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The Annals of Thoracic Surgery May 2022Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to...
Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.
Topics: Aged; Aortic Valve; Aortic Valve Stenosis; Humans; Medicare; Multicenter Studies as Topic; Registries; Risk Factors; Time Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome; United States
PubMed: 35367049
DOI: 10.1016/j.athoracsur.2022.01.018 -
The American Journal of Emergency... May 2022The outcomes of large-volume IVF administration to septic shock patients with comorbid congestive heart failure (CHF) and/or end-stage renal disease (ESRD) are uncertain... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The outcomes of large-volume IVF administration to septic shock patients with comorbid congestive heart failure (CHF) and/or end-stage renal disease (ESRD) are uncertain and widely debated in the existing literature. Despite this uncertainty, CMS continues to recommend that 30 ml/kg of an intravenous crystalloid solution be administered to patients in septic shock starting within 3 h of presentation. We performed a systematic review and meta-analysis to assess the relationship between adherence to this guideline and outcomes among patients whose underlying comorbidities present a risk of fluid overload.
METHODS
Our search was conducted on PubMed and Scopus through November 5, 2021 to identify studies that evaluated clinical outcomes among septic patients with CHF/ESRD based on volume of fluid administered. The primary outcome measured was mortality at 30 days post-hospital discharge. Other outcomes included the rates of vasopressor requirements, invasive mechanical ventilation during hospitalization, as well as length of stay in the intensive care unit and/or hospital. We used random effects meta-analysis when two or more studies reported the same outcome.
RESULTS
We included five studies in the final meta-analysis, which comprised 5804 patients, 5260 (91%) of whom received non-aggressive fluid resuscitation, as defined by the studies' authors. Random-effects meta-analysis for all-cause mortality showed that aggressive fluid resuscitation was associated with statistically non-significant increased odds of mortality (OR 1.42, 95% CI 0.88-2.3, P = 0.15, I = 35%). There was no statistical association between volume of IVF administration and other outcomes evaluated.
CONCLUSION
Among septic shock patients with CHF and/or ESRD, administration of greater than or equal to 30 ml/kg IVF was associated with a non-significant increase in odds of mortality. All other outcomes measured were found to be non-significant, although there was a trend toward better outcomes among patients in the restricted-volume compared to the standard-volume IVF groups. Since this meta-analysis only included five observational studies, more studies are needed to guide an optimal volume and rate of fluid administration in this patient population.
Topics: Centers for Medicare and Medicaid Services, U.S.; Female; Fluid Therapy; Heart Failure; Humans; Kidney Failure, Chronic; Male; Sepsis; Shock, Septic; United States; Water-Electrolyte Imbalance
PubMed: 35338881
DOI: 10.1016/j.ajem.2022.03.004 -
Clinical Pharmacology and Therapeutics Jun 2022Previous studies have suggested an association between sulfonylureas and an increased risk of cardiovascular death among patients with type 2 diabetes. A potential...
Previous studies have suggested an association between sulfonylureas and an increased risk of cardiovascular death among patients with type 2 diabetes. A potential mechanism involves sulfonylurea-induced ventricular arrhythmias (VAs). We conducted a systematic review of observational studies to determine whether the use of sulfonylureas, compared with the use of other antihyperglycemic drugs, is associated with the risk of VA (ventricular tachycardia, ventricular fibrillation, and premature ventricular complexes), cardiac arrest, and sudden cardiac death among patients with type 2 diabetes. Two independent reviewers searched MEDLINE, EMBASE, CINAHL Plus, CENTRAL, and ClinicalTrials.gov from inception to July 2021 for observational studies comparing sulfonylureas vs. other antihyperglycemic therapies or intraclass comparisons of sulfonylureas. Our systematic review included 17 studies (1,607,612 patients). Per Risk Of Bias In Non-randomized Studies of Interventions (ROBINS)-I, there were few high-quality studies (2 studies at moderate risk of bias; 4 at serious risk; and 11 at critical risk). All studies at a moderate or serious risk of bias reporting comparisons with other therapies were consistent with an increased risk of VA. Sulfonylureas were associated with a higher risk of arrhythmia vs. dipeptidyl peptidase-4 inhibitors (adjusted hazard ratio (aHR): 1.52, 95% confidence interval (CI): 1.27-1.80) and of VA vs. metformin (aHR: 1.52, 95% CI: 1.10-2.13). One moderate quality study reported inconsistent results for a composite of cardiac arrest/VA in analyses of US Medicaid claims and Optum claims data. Our systematic review suggests that, among higher-quality observational studies, sulfonylureas are associated with an increased risk of VA. However, we identified few methodologically rigorous studies, underscoring the need for additional real-world studies.
