Low Level Of Concordance Research Articles

Identification of Mood Disorders in Self-Reported Versus Health Administrative Data.

Producing relevant knowledge on the prevalence of mood disorders (MDs) requires a clear identification of people living with the condition. Analyzing this multifaceted disease from the perspective of health administrative data and population-based surveys could contribute to document inconsistencies between these data sources and highlight the strengths and limitations of each methodological approaches. The aim of this study was to estimate the prevalence of MD disease, assess concordance of MD patterns in population-based surveys versus health administrative data, and investigate statistical differences in characteristics between individuals presenting the disease in each data sources. This study used the Care Trajectories-Enriched Data (TorSaDE) cohort. The TorSaDE cohort is built by merging five waves of the Canadian Community Health Survey (CCHS) with health administrative data of the province of Quebec, Canada. The sample includes individuals who participated in at least one round of CCHS and for whom evidence of use of health services in the year of CCHS completion and the year before were present in health administrative data. The cohort was split into four groups based on the presence and absence of MD in self-reported versus health administrative data. Groups' characteristics were compared using chi-square tests and ANOVA. The study cohort was composed of 96,079 individuals, of which 10,418 (10.8%) had MD, regardless of the data sources. Self-reported prevalence of MD was 6.03%, while the prevalence from health administrative data was about 7.79%. Estimates showed a low level of concordance between the two measures, as only 27.4% of people presenting this medical condition were identified in both data sources. Furthermore, individuals identified with MD only in survey data had poorer socioeconomic outcomes but better health outcomes than those from the concordant group (i.e., identified in both data sources). In addition, people presenting MD in health administrative data only had better socioeconomic and health outcomes than those who reported MD diagnosis only in survey data. Findings suggest that each measure capture different specific subpopulations. Estimates obtained from each source should thus be contextualized and interpreted with caution.

The Role of Endometrial Sampling before Hysterectomy in Premenopausal Women with Abnormal Uterine Bleeding.

Background/Objectives: An endometrial sampling is recommended for patients experiencing abnormal uterine bleeding above the age of 40 or 45. Valid risk prediction models are needed to accurately assess the risk of endometrial cancer and avoid an unnecessary endometrial biopsy in premenopausal women. We aimed to assess the necessity and usefulness of preoperative endometrial sampling by evaluating premenopausal women who underwent hysterectomy for abnormal uterine bleeding after preoperative endometrial sampling at our clinic. Methods: A retrospective analysis was conducted on 339 patients who underwent preoperative endometrial sampling and subsequently underwent hysterectomy due to abnormal uterine bleeding. Detailed gynecologic examinations, patient histories, and reports of endometrial sampling and hysterectomy were recorded. Cohen's Kappa (κ) statistic was utilized to evaluate the concordance between histopathological results from an endometrial biopsy and hysterectomy. Results: The mean age of the cohort was 47 ± 4 years. Endometrial biopsies predominantly revealed benign findings, with 137 (40.4%) cases showing proliferative endometrium and 2 (0.6%) cases showing endometrial cancer. Following hysterectomy, final pathology indicated proliferative endometrium in 208 (61.4%) cases, with 7 (2.1%) cases showing endometrioid cancer. There was a statistically significant but low level of concordance between histopathological reports of endometrial biopsy and hysterectomy results (Kappa = 0.108; p < 0.001). Significant differences were observed only in the body mass index of patients based on hysterectomy results (p = 0.004). When demographic characteristics were compared with cancer incidence, smoking status and preoperative endometrial biopsy findings showed statistically significant differences (p = 0.042 and p = 0.010, respectively). Conclusions: The concordance between the pathological findings of a preoperative endometrial biopsy and hysterectomy is low. Body mass index is an important differentiating factor between benign histopathologic findings of endometrium and endometrial neoplasia. Moreover, adenomyosis was found to be associated with endometrial cancer cases. The current approach to premenopausal women with abnormal uterine bleeding, which includes a routine endometrial biopsy, warrants re-evaluation by international societies and experts.

