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Objectives: It is important to predict the prognosis during hospital admission of Covid-19 patients. The purpose of this study was to see how CRP/ Albumin (CAR) and Platelet/Lymphocyte (PLR) ratios, obtained from patients in the intensive care unit (ICU) within the first 24 hours of their hospitalization with a Covid-19 diagnosis, predictmortality and how they correlated with acute physiology and chronic health evaluation (APACHE II) and sequential organ failure assessment (SOFA). Method(s): Using hospital records, records of 83 patients hospitalized in the ICU with a diagnosis of Covid-19 between 11.03.2020 and 01.01.2021 were retrospectively analyzed . Patients were divided into two groups discharged (Group I) and exits (ex) group (Group II). CAR and PLR were recorded during the first 24 hours of ICU admission, and APACHE II and SOFA scores were computed. The calculated CAR and PLR were correlated with APACHE II and SOFA scores and their association with mortality was investigated. Result(s): SOFA, APACHE II, PLO, and age were higher, and albumin was lower in patients in the mortal course (p<0.05). ROC analysis revealed that APACHE II and SOFA scores could be employed to estimate mortality. Conclusion(s): We believe that APACHE II and SOFA scores can be used to predict mortality in patients admitted to the ICU due to Covid-19, whereas CRP/Albumin and Platelet/Lymphocyte ratios cannot. Copyright © 2023 by The Cardiovascular Thoracic Anaesthesia and Intensive Care.
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The recent Covid-19 pandemic has created many challenges and barriers in healthcare, which includes the treatment and management of patients with type 2 diabetes (Robson & Hosseinzadeh, 2021). The purpose of this Evidence-Based Project (EBP) project is to evaluate the effectiveness of type 2 diabetes management through telehealth and answers the following PICOT question: In patients with diabetes type 2 who have difficulties with medical visit compliance (P), will the telehealth platform (I), compared to patient's previous visit HbA1c (C) improve the Hemoglobin A1c (HbA1c) diagnostic marker (O) over a 12-week period(T)? An extensive literature search of five databases was performed, citation chasing, and a hand search yielded fourteen pieces of evidence ranging from level I to VI (Melnyk & Fineout-Overholt, 2019). The pieces of evidence selected for this project support the evidence that telehealth implementation is as effective as the "usual care" or in-person visits to treat type 2 diabetes. The John Hopkins Nursing Evidence-Based Practice (JHNEBP) model was selected. Patients with a HbA1c of greater than 6.7% have been asked to schedule two six-week telehealth visits. During the live video visit, a review of medications, and diabetes self-management education (DSME) will be conducted. Participants will be provided with education to promote lifestyle modifications. The visits will be conducted through an Electronic Medical Record (EMR) system that is Health Insurance Portability and Accountability Act (HIPAA) compliant. A paired t-Test will be used with the data collected from the pre-and post-HbA1c. Improve the management of type 2 diabetes with the incorporation of telemedicine in primary care. Research supports the need to further expand the use of telehealth in primary care, to improve patient outcomes and decrease co-morbidities related to type 2 diabetes.
