STARD Guidelines Research Articles

Performance of An Automated Algorithm in Large and Medium Vessel Occlusion Detection: A Real-World Experience.

Fast, accurate detection of large (LVO) and medium vessel occlusion (MeVO) is critical for triage and management of acute ischemic stroke. Multiple AIbased software products are commercially available. However, their strengths and limitations for detection of vessel occlusion in the context of expanding indications for mechanical thrombectomy are not entirely understood. We aimed to investigate the performance of a fully automated commercial detection algorithm to identify large and medium vessel occlusions in Code Stroke patients. We utilized a single-center, institutional, retrospective registry of all consecutive code stroke patients with CTA and automated processing using Viz.ai presenting at a comprehensive stroke center between March 2020 and February 2023. LVO was categorized as anterior LVO (aLVO), defined as occlusion of the intracranial internal cerebral artery or M1-middle cerebral artery (MCA), and posterior LVO (pLVO), defined as occlusion of the basilar artery or V4-vertebral artery. MeVO was defined as occlusion of the M2-MCA, A1/A2-anterior cerebral artery, or P1/P2-posterior cerebral artery. Reports from 12 board-certified radiologists were considered the gold standard. We analyzed the performance of the automated algorithm using STARD guidelines. Our primary outcome was accuracy of anterior LVO (aLVO) by the software. Secondary outcomes were accuracy of the software to detect three additional categories: all LVO (aLVO and pLVO), aLVO with M2-MCA, and aLVO with MeVO. Of 3,590 code stroke patients, 3,576 were technically sufficient for analysis by the automated software (median age 67 years; 51% female; 68% White), of which 616 (17.2%) had vessel occlusions. The respective sensitivity and specificity for all four pre-specified categories were: aLVO: 91% (87-94%), 93% (92-94%); all LVO: 73% (68-77%), 92% (91-93%); aLVO with M2-MCA:74% (70-78%), 93% (92-94%); aLVO with all MeVO: 65% (61-69%), and 93% (92-94%). The automated algorithm demonstrated high accuracy in identifying anterior LVO with lower performance for pLVO and MeVO. It is crucial for acute stroke teams to be aware of the discordance between automated algorithm results and true rates of LVO and MeVO for timely diagnosis and triage. LVO = large vessel occlusion; aLVO = anterior large vessel occlusion; pLVO = posterior large vessel occlusion; MeVO = medium vessel occlusion; EVT= endovascular thrombectomy; AI = artificial intelligence; ACA = anterior cerebral artery; PCA = posterior cerebral artery; BA = basilar artery; VA = vertebral artery.

Comparison of diagnostic accuracy of rapid antigen tests for COVID19 compared to the viral genetic test in adults: a systematic review and meta-analysis.

