A National Registry for People With All Stages of Kidney Disease: The National Kidney Foundation (NKF) Patient Network.

RATIONALE & OBJECTIVE: The National Kidney Foundation (NKF) launched the first national US kidney disease patient registry, the NKF Patient Network, that is open to patients throughout the continuum of chronic kidney disease (CKD). The Network provides individualized education and will facilitate patient-centered research, clinical care, and health policy decisions. Here, we present the overall design and the results of a feasibility study that was conducted July through December 2020. STUDY DESIGN: Longitudinal observational cohort study of patient-entered data with or without electronic health care record (EHR) linkage in collaboration with health systems. SETTING & PARTICIPANTS: People with CKD, age≥18 years, are invited through their provider, NKF communications, or national outreach campaign. People self-enroll and share their data through a secure portal that offers individualized education and support. The first health system partner is Geisinger. EXPOSURE: Any cause and stage of CKD, including dialysis and kidney transplant recipients. OUTCOME: Feasibility of the EHR data transfer, participants' characteristics, and their perspectives on usability and content. ANALYTICAL APPROACH: Data were collected and analyzed through the registry portal powered by the Pulse Infoframe healthie 2.0 platform. RESULTS: During the feasibility study, 80 participants completed their profile, and 42 completed a satisfaction survey. Mean age was 57.5 years, 51% were women, 83% were White, and 89% were non-Hispanic or Latino. Of the participants, 60% were not aware of their level of estimated glomerular filtration rate and 91% of their urinary albumin-creatinine ratio. LIMITATIONS: Challenges for the Network are lack of awareness of kidney disease for many with CKD, difficulty in recruiting vulnerable populations or those with low digital readiness, and loss to follow-up, all leading to selection bias. CONCLUSIONS: The Network is positioned to become a national and international platform for real-world data that can inform the development of patient-centered research, care, and treatments.

Beacons of Light: How Nurses Minister to Families.

ABSTRACT: A mother reflects on the course of illness and death of her young son, recognizing the significant care and ministry nurses provided to the family throughout the illness and the child's end of life.

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.

Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design setting and participants: We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures: Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results: Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions: We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

Impact of an interdisciplinary malnutrition quality improvement project at a large metropolitan hospital.

As many as 50% of hospitalised patients are estimated to be malnourished or at risk of malnutrition on hospital admission, but this condition often goes unrecognised, undiagnosed and untreated. Malnutrition is associated with an elevated need for continued medical interventions, higher costs of care and increased patient safety risks. Tampa General Hospital (TGH), a large teaching hospital in the southeastern USA, initiated a project to improve the quality of patient care at its institution. They did this first by focusing on improving the care quality for their malnourished patients (or patients who were at risk of malnourishment) and by using elements of the national Malnutrition Quality Improvement Initiative (MQii) Toolkit as a mechanism to measure and improve quality. The aim of this study was to evaluate the impact of quality improvement interventions on patient length of stay (LOS), infection rates and readmissions, particularly for malnourished patients. The structure of the MQii and the use of the MQii Toolkit helped staff members identify problems and systematically engage in quality improvement processes. Using the MQii Toolkit, TGH implemented a multipronged approach to improving the treatment of malnourished patients that involved creating interdisciplinary teams of staff and identifying gaps in care that could be improved through a series of changes to hospital-wide clinical workflows. They enhanced interdisciplinary coordination through increased dietitian engagement, the use of electronic health record alerts and new surgical protocols. These interventions lasted 8 months in 2016 and data reported here were collected from 985 patients before the interventions (2015) and 1046 patients after the interventions (2017). The study examines how these process changes affected LOS, infection rates and readmissions at TGH. Following implementation of these quality improvement processes, patients who were malnourished or at risk of malnutrition had a 25% reduction in LOS (from 8 to 6 days, p<0.01) and a 35.7% reduction in infection rates (from 14% to 9%, p<0.01). No statistically significant changes in readmission rates were observed. This study adds to a growing body of literature on quality improvement processes hospitals can undertake to better identify and treat malnourished patients. Hospitals and health systems can benefit from adopting similar institution-wide, quality improvement projects, while policy-makers' support for such programmes can spur more rapid uptake of nutrition-focused initiatives across care delivery settings.

Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer.

