A systematic literature review of clinical evidence and treatment burden in newly diagnosed high-risk pediatric patients with classical Hodgkin lymphoma.

This systematic literature review evaluated frontline treatment burden in pediatric and adolescent/young adult (AYA) patients with high-risk classical Hodgkin lymphoma (cHL) among studies originating from the United States. Data were extracted from 32 publications (screened: total, n = 3115; full-text, n = 98) representing 12 studies (randomized controlled trials [RCTs], n = 2; non-comparative, non-randomized, n = 7; observational, n = 3). High-risk disease definitions varied across studies. Five-year event-free survival (EFS)/progression-free survival (PFS) was 86%-100% and 79%-94%, and complete response rates were 35%-100% and 5%-64% for brentuximab vedotin (BV)-containing and chemotherapy-alone regimens, respectively. In identified RCTs, BV-containing compared with chemotherapy-alone regimens demonstrated significantly longer 3-year EFS/5-year PFS. Hematological and peripheral neuropathy were the most commonly reported adverse events of interest, although safety data were inconsistently reported. Few studies evaluated humanistic and no studies evaluated economic burden. Results from studies with the highest quality of evidence indicate an EFS/PFS benefit for frontline BV-containing versus chemotherapy-alone regimens for pediatric/AYA patients with high-risk cHL.

The effect of repeated concussions on clinical and neurocognitive symptom severity in different contact sports.

INTRODUCTION: The potential consequences of repeated concussions in sport are well documented. However, it remains unclear whether the cumulative impact of sports-related concussions differs between different contact sports. Therefore, the aim of the current study was to investigate the cumulative effects of sports-related concussions on clinical and neurocognitive health in different contact sports. MATERIALS AND METHODS: In a prospective multicenter study, we examined 507 (74 females) active professional athletes between 18 and 40 years of age from five different contact sports (soccer, handball, American football, basketball, and ice hockey). Data collection involved concussion history, clinical symptom evaluation, neurocognitive assessment, and the collection of other sports-related information. Composite scores were built for clinical symptoms (such as neck pain and balance disturbances) and for neurocognitive symptoms (such as memory and attention impairments). RESULTS: Athletes having suffered 3+ concussions in the past showed disproportionally higher clinical symptom severity than athletes with less than three concussions across all sports. The level of clinical symptom burden in athletes with 3+ concussions indicated mild impairment. The number of past concussions did not affect neurocognitive performance. DISCUSSION: Repeated sports-related concussions appear to have a cumulative impact on clinical-but not cognitive-symptom severity. Although clinical symptom burden in athletes with 3+ concussions in the past was not alarmingly high yet in our sample, increased caution should be advised at this point. Despite few exceptions, results are similar for different contact sports, suggesting a similar multidisciplinary concussion management across all types of sport.

Clinical burden related to oral corticosteroid treatment of severe asthma in Spain: LEVANTE study.

BACKGROUND: Severe asthma treatment with oral corticosteroids (OCS) added to inhaled corticosteroids and a long-acting ß2-agonist (ICS-LABA) may result in more treatment burden and increased adverse effects. OBJECTIVE AND METHODS: This ambispective multicenter observational study aimed at describing the clinical burden in patients with severe asthma on stable high-dose ICS-LABA who received OCS during ≥6 months (maintenance group) or ≥2 cycles in the previous 12 months (bursts group). Data collection comprised a retrospective 12-month baseline period and 2 follow-up visits at 3 and 6 months. RESULTS: Eighty-nine patients were evaluable (30 on maintenance, 59 on bursts). At baseline, mean (SD) daily prednisone equivalent exposure in the total population was 24.6 (14.7) mg: 13.8 (9.4) mg on maintenance and 29.9 (14.3) mg on bursts. During the 6-month follow-up period, mean (SD) daily dose in the total cohort was 22.5 (18.8) mg: 17.2 (18.6) mg on maintenance and 28.4 (20.6) mg on bursts. The overall annual severe exacerbations rate during the 12-month baseline period was 2.05 per patient-year and 1.5 per patient-year over the 6-month follow-up, and frequency of hospitalizations and emergency department visits were similar on both maintenance and bursts use. CONCLUSIONS: Results show a suboptimal control of severe asthma despite such high doses of OCS and persistence of disease burden regardless of the prescribing pattern in maintenance or bursts. There is therapeutic inertia to continue using OCS despite the increased risk of adverse effects and the availability of biologics.

