Clinical Request Research Articles

Advanced Optical Wavefront Technologies to Improve Patient Quality of Vision and Meet Clinical Requests

Adaptive optics (AO) is employed for the continuous measurement and correction of ocular aberrations. Human eye refractive errors (lower-order aberrations such as myopia and astigmatism) are corrected with contact lenses and excimer laser surgery. Under twilight vision conditions, when the pupil of the human eye dilates to 5-7 mm in diameter, higher-order aberrations affect the visual acuity. The combined use of wavefront (WF) technology and AO systems allows the pre-operative evaluation of refractive surgical procedures to compensate for the higher-order optical aberrations of the human eye, guiding the surgeon in choosing the procedure parameters. Here, we report a brief history of AO, starting from the description of the Shack-Hartmann method, which allowed the first in vivo measurement of the eye's wave aberration, the wavefront sensing technologies (WSTs), and their principles. Then, the limitations of the ocular wavefront ascribed to the IOL polymeric materials and design, as well as future perspectives on improving patient vision quality and meeting clinical requests, are described.

BIR POSITION STATEMENT: Governance requirements for Non-Medical referrers to radiology.

The ability to request clinical imaging is included in many advanced roles of health-care professionals in the UK and is seen as a useful component in ensuring patients receive the right care, by the right person, at the right time. In order that diagnostic imaging referrals are appropriate, timely and safely made, the British Institute of Radiology has produced a position statement on the governance requirements covering clinical imaging requests from non-medical referrers (NMRs). This document is intended to help define the role of a NMR and to ensure they are practising responsibly and safely, within professional and legal frameworks, as part of the wider interprofessional team.

Minimal Diagnostic Value of Karyotyping for Suspected Myelodysplastic Syndrome in the Absence of Bone Marrow Dysplasia

BACKGROUND: Myelodysplastic syndrome (MDS) is a group of hematopoietic stem cell disorders characterized by ineffective hematopoiesis, bone marrow dysplasia, and cytopenias. Marrow morphology, cytogenetics, and sequencing panels are important for the diagnosis and prognosis of MDS and are often obtained in parallel for clinical workup. The diagnostic utility of time-consuming cytogenetic analyses in cases without any significant dysplasia is uncertain. OBJECTIVE: We sought to determine the diagnostic utility of cytogenetic analysis of bone marrow aspirate/biopsies obtained for the indication of suspected MDS in the absence of morphological dysplasia. METHODS: We identified bone marrow aspirate/biopsy cases obtained for the indication of suspected MDS between 2021-01-01 and 2022-06-22 from the Greater Vancouver Area, Canada that underwent cytogenetic analysis at clinical request. Anemia, neutropenia, and thrombocytopenia were defined as peripheral blood counts of hemoglobin <120 g/L for women or <130 g/L for men, neutrophils <2 x109/L, and platelets <150 x109/L, respectively. RESULTS: Fifty-four cases met criteria for review (55.5% male sex; mean age = 62.6 years [SD = 16.6 years]). The mean (SD) peripheral blood count parameters for the cohort were: hemoglobin 108 g/L (22 g/L), mean corpuscular volume 94 fL (8 fL), neutrophil count 2.84 x109/L (2.08 x109/L), and platelet count 175 x109/L (132 x109/L). Anemia, neutropenia, thrombocytopenia, pancytopenia, and any cytopenia were present in 41 (75.9%), 23 (42.6%), 26 (48.1%), 13 (24.1%), and 48 cases (88.9%), respectively. For cases with anemia, neutropenia, or thrombocytopenia, the corresponding mean (SD) peripheral blood counts were: 99 g/L (18 g/L), 1.25 x109/L (0.56 x109/L), and 77 x109/L (44 x109/L), respectively. Marrow was hypocellular and hypercellular for age in 11 (20.4%) and 9 (16.7%) of the cases, respectively. The only abnormal karyotypes were 2 cases of loss of chromosome Y (3.7%; 70-year-old with 18/20 metaphases and 84-year-old with 14/20 metaphases). Both cases had no evidence of hematologic neoplasia, which is in keeping with an age-related finding. Additionally, targeted myeloid panel next-generation sequencing was performed for 8/54 cases for suspected myeloid neoplasm. There were: 3 cases with no reportable variants, 3 cases with variants of uncertain significance, and 2 cases with pathogenic TET2 variants. None of the cases with reportable variants identified were found in cases showing loss of chromosome Y. CONCLUSION: This study suggests that in the absence of myeloid dysplasia of the bone marrow, there is minimal diagnostic value of cytogenetic analysis for the workup of suspected MDS. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Adapting a Patient-Reported Outcome Measure to Digital Outpatient Specialist Health Care Services for Type 1 Diabetes: User Involvement Study.