Health-related quality of life and subjective well-being among children aged 9–12 years in Shandong Province, China

PurposeTo investigate the health-related quality of life (HRQoL) and subjective well-being (SWB) of children aged 9–12 years in eastern China, and examine concordance within child self-reported and parent proxy-assessed.MethodsData was collected from 9 to 12 years old children (including their parents) in Shandong Province in 2018. Participants self-completed a hard-copy questionnaire including Child Health Utility 9D (CHU9D), Pediatric Quality of Life Inventory (PedsQL)™ 4.0 Short Form 15 Generic Core Scales (hereafter the PedsQL™), Student’s Life Satisfaction Scale (SLSS), as well as information on socio-demographic characteristics and self-report health status. Spearman’s correlation coefficients and the difference between sub-groups were conducted to assess and compare the agreement on HRQoL and SWB instruments. Exploratory factor analysis (EFA) was used to ascertain the number of unique underlying latent factors that were associated with the items covered by the two generic HRQoL and the SWB instruments. The concordance of child self-reported and parent proxy-assessed was analyzed using weighted kappa coefficient and Bland-Altman plots.ResultsA total of 810 children and 810 parents were invited to participate in the survey. A valid sample of 799 (98.6%) children and 643 (79.4%) parents completed the questionnaire. The child self-reported mean scores were CHU9D = 0.87, PedsQL™ = 83.47, and SLSS = 30.90, respectively. The parent proxy-assessed mean scores were PedsQL™ = 68.61 and SLSS = 31.23, respectively. The child self-reported PedsQL™ was moderately correlated with the CHU9D (r = 0.52). There was a weak correlation between CHU9D and SLSS (r = 0.27). The EFA result found 3 factors whilst seven SLSS items grouped into a standalone factor (factor 3), and the nine dimensions of CHU9D shared two common factors with the PedsQL™ (factor 1 and factor 2). A low level of concordance was observed across all comparisons and in all domains (weighted kappa < 0.20) between parents and their children. Furthermore, a high level of discordance was observed between child self-reported and father proxy-assessed.ConclusionsCHU9D and PedsQL™ instruments have a higher agreement in measuring the HRQoL in children. CHU9D/PedsQL™ and SLSS instruments showed a low agreement and EFA result suggested that measuring SWB in children potentially may provide further information, which might be overlooked by using HRQoL instruments exclusively. Concordance of child self-reported and parent proxy-assessed was poor. Overall, mother-child concordance was higher than father-child concordance.

Nanodroplet Flight Control in Electrohydrodynamic Redox 3D Printing.

Electrohydrodynamic 3D printing is an additive manufacturing technique with enormous potential in plasmonics, microelectronics, and sensing applications thanks to its broad material palette, high voxel deposition rate, and compatibility with various substrates. However, the electric field used to deposit material is concentrated at the depositing structure, resulting in the focusing of the charged droplets and geometry-dependent landing positions, which complicates the fabrication of complex 3D shapes. The low level of concordance between the design and printout seriously impedes the development of electrohydrodynamic 3D printing and rationalizes the simplicity of the designs reported so far. In this work, we break the electric field centrosymmetry to study the resulting deviation in the flight trajectory of the droplets. Comparison of experimental outcomes with predictions of an FEM model provides new insights into the droplet characteristics and unveils how the product of droplet size and charge uniquely governs its kinematics. From these insights, we develop reliable predictions of the jet trajectory and allow the computation of optimized printing paths counterbalancing the electric field distortion, thereby enabling the fabrication of geometries with unprecedented complexity.

Pervasive versus situational childhood ADHD: latent classes and their clinical characteristics, based on parent and teacher ratings in a large longitudinal population sample