Does the 5-2-1 criteria identify patients with advanced Parkinson's disease? Real-world screening accuracy and burden of 5-2-1-positive patients in 7 countries.

BACKGROUND: The burden of Parkinson's disease (PD) worsens with disease progression. However, the lack of objective and uniform disease classification challenges our understanding of the incremental burden in patients with advanced Parkinson's disease (APD) and suboptimal medication control. The 5-2-1 criteria was proposed by clinical consensus to identify patients with advancing PD. Our objective was to evaluate the screening accuracy and incremental clinical burden, healthcare resource utilization (HCRU), and humanistic burden in PD patients meeting the 5-2-1 screening criteria. METHODS: Data were drawn from the Adelphi Parkinson's Disease Specific Program (DSP™), a multi-country point-in-time survey (2017-2020). People with PD who were naive to device-aided therapy and on oral PD therapy were included. Patients meeting the 5-2-1 screening criteria had one or more of the three clinical indicators of APD: (i) ≥5 doses of oral levodopa/day, OR (ii) "off" symptoms for ≥2 h of waking day, OR (iii) ≥1 h of troublesome dyskinesia. Clinician assessment of PD stage was used as the reference in this study. Clinical screening accuracy of the 5-2-1 criteria was assessed using area under the curve and multivariable logistic regression models. Incremental clinical, HCRU, and humanistic burden were assessed by known-group comparisons between 5 and 2-1-positive and negative patients. RESULTS: From the analytic sample (n = 4714), 33% of patients met the 5-2-1 screening criteria. Among physician-classified APD patients, 78.6% were 5-2-1 positive. Concordance between clinician judgment and 5-2-1 screening criteria was > 75%. 5-2-1-positive patients were nearly 7-times more likely to be classified as APD by physician judgment. Compared with the 5-2-1-negative group, 5-2-1-positive patients had significantly higher clinical, HCRU, and humanistic burden across all measures. In particular, 5-2-1-positive patients had 3.8-times more falls, 3.6-times higher annual hospitalization rate, and 3.4-times greater dissatisfaction with PD treatment. 5-2-1-positive patients also had significantly lower quality of life and worse caregiver burden. CONCLUSIONS: 5-2-1 criteria demonstrated potential as a screening tool for identifying people with APD with considerable clinical, humanistic, and HCRU burden. The 5-2-1 screening criteria is an objective and reliable tool that may aid the timely identification and treatment optimization of patients inadequately controlled on oral PD medications.

Economic and clinical burden associated with respiratory viral infections after allogeneic hematopoietic cell transplant in the United States.

BACKGROUND: Allogeneic hematopoietic cell transplant (allo-HCT) recipients are at increased risk for respiratory viral infections (RVIs), which invoke substantial morbidity and mortality. Limited effective antiviral options and drug resistance often hamper successful RVI treatment, creating additional burden for patients and the health care system. METHODS: Using an open-source health care claims database, we examined differences in clinical outcomes, health resource utilization, and total reimbursements during the 1-year period following allo-HCT in patients with and without any RVI infection (respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus). RVIs were diagnosed at any time ≤1 year after allo-HCT and identified by International Classification of Disease codes. Analyses were stratified by the presence or absence of acute or chronic graft-versus-host disease (GVHD). RESULTS: The study included 13 363 allo-HCT patients, 1368 (10.2%) of whom had a diagnostic code for any RVI. A higher proportion of patients with any RVI had pneumonia ≤1 year after allo-HCT compared to patients without any RVI, with or without GVHD. Patients with any RVI had higher all-cause mortality risk, longer length of post-allo-HCT hospital stay, higher readmission rate, and higher number of hospital days after allo-HCT compared to patients without the infection (all p < .05). Total unadjusted median reimbursements were higher for those with any RVI and each specific RVI assessed than those without the specific infection, with or without GVHD. CONCLUSION: Allo-HCT patients with RVIs had significantly worse clinical outcomes and increased health resource utilization and reimbursements during the year following allo-HCT, with or without GVHD.

