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1. Pharmacist-driven outreach initiative to increase prescribing of sodium-glucose cotransporter-2 inhibitors in eligible VHA patients with chronic kidney disease: a study protocol

Author: Deborah L. Pestka, Daniel Murphy, Pearl Huynh, Jessica A. Rechtzigel, Shari Kjos, Lisa Marie Ellich, Adam N. Kaplan, Brent C. Taylor, Melissa Atwood, Beth A. Polsfuss, Joseph Y. Lee, and Areef Ishani
Subjects: Chronic Kidney Disease, Implementation strategy, Clinical pharmacy services, Diseases of the genitourinary system. Urology, RC870-923
Abstract: Abstract Background Patients with chronic kidney disease (CKD) are at increased risk for multiple adverse events, several of which have been proven to be less likely with the use of sodium-glucose cotransporter-2 inhibitors (SGLT2i). As a result, guidelines now recommend SGLT2i be given to those with mild to moderate CKD and type 2 diabetes. The objective of this study is to evaluate if a pharmacist-driven SGLT2i prescribing initiative among eligible patients with CKD and diabetes within the VA could more rapidly improve the adoption of SGLT2i via a pragmatic approach aligned with learning health systems. Methods Eligible patients will be identified through an established VA diabetes dashboard. Veterans with an odd social security number (SSN), which is effectively a random number, will be the intervention group. Those with even SSNs will serve as the control while awaiting a second iteration of the same interventional program. The intervention will be implemented in a rolling fashion across one Veterans Integrated Service Network. Our primary outcome is initiation of an SGLT2i. Secondary outcomes will include medication adherence and safety-related outcomes. Discussion This project tests the impact of a pharmacist-driven medication outreach initiative as a strategy to accelerate initiation of SGLT2i. The results of this work will not only illustrate the effectiveness of this strategy for SGLT2is but may also have implications for increasing other guideline-concordant care. Furthermore, the utilization of SSNs to select Veterans for the first wave of this program has created a pseudo-randomized interventional trial supporting a pragmatic learning health system approach. Trial registration ISRCTN12374636.
Published: 2024
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2. β-Blocker Use and Cardiovascular Outcomes in Hemodialysis: A Systematic ReviewPlain-Language Summary

Author: Abhinav Tella, William Vang, Eustacia Ikeri, Olivia Taylor, Alicia Zhang, Megan Mazanec, Srihari Raju, and Areef Ishani
Subjects: Acebutolol, adrenergic beta-antagonists, atenolol, β-blockers, beta blockers, bisoprolol, Diseases of the genitourinary system. Urology, RC870-923
Abstract: Rationale & Objective: There is conflicting evidence regarding the type of β-blockers to use in dialysis patients. This systematic review seeks to determine whether highly dialyzable β-blockers are associated with higher rates of cardiovascular events and mortality in hemodialysis patients than poorly dialyzable β-blockers. Study Design: A systematic review of the existing literature was conducted. A meta-analysis was performed using data from the selected studies. Setting & Study Populations: Participants were from the United States, Canada, and Taiwan. The mean ages of participants ranged from 55.9-75.7 years. Selection Criteria for Studies: We searched the Ovid MEDLINE database from 1990 to September 2020. Studies without adult hemodialysis participants and without comparisons of at least 2 β-blockers of different dialyzability were excluded. Data Extraction: Baseline and adjusted outcome data were extracted from each study. Analytical Approach: Random-effects models were used to calculate pooled risk ratios using fully adjusted models from individual studies. Results: Four cohort studies were included. Pooling fully adjusted models, highly dialyzable β-blockers did not influence mortality (HR, 0.94; 95% CI, 0.81-1.08; I2 = 0.84) compared with poorly dialyzable β-blockers but were associated with a reduction in cardiovascular events (HR, 0.88; 95% CI, 0.83-0.93). There was significant heterogeneity between studies (I2 = 0.35). Only 1 study reported on adverse events. Intradialytic hypotension was more common in those on carvedilol (a poorly dialyzable β-blocker) compared with those on metoprolol (a highly dialyzable β-blocker; adjusted incidence rate ratio, 1.10; 95% CI, 1.09-1.11). Limitations: No randomized controlled trials were identified. Each study used different analytic methods and different definitions for outcomes. Classifications of β-blockers varied. Only 1 study reported on adverse events. Conclusions: Pooled data suggest highly dialyzable β-blockers are associated with similar mortality events and fewer cardiovascular events compared with poorly dialyzable β-blockers.
Published: 2022
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3. Renal Function and Death in Older Women: Which eGFR Formula Should We Use?

Author: Muna T. Canales, Terri Blackwell, Areef Ishani, Brent C. Taylor, Allyson Hart, Rebecca J. Beyth, and Kristine E. Ensrud
Subjects: Diseases of the genitourinary system. Urology, RC870-923
Abstract: Background. The Berlin Initiative Study (BIS) eGFR equations were developed specifically for aged populations, but their predictive validity compared to standard formulae is unknown in older women. Methods. In a prospective study of 1289 community-dwelling older women (mean age 79.5 years), we compared the performance of the BIS1 SCr-based equation to the CKD-EPIcr and the BIS2 SCr- and Scysc-based equation to the CKD-EPIcr,cysc to predict cardiovascular and all-cause mortality. Results. Prevalence of specific eGFR category (i.e., ≥75, 60–74, 45–59, and
Published: 2017
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4. 2323 Large patient volume is associated with adverse patient outcomes among those requiring maintenance renal replacement therapy

Author: Scott Reule, Robert Foley, Areef Ishani, and Mark Rosenberg
Subjects: Medicine
Abstract: OBJECTIVES/SPECIFIC AIMS: We set out to describe important associations and outcomes among those requiring maintenance renal replacement therapy with the patient volume per provider. METHODS/STUDY POPULATION: Through the combination of several large administrative datasets, including the United States Renal Data System (n=237,485), the American Medical Association Master file (n=6249), and Medicare data limited to 2012, we compared characteristics of patients, by quintile of patient/provider volume. χ2 and logistic regression, adjusted for various patient and provider factors for categorical and continuous variables, was used for baseline comparisons, respectively. Cox regression, adjusted for patient, provider, and socioeconomic variables, was used to calculate risks for important clinical outcomes such as kidney transplant listing, transplant receipt, and all-cause mortality. RESULTS/ANTICIPATED RESULTS: There is a threshold patient volume at which important clinical outcomes, including kidney transplantation and all-cause mortality, may be influenced. Higher patient volume is associated with adverse patient outcome. Those receiving care from providers with the highest patient volumes are less likely to receive kidney transplantation, live in a more rural area, and be non-White. DISCUSSION/SIGNIFICANCE OF IMPACT: There is a need to identify novel and potentially modifiable factors associated with patient outcome among those with end-stage kidney disease on maintenance renal replacement therapy. Provider level variables, such as patient volume, is one such variable. As nephrologists are often tasked with the care of variable numbers of patients on dialysis, a better understanding of this association is an unmet need.
Published: 2018
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5. The Impact of Primary Care Dual-Management on Quality of Care

Author: Peter J. Kaboli MD, MS, Daniel M. Shivapour MD, Michael S. Henderson MS, Areef Ishani MD, and Mary E. Charlton PhD, RN
Subjects: Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Abstract: Background : Discontinuity is common in US healthcare. Patients access multiple systems of care and in the nation’s largest integrated healthcare system, Veteran’s Administration (VA) patients frequently use non-VA primary care providers. The impact of this “dual-management” on quality is unknown. The authors’ objective was to identify dual-management and associations with markers of care quality for hypertension and associated conditions. Methods : Data was collected via surveys and chart reviews of primary care patients with hypertension from six VA clinics in Iowa and Minnesota. Clinical measures abstracted included the following: goal blood pressure (BP) and use of guideline-concordant therapy, low-density lipoprotein (LDL) cholesterol, hemoglobin A1C, and body mass index (BMI). Dual-management data was obtained through self-report. Results : Of 189 subjects (mean age = 66), 36% were dual-managed by non-VA providers. There was no difference in hypertension quality of care measures by dual-management status. A total of 51% were at BP goal and 58% were on guideline-concordant therapy. Dual-managed patients were more likely to use thiazide diuretics (43% vs 29%; P = .03) and angiotensin receptor blockers (13% vs 3%; P < .01), but less likely to use angiotensin-converting enzyme inhibitors (43% vs 61%; P = .02). There was no difference in LDL cholesterol (97.1 mg/dl vs 100.1 mg/dl; P = .55), hemoglobin A1C (7% vs 6%; P = .74), or BMI (29.8 vs 30.9; P = .40) for dual-managed versus VA managed patients, respectively. Conclusions : Although dual-management may decrease continuity, VA/private sector dual-management did not impact quality of care, though some medication differences were observed. With the high prevalence of dual-management, future work should further address quality and evaluate redundancy of services.
Published: 2012
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6. Strategies for secondary use of real-world clinical and administrative data for outcome ascertainment in pragmatic clinical trials.

Author: Cynthia Hau, Patricia A. Woods, Amanda S. Guski, Srihari I. Raju, Liang Zhu, Patrick R. Alba, William C. Cushman, Peter A. Glassman, Areef Ishani, Addison A. Taylor, Ryan E. Ferguson, and Sarah Leatherman
Published: 2024
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7. Effect of Intensive versus Standard BP Control on AKI and Subsequent Cardiovascular Outcomes and Mortality: Findings from the SPRINT EHR Study

Author: Paul E. Drawz, Nayanjot Kaur Rai, Kristin Macfarlane Lenoir, Maritza Suarez, James R. Powell, Dominic S. Raj, Srinivasan Beddhu, Anil K. Agarwal, Sandeep Soman, Paul K. Whelton, James Lash, Frederic F. Rahbari-Oskoui, Mirela Dobre, Mark A. Parkulo, Michael V. Rocco, Andrew McWilliams, Jamie P. Dwyer, George Thomas, Mahboob Rahman, Suzanne Oparil, Edward Horwitz, Nicholas M. Pajewski, and Areef Ishani
Subjects: Treatment Outcome, Editorial, Cardiovascular Diseases, Risk Factors, Creatinine, Hypertension, Electronic Health Records, Humans, Blood Pressure, General Medicine, Acute Kidney Injury, Antihypertensive Agents
Abstract: Adjudication of inpatient AKI in the Systolic Blood Pressure Intervention Trial (SPRINT) was based on billing codes and admission and discharge notes. The purpose of this study was to evaluate the effect of intensive versus standard BP control on creatinine-based inpatient and outpatient AKI, and whether AKI was associated with cardiovascular disease (CVD) and mortality.We linked electronic health record (EHR) data from 47 clinic sites with trial data to enable creatinine-based adjudication of AKI. Cox regression was used to evaluate the effect of intensive BP control on the incidence of AKI, and the relationship between incident AKI and CVD and all-cause mortality.A total of 3644 participants had linked EHR data. A greater number of inpatient AKI events were identified using EHR data (187 on intensive versus 155 on standard treatment) as compared with serious adverse event (SAE) adjudication in the trial (95 on intensive versus 61 on standard treatment). Intensive treatment increased risk for SPRINT-adjudicated inpatient AKI (HR, 1.51; 95% CI, 1.09 to 2.08) and for creatinine-based outpatient AKI (HR, 1.40; 95% CI, 1.15 to 1.70), but not for creatinine-based inpatient AKI (HR, 1.20; 95% CI, 0.97 to 1.48). Irrespective of the definition (SAE or creatinine based), AKI was associated with increased risk for all-cause mortality, but only creatinine-based inpatient AKI was associated with increased risk for CVD.Creatinine-based ascertainment of AKI, enabled by EHR data, may be more sensitive and less biased than traditional SAE adjudication. Identifying ways to prevent AKI may reduce mortality further in the setting of intensive BP control.
Published: 2022
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8. Impact of Antihypertensive Drug Class on Outcomes in SPRINT

Author: Douglas D. DeCarolis, Amy Gravely, Christine M. Olney, and Areef Ishani
Subjects: Thiazides, Treatment Outcome, Sodium Chloride Symporter Inhibitors, Adrenergic beta-Antagonists, Hypertension, Internal Medicine, Humans, Blood Pressure, Calcium Channel Blockers, Antihypertensive Agents, Article
Abstract: Background: The primary objective of this analysis is to assess if greater exposure to any major antihypertensive drug class was associated with reduced primary composite outcome events in SPRINT (Systolic Blood Pressure Intervention Trial). Methods: This is a secondary analysis of the SPRINT trial evaluating whether longitudinal, time varying exposure to any major antihypertensive drug class had any impact on primary outcome events, after adjusting for effects of randomization arm, time varying achieved systolic blood pressure, other drug class exposure, and baseline characteristics. Results: Nine thousand two hundred fifty-two participants were included. After adjustments, exposure of one year or greater to thiazide-type diuretics or renin-angiotensin system blockers was associated with significantly fewer primary events than exposure of less than one year (hazard ratio, 0.78 [95% CI, 0.64–0.94]). There was no significant difference with longer versus shorter exposure to calcium channel blockers. Greater exposure to beta-blockers was associated with an increase in primary events compared with exposure of Conclusions: The SPRINT trial demonstrated a lower target blood pressure led to reductions in adverse cardiovascular events. This analysis suggests greater exposure to thiazide-type diuretics and renin-angiotensin system blockers also contributed to reduced adverse cardiovascular events. Greater exposure to beta-blockers was associated with increased cardiovascular events.
Published: 2022
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9. Chlorthalidone vs. Hydrochlorothiazide for Hypertension-Cardiovascular Events

Author: Areef, Ishani, William C, Cushman, Sarah M, Leatherman, Robert A, Lew, Patricia, Woods, Peter A, Glassman, Addison A, Taylor, Cynthia, Hau, Alison, Klint, Grant D, Huang, Mary T, Brophy, Louis D, Fiore, Ryan E, Ferguson, and Liang, Zhu
Subjects: Adult, Hydrochlorothiazide, Sodium Chloride Symporter Inhibitors, Hypertension, Humans, Chlorthalidone, Blood Pressure, General Medicine, Diuretics, Antihypertensive Agents, Aged
Abstract: Whether chlorthalidone is superior to hydrochlorothiazide for preventing major adverse cardiovascular events in patients with hypertension is unclear.In a pragmatic trial, we randomly assigned adults 65 years of age or older who were patients in the Department of Veterans Affairs health system and had been receiving hydrochlorothiazide at a daily dose of 25 or 50 mg to continue therapy with hydrochlorothiazide or to switch to chlorthalidone at a daily dose of 12.5 or 25 mg. The primary outcome was a composite of nonfatal myocardial infarction, stroke, heart failure resulting in hospitalization, urgent coronary revascularization for unstable angina, and non-cancer-related death. Safety was also assessed.A total of 13,523 patients underwent randomization. The mean age was 72 years. At baseline, hydrochlorothiazide at a dose of 25 mg per day had been prescribed in 12,781 patients (94.5%). The mean baseline systolic blood pressure in each group was 139 mm Hg. At a median follow-up of 2.4 years, there was little difference in the occurrence of primary-outcome events between the chlorthalidone group (702 patients [10.4%]) and the hydrochlorothiazide group (675 patients [10.0%]) (hazard ratio, 1.04; 95% confidence interval, 0.94 to 1.16; P = 0.45). There were no between-group differences in the occurrence of any of the components of the primary outcome. The incidence of hypokalemia was higher in the chlorthalidone group than in the hydrochlorothiazide group (6.0% vs. 4.4%, P0.001).In this large pragmatic trial of thiazide diuretics at doses commonly used in clinical practice, patients who received chlorthalidone did not have a lower occurrence of major cardiovascular outcome events or non-cancer-related deaths than patients who received hydrochlorothiazide. (Funded by the Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT02185417.).
Published: 2022

10. Ascertainment of stroke from administrative data to support a pragmatic embedded clinical trial

Author: Srihari Raju, Cynthia Hau, Patricia Woods, Maura Flynn, Christal Sadatis, Jacob McPherson, Abhinav Tella, Areef Ishani, Ryan E. Ferguson, and Sarah M. Leatherman
Subjects: Pharmacology (medical), General Medicine
Published: 2023
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11. Initial Invasive or Conservative Strategy for Stable Coronary Disease