Attention-deficit/hyperactivity disorder (ADHD) diagnoses require symptoms to be present in two settings. Low levels of concordance between symptoms rated at home and school raise questions regarding this approach. The aim was to examine whether there are sub-groups with context-specific expressions of ADHD symptoms (i.e., at home or school only) with clinically significant problems sufficient to support a new diagnostic formulation. We applied latent class transition analysis to parent and teacher data (N = 10,476) from the Avon Longitudinal Study of Parents and Children (ALSPAC), collected at ages 8, 10, and 20 years. We examined the short-term stability of emergent classes and their childhood and adult-associated risk profiles. In addition to an Unaffected class (~ 45%), there was a Pervasive Combined class with elevated inattentive and hyperactive/impulsive symptoms at both home and school (~ 11%) and three classes with situational expressions; School Combined (~ 9%), Home Combined (~ 18%), and School Inattentive (~ 16%). Stability ranged from 0.27 to 0.78. The Pervasive Combined class was most symptomatic and impaired. School inattentive also displayed clinical symptom levels, whereas the School and Home Combined classes displayed subclinical levels. Different profiles regarding sex, cognition, conduct problems, and substance use emerged for the three situational classes. Distinct groupings of pervasive and situational ADHD expressions are identifiable in the general population. The isolation of a stable and burdensome Pervasive Combined class lends support to the current diagnostic approach. However, there are indications of situational expressions of ADHD with clinical symptom levels and associated difficulties.

Can the inner eye canthus temperature be used as an alternative method to measure core temperature in sleep-deprived individuals?

Core temperature is used in several situations, including studies on biological rhythms and circadian markers of physical performance. Measuring the inner eye canthus (Tco) temperature is a method proposed to identify core temperature, but it has shown little concordance in physical exercise situations and has not yet been used in studies with measurements taken throughout the day. The objective of this study was to compare the measurements and daily behavior of Tco obtained by infrared thermography with rectal temperature (Tre) during a prolonged waking protocol. Eleven male individuals participated in the study, who remained in the laboratory for at least 38 h using an actigraph to determine the wakefulness time and were monitored during the entire period. The Tre and Tco measurements were performed every 3 h. The ANOVA was used for repeated measurements followed by Bonferroni’s post-hoc test to find the limits of concordance/proximity, while the Bland and Altman method and the Intraclass Correlation Coefficient were used to establish the reliability between the pairs. The significance level adopted was p < 0.05. The results demonstrate significant differences, low levels of concordance and unsatisfactory reliability levels between Tco and Tre at all 13 analyzed moments, in addition to not showing measurement reliability when all data are used together with the 143 temperature measurements. Daily behavior analysis shows moments with similar behavior with an increase in Tco and Tre, but at other times the behavior was the opposite, with a decrease in one measurement and an increase in the other. Based on the results presented, it is not recommended to use the inner eye canthus temperature as a substitute for rectal temperature for measuring core temperature at different times of the day or in sleep-deprived individuals.

Efficacy of Systematic Early-Second-Trimester Ultrasound Screening for Facial Anomalies: A Comparison between Prenatal Ultrasound and Postmortem Findings.

Second-trimester 2D ultrasound (US) assessment of the fetal anatomy, as proposed by worldwide guidelines, allows detecting the majority of fetal malformation. However, the detection rates of fetal facial anomalies seem to still be low, mostly in cases of isolated facial malformation. The purpose of this research was to assess and analyze the concordance between the antenatal imaging findings from second-trimester US screening and the results of fetal postmortem autopsy. Between January 2010 and January 2020, there were 43 cases where fetuses with prenatal ultrasound diagnosis of a face abnormality, associated or not with a genetic syndrome or chromosomal disorder, following intrauterine death (IUD) or termination of pregnancy (TOP) after the 13 weeks of pregnancy, underwent autopsy in the Pathological Anatomy section of Bari Polyclinic specializing in feto-placental autopsies. The diagnosis of the fetal facial defects at ultrasound was compared with the findings at autopsy in all cases. A very high level of agreement between prenatal ultrasound and autopsy findings was found for facial abnormalities associated with genetic syndromes or numerical abnormality of chromosomes. A lower level of concordance was instead found in isolated facial defects or those associated with other organ anomalies, but not associated with genetic syndrome or numerical chromosome anomaly. A detailed examination of aborted fetuses led to successful quality control of early-second-trimester ultrasound detection of facial anomalies; however, it was less accurate for the isolated ones. It is, thus, reasonable to propose a systematic early-second-trimester prenatal ultrasound screening for facial anatomy by operators specialized in fetal medicine field, using 2D, 3D, and 4D techniques (two-, three-, and four-dimensional ultrasound).

