Clinical Episodes Research Articles

CT-285: Patterns of Central Nervous System Complications Post-Hematopoietic Stem Cell Transplant in Pediatric Oncology Patients: A Single-Institute Experience

Context Hematopoietic stem cell transplantation (HSCT) became an integral component of the treatment of various pediatric malignancies. Post-transplant central nervous system complications (CNSC) are major contributors to morbidities in transplanted patients. Objective To describe the patterns of CNSC after HSCT in pediatric oncology patients using brain imaging. Design This retrospective study included pediatric patients transplanted between 2011 and 2019. Setting Cases were treated at the Children’s Cancer Hospital Egypt (CCHE-57357), which is a specialized center for pediatric oncology. Patients or Other Participants The study included pediatric cases who had undergone allogeneic- or autologous-HSCT. Interventions Computed tomography (CT) and/or magnetic resonance imaging (MRI) studies were evaluated for the detection and characterization of CNSC. Imaging was done following any neurological symptoms post-transplant. Brain structural abnormalities were classified as cerebrovascular complications (intra-parenchymal hemorrhage and venous thrombosis), infection, disease recurrence, atrophy, and treatment-related toxicities (posterior reversible encephalopathy syndrome [PRES] and leukoencephalopathy). Main Outcome Measures To describe the pattern of CNSC post-HSCT in pediatric oncology patients using CT and/or MRI. Results A total of 525 cases were included, of whom 311 and 214 had undergone autologous-HSCT and allogeneic-HSCT, respectively. Median follow-up for survivors was 48 months (range: 6–109 months). Hematological malignancies constituted 58% of cases. The median age was 6.5 years (range: 0.9–25 years). Sixty-eight cases (13%) presented cumulatively with 77 clinical episodes of neurological complications. The cumulative frequency of CNSC at 100 days was 5.3%. A higher incidence was observed in allogeneic-HSCT (15.9 %) compared to autologous-HSCT (11%). The most common CNSC was disease recurrence in 28/77 (36.4%), with 89% occurrence after autologous-HSCT, followed by PRES in 17/77 (22%) episodes. Females were 4.2 times as susceptible to developing PRES as males (p Conclusion The frequency of post-transplant CNSC is higher in allogeneic-HSCT compared to autologous-HSCT. The pattern of CNSC differs according to the time interval post-HSCT. Expert imaging interpretation is needed for early detection and proper management of CNSC post-HSCT.

Ambulatory intravenous furosemide for decompensated heart failure: safe, feasible, and effective.

AimsThis study aims to establish the feasibility, safety, and efficacy of outpatient intravenous (IV) diuretic treatment for the management of decompensated heart failure (HF) for patients enrolled in the HeartFailure@Home service.Methods and resultsWe retrospectively analysed the clinical episodes of decompensated HF for patients enrolled in the HeartFailure@Home service, managed by ambulatory IV diuretic treatment either at home or on a day‐case unit. A control group consisting of HF patients admitted to hospital for IV diuretics (standard‐of‐care) was also evaluated. In total, 203 episodes of decompensated HF (n = 154 patients) were evaluated. One hundred and fourteen episodes in 79 patients were managed exclusively by the ambulatory IV diuretic service—78 (68.4%) on a day‐case unit and 36 (31.6%) domiciliary; 84.1% of patient episodes under the HF@Home service were successfully managed entirely in an out‐patient setting without hospitalization. Eleven patients required admission in order to administer higher doses of IV diuretics than could be provided in the ambulatory setting. During follow‐up, there were 20 (17.5%) 30 day re‐admissions with HF or death in the ambulatory IV group and 29 (32.6%) in the standard‐of‐care arm (P = 0.02). There was no difference in 30 day HF readmissions between the two groups (14.9% ambulatory vs. 13.5% inpatients, P = 0.8), but 30 day mortality was significantly lower in the ambulatory group (3.5% vs. 21.3% inpatients, P < 0.001).ConclusionsOutpatient ambulatory management of decompensated HF with IV diuretics given either on a day case unit or in a domiciliary setting is feasible, safe, and effective in selected patients with decompensated HF. This should be explored further as a model in delivering HF services in the outpatient setting during COVID‐19.

