Standards For Reporting Diagnostic Accuracy Studies Research Articles

Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs. An Official American Thoracic Society/American College of Chest Physicians Research Statement.

Background: Advanced diagnostic bronchoscopy targeting the lung periphery has developed at an accelerated pace over the last two decades, whereas evidence to support introduction of innovative technologies has been variable and deficient. A major gap relates to variable reporting of diagnostic yield, in addition to limited comparative studies. Objectives: To develop a research framework to standardize the evaluation of advanced diagnostic bronchoscopy techniques for peripheral lung lesions. Specifically, we aimed for consensus on a robust definition of diagnostic yield, and we propose potential study designs at various stages of technology development. Methods: Panel members were selected for their diverse expertise. Workgroup meetings were conducted in virtual or hybrid format. The cochairs subsequently developed summary statements, with voting proceeding according to a modified Delphi process. The statement was cosponsored by the American Thoracic Society and the American College of Chest Physicians. Results: Consensus was reached on 15 statements on the definition of diagnostic outcomes and study designs. A strict definition of diagnostic yield should be used, and studies should be reported according to the STARD (Standards for Reporting Diagnostic Accuracy Studies) guidelines. Clinical or radiographic follow-up may be incorporated into the reference standard definition but should not be used to calculate diagnostic yield from the procedural encounter. Methodologically robust comparative studies, with incorporation of patient-reported outcomes, are needed to adequately assess and validate minimally invasive diagnostic technologies targeting the lung periphery. Conclusions: This American Thoracic Society/American College of Chest Physicians statement aims to provide a research framework that allows greater standardization of device validation efforts through clearly defined diagnostic outcomes and robust study designs. High-quality studies, both industry and publicly funded, can support subsequent health economic analyses and guide implementation decisions in various healthcare settings.

Advanced Oxidative Protein Products Had a Diagnostic Accuracy for Identifying Chronic Kidney Disease in Adult Population.

Chronic Kidney Disease (CKD) is a serious public health problem. Hyperglycemia stimulates the production of reactive oxygen species that cause oxidative damage to proteins. AOPPs constitute a group of oxidized dityrosine-containing proteins that are generated during periods of oxidative stress. They have proved to be a valuable early marker of oxidative tissue damage and active mediators of inflammation associated with the uremic state. To analyze if advanced oxidative protein products (AOPPs) have diagnostic accuracy for identifying chronic kidney disease (CKD) in the adult population. We conducted a diagnostic test validation study in 302 adults ≥20 years old, of both sexes, with and without T2D. After obtaining informed consent, a comprehensive clinical history, anthropometric measurements (weight, BMI) and blood pressure were recorded. Glucose, cholesterol, triglyceride, HDL-c, LDL-c and AOPPs were determinates. Glomerular filtration rate (GFR) was calculated using Cockcroft-Gault (C-G) corrected by body surface area (BSA, mL/min/1.73 m2), CKD-EPI and MDRD equations to identify five stages of CKD. This study follows the Standards for Reporting Diagnostic Accuracy Studies (STARD). The median value of AOPPs was 198.32 µmol/L (minimum-maximum value: 113.48-522.42 µmol/L). The group with patients diagnosed with T2D exhibited higher concentrations (median: 487.39 µmol/L) compared to the non-diabetic group (median: 158.50 µmol/L, p = 0.0001). The selected cut-off point was ≥200 µmol/L using the closest to the median value of AOPPs with sensitivity and specificity as follows: C-G: sensitivity 96.58%; specificity 80%; likelihood ratio: 4.83; CKD-EPI: sensitivity 95.76%; specificity 79.89%; likelihood ratio: 4.76; MDRD: sensitivity 86.55%; specificity: 73.22%; likelihood ratio: 3.23. A difference was observed between AOPPs and chronic kidney disease stage. This study provides evidence that AOPPs ≥ 200 µmol/L have diagnostic accuracy in identifying stage 4-5 CKD by C-G, MDRD and CKD-EPI equations in adults with and without T2D.

