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Daniel E. Forman;
Michael W. Rich;
Karen P. Alexander;
Susan Zieman;
Mathew S. Maurer;
Samer S. Najjar;
Joseph C. Cleveland;
Harlan M. Krumholz;
Nanette Wenger
Over a decade ago, the Institute of Medicine called for a national cancer data system in the United States to support quality-of-care assessment and improvement, including research on effective interventions. Although considerable progress has been achieved in cancer quality measurement and effectiveness research, the nation still lacks a population-based data infrastructure for accurately identifying cancer patients and tracking services and outcomes over time. For compelling reasons, the most effective pathway forward may be the development of state-level cancer data systems, in which central registry data are linked to multiple public and private secondary sources. These would include administrative/claims files from Medicare, Medicaid, and private insurers. Moreover, such a state-level system would promote rapid learning by encouraging adoption of near-real-time reporting and feedback systems, such as the Commission on Cancer's new Rapid Quality Reporting System. The groundwork for such a system is being laid in the state of Georgia, and similar work is advancing in other states. The pace of progress depends on the successful resolution of issues related to the application of information technology, financing, and governance.
Objectives: Acute intoxications in children account for 4.6% of annual admissions to the PICU. We aimed to describe the interventions and monitoring required for children admitted to the PICU following intoxications with the ultimate goal of determining patient and intoxication characteristics associated with the need for PICU interventions. Design: Retrospective review of prospectively collected data from Virtual Pediatric Systems, LLC. Setting: United States PICUs participating in the Virtual Pediatric Systems database from 2011 to 2014. Patients: Less than or equal to 18 years old admitted to a PICU with a diagnostic code for poisoning, ingestion, intoxication, or overdose. Interventions: None. Measurements and Main Results: In total, 12,021 patients were included with a median PICU length of stay of 0.97 days (interquartile range, 0.67-1.60). Seventy-eight percent of the intoxications were intentional. The top five classes of medications ingested were unknown substances (21.6%), antidepressants (11.5%), other chemicals (10.7%), analgesics (7.3%), and antihypertensives (6.2%). Seventy-six (0.61%) patients died. Any of the interventions reported in the Virtual Pediatric Systems database were performed in only 29.1% of the total cases. Conclusions: The majority of cases (70.9%) admitted to the PICU following an intoxication did not undergo any significant intervention. Future studies should focus on distinguishing patient and intoxication characteristics associated with need for PICU intervention to optimize patient safety and minimize resource burden.
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Laurence W. Busse;
Xueyuan Shelly Wang;
Divya M. Chalikonda;
Kevin W. Finkel;
Ashish K. Khanna;
Harold M. Szerlip;
David Yoo;
Sharon L. Dana;
Lakhmir S. Chawla
Objective: Angiotensin II is an endogenous hormone with vasopressor and endocrine activities. This is a systematic review of the safety of IV angiotensin II. Data Sources: PubMed, Medline, Scopus, and Cochrane. Study Selection: Studies in which human subjects received IV angiotensin II were selected whether or not safety was discussed. Data Extraction: In total, 18,468 studies were screened by two reviewers and one arbiter. One thousand one hundred twenty-four studies, in which 31,281 participants received angiotensin II (0.5-3,780 ng/kg/min), were selected. Data recorded included number of subjects, comorbidities, angiotensin II dose and duration, pressor effects, other physiologic and side effects, and adverse events. Data Synthesis: The most common nonpressor effects included changes in plasma aldosterone, renal function, cardiac variables, and electrolytes. Adverse events were infrequent and included headache, chest pressure, and orthostatic symptoms. The most serious side effects were exacerbation of left ventricular failure in patients with congestive heart failure and bronchoconstriction. One patient with congestive heart failure died from refractory left ventricular failure. Refractory hypotensive shock was fatal in 55 of 115 patients treated with angiotensin II in case studies, cohort studies, and one placebo-controlled study. One healthy subject died after a pressor dose of angiotensin II was infused continuously for 6 days. No other serious adverse events attributable to angiotensin II were reported. Heterogeneity in study design prevented meta-analysis. Conclusion: Adverse events associated with angiotensin II were infrequent; however, exacerbation of asthma and congestive heart failure and one fatal cerebral hemorrhage were reported. This systematic review supports the notion that angiotensin II has an acceptable safety profile for use in humans.
