scholarly journals Compliance With Standards for STARD 2015 Reporting Recommendations in Pathology

2020 ◽  
Vol 154 (6) ◽  
pp. 828-836
Author(s):  
Keenan O Hogan ◽  
Garth R Fraga
Keyword(s):  
Diagnostic Accuracy ◽  
Scientific Literature ◽  
Individual Item ◽  
Research Reporting ◽  
Study Protocols ◽  
Sample Size Calculations ◽  
Full Study ◽  
Flow Diagrams ◽  
Substantial Heterogeneity ◽  
Reporting Recommendations

Abstract Objectives Lack of experimental reproducibility has led to growing interest in guidelines to enhance completeness and transparency in research reporting. This retrospective survey sought to determine compliance with Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015 statement in the recent pathology scientific literature. Methods Two raters independently scored 171 pathology diagnostic accuracy studies for compliance with 34 STARD items and subcomponents. Overall adherence was calculated as a proportion after excluding nonapplicable items. Results After excluding nonapplicable items, there was 50% overall adherence to STARD reporting recommendations. In total, 15.44 ± 3.59 items were reported per article (range, 4-28 out of maximum possible of 34). There was substantial heterogeneity in individual item reporting, with greater than 75% reporting in eight of 34 items and less than 25% reporting in 11 of 34 items. Less than 10% of articles reported hypotheses, subgroup analyses for confounding, sample size calculations, subject flow diagrams, study registrations, and links to full study protocols. Significantly more items were reported in articles from journals that endorsed STARD (16.14 vs 14.84, P = .0175). Conclusions These findings demonstrate incomplete reporting of essential items in pathology diagnostic accuracy studies. More vigorous enforcement of reporting checklists might improve adherence to minimum reporting standards.

scholarly journals Assessment of Adherence of Diagnostic Accuracy Studies Published in Radiology Journals to STARD Statement Indexed in Web of Science, PubMed & Scopus in 2015

2018 ◽  
Vol 8 (3Sep) ◽  
Author(s):  
F Zarei ◽  
B Zeinali-Rafsanjani
Keyword(s):  
Diagnostic Accuracy ◽  
Study Protocol ◽  
Web Of Science ◽  
Discussion Section ◽  
Search Terms ◽  
Other Information ◽  
Full Study ◽  
Registration Number

Rationale and Objective: The objective of this study is to evaluate the methodological adherence of diagnostic accuracy studies published in radiology journals, which were indexed in different databases with the STARD standard guide 2015.Materials and Methods: The different databases were searched in order to find suitable journals. Among 84 English radiology journals, 31 journal were selected randomly. In order to find the articles, the same search fields and search terms were used. All the items of STARD checklist 2015 were considered to take in to account in assessment of the adherence of the articles to the standard. Total STARD score for each article was calculated by summing the number of reported items.Results: 151 articles from 31 journals were evaluated to check the adherence of their structure to STARD standard. Based on the results the articles had the most adherence with the STARD standard in material and method part the item of participants, discussion section, and title or abstract. On the contrary, most of the articles were not adhere to other information which are new items in STARD 2015. Among radiology diagnostic accuracy articles only one article (0.66%) had a registration number and 10 (6.62%) articles had a link to full study protocol. More than 60% of articles adhered to the ethics (69.54%) and source of support (63.58%).Conclusions: The radiology diagnostic accuracy studies were adhered to 69.45% STARD items, which shows an improvement in reporting the diagnostic accuracy articles in comparison to previous studies.

Assigning readers to cases in imaging studies using balanced incomplete block designs

2021 ◽  
Vol 30 (10) ◽  
pp. 2288-2312
Author(s):  
Erich P Huang ◽  
Joanna H Shih
Keyword(s):  
Data Analysis ◽  
Diagnostic Accuracy ◽  
Standard Errors ◽  
Block Designs ◽  
Incomplete Block ◽  
Simulation Studies ◽  
Imaging Studies ◽  
Balanced Incomplete Block Designs ◽  
Sample Size Calculations ◽  
Balanced Incomplete Block

In many imaging studies, each case is reviewed by human readers and characterized according to one or more features. Often, the inter-reader agreement of the feature indications is of interest in addition to their diagnostic accuracy or association with clinical outcomes. Complete designs in which all participating readers review all cases maximize efficiency and guarantee estimability of agreement metrics for all pairs of readers but often involve a heavy reading burden. Assigning readers to cases using balanced incomplete block designs substantially reduces reading burden by having each reader review only a subset of cases, while still maintaining estimability of inter-reader agreement for all pairs of readers. Methodology for data analysis and power and sample size calculations under balanced incomplete block designs is presented and applied to simulation studies and an actual example. Simulation studies results suggest that such designs may reduce reading burdens by >40% while in most scenarios incurring a <20% increase in the standard errors and a <8% and <20% reduction in power to detect between-modality differences in diagnostic accuracy and [Formula: see text] statistics, respectively.

