Publications by authors named "Nilay Shah"

513 Publications

Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial.

Nat Med 2021 May 6. Epub 2021 May 6.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

We have conducted a pragmatic clinical trial aimed to assess whether an electrocardiogram (ECG)-based, artificial intelligence (AI)-powered clinical decision support tool enables early diagnosis of low ejection fraction (EF), a condition that is underdiagnosed but treatable. In this trial ( NCT04000087 ), 120 primary care teams from 45 clinics or hospitals were cluster-randomized to either the intervention arm (access to AI results; 181 clinicians) or the control arm (usual care; 177 clinicians). ECGs were obtained as part of routine care from a total of 22,641 adults (N = 11,573 intervention; N = 11,068 control) without prior heart failure. The primary outcome was a new diagnosis of low EF (≤50%) within 90 days of the ECG. The trial met the prespecified primary endpoint, demonstrating that the intervention increased the diagnosis of low EF in the overall cohort (1.6% in the control arm versus 2.1% in the intervention arm, odds ratio (OR) 1.32 (1.01-1.61), P = 0.007) and among those who were identified as having a high likelihood of low EF (that is, positive AI-ECG, 6% of the overall cohort) (14.5% in the control arm versus 19.5% in the intervention arm, OR 1.43 (1.08-1.91), P = 0.01). In the overall cohort, echocardiogram utilization was similar between the two arms (18.2% control versus 19.2% intervention, P = 0.17); for patients with positive AI-ECGs, more echocardiograms were obtained in the intervention compared to the control arm (38.1% control versus 49.6% intervention, P < 0.001). These results indicate that use of an AI algorithm based on ECGs can enable the early diagnosis of low EF in patients in the setting of routine primary care.
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http://dx.doi.org/10.1038/s41591-021-01335-4DOI Listing
May 2021

Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases.

NPJ Vaccines 2021 Apr 29;6(1):65. Epub 2021 Apr 29.

Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK.

Rapid-response vaccine production platform technologies, including RNA vaccines, are being developed to combat viral epidemics and pandemics. A key enabler of rapid response is having quality-oriented disease-agnostic manufacturing protocols ready ahead of outbreaks. We are the first to apply the Quality by Design (QbD) framework to enhance rapid-response RNA vaccine manufacturing against known and future viral pathogens. This QbD framework aims to support the development and consistent production of safe and efficacious RNA vaccines, integrating a novel qualitative methodology and a quantitative bioprocess model. The qualitative methodology identifies and assesses the direction, magnitude and shape of the impact of critical process parameters (CPPs) on critical quality attributes (CQAs). The mechanistic bioprocess model quantifies and maps the effect of four CPPs on the CQA of effective yield of RNA drug substance. Consequently, the first design space of an RNA vaccine synthesis bioreactor is obtained. The cost-yield optimization together with the probabilistic design space contribute towards automation of rapid-response, high-quality RNA vaccine production.
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http://dx.doi.org/10.1038/s41541-021-00322-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8085199PMC
April 2021

Geographic Variation in Trends and Disparities in Heart Failure Mortality in the United States, 1999 to 2017.

J Am Heart Assoc 2021 May 23;10(9):e020541. Epub 2021 Apr 23.

Department of Preventive Medicine Northwestern University Feinberg School of Medicine Chicago IL.

Background Cardiovascular disease mortality related to heart failure (HF) is rising in the United States. It is unknown whether trends in HF mortality are consistent across geographic areas and are associated with state-level variation in cardiovascular health (CVH). The goal of the present study was to assess regional and state-level trends in cardiovascular disease mortality related to HF and their association with variation in state-level CVH. Methods and Results Age-adjusted mortality rates (AAMR) per 100 000 attributable to HF were ascertained using the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research from 1999 to 2017. CVH at the state-level was quantified using the Behavioral Risk Factor Surveillance System. Linear regression was used to assess temporal trends in HF AAMR were examined by census region and state and to examine the association between state-level CVH and HF AAMR. AAMR attributable to HF declined from 1999 to 2011 and increased between 2011 and 2017 across all census regions. Annual increases after 2011 were greatest in the Midwest (β=1.14 [95% CI, 0.75, 1.53]) and South (β=0.96 [0.66, 1.26]). States in the South and Midwest consistently had the highest HF AAMR in all time periods, with Mississippi having the highest AAMR (109.6 [104.5, 114.6] in 2017). Within race‒sex groups, consistent geographic patterns were observed. The variability in HF AAMR was associated with state-level CVH (<0.001). Conclusions Wide geographic variation exists in HF mortality, with the highest rates and greatest recent increases observed in the South and Midwest. Higher levels of poor CVH in these states suggest the potential for interventions to promote CVH and reduce the burden of HF.
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http://dx.doi.org/10.1161/JAHA.120.020541DOI Listing
May 2021

Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP).

Implement Sci Commun 2021 Apr 21;2(1):43. Epub 2021 Apr 21.

Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Background: The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use.

Methods: This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM).

Discussion: By the project's end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care.

Trial Registration: ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.
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http://dx.doi.org/10.1186/s43058-021-00145-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8058970PMC
April 2021

Epidemiology of cardiogenic shock and cardiac arrest complicating non-ST-segment elevation myocardial infarction: 18-year US study.

ESC Heart Fail 2021 Apr 9. Epub 2021 Apr 9.

Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Aims: This study aims to evaluate the impact of the combination of cardiogenic shock (CS) and cardiac arrest (CA) complicating non-ST-segment elevation myocardial infarction (NSTEMI).

