Diagnostic Test Study Research Articles

Serum Creatinine and Tacrolimus Assessment With VAMS Finger-Prick Microsampling: A Diagnostic Test Study.

Kidney transplant recipients require frequent venipunctures. Microsampling methods that use a finger-prick draw of capillary blood, like volumetric absorptive microsamplers (VAMS), have the potential to reduce the pain, inconvenience, and volume of blood loss associated with venipuncture. This study aimed to provide diagnostic accuracy using VAMS for measurement of tacrolimus and creatinine compared to gold standard venous blood in adult kidney transplant recipients. Diagnostic test study. Prospective blood samples for measurement of tacrolimus and creatinine were collected using Mitra VAMS and venipuncture immediately before and 2 hours after tacrolimus dosing. A convenience sample of 40 adult kidney transplant participants in the outpatient setting. Method comparison was assessed by Passing-Bablok regression and Bland-Altman analysis. The predictive performance of VAMS measurement compared to venipuncture was also assessed through estimation of the median prediction error and median absolute percentage prediction error. A total of 74 tacrolimus samples and 70 creatinine samples were analyzed from 40 participants. Passing-Bablok regression showed a systematic difference between VAMS and venipuncture when measuring tacrolimus and creatinine with a slope of 1.08 (95% CI, 1.03-1.13) and a slope of 0.65 (95% CI, 0.6-0.7), respectively. These values were then corrected for the systematic difference. When used forBland-Altman analysis, corrected values oftacrolimus and creatinine showed a bias of-0.1μg/L and 0.04mg/dL, respectively. Tacrolimus (corrected) and creatinine (corrected) microsampling values when compared to corresponding venipuncture values met median prediction error and median absolute percentage prediction error predefined acceptability limits of<15%. This study was conducted in a controlled environment using a trained nurse to collect VAMS samples. In this study, VAMS was used to reliably measured tacrolimus and creatinine. This represents a clear opportunity for more frequent and less invasive sampling for patients.

Usefulness of Doppler ultrasound-obtained resistance index in thyroid nodules with ultrasonographic malignant characteristics

Introduction Thyroid nodular disease is highly prevalent in the general population. Its diagnosis has increased with Doppler ultrasound, by means of which features suggestive of malignancy can be detected, such as resistance and pulsatility indices elevation. Objective To assess the correlation of a high resistance index and histopathological findings in patients with ultrasonographic suspicion of malignant thyroid nodules. Method Prospective, cross-sectional, analytic, observational study of diagnostic tests carried out at Specialty Hospital 25, in Monterrey, Nuevo Leon. Patients with thyroid nodules of ultrasonographic malignant characteristics were included; the resistance index of the nodules was obtained and compared with histopathological findings. Results Forty-eight patients with ultrasonographic diagnosis of malignant nodules were included. The correlation of elevated resistance indices with malignant thyroid nodule histopathologic diagnosis was significant (p = 0.001). Sensitivity was 73.3% and specificity 78.7%; positive predictive value was 61.1% and negative predictive value was 86.6%. Conclusion The resistance index determination is increasingly being used, but its sensitivity and specificity are low, and it is not a reliable method, and other complementary methods are therefore still required.

Rapid Identification Protocols in bacteria by MALDI-TOF from positive blood cultures. A literature review

Objective. To identify protocols for rapid identification of bacteria by MALDI-TOF from positive blood cultures that are as accurate as standardized ones. Methods. A bibliographic review was conducted on experimental articles, systematic reviews, experimental studies, and diagnostic test studies on the rapid identification of bacteria by MALDI-TOF from positive blood cultures. The QUADAS-2 tool was applied to evaluate the risk of bias in the articles. Results. There are various methodologies for the rapid identification of bacteria from positive blood cultures, all with a processing time of no more than one hour and with materials accessible in laboratories. These methodologies, such as Sepsityper and artisanal methods, achieve good accuracy in identifying Gram-negative bacteria, but there are still limitations in identifying Gram-positive bacteria depending on the genus and species of the bacterium. It is important to note that the quality of evidence in most studies is moderate, so the results should be taken with caution. Conclusion. There are several methodologies for rapid identification of bacteria in positive blood cultures, with short processing times and accessible materials in laboratories, that achieve good accuracy in identifying Gram-negative bacteria but have limitations in identifying Gram-positive bacteria. The quality of evidence is moderate, indicating that further studies with better design and higher quality and certainty results are needed to draw inferences obtained.

Validation of circulating microRNAs miR-142-3p and miR-598-3p in women with polycystic ovary syndrome as potential diagnostic markers.