scholarly journals A Scoping Review of Pre-hospital Technology to Assist Ambulance Personnel with Patient Diagnosis or Stratification during the Emergency Assessment of Suspected Stroke

2020 ◽  
Author(s):  
Hannah Amanda Lumley ◽  
Darren Flynn ◽  
Lisa Shaw ◽  
Graham McClelland ◽  
Gary A. Ford ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Meta Analysis ◽  
Hospital Setting ◽  
Imaging Biomarkers ◽  
Bibliographic Databases ◽  
Ambulance Personnel ◽  
Vessel Occlusion ◽  
Time Saving ◽  
Study Protocols ◽  
Suspected Stroke

Abstract Background: Pre-hospital identification of key subgroups within the suspected stroke population could reduce delays to emergency treatment. We aimed to identify and describe technology with existing proof of concept for diagnosis or stratification of patients in the pre-hospital setting. Methods: A systematic electronic search of published literature (from 01/01/2000 to 06/06/2019) was conducted in five bibliographic databases. Two reviewers independently assessed eligibility of studies or study protocols describing direct stratification methods (portable imaging/biomarkers) or facilitative technology (telemedicine) used by ambulance personnel during the assessment of suspected stroke. Eligible descriptions involved use of technology during the actual assessment of suspected stroke to provide information directly to ambulance personnel in the prehospital setting. Due to study, intervention and setting heterogeneity there was no attempt at meta-analysis. Results: 2887 articles were screened for eligibility, 19 of which were retained. Blood biomarker studies (n=2) were protocols of prospective diagnostic accuracy studies, one examining purines and the other a panel of known and novel biomarkers for identifying stroke sub-types (versus mimic). No data were available on diagnostic accuracy or patient health outcomes. Portable imaging studies (n=2) reported that an infrared screening device for detecting haemorrhages yielded moderate sensitivity and poor specificity in a small study, whilst a dry-EEG study to detect large vessel occlusion in ischaemic stroke has not yet reported results. Fifteen evaluations of pre-hospital telemedicine were identified (12 observational and 3 controlled comparisons) which all involved transmission of stroke assessment data from the pre-hospital setting to the hospital. Diagnosis was generally comparable with hospital diagnosis and most telemedicine systems reduced time-to-treatment; however, it is unknown whether this time saving translated into more favourable clinical outcomes. Telemedicine systems were deemed acceptable by clinicians. Conclusions: Pre-hospital technologies to stratify suspected stroke into clinically important subgroups may be feasible but insufficient evidence precludes recommendations on their routine use in the pre-hospital setting. Multi-centre diagnostic accuracy studies and clinical utility trials combining promising technologies are warranted. Keywords: Stroke; pre-hospital; stratification; diagnosis; technology; biomarkers; imaging; telemedicine; ambulance; paramedic.

Event-Related Potentials for Diagnosing Children and Adults With ADHD

2016 ◽  
Vol 24 (11) ◽  
pp. 1581-1587 ◽  
Author(s):  
Alex Gamma ◽  
Olga Kara
Keyword(s):  
Diagnostic Accuracy ◽  
Diagnostic Tests ◽  
Scientific Literature ◽  
Event Related Potentials ◽  
Healthy Controls ◽  
Study Quality ◽  
Inclusion Criteria ◽  
Concerted Action ◽  
Related Potentials ◽  
Behavioral Criteria

Objective: The diagnosis of ADHD is based on behavioral criteria, which allow for subjective variability and invite criticism regarding the reality of the disorder. In this situation, more objective criteria would be desirable. We review the scientific literature for diagnostic tests based on event-related potentials (ERPs). Method: Seven studies met the inclusion criteria of reporting the sensitivity and specificity of an ERP-based classifier discriminating participants with ADHD from healthy controls. Study quality was rated using the second version of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) system. Results: Overall, study quality was acceptable. The largest biases were lack of representativeness and overfitting. Sensitivities and specificities ranged from 57% to 96%, and 63% to 92%, respectively. However, no two studies used the same diagnostic test. Conclusion: There is a serious lack of coordination in worldwide efforts to find more objective ERP-based criteria for the diagnosis of ADHD. Concerted action is needed.

