Diagnostic accuracy studies: how to report and analyse inconclusive test results

Failure to report inconclusive test results can lead to misleading conclusions regarding the accuracy and clinical usefulness of a diagnostic tool. We show that these results are often overlooked in research on test accuracy and provide guidance on suitable approaches to reporting and analysing these problematic results.

[1]  N. Obuchowski,et al.  Accuracy of MRI in the diagnosis of meniscal tears in older patients. , 2012, AJR. American journal of roentgenology.

[2]  R. Sokol,et al.  Pancreatic Insufficiency Is Not a Prevalent Problem in Alagille Syndrome , 2012, Journal of pediatric gastroenterology and nutrition.

[3]  Peter Schlattmann,et al.  Use of 3×2 tables with an intention to diagnose approach to assess clinical performance of diagnostic tests: meta-analytical evaluation of coronary CT angiography studies , 2012, BMJ : British Medical Journal.

[4]  S. Nazir,et al.  Evaluation of diagnostic strategies for bladder cancer using computed tomography (CT) urography, flexible cystoscopy and voided urine cytology: results for 778 patients from a hospital haematuria clinic , 2012, BJU international.

[5]  W. Roberts,et al.  Accuracy of two-dimensional echocardiography in determining aortic valve structure in patients >50 years of age having aortic valve replacement for aortic stenosis. , 2011, The American journal of cardiology.

[6]  L. Haramati,et al.  Successful and Safe Implementation of a Trinary Interpretation and Reporting Strategy for V/Q Lung Scintigraphy , 2011, The Journal of Nuclear Medicine.

[7]  R. Morris,et al.  The quality of reporting of primary test accuracy studies in obstetrics and gynaecology: application of the STARD criteria , 2011, BMC women's health.

[8]  A. Perry,et al.  Screening Tools Assessing Risk of Suicide and Self-Harm in Adult Offenders: A Systematic Review , 2010, International journal of offender therapy and comparative criminology.

[9]  M. Soares,et al.  Quality reporting of endoscopic diagnostic studies in gastrointestinal journals: where do we stand on the use of the STARD and CONSORT statements? , 2010, Endoscopy.

[10]  N. Dendukuri,et al.  Quality and Reporting of Diagnostic Accuracy Studies in TB, HIV and Malaria: Evaluation Using QUADAS and STARD Standards , 2009, PloS one.

[11]  D. Loring,et al.  The diagnostic utility of multiple-level likelihood ratios , 2009, Journal of the International Neuropsychological Society.

[12]  A. Roposch,et al.  Juvenile idiopathic arthritis of peripheral joints: quality of reporting of diagnostic accuracy of conventional MRI. , 2009, Academic radiology.

[13]  L. Krzych,et al.  No improvement in studies reporting the diagnostic accuracy of B-type natriuretic peptide. , 2009, Medical science monitor : international medical journal of experimental and clinical research.

[14]  A. Szczepura,et al.  Non-invasive fetal RHD genotyping tests: a systematic review of the quality of reporting of diagnostic accuracy in published studies. , 2009, European journal of obstetrics, gynecology, and reproductive biology.

[15]  D. Reid,et al.  Validity of the McMurray's Test and Modified Versions of the Test: A Systematic Literature Review , 2009, The Journal of manual & manipulative therapy.

[16]  Frank Buntinx,et al.  The evidence base of clinical diagnosis , 2008 .

[17]  P. Biban,et al.  Procalcitonin for the diagnosis of early-onset neonatal sepsis: a multilevel probabilistic approach. , 2008, Clinical biochemistry.

[18]  J. Spencer,et al.  Indeterminate lesions in cancer imaging. , 2008, Clinical radiology.

[19]  A. Zafar,et al.  The quality of reporting of diagnostic accuracy studies in diabetic retinopathy screening: a systematic review , 2008, Clinical & experimental ophthalmology.

[20]  A. Azuara-Blanco,et al.  The Quality of Reporting of Diagnostic Accuracy Studies in Glaucoma Using Scanning Laser Polarimetry , 2007, Journal of glaucoma.

[21]  G. Elwyn,et al.  Instruments to assess the perception of physicians in the decision-making process of specific clinical encounters: a systematic review , 2007, BMC Medical Informatics Decis. Mak..

[22]  A. Azuara-Blanco,et al.  The quality of reporting of diagnostic accuracy studies of optical coherence tomography in glaucoma. , 2007, Ophthalmology.

[23]  J. Mahoney,et al.  Assessing the quality of glucose monitor studies: a critical evaluation of published reports. , 2007, Clinical chemistry.