Biomarkers of brain injury after cardiac arrest; a statistical analysis plan from the TTM2 trial biobank investigators

BackgroundSeveral biochemical markers in blood correlate with the magnitude of brain injury and may be used to predict neurological outcome after cardiac arrest. We present a protocol for the evaluation of prognostic accuracy of brain injury markers after cardiac arrest. The aim is to define the best predictive marker and to establish clinically useful cut-off levels for routine implementation. MethodsProspective international multicenter trial within the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest (TTM2) trial in collaboration with Roche Diagnostics International AG. Samples were collected 0, 24, 48, and 72 hours after randomisation (serum) and 0 and 48 hours after randomisation (plasma), and pre-analytically processed at each site before storage in a central biobank. Routine markers neuron-specific enolase (NSE) and S100B, and neurofilament light, total-tau and glial fibrillary acidic protein will be batch analysed using novel Elecsys® electrochemiluminescence immunoassays on a Cobas e601 instrument. ResultsStatistical analysis will be reported according to the Standards for Reporting Diagnostic accuracy studies (STARD) and will include comparisons for prediction of good versus poor functional outcome at six months post-arrest, by modified Rankin Scale (0–3 vs. 4–6), using logistic regression models and receiver operating characteristics curves, evaluation of mortality at six months according to biomarker levels and establishment of cut-off values for prediction of poor neurological outcome at 95–100% specificities. ConclusionsThis prospective trial may establish a standard methodology and clinically appropriate cut-off levels for the optimal biomarker of brain injury which predicts poor neurological outcome after cardiac arrest.

Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning

BackgroundMicroscopic examination of Giemsa-stained blood films remains the reference standard for malaria parasite detection and quantification, but is undermined by difficulties in ensuring high-quality manual reading and inter-reader reliability. Automated parasite detection and quantification may address this issue.MethodsA multi-centre, observational study was conducted during 2018 and 2019 at 11 sites to assess the performance of the EasyScan Go, a microscopy device employing machine-learning-based image analysis. Sensitivity, specificity, accuracy of species detection and parasite density estimation were assessed with expert microscopy as the reference. Intra- and inter-device reliability of the device was also evaluated by comparing results from repeat reads on the same and two different devices. This study has been reported in accordance with the Standards for Reporting Diagnostic accuracy studies (STARD) checklist.ResultsIn total, 2250 Giemsa-stained blood films were prepared and read independently by expert microscopists and the EasyScan Go device. The diagnostic sensitivity of EasyScan Go was 91.1% (95% CI 88.9–92.7), and specificity 75.6% (95% CI 73.1–78.0). With good quality slides sensitivity was similar (89.1%, 95%CI 86.2–91.5), but specificity increased to 85.1% (95%CI 82.6–87.4). Sensitivity increased with parasitaemia rising from 57% at < 200 parasite/µL, to ≥ 90% at > 200–200,000 parasite/µL. Species were identified accurately in 93% of Plasmodium falciparum samples (kappa = 0.76, 95% CI 0.69–0.83), and in 92% of Plasmodium vivax samples (kappa = 0.73, 95% CI 0.66–0.80). Parasite density estimates by the EasyScan Go were within ± 25% of the microscopic reference counts in 23% of slides.ConclusionsThe performance of the EasyScan Go in parasite detection and species identification accuracy fulfil WHO-TDR Research Malaria Microscopy competence level 2 criteria. In terms of parasite quantification and false positive rate, it meets the level 4 WHO-TDR Research Malaria Microscopy criteria. All performance parameters were significantly affected by slide quality. Further software improvement is required to improve sensitivity at low parasitaemia and parasite density estimations.Trial registration ClinicalTrials.gov number NCT03512678.

Diagnostic accuracy of clinical indicators of Imbalanced nutrition in pediatric patients submitted to chemotherapy.

To analyze the accuracy of clinical indicators of nursing diagnosis, Imbalanced nutrition: less than the body requirements in pediatric patients undergoing chemotherapy. A cross-sectional study was carried out in a pediatric oncohematology unit. A total of 123 children aged 5-18 years were evaluated. The Standards for Reporting Diagnostic Accuracy Studies (STARD) protocol was used. Latent class analysis was performed to obtain sensitivity and specificity of clinical indicators. The diagnosis was identified in six children (5.23%). The most frequent clinical indicator in the study was report of food intake less than recommended daily allowance (n = 61; 49.6%), followed by excessive hair loss (n = 49; 39.8%), misperception (n = 42; 34.1%), satiety immediately upon ingesting food (n = 32; 26%), lack of information (n = 30; 24.4%), and pale mucous membranes (n = 22; 17.9%). The 10 indicators that sensitivity and specificity were statistically superior to 50% were food intake less than recommended daily allowance, misperception, insufficient interest in food, lack of food, hyperactive bowel sounds, body weight 20% or more below ideal weight range, insufficient muscle tone, food aversion, abdominal cramping, and misinformation. The clinical indicators Food intake less than recommended daily allowance and Misperception can be considered the most important indicators for the initial inference of the diagnosis due to their high values of specificity and sensitivity. It is essential that nurses provide targeted and qualified assistance based on the signs and symptoms presented by patients, as they will be able to design appropriate interventions to obtain the desired results.