Diabetes self-management is crucial for patients with type 1 diabetes, and digital services can support their self-management and facilitate flexible follow-up. The potential of using digital patient-reported outcome (PRO) measures in routine outpatient care is not fully used owing to a lack of adapted PRO measures. This study presents the process of identifying and adapting a digital PRO measure for use in clinical diabetes practice and describes the preferred item topics of the adapted PRO measure, as reported by patients and diabetes specialist nurses. With the involvement of patients, diabetes specialist nurses, management, and researchers, we hosted a series of workshops and 2 dialogue conferences. Scoping searches to identify relevant PRO measures formed the foundation for the process. An in-person dialogue conference was conducted with diabetes specialist nurses as participants, and a digital dialogue conference was conducted with patients with type 1 diabetes as participants. A diabetes-specific PRO measure was translated and adapted to our digital platform. Notes and summaries from the dialogue conferences were imported into NVivo (QSR International) and thematically analyzed as a single combined data set. The thematic analysis of the 2 dialogue conferences aimed to explore the views of patients with type 1 diabetes and diabetes specialist nurses on the outcomes necessary to measure. An overarching theme, Ensuring that the PRO measure captures the patients' needs precisely and accurately, in a way that facilitates care and communication with health care personnel, was identified and supported with data from both the patients and diabetes specialist nurses. This theme contained four categories: The need for explanatory text after questions to ensure understanding and accurate response, Capturing individual needs in standardized questions, getting to the heart of the patient's problem, and The questions increase patient reflection. We successfully conducted an iterative process that identified a PRO measure aligned with the topics raised by the diabetes specialist nurses. Similarly, the patients found the PRO measure to be relevant and one that was addressing their needs. Only minor adjustments were necessary when programming the PRO measure in the digital platform. Our management, patients, and diabetes specialist nurses had a valuable impact on the results. User involvement facilitated a specific focus on the clinical requests to be met by PRO measures and how they must be adapted to local and digital platforms. Overall, this has facilitated the current implementation of the adapted digital PRO measure.

Evaluation of Laboratory Performance in Consideration with Pre analytical and Post analytical Quality Indicators.

Implementation of Quality indicators (QIs) plays an imperative role in improving the total testing process, as it provides a quantitative basis for evaluating the laboratory performance. Besides monitoring of analytical quality specifications, several lines of experimental and clinical evidence have alluded a pivotal role of extra-analytical phases in improving the quality of laboratory services and therefore a relevance of pre- and post-analytical steps have been speculated on the overall quality in the total testing process and consequently on clinical decision-making. This was a retrospective study designed to evaluate and review different extra-analytical quality indicators in NABL accredited clinical biochemistry laboratory at BJ Medical College and Civil Hospital, Ahmedabad, Gujarat in an endeavour to ameliorate the performance of the laboratory. All Clinical Chemistry Laboratory test requests with their respective samples from January 2018 to December 2021 were included in the study. A total of 1,439,011samples were processed, and were evaluated for seven QIs [(% of number of suitable samples not received; QI-8), (% of number of samples received in inappropriate container; QI-9), (% of number of samples hemolysed; QI-10), (% of number of samples with inadequate sample volume; QI 12) (% of number of samples received mismatched; QI 15), (% of number of samples reported after turnaround time; QI 21) and (% of number of samples with critical values informed; QI 22)] based on defined criteria of Quality Specification given by International Federation of Clinical Chemistry. Total number of preanalytical errors was 53,669 (3.72%). Among the preanalytical errors, inadequate sample volume (2.37% of total samples; 63.49% of total pre-analytical errors) was the most common anomaly followed by Not received samples (24.18%) hemolysis (8.26%) mismatched (3.91%) and 0.14% samples were received in Inappropriate container; manifesting that the error frequency was unacceptable for QI 21 and QI 8, acceptable for QI 10, minimally acceptable for QI 15 and optimum for QI QI 9. Furthermore, there was year-wise progressive decline in error rate of inadequate sample volume, hemolysed sample received and mismatched samples. Total number of post analytical errors were 19,002 (1.32%). TAT outlier and critical values communicated were the two QIs evaluated for this phase and results of both QI were within acceptable limits. Quality indicators serve as a tool to monitor process performance and consequently derived error rates warrant active intervention to improve the laboratory services and patient health care. Dissemination of certified documents, regular staff training and evaluation needs to be conducted.

