Publications by authors named "Erin F Barreto"

45 Publications

Development of a Theory-Informed Behavior Change Intervention to Reduce Inappropriate Prescribing of Nephrotoxins and Renally Eliminated Drugs.

Ann Pharmacother 2021 Apr 15:10600280211009567. Epub 2021 Apr 15.

University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

Background: Goals of managing patients with acute kidney injury (AKI) are mitigating disease progression and ensuring safety while providing supportive care because no effective treatment exists. One strategy recommended in guidelines to meet these goals is optimizing medication management. Unfortunately, guideline implementation appears to be lacking as observed by the frequent occurrence of medication errors and adverse drug events.

Objective: To address this performance gap in the care of hospitalized patients receiving nephrotoxins and renally eliminated drugs, we sought to provide a potential intervention based on theory-informed behavior change.

Methods: Formative research with a qualitative analysis identifying what needs to change in patient care was completed by obtaining clinician opinion and expert opinion and reviewing the published literature. Frontline providers, including 8 physicians, 4 pharmacists, and a multiprofessional group of authors, provided insight into possible barriers to appropriate prescribing. Capability, Opportunity, Motivation and Behavior model and Theoretical Domain Framework were applied to characterize behavior change interventions and inform a potential implementation intervention for changing inappropriate prescribing behaviors.

Results: Lack of knowledge about appropriate drug management in patients at risk for adverse outcomes was provided as a major barrier. Other reported barriers included a lack of: (1) tools to assist with drug management, (2) motivation to make changes, (3) routinization, and (4) an accountable clinician.

Conclusions And Relevance: Assigning a designated clinician to execute a stepwise, routine care process following the checklist provided is a recommended intervention to overcome barriers. The intended impact is behavior change that reduces inappropriate prescribing.
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http://dx.doi.org/10.1177/10600280211009567DOI Listing
April 2021

Provider perspectives on beta-lactam therapeutic drug monitoring programs in the critically ill: a protocol for a multicenter mixed-methods study.

Implement Sci Commun 2021 Mar 24;2(1):34. Epub 2021 Mar 24.

Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.

Background: Beta-lactams (i.e., penicillins, cephalosporins, carbapenems, monobactams) are the most widely used class of antibiotics in critically ill patients. There is substantial interpatient variability in beta-lactam pharmacokinetics which renders their effectiveness and safety largely unpredictable. One strategy to ensure achievement of therapeutic concentrations is drug level testing ("therapeutic drug monitoring"; TDM). While studies have suggested promise with beta-lactam TDM, it is not yet widely available or implemented. This protocol presents a mixed-methods study designed to examine healthcare practitioners' perspectives on the use and implementation of beta-lactam TDM in the critically ill.

Methods: An explanatory sequential mixed-methods design will be used [QUANT → qual]. First, quantitative data will be collected through a web-based questionnaire directed at clinicians at three academic medical centers at different phases of beta-lactam TDM implementation (not yet implemented, partially implemented, fully implemented). The sampling frame will include providers from a variety of disciplines that interact with drug level testing and interpretation in the critical care environment including pharmacists, intensivists, infectious diseases experts, medical/surgical trainees, and advanced practice providers. Second, approximately 30 individuals will be purposively sampled from survey respondents to conduct in-depth qualitative interviews to explain and expand upon the results from the quantitative strand. Normalization Process Theory and the Consolidated Framework for Implementation Science will be used to guide data analysis.

Discussion: These data will be used to answer two specific questions: "What are ICU practitioners' perspectives on implementing beta-lactam TDM?" and "What factors contribute to the success of beta-lactam TDM program implementation?" Results of this study will be used to design future implementation strategies for beta-lactam TDM programs in the critically ill.

Trial Registration: NCT04755777 .
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http://dx.doi.org/10.1186/s43058-021-00134-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7992791PMC
March 2021

Early, empiric high-dose leucovorin rescue in lymphoma patients treated with sequential doses of high-dose methotrexate.

Support Care Cancer 2021 Mar 4. Epub 2021 Mar 4.

Division of Hematology, Department of Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Background: In patients exposed to high-dose methotrexate (HDMTX; >1g/m) with a history of elevated methotrexate (MTX) concentrations during previous doses, it is unclear whether prescribing high-dose leucovorin (HDLV) rescue limits future high levels or reduces the likelihood of acute kidney injury (AKI).

Methods: This retrospective, single-center study longitudinally followed adult lymphoma patients treated with HDMTX between 1/1/2011 and 10/31/2017 from diagnosis until 30 days after the last HDMTX dose. Endpoints included elevated MTX concentrations at 48 h (>1.0 μmol/L) and incident AKI after each HDMTX dose.

Results: The 321 included patients had a median (IQR) age of 65 (57, 72) years, 190 (59%) were male, and 293 (91%) were Caucasian. There were 1558 HDMTX doses [median (IQR) 3 (2, 6) doses per patient] prescribed with 265 (83%) patients receiving more than one MTX dose. Those receiving HDLV rescue were more likely to have an elevated MTX concentration after that dose (OR = 2.69, 95% CI: 1.75-4.11, p < 0.001). Receiving HDLV rescue was associated with a greater likelihood of AKI after MTX (OR = 2.18, 95% CI: 1.38-3.43, p < 0.001). Hospital LOS was longer in those prescribed empiric HDLV rescue after MTX than those prescribed standard leucovorin with an estimated difference of 1.1 days, (95% CI: 0.5-1.7, p < 0.001).

