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Background: 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. Purpose: 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. Study Type: Retrospective cross-sectional study. Study Sample: 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. Assessment: 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. Statistical Tests: Two-tailed paired t-tests and paired Wilcoxon signed-rank tests were used for comparisons. A P value

Poster session 3, September 23, 2022, 12:30 PM - 1:30 PM Background Cryptococcal meningitis (CM) remains a leading cause of HIV-related meningoencephalitis in African low- and middle-income countries (LMICs), causing 15%-20% of HIV-related deaths. Rapid Diagnostic Tests (RDTs) are powerful tools and key to speeding-up the diagnosis at the bedside, allowing for rapid and targeted treatment, especially in LMICs. For the past 10 years, Cryptococcal Antigen (CrAg) RDTs have a major role in CM management. Driving Reduced AIDS Meningo-Encephalitis Mortality (DREAMM) was a multicenter implementation science study and a capacity-building project to reduce the mortality of HIV-related central nervous system infections (CNS). One of the main DREAMM approaches was to improve the diagnosis of CNS infections at the bedside and in parallel in local laboratories. Within DREAMM, HIV-infected, adult people living with HIV (>18 years old) with suspected CNS infections were recruited in five hospital sites in Cameroon, Malawi, and Tanzania. Objectives Our objective was to evaluate the implementation of CrAg CryptoPS (Biosynex, Illkirch Graffenstaden, France), a new semi-quantitative RDT, in routine care settings in Sub-Saharan Africa. Methods All CrAg CryptoPS performed were compared to the reference CrAg lateral flow assay (Immy®). The evaluation was done by the local research teams in four DREAMM laboratories sites. CrAg CryptoPS's implementation was evaluated in 301 plasma samples and 258 cerebrospinal fluid (CSF) samples from 320 participants (patients diagnosed with cerebral toxoplasmosis did not have a lumbar puncture). In this analysis, the results will be considered in a binary way (positive/negative). Results Between January 2018 and March 2021, 356 participants were prospectively enrolled with suspected HIV-related CNS infections, including CM, tuberculous meningitis, cerebral toxoplasmosis, and bacterial meningitis cases. Cryptococcal meningitis was the leading cause of CNS infections in Malawi and Tanzania with 66.3% (53/80) and 59.6% (59/99) cases respectively, and the second cause in Cameroon with 40.0% (39/90) cases after cerebral toxoplasmosis. In plasma, CryptoPS's sensitivity was 99.23% (95% CI, 0.98-1.01) and specificity was 94.15% (95% CI, 0.91-0.98); positive and negative predictive values were 92.8% and 99.4%, respectively. In CSF, the sensitivity and specificity of CryptoPS were 100% (95% CI, 0.0-0.0), and 99.26% (95% CI, 0.98-1.01), respectively; positive and negative predictive values were both 100%. A low number of false-positives were observed ( Conclusion CryptoPS was evaluated in a context of hospitalized patients within a project including all causes of HIV-related CNS infection, not only CM. The sensitivity and specificity of CryptoPS calculated in these preliminary results are promising. Semi-quantitative CryptoPS has the potential to be used to tailor antifungal therapy but further optimizations need to be done prior to large-scale implementation in African LMICs. In addition, future work to determine CrAg antigen titres is planned, in the perspective to optimize treatment of CrAg positive cases who decline lumbar puncture.

S7.1 Update in management of fungal infection in adult hematology, September 23, 2022, 10:30 AM - 12:00 PM Background Bedside point-of-care (POC) testing, with parallel laboratory testing, represents a unique opportunity to improve and speed up the diagnostic workup of people living with HIV with suspected CNS infection in resource-limited settings. Objectives To assess the agreement between POC tests for Cryptococcus neoformans, Mycobacterium tuberculosis, and Streptococcus pneumoniae performed at the bedside and in the routine laboratory, in African low- and middle-income countries (LMICs). Methods From January 2018 to March 2021, the following POC tests were performed in parallel at the bedside and in the routine laboratory: Cryptococcal antigen lateral flow assay (CrAg LFA, Immy) in blood and cerebrospinal fluid (CSF), tuberculosis lipoarabinomannan (TB-LAM, Alere) in urine, and, where indicated, pneumococcal antigen (Streptococcus pneumoniae (SP), Biosynex) in CSF. Participants: HIV-infected adults (>18 years old) suspected of CNS infection. Setting: The prospective multicenter DREAMM project (Driving Reduced AIDS Meningo-Encephalitis Mortality) in five hospital sites in Cameroon, Malawi, and Tanzania. Primary outcome: Cohen's kappa statistic of agreement between the results of POC tests obtained at the bedside and the routine laboratory. Results The study included 356 consecutive participants (mean age 39.5 +/- 10 years; 68.7% ART-experienced; 46.3% male; median CD4 count 75/mm3; abnormal mental status 75%). In total, 148/355 (41.7%) participants had positive bedside CrAg in blood, 140/315 (44.4%) positive bedside CrAg in CSF, 64/339 (18.9%) positive bedside TB-LAM in urine, and 10/175 (5.7%) positive bedside SP in CSF. Kappa statistics evaluating agreement between bedside and laboratory test results were: 0.98 [95% confidence interval (CI) 0.96-1.00; n = 347] for blood CrAg, 0.99 (95%CI, 0.98-1.00; n = 307) for CSF CrAg, 0.92 (95% CI, 0.87-0.98; n = 330) for urinary TB-LAM, and 0.68 (95%CI, 0.40-0.96; n = 34) for CSF SP. Conclusions Bedside POC tests for Cryptococcus spp. are highly reliable and can be safely performed in parallel to laboratory testing to expedite targeted treatment in people living with HIV with suspected CNS infection in African LMICs. Other bedside POC tests need further evaluation before large-scale implementation.