The objective of this review is to determine the diagnostic accuracy of the currently available and upcoming point-of-care rapid antigen tests (RATs) used in primary care settings relative to the viral genetic real-time reverse transcriptase polymerase chain reaction (RT-PCR) test as a reference for diagnosing COVID-19/SARS-CoV-2 in adults. Accurate COVID-19 point-of-care diagnostic tests are required for real-time identification of SARS-CoV-2 infection in individuals. Real-time RT-PCR is the accepted gold standard for diagnostic testing, requiring technical expertise and expensive equipment that are unavailable in most primary care locations. RATs are immunoassays that detect the presence of a specific viral protein, which implies a current infection with SARS-CoV-2. RATs are qualitative or semi-quantitative diagnostics that lack thresholds that provide a result within a short time frame, typically within the hour following sample collection. In this systematic review, we synthesized the current evidence regarding the accuracy of RATs for detecting SARS-CoV-2 compared with RT-PCR. Studies that included nonpregnant adults (18 years or older) with suspected SARS-CoV-2 infection, regardless of symptomology or disease severity, were included. The index test was any available SARS-CoV-2 point-of-care RAT. The reference test was any commercially distributed RT-PCR-based test that detects the RNA genome of SARS-CoV-2 and has been validated by an independent third party. Custom or in-house RT-PCR tests were also considered, with appropriate validation documentation. The diagnosis of interest was COVID-19 disease and SARS-CoV-2 infection. This review considered cross-sectional and cohort studies that examined the diagnostic accuracy of COVID-19/SARS-CoV-2 infection where the participants had both index and reference tests performed. The keywords and index terms contained in relevant articles were used to develop a full search strategy for PubMed and adapted for Embase, Scopus, Qinsight, and the WHO COVID-19 databases . Studies published from November 2019 to July 12, 2022, were included, as SARS-CoV-2 emerged in late 2019 and is the cause of a continuing pandemic. Studies that met the inclusion criteria were critically appraised using QUADAS-2. Using a customized tool, data were extracted from included studies and were verified prior to analysis. The pooled sensitivity, specificity, positive predictive, and negative predictive values were calculated and presented with 95% CIs. When heterogeneity was observed, outlier analysis was conducted, and the results were generated by removing outliers. Meta-analysis was performed on 91 studies of 581 full-text articles retrieved that provided true-positive, true-negative, false-positive, and false-negative values. RATs can identify individuals who have COVID-19 with high reliability (positive predictive value 97.7%; negative predictive value 95.2%) when considering overall performance. However, the lower level of sensitivity (67.1%) suggests that negative test results likely need to be retested through an additional method. Most reported RAT brands had only a few studies comparing their performance with RT-PCR. Overall, a positive RAT result is an excellent predictor of a positive diagnosis of COVID-19. We recommend that Roche's SARS-CoV-2 Rapid Antigen Test and Abbott's BinaxNOW tests be used in primary care settings, with the understanding that negative results need to be confirmed through RT-PCR. We recommend adherence to the STARD guidelines when reporting on diagnostic data. PROSPERO CRD42020224250.

Accuracy of the Wound Healing Questionnaire in the diagnosis of surgical-site infection after abdominal surgery in low- and middle-income countries.

Telemedicine is being adopted for postoperative surveillance but requires evaluation for efficacy. This study tested a telephone Wound Healing Questionnaire (WHQ) to diagnose surgical site infection (SSI) after abdominal surgery in low- and middle-income countries. A multi-centre, international, prospective study was embedded in the FALCON trial; a factorial RCT testing measures to reduce SSI in seven low- and middle-income countries (NCT03700749). It was conducted according to a pre-registered protocol (SWAT126) and reported according to STARD guidelines. The reference test was in-person review by a trained clinician at 30 postoperative days according to US Centres for Disease Control criteria. The index test was telephone administration of an adapted WHQ at 27 to 30 postoperative days by a researcher blinded to the outcome of in-person review. The sum of item response scores generated an overall score between 0 and 29. The primary outcome was the diagnostic accuracy of the WHQ, defined as the proportion of SSI correctly identified by the telephone WHQ, and summarized using the area under the receiving operator characteristic curve (AUROC) and diagnostic test accuracy statistics. Patients were included from three upper-middle income (396 patients, 13 hospitals), three lower-middle income (746 patients, 19 hospitals), and one low-income country (54 patients, 4 hospitals). 90.3% (1088 of 1196) patients were successfully contacted. Those with non-midline incisions (adjusted odds ratio: 0.36, 95% c.i. 0.17 to 0.73, P=0.005) or a confirmed diagnosis of SSI on in-person assessment (odds ratio: 0.42, 95% c.i. 0.20 to 0.92, P=0.006) were harder to reach. The questionnaire correctly discriminated between most patients with and without SSI (AUROC 0.869, 95% c.i. 0.824 to 0.914), which was consistent across subgroups. A representative cut-off score of ≥4 displayed a sensitivity of 0.701 (0.610-0.792), specificity of 0.911 (0.878-0.943), positive predictive value of 0.723 (0.633-0.814) and negative predictive value of 0.901 (0.867-0.935). SSI can be diagnosed using a telephone questionnaire (obviating in-person assessment) in low resource settings.

STROBE, CONSORT, PRISMA, MOOSE, STARD, SPIRIT, and other guidelines - Overview and application.

