Tool In Routine Clinical Practice Research Articles

A service-user digital intervention to collect real-time safety information on acute, adult mental health wards: the WardSonar mixed-methods study.

Acute inpatient mental health services report high levels of safety incidents. The application of patient safety theory has been sparse, particularly concerning interventions that proactively seek patient perspectives. Develop and evaluate a theoretically based, digital monitoring tool to collect real-time information from patients on acute adult mental health wards about their perceptions of ward safety. Theory-informed mixed-methods study. A prototype digital monitoring tool was developed from a co-design approach, implemented in hospital settings, and subjected to qualitative and quantitative evaluation. Phase 1: scoping review of the literature on patient involvement in safety interventions in acute mental health care; evidence scan of digital technology in mental health contexts; qualitative interviews with mental health patients and staff about perspectives on ward safety. This, alongside stakeholder engagement with advisory groups, service users and health professionals, informed the development processes. Most data collection was virtual. Phase 1 resulted in the technical development of a theoretically based digital monitoring tool that collected patient feedback for proactive safety monitoring. Phase 2: implementation of the tool in six adult acute mental health wards across two UK NHS trusts; evaluation via focused ethnography and qualitative interviews. Statistical analysis of WardSonar data and routine ward data involving construction of an hour-by-hour data set per ward, permitting detailed analysis of the use of the WardSonar tool. A total of 8 patients and 13 mental health professionals participated in Phase 1 interviews; 33 staff and 34 patients participated in Phase 2 interviews. Patients could use a web application (the WardSonar tool) to record real-time perceptions of ward safety. Staff could access aggregated, anonymous data to inform timely interventions. Coronavirus disease 2019 restrictions greatly impacted the study. Stakeholder engagement permeated the project. Phase 1 delivered a theory-based, collaboratively designed digital tool for proactive patient safety monitoring. Phase 2 showed that the tool was user friendly and broadly acceptable to patients and staff. The aggregated safety data were infrequently used by staff. Feasibility depended on engaged staff and embedding use of the tool in ward routines. There is strong evidence that an incident leads to increased probability of further incidents within the next 4hours. This puts a measure on the extent to which social/behavioural contagion persists. There is weak evidence to suggest that an incident leads to a greater use of the WardSonar tool in the following hour, but none to suggest that ward atmosphere predicts future incidents. Therefore, how often patients use the tool seems to send a stronger signal about potential incidents than patients' real-time reports about ward atmosphere. Implementation was limited to two NHS trusts. Coronavirus disease 2019 impacted design processes including stakeholder engagement; implementation; and evaluation of the monitoring tool in routine clinical practice. Higher uptake could enhance validity of the results. WardSonar has the potential to provide a valuable route for patients to communicate safety concerns. The WardSonar monitoring tool has a strong patient perspective and uses proactive real-time safety monitoring rather than traditional retrospective data review. The WardSonar tool can be refined and tested further in a post Coronavirus disease 2019 context. This study is registered as ISRCTN14470430. This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128070) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 14. See the NIHR Funding and Awards website for further award information.

Approach to headache disorders and the management of migraine: consensus guidelines from the Headache Society of Singapore, first edition (2023).

Headache disorders, particularly migraine, are one of the most common and disabling neurological disorders. There is a need for high-quality, accessible care for patients with headache disorders across all levels of the healthcare system in Singapore. The role of the Headache Society of Singapore is to increase awareness and advance the understanding of these disorders and to advocate for the needs of affected patients. In this first edition of local consensus guidelines, we focus on treatment approaches for headaches and provide consensus recommendations for the management of migraine in adults. The recommendations in these guidelines can be used as a practical tool in routine clinical practice by primary care physicians, neurologists and other healthcare professionals who have a common interest in headache disorders.