Evaluating the Impact of Peer Review on the Completeness of Reporting in Imaging Diagnostic Test Accuracy Research.

Despite the nearly ubiquitous reported use of peer review among reputable medical journals, there is limited evidence to support the use of peer review to improve the quality of biomedical research and in particular, imaging diagnostic test accuracy (DTA) research. To evaluate whether peer review of DTA studies published by imaging journals is associated with changes in completeness of reporting, transparency for risk of bias assessment, and spin. Retrospective cross-sectional study. Cross-sectional study of articles published in Journal of Magnetic Resonance Imaging (JMRI), Canadian Association of Radiologists Journal (CARJ), and European Radiology (EuRad) before March 31, 2020. Initial submitted and final versions of manuscripts were evaluated for completeness of reporting using the Standards for Reporting Diagnostic Accuracy Studies (STARD) 2015 and STARD for Abstracts guidelines, transparency of reporting for risk of bias assessment based on Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2), and actual and potential spin using modified published criteria. Two-tailed paired t-tests and paired Wilcoxon signed-rank tests were used for comparisons. A P value <0.05 was considered to be statistically significant. We included 84 diagnostic accuracy studies accepted by three journals between 2014 and 2020 (JMRI = 30, CARJ = 23, and EuRad = 31) of the 692 which were screened. Completeness of reporting according to STARD 2015 increased significantly between initial submissions and final accepted versions (average reported items: 16.67 vs. 17.47, change of 0.80 [95% confidence interval 0.25-1.17]). No significant difference was found for the reporting of STARD for Abstracts (5.28 vs. 5.25, change of -0.03 [-0.15 to 0.11], P = 0.74), QUADAS-2 (6.08 vs. 6.11, change of 0.03 [-1.00 to 0.50], P = 0.92), actual "spin" (2.36 vs. 2.40, change of 0.04 [0.00 to 1.00], P = 0.39) or potential "spin" (2.93 vs. 2.81, change of -0.12 [-1.00 to 0.00], P = 0.23) practices. Peer review is associated with a marginal improvement in completeness of reporting in published imaging DTA studies, but not with improvement in transparency for risk of bias assessment or reduction in spin. 3 TECHNICAL EFFICACY STAGE: 1.

Predictive Score of Nodal Involvement in Endometrial Cancer Patients: A Large Multicentre Series.

Sentinel lymph node (SLN) biopsy is considered the standard of care in early-stage endometrial cancer (EC). For SLN failure, a side-specific lymphadenectomy is recommended. Nevertheless, most hemipelvises show no nodal involvement. The authors previously published a predictive score of lymphovascular involvement in EC. In case of a negative score (value 3-4), the risk of nodal metastases was extremely low. This multicenter study aimed to analyze a predictive score of nodal involvement in EC patients. The study enrolled patients with EC who had received comprehensive surgical staging with nodal assessment. A preoperative predictive score of nodal involvement was calculated for all the patients before surgery. The score included myometrial infiltration, tumor grading (G), tumor diameter, and Ca125 assessment. The STARD (standards for Reporting Diagnostic accuracy studies) guidelines were followed for score accuracy. The study analyzed 1038 patients and detected 155 (14.9%) nodal metastases. The score was negative (3 or 4) for 475 patients and positive (5-7) for 563 of these patients. The score had a sensitivity of 83.2%, a specificity of 50.8%, a negative predictive value of 94.5%, and a diagnostic value of 55.7%. The area under the curve was 0.75. The logistic regression showed a significant correlation between a negative score and absence of nodal metastasis (odds ration [OR], 5.133, 95% confidence interval [CI], 3.30-7.98; p < 0.001). The proposed predictive score is a useful test to identify patients at low risk of nodal involvement. In case of SLN failure, the application of the current score in the SLN algorithm could allow avoidance of unnecessary lymphadenectomies.