The purpose of research is to seek answers and new knowledge. When conducted properly and systematically, research adds to humanity's corpus of knowledge and hence to our general advancement. However, this is only possible if reported research is accurate and transparent. Guidelines for all the major types of studies (STROBE, CONSORT, PRISMA, MOOSE, STARD, and SPIRIT) have been developed and refined over the years, and their inception, development, and application are briefly discussed in this paper. Indeed, there are currently over 250 of these guidelines for various types of medical research, and these are published by the EQUATOR network. This paper will also briefly review progress in acceptance and adoption of these guidelines.

Computed tomography improves the diagnostic accuracy but not the interobserver reliability of the Boileau classification of proximal humerus fracture sequelae.

The aim of this study was to investigate the impact of computed tomography on the reliability of Boileau classification for proximal humerus fracture sequelae. A prospective study was designed using STARD guidelines. We included all patients diagnosed with proximal humerus fracture sequelae who underwent surgery at our institution between 2017 and 2021. Preoperative radiographs and computed tomography scans were reviewed by three independent observers. Intra- and inter-observer reliability and the diagnostic accuracy of radiographs and computed tomography scans in detecting chronic dislocation, nonunion, and severe greater tuberosity dislocation were assessed. Fifty-two patients were included in the study. The overall interobserver agreement was low on both radiographs and computed tomography scans. On radiographic images, we found a sensitivity of 97%, 88.9%, and 84.1%, and a specificity of 58.3%, 40%, and 53.3% to detect chronic dislocation, nonunion, and greater tuberosity dislocation, respectively. On computed tomography scans we reported a sensitivity of 100%, 96.8%, and 93.7%, and a specificity of 91.7%, 86.7%, and 93.3% to detect chronic dislocation, nonunion, and greater tuberosity dislocation, respectively. Computed tomography scan was more specific than radiographs in the assessment of proximal humerus fracture sequelae. However, even using a three-dimensional evaluation of the deformity, the Boileau classification had a poor interobserver reliability. I. Testing previously developed diagnostic criteria in a consecutive series of patients and a universally applied "gold standard."

Role of Lung Ultrasound in Confirmation of Double Lumen Endotracheal Tube Placement for Thoracic Surgeries: A Prospective Diagnostic Accuracy Study.

In thoracic surgeries requiring thoracotomy incisions, correct positioning of the double-lumen endotracheal tube (DLT) is mandatory. After the pandemic of novel COVID-19, using simple, noninvasive technology such as lung ultrasound (LUS) can be important in avoiding the possibility of spreading infectious diseases or contagious infections that can follow using fiberoptic bronchoscopy (FOB). We aimed to assess the accuracy of auscultation and LUS in relation to FOB in the assessment of DLT placement and to identify the possibility of using LUS as an alternative to FOB during DLT insertion. This diagnostic accuracy study was conducted according to STARD guidelines; enrolled 120 cases requiring DLT intubation. After DLT insertion, all patients were examined by stethoscope, then by LUS for determination of DLT position, and then confirmed by FOB in the same patient. Three patients dropped out due to failed intubation, and only 117 cases were analyzed. Time was significantly longer for LUS than for auscultation and FOB and was insignificantly different between auscultation and FOB. Auscultation had 76.14% sensitivity, 34.48% specificity, and 65.81% accuracy in the determination of correct DLT placement. LUS had 92.05% sensitivity, 79.31% specificity, and 88.89% accuracy in detecting correct DLT placement. There was substantial agreement between LUS and FOB (κ = 0.705) and poor agreement between auscultation and FOB (κ = 0.104). LUS can be used as a simple, noninvasive tool for detecting DLT placement with a substantial agreement with FOB.

Prognostic accuracy of head computed tomography for prediction of functional outcome after out-of-hospital cardiac arrest: Rationale and design of the prospective TTM2-CT-substudy