Methods And Results: Adult (>18 years) NSTEMI admissions using the National Inpatient Sample database (2000 to 2017) were stratified by the presence of CA and/or CS. Outcomes of interest included in-hospital mortality, early coronary angiography, hospitalization costs, and length of stay. Of the 7 302 447 hospitalizations due to NSTEMI, 147 795 (2.0%) had CS only, 155 522 (2.1%) had CA only, and 41 360 (0.6%) had both CS and CA. Compared with 2000, the adjusted odds ratios (ORs) and 95% confidence interval (CIs) for CS, CA, and both CS and CA in 2017 were 3.75 (3.58-3.92), 1.46 (1.42-1.50), and 4.52 (4.16-4.87), respectively (all P < 0.001). The CS + CA (61.2%) cohort had higher multiorgan failure than CS (42.3%) and CA only (32.0%) cohorts, P < 0.001. The CA only cohort had lower rates of overall (52% vs. 59-60%) and early (17% vs. 18-27%) angiography compared with the other groups (all P < 0.001). CS + CA admissions had higher in-hospital mortality compared with those with CS alone (aOR 4.12 [95% CI 4.00-4.24]), CA alone (aOR 1.69 [95% CI 1.65-1.74]), or without CS/CA (aOR 22.66 [95% CI 22.06-23.27]). The presence of CS, either alone or with CA, was associated with higher hospitalization costs and longer hospital length of stay.

Conclusions: The combination of CS and CA is associated with higher rates of acute non-cardiac organ failure and in-hospital mortality in NSTEMI admissions as compared with those with either CS or CA alone.
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http://dx.doi.org/10.1002/ehf2.13321DOI Listing
April 2021

Race and sex differences in the initiation of diabetes drugs by privately insured US adults.

Endocrine 2021 Apr 8. Epub 2021 Apr 8.

Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Rochester, MN, USA.

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http://dx.doi.org/10.1007/s12020-021-02710-4DOI Listing
April 2021

Correction: Kis, Z. et al. Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand. 2021, , 3.

Vaccines (Basel) 2021 Mar 1;9(3). Epub 2021 Mar 1.

Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London SW7 2AZ, UK.

The authors wish to make the following corrections to this paper [...].
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http://dx.doi.org/10.3390/vaccines9030205DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999672PMC
March 2021

Association of Social Network Characteristics With Cardiovascular Health and Coronary Artery Calcium in South Asian Adults in the United States: The MASALA Cohort Study.

J Am Heart Assoc 2021 Apr 24;10(7):e019821. Epub 2021 Mar 24.

Department of Preventive Medicine Northwestern University Feinberg School of Medicine Chicago IL.

Background South Asian adults have worse cardiovascular health (CVH) and more coronary artery calcium compared with other race/ethnicities. The impact of the social environment has not been examined as a potential driver of CVH or coronary artery calcium in this population. We evaluated associations of social network characteristics with CVH and coronary artery calcium in South Asian American adults to inform strategies for CVH promotion in this at-risk population. Methods and Results Using data from the MASALA (Mediators of Atherosclerosis in South Asians Living in America) cohort study, multinomial and multivariable logistic regression were used to evaluate associations of participant social network size and density, proportion of network who are kin or South Asian ethnicity and reported health of participant's identified social network members ("alters"), with participant CVH and presence of coronary artery calcium. The 699 MASALA participants included were mean age 59.2 (SD, 9.2) years and 42.9% women. After adjustment, a 1-person larger social network size was associated with 13% higher odds of ideal CVH (odds ratio [OR], 1.13; 95% CI, 1.01-1.27). Reporting an alter with high blood pressure was associated with lower odds of ideal CVH (OR, 0.51; 95% CI, 0.29-0.88), and reporting an alter with high cholesterol was associated with lower odds of ideal CVH (OR, 0.54; 95% CI, 0.30-0.94). Conclusions Social network characteristics are associated with CVH in South Asian American adults. Engaging social networks may help promote CVH in this population.
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http://dx.doi.org/10.1161/JAHA.120.019821DOI Listing
April 2021

Association of outpatient ACE inhibitors and angiotensin receptor blockers and outcomes of acute respiratory illness: a retrospective cohort study.

BMJ Open 2021 Mar 17;11(3):e044010. Epub 2021 Mar 17.

Emergency Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Objectives: Evaluate associations between ACE inhibitors (ACEis) and angiotensin receptor blockers (ARBs) and clinical outcomes in acute viral respiratory illness (AVRI).

Design: Retrospective cohort analysis of claims data.

Setting: The USA; 2018-2019 influenza season.

Participants: Main cohort: people with hypertension (HTN) taking an ACEi, ARB or other HTN medications, and experiencing AVRI. Falsification cohort: parallel cohort receiving elective knee or hip replacement.

Main Outcome Measures: Main cohort: hospital admission, intensive care unit, acute respiratory distress (ARD), ARD syndrome and all-cause mortality. Falsification cohort: complications after surgery and all-cause mortality.

Results: The main cohort included 236 843 episodes of AVRI contributed by 202 629 unique individuals. Most episodes were in women (58.9%), 81.4% in people with Medicare Advantage and 40.3% in people aged 75+ years. Odds of mortality were lower in the ACEi (0.78 (0.74 to 0.83)) and ARB (0.64 (0.61 to 0.68)) cohorts compared with other HTN medications. On all other outcomes, people taking ARBs (but not ACEis) had a >10% reduction in odds of inpatient stays compared with other HTN medications.In the falsification analysis (N=103 353), both ACEis (0.89 (0.80 to 0.98)) and ARBs (0.82 (0.74 to 0.91)) were associated with decreased odds of complications compared with other HTN medications; ARBs (0.64 (0.47 to 0.87)) but not ACEis (0.79 (0.60 to 1.05)) were associated with lower odds of death compared with other HTN medications.