Conclusion: Sequential HDMTX doses are associated with a significant incidence of elevated MTX levels and AKI during lymphoma management. HDLV rescue prescribed during subsequent MTX doses in patients with a previously elevated level was not associated with improved safety outcomes. The optimal supportive care strategy following HDMTX administration requires further investigation.
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http://dx.doi.org/10.1007/s00520-021-06106-yDOI Listing
March 2021

A Critical Appraisal of the Effects of Anesthetics on Immune-system Modulation in Critically Ill Patients With COVID-19.

Clin Ther 2021 03 9;43(3):e57-e70. Epub 2021 Jan 9.

European University Cyprus, School of Medicine, Nicosia, Cyprus.

Purpose: The aim of the present article was to briefly summarize current knowledge about the immunomodulatory effects of general anesthetics and the possible clinical effects of this immunomodulation in patients with COVID-19.

Methods: The PubMed, Scopus, and Google Scholar databases were comprehensively searched for relevant studies.

Findings: The novel coronavirus causes a wide spectrum of clinical manifestations, with a large absolute number of patients experiencing severe pneumonia and rapid progression to acute respiratory distress syndrome and multiple organ failure. In these patients, the equilibrium of the inflammatory response is a major determinant of survival. The impact of anesthetics on immune-system modulation may vary and includes both pro-inflammatory and anti-inflammatory effects.

Implications: Inhibition of the development of severe inflammation and/or the enhancement of inflammation resolution by anesthetics may limit organ damage and improve outcomes in patients with COVID-19.
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http://dx.doi.org/10.1016/j.clinthera.2021.01.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833032PMC
March 2021

Including urinary output to define AKI enhances the performance of machine learning models to predict AKI at admission.

J Crit Care 2021 Apr 20;62:283-288. Epub 2021 Jan 20.

Division of Nephrology and Hypertension, Department of Medicine, Mayo Clinic, Rochester, MN, USA; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA. Electronic address:

Purpose: Acute kidney injury (AKI) is a prevalent and detrimental condition in intensive care unit patients. Most AKI predictive models only predict creatinine-triggered AKI (AKI) and might underperform when predicting urine-output-triggered AKI (AKI). We aimed to describe how admission AKI prediction models perform in all AKI patients.

Materials And Methods: Three types of models were trained: 1) pAKI, predicting AKI based on creatinine or urine output, 2) pAKI, predicting AKI based only on urine output, and 3) pAKI, predicting AKI based only on creatinine. We compared model performance and predictive features.

Results: The pAKI models had the best overall performance (AUROC 0.673-0.716) and the most consistent performance across three patient cohorts grouped by type of AKI trigger (min AUROC of 0.636). The pAKI models had fair performance in predicting AKI (AUROCs 0.702-0.748) but poor performance predicting AKI (AUROCs 0.581-0.695). The predictive features for the pAKI models and pAKI models were distinct, while top features for the pAKI models were consistently a combination of those for the pAKI and pAKI models.

Conclusion: Ignoring urine output in the outcome during model training resulted in models that are unlikely to predict AKI adequately and may miss a substantial proportion of patients in practice.
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http://dx.doi.org/10.1016/j.jcrc.2021.01.003DOI Listing
April 2021

Biomarker-Concordant Steroid Use in Critically Ill Patients with Pneumonia.

Mayo Clin Proc Innov Qual Outcomes 2020 Dec 10;4(6):649-656. Epub 2020 Dec 10.

Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN.

Objectives: To evaluate the frequency and consequences of prescribing corticosteroids for pneumonia in a biomarker-concordant manner.

Patients And Methods: This was a single-center retrospective cohort study of adults with pneumonia admitted to the medical intensive care unit (ICU) at Mayo Clinic in Rochester, Minnesota, between January 1, 2009, and June 30, 2014. Steroid use was "biomarker concordant" if given when C-reactive protein (CRP) was ≥150 mg/L or withheld when CRP was <150 mg/L, and vice versa for biomarker discordant.

Results: Of 3481 ICU admissions with community-acquired pneumonia, 169 (4.9%) had CRPs measured within 48 hours of admission to the ICU. Steroid use in the ICU was biomarker concordant in 88 (52%) patients and biomarker discordant in 81 (48%) patients. Biomarker-concordant steroid use was associated with faster resolution of lung injury: median fraction of inspired oxygen on day 3 (0.4 [0.3, 0.5] vs 0.3 [0.21, 0.4], =.005), day 4 (0.35 [0.3, 0.5] vs 0.28 [0.21, 0.38], =<.001), and day 5 (0.30 [0.24, 0.45] vs 0.28 [0.21, 0.40], =.03), and increased ICU (3.5; 95% CI, 0.5 to 6.4, =.02), and hospital-free days (3.6; 95% CI, 0.4 to 6.8, =.03) on multivariate analysis.

Conclusions: In critically ill patients with community-acquired pneumonia, steroid use is rarely biomarker informed and often discordant with inflammatory biomarker levels. Biomarker-concordant steroid use was associated with a faster recovery of hypoxemia and increased ICU- and hospital-free days. Future well-designed prospective studies are justified to test the potential value of biomarker-concordant steroid therapy.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.07.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749267PMC
December 2020

Clinician perspectives on inpatient cystatin C utilization: A qualitative case study at Mayo Clinic.

PLoS One 2020 11;15(12):e0243618. Epub 2020 Dec 11.

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

Introduction: Serum creatinine (SCr) testing has been the mainstay of kidney function assessment for decades despite known limitations. Cystatin C (CysC) is an alternative biomarker that is generally less affected than SCr by pertinent non-renal factors in hospitalized patients, such as muscle mass. Despite its potential advantages, the adoption of CysC for inpatient care is not widespread. At one hospital with CysC testing, we demonstrated a significant rise in non-protocolized use over the last decade. This study uses qualitative methods to provide the first report of how clinicians understand, approach, and apply CysC testing in inpatient care.