BackgroundHead computed tomography (CT) is a guideline recommended method to predict functional outcome after cardiac arrest (CA), but standardized criteria for evaluation are lacking. To date, no prospective trial has systematically validated methods for diagnosing hypoxic-ischaemic encephalopathy (HIE) on CT after CA. We present a protocol for validation of pre-specified radiological criteria for assessment of HIE on CT for neuroprognostication after CA. Methods/designThis is a prospective observational international multicentre substudy of the Targeted Hypothermia versus Targeted Normothermia after out-of-hospital cardiac arrest (TTM2) trial. Patients still unconscious 48 hours post-arrest at 13 participating hospitals were routinely examined with CT. Original images will be evaluated by examiners blinded to clinical data using a standardized protocol. Qualitative assessment will include evaluation of absence/presence of “severe HIE”. Radiodensities will be quantified in pre-specified regions of interest for calculation of grey-white matter ratios (GWR) at the basal ganglia level. Functional outcome will be dichotomized into good (modified Rankin Scale 0–3) and poor (modified Rankin Scale 4–6) at six months post-arrest. Prognostic accuracies for good and poor outcome will be presented as sensitivities and specificities with 95% confidence intervals (using pre-specified cut-offs for quantitative analysis), descriptive statistics (Area Under the Receiver Operating Characteristics Curve), inter- and intra-rater reliabilities according to STARD guidelines. ConclusionsThe results from this prospective trial will validate a standardized approach to radiological evaluations of HIE on CT for prediction of functional outcome in comatose CA patients.The TTM2 trial and the TTM2 CT substudy are registered at ClinicalTrials.gov NCT02908308 and NCT03913065.

MicroRNAs as diagnostic biomarkers for Tuberculosis: A systematic review and meta- analysis.

BackgroundThe early diagnosis of tuberculosis using novel non-sputum-based biomarkers is of high priority in the End TB strategy. MicroRNAs (miRNAs) are significant regulators of TB pathogenesis and their differential expression pattern among healthy, latent, and active TB population has revealed their potentiality as biomarkers in recent studies. Thus, we systematically reviewed and performed a meta-analysis on the role of host miRNAs in TB diagnosis. We also reviewed the involvement of miRNAs in the immune response to Mycobacterium tuberculosis (Mtb).MethodsPubmed, Ovid and Cochrane databases were searched to retrieve published literature from 2000 to 2020 using predefined keywords. We screened relevant studies based on inclusion and exclusion criteria and the included studies were assessed for their quality using STARD guidelines and QUADAS-2 tool. Funnel plots were constructed to assess the publication bias. The heterogeneity of studies and overall pooled results of sensitivity, specificity and DOR were determined using forest plots.ResultsWe retrieved a total of 447 studies collectively from all the databases, out of which 21 studies were included for qualitative analysis. In these studies, miR-29, miR-31, miR-125b, miR146a and miR-155 were consistently reported. The overall sensitivity, specificity and DOR of these miRNAs were found to be 87.9% (81.7-92.2), 81.2% (74.5-86.5) and 43.1(20.3-91.3) respectively. Among these, miR-31 had the maximum diagnostic accuracy, with a sensitivity of 96% (89.7-98.5), specificity of 89% (81.2-93.8) and DOR of 345.9 (90.2-1326.3), meeting the minimal target product profile (TPP) for TB diagnostics.ConclusionmiRNAs can thus be exploited as potential biomarkers for rapid detection of tuberculosis as evident from their diagnostic performance. Systematic Review Registration https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021226559 PROSPERO (CRD42021226559).

Has the STARD statement improved the quality of reporting of diagnostic accuracy studies published in European Radiology?

ObjectivesTo investigate whether encouraging authors to follow the Standards for Reporting Diagnostic Accuracy (STARD) guidelines improves the quality of reporting of diagnostic accuracy studies.MethodsIn mid-2017, European Radiology started encouraging its authors to follow the STARD guidelines. Our MEDLINE search identified 114 diagnostic accuracy studies published in European Radiology in 2015 and 2019. The quality of reporting was evaluated by two independent reviewers using the revised STARD statement. Item 11 was excluded because a meaningful decision about adherence was not possible. Student’s t test for independent samples was used to analyze differences in the mean number of reported STARD items between studies published in 2015 and in 2019. In addition, we calculated differences related to the study design, data collection, and citation rate.ResultsThe mean total number of reported STARD items for all 114 diagnostic accuracy studies analyzed was 15.9 ± 2.6 (54.8%) of 29 items (range 9.5–22.5). The quality of reporting of diagnostic accuracy studies was significantly better in 2019 (mean ± standard deviation (SD), 16.3 ± 2.7) than in 2015 (mean ± SD, 15.1 ± 2.3; p < 0.02). No significant differences in the reported STARD items were identified in relation to study design (p = 0.13), data collection (p = 0.87), and citation rate (p = 0.09).ConclusionThe quality of reporting of diagnostic accuracy studies according to the STARD statement was moderate with a slight improvement since European Radiology started to recommend its authors to follow the STARD guidelines.Key Points• The quality of reporting of diagnostic accuracy studies was moderate with a mean total number of reported STARD items of 15.9 ± 2.6.• The adherence to STARD was significantly better in 2019 than in 2015 (16.3 ± 2.7 vs. 15.1 ± 2.3; p = 0.016).• No significant differences in the reported STARD items were identified in relation to study design (p = 0.13), data collection (p = 0.87), and citation rate (p = 0.09).

