Digestive diseases represent a diverse group of clinical conditions that impact the population. Their heterogeneity in classification, presentation, acuity, chronicity, and need for drug therapy ...presents a challenge when comparing and contrasting the burden associated with these conditions. Prior studies use an outdated classification system and aggregate costs at the population level or focus on specific diseases, limiting the ability to characterize the overall landscape. Our aim was to provide the most up-to-date assessment of cost, utilization, and prevalence associated with digestive diseases.
We examined digestive disease claims and payment data for a commercially insured adult population between 2016 and 2018 to provide a comprehensive summary of costs, utilization, and prevalence across 38 conditions. Outcome variables included point prevalence and relative prevalence, annualized all-cause medical and drug costs, digestive disease-specific average medical cost, digestive disease-specific cost per fill, and utilization by clinical setting and by clinical condition.
A total of 7,297,435 individuals with a digestive disease diagnosis were included in the study. The point prevalence of having a digestive disease in the total population was 24%. Annualized total costs by clinical category ranged from $10,038 (eosinophilic esophagitis) to $107,007 (hepatitis C), with medical costs accounting for most of the expenditures in a majority of conditions. Annualized total costs for common conditions included $39,653 for alcoholic liver disease, $42,554 for acute pancreatitis, $62,735 for Crohn’s disease, $13,948 for functional gastrointestinal disorders, $53,214 for nonalcoholic cirrhosis, and $36,441 for ulcerative colitis. Average cost of inpatient stays ranged from $12,218 (noninfectious gastroenteritis/colitis) to $78,259 (nonalcoholic steatohepatitis). Outpatient visits ranged from $784 (gastrointestinal infection) to $4629 (gallbladder and biliary tract disease). Average drug cost per fill ranged from $83 (gastroesophageal reflux disease) to $1458 (hepatitis C). A total of 27,429,046 clinical encounters occurred across all conditions during the study period, with 90% taking place as outpatient visits. Abdominal pain was the single largest contributor to outpatient visits and emergency department to home encounters. Inpatient stays were considerably more heterogeneous, with no condition accounting for more than 12% (gallbladder and biliary tract disease) of the total.
The results demonstrate digestive diseases are common, heterogeneous in cost and utilization, and collectively exact a significant financial burden on the U.S. adult population.
Accurate estimates of natural and/or vaccine-induced antibodies to SARS-CoV-2 are difficult to obtain. Although model-based estimates of seroprevalence have been proposed, they require inputting ...unknown parameters including viral reproduction number, longevity of immune response, and other dynamic factors. In contrast to a model-based approach, the current study presents a data-driven detailed statistical procedure for estimating total seroprevalence (defined as antibodies from natural infection or from full vaccination) in a region using prospectively collected serological data and state-level vaccination data. Specifically, we conducted a longitudinal statewide serological survey with 88,605 participants 5 years or older with 3 prospective blood draws beginning September 30, 2020. Along with state vaccination data, as of October 31, 2021, the estimated percentage of those 5 years or older with naturally occurring antibodies to SARS-CoV-2 in Texas is 35.0% (95% CI = (33.1%, 36.9%)). This is 3x higher than, state-confirmed COVID-19 cases (11.83%) for all ages. The percentage with naturally occurring or vaccine-induced antibodies (total seroprevalence) is 77.42%. This methodology is integral to pandemic preparedness as accurate estimates of seroprevalence can inform policy-making decisions relevant to SARS-CoV-2.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract
Understanding the duration of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus that causes COVID-19 is important to controlling the current pandemic. ...Participants from the Texas Coronavirus Antibody Response Survey (Texas CARES) with at least 1 nucleocapsid protein antibody test were selected for a longitudinal analysis of antibody duration. A linear mixed model was fit to data from participants (n = 4553) with 1 to 3 antibody tests over 11 months (1 October 2020 to 16 September 2021), and models fit showed that expected antibody response after COVID-19 infection robustly increases for 100 days postinfection, and predicts individuals may remain antibody positive from natural infection beyond 500 days depending on age, body mass index, smoking or vaping use, and disease severity (hospitalized or not; symptomatic or not).
A longitudinal model shows that expected antibody response after COVID-19 infection increases for 100 days postinfection, and predicts individuals may remain antibody positive beyond 500 days, depending on age, body mass index, smoking or vaping use, and disease severity.