Diagnostic concordance among nursing clinical decision support system users: a pilot study.

To analyze the nursing diagnostic concordance among users of a clinical decision support system (CDSS), The Electronic Documentation System of the Nursing Process of the University of São Paulo (PROCEnf-USP®), structured according to the Nanda International, Nursing Intervention Classification and Nursing Outcome Classification (NNN) Taxonomy. This pilot, exploratory-descriptive study was conducted from September 2017 to January 2018. Participants were nurses, nurse residents, and nursing undergraduates. Two previously validated written clinical case studies provided participants with comprehensive initial assessment clinical data to be registered in PROCEnf-USP®. After having registered the clinical data in PROCEnf-USP®, participants could either select diagnostic hypotheses offered by the system or add diagnoses not suggested by the system. A list of nursing diagnoses documented by the participants was extracted from the system. The concordance was analyzed by Light's Kappa (K). The research study included 37 participants, which were 14 nurses, 10 nurse residents, and 13 nursing undergraduates. Of the 43 documented nursing diagnoses, there was poor concordance (K = 0.224) for the diagnosis "Ineffective airway clearance" (00031), moderate (K = 0.591) for "Chronic pain" (00133), and elevated (K = 0.655) for "Risk for unstable blood glucose level" (00179). The other nursing diagnoses had poor or no concordance. Clinical reasoning skills are essential for the meaningful use of the CDSS. There was concordance for only 3 nursing diagnoses related to biological needs. The low level of concordance might be related to the clinical judgment skills of the participants, the written cases, and the sample size.

Haplotyping interspecific hybrids by dual alignment to both parental genomes.

Sequencing-based genotyping of heterozygous diploids requires sufficient depth to accurately call heterozygous genotypes. In interspecific hybrids, alignment of reads to both parental genomes simultaneously can generate haploid data, potentially eliminating the problem of heterozygosity. Two populations of interspecific hybrid rootstocks of walnut (Juglans) and pistachio (Pistacia) were genotyped using alignment to the maternal genome, paternal genome, and dual alignment to both genomes simultaneously. Downsampling was used to examine concordance of imputed genotype calls as a function of sequencing depth. Dual alignment resulted in datasets essentially free of heterozygous genotypes, simplifying the identification and removal of cross-contaminated samples. Concordance between full and downsampled genotype calls was always highest after dual alignment. Nearly all single nucleotide polymorphisms (SNPs) in dual alignment datasets were shared with the corresponding single-parent datasets, but 60%-90% of single-parent SNPs were private to that dataset. Private SNPs in single-parent datasets had higher rates of heterozygosity, lower levels of concordance, and were enriched in fixed differences between parental genomes ("homeo-SNPs") compared to shared SNPs in the same dataset. In multi-parental walnut hybrids, the paternal-aligned dataset was ineffective at resolving population structure in the maternal parent. Overall, the dual alignment strategy effectively produced phased, haploid data, increasing data quality and reducing cost.

P288 Application of a new classification of Fistulizing Perianal Crohn’s Disease (FPCD) in clinical practice: evaluating the correlation between clinician and patient’s assessments and FPCD patient′s quality of life