Author: Maron D. J., Hochman J. S., Reynolds H. R., Bangalore S., O'Brien S. M., Boden W. E., Chaitman B. R., Senior R., Lopez-Sendon J., Alexander K. P., Lopes R. D., Shaw L. J., Berger J. S., Newman J. D., Sidhu M. S., Goodman S. G., Ruzyllo W., Gosselin G., Maggioni A. P., White H. D., Bhargava B., Min J. K., John Mancini G. B., Berman D. S., Picard M. H., Kwong R. Y., Ali Z. A., Mark D. B., Spertus J. A., Krishnan M. N., Elghamaz A., Moorthy N., Hueb W. A., Demkow M., Mavromatis K., Bockeria O., Peteiro J., Miller T. D., Szwed H., Doerr R., Keltai M., Selvanayagam J. B., Gabriel Steg P., Held C., Kohsaka S., Mavromichalis S., Kirby R., Jeffries N. O., Harrell F. E., Rockhold F. W., Broderick S., Bruce Ferguson T., Williams D. O., Harrington R. A., Stone G. W., Rosenberg Y, ISCHEMIA Research Group: Joseph Ricci, A Tello Montoliu, A I Robero Aniorte, Abbey Mulder, Abhay A Laddu, Abhinav Goyal, Abhishek Dubey, Abhishek Goyal, Abigail Knighton, Abraham Oomman, Adam J Jaskowiak, Adam Kolodziej, Adam Witkowski, Adnan Hameed, Adriana Anesini, Afshan Hussain, Agne Juceviciene, Agne Urboniene, Agnes Jakal, Agnieszka Szramowska, Ahmad Khairuddin, Ahmed Abdel-Latif, Ahmed Adel, Ahmed Aljzeeri, Ahmed Kamal, Ahmed Talaat, Aimee Mann, Aira Contreras, Ajit Kumar, V K Kumar, Akemi Furukawa, Akshay Bagai, Akvile Smigelskaite, Alain Furber, Alain Rheault, Alaine Melanie Loehr, Alan Rosen, Albert Varga, Albertina Qelaj, Alberto Barioli, Aldo Russo, Alec Moorman, Alejandro Gisbert, Aleksandra Fratczak, Aleksandras Laucevicius, Alena Kuleshova, Alessandro Sionis, Alexander A Sirker, Alexander M Chernyavskiy, Alexandra Craft, Alexandra Vazquez, Alexandre Ciappina Hueb, Alexandre S Colafranseschi, Alexandre Schaan de Quadros, Alexandre Tognon, Ali Alghamdi, Alice Manica Muller, Aline Nogueira Rabaça, Aline Peixoto Deiro, Alison Hallam, Allegra Stone, Allison Schley, Almudena Castro, Alvaro Rabelo Ales, Amanda Germann, Amanda O'Malley, Amar Uxa, Amarachi Ojajuni, Amarino C Oliveira Jr, Amber B Hull, Ambuj Roy, Amer Zarka, Amir Janmohamed, Ammani Brown, Ammy Malinay, Amparo Martinez Monzonis, Amy J Richards, Amy Iskandrian, Amy Ollinger, Ana D Djordjevic-Dikic, Ana Fernández Martínez, Ana Gomes Almeida, Ana Paula Batista, Ana Rita Francisco, Ana S Mladenovic, Ana Santana, Anam Siddiqui, Anastasia M Kuzmina-Krutetskaya, Andras Vertes, Andre S Sousa, Andre Gabriel, André Schmidt, Andrea M Lundeen, Andrea Bartykowszki, Andrea Lorimer, Andrea Mortara, Andrea Pascual, Andreia Coelho, Andreia Rocha, Andrés García-Rincón, Andrew G Howarth, Andrew J Moriarty, Andrew Docherty, Andrew Starovoytov, Andrew Zurick, Andrzej Łabyk, Andrzej Swiatkowski, Andy Lam, Anelise Kawakami, Angela Hoye, Angela Kim, Angelique Smit, Angelo Nobre, Anil V Shah, Anja Ljubez, Anjali Anand, Ankush Sachdeva, Ann Greenberg, Ann Luyten, Ann Ostrander, Anna Di Donato, Anna Cichocka-Radwan, Anna Fojt, Anna Plachcinska, Anna Proietti, Anna Teresinska, Anne Marie Webb, Anne Cartwright, Anne Heath, Anne Mackin, Anong Amaritakomol, Anong Chaiyasri, Anoop Chauhan, Anoop Mathew, Anthony Gemignani, Anto Luigi Andres, Antonia Vega, Antonietta Hansen, Antonino Ginel Iglesias, Antonio Carlos Carvalho, Antonio Di Chiara, Antonio Serra Peñaranda, Antonio Carvalho, Antonio Colombo, Antonio Fiarresga, Anupama Rao, Aquiles Valdespino-Estrada, Araceli Boan, Areef Ishani, Ariel Diaz, Arijit Ghosh, Arintaya Prommintikul, Arline Roberts, Arnold H Seto, Arnold P Good, Arshed Quyyumi, Arthur J Labovitz, Arthur Kerner, Arturo S Campos-Santaolalla, Arunima Misra, Ashok Mukherjee, Ashok Seth, Ashraf Seedhom, Asim N Cheema, Asker Ahmed, Atul Mathur, Atul Verma, Audrey W Leong, Axel Åkerblom, Axelle Fuentes, Aynun Naher, Badhma Valaiyapathi, Baljeet Kaur, Bandula Guruge, Barbara Brzezińska, Barbara Nardi, Bartosz Czarniak, Bebek Singh, Begoña Igual, Bela Merkely, Belen Cid Alvarez, Benjamin J Spooner, Benjamin J W Chow, Benjamin Cheong, Benoy N Shah, Bernard de Bruyne, Bernardas Valecka, Bernhard Jäger, Beth A Archer, Beth Abramson, Beth Jorgenson, Bethany Harvey, Betsy O'Neal, Bev Atkinson, Bev Bozek, Bevin Lang, Bijulal Sasidharan, Bin Yang, Bin Zhang, Binoy Mannekkattukudy Kurian, Bjoern Goebel, Bob Hu, Bogdan A Popescu, Bogdan Crnokrak, Bolin Zhu, Bonnie J Kirby, Brandi D Zimbelman, Brandy Starks, Branko D Beleslin, Brenda Hart, Brian P Shapiro, Brian McCandless, Brianna Wisniewski, Brigham R Smith, Brooks Mirrer, Bruce McManus, Bruce Rutkin, Bruna Edilena Paulino, Bruna Maria Ascoli, Bryn Smith, Byron J Allen, C Michael Gibson, C Noel Bairey Merz, Calin Pop, Cameron Hague, Camila Thais de Ormundo, Candace Gopaul, Candice P Edillo, Carísi A Polanczyk, Carita Krannila, Carla Vicente, Carl-Éric Gagné, Carlo Briguori, Carlos Peña Gil, Carlos Alvarez, Carly Ohmart, Carmen C Beladan, Carmen Ginghina, Carol M Kartje, Caroline Alsweiler, Caroline Brown, Caroline Callison, Caroline Pinheiro, Caroline Rodgers, Caroline Spindler, Carolyn Corbett, Carrie Drum, Casey Riedberger, Catherine Bone, Catherine Fleming, Catherine Gordon, Catherine Jahrsdorfer, Catherine Lemay, Catherine Weick, Cathrine Patten, Cecilia Goletto, Cezary Kepka, Chandini Suvarna, Chang Xu, Chantale Mercure, Charle A Viljoen, Charlene Wiyarand, Charles Jia-Yin Hou, Charles Y Lui, Charles Cannan, Charles Cornet, Charlotte Pirro, Chataroon Rimsukcharoenchai, Chen Wang, Cheng-Ting Tsai, Chen-Yen Chien, Cheryl A Allardyce, Chester M Hedgepeth, Chetan Patel, Chiara Attanasio, Chih-Hsuan Yen, Chi-Ming Chow, Ching Min Er, Ching-Ching Ong, Cholenahally Nanjappa Manjunath, Chris Beck, Chris Buller, Christel Vassaliere, Christian Hamm, Christiano Caldeira, Christie Ballantyne, Christina Björklund, Christine R Hinton, Christine Bergeron, Christine Masson, Christine Roraff, Christine Shelley, Christophe Laure, Christophe Thuaire, Christopher Kinsey, Christopher McFarren, Christopher Spizzieri, Christopher Travill, Chun-Chieh Liu, Chung-Lieh Hung, Chunguang Li, Chun-Ho Yun, Chunli Xia, Ciarra Heard, Cidney Schultz, Clare Venn-Edmonds, Claudia P Hochberg, Claudia Wegmayr, Claudia Cortés, Claudia Escobar, Cláudia Freixo, Claudio T Mesquita, Clemens T Kadalie, Colin Berry, Constance Philander, Corine Thobois, Costantino Costantini, Courtney Page, Craig Atkinson, Craig Barr, Craig Paterson, Cristina Bare, Cynthia Baumann, Cynthia Burman, Dalisa Espinosa, Damien Collison, Dan Deleanu, Dan Elian, Dan Gao, Dana Oliver, Daniel P Vezina, Daniel O'Rourke, Daniele Komar, Danielle Schade, Darrel P Francis, Dastan Malaev, David A Bull, David E Winchester, David P Faxon, David Booth, David Cohen, David DeMets, David Foo, David Schlichting, David Taggart, David Waters, David Wohns, Davis Vo, Dawid Teodorczyk, Dawn Shelstad, Dawn Turnbull, Dayuan Li, Dean Kereiakes, Deborah O'Neill, Deborah Yip, Debra K Johnson, Debra Dees, Deepak L Bhatt, Deepika Gopal, Deepti Kumar, Deirdre Mattina, Deirdre Murphy, Delano R Small, Delsa K Rose, Dengke Jiang, Denis Carl Phaneuf, Denise Braganza, Denise Fine, Derek Cyr, Desiree Tobin, Diana Cukali, Diana Parra, Diane Camara, Diane Minshall Liu, Diego Adrián Vences, Diego Franca de Cunha, Dimitrios Stournaras, Dipti Patel, Dongze Li, Donna Exley, Dorit Grahl, Dragana Stanojevic, Duarte Cacela, Dwayne S G Conway, E Pinar Bermudez, Eapen Punnoose, Edgar L Tay, Edgar Karanjah, Edoardo Verna, Eduardo Hernandez-Rangel, Edward D Nicol, Edward O McFalls, Edward T Martin, Edyta Kaczmarska, Ekaterina I Lubinskaya, Elena A Demchenko, Elena Refoyo Salicio, Eli Feen, Elihú Durán-Cortés, Elisabeth M Janzen, Elise L Hannemann, Elise van Dongen, Elissa Restelli Piloto, Eliza Kaplan, Elizabeta Srbinovska Kostovska, Elizabeth Capasso-Gulve, Elizabeth Congdon, Elizabeth Ferguson, Elizaveta V Zbyshevskaya, Ellen Magedanz, Ellie Fridell, Ellis W Lader, Elvin Kedhi, Emanuela Racca, Emilie Tachot, Emily DeRosa, Encarnación Alonso-Álvarez, Eric Nicollet, Eric Peterson, Erick Alexánderson Rosas, Erick Donato Morales, Erin Orvis, Ermina Moga, Estelle Montpetit, Estevao Figueiredo, Eugene Passamani, Eugenia Nikolsky, Eunice Yeoh, Evgeniy I Kretov, Ewa Szczerba, Ewelina Wojtala, Expedito Eustáquio Ribeiro Silva, F Marin Ortuño, Fabio R Farias, Fabio Fimiani, Fabrizio Rolfo, Fa-Chang Yu, Fadi Hage, Fadi Matar, Fahim Haider Jafary, Fang Feng, Fang Liu, Fatima Ranjbaran, Fatima Rodriguez, Fausto J Pinto, Fauzia Rashid, Federica Ramani, Fei Wang, Fernanda Igansi, Filipa Silva, Filippo Ottani, Fiona Haines, Firas Al Solaiman, Flávia Egydio, Flavio Lyra, Florian Egger, Fran Farquharson, Frances Laube, Francesc Carreras Costa, Francesca de Micco, Francesca Bianchini, Francesca Pezzetta, Francesca Pietrucci, Francesco Orso, Francesco Pisano, Francis Burt, Francisca Patuleia Figueiras, Francisco Fernandez-Aviles, Francois Pierre Mongeon, Frans Van de Werf, Franziska Guenther, Fraser N Witherow, Fred Mohr, Frederico Dall'Orto, Fumiyuki Otsuka, G De La Morena, G Karthikeyan, Gabor Dekany, Gabor Kerecsen, Gabriel Galeote, Gabriel Grossmann, Gabriel Vorobiof, Gabriela Sanchez de Souza, Gabriela Guzman, Gabriela Zeballos, Gabriele Gabrielli, Gabriele Jakl-Kotauschek, Gail A Shammas, Gail Brandt, Gang Chen, Gary E Lane, Gary J Luckasen, Gautam Sharma, Gelmina Mikolaitiene, Gennie Yee, Georg Nickenig, George E Revtyak, George J Juang, Gerald Fletcher, Gerald Leonard, Gerard Patrick Devlin, Gerard Esposito, Gergely Ágoston, Gervasio Lamas, Geza Fontos, Ghada Mikhail, Gia Cobb, Gian Piero Perna, Gianpiero Leone, Giles Roditi, Gilles Barone-Rochette, Girish Mishra, Giuseppe Tarantini, Glenda Wong, Glenn S Hamroff, Glenn Rayos, Gong Cheng, Gonzalo Barge-Caballero, Goran Davidović, Goran Stankovic, Gordana Stevanovic, Grace Jingyan Wang, Grace M Young, Graceanne Wayser, Graciela Scaro, Graham S Hillis, Graham Wong, Grazyna Anna Szulczyk, Gregor Simonis, Gregory Kumkumian, Gretchen Ann Peichel, Grzegorz Gajos, Gudrun Steinmaurer, Guilherme G Rucatti, Guilherme Portugal, Guilhermina Cantinho Lopes, Guillem Pons Lladó, Gunnar Frostfelt, Gurpreet S Wander, Gurpreet Gulati, Gustavo Pucci, Hafidz Abd Hadi, Haibo Zhang, Haitao Wang, Halina Marciniak, Han Chen, Hanan Kerr, Hani Najm, Hanna Douglas, Hannah Phillips, Hao Dai, Haojian Dong, Haqeel Jamil, Harikrishnan Sivadasanpillai, Harry Suryapranata, Hassan Reda, Hayley Pomeroy, Heather Barrentine, Heather Golden, Heather Hurlburt, Heidi Wilson, Helen C Tucker, Helene Abergel, Hemalata Siddaram, Hermine Osseni, Herwig Schuchlenz, Hesong Zeng, Hicham Skali, Hilda Solomon, Hollie Horton, Holly Hetrick, Holly Little, Holly Park, Hongjie Chi, Hossam Mahrous, Howard A Levite, Hristo Pejkov, Huajun Li, Hugo Bloise-Adames, Hugo Marques, Hui Zhong, Hui-Min Zhang, Humayrah Hashim, Hung-I Yeh, Hussien El Fishawy, Ian Webb, Iftikhar Kullo, Igor O Grazhdankin, Ihab Hamzeh, Ikraam Hassan, Ikuko Ueda, Ileana L Pina, Ilona Tamasauskiene, Ilse Bouwhuis, Imran Arif, Ina Wenzelburger, Inês Zimbarra Cabrita, Ines Rodrigues, Inga H Robbins, Inga Soveri, Ingela Schnittger, Iqbal Karimullah, Ira M Dauber, Iram Rehman, Irena Peovska Mitevska, Irene Marthe Lang, Irina Subbotina, Irma Kalibataite-Rutkauskiene, Irni Yusnida, Isabel Estela Carvajal, Isabella C Palazzo, Isabelle Hogan, Isabelle Roy, Ishba Syed, Ishita Tejani, Ivan A Naryshkin, Ivana Jankovic, Iwona Niedzwiecka, J David Knight, Jacek Kusmierek, Jackie M White, Jackie Chow, Jacob Udell, Jacqueline E Tamis-Holland, Jacqueline Fannon, Jacquelyn A Quin, Jacquelyn Do, Jaekyeong Heo, Jakub Maksym, James E Davies, James H O'Keefe Jr, James J Jang, James Cha, James Harrison, James Hirsch, James Stafford, James Tatoulis, Jamie Rankin, Jan Henzel, Jan Orga, Jana Tancredi, Janaina Oliveira, Jane Burton, Jane Eckstein, Jane Marucci, Janet P Knight, Janet Blount, Janet Halliday, Janetta Kourzenkova, Janitha Raj, Jan-Malte Sinning, Jaqueline Pozzibon, Jaroslaw Drozdz, Jaroslaw Karwowski, Jason D Glover, Jason Loh Kwok, Jason T Call, Jason Linefsky, Jassira Gomes, Jati Anumpa, Javier J Garcia, Javier Courtis, Jay Meisner, K Jayakumar, Jayne Scales, Jean E Denaro, Jean Michel Juliard, Jean Ho, Jeanette K Stansborough, Jean-Michel Juliard, Jeanne Russo, Jeannette J M Schoep, Jeet Thambyrajah, Jeff Leimberger, Jeffery A Breall, Jeffrey A Kohn, Jeffrey C Milliken, Jeffrey Anderson, Jeffrey Blume, Jeffrey Kanters, Jeffrey Lorin, Jeffrey Moses, Jelena J Stepanovic, Jelena Celutkiene, Jelena Djokic, Jelena Stojkovic, Jenne M Jose, Jenne Manchery, Jennifer A Mull, Jennifer H Czerniak, Jennifer L Stanford, Jennifer Gillis, Jennifer Horst, Jennifer Isaacs, Jennifer Langdon, Jennifer Thomson, Jennifer Tomfohr, Jennifer White, Jen-Yuan Kuo, Jeremy Rautureau, Jerome Fleg, Jessica Berg, Jessica Rodriguez, Jessica Waldron, Jhina Patro, Jia Li, Jiajia Mao, Jiamin Liu, Jian'an Wang, Jianhua Li, Jianxin Zhang, Jie Qi, Jihyun Lyo, Jill Marcus, Jim Blankenship, Jing Zhang, Jingjing Liu, Jing-Yao Fan, Jiun-Yi Li, Jiwan Pradhan, Jiyan Chen, J M Rivera Caravaca, Jo Evans, Joan Garcia Picart, Joan Hecht, Joanna Jaroch, Joanna Zalewska, Joanne Kelly, Joanne Taaffe, João Reynaldo Abbud, João V Vitola, Joaquín V Peñafiel, Jocelyne Benatar, Jody Bindeman, Joe Sabik, Joel Klitch, Johann Christopher, Johannes Aspberg, John D Friedman, John F Beltrame, John F Heitner, John Joseph Graham, John R Davies, John Doan, John Kotter, John Kurian, John Mukai, John Pownall, Jolanta Sobolewska, Jon Kobashigawa, Jonathan L Goldberg, Jonathan W Bazeley, Jonathan Byrne, Jonathan Himmelfarb, Jonathan Leipsic, Jonean Thorsen, Jorge F Trejo Gutierrez, Jorge Escobedo, Jorik Timmer, José A Ortega-Ramírez, José Antonio Marin-Neto, Jose D Salas, Jose Enrique Castillo, Jose Francisco Saraiva, José J Cuenca-Castillo, Jose L Diez, José Luis Narro Villanueva, José Luiz da Vieira, José M Flores-Palacios, Jose Ramon Gonzalez, Jose Seijas Amigo, Jose Fragata, Josep Maria Padró, Josheph F X McGarvey Jr, Joseph Hannan, Joseph Sacco, Joseph Sweeny, Joseph Wiesel, Josephine D Abraham, Joshua P Loh, Joy Burkhardt, Joyce R White, Joyce Riestenberg-Smith, Judit Sebo, Judith L Meadows, Judith Wright, Judy Mae Foltz, Judy Hung, Judy Otis, Juergen Stumpf, Jui-Peng Tsai, Julia S Dionne, Julia de Aveiro Morata, Julie Bunke, Julie Morrow, Julio César Figal, Jun Fujita, Jun Jiang, Junhua Li, Junqing Yang, Juntima Euathrongchit, Jyotsna Garg, K Manjula Rani, K Preethi, Kaatje Goetschalckx, Kai Eggers, Kamalakar Surineni, Kanae Hirase, T R Kapilamoorthy, Karen Calfas, Karen Gratrix, Karen Hallett, Karen Hultberg, Karen Nugent, Karen Petrosyan, Karen Swan, Karolina Kryczka, Karolina Wojtczak-Soska, Karolina Wojtera, Karsten Lenk, Karthik Ramasamy, Katarzyna Łuczak, Katarzyna Malinowska, Kate Pointon, Kate Robb, Katherine Martin, Kathleen Claes, Kathryn Carruthers, Kathy E Siegel, Katia Drouin, Katie Fowler-Lehman, Kavita Rawat, Kay Rowe, Keiichi Fukuda, Keith A A Fox, Ken Mahaffey, Kendra Unterbrink, Kenneth Giedd, Kerrie Van Loo, Kerry Lee, Kerstin Bonin, Kevin R Bainey, Kevin T Harley, Kevin Anstrom, Kevin Chan, Kevin Croce, Kevin Landolfo, Kevin Marzo, Keyur Patel, Khaled Abdul-Nour, Khaled Alfakih, Khaled Dajani, Khaled Ziada, Khaula Baloch, Khrystyna Kushniriuk, Kian-Keong Poh, Kim F Ireland, Kim Holland, Kimberly Ann Byrne, Kimberly E Halverson, Kimberly Elmore, Kimberly Miller-Cox, Kiran Reddy, Kirsten J Quiles, Kirsty Abercrombie, Klaus Matschke, Konrad Szymczyk, Koo Hui Chan, Kotiboinna Preethi, Kozhaya Sokhon, Krissada Meemuk, Kristian Thygesen, Kristin M Salmi, Kristin Newby, Kristina Wippler, Kristine Arges, Kristine Teoh, Krystal Etherington, Krystyna Łoboz-Grudzień, Krzysztof W Reczuch, Krzysztof Bury, Krzysztof Drzymalski, Krzysztof Kukuła, Kuo-Tzu Sung, Kurt Huber, Ladda Douangvila, Lance Sullenberger, Larissa Miranda Trama, Laszlone Matics, Laura Drew, Laura Flint, Laura Keinaite, Laura Sarti, Laurel Kolakaluri, Lawrence M Phillips, Lawrence Friedman, Lawrence Phillips, Lazar Velicki, Leah Howell, Leandro C Maranan, Leanne Cox, Ledjalem Daba, Lei Zhang, Lekshmi Dharmarajan, Leo Bockeria, Leonardo Pizzol Caetano, Leonardo Bridi, Leonid L Bershtein, Leszek Sokalski, Li Hai Yan, Li Li, Lia Nijmeijer, Lidia Sousa, Lihong Xu, Lihua Zhang, Lili Zhang, Lilia Schiavi, Lilian Mazza Barbosa, Lillian L Khor, Lina Felix-Stern, Linda L Hall, Linda M Hollenweger, Linda Arcand, Linda Davidson-Ray, Linda Schwarz, Lindsey N Sikora, Lingping Chi, Lino Patricio, Liping Zhang, Lisa Chaytor, Lisa Hatch, Lisa McCloy, Lisa Wong, Liselotte Persson, Lixin Jiang, Liz Low, Ljiljana Pupic, Loïc Bière, Lorenzo Monti, Lori Christensen, Lori Pritchard, Loriane Black, Lori-Ann Desimone, Lori-Ann Larmand, Lorraine McGregor, Louise Morby, Louise Thomson, Luc Harvey, Luciana de Pádua Baptista, Lucilla Garcia, Ludivine Eliahou, Ludmila Helmer, Luis F Smidt, Luis Bernanrdes, Luis Guzman, Luiz A Carvalho, Luyang Xiong, Lynette L Teo, Lynn M Neeson, Lynne Winstanley, M Barbara Srichai-Parsia, M Quintana Giner, M Sowjanya Reddy, M Valdés Chávarri, M Grazia Rossi, Maarten Simoons, Maayan Konigstein, Maciej Lesiak, Maciej Olsowka, Mafalda Selas, Magalie Corfias, Magdalena Madero Rovalo, Magdalena Łanocha, Magdalena Miller, Magdalena Misztal-Teodorczyk, Magdalena Rantinella, Magdy Abdelhamid, Magnolia Jimenez, Mahboob Alam, Mahevamma Mylarappa, Mahfouz El Shahawy, Mahmoud Mohamed, Mahmud Al-Bustami, Majo X Joseph, Malgorzata Frach, Małgorzta Celińska-Spodar, Malte Helm, Manas Chacko, Mandy Murphy, Manitha Vinod, Manjula Rani, Manu Dhawan, Manuela Mombelli, Marcel Weber, Marcello Galvani, Marcelo Jamus Rodrigues, Marcia F Dubin, Marcia F Werner Bayer, Marcin Szkopiak, Marco Antonio Monsalve, Marco Bizzaro Santos, Marco Magnoni, Marco Marini, Marco Sicuro, Marco Zenati, Marcos Valério Coimbra Resende, Marek Roik, Margalit Bentzvi, Margaret Gilsenan, Margaret Iraola, Margot C Quinn, Maria A Alfonso, Maria Antonieta Pereira Moraes, María Dolores Martínez-Ruíz, María Fernanda Canales, Maria Inês Caetano, Maria P Corral, Maria Pérez García, Maria Victoria Actis, Maria Aguirre, Maria Andreasson, Maria Aprile, Maria Colton, Maria Eugenia Martin, Maria Lasala, Maria Lorenzo, Maria Posada, Maria Shier, Maria Thottam, Mariana V Furtado, Mariana Yumi Okada, Marianna D A Dracoulakis, Marianne De Andrade, Mariano Rubio, Marie Essermark, Marielle Scherrer-Crosbie, Marija T Petrovic, Marija Zdravkovic, Marilyn Black, Marina Garcia, Mario J Garcia, Mariola Szulik, Marisa Orgera, Mark A de Belder, Mark Harbinson, Mark Hyun, Mark Peterson, Mark Xavier, Marlowe Mosley, Marta Capinha, Marta Marcinkiewicz-Siemion, Marta Swiderek, Martha Meyer, Martina Ceseri, Martina Tricoli, Marvin Kronenberg, Mary Williams, Mary Ann Champagne, Mary Colleen Rogge, Mary R Soltau, Mary Streif, Massimo Villella, Massoud Leesar, Matei Claudia, Mateusz Solecki, Matías Nicolás Mungo, Matthew Wall Jr, Matthew Budoff, Matthew Jezior, Matthew Luckie, Matthias Friedrich, Mauren P Haeffner, Maximilian Tscharre, Max-Paul Winter, Mayana Almeida, Mayil S Krishnam, Mayuri Patel, Meenakshi Mishra, Megan Manocchia, Meghana Kakade, Melanie J Munro, Melissa D Chaplin, Melissa LeFevre, Mervyn Andiapen, Michael A Gibson, Michael B Rubens, Michael C Turner, Michael D Shapiro, Michael W Lee, Michael Berlowitz, Michael Davidson, Michael Mack, Michael McDaniel, Michael Mumma, Michal Wlodarczyk, Michel G Khouri, Michel S Slama, Michele Rawlins, Michelle M Bonner, Michelle M Seib, Michelle Chang, Michelle Crowder, Michelle Dixon, Michelle Mayon, Michelle McEvoy, Michelle Yee, Miguel M Fernandes, Miguel Nobre Menezes, Miguel Souto Bayarri, Miguel Barrero, Mikhail T Torosoff, Milan R Dobric, Milan Dobric, Milica Nikola Dekleva, Milind Avdhoot Gadkari, Millie Gomez, Min Tun Kyaw, Miriam Brooks, Miroslav Stevo Martinovic, Mitchel B Lustre, Mohammad Tariq Vakani, Mohammad El-Hajjar, Mohammed Al-Amoodi, 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Mokhtar, Noppon Taksaudom, Nor Asiah Basri, Nora Marchelletta, Norma Hogg, Nungshi Jungla, Nuno Ferreira, Oksana A Lubyanaya, Olga B Nikolaeva, Olga Cañavate, Olga Sobrino, Olga Walesiak, Olga Walter, Olga Zdończyk, Olivia J Lim, Olivia Anaya, Olivia Mancilla, Olivier Dubourg, Olugbenga Bello, Omar Almousalli, Omar Thompson, Oni Olurinde, Or Harel, Osama Raheem, Oscar Méndiz, Óscar Prada-Delgado, Oz Shapira, P Christian Schulze, Pachara Panpunuan, Pal Maurovich-Horvat, Pallav Garg, Paloma Moraga, Pam Singh, Pamela Julian, Pamela Ouyang, Pamela Sigel, Pamela Woodard, Panpan Zhou, Paola Emanuela Poggio, Paola Smanio, Paolo Calabro, Paramjit Jeetley, Pascal Goube, Patricia K Nguyen, Patricia Alarie, Patricia Arakelian, Patricia Arsenault, Patricia Blaise, Patricia Brito, Patricia Cowper, Patricia Endsley, Patricia Mieses, Patrick B Alexander, Patrick Donnelly, Patrick Wilmot, Patrycja Lebioda, Paul C Gordon, Paul Der Mesropian, Paul Galiwango, Paul Hauptman, Paul Kennedy, Paula Beardsley, Paula García-González, Paulo Cury Rezende, Paulo Ricardo Caramori, Pavel S Kozlov, Pedro Canas Silva, Pedro Gabriel Melo Barros E Silva, Pedro Píccaro de Oliveira, Pedro Carvalho, Pedro Modas, Pedro Rio, Peeyush Jain, Peiyu He, Peter A McCullough, Peter H Stone, Peter M Pollak, Peter Douglass, Peter Henriksen, Peter OKane, Peter Ong, Philip Jones, Philip Rogal, Philippe Généreux, Philippe Menasche, Philippe Rheault, Phoebe Goold, Pierre Gervais, Pierre Michaud, Pilar Calvillo, Ping Chai, Piotr Jakubowski, Piotr Pruszczyk, Piotr Slomka, Piyamitr Sritara, Poay-Huan Loh, Poonam Sonawane, Pouneh Samadi, Pragnesh P Parikh, Prakash Deedwania, Pranav M Patel, Praneeth Polamuri, Pratiksha Sharma, Precilia Vasquez, Preeti Kamath, Prince Thomas, Priyadarshani Arambam, Puja K Mehta, Purvez Grant, Pushpa Naik, Qi Zhong, Qian Zhao, Qiang Zhou, Qianqian Yuan, Qin Yu, Qingxian Li, Qiulan Xie, Qiutang Zeng, R J Vindhya, R James Gerlach, Rachel King, Rada Vučić, Radmila Lyubarova, Radoslaw Pracon, Raewyn Fisher, Rafael Beyar, Rafael Diaz, Rafael Selgas, Raffaele Bugiardini, Raffaele Fanelli, Raisa Kavalakkat, V S Rajalekshmi, Rajat S Barua, Rajeev Menon, Rajesh Gopalan Nair, Rajesh Francis, Rajiv Narang, Rakesh Yadav, Ralph Alan Huston, T Ramakrishnan, Ramesh de Silva, Rami El Mahmoud, Ramiro Carvalho, Ramon de Jesús-Pérez, Ramona Stevens, Ran Leng, Ranjan Kachru, Ranjit Kumar Nath, Raquel Sanchez, Raven R Dwyer, Raven Lee, Ray Wyman, Raymond C Wong, Raymond W Little, Raymundo Ocaranza Sanchez, Rebecca J Wimmer, Rebecca Bariciano, Rebecca Otis, Rebekah R Herrmann, Reem Yunis, Reinette Hampson, Renato Abdala Karam, Renee C Hessian, Renee Kaneshiro, Reshma Ravindran, Reto Andreas Gamma, Reyna Bhandari, Reza Arsanjani, Ricardo L Lopes, Ricardo Mendes Oliveira, Ricardo Costa, Richa Bhatt, Richard F Davies, Richard H J Trimlett, Richard Goldweit, Rik Hermanides, Rine Nakanishi, Rinu R Sidh, Risha Patel, Rita Coram, Rizwan A Siddiqui, Rob S Beanlands, Robert J Hamburger, Robert K Riezebos, Robert M Donnino, Robert Bojar, Robert Chilton, Robert Guyton, Robert Henderson, Robert Kornberg, Robert Leber, Robert Mao, Robert Stenberg, Roberta P Santos, Roberto René Favaloro, Roberto Amati, Rodolfo G S D Lima, Rodrigo J Cerci, Rogerio Tumelero, Rohit Tandon, Roma Tewari, Romalisa Miranda-Peats, Ron Wald, Ronald A Mastouri, Ronald G Morford, Ronald G Schwartz, Ronald P Pedalino, Rongrong Hu, Ronnell A Hansen, Ronny A Cohen, Rory Hachamovitch, Rosa Homem, Rosa Sandonato, Rosane Laimer, Rosann Gans, Roxanne Yost, Roy Mathew, Rubén Baleón-Espinosa, Ruben Ramos, Rubine Gevorgyan, Rui Ferreira, Rui Jing, Ruth Pérez-Fernández, S K Dwivedi, S Ramakrishnan, Saadat Khan, Sabahat Bokhari, Sabu Thomas, Sadath Lubna, Sajeeda Parveen Khan, Sajeev Chakanalil Govindan, Saket Girotra, Saleem Kassam, Sallie Canada, Salvador Cruz-Flores, Samaa Mohamed, Samantha Ly, Sameh El Kaffas, Samia Massalha, Sampoornima Setty, Samuel Nwosu, Sandeep Seth, Sandeep Singh, Sander R Niehe, Sandra M 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S.G., Ruzyllo W., Gosselin G., Maggioni A.P., White H.D., Bhargava B., Min J.K., John Mancini G.B., Berman D.S., Picard M.H., Kwong R.Y., Ali Z.A., Mark D.B., Spertus J.A., Krishnan M.N., Elghamaz A., Moorthy N., Hueb W.A., Demkow M., Mavromatis K., Bockeria O., Peteiro J., Miller T.D., Szwed H., Doerr R., Keltai M., Selvanayagam J.B., Gabriel Steg P., Held C., Kohsaka S., Mavromichalis S., Kirby R., Jeffries N.O., Harrell F.E., Rockhold F.W., Broderick S., Bruce Ferguson T., Williams D.O., Harrington R.A., Stone G.W., Rosenberg Y, and ISCHEMIA Research Group: Joseph Ricci, A Tello Montoliu, A I Robero Aniorte, Abbey Mulder, Abhay A Laddu, Abhinav Goyal, Abhishek Dubey, Abhishek Goyal, Abigail Knighton, Abraham Oomman, Adam J Jaskowiak, Adam Kolodziej, Adam Witkowski, Adnan Hameed, Adriana Anesini, Afshan Hussain, Agne Juceviciene, Agne Urboniene, Agnes Jakal, Agnieszka Szramowska, Ahmad Khairuddin, Ahmed Abdel-Latif, Ahmed Adel, Ahmed Aljzeeri, Ahmed Kamal, Ahmed Talaat, Aimee Mann, Aira Contreras, Ajit Kumar, V K Kumar, Akemi Furukawa, Akshay Bagai, Akvile Smigelskaite, Alain Furber, Alain Rheault, Alaine Melanie Loehr, Alan Rosen, Albert Varga, Albertina Qelaj, Alberto Barioli, Aldo Russo, Alec Moorman, Alejandro Gisbert, Aleksandra Fratczak, Aleksandras Laucevicius, Alena Kuleshova, Alessandro Sionis, Alexander A Sirker, Alexander M Chernyavskiy, Alexandra Craft, Alexandra Vazquez, Alexandre Ciappina Hueb, Alexandre S Colafranseschi, Alexandre Schaan de Quadros, Alexandre Tognon, Ali Alghamdi, Alice Manica Muller, Aline Nogueira Rabaça, Aline Peixoto Deiro, Alison Hallam, Allegra Stone, Allison Schley, Almudena Castro, Alvaro Rabelo Ales, Amanda Germann, Amanda O'Malley, Amar Uxa, Amarachi Ojajuni, Amarino C Oliveira Jr, Amber B Hull, Ambuj Roy, Amer Zarka, Amir Janmohamed, Ammani Brown, Ammy Malinay, Amparo Martinez Monzonis, Amy J Richards, Amy Iskandrian, Amy Ollinger, Ana D Djordjevic-Dikic, Ana Fernández Martínez, Ana Gomes Almeida, Ana Paula Batista, Ana Rita Francisco, Ana S Mladenovic, Ana Santana, Anam Siddiqui, Anastasia M Kuzmina-Krutetskaya, Andras Vertes, Andre S Sousa, Andre Gabriel, André Schmidt, Andrea M Lundeen, Andrea Bartykowszki, Andrea Lorimer, Andrea Mortara, Andrea Pascual, Andreia Coelho, Andreia Rocha, Andrés García-Rincón, Andrew G Howarth, Andrew J Moriarty, Andrew Docherty, Andrew Starovoytov, Andrew Zurick, Andrzej Łabyk, Andrzej Swiatkowski, Andy Lam, Anelise Kawakami, Angela Hoye, Angela Kim, Angelique Smit, Angelo Nobre, Anil V Shah, Anja Ljubez, Anjali Anand, Ankush Sachdeva, Ann Greenberg, Ann Luyten, Ann Ostrander, Anna Di Donato, Anna Cichocka-Radwan, Anna Fojt, Anna Plachcinska, Anna Proietti, Anna Teresinska, Anne Marie Webb, Anne Cartwright, Anne Heath, Anne Mackin, Anong Amaritakomol, Anong Chaiyasri, Anoop Chauhan, Anoop Mathew, Anthony Gemignani, Anto Luigi Andres, Antonia Vega, Antonietta Hansen, Antonino Ginel Iglesias, Antonio Carlos Carvalho, Antonio Di Chiara, Antonio Serra Peñaranda, Antonio Carvalho, Antonio Colombo, Antonio Fiarresga, Anupama Rao, Aquiles Valdespino-Estrada, Araceli Boan, Areef Ishani, Ariel Diaz, Arijit Ghosh, Arintaya Prommintikul, Arline Roberts, Arnold H Seto, Arnold P Good, Arshed Quyyumi, Arthur J Labovitz, Arthur Kerner, Arturo S Campos-Santaolalla, Arunima Misra, Ashok Mukherjee, Ashok Seth, Ashraf Seedhom, Asim N Cheema, Asker Ahmed, Atul Mathur, Atul Verma, Audrey W Leong, Axel Åkerblom, Axelle Fuentes, Aynun Naher, Badhma Valaiyapathi, Baljeet Kaur, Bandula Guruge, Barbara Brzezińska, Barbara Nardi, Bartosz Czarniak, Bebek Singh, Begoña Igual, Bela Merkely, Belen Cid Alvarez, Benjamin J Spooner, Benjamin J W Chow, Benjamin Cheong, Benoy N Shah, Bernard de Bruyne, Bernardas Valecka, Bernhard Jäger, Beth A Archer, Beth Abramson, Beth Jorgenson, Bethany Harvey, Betsy O'Neal, Bev Atkinson, Bev Bozek, Bevin Lang, Bijulal Sasidharan, Bin Yang, Bin Zhang, Binoy Mannekkattukudy Kurian, Bjoern Goebel, Bob Hu, Bogdan A Popescu, Bogdan Crnokrak, Bolin Zhu, Bonnie J Kirby, Brandi D Zimbelman, Brandy Starks, Branko D Beleslin, Brenda Hart, Brian P Shapiro, Brian McCandless, Brianna Wisniewski, Brigham R Smith, Brooks Mirrer, Bruce McManus, Bruce Rutkin, Bruna Edilena Paulino, Bruna Maria Ascoli, Bryn Smith, Byron J Allen, C Michael Gibson, C Noel Bairey Merz, Calin Pop, Cameron Hague, Camila Thais de Ormundo, Candace Gopaul, Candice P Edillo, Carísi A Polanczyk, Carita Krannila, Carla Vicente, Carl-Éric Gagné, Carlo Briguori, Carlos Peña Gil, Carlos Alvarez, Carly Ohmart, Carmen C Beladan, Carmen Ginghina, Carol M Kartje, Caroline Alsweiler, Caroline Brown, Caroline Callison, Caroline Pinheiro, Caroline Rodgers, Caroline Spindler, Carolyn Corbett, Carrie Drum, Casey Riedberger, Catherine Bone, Catherine Fleming, Catherine Gordon, Catherine Jahrsdorfer, Catherine Lemay, Catherine Weick, Cathrine Patten, Cecilia Goletto, Cezary Kepka, Chandini Suvarna, Chang Xu, Chantale Mercure, Charle A Viljoen, Charlene Wiyarand, Charles Jia-Yin Hou, Charles Y Lui, Charles Cannan, Charles Cornet, Charlotte Pirro, Chataroon Rimsukcharoenchai, Chen Wang, Cheng-Ting Tsai, Chen-Yen Chien, Cheryl A Allardyce, Chester M Hedgepeth, Chetan Patel, Chiara Attanasio, Chih-Hsuan Yen, Chi-Ming Chow, Ching Min Er, Ching-Ching Ong, Cholenahally Nanjappa Manjunath, Chris Beck, Chris Buller, Christel Vassaliere, Christian Hamm, Christiano Caldeira, Christie Ballantyne, Christina Björklund, Christine R Hinton, Christine Bergeron, Christine Masson, Christine Roraff, Christine Shelley, Christophe Laure, Christophe Thuaire, Christopher Kinsey, Christopher McFarren, Christopher Spizzieri, Christopher Travill, Chun-Chieh Liu, Chung-Lieh Hung, Chunguang Li, Chun-Ho Yun, Chunli Xia, Ciarra Heard, Cidney Schultz, Clare Venn-Edmonds, Claudia P Hochberg, Claudia Wegmayr, Claudia Cortés, Claudia Escobar, Cláudia Freixo, Claudio T Mesquita, Clemens T Kadalie, Colin Berry, Constance Philander, Corine Thobois, Costantino Costantini, Courtney Page, Craig Atkinson, Craig Barr, Craig Paterson, Cristina Bare, Cynthia Baumann, Cynthia Burman, Dalisa Espinosa, Damien Collison, Dan Deleanu, Dan Elian, Dan Gao, Dana Oliver, Daniel P Vezina, Daniel O'Rourke, Daniele Komar, Danielle Schade, Darrel P Francis, Dastan Malaev, David A Bull, David E Winchester, David P Faxon, David Booth, David Cohen, David DeMets, David Foo, David Schlichting, David Taggart, David Waters, David Wohns, Davis Vo, Dawid Teodorczyk, Dawn Shelstad, Dawn Turnbull, Dayuan Li, Dean Kereiakes, Deborah O'Neill, Deborah Yip, Debra K Johnson, Debra Dees, Deepak L Bhatt, Deepika Gopal, Deepti Kumar, Deirdre Mattina, Deirdre Murphy, Delano R Small, Delsa K Rose, Dengke Jiang, Denis Carl Phaneuf, Denise Braganza, Denise Fine, Derek Cyr, Desiree Tobin, Diana Cukali, Diana Parra, Diane Camara, Diane Minshall Liu, Diego Adrián Vences, Diego Franca de Cunha, Dimitrios Stournaras, Dipti Patel, Dongze Li, Donna Exley, Dorit Grahl, Dragana Stanojevic, Duarte Cacela, Dwayne S G Conway, E Pinar Bermudez, Eapen Punnoose, Edgar L Tay, Edgar Karanjah, Edoardo Verna, Eduardo Hernandez-Rangel, Edward D Nicol, Edward O McFalls, Edward T Martin, Edyta Kaczmarska, Ekaterina I Lubinskaya, Elena A Demchenko, Elena Refoyo Salicio, Eli Feen, Elihú Durán-Cortés, Elisabeth M Janzen, Elise L Hannemann, Elise van Dongen, Elissa Restelli Piloto, Eliza Kaplan, Elizabeta Srbinovska Kostovska, Elizabeth Capasso-Gulve, Elizabeth Congdon, Elizabeth Ferguson, Elizaveta V Zbyshevskaya, Ellen Magedanz, Ellie Fridell, Ellis W Lader, Elvin Kedhi, Emanuela Racca, Emilie Tachot, Emily DeRosa, Encarnación Alonso-Álvarez, Eric Nicollet, Eric Peterson, Erick Alexánderson Rosas, Erick Donato Morales, Erin Orvis, Ermina Moga, Estelle Montpetit, Estevao Figueiredo, Eugene Passamani, Eugenia Nikolsky, Eunice Yeoh, Evgeniy I Kretov, Ewa Szczerba, Ewelina Wojtala, Expedito Eustáquio Ribeiro Silva, F Marin Ortuño, Fabio R Farias, Fabio Fimiani, Fabrizio Rolfo, Fa-Chang Yu, Fadi Hage, Fadi Matar, Fahim Haider Jafary, Fang Feng, Fang Liu, Fatima Ranjbaran, Fatima Rodriguez, Fausto J Pinto, Fauzia Rashid, Federica Ramani, Fei Wang, Fernanda Igansi, Filipa Silva, Filippo Ottani, Fiona Haines, Firas Al Solaiman, Flávia Egydio, Flavio Lyra, Florian Egger, Fran Farquharson, Frances Laube, Francesc Carreras Costa, Francesca de Micco, Francesca Bianchini, Francesca Pezzetta, Francesca Pietrucci, Francesco Orso, Francesco Pisano, Francis Burt, Francisca Patuleia Figueiras, Francisco Fernandez-Aviles, Francois Pierre Mongeon, Frans Van de Werf, Franziska Guenther, Fraser N Witherow, Fred Mohr, Frederico Dall'Orto, Fumiyuki Otsuka, G De La Morena, G Karthikeyan, Gabor Dekany, Gabor Kerecsen, Gabriel Galeote, Gabriel Grossmann, Gabriel Vorobiof, Gabriela Sanchez de Souza, Gabriela Guzman, Gabriela Zeballos, Gabriele Gabrielli, Gabriele Jakl-Kotauschek, Gail A Shammas, Gail Brandt, Gang Chen, Gary E Lane, Gary J Luckasen, Gautam Sharma, Gelmina Mikolaitiene, Gennie Yee, Georg Nickenig, George E Revtyak, 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Hayley Pomeroy, Heather Barrentine, Heather Golden, Heather Hurlburt, Heidi Wilson, Helen C Tucker, Helene Abergel, Hemalata Siddaram, Hermine Osseni, Herwig Schuchlenz, Hesong Zeng, Hicham Skali, Hilda Solomon, Hollie Horton, Holly Hetrick, Holly Little, Holly Park, Hongjie Chi, Hossam Mahrous, Howard A Levite, Hristo Pejkov, Huajun Li, Hugo Bloise-Adames, Hugo Marques, Hui Zhong, Hui-Min Zhang, Humayrah Hashim, Hung-I Yeh, Hussien El Fishawy, Ian Webb, Iftikhar Kullo, Igor O Grazhdankin, Ihab Hamzeh, Ikraam Hassan, Ikuko Ueda, Ileana L Pina, Ilona Tamasauskiene, Ilse Bouwhuis, Imran Arif, Ina Wenzelburger, Inês Zimbarra Cabrita, Ines Rodrigues, Inga H Robbins, Inga Soveri, Ingela Schnittger, Iqbal Karimullah, Ira M Dauber, Iram Rehman, Irena Peovska Mitevska, Irene Marthe Lang, Irina Subbotina, Irma Kalibataite-Rutkauskiene, Irni Yusnida, Isabel Estela Carvajal, Isabella C Palazzo, Isabelle Hogan, Isabelle Roy, Ishba Syed, Ishita Tejani, Ivan A Naryshkin, Ivana Jankovic, Iwona Niedzwiecka, J David Knight, Jacek Kusmierek, Jackie M White, Jackie Chow, Jacob Udell, Jacqueline E Tamis-Holland, Jacqueline Fannon, Jacquelyn A Quin, Jacquelyn Do, Jaekyeong Heo, Jakub Maksym, James E Davies, James H O'Keefe Jr, James J Jang, James Cha, James Harrison, James Hirsch, James Stafford, James Tatoulis, Jamie Rankin, Jan Henzel, Jan Orga, Jana Tancredi, Janaina Oliveira, Jane Burton, Jane Eckstein, Jane Marucci, Janet P Knight, Janet Blount, Janet Halliday, Janetta Kourzenkova, Janitha Raj, Jan-Malte Sinning, Jaqueline Pozzibon, Jaroslaw Drozdz, Jaroslaw Karwowski, Jason D Glover, Jason Loh Kwok, Jason T Call, Jason Linefsky, Jassira Gomes, Jati Anumpa, Javier J Garcia, Javier Courtis, Jay Meisner, K Jayakumar, Jayne Scales, Jean E Denaro, Jean Michel Juliard, Jean Ho, Jeanette K Stansborough, Jean-Michel Juliard, Jeanne Russo, Jeannette J M Schoep, Jeet Thambyrajah, Jeff Leimberger, Jeffery A Breall, Jeffrey A Kohn, Jeffrey C Milliken, Jeffrey Anderson, Jeffrey Blume, Jeffrey Kanters, Jeffrey Lorin, Jeffrey Moses, Jelena J Stepanovic, Jelena Celutkiene, Jelena Djokic, Jelena Stojkovic, Jenne M Jose, Jenne Manchery, Jennifer A Mull, Jennifer H Czerniak, Jennifer L Stanford, Jennifer Gillis, Jennifer Horst, Jennifer Isaacs, Jennifer Langdon, Jennifer Thomson, Jennifer Tomfohr, Jennifer White, Jen-Yuan Kuo, Jeremy Rautureau, Jerome Fleg, Jessica Berg, Jessica Rodriguez, Jessica Waldron, Jhina Patro, Jia Li, Jiajia Mao, Jiamin Liu, Jian'an Wang, Jianhua Li, Jianxin Zhang, Jie Qi, Jihyun Lyo, Jill Marcus, Jim Blankenship, Jing Zhang, Jingjing Liu, Jing-Yao Fan, Jiun-Yi Li, Jiwan Pradhan, Jiyan Chen, J M Rivera Caravaca, Jo Evans, Joan Garcia Picart, Joan Hecht, Joanna Jaroch, Joanna Zalewska, Joanne Kelly, Joanne Taaffe, João Reynaldo Abbud, João V Vitola, Joaquín V Peñafiel, Jocelyne Benatar, Jody Bindeman, Joe Sabik, Joel Klitch, Johann Christopher, Johannes Aspberg, John D Friedman, John F Beltrame, John F Heitner, John Joseph Graham, John R Davies, 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Euathrongchit, Jyotsna Garg, K Manjula Rani, K Preethi, Kaatje Goetschalckx, Kai Eggers, Kamalakar Surineni, Kanae Hirase, T R Kapilamoorthy, Karen Calfas, Karen Gratrix, Karen Hallett, Karen Hultberg, Karen Nugent, Karen Petrosyan, Karen Swan, Karolina Kryczka, Karolina Wojtczak-Soska, Karolina Wojtera, Karsten Lenk, Karthik Ramasamy, Katarzyna Łuczak, Katarzyna Malinowska, Kate Pointon, Kate Robb, Katherine Martin, Kathleen Claes, Kathryn Carruthers, Kathy E Siegel, Katia Drouin, Katie Fowler-Lehman, Kavita Rawat, Kay Rowe, Keiichi Fukuda, Keith A A Fox, Ken Mahaffey, Kendra Unterbrink, Kenneth Giedd, Kerrie Van Loo, Kerry Lee, Kerstin Bonin, Kevin R Bainey, Kevin T Harley, Kevin Anstrom, Kevin Chan, Kevin Croce, Kevin Landolfo, Kevin Marzo, Keyur Patel, Khaled Abdul-Nour, Khaled Alfakih, Khaled Dajani, Khaled Ziada, Khaula Baloch, Khrystyna Kushniriuk, Kian-Keong Poh, Kim F Ireland, Kim Holland, Kimberly Ann Byrne, Kimberly E Halverson, Kimberly Elmore, Kimberly Miller-Cox, Kiran Reddy, Kirsten J Quiles, Kirsty Abercrombie, Klaus Matschke, Konrad Szymczyk, Koo Hui Chan, Kotiboinna Preethi, Kozhaya Sokhon, Krissada Meemuk, Kristian Thygesen, Kristin M Salmi, Kristin Newby, Kristina Wippler, Kristine Arges, Kristine Teoh, Krystal Etherington, Krystyna Łoboz-Grudzień, Krzysztof W Reczuch, Krzysztof Bury, Krzysztof Drzymalski, Krzysztof Kukuła, Kuo-Tzu Sung, Kurt Huber, Ladda Douangvila, Lance Sullenberger, Larissa Miranda Trama, Laszlone Matics, Laura Drew, Laura Flint, Laura Keinaite, Laura Sarti, Laurel Kolakaluri, Lawrence M Phillips, Lawrence Friedman, Lawrence Phillips, Lazar Velicki, Leah Howell, Leandro C Maranan, Leanne Cox, Ledjalem Daba, Lei Zhang, Lekshmi Dharmarajan, Leo Bockeria, Leonardo Pizzol Caetano, Leonardo Bridi, Leonid L Bershtein, Leszek Sokalski, Li Hai Yan, Li Li, Lia Nijmeijer, Lidia Sousa, Lihong Xu, Lihua Zhang, Lili Zhang, Lilia Schiavi, Lilian Mazza Barbosa, Lillian L Khor, Lina Felix-Stern, Linda L Hall, Linda M Hollenweger, Linda Arcand, Linda Davidson-Ray, Linda Schwarz, Lindsey N Sikora, Lingping Chi, Lino Patricio, Liping Zhang, Lisa Chaytor, Lisa Hatch, Lisa McCloy, Lisa Wong, Liselotte Persson, Lixin Jiang, Liz Low, Ljiljana Pupic, Loïc Bière, Lorenzo Monti, Lori Christensen, Lori Pritchard, Loriane Black, Lori-Ann Desimone, Lori-Ann Larmand, Lorraine McGregor, Louise Morby, Louise Thomson, Luc Harvey, Luciana de Pádua Baptista, Lucilla Garcia, Ludivine Eliahou, Ludmila Helmer, Luis F Smidt, Luis Bernanrdes, Luis Guzman, Luiz A Carvalho, Luyang Xiong, Lynette L Teo, Lynn M Neeson, Lynne Winstanley, M Barbara Srichai-Parsia, M Quintana Giner, M Sowjanya Reddy, M Valdés Chávarri, M Grazia Rossi, Maarten Simoons, Maayan Konigstein, Maciej Lesiak, Maciej Olsowka, Mafalda Selas, Magalie Corfias, Magdalena Madero Rovalo, Magdalena Łanocha, Magdalena Miller, Magdalena Misztal-Teodorczyk, Magdalena Rantinella, Magdy Abdelhamid, Magnolia Jimenez, Mahboob Alam, Mahevamma Mylarappa, Mahfouz El Shahawy, Mahmoud 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Pierre Michaud, Pilar Calvillo, Ping Chai, Piotr Jakubowski, Piotr Pruszczyk, Piotr Slomka, Piyamitr Sritara, Poay-Huan Loh, Poonam Sonawane, Pouneh Samadi, Pragnesh P Parikh, Prakash Deedwania, Pranav M Patel, Praneeth Polamuri, Pratiksha Sharma, Precilia Vasquez, Preeti Kamath, Prince Thomas, Priyadarshani Arambam, Puja K Mehta, Purvez Grant, Pushpa Naik, Qi Zhong, Qian Zhao, Qiang Zhou, Qianqian Yuan, Qin Yu, Qingxian Li, Qiulan Xie, Qiutang Zeng, R J Vindhya, R James Gerlach, Rachel King, Rada Vučić, Radmila Lyubarova, Radoslaw Pracon, Raewyn Fisher, Rafael Beyar, Rafael Diaz, Rafael Selgas, Raffaele Bugiardini, Raffaele Fanelli, Raisa Kavalakkat, V S Rajalekshmi, Rajat S Barua, Rajeev Menon, Rajesh Gopalan Nair, Rajesh Francis, Rajiv Narang, Rakesh Yadav, Ralph Alan Huston, T Ramakrishnan, Ramesh de Silva, Rami El Mahmoud, Ramiro Carvalho, Ramon de Jesús-Pérez, Ramona Stevens, Ran Leng, Ranjan Kachru, Ranjit Kumar Nath, Raquel Sanchez, Raven R Dwyer, Raven Lee, Ray Wyman, Raymond C Wong, Raymond W Little, Raymundo Ocaranza Sanchez, Rebecca J Wimmer, Rebecca Bariciano, Rebecca Otis, Rebekah R Herrmann, Reem Yunis, Reinette Hampson, Renato Abdala Karam, Renee C Hessian, Renee Kaneshiro, Reshma Ravindran, Reto Andreas Gamma, Reyna Bhandari, Reza Arsanjani, Ricardo L Lopes, Ricardo Mendes Oliveira, Ricardo Costa, Richa Bhatt, Richard F Davies, Richard H J Trimlett, Richard Goldweit, Rik Hermanides, Rine Nakanishi, Rinu R Sidh, Risha Patel, Rita Coram, Rizwan A Siddiqui, Rob S Beanlands, Robert J Hamburger, Robert K Riezebos, Robert M Donnino, Robert Bojar, Robert Chilton, Robert Guyton, Robert Henderson, Robert Kornberg, Robert Leber, Robert Mao, Robert Stenberg, Roberta P Santos, Roberto René Favaloro, Roberto Amati, Rodolfo G S D Lima, Rodrigo J Cerci, Rogerio Tumelero, Rohit Tandon, Roma Tewari, Romalisa Miranda-Peats, Ron Wald, Ronald A Mastouri, Ronald G Morford, Ronald G Schwartz, Ronald P Pedalino, Rongrong Hu, Ronnell A Hansen, Ronny A Cohen, Rory Hachamovitch, Rosa Homem, Rosa Sandonato, Rosane Laimer, Rosann Gans, Roxanne Yost, Roy Mathew, Rubén Baleón-Espinosa, Ruben Ramos, Rubine Gevorgyan, Rui Ferreira, Rui Jing, Ruth Pérez-Fernández, S K Dwivedi, S Ramakrishnan, Saadat Khan, Sabahat Bokhari, Sabu Thomas, Sadath Lubna, Sajeeda Parveen Khan, Sajeev Chakanalil Govindan, Saket Girotra, Saleem Kassam, Sallie Canada, Salvador Cruz-Flores, Samaa Mohamed, Samantha Ly, Sameh El Kaffas, Samia Massalha, Sampoornima Setty, Samuel Nwosu, Sandeep Seth, Sandeep Singh, Sander R Niehe, Sandra M Rivest, Sandra S Zier, Sandra Ahoud, Sandy Carr, Sanjay Ganapathi, Sanjay Shetty, Sanjeev Sharma, Santa Jimenez, Santhosh Satheesh, Santiago A Garcia, Sara Fernandez, Sara Karlsson, Sara Salkind, Sara Temiyasathit, Sarah Medina Rodriguez, Sarah Beaudry, Sarah Hadjih, Sarah Williams, Sarah Zahrani, Sarju Ralhan, Sasa Hinic, Sasko Kedev, Satinder Singh, Satoshi Yasuda, Satvic Cholenahally Manjunath, Sau Lee, Scott M Kaczkowski, Scott Kinlay, Sean W Hayes, Sebastian Sobczak, Senait Asier, Sergey A Sayganov, Seth I Sokol, Shaheen Pandie, Shaiful Azmi Yahaya, Shamir Mehta, Shao-Ping Nie, Sharad Chandra, Sharder Islam, Sharon Tai, Sheetal Rupesh Karwa, Sheri Ussery, Sheromani Bajaj, Sherron C Crook, Shigeyuki Nishimura, Shintaro Nakano, Shirin Heydari, Shiv Kumar Choudhary, Shivali Patel, Shobana Ganesan, Shruti Pandey, Shuyang Zhang, Shweta Hande, Siddharth Gadage, Sik-Yin V Tan, Silvia Zottis Poletti, Silvia Riera, Silvia Valbuena, Simon Walsh, Simona Maspoli, Simone Savaris, Si-Ting Feng, So Yang Cho, Solomon Yakubov, Songlin Zhu, Songtao Wang, Sonia Guerrero, Sonika Gupta, Sonja Salinger Martinovic, Sonya Brons, Sorin Brener, Sothinathan Gurunathan, Souheil Saba, Soundarya Nayak, Sowjanya Reddy, Srinivasa Potluri, Sriram Sudarshan, Srun Kuanprasert, Stacie Van Oosterhout, Stamatios Lerakis, Stanley E Cobos, Stefan C Bertog, Stefan M Simović, Stefan Weikl, Stefano Di Marco, Stefano Provasoli, Stephanie A Tirado, Stephanie C Boer, Stephanie M Lane, Stephanie Ferket, Stephanie Kelly, Stephanie Wasmiller, Stephen H McKellar, Stephen P Hoole, Stephen Fremes, Stephen Preston, Steve Leung, Steven A Fein, Steven J Lindsay, Steven P Sedlis, Steven Giovannone, Steven Michael, Steven Weitz, Stijn van Vugt, Subhash Banerjee, Sudhir Naik, Suellen Hosino, Sukie Desire, Sukit Yamwong, Suku T Thambar, Sulagna Mookherjee, Suman Singh, Sundeep Mishra, Sunil Kumar Verma, Supap Kulthawong, Supatchara Khwakhong, Surendra Naik, Suresh Babu, Surin Woragidpoonpol, Suryaprakash Narayanappa, Susan Derbyshire, Susan Gent, Susan Mathus, Susan Milbrandt, Susan Moore, Susan Regan, Susan Stinson, Susan Webber, Susana Silva, Susanna Stevens, Susanne Gruensfelder, Suthara Aramcharoen, Suvarna Kolhe, Suzana Tavares, Suzanne Arnold, Suzanne Welsh, Svetlana Apostolovic, Swapna Kunhunny, Ta-Chuan Hung, Taissa Zappernick, Tali Sharir, Talita Silva, Tamara Colaiácovo Soares, Tapan Umesh Pillay, Tarun K Mittal, Tatiana Trifonova, Tauane Bello Duarte, Tauqir Huk, Téodora Dutoiu, Terrance Chua, Terry Weyand, Thabitha Charles, Theodoros Kofidis, Theresa McCreary, Thierry Lefevre, Thippeekaa Arumairajah, Thitipong Tepsuwan, Thomas J Mulhearn, Thomas M Meyer, Thomas P Rocco, Thomas R Downes, Thomas Crain, Thomas Haldis, Thomas Mathew, Thomas Redick, Thounaojam Indira Devi, Thuraia Nageh, Tia Cauthren, Tiago Silva, Tiffany Little, Tijana Andric, Tina Harding, Titus Lau, Tiziana Formisano, Tiziano Moccetti, Tomasz Ciurus, Tomasz Mazurek, Tomasz Tarchalski, Toshiyuki Nagai, Tri Tran, Tricia Youn, Trish Tucker, Trudie Milner, Tuhina Bose, Tushar Kotecha, Udo Sechtem, Uma S Valeti, Umberto Cucchini, Umesh Badami, Upendra Kaul, V K Bahl, V S Narain, Valentina Casali, Valeria Godoy, Valerie Robesyn, Vamshi P Priya, Vandana Yadav, Vera McKinney, Veronica De Lenges, Veronica Tinnirello, Vicente Miro, Victor Navarro, Victoria Gumerova, Victoria Hernandez, Vidya Seeratan, Vijay Kumar, Vikentiy Y Kozulin, Viktoria Bulkley, Vilmar Veiga Jr, Vincent Setang, C P Vineeth, Virginai Pubull Nuñez, Virginia Fernández-Figares, Vitor Gomes, Viviana Gabriel, Viviane Dos Santos, Viviane Almeida, Vlad A Iliescu, Vladan Mudrenovic, Vladimir Dzavik, Vojislav L Giga, Walter Enrique Mogrovejo, Wan Xian Chan, Wanda C Marfori, Wanda Parker, Warangkana Mekara, Wassim Nona, Wayne Old, Wayne Pennachi, Weerachai Nawarawong, Wei Chen, Wei Su, Weibing Xing, Wei-Ren Lan, Wenda Crawford, Wendy L Stewart, Wendy Drewes, Wenhua Lin, William B Abernethy, William D Salerno, William F Fearon, William Vergoni, William Weintraub, Winnie C Sia, Wlodzimierz J Musial, Xacobe Flores-Ríos, Xavier Garcia-Moll Marimon, Xi Su, Xiang Ma, Xiangqiong Gu, Xiao Wang, Xiaomei Li, Xiaowei Yao, Xin Fu, Xin Su, Xin Zeng, Xinchun Yang, Xiuhong Li, Xuehua Fang, Xutong Wang, Yaming Geng, Yan Yan, Yanek Pépin-Dubois, Yanfu Wang, Yang Wang, Yanmeng Tian, Yaping Huang, Yechen Han, Yesenia Zambrano, Yi-Hsuan Yang, Ying Tung Sia, Yining Yang, Yitong Ma, Yolayfi Peralta, Yongjian Wu, Yu Kunwu, Yu Zhao, Yudong Peng, Yueh-Hung Lin, Yulan Zhao, Yumei Dong, Yunhai Zhao, Yutthaphan Wannasopha, Yvonne Taul, Zakir Sahul, Zalina Kudzoeva, Zbigniew Kalarus, Zeljko Z Markovic, Zhen Huang, Zheng Ji, Zhenyu Liu, Zhou Yue, Zhulin Zhang, Zhuxi Li, Zile Singh Meharwal, Ziliang Bai, Zixiang Yu, Zohra Huda, Zoltan Davidovits
Subjects: Male, Cardiac Catheterization, Computed Tomography Angiography, medicine.medical_treatment, Myocardial Ischemia, Coronary Disease, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Coronary Angiography, ISCHEMIA Research Group, law.invention, Angina, Coronary artery disease, 0302 clinical medicine, Randomized controlled trial, law, Cardiovascular Disease, Myocardial Revascularization, 030212 general & internal medicine, Coronary Artery Bypass, 11 Medical and Health Sciences, Cardiac catheterization, General Medicine, Middle Aged, humanities, Cardiovascular Diseases, Cardiology, Female, Human, medicine.medical_specialty, Ischemia, Article, 03 medical and health sciences, Geriatric cardiology, Percutaneous Coronary Intervention, General & Internal Medicine, Internal medicine, medicine, Humans, Angina, Unstable, Aged, business.industry, Coronary Artery Bypa, Percutaneous coronary intervention, Bayes Theorem, medicine.disease, Heart failure, Quality of Life, business
Abstract: BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).
Published: 2020
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12. Estimated GFR Variability and Risk of Cardiovascular Events and Mortality in SPRINT (Systolic Blood Pressure Intervention Trial)

