Conflicts of Interest and the Quality of Recommendations in Clinical Guidelines

Background: There is increasing concern that conflicts of interest affect the development process of clinical practice guidelines. We evaluated The American Psychiatric Association\u27s Practice Guideline for the Treatment of Patients with Major Depressive Disorder to determine the existence of financial and intellectual conflicts of interest and examine their possible effects. We selected this guideline because of its influence on clinical practice and because this guideline recommends pharmacotherapy for all levels of depression, despite controversies over the evidence base. Methods and Findings: We determined the number and type of financial conflicts of interest for members of the guideline development group as well as for the independent panel charged with mitigating any effect of these conflicts. We also quantified the potential for intellectual conflicts of interest. We examined the quality of references used to support recommendations, as well as the degree of congruence between the research results and the recommendations. Fewer than half (44.4%) of the studies supporting the recommendations met criteria for high quality. Over one-third (34.2%) of the cited research did not study outpatients with major depressive disorder, and 17.2% did not measure clinically relevant results. One-fifth (19.7%) of the references were not congruent with the recommendations. Financial ties to industry were disclosed by all members (100%) of the guideline development committee with members reporting a mean 20.5 relationships (range 9–33). The majority of the committee participated on pharmaceutical companies\u27 speakers\u27 bureaus. Members of the independent panel that reviewed the guidelines for bias had undeclared financial relationships. As a marker of intellectual conflict of interest, 9.1% of all cited research and 13% of references supporting the recommendations were co-authored by the six guideline developers. Conclusions: The prevalence of conflicts of interest among panel members was high. The quality of the evidence cited raises questions about the validity of the recommendations. Attention to the quality of cited studies and to the risk of bias resulting from conflicts of interest should be a priority for guideline development groups

The Current Crisis in Emergency Care and the Impact on Disaster Preparedness

<p>Abstract</p> <p>Background</p> <p>The Homeland Security Act (HSA) of 2002 provided for the designation of a critical infrastructure protection program. This ultimately led to the designation of emergency services as a targeted critical infrastructure. In the context of an evolving crisis in hospital-based emergency care, the extent to which federal funding has addressed disaster preparedness will be examined.</p> <p>Discussion</p> <p>After 9/11, federal plans, procedures and benchmarks were mandated to assure a unified, comprehensive disaster response, ranging from local to federal activation of resources. Nevertheless, insufficient federal funding has contributed to a long-standing counter-trend which has eroded emergency medical care. The causes are complex and multifactorial, but they have converged to present a severely overburdened system that regularly exceeds emergency capacity and capabilities. This constant acute overcrowding, felt in communities all across the country, indicates a nation at risk. Federal funding has not sufficiently prioritized the improvements necessary for an emergency care infrastructure that is critical for an all hazards response to disaster and terrorist emergencies.</p> <p>Summary</p> <p>Currently, the nation is unable to meet presidential preparedness mandates for emergency and disaster care. Federal funding strategies must therefore be re-prioritized and targeted in a way that reasonably and consistently follows need.</p

Soil type influences crop mineral composition in Malawi

Food supply and composition data can be combined to estimate micronutrient intakes and deficiency risks among populations. These estimates can be improved by using local crop composition data that can capture environmental influences including soil type. This study aimed to provide spatially resolved crop composition data for Malawi, where information is currently limited. Six hundred and fifty-two plant samples, representing 97 edible food items, were sampled from N150 sites in Malawi between 2011 and 2013. Samples were analysed by ICP-MS for up to 58 elements, including the essential minerals calcium (Ca), copper (Cu), iron (Fe), magnesium (Mg), selenium (Se) and zinc (Zn). Maize grain Ca, Cu, Fe, Mg, Se and Zn concentrations were greater from plants grown on calcareous soils than those from the more widespread low-pH soils. Leafy vegetables from calcareous soils had elevated leaf Ca, Cu, Fe and Se concentrations, but lower Zn concentrations. Several foods were found to accumulate high levels of Se, including the leaves of Moringa, a crop not previously been reported in East African food composition data sets. New estimates of national dietary mineral supplies were obtained for non-calcareous and calcareous soils. High risks of Ca (100%), Se (100%) and Zn (57%) dietary deficiencies are likely on non-calcareous soils. Deficiency risks on calcareous soils are high for Ca (97%), but lower for Se (34%) and Zn (31%). Risks of Cu, Fe and Mg deficiencies appear to be low on the basis of dietary supply levels

Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all species: Ferrous sulphate monohydrate based on a dossier submitted by Kronos International, Inc.