The COVID-19 pandemic and the containment and mitigation measures taken were feared to be associated with increased child abuse.To investigate the trend of abusive head trauma (AHT) incidence and severity in infants during the COVID-19 pandemic.In a time-series analysis of a longitudinal, population-based, cohort study, all consecutive cases of AHT in infants younger than 12 months old referred between January 2017 and December 2021 to Necker Hospital for Sick Children, the single regional pediatric neurosurgery center for the Paris metropolitan area, were included. AHT was defined as 1 or more subdural hemorrhage and a positive multidisciplinary evaluation after a social, clinical, biological, and radiological workup. Data were analyzed from January to March 2022.The primary outcome was the monthly incidence of AHT, which was analyzed using Poisson regression modeling. Secondary outcomes included mortality and severe morbidity and were studied with logistic and linear regressions. The monthly incidence of neurosurgical interventions for hydrocephalus was used as a control series.Among the 99 included infants with AHT (median [IQR] age, 4 [3-6] months; 64 boys [65%]), 86 of 99 (87%) had bridging vein thrombosis, 74 of 99 (75%) had retinal hemorrhages, 23 of 72 (32%) had fractures, 26 of 99 (26%) had status epilepticus, 20 of 99 (20%) had skin injuries, 53 of 99 (54%) underwent neurosurgical interventions, and 13 of 99 (13%) died. Compared with the prepandemic period (2017-2019), AHT incidence was stable in 2020 (adjusted incidence rate ratio, 1.02; 95% CI, 0.59-1.77) and then significantly increased in 2021 (adjusted incidence rate ratio, 1.92; 95% CI, 1.23-2.99). The severity of AHT worsened in 2021 in terms of mortality (odds ratio 9.39; 95% CI, 1.88-47.00). Other secondary outcomes and the control series were not significantly modified.In this cohort study, a marked increase in AHT incidence and severity occurred during the COVID-19 pandemic in the Paris metropolitan area. These results suggest the need for clinical awareness and preventive actions.

Background: Preferential publication of studies with positive findings can lead to overestimation of diagnostic test accuracy (i.e. publication bias). Understanding the contribution of the editorial process to publication bias could inform interventions to optimize the evidence guiding clinical decisions. Purpose/Hypothesis: To evaluate whether accuracy estimates, abstract conclusion positivity, and completeness of abstract reporting are associated with acceptance to radiology conferences and journals. Study Type: Meta-research. Population: Abstracts submitted to radiology conferences (European Society of Gastrointestinal and Abdominal Radiology (ESGAR) and International Society for Magnetic Resonance in Medicine (ISMRM)) from 2008 to 2018 and manuscripts submitted to radiology journals (Radiology, Journal of Magnetic Resonance Imaging [JMRI]) from 2017 to 2018. Primary clinical studies evaluating sensitivity and specificity of a diagnostic imaging test in humans with available editorial decisions were included. Assessment: Primary variables (Youden's index [YI > 0.8 vs. 0.8; CI = 0.70–1.35), conclusion positivity (OR = 1.21 for positive conclusions; CI = 0.75–1.90) or STARD for Abstracts adherence (OR = 0.96 per unit increase in reported items; CI = 0.82–1.18). Manuscripts with positive abstract conclusions were less likely to be accepted by radiology journals (OR = 0.45; CI = 0.24–0.86), while YI (OR = 0.85; CI = 0.56–1.29) and STARD for Abstracts adherence (OR = 1.06; CI = 0.87–1.30) showed no significant association. Positive conclusions were present in 86.7% of submitted conference abstracts and 90.2% of journal manuscripts. Data Conclusion: Diagnostic test accuracy studies with positive findings were not preferentially accepted by the evaluated radiology conferences or journals. Evidence Level: 3. Technical Efficacy: Stage 2.

Dominant negative (DN) mutations in signal transducer and activator of transcription 3 (STAT3) are known to cause hyper-IgE syndrome, a rare primary immunodeficiency. STAT3 DN patients are prone to develop fungal infections, including chronic mucocutaneous candidiasis due to impaired IL-17-mediated immunity, and pulmonary aspergillosis. Despite having preserved phagocyte functions, STAT3 DN patients present connective tissue abnormalities and a defect in the immunological skin barrier. Fusarium species are ubiquitous molds, whose potential to infect humans depends on the host's innate and cellular immune status. Our aim was to describe four STAT3 DN patients with fusariosis confined to the skin. Medical records were reviewed and summarized. Four patients, aged 4, 11, 30, and 33 years, presented with chronic skin lesions which started in the extremities. Two patients had remote lesions, and none had systemic involvement. Skin biopsies showed mycelial threads with deep inflammatory-occasionally granulomatous-infiltrates, reaching the dermis; cultures grew Fusarium solani. Response to treatment was heterogeneous, often requiring multimodal therapies, including topical antifungal preparations. In this work, we describe primary invasive cutaneous fusariosis as a syndromic entity in four STAT3 DN patients.

Objectives To assess whether a retail sales database could be used to monitor antibiotic utilization in the outpatient setting at the national level. Methods We extracted 2012–17 outpatient antibiotic extrapolated retail sales (IQVIA’s Xponent) and reimbursement data from the National Health Insurance (SNDS) in metropolitan France. We compared estimates of antibiotic use and consumption [number of antibiotic drug deliveries (DrID) and defined daily doses (DID) per 1000 inhabitants per day]. We relied on relative differences, Pearson’s r statistics and time series using autoregressive integrated moving average (ARIMA) modelling to study: (i) differences in point estimates, (ii) correlation, and (iii) consistency in time trends between Xponent and SNDS. The analysis was conducted overall and in subgroups (age groups, therapeutic classes, major antimicrobial agents and regions). Results We analysed approximately 377 million antibiotic drug deliveries, comprising nearly 3.4 billion DDDs. Overall, Xponent slightly overestimated SNDS point estimates with yearly relative differences of +3.5% for DrID and +3.3% for DID. Peaks in relative differences were observed for July and August months. Relative differences were Conclusions IQVIA’s Xponent and SNDS data were highly consistent. Xponent database seems suitable for monitoring outpatient antibiotic utilization in France.

