARK/STARD and other reporting norms to improve external verifiability and Clinical promotion value (Sauerbrei et al., 2018; Bossuyt et al., 2015).”
Zero-Heat-Flux and Esophageal Temperature Monitoring in Orthopedic Surgery: An Observational Study
Munday, J., Higgins, N., Jones, L. V., Vagenas, D., van Zundert, A. A. J., & Keogh, S. J. (2021) · Journal of Multidisciplinary Healthcare · doi:10.2147/jmdh.s313310 · Cited by 10
Serotonin secretion by blood platelets: accuracy of high-performance liquid chromatography-electrochemical technique compared with the isotopic test and use in a clinical laboratory
Aranda, E., Iha, S., Solari, S., Rodríguez, D., Romero, V., Villarroel, L. A., Pereira, J. I., Panes, O., & Mezzano, D. (2023) · Research and Practice in Thrombosis and Haemostasis · doi:10.1016/j.rpth.2023.102156 · Cited by 10
A Survey of Conversational Agents and Their Applications for Self-Management of Chronic Conditions
Park, M. S., Upama, P. B., Anik, A. A., Ahamed, S. I., Luo, J., Tian, S., Rabbani, M., & Oh, H. (2023) · IEEE Annual International Computer Software and Applications Conference (COMPSAC) · doi:10.1109/compsac57700.2023.00162 · Cited by 14
Identification potential biomarkers for diagnosis, and progress of breast cancer by using high-pressure photon ionization time-of-flight mass spectrometry
Zhang, J., He, X., Guo, X., Wang, J., Gong, X., Jiao, D., Chen, H., & Liu, Z. (2024) · Analytica Chimica Acta · doi:10.1016/j.aca.2024.342883 · Cited by 10
Reporting checklists in neuroimaging: promoting transparency, replicability, and reproducibility
Ekhtiari, H., Zare-Bidoky, M., Sangchooli, A., Valyan, A., Abi‐Dargham, A., Cannon, D. M., Carter, C. S., Garavan, H., George, T. P., Ghobadi‐Azbari, P., et al. (2024) · Neuropsychopharmacology · doi:10.1038/s41386-024-01973-5 · Cited by 14
Single-cell AI-based detection and prognostic and predictive value of DNA mismatch repair deficiency in colorectal cancer
Nowak, M., Jabbar, F., Rodewald, A., Gneo, L., Tomasevic, T., Harkin, A., Iveson, T. J., Saunders, M. P., Kerr, R. S., Oein, K., et al. (2024) · Cell Reports Medicine · doi:10.1016/j.xcrm.2024.101727 · Cited by 10

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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