Ferrous sulphate monohydrate is safe when supplied up to a maximum iron content per kilogram complete feedingstuff of 450 mg for bovines and poultry, 500 mg for ovines, 600 mg for pets, and 750 mg for other species/categories, except horses and fish; for piglets up to one week before weaning a maximum of 250 mg Fe/day is considered safe. Because of insufficient data on horses and fish, as a provisional measure, the current value (750 mg Fe/kg) could be maintained. The values for total dietary iron for pigs, ovines, horses, fish and other species/categories (except poultry, bovines and pets) are in line with those currently authorised. Iron from ferrous sulphate monohydrate is unlikely to modify the iron concentration in edible tissues and products of animal origin. Consumer exposure in the EU is not associated with a risk of excess iron intake to the general population. Therefore, the FEEDAP Panel does not foresee any concern for consumer safety resulting from the use of ferrous sulphate monohydrate in animal nutrition, provided that the maximum iron content in complete feedingstuffs is respected. Ferrous sulphate monohydrate is irritant and corrosive to the skin, eyes and respiratory tract. The additive contains up to 109 mg Ni/kg. Nickel is a dermal and respiratory sensitiser, and inhalation may cause lung cancer. Thus, handling the additive poses a risk to the user/worker. Considering the high concentration of iron and sulphur in soil and water, the supplementation of feed with the additive is not expected to pose an environmental risk. Ferrous sulphate monohydrate is an effective iron source for all animal species and categories. The FEEDAP Panel recommends that the currently authorised maximum iron content in complete feed be reduced for bovines and poultry from 750 to 450 mg Fe/kg, and for pets from 1250 to 600 mg Fe/kg

Disparities in breast cancer survival in the United States (2001-2009): Findings from the CONCORD-2 study.

BACKGROUND: Reducing breast cancer incidence and achieving equity in breast cancer outcomes remains a priority for public health practitioners, health care providers, policy makers, and health advocates. Monitoring breast cancer survival can help evaluate the effectiveness of health services, quantify inequities in outcomes between states or population subgroups, and inform efforts to improve the effectiveness of cancer management and treatment. METHODS: We analyzed breast cancer survival using individual patient records from 37 statewide registries that participated in the CONCORD-2 study, covering approximately 80% of the US population. Females were diagnosed between 2001 and 2009 and were followed through December 31, 2009. Age-standardized net survival at 1 year, 3 years, and 5 years after diagnosis was estimated by state, race (white, black), stage at diagnosis, and calendar period (2001-2003 and 2004-2009). RESULTS: Overall, 5-year breast cancer net survival was very high (88.2%). Survival remained remarkably high from 2001 through 2009. Between 2001 and 2003, survival was 89.1% for white females and 76.9% for black females. Between 2004 and 2009, survival was 89.6% for white females and 78.4% for black females. CONCLUSIONS: Breast cancer survival was more than 10 percentage points lower for black females than for white females, and this difference persisted over time. Reducing racial disparities in survival remains a challenge that requires broad, coordinated efforts at the federal, state, and local levels. Monitoring trends in breast cancer survival can highlight populations in need of improved cancer management and treatment. Cancer 2017;123:5100-18. Published 2017. This article is a U.S. Government work and is in the public domain in the USA

The National Survey of American Life: a study of racial, ethnic and cultural influences on mental disorders and mental health

The objectives of the National Survey of American Life (NSAL) are to investigate the nature, severity, and impairment of mental disorders among national samples of the black and non-Hispanic white (n = 1,006) populations in the US. Special emphasis in the study is given to the nature of race and ethnicity within the black population by selecting and interviewing national samples of African-American (N = 3,570), and Afro-Caribbean (N = 1,623) immigrant and second and older generation populations. National multi-stage probability methods were used in generating the samples and race/ethnic matching of interviewers and respondents were used in the largely face-to-face interview, which lasted on average 2 hours and 20 minutes. The Diagnostic and Statistical Manual (DSM) IV World Mental Health Composite Interview (WHO-CIDI) was used to assess a wide range of serious mental disorders, potential risk and resilience factors, and help seeking and service use patterns. This paper provides an overview of the design of the NSAL, sample selection procedures, recruitment and training of the national interviewing team, and some of the special problems faced in interviewing ethnically and racially diverse national samples. Unique features of sample design, including special screening and listing procedures, interviewer training and supervision, and response rate outcomes are described. Copyright © 2004 Whurr Publishers Ltd.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/34224/1/177_ftp.pd