OBJECTIVES: Management of colorectal cancer warrants mutational analysis of KRAS/NRAS when considering anti-epidermal growth factor receptor therapy and BRAF testing for prognostic stratification. In this multicenter study, we compared a fully integrated, cartridge-based system to standard-of-care assays used by participating laboratories. METHODS: Twenty laboratories enrolled 874 colorectal cancer cases between November 2017 and December 2018. Testing was performed on the Idylla automated system (Biocartis) using the KRAS and NRAS-BRAF cartridges (research use only) and results compared with in-house standard-of-care testing methods. RESULTS: There were sufficient data on 780 cases to measure turnaround time compared with standard assays. In-house polymerase chain reaction (PCR) had an average testing turnaround time of 5.6 days, send-out PCR of 22.5 days, in-house Sanger sequencing of 14.7 days, send-out Sanger of 17.8 days, in-house next-generation sequencing (NGS) of 12.5 days, and send-out NGS of 20.0 days. Standard testing had an average turnaround time of 11 days. Idylla average time to results was 4.9 days with a range of 0.4 to 13.5 days. CONCLUSIONS: The described cartridge-based system offers rapid and reliable testing of clinically actionable mutation in colorectal cancer specimens directly from formalin-fixed, paraffin-embedded tissue sections. Its simplicity and ease of use compared with other molecular techniques make it suitable for routine clinical laboratory testing.

The Malnutrition Quality Improvement Initiative: A Multiyear Partnership Transforms Care.

The Academy of Nutrition and Dietetics, representing credentialed nutrition and dietetics practitioners-registered dietitian nutritionists (RDNs) and nutrition and dietetics technicians, registered, and students and interns and professionals holding nutrition and dietetics undergraduate and advanced degrees-and Avalere Health, a Washington, DC-based strategic advisory services firm, have led the charge in closing malnutrition gaps with the Malnutrition Quality Improvement Initiative (MQii), a national nutrition-focused quality improvement initiative. The initiative's journey from 2013-2019 utilized technical advisors and stakeholders to improve care and outcomes for hospitalized adults age 65 and older with a series of innovations. These innovations include the development of the first malnutrition electronic clinical quality measures (eCQMs) and a complementary interdisciplinary quality improvement toolkit and establishing the first nutrition-focused national Learning Collaborative. MQii's vision for future directions and applications in 2020 and beyond will explore partnerships to include the malnutrition eCQM in available clinical data registries. Qualified Clinical Data Registries will provide a pathway for collecting nutrition data relevant to RDNs because as of 2020, payments for Medicare Part B nutrition services and quality improvement are available for eligible RDNs participating in the Centers for Medicare and Medicaid Services Quality Payment Program. The MQii Toolkit's technical specification manuals, data dictionaries, and implementation guides will help RDNs integrate the malnutrition quality measures into existing electronic health records and lead nutrition data collection and analysis. RDNs' continued advancement with information technology leaders to incorporate terminology and clinical standards into electronic health record platforms will provide for malnutrition data transfer across care settings. FUNDING/SUPPORT: Publication of this supplement was supported by Abbott. The Academy of Nutrition and Dietetics does not receive funding for the MQii. Avalere Health's work to support the MQii was funded by Abbott.

Enhancing Identification and Management of Hospitalized Patients Who Are Malnourished: A Pilot Evaluation of Electronic Quality Improvement Measures.

Malnutrition in hospitalized patients has long been recognized as a contributor to poor patient outcomes; malnutrition often leads to higher costs of care. Thus, it is important to improve the identification of patients who are at risk for malnutrition or already malnourished and to initiate treatment to optimize outcomes. The Malnutrition Quality Improvement Initiative (MQii) is based on a dual-pronged approach consisting of a set of four electronic clinical quality measures and a Quality Improvement Toolkit that support delivery of high-quality malnutrition care by clinicians including nurses, registered dietitian nutritionists, and physicians. A large pilot hospital validated the four malnutrition electronic clinical quality measures (screening for nutrition risk, assessment, care plan, diagnosis), demonstrating their value in support of continuous quality improvement for hospital-based malnutrition care with the ultimate goal of better patient outcomes while reducing health care costs. FUNDING/SUPPORT: Publication of this supplement was supported by Abbott. The Academy of Nutrition and Dietetics does not receive funding for the MQii. Avalere Health's work to support the MQii was funded by Abbott.

