Vaccine Policy in the United States.

In an era when the success of the US vaccination policies to date is threatened by vaccine hesitancy, it is important for clinicians to have a working understanding of how vaccines are developed and recommended for use in the United States and how federal and state governments are coordinated to ensure a safe and effective vaccine supply. This article discusses the federal agencies involved in vaccine development and recommendation, other organizations involved in vaccine policy, and the role of vaccine-related public health law in promoting universal vaccination.

Prostate cancer incidence across stage, NCCN risk groups, and age before and after USPSTF Grade D recommendations against prostate-specific antigen screening in 2012.

BACKGROUND: We sought to determine the extent to which US Preventive Services Task Force (USPSTF) 2012 Grade D recommendations against prostate-specific antigen screening may have impacted recent prostate cancer disease incidence patterns in the United States across stage, National Comprehensive Cancer Network (NCCN) risk groups, and age groups. METHODS: SEER*Stat version 8.3.4 was used to calculate annual prostate cancer incidence rates from 2010 to 2015 for men aged ≥50 years according to American Joint Committee on Cancer stage at diagnosis (localized vs metastatic), NCCN risk group (low vs unfavorable [intermediate or high-risk]), and age group (50-74 years vs ≥75 years). Age-adjusted incidences per 100,000 persons with corresponding year-by-year incidence ratios (IRs) were calculated using the 2000 US Census population. RESULTS: From 2010 to 2015, the incidence (per 100,000 persons) of localized prostate cancer decreased from 195.4 to 131.9 (Ptrend  < .001) and from 189.0 to 123.4 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively. The largest relative year-by-year decline occurred between 2011 and 2012 in NCCN low-risk disease (IR, 0.77 [0.75-0.79, P < .0001] and IR 0.68 [0.62-0.74, P < .0001] for men aged 50-74 and ≥75 years, respectively). From 2010-2015, the incidence of metastatic disease increased from 6.2 to 7.1 (Ptrend  < .001) and from 16.8 to 22.6 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively. CONCLUSIONS: This report illustrates recent prostate cancer "reverse migration" away from indolent disease and toward more aggressive disease beginning in 2012. The incidence of localized disease declined across age groups from 2012 to 2015, with the greatest relative declines occurring in low-risk disease. Additionally, the incidence of distant metastatic disease increased gradually throughout the study period.

TREatment of ATopic eczema (TREAT) Registry Taskforce: consensus on how and when to measure the core dataset for atopic eczema treatment research registries.

BACKGROUND: Comparative, real-life and long-term evidence on the effectiveness and safety of phototherapy and systemic therapy in moderate-to-severe atopic eczema (AE) is limited. Such data must come from well-designed prospective patient registries. Standardization of data collection is needed for direct comparisons and data pooling. OBJECTIVES: To reach a consensus on how and when to measure the previously defined domain items of the TREatment of ATopic eczema (TREAT) Registry Taskforce core dataset for research registries for paediatric and adult patients with AE. METHODS: Proposals for the measurement instruments were based on recommendations of the Harmonising Outcome Measures for Eczema (HOME) initiative, the existing AE database of TREATgermany, systematic reviews of the literature and expert opinions. The proposals were discussed at three face-to-face consensus meetings, one teleconference and via e-mail. The frequency of follow-up visits was determined by an expert survey. RESULTS: A total of 16 experts from seven countries participated in the 'how to measure' consensus process and 12 external experts were consulted. A consensus was reached for all domain items on how they should be measured by assigning measurement instruments. A minimum follow-up frequency of initially 4 weeks after commencing treatment, then every 3 months while on treatment and every 6 months while off treatment was defined. CONCLUSIONS: This core dataset for national AE research registries will aid in the comparability and pooling of data across centres and country borders, and enables international collaboration to assess the long-term effectiveness and safety of phototherapy and systemic therapy used in patients with AE. What's already known about this topic? Comparable, real-life and long-term data on the effectiveness and safety of phototherapy and systemic therapy in patients with atopic eczema (AE) are needed. There is a high diversity of outcomes and instruments used in AE research, which require harmonization to enhance comparability and allow data pooling. What does this study add? Our taskforce has reached international consensus on how and when to measure core domain items for national AE research registries. This core dataset is now available for use by researchers worldwide and will aid in the collection of unified data. What are the clinical implications of this work? The data collected through this core dataset will help to gain better insights into the long-term effectiveness and safety of phototherapy and systemic therapy in AE and will provide important information for clinical practice. Standardization of such data collection at the national level will also allow direct data comparisons and pooling across country borders (e.g. in the analysis of treatment-related adverse events that require large patient numbers).