Conclusions: Outpatient use of ARBs was associated with better outcomes with AVRI compared with other medications for HTN. ACEis were associated with reduced risk of death, but with minimal or no reduction in risk of other complications. A falsification analysis conducted to provide context on the possible causal implications of these findings did not provide a clear answer. Further analysis using observational data will benefit from additional approaches to assess causal relationships between these drugs and outcomes in AVRI.
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http://dx.doi.org/10.1136/bmjopen-2020-044010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7978099PMC
March 2021

Impact of the COVID-19 Vaccine on Asymptomatic Infection Among Patients Undergoing Pre-Procedural COVID-19 Molecular Screening.

Clin Infect Dis 2021 Mar 10. Epub 2021 Mar 10.

Division of Infectious Diseases, Mayo Clinic, Rochester, MN, USA.

Background: Several vaccines are now clinically available under emergency use authorization in the United States and have demonstrated efficacy against symptomatic COVID-19. The impact of vaccines on asymptomatic SARS-CoV-2 infection is largely unknown.

Methods: We conducted a retrospective cohort study of consecutive, asymptomatic adult patients (n = 39,156) within a large United States healthcare system who underwent 48,333 pre-procedural SARS-CoV-2 molecular screening tests between December 17, 2020 and February 8, 2021. The primary exposure of interest was vaccination with at least one dose of an mRNA COVID-19 vaccine. The primary outcome was relative risk of a positive SARS-CoV-2 molecular test among those asymptomatic persons who had received at least one dose of vaccine, as compared to persons who had not received vaccine during the same time period. Relative risk was adjusted for age, sex, race/ethnicity, patient residence relative to the hospital (local vs. non-local), healthcare system regions, and repeated screenings among patients using mixed effects log-binomial regression.

Results: Positive molecular tests in asymptomatic individuals were reported in 42 (1.4%) of 3,006 tests performed on vaccinated patients and 1,436 (3.2%) of 45,327 tests performed on unvaccinated patients (RR=0.44 95% CI: 0.33-0.60; p<.0001). Compared to unvaccinated patients, the risk of asymptomatic SARS-CoV-2 infection was lower among those >10 days after 1 st dose (RR=0.21; 95% CI: 0.12-0.37; p<.0001) and >0 days after 2 nd dose (RR=0.20; 95% CI: 0.09-0.44; p<.0001) in the adjusted analysis.

Conclusions: COVID-19 vaccination with an mRNA-based vaccine showed a significant association with a reduced risk of asymptomatic SARS-CoV-2 infection as measured during pre-procedural molecular screening. The results of this study demonstrate the impact of the vaccines on reduction in asymptomatic infections supplementing the randomized trial results on symptomatic patients.
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http://dx.doi.org/10.1093/cid/ciab229DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989519PMC
March 2021

U.S. Prescribing of On-and-Off-Label Medications for Alcohol Use Disorder in Outpatient Visits: NAMCS 2014 to 2016.

J Gen Intern Med 2021 Mar 5. Epub 2021 Mar 5.

Section of General Internal Medicine, Yale School of Medicine, New Haven, CT, USA.

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http://dx.doi.org/10.1007/s11606-021-06668-xDOI Listing
March 2021

Deployment of an Interdisciplinary Predictive Analytics Task Force to Inform Hospital Operational Decision-Making During the COVID-19 Pandemic.

Mayo Clin Proc 2021 03 30;96(3):690-698. Epub 2020 Dec 30.

Department of Health Sciences Research and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN; Department of Health Sciences Research, Mayo Clinic, Rochester, MN.

In March 2020, our institution developed an interdisciplinary predictive analytics task force to provide coronavirus disease 2019 (COVID-19) hospital census forecasting to help clinical leaders understand the potential impacts on hospital operations. As the situation unfolded into a pandemic, our task force provided predictive insights through a structured set of visualizations and key messages that have helped the practice to anticipate and react to changing operational needs and opportunities. The framework shared here for the deployment of a COVID-19 predictive analytics task force could be adapted for effective implementation at other institutions to provide evidence-based messaging for operational decision-making. For hospitals without such a structure, immediate consideration may be warranted in light of the devastating COVID-19 third-wave which has arrived for winter 2020-2021.
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http://dx.doi.org/10.1016/j.mayocp.2020.12.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833949PMC
March 2021

Trends in heart failure-related cardiovascular mortality in rural versus urban United States counties, 2011-2018: A cross-sectional study.

PLoS One 2021 3;16(3):e0246813. Epub 2021 Mar 3.

Division of Cardiology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States of America.

Background: Adults in rural counties in the United States (US) experience higher rates broadly of cardiovascular disease (CVD) compared with adults in urban counties. Mortality rates specifically due to heart failure (HF) have increased since 2011, but estimates of heterogeneity at the county-level in HF-related mortality have not been produced. The objectives of this study were 1) to quantify nationwide trends by rural-urban designation and 2) examine county-level factors associated with rural-urban differences in HF-related mortality rates.

Methods And Findings: We queried CDC WONDER to identify HF deaths between 2011-2018 defined as CVD (I00-78) as the underlying cause of death and HF (I50) as a contributing cause of death. First, we calculated national age-adjusted mortality rates (AAMR) and examined trends stratified by rural-urban status (defined using 2013 NCHS Urban-Rural Classification Scheme), age (35-64 and 65-84 years), and race-sex subgroups per year. Second, we combined all deaths from 2011-2018 and estimated incidence rate ratios (IRR) in HF-related mortality for rural versus urban counties using multivariable negative binomial regression models with adjustment for demographic and socioeconomic characteristics, risk factor prevalence, and physician density. Between 2011-2018, 162,314 and 580,305 HF-related deaths occurred in rural and urban counties, respectively. AAMRs were consistently higher for residents in rural compared with urban counties (73.2 [95% CI: 72.2-74.2] vs. 57.2 [56.8-57.6] in 2018, respectively). The highest AAMR was observed in rural Black men (131.1 [123.3-138.9] in 2018) with greatest increases in HF-related mortality in those 35-64 years (+6.1%/year). The rural-urban IRR persisted among both younger (1.10 [1.04-1.16]) and older adults (1.04 [1.02-1.07]) after adjustment for county-level factors. Main limitations included lack of individual-level data and county dropout due to low event rates (<20).

