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Concept: United States Declaration of Independence

345

Recent advances in Bayesian hypothesis testing have led to the development of uniformly most powerful Bayesian tests, which represent an objective, default class of Bayesian hypothesis tests that have the same rejection regions as classical significance tests. Based on the correspondence between these two classes of tests, it is possible to equate the size of classical hypothesis tests with evidence thresholds in Bayesian tests, and to equate P values with Bayes factors. An examination of these connections suggest that recent concerns over the lack of reproducibility of scientific studies can be attributed largely to the conduct of significance tests at unjustifiably high levels of significance. To correct this problem, evidence thresholds required for the declaration of a significant finding should be increased to 25-50:1, and to 100-200:1 for the declaration of a highly significant finding. In terms of classical hypothesis tests, these evidence standards mandate the conduct of tests at the 0.005 or 0.001 level of significance.

Concepts: Scientific method, Statistics, Statistical significance, Statistical hypothesis testing, Falsifiability, Bayesian inference, Statistical power, United States Declaration of Independence

142

The Common Rule is a set of ethical principles that provide guidance on the management of human subjects taking part in biomedical and behavioral research in the United States. The elements of the Common Rule were initially developed in 1981 following a revision of the Declaration of Helsinki in 1975. Most academic facilities follow the Common Rule in the regulation of clinical trials research. Recently, the government has suggested a revision of the Common Rule to include more contemporary and streamlined oversight of clinical research. In this commentary, the leadership of the Society for Immunotherapy of Cancer (SITC) provides their opinion on this plan. While the Society recognizes the considerable contribution of clinical research in supporting progress in tumor immunotherapy and supports the need for revisions to the Common Rule, there is also some concern over certain elements which may restrict access to biospecimens and clinical data at a time when high throughput technologies, computational biology and assay standardization is allowing major advances in understanding cancer biology and providing potential predictive biomarkers of immunotherapy response. The Society values its professional commitment to patients for improving clinical outcomes with tumor immunotherapy and supports continued discussion with all stakeholders before implementing changes to the Common Rule in order to ensure maximal patient protections while promoting continued clinical research at this historic time in cancer research.

Concepts: Clinical trial, Cancer, Informed consent, The Canon of Medicine, United States, Clinical research, Clinical data acquisition, United States Declaration of Independence

29

In ambient particle source apportionment studies, data for holidays such as July 4 (US Independence Day) are normally removed because of the high concentrations of chemical species and unusually high particle mass concentrations that are due to fireworks. Many cultures celebrate events with fireworks. A near real-time measurement that could indicate fireworks would be useful in indicating their impact on air quality. Commonly monitored ambient pollutants include PM(2.5), CO, SO(2), O(3), 10-500-nm particle number, and black carbon (BC). Using a two-wavelength aethalometer, another parameter, delta-C (UVBC(370 nm)-BC(880 nm), aethalometer), can be calculated. These variables were continuously monitored during July 1-7, 2005-2010, in Rochester, New York. High delta-C values are normally associated with biomass combustion particles. However, statistically higher delta-C values were observed on Independence Day compared to the other period. Back trajectory analysis showed transport of local fireworks smoke to the sampling site on the night of July 4. An enhanced correlation between delta-C and BC during the fireworks episodes suggests changes from the usual BC sources. Fireworks emissions changed the ambient carbonaceous particulate species during these intervals. The delta-C value was found to be a readily measured indicator of fireworks emissions during periods when wood combustion was not likely to be present and provides a tool for monitoring such emissions where they might be more common such as amusement parks.

Concepts: United States, Chemistry, Fireworks, Biomass, Chicago, New York, United States Declaration of Independence, American Revolution

6

On 16 December 2012, a group of editors and publishers of scholarly journals gathered at the Annual Meeting of The American Society for Cell Biology in San Francisco, CA, USA to discuss current issues related to how the quality of research output is evaluated and how the primary scientific literature is cited. The outcome of the meeting and further discussions is a set of recommendations that is referred to as the San Francisco Declaration on Research Assessment, published in May 2013. Disease Models & Mechanisms (DMM) fully supports this initiative. In concordance with the recommendations of the Declaration, DMM provides impact factor alongside a variety of other journal-based metrics, requests an author contribution statement for all research articles, places no restrictions on the reuse of reference lists, and has no limitation on the number of references in research articles.