Coexistence of Rheumatoid Arthritis and Familial Mediterrean Fever: A Case Report and Review of the Literature

Familial Mediterranean Fever (FMF) is the most prevalent monogenic autoinflammatory disease characterized by clinical featuresof recurrent episodes of fever, leukocitosis, serositis, myalgia, erysipelas-like skin lesions, lasting 12-72 hours. Rheumatoidarthritis (RA) is a chronic, systemic inflammatory disease. The most prominent feature is symmetrical pain and swelling of thehands, wrists, feet, and knees. The exact mechanisms underlying the coexistence of FMF and RA has not been reported previously.So far, only 8 cases of the coexistence of FMF and RA have been reported. In this report, we aimed to explain the associationbetween FMF and RA and report one more case of this coexistence.

Insulin choice in feline diabetes mellitus

PICO question&#x0D; In cats with diabetes mellitus, do protamine zinc insulin (PZI) and glargine show a similar effect in reducing clinical signs and hypoglycaemia episodes?&#x0D; &#x0D; Clinical bottom line&#x0D; Category of research question&#x0D; Treatment&#x0D; The number and type of study designs reviewed&#x0D; The number and type of study designs that were critically appraised was one. This study was a non-randomised retrospective trial. A systematic review was also found, which analyses the influence of insulin in diabetic remission&#x0D; Strength of evidence&#x0D; Weak&#x0D; Outcomes reported&#x0D; Compared to PZI, using glargine in recently diagnosed diabetic cats fed exclusively an ultra-low carbohydrate-high protein canned diet, may result in lower fructosamine and mean 12 hour blood glucose concentrations as well as less episodes of hypoglycaemia&#x0D; Conclusion&#x0D; In view of the strength of evidence and the outcomes from the study the following conclusion is made: in cats with diabetes mellitus where currently licensed insulin fails to result in a good glycaemic control, glargine may be considered&#x0D; &#x0D; How to apply this evidence in practice&#x0D; The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources.&#x0D; Knowledge Summaries are a resource to help reinforce or inform decision making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.&#x0D; &#x0D;

Anaphylaxis and Pregnancy: A Systematic Review and Call for Public Health Actions

Although rare, anaphylaxis during pregnancy implies a risk to both mothers and newborns. This systematic review is intended to identify key issues in the diagnosis and management of this condition to support prevention strategies and decrease the risk for death related to anaphylaxis during pregnancy. We searched MEDLINE, Cochrane, LILACS, SciELO, and Science Direct databases for manuscripts concerning the term "anaphylaxis during pregnancy," without language restrictions. We screened studies, extracted data, and assessed the risk for bias independently in duplicate. We selected 12 articles. Frequency of anaphylaxis during maternity was estimated to be 1.5 to 3.8 per 100,000 pregnancies. Only one study provided anaphylaxis mortality data in pregnant women; the rate of anaphylaxis-related maternal mortality was estimated at 0.05/100,000 live births. No standard definition of anaphylaxis severity has been used. A total of 49% to 74% of anaphylaxis cases were described during caesarean section. Beta-lactam antibiotics (58%), latex (25%), and anesthetic agents (17%) were the main causes. In 17% of reports, causative agents were proven by allergy testing. Moreover, 72% of articles proposed the same management and treatment for a clinical episode of anaphylaxis during pregnancy as for nonpregnant patients, and the use of epinephrine in the patient's care during anaphylaxis in pregnancy. Few studies address anaphylaxis during pregnancy. Most have been produced by nonallergy specialists. Collaboration among different specialists involved in the care of pregnant women should be established to support preventive strategies and reduce avoidable deaths.

Clinical Characteristics of Adult Hemophagocytic Lymphohistiocytosis in the Emergency Department.