Conclusions: Differences in county-level factors may account for a significant amount of the observed variation in HF-related mortality between rural and urban counties. Efforts to reduce the rural-urban disparity in HF-related mortality rates will likely require diverse public health and clinical interventions targeting the underlying causes of this disparity.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0246813PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928489PMC
March 2021

Asthma Patients Who Stop Asthma Biologics Have a Similar Risk of Asthma Exacerbations as Those Who Continue Asthma Biologics.

J Allergy Clin Immunol Pract 2021 Feb 27. Epub 2021 Feb 27.

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Division of Allergy, Asthma, and Clinical Immunology, Mayo Clinic, Scottsdale, Ariz; Division of Pulmonology, Phoenix Children's Hospital, Phoenix, Ariz. Electronic address:

Background: There is limited information about outcomes associated with stopping asthma biologics.

Objective: To compare outcomes in people who stopped or continued asthma biologics.

Methods: We identified a cohort of people with asthma who stopped or continued asthma biologics in the Optum Labs Database Warehouse, using a propensity matching method for case and control groups with the variables of age, sex, race, region, insurance, income, specialist access, Charlson comorbidity, specific medical conditions, pre-index exacerbation count, pre-index rescue inhaler pharmacy fills, and pre-index inhaled corticosteroid with or without long-acting β-agonist pharmacy fills. Primary outcome used to assess failure of stopping was an increase of 50% or more in the asthma exacerbation rate in the 6 months after discontinuing the biologic compared with the 6-month period before biologic initiation.

Results: Among a cohort of 4960 asthma biologic users, 1249 were observed to stop use after 6 to 12 months of use. We identified a matched cohort of 1247 stoppers and 1247 people who continued biologic use for at least 18 months. In the first 6 months after stopping or sham stopping, 10.2% of stoppers and 9.5% of continuers had an increase of 50% or more in asthma exacerbations. We found a similar adjusted odds of failing among stoppers and continuers (odds ratio = 1.085; 95% confidence interval, 0.833-1.413).

Conclusions: An increase in asthma exacerbations is infrequently observed in people who stopped asthma biologics and was observed at similar rates as in matched controls who continued asthma biologics.
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http://dx.doi.org/10.1016/j.jaip.2021.02.031DOI Listing
February 2021

Comparative Risk of Serious Infections with Tumor Necrosis Factor-α Antagonists vs. Vedolizumab in Patients with Inflammatory Bowel Diseases.

Clin Gastroenterol Hepatol 2021 Feb 25. Epub 2021 Feb 25.

Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.

Background And Aims: We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-α (TNFα) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD).

Methods: Using an administrative claims database, we identified patients with IBD who were new-users of either TNFα antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFα antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates.

Results: We included 4881 patients treated with TNFα antagonists (age, 41±15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44±16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFα antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD.

Conclusions: In an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFα antagonists, in patients with UC, but not in patients with CD.
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http://dx.doi.org/10.1016/j.cgh.2021.02.032DOI Listing
February 2021

Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock.

JAMA Netw Open 2021 02 1;4(2):e2037748. Epub 2021 Feb 1.

Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.

Importance: Mechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit.

Objective: To examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use.

Design, Setting, And Participants: This cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020.

Exposures: Therapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only.

Main Outcomes And Measures: Use of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use.

Results: Among the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only.

Conclusions And Relevance: This study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.37748DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900859PMC
February 2021

Physician variation in the de-adoption of ineffective statin and fibrate therapy.

Health Serv Res 2021 Feb 10. Epub 2021 Feb 10.

University of Minnesota, Minneapolis, Minnesota, USA.

Objective: To describe physicians' variation in de-adopting concurrent statin and fibrate therapy for type 2 diabetic patients following a reversal in clinical evidence.

Data Sources: We analyzed 2007-2015 claims data from OptumLabs Data Warehouse, a longitudinal, real-world data asset with de-identified administrative claims and electronic health record data.

Study Design: We modeled fibrate use among Medicare Advantage and commercially insured type 2 diabetic statin users before and after the publication of the ACCORD lipid trial, which found statins and fibrates were no more effective than statins alone in reducing cardiovascular events among type 2 diabetic patients. We modeled fibrate use trends with physician random effects and physician characteristics such as age and specialty.

Data Extraction: We identified patient-year-quarters with one year of continuous insurance enrollment, type 2 diabetes diagnoses, and fibrate use. We designated the physician most responsible for patients' diabetes care based on evaluation and management visits and prescriptions of glucose-lowering drugs.

Principal Findings: Fibrate use increased by 0.12 percentage points per quarter among commercial patients (95% CI, 0.10 to 0.14) and 0.17 percentage points per quarter among Medicare Advantage patients (95% CI, 0.13 to 0.20) before the trial and then decreased by 0.16 percentage points per quarter among commercial patients (95% CI, -0.18 to -0.15) and 0.05 percentage points per quarter among Medicare Advantage patients (95% CI, -0.06 to -0.03) after the trial. However, 45% of physicians treating commercial patients and 48% of physicians treating Medicare Advantage patients had positive trends in prescribing following the trial. Physicians' characteristics did not explain their variation (pseudo R  = 0.000).