Cryptococcal antigen (CrAg) detection could direct the timely initiation of antifungal therapy. We searched MEDLINE and Embase for studies where CrAg detection in serum/cerebrospinal fluid (CSF) and CSF fungal culture were done on adults living with human immunodeficiency virus (HIV) who had suspected cryptococcal meningitis (CM). With Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2), we evaluated the risk of bias in 11 included studies with 3600 participants, and used a random-effects meta-analysis to obtain summary sensitivity and specificity of serum and CSF CrAg, as well as agreement between CSF CrAg and CSF culture. Summary sensitivity and specificity of serum CrAg were 99.7% (97.4–100) and 94.1% (88.3–98.1), respectively, and summary sensitivity and specificity of CSF CrAg were 98.8% (96.2–99.6) and 99.3% (96.7–99.9), respectively. Agreement between CSF CrAg and CSF culture was 98% (97–99). In adults living with HIV who have CM symptoms, serum CrAg negativity may rule out CM, while positivity should prompt induction antifungal therapy if lumbar puncture is not feasible. In a first episode of CM, CSF CrAg positivity is diagnostic.

Background Interventions to mitigate the COVID-19 pandemic may impact other respiratory diseases. Aims We aimed to study the course of pertussis in France over an 8-year period including the beginning of the COVID-19 pandemic and its association with COVID-19 mitigation strategies, using multiple nationwide data sources and regression models. Methods We analysed the number of French pertussis cases between 2013 and 2020, using PCR test results from nationwide outpatient laboratories (Source 1) and a network of the paediatric wards from 41 hospitals (Source 2). We also used reports of a national primary care paediatric network (Source 3). We conducted a quasi-experimental interrupted time series analysis, relying on negative binomial regression models. The models accounted for seasonality, long-term cycles and secular trend, and included a binary variable for the first national lockdown (start 16 March 2020). Results We identified 19,039 pertussis cases from these data sources. Pertussis cases decreased significantly following the implementation of mitigation measures, with adjusted incidence rate ratios of 0.10 (95% CI: 0.04–0.26) and 0.22 (95% CI: 0.07–0.66) for Source 1 and Source 2, respectively. The association was confirmed in Source 3 with a median of, respectively, one (IQR: 0–2) and 0 cases (IQR: 0–0) per month before and after lockdown (p = 0.0048). Conclusions The strong reduction in outpatient and hospitalised pertussis cases suggests an impact of COVID-19 mitigation measures on pertussis epidemiology. Pertussis vaccination recommendations should be followed carefully, and disease monitoring should be continued to detect any resurgence after relaxation of mitigation measures.

BACKGROUND: Patients with fractures are a common emergency presentation and may be misdiagnosed at radiologic imaging. An increasing number of studies apply artificial intelligence (AI) techniques to fracture detection as an adjunct to clinician diagnosis. PURPOSE: To perform a systematic review and meta-analysis comparing the diagnostic performance in fracture detection between AI and clinicians in peer-reviewed publications and the gray literature (ie, articles published on preprint repositories). MATERIALS AND METHODS: A search of multiple electronic databases between January 2018 and July 2020 (updated June 2021) was performed that included any primary research studies that developed and/or validated AI for the purposes of fracture detection at any imaging modality and excluded studies that evaluated image segmentation algorithms. Meta-analysis with a hierarchical model to calculate pooled sensitivity and specificity was used. Risk of bias was assessed by using a modified Prediction Model Study Risk of Bias Assessment Tool, or PROBAST, checklist. RESULTS: Included for analysis were 42 studies, with 115 contingency tables extracted from 32 studies (55 061 images). Thirty-seven studies identified fractures on radiographs and five studies identified fractures on CT images. For internal validation test sets, the pooled sensitivity was 92% (95% CI: 88, 93) for AI and 91% (95% CI: 85, 95) for clinicians, and the pooled specificity was 91% (95% CI: 88, 93) for AI and 92% (95% CI: 89, 92) for clinicians. For external validation test sets, the pooled sensitivity was 91% (95% CI: 84, 95) for AI and 94% (95% CI: 90, 96) for clinicians, and the pooled specificity was 91% (95% CI: 81, 95) for AI and 94% (95% CI: 91, 95) for clinicians. There were no statistically significant differences between clinician and AI performance. There were 22 of 42 (52%) studies that were judged to have high risk of bias. Meta-regression identified multiple sources of heterogeneity in the data, including risk of bias and fracture type. CONCLUSION: Artificial intelligence (AI) and clinicians had comparable reported diagnostic performance in fracture detection, suggesting that AI technology holds promise as a diagnostic adjunct in future clinical practice. Clinical trial registration no. CRD42020186641 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Cohen and McInnes in this issue.