Topics: Arrhythmias, Cardiac; Death, Sudden, Cardiac; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Sulfonylurea Compounds
PubMed: 35238022
DOI: 10.1002/cpt.2570 -
Stem Cell Investigation 2021Hematopoietic stem cell transplant (HSCT) is an expensive and complex treatment regimen that can be curative in many diseases of the bone marrow, including malignant and... (Review)
Review
BACKGROUND
Hematopoietic stem cell transplant (HSCT) is an expensive and complex treatment regimen that can be curative in many diseases of the bone marrow, including malignant and non-malignant conditions. The introduction of the Affordable Care Act increased access to potential candidates and removed or reduced many barriers previously identified in the literature, however, racial disparities continue to persist. As HSCT expands its utilization and indications, there is a continued need to understand the multifactorial barriers which lead to inequalities in transplant referral, utilization, and survival. The objective of this systematic review is to summarize these racial disparities, expand the current understanding of the literature, and determine whether the increases in insurance status from Medicaid expansion have played a role in HSCT utilization and survival rates by race.
METHODS
We explored studies based on retrospective reviews, literature reviews, and focus groups with the key-terms of 'race', 'hematopoietic stem cell transplant', and 'disparities'. The included studies were extracted from Cochrane and Medline databases. After screening for relevancy to research aims and objectives, 10 articles were utilized for background information and discussion, while 30 articles were categorized into main groups of outcomes, chiefly, (I) access/referral to transplant and (II) survival.
RESULTS
Eight of the eleven retrospective reviews found substantial variation in access to HSCT by ethnic minorities (Black, Hispanic, or Asian) when compared to their Caucasian counterparts. Thirteen of the fourteen publications found racial disparities in either overall survival, progression free survival, treatment related mortality, relapse, or combinations of these outcomes. The majority of the studies evaluated African American patients with six of eight studies showing significantly elevated mortality compared to Caucasian patients.
DISCUSSION
Substantial variation exists in access to HSCT, particularly in black patients. Having less generous insurance coverage was previously hypothesized to reduce the likelihood of HSCT utilization. Studies performed after full implementation of the Affordable Care Act continue to show poorer survival among ethnic minorities, particularly black patients, despite this increased coverage. Perceived racial bias and health-related stigma, as well as physician decisions and delay in referral process are likely contributing factors.
PubMed: 35071585
DOI: 10.21037/sci-2021-058 -
Obstetrics and Gynecology Feb 2022To synthesize the empirical research evidence about the association between Medicaid expansion under the Affordable Care Act (ACA) and increasing perinatal care access... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To synthesize the empirical research evidence about the association between Medicaid expansion under the Affordable Care Act (ACA) and increasing perinatal care access and utilization among low-income women.
DATA SOURCES
We searched MEDLINE through PubMed (1966-present), EMBASE (Ovid), the Cumulative Index to Nursing and Allied Health (1982-present), PAIS Index (ProQuest), Web of Science (1900-present), and the Cochrane Central Register of Controlled Trials. Our review focuses on the association between Medicaid expansion under the ACA and perinatal care access and utilization, which cannot be subjected to randomized controlled trials, therefore ClinicalTrials.gov was not included in our search.
METHODS OF STUDY SELECTION
A comprehensive search of the research literature was performed using Covidence. Studies were eligible if they were based on population data and research designs ensuring that the exposure (ie, Medicaid expansion under the ACA) preceded the perinatal care access or utilization outcome, had an appropriate comparison group, presented quantitative data, and examined pregnant or postpartum women. The search in six bibliographic databases returned 1,243 records, with 855 abstracts reviewed, 34 full-text articles screened for eligibility, and nine eligible studies included in the systematic review.