Circulating miRNAs previously associated with androgen excess in women might be used as diagnostic biomarkers for polycystic ovary syndrome (PCOS). Models based on circulating miR-142-3p and miR-598-3p expression show good discrimination among women with and without PCOS, particularly when coupled with easily available measurements such as waist-to-hip ratio (WHR) and circulating LH-to-FSH (LH/FSH) ratios. The lack of standardization of the signs, methods, and threshold values used to establish the presence of the diagnostic criteria (hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology) complicates the diagnosis of PCOS. Certain biomarkers may help with such a diagnosis. We conducted a validation study to check the diagnostic accuracy for PCOS of several miRNAs that were associated with the syndrome in a small pilot study that had been previously carried out by our research group. This was a diagnostic test study involving 140 premenopausal women. We included 71 women with PCOS and 69 healthy control women in the study. Both groups were selected as to be similar in terms of body mass index. We used miRCURY LNA™ Universal RT microRNA PCR to analyse the five miRNAs that had shown the strongest associations with PCOS in a much smaller pilot study previously conducted by our group. We studied diagnostic accuracy using receiver operating characteristics (ROC) curve analysis. Only the expression of two miRNAs, miR-142-3p and miR-598-3p, of the five studied, was different between the women with PCOS and the non-hyperandrogenic controls. The diagnostic accuracy of the combination of these circulating miRNAs was good (area under the ROC curve (AUC) 0.801; 95% CI: 0.72-0.88) and was further improved when adding WHR (AUC 0.834, 95% CI: 0.756-0.912), LH/FSH ratio (AUC = 0.869, 95% CI: 0.804-0.934) or both (AUC = 0.895, 95% CI: 0.835-0.954). We developed several models by selecting different threshold values for these variables favouring either sensitivity or specificity, with positive and negative predictive values as high as 88% or 85%, respectively. Patients included here had the classic PCOS phenotype, consisting of hyperandrogenism and ovulatory dysfunction; hence, the present results might not apply to milder phenotypes lacking androgen excess. If confirmed in larger studies addressing different populations and PCOS phenotypes, these biomarkers may be useful to simplify the clinical diagnosis of this prevalent syndrome. This research was funded by Instituto de Salud Carlos III, Spanish Ministry of Science and Innovation (grants PI15/01686, PIE16/00050, PI18/01122 & PI21/00116) and co-funded by European Regional Development Fund 'A way to make Europe'. Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM) and Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) are also initiatives of the Instituto de Salud Carlos III. The authors have no competing interests to disclose. N/A.

Estimated GFR Accuracy When Cystatin C– and Creatinine-Based Estimates Are Discrepant in Older Adults

Serum creatinine and cystatin C are used to estimate glomerular filtration rate, but creatinine-based estimated glomerular filtration rate (eGFRcr), cystatin C-based estimated glomerular filtration rate (eGFRcys), and combined creatinine- and cystatin C-based estimated glomerular filtration rate (eGFRcr-cys) are often divergent, particularly in older adults. We investigated which estimated glomerular filtration rate (eGFR) was more accurate and less biased compared with measured glomerular filtration rate (mGFR). A diagnostic test study from the Berlin Initiative Study. The study population included 657 individuals aged 70 years or older with iohexol plasma clearance (mGFR) and serum creatinine and cystatin C measurements: 567 community-dwelling participants and 90 with a serum creatinine of≥1.5 mg/dL. We defined 3 groups on the basis of the difference eGFRcys-eGFRcr: whether< -5 mL/min/1.73 m2 (lower eGFRcys), within 5 mL/min/1.73 m2 (reference), or≥ 5 mL/min/1.73 m2 (lower eGFRcr). eGFRcr, eGFRcys, and eGFRcr-cys were compared to mGFR to assess bias and accuracy. Median bias (eGFR minus mGFR) with 95% CIs and accuracy (percentage of eGFR values within±30% of mGFR). The mean±standard deviation age was 78±6 years; the mean eGFRcys, eGFRcr, and eGFRcr-cys were 59±23, 64±20, and 61±22 mL/min/1.73 m2, respectively, and the mean mGFR was 56±19 mL/min. Half of the participants were in the lower eGFRcys group (n=337, 51%). Among them, the median bias for eGFRcys was the lowest (median bias,-2.7; 95% CI,-3.8 to-1.9) compared with the other eGFR equations. Conversely, in the lower eGFRcr group (n=121, 18%), the median bias for eGFRcr was the lowest compared with those for eGFRcys and eGFRcr-cys (2.9; [95% CI, 0.9-4.8] vs 13.8 [95% CI, 11.4-15.6] and 9.5 [95% CI, 7.7-11.0], respectively). Accuracy (percentage of eGFR values within±30% of mGFR) was 93% for eGFRcr in the lower eGFRcr group and 92% for eGFRcys and 94% for eGFRcr-cys in the lower eGFRcys group. Untested generalizability in younger populations. Among older adults, the lower eGFR between eGFRcys and eGFRcr was a more accurate and less biased estimate of mGFR when comparing the groups.