Methods: Fifteen clinicians from various disciplines were interviewed about their experience with inpatient CysC testing. The semi-structured interviews were audio-recorded, transcribed verbatim, and analyzed thematically using a phenomenological approach.

Results: Knowledge and confidence with CysC varied greatly. Clinicians reported first learning about the test from colleagues on consulting services or multidisciplinary teams. The majority believed CysC to provide a more accurate measure of kidney function than SCr. Common scenarios for CysC ordering included medication dosing, evaluation of acute kidney injury, and a thorough evaluation of kidney function in patients with risk factors for an altered SCr. Facilitators for ordering CysC included the availability of rapid results turnaround and the automated calculation of glomerular filtration rate based on the biomarker. Barriers to use included a lack of education about CysC, and the absence of an institutional protocol for use.

Discussion: Clinicians at our site decided independent of institutional guidance whether and when CysC added value to patient care. While the majority of study participants indicated advantages to rapid turnaround CysC testing, its use depended not just on the features of the specific case but on clinician familiarity and personal preference. Findings from this research can guide the implementation and expansion of CysC testing.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0243618PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732069PMC
February 2021

Prediction of Vancomycin Levels Using Cystatin C in Overweight and Obese Patients: a Retrospective Cohort Study of Hospitalized Patients.

Antimicrob Agents Chemother 2020 12 16;65(1). Epub 2020 Dec 16.

Department of Pharmacy, Mayo Clinic, Rochester, Minnesota, USA

The use of the kidney function biomarker cystatin C (cysC) can improve the accuracy of vancomycin dosing for target trough attainment in nonobese patients. It is unknown whether cysC can also improve vancomycin target trough attainment in overweight and obese patients. We conducted a retrospective observational study of overweight or obese hospitalized adults with stable renal function administered intravenous vancomycin between January 2011 and July 2019. Linear regression models were used to predict initial steady-state vancomycin troughs using several factors, including various cysC- and serum creatinine (SCr)-based estimates of kidney function. We compared the predicted proportion of patients within the target trough range (10 to 20 mg/liter) using the derived models to that observed from usual care. Of the 200 included patients, the mean trough level was 15 ± 6.3 mg/liter. The optimal model to predict the initial trough included both cysC and SCr ( = 0.48) rather than either biomarker alone. This model predicted that 79% (95% confidence interval [CI], 73% to 85%) of troughs could be between 10 and 20 mg/liter compared to the 62% observed in clinical practice ( < 0.001), a 1.3-fold increase. This study is the first to examine the role of cysC in predicting vancomycin levels in an exclusively overweight or obese population. While dosing models based on cysC appear promising in this setting, prospective validation is needed.
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http://dx.doi.org/10.1128/AAC.01487-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927827PMC
December 2020

Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.

J Am Soc Nephrol 2020 11 19;31(11):2506-2516. Epub 2020 Oct 19.

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.

The Sentinel System is a national electronic postmarketing resource established by the US Food and Drug Administration to support assessment of the safety and effectiveness of marketed medical products. It has built a large, multi-institutional, distributed data network that contains comprehensive electronic health data, covering about 700 million person-years of longitudinal observation time nationwide. With its sophisticated infrastructure and a large selection of flexible analytic tools, the Sentinel System permits rapid and secure analyses, while preserving patient privacy and health-system autonomy. The Sentinel System also offers enhanced capabilities, including accessing full-text medical records, supporting randomized clinical trials embedded in healthcare delivery systems, and facilitating effective collection of patient-reported data using mobile devices, among many other research programs. The nephrology research community can use the infrastructure, tools, and data that this national resource offers for evidence generation. This review summarizes the Sentinel System and its ability to rapidly generate high-quality, real-world evidence; discusses the program's experience in, and potential for, addressing gaps in kidney care; and outlines avenues for conducting research, leveraging this national resource in collaboration with Sentinel investigators.
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http://dx.doi.org/10.1681/ASN.2020040526DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7608970PMC
November 2020

Angiotensin II Infusion for Shock: A Multicenter Study of Postmarketing Use.

Chest 2021 Feb 31;159(2):596-605. Epub 2020 Aug 31.

Department of Pharmacy, Mayo Clinic, Rochester, MN; Multidisciplinary Epidemiology and Translational Research in Intensive Care, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN. Electronic address:

Background: Vasodilatory shock refractory to catecholamine vasopressors and arginine vasopressin is highly morbid and responsible for significant mortality. Synthetic angiotensin II is a potent vasoconstrictor that may be suitable for use in these patients.

Research Question: What is the safety and effectiveness of angiotensin II and what variables are associated with a favorable hemodynamic response?

Study Design And Methods: We performed a multicenter, retrospective study at five tertiary medical centers in the United States. The primary end point of hemodynamic responsiveness to angiotensin II was defined as attainment of mean arterial pressure (MAP) of ≥ 65 mm Hg with a stable or reduced total vasopressor dosage 3 h after drug initiation.

Results: Of 270 included patients, 181 (67%) demonstrated hemodynamic responsiveness to angiotensin II. Responders showed a greater increase in MAP (+10.3 mm Hg vs +1.6 mm Hg, P < .001) and reduction in vasopressor dosage (-0.20 μg/kg/min vs +0.04 μg/kg/min; P < .001) compared with nonresponders at 3 h. Variables associated with favorable hemodynamic response included lower lactate concentration (OR 1.11; 95% CI, 1.05-1.17, P < .001) and receipt of vasopressin (OR, 6.05; 95% CI, 1.98-18.6; P = .002). In severity-adjusted multivariate analysis, hemodynamic responsiveness to angiotensin II was associated with reduced likelihood of 30-day mortality (hazard ratio, 0.50; 95% CI, 0.35-0.71; P < .001). Arrhythmias occurred in 28 patients (10%) and VTE was identified in 4 patients.