Screening Tools for Cognitive Impairment in Adults with Substance Use Disorders: A Systematic Review.

Cognitive impairment is common in individuals with substance use disorders (SUDs), yet no evidence-based guidelines exist regarding the most appropriate screening measure for use in this population. This systematic review aimed to (1) describe different cognitive screening measures used in adults with SUDs, (2) identify substance use populations and contexts these tools are utilised in, (3) review diagnostic accuracy of these screening measures versus an accepted objective reference standard, and (4) evaluate methodology of included studies for risk of bias. Online databases (PsycINFO, MEDLINE, Embase, and CINAHL) were searched for relevant studies according to pre-determined criteria, and risk of bias and applicability was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). At each review phase, dual screening, extraction, and quality ratings were performed. Fourteen studies met inclusion, identifying 10 unique cognitive screening tools. The Montreal Cognitive Assessment (MoCA) was the most common, and two novel screening tools (Brief Evaluation of Alcohol-Related Neuropsychological Impairments [BEARNI] and Brief Executive Function Assessment Tool [BEAT]) were specifically developed for use within SUD populations. Twelve studies reported on classification accuracy and relevant psychometric parameters (e.g., sensitivity and specificity). While several tools yielded acceptable to outstanding classification accuracy, there was poor adherence to the Standards for Reporting Diagnostic Accuracy Studies (STARD) across all studies, with high or unclear risk of methodological bias. While some screening tools exhibit promise for use within SUD populations, further evaluation with stronger methodological design and reporting is required. Clinical recommendations and future directions for research are discussed.

Diagnostic accuracy and suitability of instruments that screen for obstructive sleep apnoea, insomnia and sleep quality in cardiac patients: a meta-analysis

BackgroundA number of clinical guidelines recommend that all cardiac rehabilitation patients should be screened for potential sleep disorders with a validated screening instrument. There is currently no consensus on what specific tools should be used. ObjectiveTo identify tools that are practical to use in the clinical environment and have high diagnostic accuracy. MethodsWe systematically searched online databases to identify patient reported outcome instruments that have been used in published research studies to assess the likelihood of obstructive sleep apnoea (OSA) in cardiac patients. In studies that provided diagnostic data, these data were extracted and verified via an evidence-based diagnostic calculator. Where sufficient numbers of studies were available, a meta-analysis was conducted to determine pooled estimates of specificity, sensitivity and diagnostic odds ratios. Selected papers were qualitatively assessed using the Standards for Reporting Diagnostic accuracy studies (STARD). ResultsOf the 21 instruments identified, six detected likelihood of OSA, two assessed daytime sleepiness, five assessed insomnia and eight examined sleep quality. A meta-analysis of 14 studies that assessed diagnostic accuracy of moderate OSA, revealed moderate sensitivity for the Berlin Questionnaire, Sens = 0.49 (95% CI 0.45–0.52) and good sensitivity for the Stop-BANG, Sens = 0.93 (95% CI 0.87–0.96) but poor specificity at standard cut-off criteria. ConclusionThere are promising practical tools available to screen patients with OSA and other sleep disorders in cardiac rehabilitation settings, but specificity could be improved. Additional assessment of sleep quality may enhance prognostic ability with both OSA and insomnia screening.

Brief, Performance-Based Cognitive Screening in Youth Aged 12-25: A Systematic Review.

Cognitive screening is an efficient method of detecting cognitive impairment in adults and may signal need for comprehensive assessment. Cognitive screening is not, however, routinely used in youth aged 12-25, limiting clinical recommendations. The aims of this review were to describe performance-based cognitive screening tools used in people aged 12-25 and the contexts of use, review screening accuracy in detecting cognitive impairment relative to an objective reference standard, and evaluate the risk of bias of included studies. Electronic databases (Scopus, Medline, PsychINFO, and ERIC) were searched for relevant studies according to pre-determined criteria. Risk of bias was rated using the Quality Assessment of Diagnostic Accuracy Studies-2. Dual screening, extraction, and quality ratings occurred at each review phase. Twenty studies met the review inclusion criteria. A diverse range of screening tools (length, format) were used in youth aged 12-25 with or without health conditions. Six studies investigating cognitive screening were conducted as primary accuracy studies and reported some relevant psychometric parameters (e.g., sensitivity and specificity). Fourteen studies presented correlational data to investigate the cognitive measure utility. Studies generally presented limited data on classification accuracy, which impacted full screening tool appraisal. Risk of bias was high (or unclear) in most studies with poor adherence to the Standards for Reporting Diagnostic Accuracy Studies (STARD) criteria. Few, high quality studies have investigated the utility of cognitive screening in youth aged 12-25, with no screening measure emerging as superior at detecting cognitive impairment in this age group.