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Objectives: The Covid-19 pandemic highlighted the importance of considering Social Determinants of Health (SDoH) in healthcare research. Administrative claims databases are widely used for research, but often lack SDoH data or sufficient transparency in how these data were obtained. This study describes innovative methods for integrating SDoH data with administrative claims to facilitate health equity research. Method(s): The HealthCore Integrated Research Database (HIRD) contains medical and pharmacy claims from a large, national US payer starting in 2006 and includes commercial (Comm), Medicare Advantage (MCare), and Medicaid (MCaid) populations. The HIRD includes individually identifiable information, which was used for linking with SDoH data from the following sources: national neighborhood-level data from the American Community Survey, the Food Access Research Atlas, and the National Center for Health Statistics' urbanicity classification;and member-level data on race/ethnicity from enrollment files, medical records, self-attestation, and imputation algorithms. We examined SDoH metrics for members enrolled as of 05-July-2022 and compared them to the respective US national data using descriptive statistics. We also examined telehealth utilization in 2022. Result(s): SDoH data were available for ~95% of currently active members in the HIRD (Comm/MCare/MCaid 12.5m/1m/7.6m). Socioeconomic characteristics at the neighborhood-level differed by membership type and vs. national data: % of members with at least a high-school education (90/88/84 vs. 87);median family income ($98k/$76k/$70k vs. $82k);% of members living in low-income low-food-access tracts (9/14/18 vs. 13);urban (57/52/47 vs. 61). At the member-level, the % of White Non-Hispanics, Black Non-Hispanics, Asian Non-Hispanics, and Hispanics were 61/6/5/6 (Comm), 76/12/2/2 (MCare), and 45/26/5/19 (MCaid). Imputation contributed 15-60% of race/ethnicity values across membership types. Telehealth utilization increased with socioeconomic status. Conclusion(s): We successfully integrated SDoH data from a variety of sources with administrative claims. SDoH characteristics differed by type of insurance coverage and were associated with differences in telehealth utilization.Copyright © 2023
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Electronic health records (EHRs) and medical data are classified as personal data in every privacy law, meaning that any related service that includes processing such data must come with full security, confidentiality, privacy, and accountability. Solutions for health data management, as in storing it, sharing and processing it, are emerging quickly and were significantly boosted by the COVID-19 pandemic that created a need to move things online. EHRs make a crucial part of digital identity data, and the same digital identity trends - as in self-sovereign identity powered by decentralized ledger technologies like blockchain, are being researched or implemented in contexts managing digital interactions between health facilities, patients, and health professionals. In this paper, we propose a blockchain-based solution enabling secure exchange of EHRs between different parties powered by a self-sovereign identity (SSI) wallet and decentralized identifiers. We also make use of a consortium IPFS network for off-chain storage and attribute-based encryption (ABE) to ensure data confidentiality and integrity. Through our solution, we grant users full control over their medical data and enable them to securely share it in total confidentiality over secure communication channels between user wallets using encryption. We also use DIDs for better user privacy and limit any possible correlations or identification by using pairwise DIDs. Overall, combining this set of technologies guarantees secure exchange of EHRs, secure storage, and management along with by-design features inherited from the technological stack. © 2023 Marie Tcholakian et al.
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Aims: At our Trust, all severe inpatient hypoglycaemic episodes in individuals with diabetes (defined as a hypoglycaemic episode requiring injectable treatment) are reported to NaDIA-Harms (National Diabetes Inpatient Audit). We conducted a detailed review of the care of all these events to improve patient safety. In this study, we assessed the risk of 12-month mortality following an episode of severe inpatient hypoglycaemia. Method(s): Reportable NaDIA harms of patients admitted during the period 2018-2022 were recorded into a dataset. Applicable patient records were reviewed at 12 months following the event to see how many patients were deceased and details of comorbidities at the time of the severe hypoglycaemic episode were collected. Result(s): To date, of 107 inpatients who experienced a severe hypoglycaemic episode 55% were deceased within 12 months. In patients admitted during the peak of the Covid-19 pandemic recorded as year April 2020/March 2021, 80% of patients who had a NaDIA hypoglycaemic event died within 12 months. Conclusion(s): Mortality rate following an episode of inpatient hypoglycaemia appears to be several-fold higher than previous reported rates of 4.45%-22.1% for community-dwelling individuals who experience a severe hypoglycaemic event. This maybe partially explained by the increased frailty, polypharmacy and multimorbidity among this cohort, but there is evidence linking hypoglycaemia with cardiovascular mortality. Although no causality between severe inpatient hypoglycaemia and death can be inferred from this study because of the observational nature, it does highlight the importance preventing inpatient episodes of hypoglycaemia through effective monitoring and proactive treatment modification.