Invasive meningococcal disease in older adults in North America and Europe: is this the time for action? A review of the literature.

BACKGROUND: Neisseria meningitidis is an encapsulated Gram-negative diplococcus that asymptomatically colonises the upper respiratory tract in up to 25% of the population (mainly adolescents and young adults). Invasive meningococcal disease (IMD) caused by Neisseria meningitidis imposes a substantial public health burden,. The case fatality rate (CFR) of IMD remains high. IMD epidemiology varies markedly by region and over time, and there appears to be a shift in the epidemiology towards older adults. The objective of our review was to assess the published data on the epidemiology of IMD in older adults (those aged ≥ 55 years)in North America and Europe. Such information would assist decision-makers at national and international levels in developing future public health programmes for managing IMD. METHODS: A comprehensive literature review was undertaken on 11 August 2020 across three databases: EMBASE, Medline and BIOSIS. Papers were included if they met the following criteria: full paper written in the English language; included patients aged ≥ 56 years; were published between 1/1/2009 11/9/2020 and included patients with either suspected or confirmed IMD or infection with N. meningitidis in North America or Europe. Case studies/reports/series were eligible for inclusion if they included persons in the age range of interest. Animal studies and letters to editors were excluded. In addition, the websites of international and national organisations and societies were also checked for relevant information. RESULTS: There were 5,364 citations identified in total, of which 76 publications were included in this review. We identified that older adults with IMD were mainly affected by serogroups W and Y, which are generally not the predominant strains in circulation in most countries. Older adults had the highest CFRs, probably linked to underlying comorbidities and more atypical presentations hindering appropriate timely management. In addition, there was some evidence of a shift in the incidence of IMD from younger to older adults. CONCLUSIONS: The use of meningococcal vaccines that include coverage against serogroups W and Y in immunization programs for older adults needs to be evaluated to inform health authorities' decisions of the relative benefits of vaccination and the utility of expanding national immunization programmes to this age group.

Treatment and economic burden of mucormycosis in China: Case report review and burden estimation.

WHAT IS KNOWN AND OBJECTIVE: Mucormycosis is an opportunistic fungal infection associated with low incidence but high mortality. Few studies have shown the treatment and disease burden of mucormycosis in China. This study aims at collecting all the reported cases to describe the characteristics and treatment patterns and to assess the economic burden of mucormycosis in China. METHODS: We conducted a literature review of mucormycosis case reports in Chinese patients to summarize the characteristics and treatment patterns of the disease in China. An economic model was built to evaluate the total cost of mucormycosis per person, including direct medical cost, direct non-medical cost and indirect cost. RESULTS AND DISCUSSION: A total of 676 case reports showed that the most common type of mucormycosis was pulmonary mucormycosis (299/676, 44.2%), and rhinocerebral mucormycosis had the highest case fatality rate (122/185, 68.5%). Among those who used empiric therapies, 48.8% (231/473) did not include anti-mucor drugs; 79.8% (336/421) of the therapies include amphotericin B (AMB) or AMB-lipo after detection of mucormycetes; 98.6% (69/70) of the reported adverse events were associated with AMB and AMB-lipo. The duration of treatment ranged from 90 to 180 days; the length of stay ranged from 22 to 95 days. The average total cost per patient was 166 thousand Chinese Yuan (CNY), of which 93.1% was the direct medical cost (155 thousand CNY). WHAT IS NEW AND CONCLUSION: There are a limited number of antifungal treatment options for mucormycosis in China. This study highlights the critical need to introduce innovative and broader spectrum antifungal drugs with improved safety, better clinical efficacy, easier administration and reduced economic burden to Chinese mucormycosis patients.

Association Between Clinical Burden and Blood Eosinophil Counts in Asthma: Findings From a Korean Adult Asthma Cohort.