scholarly journals Targeted test evaluation: a framework for designing diagnostic accuracy studies with clear study hypotheses

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Daniël A. Korevaar ◽  
Gowri Gopalakrishna ◽  
Jérémie F. Cohen ◽  
Patrick M. Bossuyt
Keyword(s):  
Diagnostic Accuracy ◽  
Sample Size ◽  
Test Performance ◽  
Index Test ◽  
Test Results ◽  
Scientific Rigor ◽  
Medical Interventions ◽  
Sample Size Calculations ◽  
Intended Use

AbstractMost randomized controlled trials evaluating medical interventions have a pre-specified hypothesis, which is statistically tested against the null hypothesis of no effect. In diagnostic accuracy studies, study hypotheses are rarely pre-defined and sample size calculations are usually not performed, which may jeopardize scientific rigor and can lead to over-interpretation or “spin” of study findings. In this paper, we propose a strategy for defining meaningful hypotheses in diagnostic accuracy studies. Based on the role of the index test in the clinical pathway and the downstream consequences of test results, the consequences of test misclassifications can be weighed, to arrive at minimally acceptable criteria for pre-defined test performance: levels of sensitivity and specificity that would justify the test’s intended use. Minimally acceptable criteria for test performance should form the basis for hypothesis formulation and sample size calculations in diagnostic accuracy studies.

scholarly journals Systematic Criteria for Type and Screen Based on Procedure's Probability of Erythrocyte Transfusion

2012 ◽  
Vol 116 (4) ◽  
pp. 768-778 ◽  
Author(s):  
Franklin Dexter ◽  
Johannes Ledolter ◽  
Erika Davis ◽  
Thomas A. Witkowski ◽  
Jay H. Herman ◽  
...  
Keyword(s):  
Scientific Literature ◽  
Information Management System ◽  
Random Effects Model ◽  
Erythrocyte Transfusion ◽  
Estimated Blood Loss ◽  
System Data ◽  
Elective Surgical Procedure ◽  
Low Incidence ◽  
Test Ordering ◽  
Substantial Heterogeneity

Background At many hospitals, the type and screen decision is guided by the hospital's maximum surgical blood order schedule, a document that includes for each scheduled (elective) surgical procedure a recommendation of whether a preoperative type and screen be performed. There is substantial heterogeneity in the scientific literature for how that decision should be made. Methods Anesthesia information management system data were retrieved from the 160,207 scheduled noncardiac cases in adults of 1,253 procedures at a hospital. Results Neither assuming a Poisson distribution of mean erythrocyte units transfused, nor grouping rare procedures into larger groups based on their anesthesia Current Procedural Terminology code, was reliable. In contrast, procedures could be defined to have minimal estimated blood loss (less than 50 ml) based on low incidence of transfusion and low incidence of the hemoglobin being checked preoperatively. Among these procedures, when the lower 95% confidence limit for erythrocyte transfusion was less than 5%, type and screen was shown to be unnecessary. The method was useful based on including multiple differences from the hospital's maximum surgical blood order schedule and clinicians' test ordering (greater than or equal to 29% fewer type and screen). Results were the same with a Bayesian random effects model. Conclusions We validated a method to determine procedures on the maximum surgical blood order schedule for which type and screen was not indicated using the estimated blood losses and incidences of transfusion.

scholarly journals Review of study reporting guidelines for clinical studies using artificial intelligence in healthcare

2021 ◽  
Vol 28 (1) ◽  
pp. e100385
Author(s):  
Susan Cheng Shelmerdine ◽  
Owen J Arthurs ◽  
Alastair Denniston ◽  
Neil J Sebire
Keyword(s):  
Artificial Intelligence ◽  
Diagnostic Accuracy ◽  
Prediction Model ◽  
Clinical Investigation ◽  
Health Interventions ◽  
Reporting Guidelines ◽  
High Quality Research ◽  
Specific Element ◽  
Model Studies ◽  
Study Protocols