PurposeTo determine the clinical manifestations and results of adult hemophagocytic lymphohistiocytosis (HLH) patients in our emergency department.MethodsWe retrospectively evaluated patients with HLH from 1 April 2018 to 31 December 2020. The clinical data of these patients (basic information, symptoms, vital signs, laboratory results, HLH diagnostic criteria, H Score, main treatments, outcomes) were collected.ResultsThirty-three patients (23 males and 10 females; 40.55±18.78 years) with 34 clinical episodes (one male had two clinical episodes and died during the second episode) were enrolled. Twenty-five patients were placed in a “survivor” group, and nine patients were categorized into a “deceased” group. Fever, splenomegaly, hemoglobin <90 g/L and platelet count <100×109/L most commonly met the diagnostic standard for HLH. The H Score results in the survival group and deceased group was 212.4±37.18 and 252.1±40.95, respectively. Viral infection was the most common reason for HLH, followed by immune-system disease and cancer. Laboratory tests showed that deceased-group patients had multiple-organ dysfunction. Multivariate logistic regression showed that the lactate dehydrogenase (lactate dehydrogenase) level (P = 0.039; odds ratio, 0.999) was significantly related to death.ConclusionIn the emergency department, HLH should be considered for critically ill patients with fever, splenomegaly, low hemoglobin and low platelet count. The H Score might be useful to diagnose HLH quickly. In our study, 26.47% of HLH patients died in the emergency department, and patients with a significantly increased lactate dehydrogenase level had a markedly increased risk of death.

Hospital Participation Decisions In Medicare Bundled Payment Program Were Influenced By Third-Party Conveners.

The Bundled Payments for Care Improvement initiative Advanced Model (BPCI Advanced) is a voluntary Medicare bundled payment model in which hospitals may participate with third-party conveners-private consulting firms that share in the financial risk built into the program. We found that nonteaching and for-profit status was associated with a higher probability of hospital partnership with third-party conveners in BPCI Advanced. Among hospitals participating in at least one inpatient clinical episode, hospitals that partnered with third-party conveners were more likely to select episodes with higher target prices: A $1,000 increase in episode target price was associated with a 1.66-percentage-point increase in the probability of episode participation in BPCI Advanced compared with a 0.72-percentage-point increase for participating hospitals without third-party conveners. Hospitals with third-party conveners also were more likely than those without them to select inpatient clinical episodes with greater opportunities to reduce spending on postacute care and readmissions. These findings have important implications for understanding the role of private consulting firms in the program and for planning potential program modifications in the future.

O23 Outcomes after non-operative management of perforated diverticular disease: a population based cohort study

Abstract Introduction The management of perforated diverticular disease has changed in the last 10 years with a move towards less surgical intervention. This population based cohort study aimed to define the risk of mortality and readmission following non-operative management of perforated diverticular disease (DD). Method Patients diagnosed with perforated DD and managed without surgery were identified from the linked Clinical Practice Research Datalink and Hospital Episode Statistics data from 2000 to 2013. The outcomes were 1-year case-fatality, re-admissions and surgery at re-admission. Result In total, 880 patients with perforated DD were managed without surgery, comprising of 523 females (59.4%). One year case-fatality was 33.2% (293/880). The majority of deaths occurred in the first 90 days following the index admission with a 90 day case-fatality of 28.8%. 90 day survival varied by age with 97.2% survival at 90 days in those under 65 years compared to 85.0% in those between 65–74 years and 51.5% in those over 75 years. Of 767 patients discharged from hospital, 250 (32.6%, 250/767) were re-admitted (47 elective(6.1%) and 203 emergency(26.5%)) during a median of 1.6 years of follow-up (iqr 0.1–3.9 years) with similar proportions in each age category. In the first year of follow-up only 5.1% of patients required surgery of whom 16/767 (2.1%) required elective and 23/767 (3.0%) emergency surgery. Conclusion Conservative management of perforated diverticulitis in those under 65 years is feasible and safe. A third of patients are readmitted during follow-up, however, re-intervention rates following conservative management were low across all age categories. Take-home Message In younger patients (&amp;lt;65yrs) conservative management of perforated diverticulitis is feasible and safe. A third of conservatively managed patients are readmitted during follow-up, however, need for surgery on readmission is rare.

