The Origins and Drafting of the Belmont Report.

This article describes the origins and drafting of the Belmont Report by members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

What Is Human Research For? Reflections on the Omission of Scientific Integrity from the Belmont Report.

The Belmont Report has provided a useful and virtually universal framework for protecting human subjects from research abuses. However, it provides little to no guidance on the substance of human research. In an environment where major decisions concerning health-care access, funding, and regulation hinge on human research, this omission leaves downstream users of human research virtually unprotected and with few tools or frameworks to protect against a variety of practices that compromise the social value of human research. This essay advocates for the addition of a fourth principle to the Belmont three: "scientific integrity." Such a principle would seek to train human research on important social objectives while maximizing the accessibility, credibility, and generalizability of findings.

Geographic Disparities in Access to Simultaneous Pancreas and Kidney Transplant in the Pre- and Post-Pancreas Allocation System Eras.

BACKGROUND: The 2014 pancreas allocation system (PAS) intended to decrease geographic variability in listing practices for simultaneous pancreas and kidney (SPK) transplant and define eligibility criteria for those with type 2 diabetes mellitus (T2DM). Our primary aims were to evaluate geographic disparities in access to SPK and assess T2DM SPK listings in the pre- and post-PAS eras. METHODS: Adult listings for SPK and kidney transplant (pre-PAS, January 2010 to October 29, 2014; post-PAS, October 30, 2014, to June 2, 2017) were identified in the Scientific Registry of Transplant Recipients. Multivariable logistic regression models tested associations of geography and/or diabetes mellitus type on the likelihood of SPK versus kidney transplant listing pre- and post-PAS. Competing risk models tested the likelihood of SPK transplantation within 2 years of listing for SPK. RESULTS: Among 41 205 listings (27 393 pre-PAS; 24 439 T2DM), univariate analysis showed reduced percentages for SPK post-PAS (22.1%-20.8%; P = 0.003). After adjusting for patient and center characteristics, geographic disparities declined slightly but persisted post-PAS (era by region interaction P < 0.001). The era by type of diabetes mellitus interaction effect was statistically significant (P = 0.039), reflecting that the proportions of SPK listings for T2DM increased in the post-PAS era (3.4%-3.9%; univariate P = 0.038), while those for type 1 diabetes mellitus remained statistically stable (47.9%-48.4%; univariate P = 0.571). Among people listed for SPK, geographic disparities in the cumulative incidence of transplantation within 2 years declined and the overall likelihood of transplantation increased in the post-PAS era (both P < 0.001). CONCLUSIONS: Geographic disparities in access to SPK declined slightly but persisted post-PAS. With new allocation change proposals and elimination of listing criteria for T2DM, further monitoring is warranted.

Institutional Review Boards: What Clinician Researchers Need to Know.

The institutional review board (IRB) is a group federally mandated to review and monitor research involving humans to ensure protection of their rights and welfare as research participants. Clinicians engaged in research require IRB approval for all research involving human participants, whether living individuals, data, or specimens. The process for obtaining IRB approval may seem like a daunting task. However, it is critical for clinical researchers to conduct research in a manner that protects human participants, and it is the mission of the IRB to help researchers accomplish this task. The purpose of this article is to review the role and purpose of the IRB, highlight federal and regulatory standards in human research participants protection, and help clinical researchers have a broader understanding of IRB functions that will help them conduct high-quality research with human participants.

CE: Viral Hepatitis: New U.S. Screening Recommendations, Assessment Tools, and Treatments.

OVERVIEW: Over the past 15 years, the incidences of hepatitis A and B virus infection in the United States have declined significantly. By contrast, the incidence of hepatitis C virus infection, formerly stable or in decline, has increased by 75% since 2010. Suboptimal therapies of the past, insufficient provider awareness, and low screening rates have hampered efforts to improve diagnosis, management, and treatment of viral hepatitis. New screening recommendations, innovations in assessment and treatment, and an updated action plan from the U.S. Department of Health and Human Services (HHS) seem likely to lead to significant progress in the coming years. This article reviews the epidemiology, natural history, and diagnosis of viral hepatitis; discusses new screening recommendations, assessment tools, and treatments; and outlines the HHS action plan, focusing on the role of nurses in prevention and treatment.

Evidence from the field: Findings on issues related to planning, implementing and evaluating gender-based programs.