Concepts: Cell, United States, Academic publishing, Science, Research, Impact factor, Publishing, United States Declaration of Independence

5

Patient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed.

Concepts: Clinical trial, United States, United Kingdom, United States Constitution, Clinical research, Best practice, Republic of China, United States Declaration of Independence

3

In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation.

Concepts: Time, Scientific method, Clinical trial, Informed consent, Clinical research, Placebo, Declaration of Helsinki, United States Declaration of Independence

2

Social media (SM) offer huge potential for public health research, serving as a vehicle for surveillance, delivery of health interventions, recruitment to trials, collection of data, and dissemination. However, the networked nature of the data means they are riddled with ethical challenges, and no clear consensus has emerged as to the ethical handling of such data. This article outlines the key ethical concerns for public health researchers using SM and discusses how these concerns might best be addressed. Key issues discussed include privacy; anonymity and confidentiality; authenticity; the rapidly changing SM environment; informed consent; recruitment, voluntary participation, and sampling; minimizing harm; and data security and management. Despite the obvious need, producing a set of prescriptive guidelines for researchers using SM is difficult because the field is evolving quickly. What is clear, however, is that the ethical issues connected to SM-related public health research are also growing. Most importantly, public health researchers must work within the ethical principles set out by the Declaration of Helsinki that protect individual users first and foremost. (Am J Public Health. Published online ahead of print January 18, 2018: e1-e6. doi:10.2105/AJPH.2017.304249).

Concepts: Public health, Informed consent, Research, Autonomy, Ethics, Declaration of Helsinki, United States Declaration of Independence, Intrinsic value

2

The ocular manifestations and sequelae of Zika virus infection are not well known. Recently, the World Health Organization changed the declaration of Zika as a public health emergency and designated the viral outbreak and related microcephaly clusters as a long-term program of work. This change indicates the urgent need to evaluate and document ophthalmic manifestations in patients for timely management of this disease. In addition, confirmation whether the public health problem in Brazil extends to other regions in South America is needed.

Concepts: Epidemiology, United States, Colombia, Brazil, World Health Organization, South America, Latin America, United States Declaration of Independence

2

To test the hypothesis that age at retirement is associated with dementia risk among self-employed workers in France, we linked health and pension databases of self-employed workers and we extracted data of those who were still alive and retired as of December 31st 2010. Dementia cases were detected in the database either through the declaration of a long-term chronic disease coded as Alzheimer’s disease and other dementia (International Classification of Disease codes G30, F00, F01, F03) or through the claim for reimbursement of one of the anti-dementia drugs. Data were analyzed using Cox proportional hazard model adjusting for potential confounders. Among the 429,803 retired self-employed workers alive on December 31st 2010, prevalence of dementia was 2.65 %. Multivariable analyses showed that the hazard ratio of dementia was 0.968 [95 % confidence interval = (0.962-0.973)] per each extra year of age at retirement. After excluding workers who had dementia diagnosed within the 5 years following retirement, the results remained unchanged and highly significant (p < 0.0001). We show strong evidence of a significant decrease in the risk of developing dementia associated with older age at retirement, in line with the "use it or lose it" hypothesis. Further evidence is necessary to evaluate whether this association is causal, but our results indicate the potential importance of maintaining high levels of cognitive and social stimulation throughout work and retiree life.

Concepts: Alzheimer's disease, Proportional hazards models, Gerontology, Old age, Ageing, Retirement, United States Declaration of Independence, Pension

2

In the United States, more than 600 municipalities have smoke-free parks, and more than 100 have smoke-free beaches. Nevertheless, adoption of outdoor smoke-free policies has been slow in certain regions. Critical to widespread adoption is the sharing of knowledge about the policy development and implementation process. In this article, we describe our experience in making City of Philadelphia recreation centers and playgrounds smoke-free.

Concepts: United States, Policy, Implementation, New Jersey, Humid subtropical climate, Pennsylvania, United States Declaration of Independence, Philadelphia