Motorized spiral enteroscopy in clinical practice: Benefits and results in a single-center cohort study of 204 procedures

ObjectivesThe aim of this paper relies on our clinical experience in a single center with an evaluation of feasibility, clinical benefits, and safety in daily practice based on diagnosis and therapeutic yield using a newly designed Motorized Spiral Enteroscope (MSE) marked by Olympus. MethodAll examinations were conducted in the usual endoscopy suite with patients in the left lateral position with deep propofol sedation monitored by an anesthesiologist (bolus 2 ​mg/kg then 0.5 ​mg/kg on demand with mean total dose 300 ​mg (225.6–386 ​mg). For the anal route, MSE was performed on the X-ray table in order to monitor colonic passage and ileocecal intubation. Inflation was carried out with CO2 used. ResultsFrom June 2019 to July 2022, 204 procedures have been carried out. 188 patients were involved as repeated MSE was required due to multiple bleeding (male 111, 57.1%, female 87, 46.2%). In all cases, we considered a successful MSE when the enteroscope was deeply inserted in the ileum and achieved diagnosis or therapeutic indications as an endpoint (195 patients, 95.5%). Diagnostic yield was achieved in 134 procedures (65.7%).Time to deep insertion was 11:36 ​± ​05.05 ​min, and the total procedure time was 22:07 ​± ​07:25 ​min. Minor mucosal damage occurred in 59 patients (28.9%). ConclusionsIn our 204 procedures MSE is a safe and useful new tool in routine clinical practice with an overall benefit for our patients.

Enhanced detection of severe aortic stenosis via artificial intelligence: a clinical cohort study

ObjectiveWe developed an artificial intelligence decision support algorithm (AI-DSA) that uses routine echocardiographic measurements to identify severe aortic stenosis (AS) phenotypes associated with high mortality.Methods631 824 individuals with 1.08 million...

Screening for Anxiety in Patients With Inflammatory Arthritis Using the Multidimensional Health Assessment Questionnaire.

To analyze the Multidimensional Health Assessment Questionnaire (MDHAQ) in screening for anxiety in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA), compared to the Hospital Anxiety and Depression Scale (HADS) as the reference standard. Patients with a physician diagnosis of RA or PsA were invited to complete the MDHAQ and HADS at their routine rheumatology clinic visit. Sensitivity, specificity, percent agreement, and [Formula: see text] statistics were used to evaluate agreement between 2 MDHAQ items for anxiety and HADS subscale for Anxiety (HADS-A) score of ≥ 8. The first item is a question asked on a 4-point scale (0-3.3), and the second is a yes or no (blank) question asked within a 60-item review of symptoms (ROS) checklist. The study included 183 participants, of whom 126 (68.9%) had RA and 57 (31.1%) had PsA. The mean age was 57.3 years and 66.7% were female. Positive screening for anxiety according to a HADS-A score of ≥ 8 was seen in 39.3% of patients. Compared to those with a HADS-A score of ≥ 8, patients with an MDHAQ score of ≥ 2.2 or a positive on ROS had a sensitivity of 69.9%, specificity of 73.6% and substantial agreement (agreement 80.9%, [Formula: see text] 0.59). The MDHAQ provides information similar to the HADS in screening for anxiety in patients with RA and PsA. The use of this single questionnaire, which can also be used to monitor clinical status and to screen for fibromyalgia and depression without requiring multiple questionnaires, may prove a valuable tool in routine clinical practice.

A novel risk prediction tool for contrast-induced nephropathy in patients with chronic kidney disease who underwent diagnostic coronary angiography.

The incidence of contrast-induced nephropathy (CIN) is higher than 20% in patients with chronic kidney disease. In this study, we sought to define the predictors of CIN and develop a risk prediction tool in patients with chronic kidney disease. Patients aged 18 years and older who underwent invasive coronary angiography with an iodine-based contrast media between March 2014 and June 2017 were retrospectively analyzed. Independent predictors for CIN development were identified and a new risk prediction tool was created that included these predictors. In total, 283 patients included in the study were divided into those who developed CIN (n=39, 13.8%) and those who did not (n=244, 86.2%). Male gender (OR: 4.874, 95% CI: 2.044-11.621), LVEF (OR: 0.965, 95% CI: 0.936-0.995), diabetes mellitus (OR: 1.711, 95% CI: 1.094-2.677), and e-GFR (OR: 0.880, 95% CI: 0.845-0.917), were identified as independent predictors for the development of CIN in the multivariate analysis. A new scoring system has been designed that can score a minimum of 0 and a maximum of 8 points. Patients with a new scoring system score of ≥4 were at approximately 40 times higher risk of developing CIN than others (OR: 39.9, 95% CI: 5.4-295.3). The area under the curve value of CIN's new scoring system was 0.873 (95% CI, 0.821-0.925). We found that four easily accessible and routinely collected variables, including sex, diabetes status, e-GFR, and LVEF, were independently associated with the development of CIN. We believe that using this risk prediction tool in routine clinical practice may guide physicians to use preventive medications and techniques in high-risk patients for CIN.