TABULATION, INTEGRATION, AND RESULTS
Stata 16 software was used to generate summary estimates, forest plots, funnel plots, and heterogeneity statistics. Random effects modeling based on pooled data revealed that Medicaid expansion was associated with a 6.1% increase in Medicaid enrollment for pregnant women (95% CI 1.3-10.9%) and a 3.3% increase in perinatal care utilization (95% CI 0.2-6.3%).
CONCLUSION
Medicaid expansion under the ACA is associated with a modest and statistically significant increase in perinatal care access and utilization among low-income women.
Topics: Female; Health Services Accessibility; Humans; Medicaid; Patient Protection and Affordable Care Act; Perinatal Care; Pregnancy; United States
PubMed: 34991110
DOI: 10.1097/AOG.0000000000004647 -
The American Journal of Occupational... Jan 2022Practitioners need to be familiar with, and involved in, managing quality-related adverse events in postacute care.
IMPORTANCE
Practitioners need to be familiar with, and involved in, managing quality-related adverse events in postacute care.
OBJECTIVE
To determine interventions within the scope of occupational therapy that address preventable adverse events in adult postacute inpatient and home health settings.
DATA SOURCES
Articles published from January 1995 through 2019 identified through searches of MEDLINE, PsycINFO, CINAHL, OTseeker, and Cochrane databases. Study Selection and Data Collection: Articles were collected, evaluated, and analyzed by two independent reviewers. They were assessed and synthesized with a goal of informing clinical practice.
FINDINGS
Twenty-four articles were included in the review. Of the 10 Centers for Medicare & Medicaid Services preventable adverse events, 6 were addressed: diabetes management (n = 2), dysphagia (n = 5), infection control (n = 1), pressure ulcers (n = 6), falls (n = 5), and discharge management (n = 5). There was strong strength of evidence that exercise programs should, when appropriate, be implemented in both inpatient and home health settings to decrease the risk of falls. There was moderate strength of evidence that practitioners could consider implementing a facility wide evidence-based pressure ulcer program; providing multidisciplinary rehabilitation and swallow strengthening exercises for dysphagia; implementing a multidisciplinary, multicomponent falls program; and using a manualized depression intervention in home health to decrease hospital readmission.
CONCLUSIONS AND RELEVANCE
The review highlights the importance of preventable adverse events and of occupational therapy practitioners acknowledging and managing these events to enhance health outcomes and to control health care costs. What This Article Adds: Many interventions typically performed by occupational therapy practitioners address preventable adverse events. The review highlights the importance of practitioners being aware of this category of impairment or injury.
Topics: Adult; Aged; Humans; Inpatients; Medicare; Occupational Therapy; Patient Readmission; Subacute Care; United States
PubMed: 34990510
DOI: 10.5014/ajot.2022.047589 -
Health Affairs (Project Hope) Jan 2022The Affordable Care Act (ACA) Medicaid expansion increased Medicaid eligibility for low-income adults regardless of their pregnancy or parental status. Variation in...
The Affordable Care Act (ACA) Medicaid expansion increased Medicaid eligibility for low-income adults regardless of their pregnancy or parental status. Variation in states' adoption of this expansion created a natural experiment to study the effects of expanding public insurance on insurance coverage, health care use, and health outcomes during preconception, pregnancy, and postpartum. We conducted a systematic review of relevant literature on this topic, analyzing twenty-four studies published between January 2014 and April 2021. We found that the ACA Medicaid expansion increased preconception and postpartum Medicaid coverage with corresponding declines in uninsurance, private insurance coverage, and insurance churn. There was limited evidence that Medicaid expansion increased perinatal health care use or improved infant birth outcomes overall, although some studies reported reduced racial and ethnic disparities in rates of prenatal and postpartum visit attendance, maternal mortality, low birthweight, and preterm births. Stronger data collection on preconception and postpartum outcomes with sufficient sample sizes to stratify by race and ethnicity is needed to assess the full impact of the ACA and emerging Medicaid policy changes, such as the postpartum Medicaid extension.