BACKGROUND: Some reports have suggested that the clinical and economic burdens of asthma are associated with blood eosinophil levels. The association between clinical burden and blood eosinophil counts were evaluated in a Korean adult asthma cohort. METHODS: Clinical information including blood eosinophil counts that were not affected by systemic corticosteroids were extracted from the Cohort for Reality and Evolution of Adult Asthma in Korea database. Clinical burden was defined as 1) asthma control status, 2) medication demand and 3) acute exacerbation (AE) events during 1 consecutive year after enrollment. All patients were divided into atopic and non-atopic asthmatics. The associations between asthma outcomes and the blood eosinophil count were evaluated. RESULTS: In total, 302 patients (124 atopic and 178 non-atopic asthmatics) were enrolled. In all asthmatics, the risk of severe AE was higher in patients with blood eosinophil levels < 100 cells/µL than in patients with levels ≥ 100 cells/µL (odds ratio [OR], 5.406; 95% confidence interval [CI], 1.266-23.078; adjusted P = 0.023). Among atopic asthmatics, the risk of moderate AE was higher in patients with blood eosinophil levels ≥ 300 cells/µL than in patients with levels < 300 cells/µL (OR, 3.558; 95% CI, 1.083-11.686; adjusted P = 0.036). Among non-atopic asthmatics, the risk of medication of Global Initiative for Asthma (GINA) steps 4 or 5 was higher in patients with high blood eosinophil levels than in patients with low blood eosinophil levels at cutoffs of 100, 200, 300, 400, and 500 cells/µL. CONCLUSION: The baseline blood eosinophil count may predict the future clinical burden of asthma.

The prevalence, burden of disease, and healthcare utilization of patients with eosinophilic granulomatosis with polyangiitis in Japan: a retrospective, descriptive cohort claims database study.

OBJECTIVES: To estimate eosinophilic granulomatosis with polyangiitis (EGPA) prevalence and disease burden in patients with newly diagnosed EGPA in Japan. METHODS: This retrospective descriptive cohort study (GSK ID: 209751, HO-18-19652) used administrative claim data from patients (aged ≤74 years) with EGPA (study period: January 1, 2005-December 31, 2017), identified from their first ICD-10 code for EGPA (index). Data were examined during the 12 months before (baseline) and 12 months following the index date (follow-up). EGPA prevalence, respiratory comorbidities, all-cause healthcare utilization, and oral corticosteroid (OCS) use were assessed. RESULTS: EGPA prevalence (95%CI) increased from 4.2 (0,23.7)/million people (2005) to 38.0 (31.8,45.1)/million people (2017), was generally more common in females versus males, and increased with age. Of the 45 patients with newly diagnosed EGPA, 57.8% had acute bronchitis and 42.2% had upper respiratory tract infections during baseline. During follow-up, 60.0% of patients were hospitalized at least once and 77.8% used OCS (OCS dependent [≥80% of days]: 73.1%). CONCLUSIONS: In Japan, EGPA prevalence increased over time, was generally more common in females, and increased with patient age. EGPA burden was high; respiratory comorbidities were common, and most patients required hospitalization and OCS use. Our data suggest additional EGPA treatment options are needed.

Group B Streptococcal Disease in England (1998 - 2017): A Population-based Observational Study.

BACKGROUND AND OBJECTIVES: Group B Streptococcus (GBS) is the leading cause of sepsis and meningitis in infants <90 days. In this study, the burden of GBS disease and mortality in young infants in England was assessed. METHODS: Using linked hospitalization records from every National Health Service (NHS) hospital from April 1, 1998 to March 31, 2017, we calculated annual GBS incidence in infants aged <90 days and, using regression models, compared their perinatal factors, rates of hospital-recorded disease outcomes, and all-cause infant mortality rates with those of the general infant population. RESULTS: 15 429 infants aged <90 days had a hospital-recorded diagnosis of GBS, giving an average annual incidence of 1.28 per 1000 live births (95% CI 1.26-1.30) with no significant trend over time. GBS-attributable mortality declined significantly from 0.044 (95% CI .029-.065) per 1000 live births in 2001 to 0.014 (95% CI .010-.026) in 2017 (annual percentage change -6.6, 95% CI -9.1 to -4.0). Infants with GBS had higher relative rates of visual impairment (HR 7.0 95% CI 4.1-12.1), cerebral palsy (HR 9.3 95% CI 6.6-13.3), hydrocephalus (HR 17.3 95% CI 13.8-21.6), and necrotizing enterocolitis (HR 18.8 95% CI 16.7-21.2) compared with those without GBS. CONCLUSIONS: Annual rates of GBS disease in infants have not changed over 19 years. The reduction in mortality is likely multifactorial and due to widespread implementation of antibiotics in at-risk mothers and babies, as well as advances in managing acutely unwell infants. New methods for prevention, such as maternal vaccination, must be prioritized.