Detecting SARS-CoV-2 at point of care: preliminary data comparing loop-mediated isothermal amplification (LAMP) to polymerase chain reaction (PCR)

BackgroundA cost effective and efficient diagnostic tool for COVID-19 as near to the point of care (PoC) as possible would be a game changer in the current pandemic. We tested reverse transcription loop mediated isothermal amplification (RT-LAMP), a method which can produce results in under 30 min, alongside standard methods in a real-life clinical setting.MethodsThis prospective service improvement project piloted an RT-LAMP method on nasal and pharyngeal swabs on 21 residents of a high dependency care home, with two index COVID-19 cases, and compared it to multiplex tandem reverse transcription polymerase chain reaction (RT-PCR). We recorded vital signs of patients to correlate clinical and laboratory information and calculated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a single swab using RT-LAMP compared with the current standard, RT-PCR, as per Standards for Reporting Diagnostic Accuracy Studies (STARD) guidelines.ResultsThe novel method accurately detected 8/10 RT-PCR positive cases and identified a further 3 positive cases. Eight further cases were negative using both methods. Using repeated RT-PCR as a “gold standard”, the sensitivity and specificity of a single novel test were 80 and 73% respectively. PPV was 73% and NPV was 83%. Incorporating retesting of low signal RT-LAMP positives improved the specificity to 100%. We also speculate that hypothermia may be a significant early clinical sign of COVID-19.ConclusionsRT-LAMP testing for SARS-CoV-2 was found to be promising, fast and to work equivalently to RT-PCR methods. RT-LAMP has the potential to transform COVID-19 detection, bringing rapid and accurate testing to the PoC. RT-LAMP could be deployed in mobile community testing units, care homes and hospitals to detect disease early and prevent spread.

An Evaluation of Reporting Guidelines and Clinical Trial Registry Requirements Among Addiction Medicine Journals.

Robust methodology and ethical reporting are paramount for quality scientific research, but recently, that quality in addiction research has been questioned. Avenues to improve such research quality include adherence to reporting guidelines and proper usage of clinical trial registries. Reporting guidelines and clinical trial registries have been shown to lead researchers to more ethical and transparent methodology. To investigate the reporting guideline and clinical trial registration policies of addiction research journals and identify areas of improvement. We used Google Scholar Metrics' h-5 index to identify the top 20 addiction research journals. We then examined the instructions for authors from each journal to identify whether they required, recommended, or made no mention of trial registration and reporting guidelines, including the Consolidated Standards of Reporting Trials (CONSORT), Meta-Analysis of Observational Studies in Epidemiology (MOOSE), Quality of Reporting of Meta-analyses (QUOROM), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Standards for Reporting Diagnostic Accuracy Studies (STARD), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Animal Research: Reporting of In Vivo Experiments (ARRIVE), Case Reports (CARE), Consolidated Health Economic Evaluation Reporting Standards (CHEERS), Standards for Reporting Qualitative Research (SRQR), Standards for Quality Improvement Reporting Excellence (SQUIRE), Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), Consolidated Criteria for Reporting Qualitative Research (COREQ), Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD), Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P), and the International Committee of Medical Journal Editors (ICMJE) guidelines. We performed the same analysis regarding requirements for clinical trial registration. Of the 20 journals included in this study, 10 journals (50%) did not require adherence to any reporting guidelines. Trial registration followed a similar trend; 15 journals (75%) did not mention any form of trial or systematic review registration, and ClinicalTrials.gov was only recommended by only 1 journal (5%). Among top addiction medicine journals, required adherence to reporting guidelines and clinical trial registry policies remains substandard. A step toward fulfilling the National Institute on Drug Abuses' call for improvement in transparency and reproducibility within addiction research should include all journals adopting a strict reporting guideline and clinical trial registry adherence policy.