Author: Areef Ishani, Paul K. Whelton, Joachim H. Ix, Suzanne Oparil, Vasilios Papademetriou, Vasantha Jotwani, Adhish Agarwal, Anthony A. Killeen, Kalani L. Raphael, William C. Cushman, Ronit Katz, Chirag R. Parikh, Rakesh Malhotra, Leonardo Tamariz, Michael V. Rocco, Michael G. Shlipak, Jackson T. Wright, Dalane W. Kitzman, and Debbie L. Cohen
Subjects: Male, medicine.medical_specialty, Acute coronary syndrome, 030232 urology & nephrology, Blood Pressure, Risk Assessment, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Longitudinal Studies, 030212 general & internal medicine, Myocardial infarction, Stroke, Aged, Randomized Controlled Trials as Topic, business.industry, Proportional hazards model, Hazard ratio, Middle Aged, medicine.disease, Blood pressure, Cardiovascular Diseases, Nephrology, Heart failure, Albuminuria, Cardiology, Female, medicine.symptom, business, Glomerular Filtration Rate
Abstract: RATIONALE AND OBJECTIVE. While low estimated glomerular filtration rate (eGFR) is associated with cardiovascular disease (CVD) events and mortality, the clinical significance of variability in eGFR over time is uncertain. We aimed to evaluate the association between variability in eGFR and the risk of CVD events and all-cause mortality. STUDY DESIGN. Longitudinal analysis of clinical trial participants. SETTINGS AND PARTICIPANTS. 7,520 Systolic Blood Pressure Intervention Trial (SPRINT) participants aged ≥ 50 year with 1 or more CVD risk factors. PREDICTORS. eGFR variability, estimated by the coefficients of variation of eGFR measurements at the 6, 12, and 18-month study visits. OUTCOMES. SPRINT primary CVD composite outcome (myocardial infarction, acute coronary syndrome, stroke, heart failure, or CVD death) and all-cause mortality from month 18 to end of follow-up. ANALYTICAL APPROACH. Cox models evaluated associations between eGFR variability and CVD outcomes and all-cause mortality. Models were adjusted for demographics, randomization arm, CVD risk factors, albuminuria and month 18 eGFR. RESULTS. Mean age was 68±9 years, 65% were men, and 58% were white. The mean eGFR was 73±21 ml/min/1.73m(2) at 6 months. There were 370 CVD events and 154 deaths during a median follow-up of 2.4 years. Greater eGFR variability was associated with higher risk for all-cause mortality (hazard ratio (HR) per standard deviation (SD) greater variability, 1.29; 95% confidence interval (CI) 1.14 to 1.45) but not CVD events (HR 1.05; 95% CI 0.95 to 1.16) after adjusting for albuminuria at baseline, eGFR at month 18, and other CVD risk factors. Associations were similar when stratified by treatment arm and baseline CKD status, when accounting for concurrent systolic BP changes, use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and diuretic medications during follow-up. LIMITATIONS. Persons with diabetes and proteinuria > 1 g/day were excluded. CONCLUSIONS. In trial participants at high risk for CVD with hypertension, greater eGFR variability was independently associated with all-cause mortality but not CVD events.
Published: 2021
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13. The impact of COVID-19 on a large pragmatic clinical trial embedded in primary care