Scoring model to predict early-onset bacterial sepsis at Dr. Mohammad Hoesin Hospital, Palembang

Background Early-onset bacterial neonatal sepsis (bacterial EONS) is one of the most common causes of death and illness in newborns. Assessment of risk factors is important to identify infants who are more susceptible to bacterial EONS. A scoring model based on maternal and infant risk factors would be useful for predicting bacterial EONS.&#x0D; Objective To develop a scoring model to predict bacterial EONS by examining maternal and neonatal risk factors.&#x0D; Methods This diagnostic test study was conducted at Mohammad Hoesin Hospital, Palembang between January-September 2021 using various maternal and infant risk factors. Subjects were newborns suspected of having early-onset bacterial sepsis with birth weight &gt;1000 grams. The potential risk factors evaluated consisted of premature rupture of membranes &gt;18 hours, greenish-thick-and-foul-smelling amniotic fluid, maternal body temperature &gt;38°C, maternal leukocytosis &gt;15.000/?L, gestational of &lt;37 weeks, birth weight of &lt;2500 grams, and APGAR score of &lt;7 at 1 minute. One hundred sixty-two subjects were selected consecutively. Analyses included odds ratio, logistic regression test, and ROC curve to assess sensitivity and specificity of each risk factor.&#x0D; Results Premature rupture of membranes &gt;18 hours, greenish-thick-and-foul-smelling amniotic fluid, male sex, and gestation of &lt;37 weeks were risk factors for bacterial EONS. In the multivariate analysis, premature rupture of membranes &gt;18 hours had an OR of 5.94 (95%CI 1.69 to 20.86, P=0.005), greenish-thick-and-foul-smelling amniotic fluid had an OR of 3.74(95%CI 1.16 to 12.02, P=0,027), male sex had an OR of 4.28 (95%CI 1.14 to 16.02, P=0.031), and gestation of &lt;37 weeks had an OR of 3.1 (95%CI 0.82 to 11.72, P=0.094). In the scoring model, each of these four risk factors were assigned a score of 2 (for maternal risk factors) and 1 (for neonatal risk factors). Using a cut-off score of 2.5 to predict bacterial EONS, the scoring system had a sensitivity of 80% and specificity of 47%.&#x0D; Conclusion Our scoring model of maternal and infant risk factors can be used to screen for possible bacterial EONS at an earlier stage of illness, although with limited specificity.

Blood pressure to height ratio for screening hypertension among Indonesian adolescents

Background Pediatric hypertension is an emerging health issue due to its increasing prevalence. Age-, gender-, and height-specific blood pressure percentiles have been widely used as a primary tool for detection of hypertension in the pediatric population. However, this method is too complicated to be used in general pediatric practice. The blood pressure to height ratio has been proposed as a practical tool to detect hypertension in children.&#x0D; Objective To evaluate the accuracy of blood pressure to height ratio to be used as a tool for screening high blood pressure in Indonesian adolescents.&#x0D; Methods This diagnostic test study using data from the 2013 Indonesia Basic Health Research (Riset Kesehatan Dasar/RISKESDAS) report included 39,057 adolescents aged 15-18 years with complete data on age, gender, weight, height, and blood pressure. Blood pressure values were classified using the 2017 American Academy of Pediatrics (AAP) hypertension clinical guidelines. Blood pressure to height ratio was calculated as mmHg/cm body height. A receiver-operator characteristics (ROC) curve analysis was performed to assess the accuracy of systolic blood pressure to height ratio (SBPHR) and diastolic blood pressure to height ratio (DBPHR) for screening high blood pressure in adolescents. The optimal cut-off points, sensitivity, and specificity of SBPHR and DBPHR were calculated.&#x0D; Results The optimal cut-off points for defining elevated blood pressure in male adolescents aged 13-18 years were SBPHR 0.69 for male adolescents (sensitivity 96%, specificity 80%) and DBPHR 0.46 (sensitivity 97%, specificity 84%). In female adolescents, the optimal cut-offs were SBPHR 0.72 (sensitivity 97%, specificity 82%) and DBPHR 0.48 (sensitivity 98% and specificity 79%).&#x0D; Conclusion Blood pressure to height ratio is a practical method with high sensitivity and specificity for detecting elevated blood pressure in Indonesian adolescents aged 15 to 18 years.