Targeted literature review of current treatments and unmet need in moderate rheumatoid arthritis in the United Kingdom.

OBJECTIVES: The burden and treatment landscape of RA is poorly understood. This research aimed to identify evidence on quality of life, caregiver burden, economic burden, treatment patterns and clinical outcomes for patients with moderate RA in the United Kingdom. METHODS: A systematic literature review was performed across multiple databases and screened against pre-defined inclusion criteria. RESULTS: A total of 2610 records were screened; seven studies presenting evidence for moderate RA were included. These patients were found to incur substantial burden, with moderate to severe levels of disability. Compared with patients in remission, moderate RA patients reported higher levels of disability and decreased EQ-5D utility scores. The majority of patients did not feel that their current therapy adequately controlled their disease or provided sufficient symptom relief. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) have not approved advanced therapies (such as biological disease-modifying anti-rheumatic drugs) for patients with moderate disease, which restricts access for these patients. CONCLUSION: The evidence available on the burden of moderate RA is limited. Despite current treatments, moderate RA still has a substantial negative impact, given that a DAS28 disease activity score defined as being in the moderate range does not qualify them for access to advanced therapies in the United Kingdom. For these patients, there is a particular need for further studies that investigate their burden and the impact of treating them earlier. Such information would help guide future treatment decisions and ensure the most effective use of resources to gain the best outcomes for patients with moderate RA.

Modelling the economic and clinical burden of non-alcoholic steatohepatitis in East Asia: Data from Hong Kong.

AIM: Non-alcoholic steatohepatitis (NASH) is the progressive form of non-alcoholic fatty liver disease (NAFLD) and prevalence is rising in Asia due to increasing rates of urbanization, sedentary lifestyles, and poor nutrition. METHODS: We built a Markov model with 20-year horizon to estimate the burden of NASH in Hong Kong. Cohort size was determined by population size, prevalence of NAFLD, and incidence of NASH in 2017. Health states include hepatic steatosis, fibrosis stages 0-3, compensated and decompensated cirrhosis, hepatocellular carcinoma, post-liver transplant, and liver-related, cardiovascular, and background mortality. Transition probabilities were estimated from published reports and we converted 2017 Gazette price from the Hospital Authority of Hong Kong to US dollars. We discounted costs by 3% annually. Health utilities were assumed to be the same as in the USA. RESULTS: Non-alcoholic steatohepatitis will cost $1.32 billion and 124 liver transplants over 20 years, with average cost per person-year of $257. Sensitivity analyses show our model is robust in predicting costs for the prevalent population but likely overestimates costs for the incident population. CONCLUSIONS: Non-alcoholic steatohepatitis will contribute to a significant clinical and economic burden in Hong Kong over the next two decades. Due to the limited number of donors and small number of liver transplants undertaken annually, patients with advanced liver disease due to NASH in Hong Kong are more likely to die from NASH than their counterparts in North America and Europe. Thus, rising prevalence of metabolic syndrome in elderly adults in Hong Kong make NASH an important consideration for clinicians and policy makers.

Disease burden of Crigler-Najjar syndrome: Systematic review and future perspectives.

BACKGROUND AND AIM: Crigler-Najjar syndrome (CNS) results from biallelic mutations of UGT1A1 causing partial or total loss of uridine 5'-diphosphate glucuronyltransferase activity leading to unconjugated hyperbilirubinemia and its attendant risk for irreversible neurological injury (kernicterus). CNS is exceedingly rare and has been only partially characterized through relatively small studies, each comprising between two and 57 patients. METHODS: A systematic literature review was conducted to consolidate data on the patient, caregiver, and societal burden of CNS. RESULTS: Twenty-eight articles on clinical aspects of CNS were identified, but no published data on its humanistic or economic burden were found. In patients with complete UGT1A1 deficiency (type 1 CNS [CNS-I]), unconjugated bilirubin levels increase 3-6 mg/dL/day during the newborn period and reach neurologically dangerous levels between 5 and 14 days of age. Phototherapy is the mainstay of treatment but poses significant challenges to patients and their families. Despite consistent phototherapy, patients with CNS-I have worsening hyperbilirubinemia with advancing age. Liver transplantation is the only definitive therapy for CNS-I and is increasingly associated with excellent long-term survival but also incurs high costs, medical and surgical morbidities, and risks of immunosuppression. CONCLUSIONS: Crigler-Najjar syndrome is associated with a substantial burden, even with existing standards of care. The development of novel disease-modifying therapies has the potential to reduce disease burden and improve the lives of CNS patients and their families.