Author: Sarah M. Leatherman, Cynthia Hau, Alison Klint, Peter A. Glassman, Addison A. Taylor, Ryan E. Ferguson, William C. Cushman, and Areef Ishani
Subjects: Pharmacology (medical), General Medicine
Abstract: Introduction The COVID-19 pandemic has had significant impact on clinical care and traditional clinical trial operations, but it is unclear whether these impacts persist in pragmatic trials with a centralized study design. The Diuretic Comparison Project (DCP) is a Point-of Care pragmatic trial testing the hypothesis that chlorthalidone is superior to hydrochlorothiazide at the prevention of major cardiovascular (CV) events and non-cancer death. DCP relies on telephone consent, data collection from the electronic health record and Medicare, forgoes study visits, and limits provider time beyond usual care. DCP paused recruitment on VA directive in response to COVID-19 from 3/17/2020 until 7/1/2020. We assessed the impact of the COVID-19 pandemic on the centralized recruitment, patient follow-up, data collection, and outcome ascertainment performed in the DCP. Methods To assess clinical activity level and trial metrics, we compared data from two 8-month time periods: Pre-Pandemic (July 2019 – February 2020) and Mid-Pandemic (July 2020 – February 2021). Consent and randomization rates, study medication adherence, blood pressure (BP) and electrolyte follow-up rates, VA records of CV events, all-cause hospitalization, and death rates were compared for these two periods. Results Providers agreed to participate at a lower rate mid-pandemic (71%) than pre-pandemic (65%), but more patients were contacted (5,363 vs. 7,622) and consented (3,048 vs. 3,718) mid-pandemic. Patients refilled medications and remained on their randomized diuretic at the same frequency (90%) in both periods. Overall, rates of BP, electrolyte measurements, and hospitalizations decreased mid-pandemic while deaths increased. Conclusions While recruitment, enrollment, and adherence did not suffer during the pandemic, documented blood pressure checks and laboratory evaluations decreased, likely due to fewer in-person visits during the pandemic. All-cause VA hospitalizations decreased, despite a considerable number of COVID-related hospitalizations. While this suggests some changes in clinical care during the pandemic, the overall impact on DCP’s ability to operate mostly unimpacted during a global pandemic is another important strength of Point of Care clinical trials. Clinical Trial Registration NCT02185417 Registered 9 July 9 2014 https://clinicaltrials.gov/ct2/show/NCT02185417
Published: 2023
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14. Concordance between clinical outcomes in the Systolic Blood Pressure Intervention Trial and in the electronic health record

Author: Chi D. Chu, Kristin M. Lenoir, Nayanjot Kaur Rai, Sandeep Soman, Jamie P. Dwyer, Michael V. Rocco, Anil K. Agarwal, Srinivasan Beddhu, James R. Powell, Maritza M. Suarez, James P. Lash, Andrew McWilliams, Paul K. Whelton, Paul E. Drawz, Nicholas M. Pajewski, Areef Ishani, and Delphine S. Tuot
Subjects: Pharmacology (medical), General Medicine
Published: 2023
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15. Telephone informed consent in a pragmatic point-of-care clinical trial embedded in primary care

Author: Alison Klint, Sarah M. Leatherman, Olivia Taylor, Peter A. Glassman, Ryan E. Ferguson, William C. Cushman, and Areef Ishani
Subjects: Pharmacology (medical), General Medicine
Published: 2023
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16. US Renal Data System 2021 Annual Data Report: Epidemiology of Kidney Disease in the United States

Author: Kirsten L. Johansen, Glenn M. Chertow, David T. Gilbertson, Charles A. Herzog, Areef Ishani, Ajay K. Israni, Elaine Ku, Shuling Li, Suying Li, Jiannong Liu, Gregorio T. Obrador, Ann M. O’Hare, Yi Peng, Neil R. Powe, Nicholas S. Roetker, Wendy L. St. Peter, Fahad Saeed, Jon Snyder, Craig Solid, Eric D. Weinhandl, Wolfgang C. Winkelmayer, and James B. Wetmore
Subjects: Kidney Failure, Nephrology, Clinical Sciences, Public Health and Health Services, Data Systems, Humans, Kidney Failure, Chronic, Kidney Diseases, Chronic, Urology & Nephrology, Kidney, United States
Published: 2022

17. Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project

Author: Ryan E Ferguson, Sarah M Leatherman, Patricia Woods, Cynthia Hau, Robert Lew, William C Cushman, Mary T Brophy, Louis Fiore, and Areef Ishani
Subjects: Pharmacology, General Medicine
Abstract: Background/Aims: The US Department of Veterans Affairs Point of Care Clinical Trial Program conducts studies that utilize informatics infrastructure to integrate clinical trial protocols into routine care delivery. The Diuretic Comparison Project compared hydrochlorothiazide to chlorthalidone in reduction of major cardiovascular events in subjects with hypertension. Here we describe the cultural, technical, regulatory, and logistical challenges and solutions that enabled successful implementation of this large pragmatic comparative effectiveness Point of Care clinical trial. Methods: Patients were recruited from 72 Veterans Affairs Healthcare Systems using centralized processes for subject identification, obtaining informed consent, data collection, safety monitoring, site communication, and endpoint identification with minimal perturbation of the local clinical care ecosystem. Patients continued to be managed exclusively by their clinical care providers without protocol specified study visits, treatment recommendations, or data collection extraneous to routine care. Centralized study processes were operationalized through the application layer of the electronic health record via a data coordinating center staffed by clinical nurses, data scientists, and statisticians without site-based research coordinators. Study data was collected from the Veterans Affairs electronic health record supplemented by Medicare and National Death Index data. Results: The study exceeded its enrolled goal (13,523 subjects) and followed subjects for the 5-year study duration. The key determinant of program success was collaboration between researchers, regulators, clinicians, and administrative staff at the site level to customize study procedures to align with local clinical practice. This flexibility was enabled by designation of the study as minimal risk and determination that clinical care providers were not engaged in research by the Veterans Affairs Central Institutional Review Board. Cultural, regulatory, technical, and logistical problems were identified and solved through iterative collaboration between clinical and research entities. Paramount among these problems was customization of the Veterans Affairs electronic health record and data systems to accommodate study procedures. Conclusions: Leveraging clinical care for large-scale clinical trials is feasible but requires a rethinking of traditional clinical trial design (and regulation) to better meet requirements of clinical care ecosystems. Study designs must accommodate site-specific practice variation to reduce the impact on clinical care. A tradeoff thus exists between designing trial processes tailored to expedite local study implementation versus those to produce a more refined response to the research question. The availability of a uniform and flexible electronic health record in the Department of Veterans Affairs played a major role in the success of the trial. Conducting Point of Care research in other healthcare systems without such research-friendly infrastructure presents a more formidable challenge.
Published: 2023
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18. Kidney Disease, Hypertension Treatment, and Cerebral Perfusion and Structure

Author: Manjula Kurella Tamura, Sarah Gaussoin, Nicholas M. Pajewski, Greg Zaharchuk, Barry I. Freedman, Stephen R. Rapp, Alexander P. Auchus, William E. Haley, Suzanne Oparil, Jessica Kendrick, Christianne L. Roumie, Srinivasan Beddhu, Alfred K. Cheung, Jeff D. Williamson, John A. Detre, Sudipto Dolui, R. Nick Bryan, Ilya M. Nasrallah, Paul Whelton, Karen C. Johnson, Joni Snyder, Diane Bild, Denise Bonds, Nakela Cook, Jeffrey Cutler, Lawrence Fine, Peter Kaufmann, Paul Kimmel, Lenore Launer, Claudia Moy, William Riley, Laurie Ryan, Eser Tolunay, Song Yang, David Reboussin, Jeff Williamson, Walter T. Ambrosius, William Applegate, Greg Evans, Capri Foy, Dalane Kitzman, Mary Lyles, Nick Pajewski, Steve Rapp, Scott Rushing, Neel Shah, Kaycee M. Sink, Mara Vitolins, Lynne Wagenknecht, Valerie Wilson, Letitia Perdue, Nancy Woolard, Tim Craven, Katelyn Garcia, Laura Lovato, Jill Newman, James Lovato, Lingyi Lu, Chris McLouth, Greg Russell, Bobby Amoroso, Patty Davis, Jason Griffin, Darrin Harris, Mark King, Kathy Lane, Wes Roberson, Debbie Steinberg, Donna Ashford, Phyllis Babcock, Dana Chamberlain, Vickie Christensen, Loretta Cloud, Christy Collins, Delilah Cook, Katherine Currie, Debbie Felton, Stacy Harpe, Marjorie Howard, Michelle Lewis, Pamela Nance, Nicole Puccinelli-Ortega, Laurie Russell, Jennifer Walker, Brenda Craven, Candace Goode, Margie Troxler, Janet Davis, Sarah Hutchens, Anthony A. Killeen, Anna M. Lukkari, Robert Ringer, Brandi Dillard, Norbert Archibeque, Stuart Warren, Mike Sather, James Pontzer, Zach Taylor, Elsayed Z. Soliman, Zhu-Ming Zhang, Yabing Li, Chuck Campbell, Susan Hensley, Julie Hu, Lisa Keasler, Mary Barr, Tonya Taylor, Christos Davatzikos, Ilya Nasarallah, Lisa Desiderio, Mark Elliott, Ari Borthakur, Harsha Battapady, Guray Erus, Alex Smith, Ze Wang, Jimit Doshi, Jackson T. Wright, Mahboob Rahman, Alan J. Lerner, Carolyn Still, Alan Wiggers, Sara Zamanian, Alberta Bee, Renee Dancie, George Thomas, Martin Schreiber, Sankar Dass Navaneethan, John Hickner, Michael Lioudis, Michelle Lard, Susan Marczewski, Jennifer Maraschky, Martha Colman, Andrea Aaby, Stacey Payne, Melanie Ramos, Carol Horner, Paul Drawz, Pratibha P. Raghavendra, Scott Ober, Ronda Mourad, Muralidhar Pallaki, Peter Russo, Pratibha Raghavendra, Pual Fantauzzo, Lisa Tucker, Bill Schwing, John R. Sedor, Edward J. Horwitz, Jeffrey R. Schellling, John F. O’Toole, Lisa Humbert, Wendy Tutolo, Suzanne White, Alishea Gay, Walter Clark, Robin Hughes, Mirela Dobre, Carolyn H. Still, Monique Williams, Udayan Bhatt, Lee Hebert, Anil Agarwal, Melissa Brown Murphy, Nicole Ford, Cynthia Stratton, Jody Baxter, Alicia A. Lykins, Alison McKinley Neal Leena Hirmath, Osei Kwame, Kyaw Soe, William F. Miser, Colleen Sagrilla, Jan Johnston, Amber Anaya, Ashley Mintos, Angel A. Howell, Kelly Rogers, Sara Taylor, Donald Ebersbacher, Lucy Long, Beth Bednarchik, Adrian Schnall, Jonathan Smith, Lori Peysha, Lisa Leach, Megan Tribout, Carla Harwell, Pinkie Ellington, Mary Ann Banerji, Pranav Ghody, Melissa Vahídeh Rambaud, Raymond Townsend, Debbie Cohen, Yonghong Huan, Mark Duckworth, Virginia Ford, Juliet Leshner, Ann Davison, Sarah Vander Veen, Crystal A. Gadegbeku, Avi Gillespie, Anuradha Paranjape, Sandra Amoroso, Zoe Pfeffer, Sally B. Quinn, Jiang He, Jing Chen, Eva Lustigova, Erin Malone, Marie Krousel-Wood, Richard Deichmann, Patricia Ronney, Susan Muery, Donnalee Trapani, Michael Rocco, David Goff, Carlos Rodriguez, Laura Coker, Amret Hawfield, Joseph Yeboah, Lenore Crago, John Summerson, Anita Hege, Matt Diamond, Laura Mulloy, Marcela Hodges, Michelle Collins, Charlene Weathers, Heather Anderson, Emily Stone, Walida Walker, Andrew McWilliams, Michael Dulin, Lindsay Kuhn, Susan Standridge, Lindsay Lowe, Kelly Everett, Kelry Preston, Susan Norton, Silena Gaines, Ali A. Rizvi, Andrew W. Sides, Diamond Herbert, Matthew M. Hix, Melanie Whitmire, Brittany Arnold, Philip Hutchinson, Joseph Espiritu, Mark Feinglos, Eugene Kovalik, Georgianne Gedon-Lipscomb, Kathryn Evans, Connie Thacker, Ronna Zimmer, Mary Furst, MaryAnn Mason, James Powell, Paul Bolin, Junhong Zhang, Mary Pinion, Gail Davis, Winifred Bryant, Presley Phelps, Connie Garris-Sutton, Beatrice Atkinson, Gabriele Contreras, Maritza Suarez, Ivonne Schulman, Don Koggan, Jackie Vassallo, Gloria Peruyera, Sheri Whittington, Cassandra Bethea, Laura Gilliam, Carolyn Pedley, Geraldine Zurek, Miriam Baird, Charles Herring, Mary Martha Smoak, Julie Williams, Samantha Rogers, Lindsay Gordon, Erin Kennedy, Beverly Belle, Jessica McCorkle-Doomy, Jonathan Adams, Ramon Lopez, Juris Janavs, Frederic Rahbari-Oskoui, Arlene Chapman, Allen Dollar, Olubunmi Williams, Yoosun Han, William Haley, Peter Fitzpatrick, Joseph Blackshear, Brian Shapiro, Anna Harrell, Arta Palaj, Katelyn Henderson, Ashley Johnson, Heath Gonzalez, Jermaine Robinson, Leonardo Tamariz, Jennifer Denizard, Rody Barakat, Dhurga Krishnamoorthy, Frank Greenway, Ron Monce, Timothy Church, Chelsea Hendrick, Aimee Yoches, Leighanne Sones, Markee Baltazar, Priscilla Pemu, Connie Jones, Derrick Akpalu, Gordon Chelune, Jeffrey Childs, Lisa Gren, Anne Randall, Laura Dember, Denise Soares, Jerry Yee, Kausik Umanath, Naima Ogletree, Schawana Thaxton, Karen Campana, Dayna Sheldon, Krista MacArthur, J. Brent Muhlestein, Nathan Allred, Brian Clements, Ritesh Dhar, Kent Meredith, Viet Le, Edward Miner, James Orford, Erik R. Riessen, Becca Ballantyne, Ben Chisum, Kevin Johnson, Dixie Peeler, Glenn Chertow, Manju Tamura, Tara Chang, Kevin Erickson, Jenny Shen, Randall S. Stafford, Gregory Zaharchuk, Margareth Del Cid, Michelle Dentinger, Jennifer Sabino, Rukmani Sahay, Ekaterina Telminova, Daniel E. Weiner, Mark Sarnak, Lily Chan, Amanda Civiletto, Alyson Heath, Amy Kantor, Priyanka Jain, Bethany Kirkpatrick, Andrew Well, Barry Yuen, Michel Chonchol, Beverly Farmer, Heather Farmer, Carol Greenwald, Mikaela Malaczewski, James Lash, Anna Porter, Ana Ricardo, Robert T. Rosman, Janet Cohan, Nieves Lopez Barrera, Daniel Meslar, Patricia Meslar, Margaret Conroy, Mark Unruh, Rachel Hess, Manisha Jhamb, Holly Thomas, Pam Fazio, Elle Klixbull, Melissa Komlos-Weimer, LeeAnne Mandich, Tina Vita, Robert Toto, Peter Van Buren, Julia Inrig, Martha Cruz, Tammy Lightfoot, Nancy Wang, Lori Webster, Kalani Raphael, Barry Stults, Tahir Zaman, Debra Simmons, Tooran Lavasani, Rebecca Filipowicz, Guo Wei, Gracie Mary Miller, Jenice Harerra, Jeff Christensen, Ajay Giri, Xiaorui Chen, Natalie Anderton, Arianna Jensen, Julia Lewis, Anna Burgner, Jamie P. Dwyer, Gerald Schulman, Terri Herrud, Ewanda Leavell, Tiffany McCray, Edwina McNeil-Simaan, Munmun Poudel, Malia Reed, Mohammed Sika, Delia Woods, Janice L. Zirkenbach, Dominic S. Raj, Scott Cohen, Samir Patel, Manuel Velasquez, Roshni S. Bastian, Maria Wing, Akshay Roy-Chaudhury, Thomas Depner, Lorien Dalyrymple, George Kaysen, Susan Anderson, John Nord, Joachim H. Ix, Leonard Goldenstein, Cynthia M. Miracle, Nketi Forbang, Maja Mircic, Brenda Thomas, Tiffany Tran, Anjay Rastogi, Mihae Kim, Mohamad Rashid, Bianca Lizarraga, Amy Hocza, Kristine Sarmosyan, Jason Norris, Tushar Sharma, Amanda Chioy, Eric Bernard, Eleanore Cabrera, Christina Lopez, Susana Nunez, Joseph Riad, Suzanne Schweitzer, Siran Sirop, Sarah Thomas, Lauren Wada, Holly Kramer, Vinod Bansal, Corliss E. Taylor, Mark S. Segal, Karen L. Hall, Amir Kazory, Lesa Gilbert, Linda Owens, Danielle Poulton, Elaine Whidden, Jocelyn Wiggins, Caroline Blaum, Linda Nyquist, Lillian Min, Tanya Gure, Ruth Lewis, Jennifer Mawby, Eileen Robinson, Cora E. Lewis, Virginia Bradley, David Calhoun, Stephen Glasser, Kim Jenkins, Tom Ramsey, Nauman Qureshi, Karen Ferguson, Sumrah Haider, Mandy James, Christy Jones, Kim Renfroe, April Seay, Carrie Weigart, Denyse Thornley-Brown, Dana Rizik, Bari Cotton, Meredith Fitz-Gerald, Tiffany Grimes, Carolyn Johnson, Sara Kennedy, Chanel Mason, Lesa Rosato-Burson, Robin Willingham, Eric Judd, Tonya Breaux-Shropshire, Felice Cook, Julia Medina, Lama Ghazi, Hemal Bhatt, James Lewis, Roman Brantley, John Brouilette, Jeffrey Glaze, Stephanie Hall, Nancy Hiott, David Tharpe, Spencer Boddy, Catherine Mack, Catherine Womack, Keiko Asao, Beate Griffin, Carol Hendrix, Karen Johnson, Lisa Jones, Chelsea Towers, Henry Punzi, Kathy Cassidy, Kristin Schumacher, Carmen Irizarry, Ilma Colon, Pedro Colon-Ortiz, Pedro J. Colón-Hernández, Orlando J. Carrasquillo-Navarro, Merari Carrasquillo, Nivea Vazquez, Miguel Sosa-Padilla, Alex Cintron-Pinero, Mayra Ayala, Olga Pacheco, Catalina Rivera, Irma Sotomayor-Gonzalez, Jamie Claudio, Jose Lazaro, Migdalia Arce, Lourdes Heres, Alba Perez, Jose Tavarez-Valle, Ferlinda Arocho, Mercedes Torres, Melvaliz Vazquez, Gerard P. Aurigemma, Rebecca Takis-Smith, Julia Andrieni, Noelle Bodkin, Kiran Chaudhary, Paula Hu, John Kostis, Nora Cosgrove, Denise Bankowski, Monica Boleyn, Laurie Casazza, Victoria Giresi, Tosha Patel, Erin Squindo, Yan Wu, Zeb Henson, Marion Wofford, Jessica Lowery, Deborah Minor, Kimberley Harkins, Alexander Auchus, Michael Flessner, Cathy Adair, Jordan Asher, Debbie Loope, Rita Cobb, Reiner Venegas, Thomas Bigger, Natalie Bello, Shunichi Homma, Daniel Donovan, Carlos Lopez-Jimenez, Amilcar Tirado, Asqual Getaneh, Rocky Tang, Sabrina Durant, Mathew Maurer, Sergio Teruya, Stephen Helmke, Julissa Alvarez, Ruth Campbell, Roberto Pisoni, Rachel Sturdivant, Deborah Brooks, Caroline Counts, Vickie Hunt, Lori Spillers, Donald Brautigam, Timothy Kitchen, Timothy Gorman, Jessica Sayers, Sarah Button, June Chiarot, Rosemary Fischer, Melissa Lyon, Maria Resnick, Nicole Hodges, Jennifer Ferreira, William Cushman, Barry Wall, Linda Nichols, Robert Burns, Jennifer Martindale-Adams, Dan Berlowitz, Elizabeth Clark, Sandy Walsh, Terry Geraci, Carol Huff, Linda Shaw, Karen Servilla, Darlene Vigil, Terry Barrett, Mary Ellen Sweeney, Rebecca Johnson, Susan McConnell, Khadijeh Shahid Salles, Francoise Watson, Cheryl Schenk, Laura Whittington, Maxine Maher, Jonathan Williams, Stephen Swartz, Paul Conlin, George Alexis, Rebecca Lamkin, Patti Underwood, Helen Gomes, Clive Rosendorff, Stephen Atlas, Saadat Khan, Waddy Gonzalez, Samih Barcham, Lawrence Kwon, Matar Matar, Anwar Adhami, Jan Basile, Joseph John, Deborah Ham, Hadi Baig, Mohammed Saklayen, Jason Yap, Helen Neff, Carol Miller, Ling Zheng-Phelan, Saib Gappy, Shiva Rau, Arathi Raman, Vicki Berchou, Elizabeth Jones, Erin Olgren, Cynthia Marbury, Michael Yudd, Sithiporn Sastrasinh, Jennine Michaud, Jessica Fiore, Marianne Kutza, Ronald Shorr, Rattana Mount, Helen Dunn, Susan Stinson, Jessica Hunter, Addison Taylor, Jeffery Bates, Catherine Anderson, Kent Kirchner, Jodi Stubbs, Ardell Hinton, Anita Spencer, Santosh Sharma, Thomas Wiegmann, Smita Mehta, Michelle Krause, Kate Dishongh, Richard Childress, Geeta Gyamlani, Atossa Niakan, Cathy Thompson, Janelle Moody, Carolyn Gresham, Jeffrey Whittle, Gary Barnas, Dawn Wolfgram, Heidi Cortese, Jonette Johnson, Christianne Roumie, Adriana Hung, Jennifer Wharton, Kurt Niesner, Lois Katz, Elizabeth Richardson, George Brock, Joanne Holland, Troy Dixon, Athena Zias, Christine Spiller, Penelope Baker, James Felicetta, Shakaib Rehman, Kelli Bingham, Suzanne Watnick, David Cohen, Jessica Weiss, Tera Johnston, Stephen Giddings, Hala Yamout, Andrew Klein, Caroline Rowe, Kristin Vargo, Kristi Waidmann, Vasilios Papademetriou, Jean Pierre Elkhoury, Barbara Gregory, Susan Amodeo, Mary Bloom, Dalia Goldfarb-Waysman, Richard Treger, Mehran Kashefi, Christina Huang, Karen Knibloe, Areef Ishani, Yelena Slinin, Christine Olney, Jacqueline Rust, Paolo Fanti, Christopher Dyer, Shweta Bansal, Monica Dunnam, Lih-Lan Hu, and Perla Zarate-Abbott
Subjects: Male, medicine.medical_specialty, Renal function, Perfusion scanning, Blood Pressure, Article, chemistry.chemical_compound, Internal medicine, medicine, Humans, Cerebral perfusion pressure, Renal Insufficiency, Chronic, Antihypertensive Agents, Aged, Creatinine, business.industry, medicine.disease, Perfusion, Blood pressure, chemistry, Cerebral blood flow, Nephrology, Cerebrovascular Circulation, Hypertension, Albuminuria, Cardiology, Female, medicine.symptom, business, Kidney disease, Glomerular Filtration Rate
Abstract: RATIONALE AND OBJECTIVE: The safety of intensive blood pressure (BP) targets is controversial for persons with chronic kidney disease (CKD). We studied the effects of hypertension treatment on cerebral perfusion and structure in those with and without CKD. STUDY DESIGN: Neuroimaging substudy of a randomized trial. SETTING & PARTICIPANTS: A subset of participants in the Systolic Blood Pressure Intervention Trial who underwent brain MRI studies. Presence of baseline CKD was assessed by estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). INTERVENTION: Participants were randomly assigned to intensive (systolic BP 30 mg/g (N=151), the effects of intensive versus standard BP treatment on change in global cerebral blood flow, WMLs and total brain volume were 1.91 ml/100g/min (95% CI −3.01, 6.82), 0.003 cm(3) (asinh transformed, 95% CI −0.13, 0.13), and −7.0 cm(3) (95% CI −13.3, −0.3), respectively. The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04). LIMITATIONS: Measurement variability due to multi-site design. CONCLUSIONS: Among hypertensive adults with primarily early kidney disease, intensive versus standard blood pressure treatment did not appear to have a detrimental effect on brain perfusion or structure. The findings support the safety of intensive blood pressure treatment targets on brain health in persons with early kidney disease. FUNDING: The Systolic Blood Pressure Intervention Trial was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke), and this substudy was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: SPRINT was registered at ClinicalTrials.gov with the study number NCT01206062.
Published: 2021

19. Abstract P268: The Impact Of Covid-19 On A Large Pragmatic Clinical Trial Embedded In Primary Care

Author: Alison Majkut Klint, William C. Cushman, Areef Ishani, Addison A. Taylor, Cynthia Hau, Peter A. Glassman, and Sarah Leatherman
Subjects: Geriatrics, Clinical trial, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pandemic, Internal Medicine, medicine, Primary care, Intensive care medicine, business
Abstract: Introduction: The COVID-19 pandemic has had a significant impact on traditional clinical trial operations, but it is unclear whether the impact persists in pragmatic trials with a centralized study design. The Diuretic Comparison Project (DCP) is a Point-of Care pragmatic trial that operates through a usual care system to compare chlorthalidone and hydrochlorothiazide at preventing major cardiovascular (CV) events and non-cancer death. We assessed the impact of the COVID-19 pandemic on the centralized recruitment, patient follow-up, data collection, and outcome ascertainment performed in the DCP. Methods: We assessed operations in two 8-month periods: Pre-COVID-19 (Jul 2019 - Feb 2020) and Mid-COVID-19 (Jul 2020 - Feb 2021). Enrollment, study medication adherence, blood pressure (BP) and electrolyte follow-up rates, VA records of CV events, all-cause hospitalization, and death rates were compared. Results: Providers agreed to participate at a lower rate, but more patients were contacted and randomized during mid-COVID-19. While BP evaluations decreased, the rates of electrolyte, major CV, and medication prescription records were comparable to the pre-COVID-19 period ( Table 1 ). Conclusions: The DCP was able to recruit and maintain critical data collection at the pre-COVID-19 levels. There were some decreases in BP evaluations, likely due to fewer in-person visits. All-cause VA hospitalizations also decreased, despite rises in COVID-related hospitalizations and death. While the impact on outcome and safety rates awaits complete data from Medicare, the DCP has demonstrated a promising centralized design that can support pragmatic trial operations during a pandemic.
Published: 2021
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20. Impacts of Research Staff Burnout for a National Large Scale Pragmatic Clinical Trial