Early detection of new outbreak waves is critical for effective and sustained response to the COVID-19 pandemic. We conducted a growth rate analysis using local community and inpatient records from ...seven hospital systems to characterize distinct phases in SARS-CoV-2 outbreak waves in the Greater Houston area. We determined the transition times from rapid spread of infection in the community to surge in the number of inpatients in local hospitals. We identified 193,237 residents who tested positive for SARS-CoV-2 via molecular testing from April 8, 2020 to June 30, 2021, and 30,031 residents admitted within local healthcare institutions with a positive SARS-CoV-2 test, including emergency cases. We detected two distinct COVID-19 waves: May 12, 2020-September 6, 2020 and September 27, 2020-May 15, 2021; each encompassed four growth phases: lagging, exponential/rapid growth, deceleration, and stationary/linear. Our findings showed that, during early stages of the pandemic, the surge in the number of daily cases in the community preceded that of inpatients admitted to local hospitals by 12-36 days. Rapid decline in hospitalized cases was an early indicator of transition to deceleration in the community. Our real-time analysis informed local pandemic response in one of the largest U.S. metropolitan areas, providing an operationalized framework to support robust real-world surveillance for outbreak preparedness.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Levosimendan was first approved for clinic use in 2000, when authorisation was granted by Swedish regulatory authorities for the haemodynamic stabilisation of patients with acutely decompensated ...chronic heart failure. In the ensuing 20 years, this distinctive inodilator, which enhances cardiac contractility through calcium sensitisation and promotes vasodilatation through the opening of adenosine triphosphate-dependent potassium channels on vascular smooth muscle cells, has been approved in more than 60 jurisdictions, including most of the countries of the European Union and Latin America. Areas of clinical application have expanded considerably and now include cardiogenic shock, takotsubo cardiomyopathy, advanced heart failure, right ventricular failure and pulmonary hypertension, cardiac surgery, critical care and emergency medicine. Levosimendan is currently in active clinical evaluation in the US. Levosimendan in IV formulation is being used as a research tool in the exploration of a wide range of cardiac and non-cardiac disease states. A levosimendan oral form is at present under evaluation in the management of amyotrophic lateral sclerosis. To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, UK and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute heart failure arena in recent times and charts a possible development trajectory for the next 20 years.
Abstract
Objective
To update the “Testosterone Therapy in Men With Androgen Deficiency Syndromes” guideline published in 2010.
Participants
The participants include an Endocrine Society–appointed ...task force of 10 medical content experts and a clinical practice guideline methodologist.
Evidence
This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies.
Consensus Process
One group meeting, several conference calls, and e-mail communications facilitated consensus development. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline.
Conclusions
We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone–binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia. We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy.
This update to the Endocrine Society’s 2010 testosterone guideline, prepared by an expert panel, describes the diagnosis, screening, treatment, and monitoring of hypogonadal men.
IMPORTANCE: Reducing early (<30 days) hospital readmissions is a policy priority aimed at improving health care quality. The cumulative complexity model conceptualizes patient context. It predicts ...that highly supportive discharge interventions will enhance patient capacity to enact burdensome self-care and avoid readmissions. OBJECTIVE: To synthesize the evidence of the efficacy of interventions to reduce early hospital readmissions and identify intervention features—including their impact on treatment burden and on patients’ capacity to enact postdischarge self-care—that might explain their varying effects. DATA SOURCES: We searched PubMed, Ovid MEDLINE, Ovid EMBASE, EBSCO CINAHL, and Scopus (1990 until April 1, 2013), contacted experts, and reviewed bibliographies. STUDY SELECTION: Randomized trials that assessed the effect of interventions on all-cause or unplanned readmissions within 30 days of discharge in adult patients hospitalized for a medical or surgical cause for more than 24 hours and discharged to home. DATA EXTRACTION AND SYNTHESIS: Reviewer pairs extracted trial characteristics and used an activity-based coding strategy to characterize the interventions; fidelity was confirmed with authors. Blinded to trial outcomes, reviewers noted the extent to which interventions placed additional work on patients after discharge or supported their capacity for self-care in accordance with the cumulative complexity model. MAIN OUTCOMES AND MEASURES: Relative risk of all-cause or unplanned readmission with or without out-of-hospital deaths at 30 days postdischarge. RESULTS: In 42 trials, the tested interventions prevented early readmissions (pooled random-effects relative risk, 0.82 95% CI, 0.73-0.91; P < .001; I2 = 31%), a finding that was consistent across patient subgroups. Trials published before 2002 reported interventions that were 1.6 times more effective than those tested later (interaction P = .01). In exploratory subgroup analyses, interventions with many components (interaction P = .001), involving more individuals in care delivery (interaction P = .05), and supporting patient capacity for self-care (interaction P = .04) were 1.4, 1.3, and 1.3 times more effective than other interventions, respectively. A post hoc regression model showed incremental value in providing comprehensive, postdischarge support to patients and caregivers. CONCLUSIONS AND RELEVANCE: Tested interventions are effective at reducing readmissions, but more effective interventions are complex and support patient capacity for self-care. Interventions tested more recently are less effective.