Abstract Background FPCD remains a challenging condition with negative impact on quality of life. Recently, a novel classification was proposed intending to optimize and standardize the management of these patients (Geldof J, et al. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):576-584). We aimed to characterize and classify a population of patients with FPCD according to this recent classification, evaluate the agreement between patient and clinician perspectives regarding disease treatment goals and correlate the new classification with patient’s quality of life. Methods Cross-sectional study which consecutively included FPCD’ adult patients (diagnosis &amp;gt; 6 months) followed at a gastroenterology consultation, from September to November 11, 2022. A Portuguese translated diagram of the new classification was presented to included patients, which had to select the class that most faithfully represents the current moment of their disease status. Subsequently, the IBDQ-32 questionnaire was completed. A separate form completed by a senior gastroenterologist include all the demographic and clinical data of each patient and the respective blindly chosen class. Results 23 patients (mean age of 34.4 ± 13.8 years, 60.7% woman) with FPCD were included. Disease location (Montreal Classification) was L1 in 9/23 patients, L2 in 5/23 patients and L3 in 9/23 patients. Two patients had also upper gastrointestinal tract involvement (L4). Crohn’s disease duration was 8.87 ± 8.176 years and fistula duration 4.26 ± 3.063 years (table 1). Therapy data including surgery is shown in Table 2. Most patients had a transphincteric (13/23) and complex fistula (20/23). Mean PDAI was 6±2.6 and HBI 2.2±1.65. Class 2a (repair) was the most frequently chosen by patients and clinician (62.5% and 58.3% respectively) (table 3). Mean IBDQ32 score was 97.6 ± 16.9 (table 4). A slight agreement between patient and clinician regarding the new classification system was found (Cohen’s Kappa of 0.176), and a negative correlation between the class chosen by the patient and the respective IBDQ-32 score (Kendalls’ Tau correlation coefficient -0.359, p = 0.033 (p&amp;lt;0,05)). Conclusion The low level of concordance between patient and clinician (with the limitation of a small sample size) draws attention to a gap in the treatment decision-making process of FPCD patients. A turning point in the management of these patients may occur with a progressive implementation of this classification into clinical practice after its validation, as it may allow for a shared discussion and greater patient responsibility in therapeutic decisions. The significant disease burden carried by these patients is underscored by the progressive lower IBDQ32 scores associated with higher class in this new system classification.

Assessing the Interoperability of mLab and Ushauri mHealth Systems to Enhance Care for HIV/AIDS Patients in Kenya

The core thesis of this study is to explore the legal and technological feasibility to interoperate two mobile health-based solutions in Kenya: Ushauri-Text for Adherence (T4A), and Mobile Laboratory (mLab), to enhance HIV/AIDS care and treatment. This paper focuses on two aspects namely data interoperability by analysing secondary data abstracted from the mLab and the Ushauri databases from June 2017 to June 2018 and doctrinal analysis of the legal and policy environment to support the interoperability. This paper is a case study of the mLab and the Ushauri systems in terms of the technological stack for interoperability which has some legal implications. It includes a pilot study that employed a multistage sampling method in which thirty-nine health facilities in Siaya, Homa bay, Nyeri, and Muranga were selected. Findings show a satisfactory legal environment to augment the interoperability of the two mHealth systems. It is also evident that the two systems were considerably interoperable in terms of technology, semantics, data, and processes. However, interoperating them could largely be compromised by language semantics leading to a discrepancy of characters and numbering in unique identifiers in data entry. Though data in the systems were for the same individuals, it is critical to note that there was a low level of concordance in patient identification numbers in the same facilities where the same patients were receiving clinical services. Additionally, healthcare workers across the various facilities did not follow the NASCOP (2010) eleven-digit unique identifier system. Standardizing human activities while using systems such as the allocation of patient identifiers and following laid down standards while developing systems are critical ways of ensuring interoperability. This paper highlights the need to achieve full-scale implementation of laid down policies and legal requirements such as the systems’ interoperability certification process to standardise the systems and make them interoperable.

A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States.

PurposeScientific information in the drug labeling is expected to be the most up-to-date and consistent information across countries where medicine is approved. The objective of the present study is to investigate the consistency of safety-related information on product labeling for novel therapeutics concurrently approved in Japan and the US.MethodsSafety information at the time of initial approval of new drugs approved concurrently both in Japan and the US in the recent 7 years were identified and reviewed for concordance. Factors associated with the discordance were also investigated.ResultsDespite the similar medical practices, population health, and regulation in Japan and the US, the level of concordance of safety information found in the drug labeling of 45 new active substances was low (20.4%). The development strategy of the drugs and having the same MAH were significantly associated with the concordance rate. The mean concordance rate among the 9 drugs with Black Box Warning in both countries was also low (32.9%).ConclusionsWe found a low level of concordance between Japan and the US even when related to clinically important information raised by Black Box Warnings. The low concordance rate highlighted the need for a greater transparency in decision-making processes about the safety information in a drug labeling by both industry and regulators to take appropriate countermeasures against the discordance.