MYB RNA detection by in situ hybridisation has high sensitivity and specificity for the diagnosis of adenoid cystic carcinoma

Adenoid cystic carcinoma (ACC) is one of the most common primary salivary gland cancers. ACC has several benign and malignant mimics amongst salivary gland neoplasms. An accurate diagnosis of ACC is essential for optimal management of the patients and their follow-up. Upregulation of MYB has been described in 85-90% of ACC, but not in other salivary gland neoplasms. In ACC, MYB upregulation can occur as a result of a genetic rearrangement t(6;9) (q22-23;p23-24), MYB copy number variation (CNV), or enhancer hijacking of MYB. All mechanisms of MYB upregulation result in increased RNA transcription that can be detected using RNA in situ hybridisation (ISH) methods. In this study, utilising 138 primary salivary gland neoplasms including 78 ACC, we evaluate the diagnostic utility of MYB RNA ISH for distinguishing ACC from other primary salivary gland neoplasms with a prominent cribriform architecture including pleomorphic adenoma, basal cell adenoma, basal cell adenocarcinoma, epithelial myoepithelial carcinoma, and polymorphous adenocarcinoma. Fluorescent in situ hybridisation and next generation sequencing were also performed to evaluate the sensitivity and specificity of RNA ISH for detecting increased MYB RNA when MYB gene alterations were present. Detection of MYB RNA has 92.3% sensitivity and 98.2% specificity for a diagnosis of ACC amongst salivary gland neoplasms. The sensitivity of MYB RNA detection by ISH (92.3%) is significantly higher than that of the FISH MYB break-apart probe (42%) for ACC. Next generation sequencing did not demonstrate MYB alterations in cases that lacked MYB RNA overexpression indicating high sensitivity of MYB RNA ISH for detecting MYB gene alterations. The possibility that the sensitivity may be higher in clinical practice with contemporary samples as compared with older retrospective tissue samples with RNA degradation is not entirely excluded. In addition to the high sensitivity and specificity, MYB RNA testing can be performed using standard IHC platforms and protocols and evaluated using brightfield microscopy making it a time and cost-efficient diagnostic tool in routine clinical practice.

Translational Molecular Imaging Tool of Vulnerable Carotid Plaque: Evaluate Effects of Statin Therapy on Plaque Inflammation and American Heart Association–Defined Risk Levels in Cuff-Implanted Apolipoprotein E–Deficient Mice

Identification of high-risk carotid plaques in asymptomatic patients remains a challenging but crucial step in stroke prevention. The challenge is to accurately monitor the development of high-risk carotid plaques and promptly identify patients, who are unresponsive to best medical therapy, and hence targeted for carotid surgical interventions to prevent stroke. Inflammation is a key operator in destabilisation of plaques prior to clinical sequelae. Currently, there is a lack of imaging tool in routine clinical practice, which allows assessment of inflammatory activity within the atherosclerotic plaque. Herein, we have used a periarterial cuff to generate a progressive carotid atherosclerosis model in apolipoprotein E–deficient mice. This model produced clinically relevant plaques with different levels of risk, fulfilling American Heart Association (AHA) classification, at specific timepoints and locations, along the same carotid artery. Exploiting this platform, we have developed smart molecular magnetic resonance imaging (MRI) probes consisting of dual-targeted microparticles of iron oxide (DT-MPIO) against VCAM-1 and P-selectin, to evaluate the anti-inflammatory effect of statin therapy on progressive carotid atherosclerosis. We demonstrated that in vivo DT-MPIO-enhanced MRI can (i) quantitatively track plaque inflammation from early to advanced stage; (ii) identify and characterise high-risk inflamed, vulnerable plaques; and (iii) monitor the response to statin therapy longitudinally. Moreover, this molecular imaging–defined therapeutic response was validated using AHA classification of human plaques, a clinically relevant parameter, approximating the clinical translation of this tool. Further development and translation of this molecular imaging tool into the clinical arena may potentially facilitate more accurate risk stratification, permitting timely identification of the high-risk patients for prophylactic carotid intervention, affording early opportunities for stroke prevention in the future.