Abstract Introduction and aims Public engagement is an essential part of research design. It provides opportunities for both scientists and the public to learn, and inspires the next generation of ...researchers. We are fortunate to have a public engagement centre within our institution, which contains digital games, an established and effective way to engage children. We developed a new game for school-age children to engage them in the Paediatric Human Cell Atlas, a collaborative project that aims to map single-cell profiles and spatial characterization of gene expression across human tissues and organs throughout development. Our aim was to develop a game that involved different skin cell types, variation in skin colour and common skin disorders. Methods Initial steps included brainstorming with our public engagement staff about content and then developing a lay summary and agreeing on the following key themes: the skin as a barrier, the cells of the skin, and eczema, a common skin disorder. The game was based on the arcade game Breakout. It features a customizable paddle representing the skin, demonstrating how changes in quantities of different skin components can change appearance/function (e.g. melanin production, adipocytes, hair follicles), which players must move across the screen to keep pathogens and allergens out and keep water and protein in. In the last level, barrier function is impaired by eczema and the children can catch cream to repair the barrier. Results The game was developed for our public engagement centre where it has undergone testing by target audiences. Conclusions We have created a game as an innovative way to engage and educate paediatric communities in our research. It was challenging to simplify scientific content for use in a game while staying true to the scientific concepts. We will increase reach by adapting the game for desktop and app-based formats.
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BFBNIB, FZAB, GIS, IJS, KILJ, OILJ, SBCE, SBMB, UPUK
e17104 Background: Understanding the prognostic impact of BRCA mutation status across prostate cancer (PCa) patient segments is critical to deploying the right therapies at the right time in a ...patient’s journey. Prior studies have shown that germline BRCA mutations are associated with poorer outcomes in an all-risk localized PCa population. To examine whether this association extends to a high-risk PCa population with either somatic or germline BRCA mutations, we evaluate the prevalence and independent prognostic impact of BRCA mutations in a real-world (RW), high-risk, localized/locoregional PCa population. Methods: A retrospective study (2016-2023) was performed using a de-identified multimodal RW dataset of patients undergoing Tempus xT next-generation sequencing. Eligible patients had localized/locoregional PCa at primary diagnosis (pDx), were biopsied prior to metastatic diagnosis, received adjuvant radiotherapy and/or had a prostatectomy, and had an evaluable Gleason score (GS). Risk groups were categorized as low/intermediate (low/int)-risk (total GS <8) and high-risk (total GS ≥8). BRCA status was defined as BRCAm if the patient had a short variant that was predicted or known to be pathogenic or a copy number loss in BRCA1 or BRCA2 and BRCAwt if no mutation was detected. Median real-world metastasis-free survival (rwMFS), defined as time from primary intervention to first metastatic diagnosis, was estimated using Kaplan-Meier methods and stratified by combined BRCA status and risk group (BRCAm high-risk, BRCAm low/int-risk, BRCAwt high-risk, BRCAwt low/int-risk). To assess the independent prognostic value of BRCA status among all patients and within a high-risk subset, two multivariate Cox models were performed adjusting for risk group, age at pDx, baseline PSA, primary intervention type, and T and N stage at pDx. Results: Among 607 eligible patients, 67 (11%) had a BRCA mutation (11 germline, 27 somatic, 29 tumor/unknown). Median rwMFS was longest in the BRCAwt low/int-risk group (n=147) at 50 mos (95% CI: 41, NA), followed by the BRCAwt high-risk group (n=393) at 36 mos (95% CI: 31, 42), and the BRCAm high-risk group (n=61) at 22 mos (95% CI: 11, 45). Median rwMFS estimates in the BRCAm low/int-risk group were unreliable due to a small sample size (n=6). From the adjusted Cox model, BRCAm patients had higher risk of metastasis compared to BRCAwt patients in the all-risk group (HR=1.48, 95% CI: 1.06, 2.09) and in the high-risk subset (HR=1.50, 95% CI: 1.04, 2.17). Conclusions: Our findings show that BRCAm is independently prognostic of metastasis in a RW, localized/locoregional, high-risk PCa population. We identify high-risk BRCAm patients as a subgroup with significantly elevated risk of developing metastasis; clinical trials with targeted therapeutic intervention may be needed to address the clinical unmet need.
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