Objective(s)To systematically assess the extent to which bone scintigraphy (BS) could improve the detection rate of skeletal injury in children suspected of physical abuse with an initial negative radiological skeletal survey (RSS).Study designWe searched MEDLINE and Web of Science for series of ≥20 children suspected of physical abuse who underwent RSS and add-on BS. We assessed the risk of bias and the heterogeneity and performed random-effects meta-analyses.ResultsAfter screening 1140 unique search results, we reviewed 51 full-text articles, and included 7 studies (783 children, mostly ≤3 years old). All studies were of either high or unclear risk of bias. Substantial heterogeneity was observed in meta-analyses. The summary detection rate of skeletal injury with RSS alone was 52% (95% CI 37 to 68). The summary absolute increase in detection rate with add-on BS was 10 percentage points (95% CI 6 to 15); the summary relative detection rate was 1.19 (95% CI 1.13 to 1.25); the summary number of children with a negative RSS who needed to undergo a BS to detect one additional child with skeletal injury (number needed to test) was 3 (95% CI 2 to 7).ConclusionsFrom the available evidence, add-on BS in young children suspected of physical abuse with a negative RSS might allow for a clinically significant improvement of the detection rate of children with skeletal injury, for a limited number of BS procedures required. The quality of the reviewed evidence was low, pointing to the need for high-quality studies in this field.

Aim We assessed the diagnostic accuracy of serum (1 → 3)-β-D-glucan (BDG) for neonatal invasive candidiasis (NIC) using the recommended cut-off usually used in adults for detecting invasive candidiasis and searched for an optimal cut-off for ruling out NIC. Methods We conducted a prospective cross-sectional study at Nantes University medical centre from January 2017 to July 2018. All consecutive newborn infants of less than 28 days of corrected age, with clinically suspected NIC, who underwent BDG assay, were included. Sensitivity and specificity were calculated by using the recommended cut-off of 80 pg/mL. Receiver operating characteristic curve analysis was used to identify an optimal cut-off value. Results We included 55 newborn infants with 61 episodes of suspected NIC. Their median gestational and chronological ages were 28.0 weeks (interquartile range [IQR] 26.4-34.1) and 10.0 days (IQR 6.0-22.0), respectively. Of 61 episodes, seven revealed NIC. Sensitivity and specificity were 85.7% (95% confidence interval [CI] 42.1%-99.6%) and 51.9% (37.8%-65.7%) with the recommended cut-off, respectively. An optimal cut-off of 174 pg/mL offered the same sensitivity but higher specificity 77.8% (64.4%-88.0%). Conclusion The recommended cut-off of 80 pg/mL was probably too low for ruling out NIC. A higher cut-off might have been more appropriate.

Objectives The objective of this study was to clarify a difference between two approaches while evaluating the diagnostic accuracy of medical tests, labeled here as “pragmatic” vs. “explanatory” studies. Methods Using the definitions and characteristics described by Schwartz and Lellouch for randomized trials of interventions, and Schwartz' more general distinction between a pragmatic and an explanatory approach in medical research, we define a similar continuum for diagnostic accuracy studies. Explanatory studies aim to better understand the behavior of a test; pragmatic ones are done to support recommendations or decisions about using the test in clinical practice. Results Pragmatic test accuracy studies differ from explanatory test accuracy studies in several ways. The difference in aims has implications for key elements of study design, such as the study eligibility criteria, the recruitment of patients, the reference standard, and the choice of the statistical analysis. Explanatory accuracy studies are often designed to test a hypothesis. They are typically selective in recruitment, may include “healthy controls,” with a small sample size, often recruited at a single center. They ignore testing failures in the analysis and more often present their results as ROC curves. By contrast, pragmatic studies are designed to guide decision making. They ideally will recruit a single, large, and representative group of patients at multiple sites and will more often present their results as estimates of sensitivity and specificity or predictive values at a prespecified threshold. Conclusion Distinguishing between a pragmatic and an explanatory approach can help in the design, analysis, and interpretation of diagnostic accuracy studies. It can clarify debates about the appropriateness of design features to the study purpose and about the validity and applicability of study findings.

BACKGROUND: Rhabdomyosarcoma (RMS) is the most common paediatric soft‐tissue sarcoma and can emerge throughout the whole body. For patients with newly diagnosed RMS, prognosis for survival depends on multiple factors such as histology, tumour site, and extent of the disease. Patients with metastatic disease at diagnosis have impaired prognosis compared to those with localised disease. Appropriate staging at diagnosis therefore plays an important role in choosing the right treatment regimen for an individual patient. Fluorine‐18‐fluorodeoxyglucose ((18)F‐FDG) positron emission tomography (PET) is a functional molecular imaging technique that uses the increased glycolysis of cancer cells to visualise both structural information and metabolic activity. (18)F‐FDG‐PET combined with computed tomography (CT) could help to accurately stage the extent of disease in patients with newly diagnosed RMS. In this review we aimed to evaluate whether (18)F‐FDG‐PET could replace other imaging modalities for the staging of distant metastases in RMS. OBJECTIVES: To determine the diagnostic accuracy of (18)F‐FDG‐PET/CT imaging for the detection of bone, lung, and lymph node metastases in RMS patients at first diagnosis. SEARCH METHODS: We searched MEDLINE in PubMed (from 1966 to 23 December 2020) and Embase in Ovid (from 1980 to 23 December 2020) for potentially relevant studies. We also checked the reference lists of relevant studies and review articles; scanned conference proceedings; and contacted the authors of included studies and other experts in the field of RMS for information about any ongoing or unpublished studies. We did not impose any language restrictions. SELECTION CRITERIA: We included cross‐sectional studies involving patients with newly diagnosed proven RMS, either prospective or retrospective, if they reported the diagnostic accuracy of (18)F‐FDG‐PET/CT in diagnosing lymph node involvement or bone metastases or lung metastases or a combination of these metastases. We included studies that compared the results of the (18)F‐FDG‐PET/CT imaging with those of histology or with evaluation by a multidisciplinary tumour board as reference standard. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, data extraction, and methodological quality assessement according to Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS‐2). We analysed data for the three outcomes (nodal involvement and lung and bone metastases) separately. We used data from the 2 × 2 tables (consisting of true positives, false positives, true negatives, and false negatives) to calculate sensitivity and specificity in each study and corresponding 95% confidence intervals. We did not consider a formal meta‐analysis to be relevant because of the small number of studies and substantial heterogeneity between studies. MAIN RESULTS: Two studies met our inclusion criteria. The diagnostic accuracy of (18)F‐FDG‐PET/CT was reported in both studies, which included a total of 36 participants. We considered both studies to be at high risk of bias for the domain reference standard. We considered one study to be at high risk of bias for the domain index test and flow and timing. Sensitivity and specificity of (18)F‐FDG‐PET/CT for the detection of bone metastases was 100% in both studies (95% confidence interval (CI) for sensitivity was 29% to 100% in study one and 40% to 100% in study two; 95% CI for specificity was 83% to 100% in study one and 66% to 100% in study two). The reported sensitivity of (18)F‐FDG‐PET/CT for the detection of lung metastases was not calculated since only two participants in study two showed lung metastases, of which one was detected by (18)F‐FDG‐PET/CT. Reported specificity was 96% in study one (95% CI 78% to 100%) and 100% (95% CI 72% to 100%) in study two. The reported sensitivity for the detection of nodal involvement was 100% (95% CI 63% to 100% in study one and 40% to 100% in study two); the reported specificity was 100% (95% CI 78% to 100%) in study one and 89% (95% CI 52% to 100%) in study two. AUTHORS' CONCLUSIONS: The diagnostic accuracy of (18)F‐FDG‐PET/CT for the detection of bone, lung, and lymph node metastases was reported in only two studies including a total of only 36 participants with newly diagnosed RMS. Because of the small number of studies (and participants), there is currently insufficient evidence to reliably determine the diagnostic accuracy of (18)F‐FDG‐PET/CT in the detection of distant metastases. Larger series evaluating the diagnostic accuracy of (18)F‐FDG‐PET/CT for the detection of metastases in patients with RMS are necessary.