Author: Srihari Raju, Abhinav Tella, Areef Ishani, Rebecca Windschitl, Jacob McPherson, William Vang, and Alison Majkut Klint
Subjects: Clinical trial, Scale (ratio), Applied psychology, Pharmacology (medical), Open Access Journal of Clinical Trials, Burnout, Psychology, Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Abstract: Alison Majkut Klint,1 Jacob McPherson,2 Abhinav Tella,2 William Vang,2 Srihari Raju,2 Rebecca Windschitl,2 Areef Ishani3 1Boston CSPCC, VA Boston Healthcare System, Jamaica Plain, MA, USA; 2Research, Minneapolis VAHCS, Minneapolis, MN, USA; 3Primary Care and Specialty Care Integrated Care Community (ICC), Minneapolis VAHCS, Minneapolis, MN, USACorrespondence: Alison Majkut KlintVA Boston Healthcare System, 150 S Huntington Ave, Jamaica Plain, MA, 02130, USATel +1 857-364-4885Email Alison.Majkut@va.govIntroduction: Burnout can have a negative impact on job satisfaction and productivity. Antecedents to burnout include workload, control, values, fairness, reward, community and job-person incongruency.Purpose: To better understand the impact of burnout in research staff, these seven antecedents to burnout were analyzed retrospectively within the call centers for the Diuretic Comparison Project.Methods: Two call centers were analyzed with respect to these antecedents to burnout. Consent rates and employee turnover of the two call centers were compared as a means of comparing productivity and job satisfaction, respectively.Results: An odds ratio of 0.13 (95% CI=[0.0164, 1.0853]) indicates that an employee at the Minneapolis call center had lower odds of leaving than an employee at the Canandaigua call center. The call center in Canandaigua had a consent rate of 2.7% (Figure 2). The consent rate for the same months of the following year in Minneapolis came out to 14.6%.Conclusion: A higher consent rate and lower turnover rate of the call center in Minneapolis could be a result of lower levels of burnout among callers. The confidence interval of the odds ratio calculated for turnover indicates that the result is not statistically significant. Due to the retrospective nature of the analysis, extraneous variables were not controlled for analyzing this data. The protocol of the Minneapolis call center appears to take into consideration the antecedents to burnout more than that of the Canandaigua call center. Further studies on burnout prevention methods for clinical research are needed. Research staff could benefit from strategies to help reduce burnout. Organizations should provide proper protocols and training concerning stress and burnout to improve the well-being of employees and, in turn, their productivity.Clinical Trial Registration: : CSP597 or clinicaltrials.gov NCT02185417.Keywords: researcher burnout, clinical trial, call center
Published: 2021

21. US Renal Data System 2020 Annual Data Report: Epidemiology of Kidney Disease in the United States

Author: Manjula Kurella Tamura, Wolfgang C. Winkelmayer, Jon J. Snyder, James B. Wetmore, Jiannong Liu, Gregorio T. Obrador, Robert N. Foley, Elaine Ku, Nicholas S. Roetker, Areef Ishani, Ann M. O’Hare, Kirsten L. Johansen, Kevin C. Abbott, Kevin E. Chan, Shuling Li, Charles A. Herzog, Suying Li, Ivonne Hernandez Schulman, Ajay K. Israni, Glenn M. Chertow, Yi Peng, Craig A. Solid, David T. Gilbertson, Eric D. Weinhandl, Wendy L. St. Peter, and Neil R. Powe
Subjects: medicine.medical_specialty, business.industry, MEDLINE, Annual Reports as Topic, medicine.disease, Article, Centers for Medicare and Medicaid Services, U.S, United States, Nephrology, National Institute of Diabetes and Digestive and Kidney Diseases (U.S.), Family medicine, Epidemiology, medicine, Data Systems, Humans, Kidney Failure, Chronic, business, Kidney disease
Published: 2021

22. Design of a pragmatic clinical trial embedded in the Electronic Health Record: The VA's Diuretic Comparison Project

Author: Areef, Ishani, Sarah M, Leatherman, Patricia, Woods, Cynthia, Hau, Alison, Klint, Robert A, Lew, Addison A, Taylor, Peter A, Glassman, Mary T, Brophy, Louis D, Fiore, Ryan E, Ferguson, and William C, Cushman
Subjects: Hydrochlorothiazide, Hypertension, Chlorthalidone, Electronic Health Records, Humans, Blood Pressure, Pharmacology (medical), Prospective Studies, General Medicine, Diuretics, Antihypertensive Agents
Abstract: Recent US guidelines recommend chlorthalidone over other thiazide-type diuretics for the treatment of hypertension based on its long half-life and proven ability to reduce CVD events. Despite recommendations most clinicians prescribe hydrochlorothiazide (HCTZ) over chlorthalidone (CTD). No randomized controlled data exist comparing these two diuretics on cardiovascular outcomes.The Diuretic Comparison Project (DCP) is a multicenter, two-arm, parallel, Prospective Randomized Open, Blinded End-point (PROBE) trial testing the primary hypothesis that CTD is superior to HCTZ in the prevention of non-fatal CVD events and non-cancer death. Patients with hypertension taking HCTZ 25 or 50 mg were randomly assigned to either continue their current HCTZ or switch to an equipotent dose of CTD. The primary outcome is time to the first occurrence of a composite outcome consisting of a non-fatal CVD event (stroke, myocardial infarction, urgent coronary revascularization because of unstable angina, or hospitalization for acute heart failure) or non-cancer death. The trial randomized 13,523 patients at 72 VA medical centers. The study is conducted by a centralized research team with site procedures embedded in the electronic health record and all data collected through administrative claims data, with no study related visits for participants. The trial will have 90% power to detect an absolute reduction in the composite event rate of 2.4%.Enrollment ended in November 2021. There are 4128 participting primary care providers and 16,595 patients individually consented to participate, 13,523 of whom were randomized.DCP should provide much needed evidence as to whether CTD is superior to HCTZ in preventing cardiovascular events in hypertensive patients.NCT02185417 [https://clinicaltrials.gov/ct2/show/NCT02185417].
Published: 2022
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23. Prevalence and correlates of sleep apnea among US Veterans with chronic kidney disease

Author: Areef Ishani, Shahab Bozorgmehri, Rebecca J. Beyth, Richard B. Berry, I. David Weiner, and Muna T. Canales
Subjects: Adult, Male, medicine.medical_specialty, Adolescent, Polysomnography, Cognitive Neuroscience, Population, Logistic regression, Cohort Studies, Young Adult, 03 medical and health sciences, Behavioral Neuroscience, Sleep Apnea Syndromes, 0302 clinical medicine, Risk Factors, Surveys and Questionnaires, Internal medicine, Diabetes mellitus, Prevalence, medicine, Humans, Prospective Studies, Renal Insufficiency, Chronic, education, Aged, Veterans, Aged, 80 and over, education.field_of_study, medicine.diagnostic_test, business.industry, Sleep apnea, General Medicine, Middle Aged, medicine.disease, Cross-Sectional Studies, 030228 respiratory system, Cohort, Female, business, Body mass index, 030217 neurology & neurosurgery, Kidney disease
Abstract: The prevalence and correlates of sleep apnea (SA) among Veterans with chronic kidney disease (CKD), a population at high risk of both SA and CKD, are unknown. We performed a cross-sectional analysis of 248 Veterans (18-89 years) selected only for presence of moderate to severe CKD. All participants underwent full, unattended polysomnography, measurement of renal function and a sleepiness questionnaire. Logistic regression with backward selection was used to identify predictors of prevalent SA (apnea-hypopnea index [AHI, ≥15 events/hr] and prevalent nocturnal hypoxia [NH, % of total sleep time spent at
Published: 2020
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24. Dyslipidemia and Chronic Kidney Disease

Author: Areef Ishani, David Goldsmith, and Scott Reule
Subjects: medicine.medical_specialty, Statin, Triglyceride, Cholesterol, business.industry, medicine.drug_class, medicine.disease, chemistry.chemical_compound, Ezetimibe, chemistry, Internal medicine, medicine, lipids (amino acids, peptides, and proteins), In patient, Medical prescription, business, Dyslipidemia, medicine.drug, Kidney disease
Abstract: Dyslipidemia in patients with chronic kidney disease (CKD) is common, characterized by high triglyceride levels and low HDL concentrations, while total and LDL cholesterol (LDL-C) are normal or low. Most CKD patients are at very high risk of cardiovascular events. CKD patients with low as well as high levels of total and LDL-C are at the highest risk of developing adverse outcomes. Thus, elevated cholesterol seems unsuitable as the sole criterion for prescription of statins in CKD patients. The decision to treat patients should be based on pretreatment risk of cardiovascular events and not solely pretreatment LDL-C. The new Kidney Disease: Improving Global Outcomes clinical practice guidelines on lipid management recommend fixed statin or statin/ezetimibe treatment in adults aged ≥50 years with eGFR
Published: 2020
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25. The impact of outpatient acute kidney injury on mortality and chronic kidney disease: a retrospective cohort study

Author: Scott Reule, Paul E. Drawz, Luke Bicknese, Maxwell D. Leither, David M. Vock, Daniel Murphy, Robert N. Foley, and Areef Ishani
Subjects: Adult, Male, medicine.medical_specialty, 030232 urology & nephrology, Renal function, 030204 cardiovascular system & hematology, urologic and male genital diseases, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Internal medicine, Outpatients, medicine, Humans, Renal Insufficiency, Chronic, Risk factor, Retrospective Studies, Transplantation, Creatinine, urogenital system, Proportional hazards model, business.industry, Hazard ratio, Acute kidney injury, Retrospective cohort study, Acute Kidney Injury, Middle Aged, Prognosis, medicine.disease, female genital diseases and pregnancy complications, Hospitalization, Survival Rate, chemistry, Nephrology, Female, ORIGINAL ARTICLES, business, Glomerular Filtration Rate, Kidney disease
Abstract: BACKGROUND: Acute kidney injury (AKI) has been extensively studied in hospital settings. Limited data exist regarding outcomes for patients with outpatient AKI who are not subsequently admitted. We investigated whether outpatient AKI, defined by a 50% increase in creatinine (Cr), is associated with increased mortality and renal events. METHODS: In this retrospective study, outpatient serum Cr values from adults receiving primary care at a health system during an 18-month exposure period were used to categorize patients into one of five groups (no outpatient AKI, outpatient AKI with recovery, outpatient AKI without recovery, outpatient AKI without repeat Cr and no Cr). Principal outcomes of all-cause mortality and renal events (50% decline in estimated glomerular filtration rate to
Published: 2018
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26. Hospital Readmission Rates Following AMI: Potential Interventions to Improve Efficiency

Author: Santiago Garcia, Richard Madlon-Kay, Kairav Vakil, Edward O. McFalls, Anders Westanmo, Jennifer T. Nguyen, Areef Ishani, and Selcuk Adabag
Subjects: medicine.medical_specialty, Hospitals, Veterans, medicine.medical_treatment, Myocardial Infarction, Psychological intervention, 030204 cardiovascular system & hematology, Efficiency, Organizational, Chest pain, Revascularization, Patient Readmission, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Veterans Affairs, Aged, Quality Indicators, Health Care, Hospital readmission, business.industry, General Medicine, Emergency department, Length of Stay, Middle Aged, medicine.disease, Quality Improvement, Triage, Treatment Outcome, Emergency medicine, medicine.symptom, business
Abstract: Quality of care utilization measures for patients admitted to the hospital with an acute myocardial infarction (AMI) include length of stay (LOS) and 30-day readmission rates. Our aim was to test whether efforts resulting in reduced LOS in patients diagnosed as having AMI would result in a higher risk of readmission within 30 days of hospital discharge and whether specific interventions could be targeted to reduce readmissions.Using data supplied by the Veterans Affairs Inpatient Evaluation Center, we analyzed both the readmissions within 30 days of an AMI and LOS and determined the timing of readmissions and associated diagnoses.During 2013-2015, 35 (13.3%) of 263 patients with AMI were readmitted within 30 days of discharge compared with 19 (13.4%) of 142 patients during 2016 (not significant). During the same time, LOS was3 days in most patients. From 2013 to 2015, the initial hospital time was 6 ± 6 days, whereas time out of the hospital before readmission was 11 ± 8 days; these times did not differ from 2016. Initial therapeutic decisions were based on coronary anatomy in90% of patients with a decision to proceed with revascularization in most patients. Diagnoses during readmission to the hospital were also similar during early and later time periods and most frequently were a result of either coronary artery bypass grafting-related complications from the initial hospitalization or elective coronary artery bypass grafting. Acute coronary syndrome-related diagnoses and recurrent noncardiac causes of chest pain also were common diagnoses during both time periods and did not involve extensive workup during the readmission.Readmissions for patients with AMI were stable during a 4-year period, at a time that efforts to reduce LOS were emphasized. Because a significant proportion of readmissions involved noncardiac sources of chest pain, improved communication between the emergency department and in-patient cardiology services at the time of triage may be a feasible way to improve efficiency of utilization.
Published: 2018
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27. Pragmatic clinic randomized trial to improve chronic kidney disease care: Design and adaptation due to COVID disruptions

Author: James B. Wetmore, JoAnn M. Sperl-Hillen, Areef Ishani, James Wheeler, Lilian Chumba, Patrick J. O'Connor, A. Lauren Crain, Heidi L. Ekstrom, Kristen M. Kopski, and Deepika Appana
Subjects: Adult, Nephrology, medicine.medical_specialty, Adolescent, Referral, Angiotensin-Converting Enzyme Inhibitors, Telehealth, Pragmatic clinical trial, urologic and male genital diseases, Clinical decision support system, Article, COVID care disruption, law.invention, Angiotensin Receptor Antagonists, Young Adult, Randomized controlled trial, law, Chronic kidney disease, Internal medicine, Intervention (counseling), medicine, Humans, Pharmacology (medical), Renal Insufficiency, Chronic, Pandemics, Aged, Primary Health Care, SARS-CoV-2, business.industry, COVID-19, Clinical decision support, General Medicine, Middle Aged, Primary care, medicine.disease, female genital diseases and pregnancy complications, Blood pressure, Emergency medicine, business, Kidney disease
Abstract: Background We describe a clinic-randomized trial to improve chronic kidney disease (CKD) care through a CKD-clinical decision support (CKD-CDS) intervention in primary care clinics and the challenges we encountered due to COVID-19 care disruption. Methods/design Primary care clinics (N = 32) were randomized to usual care (UC) or to CKD-CDS. Between April 17, 2019 and March 14, 2020, more than 7000 patients had accrued for analysis by meeting study-eligibility criteria at an index office visit: age 18–75, laboratory criteria for stage 3 or 4 CKD (eGFR 15–59 mL/min/1.73 m2), and one or more opportunities algorithmically identified to improve CKD care such as blood pressure (BP) or glucose control, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use, discontinuance of a nonsteroidal anti-inflammatory drug (NSAID), or nephrology referral. At CKD-CDS clinics, CDS provided individualized treatment suggestions that were printed for patients and clinicians at the start of office encounters and were viewable within the electronic health record. By initial design, the impact of the CKD-CDS intervention on care gaps was to be assessed 12 months after the index date, but COVID-19 caused major disruptions to care delivery during the intervention period. In response to disruptions, the intervention was temporarily suspended while we expanded CDS use for telehealth encounters and programmed new criteria for displaying the CKD-CDS to intervention patients due to clinic closures and scheduling changes. Discussion We describe a NIH-funded pragmatic trial of web-based EHR-integrated CKD-CDS and modifications necessary mid-study to complete the study as intended in the face of COVID-19 pandemic challenges.
Published: 2021
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28. Association of Increased Urinary Albumin With Risk of Incident Clinical Fracture and Rate of Hip Bone Loss: the Osteoporotic Fractures in Men Study

Author: Kristine E. Ensrud, Howard A Fink, John T. Schousboe, Joshua I. Barzilay, Nancy E Lane, Areef Ishani, Tien N Vo, Muna T. Canales, Lisa Langsetmo, Jane A. Cauley, and Eric S. Orwoll
Subjects: musculoskeletal diseases, Creatinine, medicine.medical_specialty, business.industry, Proportional hazards model, Endocrinology, Diabetes and Metabolism, Incidence (epidemiology), Osteoporosis, 030232 urology & nephrology, Urology, Urine, medicine.disease, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, medicine.anatomical_structure, chemistry, Hip bone, Albuminuria, Medicine, Orthopedics and Sports Medicine, 030212 general & internal medicine, medicine.symptom, business, Prospective cohort study
Abstract: Prior studies suggest that increased urine albumin is associated with a heightened fracture risk in women, but results in men are unclear. We used data from Osteoporotic Fractures in Men (MrOS), a prospective cohort study of community-dwelling men aged ≥65 years, to evaluate the association of increased urine albumin with subsequent fractures and annualized rate of hip bone loss. We calculated albumin/creatinine ratio (ACR) from urine collected at the 2003-2005 visit. Subsequent clinical fractures were ascertained from triannual questionnaires and centrally adjudicated by review of radiographic reports. Total hip BMD was measured by DXA at the 2003-2005 visit and again an average of 3.5 years later. We estimated risk of incident clinical fracture using Cox proportional hazards models, and annualized BMD change using ANCOVA. Of 2982 men with calculable ACR, 9.4% had ACR ≥30 mg/g (albuminuria) and 1.0% had ACR ≥300 mg/g (macroalbuminuria). During a mean of 8.7 years of follow-up, 20.0% of men had an incident clinical fracture. In multivariate-adjusted models, neither higher ACR quintile (p for trend 0.75) nor albuminuria (HR versus no albuminuria, 0.89; 95% CI, 0.65 to 1.20) was associated with increased risk of incident clinical fracture. Increased urine albumin had a borderline significant, multivariate-adjusted, positive association with rate of total hip bone loss when modeled in ACR quintiles (p = 0.06), but not when modeled as albuminuria versus no albuminuria. Macroalbuminuria was associated with a higher rate of annualized hip bone loss compared to no albuminuria (-1.8% more annualized loss than in men with ACR
Published: 2017
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29. Clock gene expression is altered in veterans with sleep apnea

Author: Areef Ishani, Muna T. Canales, I. David Weiner, Michelle L. Gumz, Meaghan Holzworth, Rebecca J. Beyth, Shahab Bozorgmehri, and Richard B. Berry
Subjects: Male, Physiology, CLOCK Proteins, Gene Expression, Biology, Bioinformatics, Real-Time Polymerase Chain Reaction, Cohort Studies, Sleep Apnea Syndromes, Genetics, medicine, Humans, Circadian rhythm, Hypoxia, Aged, Veterans, Aged, 80 and over, Sleep apnea, Middle Aged, medicine.disease, Sleep in non-human animals, Circadian Rhythm, CLOCK, Cross-Sectional Studies, Gene Expression Regulation, Female, Research Article
Abstract: Clock gene dysregulation has been shown to underlie various sleep disorders and may lead to negative cardio-metabolic outcomes. However, the association between sleep apnea (SA) and core clock gene expression is unclear. We performed a cross-sectional analysis of 49 Veterans enrolled in a study of SA outcomes in veterans with chronic kidney disease, not selected for SA or sleep complaints. All participants underwent full polysomnography and next morning whole blood collection for clock gene expression. We defined SA as an apnea-hypopnea index ≥15 events/h; nocturnal hypoxemia(NH) was defined as ≥10% of total sleep time spent at 2 (SD 5); 41% had SA, and 27% had NH. Compared with those without SA, Per3 expression was reduced by 35% in SA ( P = 0.027). Compared with those without NH, NPAS2, Per1, and Rev-Erb-α expression was reduced in NH (50.4%, P = 0.027; 28.7%, P = 0.014; 31%, P = 0.040, respectively). There was no statistical difference in expression of the remaining clock genes by SA or NH status. Our findings suggest that SA or related NH and clock gene expression may be interrelated. Future study of 24 h clock gene expression in SA is needed to establish the role of clock gene regulation on the pathway between SA and cardio-metabolic outcomes.
Published: 2019

30. Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies

Author: Fan F Hou, Kimberly Smith, David Shepherd, William G. Herrington, Andrew S. Levey, Keiichi Sumida, Marc Froissart, Kazunobu Ichikawa, Jamie A. Green, Mila Tang, John Chalmers, Paul L Drury, Jack F.M. Wetzels, Misghina Weldegiorgis, Laura E Clark, Enyu Imai, Di Xie, John K Cuddeback, Gabriel Chodick, Gordon Prescott, Tom Greene, Julia B. Lewis, Sankar D. Navaneethan, Thorsten Vetter, Sadayoshi Ito, Kaleab Z. Abebe, Staffan Schön, Dick de Zeeuw, Ronald D. Perrone, Rajiv Nadukuru, C Yenchih Hsu, Carl-Gustaf Elinder, Stephen J Bakker, James F Medcalf, John F. Collins, Aliza Thompson, Fumiaki Kobayashi, Raina C Elley, Edmund J. Lewis, Richard D. Rohde, Brad C. Astor, Hirofumi Makino, Miklos Z. Molnar, Mark J. Sarnak, Abdul Rashid Qureshi, Roger A. Rodby, Hrefna Gudmundsdottir, Nigel J. Brunskill, Adeera Levin, Caroline S. Fox, Giuseppe Remuzzi, Hisatomi Arima, Varda Shalev, Arjan D. van Zuilen, Mårten Segelmark, Ognjenka Djurdjev, Margaret Smith, Simerjot K. Jassal, Sushrut S. Waikar, Nick Fluck, Joachim H. Ix, Barry M. Brenner, Mark Woodward, Kunihiro Matsushita, Chi Pang Wen, Kornelis Jj Van Hateren, Nanne Kleefstra, Jean-Philippe Haymann, Joseph V. Nally, Elizabeth L Ciemins, Henk J. G. Bilo, Lawrence J. Appel, Kerry Willis, Peter J. Blankestijn, Lesley A. Inker, Hans-Henrik Parving, Hiddo J.L. Heerspink, Luxia Zhang, Teresa K. Chen, Marie Evans, Areef Ishani, Girish N. Nadkarni, Pascal Houillier, Kai-Uwe Eckardt, Mitsumasa Umesawa, Jingsha Chen, Stein Hallan, Maria Stendahl, Corri Black, Robert G. Nelson, H. Lester Kirchner, Björn Runesson, Shoshana H. Ballew, Elizabeth Barrett-Connor, Angharad Marks, Ron T. Gansevoort, Martin Flamant, William C. Knowler, Jaclyn Bergstrom, Tsuneo Konta, Jan A.J.G. van den Brand, Stephen G Ellis, Marit Dahl Solbu, Lucia Kwak, Bénédicte Stengel, Alex R. Chang, Aditya Surapaneni, Jesse D. Schold, Shih-Jen Hwang, Marcello Tonelli, Juan Jesus Carrero, Tom Manley, Timothy Kenealy, Erwin P. Bottinger, Nikita Stempniewicz, Johan Ärnlöv, Rich Stempniewicz, Norman Stockbridge, Gijs W D Landman, Vlado Perkovic, Piero Ruggenenti, Marie Metzger, David Naimark, Josef Coresh, Lawrence G. Hunsicker, Kevin Ho, Solfrid Romundstad, Morgan E. Grams, Csaba P. Kovesdy, Atsushi Hirayama, Harold I. Feldman, Yingying Sang, Kevan R. Polkinghorne, Romaldas Maciulaitis, Navdeep Tangri, Rupert W. Major, Maneesh Sud, Groningen Kidney Center (GKC), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Cardiovascular Centre (CVC)
Subjects: SURROGATE, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Regression dilution, Renal function, 030209 endocrinology & metabolism, ALL-CAUSE, Kidney Function Tests, GLOMERULAR-FILTRATION-RATE, Article, APPROPRIATE THERAPEUTIC TARGET, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Risk Factors, Internal medicine, Diabetes mellitus, CKD, medicine, Internal Medicine, Albuminuria, Humans, 030212 general & internal medicine, Surrogate endpoint, business.industry, urogenital system, MORTALITY, Hazard ratio, PROTEINURIA, medicine.disease, Prognosis, Diabetes and Metabolism, RENAL-DISEASE, Observational Studies as Topic, COLLABORATIVE METAANALYSIS, Cohort, Disease Progression, Kidney Failure, Chronic, medicine.symptom, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11], business, POINT, Kidney disease, Glomerular Filtration Rate
Abstract: Item does not contain fulltext BACKGROUND: Change in albuminuria as a surrogate endpoint for progression of chronic kidney disease is strongly supported by biological plausibility, but empirical evidence to support its validity in epidemiological studies is lacking. We aimed to assess the consistency of the association between change in albuminuria and risk of end-stage kidney disease in a large individual participant-level meta-analysis of observational studies. METHODS: In this meta-analysis, we collected individual-level data from eligible cohorts in the Chronic Kidney Disease Prognosis Consortium (CKD-PC) with data on serum creatinine and change in albuminuria and more than 50 events on outcomes of interest. Cohort data were eligible if participants were aged 18 years or older, they had a repeated measure of albuminuria during an elapsed period of 8 months to 4 years, subsequent end-stage kidney disease or mortality follow-up data, and the cohort was active during this consortium phase. We extracted participant-level data and quantified percentage change in albuminuria, measured as change in urine albumin-to-creatinine ratio (ACR) or urine protein-to-creatinine ratio (PCR), during baseline periods of 1, 2, and 3 years. Our primary outcome of interest was development of end-stage kidney disease after a baseline period of 2 years. We defined an end-stage kidney disease event as initiation of kidney replacement therapy. We quantified associations of percentage change in albuminuria with subsequent end-stage kidney disease using Cox regression in each cohort, followed by random-effects meta-analysis. We further adjusted for regression dilution to account for imprecision in the estimation of albuminuria at the participant level. We did multiple subgroup analyses, and also repeated our analyses using participant-level data from 14 clinical trials, including nine clinical trials not in CKD-PC. FINDINGS: Between July, 2015, and June, 2018, we transferred and analysed data from 28 cohorts in the CKD-PC, which included 693 816 individuals (557 583 [80%] with diabetes). Data for 675 904 individuals and 7461 end-stage kidney disease events were available for our primary outcome analysis. Change in ACR was consistently associated with subsequent risk of end-stage kidney disease. The adjusted hazard ratio (HR) for end-stage kidney disease after a 30% decrease in ACR during a baseline period of 2 years was 0.83 (95% CI 0.74-0.94), decreasing to 0.78 (0.66-0.92) after further adjustment for regression dilution. Adjusted HRs were fairly consistent across cohorts and subgroups (ie, estimated glomerular filtration rate, diabetes, and sex), but the association was somewhat stronger among participants with higher baseline ACR than among those with lower baseline ACR (pinteraction
Published: 2019

31. Long-term Outcomes of Living Kidney Donation

Author: Areef Ishani, Maureen Carlyle, Michelle Brasure, Jason R. Bydash, Timothy J Wilt, Keith E Eidman, Saugar Maripuri, and Yelena Slinin
Subjects: Transplantation, medicine.medical_specialty, urogenital system, business.industry, 030232 urology & nephrology, MEDLINE, Kidney donation, 030230 surgery, 03 medical and health sciences, 0302 clinical medicine, Long term outcomes, Medicine, business, Intensive care medicine
Abstract: In an effort to improve outcomes associated with living kidney donation, the Kidney Diseases Improving Global Outcomes (KDIGO) assembled a Work Group to develop comprehensive guidelines addressing the evaluation and care of living kidney donors. We conducted this systematic review to inform guideline development.We searched Ovid Medline, Ovid Embase, and the Cochrane Library to identify systematic reviews, randomized controlled trials, and observational studies published through September of 2014 and consulted the KDIGO Expert Work Group. We extracted data from systematic reviews and observational studies with sample size over 100 and mean follow-up time of at least 5 years. Studies had to have an adequate comparison group that excludes subjects with contraindications to kidney donation.For the long-term donor outcomes, we extracted 5 systematic reviews and 40 observational studies. Moderate grade evidence reveals an association between living kidney donation and greater risk of end-stage renal disease. This association is true for donors of all races with African American donors sustaining the greatest increase in absolute risk. We found very low grade evidence that kidney donation is associated with lower kidney function, proteinuria, hypertension, and psychosocial outcomes. Consistent evidence from 3 studies reveals that donors are at higher risk for preeclampsia and gestational hypertension with postdonation pregnancies and compared with healthy matched nondonors.Living kidney donation appears to be associated with a small absolute increase in risk of end-stage renal disease, hypertension, and pregnancy complications, such as preeclampsia and gestational hypertension.
Published: 2016
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32. The SPRINT trial suggests that markers of tubule cell function in the urine associate with risk of subsequent acute kidney injury while injury markers elevate after the injury

Author: James P. Lash, Alexandra K. Lee, Michelle M. Estrella, Henry Punzi, Chirag R. Parikh, Areef Ishani, William E. Haley, Alexander L. Bullen, Cheryl A.M. Anderson, Vasantha Jotwani, Pranav S. Garimella, Rakesh Malhotra, Ronit Katz, Erik Riessen, Javier A. Neyra, Alfred K. Cheung, Michael G. Shlipak, Anjay Rastogi, Udayan Bhatt, Michael V. Rocco, Barry M. Wall, and Joachim H. Ix
Subjects: 0301 basic medicine, Male, Kidney Disease, Tamm–Horsfall protein, uromodulin, 030232 urology & nephrology, urologic and male genital diseases, interleukin-18, 0302 clinical medicine, Risk Factors, 80 and over, Renal Insufficiency, Longitudinal Studies, Chronic, Aged, 80 and over, biology, Reabsorption, Hazard ratio, Acute kidney injury, Interleukin-18, neutrophil gelatinase-associated lipocalin, Urology & Nephrology, Acute Kidney Injury, Middle Aged, Kidney Tubules, Nephrology, chitinase-3-like protein, Female, medicine.symptom, Glomerular Filtration Rate, medicine.medical_specialty, beta-2 microglobulin, Clinical Sciences, monocyte chemoattractant protein-1, Renal and urogenital, Urology, Renal function, Risk Assessment, Article, alpha-1 microglobulin, 03 medical and health sciences, Lipocalin-2, Clinical Research, Alpha-Globulins, Uromodulin, medicine, Albuminuria, Humans, Chitinase-3-Like Protein 1, Renal Insufficiency, Chronic, kidney injury molecule-1, Aged, business.industry, urogenital system, Prevention, medicine.disease, Renal Reabsorption, Good Health and Well Being, 030104 developmental biology, Blood pressure, biology.protein, Alpha-1-microglobulin, business, Biomarkers, Follow-Up Studies
Abstract: Urine markers can quantify tubular function including reabsorption (α-1 microglobulin [α1m]) and β-2-microglobulin [β2m]) and protein synthesis (uromodulin). Individuals with tubular dysfunction may be less able to compensate to insults than those without, despite similar estimated glomerular filtration rate (eGFR) and albuminuria. Among Systolic Blood Pressure Intervention Trial (SPRINT) participants with an eGFR under 60 ml/min/1.73m2, we measured urine markers of tubular function and injury (neutrophil gelatinase-associated lipocalin [NGAL], kidney injury molecule-1 [KIM-1], interleukin-18 [IL-18], monocyte chemoattractant protein-1, and chitinase-3-like protein [YKL-40]) at baseline. Cox models evaluated associations with subsequent acute kidney injury (AKI) risk, adjusting for clinical risk factors, baseline eGFR and albuminuria, and the tubular function and injury markers. In a random subset, we remeasured biomarkers after four years, and compared changes in biomarkers in those with and without intervening AKI. Among 2351 participants, 184 experienced AKI during 3.8 years mean follow-up. Lower uromodulin (hazard ratio per two-fold higher (0.68, 95% confidence interval [0.56, 0.83]) and higher α1m (1.20; [1.01, 1.44]) were associated with subsequent AKI, independent of eGFR and albuminuria. None of the five injury markers were associated with eventual AKI. In the random subset of 947 patients with repeated measurements, the 59 patients with intervening AKI versus without had longitudinal increases in urine NGAL, IL-19, and YKL-40 and only 1 marker of tubule function (α1m). Thus, joint evaluation of tubule function and injury provided novel insights to factors predisposing to AKI, and responses to kidney injury.
Published: 2018

33. Ultrafiltration rate in conventional hemodialysis: Where are the limits and what are the consequences?

Author: Areef Ishani, Yelena Slinin, and Megha Babu
Subjects: Male, medicine.medical_specialty, Younger age, medicine.medical_treatment, 030232 urology & nephrology, Renal function, Hemodiafiltration, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, medicine, Humans, Intensive care medicine, Survival rate, Dialysis, business.industry, Confounding, Quality Improvement, Survival Rate, Treatment Outcome, Nephrology, Kidney Failure, Chronic, Observational study, Female, Hemodialysis, business
Abstract: Background Ultrafiltration rate (UFR) has attracted attention as a modifiable aspect of volume management. Objective The objective of this review is to summarize the evidence that links UFR to patient outcomes and discuss UFR cut-offs proposed, and discuss possible consequences of adapting UFR as a quality metric. Results Higher UFRs has been associated with younger age, longer dialysis vintage, greater prevalence of comorbidities, higher Kt/V, lower weight, greater interdialytic weight gain, lower residual renal function, and shorter treatment times. Many of the characteristics associated with high UFRs have also been independently associated with poor patient outcomes. Four observational studies have assessed the association between UFR and patient mortality. All of them reported an association between higher UFR and greater patient mortality, though the studies differed in their definition of UFR, follow-up, and adjustment for confounding. Evidence for the association between higher UFR and potential mediations of the mortality association, such as interdialytic hypotension, cardiac remodeling, and cardiovascular events was less consistent. There was a graded association between higher UFRs and all-cause mortality; no definitive cut-off for acceptable UFR can be established based on the current evidence. Targeting UFR in isolation might result in volume expansion and worsening patient outcomes. Residual confounding likely contributed to the findings of the observational studies. No randomized controlled trials addressed the questions. Conclusion Evidence supporting UFR limits is weak and confounded. Randomized controlled trials are needed before UFR can be used as a quality of care indicator.
Published: 2018

34. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 Update

Author: Milagros Samaniego-Picota, Areef Ishani, Carin M Olson, Daniel E. Weiner, Rajnish Mehrotra, Rita S. Suri, Kerry Willis, Michael V. Rocco, Michael Rocco, Michael J. Choi, Paul J. Scheel, Holly J. Kramer, Indulis Rutks, Jula K. Inrig, Jessica Joseph, Roderick MacDonald, Thomas A. Depner, Timothy J Wilt, John T. Daugirdas, Yelena Slinin, Nancy Greer, and Laura Brereton
Subjects: medicine.medical_specialty, business.industry, medicine.medical_treatment, Guideline, medicine.disease, Clinical trial, Nephrology, Hemofiltration, medicine, Observational study, Hemodialysis, Medical prescription, Intensive care medicine, Grading (education), business, Kidney disease
Abstract: The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) has provided evidence-based guidelines for all stages of chronic kidney disease (CKD) and related complications since 1997. The 2015 update of the KDOQI Clinical Practice Guideline for Hemodialysis Adequacy is intended to assist practitioners caring for patients in preparation for and during hemodialysis. The literature reviewed for this update includes clinical trials and observational studies published between 2000 and March 2014. New topics include high-frequency hemodialysis and risks; prescription flexibility in initiation timing, frequency, duration, and ultrafiltration rate; and more emphasis on volume and blood pressure control. Appraisal of the quality of the evidence and the strength of recommendations followed the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Limitations of the evidence are discussed and specific suggestions are provided for future research.
Published: 2015
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35. Timing of Dialysis Initiation, Duration and Frequency of Hemodialysis Sessions, and Membrane Flux: A Systematic Review for a KDOQI Clinical Practice Guideline

Author: Areef Ishani, Timothy J Wilt, Roderick MacDonald, Yelena Slinin, Indulis Rutks, Nancy Greer, and Carin M Olson
Subjects: medicine.medical_specialty, Time Factors, medicine.medical_treatment, Population, Myocardial Infarction, Renal Dialysis, Early Medical Intervention, medicine, Humans, Intensive care medicine, education, Stroke, Dialysis, education.field_of_study, Depression, business.industry, Clinical study design, Guideline, medicine.disease, Hospitalization, Clinical trial, Treatment Outcome, Cardiovascular Diseases, Nephrology, Practice Guidelines as Topic, Emergency medicine, Quality of Life, Kidney Failure, Chronic, Hemodialysis, business, Kidney disease
Abstract: Background In 2006, NKF-KDOQI (National Kidney Foundation–Kidney Disease Outcomes Quality Initiative) published clinical practice guidelines for hemodialysis adequacy. Recent studies evaluating hemodialysis adequacy as determined by initiation timing, frequency, duration, and membrane type and prompted an update to the guideline. Study Design Systematic review and evidence synthesis. Setting & Population Patients with advanced chronic kidney disease receiving hemodialysis. Selection Criteria for Studies We screened publications from 2000 to March 2014, systematic reviews, and references and consulted the NKF-KDOQI Hemodialysis Adequacy Work Group members. We included randomized or controlled clinical trials in patients undergoing long-term hemodialysis if they reported outcomes of interest. Interventions Early versus late dialysis therapy initiation; more frequent (>3 times a week) or longer duration (>4.5 hours) compared to conventional hemodialysis; low- versus high-flux dialyzer membranes. Outcomes All-cause and cardiovascular mortality, myocardial infarction, stroke, hospitalizations, quality of life, depression or cognitive function scores, blood pressure, number of antihypertensive medications, left ventricular mass, interdialytic weight gain, and harms or complications related to vascular access or the process of dialysis. Results We included 32 articles reporting on 19 trials. Moderate-quality evidence indicated that earlier dialysis therapy initiation (at estimated creatinine clearance [eClcr] of 10-14mL/min) did not reduce mortality compared to later initiation (eClcr of 5-7mL/min). More than thrice-weekly hemodialysis and extended-length hemodialysis during a short follow-up did not improve clinical outcomes compared to conventional hemodialysis and resulted in a greater number of vascular access procedures (very low-quality evidence). Hemodialysis using high-flux membranes did not reduce all-cause mortality, but reduced cardiovascular mortality compared to hemodialysis using low-flux membranes (moderate-quality evidence). Limitations Few studies were adequately powered to evaluate mortality. Heterogeneity of study designs and interventions precluded pooling data for most outcomes. Conclusions Limited data indicate that earlier dialysis therapy initiation and more frequent and longer hemodialysis did not improve clinical outcomes compared to conventional hemodialysis.
Published: 2015
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36. Changes in secondary hyperparathyroidism-related biochemical parameters and medication use following parathyroidectomy

Author: Thy P. Do, Areef Ishani, Jiannong Liu, Allan J. Collins, Kimberly Lowe, James B. Wetmore, Brian D. Bradbury, and Geoffrey A. Block
Subjects: Adult, Male, Parathyroidectomy, medicine.medical_specialty, medicine.medical_treatment, Population, 030232 urology & nephrology, Urology, Parathyroid hormone, End stage renal disease, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Renal Dialysis, medicine, Humans, Young adult, education, Aged, Retrospective Studies, Transplantation, education.field_of_study, business.industry, Phosphorus, Retrospective cohort study, Middle Aged, medicine.disease, Combined Modality Therapy, Surgery, Parathyroid Hormone, Nephrology, 030220 oncology & carcinogenesis, Kidney Failure, Chronic, Calcium, Female, Hyperparathyroidism, Secondary, Secondary hyperparathyroidism, Hemodialysis, business
Abstract: Background Little is known about changes in parathyroid hormone (PTH), calcium and phosphorous levels after parathyroidectomy in hemodialysis patients. We studied the effects of parathyroidectomy on these biochemical values in a large cohort of patients receiving maintenance hemodialysis. Methods This retrospective cohort study included patients identified in both the United States Renal Data System and the database of a large dialysis organization who underwent parathyroidectomy in 2007-09, were aged ≥ 18 years, had Medicare Parts A and B as primary payer and had received hemodialysis for ≥ 1 year pre-parathyroidectomy. Descriptive statistics were calculated for continuous variables; categorical variables were used to characterize the population and evaluate monthly laboratory and medication use; median values were calculated for laboratory measures. Results Among 1402 parathyroidectomy patients, mean age was 48.9 years, 52.4% were males, 58.8% were African American and mean dialysis duration was 7.5 years. Median PTH levels increased over the year before parathyroidectomy from 1039 to 1661 pg/mL and decreased afterward to 98 pg/mL at 1 month; levels remained ≥ 897 pg/mL for 10% of patients. Median calcium levels fell from 9.6 mg/dL before to 7.9 mg/dL 1 month after parathyroidectomy; levels were ≤ 7.1 mg/dL for 25% and remained ≤ 7.2 mg/dL for the lowest 25% at 3 months. Median phosphorous level was 6.8 mg/dL immediately before parathyroidectomy, decreased to 3.8 mg/dL immediately after and reached 5.8 mg/dL at 1 year. Conclusions While PTH levels dropped after parathyroidectomy for most patients, surgery was sometimes ineffective in reducing levels and sometimes led to over-suppression. Hypocalcemia could be profound and long lasting, suggesting the need for prolonged vigilance.
Published: 2015
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37. Clinical Outcomes after Parathyroidectomy in a Nationwide Cohort of Patients on Hemodialysis

Author: Brian D. Bradbury, Areef Ishani, Allan J. Collins, Thy P. Do, James B. Wetmore, Geoffrey A. Block, Kimberly Lowe, and Jiannong Liu
Subjects: Parathyroidectomy, Transplantation, Pediatrics, medicine.medical_specialty, Epidemiology, business.industry, medicine.medical_treatment, Original Articles, Critical Care and Intensive Care Medicine, Rate ratio, Intensive care unit, Surgery, law.invention, Randomized controlled trial, Nephrology, law, Intensive care, Cohort, Medicine, Hemodialysis, business, Dialysis
Abstract: Background and objectives Patients receiving dialysis undergo parathyroidectomy to improve laboratory parameters in resistant hyperparathyroidism with the assumption that clinical outcomes will also improve. However, no randomized clinical trial data demonstrate the benefits of parathyroidectomy. This study aimed to evaluate clinical outcomes up to 1 year after parathyroidectomy in a nationwide sample of patients receiving hemodialysis. Design, setting, participants, & measurements Using data from the US Renal Data System, this study identified prevalent hemodialysis patients aged ≥18 years with Medicare as primary payers who underwent parathyroidectomy from 2007 to 2009. Baseline characteristics and comorbid conditions were assessed in the year preceding parathyroidectomy; clinical events were identified in the year preceding and the year after parathyroidectomy. After parathyroidectomy, patients were censored at death, loss of Medicare coverage, kidney transplant, change in dialysis modality, or 365 days. This study estimated cause-specific event rates for both periods and rate ratios comparing event rates in the postparathyroidectomy versus preparathyroidectomy periods. Results Of 4435 patients who underwent parathyroidectomy, 2.0% died during the parathyroidectomy hospitalization and the 30 days after discharge. During the 30 days after discharge, 23.8% of patients were rehospitalized; 29.3% of these patients required intensive care. In the year after parathyroidectomy, hospitalizations were higher by 39%, hospital days by 58%, intensive care unit admissions by 69%, and emergency room/observation visits requiring hypocalcemia treatment by 20-fold compared with the preceding year. Cause-specific hospitalizations were higher for acute myocardial infarction (rate ratio, 1.98; 95% confidence interval, 1.60 to 2.46) and dysrhythmia (rate ratio 1.4; 95% confidence interval1.16 to 1.78); fracture rates did not differ (rate ratio 0.82; 95% confidence interval 0.6 to 1.1). Conclusions Parathyroidectomy is associated with significant morbidity in the 30 days after hospital discharge and in the year after the procedure. Awareness of clinical events will assist in developing evidence-based risk/benefit determinations for the indication for parathyroidectomy.
Published: 2015
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38. Race, Ethnicity, and End-of-Life Care in Dialysis Patients in the United States

Author: Robert N. Foley, Paul E. Drawz, Donal J. Sexton, Areef Ishani, and Scott Reule
Subjects: Male, Race ethnicity, medicine.medical_specialty, Minority group, medicine.medical_treatment, 030232 urology & nephrology, Ethnic group, Dialysis patients, Medicare, Risk Assessment, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), Racism, Renal Dialysis, Cause of Death, Outcome Assessment, Health Care, medicine, Odds Ratio, Humans, Clinical Epidemiology, 030212 general & internal medicine, Registries, Healthcare Disparities, Dialysis, Minority Groups, Aged, Retrospective Studies, Terminal Care, business.industry, Incidence, General Medicine, Hispanic or Latino, Middle Aged, United States, Discontinuation, Black or African American, Nephrology, Family medicine, Kidney Failure, Chronic, Female, business, End-of-life care
Abstract: BACKGROUND: End-of-life care is a prominent consideration in patients on maintenance dialysis, especially when death appears imminent and quality of life is poor. To date, examination of race- and ethnicity-associated disparities in end-of-life care for patients with ESRD has largely been restricted to comparisons of white and black patients. METHODS: We performed a retrospective national study using United States Renal Data System files to determine whether end-of-life care in United States patients on dialysis is subject to racial or ethnic disparity. The primary outcome was a composite of discontinuation of dialysis and death in a nonhospital or hospice setting. RESULTS: Among 1,098,384 patients on dialysis dying between 2000 and 2014, the primary outcome was less likely in patients from any minority group compared with the non-Hispanic white population (10.9% versus 22.6%, P
Published: 2017