How a pandemic changed advanced nurse practitioner (ANP) chest pain assessment from face-to-face to virtual: The impact on clinical workload, diagnosis &amp; patient safety

Abstract Funding Acknowledgements Type of funding sources: None. Chest pain presentations to the Emergency Dept. (ED) account for 8% of ED cases annually. In response to the pandemic the usual care pathway of nurse-led assessment in ED and discharge to a chest pain clinic (Ingram 2017) ceased, as face-to-face clinics and diagnostics were curtailed, and staff redeployed. A virtual chest pain clinic was created by one ANP. Telehealth is defined as ‘the entire spectrum of activities used to deliver care remotely, without direct physical contact with the patient’ (Wosik 2020) Purpose This analysis aims to compare the outcomes of the Covid-19 virtual chest pain clinic in 2020 to the same face-to- face clinic period in 2019 with a focus on i. Clinic workload, ii. Patient Outcomes iii. Patient Safety, Methods The ANP performed a telephone consultation and referred for limited diagnostic testing or discharged to primary care. The patient management system (iPIMS) was used as a clinical and audit tool. This service evaluation was registered as quality improvement project. Results From 1/4/20 to 21/7/2020, 130 e-referrals were received compared to 154 face-to-face consults in the same period of 2019. The overall number of clinic episodes was 17% greater during the pandemic period (Fig.1), carried out by 1/3 of the 2019 staff quota. Access to exercise stress testing (EST) was reduced by 88%. CHD was diagnosed in 26%. Virtual assessment in this high risk group in the absence of timely diagnostics is a risk however 30 day mortality was 0%. Discussion The pandemic of covid-19 required a rapid redesign of the chest pain service in the midst of staff redeployment. Whilst the total number of referrals is less that the same timeframe in 2019 the ‘virtual’ nature of the service created additional episodes of care with the need for the return clinic in person or by telephone. Conclusion In response to the pandemic the change to a virtual clinic was enabled by ANP experience and permitted continued safe discharge of chest pain patients from the ED. The virtual service does add to the ANP clinical workload with potential risk. As it requires more office time, it prevents the ANP presence in the ED. It is hoped in time to return to the original model of care as this will be more efficient for the service and the patient.

Bundled Payment Episodes Initiated by Physician Group Practices: Medicare Beneficiary Perceptions of Care Quality.

The Bundled Payments for Care Improvement (BPCI) initiative incentivizes participating providers to reduce total Medicare payments for an episode of care. However, there are concerns that reducing payments could reduce quality of care. To assess the association of BPCI with patient-reported functional status and care experiences. We surveyed a stratified random sample of Medicare beneficiaries with BPCI episodes attributed to participating physician group practices, and matched comparison beneficiaries, after hospitalization for one of the 18 highest volume clinical episodes. The sample included beneficiaries discharged from the hospital from February 2017 through September 2017. Beneficiaries were surveyed approximately 90 days after their hospital discharge. We estimated risk-adjusted differences between the BPCI and comparison groups, pooled across all 18 clinical episodes and separately for the five largest clinical episodes. Medicare beneficiaries with BPCI episodes (n=16,898, response rate=44.5%) and comparison beneficiaries hospitalized for similar conditions selected using coarsened exact matching (n=14,652, response rate=46.2%). Patient-reported functional status, care experiences, and overall satisfaction with recovery. Overall, we did not find differences between the BPCI and comparison respondents across seven measures of change in functional status or overall satisfaction with recovery. Both BPCI and comparison respondents reported generally positive care experiences, but BPCI respondents were less likely to report positive care experience for 3 of 8 measures (discharged at the right time, -1.2 percentage points (pp); appropriate level of care, -1.8 pp; preferences for post-discharge care taken into account, -0.9 pp; p<0.05 for all three measures). The proportion of respondents with favorable care experiences was smaller for BPCI than comparison respondents. However, we did not detect differences in self-reported change in functional status approximately 90 days after hospital discharge, indicating that differences in care experiences did not affect functional recovery.