Counselling of immigrant students in schools – the development of shared understanding between advisers and students

ABSTRACT Careers advisers in schools are of great importance. In order for the counselling to be effective, a social capital-intensive relationship must be built up between adviser and student, characterised by trust and shared understanding of roles and expectations. The aim of this quantitative study is to investigate the influence of a student’s immigration status on the judgement of counselling by both adviser and student as well as its influence on the concordance between these judgements and on the development of this concordance over time. The results show that in general the judgement of counselling by both advisers and students was positive. However, there was a lower level of concordance between advisers and first-generation students than between advisers and native students.

Abstract 110: Planned versus observed effect sizes in early phase chemoprevention trials

Abstract Early phase chemoprevention trials are designed to demonstrate safety, tolerability, feasibility, and signals of efficacy. Yet it is often observed that most trials fail to detect intervention effects. The purpose of this review was to analyze intervention effects in such trials by comparing planned vs observed effect sizes. Single or multi-arm efficacy and biomarker chemoprevention trials conducted under the Phase 0-II Cancer Prevention Clinical Trial Program of the Division of Cancer Prevention, National Cancer Institute between 2003 and 2019 were evaluated. Protocols were reviewed to gather information regarding study design, primary endpoint(s), analysis plan, analysis population(s), and sample size justifications with planned effect sizes. Reports and manuscripts were reviewed to obtain study results information. Intervention effects for differences were quantified by calculating standardized Cohen's d effect sizes. In studies where only p-values were reported without effect sizes, observed effect sizes were estimated using p-values and sample size information. Planned effect sizes were compared to observed effect sizes and post-hoc power calculations were conducted. Of a total of 59 trials reviewed, twenty-four trials were efficacy or biomarker studies with complete information on planned and observed effect sizes. Organ sites of focus included 5 (21%) breast, 6 (25%) prostate, 4 (17%) lung, and 9 (38%) gastrointestinal and other sites. The majority of the trials (n=18) were multi-arm randomized studies of which 15 trials were blinded. The median planned effect size for detecting an intervention effect was 0.75 (range 0.2-1.14), while the median planned sample size per arm was n=30 (range 11-101). The planned effect sizes were larger than the observed effects sizes in the majority of the studies (88%). The observed effect sizes in most studies were small with a median of 0.34 (range 0-0.66). The median difference between planned vs observed effect size was -0.37. A low level of concordance between planned vs observed effect size was observed with an intra-class correlation coefficient 0.18 (95% CI: -0.1-0.50). The median post-hoc power for detecting the observed effect sizes was only 0.29 (range 0.03-0.93). There were no significant differences detected between planned vs observed effect sizes when stratified by accrual goals, analysis populations, or study design (multi-arm randomized vs single arm). The results indicate that the majority of early phase chemoprevention trials have much smaller observed effect sizes than planned. Sample size calculations for such trials need to balance the known attributes of the study endpoints, e.g. the potential detectable effect sizes in populations that can be realistically and cost-effectively accrued, with the need to detect only effect sizes large enough to justify subsequent phase III trials. Utilization of interim analyses for futility may be considered. Citation Format: Jens C. Eickhoff, Jen Birstler, Guanhua Chen, Zhumin Zhang, Vikrant Sahasrabuddhe, Eva Szabo, KyungMann Kim. Planned versus observed effect sizes in early phase chemoprevention trials [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 110.

A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States.

It is important to make the most up-to-date drug safety information available to the public in a timely manner so that health care professionals and patients can consider the information. The aim of the present study was to investigate the consistency and simultaneity of safety related updates in product labeling in Japan and the United States. New safety label changes that were made for new drugs approved concurrently both in Japan and the United States in the recent 5 years were identified and reviewed for concordance and time lag analysis. Factors associated with the time lag were also investigated. Despite similar medical practices, population health and regulation in the countries, a low level of concordance (40/115, 34.8%) in the decision of labeling change was found in 31 new active substances. Only 3/40 (7.5%) of the concordant changes were made simultaneously. Labeling change orders issued by regulators and domestic postmarketing adverse event reports were associated with a significant difference in the timing of labeling change between the countries. We found a low level of concordance between regulators in the decision of labeling changes and the timeliness of the changes. The low concordance and time lag highlighted the need for further international collaboration between regulators and industry and greater transparency in the decision-making process for the label change.