Application of metagenomic next-generation sequencing in the detection of pathogens in spinal infections

The precise diagnosis and treatment of spinal infections (SI) remains challenging for spine surgeons. Identifying the pathogens of SI through metagenomic next-generation sequencing (mNGS) may be a key approach to addressing this challenge. To evaluate the accuracy and applicability of mNGS in determining the etiology of SI. Diagnostic test study. Twenty-five patients who had a clinical suspicion of SI and underwent mNGS testing. The specificity, sensitivity, and time cost of mNGS and bacterial culture were compared. Clinical outcomes were assessed using the numeric rating scale (NRS) score, Oswestry Disability Index (ODI), and the Japanese Orthopedic Association (JOA) score. Demographic data and laboratory results (blood cell count (WBC), erythrocyte sedimentation rate (ESR), neutrophil percentage (NEUT%), and C-reactive protein level (CRP) were also evaluated. In this retrospective study, samples were obtained from 25 eligible patients via surgery or CT-guided puncture and subjected to histopathological examination, bacterial culture, and mNGS. The sensitivity and specificity of the bacterial cultures and mNGS were calculated with respect to the histopathological results as a reference. Postoperative antibiotics or antituberculosis drugs were administered on the basis of mNGS results, combined with clinical manifestations, imaging examination, and histopathology. The changes of clinical outcomes and laboratory results after treatment were observed. Of the 25 patients, 21 had a positive pathology, of which 10 showed a tuberculous pathology, and the remaining 11 showed a nontuberculous inflammatory pathology. The sensitivity of mNGS was higher than that of the bacterial culture. However, the difference in specificity between bacterial culture and mNGS was not significant. Moreover, the time needed to perform mNGS was significantly lower than that of bacterial culture and pathology. All patients were followed up for more than three months, and CRP and NEUT% significantly decreased by three months after treatment. There was no significant difference in WBC and ESR. The ODI, NRS and JOA scores were significantly improved after treatment. Metagenomic next-generation sequencing technology can play an important role in the detection of pathogens in SI and should be further investigated and applied in future studies.

Can lung ultrasound score accurately predict surfactant replacement? A systematic review and meta-analysis of diagnostic test studies.

Clinical and radiographic criteria are traditionally used to determine the need for surfactant therapy in preterm infants. Lung ultrasound is a bedside test that offers a rapid, radiation-free, alternative to this approach. To conduct a systematic review and meta-analysis to determine the accuracy of a lung ultrasound score (LUS) in identifying infants who would receive at least one surfactant dose. Secondary aims were to evaluate the predictive accuracy for ≥2 doses and the accuracy of a different image classification system based on three lung ultrasound profiles. PubMed, SCOPUS, Biomed Central, and the Cochrane library between January 2011 and December 2021 were searched. Full articles enrolling preterm neonates who underwent lung ultrasound to predict surfactant administration were assessed and analyzed following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols(PRISMA-P) and QUADAS-2 guidelines. Seven prospective studies recruiting 697 infants met the inclusion criteria. Risk of bias was generally low. Oxygen requirement, clinical and radiographic signs of respiratory distress syndrome were used as reference standards for surfactant replacement. The summary receiver operator characteristic(sROC) curve for LUS predicting first surfactant dose showed an area under the curve(AUC) = 0.88 (95% confidence interval [CI]: 0.82-0.91); optimal specificity and sensitivity (Youden index) were 0.83 and 0.81 respectively. Pooled estimates of sensitivity, specificity, diagnostic odds ratio, negative predictive value,and positive predictive valuefor LUS predicting the first surfactant dose were 0.89 (0.82-0.95), 0.86 (0.78-0.95), 3.78 (3.05-4.50), 0.92 (0.87-0.97), 0.79 (0.65-0.92). The sROC curve for the accuracy of Type 1 lung profile in predicting first surfactant dose showed an AUC of 0.88; optimal specificity and sensitivity were both 0.86. Two studies addressing the predictive accuracy of LUS for ≥2 surfactant doses had high heterogeneity and were unsuitable to combine in a meta-analysis. Despite current significant variation in LUS thresholds, lung ultrasound is highly predictive of the need for early surfactant replacement. This evidence was derived from studies with homogeneous patient characteristics and low risk of bias.

Cervical Cytology and Histology Correlation as an Analytic Quality Assurance Exercise: Experience from an Accredited Cytology Laboratory.