Interpretation: In postmarketing use for vasopressor-refractory shock, 67% of angiotensin II recipients demonstrated a favorable hemodynamic response. Patients with lower lactate concentrations and those receiving vasopressin were more likely to respond to angiotensin II. Patients who responded to angiotensin II experienced reduced mortality.
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http://dx.doi.org/10.1016/j.chest.2020.08.2074DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856533PMC
February 2021

Patterns of Cystatin C Uptake and Use Across and Within Hospitals.

Mayo Clin Proc 2020 08;95(8):1649-1659

Department of Pharmacy, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN. Electronic address:

Objective: To characterize the use of cystatin C (cysC) across and within hospitals.

Patients And Methods: This 2-part study first evaluated access to cysC testing across 129 hospitals in the state of Minnesota, using a telephone-based survey. Second, granular data from a single center (Mayo Clinic) with on-site, rapid-turnaround testing (<1 day) and automated estimated glomerular filtration rate (eGFR) reporting was used to describe temporal patterns. The characteristics of hospitals that offered cysC testing and of patients who underwent rapid cysC testing at Mayo Clinic between January 1, 2011, and March 31, 2018, were described. Poisson regression analyzed temporal trends in cysC testing.

Results: Of the 114 hospitals (88%) that responded to the statewide survey, cysC was available in 91 (80%), but only 3 of 91 (3%) reported a turnaround time of <1 day. At Mayo Clinic, cysC use increased from 0.74 tests per 1000 patient-days in 2011 to 14 tests per 1000 patient-days in 2018 (P=.004). Of the 3774 patients with cysC tests, the mean first available eGFR was 46 mL/min per 1.73 m using cysC and 59 mL/min per 1.73 m using serum creatinine (P<.001). CysC testing was used across all intensities of care and was ordered by a variety of specialties. Nephrology was consulted in only 42% of cases.

Conclusion: In the hospital, rapid-turnaround cysC testing is necessary for practical use but was not widely available in Minnesota. When available, a marked increase in cysC testing was observed over the study timeframe. Additional research is needed to determine optimal strategies for implementation of cysC within hospitals.
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http://dx.doi.org/10.1016/j.mayocp.2020.03.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7412578PMC
August 2020

Framework and Outcomes of a Critical Care Pharmacy Visiting Clinical Professor Program.

Crit Care Explor 2020 Jun 18;2(6):e0137. Epub 2020 Jun 18.

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

Objectives: Experiences with utilizing a visiting clinical professor program to mentor institutions and collaborate on best practices in critical care pharmacy are described to provide a framework for these services and a synopsis of key outcomes.

Design: The Society of Critical Care Medicine Clinical Pharmacy and Pharmacology Section implemented a visiting clinical professor program to address the need for collaboration, idea-sharing, mentorship, and diffusion of innovation to clinicians in critical care practice.

Setting: Critical care pharmacy departments at 12 medical centers.

Subjects: Twelve visiting clinical professors and host institutions from 2007-2018.

Intervention: After an application is submitted to the section steering committee, an experienced clinician is paired with an institution, and a site visit is planned in collaboration with the visiting clinical professor program coordinators. The expert clinician visits the institution to share their insights and best practices based on visit goals and objectives. Reflective debriefing with both the host institution and the visiting clinical professor occurs after the visit.

Measurements And Main Results: The program has demonstrated numerous benefits including shared best practices related to critical care clinical services, expansion and refinement of care delivery models, development and optimization of research programs, and advancement of new training programs including specialty pharmacy residencies. Both the site and visiting professor find these partnerships beneficial, which has resulted in sustained success of the program over an 11-year period. Key resultant deliverables after visits have included new pharmacist positions, advancement of pharmacy services, and expanded access to academic opportunities.

Conclusions: A professional organization led visiting clinical professor program is viable, sustainable, and yields clear benefit for critical care pharmacy programs across the country. Application of this framework to other areas of pharmacy practice may be an avenue to share best practices and advance pharmacy services.
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http://dx.doi.org/10.1097/CCE.0000000000000137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7314337PMC
June 2020

Quality of care after AKI development in the hospital: Consensus from the 22nd Acute Disease Quality Initiative (ADQI) conference.

Eur J Intern Med 2020 10 30;80:45-53. Epub 2020 Jun 30.

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

Background: Acute kidney injury (AKI) is independently associated with increased morbidity and mortality. Quality improvement has been identified as an important goal in the care of patients with AKI. Different settings can be targeted to improve AKI care, broadly classified these include the inpatient and outpatient environments. In this paper, we will emphasize quality indicators associated with the management and secondary prevention of AKI in hospitalized patients to limit the severity, duration, and complications.

Methods: During the 22nd Acute Disease Quality Initiative (ADQI) consensus conference, a multidisciplinary group of experts discussed the evidence and used a modified Delphi process to achieve consensus on recommendations for AKI-related quality indicators (QIs) and care processes to improve patient outcomes. The management and secondary prevention of AKI in hospitalized patients were discussed, and recommendations were summarized.

Results: The first step in optimizing the quality of AKI management is the determination of baseline performance. Data regarding each institution's/center's performance can provide a reference point from which to benchmark quality efforts. Quality program initiatives should prioritize achievable goals likely to have the highest impact according to the setting and context. Key AKI quality metrics should include improvement in timely recognition, appropriate diagnostic workup, and implementation of known interventions that limit progression and severity, facilitating recovery, and mitigating AKI-associated complications. We propose the Recognition-Action-Results framework to plan, measure, and report the progress toward improving AKI management quality.