Topics: Adult; Female; Health Services Accessibility; Humans; Infant, Newborn; Insurance Coverage; Insurance, Health; Medicaid; Medically Uninsured; Patient Protection and Affordable Care Act; Pregnancy; United States
PubMed: 34982621
DOI: 10.1377/hlthaff.2021.01150 -
Journal of Managed Care & Specialty... Jan 2022Benzodiazepines are indicated for the treatment of many conditions, such as anxiety disorders, muscle spasms, alcohol withdrawal, agitation, movement disorders, and...
Benzodiazepines are indicated for the treatment of many conditions, such as anxiety disorders, muscle spasms, alcohol withdrawal, agitation, movement disorders, and epilepsy, and are one of the most frequently prescribed medication classes. This class of medication has important safety considerations, including an increased risk of dependence and addiction, falls, and death from opioid overdose. Although benzodiazepine safety and prescribing encompasses a rich and important research area, there is a lack of pharmacoepidemiologic literature addressing benzodiazepine dosing intensity in real-world settings. To develop and apply a standardized benzodiazepine milligram equivalency conversion algorithm and assess the dose intensity of benzodiazepine use in Rhode Island (RI) in 2018. A systematic literature review was conducted to identify the most commonly used benzodiazepine equivalency values. We then conducted a cross-sectional analysis of 2018 data from the RI Prescription Drug Monitoring Program (PDMP) to calculate the mean daily diazepam milligram equivalency (DME) based on a patient's most recent dispensing. A multivariable logistic regression analysis was conducted to determine the association between higher benzodiazepine doses (≥ 15 DME/day) and recipient characteristics, including concurrent use of opioids or stimulants. We identified 143,026 patients who received at least 1 prescription for a benzodiazepine in RI in 2018. The mean (SD) daily DME was 10.60 (9.05), and 26.2% of individuals had a mean DME per day of at least 15. Approximately 14% (n = 20,168) of patients prescribed a benzodiazepine had concurrent use with a prescription opioid, and 6.7% (n = 9,547) had concurrent use with a prescription stimulant. Females had a 28% lower adjusted odds of receiving a benzodiazepine dose of at least 15 DME per day compared with males (adjusted odds ratio [aOR] = 0.72, 95% CI = 0.70-0.73). The adjusted odds of receiving a benzodiazepine prescription of at least 15 DME per day was lower among the younger (aged 18-34 years) and older age groups (aged 65 years and older) compared with patients aged 35-64 years. Compared with commercial insurance, all other forms of payment had significantly higher adjusted odds of a daily benzodiazepine dose of at least 15 DME per day. The adjusted odds receiving a daily DME of at least 15 was 67% higher among those who also received a concurrent pharmacy dispensing for an opioid and 84% higher among those who also received a concurrent dispensing for a stimulant drug (aOR = 1.67, 95% CI = 1.61-1.72; aOR = 1.84, 95% CI = 1.76-1.93, respectively). Individuals aged 35-64 years with Medicaid insurance and those aged under 65 years with Medicare were more likely to be prescribed a benzodiazepine of at least 15 DME per day. Higher benzodiazepine DMEs were also dispensed to patients who concurrently used prescription opioids or stimulants who may be at increased risk of medication-related harm. We advocate for routine measurement of benzodiazepine dose intensity as a risk reduction strategy. No funding supported this study. The authors have no conflicts of interest to disclose. The content and results of this study are solely the responsibility of the authors and do not necessarily represent the official views of the Rhode Island Department of Health. Kogut is partially supported by Institutional Development Award Numbers U54GM115677 and P20GM125507 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR) and the RI Lifespan Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose, respectively. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Contents of this study were presented as a poster presentation at AMCP 2019 Nexus; October 29-November 1, 2019; National Harbor, MD.
Topics: Adolescent; Adult; Algorithms; Benzodiazepines; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Logistic Models; Male; Middle Aged; Rhode Island; Young Adult
PubMed: 34949119
DOI: 10.18553/jmcp.2022.28.1.58 -
International Journal of Mental Health... Jun 2022Long-acting injectable (LAI) antipsychotic medications may be an important modality of reducing costs, improving symptoms, and fostering quality of life outcomes for... (Meta-Analysis)
Meta-Analysis Review
The effect of long-acting injectable antipsychotic medications compared with oral antipsychotic medications among people with schizophrenia: A systematic review and meta-analysis.