Guidelines for reporting diagnostic accuracy studies of Siddha anthropometric tool Manikkadai Nool

Background: Manikkadai-Nool (MK) is an ancient Siddha treatise of Anthropometric based predictions very much acclaimed for its diagnostic value in clinical practice. A well-set protocol is lacking for the methodology, limiting its expected outcome of predictive values. Moreover, the systematic approach of case reporting pertaining to its diagnostic accuracy studies (DAS) is showing many pitfalls. This purposes the induction of guidelines particular to MK that covers the entire aspects of case reporting. Materials and Methods: Available case reporting guidelines for Diagnostic studies (STARD guidelines) were overlooked to develop the core elements for DAS with 9 sections including 24 items. Discussion: The enlisted 24 items of Siddha Anthropometric Tool (SAT) guidelines have been depicted with examples that enable physicians and researchers to accomplish clinical reporting based on MK with much ease and accuracy. The guidelines may help peer reviewers for evaluating the concerning studies. Conclusion: SAT guidelines improve the quality of studies pertaining to MK that imprints the lead for further scientific acceptance. Further periodical up-gradation is warranted.

Evaluation of head posture using an inertial measurement unit

An inertial measurement unit (IMU) is an electronic device that measures and track the orientation of a body. We conducted this study in accordance with the STARD guidelines to evaluate the accuracy of IMU (index test) for measuring head posture compared to the current gold standard using a cervical range of motion (CROM) device. The reproducibility of the hunter and mirror-guided head posture was also evaluated. In vitro and in vivo tests were carried out to assess the validity of the IMU. To assess reproducibility, thirty healthy young adults were asked to look at four different locations in two different sessions while the head posture was recorded. Excellent correlation (r = 0.99; p < 0.001) was found between the IMU and CROM device with an absolute mean difference of 0.45° ± 0.58° (p = 0.85) for the in vitro test and 0.88° ± 1.20° (p = 0.99) for the in vivo test. For the reproducibility test, moderate to good correlation coefficients were found (r = 0.55 to 0.89; all p < 0.05) between the two sessions. The intraclass correlation coefficient ranged from moderate to excellent reliability (ICC from 0.74 to 0.96). These results suggest that the IMU sensors, when calibrated correctly, can be adequate to analyze head posture.

Diagnostic performance of serology against histologic assessment to diagnose Sjogren’s syndrome: a systematic review

The objective of this review was to assess and evaluate whether the published diagnostic accuracy studies provide evidence to sustain the current diagnostic guidelines put forth by ACR/EULAR used for patients with suspected Sjögren's syndrome (SS). Literature databases, including Medline, Embase, and EBM Reviews, were searched for relevant studies on the correlation between ACR/EULAR criteria, particularly those with a direct comparison between their accuracy in diagnosing Sjögren's syndrome. We followed Cochrane, QUADAS-2, and STARD guidelines and the four-phase flow diagram by the PRISMA Statement. Reports in several languages, but only human studies were considered. Three studies assessed the accuracy of the current diagnostic tests, and these did not present adequate designs that would allow a well-supported conclusion with a high level of certainty. Due to significant clinical and methodological heterogeneity, a meta-analysis was not performed. A qualitative review of the papers was undertaken. Neither the comparative nor the non-comparative study designs permit conclusive recommendations regarding an alternative diagnostic pathway for SS. Well-designed studies of the diagnostic accuracy of SS tests are needed to validate current guidelines or to suggest changes to the current guidelines.