27. Review and comparison of the Oncomine Myeloid Assay GX v2 on Genexus System

Rapid molecular results for FLT3, IDH1/2 and NPM1 are necessary for treatment decisions of newly diagnosed acute leukemia patients. However, as treatment protocols and clinical trials request more gene variants with a faster turnaround time, single gene STAT testing using polymerase chain reaction-based testing becomes more cumbersome for the molecular diagnostic laboratory. Therefore, a rapid next generation sequencing panel for acute leukemias is necessary for laboratory operations and, more importantly, clinical utility. Cedars-Sinai molecular pathology laboratory validated the automated Oncomine? Myeloid Assay GX v2 panel using the Ion Torrent? Genexus? Integrated Sequencer (v.6.6) for a 24-hour turnaround time from DNA and RNA purification to variant reporting. We compared the results from Oncomine? Myeloid Assay GX v2 panel to Archer® VariantPlex® Myeloid panel on Illumina-based platforms. The differences between the two systems include technician intervention, turnaround time, variant accuracy, and the usability of the software package. While Archer® VariantPlex® Myeloid panel demonstrates unrivaled accuracy and reliability, the ThermoFisher Myeloid Assay GX v2 using the Genexus (IonTorrent sequencing) offers quick results and fusion detection. Therefore, we have chosen to implement both systems as standard clinical diagnostics for new acute leukemia patients.

Application of exome sequencing for prenatal diagnosis of fetal structural anomalies: clinical experience and lessons learned from a cohort of 1618 fetuses

BackgroundExome sequencing (ES) is becoming more widely available in prenatal diagnosis. However, data on its clinical utility and integration into clinical management remain limited in practice. Herein, we report our experience implementing prenatal ES (pES) in a large cohort of fetuses with anomalies detected by ultrasonography using a hospital-based in-house multidisciplinary team (MDT) facilitated by a three-step genotype-driven followed by phenotype-driven analysis framework.MethodsWe performed pES in 1618 fetal cases with positive ultrasound findings but negative for karyotyping and chromosome microarray analysis between January 2014 and October 2021, including both retrospective (n=565) and prospective (n=1053) cohorts. The diagnostic efficiency and its correlation to organ systems involved, phenotypic spectrum, and the clinical impacts of pES results on pregnancy outcomes were analyzed.ResultsA genotype-driven followed by phenotype-driven three-step approach was carried out in all trio pES. Step 1, a genotype-driven analysis resulted in a diagnostic rate of 11.6% (187/1618). Step 2, a phenotype-driven comprehensive analysis yielded additional diagnostic findings for another 28 cases (1.7%; 28/1618). In the final step 3, data reanalyses based on new phenotypes and/or clinical requests found molecular diagnosis in 14 additional cases (0.9%; 14/1618). Altogether, 229 fetal cases (14.2%) received a molecular diagnosis, with a higher positive rate in the retrospective than the prospective cohort (17.3% vs. 12.4%, p<0.01). The diagnostic rates were highest in fetuses with skeletal anomalies (30.4%) and multiple organ involvements (25.9%), and lowest in fetuses with chest anomalies (0%). In addition, incidental and secondary findings with childhood-onset disorders were detected in 11 (0.7%) cases. Furthermore, we described the prenatal phenotypes for the first time for 27 gene-associated conditions (20.0%, 27/135) upon a systematic analysis of the diagnosed cases and expanded the phenotype spectrum for 26 (19.3%) genes where limited fetal phenotypic information was available. In the prospective cohort, the combined prenatal ultrasound and pES results had significantly impacted the clinical decisions (61.5%, 648/1053).ConclusionsThe genotype-driven approach could identify about 81.7% positive cases (11.6% of the total cohort) with the initial limited fetal phenotype information considered. The following two steps of phenotype-driven analysis and data reanalyses helped us find the causative variants in an additional 2.6% of the entire cohort (18.3% of all positive findings). Our extensive phenotype analysis on a large number of molecularly confirmed prenatal cases had greatly enriched our current knowledge on fetal phenotype-genotype correlation, which may guide more focused prenatal ultrasound in the future. This is by far the largest pES cohort study that combines a robust trio sequence data analysis, systematic phenotype-genotype correlation, and well-established MDT in a single prenatal clinical setting. This work underlines the value of pES as an essential component in prenatal diagnosis in guiding medical management and parental decision making.