Conclusion: On average, physicians decreased fibrate prescribing following the ACCORD lipid trial. However, many physicians increased prescribing following the trial. Observable physician characteristics did not explain variations in prescribing. Future research should examine whether physicians vary similarly in other de-adoption settings.
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http://dx.doi.org/10.1111/1475-6773.13630DOI Listing
February 2021

Adherence to Asthma Biologics: Implications for Patient Selection, Step Therapy, and Outcomes.

Chest 2021 Mar 24;159(3):924-932. Epub 2020 Oct 24.

Division of Pulmonology, Phoenix Children's Hospital, Phoenix, AZ; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN; Division of Allergy, Asthma, and Clinical Immunology, Mayo Clinic, Scottsdale, AZ. Electronic address:

Background: Little is known about adherence to asthma biologics.

Research Question: Is adherence to inhaled corticosteroid (ICS) associated with subsequent asthma biologic adherence?

Study Design And Methods: We analyzed individuals with asthma who started asthma biologics in the OptumLab Data Warehouse and used that data until October 2019. We calculated proportion days covered (PDC) for ICS ± long-acting β-agonists in the 6 months before and after asthma biologics were started and asthma biologic PDC for the first 6 months of use. We performed a multivariable analysis to identify factors associated with asthma biologic PDC ≥0.75, ICS PDC ≥0.75 during the 6-month period after asthma biologic were started, and achievement of a ≥50% reduction in asthma exacerbations during the first 6 months of asthma biologic use.

Results: We identified 5,319 people who started asthma biologics. The mean PDC for asthma biologics was 0.76 (95% CI, 0.75-0.77) in the first 6 months after starting, higher than the mean PDCs for ICS in the 6 months before (0.44 [95% CI, 0.43-0.45]) and after (0.40 [95% CI, 0.39-0.40]) starting the asthma biologic. PDC ≥0.75 for ICS 6 months before index biologic use is associated with PDC for asthma biologics ≥0.75 (OR, 1.25; 95% CI, 1.10-1.43) and for ICS during the first 6 months of biologic use (OR, 9.93; 95% CI, 8.55-11.53). Neither ICS PDC ≥0.75 (OR, 0.92; 95% CI, 0.74-1.14) nor asthma biologic PDC ≥0.75 (OR, 1.15; 95% CI, 0.97-1.36) is associated with a statistically significant reduction in asthma exacerbations during the first 6 months of asthma biologic use among people with any exacerbation in the 6 months before first use.

Interpretation: Adherence to asthma biologic is higher than to ICS and is associated with different factors.
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http://dx.doi.org/10.1016/j.chest.2020.10.050DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7965652PMC
March 2021

Comparison of Diabetes Medications Used by Adults With Commercial Insurance vs Medicare Advantage, 2016 to 2019.

JAMA Netw Open 2021 02 1;4(2):e2035792. Epub 2021 Feb 1.

Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.

Importance: Glucagonlike peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT2i), and dipeptidyl peptidase-4 inhibitors (DPP-4i) are associated with low rates of hypoglycemia, and postmarketing trials of GLP-1RA and SGLT2i demonstrated that these medications improved cardiovascular and kidney outcomes.

Objective: To compare trends in initiation of treatment with GLP-1RA, SGLT2i, and DPP-4i by older adults with type 2 diabetes insured by Medicare Advantage vs commercial health plans.

Design, Setting, And Participants: This retrospective cohort study used administrative claims data from a deidentified database of commercially insured and Medicare Advantage beneficiaries. Adults aged 58 to 66 years with type 2 diabetes who filled any medication prescription to lower glucose levels from January 1, 2016, to December 31, 2019, were compared between groups.

Exposure: Enrollment in a Medicare Advantage or commercial health insurance plan.

Main Outcomes And Measures: The odds of initiating GLP-1RA, SGLT2i, and DPP-4i treatment were examined for Medicare Advantage vs commercial insurance beneficiaries using 3 separate logistic regression models adjusted for year and demographic and clinical factors. These models were used to calculate adjusted annual rates of medication initiation by health plan.

Results: A total of 382 574 adults with pharmacologically treated type 2 diabetes (52.9% men; mean [SD] age, 62.4 [2.7] years) were identified, including 172 180 Medicare Advantage and 210 394 commercial beneficiaries. From 2016 to 2019, adjusted rates of initiation of GLP-1RA, SGLT2i, and DPP-4i treatment increased among all beneficiaries, from 2.14% to 20.02% for GLP-1RA among commercial insurance beneficiaries and from 1.50% to 11.44% among Medicare Advantage beneficiaries; from 2.74% to 18.15% for SGLT2i among commercial insurance beneficiaries and from 1.57% to 8.51% among Medicare Advantage beneficiaries; and from 3.30% to 11.71% for DPP-4i among commercial insurance beneficiaries and from 2.44% to 7.68% among Medicare Advantage beneficiaries. Initiation rates for all 3 drug classes were consistently lower among Medicare Advantage than among commercial insurance beneficiaries. Within each calendar year, the odds of initiating GLP-1RA treatment ranged from 0.28 (95% CI, 0.26-0.29) to 0.70 (95% CI, 0.65-0.75) for Medicare Advantage and commercial insurance beneficiaries, respectively; SGLT2i, from 0.21 (95% CI, 0.20-0.22) to 0.57 (95% CI, 0.53-0.61), respectively; and DPP-4i, from 0.37 (95% CI, 0.34-0.39) to 0.73 (95% CI, 0.69-0.78), respectively (P < .001 for all). The odds of starting GLP-1RA and SGLT2i increased with income; for an income of $200 000 and higher vs less than $40 000, the odds ratio for GLP-1RA was 1.23 (95% CI, 1.15-1.32) and for SGLT2i was 1.16 (95% CI, 1.09-1.24).

