scholarly journals Contrasting Medical and Legal Standards of Evidence: A Precision Medicine Case Study

2016 ◽  
Vol 44 (1) ◽  
pp. 194-204 ◽  
Author(s):  
Gary E. Marchant ◽  
Kathryn Scheckel ◽  
Doug Campos-Outcalt
Keyword(s):  
Precision Medicine ◽  
New Technologies ◽  
Clinical Care ◽  
Large Body ◽  
Standard Of Care ◽  
Genetic Profile ◽  
Legal Standards ◽  
Standards Of Evidence ◽  
The Individual

As the health care system transitions to a precision medicine approach that tailors clinical care to the genetic profile of the individual patient, there is a potential tension between the clinical uptake of new technologies by providers and the legal system's expectation of the standard of care in applying such technologies. We examine this tension by comparing the type of evidence that physicians and courts are likely to rely on in determining a duty to recommend pharmacogenetic testing of patients prescribed the oral anti-coagulant drug warfarin. There is a large body of inconsistent evidence and factors for and against such testing, but physicians and courts are likely to weigh this evidence differently. The potential implications for medical malpractice risk are evaluated and discussed.

scholarly journals Accounting for Blood Pressure Seasonality Alters Evaluation of Practice-Level Blood Pressure Control Intervention

2019 ◽  
Author(s):  
Thomas Gepts ◽  
Ann M Nguyen ◽  
Charles Cleland ◽  
Winfred Wu ◽  
Hang Pham-Singer ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Fixed Effects ◽  
Clinical Care ◽  
Large Body ◽  
Negative Association ◽  
Seasonal Effects ◽  
Intervention Effect ◽  
Contrast Model ◽  
Practice Level

Abstract Background Despite the large body of literature evaluating interventions to improve hypertension management, few studies have addressed seasonal variation in blood pressure (BP) control. This underreported phenomenon has implications for interpreting study findings and informing clinical care. We share a methodology that accounts for BP seasonality, presented through a case study – HealthyHearts NYC, an intervention aimed at increasing adherence to the Million Hearts BP control evidence-based guidelines in primary care practices. Methods We used a randomized stepped-wedge design (n = 257 practices). Each intervention included 13 visits from practice facilitators trained in improving practice-level BP control over 12 months. Two models were used to assess the intervention effect–one that did not account for seasonality (Model 1) and one that did (Model 2). Model 2 was a re-specification of Model 1 to include our proposed two fixed-effects terms to address BP seasonality. Results Model 1 showed a significant negative association between the intervention and BP control (IRR=0.98, 95% CI=0.96-0.99, p=<.05). In contrast, Model 2, which did address seasonality, showed no intervention effect on BP control (IRR = 0.99, 95% CI=0.97-1.01, p=.19). Conclusions These findings reveal that analyses that do not account for BP seasonality may not present an accurate picture of intervention effects. In our case study, accounting for BP seasonality turned a negative association into a null association. We recommend that when evaluating BP control, studies compare outcome measures across similar seasons and that the measurement period last long enough to account for seasonal effects. Trial Registration Number NCT02646488

scholarly journals Patient-Derived Explants as a Precision Medicine Patient-Proximal Testing Platform Informing Cancer Management

2021 ◽  
Vol 11 ◽  
Author(s):  
Abby R. Templeton ◽  
Penny L. Jeffery ◽  
Patrick B. Thomas ◽  
Mahasha P. J. Perera ◽  
Gary Ng ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Exome Sequencing ◽  
Clinical Management ◽  
Ex Vivo ◽  
Standard Of Care ◽  
Tissue Preparation ◽  
Preclinical Models ◽  
Cancer Management ◽  
Whole Exome ◽  
The Individual

Precision medicine approaches that inform clinical management of individuals with cancer are progressively advancing. Patient-derived explants (PDEs) provide a patient-proximal ex vivo platform that can be used to assess sensitivity to standard of care (SOC) therapies and novel agents. PDEs have several advantages as a patient-proximal model compared to current preclinical models, as they maintain the phenotype and microenvironment of the individual tumor. However, the longevity of PDEs is not compatible with the timeframe required to incorporate candidate therapeutic options identified by whole exome sequencing (WES) of the patient’s tumor. This review investigates how PDE longevity varies across tumor streams and how this is influenced by tissue preparation. Improving longevity of PDEs will enable individualized therapeutics testing, and thus contribute to improving outcomes for people with cancer.