The performance parameters of cervical cytology in any accredited cytology laboratory requires implementation of quality control exercise, which ensures acceptable performance by a laboratory. This study aims to assess the analytical aspect of quality control measures by evaluating the frequency and accuracy of epithelial abnormalities as detected in cervical Pap smears using histopathologic diagnosis as the gold standard. A retrospective diagnostic test study from 2018 to 2020 was conducted. Out of the total 6000 Pap smears, histopathologic correlation was available in 150 cases in the form of colposcopic-directed biopsy (CDB) and loop electrosurgical excision procedure (LEEP) tissue in 105 cases. The quality control measures analyzed were Atypical Squamous Cell: Squamous Intraepithelial Lesion (ASC: SIL) ratio, cyto-histo correlation, and study parameters like sensitivity, specificity, positive predictive value, and negative predictive value of Pap smears as against CDB and LEEP. 4.5% smears were reported as inadequate, 92.3% as Negative for intraepithelial lesion or malignancy (NILM), followed by epithelial abnormality found in 3.21%. The ASC: SIL ratio was 1.3:1. Concordance rate against CDB was 100% in Squamous cell carcinoma (SCC), 82.35% in high-grade squamous intraepithelial lesion (HSIL), 82% in atypical squamous cells of undetermined significance (ASCUS), 65.6% in low-grade squamous intraepithelial lesion (LSIL), and 50% in Atypical Squamous Cell ,High grade Squamous Intraepithelial Lesion can not be ruled out (ASC-H). Total concordance rate was 84.15%. Sensitivity of Pap smear was 65% for LSIL and 82% for HSIL. Specificity, positive predictive value, and negative predictive value were 63.63%, 90%, and 75%, respectively. Concordance rate was 96% with LEEP. Quality control measures give an insight of performance of any accredited cytology laboratory. This exercise needs to be conducted on a regular basis, so that relevant steps can be taken in case of major discrepancy.

The accuracy of the Global Trigger Tool is higher for the identification of adverse events of greater harm: a diagnostic test study.

Global Trigger Tool (GTT) of the Institute for Healthcare Improvement (IHI) has been used as a measurement strategy for patient safety by several institutions and national programs. Although the greater ability of the GTT to identify adverse events (AEs) compared to other methods has already been demonstrated, there are few data on its accuracy, and studies suggest lower sensitivity for minor AEs. This study aimed to assess the accuracy of the GTT for identifying AEs in adult inpatients for all AEs and for the subgroup of AEs with greater harm to the patient, classified as F-I on the IHI-GTT adapted version of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for Categorizing Errors. In this diagnostic test study, GTT is the index test and identification of AEs (yes/no) represents the condition of interest. Due to the lack of a gold standard test, a composite reference standard method was developed. Reference standard method combined real-time (during hospitalizations) and retrospective search of medical records and administrative data for screening criteria and AEs. Both tests were applied to a random sample of 211 hospitalizations of adult inpatients during October-November 2016 in a large public hospital in Belo Horizonte, Brazil. The accuracy of the GTT was evaluated using sensitivity, specificity, and global accuracy. A total of 176 AEs were identified in 67 admissions using reference standard method and 129 AEs in 76 admissions using GTT, resulting in rates of 126 and 93 AEs/1000 patient-days, respectively. Sensitivity, specificity, and global accuracy of the GTT for the identification of individual AEs were, respectively, 0.41 (95% confidence interval [CI] 0.34; 0.49), 0.68 (95% CI 0.60; 0.74), and 0.54 (95% CI 0.49; 0.60) for all AEs, regardless of the harm categorization, and 0.85 (95% CI 0.72; 0.93), 0.88 (95% CI 0.82; 0.92), and 0.87 (95% CI 0.82; 0.91) for the subgroup of AEs categorized as harm F-I. Among the main AEs missed by the GTT are AEs related to nursing care, such as those related to peripheral venous access and gastric/enteric catheters. GTT proved to be a valid method for identifying AEs in adult inpatients. Its accuracy increases when minor harm AEs are not counted. Among the main AEs missed by the GTT are those related to nursing care. Therefore, the GTT should be used in conjunction with other measurement strategies to achieve results that are representative of the quality profile of the care provided and, thus, guide the best improvement strategies.

The Use of Thermal Imaging in Free Perforator Flap Planning

Background. Preoperative planning and design of microsurgical perforator flaps are the main steps for successful operation. The aim of this study was to determine the concordance between thermographic images obtained with smartphone thermal imaging camera and hand-held Doppler in the anterolateral thigh flap (ALT) model. Methods. A concordance study of diagnostic tests was carried out in Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Plastic and Reconstructive Surgery Department during 2020–2022. Patients’ who were scheduled to undergo reconstruction with ALT flap and healthy volunteers were included in the study. Dynamic thermal images were performed with smartphone thermal camera FLIR One PRO in the typical ALT flap territory. The number and distance of hotspots in the thermogram with respect to anterior superior iliac spine were recorded in the study protocol. Later, the examination was repeated with hand-held Doppler and the control of hotspot was performed. Sensitivity, specificity and concordance index calculations were performed. Statistical analysis was performed using IMB SPSS 23.0. Results. A total of 100 ALT flap territories were examined. 266 hotspots were detected with thermal imaging and 275 perforators with hand-held Doppler. In 96.6% of cases, hotspots detected by a thermal camera were confirmed by hand-held Doppler as perforators. The sensitivity and specificity of thermography for the detection of perforators with respect to the hand-held Doppler were 93.5% and 96.9% respectively. The measure of concordance kappa index was 0.095 (p = 0.001). Conclusion. Smartphone thermal imaging have a high concordance with hand-held Doppler in perforator mapping, thus could be considered a useful adjunct to conventional methods.