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Objectives: Developing a control group of a clinical trial using real world data is desirable and ethically sound despite challenges pertaining to internal validity. To examine the internal validity, we reproduced the control group in a Randomized Controlled Trial (RCT) using Electric Health Record (EHR) data and evaluated the difference between the outcome of the original trial and that of the reproduced analysis. Method(s): We selected an RCT, REMDACTA trial, that was performed to evaluate the efficacy of tocilizumab plus remdesivir against placebo plus remdesivir in patients with severe COVID-19 pneumonia. We reproduced its control group (patients with severe COVID-19 pneumonia taking only remdesivir), using Japanese EHR data, Millennial Medical Record provided by Life Data Initiative. Target patients for the main analysis were those prescribed remdesivir within 2 days after admission and diagnosed with COVID-19 (defined by ICD-10 code, U07.1) and/or with COVID-19 pneumonia (defined by diagnosis name). Patients in the sub analysis included only those with COVID-19 pneumonia diagnosis. Among the target patients, those undergoing image inspection, oxygen administration, and not taking any medicines for pneumonia before the first remdesivir prescription were eligible for the analyses. Median length of stay was compared in the reproduced group and in REMDACTA trial. Result(s): The database included 676 and 110 target patients for the main and sub analyses, respectively. However, only 57 and 14 patients met the eligibility criteria for the main and sub analyses, respectively. The reduction in the number of patients is attributed to the criteria of image inspection and oxygen administration. Median length of stay in the reproduced group were 13 and 11 days in the main and sub analyses, respectively. In REMDACTA trial, 95% CI of median time was 11.0-16.0. Conclusion(s): We successfully reproduced the median time of the control group by EHR data.Copyright © 2023
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Background: Previous data of COVID-19 indicates the obstetric population to be at specified risk for critical COVID-19 disease. In this study patient records were analyzed to gain information about the connection between pregnancy and intensive care treatment due to COVID-19 infection. Material(s) and Method(s): A retrospective study of all COVID-19 positive obstetric patients in Helsinki University Hospital admitted to intensive care units (ICU) from the beginning of March 2020 until the end of January 2022. Primary outcome is to compare the number of COVID-19 positive obstetric ICU patients to all ICU patients. Secondary outcomes are maternal 30-day survival and immediate neonatal survival. The study also looks at number of variables related to pregnancy and ICU treatment including age, previous medical history, BMI and COVID-19 vaccination status, obstetric data (i.e., gestational weeks, obstetric complications and route of delivery), treatments received at the ICU and length of ICU and hospital stay. Result(s): In total 20 obstetric patients with COVID-19 were admitted to the intensive care unit during the observation period. This is 2,3% of all COVID-19 patients and 27,4% of all 18-45 years old female COVID-19 patients treated in the intensive care unit in Helsinki University Hospital. Maternal 30-day survival was 95% (n = 19). Immediate neonatal survival was 95% (n = 19). Conclusion(s): Pregnancy increased the risk of ICU admission for COVID-19 infection. These results align with previous studies reporting pregnancy as a risk for critical COVID-19 infection and ICU admission. The 30-day survival was high compared to all ICU patients.
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Objectives: The COVID-19 pandemic has led to significant morbidity and mortality in lung transplant recipients (LTR). Respiratory viral infections may be associated with de-novo HLA donor-specific antibody (DSA) production and impact lung transplant outcome. Since one of the immunomodulation strategies post-SARS-CoV-2 infection in LTR include decreasing or holding anti-metabolites, concerns have been raised for higher incidence of de-novo DSA production in LTR. Method(s): We performed a retrospective chart review of 80 consecutive LTR diagnosed with COVID-19 to investigate this concern. COVID-19 disease severity was divided into 3 groups: mild, moderate, and severe. Mild disease was defined as patients with COVID-19 diagnosis who were stable enough to be treated as out-patients. Moderate disease was defined as patients who required admission to the hospital and were on less than 10 liters of oxygen at rest. Severe disease was identified as patients who required hospitalization and were on more than 10 liters of oxygen with or without mechanical ventilation or extra corporal membrane oxygenation (ECMO). Groups were compared using the Kruskal-Wallis test. Result(s): A total of 23, 47, and 10 LTR were diagnosed with mild, moderate, and severe COVID-19 respectively. De-novo HLA DSAwere detected in 0/23 (0%), 3/47 (6.3%), and 4/10 (40%) LTR with mild, moderate, and severe COVID-19 respectively (p = 0.0007) within 6 months post-COVID-19 diagnosis. Conclusion(s): Severe COVID-19 may be associated with increased risk of de novo HLA DSA production resulting in allograft dysfunction.Copyright © 2023 Elsevier Inc.