Improving Malnutrition in Hospitalized Older Adults: The Development, Optimization, and Use of a Supportive Toolkit.

Malnutrition is a leading cause of morbidity and mortality, especially among older adults. However, diagnosis and treatment of malnutrition in the hospital setting are often overlooked. In recent years, quality improvement (QI) initiatives to increase the assessment and treatment of malnutrition in hospital settings have been implemented and shown to improve both patient health and economic outcomes. The Malnutrition Quality Improvement Initiative (MQii) Toolkit was designed in an effort to support hospitals seeking to implement malnutrition QI initiatives. The Toolkit has been implemented, studied, and updated for optimization of content, adaptability, and usability over several cycles of improvement from 2016-2017 at more than 50 hospital centers in the United States. The result is an open access, customizable, and user-friendly MQii Toolkit that can facilitate the implementation of malnutrition QI initiatives in individual facilities. This article introduces the MQii Toolkit, describes the process by which it was designed and improved, and orients clinical care teams to its use. FUNDING/SUPPORT: Publication of this supplement was supported by Abbott. The Academy of Nutrition and Dietetics does not receive funding for the MQii. Avalere Health's work to support the MQii was funded by Abbott.

Effectiveness of the Malnutrition Quality Improvement Initiative on Practitioner Malnutrition Knowledge and Screening, Diagnosis, and Timeliness of Malnutrition-Related Care Provided to Older Adults Admitted to a Tertiary Care Facility: A Pilot Study.

BACKGROUND: Malnutrition is present in 30% to 50% of hospitalized patients aged 60 years or older. As few as 3.2% of patients identified as high risk have a malnutrition diagnosis documented by medical providers. The Malnutrition Quality Improvement Initiative (MQii) aims to reduce the burden of hospital malnutrition by improving the process and delivery of care. OBJECTIVE: To evaluate implementing the MQii toolkit of best practice resources for screening, diagnosis, documentation, and timeliness of malnutrition care. DESIGN: This 6-month prospective pilot included a 3-month intervention with training and education modules tailored to type of practitioner and integrated into existing teaching and clinical workflow. PARTICIPANTS/SETTING: Forty-five health care professionals from geriatric, general medicine, and general surgery units at Vanderbilt University Hospital during January to June 2016. MAIN OUTCOME MEASURES: Malnutrition knowledge by 30-item questionnaire; electronic medical record (EMR) documentation; and timeliness of malnutrition screening, diagnosis, intervention, and discharge planning. STATISTICAL ANALYSES: Analysis of variance was used to test change over time. RESULTS: Malnutrition knowledge score increased 14%, from 39% to 53% (P=0.009). All patients whose nutrition screen indicated they were malnourished/high risk had registered dietitian nutritionist diagnosis of malnutrition documented in the EMR. The proportion who had medical provider (physician, nurse practitioner, or physician assistant) malnutrition diagnosis documented in the EMR increased 11.6%, from 26.7% to 38.3% (P=0.08). About 95% of malnourished/high risk patients had a documented intervention addressing malnutrition. Inclusion of malnutrition care in the discharge plan increased 4.8%, from 70.0% to 74.8% (P=0.13). CONCLUSIONS: This pilot study demonstrated feasibility of implementing the MQii resources to improve malnutrition knowledge and professionals' skills relevant to screening, diagnosis, intervention, and timeliness of malnutrition care. By optimizing the process and delivery of malnutrition care, it is expected that the quality of clinical care provided to older adults with malnutrition or at high malnutrition risk will improve.

The association between guideline-based treatment instructions at the point of discharge and lower 1-year mortality in Medicare patients after acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice (GAP) initiative in Michigan.

