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Published in Ken Addley, MCQs, MEQs and OSPEs in Occupational Medicine, 2023
The Bradford Hill criteria published in 1965, otherwise known as Hill’s criteria for causation, are a group of nine principles that can be useful in establishing epidemiologic evidence of a causal relationship between a presumed cause and an observed effect and have been widely used in public health research.
It's Not the Vicar's Fault!
Published in Norman Begg, The Remarkable Story of Vaccines, 2023
Bradford Hill criteria are: strength of association, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment and analogy. That’s rather a mouthful, but as these criteria are still widely used today it’s worth looking at them in more detail.
The philosophical implications of fundamental cause theory
Published in Sridhar Venkatapuram, Alex Broadbent, The Routledge Handbook of Philosophy of Public Health, 2023
The problem of causation is a thorny one, and this has not escaped the attention of epidemiologists. One of the most popular tools for addressing this within the practice are the Bradford Hill “criteria,” a set of nine “aspects of association,” which can be used to justify causal inferences within epidemiology. They are as follows: strength of association;consistency;specificity;temporality;biological gradient;plausibility;coherence;experiment; andanalogy.
Blinding and expectancy confounds in psychedelic randomized controlled trials
Published in Expert Review of Clinical Pharmacology, 2021
Suresh D. Muthukumaraswamy, Anna Forsyth, Thomas Lumley
This paper has limited its scope to the role that RCTs might play in establishing a causal role for psychedelics in treating psychiatric diseases. However, it is important to acknowledge that other forms of evidence are used in medicine to establish causation. These could be considered in future work; for example the application of the Bradford-Hill criteria [26] or the potential for surrogate biomarkers (such as blood or neuroimaging biomarkers) to be used in order to strengthen evidence for causality. Indeed, one shortcoming of relying solely on clinical trial and ATE estimation from a scientific perspective is the lack of any consideration for mechanistic credibility. The philosophers Cartwright and Hardie [144] write ‘We suppose that causes do not produce their effects by accident, at least not if you are to be able to make reliable predictions about what will happen if you intervene. Rather, if a cause produces an effect, it does so because there is a reliable, systematic connection between the two, a connection that is described in a causal principle’ (Ch2, pg 8). Psychedelic science is making rapid advances in understanding the mechanistic basis by which psychedelics exert effects at both molecular- and systems-levels. In the future, integrating mechanistic information into purely statistical considerations of treatment effects may help to establish a firm scientific foundation for if, and how, psychedelics exert therapeutic action.
Ever-use of the intra-uterine device and the risk of ovarian cancer
Published in Journal of Obstetrics and Gynaecology, 2021
Jacques Balayla, Yaron Gil, Ariane Lasry, Cristina Mitric
In this light, the Bradford-Hill criteria suggest that in order to establish epidemiologic evidence of a causal relationship between a presumed cause and an observed effect, studies need to abide by certain principles, most of which the studies included in this meta-analysis do. In particular, the criteria of strength, temporality and biological plausibility are prominent in our study question. However, in the authors’ view, the most important Bradford-Hill criteria as applied to the current study findings is that of consistency, which suggests that findings that are replicated across different researchers, populations and clinical scenarios are likely to be indicative of a true underlying causal relationship. In our study, consistency is manifested by having similar estimates across most studies, with quasi-identical findings when stratified by study design, and type of IUD used.
A methodology for developing key events to advance nanomaterial-relevant adverse outcome pathways to inform risk assessment
Published in Nanotoxicology, 2021
Sabina Halappanavar, James D. Ede, Indrani Mahapatra, Harald F. Krug, Eileen D. Kuempel, Iseult Lynch, Rob J. Vandebriel, Jo Anne Shatkin
The work presented here builds on the previous efforts of Halappanavar, Ede, et al. (2019) and summarizes the outcomes of a recently completed multi-stakeholder project, the primary objective of which was to develop a methodology to extract, curate and apply the existing nanotoxicology literature in support of advancing the future development of MN-relevant AOPs. Halappanavar, Ede, et al. (2019) outlined (i) a systematic process for mining the nanotoxicology literature to identify potential KEs relevant for MNs and (ii) a strategy to prioritize potential KEs for development. The study also selected ‘tissue injury’ as an appropriate KE of relevance to MN-induced AOs, for further development. In the present follow-up study, using a case study approach, we examine the available evidence in the literature for assessing the (i) biological plausibility, (ii) measurability, and (iii) regulatory relevance of the KE ‘tissue injury’ following exposure to MNs and its applicability for future development of AOPs. These criteria align with the evolved Bradford Hill criteria described by Becker et al. (2017). The various challenges concerning the utility of the available nanotoxicology literature are discussed and preliminary insights and guidance are provided on standard reporting of nanotoxicity study results of relevance to AOP development. In addition, a second case study is presented that demonstrates the utility of the Nano-AOP database, the primary outcome of the project, to provide additional weight of evidence for identified KEs and MN-induced AOs and to build KERs in support of future development of AOPs.