Progressive Lacunar Strokes: A Predictive Score

Background and PurposeProgressive lacunar syndromes (PLS) occur in up to 20-30% of patients with lacunar strokes, increasing the risk of long term dependency. Our aim is to develop a predictive score to identify patients at high risk of presenting PLS. MethodsWe derived a risk score for PLS in a cohort of consecutive patients (n=187) presenting with one of the five classic lacunar syndromes (LS) and absence of vascular occlusion, perfusion deficit or symptomatic stenosis. A risk score was developed using the coefficients from the logistic regression model, and receiver operating characteristic (ROC) analysis was conducted to assess the prognostic value of the risk score. Sensitivity, specificity and accuracy were estimated for each total point score. ResultsOut of 187 patients included in our sample, 52 (27.8%) presented PLS. Previous history of diabetes mellitus (1 point), diastolic blood pressure at admission (2 points), clinical deficits consistent with a pure motor syndrome (1 point) and asymptomatic intracranial atheromatosis or stenosis in non-symptomatic territory (1 point) were independent predictors for PLS. The estimated area under the ROC curve for this model was 0.77 (95% CI,0.68 - 0.84). ConclusionThis score could be a useful tool in routine clinical practice to predict the occurrence of PLS, allowing the identification of those patients with LS who are at high risk of long term dependency due to early neurological worsening, and who would benefit the most from an intensive treatment.

Ex Vivo Test for Measuring Complement Attack on Endothelial Cells: From Research to Bedside

As part of the innate immune system, the complement system plays a key role in defense against pathogens and in host cell homeostasis. This enzymatic cascade is rapidly triggered in the presence of activating surfaces. Physiologically, it is tightly regulated on host cells to avoid uncontrolled activation and self-damage. In cases of abnormal complement dysregulation/overactivation, the endothelium is one of the primary targets. Complement has gained momentum as a research interest in the last decade because its dysregulation has been implicated in the pathophysiology of many human diseases. Thus, it appears to be a promising candidate for therapeutic intervention. However, detecting abnormal complement activation is challenging. In many pathological conditions, complement activation occurs locally in tissues. Standard routine exploration of the plasma concentration of the complement components shows values in the normal range. The available tests to demonstrate such dysregulation with diagnostic, prognostic, and therapeutic implications are limited. There is a real need to develop tools to demonstrate the implications of complement in diseases and to explore the complex interplay between complement activation and regulation on human cells. The analysis of complement deposits on cultured endothelial cells incubated with pathologic human serum holds promise as a reference assay. This ex vivo assay most closely resembles the physiological context. It has been used to explore complement activation from sera of patients with atypical hemolytic uremic syndrome, malignant hypertension, elevated liver enzymes low platelet syndrome, sickle cell disease, pre-eclampsia, and others. In some cases, it is used to adjust the therapeutic regimen with a complement-blocking drug. Nevertheless, an international standard is lacking, and the mechanism by which complement is activated in this assay is not fully understood. Moreover, primary cell culture remains difficult to perform, which probably explains why no standardized or commercialized assay has been proposed. Here, we review the diseases for which endothelial assays have been applied. We also compare this test with others currently available to explore complement overactivation. Finally, we discuss the unanswered questions and challenges to overcome for validating the assays as a tool in routine clinical practice.

Introducing CatchU<sup>TM</sup>: A Novel Multisensory Tool for Assessing Patients’ Risk of Falling<xref ref-type="fn" rid="jpi0146fn1"><sup>†</sup></xref>