Conclusions: These recommendations identified and outlined an approach to define and evaluate the quality of AKI management in hospitalized patients.
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http://dx.doi.org/10.1016/j.ejim.2020.04.056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7553709PMC
October 2020

Predictors of Augmented Renal Clearance in a Heterogeneous ICU Population as Defined by Creatinine and Cystatin C.

Nephron 2020 19;144(7):313-320. Epub 2020 May 19.

Department of Pharmacy, Mayo Clinic, Rochester, Minnesota, USA.

Introduction: The incidence of augmented renal clearance (ARC) in the intensive care unit (ICU) is highly variable, and identification of these patients remains challenging.

Objective: The objective of this study was to define the incidence of ARC in a cohort of critically ill adults, using serum Cr and cystatin C, and to identify factors associated with its development.

Methods: This is a retrospective cohort study of critically ill patients without stage 2 or 3 acute kidney injury with both serum Cr and cystatin C available. The incidence of ARC was defined as a Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)Cr-cystatin C-estimated glomerular filtration rate >130 mL/min. A multivariable logistic regression model using a penalized Lasso method was fit to identify independent predictors of ARC.

Results: Among the 368 patients included in the study, indication for ICU admission was nonoperative in 55% of patients, and 9% of patients were admitted for major trauma. The overall incidence of ARC was low at 4.1%. In a multivariable logistic regression model, Charlson comorbidity index, major trauma, intracerebral hemorrhage, age, and Sequential Organ Failure Assessment score were found to predict ARC.

Conclusion: The incidence of ARC in this study was low, but prediction models identified several factors for early identification of patients with risk factors for or who develop ARC, particularly in a cohort with a low baseline risk of ARC. These factors could be used to help identify patients who may develop ARC.
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http://dx.doi.org/10.1159/000507255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371523PMC
May 2020

Cystatin C: A Primer for Pharmacists.

Pharmacy (Basel) 2020 Mar 9;8(1). Epub 2020 Mar 9.

Department of Pharmacy, Mayo Clinic, Rochester, MN 55905, USA.

Pharmacists are at the forefront of dosing and monitoring medications eliminated by or toxic to the kidney. To evaluate the effectiveness and safety of these medications, accurate measurement of kidney function is paramount. The mainstay of kidney assessment for drug dosing and monitoring is serum creatinine (SCr)-based estimation equations. Yet, SCr has known limitations including its insensitivity to underlying changes in kidney function and the numerous non-kidney factors that are incompletely accounted for in equations to estimate glomerular filtration rate (eGFR). Serum cystatin C (cysC) is a biomarker that can serve as an adjunct or alternative to SCr to evaluate kidney function for drug dosing. Pharmacists must be educated about the strengths and limitations of cysC prior to applying it to medication management. Not all patient populations have been studied and some evaluations demonstrated large variations in the relationship between cysC and GFR. Use of eGFR equations incorporating cysC should be reserved for drug management in scenarios with demonstrated outcomes, including to improve pharmacodynamic target attainment for antibiotics or reduce drug toxicity. This article provides an overview of cysC, discusses evidence around its use in medication dosing and in special populations, and describes practical considerations for application and implementation.
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http://dx.doi.org/10.3390/pharmacy8010035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151673PMC
March 2020

The professional sabbatical: A systematic review and considerations for the health-system pharmacist.

Res Social Adm Pharm 2020 Dec 24;16(12):1632-1644. Epub 2020 Feb 24.

Department of Pharmacy, Mayo Clinic, Rochester, MN, USA.

Background: Sabbaticals are considered a professional development experience meant to foster growth and revitalize careers. The personal accounts of sabbaticals among medical professionals indicate high value from this experience. Benefits seen at the institutional and individual level include, but are not limited to, reduced burnout and increased job retention. Staffing issues, determining eligibility, and justifying time utilized may be just some barriers to implementing a sabbatical program accessible to the health-system pharmacist. In the literature, there is a dearth of information related to sabbaticals granted to the health-system pharmacist. However, many published experiences of nurses and physicians exist.

Objectives: A systematic review was performed to synthesize a qualitative yet evidence-based summary of information regarding sabbaticals. The primary aim of this review was to assess the reported benefits and prohibitive factors of taking a sabbatical as it may apply to the health-system pharmacist.

Methods: Three hundred twenty-eight English-language articles were identified through searching Ovid Medline, PsycINFO, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL and Scopus from database inception through December 6, 2019.

Results: A total of 172 articles consisting of studies, descriptions of institutional processes, individual accounts, editorials and letters to the editor, and review articles were included in this systematic review. Rejuvenation and new perspectives/skills to bring back to practice should be regarded as important benefits by institutional/departmental leadership as well as the benefits of reduced turnover and improved job satisfaction. Numerous barriers to completing a sabbatical can be overcome with proper planning.

Conclusion: This review provides limited insight into benefits and barriers to taking sabbaticals and serves as a basis for health-system pharmacy departments to consider initiating a program if one is not currently in place. Mini-sabbaticals may allow the health-system pharmacist to take a professional time away. Corollaries are drawn between a longitudinal pharmacy research award granted at Mayo Clinic - Rochester and ideas are provided for clinical or educational sabbaticals. It is clear that health-system pharmacy-specific information is lacking, and pharmacy department leadership should be encouraged to continue to share experiences of sabbaticals and outcomes.
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http://dx.doi.org/10.1016/j.sapharm.2020.02.011DOI Listing
December 2020

Effect of a multimodal multidisciplinary training program on pharmacy residents' knowledge and confidence toward research and biostatistics.