Comparing the old to the new: A comparison of similarities and differences of the accreditation standards of the chiropractic council on education-international from 2010 to 2016.

Background: Chiropractic programs are accredited and monitored by regional Councils on Chiropractic Education (CCE). The CCE-International has historically been a federation of regional CCEs charged with harmonising world standards to produce quality chiropractic educational programs. The standards for accreditation periodically undergo revision. We conducted a comparison of the CCE-International 2016 Accreditation Standards with the previous version, looking for similarities and differences, expecting to see some improvements. Method: The CCE-International current (2016) and previous versions (2010) were located and downloaded. Word counts were conducted for words thought to reflect content and differences between standards. These were tabulated to identify similarities and differences. Interpretation was made independently followed by discussion between two researchers. Results: The 2016 standards were nearly 3 times larger than the previous standards. The 2016 standards were created by mapping and selection of common themes from member CCEs' accreditation standards and not through an evidence-based approach to the development and trialling of accreditation standards before implementation. In 2010 chiropractors were expected to provide attention to the relationship between the structural and neurological aspects of the body in health and disease. In 2016 they should manage mechanical disorders of the musculoskeletal system. Many similarities between the old and the new standards were found. Additions in 2016 included a hybrid model of accreditation founded on outcomes-based assessment of education and quality improvement. Both include comprehensive competencies for a broader role in public health. Omissions included minimal faculty qualifications and the requirement that students should be able to critically appraise scientific and clinical knowledge. Another omission was the requirement for chiropractic programs to be part of a not-for-profit educational entity. There was no mention of evidence-based practice in either standards but the word 'evidence-informed' appeared once in the 2016 standards. Conclusions: Some positive changes have taken place, such as having bravely moved towards the musculoskeletal model, but on the negative side, the requirement to produce graduates skilled at dealing with scientific texts has been removed. A more robust development approach including better transparency is needed before implementation of CCE standards and evidence-based concepts should be integrated in the programs. The CCE-International should consider the creation of a recognition of excellence in educational programs and not merely propose minimal standards.

Avances y retos de las Comisiones Estatales de Bioética en México / State Bioethics Commissions in Mexico, Achievements and Challenges

Se han realizado estudios comparativos sobre comisiones nacionales de bioética, comités hospitalarios de bioética y de ética en investigación de diversos países; sin embargo existen pocos datos sobre la aplicación de la bioética a nivel subnacional. Este trabajo ofrece una aproximación a la evolución de las Comisiones Estatales de Bioética en México, se identifican como actividades de su quehacer acciones de capacitación, difusión, asesoría y promoción de la bioética en la atención médica y la vinculación con la Comisión Nacional de Bioética y otras instituciones de salud y educativas. Las Comisiones Estatales ayudan a fomentar la bioética a nivel subnacional y a extender la atención integral en situaciones complejas en el ámbito médico e investigativo (AU)

Comparative studies have been developed on the infrastructure on bioethics of different countries, comprised mainly by national commissions, hospital bioethics and research ethics committees; however, there are few data on the application of bioethics at the subnational level. This work offers an approximation to the evolution of the State Commissions of Bioethics in Mexico and accounts for their work in outreach, education, and counseling, as well as entrenching a culture of bioethics in medical care and networking with the National Bioethics Commission and other health and educational institutions. State Commissions help to promote bioethics at the subnational level and to foster comprehensive care in complex medical and research settings (AU)

ACCF/AHA methodology for the development of quality measures for cardiovascular technology: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures.