Examining the utility of the Violence Prevention Climate scale: In a metropolitan Australian general hospital.

To evaluate and examine the utility of the Violence Prevention Climate scale by generalist healthcare professionals. Workplace violence in general hospital settings remains a challenge for healthcare organisations. High rates of violence are still being reported towards healthcare workers, despite organisational violence prevention strategies being implemented. There is a major challenge to healthcare organisation in the measurement of the effectiveness of these interventions, traditionally completed via the reporting and monitoring of workplace violent incidents. A novel approach to measuring workplace violence is by studying hospital atmosphere or climate. A cross-sectional survey using the STARD guidelines was used. The Violence Prevention Climate scale was completed by 194 healthcare staff working in the emergency department, medical/surgical wards, respiratory/infectious disease, spinal care, renal unit, corrections health, and rehabilitation and community services of a major Australian tertiary referral hospital. The Violence Prevention Climate scale has previously been validated and used in mental health settings, but not general hospital settings. A content analysis of an open-ended question on violence prevention management strategies was also conducted. Comprising of 14 items with two factors (patients and staff), the study revealed a 9-item staff factor scale that can be used in the general hospital setting, the patient factor did not show adequate reliability. The content analysis revealed seven categories of staff identified violence prevention and management strategies. The use of the 9-item scale across an organisation annually, or added to existing organisational workforce surveys, could prove to be practical way of measuring the social climate of violence in a general hospital setting. The results of which could guide clinical practice, workplace safety, policy and educational initiatives for the prevention and management of workplace violence.

Tumour markers with clinically controlled cut-offs for suspected cancer.

Due to insufficient scientific evidence, panels of tumour markers (TMs) are currently not recommended for use in suspected cancer. However, recent well-designed studies have revealed a potential clinical value in lung cancer. We analysed the diagnostic accuracy of a panel of 11 circulating TMs with clinically controlled thresholds in the differentiation of cancer from nonmalignant diseases. We prospectively recruited 4776 consecutive patients presenting with focal or nonspecific symptoms suggestive of cancer who underwent testing for 11 serum TMs before diagnosis was known. The study abided by 2015 STARD guidelines. Tumour markers included, among others, carbohydrate antigen 19-9, carcinoembryonic antigen, alpha-fetoprotein, squamous cell carcinoma-associated antigen, prostate-specific antigen (males), neuron-specific enolase, progastrin-releasing peptide and carbohydrate antigen 125. Thresholds were adjusted for the presence of kidney failure, liver disease, effusions and dermatological disorders. Results showing ≥1 TMs with concentrations above threshold were considered positive. Benign diseases were diagnosed in 3281 (68.7%) patients and cancer in 1495 (31.3%), with epithelial cancers in 1214 (77% at stage IV). When applying criteria for controlled thresholds, overall specificity was 98%. Overall sensitivity of the panel in epithelial cancers was 72.2%, positive predictive value 93% and negative predictive value 90.5%. The area under the receiver operating characteristic curve was 0.920 (95% confidence interval, 0.902-0.924). By using clinically controlled cut-offs, the combined panel demonstrated an excellent ability to discriminate epithelial cancers from nonmalignant diseases. However, its use in clinical practice would need formal validation through a multicentre controlled trial assessing a panel-guided strategy vs. standard diagnosis.

Development and Validation of a Novel Scoring System for Noninvasive Nonalcoholic Steatohepatitis Detection in Bariatric Patients