39. Renal Function and Death in Older Women: Which eGFR Formula Should We Use?

Author: Areef Ishani, Allyson Hart, Rebecca J. Beyth, Kristine E. Ensrud, Brent C Taylor, Terri Blackwell, and Muna T. Canales
Subjects: Gerontology, medicine.medical_specialty, Article Subject, business.industry, 030232 urology & nephrology, Renal function, Mean age, lcsh:Diseases of the genitourinary system. Urology, lcsh:RC870-923, Cardiovascular death, 03 medical and health sciences, 0302 clinical medicine, Increased risk, Nephrology, Internal medicine, medicine, 030212 general & internal medicine, Risk of death, Prospective cohort study, business, Research Article
Abstract: Background. The Berlin Initiative Study (BIS) eGFR equations were developed specifically for aged populations, but their predictive validity compared to standard formulae is unknown in older women.Methods. In a prospective study of 1289 community-dwelling older women (mean age 79.5 years), we compared the performance of the BIS1 SCr-based equation to the CKD-EPIcrand the BIS2 SCr- and Scysc-based equation to the CKD-EPIcr,cyscto predict cardiovascular and all-cause mortality.Results. Prevalence of specific eGFR category (i.e., ≥75, 60–74, 45–59, and EPIcr; 14.1%, 38.6%, 37.6%, and 9.6% for BIS2; and 33.5%, 33.4%, 22.0%, and 11.1% for CKD-EPIcr,cysc, respectively. Over9±4years, 667 (51.8%) women died. For each equation, women with eGFR EPIcr, 1.7 (1.3–2.2); BIS2, 2.0 (1.4–2.8); CKD-EPIcr,cysc, 1.8 (1.4–2.3);p-trend Conclusions. Compared to CKD-EPI, BIS equations identified a greater proportion of older women as having CKD but performed similarly to predict mortality risk. Thus, the BIS equations should not replace CKD-EPI equations to predict risk of death in older women.
Published: 2017

40. Cystatin C and Cognitive Impairment 10 Years Later in Older Women

Author: Kristine Yaffe, Areef Ishani, Kristine E. Ensrud, Yelena Slinin, Katherine W. Peters, Katie L. Stone, Howard A Fink, and Michael W. Steffes
Subjects: Aging, medicine.medical_specialty, Renal function, Neuropsychological Tests, chemistry.chemical_compound, Internal medicine, medicine, Humans, Dementia, Cognitive Dysfunction, Longitudinal Studies, Prospective Studies, Cystatin C, Prospective cohort study, Aged, Creatinine, biology, business.industry, Confounding, Neuropsychology, Odds ratio, medicine.disease, United States, Endocrinology, chemistry, biology.protein, Female, Geriatrics and Gerontology, business, Glomerular Filtration Rate, Research Article
Abstract: Background. R esults of prospective studies examining the association between cystatin C and incident cognitive impairment have been inconsistent. We tested the hypothesis that there is a U-shaped association in older women between cystatin C and risk of incident cognitive impairment 10 years later. Methods. W e conducted a longitudinal analysis of a prospective cohort of 1,332 communitydwelling elderly women without dementia at baseline who had baseline cystatin C and serum creatinine measurements and completed an extended cognitive battery of neuropsychological tests with determination of cognitive status 10 years later. Incident cognitive impairment was defined as either new onset of adjudicated diagnosis of mild cognitive impairment or dementia. Results. Incident mild cogniti ve impairment or dementia was identified among 140 (26.0%) women in quartile 1 (Q1), 122 (22.6%) in Q2, 121 (22.5%) in Q3, and 156 (28.9%) in Q4 of cystatin C. In the fully adjusted model, compared to women in Q2–Q3 of cystatin C, adjusted odds ratios (95% CI) for incident cognitive impairment were 1.31 (0.98–1.75) for Q1, and 1.25 (0.94–1.66) for Q4 Compared to women in Q2–Q3 of estimated glomerular filtration rate (eGFR CysC ), adjusted odds ratios (95% CI) for incident cognitive impairment after 10 years of follow-up were 1.18 (0.88–1.58) for Q4 (eGFR CysC 76.1–109.4 mL/min/1.73 m 2 ) and 1.26 (0.94–1.67) for Q1 (eGFR CysC 21.8–55.5 mL/min/1 .73 m 2 ). Conclusions. These results suppor t a U-shaped association between cystatin C concentration and risk of cognitive impairment or dementia 10 years later, but the association is not independent of potential confounding factors.
Published: 2014
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41. Provider and Care Characteristics Associated with Timing of Dialysis Initiation

Author: Allan J. Collins, Suying Li, Benjamin Morgan, David T. Gilbertson, Kristine E. Ensrud, Jiannong Liu, Areef Ishani, Haifeng Guo, and Yelena Slinin
Subjects: Male, Nephrology, medicine.medical_specialty, Epidemiology, medicine.medical_treatment, Renal function, Kidney, urologic and male genital diseases, Critical Care and Intensive Care Medicine, Logistic regression, Time-to-Treatment, Renal Dialysis, Internal medicine, medicine, Humans, Practice Patterns, Physicians', Renal Insufficiency, Chronic, Intensive care medicine, Dialysis, Transplantation, business.industry, Retrospective cohort study, Original Articles, Odds ratio, female genital diseases and pregnancy complications, Master file, Cohort, Emergency medicine, Female, business
Abstract: Summary Background andobjectivesThereisatrendintheUnited Statesto maintenancedialysisinitiationathigher levels of estimated GFR. This study aimed to determine whether provider characteristics and pre-ESRD nephrology care and vascular access are independently associated with higher estimated GFR at initiation. Design, setting, participants, & measurements This retrospective cohort study used US Renal Data System data for patients who initiated dialysis in 2006 (n=83,621) and American Medical Association Physician Master File data for provider characteristics. Patient characteristics and estimated GFR were defined, and providers at dialysis initiation were identified. Earlier dialysis initiation was defined as initiation at estimated GFR.10 ml/min per 1.73 m 2 . Nephrologist density per 100 ESRD patients was calculated by Health Service Area in 2006. Associations between provider characteristics and estimated GFR were determined using logistic regression and linear regression models, accounting for provider clustering. Results Of the cohort, 47.8% of patients initiated dialysis at estimated GFR.10 ml/min per 1.73 m 2 , and 16.2% of patients initiated dialysis at estimated GFR$15 ml/min per 1.73 m 2 . Predialysis nephrologist care for 0–12 months was associated with greater odds of earlier initiation compared with no care. Patients initiating with an arteriovenous fistula or graft were more likely to initiate earlier than patients initiating with a catheter. Provider sex was not associated with timing of dialysis initiation as measured by estimated GFR. Care by providers who graduated from nondomestic medical schools was associated with greater odds of earlier initiation. Greater provider experience was associated with lower likelihood of earlier initiation. Conclusion This study supports the hypothesis that provider factors are associated with timing of dialysis initiation in the United States. Clin J Am Soc Nephrol 9: ccc–ccc, 2014. doi: 10.2215/CJN.04190413
Published: 2014
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42. Predialysis Care and Dialysis Outcomes in Hemodialysis Patients with a Functioning Fistula

Author: Allan J. Collins, Areef Ishani, David T. Gilbertson, Brian D. Bradbury, and Deborah Kim
Subjects: Male, medicine.medical_specialty, Fistula, medicine.medical_treatment, Myocardial Ischemia, Vascular access, Medicare, Diabetes Complications, Arteriovenous Shunt, Surgical, Renal Dialysis, Risk Factors, Epidemiology, medicine, Humans, Renal Insufficiency, Intensive care medicine, Dialysis, Aged, Retrospective Studies, Heart Failure, business.industry, Middle Aged, medicine.disease, United States, Treatment Outcome, Nephrology, Female, Hemodialysis, business
Abstract: Background/Aims: Predialysis care has been associated with improved first-year outcomes. We investigated types of predialysis care associated with improved patient outcomes in patients initiating dialysis with a fistula and at least 2 years of predialysis care. Methods: In this retrospective cohort of incident hemodialysis patients with ≥2 years of Medicare coverage before dialysis initiation, care patterns and patients were determined using Medicare claims. Fistula use at initiation was ascertained from the Medical Evidence Report. Results: Patients aged ≥67 years who initiated hemodialysis with a fistula (n = 14,459) differed demographically and clinically from patients who initiated with other vascular access types; however, 55% had diabetes, 28% heart failure, and 40% ischemic heart disease. In the year preceding initiation, 88% of these patients visited a nephrologist, 66% a cardiologist, 9% an endocrinologist, and 3% a dietician; most underwent routine laboratory measurements. In the first year of dialysis, 50% were hospitalized and 1.3% underwent transplant; the mortality rate remained constant (∼20 per 100 patient-years). Of predialysis care factors evaluated, only fistula placement more than 1 month before dialysis initiation was associated with lower hospitalization and mortality risk and greater likelihood of transplant. Other potentially modifiable factors included more contact with cardiologists and endocrinologists. Conclusion: Patients initiating dialysis with a functioning fistula appear to receive substantial predialysis preparation. This selected population does not show the excess mortality risk often observed early in dialysis treatment. Earlier fistula placement and referral to cardiology and endocrinology appear to be important aspects of predialysis care.
Published: 2014
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43. 0876 Sleep Apnea and Change in Quality of Life Among Veterans with Kidney Disease: A Prospective Cohort Study

Author: Rebecca J. Beyth, Areef Ishani, Richard B. Berry, L A Johnson, D Weiner, Muna T. Canales, and S Bozogmehri
Subjects: Pediatrics, medicine.medical_specialty, Quality of life (healthcare), business.industry, Physiology (medical), Medicine, Sleep apnea, Neurology (clinical), business, Prospective cohort study, medicine.disease, Kidney disease
Published: 2018
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44. Cystatin C and Frailty in Older Men

Author: Kristine E. Ensrud, Peggy M. Cawthon, Areef Ishani, Brent C Taylor, Eric S. Orwoll, Misti L. Paudel, and Allyson Hart
Subjects: Gerontology, medicine.medical_specialty, biology, business.industry, Renal function, Odds ratio, Confidence interval, Quartile, Cystatin C, Internal medicine, Cohort, medicine, biology.protein, Geriatrics and Gerontology, business, Prospective cohort study, Cohort study
Abstract: Objectives: To determine whether higher cystatin C would be associated with greater frailty in men aged 65 and older. Design: Cross-sectional cohort study. Setting: Six U.S. sites. Participants: A random sample of community-dwelling men aged 65 and older enrolled in the Osteoporotic Fractures in Men (MrOS) Study (mean age 73.8; 9.8% frail and 47.2% intermediate frailty; N = 1,602). Measurements: Serum cystatin C, creatinine, and frailty were measured. Frailty was analyzed as an ordinal outcome of robust, intermediate frailty, and frail using a multinomial logistic regression model, and the base model was adjusted for age, race, and clinical site. Results: Higher cystatin C was associated with seven times greater odds of being frail than being robust (odds ratio (OR) quartile 4 vs 1 = 7.12, 95% confidence interval (CI) = 3.76�13.46) and 2.4 times greater odds of intermediate frailty than robust (OR quartile 4 vs 1 = 2.38, 95% CI = 1.70�3.32). The association was attenuated but persisted after adjusting for multiple possible confounders. In contrast, neither higher serum creatinine (OR quartile 4 vs 1 = 1.36, 95% CI = 0.78�2.40) nor lower creatinine-based estimated glomerular filtration rate (OR quartile 4 vs 1 = 1.01, 95% CI = 0.54�1.87) was associated in a graded manner with greater odds of frailty. Conclusion: Higher cystatin C, but not creatinine-based measures, was associated with greater odds of frailty in this cohort of older men.
Published: 2013
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45. Cystatin C and risk of hip fractures in older women

Author: Areef Ishani, Jane A. Cauley, Yelena Slinin, Kristine E. Ensrud, Neeta Parimi, Michael W. Steffes, Steven R. Cummings, Teresa A. Hillier, and Brent C Taylor
Subjects: Creatinine, Hip fracture, medicine.medical_specialty, biology, business.industry, Endocrinology, Diabetes and Metabolism, Hazard ratio, Renal function, medicine.disease, Surgery, chemistry.chemical_compound, medicine.anatomical_structure, chemistry, Quartile, Cystatin C, Hip bone, Internal medicine, medicine, biology.protein, Orthopedics and Sports Medicine, business, Body mass index
Abstract: To test the hypothesis that older women with higher cystatin C are at increased risk of hip fracture independent of traditional risk factors including hip bone mineral density (BMD), we performed a case-cohort analysis nested in a cohort of 4709 white women attending a Year 10 (1997–1998) examination of the Study of Osteoporotic Fractures that included a random sample of 1170 women and the first 300 women with incident hip fracture occurring after Year 10 examination. Serum cystatin C and creatinine were measured in Year 10 sera. In a model adjusted for age, clinical site, body mass index, and total hip BMD, higher cystatin C was associated with an increased risk of hip fracture (p for linear trend 0.008) with women in quartile 4 having a 1.9-fold higher risk (hazard ratio [HR] 1.91; 95% confidence interval [CI], 1.24–2.95) compared with those in quartile 1 (referent group). Further adjustment for additional risk factors only slightly attenuated the association; the risk for hip fracture was 1.7-fold higher (HR 1.74; 95% CI, 1.11–2.72) in women in quartile 4 compared with those in quartile 1. In contrast, neither serum creatinine nor creatinine-based estimated glomerular filtration rate (eGFRCr) were associated with risk of hip fracture. Older women with higher cystatin C, but not higher serum creatinine or lower eGFRCr, have an increased risk of hip fracture independent of traditional risk factors. These findings suggest that cystatin C may be a promising biomarker for identification of older adults at high risk of hip fracture.
Published: 2013
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46. Geographic variation of parathyroidectomy in patients receiving hemodialysis: a retrospective cohort analysis

Author: Allan J. Collins, Geoffrey A. Block, James B. Wetmore, Areef Ishani, Paul J. Dluzniewski, and Jiannong Liu
Subjects: Parathyroidectomy, Adult, Male, medicine.medical_specialty, Mineral metabolism, medicine.medical_treatment, 030232 urology & nephrology, 030204 cardiovascular system & hematology, Logistic regression, End stage renal disease, 03 medical and health sciences, End-stage renal disease, Young Adult, 0302 clinical medicine, Renal Dialysis, medicine, Humans, Dialysis, Aged, Retrospective Studies, business.industry, Retrospective cohort study, General Medicine, Odds ratio, Middle Aged, medicine.disease, United States, Surgery, Secondary hyperparathyroidism, Kidney Failure, Chronic, Female, Hyperparathyroidism, Secondary, Hemodialysis, business, Research Article
Abstract: Background Secondary hyperparathyroidism (SHPT) is associated with adverse outcomes in patients receiving maintenance dialysis. Parathyroidectomy is a treatment for SHPT; whether parathyroidectomy utilization varies geographically in the US is unknown. Methods A retrospective cohort analysis was undertaken to identify all patients aged 18 years or older who were receiving in-center hemodialysis between 2007 and 2009, were covered by Medicare Parts A and B, and had been receiving hemodialysis for at least 1 year. Parathyroidectomy was identified from inpatient claims using relevant International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. Patient characteristics and End-Stage Renal Disease Network (a proxy for geography) were ascertained. Adjusted odds ratios for parathyroidectomy were estimated from a logistic model. Results A total of 286,569 patients satisfied inclusion criteria, of whom 4435 (1.5%) underwent PTX. After adjustment for a variety of patient characteristics, there was a 2-fold difference in adjusted odds of parathyroidectomy between the most- and least-frequently performing regions. Adjusted odds ratios were more than 20% higher than average in four networks, and more than 20% lower in four networks. Conclusions Parathyroidectomy use varies substantially by geography in the US; the factors responsible should be further investigated.
Published: 2016

47. Incidence and severity of pseudohyperkalemia in chronic lymphocytic leukemia: a longitudinal analysis

Author: Areef Ishani, Lauren Katkish, Pankaj Gupta, and Thomas S. Rector
Subjects: Male, 030213 general clinical medicine, Cancer Research, medicine.medical_specialty, Hyperkalemia, Leukocytosis, Chronic lymphocytic leukemia, Comorbidity, 030204 cardiovascular system & hematology, Potassium blood, Gastroenterology, Severity of Illness Index, 03 medical and health sciences, Leukocyte Count, 0302 clinical medicine, Internal medicine, Severity of illness, medicine, Humans, Longitudinal Studies, Aged, Aged, 80 and over, business.industry, Incidence (epidemiology), Incidence, Hematology, Middle Aged, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Oncology, Potassium, medicine.symptom, Potassium level, business
Abstract: An artifactually elevated measured potassium level is referred to as pseudohyperkalemia or false/apparent/spurious hyperkalemia, first described with extreme leukocytosis.[1] It has since been repo...
Published: 2016

48. Estimated GFR and Mortality in Older Men: Are All eGFR Formulae Equal?

Author: Katie L. Stone, Brent C Taylor, Elizabeth Barrett-Connor, Muna T. Canales, Allyson Hart, Kristine E. Ensrud, Areef Ishani, Terri Blackwell, Rebecca J. Beyth, and Cora E. Lewis
Subjects: Male, medicine.medical_specialty, MEDLINE, Urology, Renal function, 030204 cardiovascular system & hematology, urologic and male genital diseases, Article, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, Medicine, Humans, 030212 general & internal medicine, Prospective Studies, Mortality, Prospective cohort study, Aged, Aged, 80 and over, business.industry, Extramural, Geriatric nephrology, female genital diseases and pregnancy complications, United States, Multicenter study, Nephrology, Predictive value of tests, business, Glomerular Filtration Rate
Abstract: Background: Recently, the first estimated glomerular filtration rate (eGFR) formula specifically developed for community-dwelling older adults, the Berlin Initiative Study Equation 2 (BIS2), was reported. To date, however, no study has examined the performance of the BIS2 to predict death in older adults as compared to equations used clinically and in research. Methods: We prospectively followed 2,994 community-dwelling men (age 76.4 ± 5.6) enrolled in the MrOS Sleep Study. We calculated baseline eGFR from serum creatinine and cystatin-C using the BIS2, Chronic Kidney Disease Epidemiology (CKD-EPIcr,cysc), CKD-EPIcysc and CKD-EPIcr equations. Analyses included Cox-proportional hazards regression and net reclassification improvement (NRI) for the outcomes of all-cause and cardiovascular death. Results: Follow-up time was 7.3 ± 1.9 years. By BIS2, 42 and 11% had eGFR cr (23 and 6%), CKD-EPIcysc (36 and 13%) and CKD-EPIcr,cysc (28 and 8%). BIS2 eGFR cr,cysc cysc cr cr,cysc, both BIS2 and CKD-EPIcr equations more often misclassified participants with respect to mortality. We found similar results for cardiovascular death. Conclusion: The BIS2 did not outperform and the CKD-EPIcr was inferior to the cystatin C-based CKD-EPI equations to predict death in this cohort of older men. Thus, the cystatin C-based CKD-EPI equations are the formulae of choice to predict death in community-dwelling older men.
Published: 2016

49. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update

Author: Kumar Sharma, Rudolf W. Bilous, Andrew S. Narva, Areef Ishani, Michael Mauer, Mark E. Molitch, M Carlyle, Thomas S. Rector, Robert G. Nelson, Patrick Fitzgerald, JM Gonzalez-Campoy, Timothy J Wilt, JE Fradkin, Jeffrey S. Berns, Katherine R. Tuttle, Yelena Slinin, and Michael V. Rocco
Subjects: medicine.medical_specialty, business.industry, Guideline, medicine.disease, Clinical Practice, Hemoglobin A, Systematic review, Nephrology, Diabetes mellitus, Diabetes Mellitus, medicine, Albuminuria, Humans, Diabetic Nephropathies, Renal Insufficiency, Chronic, medicine.symptom, Intensive care medicine, business, Lipoprotein cholesterol, Kidney disease
Abstract: The 2012 update of the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline for Diabetes and Chronic Kidney Disease (CKD) is intended to assist the practitioner caring for patients with diabetes and CKD. Substantial high-quality new evidence has emerged since the original 2007 KDOQI guideline that could significantly change recommendations for clinical practice. As such, revisions of prior guidelines are offered that specifically address hemoglobin A(1c) (HbA(1c)) targets, treatments to lower low-density lipoprotein cholesterol (LDL-C) levels, and use of angiotensin-converting enzyme inhibitor (ACE-I) and angiotensin receptor blocker (ARB) treatment in diabetic patients with and without albuminuria. Treatment approaches are addressed in each section and the stated guideline recommendations are based on systematic reviews of relevant trials. Appraisal of the quality of the evidence and the strength of recommendations followed the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Limitations of the evidence are discussed and specific suggestions are provided for future research.
Published: 2012
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50. Association of Provider–Patient Visit Frequency and Patient Outcomes on Hemodialysis

Author: Jiannong Liu, Areef Ishani, David T. Gilbertson, Kristine E. Ensrud, Allan J. Collins, Suying Li, Haifeng Guo, and Yelena Slinin
Subjects: Adult, Male, medicine.medical_specialty, Pediatrics, medicine.medical_treatment, Medicare, Lower risk, Ambulatory Care Facilities, Cohort Studies, Renal Dialysis, Outcome Assessment, Health Care, Outpatients, medicine, Humans, Clinical Epidemiology, Survival rate, Aged, Proportional Hazards Models, Retrospective Studies, Aged, 80 and over, Medicaid, business.industry, Proportional hazards model, Retrospective cohort study, General Medicine, Middle Aged, United States, Hospitalization, Survival Rate, Treatment Outcome, Nephrology, Cohort, Emergency medicine, Kidney Failure, Chronic, Female, Hemodialysis, business, Cohort study
Abstract: In January of 2004, the Centers for Medicare & Medicaid Services tied provider reimbursement for outpatient hemodialysis services to the number of provider–patient visits per month. We aimed to determine whether greater visit frequency associated with lower mortality and hospitalization rates among incident hemodialysis patients in a large, nationally representative contemporary cohort. Using US Renal Data System data for 130,892 patients who initiated in-center hemodialysis between October 1, 2003 and September 30, 2006, we determined associations between the frequency of provider visits and mortality, first hospitalization, multiple hospitalizations, and cause-specific hospitalizations. Our primary analysis used Cox proportional hazards models, but we also performed time-varying Cox proportional hazards and instrumental variable analyses. In the primary analysis, we did not detect a significance difference in mortality among patients with four provider visits per month compared with those patients with fewer provider visits (adjusted HR=0.98; 95% CI=0.96–1.01), but the risk for first hospitalization was 4% lower among those patients with more frequent visits (adjusted HR=0.96; 95% CI=0.95–0.97). The time-varying Cox analysis produced similar results. The fully adjusted instrumental variable analysis showed a 0.07% higher risk for death that was not statistically significant (P=0.88) but a significant 2.3% lower risk for first hospitalization (P=0.001) for patients with four provider visits per month. In summary, greater frequency of provider visits to hemodialysis patients associates with a small but significant reduction in hospitalizations, but it does not consistently associate with lower risk for death.
Published: 2012
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