Acute kidney injury in hospitalized patients with nonexacerbated chronic obstructive pulmonary disease.

BACKGROUND: The epidemiology of acute kidney injury (AKI) in nonexacerbated chronic obstructive pulmonary disease (NECOPD) patients is unknown. This study investigated the factors associated with AKI and the association between AKI and in-hospital mortality in the hospitalized NECOPD population. METHODS: The electronic medical records of 2897 patients hospitalized with NECOPD were analyzed retrospectively. Demographic information, medicine used before AKI, diagnosis records and laboratory data were collected. AKI was classified as community-acquired (CA-) or hospital-acquired (HA-) AKI according to the serum creatinine criteria. Risk factors for HA-AKI and in-hospital mortality were analyzed by logistic regression analyses. To avoid an interaction between cor pulmonale and AKI, the association between AKI and in-hospital morality was further analyzed with cor pulmonale stratification. RESULTS: The incidence rates of CA- and HA-AKI were 7.1 and 12.0%, respectively. Increased age, female sex, cor pulmonale comorbidity, chronic kidney disease stage, diuretic and glycopeptide use before AKI and iodine-containing contrast medium exposure were independently associated with HA-AKI. A total of 5.7% of the patients died. After adjustment for age, sex, cor pulmonale, chronic kidney disease, Charlson comorbidity index score (without renal disease) and hemoglobin level, HA-AKI was an independent risk factor for in-hospital mortality [OR 13.909 (95% CI 8.699-22.238) in non-cor pulmonale subgroup; OR 26.604 (95% CI 12.166-58.176) in cor pulmonale subgroup], whereas CA-AKI was not. CONCLUSIONS: AKI is common in the NECOPD population. Diuretics and contrast media are associated with HA-AKI in this population. The patients with HA-AKI have a higher mortality risk than the patients without AKI.

Pastoralists' knowledge and practices towards clinical bovine dermatophilosis in cattle herds of North-Central Nigeria: the associated factors, burden and economic impact.

Dermatophilosis is a contagious disease of high economic importance. The study assessed knowledge/awareness and clinical burden of and mitigation measures practised against clinical bovine dermatophilosis in pastoral herds of North-Central Nigeria and associated socio-cultural factors that predisposed to its occurrence in herds. A cross-sectional survey was conducted between October 2015 and September 2016. Questionnaires were administered on pastoralists and clinical assessment of cattle with gross pathological lesions indicative of dermatophilosis conducted. Associated economic impact was estimated. All 384 selected pastoralists participated in the survey. The majorities of nomadic (97.4%) and sedentary (68.2%) pastoralists significantly (p < 0.05) reported to have heard about dermatophilosis. Majorities of the sedentary (91.7%) and nomadic (97.4%) pastoralists mentioned the use antibiotics to manage the disease. Pastoralists in age group 70-79 years were more likely (OR 15.22; 95% CI 4.69, 49.34) to possess satisfactory knowledge about the disease. Culture of giving out cattle as gift or payment for dowry was more likely (OR 28.56; 95% CI 15.64, 52.12) to influence dermatophilosis occurrence in herds. Overall clinical dermatophilosis burden was 3.6% (95% CI 3.46, 3.80) and the annual economic impact was estimated at 908,463.9 USD. This study has given an idea to the status of pastoralists' levels of awareness about dermatophilosis in Nigeria, which can be harnessed by policy makers to develop its mitigation measures. Significant influence of pastoralists' socio-cultural activities on dermatophilosis occurrence in herds was identified. Surveillance and control programmes towards dermatophilosis that take these factors into consideration will be beneficial to the herders.