Partnerships to Advance Excellence in Physical Therapy Education and Practice: The Time Is Now.

A practice owner is on a morning run. He counts 20 emails from academic programs by the end of his run. He’s confused, then realizes, “It’s March 1st, the annual clinical education request date. I have significant relationships with only 3 of these people.” His thoughts turn to how he will make decisions about clinical education this year. “The staff is busy…what will I say to them to advocate? I need to hire 2–4 more clinicians…who will advocate on the clinic’s behalf?” There has been recent attention on physical therapist education in the United States arising from factors including the evolving health care and higher education climates and student debt.1–3 These factors have placed quality and sustainability of our profession in jeopardy because of the impact on training of physical therapists and the pipeline for workforce development across all sectors. The term “partnership” has emerged to describe relationships between academic and clinical stakeholders4 and has been strongly associated with excellence in physical therapist education and practice.2,5 We challenge the general assumption that these are true partnerships because of perceptions that these relationships are unbalanced.5 Given the financial realities under which both health care and education must operate, it is imperative that we advance these relationships to adapt to current and future conditions and collectively strategize educational and workforce solutions. The purpose of this Point of View is to call for action in evolving academic-clinical partnerships to prepare and sustain our workforce and meet our social contract.

The Story of the Magee Equations: The Ultimate in Applied Immunohistochemistry.

Magee equations (MEs) are a set of multivariable models that were developed to estimate the actual Onco type DX (ODX) recurrence score in invasive breast cancer. The equations were derived from standard histopathologic factors and semiquantitative immunohistochemical scores of routinely used biomarkers. The 3 equations use slightly different parameters but provide similar results. ME1 uses Nottingham score, tumor size, and semiquantitative results for estrogen receptor (ER), progesterone receptor, HER2, and Ki-67. ME2 is similar to ME1 but does not require Ki-67. ME3 includes only semiquantitative immunohistochemical expression levels for ER, progesterone receptor, HER2, and Ki-67. Several studies have validated the clinical usefulness of MEs in routine clinical practice. The new cut-off for ODX recurrence score, as reported in the Trial Assigning IndividuaLized Options for Treatment trial, necessitated the development of Magee Decision Algorithm (MDA). MEs, along with mitotic activity score can now be used algorithmically to safely forgo ODX testing. MDA can be used to triage cases for molecular testing and has the potential to save an estimated $300,000 per 100 clinical requests. Another potential use of MEs is in the neoadjuvant setting to appropriately select patients for chemotherapy. Both single and multi-institutional studies have shown that the rate of pathologic complete response (pCR) to neoadjuvant chemotherapy in ER+/HER2-negative patients can be predicted by ME3 scores. The estimated pCR rates are 0%, <5%, 14%, and 35 to 40% for ME3 score <18, 18 to 25, >25 to <31, and 31 or higher, respectively. This information is similar to or better than currently available molecular tests. MEs and MDA provide valuable information in a time-efficient manner and are available free of cost for anyone to use. The latter is certainly important for institutions in resource-poor settings but is also valuable for large institutions and integrated health systems.