The utility of Endoscopic Functional Luminal Imaging (EndoFLIP) in the diagnosis and management of children with achalasia

Per-oral endoscopic myotomy (POEM) has is an alternative treatment to laparoscopic Heller myotomy for children with achalasia. The EndoFLIP functional luminal imaging system is used to measure esophagogastric junction (EGJ) distensibility pre- and post-POEM. Previous adult studies have established a correlation between obstructive symptoms and Distensibility Index (DI). Here we analyze the utility of EndoFLIP in diagnosis and management of achalasia in the largest study on pediatric POEM patients and hypothesize that DI may aid diagnosis and treatment of pediatric achalasia. Demographics, preoperative basal and residual pressures measured on manometry, and EndoFLIP measurements pre- and post-POEM were recorded for children that underwent POEM. Pearson correlation coefficient and T-scores were used to assess for correlation between manometry measurements and pre-POEM DI. Linear regression was conducted to analyze the relationship between pre-POEM DI, Eckardt scores, and manometry pressures. Of 33 patients that underwent POEM and EndoFLIP since 2014 (21 male, 12 female), the median pre-POEM Eckardt score decreased from 7 to 1 post-POEM. The median basal pressure was 50±25mmHg, pre-POEM DI was 0.9 (0.8-1.6) mm2/mmHg and the post-POEM DI was 3.8 (3.2-4.4) mm2/mmHg. There was no correlation between DI and basal pressure or residual pressure, though there was a strong negative correlation between Eckardt scores and DI. The EndoFLIP system is a valuable tool in adult patients in diagnosing achalasia and defining the endpoint of the POEM procedure. We find that there is a role for EndoFLIP in the pediatric population in diagnosis and management of the disease. Study of diagnostic test; Level IV.

Caudal vena cava measurements and fluid responsiveness in hospitalized cats with compromised hemodynamics and tissue hypoperfusion.

To evaluate the use of the caudal vena cava collapsibility index (CVCCI) and the inspiratory/minimum and expiratory/maximum diameters of the vena cava to predict fluid responsiveness in hospitalized, critically ill cats with hemodynamic and tissue perfusion abnormalities. Diagnostic test study in a prospective cohort of hospitalized cats. Private practice referral hospital. Twenty-four hospitalized cats with spontaneous breathing and compromised hemodynamics and tissue hypoperfusion. Ultrasonographic examination before and after fluid expansion with 10ml/kg of lactated Ringer's solution. Fluid responsiveness was evaluated using the velocity-time integral (VTI) of the subaortic blood flow, by measuring it before and after a fluid load of 10ml/kg of lactated Ringer's solution. The CVCCI was calculated using the following formula: (maximum diameter-minimum diameter / maximum diameter)×100. Ten cats were fluid responders (42 %) and 14 were nonresponders (58 %). The area under the receiver operating characteristic curve (AUROC) with their 95% confidence interval for the predictors and the best cutoff values were as follows: CVCCI, AUROC=0.83 (0.66-1.00) and cutoff=31%; inspiratory/minimum diameter, AUROC=0.86 (0.70-1.00) and cutoff=0.24cm; expiratory/maximum diameter, AUROC=0.88 (0.74-1.00) and cutoff=0.22cm. A significant lineal correlation was observed between the percentage of increase in VTI after expansion and CVCCI (rs =0.68, P<0.001), expiratory/maximum diameter (rs =-0.72, P<0.001), and inspiratory/minimum diameter (rs =-0.71, P<0.001). The intraobserver and interobserver variability was low for VTI, and the expiratory/maximum diameter and inspiratory/minimum diameter were high for CVCCI. Caudal vena cava measurements could be useful to predict the response to fluids in hospitalized cats with hemodynamic and tissue perfusion alterations. Additional studies are required to draw definitive conclusions about the role of these variables to guide fluid administration in cats.