Social and ethnic group differences in healthcare use by children aged 0–14 years: a population-based cohort study in England from 2007 to 2017

ObjectiveTo describe social and ethnic group differences in children’s use of healthcare services in England, from 2007 to 2017.DesignPopulation-based retrospective cohort study.Setting/PatientsWe performed individual-level linkage of electronic health records from...

Clinical-Community Connections: Incorporating Evidence-Based Programs for Improved Patient Outcomes.

Incorporating evidence-based community programs into clinical care recommendations and goals may help bridge the clinic-to-community transition for older adults. Engagement in evidence-based programs can help older adults manage chronic conditions and reduce fall risk through behavior change and self-management following a clinical episode of care. This paper describes evidence-based fall prevention and physical activity programs, provides resources to locate programs, and strategies to match older adults to the right programs.

Replication of machine learning methods to predict treatment outcome with antidepressant medications in patients with major depressive disorder from STAR*D and CAN-BIND-1.

Antidepressants are first-line treatments for major depressive disorder (MDD), but 40-60% of patients will not respond, hence, predicting response would be a major clinical advance. Machine learning algorithms hold promise to predict treatment outcomes based on clinical symptoms and episode features. We sought to independently replicate recent machine learning methodology predicting antidepressant outcomes using the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) dataset, and then externally validate these methods to train models using data from the Canadian Biomarker Integration Network in Depression (CAN-BIND-1) dataset. We replicated methodology from Nie et al (2018) using common algorithms based on linear regressions and decision trees to predict treatment-resistant depression (TRD, defined as failing to respond to 2 or more antidepressants) in the STAR*D dataset. We then trained and externally validated models using the clinical features found in both datasets to predict response (≥50% reduction on the Quick Inventory for Depressive Symptomatology, Self-Rated [QIDS-SR]) and remission (endpoint QIDS-SR score ≤5) in the CAN-BIND-1 dataset. We evaluated additional models to investigate how different outcomes and features may affect prediction performance. Our replicated models predicted TRD in the STAR*D dataset with slightly better balanced accuracy than Nie et al (70%-73% versus 64%-71%, respectively). Prediction performance on our external methodology validation on the CAN-BIND-1 dataset varied depending on outcome; performance was worse for response (best balanced accuracy 65%) compared to remission (77%). Using the smaller set of features found in both datasets generally improved prediction performance when evaluated on the STAR*D dataset. We successfully replicated prior work predicting antidepressant treatment outcomes using machine learning methods and clinical data. We found similar prediction performance using these methods on an external database, although prediction of remission was better than prediction of response. Future work is needed to improve prediction performance to be clinically useful.

Extended follow-up of children in a phase2b trial of the GMZ2 malaria vaccine

BackgroundThe GMZ2/alum candidate malaria vaccine had an efficacy of 14% (95% confidence interval [CI]: 3.6%, 23%) against clinical malaria over 6 months of follow-up in a phase2b multicentre trial in children 1–5 years of age. Here we report the extended follow up of safety and efficacy over 2 years. MethodsA total of 1849 (GMZ2 = 926, rabies = 923) children aged 12–60 months were randomized to receive intramuscularly, either 3 doses of 100 μg GMZ2/alum or 3 doses of rabies vaccine as control 28 days apart. The children were followed-up for 24 months for clinical malaria episodes and adverse events. The primary endpoint was documented fever with parasitaemia of at least 5000/μL. ResultsThere were 2,062 malaria episodes in the GMZ2/alum group and 2,115 in the rabies vaccine group in the intention-to-treat analysis, vaccine efficacy (VE) of 6.5% (95%: CI −1.6%, 14.0%). In children aged 1–2 years at enrolment, VE was 3.6% (95 %CI: −9.1%, 14.8%) in the first year and −4.1% (95 %CI: −18.7%, 87%) in the second year. In children aged 3–5 years at enrolment VE was 19.9% (95 %CI: 7.7%, 30.4%) in the first year and 6.3% (95 %CI: −10.2%, 20.3%) in the second year (interaction by year, P = 0.025, and by age group, P = 0.085). A total of 187 (GMZ2 = 91, rabies = 96) serious adverse events were recorded in 167 individuals over the entire period of the study. There were no GMZ2 vaccine related serious adverse events. ConclusionsGMZ2/alum was well tolerated. Follow-up over 2 years confirmed a low level of vaccine efficacy with slightly higher efficacy in older children, which suggests GMZ2 may act in concert with naturally acquired immunity.