A Computational Template for Three-Dimensional Modeling of the Vascular Scaffold of the Human Thyroid Gland.

We recently designed an innovative scaffold-bioreactor unit for the bioengineering of a three-dimensional (3D) bioartificial human thyroid gland or its miniaturized replica as a part of a microfluidic chip test system. This device is based on the evidence that the 3D geometry of the intraglandular stromal/vascular scaffold (SVS; i.e., the fibrous and vascular matrix) of mammalian viscera plays a key role in guiding growth and differentiation of in vitro seeded cells. Therefore, we initiated a research program focused on computer-aided reconstruction of the 2nd to 4th order intralobar arterial network (IAN) of the human thyroid gland as a reliable surrogate for its 3D SVS, to be used as an input for rapid prototyping of a biomaterial replica. To this end, we developed a computational template that works within the Mathematica environment, giving rise to a quasi-fractal growth of the IAN distribution, constrained within an approximation of the thyroid lobe shape as a closed surface. Starting from edge detection of planar images of real human thyroid lobes acquired by in vivo real-time ultrasonography, we performed data approximation of the lobar profiles based on splines and Bezier curves, providing 3D lobar shapes as geometric boundaries for vessel growth by a diffusion-limited aggregation model. Our numerical procedures allowed for a robust connection between development of lobar arterial trees and thyroid lobe shape, led to a vascular self-similarity consistent with that of a cadaveric lobar arterial cast, and reproduced arterial vessels in a proportion not statistically different from that described for the real human thyroid gland. We conclude that our algorithmic template offers a reliable reproduction of the extremely complex IAN of the adult human thyroid lobe, potentially useful as a computational guidance for bioprinting of thyroid lobe matrix replicas. In addition, due to the simplicity and limited number of morphometrical parameters required by our system, we predict its application to the design of a number of patient-tailored human bioartificial organs and organs-on-chip, including parenchymal viscera and bones. Impact statement The study introduces the computer simulation of the three-dimensional (3D) intrinsic vascular matrix of the human thyroid gland, offering a general concept applicable to a number of other human viscera. Indeed, it provides a flexible software tool for reproduction of a 3D surrogate of the organ's 3D stromal matrix, suitable for eventual 3D bioprinting with biomaterials, and recellularization with organ-specific stem cells/progenitors. The final expectation is the design of patient-tailored 3D organ's matrices upon clinical request.

Effect of age, sex, and morbidity count on trial attrition: meta-analysis of individual participant level data from phase 3/4 industry funded clinical trials

ObjectivesTo estimate the association between individual participant characteristics and attrition from randomised controlled trials.DesignMeta-analysis of individual participant level data (IPD).Data sourcesClinical trial repositories (Clinical Study Data Request and Yale University...

Abstracts from the 42nd Annual National Academy of Neuropsychology Conference

Abstract The abstracts published in this special edition are provided as a service to the membership of the National Academy of Neuropsychology, the conference attendees, and the field of clinical neuropsychology. Abstracts in this issue have been reviewed by the Poster Committee for the 42nd Annual Conference of the National Academy of Neuropsychology. They have not undergone the standard peer-reviewed process for papers published in Archives of Clinical Neuropsychology. The Conference Poster Chair and the Editor-in-Chief of Archives of Clinical Neuropsychology request that the following method be used in citing published abstracts based upon a poster presentation at the Annual Conference of the National Academy of Neuropsychology. Author 1 &amp; Author 2 (2022) [Abstract published in Archives of Clinical Neuropsychology, vol, page number]. Abstract Title. Based upon poster presented at the 42nd Annual Conference of the National Academy of Neuropsychology. National Academy of Neuropsychology Abstracts from the 42nd Annual Conference October 12–15, 2022 Conference Abstracts Accepted under the Guest Editorship of Dede Ukueberuwa O’Shea, Ph.D., Poster Chair. Members of the 2022 NAN Poster Program Review Committee: Patrick Armistead-Jehle. Jacques Arrieux. Lee Ashendorf. Jason Bailie. Veronica Burton. Noelle Carlozzi. Lucia Cavanagh. Wes Cole. Douglas Cooper. Jeremy Davis Jennifer Davis. Mark Ettenhofer. Cynthia Funes. Brian Ivins. Colleen Jackson. Mi-Yeoung Jo. Katherine Kane. Justin Karr. Sahra Kim. Rael Lange. Sara Lippa. Ashlee Loughan. Roy Martin. Victoria Merritt. Jessica Meyer. Chris Nguyen. Kyle Noll. Kevin O’Brien. Brett Parmenter. Surabhi Patwardhan. Russell Pella Amir Poreh. Jaclyn Reckow. Summer Rolin. Karen Sullivan. Matthew Thornton. Geoffrey Tremont. Michael Williams. Vanessa Williams. Kristin Wilmoth Steven Woods