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Coronavirus disease has many systemic disease symptoms and has severe consequences for the cardiovascular system. Objective. To assess the role of clinical and laboratory indicators in determining the risk of chronic heart failure (CHF) in COV-ID-19 survivors. Material and methods. In total, 151 patients treated in a monoinfectious hospital from 03.11.20 to 10.02.21 with a confirmed diagnosis of COVID-19 were retrospectively selected. Medical history and laboratory data were collected by reviewing electronic medical records. The data included age, gender, body mass index, smoking status, and comorbidities. The laboratory data included the results of hematology and blood chemistry, coagulation, and the levels of acute-phase proteins. The CHF occurrence was used as the study endpoint. Results and discussion. The study patients were divided into two groups depending on the presence of CHF: group 1 included 46 patients with CHF, and group 2 included 105 patients without CHF. The median age was 66.2 (50-92) years;91 (60.3%) were females. Laboratory tests, such as levels of the hs-C-reactive protein, lactate dehydrogenase, procalcitonin, creatinine, and bilirubin, were statistically significantly different in patients of the study groups, and the median values were higher in patients with CHF. Neutrophil-lymphocyte ratio (NLR) showed statistically significant differences between groups: in patients with CHF, the median was 4.97% compared to 3.62% (p=0.011) in those without CHF. The most significant predictors of an increased risk of CHF were age >=66 years (OR=8.038, p<0.001), procalcitonin level >=0.09 ng/mL (increased the CHF risk by 3.8 times, p<0.001), thrombocy-topenia <=220x109/L (p=0.010), an NLR ratio >=4.11% (p=0.010), and a history of chronic kidney disease (p=0.018). Conclusion. A model has been developed to determine the factors closely associated with the risk of chronic heart failure in CO-VID-19 survivors.Copyright © 2023, Media Sphera Publishing Group. All rights reserved.
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Bruton tyrosine kinase inhibitors (BTKis) were approved for use at the end of 2013 and have since been used for indications including chronic lymphocytic leukaemia (CLL), Waldenstrom's macroglobulinaemia and mantle cell lymphoma. The use of BTKis has increased significantly in the UK since they achieved NICE (National Institute for Health and Care Excellence) approval for frontline treatment of CLL in 2021. However, they are associated with significant adverse cardiovascular events. In September 2021 the British Journal of Haematology published good practice guidelines for the management of cardiovascular complications of BTKis. Our aim was to see whether these guidelines had been adhered to for patients taking BTKis. Method(s): Data was collected for all patients being prescribed BTKis (ibrutinib and acalabrutinib) in the South Tees NHS Trust in July 2022. Patients' medical records were used to assess whether their management adhered to the good practice guidelines. Data was collated for 67 patients in total. Result(s): The data showed that although all patients were consented for the risk of atrial fibrillation only 6% were consented for hypertension and only 1.5% for ventricular arrhythmias and sudden cardiac death. The guidelines recommend a baseline ECG (electrocardiogram) on commencement of treatment;however, only 7% had this completed and 0% had the minimum monitoring recommendation of 6-monthly ECGs. Thirty patients (45%) had an indication for a baseline echocardiogram;however, only one had this completed. For patients reporting symptoms of syncope, dizziness or palpitations only 50% had an ECG completed. Three patients developed worsening heart failure. The recommendations suggest referral to a cardio-oncologist;however, due to lack of availability of this service the referrals were instead made to the usual cardiologist. Conclusion(s): Although there was a lack of compliance with guideline recommendations, it should be considered that most usual checks were affected by COVID-19 outbreaks and a drop in face-to- face clinics, which were replaced by phone clinics and home delivery of medications. However, the premade consent forms for BTKis need to be updated to include consent for ventricular arrhythmias and sudden cardiac death. There also needs to be routine procedures in place to ensure that regular blood pressure testing and ECG monitoring occurs and that there is prompt recognition of cardiovascular complications. Action and implementation: To ensure improved compliance with these guidelines we plan to update our consent forms and create a proforma for clinic use to ensure that clinicians are aware of the various monitoring criteria required.