[24]  A. Roposch,et al.  Developmental dysplasia of the hip: quality of reporting of diagnostic accuracy for US. , 2006, Radiology.

[25]  Jacques Pouchot,et al.  A gray zone assigned to inconclusive results of quantitative diagnostic tests: Application to the use of brain natriuretic peptide for diagnosis of heart failure in acute dyspneic patients. , 2006, Clinical chemistry.

[26]  P. Bossuyt,et al.  Quality of reporting of test accuracy studies in reproductive medicine: impact of the Standards for Reporting of Diagnostic Accuracy (STARD) initiative. , 2006, Fertility and sterility.

[27]  B. Lumbreras,et al.  Evaluation of the research methodology in genetic, molecular and proteomic tests. , 2006, Gaceta sanitaria.

[28]  S. Apsingi,et al.  Quality of Reporting of Orthopaedic Diagnostic Accuracy Studies is Suboptimal , 2006, Clinical orthopaedics and related research.

[29]  Augusto Azuara-Blanco,et al.  The quality of reporting of diagnostic accuracy studies in glaucoma using the Heidelberg retina tomograph. , 2006, Investigative ophthalmology & visual science.

[30]  Patrick Royston,et al.  The cost of dichotomising continuous variables , 2006, BMJ : British Medical Journal.

[31]  P. Bossuyt,et al.  Reproducibility of the STARD checklist: an instrument to assess the quality of reporting of diagnostic accuracy studies , 2006, BMC medical research methodology.

[32]  Yan Liu,et al.  Sensitivity and specificity of color duplex ultrasound measurement in the estimation of internal carotid artery stenosis: a systematic review and meta-analysis. , 2005, Journal of vascular surgery.

[33]  T. Selman,et al.  An evidence-based approach to test accuracy studies in gynecologic oncology: the 'STARD' checklist. , 2005, Gynecologic oncology.

[34]  A. Azuara-Blanco,et al.  The quality of reporting of diagnostic accuracy studies published in ophthalmic journals , 2005, British Journal of Ophthalmology.

[35]  J. Knottnerus,et al.  The standards for reporting of diagnostic accuracy. , 2003, Journal of clinical epidemiology.

[36]  Johannes B Reitsma,et al.  The STARD initiative , 2003, The Lancet.

[37]  G. Andrews,et al.  Stratum-specific likelihood ratios of the General Health Questionnaire in the community: help-seeking and physical co-morbidity affect the test characteristics , 2002, Psychological Medicine.

[38]  Z. Baloch,et al.  Diagnosis of “follicular neoplasm”: A gray zone in thyroid fine‐needle aspiration cytology , 2002, Diagnostic cytopathology.

[39]  S. Rabe-Hesketh,et al.  Stratum-specific likelihood ratios of two versions of the General Health Questionnaire , 2001, Psychological Medicine.

[40]  P. Vernazza,et al.  Cervical squamous intraepithelial lesions in HIV-infected women: prevalence, incidence and regression , 2000 .

[41]  J. Sonis.  How to use and interpret interval likelihood ratios. , 1999, Family medicine.

[42]  S. Satya‐Murti.  Evidence-based Medicine: How to Practice and Teach EBM , 1997 .

[43]  R. G. Cornell,et al.  Integrating Stratum-specific Likelihood Ratios with the Analysis of ROC Curves , 1993, Medical decision making : an international journal of the Society for Medical Decision Making.

[44]  H. Farzadegan,et al.  Frequency of indeterminate western blot tests in healthy adults at low risk for human immunodeficiency virus infection. The NIAID AIDS Vaccine Clinical Trails Network. , 1990, The Journal of infectious diseases.

[45]  E. DeLong,et al.  Intermediate, Indeterminate, and Uninterpretable Diagnostic Test Results , 1987, Medical decision making : an international journal of the Society for Medical Decision Making.

[46]  R. Rifkin,et al.  Maximum Shannon Information Content of Diagnostic Medical Testing , 1985, Medical decision making : an international journal of the Society for Medical Decision Making.

[47]  T. Poynard,et al.  Relations Between Effectiveness of a Diagnostic Test, Prevalence of the Disease, and Percentages of Uninterpretable Results , 1982, Medical decision making : an international journal of the Society for Medical Decision Making.

[48]  BMC Medical Research Methodology , 2003 .

[49]  A R Feinstein,et al.  The inadequacy of binary models for the clinical reality of three-zone diagnostic decisions. , 1990, Journal of Clinical Epidemiology.

[50]  R A Greenes,et al.  The influence of uninterpretability on the assessment of diagnostic tests. , 1986, Journal of chronic diseases.