Clinical Question Influence on Radiation Dose of Cardiac CT Scan in Children.

Background: To assess the impact of different clinical questions on radiation doses acquired during cardiac computed tomography in children. Methods: A total of 116 children who underwent cardiac CT on a third-generation dual-source CT scanner were included. The clinical questions were divided into three main categories: the extent of scanning in the z-axis, coronary artery assessment and cardiac function assessment. Radiation dose values represented as a dose-length product (DLP) in mGy*cm were recorded from the CT scanner protocols. Results: There were significantly higher doses in cases with cardiac function assessment (median DLP 348 versus 59 mGy*cm, p < 0.01) and in cases with coronary artery assessment (median DLP 133 versus 71 mGy*cm, p < 0.01). Conclusion: The most important factor was the assessment of cardiac function, where the median radiation dose was 4.3× higher in patients with a request for cardiac function assessment. We strongly recommend that clinical requests for cardiac CT should be carefully considered in the paediatric population.

Genetic counselors' experience with reimbursement and patient out-of-pocket cost for multi-cancer gene panel testing for hereditary cancer syndromes.

Multi-cancer gene panels for hereditary cancer syndromes (hereditary cancer panels, HCPs) are widely available, and some laboratories have programs that limit patients' out-of-pocket (OOP) cost share. However, little is known about practices by cancer genetic counselors for discussing and ordering an HCP and how insurance reimbursement and patient out-of-pocket share impact these practices. We conducted a survey of cancer genetic counselors based in the United States through the National Society of Genetic Counselors to assess the impact of reimbursement and patient OOP share on ordering of an HCP and hereditary cancer genetic counseling. Data analyses were conducted using chi-square and t tests. We received 135 responses (16% response rate). We found that the vast majority of respondents (94%, 127/135) ordered an HCP for patients rather than single-gene tests to assess hereditary cancer predisposition. Two-thirds of respondents reported that their institution had no protocol related to discussing HCPs with patients. Most respondents (84%, 114/135) indicated clinical indications and patients' requests as important in selecting and ordering HCPs, while 42%, 57/135, considered reimbursement and patient OOP share factors important. We found statistically significant differences in reporting of insurance as a frequently used payment method for HCPs and in-person genetic counseling (84% versus 59%, respectively, p< 0.0001). Perceived patient willingness to pay more than $100 was significantly higher for HCPs than for genetic counseling(41% versus 22%, respectively, p< 0.01). In sum, genetic counselors' widespread selection and ordering of HCPs is driven more by clinical indications and patient preferences than payment considerations. Respondents perceived that testing is more often reimbursed by insurance than genetic counseling, and patients are more willing to pay for an HCP than for genetic counseling. Policy efforts should address this incongruence in reimbursement and patient OOP share. Patient-centered communication should educate patients on the benefit of genetic counseling.