Curr Pharm Teach Learn 2020 01 21;12(1):20-26. Epub 2019 Nov 21.

Department of Pharmacy, Mayo Clinic, 200 First Street SW, Rochester, MN, United States; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, United States.

Introduction: The optimal method to increase pharmacy resident knowledge and confidence toward research remains unknown.

Objective: This study evaluated the impact of a structured curriculum on pharmacy residents' knowledge, confidence and attitude toward biostatistics and research.

Methods: This prospective, multicenter study included pharmacy residents from 2016 to 2017. Residents underwent research training with (1) 60-hours of online modules delivered by multidisciplinary senior faculty (MD, PhD), (2) a 2-day interactive workshop delivered by experienced pharmacy researchers and (3) a mentored longitudinal research experience. Fifteen residents were invited to complete a questionnaire at baseline and again before graduation to measure knowledge, confidence and attitudes about research. Residents were followed for one additional year to measure peer-reviewed publications.

Results: Eleven (73%) residents provided complete responses to ≥1survey domain. At baseline, 27% of respondents reported being at least somewhat confident about their biostatistics and research skills (a favorable response for ≥5 of the 9 confidence items). At follow-up, 91% self-reported confidence. Self-reported familiarity with statistical terminology (a score of 4 or 5) increased from 19% at baseline to 82% at follow-up. The mean correct score on the knowledge items at baseline was 15 ± 2.5 (total possible 28) and increased to 20 ± 2.7 after training. By one year after graduation, 53% of residents published at least 1 peer-reviewed manuscript and 20 peer-reviewed publications as first or co-author with a median journal impact factor of 3.16 (IQR: 2.61-4.59).

Conclusion: This study provides a framework for sustainable, multidisciplinary, multimodal research education that increased confidence and knowledge among pharmacy residents and resulted in tangible contributions to the scientific literature. Future studies should explore long-term knowledge gained and publications.
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http://dx.doi.org/10.1016/j.cptl.2019.10.002DOI Listing
January 2020

The authors reply.

Crit Care Med 2020 01;48(1):e79-e80

Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN Department of Pharmacy, Mayo Clinic, Rochester, MN Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN, and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.1097/CCM.0000000000004088DOI Listing
January 2020

Use of Potentially Nephrotoxic Medications by U.S. Adults with Chronic Kidney Disease: NHANES, 2011-2016.

J Gen Intern Med 2020 04 2;35(4):1092-1101. Epub 2019 Dec 2.

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

Background: People with chronic kidney disease (CKD) are at risk for adverse events and/or CKD progression with use of renally eliminated or nephrotoxic medications.

Objective: To examine the prevalence of potentially inappropriate medication (PIM) use by U.S. adults by CKD stage and self-reported CKD awareness.

Design: Cross-sectional analysis of National Health and Nutrition Examination Surveys, 2011-2016 PARTICIPANTS: Non-pregnant adults with stages 3a (eGFR 45-59 mL/min/1.73 m), 3b (eGFR 30-44), or 4-5 (eGFR < 30) CKD, stratified as CKD-aware/unaware.

Main Measures: PIMs were identified on the basis of KDIGO guidelines, label information, and literature review. We calculated proportions using any and individual PIMs, assessing for differences over CKD awareness within each CKD stage. Analyses were adjusted for age, sex, race/ethnicity, education, comorbidities, and insurance type.

Key Results: Adjusted proportions of U.S. adults taking any PIM(s) exceeded 50% for all CKD stages and awareness categories, and were highest among CKD-unaware patients with stages 4-5 CKD: 66.6% (95% CI, 55.5-77.8). Proton pump inhibitors, opioids, metformin, sulfonylureas, and non-steroidal anti-inflammatory drugs (NSAIDs) were all used frequently across CKD stages. NSAIDs were used less frequently when CKD-aware by patients with stage 3a CKD (2.2% [95% CI, - 0.3 to 4.7] vs. 10.7% [95% CI, 7.6 to 13.8]) and stages 4-5 CKD (0.8% [95% CI, - 0.9 to 2.5] vs. 16.5% [95% CI, 4.0 to 29.0]). Metformin was used less frequently when CKD-aware by patients with stage 3b CKD (8.1% [95% CI, 0.3-15.9] vs. 26.5% [95% CI, 17.4-35.7]) and stages 4-5 CKD (none vs. 20.8% [95% CI, 1.8-39.8]). The impact of CKD awareness was statistically significant after correction for multiple comparisons only for NSAIDs in stage 3a CKD.

Conclusions: PIMs are frequently used by people with CKD, with some impact of CKD awareness on NSAID and metformin use. This may lead to adverse outcomes or hasten CKD progression, reinforcing the need for improved medication management among people with CKD.
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http://dx.doi.org/10.1007/s11606-019-05557-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7174522PMC
April 2020

Altered Pharmacokinetics and Dosing of Liposomal Amphotericin B and Isavuconazole during Extracorporeal Membrane Oxygenation.

Pharmacotherapy 2020 01 13;40(1):89-95. Epub 2019 Dec 13.

Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota.

Drug pharmacokinetics may be significantly altered in patients receiving extracorporeal membrane oxygenation (ECMO). Ensuring the optimized effective dosing of antimicrobials on ECMO remains a challenge. To date, limited data are available regarding the optimal use of amphotericin and triazoles during ECMO. We report a case of altered pharmacokinetics, insufficient liposomal amphotericin B and isavuconazole levels, and the need for escalated doses during ECMO in a patient with severe acute respiratory distress syndrome secondary to pulmonary blastomycosis. A 2-fold increase in the standard total daily dose of both drugs was necessary to overcome low serum concentrations thought to be secondary to drug loss from ECMO circuit sequestration. These findings have important implications for optimizing antimicrobial therapy in patients receiving ECMO to maximize therapeutic efficacy. The use of therapeutic drug monitoring for patients receiving antimicrobial therapy with concurrent ECMO may facilitate appropriate drug dosing to achieve adequate serum concentrations and optimize favorable patient outcomes. Further studies exploring antimicrobial pharmacokinetics during ECMO are needed to inform dosing recommendations in critically ill patients.
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http://dx.doi.org/10.1002/phar.2348DOI Listing
January 2020

Cost-effectiveness of second-line vasopressors for the treatment of septic shock.