Conclusions And Relevance: These findings suggest that Medicare Advantage beneficiaries may be less likely than commercially insured beneficiaries to be treated with newer medications to lower glucose levels, with greater disparities among lower-income patients. Better understanding of nonclinical factors contributing to treatment decisions and efforts to promote greater equity in diabetes management appear to be needed.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.35792DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7851726PMC
February 2021

Trends in Pain Medication Initiation Among Patients With Newly Diagnosed Diabetic Peripheral Neuropathy, 2014-2018.

JAMA Netw Open 2021 01 4;4(1):e2035632. Epub 2021 Jan 4.

Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1001/jamanetworkopen.2020.35632DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7844595PMC
January 2021

Optimizing Huddle Engagement Through Leadership and Problem Solving Within Primary Care: Results from a Cluster-Randomized Trial.

J Gen Intern Med 2021 Jan 26. Epub 2021 Jan 26.

Department of Family Medicine, Mayo Clinic Health System-Franciscan Healthcare, La Crosse, WI, USA.

Background: Leaders play a crucial role in implementing and sustaining changes in clinical practice, yet there is limited evidence on the strategies to engage them in team problem solving and communication.

Objective: Examine the impact of an intervention focused on facilitating leadership during daily huddles on optimizing team-based care and improving outcomes.

Design: Cluster-randomized trial using intention-to-treat analysis to measure the effects of the intervention (n = 13 teams) compared with routine practice (n = 16 teams).

Participants: Twenty-nine primary care clinics affiliated with a large integrated health system in the upper Midwest; representing differing practice types and geographic settings.

Intervention: Full-day leadership training retreat for team leaders to facilitate of care team huddles. Biweekly coaching calls and two site visits with an assigned coach.

Main Measures: Primary outcomes of team development and function were collected, pre- and post-intervention using surveys. Patient satisfaction and quality outcomes were compared pre- and post-intervention as secondary outcomes. Leadership engagement and adherence to the intervention were also assessed.

Key Results: A total of 279 pre-intervention and 272 post-intervention surveys were completed. We found no impact on team development (- 0.98, 95% CI (- 3.18, 1.22)), improved team credibility (0.18, 95% CI (0.00, 0.35)), but worse psychological safety (- 0.19, 95% CI (- 0.38, 0.00)). No differences were observed in patient satisfaction; however, results were mixed among quality outcomes. Post hoc analysis within the intervention group showed higher adherence to the intervention was associated with improvement in team coordination (0.47, 95% CI (0.18, 0.76)), credibility (0.28, 95% CI (0.02, 0.53)), team learning (0.42, 95% CI (0.10, 0.74)), and knowledge creation (0.74, 95% CI (0.35, 1.13)) compared to teams that were less engaged.

Conclusions: Results of this evaluation showed that leadership training and facilitation were not associated with better team functioning. Additional components to the intervention tested may be necessary to enhance team functioning.

Trial Registration: Clinicaltrials.gov Identifier NCT03062670. Registration Date: February 23, 2017. URL: https://clinicaltrials.gov/ct2/show/NCT03062670.
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http://dx.doi.org/10.1007/s11606-020-06487-6DOI Listing
January 2021

Validation of prognostic indices for short term mortality in an incident dialysis population of older adults >75.

PLoS One 2021 20;16(1):e0244081. Epub 2021 Jan 20.

Knowledge Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota, United States of America.

Rational And Objective: Prognosis provides critical knowledge for shared decision making between patients and clinicians. While several prognostic indices for mortality in dialysis patients have been developed, their performance among elderly patients initiating dialysis is unknown, despite great need for reliable prognostication in that context. To assess the performance of 6 previously validated prognostic indices to predict 3 and/or 6 months mortality in a cohort of elderly incident dialysis patients.

Study Design: Validation study of prognostic indices using retrospective cohort data. Indices were compared using the concordance ("c")-statistic, i.e. area under the receiver operating characteristic curve (ROC). Calibration, sensitivity, specificity, positive and negative predictive values were also calculated.

Setting & Participants: Incident elderly (age ≥75 years; n = 349) dialysis patients at a tertiary referral center.

Established Predictors: Variables for six validated prognostic indices for short term (3 and 6 month) mortality prediction (Foley, NCI, REIN, updated REIN, Thamer, and Wick) were extracted from the electronic medical record. The indices were individually applied as per each index specifications to predict 3- and/or 6-month mortality.

Results: In our cohort of 349 patients, mean age was 81.5±4.4 years, 66% were male, and median survival was 351 days. The c-statistic for the risk prediction indices ranged from 0.57 to 0.73. Wick ROC 0.73 (0.68, 0.78) and Foley 0.67 (0.61, 0.73) indices performed best. The Foley index was weakly calibrated with poor overall model fit (p <0.01) and overestimated mortality risk, while the Wick index was relatively well-calibrated but underestimated mortality risk.

Limitations: Small sample size, use of secondary data, need for imputation, homogeneous population.

Conclusion: Most predictive indices for mortality performed moderately in our incident dialysis population. The Wick and Foley indices were the best performing, but had issues with under and over calibration. More accurate indices for predicting survival in older patients with kidney failure are needed.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0244081PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816982PMC
April 2021

Adoption of the Anti-Fibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis.

Ann Am Thorac Soc 2021 Jan 19. Epub 2021 Jan 19.

Mayo Clinic Rochester, 4352, Division of Pulmonary and Critical Care Medicine, Rochester, Minnesota, United States.