To date, only a few studies have investigated the clinical translational value of multisensory integration. Our previous research has linked the magnitude of visual-somatosensory integration (measured behaviorally using simple reaction time tasks) to important cognitive (attention) and motor (balance, gait, and falls) outcomes in healthy older adults. While multisensory integration effects have been measured across a wide array of populations using various sensory combinations and different neuroscience research approaches, multisensory integration tests have not been systematically implemented in clinical settings. We recently developed a step-by-step protocol for administering and calculating multisensory integration effects to facilitate innovative and novel translational research across diverse clinical populations and age-ranges. In recognizing that patients with severe medical conditions and/or mobility limitations often experience difficulty traveling to research facilities or joining time-demanding research protocols, we deemed it necessary for patients to be able to benefit from multisensory testing. Using an established protocol and methodology, we developed a multisensory falls-screening tool called CatchU ™ (an iPhone app) to quantify multisensory integration performance in clinical practice that is currently undergoing validation studies. Our goal is to facilitate the identification of patients who are at increased risk of falls and promote physician-initiated falls counseling during clinical visits (e.g., annual wellness, sick, or follow-up visits). This will thereby raise falls-awareness and foster physician efforts to alleviate disability, promote independence, and increase quality of life for our older adults. This conceptual overview highlights the potential of multisensory integration in predicting clinical outcomes from a research perspective, while also showcasing the practical application of a multisensory screening tool in routine clinical practice.

Impact of the iCODEX tool in routine clinical practice in Spain

Introduction The prognosis of COPD patients can be calculated using multidimensional indexes that improve the predictive capacity of the individual variables. The CODEX index can be calculated using iCODEX, a digital support tool available on the web and in an app. The aim of this study was to evaluate how the usefulness and applicability of iCODEX and its recommendations in routine clinical practice are perceived by specialists in internal medicine, pneumology, and primary care. Methods A cross-sectional study was conducted from November 2019 to February 2020 with the participation of specialists in internal medicine, primary care, and pneumology. All respondents completed a survey consisting of 104 questions on their perception of the iCODEX tool. Results Overall, 335 physicians responded. Of these, 95.2% had no difficulty accessing the tool and 83.1% were quite or very satisfied with it. Regarding the applicability and implementation of iCODEX recommendations in routine clinical practice, respondents reported that the recommendations were generally applicable: most questions obtained a median score of ≥ 4 out of 5. The recommendations with the greatest expected clinical benefit are listed. Conclusions Our study shows that the iCODEX tool is easy for participating specialists to use and identifies the recommendations that have the greatest clinical impact in areas such as lung obstruction, severe exacerbations, exercise, smoking, and patient follow-up.

Allele-specific PCR and Next-generation sequencing based genetic screening for Congenital Adrenal Hyperplasia in India

Genetic screening of Congenital Adrenal Hyperplasia (CAH) is known to be challenging due to the complexities in CYP21A2 genotyping and has not been the first-tier diagnostic tool in routine clinical practice. Also, with the advent of massive parallel sequencing technology, there is a need for investigating its utility in screening extended panel of genes implicated in CAH. In this study, we have established and utilized an Allele-Specific Polymerase Chain Reaction (ASPCR) based approach for screening eight common mutations in CYP21A2 gene followed by targeted Next Generation Sequencing (NGS) of CYP21A2, CYP11B1, CYP17A1, POR, and CYP19A1 genes in 72 clinically diagnosed CAH subjects from India. Through these investigations, 88.7% of the subjects with 21 hydroxylase deficiency were positive for eight CYP21A2 mutations with ASPCR. The targeted NGS assay was sensitive to pick up all the mutations identified by ASPCR. Utilizing NGS in subjects negative for ASPCR, five study subjects were homozygous positive for other CYP21A2 variants: one with a novel c.1274G>T, three with c.1451G>C and one with c.143A>G variant. One subject was compound heterozygous for c.955C>T and c.1042G>A variants identified using ASPCR and NGS. One subject suspected for a Simple Virilizing (SV) 21 hydroxylase deficiency was positive for a CYP19A1:c.1142A>T variant. CYP11B1 variants (c.1201-1G>A, c.1200+1del, c.412C>T, c.1024C>T, c.1012dup, c.623G>A) were identified in all six subjects suspected for 11 beta-hydroxylase deficiency. The overall mutation positivity was 97.2%. Our results suggest that ASPCR followed by targeted NGS is a cost-effective and comprehensive strategy for screening common CYP21A2 mutations and the CAH panel of genes in a clinical setting.