High-quality research is essential in guiding evidence-based care, and should be reported in a way that is reproducible, transparent and where appropriate, provide sufficient detail for inclusion in future meta-analyses. Reporting guidelines for various study designs have been widely used for clinical (and preclinical) studies, consisting of checklists with a minimum set of points for inclusion. With the recent rise in volume of research using artificial intelligence (AI), additional factors need to be evaluated, which do not neatly conform to traditional reporting guidelines (eg, details relating to technical algorithm development). In this review, reporting guidelines are highlighted to promote awareness of essential content required for studies evaluating AI interventions in healthcare. These include published and in progress extensions to well-known reporting guidelines such as Standard Protocol Items: Recommendations for Interventional Trials-AI (study protocols), Consolidated Standards of Reporting Trials-AI (randomised controlled trials), Standards for Reporting of Diagnostic Accuracy Studies-AI (diagnostic accuracy studies) and Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-AI (prediction model studies). Additionally there are a number of guidelines that consider AI for health interventions more generally (eg, Checklist for Artificial Intelligence in Medical Imaging (CLAIM), minimum information (MI)-CLAIM, MI for Medical AI Reporting) or address a specific element such as the ‘learning curve’ (Developmental and Exploratory Clinical Investigation of Decision-AI) . Economic evaluation of AI health interventions is not currently addressed, and may benefit from extension to an existing guideline. In the face of a rapid influx of studies of AI health interventions, reporting guidelines help ensure that investigators and those appraising studies consider both the well-recognised elements of good study design and reporting, while also adequately addressing new challenges posed by AI-specific elements.

scholarly journals Recent developments in techniques for respiratory motion correction in PET-CT imaging

2015 ◽  
Vol 17 (1) ◽  
pp. 84-90
Author(s):  
Salam Sadia ◽  
Nafees F Ali ◽  
Afroz Shahana
Keyword(s):  
Diagnostic Accuracy ◽  
Motion Correction ◽  
Respiratory Motion ◽  
Hybrid Imaging ◽  
Scientific Literature ◽  
High Sensitivity ◽  
Motion Artefacts ◽  
Pet Ct ◽  
Recent Developments ◽  
Prompt Diagnosis

The advent of hybrid imaging in the form of PET CT has revolutionised the practice of respiratory medicine. Due to the high sensitivity and specificity of this technique, it is possible to detect pulmonary pathologies in early stages with high degrees of certitude thereby facilitating prompt diagnosis and treatment. However, the presence of respiratory motion artefacts depreciates the diagnostic accuracy of this technique. Multiple motion correction techniques have been developed to overcome this predicament. In this paper, these techniques have been reviewed from existing scientific literature. DOI: http://dx.doi.org/10.3329/bjnm.v17i1.22496 Bangladesh J. Nuclear Med. 17(1): 84-90, January 2014

Study design, result posting, and publication of late-stage cardiovascular trials

2020 ◽  
Author(s):  
Chris J Kapelios ◽  
Huseyin Naci ◽  
Panos E Vardas ◽  
Elias Mossialos
Keyword(s):  
Study Design ◽  
Late Stage ◽  
Scientific Literature ◽  
Late Phase ◽  
Open Label ◽  
Clinical Endpoints ◽  
Explanatory Factors ◽  
Study Protocols ◽  
Study Results ◽  
Design Result

Abstract Aims Pre-registration of study protocols in accessible databases is required for publication of study results in high-impact medical journals. Nonetheless, data on characteristics of clinical trials registered in these databases and their outcome, in terms of result reporting and publication are limited. Methods and results We searched for interventional, late-phase cardiovascular disease (CVD) studies in adults registered in Clinicaltrials.gov. first posted after 1 January 2013 and completed up to 31 December 2018. Data on study design, result reporting, and publication were collected, and potential associations with a pre-defined set of explanatory factors were examined. In total, 250 CVD trials were included in the analysis. Of these, 193 (77.2%) were randomized studies, 99 (39.6%) open label designs, and 126 (50.4%) had industry as main sponsor. One hundred and seventy-nine trials (71.6%) evaluated the effect of drugs and 27 (10.8%) evaluated devices. The most common primary outcomes were non-clinical endpoints (76.0%), with only 17% of studies evaluating clinical endpoints. Industry-funded trials focused on patent-protected drugs and devices more often than non-industry-funded trials (72.0% vs. 30.6%, P &lt; 0.001 and 55.0% vs. 26.3%, P = 0.033, respectively). Sixty-three studies (25.2%) had results posted on clinicaltrials.gov, and 116 (46.4%) had results published in the scientific literature. In multivariate analysis, industry sponsorship was statistically significantly associated with results posting [odds ratio (OR): 3.38; 95% confidence interval (CI): 1.56–7.30, P = 0.002] and publication (OR: 0.41; 95% CI: 0.23–0.75, P = 0.004). Conclusion Among late-stage cardiovascular trials only one-fourth had results posted on clinicaltrials.gov and &lt;50% had results published. Industry sponsors were more likely to invest in research on patent-protected drugs and devices than were non-industry sponsors. Industry-sponsored studies were more likely to have their results posted, but less likely to have their results published in the scientific literature.

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