Health and Illness in Newly Arrived Migrants and Refugees Arriving at Europe's Shores: Analysis of the Electronic Personal Health Record System in Seven Countries

Background: The electronic Personal Health (ePHR) Record is a health information system for newly arriving migrants that has been implemented in seven European countries (Bulgaria, Croatia, Cyprus, Greece, Italy, Serbia and Slovenia). This is a cross-sectional study of all migrants who attended as part of the health assessment programme established in the reception centres between 2016 and 2019 that provides a comprehensive overview of illness and health in the migrant cohort. Methods: Data were collected on demographics, clinical and laboratory findings and diagnostics performed, including medical records. We classified all diseases using pre-specified algorithms according to information on prespecified variables from the ePHR questionnaire, ICD-10 codes, positive laboratory findings that identified a health condition or review of medical records using natural language processing. Crude and adjusted prevalence ratios or adjusted proportions were estimated using logistic regression modelling. Results: The data set contained a total number of 19,564 clinical episodes in 14,440 individuals, recorded between 5 January 2016 to 4 October 2019. Most individuals (75%) were refugees or asylum seekers (22%) from 92 different nationalities. In total 811 (5.6%) individuals presented with cardiovascular disease and 1083 (8·2%) presented with a neurological condition. Having Diabetes Mellitus (OR 4, [95%CI 2·4-6·6], p<0.001), and neurological disorders (3·6, [95%CI 2·5-5·2], p<0.001) being older (OR 1·07 [95% CI 1·06-1·08]; p<0·001) and being male (OR 0·7, [95% CI 0·5-0·9]; p<0·001) was associated with cardiovascular disorders in the multivariable logistic regression model. Mental health problems were reported in 627 (4·4%) and were associated with older ages. There were 2,531 episodes of infectious diseases reported during the study period; 1283, (47·9%) pharyngo-tonsillitis, 529 (19·8%) scabies, 158 (6·2%) viral hepatitis and 156 (6·1%) lower respiratory infections. Conclusions: We demonstrated that infectious diseases were common, particularly among children, with a significant minority having a range of chronic diseases. Our findings show an important and less known disease burden, making a strong case for the improvement of accuracy and quality of data to improve the efficiency of the health care delivery and the monitoring and surveillance of migrant health needs. Funding: This work has been supported by a grant from the European Commission (N. 20175101).\ Conflict of Interest: All authors declare no competing interest. Ethical Approval: Internal IOM approval was granted, no external approval was needed, as this study is a service evaluation of routine systems and care. The reporting of this study conforms to the STROBE statement