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Objectives: Patients with severe COVID-19 infections have been shown to have prolonged periods of coma followed by meaningful neurological recovery. Therefore, neurological prognostication is challenging, particularly in those who require veno-venous extracorporeal membrane oxygenation (VV-ECMO) support. We hoped to evaluate which variables can be considered when trying to predict neurological recovery. Method(s): We conducted a case-control retrospective chart review of patients on VV-ECMO from March 2020 to January 2022. This time-frame was selected to limit the effect of post-pandemic changes in sedation practices. Our outcome was duration of unconsciousness, defined as days with GCS motor score <6. We first conducted a matched cohort analysis, comparing COVID and non-COVID patients. We then performed a Classification and Regression Tree (CART) analysis to determine the Relative Variable Importance (RVI) of clinical variables associated with duration of unconsciousness. Result(s): Our matched analysis included 52 patients, 27 (52%) of whom had COVID-19. There were no significant differences in the baseline characteristics of the groups (Table 1). Patients with COVID-19 had a significantly longer median duration on ECMO (p<0.001) and hospital length of stay (p=0.003). The median duration of unconsciousness was similar between COVID-19 and non-COVID patients (p=0.58). The CART analysis results (Figure 1) showed that the most important variables to predict duration of unconsciousness were successive variations in GCS (RVI 100%) and GCS standard deviation (RVI 99%). COVID positivity only had a weak predictability (RVI 4%). Conclusion(s): Our analysis has shown that in patients on VV-ECMO, those with COVID-19 spent a longer time on ECMO and in the hospital. While there was no significant difference in the duration of unconsciousness, we found that patients who had high fluctuations of GCS during ECMO had a shorter duration of coma. (Figure Presented).
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Transfusion-dependent thalassemia is the most severe form of thalassemia in which patients require a regular blood transfusion to maintain their haemoglobin level. COVID-19 pandemic has disrupted the routine measure in controlling chronic diseases like thalassemia. This study aims to measure the difference in pre-transfusion haemoglobin level and frequency of transfusion before and during pandemics. This retrospective cross-sectional study utilized medical records data of 101 transfusion-dependent thalassemia (TDT) patients treated in Cipto Mangunkusumo Hospital (CMH) from 2019-2021. The dependent variables of this study were pre-transfusion haemoglobin level and transfusion attendance. The pre-pandemic phase was defined from March 30, 2019, to March 29, 2020, whereas the during-pandemic phase was from March 30, 2020, to March 29, 2021. Up to 59.4% of subjects had suboptimal Hb level of < 9.0 g/dL even before the pandemic and it increased to 71.3% during a pandemic. Transfusion frequency of pre-pandemic and during-pandemic phases showed no significant difference (p-value = 0.990). The mean pre-transfusion haemoglobin level before the pandemic was 8.71 g/dL and it decreased to 8.46 g/dL (p-value <0.001). Our study showed poorer control of pre-transfusion Hb levels during the pandemic and decreased transfusion frequency. This puts them at a higher risk of developing many longterm complications.
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Early identification of PNH, a rare life-threatening disease is essential to ensure appropriate management via the UK PNH service. Since testing for PNH is expensive (75.97 per test), we set out to assess the suitability of PNH requests against guidelines with the aim to feedback to colleagues and reduce unnecessary testing. To determine whether PNH requests at UHNM were in line with criteria in British Society for Haematology (BSH) guidelines. All patients over 18 years of age who had PNH testing for the first time and those who had repeat testing for monitoring between 01/04/2019 and 31/03/2020 were included. Patients were selected from electronic records of PNH sample receipt to laboratories. Hospital records were reviewed for clinical details and investigation Results. 82 requests including 79 individual patients were audited. 57% were male and 43% were female. Median age was 56 years. 97.6% of PNH tests were requested by a haematologist whilst only 2.5% requests were done by non-haematology clinicians. 52.4% requests were in keeping with BSH recommendations, whilst 47.6% tests did not meet criteria for testing. All patients tested outside of guideline recommendations were negative. Of the reasonable requests, only 23.3% (10) were positive. Of the PNH positive patients, 8 patients were known to have a PNH clone with aplastic anaemia;one patient had a hypoplastic bone marrow and a known PNH clone whilst only one patient with cytopenia had a new positivity for PNH. The frequency monitoring for aplastic anaemia and a PNH clone was 100% concordant with BSH recommendations. With appropriate testing, only one new patient was identified. Our audit has limitations. We have not been able to assess whether any patients outside of those monitored for PNH in aplastic anaemia have been overlooked for testing. Also, the time period includes the COVID-19 pandemic so our findings may not reflect usual practice. New BSH guidelines for thrombophilia testing were published in 2022 and recommend testing for PNH in patients with thrombosis at unusual sites and abnormal haematological parameters and for patients with arterial thrombosis and abnormal blood parameters. This will likely limit excess tests although the sensitivity and specificity of such an approach has not been formally evaluated. In a finite health system, it is our responsibility to rationalise investigations. The cost of a year's testing was 6229.54 and that of inappropriate testing was 2962.83. As a department, we could, therefore, save 2962.83.