Rationale: In October 2014, the anti-fibrotic medications pirfenidone and nintedanib became the first medications approved by the Food and Drug Administration for use in patients with idiopathic pulmonary fibrosis. Since approval, there has been no non-registry analysis of the real-world adoption of these medications in every day clinical practice.

Objective: To evaluate the adoption, persistence, and out-of-pocket costs of pirfenidone and nintedanib since their approval in the US in 2014 Methods: A retrospective cohort analysis was performed by identifying privately insured and Medicare Advantage beneficiaries with idiopathic pulmonary fibrosis. We then split the patients into three cohorts: those who were untreated and those that filled a prescription for either pirfenidone or nintedanib between October 1, 2014 and July 31, 2019. The primary outcome was adoption of the medications. Secondary outcomes included medication persistence and prescription drug costs.

Results: A total of 10,996 patients with IPF were identified in the dataset. A minority of patients (26.4%) with idiopathic pulmonary fibrosis identified in the cohort started either medication since approval in 2014, with the adoption of both medications comparable at around 13.2%. Those receiving the medications were younger (72 years old for both medications compared to 73.9, p-value<0.0001) and healthier (3.9 co-morbidities versus 4.9, p-value <0.0001) compared to those not receiving treatment. Men were significantly more likely to receive treatment than woman (30.0% versus 21.9%, p-value <0.0001). 42.8% of treated patients discontinued the medications during the study period. Patients' out-of-pocket expenses per month were high for both drugs (mean, $397.51 for nintedanib; $394.49 for pirfenidone).

Conclusion: The adoption of both the anti-fibrotic medications in the United States in every day practice has been low since approval and may be associated with the high out-of-pocket cost.
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http://dx.doi.org/10.1513/AnnalsATS.202007-901OCDOI Listing
January 2021

Proprotein convertase subtilisin/kexin type 9 inhibitor utilization and low-density lipoprotein-cholesterol control in familial hypercholesterolemia.

J Clin Lipidol 2020 Dec 27. Epub 2020 Dec 27.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA. Electronic address:

Background: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors were approved in August 2015 as an adjunct to maximally tolerated statin treatment in those with familial hypercholesterolemia (FH).

Objective: To assess PCSK9 inhibitor utilization patterns and cholesterol control in the high-risk FH population.

Methods: This study was a retrospective analysis of a large administrative database that includes privately insured and Medicare Advantage patients. Individuals with diagnosis codes for FH from October 2016-September 2019 were identified. Differences in PCSK9 inhibitor utilization between various groups were evaluated using multivariable logistic regression.

Results: During the study period, 1:371 people enrolled in medical/pharmacy plans had a diagnosis of FH. While 62.5% (n = 33,649) had medication fills for statins (without PCSK9 inhibitors), only 2.0% (n = 1062) had medication fills for PCSK9 inhibitors (with or without other medications). Compared to men, women were more likely to be untreated (OR 1.23, 95% confidence interval (CI):1.18-1.28, p < 0.01) but more likely to be treated with PCSK9 inhibitors (OR 2.18, 95%CI:1.90-2.49, p < 0.01). Compared to those younger than 55 years of age, older individuals were more likely to be treated (OR 1.64, 95%CI:1.56-1.72, p < 0.01) but less likely to be treated with PCSK9 inhibitors (OR 0.40, 95%CI:0.34-0.47, p < 0.01). Lastly, those with household incomes ≥$40,000 were more likely to be treated with PCSK9 inhibitors than those with lower household incomes (OR 1.69, 95%CI:1.41-2.02, p < 0.01).

Conclusion: PCSK9 inhibitor utilization in FH remains low. Significant differences exist based on demographic factors. Female sex, higher household incomes, and younger age were associated with increased PCSK9 inhibitor utilization.
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http://dx.doi.org/10.1016/j.jacl.2020.12.009DOI Listing
December 2020

Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand.

Vaccines (Basel) 2020 Dec 23;9(1). Epub 2020 Dec 23.

Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London SW7 2AZ, UK.

To overcome pandemics, such as COVID-19, vaccines are urgently needed at very high volumes. Here we assess the techno-economic feasibility of producing RNA vaccines for the demand associated with a global vaccination campaign. Production process performance is assessed for three messenger RNA (mRNA) and one self-amplifying RNA (saRNA) vaccines, all currently under clinical development, as well as for a hypothetical next-generation saRNA vaccine. The impact of key process design and operation uncertainties on the performance of the production process was assessed. The RNA vaccine drug substance (DS) production rates, volumes and costs are mostly impacted by the RNA amount per vaccine dose and to a lesser extent by the scale and titre in the production process. The resources, production scale and speed required to meet global demand vary substantially in function of the RNA amount per dose. For lower dose saRNA vaccines, global demand can be met using a production process at a scale of below 10 L bioreactor working volume. Consequently, these small-scale processes require a low amount of resources to set up and operate. RNA DS production can be faster than fill-to-finish into multidose vials; hence the latter may constitute a bottleneck.
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http://dx.doi.org/10.3390/vaccines9010003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824664PMC
December 2020

Frailty and Risk of Serious Infections in Biologic-treated Patients With Inflammatory Bowel Diseases.

Inflamm Bowel Dis 2020 Dec 16. Epub 2020 Dec 16.

Division of Geriatrics and Gerontology, Department of Medicine, University of California San Diego, La Jolla, California, USA.

Background: Identifying biologic-treated patients with inflammatory bowel diseases (IBDs) at higher risk of serious infections is a priority. We conducted a retrospective cohort study evaluating frailty and risk of serious infections in biologic-treated patients with IBD.