Key Points Question Are clinical guidelines for the early detection and diagnostic workup of child physical abuse complete, clear, and consistent across high-income countries? Findings In this systematic review that included 20 clinical guidelines issued in 15 countries, guidelines were clear but incomplete and discrepant, particularly in the definition of sentinel injuries and in recommendations for exploratory laboratory testing and advanced imaging. Meaning This systematic review found a lack of standardized guidelines for the identification and management of child physical abuse, which may contribute to practice variation., This systematic review evaluates the completeness, clarity, and consistency of guidelines from high-income countries for the detection and diagnosis of child physical abuse., Importance The highly variable practices observed regarding the early detection and diagnostic workup of suspected child physical abuse contribute to suboptimal care and could be partially related to discrepancies in clinical guidelines. Objective To systematically evaluate the completeness, clarity, and consistency of guidelines for child physical abuse in high-income countries. Evidence Review For this systematic review, national or regional guidelines that were disseminated from 2010 to 2020 related to the early detection and diagnostic workup of child physical abuse in infants aged 2 years or younger by academic societies or health agencies in high-income countries were retrieved. The definitions of sentinel injuries and the recommended diagnostic workup (imaging and laboratory tests) for child physical abuse were compared. Data were analyzed from July 2020 to February 2021. Findings Within the 20 included guidelines issued in 15 countries, 168 of 408 expected statements (41%) were missing and 10 statements (4%) were unclear. Among 16 guidelines characterizing sentinel injuries, all of them included skin injuries, such as bruises, hematoma, or burns, but only 8 guidelines (50%) included intraoral injuries and fractures. All 20 guidelines agreed on the indication for radiological skeletal survey, head computed tomography, and head magnetic resonance imaging but differed for those of bone scintigraphy, follow-up skeletal survey, spinal magnetic resonance imaging, cranial ultrasonography, chest computed tomography, and abdominal ultrasonography and computed tomography. Additionally, 16 guidelines agreed on exploring primary hemostasis and coagulation but not on the tests to perform, and 8 guidelines (50%) mentioned the need to investigate bone metabolism. Conclusions and Relevance These findings suggest that guidelines for the diagnosis of child physical abuse in infants were often clear but lacked completeness and were discrepant on major issues. These results may help identify priorities for well-designed original diagnostic accuracy studies, systematic reviews, or an international consensus process to produce clear and standardized guidelines to optimize practices and infant outcomes.

To describe the ambulatory proton pump inhibitor (PPI) prescription in French children, its trends, and the impact of French (2014) and international (2018) clinical guidelines.We described PPI prescription rates based on national dispensation data in French children (IQVIA's Xponent database, 2009-2019). Using a segmented linear regression, we assessed the impact of clinical guidelines on PPI prescription rates. Analyses were performed for the overall pediatric population and by age subgroups (infants2 years old, children 2-11 years old, adolescents 12-17 years old).During the study period, 8 060 288 pediatric PPI prescriptions were filled, with a mean PPI prescription rate of 52.5 per 1000 inhabitants per year. Between 2009 and 2019, the PPI prescription rate increased by 41% in the overall pediatric population (+110% in infants). The PPI prescription rate showed seasonal patterns with peaks in winter. After the release of French guidelines, significant decreases in trends of prescription rates occurred overall (change in trend -0.28, 95% CI -0.34;-0.23) and across all age groups. In infants, this change in trend was not sufficient to reverse the PPI prescription rate that was still increasing over time. In children, the PPI prescription rate slightly decreased and in adolescents, it was stable. After the release of international guidelines, a significant decrease in trend occurred in adolescents only (change in trend -0.26, 95% CI -0.47; -0.04).The pediatric PPI prescription rate in France was high, displayed a major increase over the last decade, mainly among infants, and was modestly affected by clinical guidelines.