scholarly journals A novel artificial lung organoid for simulating a patient derived adenocarcinoma of lung for personalized oncology

2021 ◽  
Author(s):  
Sally Esmail ◽  
Wayne R Danter
Keyword(s):  
Drug Screening ◽  
Large Scale ◽  
Disease Modeling ◽  
Standard Of Care ◽  
Cancer Drug ◽  
Genetic Profile ◽  
Precision Oncology ◽  
Mutational Profiling ◽  
Approved Drugs ◽  
The Individual

ABSTRACTOptimizing patient care based on precision oncology will inevitably become the standard of care. If we accept the principle that every persons’ cancer is different then the most effective therapies will have to be designed for the individual patient and for their tumors genetic profile. Access to tumor mutational profiling is now widely available but continues to be limited by cost and actionable information. For example, novel combinations of approved drugs are rarely considered. These considerations lead us to hypothesize that artificially induced Lung Adenocarcinoma (LUAD) derived lung organoids could provide a novel, alternate approach for LUAD disease modeling and large-scale targeted drug screening.In this project, we used data from a commercially available tumor mutation profile to generate and then validate the artificially induced LUAD-derived lung organoid simulations (aiLUNG-LUAD) to model LUAD and identify several drug combinations that effectively reverse the tumors’ genotypic and phenotypic features when compared with placebo. These results complement previous LUAD-derived lung organoids research and provide a novel and widely applicable cancer drug-screening approach for precision/individualized oncology.

Molecular genetics and the assessment of human cancers

1999 ◽  
Vol 1 (8) ◽  
pp. 1-19
Author(s):  
Carlos Caldas ◽  
Paul D.P. Pharoah
Keyword(s):  
Clinical Care ◽  
Molecular Genetic ◽  
Large Body ◽  
Clinical Staging ◽  
Genetic Profile ◽  
Molecular Fingerprint ◽  
Genetic Changes ◽  
Rigorous Evaluation ◽  
Human Cancers ◽  
Genetic Technologies

The past 20 years have seen rapid advances in the understanding of the biology of human cancers, and a large body of evidence now supports the idea that accumulated genetic changes underlie the development of neoplasia. In this article, we have reviewed the current research into the genetic bases of cancer and discussed the potential clinical applications of recent advances, with particular reference to the possibility of using molecular genetic tests for pre-symptomatic screening, clinical diagnosis and clinical staging. The possibility that the genetic profile of a tumour, its ‘molecular fingerprint’, will improve the ability of oncologists to predict tumour behaviour and thus help to determine optimum treatment has also been considered. Although the potential for the application of molecular genetic technologies is enormous, these technologies have yet to be subjected to rigorous evaluation in a clinical setting, and much work needs to be done before they are adopted for use in routine clinical care.

“School-Cinema”

2018 ◽  
pp. 83-111
Author(s):  
Daniela Tamburini
Keyword(s):  
Action Research ◽  
Participatory Research ◽  
New Technologies ◽  
Pedagogical Approach ◽  
Professional Skills ◽  
Construction Of Knowledge ◽  
The Individual ◽  
Learning Relationships

This chapter presents an educational and consulting path for the use of new technologies that support the improvement of learning relationships in groups (Parmigiani, 2009), the construction of knowledge (Lakkala et al., 2007; Kangas et al., 2007) and the ability to recognize and explore the experience of communication and relationship at professional and personal levels, for the individual and for groups in order to enhance abilities and professional skills on several levels: cognitive, affective, conative and practical (Paquay, Altet, Charlier, & Perrenoud, 2001). Through the report of the experiments carried out for two years and applied to two training projects for teachers of five Primary and Secondary Italian schools, the main objective is to describe and present the overall results. The approaches used were inspired by the method of participatory research and action research with a clinical and pedagogical approach. The methodology is based on the case study of the Clinica della Formazione (Massa, 1992; Franza, 2003) that increases the emotional, communicative and relationship dimensions and gives concreteness not only to the educational action but also to the process behind it, which then becomes the target of investigations.