Reasonable requests: echocardiography referral forms as a measure of coherent clinical communication

BackgroundWell performed clinical communication is a cornerstone of collaborative care in medicine but may be confounded by inconsistent intentions of the messenger and biased interpretation by the recipient. A comparison of the findings of electronic echocardiography reports with clinician-completed standardised request forms provided an opportunity to assess communication quality.AimThe study aimed to determine clinician aptitude to complete written echocardiography referral forms by assessing the completeness, appropriateness, accuracy, and coherency of the reported clinical findings, conclusions and requests made on the referral forms. The study explored factors that may influence the quality of communication through this referral medium.MethodsA retrospective cohort study was conducted on patients who underwent trans-thoracic echocardiography imaging at Cecilia Makiwane Hospital in East London over 26 months. Paper echocardiography request forms that recorded the requesting clinician’s findings on examination, the provisional clinical diagnosis, and the specific echocardiographic information sought, were compared with the actual findings on echocardiography.ResultsOf 613 request forms reviewed, 97 cases were excluded due to illegibility or because they lacked analysable information or requester details, leaving 516 forms suitable for study. No pathology was found on echocardiography in 31%. Of the murmurs expected from the echocardiography findings, only half were recorded on the request form (sensitivity and positive predictive value both 52%.). Only 35% of request forms that mentioned a mitral systolic murmur gave a working diagnosis of mitral regurgitation and only 38% of request forms that mentioned an aortic systolic murmur considered aortic stenosis. Clinically suspected cardiomyopathy (CMO) had a PPV of 43% and echocardiographic CMO was missed clinically in 41%. Apex beat displacement reported clinically was not associated with echocardiographic LV dilatation in 65% of cases. One-third (34%) of forms reporting murmurs did not request valve function assessment and 17% considering cardiomyopathy did not request left ventricular function assessment.ConclusionEchocardiography request forms highlight vulnerabilities in clinical communication. Specifically, important clinical features were missing and more concerningly, included when unlikely to be present. There was a lack of concordance between recorded clinical findings and postulated diagnoses. Clinicians sometimes appeared unclear about the value or appropriateness of the requested assistance. Greater emphasis on teaching examination and communication skills may foster safer and more efficient use of scarce resources.

Clinical predictors of response to methotrexate in patients with rheumatoid arthritis: a machine learning approach using clinical trial data

BackgroundMethotrexate is the preferred initial disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis (RA). However, clinically useful tools for individualized prediction of response to methotrexate treatment in patients with RA are lacking. We aimed to identify clinical predictors of response to methotrexate in patients with rheumatoid arthritis (RA) using machine learning methods.MethodsRandomized clinical trials (RCT) of patients with RA who were DMARD-naïve and randomized to placebo plus methotrexate were identified and accessed through the Clinical Study Data Request Consortium and Vivli Center for Global Clinical Research Data. Studies with available Disease Activity Score with 28-joint count and erythrocyte sedimentation rate (DAS28-ESR) at baseline and 12 and 24 weeks were included. Latent class modeling of methotrexate response was performed. The least absolute shrinkage and selection operator (LASSO) and random forests methods were used to identify predictors of response.ResultsA total of 775 patients from 4 RCTs were included (mean age 50 years, 80% female). Two distinct classes of patients were identified based on DAS28-ESR change over 24 weeks: “good responders” and “poor responders.” Baseline DAS28-ESR, anti-citrullinated protein antibody (ACPA), and Health Assessment Questionnaire (HAQ) score were the top predictors of good response using LASSO (area under the curve [AUC] 0.79) and random forests (AUC 0.68) in the external validation set. DAS28-ESR ≤ 7.4, ACPA positive, and HAQ ≤ 2 provided the highest likelihood of response. Among patients with 12-week DAS28-ESR > 3.2, ≥ 1 point improvement in DAS28-ESR baseline-to-12-week was predictive of achieving DAS28-ESR ≤ 3.2 at 24 weeks.ConclusionsWe have developed and externally validated a prediction model for response to methotrexate within 24 weeks in DMARD-naïve patients with RA, providing variably weighted clinical features and defined cutoffs for clinical decision-making.

Tuscany consensus for the treatment of moderate-severe psoriasis: update and focus on practical guidelines for place in therapy of anti-IL-17 and anti-IL-23 biologics.