English

BACKGROUND Methylenetetrahydrofolate reductase (MTHFR) C677T and A1298C variants are considered as potential genetic risk factors for vaso-occlusive complications in sickle cell disorder (SCD). The purpose of the study was to determine the interaction of the combined haplotypes on the clinical presentations in children with sickle cell disorder. METHODS A cross-sectional study was conducted on 249 children, confirmed for sickle cell disorder. Clinical details and frequencies of clinical episodes in the past one year were noted and a severity index number was allotted to each child and evaluated for their relationship with the combined haplotypes of C677T and A1298C single nucleotide polymorphisms genotyped by real-time PCR. RESULTS The frequency for 677T / 1298A haplotype was 46.4 % and that of 677C / 1298C was 12.4 %. The three variant combined haplotypes had higher plasma homocysteine values than the wild 677C / 1298A haplotypes (P &lt; 0.001). Clinical events like vasoocclusive crisis (VOC), homocysteinemia, hospitalization frequency and SI were found significantly related among the children in sickle cell trait (SCT) group (P &lt; 0.001) but not so in SCD group. Chances for anemia was 1.93 times more in presence of dual variant alleles (95 %CI: 0.95 to 3.92, P = 0.07) in SCT. The 677T / 1298C haplotype accounted for higher SI was 7.85 times more than the wild haplotypic children even in SCT children and 1.67 times in SCD children. CONCLUSIONS Presence of the variant haplotypes had significant implication on crisis events in children with sickle cell trait and make them more prone for the clinical severity. A preliminary allelic screening might be helpful in them. KEY WORDS Dual Variant Alleles, Heterozygous, Homozygous, MTHFR, Variant Haplotypes

Improving target price calculations in Medicare bundled payment programs.

To compare the predictive accuracy of two approaches to target price calculations under Bundled Payments for Care Improvement-Advanced (BPCI-A): the traditional Centers for Medicare and Medicaid Services (CMS) methodology and an empirical Bayes approach designed to mitigate the effects of regression to the mean. Medicare fee-for-service claims for beneficiaries discharged from acute care hospitals between 2010 and 2016. We used data from a baseline period (discharges between January 1, 2010 and September 30, 2013) to predict spending in a performance period (discharges between October 1, 2015 and June 30, 2016). For 23 clinical episode types in BPCI-A, we compared the average prediction error across hospitals associated with each statistical approach. We also calculated an average across all clinical episode types and explored differences by hospital size. We used a 20% sample of Medicare claims, excluding hospitals and episode types with small numbers of observations. The empirical Bayes approach resulted in significantly more accurate episode spending predictions for 19 of 23 clinical episode types. Across all episode types, prediction error averaged $8456 for the CMS approach versus $7521 for the empirical Bayes approach. Greater improvements in accuracy were observed with increasing hospital size. CMS should consider using empirical Bayes methods to calculate target prices for BPCI-A.

Mental Activity During Episodes of Sleepwalking, Night Terrors or Confusional Arousals: Differences Between Children and Adults.

Objective/BackgroundNight terrors, sleepwalking and confusional arousals are behavioral manifestations of incomplete awakenings from sleep. According to international diagnostic criteria, these behaviors occur in the absence of any mental experience, or in the presence of very limited cognition or dream imagery (eg, a single visual scene). The aim of this study was to systematically and retrospectively investigate the mental content associated with sleep terrors and/or sleepwalking in both children and adults.Patients and MethodsForty-five consecutive patients referred for a diagnosis of disorders of arousal (DOA) of all subtypes (sleepwalking/sleep terrors/confusional arousals) (25 adults: 30 ± 6 y, 15 females; 20 children: 10 ± 3 y, 6 females) underwent a detailed semi-structured interview about the mental content associated with their nocturnal episodes. The interview was comprehensive of specific questions about their subjective recall rate, several content details (characters, emotions, actions and setting/context), and hallucinatory or dissociative experiences during clinical episodes. Patients’ reports were classified for complexity (Orlinsky scale) and content (Hall and Van de Castle categories).ResultsMore than two-third of the children (n = 14) could not recall any mental activity associated with their episodes, whereas more than two-third (n = 16) of the adults recalled at least one mental experience. Half of the adult patients (n = 8) estimated that a specific mental content was subjectively present around 50% or more of the times. Seven adults and one child described clear and vivid hallucinatory experiences of “dreamed” objects or characters projected onto their real home environment, in the absence of any reality testing. Five adults and two children described one or more dissociative experiences. The content of the collected reports was dominated by dynamic actions acted out from a self-perspective, often with apprehension and in response to misfortune and danger, in a home-setting environment.ConclusionThese results suggest that current diagnostic criteria are tailored around the typical presentation of DOA in children, and do not always fit to adult patients with DOA. Furthermore, they support the concept that consciousness may reemerge in DOA patients during clinical episodes, in a peculiar dissociated, psychotic-like form.