J Crit Care 2020 02 23;55:48-55. Epub 2019 Oct 23.

Department of Pharmacy, Cleveland Clinic, Cleveland, OH, USA.

Purpose: To determine the cost-effectiveness of escalating doses of norepinephrine or norepinephrine plus the adjunctive use of vasopressin or angiotensin II as a second-line vasopressor for septic shock.

Materials And Methods: Decision tree analysis was performed to compare costs and outcomes associated with norepinephrine monotherapy or the two adjunctive second-line vasopressors. Short- and long-term outcomes modeled included ICU survival and lifetime quality-adjusted-life-years (QALY) gained. Costs were modeled from a payer's perspective, with a willingness-to-pay threshold set at $100,000/unit gained. One-way (tornado diagrams) and probabilistic sensitivity analyses were performed.

Results: Adjunctive vasopressin was the most cost-effective therapy, and dominated both norepinephrine monotherapy and adjunctive angiotensin II by producing higher ICU survival at less cost. For the lifetime horizon, while norepinephrine monotherapy was least expensive, adjunctive vasopressin was the most cost-effective with an incremental cost-effectiveness ratio of $19,762 / QALY gained. Although adjunctive angiotensin II produced more QALYs compared to norepinephrine monotherapy, it was dominated in the long-term evaluation by second-line vasopressin. Sensitivity analyses demonstrated model robustness and medication costs were not significant drivers of model results.

Conclusions: Vasopressin is the most cost-effective second-line vasopressor in both the short- and long-term evaluations. Vasopressor price is a minor contributor to overall cost.
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http://dx.doi.org/10.1016/j.jcrc.2019.10.005DOI Listing
February 2020

Parenteral Nutrition Drug Shortages: A Single-Center Experience With Rapid Process Change.

JPEN J Parenter Enteral Nutr 2019 07 8;43(5):583-590. Epub 2019 Apr 8.

Department of Pharmacy, Mayo Clinic, Rochester, Minnesota, USA.

Disruptions in the medication supply chain and consequent drug product shortages, including shortages of parenteral products used for parenteral nutrition (PN) compounding, have become an increasingly common occurrence. The amino acid solution shortage that resulted from the devastating impact of Hurricanes Maria and Irma on manufacturing facilities in Puerto Rico in 2017 necessitated a rapid, coordinated shift from use of compounded PN to commercial multichamber-bag PN (MCB-PN) at our hospitals. We describe our experience operationalizing this intervention via a framework that may be adapted for addressing other drug product shortages to promote rapid yet safe use of therapeutic alternatives.
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http://dx.doi.org/10.1002/jpen.1538DOI Listing
July 2019

The authors reply.

Crit Care Med 2019 10;47(10):e845-e846

Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN Department of Pharmacy, Mayo Clinic, Rochester, MN Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN, and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.1097/CCM.0000000000003953DOI Listing
October 2019

Supplement Use by US Adults With CKD: A Population-Based Study.

Am J Kidney Dis 2019 12 18;74(6):862-865. Epub 2019 Jul 18.

Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN; Division of Community Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN; Division of Health Care Policy & Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN. Electronic address:

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http://dx.doi.org/10.1053/j.ajkd.2019.05.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875608PMC
December 2019

Reply to Kollef et al.

Clin Infect Dis 2020 03;70(7):1521

Department of Pharmacy, Rochester, Minnesota.

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http://dx.doi.org/10.1093/cid/ciz644DOI Listing
March 2020

Role of Loop Diuretic Challenge in Stage 3 Acute Kidney Injury.

Mayo Clin Proc 2019 08 3;94(8):1509-1515. Epub 2019 Jul 3.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic, Rochester, MN; Division of Nephrology, Department of Medicine, Mayo Clinic, Rochester, MN.

Objective: To assess whether loop diuretic challenge predicts the need for dialysis among critically ill patients with acute kidney injury (AKI) stage 3.

Patients And Methods: Adult patients admitted to intensive care units between January 1, 2004, and December 31, 2016, were screened. Acute kidney injury stage 3 was identified by an electronic surveillance tool, and patients who received loop diuretics in a dosage of at least 1mg/kg intravenous bolus furosemide equivalent were included. Urine output following loop diuretic challenge was modeled as a restricted cubic spline. We then compared the area under the receiver operating characteristic curve for urine outputs at 2 hours and 6 hours after loop diuretic challenge to predict the need for dialysis within the next 24 hours.

Results: Of 687 patients included in the study, those who received dialysis were younger and had higher Sequential Organ Failure Assessment scores on the day of loop diuretic challenge. Urine outputs at 2 hours and 6 hours were lower in patients who needed dialysis, but urine output by 6 hours was better in predicting dialysis initiation within 24 hours (area under the curve, 0.71 vs 0.67; P=.02). The sensitivity and specificity of 6-hour urine output cutoff of 600 mL or less to predict dialysis was 80.9% and 50.5%, respectively, and that for 300 mL or less was 64.2% and 68.2%, respectively.