Consistent with the growing national focus on healthcare quality, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have taken a leadership role over the past decade in developing measures of the quality of cardiovascular care by convening a joint ACCF/AHA Task Force on Performance Measures. The Task Force is charged with identifying the clinical topics appropriate for the development of performance measures and with assembling writing committees composed of clinical and methodological experts in collaboration with appropriate subspecialty societies. The Task Force has also created methodology documents that offer guidance in the development of process, outcome, composite, and efficiency measures. Cardiovascular performance measures using existing ACCF/AHA methodology are based on Class I or Class III guidelines recommendations, usually with Level A evidence. These performance measures, based on evidence-based ACCF/AHA guidelines, remain the most rigorous quality measures for both internal quality improvement and public reporting. However, many of the tools for diagnosis and treatment of cardiovascular disease involve advanced technologies, such as cardiac imaging, for which there are often no underlying guideline documents. Because these technologies affect the quality of cardiovascular care and also have the potential to contribute to cardiovascular health expenditures, there is a need for more critical assessment of the use of technology, including the development of quality and performance measures in areas in which guideline recommendations are absent. The evaluation of quality in the use of cardiovascular technologies requires consideration of multiple parameters that differ from other healthcare processes. The present document describes methodology for development of 2 new classes of quality measures in these situations, appropriate use measures and structure/safety measures. Appropriate use measures are based on specific indications, processes, or parameters of care for which high level of evidence data and Class I or Class III guideline recommendations may be lacking but are addressed in ACCF appropriate use criteria documents. Structure/safety measures represent measures developed to address structural aspects of the use of healthcare technology (e.g., laboratory accreditation, personnel training, and credentialing) or quality issues related to patient safety when there are neither guidelines recommendations nor appropriate use criteria. Although the strength of evidence for appropriate use measures and structure/safety measures may not be as strong as that for formal performance measures, they are quality measures that are otherwise rigorously developed, reviewed, tested, and approved in the same manner as ACCF/AHA performance measures. The ultimate goal of the present document is to provide direction in defining and measuring the appropriate use-avoiding not only underuse but also overuse and misuse-and proper application of cardiovascular technology and to describe how such appropriate use measures and structure/safety measures might be developed for the purposes of quality improvement and public reporting. It is anticipated that this effort will help focus the national dialogue on the use of cardiovascular technology and away from the current concerns about volume and cost alone to a more holistic emphasis on value.

Variation in preoperative and intraoperative care for first-stage palliation of single-ventricle heart disease: a report from the Joint Council on Congenital Heart Disease National Quality Improvement Collaborative.

BACKGROUND AND METHODS: As the first multicenter quality improvement collaborative in pediatric cardiology, the Joint Council on Congenital Heart Disease National Pediatric Cardiology Quality Improvement Collaborative registry collects information on the clinical care and outcomes of infants discharged home after first-stage palliation of single-ventricle heart disease, the Norwood operation, and variants. We sought to describe the preoperative and intraoperative characteristics of the first 100 patients enrolled in the National Pediatric Cardiology Quality Improvement Collaborative registry. RESULTS: From 21 contributing centers, 59% of infants were male, with median birth weight of 3.1 kg (1.9-5.0 kg); the majority had hypoplastic left heart syndrome (71%). A prenatal diagnosis of congenital heart disease was made in 75%; only one had fetal cardiac intervention. Chromosomal anomalies were present in 8%, and major noncardiac organ system anomalies were present in 9%. Preoperative risk factors were common (55%) but less frequent in those with prenatal cardiac diagnosis (P= .001). Four patients underwent a preoperative transcatheter intervention. Substantial variation across participating sites was demonstrated for choice of initial palliation for the 93 patients requiring a full first-stage approach, with 50% of sites performing stage I with right ventricle to pulmonary artery conduit as the preferred operation; 89% of hybrid procedures were performed at a single center. Significant intraoperative variation by site was noted for the 83 patients who underwent traditional surgical stage I palliation, particularly with use of regional perfusion and depth of hypothermia. CONCLUSIONS: In summary, there is substantial variation across surgical centers in the successful initial palliation of infants with single-ventricle heart disease, particularly with regard to choice of palliation strategy, and intraoperative techniques including use of regional perfusion and depth of hypothermia. Further exploration of the relationship of such variables to subsequent outcomes after hospital discharge may help reduce variability and improve long-term outcomes.