Implications of different definitions for aortic arch classification provided by contemporary guidelines on thoracic aortic repair.

Contemporary guidelines on thoracic aortic repair provide inconsistent reporting standards for the definition of aortic arch classification in Types I, II and III. The different reported criteria cannot be used interchangeably, due to a very low level of concordance, and this finding has relevant implications for the comparisons between studies using different classifications, and between different datasets of multicentre trials, which are not consistently analyzed with the same criteria. Also, the reported definitions, which were originally proposed for predicting difficult carotid stenting and therefore were conceived for healthy aortic arches, can be influenced by the pathological derangements of the aortic wall, including aneurysms and dissections. In this respect, the Madhwal's classification, which is based on the diameter of the left common carotid artery, appears to be the more suitable one for aortic arch classification in patients with thoracic aortic disease because it provides relevant clinical information along with an adequate reproducibility.

Distinct mutation profiles between primary bladder cancer and circulating tumor cells warrant the use of circulating tumors cells as cellular resource for mutation follow-up

BackgroundWhile circulating tumor cells may serve as minimally invasive cancer markers for bladder cancers, the relationship between primary bladder cancers and circulating tumor cells in terms of somatic mutations is largely unknown. Genome sequencing of bladder tumor and circulating tumor cells is highlighted to identify the somatic mutations of primary bladder cancer.MethodsBladder cancer tissue was collected by transurethral resection of the bladder and preserved by snap-freezing. Circulating tumor cells were Isolated from the blood obtained before treatment. We performed whole exome sequencing of 20 matched pairs of primary bladder cancers and circulating tumor cells to identify and compare somatic mutations of these two different genomic resources.ResultsWe observed that mutation abundances of primary bladder cancers and circulating tumor cells were highly variable. The mutation abundance was not significantly correlated between matched pairs. Of note, the mutation concordance between two resources was only 3–24% across 20 pairs examined, suggesting that the circulating tumor cell genomes of bladder cancer patients might be genetically distinct from primary bladder cancers. A relative enrichment of mutations belonging to APOBEC-related signature and a depletion of C-to-G transversions were observed for primary- and circulating tumor cells specific mutations, respectively, suggesting that distinct mutation forces might have been operative in respective lesions during carcinogenesis.ConclusionsThe observed discrepancy of mutation abundance and low concordance level of mutations between genomes of primary bladder cancers and circulating tumor cells should be taken into account when evaluating clinical utility of circulating tumor cells for treatments and follow-up of bladder cancers.Trial registrationPatients were selected and registered retrospectively, and medical records were evaluated.

Poor concordance between definitions of type III arch and implications for risk prediction and assessment for carotid artery stenting

ObjectiveThe type III arch configuration has been inconsistently reported as a stroke risk factor during carotid artery stenting. However, at least three different methods for the definition of type III arch can be identified in the literature, related to the level of the origin of the innominate artery (IA). According to Casserly's definition, a type III arch presents with an origin of the IA below the horizontal plane of the inner curvature. According to Madhwal's definition, a type III arch has a distance greater than twice the diameter of the left common carotid artery between the highest point of the arch and the origin of the IA. According to MacDonald's definition, a type III arch presents with a distance of ≥2 cm between the highest point of the arch and the origin of the IA. Our aim was to assess the level of concordance between these different methods. MethodsAnonymized thoracic computed tomography scans of 100 healthy patients were reviewed. Two of us independently stratified the selected cases as a type I to III arch, according to the three considered definitions. The interobserver level of concordance for each type III arch classification and level of concordance among the three definitions were assessed. ResultsThe 100 selected patients (64% male) were 76 ± 7 years old. For each definition, the interobserver repeatability was almost perfect for all three (Madhwal, κ = 0.81; 95% confidence interval [CI], 0.71-0.99; MacDonald, κ = 0.82; 95% CI, 0.72-0.92; Casserly, κ = 0.84; 95% CI, 0.74-0.93). The level of concordance among the different definitions was very low (Madhwal vs MacDonald, 85% [P = .002]; 33% for type III arch; Madhwal vs Casserly, 60% [P < .0001]; 12% for type III arch; MacDonald vs Casserly, 75% [P < .0001]; 12% for type III arch). ConclusionsThe three definitions of the type III arch have a very low level of concordance, which might account for the varying clinical relevance of this configuration. Our findings have relevant implications for risk prediction for carotid artery stenting based on the presence of a type III arch, for comparisons of the results from different studies, and for comparisons of different datasets from multicenter trials.