Tricuspid regurgitation pressure gradient to diagnose pulmonary hypertension: a diagnostic accuracy study

Background Pulmonary hypertension carries significant morbidity and mortality in children. Early diagnosis and management may improve outcomes in children with pulmonary hypertension. Heart catheterization, a gold standard for diagnosing pulmonary hypertension, is an invasive procedure and not widely available. Echocardiography can be used as an alternative diagnostic tool for pulmonary hypertension.&#x0D; Objective To determine the diagnostic value of tricuspid regurgitation pressure gradient on echocardiography compared to heart catheterization to diagnose pulmonary hypertension in children.&#x0D; Methods This diagnostic test study was done with medical record data of children with acyanotic congenital heart disease who underwent cardiac catheterization and echocardiography procedures from January 2018 to December 2020 at Dr. Sardjito Hospital, Yogyakarta, Indonesia.&#x0D; Data were analyzed to obtain sensitivity, specificity, positive and negative predictive values, as well as positive and negative likelihood ratios.&#x0D; Results A total of 98 children with acyanotic congenital heart disease were included. The sensitivity and specificity of the tricuspid regurgitation pressure gradient to determine pulmonary artery pressure compared to heart catheterization were 64.4% and 54.5%, respectively. The positive likelihood ratio was 1.42. The pre-test and post-test probability of this study were 88.7% and 91.7%, respectively.&#x0D; Conclusion Tricuspid regurgitation pressure gradient measured using echocardiography has poor sensitivity and specificity to diagnose pulmonary hypertension.

Characteristics of Depression Clinical Trials Registered on ClinicalTrials.gov.

Mental disorders are among the leading causes of the global health-related burden, and depression is one of the most disabling mental disorders. The emergence of the COVID-19 pandemic has created an environment where many determinants of mental health are exacerbated. Many studies have been registered and conducted over the past 16 years, but how to choose the proper design for depression clinical trials remains the main concern. This study aimed to characterize the current status of global depression clinical trials registered on ClinicalTrials.gov. We examined all the trials registered on ClinicalTrials.gov from 2007 to 2021. Overall, 7623 depression clinical trials were identified for analysis. Of those trials, 6402 (83.98%) were intervention trials and 1212 (15.90%) were observational trials. The majority of intervention types were behavioral (35.2%) and drug (28.55%), with very few procedures, dietary supplements, and diagnostic test studies. In addition, 55.53% of trials enrolled <100 participants. The proportions of trials registered in North America were higher than on other continents. Furthermore, the trials that involved only females (12.6%) were more than only males (0.87%) from 2019 to 2021. Depression clinical trials registered on ClinicalTrials.gov were dominated by small sample size trials, and there is a lack of trials related to COVID-19. The choice of study design is crucial, and properly designed trials can help improve study efficiency and reduce the likelihood of study failure. Given the increased number of RCT trials, the trial quality is gradually improving over the years. In addition, depression trials concentrating on children and older adults need more scientific attention. Further studies related to COVID-19 are needed, given the great damage that causes to people's physical and mental health.

Novel Decision Tool for More Severe α-Thalassemia Genotypes Screening with Functional Loss of Two or More α-Globin Genes: A Diagnostic Test Study.

After the exclusion of iron deficiency and β-thalassemia, molecular research for α-thalassemia is recommended to investigate microcytic anemia. Aiming to suggest more efficiently the molecular analysis for individuals with a greater chance of having a symptomatic form of the disease, we have developed and validated a new decision tool to predict the presence of two or more deletions of α-thalassemia, increasing considerably the pre-test probability. The model was created using the variables: the percentage of HbA2, serum ferritin and mean corpuscular volume standardized by age. The model was trained in 134 patients and validated in 160 randomly selected patients from the total sample. We used Youden's index applied to the ROC curve methodology to establish the optimal odds ratio (OR) cut-off for the presence of two or more α-globin gene deletions. Using the OR cut-off of 0.4, the model's negative predictive value (NPV) was 96.8%; the cut-off point accuracy was 85.4%; and the molecular analysis pre-test probability increased from 25.9% to 65.4% after the use of the proposed model. This tool aims to assist the physician in deciding when to perform molecular studies for the diagnosis of α-thalassemia. The model is useful in places with few financial health resources.

A retrospective diagnostic test study on circulating tumor cells and artificial intelligence imaging in patients with lung adenocarcinoma.