Psoriasis is a common chronic skin disease characterized by a worldwide distribution and a natural tendency towards progression. According to the many clinical forms, the extension of the disease and the many comorbidities, almost the 20% of the patients require a systemic treatment. Biologics have greatly changed the ongoing of psoriasis and the quality of life of psoriasis patients. After the anti-TNF-alpha, which were the first biologics in use for psoriasis, the improvement in knowledge of the pathogenetic mechanisms underlying the disease has led to the development of a series of more specific therapies for psoriasis. This "second generation" of biologics includes the interleukin (IL)-12/23 inhibitor ustekinumab, IL-17 inhibitors (secukinumab and ixekizumab), the IL-17 receptor A (IL-17RA) antagonist brodalumab, and the IL-23 inhibitors guselkumab, risankizumab and tildrakizumab. This study represents an update of the Tuscany consensus focused on the use of new drugs, such as anti-IL-17 and anti-IL-23 in moderate-to-severe psoriasis and their correct place in therapy according to specific clinical requests and in full respect of the current financial restrictions.

Ethical issues in oncology practice: a qualitative study of stakeholders’ experiences and expectations

BackgroundClinical Ethics Support Services (CESS) have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we carried out a qualitative study conducting in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders’ expectations about a potential CESS to be implemented within the Institution.MethodsThe study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders’ professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory.ResultsTwenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases.ConclusionsThe interviewees showed a limited degree of ‘ethical awareness’: despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients.

Introduction of a Novel Image-Based and Non-Invasive Method for the Estimation of Local Elastic Properties of Great Vessels

Background: In the context of a growing demand for the use of in silico models to meet clinical requests, image-based methods play a crucial role. In this study, we present a parametric equation able to estimate the elasticity of vessel walls, non-invasively and indirectly, from information uniquely retrievable from imaging. Methods: A custom equation was iteratively refined and tuned from the simulations of a wide range of different vessel models, leading to the definition of an indirect method able to estimate the elastic modulus E of a vessel wall. To test the effectiveness of the predictive capability to infer the E value, two models with increasing complexity were used: a U-shaped vessel and a patient-specific aorta. Results: The original formulation was demonstrated to deviate from the ground truth, with a difference of 89.6%. However, the adoption of our proposed equation was found to significantly increase the reliability of the estimated E value for a vessel wall, with a mean percentage error of 9.3% with respect to the reference values. Conclusion: This study provides a strong basis for the definition of a method able to estimate local mechanical information of vessels from data easily retrievable from imaging, thus potentially increasing the reliability of in silico cardiovascular models.

Call the Psychiatrist! - Study about Delirium in the context of liaison psychiatry

IntroductionDelirium is characterized as a short-term consciousness and cognition disturbance which tends to fluctuate during the course of the day. It is a common and serious problem, mainly in hospitalized older adults, potentially avoidable and often poorly recognized.ObjectivesWe propose an analysis on the theme through a work that evaluates the requests for psychiatric consultation made in a district hospital in Portugal during the course of 12 months.MethodsWe identified all patients on the requests for psychiatric consultation and obtained a demographic, clinical and consultation requests by medical specialties data and conducted statistical analysis using Excel.ResultsWe identified 106 consultation requests, in which 41 cases were eventually diagnosed as delirium. Most (83%) were hyperactive delirium, 12% were hypoactive delirium and 5% were mixed delirium. Incidence was higher in males (59%) and in those aged between 66 and 80 years old (56.1%). Most consultation requests were made by Internal Medicine (46.3%), followed by General Surgery (26.8%), Pulmonology (14.6%), Orthopedics (9.8%) and Neurology (2.5%). Finally, we analyzed which symptoms mentioned in the request made physicians consider requesting a psychiatric evaluation. Approximately half of the cases (48.8%) reported psychomotor agitation, followed by temporal/spatial disorientation (41.5%) and aggressive behaviour (17.1%).ConclusionsWe highlight a still notorious lack of proper identification of delirium, resulting in symptoms being incorrectly interpreted as a psychiatric disorder. This may cause a delay in the adequate diagnosis and management of the condition, increasing the morbidity and mortality of patients.DisclosureNo significant relationships.