Diagnostic tests play a crucial role in the management of the COVID-19 pandemic, helping to contain the spread of SARS-CoV-2 by detecting and isolating cases, enabling contact tracing, and guiding public health decisions about the initiation of lockdowns, thereby protecting people at increased risk of severe disease and our healthcare systems. Likewise, treatment decisions and enrollment in therapeutic trials require diagnostic confirmation. Because testing for SARS-CoV-2 is currently being done on a massive scale worldwide, false-positive and false-negative results may have considerable adverse downstream consequences [1]. Despite progress made in the last decades in our understanding of the complexity of medical test evaluation, assessing the value of diagnostic tests for COVID-19 still poses considerable challenges [1], [2], [3], [4], [5], [6]. One major challenge is that multiple target conditions can be defined. For example, the target condition may be (past or present) SARS-CoV-2 infection, infectiousness, or COVID-19 (i.e., the acute disease caused by SARS-CoV-2). Additionally, COVID-19 has a broad clinical spectrum, which may vary from asymptomatic and mildly symptomatic cases of SARS-CoV-2 infection, to cases of severe pneumonia with or without acute respiratory distress syndrome (ARDS) and multiorgan failure [7]. Furthermore, SARS-CoV-2 may also trigger severe post-infectious processes such as myocarditis, multiorgan failure, and Kawasaki-like illness, notably in children (referred to as ‘Paediatric inflammatory multisystem syndrome temporally associated with COVID-19′ (PIMS-TS)) [8]. It is important that researchers carefully define the target condition before initiating a test accuracy study of a test for COVID-19 [2,9]. However, errors in such studies may still occur if the final diagnosis entirely relies on detecting SARS-CoV-2. For example, patients with respiratory symptoms due to pulmonary embolism or community-acquired pneumonia due to Streptococcus pneumoniae may be misclassified as COVID-19 if they are concomitant carriers of SARS-CoV-2. Yet, carriage is still highly relevant to detect as part of contact tracing strategies because it may warrant isolation to contain the spread of SARS-CoV-2. What makes test accuracy studies of COVID-19 tests particularly challenging is the absence of a reliable clinical reference standard. Because of this, the results of most test accuracy studies of COVID-19 tests are of limited value to clinicians and policymakers and may represent a considerable waste of research resources [10]. In this commentary article, we will discuss our views on the extent of this problem and provide potential solutions, based on our experience as clinicians and researchers, and with examples from published literature.

Rhinocladiella mackenziei cerebral phaeohyphomycosis is a rare severe disease that has been typically described in the Middle East. Here, we report 2 cases of R. mackenziei cerebral phaeohyphomycosis in patients from Morocco, diagnosed and treated in France, and raise a concern about the ever-going extension of the area at risk for this devastating invasive fungal infection.

BackgroundInterventions to mitigate coronavirus disease 19 (COVID-19) pandemic may impact other respiratory diseases such as pertussis. We aimed to study the course of pertussis in France over an 8-year period and its association with COVID-19 mitigation strategies, using multiple nationwide data sources.MethodsWe analyzed the number of French pertussis cases between 2013 and 2020, using the PCR test results from nationwide outpatient laboratories (Source 1) and the pediatric network of 41 hospitals (Source 2), and using the reports of an office-based pediatric national network (Source 3). We conducted a quasi-experimental interrupted time-series analysis, relying on negative binomial regression models. The models accounted for seasonality, long-term cycles, and secular trend, and included a binary variable for the first national lockdown (ordered on March 16, 2021).ResultsWe identified 19,039 cases of pertussis from the three data sources during the study period. There was a significant decrease of pertussis cases following the implementation of mitigation measures, with adjusted incidence rate ratios of 0.102 (95% CI 0.040-0.256) and 0.216 (95% CI 0.071-0.656) for Source 1 and Source 2, respectively. The association was confirmed in Source 3 (median of 1 [IQR 0-2] vs. 0 [IQR 0-0] pertussis cases per month before and after lockdown, respectively, p=0.0048).ConclusionThe drastic reduction of outpatient and hospitalized cases of pertussis strongly suggests an impact of COVID-19 mitigation measures and their consequences on pertussis epidemiology. Pertussis vaccination recommendations should be carefully followed, and disease monitoring should be continued to detect any resurgence after relaxation of mitigation measures.FundingThere was no specific funding for the study.