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Basilia Zingarelli;
Craig Coopersmith;
Susanne Drechsler;
Philip Efron;
John C. Marshall;
Lyle Moldawer;
W. Joost Wiersinga;
Xianzhong Xiao;
Marcin F. Osuchowski;
Christoph Thiemermann
Preclinical animal studies are mandatory before new treatments can be tested in clinical trials. However, their use in developing new therapies for sepsis has been controversial because of limitations of the models and inconsistencies with the clinical conditions. In consideration of the revised definition for clinical sepsis and septic shock (Sepsis-3), a Wiggers-Bernard Conference was held in Vienna in May 2017 to propose standardized guidelines on preclinical sepsis modeling. The participants conducted a literature review of 260 most highly cited scientific articles on sepsis models published between 2003 and 2012. The review showed, for example, that mice were used in 79% and euthanasia criteria were defined in 9% of the studies. Part I of this report details the recommendations for study design and humane modeling endpoints that should be addressed in sepsis models. The first recommendation is that survival follow-up should reflect the clinical time course of the infectious agent used in the sepsis model. Furthermore, it is recommended that therapeutic interventions should be initiated after the septic insult replicating clinical care. To define an unbiased and reproducible association between a new treatment and outcome, a randomization and blinding of treatments as well as inclusion of all methodological details in scientific publications is essential. In all preclinical sepsis studies, the high standards of animal welfare must be implemented. Therefore, development and validation of specific criteria for monitoring pain and distress, and euthanasia of septic animals, as well as the use of analgesics are recommended. A set of four considerations is also proposed to enhance translation potential of sepsis models. Relevant biological variables and comorbidities should be included in the study design and sepsis modeling should be extended to mammalian species other than rodents. In addition, the need for source control (in case of a defined infection focus) should be considered. These recommendations and considerations are proposed as "best practices" for animal models of sepsis that should be implemented.
Objectives With the objective of bringing clinical decision support systems to reality, this article reviews histopathological whole-slide imaging informatics methods, associated challenges, and future research opportunities.
Target audience This review targets pathologists and informaticians who have a limited understanding of the key aspects of whole-slide image (WSI) analysis and/or a limited knowledge of state-of-the-art technologies and analysis methods.
Scope First, we discuss the importance of imaging informatics in pathology and highlight the challenges posed by histopathological WSI. Next, we provide a thorough review of current methods for: quality control of histopathological images; feature extraction that captures image properties at the pixel, object, and semantic levels; predictive modeling that utilizes image features for diagnostic or prognostic applications; and data and information visualization that explores WSI for de novo discovery. In addition, we highlight future research directions and discuss the impact of large public repositories of histopathological data, such as the Cancer Genome Atlas, on the field of pathology informatics. Following the review, we present a case study to illustrate a clinical decision support system that begins with quality control and ends with predictive modeling for several cancer endpoints. Currently, state-of-the-art software tools only provide limited image processing capabilities instead of complete data analysis for clinical decision-making. We aim to inspire researchers to conduct more research in pathology imaging informatics so that clinical decision support can become a reality.
Objectives To identify the types of cancer patients admitted to inpatient medical rehabilitation and to describe their rehabilitation outcomes.
Design Retrospective cohort study. Setting U.S. inpatient rehabilitation facilities (IRFs). Participants Adult patients (N=27,952) with a malignant cancer diagnosis admitted to an IRF with a cancer-related impairment between October 2010 and September 2012 were identified from the Uniform Data System for Medical Rehabilitation database. Interventions Not applicable.
Main Outcome Measures Demographic, medical, and rehabilitation characteristics for patients with various cancer tumor types were summarized using data collected from the Inpatient Rehabilitation Facility–Patient Assessment Instrument. Rehabilitation outcomes included the percentage of patients discharged to the community and acute care settings, and functional change from admission to discharge. Functional status was measured using the FIM instrument.
Results Cancer patients constituted about 2.4% of the total IRF patient population. Cancer types included brain and nervous system (52.9%), digestive (12.0%), bone and joint (8.7%), blood and lymphatic (7.6%), respiratory (7.1%), and other (11.7%). Overall, 72% were discharged to a community setting, and 16.5% were discharged back to acute care. Patients with blood and lymphatic cancers had the highest frequency of discharge back to acute care (28%). On average, all cancer patient groups made significant functional gains during their IRF stay (mean FIM total change ± SD, 23.5±16.2).
Conclusions In a database representing approximately 70% of all U.S. patients in IRFs, we found that patients with a variety of cancer types are admitted to inpatient rehabilitation. Most cancer patients admitted to IRFs were discharged to a community setting and, on average, improved their function. Future research is warranted to understand the referral patterns of admission to postacute care rehabilitation and to identify factors that are associated with rehabilitation benefit in order to inform the establishment of appropriate care protocols.