Variation in postoperative care following stage I palliation for single-ventricle patients: a report from the Joint Council on Congenital Heart Disease National Quality Improvement Collaborative.

BACKGROUND AND METHODS: The National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) has established a national data registry for patients with hypoplastic left heart syndrome and its variants undergoing staged palliation. The goal of this collaborative is to better understand current care practices and to improve outcomes in children with these severe and complex forms of congenital heart disease. In this study, we describe the postoperative intensive care course, and its variations, for the first 100 patients enrolled into the registry. RESULTS: Patients were enrolled from 21 contributing sites and were discharged home after stage I palliation between July 2008 and February 2010. Following stage I palliation, enrolled participants remained in the intensive care unit for a median duration of 11 days (range: 3-68 days). Duration of intensive care unit stay varied and was greatest for those patients with aortic atresia versus aortic hypoplasia (P= 0.04) and for those who underwent a modified Blalock-Taussig shunt as part of their palliation. The duration of intensive care unit stay also varied by contributing site (medians ranged from 8 to 18 days). Participants requiring reoperation had significantly prolonged lengths of stay (P= .0003). Inotropic agent use among univentricular registry participants also varied by site. The majority of recipients received milrinone (87%), dopamine (64%), and epinephrine (62%). Cardiac catheterization following surgery occurred in 20 patients. Fifteen percent of participants underwent an interventional procedure. Complication following stage I palliation was also fairly common. CONCLUSIONS: Considerable variation exists in the postoperative course and management of univentricular patients following stage I palliation. Variation in length of intensive care unit stay, inotropic agent use, need for reoperation or cardiac catheterization, and postoperative complications are described. Further studies to determine etiologies for observed variation may result in improved standards of care and better outcomes during the interstage period.

Variation in interstage outpatient care after the Norwood procedure: a report from the Joint Council on Congenital Heart Disease National Quality Improvement Collaborative.

OBJECTIVE: The National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) is the first quality improvement collaborative in pediatric cardiology, and its registry captures information on interstage care and outcomes of infants after the Norwood procedure. The purpose of this study was to evaluate variation in interstage outpatient clinical care practices for infants discharged home after the Norwood procedure. DESIGN: Data for the first 100 infants enrolled in the NPC-QIC registry were evaluated. The care domains assessed for variation included: (1) discharge communication with outpatient cardiologist and primary care physician (PCP); (2) nutrition plan at hospital discharge; and (3) planned use of home surveillance strategies. RESULTS: One hundred infants were discharged home between July 2008 and February 2010, from 21 participating US pediatric cardiac programs. Median age at discharge was 29 (11-188) days. Interstage outpatient care was provided at the Norwood center for 62 infants, at other centers for 25, and at a combination of centers for 13. Complete discharge communication (defined as written communication of medication list, nutrition plan, and red flag checklist) was relayed to only 45 outpatient cardiologists and to 26 PCPs. Nutrition route at discharge was exclusively oral in 49, combined oral and nasogastric (NG)/nasojejunal (NJ) in 38, exclusively NG/NJ in six, combined oral and gastrostomy tube (GT) in six, and exclusively GT in one infant. Home surveillance strategies were utilized for 81 infants (oximetry and weight monitoring in 77, oximetry alone in four), with no home surveillance in 19 infants. CONCLUSIONS: Considerable variation exists in interstage outpatient care after the Norwood procedure in the care domains of discharge communication, nutrition, and home surveillance. Standardizing care around evidence-based practices may improve the outcomes for these very high-risk children.

Why the United States still needs improved dietary supplement regulation and oversight.

It has been 3 years since the American Society for Clinical Pharmacology and Therapeutics (ASCPT) issued a position statement regarding dietary supplement safety and regulation. I was the Chair of the ASCPT task force charged with issuing the statement. At the time, after careful review of available data, the other members and I concluded that dietary supplement legislation in the United States was lacking and that enhanced oversight was essential to increase the safety of these products for the American consumer.