Background The respiratory illness caused by SARS‐CoV‐2 infection continues to present diagnostic challenges. Our 2020 edition of this review showed thoracic (chest) imaging to be sensitive and moderately specific in the diagnosis of coronavirus disease 2019 (COVID‐19). In this update, we include new relevant studies, and have removed studies with case‐control designs, and those not intended to be diagnostic test accuracy studies. Objectives To evaluate the diagnostic accuracy of thoracic imaging (computed tomography (CT), X‐ray and ultrasound) in people with suspected COVID‐19. Search methods We searched the COVID‐19 Living Evidence Database from the University of Bern, the Cochrane COVID‐19 Study Register, The Stephen B. Thacker CDC Library, and repositories of COVID‐19 publications through to 30 September 2020. We did not apply any language restrictions. Selection criteria We included studies of all designs, except for case‐control, that recruited participants of any age group suspected to have COVID‐19 and that reported estimates of test accuracy or provided data from which we could compute estimates. Data collection and analysis The review authors independently and in duplicate screened articles, extracted data and assessed risk of bias and applicability concerns using the QUADAS‐2 domain‐list. We presented the results of estimated sensitivity and specificity using paired forest plots, and we summarised pooled estimates in tables. We used a bivariate meta‐analysis model where appropriate. We presented the uncertainty of accuracy estimates using 95% confidence intervals (CIs). Main results We included 51 studies with 19,775 participants suspected of having COVID‐19, of whom 10,155 (51%) had a final diagnosis of COVID‐19. Forty‐seven studies evaluated one imaging modality each, and four studies evaluated two imaging modalities each. All studies used RT‐PCR as the reference standard for the diagnosis of COVID‐19, with 47 studies using only RT‐PCR and four studies using a combination of RT‐PCR and other criteria (such as clinical signs, imaging tests, positive contacts, and follow‐up phone calls) as the reference standard. Studies were conducted in Europe (33), Asia (13), North America (3) and South America (2); including only adults (26), all ages (21), children only (1), adults over 70 years (1), and unclear (2); in inpatients (2), outpatients (32), and setting unclear (17). Risk of bias was high or unclear in thirty‐two (63%) studies with respect to participant selection, 40 (78%) studies with respect to reference standard, 30 (59%) studies with respect to index test, and 24 (47%) studies with respect to participant flow. For chest CT (41 studies, 16,133 participants, 8110 (50%) cases), the sensitivity ranged from 56.3% to 100%, and specificity ranged from 25.4% to 97.4%. The pooled sensitivity of chest CT was 87.9% (95% CI 84.6 to 90.6) and the pooled specificity was 80.0% (95% CI 74.9 to 84.3). There was no statistical evidence indicating that reference standard conduct and definition for index test positivity were sources of heterogeneity for CT studies. Nine chest CT studies (2807 participants, 1139 (41%) cases) used the COVID‐19 Reporting and Data System (CO‐RADS) scoring system, which has five thresholds to define index test positivity. At a CO‐RADS threshold of 5 (7 studies), the sensitivity ranged from 41.5% to 77.9% and the pooled sensitivity was 67.0% (95% CI 56.4 to 76.2); the specificity ranged from 83.5% to 96.2%; and the pooled specificity was 91.3% (95% CI 87.6 to 94.0). At a CO‐RADS threshold of 4 (7 studies), the sensitivity ranged from 56.3% to 92.9% and the pooled sensitivity was 83.5% (95% CI 74.4 to 89.7); the specificity ranged from 77.2% to 90.4% and the pooled specificity was 83.6% (95% CI 80.5 to 86.4). For chest X‐ray (9 studies, 3694 participants, 2111 (57%) cases) the sensitivity ranged from 51.9% to 94.4% and specificity ranged from 40.4% to 88.9%. The pooled sensitivity of chest X‐ray was 80.6% (95% CI 69.1 to 88.6) and the pooled specificity was 71.5% (95% CI 59.8 to 80.8). For ultrasound of the lungs (5 studies, 446 participants, 211 (47%) cases) the sensitivity ranged from 68.2% to 96.8% and specificity ranged from 21.3% to 78.9%. The pooled sensitivity of ultrasound was 86.4% (95% CI 72.7 to 93.9) and the pooled specificity was 54.6% (95% CI 35.3 to 72.6). Based on an indirect comparison using all included studies, chest CT had a higher specificity than ultrasound. For indirect comparisons of chest CT and chest X‐ray, or chest X‐ray and ultrasound, the data did not show differences in specificity or sensitivity. Authors' conclusions Our findings indicate that chest CT is sensitive and moderately specific for the diagnosis of COVID‐19. Chest X‐ray is moderately sensitive and moderately specific for the diagnosis of COVID‐19. Ultrasound is sensitive but not specific for the diagnosis of COVID‐19. Thus, chest CT and ultrasound may have more utility for excluding COVID‐19 than for differentiating SARS‐CoV‐2 infection from other causes of respiratory illness. Future diagnostic accuracy studies should pre‐define positive imaging findings, include direct comparisons of the various modalities of interest in the same participant population, and implement improved reporting practices., Plain language summary How accurate is chest imaging for diagnosing COVID‐19? Why is this question important? People with suspected COVID‐19 need to know quickly whether they are infected, so they can receive appropriate treatment, self‐isolate, and inform close contacts. Currently, a formal diagnosis of COVID‐19 requires a laboratory test (RT‐PCR) of nose and throat samples. RT‐PCR requires specialist equipment and takes at least 24 hours to produce a result. It is not completely accurate, and may require a second RT‐PCR or a different test to confirm diagnosis. COVID‐19 is a respiratory disease. Clinicians may use chest imaging to diagnose people who have COVID‐19 symptoms, while awaiting RT‐PCR results or when RT‐PCR results are negative, and the person has COVID‐19 symptoms. What did we want to find out? We wanted to know whether chest imaging is accurate enough to diagnose COVID‐19 in people with suspected infection. This is the second update of this review; in it, we included studies in people with suspected COVID‐19 only; we excluded studies in people with confirmed COVID‐19. The evidence is up to date to 30 September 2020. What are chest imaging tests? X‐rays or scans produce an image of the organs and structures in the chest. ‐ X‐rays (radiography) use radiation to produce a 2‐D image. Usually done in hospitals, using fixed equipment by a radiographer, they can also be done on portable machines. ‐ Computed tomography (CT) scans use a computer to merge 2‐D X‐ray images and convert them to a 3‐D image. They require highly specialised equipment and are done in hospital by a specialist radiographer. ‐ Ultrasound scans use high‐frequency sound waves to produce an image. They can be done in hospitals or other healthcare settings, such as a doctor’s office. What did we do? We searched for studies that assessed the accuracy of chest imaging to diagnose COVID‐19 in people of any age with suspected COVID‐19. Studies could be of any design, except for case control studies, and could take place anywhere. What did we find? We found 51 studies with 19,775 participants. Of these people, 10,155 (51%) had a final diagnosis of COVID‐19. Forty‐seven studies confirmed COVID‐19 infection using RT‐PCR alone. Four studies used RT‐PCR with another test. Forty‐seven studies evaluated one imaging technique each, and four studies evaluated two imaging techniques each. Chest CT was evaluated by 41 studies (16,133 participants, 8110 (50%) confirmed COVID‐19 cases), chest X‐ray by nine studies (3694 participants, 2111 (57%) confirmed COVID‐19 cases), and ultrasound by five studies (446 participants, 211 (47%) confirmed COVID‐19 cases). Thirty‐three studies were conducted in Europe, 13 in Asia, three in North America and two in South America. Twenty‐six studies included only adults, 21 included both adults and children, one included only children, one included participants aged 70 years and older, and two studies did not report participants' ages. Two studies included hospital inpatients and 32 included hospital outpatients. The setting was unclear in the remaining 17 studies. Where four or more studies evaluated a particular type of chest imaging, we pooled their results and analysed them together. Chest CT Pooled results showed that chest CT correctly diagnosed COVID‐19 in 87.9% of people who had COVID‐19. However, it incorrectly identified COVID‐19 in 20% of people who did not have COVID‐19. Chest X‐ray Pooled results showed that chest X‐ray correctly diagnosed COVID‐19 in 80.6% of people who had COVID‐19. However, it incorrectly identified COVID‐19 in 28.5% of people who did not have COVID‐19. Lung ultrasound Pooled results showed that lung ultrasound correctly diagnosed COVID‐19 in 86.4% of people with COVID‐19. However, it incorrectly diagnosed COVID‐19 in 45% of people who did not have COVID‐19. How reliable are the results? The studies differed from each other and used different methods to report their results. Few studies evaluated chest X‐ray and chest ultrasound; and very few studies directly compared one type of imaging test with another. Therefore, we cannot draw confident conclusions based on results from studies in this review. What does this mean? The evidence suggests that chest CT is better at ruling out COVID‐19 infection than distinguishing it from other respiratory problems. So, its usefulness may be limited to excluding COVID‐19 infection rather than distinguishing it from other causes of lung infection. We plan to update this review as more evidence becomes available. Future studies should predefine what a positive test is, and compare different types of imaging tests on similar groups of people.

