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Open AccessJournal ArticleDOI

STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration

TLDR
The rationale for each of the 30 items on the STARD 2015 checklist is clarified, and what is expected from authors in developing sufficiently informative study reports is described.
Abstract
Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports.

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Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study

TL;DR: PSMA PET-CT is a suitable replacement for conventional imaging, providing superior accuracy, to the combined findings of CT and bone scanning, andSubgroup analyses showed the superiority of PSMAPET-CT (area under the curve of the receiver operating characteristic curve 91% vs 59% [32% absolute difference; 28-35] for patients with pelvic nodal metastases, and 95% vs 74% [22%absolute difference; 18-26] for Patients with distant metastases).
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Prostate MRI, with or without MRI‐targeted biopsy, and systematic biopsy for detecting prostate cancer

TL;DR: The diagnostic accuracy of the index tests MRI only, MRI-targeted biopsy, the MRI pathway and systematic biopsy as compared to template-guidedBiopsy as the reference standard in detecting clinically significant prostate cancer as the target condition was determined.
Journal ArticleDOI

Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies.

TL;DR: In this article, the importance of sample size and its relationship to effect size (ES) and statistical significance is discussed. But, there is no straightforward way of calculating the effective sample size for reaching an accurate conclusion, and use of a statistically incorrect sample size may lead to inadequate results in both clinical and laboratory studies.
References
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Journal ArticleDOI

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

TL;DR: The Consort 2010 Statement as discussed by the authors has been used worldwide to improve the reporting of randomised controlled trials and has been updated by Schulz et al. in 2010, based on new methodological evidence and accumulating experience.
Journal ArticleDOI

QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies

TL;DR: The QUADAS-2 tool will allow for more transparent rating of bias and applicability of primary diagnostic accuracy studies.
Journal ArticleDOI

Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors

TL;DR: In this article, an easily interpretable index of predictive discrimination as well as methods for assessing calibration of predicted survival probabilities are discussed, which are particularly needed for binary, ordinal, and time-to-event outcomes.
Journal ArticleDOI

CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials

TL;DR: The 2010 version of the CONSORT Statement is described, which updates the previous reporting guideline based on new methodological evidence and accumulated experience.
Book ChapterDOI

Prognostic/Clinical Prediction Models: Multivariable Prognostic Models: Issues in Developing Models, Evaluating Assumptions and Adequacy, and Measuring and Reducing Errors

TL;DR: An easily interpretable index of predictive discrimination as well as methods for assessing calibration of predicted survival probabilities are discussed, applicable to all regression models, but are particularly needed for binary, ordinal, and time-to-event outcomes.
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