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Vamadevan S Ajay;
Maoyi Tian;
Hao Chen;
Yangfeng Wu;
Xian Li;
Danzeng Dunzhu;
Mohammed Ali;
Nikhil Tandon;
Anand Krishnan;
Dorairaj Prabhakaran;
Lijing L Yan
Methods/design. This yearlong cluster-randomized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana. Randomization of villages to usual care or intervention will be stratified by country. High cardiovascular disease risk individuals (aged 40 years or older, history of heart disease, stroke, diabetes, or measured systolic blood pressure of 160 mmHg or higher) will be screened at baseline. Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified '2 + 2' intervention model involving two lifestyle recommendations and the appropriate prescription of two medications. A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management. Baseline and follow-up surveys will be conducted in a standardized fashion in all villages. The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention. Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure. Process and economic evaluations will also be conducted.Discussion. To our knowledge, this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients. If effective, this intervention strategy can serve as a model that can be implemented, where applicable, in rural China, India, and other resource-constrained areas. Trial registration. The trial was registered in the clinicaltrials.gov database on 30 December, 2011 and the registration number is NCT01503814.Background: In resource-poor areas of China and India, the cardiovascular disease burden is high, but availability of and access to quality healthcare is limited. Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management. The study aims to develop, implement, and evaluate the feasibility and effectiveness of a simplified, evidence-based cardiovascular management program delivered by community healthcare workers in resource-constrained areas in Tibet, China and Haryana, India.
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Michael Gaies;
David S. Cooper;
Sarah Tabbutt;
Steven M. Schwartz;
Nancy Ghanayem;
Nikhil Chanani;
John M. Costello;
Ravi R. Thiagarajan;
Peter C. Laussen;
Lara S. Shekerdemian;
Janet E. Donohue;
Gina M. Willis;
J. William Gaynor;
Jeffrey P. Jacobs;
Richard G. Ohye;
John R. Charpie;
Sara K. Pasquali;
Mark A. Scheurer
Despite many advances in recent years for patients with critical paediatric and congenital cardiac disease, significant variation in outcomes remains across hospitals. Collaborative quality improvement has enhanced the quality and value of health care across specialties, partly by determining the reasons for variation and targeting strategies to reduce it. Developing an infrastructure for collaborative quality improvement in paediatric cardiac critical care holds promise for developing benchmarks of quality, to reduce preventable mortality and morbidity, optimise the long-term health of patients with critical congenital cardiovascular disease, and reduce unnecessary resource utilisation in the cardiac intensive care unit environment. The Pediatric Cardiac Critical Care Consortium (PC4) has been modelled after successful collaborative quality improvement initiatives, and is positioned to provide the data platform necessary to realise these objectives. We describe the development of PC4 including the philosophical, organisational, and infrastructural components that will facilitate collaborative quality improvement in paediatric cardiac critical care.
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Ying Xian;
Ann Marie Navar;
Shuang Li;
Zhuokai Li;
Jennifer Robinson;
Salim S. Virani;
Michael J. Louie;
Andrew Koren;
Anne Goldberg;
Veronique L. Roger;
Peter W Wilson;
Eric D. Peterson;
Tracy Y. Wang
Background Current treatment guidelines strongly recommend statin therapy for secondary prevention. However, it remains unclear whether patients' perceptions of cardiovascular risk, beliefs on cholesterol, or the intensity of prescribed statin therapy differs for patients with coronary artery disease (CAD) versus cerebrovascular disease (CeVD) versus both CAD and CeVD (CAD&CeVD). Methods and Results The PALM (Patient and Provider Assessment of Lipid Management) registry collected data on statin use, intensity, and core laboratory low-density lipoprotein cholesterol levels for 3232 secondary prevention patients treated at 133 US clinics. Among individuals with CeVD only (n=403), CAD only (n=2202), and CeVD&CAD (n=627), no significant differences were observed in patient-perceived cardiovascular disease risk, beliefs on cholesterol lowering, or perceived effectiveness and safety of statin therapy. However, patients with CeVD only were less likely to receive any statin therapy (76.2% versus 86.2%; adjusted odds ratio 0.64, 95% CI 0.45-0.91), or guideline-recommended statin intensity (34.6% versus 50.4%; adjusted odds ratio 0.60, 95% CI 0.45-0.81) than those with CAD only. Individuals with CeVD only were also less likely to achieve low-density lipoprotein cholesterol <100 mg/dL (59.2% versus 69.7%; adjusted odds ratio 0.79, 95% CI 0.64-0.99) than individuals with CAD alone. There were no significant differences in the use of any statin therapy or guideline-recommended statin intensity between individuals with CAD&CeVD and those with CAD only. Conclusions Despite lack of significant differences in patient-perceived cardiovascular risk or statin beliefs, patients with CeVD were significantly less likely to receive higher intensity statin or achieve low-density lipoprotein cholesterol <100 mg/dL than those with CAD only.