Use of Neurodynamic or Orthopedic Tension Tests for the Diagnosis of Lumbar and Lumbosacral Radiculopathies: Study of the Diagnostic Validity.

Background: Lumbar radiculopathy is a nerve root disorder whose correct diagnosis is essential. The objective of the present study was to analyze the reliability diagnostic validity of eight neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard. Methods: An epidemiological study of randomized consecutive cases which was observational, descriptive, transversal, double blinded and was conducted following the Standards for Reporting Diagnostic accuracy studies (STARD) declaration. The sample size was 864 participants. Internal and external validity (CI = 95%) and reliability, were calculated for all tests performed independently. The diagnostic validity of the combined and multiple tests in parallel was also calculated. Results: The analysis indicated that only two tests performed independently had external validity, but neither had reliability or precision. The Straight Leg Raise test and the Bragard test performed in a multiple parallel way showed high sensitivity (97.40%), high negative predictive value (PV− 96.64%) and external validity (Likelihood Ratio− 0.05). The combined test of the Slump test and the Dejerine’s triad had internal and external validity. Conclusions: The Straight Leg Raise test and the Bragard test performed in a multiple parallel way and the combined test of the Slump Test and the Dejerine’s triad have clinical validity to discard lumbar or lumbar-sacral radiculopathy.

Artificial intelligence abstracts from the European Congress of Radiology: analysis of topics and compliance with the STARD for abstracts checklist

ObjectivesTo analyze all artificial intelligence abstracts presented at the European Congress of Radiology (ECR) 2019 with regard to their topics and their adherence to the Standards for Reporting Diagnostic accuracy studies (STARD) checklist.MethodsA total of 184 abstracts were analyzed with regard to adherence to the STARD criteria for abstracts as well as the reported modality, body region, pathology, and use cases.ResultsMajor topics of artificial intelligence abstracts were classification tasks in the abdomen, chest, and brain with CT being the most commonly used modality. Out of the 10 STARD for abstract criteria analyzed in the present study, on average, 5.32 (SD = 1.38) were reported by the 184 abstracts. Specifically, the highest adherence with STARD for abstracts was found for general interpretation of results of abstracts (100.0%, 184 of 184), clear study objectives (99.5%, 183 of 184), and estimates of diagnostic accuracy (96.2%, 177 of 184). The lowest STARD adherence was found for eligibility criteria for participants (9.2%, 17 of 184), type of study series (13.6%, 25 of 184), and implications for practice (20.7%, 44 of 184). There was no significant difference in the number of reported STARD criteria between abstracts accepted for oral presentation (M = 5.35, SD = 1.31) and abstracts accepted for the electronic poster session (M = 5.39, SD = 1.45) (p = .86).ConclusionsThe adherence with STARD for abstract was low, indicating that providing authors with the related checklist may increase the quality of abstracts.

A Novel Approach for Differential Serodiagnosis between Zika and Dengue Viral Infection with Comprehensive Evaluation

Background: Diagnostic testing for Zika virus (ZIKV) or dengue virus (DENV) infection can be accomplished by a nucleic acid detection method; however, a negative result does not exclude infection due to the low virus titer during infection depending on the timing of sample collection. Therefore, a ZIKV- or DENV-specific serological assay is essential for the accurate diagnosis of patients and to prevent potential severe health outcomes. Methods: A retrospective study design with dual approaches of collecting human serum samples for testing was developed. All serum samples were extensively evaluated by using both non-infectious virus-like particles (VLPs) and soluble non-structural protein 1 (NS1) in the standard immunoglobulin M (IgM) antibody-capture enzyme-linked immunosorbent assay (MAC-ELISA). Findings: Both VLP- and NS1-MAC-ELISAs were found to have similar sensitivity for detecting anti-premembrane/envelope and NS1 antibodies from ZIKV-infected patient sera. Group cross reactive (GR)-antibody-ablated homologous fusion peptide-mutated (FP)-VLPs consistently showed higher P/N values than homologous wild-type VLPs. Therefore, FP-VLPs were used to develop the algorithm for differentiating ZIKV from DENV infection. Overall, the sensitivity and specificity of the FP-VLP-MAC-ELISA and the NS1-MAC-ELISA were each higher than 80% with no statistical significance. Interpretation: A novel approach to differentiate ZIKV from DENV infection serologically has been developed. The accuracy can reach up to 95% when combining both VLP and NS1 assays. In comparison to current guidelines using neutralization tests to measure ZIKV antibody, this approach can facilitate laboratory screening for ZIKV infection, especially in regions where DENV infection is endemic and capacity for neutralization testing does not exist. Funding Statement: Portions of this publication was made possible through support provided by the CDC intramural research fund and the Office of Infectious Disease, Bureau for Global Health, U.S. Agency for International Development, under the terms of an Interagency Agreement with CDC. The opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the CDC and U.S. Agency for International Development. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: This study was conducted and reported in accordance with the Standards for Reporting Diagnostic Accuracy Studies (STARD) guidelines. Informed consent documents for all eligible participants were waived based on the protocol number 6874. An institutional review board (IRB) waiver to use this serum panel for research purposes was approved by the CDC-human studies review board.