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Background: Coronavirus Disease-2019 (COVID-19) is an infectious disease caused by SARS-CoV-2 virus. Severity of this disease influenced by old age, sex, comorbidities, and other factors. Hypertension and type 2 diabetes mellitus are the most common comorbidities in COVID-19 patients that cause high morbidity and mortality. Objective(s): To analyze the survival of COVID-19 patients with hypertension comorbidity and compare it between diabetes mellitus and non-diabetes mellitus group. Method(s): This retrospective, descriptive study included COVID-19 patients with hypertension comorbidity at Internal Medicine ward Dr. Soetomo Hospital Surabaya from May 2020 to December 2021. Data on age, sex, hypertension, diabetes mellitus type 2, symptoms, vital signs, laboratory finding, length of stay, and outcome were taken from medical records and we carried out kaplan-meier method and log rank test by using SPSS. Result(s): This study obtained 698 sample of confirmed COVID-19 patients and after applying exclusion criteria there were 174 patients with hypertension comorbidity. Most patient were female (60.3%) and age 51-60 years (38.5%). The most common symptoms were shortness of breath (62.1%) and cough (50.6%). There were 50 hypertension and 79 non-hypertension patients died and Survival analysis showed a significant statistical difference between both groups (p=0.042). From 50 deceased hypertensive patients, there are 36 and 14 hypertensive patients with and without diabetes mellitus respectively but survival analysis showed a non-significant statistical difference between both groups (p=0.081) Conclusion(s): There is significant statistical difference in survival analysis in patients with hypertension. We should be aware about COVID-19 patients with hypertension.
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Introduction: COVID-19 related encephalitis has been reported in pediatric patients;however, there are no reports in patients with inborn errors of immunity (IEI). Activated PI3K Delta Syndrome (APDS) is a disease of immune dysregulation with immunodeficiency, autoimmunity, and abnormal lymphoproliferation resulting from autosomal dominant gain-offunction variants in PIK3CD or PIK3R1 genes. We investigate a family with APDS, one mother and three children, one of whom developed COVID-19 related encephalitis. Method(s): Patients were consented to an IRB-approved protocol at our institution. Medical records and detailed immunophenotyping were reviewed. Family members were sequenced for IEI with a targeted gene panel. Result(s): The index case is a 10-year-old female with a known pathogenic variant in PIK3CD (c.3061 G > A, p.Glu1021Lys), who contracted SARS-COV-2 despite one COVID-19 vaccination in the series. Her disease course included COVID-related encephalitis with cerebellitis and compression of the pons, resulting in lasting truncal ataxia and cerebellar mutism. At that time, the patient was not on immunoglobulin replacement therapy (IgRT), but was receiving Sirolimus. Besides the index case, 3 family members (2 brothers, 1 mother) also share the same PIK3CD variant with variable clinical and immunological phenotypes. All children exhibited high transitional B-cells, consistent with developmental block to follicular B cell stage. Increased non-class switched IgM+ memory B cells and skewing towards CD21lo B cell subset, which is considered autoreactive-like, was observed in all patients. Of note, the patient had low plasmablasts, but normal immunoglobulins. Of her family members, only one was receiving both sirolimus and IgRT. Conclusion(s): We describe a rare case of COVID-19-related encephalitis in a patient with inborn error of immunity while not on IgRT. This may indicate infection susceptibility because of a lack of sufficient immunity to SARS-CoV-2, unlike the rest of her family with the same PIK3CD variant.Copyright © 2023 Elsevier Inc.