Introduction: Nonalcoholic fatty liver disease covers a broad spectrum. Simple steatosis has usually a benign course while nonalcoholic steatohepatitis (NASH) can progress into hepatocellular carcinoma, and cirrhosis. Therefore, differentiating patients with benign steatosis and NASH is crucial. Liver biopsy, the usual gold standard for NASH diagnosis, cannot be used as a screening method due to its associated risks. This is especially problematic for obese patients with a prevalence of nonalcoholic fatty liver disease (NAFLD) in >80% of patients. The aim of this study was therefore to develop and validate a noninvasive NASH screening test in a cohort of high-risk, morbidly obese patients. Methods: This prospective study examined diagnostic accuracy in accordance with STARD guidelines. 112 liver biopsies were consecutively assigned to either a training or validation cohort. Using the Bedossa histological scoring system, the cohorts were subdivided into NASH versus NAFLD/No NAFLD. Predictors of NASH were evaluated with receiver operating characteristic (ROC) curves. A model was then constructed using a backward stepwise logistic regression and evaluated in an independent validation cohort. Results: 53.5% of the patients had NASH and 4 patients had cirrhosis. Mean body mass index (BMI) was 49.8 ± 7.5 kg/m². Backward stepwise logistic regression identified 4 parameters associated with the presence of NASH: alanin-aminotransferase, albumin, BMI, and triglycerides. The noninvasive NASH detection score (NI-NASH-DS) had an ROC of 0.851 and 0.727 in the training and validation cohorts, respectively. Sensitivity and specificity were 77.1% and 88% in the training cohort and 88% and 48% in the validation cohort which was much better than the established noninvasive scores. Discussion/Conclusion: The NI-NASH-DS is easy-to-use, inexpensive, and noninvasive and can reliably detect NASH in patients with morbid obesity. Due to its simplicity, it can be used frequently and repeatedly.

Diagnostic accuracy of patient-reported dry mouth as a predictor for oral dryness in terminally ill cancer patients.

The aim of the study was to determine the diagnostic accuracy of patient-reported dry mouth using an oral moisture-checking device in terminally ill cancer patients. The study was conducted following the STARD guidelines, and the participants were recruited prospectively from the Palliative Care Unit, Kyoto Medical Center, Japan, between 1 January 2017 and 30 November 2018. Patients reporting dry mouth were asked to rate oral dryness on a 5-point rating scale. The outcome was oral dryness at the lingual mucosa, measured using an oral moisture-checking device. Receiver operating characteristic (ROC) curves were plotted, and the sensitivity, specificity, positive and negative predictive values (PPV and NPV), positive and negative likelihood ratios (LR), and overall diagnostic accuracy were calculated. Of 103 participants, the prevalence of oral dryness was 65.0%. ROC analysis indicated that patient-reported dry mouth was a poor predictor of oral dryness, with an area under the curve of 0.616 (95% confidence interval: 0.508-0.723), a sensitivity of 46.3%, a specificity of 75.8%, a PPV of 55.9%, an NPV of 68.1, a positive LR of 1.9, a negative LR of 0.7, and an overall diagnostic accuracy of 64.1%, with a cut-off value of 3 points. In conclusion, patient-reported dry mouth is not a useful parameter for the assessment of oral dryness in terminally ill cancer patients.

Deep Learning for Diagnostic Binary Classification of Multiple-Lesion Skin Diseases.

Background: Diagnosis of skin diseases is often challenging and computer-aided diagnostic tools are urgently needed to underpin decision making.Objective: To develop a convolutional neural network model to classify clinically relevant selected multiple-lesion skin diseases, this in accordance to the STARD guidelines.Methods: This was an image-based retrospective study using multi-task learning for binary classification. A VGG-16 model was trained on 16,543 non-standardized images. Image data was distributed in training set (80%), validation set (10%), and test set (10%). All images were collected from a clinical database of a Danish population attending one dermatological department. Included was patients categorized with ICD-10 codes related to acne, rosacea, psoriasis, eczema, and cutaneous t-cell lymphoma.Results: Acne was distinguished from rosacea with a sensitivity of 85.42% CI 72.24–93.93% and a specificity of 89.53% CI 83.97–93.68%, cutaneous t-cell lymphoma was distinguished from eczema with a sensitivity of 74.29% CI 67.82–80.05% and a specificity of 84.09% CI 80.83–86.99%, and psoriasis from eczema with a sensitivity of 81.79% CI 78.51–84.76% and a specificity of 73.57% CI 69.76–77.13%. All results were based on the test set.Conclusion: The performance rates reported were equal or superior to those reported for general practitioners with dermatological training, indicating that computer-aided diagnostic models based on convolutional neural network may potentially be employed for diagnosing multiple-lesion skin diseases.