Conclusion: Among patients with stage 3 AKI, 6-hour urine output after the loop diuretic challenge had a modest discriminant capacity to identify dialysis initiation within the next 24 hours.
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http://dx.doi.org/10.1016/j.mayocp.2019.01.040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746153PMC
August 2019

Impact of early rasburicase on incidence of clinical tumor lysis syndrome in lymphoma.

Leuk Lymphoma 2019 09 21;60(9):2271-2277. Epub 2019 Jun 21.

Division of Hematology, Mayo Clinic , Rochester , MN , USA.

Early administration of rasburicase to enhance uric acid (UA) elimination has been adopted without robust evidence in support of its impact on clinical outcomes in tumor lysis syndrome (TLS), specifically, the prevention of acute kidney injury (AKI). This was a retrospective cohort study of adult lymphoma patients at intermediate or high risk for TLS. Excluded patients had AKI or were on dialysis at hospital admission. The incidence of new AKI in the setting of TLS was described along with predictors of its development, including early rasburicase use. In 383 included patients, the incidence of new-onset AKI during hospitalization was 6%. Predictors included age, history of renal or cardiovascular disease, and UA >8 mg/dL. Rasburicase use did not significantly impact the risk of developing AKI (HR 2.3;  = .11). The UA level at the time of administration did not modify the effect of rasburicase on prevention of AKI ( = .36 for the interaction term).
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http://dx.doi.org/10.1080/10428194.2019.1574000DOI Listing
September 2019

Continuation of Newly Initiated Midodrine Therapy After Intensive Care and Hospital Discharge: A Single-Center Retrospective Study.

Crit Care Med 2019 08;47(8):e648-e653

Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN.

Objectives: Midodrine is an α1-agonist approved for orthostatic hypotension. Recently, it has received attention as an oral vasopressor to facilitate ICU discharge. The purpose of this study was to identify the incidence of continuation of newly initiated midodrine upon ICU and hospital discharge and identify risk factors associated with its occurrence.

Design: Single-center retrospective study.

Setting: ICU patients from January 2011 to October 2016 at Mayo Clinic, Rochester.

Patients: Adult patients admitted to any ICU who received new midodrine for hypotension and survived to discharge.

Interventions: None.

Measurements And Main Results: During the study period, 1,010 patients were newly started on midodrine and survived to ICU discharge. Midodrine was continued in 67% (672/1,010) of patients at ICU discharge. Admission to cardiovascular surgery ICU and mixed medical/surgical ICU was a risk factor for midodrine continuation at ICU discharge (odds ratio, 3.94 [2.50-6.21] and 2.03 [1.29-3.20], respectively). At hospital discharge, 34% (311/909) of patients were continued on midodrine therapy. History of congestive heart failure predicted midodrine continuation at hospital discharge (odds ratio, 1.49 [1.05-2.12]). Hypertension and use of mechanical ventilation were associated with a decreased odds of midodrine prescription at both ICU and hospital discharge. Of those discharged from the ICU or hospital on midodrine, 50% were concomitantly prescribed antihypertensives. Discharge from the ICU on midodrine was associated with a significantly shorter ICU length of stay (7.5 ± 8.9 vs 10.6 ± 13.4 d) and reduced risk of in-hospital mortality (hazard ratio, 0.47 [95% CI, 0.32-0.70]; p < 0.001), despite no difference in baseline severity of illness scores. In contrast, patients discharged from the hospital on midodrine had a higher risk of 1-year mortality (hazard ratio, 1.60 [95% CI, 1.26-2.04]; p < 0.001).

Conclusions: This study established a high prevalence of midodrine continuation in transitions of care. The risks and benefits of this practice remain unclear. Future studies should explore the impact of this practice on patient outcomes and resource utilization. These insights could be used to model interventions for proper tapering, discontinuation, or follow-up of new start midodrine.
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http://dx.doi.org/10.1097/CCM.0000000000003814DOI Listing
August 2019

Quality Improvement Goals for Acute Kidney Injury.

Clin J Am Soc Nephrol 2019 06 17;14(6):941-953. Epub 2019 May 17.

Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.

AKI is a global concern with a high incidence among patients across acute care settings. AKI is associated with significant clinical consequences and increased health care costs. Preventive measures, as well as rapid identification of AKI, have been shown to improve outcomes in small studies. Providing high-quality care for patients with AKI or those at risk of AKI occurs across a continuum that starts at the community level and continues in the emergency department, hospital setting, and after discharge from inpatient care. Improving the quality of care provided to these patients, plausibly mitigating the cost of care and improving short- and long-term outcomes, are goals that have not been universally achieved. Therefore, understanding how the management of AKI may be amenable to quality improvement programs is needed. Recognizing this gap in knowledge, the 22nd Acute Disease Quality Initiative meeting was convened to discuss the evidence, provide recommendations, and highlight future directions for AKI-related quality measures and care processes. Using a modified Delphi process, an international group of experts including physicians, a nurse practitioner, and pharmacists provided a framework for current and future quality improvement projects in the area of AKI. Where possible, best practices in the prevention, identification, and care of the patient with AKI were identified and highlighted. This article provides a summary of the key messages and recommendations of the group, with an aim to equip and encourage health care providers to establish quality care delivery for patients with AKI and to measure key quality indicators.
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http://dx.doi.org/10.2215/CJN.01250119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6556737PMC
June 2019

Reply to letter regarding: "Validation of the sarcopenia index to assess muscle mass in the critically ill: A novel application of kidney function markers".

Authors:
Erin F Barreto

Clin Nutr 2019 06 14;38(3):1478. Epub 2019 Mar 14.

Department of Pharmacy, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. Electronic address:

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http://dx.doi.org/10.1016/j.clnu.2019.02.044DOI Listing
June 2019