BACKGROUND: The American College of Cardiology's Guidelines Applied in Practice (GAP) initiative for acute myocardial infarction (AMI) has been shown to increase the use of guideline-based therapies and improve outcomes in patients with AMI. It is unknown whether hospitals that are more successful in using the standard discharge contract--a key component of GAP that emphasizes guideline-based medications, lifestyle modification, and follow-up planning--experience a proportionally greater improvement in patient outcomes. METHODS: Medicare patients treated for AMI in all 33 participating GAP hospitals in Michigan were enrolled. We aggregated the hospitals into 3 tertiles based on the rates of discharge contract use: 0% to 8.4% (tertile 1), >8.4% to 38.0% (tertile 2), and >38.0% to 61.1% (tertile 3). We analyzed 1-year follow-up mortality both pre- and post-GAP and compared the mortality decline post-GAP with discharge contract use according to tertile. RESULTS: There were 1368 patients in the baseline (pre-GAP) cohort and 1489 patients in the post-GAP cohort. After GAP implementation, mortality at 1 year decreased by 1.2% (P = .71), 1.2% (P = .68), and 6.0% (P = .03) for tertiles 1, 2, and 3, respectively. After multivariate adjustment, discharge contract use was significantly associated with decreased 1-year mortality in tertile 2 (odds ratio 0.43, 95% CI 0.22-0.84) and tertile 3 (odds ratio 0.45, 95% CI 0.27-0.75). CONCLUSIONS: Increased hospital utilization of the standard discharge contract as part of the GAP program is associated with decreased 1-year mortality in Medicare patient populations with AMI. Hospital efforts to promote adherence to guideline-based care tools such as the discharge contract used in GAP may result in mortality reductions for their patient populations at 1 year.

Frequency of percutaneous coronary interventions at facilities without on-site cardiac surgical backup--a report from the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR).

The practice of performing percutaneous coronary intervention (PCI) in centers without on-site cardiac surgical backup is controversial. Using data from facilities that participated in the American College of Cardiology/National Cardiovascular Data Registry, the incidence of PCI without on-site surgical backup was evaluated. From January 1, 2001 through December 31, 2004, 39 of 449 (8.7%) centers were identified as sites that performed PCI without on-site surgical backup. By the end of 2005, 75 of 463 (16%) participating facilities were performing PCI without on-site backup. By using standardized data element definitions, it was possible to differentiate between patients who underwent elective PCI and those who had urgent nonelective PCI for acute ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction. This analysis showed that the number of elective and nonelective PCI procedures with or without on-site surgical backup per quarter had increased significantly (p <0.0001) from 2001 to 2004. The number of PCI procedures performed without on-site surgical backup continued to increase in 2005. In conclusion, the significant increase in elective PCIs performed at facilities without on-site surgical backup occurred despite national guidelines that state elective PCI should not be done in centers without on-site cardiac surgery.

Sex differences in the application of evidence-based therapies for the treatment of acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice projects in Michigan.

BACKGROUND: Studies have shown that women with acute myocardial infarction (AMI) are less likely to receive evidence-based care compared with men. The American College of Cardiology's AMI Guidelines Applied in Practice (GAP) program has been shown to increase the rates of evidence-based medicine use and reduce mortality in patients with AMI. The objective of this study was to investigate the relative benefits of the GAP program in men and women. METHODS: By using a predesign-postdesign, standard orders, and a discharge tool to improve evidence-based indicator rates and long-term mortality in patients with AMI in Michigan, this study compared the success of GAP in men vs women. Logistic regression was used to develop predictive models for death at 30 days and 1 year in men and women. RESULTS: Use of evidence-based care, including use of beta-blockers and aspirin in men and women at hospital discharge and lipid-lowering agent use in men, was higher in the post-GAP sample (P<.01 for all). Use of the discharge tool promoted by the GAP program was independently protective against death at 1 year in women (adjusted odds ratio, 0.46; 95% confidence interval, 0.27-0.79), and a trend existed for similar results in men (adjusted odds ratio, 0.62; 95% confidence interval, 0.36-1.06). However, the tool was used slightly less often with women (27.9% vs 33.96%; P=.003). CONCLUSIONS: The GAP program increased the use of evidence-based therapies in male and female patients. In addition, the GAP discharge tool may decrease mortality rates at 1 year in patients with AMI; however, the tool was used less often with women. Greater use of the GAP discharge tool in women might narrow the post-MI sex mortality gap.

American College of Cardiology and American Heart Association methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care.