Persistent Submicroscopic Plasmodium falciparum Parasitemia 72 Hours after Treatment with Artemether-Lumefantrine Predicts 42-Day Treatment Failure in Mali and Burkina Faso.

ABSTRACTA recent randomized controlled trial, the WANECAM (West African Network for Clinical Trials of Antimalarial Drugs) trial, conducted at seven centers in West Africa, found that artemether-lumefantrine, artesunate-amodiaquine, pyronaridine-artesunate, and dihydroartemisinin-piperaquine all displayed good efficacy. However, artemether-lumefantrine was associated with a shorter interval between clinical episodes than the other regimens. In a further comparison of these therapies, we identified cases of persisting submicroscopic parasitemia by quantitative PCR (qPCR) at 72 h posttreatment among WANECAM participants from 5 sites in Mali and Burkina Faso, and we compared treatment outcomes for this group to those with complete parasite clearance by 72 h. Among 552 evaluable patients, 17.7% had qPCR-detectable parasitemia at 72 h during their first treatment episode. This proportion varied among sites, reflecting differences in malaria transmission intensity, but did not differ among pooled drug treatment groups. However, patients who received artemether-lumefantrine and were qPCR positive at 72 h were significantly more likely to have microscopically detectable recurrent Plasmodium falciparum parasitemia by day 42 than those receiving other regimens and experienced, on average, a shorter interval before the next clinical episode. Haplotypes of pfcrt and pfmdr1 were also evaluated in persisting parasites. These data identify a possible threat to the parasitological efficacy of artemether-lumefantrine in West Africa, over a decade since it was first introduced on a large scale.

Impact of clinical trial enrollment on episode costs in the Oncology Care Model (OCM).

6513 Background: Clinical trials are critical for improving outcomes for patients with cancer. However, there is some concern from health insurers that clinical trial participation can increase total cost of care for cancer patients. We investigated the impact of clinical trial participation on total costs paid by Medicare during the OCM program in a large community-based practice. Methods: Tennessee Oncology (TO) is a community oncology practice comprising over 90 oncologists across 30 sites of care. We linked TO trial data and electronic medical record data with OCM data for episodes of care from 2016-2018. To assess the impact of trial participation on total cost relative to routine care, we created matched comparator groups for each OCM episode based on cancer type, metastatic status, number of comorbidities, performance status, and age. Patients with breast cancer receiving hormone therapy only were excluded. Absolute and percent cost differences between groups were calculated for episodes that had a comparator group size of five or greater. Differences in total cost for trial episodes were compared to non-trial episodes, and significance was assessed using the Mann–Whitney U test. We also studied the impact of trial participation on receipt of active treatment in the last 14 days of life (TxEOL), hospice use, and hospitalizations. Results: During the study period, 8,026 completed OCM episodes met study criteria. Patients were enrolled in a clinical trial for 459 of these episodes. On average, episodes during which patients were on trial cost $5,973 less than matched non-trial episodes (Table), independent of early versus late-phase trial. Most savings resulted from decreased drug costs. There were no differences in rates of TxEOL (15% vs. 14% p=1.0), rates of hospitalizations (31% vs. 30% p=0.54), or hospice use (52% vs. 62% p=0.08) between trial and non-trial episodes. Median difference from comparator group average cost was significantly lower for clinical trial episodes (-18% vs. -6%, p&lt;0.01). Conclusions: In the community setting, total costs paid by Medicare for patients participating in clinical trials during OCM episodes were lower than costs for similar patients receiving routine care. Clinical trial participation did not adversely impact end-of-life care or likelihood of hospitalization. These findings suggest that patient participation in clinical trials does not increase total cost of care nor enhance financial risk to payers.[Table: see text]