Serie de Redacción Científica: Estudios Trasversales

Los estudios transversales se caracterizan por la medición simultánea de la exposición y el outcome de interés. Son el diseño idóneo para estimar prevalencias, analizar la precisión diagnóstica de una prueba y validar instrumentos, para lo cual es esencial controlar los sesgos de información, selección y confusión ya sea por diseño o por análisis. Asimismo, es crucial escoger la medida de asociación idónea para cada outcome de interés, llámese el odds ratio para eventos raros y la razón de prevalencias para los eventos frecuentes. Finalmente, para su redacción y publicación se recomienda revisar las guías STROBE y STARD

Ultrasound and CT in the Diagnosis of Appendicitis: Accuracy With Consideration of Indeterminate Examinations According to STARD Guidelines.

OBJECTIVE. The objective of our study was to determine the accuracy of ultrasound (US) and CT in diagnosing appendicitis at our institution while taking into account the number of indeterminate examinations in accordance with the Standards for Reporting Diagnostic Accuracy (STARD) guidelines. MATERIALS AND METHODS. We retrospectively evaluated 790 patients who underwent US, CT, or both for evaluation of suspected appendicitis between May 1, 2013, and April 30, 2015. Patient characteristics and US and CT examination results were recorded. The reference standard was histopathology or 3 months of medical record follow-up if surgery was not performed; 3 × 2 tables were generated, and sensitivity, specificity, overall test yield, and accuracy were calculated according to STARD guidelines. For surgical cases, time to surgery (one-way ANOVA) was compared among patients who underwent US alone, CT alone, or both US and CT. RESULTS. A total of 473 of 562 US examinations had indeterminate findings (overall test yield, 15.8%); sensitivity and specificity in the 89 diagnostic examinations were 98.5% and 54.2%, respectively. Thirteen of 522 CT examinations were indeterminate (overall test yield, 97.5%); sensitivity and specificity in the remaining 509 CT examinations were 98.9% and 97.2%, respectively. Taking indeterminate studies into account, the accuracy was 13.7% for US and 95.6% for CT. The negative appendectomy rates were 17.7% (11/62) for US and 3.3% (9/276) for CT (p = 0.0002). Time to surgery was longer for patients who underwent US and CT (mean ± SD, 17.7 ± 8.9 hours) than US alone (12.9 ± 6.4 hours; p = 0.002) but was not longer for patients who underwent CT alone (16.3 ± 8.4 hours; p = 0.45). CONCLUSION. At our institution, a large proportion of US examinations are indeterminate for appendicitis. CT is the preferred first-line imaging test for evaluating appendicitis in nonobstetric adult patients.

Detecting SARS-CoV-2 at Point of Care: Preliminary Data Comparing Loop-Mediated Isothermal Amplification (LAMP) to PCR

Background: The need for a fast and reliable test for COVID-19 is paramount in managing the current pandemic. A cost effective and efficient diagnostic tool as near to the point of care (PoC) as possible would be a game changer in current testing. We tested reverse transcription loop mediated isothermal amplification (RT-LAMP), a method which can produce results in under 30 minutes, alongside standard methods in a real-life clinical setting. Methods: This service improvement project piloted a research RT-LAMP method on nasal and pharyngeal swabs on 21 residents in an NHS Category 1 care home, with two index COVID-19 cases, and compared it to multiplex tandem reverse transcription polymerase chain reaction (RT-PCR). We calculated the sensitivity, specificity, positive and negative predictive values of a single RT-LAMP swab compared to RT-PCR, as per STARD guidelines. We also recorded vital signs of patients to correlate clinical and laboratory information. Findings: The novel method accurately detected 8/10 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 the novel test were 80% and 73% respectively. Positive predictive value (PPV) was 73% and negative predictive value (NPV) was 83%. We also observed hypothermia to be a significant early clinical sign in a number of COVID-19 patients in this setting. Interpretation: RT-LAMP testing for SARS-CoV-2 was found to be promising, fast, easy to use and to work equivalently to RT-PCR methods. Definitive studies to evaluate this method in larger cohorts are underway. RT-LAMP has the potential to transform COVID-19 detection, bringing rapid and accurate testing to the point of care. This method could be deployed in mobile testing units in the community, care homes and hospitals to detect disease early and prevent spread.