Methods: Using an administrative claims database, we identified biologic-treated patients with IBD between 2014 and 2018 with follow-up 1 year before and after treatment initiation. Using a validated claims-based hospital frailty risk scoring system, patients were classified as frail and nonfrail. We compared the risk of serious infections (infections requiring hospitalization) between frail and nonfrail patients using Cox proportional hazard analysis adjusting for age, comorbidities, disease characteristics, health care utilization, use of corticosteroids, immunomodulators, and opiates.

Results: We included 5987 biologic-treated patients with IBD (4881 on TNFα antagonists, 1106 on vedolizumab), of whom 2350 (39.3%) were classified as frail; over 7115 person-years of follow-up was included, and 520 patients developed serious infection. Frailty was not associated with increased risk of serious infection (adjusted hazard ratio [aHR], 1.12; 95% CI, 0.93-1.36), whereas advanced age (older than 60 years), high comorbidity burden, corticosteroid use, opiate use, and prior serious infection were associated with increased risk of serious infection. On stratified analysis, frailty was associated with increased risk of serious infections in vedolizumab-treated patients (aHR, 1.69; 95% CI, 1.03-2.79) but not in TNFα antagonist-treated patients (aHR, 1.03; 95% CI, 0.83-1.27).

Conclusions: In biologic-treated patients with IBD, frailty assessed using a claims-based frailty index was not independently associated with increased risk of serious infections. Future studies evaluating objective and biological measures of frailty are warranted to risk-stratify older patients with IBD.
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http://dx.doi.org/10.1093/ibd/izaa327DOI Listing
December 2020

Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products.

Mayo Clin Proc 2020 12 21;95(12):2609-2611. Epub 2020 Oct 21.

Section of General Internal Medicine and National Clinician Scholars Program, Yale School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT.

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http://dx.doi.org/10.1016/j.mayocp.2020.04.013DOI Listing
December 2020

Values informing the development of an indicator of appropriate diabetes therapy: qualitative study.

BMJ Open 2020 12 2;10(12):e044395. Epub 2020 Dec 2.

Division of Health Care Policy & Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA

Objectives: Despite increasing focus on individualised diabetes management, current diabetes quality measures are based on meeting generic haemoglobin A thresholds and do not reflect considerations of clinical complexity, hypoglycaemic susceptibility or treatment burden. Our team observed a multidisciplinary stakeholder panel tasked with informing an appropriate diabetes therapy indicator (ADTI) and analysed their deliberations, seeking to understand what constitutes appropriate diabetes therapy and how it can be captured using an operational quality indicator. We focused specifically on factors the panel in an ideal indicator, how they appropriateness and how they thought an indicator of appropriateness could be .

Design: Qualitative study examining Delphi panel deliberations as it iteratively refined the ADTI.

Participants And Methods: The 12-member panel was comprised of clinicians (endocrinology, primary care, geriatrics), pharmacists, nurses, researchers, and representatives of public and private health plans. It met for four teleconference calls and deliberated asynchronously using semi-structured questionnaires following each call to develop the ADTI. These semistructured questionnaires, as well as the meeting minutes, were then analysed using an inductive thematic approach.

Results: We identified three themes in panellist discussions that represented the core value systems underpinning the indicator and its formation: (1) promoting individualised, evidence-based and equitable care; (2) balancing autonomy and prescriptiveness in clinical decision-making; and (3) ensuring an accurate, reliable and practical indicator. These three principles were operationalised into definitions of treatment intensity and clinical complexity, and yielded an indicator that participants judged both fair and effective.

Conclusions: Better understanding of what multidisciplinary stakeholders perceive as appropriate diabetes management can help develop quality indicators that are patient-centred, evidence-based, equitable and pragmatic across a range of clinical settings.
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http://dx.doi.org/10.1136/bmjopen-2020-044395DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7713200PMC
December 2020

Development and evaluation of a patient-centered quality indicator for the appropriateness of type 2 diabetes management.

BMJ Open Diabetes Res Care 2020 11;8(2)

Division of Health Care Policy & Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.

Introduction: Current diabetes quality measures are agnostic to patient clinical complexity and type of treatment required to achieve it. Our objective was to introduce a patient-centered indicator of appropriate diabetes therapy indicator (ADTI), designed for patients with type 2 diabetes, which is based on hemoglobin A1c (HbA1c) but is also contextualized by patient complexity and treatment intensity.

Research Design And Methods: A draft indicator was iteratively refined by a multidisciplinary Delphi panel using existing quality measures, guidelines, and published literature. ADTI performance was then assessed using OptumLabs Data Warehouse data for 2015. Included adults (n=206 279) with type 2 diabetes were categorized as clinically complex based on comorbidities, then categorized as treated appropriately, overtreated, or undertreated based on a matrix of clinical complexity, HbA1c level, and medications used. Associations between ADTI and emergency department/hospital visits for hypoglycemia and hyperglycemia were assessed by calculating event rates for each treatment intensity subset.

Results: Overall, 7.4% of patients with type 2 diabetes were overtreated and 21.1% were undertreated. Patients with high complexity were more likely to be overtreated (OR 5.60, 95% CI 5.37 to 5.83) and less likely to be undertreated (OR 0.65, 95% CI 0.62 to 0.68) than patients with low complexity. Overtreated patients had higher rates of hypoglycemia than appropriately treated patients (22.0 vs 6.2 per 1000 people/year), whereas undertreated patients had higher rates of hyperglycemia (8.4 vs 1.9 per 1000 people/year).

Conclusions: The ADTI may facilitate timely, patient-centered treatment intensification/deintensification with the goal of achieving safer evidence-based care.
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http://dx.doi.org/10.1136/bmjdrc-2020-001878DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689069PMC
November 2020