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Introduction: Since COVID-19 spurred transitions from in-person to virtual telehealth visits, Press Ganey scores across adult specialties have shown improved patient satisfaction. The impact of telehealth on the pediatric surgery population, however, has not been characterized. This study aims to evaluate telehealth feasibility in pediatric surgery by examining Press Ganey surveys from the largest pediatric surgery telehealth group in the US. Method(s): Demographics were extracted from medical records of patients evaluated by general pediatric surgeons at a tertiary pediatric center from January to September of 2019 and 2021. Customized Press Ganey results were compared between in-person and telehealth patients. Ratings were categorized as satisfied (good, very good) or not satisfied (very poor, poor, fair). Analysis was performed using two-sample t-test or Fisher's Chi- Squared test. Result(s): In 2019, 7,965 (99.9%) patients were evaluated in-person and 3 by telehealth. In 2021, 8,454 (77%) were evaluated in-person and 2,514 (23%) by telehealth. Telehealth patients were more likely to no-show (11.2% vs 6.1%,p<0.01) and leave without being seen (1.4% vs 0.02%,p<0.01). Spanish speakers attended more in-person visits than telehealth (14% vs 8%,p<0.001). In 2021, telehealth patients reported greater satisfaction with providers and greater likelihood of recommending their provider. Conclusion(s): This study demonstrates improvement in patient satisfaction with telehealth implementation in a large pediatric surgery cohort. However, our data suggest that there may be access to care issues that can be optimized. Lessons from this study may be translated to other surgical disciplines and used to improve access to care and patient satisfaction.
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Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).
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Introduction: Surgical treatment of rectal cancer depends on clinical stage, size and location of primary tumor. A sphincter preserving technique such as low anterior resection (LAR) is the preferred method if negative distal margin can be achieved. If an adequate distal margin cannot be obtained, an abdominoperineal resection (APR) is required. A proctosigmoidectomy (Hartmann's procedure) is performed in patients with potentially curable obstructing rectal cancer after neoadjuvant chemoradiotherapy, or as a palliative treatment for locally advanced rectal cancer. Aim(s): The aim of this retrospective study was to investigate the impact of COVID 19 pandemic on the number and type of surgeries performed for the treatment of rectal cancer in UHC Zagreb, Department of Surgery. Material(s) and Method(s): Collected data were extracted from medical records of the patients who underwent surgery at the Department of Surgery from 1st of January 2016 to 31st of December 2022 with prior Ethics Committee approval. Total of 688 patients were included. Retrospective analysis of number and type of surgery was done consecutively by years for the period of interest. Result(s): In 2016 total of 75 patients underwent elective surgery for rectal cancer. LAR was performed in 64% (N=48) of patients, Hartmann's procedure in 20% (N=15), and APR in 16% (N=12). In 2017, 94 surgeries were performed. LAR accounted for 64% (N=60), Hartmann's procedure 17% (N=16), and APR 19% (N=18). In 2018, 115 surgeries were performed. LAR accounted for 69% (N=79), Hartmann's procedure 10% (N=12), and APR 21% (N=24). In 2019, 80 surgeries were performed. LAR accounted for 67% (N=54), Hartmann's procedure 9% (N=80), and APR 24%. In 2020, 78 surgeries were performed. LAR accounted for 59% (N=46), Hartmann's procedure 14% (N=11), and APR 27% (N=21). In 2021, 124 surgeries were performed. LAR accounted for 66% (N=82), Hartmann's procedure 14% (N=17), and APR 20% (N=25). In 2022, 122 surgeries were performed. LAR accounted for 64% (N=78), Hartmann's procedure 15% (N=18), and APR 21% (N=26). Conclusion(s): Our results show steady growth in numbers of performed surgeries in the years prior to the pandemic, with exception of the year 2019 when our department underwent organizational changes. In 2020, significant decrease in number of surgeries was observed as a result of restrictive epidemiological measures established to reduce the spread of COVID 19 infection. COVID 19 pandemic measures also resulted in delayed diagnosis and treatment of rectal cancer which is indirectly shown through the increasing share of Hartmann's procedure. In the years following the relaxation of measures, significant increase in number of performed surgeries that exceeded all the pre-pandemic years was recorded. Constant elevated share of Hartmann's procedure was noted as possible consequence of post COVID delay in diagnosis and confirmation of rectal cancer in more advanced stages of disease.