Concordance of next-generation sequencing between tissue and liquid biopsies in non-small cell lung cancer.

e21547 Background: While genetic profiling has become standard of care for patients diagnosed with non-small cell lung cancer (NSCLC), next-generation sequencing (NGS) provides a wealth of information about targetable mutations. Advances in genetic testing have led to sequencing platforms that utilize tissue itself or extracellular circulating tumor DNA in the blood, known as a “liquid biopsy.” Methods: We identified 55 patients with NSCLC who had undergone both tissue and liquid biopsy, using Foundation One and Guardant 360 at the University of Miami / Sylvester Comprehensive Cancer Center between January 2016 and December 2018, and performed retrospective analysis to determine patient characteristics as well concordance between different NGS platforms. Results: In our patient population, 34% of patients had never smoked prior to diagnosis, while 22% had more than a 30 pack-year smoking history. 64% of patients had no treatment prior to initial NGS. 40% of patients had both testing done essentially simultaneously, while 60% of patients had one test done after disease progression. Of these patients, therapy was changed as a result in 73%. Median number of days between tests was 21 days, with 56% of testing done within 90 days of the previous testing. Nine patients had an additional Foundation One tissue NGS performed. Concordance across all genes tested in both platforms was 98 ± 0.2%. Concordance with consideration of genetic alterations detected in both assays was 24.5 ± 3.0%. The median number of gene alterations determined by Foundation One testing was 4 (range 1-9), while the median for gene alterations detected by Guardant 360 was 3 (range 1-13). The median number of variants of unknown significance (VUS) was 10 (range 5-25). Conclusions: Our analysis indicates a role for both tissue-based and circulating tumor DNA-based NGS for determination of targetable mutations and thus appropriate treatment regimens. Low levels of concordance are potentially related to post-treatment changes in the tumor genetic profile as well as evolution in the testing itself.

Predictive equations are inaccurate to assess caloric needs in non-white adults from Chile.

Predictive equations are frequently used to estimate resting energy expenditure (REE) because indirect calorimetry (IC) is not always available and is expensive. The aim of this study was to determine the concordance between the estimation of REE using predictive equations and its measurement by IC. This was an analysis of the registry of indirect calorimetry performed in non-hospitalized participants. Harris-Benedict, FAO/WHO/UNU, Mifflin St. Jeor, and European Society for Clinical Nutrition and Metabolism (ESPEN) equations were used to estimate REE in these individuals. The concordance between measured and estimated REE using real, ideal, and adjusted weight was calculated using the concordance coefficient analysis of Lin and Bland- Altman plots in all participants and in subgroups separated according to their body mass index. We retrieved 680 measurements and discarded 247 that did not comply with the inclusion criteria. Thus, we studied 433 participants ages 36 y (29-48 y). Of the participants, 341 were women (79%) and the participants had a body mass index (BMI) of 30 kg/m2 (26.7-33.1 kg/m2). All predictive equations had concordance values <0.90. The proportion of participants in which the difference was >10% ranged from 36% to 87%. The ESPEN equation had the greater proportion of erroneous estimations of REE in all participants and BMI subgroups when real weight was used. We observed a low level of concordance between REE estimated using predictive equations and measured by IC. These results should alert clinicians about the inaccuracy of predictive equations.