The reporting quality of studies of diagnostic accuracy in the urologic literature.

High-quality evidence regarding questions of diagnostic accuracy relies on transparent reporting of study results. The quality of reporting for such studies in the urologic literature is unknown. In accordance with an a priori protocol, we systematically searched for all articles on diagnostic accuracy studies published in four major urologic journals in 2015. Using the 2015 STAndards for Reporting Diagnostic accuracy studies (STARD) checklist, two of us independently abstracted data. For each article, we calculated STARD summary scores (scale of 0-30, with higher scores reflecting higher-quality reporting). We compared scores by journal, topic, and sample size. We screened 819 references of which 61 met inclusion criteria. Nearly two-thirds of studies (39/61%; 63.9%) addressed prostate cancer diagnosis or staging; less than one in ten (6/61%; 9.8%) was conducted in non-oncological disease settings. The major focus for the investigation of new index tests lay in imaging modalities (33/61%; 54.1%); over half of these imaging studies addressed magnetic resonance imaging (18/61%; 29.5%). The average STARD score was 18.9 ± 2.4 (range 12-24). Six criteria had poor reporting compliance and were met by less than 20% of studies. We found no association between reporting quality and topic, journal or study size. The reporting quality of studies of diagnostic accuracy appears modest and independent of topic, journal or study size. There is an urgent need for greater awareness for the reporting quality of these studies among readers, editors, and investigators to raise evidentiary standards on issues of diagnosis.

Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations.

The diagnosis of acute human immunodeficiency virus (HIV) infection (AHI) plays a unique role in preventing the spread of HIV and ending the epidemic. Acutely infected individuals are thought to contribute substantially to forward transmissions of HIV; however, diagnosing AHI in resource-limited settings has proven to be a challenge. While fourth generation antigen-antibody combination assays have been successful in high-resource settings, rapid point of care (POC) versions of these assays have yet to demonstrate high sensitivity to detect AHI. Newer RNA/DNA based POC technologies are being validated, but the challenge to understand the additional value of these devices depends on the quality of study evaluations, in particular choice of study designs and case mix of included populations. In this commentary, we aimed to review the quality of studies evaluating a new fourth generation rapid test for detecting AHI, to identify general methodological limitations and biases in diagnostic accuracy studies, and to recommend strategies for avoiding them in future evaluations. The new studies that were evaluated continued to report the same weaknesses and biases that were seen in previous evaluations of fourth generation rapid tests. We recommend that investigators design future studies carefully, keeping in mind how diagnostic performance may be influenced by prevalence, population, patient case mixes, and reference standards. Care must be taken to avoid biases specific to diagnostic accuracy studies (spectrum, verification, incorporation and reference standard biases). To improve on quality, reporting checklists and guidelines such as Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Standards for Reporting Diagnostic accuracy studies (STARD) should be reviewed prior to conducting studies.

A STAR-Document for those interested in evaluating diagnostic research studies.

First, let me disclose that the Standards for Reporting Diagnostic Accuracy Studies (STARD) 2003 statement was published and endorsed by Clinical Biochemistry (1). Second, I will also disclose that I was doing my training in clinical chemistry during that time and I did not truly appreciate the importance of this document. Quite the omission, considering the Editor-in-Chief of Clinical Biochemistry at that time was also my supervisor.