Development of Molecular Magnetic Resonance Imaging Tools for Risk Stratification of Carotid Atherosclerotic Disease Using Dual-Targeted Microparticles of Iron Oxide

Identification of patients with high-risk asymptomatic carotid plaques remains a challenging but crucial step in stroke prevention. Inflammation is the key factor that drives plaque instability. Currently, there is no imaging tool in routine clinical practice to assess the inflammatory status within atherosclerotic plaques. We have developed a molecular magnetic resonance imaging (MRI) tool to quantitatively report the inflammatory activity in atherosclerosis using dual-targeted microparticles of iron oxide (DT-MPIO) against P-selectin and VCAM-1 as a smart MRI probe. A periarterial cuff was used to generate plaques with varying degree of phenotypes, inflammation and risk levels at specific locations along the same single carotid artery in an Apolipoprotein-E-deficient mouse model. Using this platform, we demonstrated that in vivo DT-MPIO-enhanced MRI can (i) target high-risk vulnerable plaques, (ii) differentiate the heterogeneity (i.e. high vs intermediate vs low-risk plaques) within the asymptomatic plaque population and (iii) quantitatively report the inflammatory activity of local plaques in carotid artery. This novel molecular MRI tool may allow characterisation of plaque vulnerability and quantitative reporting of inflammatory status in atherosclerosis. This would permit accurate risk stratification by identifying high-risk asymptomatic individual patients for prophylactic carotid intervention, expediting early stroke prevention and paving the way for personalised management of carotid atherosclerotic disease.

Introducing CatchU TM : A Novel Multisensory Tool for Assessing Patients’ Risk of Falling †

To date, only a few studies have investigated the clinical translational value of multisensory integration. Our previous research has linked the magnitude of visual-somatosensory integration (measured behaviorally using simple reaction time tasks) to important cognitive (attention) and motor (balance, gait, and falls) outcomes in healthy older adults. While multisensory integration effects have been measured across a wide array of populations using various sensory combinations and different neuroscience research approaches, multisensory integration tests have not been systematically implemented in clinical settings. We recently developed a step-by-step protocol for administering and calculating multisensory integration effects to facilitate innovative and novel translational research across diverse clinical populations and age-ranges. In recognizing that patients with severe medical conditions and/or mobility limitations often experience difficulty traveling to research facilities or joining time-demanding research protocols, we deemed it necessary for patients to be able to benefit from multisensory testing. Using an established protocol and methodology, we developed a multisensory falls-screening tool called CatchU TM (an iPhone app) to quantify multisensory integration performance in clinical practice that is currently undergoing validation studies. Our goal is to facilitate the identification of patients who are at increased risk of falls and promote physician-initiated falls counseling during clinical visits (e.g., annual wellness, sick, or follow-up visits). This will thereby raise falls-awareness and foster physician efforts to alleviate disability, promote independence, and increase quality of life for our older adults. This conceptual overview highlights the potential of multisensory integration in predicting clinical outcomes from a research perspective, while also showcasing the practical application of a multisensory screening tool in routine clinical practice.

Volume status and arterial stiffness evaluation in peritoneal dialysis patients.

Arterial stiffness represents an independent risk factor for cardiovascular mortality in dialysis patients and is strongly connected to hypervolemia. The aim of the study was to evaluate different methods for fluid status assessment and their association with arterial stiffness parameters in peritoneal dialysis patients. In 16 peritoneal dialysis patients (53 ± 18 years, 9/16 men) fluid status was determined by clinical examination, lung ultrasound (number of B-lines, normal up to 4), overhydration degree by bioimpedance monitor device, estimation of central venous pressure by ultrasound measurement of vena cava inferior, measurement of serum N-terminal pro b-type natriuretic peptide (NT-proBNP), and albumin level. Pulse wave velocity and augmentation index were measured non-invasively with an oscillometric device to indirectly assess arterial stiffness, blood pressure (BP) was obtained by the same device. Clinical evaluation (BP 136 ± 15/93 ± 15 mmHg, edema in 2/16 patients) and lung ultrasound (on average 3 ± 6 B-lines) showed mostly normal fluid status of patients. Patients had slightly lower albumin values (37 ± 4 g/L), slightly elevated central venous pressure (10 ± 4 mmHg), and elevated NT-proBNP (11,596 ± 13,635 ng/L). Body composition evaluation showed mild overhydration (1.5 ± 2 L), which significantly correlated with central venous pressure (p = 0.046) and NT-proBNP (p = 0.004). Lung ultrasound significantly negatively correlated with albumin (r = -0.82, p < 0.001) and positively with NT-proBNP (r = 0.62, p = 0.011). Augmentation index (22 ± 11%) and augmentation pressure correlated with lung ultrasound (r = 0.54, p = 0.032 and r = 0.67, p = 0.004, respectively), although pulse wave velocity (8.4 ± 2.5 m/s) showed no significant correlation with fluid status parameters. The multivariate model showed that lung ultrasound B-lines were an independent determinant of augmentation pressure (β = 0.58, p = 0.043). Fluid status evaluated with lung ultrasound showed good correlation with augmentation index and augmentation pressure, which are markers of arterial stiffness. The lung ultrasound B-lines were found to be an independent determinant of augmentation pressure. Overall arterial stiffness evaluated with pulse wave velocity and augmentation index was not markedly elevated in our patients, which could be due to a good euvolemic status. We conclude that different methods for fluid status evaluation are complementary, with lung ultrasound as a beneficial tool in routine clinical practice in peritoneal dialysis patients.