An Initiative of the United States Department of Health and Human Services' Office on Women's Health (OWH), Coalition for a Healthier Community (CHC), supports ten grantees across the U.S. in the implementation of gender-based health interventions targeting women and girls. A national evaluation is assessing whether gender-focused public health systems approaches are sustainable and cost effective in addressing health disparities in women and girls. To inform the evaluation, a systematic examination was conducted of literature in both the public and private sector designed to track, assess, understand, and improve women's health, public health systems approaches, and the cost-effectiveness and sustainability of gender-based programs. A two-person team assured the quality of the results following the review of abstracts and full-text articles. Of 123 articles meeting eligibility criteria (See inclusion criteria described in Section 2.2 below), only 18 met inclusion criteria specific to a focus on a systems approach, cost-effectiveness and/or sustainability. Studies assessing systems approaches suggested their effectiveness in changing perceptions and increasing knowledge within a community; increasing involvement of local decision-makers and other community leaders in women's health issues; and increasing community capacity to address women and girls' health. Further evaluation of the cost-effectiveness and sustainability of gender-based approaches is needed.

Sociodemographic correlates of meeting US Department of Health and Human Services muscle strengthening recommendations in middle-aged and older adults.

INTRODUCTION: A growing body of evidence demonstrates the health benefits of muscular strength training. Physical activity recommendations encourage all adults to participate regularly in muscle strengthening activities. The purpose of this study was to examine the prevalence of meeting the US Department of Health and Human Services (DHHS) muscular strengthening recommendations by middle-aged and older adults and the sociodemographic characteristics associated with meeting these recommendations, using data from the 2011 Behavioral Risk Factor Surveillance System (BRFSS). METHODS: Data from the 2011 BRFSS were used to examine the prevalence of meeting the DHHS muscle strengthening recommendations by adults older than 45. Simple and multiple regression analyses were used to examine the sociodemographic characteristics associated with meeting the recommendations. RESULTS: Of respondents to the muscle strengthening question (N = 333,507), 79,029 (23.7%) reported meeting the muscle strengthening recommendations. Respondents who were female (odds ratio [OR] = 0.80; 95% confidence interval [CI] 0.78-0.83), widowed (OR = 0.69; 95% CI, 0.66-0.72), 85 or older (OR = 0.63; 95% CI, 0.58-0.68), Hispanic (OR = 0.73; 95% CI, 0.67-0.78), with a body mass index of 30.0 kg/m(2) or higher (OR = 0.47; 95% CI, 0.45-0.49), and with less than a high school education (OR = 0.32, 95% CI, 0.30-0.35) were less likely to meet the recommendations than their counterparts. CONCLUSION: Sociodemographic characteristics such as sex, age, education, and race/ethnicity are significantly associated with meeting the muscle strengthening recommendations, suggesting a need to create tailored interventions and messages to promote participation in strength training.

Working to keep reform on track. A changing industry poses challenges for healthcare leaders across all sectors.

Everyone on the 100 Most Influential People in Healthcare ranking for 2013 plays some part in the massive change roiling the U.S. healthcare system. Providers, payers, regulators, politicians and advocates all grapple daily with how reform is affecting their jobs and organizations. Aetna CEO Mark Bertolini, calls it necessary. "I truly believe we have a once-in-a-lifetime opportunity to improve quality, and control costs and make healthcare work for everyone," says Bertolini, the No. 6 ranked official on this years list.

ICD-10 means better documentation is a must.

The U.S. Department of Health and Human Services has set Oct. 1, 2014, as the firm date for implementation of ICD-10. There is no grace period for implementation. All claims to any payer must use ICD-10 codes for medical diagnosis and inpatient procedures or they may be rejected and providers will have to resubmit them. The ICD-10 code set has more fields than ICD-9 and requires a more detailed level of documentation. Case managers need to understand what the new coding set means and how it will affect their work.

Progression in understanding and implementing the cultural and linguistic appropriate services standards: five-year follow-up at an academic center.

In 2001, 14 national standards on Culturally and Linguistically Appropriate Services (CLAS) in health care were issued by the US Department of Health and Human Services Office of Minority Health to guide outcomes specific to disparities affecting patients with limited English proficiency. Additionally, demographic changes are rapidly occurring throughout the United States leading to more culturally and racially diverse communities, which have increased language barriers in the health care environment. This nonrandomized, cross-sectional study assessed changes and attitudes and applications of CLAS in an academic health care setting over a 5-year period (2006 to 2011). Results indicated that, in 2006, 72.6% participants reported they were "not at all familiar with CLAS" in comparison with 28.8% in 2011. In 2006, 16.5% participants strongly agreed to the question, "I know how to work with medical interpreters" compared with 24.9% in 2011. The same trend is seen with the question, "I use medical interpreters when I have a Spanish-speaking patient," in 2006, 25.5% strongly agreed in comparison with 35.4% in 2011. This study suggests that significant improvements occurred in the use of medical interpreters and understanding of CLAS as a result of educational activities implemented from 2006 to 2011.