Long-acting injectable (LAI) antipsychotic medications may be an important modality of reducing costs, improving symptoms, and fostering quality of life outcomes for those with schizophrenia. Our objective was to systematically review and conduct a meta-analysis of the effectiveness of LAIs compared with oral antipsychotics on medication adherence, symptom remission/relapse, rehospitalization, outpatient visits, emergency department visits, healthcare costs, and social functioning. We performed a systematic search of PsycInfo, CINAHL, PubMed, and Scopus databases to examine studies meeting inclusion criteria prior to August 30th, 2020. Randomized controlled trials, retrospective studies, prospective studies among people with schizophrenia with at least 6-month follow-up data were obtained. Overall effect sizes and associated 95% confidence intervals (CI) were estimated with random-effects modeling. We found 75 articles meeting our inclusion criteria, including 341 730 individuals with schizophrenia. Systematic review results indicated that LAIs compared with orals improved medication adherence (25/29 studies), symptom remission/relapse (10/18 studies), rehospitalizations (26/49 studies), emergency department visits (9/17 studies), medical costs (11/15 studies), and social functioning (5/9 studies); however, LAIs also increased outpatient visits (7/16 studies) and pharmacy costs (10/10 studies). Meta-analytic results of studies with similar outcome measures did not find differences between LAIs and orals in respect to outcomes, except lowering emergency department visits and increasing pharmacy costs. The differences between the results of the narrative synthesis and the meta-analyses were possibly because of the low availability of studies with similar outcomes in the pooled analyses. Our overall results suggest that LAIs are at least comparable to orals in supporting important healthcare outcomes for those with schizophrenia. These findings support clinical practice in encouraging providers to prescribe LAIs when indicated.
Topics: Antipsychotic Agents; Delayed-Action Preparations; Humans; Prospective Studies; Quality of Life; Recurrence; Retrospective Studies; Schizophrenia
PubMed: 34931437
DOI: 10.1111/inm.12964 -
Archives of Physical Medicine and... May 2022To investigate social determinants of health (SDoH) interventions on individual health outcomes, population health, and cost for persons in the United States over age 18... (Review)
Review
OBJECTIVE
To investigate social determinants of health (SDoH) interventions on individual health outcomes, population health, and cost for persons in the United States over age 18 living with disabilities and receiving long-term services and supports (LTSS) in noninstitutional settings.
DATA SOURCES
A review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted of literature from PubMed, PsycINFO, REHABDATA, and Web of Science Core Collection published between January 1997 and July 2020.
STUDY SELECTION
Search terms were based on the primary SDoH domains identified by the Centers for Medicare and Medicaid's Accountable Health Communities Model. A total of 5082 abstracts were screened based on identification criteria of persons age 18 and above living in non-institutional, community-based settings receiving LTSS.
DATA EXTRACTION
During Level 2 review, articles were reviewed based on population focus, type of LTSS (personal assistance services, home care, adult day care, home modification, durable medical equipment, community transition services, caregiver supports and/or prevention services related to home- and community-based care), SDoH intervention and association with health outcomes, population health and/or cost. A total of 1037 abstracts underwent Level 2 review, yielding 131 publications or 1.3% for full review.
DATA SYNTHESIS
Studies (n=33) designed a priori to test outcomes of interventions were rated according to Grading Recommendations Assessment Development and Evaluation (GRADE) criteria. Qualifying articles that did not include interventions (n=98) were included in our summary of the literature but were not assessed by GRADE.
CONCLUSIONS
The preponderance of research surrounding SDoH and health outcomes has focused on older adults living with disabilities, and most interventions scored low or very low using GRADE criteria. Evidence is limited to the extent SDoH interventions are measured against outcomes for persons of all ages living with disabilities. Robust evaluation of models that feature SDoH interventions in partnership with community-based organizations is recommended as home and community-based care infrastructure expands in response to the American Rescue Plan Act of 2021.
Topics: Adolescent; Aged; Disabled Persons; Home Care Services; Humans; Medicare; Social Determinants of Health; United States
PubMed: 34756446
DOI: 10.1016/j.apmr.2021.06.021