Performance of digital single-operator cholangiopancreatoscope for biliopancreatic diseases in real life: results from a prospective multicenter study

Objectives Peroralcholangio-pancreatoscopy (POCP) is used for diagnosis and treatment of biliopancreatic disease when standard endoscopy (ERCP) or pre-operative imaging workup failed. We aimed to evaluate the diagnostic and therapeutic performance of POCP in complex biliary and pancreatic diseases. Materials and methods Patients with indeterminate biliary or pancreatic duct (PD) strictures, and patients with failure of complex biliary or pancreatic stones removal, were enrolled (six centers). The primary endpoint evaluated malignancy diagnostic performances (accuracy, sensitivity, specificity) and therapeutic performances (biliary or pancreatic stones extraction). Secondary endpoints evaluated: technical success in lesion visualization, ease of maneuvering, image quality and 30-days complications. Results From November 2016 to March 2018, 66 patients were included: 29/37 women/men, median age (IQR): 73 (64–82). Fifty-three patients had diagnostic POCP and 13 patients therapeutic POCP. One endoscopist with one or two endoscopy nurses performed 94% of the POCP. The ‘POCP visual impression’ of malignancy showed 92.0% sensitivity, 92.9 % specificity and 92.5 % overall accuracy compared with the final diagnosis. ‘POCP-guided samples histological analysis’ showed 75.0 % sensitivity and 91.6% specificity. The technical success for lesion visualization was 98.5%. The median VAS scores for insertions in bile and PD were respectively 9.0 (8.1–9.6) and 9.0 (8.8–10.0). Median VAS score for access to the lesion and image quality were respectively 9.0 (7.7–9.6) and 9.0 (7.9–9.7). Only three 30-day minor complications occurred without any major complications. Conclusions POCP was an effective, safe and easy-to-use tool in routine clinical practice for the management of complex diagnostic and therapeutic biliary and pancreatic diseases (NCT03190343).

Some Aspects of Drug Induced Nephrotoxicity Assessment

About 14‒23% of all clinically used drugs have nephrotoxic potential and are a frequent cause of acute and chronic kidney problems. Acute kidney injury (AKI) is associated with a high risk of repeat hospitalisation, complications, and mortality in adults and children. The aim of the study was to provide an overview of the current approaches to the assessment of drug induced nephrotoxicity. The paper summarises pathogenetic mechanisms of drug induced kidney injury as well as molecular mechanisms at the drug transporters level. It analyses risk factors for drug induced kidney injury—age, sex, ethnicity, comorbidities (chronic kidney disease, diabetes, cardiovascular disease, immune disorders, sepsis, etc.), drug dosage and duration of therapy, pharmacokinetics of drugs, combinations of potentially nephrotoxic drugs, genetic determinants of drug metabolism and transport, etc. It was demonstrated that the traditional nephrotoxicity markers—serum creatinine and urine output—have low sensitivity as indicators of early renal damage. Therefore, new kidney biomarkers are being sought for in order to be used in AKI diagnosis and monitoring in patients with different comorbidities. Some of these biomarkers are already used in drug development, preclinical and clinical trials for assessment and prediction of drug safety. The analysis showed that none of these new kidney biomarkers could be used as an all-purpose tool in routine clinical practice. The development of new AKI biomarkers is a long-range objective and is the path toward early diagnosis and successful treatment of drug-induced nephrotoxicity.