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Background: Health care systems have been facing COVID19 pandemic around the world for almost two years. Transfusion dependent (TDT) beta-thalassemia patients represent a vulnerable group,totally dependent upon hospital-based services. Aim(s): Aim of the present study was to evaluate the impact of COVID19 pandemic on management of TDT patients in a single pediatric treatment center in Northern Greece. Method(s): Patient records were reviewed in order to assess changes in management before and during the 24-month pandemic in Greece (03/01/2018-29/02/2020 and 03/01/2020 -28/02/2022, respectively) in terms of transfusion volume and transfusion frequency, mean value of pretransfusional hemoglobin, as well as laboratory parameters reflecting iron overload (ferritin levels, liver and heart MRI). Result(s): The study included 28 patients, 19 male (67.8%) and 9 female (32.2%), with an age range of 8 to 21 years. Mean number of hospital visits for transfusion was 19.97 +/- 3,52/ year prior to the pandemic and 22.38 +/- 4.35/year during the pandemic (p: 0.003). Average transfusion volume was 176.18ml +/- 38.32/kg/year kappaalphai 178.67 +/- 37.64ml/kg/year, respectively (p: 0.54). With regards to hemoglobin level, mean value was 9.56 +/- 0.42g/dl prior to the pandemic and 9.45 +/- 0.48gr/dl during the pandemic period. As to iron overload, mean ferritin level was 1362.05 +/- 517.56 ng/mL prior to the pandemic and 1021.27 +/- 508.92 ng/mL during the latter time period (p:0.016). Out of 28 enrolled patients, 26 underwent heart and liver MRI before pandemic and 23 during the pandemic period. Mean LIC values were 6.84 +/- 7.37 mg/gdw and 6.43 +/- 6.46 mg/gdw (p: 0.97) before and during the pandemic, respectively (p:0.97). Myocardial MRI values were within normal limits both before and during the pandemic. Summary-Conclusion: Covid19 pandemic did not seem to negatively affect the primary goal of transfusion therapy (pretransfusion Hb), even if an increased number of visits was required in order to transfuse the same blood volume - due to limited availability of blood units per visit. Of interest, pandemic conditions appeared to favor patient adherence to chelation therapy.
ABSTRACT
Objectives: To assess protein and energy intake and duration of venous-venous ECMO in critically ill patients with covid-19 Methods: We conducted a retrospective observational analysis on the intensive care units of a large tertiary private teaching Hospital. Adult patients admitted to intensive care unit (ICU) with laboratory confirmed SARS-CoV-2 (RT-PCR), cannulated on venous-venous ECMO and on exclusive enteral feeding were included. Data between march 2020 and june 2021 were collected. Weight and height data were acquired at the time of admission in ICU. Body mass index (BMI) was subsequently calculated. We obtained delivery and adequacy of nutrition data from a enteral nutrition form routinely filled out by nutritionists during hospitalization. Other data were obtained from electronic medical record. For statistical analysis of the data, we used SPSS version 13.0. Result(s): This cohort included 39 patients. 27 (69.2%) were men, mean age was 50 (+/- 12) years and 11 (28,2%) had more than 60 years. The more prevalent comorbidities were obesity in 22 (56%), hypertension in 20 (51,3%) and diabetes in 6 (15,4%) patients. The mean time on ECMO was 24.7 +/- 15.2 days. 29 patients (74%) died. Regarding nutritional support, the average protein intake was 0,9 +/- 0.4 g/kg/day and calories 13.9 +/- 5.2 cal/kg/day. No statistically significant association was observed between the nutritional intake and the duration on ECMO and clinical outcomes of patients. Conclusion(s): There was a high mortality in our cohort. Center;s inexperience may have played a role in these results, in addition to other factors. We observed a high prevalence of obesity. Neither energy nor protein intake were associated with the duration of ECMO and clinical outcomes. These results are similar to other recent observational studies where an insufficient energy and protein intake did not affected mortality or other outcomes. Our small sample and study design prevents a definitive conclusion on the subject. Thus, we propose further studies to elucidate the role of adequate nutrional strategies to improve outcomes and reabilitation of patients on ECMO.