Two-year outcome of an observe-and-plan regimen for neovascular age-related macular degeneration treated with Aflibercept.

PURPOSE: The purpose of our study was to investigate the two-year outcome of Aflibercept treatment for neovascular age-related macular degeneration (nAMD), using the Observe-and-Plan regimen, an individually planned treatment regimen, based on the predictability of an individual's need for retreatment, aiming to reduce the clinical burden. METHODS: Our prospective study used the Observe-and-Plan regimen with Aflibercept to treat nAMD: Three loading doses, followed by monthly observation visits until the disease-recurrence interval was determined, which then was shortened by 2 weeks in a treatment plan for the next three injections without intermediate monitoring visits. The subsequent treatment plans were adjusted according to periodically assessed disease activity. The primary outcome measures were visual acuity changes, number of injections, and number of monitoring visits. RESULTS: The study included 112 eyes of 102 patients with a mean age of 80.7 years (SD 7.6). Mean visual acuity (VA) improved from 61.8 ETDRS letters (20/60+2) at baseline, by 8.5, 8.0, and 6.2 letters at months 3, 12 and 24, respectively. Mean central retinal thickness was 438um at baseline, and reduced by 152um, 155um, and 150um at months 3, 12 and 24, respectively. The mean number of injections was 8.7 and 6.5 in the first and second year, respectively. The mean number of monitoring visits after baseline was 3.8 and 2.8 during the first and second year, respectively. CONCLUSIONS: The Observe-and-Plan regimen significantly improved VA, while fewer monitoring visits were needed as compared to other variable dosing regimens, thus reducing the workload for chronic care management of nAMD.

Clinician time used for decision making: a best case workflow study using cardiovascular risk assessments and Ask Mayo Expert algorithmic care process models.

BACKGROUND: Risk calculation is increasingly used in lipid management, congestive heart failure, and atrial fibrillation. The risk scores are then used for decisions about statin use, anticoagulation, and implantable defibrillator use. Calculating risks for patients and making decisions based on these risks is often done at the point of care and is an additional time burden for clinicians that can be decreased by automating the tasks and using clinical decision-making support. METHODS: Using Morae Recorder software, we timed 30 healthcare providers tasked with calculating the overall risk of cardiovascular events, sudden death in heart failure, and thrombotic event risk in atrial fibrillation. Risk calculators used were the American College of Cardiology Atherosclerotic Cardiovascular Disease risk calculator (AHA-ASCVD risk), Seattle Heart Failure Model (SHFM risk), and CHA2DS2VASc. We also timed the 30 providers using Ask Mayo Expert care process models for lipid management, heart failure management, and atrial fibrillation management based on the calculated risk scores. We used the Mayo Clinic primary care panel to estimate time for calculating an entire panel risk. RESULTS: Mean provider times to complete the CHA2DS2VASc, AHA-ASCVD risk, and SHFM were 36, 45, and 171 s respectively. For decision making about atrial fibrillation, lipids, and heart failure, the mean times (including risk calculations) were 85, 110, and 347 s respectively. CONCLUSION: Even under best case circumstances, providers take a significant amount of time to complete risk assessments. For a complete panel of patients this can lead to hours of time required to make decisions about prescribing statins, use of anticoagulation, and medications for heart failure. Informatics solutions are needed to capture data in the medical record and serve up automatically calculated risk assessments to physicians and other providers at the point of care.

Clinical outcomes of cryptogenic compared with non-cryptogenic cirrhosis: A retrospective cohort study.

