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Public Health as a Social Choice
Published in Rui Nunes, Healthcare as a Universal Human Right, 2022
Income inequality, and hence socioeconomic status, is a more important factor in the average life expectancy of the population than the average level of per capita income (United Nations 2019). Relative position in society prevails over absolute income likely due to the psycho-affective effect of social position and hierarchical dependence. From a sociological perspective, stratification is a more important social determinant of health than employment, income, or even the prestige of a citizen. Further, in all societies there are huge income disparities between men and women (World Economic Forum 2019). Gender-sensitive policies in all aspects of public policy are therefore of fundamental importance for an effective promotion of health (UNESCO 2014).
All Things Being Equal – But How? (Designing the Study)
Published in Mitchell G. Maltenfort, Camilo Restrepo, Antonia F. Chen, Statistical Reasoning for Surgeons, 2020
Mitchell G. Maltenfort, Camilo Restrepo, Antonia F. Chen
In stratification, patients are divided into strata based on the factors of interest – say, males < 65, males ≥65, females < 65, females ≥65. Then the analysis is done within between treatment groups within each strata. There is no pairing to be concerned with in the analysis, but now we have smaller sample sizes within each strata and may have to consider adjusting for multiple comparisons because we have multiple strata.
Ethics in the Era of Precision Medicine
Published in Lawrence S. Chan, William C. Tang, Engineering-Medicine, 2019
In 2011, the U.S. National Research Council published a report that advocated for the shift in terminology toward “precision medicine” to avoid potential confusion that ‘personalized’ may mean “that each patient will be treated differently from every other patient” (NRC 2011). By preferring the term ‘precision medicine’, the National Research Council emphasized the importance of patient stratification, specifically, “the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology and/or prognosis of those diseases they may develop, or in their response to a specific treatment” (NRC 2011). Despite such calls, the terms continue to be used interchangeably in the research literature.
MiNDAUS partnership: a roadmap for the cure and management of motor Neurone disease
Published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 2022
Steve Vucic, Naomi Wray, Anjali Henders, Robert D. Henderson, Paul Talman, Susan Mathers, Matthew Bellgard, Samar Aoun, Carol Birks, Gethin Thomas, Catherine Hansen, Geoff Thomas, Anne Hogden, Merrilee Needham, David Schultz, Tina Soulis, Bec Sheean, Jane Milne, Dominic Rowe, Margie Zoing, Matthew C Kiernan
Appropriate patient stratification is also critical, especially considering disease heterogeneity, for ensuring optimal patient recruitment(1). Stratification methods may rely on clinical parameters, genetic or other biomarkers, disease stage or trajectory. At the time of recruitment, the aim of stratification is to adequately reflect the likely disease course. and to match patients according to their likely clinical course. Standard methods which have utilized a univariate approach reliant on clinical factors such as symptom duration, respiratory function, or disease duration, have been limited by lack of external validity due to exclusion of a large proportion of patients with minimal gains in population homogeneity (27–29). Recently, an ENCALS Prediction model has provided a more accurate method of predicting functional decline and survival at a personalized level (30). The ENCALS model is composed of eight parameters, including gender, site of disease onset, vital capacity, genetic status, diagnostic delay, cognitive status, and functional score (ALSFRS-R). This model has been validated in large MND cohorts, enabling the inclusion of up to 80% of participants with minimal loss of homogeneity, and was recently adopted in the Lighthouse trial (31). Other methods of stratification include lead-in phase trial designs, which assess disease progression prior to an intervention and may be particularly important when assessing compound efficacy in smaller cohorts (32).
Induced Pluripotent Stem Cell-Based Systems for Personalising Epilepsy Treatment: Research Ethics Challenges and New Insights for the Ethics of Personalised Medicine
Published in AJOB Neuroscience, 2022
Mary Jean Walker, Jane Nielsen, Eliza Goddard, Alex Harris, Katrina Hutchison
To identify potential ethical issues upon adoption in clinical practice, we reviewed bioethical literature surrounding PM, other forms of screening, and epilepsy treatment. We identified three sources of ethical concern. First, there are issues surrounding a possible use of the iPSC-derived neural tissue system in prenatal or preimplantation testing. Despite potential benefits of utilizing the system to provide early treatment interventions for infants born with epilepsy, the fact that it may also identify genetic epilepsy risks in an embryo or fetus gives rise to different ethical considerations. Second, ethicists interested in PM have raised ethical issues related to stratification of the patient population, since identifying patient populations most likely to benefit from a treatment could in practice restrict access to treatment for those judged less likely to benefit (Prainsack 2017; Dickenson 2013; Fleck 2010; Chadwick 2014). As these judgements are probabilistic in nature, they can exclude people who would benefit from the system. The iPSC-derived neural tissue system differs from stratification as a personalizing strategy—but could raise the same issue. Third, existing work on the ethics of PM indicates potential concerns related to effects of PM on clinical decision-making and clinician-patient communication, since PM strategies provide new, more fully biomedically-focused bases for clinical decisions (Savard 2013) (Table 2).
New frontiers in precision medicine for Sjogren’s syndrome
Published in Expert Review of Clinical Immunology, 2021
Loukas Chatzis, Panayiotis G Vlachoyiannopoulos, Athanasios G Tzioufas, Andreas V Goules
Stratification in clinical practice refers to a procedure through which patients are classified according to one or a set of criteria into various risk levels for serious complications or adverse outcomes. High-risk patients may require special attention including close follow-up or early therapeutic interventions. In this way, a subgroup of patients with similar prognosis, complications, outcomes, and management define a specific medical approach that constitutes the so-called precision medicine. On the contrary, personalized medicine is based exclusively on genetic or other specific characteristics of an individual rather than a major feature that unifies a group of patients. In case of SS patients, several well-established biomarkers can be utilized in clinical practice to stratify high-risk patients for serious complications such as vasculitis and lymphoma. Although not very efficacious treatments are currently available for SS, B cell depletion therapy is warranted for patients with vasculitic manifestations while patients with adverse lymphoma predictors require a closer follow up for early diagnosis. Table 2 summarizes the currently used in clinical practice stratification factors associated with high-risk complications in SS, along with recommendations on follow up and management. After initial diagnosis, based on history, physical examination, autoantibody profile, and minor salivary gland biopsy, SS patients should be tested for cryoglobulin, C4 complement levels, and rheumatoid factors and stratified according to factors described in Table 2.