Reporting Diagnostic Accuracy Studies: Some Improvements after 10 Years of STARD

Korevaar, Daniël A.; Wang, Junfeng; Enst, Wynanda A. van; Leeflang, Mariska; Hooft, Lotty; Smidt, Nynke; Bossuyt, Patrick M.

doi:10.1148/radiol.14141160

Cited by 92 publications

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“…A growing number of evaluations have identified deficiencies in the reporting of test accuracy studies (5 ). These are studies in which a test is evaluated against a clinical reference standard, or gold standard; the results are typically reported as estimates of the test's sensitivity and specificity, which express how good the test is in correctly identifying patients as having the target condition.…”

confidence: 99%

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STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies

et al. 2015

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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. © 2015 American Association for Clinical ChemistryAs researchers, we talk and write about our studies, not just because we are happy-or disappointed-with the findings, but also to allow others to appreciate the validity of our methods, to enable our colleagues to replicate what we did, and to disclose our findings to clinicians, other health care professionals, and decision-makers, all of whom rely on the results of strong research to guide their actions.Unfortunately, deficiencies in the reporting of research have been highlighted in several areas of clinical medicine (1 ). Essential elements of study methods are often poorly described and sometimes completely omitted, making both critical appraisal and replication difficult, if not impossible. Sometimes study results are selectively reported, and other times researchers cannot resist unwarranted optimism in interpretation of their findings (2-4 ). These practices limit the value of the research and any downstream products or activities, such as systematic reviews and clinical practice guidelines.Reports of studies of medical tests are no exception. A growing number of evaluations have identified deficiencies in the reporting of test accuracy studies (5 ). These are studies in which a test is evaluated against a clinical reference standard, or gold standard; the results are typically reported as estimates of the test's sensitivity and specificity, which express how good the test is in correctly identifying patients as having the target condition. Other accuracy statistics can be used as well, such as the area under the ROC curve or positive and negative predictive values.Despite their apparent simplicity, such studies are at risk of bias (6, 7 ). If not all patients undergoing testing are included in the final analysis, for example, or if only healthy controls are included, the estimates of test accuracy may not reflect the performance of the test in clinical

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“…Since the publication of STARD, several evaluations have pointed to small but statistically significant improvements in reporting accuracy studies (mean gain 1.4 items; 95% CI 0.7 to 2.2) (5,10 ). Gradually, more of the essential items are being reported, but the situation remains far from optimal.…”

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STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies

et al. 2015

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“…The subjects' accrual flowchart (Fig 2) is based on the Standards for Reporting of Diagnostic Accuracy initiative (11) and proof of tumor burden. The final study cohort consisted of 19 patients (mean age 6 standard has four rod inserts.…”

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Dual-Source Single-Energy Multidetector CT Used to Obtain Multiple Radiation Exposure Levels within the Same Patient: Phantom Development and Clinical Validation

et al. 2017

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Purpose:To develop, in a phantom environment, a method to obtain multidetector computed tomographic (CT) data sets at multiple radiation exposure levels within the same patient and to validate its use for potential dose reduction by using different image reconstruction algorithms for the detection of liver metastases. Materials andMethods:The American College of Radiology CT accreditation phantom was scanned by using a dual-source multidetector CT platform. By adjusting the radiation output of each tube, data sets at six radiation exposure levels (100%, 75%, 50%, 37.5%, 25%, and 12.5%) were reconstructed from two consecutive dual-source single-energy (DSSE) acquisitions, as well as a conventional single-source acquisition. A prospective, HIPAA-compliant, institutional review boardapproved study was performed by using the same DSSE strategy in 19 patients who underwent multidetector CT of the liver for metastatic colorectal cancer. All images were reconstructed by using conventional weighted filtered back projection (FBP) and sinogramaffirmed iterative reconstruction with strength level of 3 (SAFIRE-3). Objective image quality metrics were compared in the phantom experiment by using multiple linear regression analysis. Generalized linear mixed-effects models were used to analyze image quality metrics and diagnostic performance for lesion detection by readers. Results:The phantom experiment showed comparable image quality between DSSE and conventional single-source acquisition. In the patient study, the mean size-specific dose estimates for the six radiation exposure levels were 13.0, 9.8, 5.8, 4.4, 3.2, and 1.4 mGy. For each radiation exposure level, readers' perception of image quality and lesion conspicuity was consistently ranked superior with SAFIRE-3 when compared with FBP (P  .05 for all comparisons). Reduction of up to 62.5% in radiation exposure by using SAFIRE-3 yielded similar reader rankings of image quality and lesion conspicuity when compared with routine-dose FBP. Conclusion:A method was developed and validated to synthesize multidetector CT data sets at multiple radiation exposure levels within the same patient. This technique may provide a foundation for future clinical trials aimed at estimating potential radiation dose reduction by using iterative reconstructions.q RSNA, 2016

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“…The impact of the profession of the person applying the Rules and setting of application on Rule accuracy has not been systematically investigated. The diagnostic research field has also progressed substantially since publication of the previous review,8 witnessing improvements in the design and reporting of studies,10 11 enhanced methods for evaluation of risk of bias12 and innovations in statistical methods for meta-analysis of diagnostic studies 13. A consideration of these factors in an updated review of the Rules has the potential to advance previous findings and address persisting uncertainties about specificity and sources of heterogeneity.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic accuracy of the Ottawa Ankle and Midfoot Rules: a systematic review with meta-analysis

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Reporting Diagnostic Accuracy Studies: Some Improvements after 10 Years of STARD

Cited by 92 publications

References 20 publications

STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies

STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies

Dual-Source Single-Energy Multidetector CT Used to Obtain Multiple Radiation Exposure Levels within the Same Patient: Phantom Development and Clinical Validation

Diagnostic accuracy of the Ottawa Ankle and Midfoot Rules: a systematic review with meta-analysis

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