Usefulness of collagen type IV in the detection of significant liver fibrosis in nonalcoholic fatty liver disease

Introduction/aimsLiver fibrosis assessment is a key issue in the evaluation of nonalcoholic fatty liver disease (NAFLD) patients. In the present study, we aimed to validate a noninvasive marker panel to assess significant and advanced fibrosis in these patients. Method126 biopsy-proven NAFLD patients were included. NAFLD diagnosis was based on histological criteria. Fibrosis stages were determined according to NASH-Clinical Research Network criteria. Clinical and laboratorial data were collected during the interval of three months before or after liver biopsy. Histological fibrosis stages were classified as significant fibrosis (F2-F4) and advanced fibrosis (F3-F4). Five serum biomarkers [hyaluronic acid (HA), collagen type IV (cIV), procollagen type III (PC III), laminin (LN) and cholylglycine (CG)] were assessed by chemiluminescence immunoassays. ResultsMost patients were female (61.61%), mean age: 55.7 ± 9.13 years old and mean BMI was 32.1 ± 5.9 kg/m2. Prevalence of diabetes, dyslipidemia, arterial hypertension, and metabolic syndrome was 68.75%, 82.29%, 63.54% and 81.05%, respectively. Patients with cIV above 30 ng/mL had a 5.57-times (IC: 1.86–16.69) the chance of having significant fibrosis and 7.61-times (IC: 2.27–25.54) the chance of having advanced fibrosis versus patients with values below 30 ng/mL. HA, PC III, LN and CG did not detect the presence of significant and advanced fibrosis. The AUROC of clV for detection of significant (0.718) and advanced fibrosis (0.791) was better than that of other serum biomarkers. ConclusionType 4 collagen could predict the presence of significant and advanced fibrosis in NAFLD patients and it would be a useful tool in routine clinical practice.

Validation of a Simple Tool for Electronic Documentation of Behavioral Responses to Anesthesia Induction.

Anxiety and distress behaviors during anesthesia induction are associated with negative postoperative outcomes for pediatric patients. Documenting behavioral responses to induction is useful to evaluate induction quality at hospitals and to optimize future anesthetics for returning patients, but we lack a simple tool for clinical documentation. The Induction Compliance Checklist is a tool for grading induction behaviors that is well validated for research purposes, but it is not practical for routine documentation in busy clinical practice settings. The Child Induction Behavioral Assessment tool was developed to provide a simple and easy to use electronic tool for clinical documentation of induction behaviors. The aim of this study was to test the Child Induction Behavioral Assessment tool's concurrent validity with the Induction Compliance Checklist and the interrater reliability. This prospective, observational study included 384 pediatric patients undergoing anesthesia inhalation induction. Concurrent validity with the Induction Compliance Checklist and interrater reliability of the Child Induction Behavioral Assessment were evaluated. Two researchers alternated scoring the Induction Compliance Checklist. The 2 researchers independently scored the Child Induction Behavioral Assessment. The anesthesia clinician caring for the patient also independently scored the Child Induction Behavioral Assessment by completing their routine documentation in the patient's medical record. Two age groups were evaluated (ages 1-3 and 4-12 years old). Clinicians' and researchers' Child Induction Behavioral Assessment scores demonstrated a strong correlation with the Induction Compliance Checklist (P < .0001). There was an excellent agreement between the 2 researchers' Child Induction Behavioral Assessment scores for the younger and older age groups, respectively (Kappa [95% CI] = 0.97 (0.94-0.99); K = 0.94 (0.89-0.99)]. The agreement between the researchers and the 117 clinicians who documented Child Induction Behavioral Assessment assessments in the medical record was good overall (intraclass correlation coefficient = 0.70), with fair agreement with the 1- to 3-year-old patients (intraclass correlation coefficient = 0.56) and good agreement for the 4- to 12-year-old patients (intraclass correlation coefficient = 0.74). The Child Induction Behavioral Assessment scale is a simple and practical electronic tool used to document pediatric behavioral responses to anesthesia inductions. This study provides evidence of the tool's validity and reliability for inhalation inductions. Future research is needed at other hospitals to confirm validity.