The ability to quantify the quality of cardiovascular care critically depends on the translation of recommendations for high-quality care into the measurement of that care. As payers and regulatory agencies increasingly seek to quantify healthcare quality, the implications of the measurement process on practicing physicians are likely to grow. This statement describes the methodology by which the American College of Cardiology and the American Heart Association approach creating performance measures and devising techniques for quantifying those aspects of care that directly reflect the quality of cardiovascular care. Methods for defining target populations, identifying dimensions of care, synthesizing the literature, and operationalizing the process of selecting measures are proposed. It is hoped that new sets of measures will be created through the implementation of this approach, and consequently, through the use of such measurement sets in the context of quality improvement efforts, the quality of cardiovascular care will improve.

American College of Cardiology and American Heart Association methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care.

The ability to quantify the quality of cardiovascular care critically depends on the translation of recommendations for high-quality care into the measurement of that care. As payers and regulatory agencies increasingly seek to quantify healthcare quality, the implications of the measurement process on practicing physicians are likely to grow. This statement describes the methodology by which the American College of Cardiology and the American Heart Association approach creating performance measures and devising techniques for quantifying those aspects of care that directly reflect the quality of cardiovascular care. Methods for defining target populations, identifying dimensions of care, synthesizing the literature, and operationalizing the process of selecting measures are proposed. It is hoped that new sets of measures will be created through the implementation of this approach, and consequently, through the use of such measurement sets in the context of quality improvement efforts, the quality of cardiovascular care will improve.

Development of first generation in-situ pathogen detection system (Gen1-IPDS) based on NanoGene assay for near real time E. coli O157:H7 detection.

We developed the first generation in-situ pathogen detection system (Gen1-IPDS) based on the NanoGene assay for detecting and quantifying Escherichia coli O157:H7 specific eaeA gene. The NanoGene assay employs the hybridization of target DNA with quantum dot labeled magnetic beads and probe DNAs to detect and quantify the target bacterial gene. The Gen1-IPDS is currently capable of executing four key steps required in the NanoGene assay: sample and reagents introduction, DNA hybridization, magnetic separation of complexes, and sample collection. Operational parameters such as magnet position, hybridization buffer composition, hybridization flow rate, and hybridization temperature were investigated. Using the experimentally determined operational parameters, the target gene was successfully quantified (R(2)=0.97) over a range of six orders of magnitude (10(-12) to 10(-6) mol L(-1)). The limit of detection (LOD) was determined to be 49×10(-15) mol L(-1). The specificity was also demonstrated by the differential discrimination of mismatched target DNAs. The NanoGene assay quantification results via Gen1-IPDS were validated by correlation with its laboratory version (R(2)=0.97).

Elevated B-type natriuretic peptide is associated with increased in-hospital mortality or cardiac arrest in patients undergoing implantable cardioverter-defibrillator implantation.

BACKGROUND: The implantable cardioverter-defibrillator (ICD) is the most effective treatment for preventing arrhythmic deaths in patients with heart failure, but periprocedural complications, including in-hospital mortality or cardiac arrest, may occur, and little is known about risk factors. We asked whether elevated B-type natriuretic peptide (BNP) level is associated with increased risk of in-hospital mortality or cardiac arrest in patients undergoing ICD implantation. METHODS AND RESULTS: From the National Cardiovascular Data Registry ICD Registry, we identified 53 198 patients who received ICD implants and underwent preoperative BNP measurement from 2006 to 2008. The patients were categorized into 4 groups by BNP levels (<100, 100 to <300, 300 to <1000, and ≥1000 pg/mL). Complication rates were compared among groups, and odds ratios for in-hospital mortality or cardiac arrest were estimated by multiple hierarchical logistic regressions. There were 2952 complications reported, including 510 in-hospital deaths and 365 cardiac arrests. The rate of in-hospital mortality or cardiac arrest significantly increased with elevated BNP level (P<0.001). The adjusted odds ratios of in-hospital mortality or cardiac arrest were statistically significant in all 3 higher BNP groups [odds ratio (95% CI), 1.99 (1.17 to 3.39), 2.49 (1.50 to 4.13), and 4.25 (2.57 to 7.06) in the second, third, and fourth groups using <100 as reference]. Among subgroups, the association was more significant in men, patients with renal dysfunction, and patients undergoing biventricular ICD implantation. CONCLUSIONS: Elevated BNP level was significantly associated with increased risk of in-hospital mortality or cardiac arrest in patients undergoing ICD implant. Strategies aimed at reducing preprocedural BNP or creating systems to manage procedural risk merit further investigation.