Either tumor volume or folate-receptor-positive circulating tumor cells (FR+CTC) has been proven effective in predicting tumor cell invasion. However, it has yet to be documented to use FR+CTC along with artificial intelligence (AI) tumor volume to differentiate between pathological subtypes of lung adenocarcinoma (LUAD). Therefore, this study is aimed to evaluate the accuracy of FR+CTC and AI tumor volume for classifying the invasiveness of LUAD. A total of 226 patients who were diagnosed with LUAD were enrolled. The inclusion criteria were: (I) FR+CTC detection and AI imaging before anticancer therapy, and (II) definite histopathologic diagnosis, which is the gold diagnosis of LUAD and its subtypes. Use the CytoploRare® Detection Kit to quantify FR+CTC and the AI-assisted diagnosis system, ScrynPro, to measure tumor volume. The clinical data were used to construct univariate and multivariate logistic regression models. A nomogram was drawn based on the multivariate logistic regression model. The validity is evaluated by the calibration curve and Hosmer-Lemeshow goodness-of-fit test. The mean age of 146 patients (96 males, 49 females and 1 gender missing) retrospectively enrolled was 56.6. In the cohort, 41 and 105 patients were assigned to adenocarcinoma in situ (AIS) + minimally invasive adenocarcinoma (MIA) and invasive pulmonary adenocarcinoma (IPA), respectively. There was no significant difference between the sex distribution and smoking history of the two groups (P=0.155 and P=0.442, respectively). In univariate analysis, the nodules type, maximum density, tumor volume and FR+CTC level were statistically significant with the invasiveness of LUAD (P<0.05). The multivariate analysis showed significant differences in FR+CTC and AI tumor volume (P<0.001). The area under the curves (AUCs) of FR+CTC and AI tumor volume in diagnosing tumor invasiveness were 0.659 and 0.698, respectively. A predictive model combining FR+CTC with AI tumor volume showed a sensitivity of 86.89% and a specificity of 70.94%, and the AUC was 0.841. The nomogram had good agreement with actual observation, and the Hosmer-Lemeshow test yielded non-significant goodness-of-fit. FR+CTC and/or AI tumor volume are independent indicators of the invasiveness of LUAD, and the nomogram based on them can be used for the preoperative screening of patients.

Comparison of New Spirometry Measures to Diagnose COPD.

COPD is diagnosed by using FEV1/FVC, which has limitations as a diagnostic test. We assessed the validity of several measures derived from the expiratory phase of the flow-volume curve obtained from spirometry to diagnose COPD: the slopes that correspond to the volume expired after the 50% and 75% of the FVC, the slope formed between the peak expiratory flow (PEF) and the FVC, and the area under the expiratory flow/volume curve. We conducted a cross-sectional diagnostic test study in 765 consecutive subjects referred for spirometry because of respiratory symptoms. We compared the reproducibility and accuracy of the proposed measures against post-bronchodilator FEV1/FVC < 0.70. We also evaluated the proportion of respiratory symptoms for the FEV1/FVC, FEV1 per FEV in the first 6 s (FEV6), and the PEF slope. The subjects had a mean age of 65.8 y, 57% were women, and 35% had COPD. The test-retest intraclass correlation coefficient values were 0.89, 0.85, and 0.83 for FEV1/FVC, FEV1/FEV6, and the PEF slope, respectively. The area under the curve values were 0.93 (expiratory flow/volume), 0.96 (potential expiratory flow/volume), 0.97 (potential expiratory flow/volume at 75% of FVC), and 0.82 (potential expiratory flow/volume at 50% of FVC). The area under the receiver operating characteristic curve was 0.99 for FEV1/FEV6, 0.99 for the slope at 50% of the FVC, and 0.98 for the PEF slope. The FEV1/FEV6, PEF slope, and 50% FVC slopes had similar diagnostic performances compared with FEV1/FVC.

Pupillary dilation reflex and behavioural pain scale: Study of diagnostic test

BackgroundThe objective of this study was to assess the value of the pupillary dilation reflex as an assessment pain tool in critically ill patients. It is important to continue working for the well-being and security of critically ill patients. MethodsWe studied the diagnostic accuracy of the pupillary dilation reflex against the Behavioral Pain Scale. Inclusion criteria were: age greater than 18, receiving mechanical ventilation, with a basal score of the Behavioural Pain Scale of three and a Richmond Agitation and Sedation score between −1 and −4. We studied the responses to a non-painful stimulus, four calibrated stimuli, after a tracheal aspiration and with and without pain. The receiver operating curve was plotted and we calculated the area under the curve. We identified the cut-off points showing the highest sensitivity and specificity and studied diagnostic performance based on negative predictive value, positive predictive value, and accuracy. These were reported with their 95% confidence intervals. Results183 measurements were performed. An AUC of 0.88(95% CI 0.83–0.94) was obtained. The pupillary dilation reflex of 11.5% had a sensitivity of 89.8%(95% CI 78.2–95.6) and a specificity of 78.4%(95% CI 70.6–84.5) with an accuracy of 81.4(75.2–86.4). The pupillary dilation reflex detected nociceptive pain response in 15.8% of the measurements that did not show pain according to the Behavioural Pain Scale. ConclusionsPupillometry may be a valid alternative for identifying pain in critically ill patients.