BACKGROUND AND AIM: The consequences of the association between the metabolic syndrome and cryptogenic cirrhosis are uncertain. We aimed to compare the differences in clinical outcomes between cryptogenic and non-cryptogenic cirrhosis. METHODS: A retrospective cohort study was conducted in a large, single academic center, over a 5-year duration. RESULTS: Complete data were available in 301 patients with cirrhosis (cryptogenic n = 94, non-cryptogenic n = 207). Compared with non-cryptogenic cirrhosis, patients with cryptogenic cirrhosis were older (mean age 66.4 ± 12.5 vs 60.7 ± 11.3 years, P < 0.0001), had more females (43.6% vs 26.6%, P = 0.003), had less disease severity (Child-Pugh C 8.5% vs 15.9%, P = 0.042), and had a higher prevalence of the metabolic syndrome (83% vs 51.2%, P < 0.0001). During the 5-year period, adults with cryptogenic Child-Pugh A cirrhosis had a longer total hospital admission duration compared with non-cryptogenic cirrhosis (median 7.0 vs 3.0 days, P = 0.035), but this was less evident in patients with more advanced disease. This difference was due to a longer duration of hospitalization for non-liver-related morbidity (median 14.0 days vs 8.0 days, P = 0.04), rather than liver-related morbidity (median 10.5 days vs 8.0 days, P = 0.34), in patients with cryptogenic compared with non-cryptogenic cirrhosis. Kaplan-Meier survival analysis showed no significant differences in survival between both types of cirrhosis for all grades of severity. CONCLUSIONS: Cryptogenic cirrhosis is associated with a longer duration of hospitalization compared with non-cryptogenic cirrhosis at an early stage of the disease. This difference is due to a greater burden of non-liver-related complications in the former.

The interplay between excess weight and hyper-glycemia on NCDs in Italy: results from a cross-sectional study.

PURPOSE: To evaluate the prevalence of chronic comorbidities according to BMI classes and assess the interplay between excess body weight and blood glucose abnormalities in increasing the risk of major chronic diseases. METHODS: The study is based on data from the Health Search/IQVIA Health LPD Longitudinal Patient Database, an Italian general practice registry, with data obtained from electronic clinical records of 800 general practitioners throughout Italy. Data relative to the year 2018 were analyzed. The study population was classified according to BMI (normal weight, overweight, and obesity classes 1, 2 and 3) and glucose metabolism status (normoglycemia-NGT; impaired fasting glucose-IFG; diabetes mellitus-DM). Comorbidities were identified through ICD-9 CM codes. RESULTS: Data relative to 991,917 adults were analyzed. The prevalence of overweight was 39.4%, while the prevalence of obesity was 11.1% (class 1: 7.9%, class 2: 2.3%, class 3: 0.9%). In the whole population, the prevalence of DM and IFG was 8.9% and 4.2%, respectively. Both overweight and obesity were associated with an increasing prevalence of glucose metabolism alterations and a large array of different chronic conditions, including cardio-cerebrovascular diseases, heart failure, chronic kidney disease, osteoarticular diseases, depression, sleep apnea, and neoplasms of the gastrointestinal tract. Within each BMI class, the presence of IFG, and to a greater extent DM, identified subgroups of individuals with a marked increase in the risk of concomitant chronic conditions. CONCLUSION: Addressing the double burden of excess weight and hyperglycemia represents an important challenge and a healthcare priority.

The Clinical and Economic Burdens of Obesity and the Value of Weight Loss for an EMR-Derived US Cohort: A Modeling Study.

Obesity-related comorbidities (ORCs) cause significant economic and clinical burdens for people with obesity and the US health care system. A reduction in weight at the population level may reduce incident ORC diagnoses and associated costs of treatment. The aim of this work is to describe obesity burden in the United States through the prevalence and direct treatment costs of ORCs, as well as the clinical and economic value of 15% weight loss in a population of adults with obesity. The IQVIA Ambulatory US electronic medical record database was used to create a cohort (7,667,023 individuals 20-69 years of age, body mass index of 30-50 kg/m2), utilized to characterize the prevalence of 10 ORCs. Direct treatment costs were collected from literature reports. A risk model was leveraged to estimate the number and cost of additional ORC diagnoses over 5 years from baseline through two scenarios: stable weight and 15% lower body weight at baseline for all members of the population. Prevalence, incidence, and cost data were scaled down to a representative subset of 100,000 individuals. In 2022, the annual treatment costs for all 10 ORCs exceeded $918 million for the representative cohort. In a stable-weight scenario, these costs were estimated to increase to ≈$1.4 billion by 2027. With 15% lower body weight at baseline, $221 million in cumulative savings was estimated, corresponding to $2205 in savings/patient over 5 years. Consequently, weight loss in this population may correspond to significantly reduced numbers of incident ORC complications translating to substantial cost savings.