Acute pharyngitis is one of the most common conditions in outpatient settings and an important source of inappropriate antibiotic prescribing. Rapid antigen detection tests (RADTs) offer diagnosis of group A streptococcus at the point of care but have limited sensitivity. Rapid nucleic acid tests (RNATs) are now available; a systematic review of their accuracy is lacking.To evaluate the accuracy of RNATs in patients with pharyngitis; to explore test-level and study-level factors that could explain variability in accuracy; and to compare the accuracy of RNATs with that of RADTs.MEDLINE, Embase, Web of Science (1990-2020).Cross-sectional studies and randomized trials.Patients with pharyngitis.RNAT commercial kits compared with throat culture.We assessed risk of bias and applicability using QUADAS-2. We performed meta-analysis of sensitivity and specificity using the bivariate random-effects model. Variability was explored by subgroup analyses and meta-regression.We included 38 studies (46 test evaluations; 17 411 test results). RNATs were most often performed in a laboratory. The overall methodological quality of primary studies was uncertain because of incomplete reporting. RNATs had a summary sensitivity of 97.5% (95% CI 96.2%-98.3%) and a summary specificity of 95.1% (95% CI 93.6%-96.3%). There was low variability in estimates across studies. Variability in sensitivity and specificity was partially explained by test type (p 0.05 for both). Sensitivity analyses limited to studies with low risk of bias showed robust accuracy estimates. RNATs were more sensitive than RADTs (13 studies; 96.8% versus 82.3%, p 0.004); there was no difference in specificity (p 0.92).The high diagnostic accuracy of RNATs may allow their use as stand-alone tests to diagnose group A streptococcus pharyngitis. Based on direct comparisons, RNATs have greater sensitivity than RADTs and equal specificity. Further studies should evaluate RNATs in point-of-care settings.

Background An outbreak of multisystem inflammatory syndrome in children, including Kawasaki disease (KD), emerged during COVID-19 pandemic. We explored whether Kawasaki-like disease (KD), when associated with confirmed SARS-CoV-2 infection, has specific characteristics. Methods We included children and adolescents with KD criteria admitted in the department of general pediatrics of a university hospital in Paris, France, between January 1, 2018, and May 26, 2020. The incidence of KD was compared between the outbreak and a pre-outbreak control period (January 1, 2018, to April 25). Characteristics of patients with positive SARS-CoV-2 testing (KD-SARS-CoV-2) were compared to those of the pre-outbreak period (classic KD). Results A total of 30 and 59 children with KD were admitted during the outbreak and pre-outbreak periods, respectively (incidence ratio 13.2 [8.3–21.0]). During the outbreak, 23/30 (77%) children were diagnosed as KD-SARS-CoV-2. When compared with patients with classic KD, those with KD-SARS-CoV-2 were more frequently of sub-Saharan African ancestry (OR 4.4 [1.6–12.6]) and older (median 8.2 vs. 4.0 years, p

For many users of the biomedical literature, abstracts may be the only source of information about a study. Hence, abstracts should allow readers to evaluate the objectives, key design features, and main results of the study. Several evaluations have shown deficiencies in the reporting of journal and conference abstracts across study designs and research fields, including systematic reviews of diagnostic test accuracy studies. Incomplete reporting compromises the value of research to key stakeholders. The authors of this article have developed a 12 item checklist of preferred reporting items for journal and conference abstracts of systematic reviews and meta-analyses of diagnostic test accuracy studies (PRISMA-DTA for Abstracts). This article presents the checklist, examples of complete reporting, and explanations for each item of PRISMA-DTA for Abstracts.