scholarly journals Analyze of individual performance indicators applied to industrial maintenance

2020 ◽  
Vol 9 (6) ◽  
pp. e129963660
Author(s):  
Rafael Follmann Pieretti ◽  
Marcos Meurer da Silva ◽  
Douglas Alberto Santos Lesme ◽  
Marcelo Vasconcelos de Almeida
Keyword(s):  
Performance Indicators ◽  
Food Industry ◽  
New Technologies ◽  
Action Plan ◽  
Individual Performance ◽  
Efficient Management ◽  
Management Of Resources ◽  
Industrial Maintenance ◽  
The Individual

The need for new technologies and efficient management of resources requires the use of performance indicators whose information ensures management in a visual and fast way. Today, maintenance is a sector that is technological and developed, and indicators that can develop the team a lot. The proposed study aims to analyze the individual performance indicators of the maintenance team, in addition to identifying the main problems affecting efficiency in the sector. To this end, a case study was carried out in the maintenance sector of a food industry. With the subsequent application of Pareto, it was possible to observe which the most impacting points were. After the application of Ishikawa, it is possible to identify the causes, and with the 5W2H points of improvement in the process were defined, planning with the actions for monitoring and execution, this action plan was proposed because of all analysis of the indicators. It is concluded that the indicators are necessary for a good management, and the application of the tools facilitates the vision of the indicators and still allows the improvement of them.

The Development of Language-Training Programs for Postrubella Hearing-Impaired Children

1973 ◽  
Vol 38 (1) ◽  
pp. 15-24 ◽  
Author(s):  
Linda Lynch ◽  
Annette Tobin
Keyword(s):  
Hearing Impaired ◽  
Treatment Programs ◽  
Individual Treatment ◽  
Target Behaviors ◽  
Systematic Fashion ◽  
Development Of Language ◽  
The Individual ◽  
Impaired Children ◽  
Hearing Impaired Children

This paper presents the procedures developed and used in the individual treatment programs for a group of preschool, postrubella, hearing-impaired children. A case study illustrates the systematic fashion in which the clinician plans programs for each child on the basis of the child’s progress at any given time during the program. The clinician’s decisions are discussed relevant to (1) the choice of a mode(s) for the child and the teacher, (2) the basis for selecting specific target behaviors, (3) the progress of each program, and (4) the implications for future programming.

‘A Routh O’ Auld Nick-Nackets’ – the antiquarian collection of John Rae

2015 ◽  
Vol 36-37 (1) ◽  
pp. 163-183
Author(s):  
Paul Taylor
Keyword(s):  
United States ◽  
Nineteenth Century ◽  
Social Context ◽  
Moral Education ◽  
The United States ◽  
Representative Case ◽  
National Museums ◽  
The Individual ◽  
The University

John Rae, a Scottish antiquarian collector and spirit merchant, played a highly prominent role in the local natural history societies and exhibitions of nineteenth-century Aberdeen. While he modestly described his collection of archaeological lithics and other artefacts, principally drawn from Aberdeenshire but including some items from as far afield as the United States, as a mere ‘routh o’ auld nick-nackets' (abundance of old knick-knacks), a contemporary singled it out as ‘the best known in private hands' (Daily Free Press 4/5/91). After Rae's death, Glasgow Museums, National Museums Scotland, the University of Aberdeen Museum and the Pitt Rivers Museum in Oxford, as well as numerous individual private collectors, purchased items from the collection. Making use of historical and archive materials to explore the individual biography of Rae and his collection, this article examines how Rae's collecting and other antiquarian activities represent and mirror wider developments in both the ‘amateur’ antiquarianism carried out by Rae and his fellow collectors for reasons of self-improvement and moral education, and the ‘professional’ antiquarianism of the museums which purchased his artefacts. Considered in its wider nineteenth-century context, this is a representative case study of the early development of archaeology in the wider intellectual, scientific and social context of the era.

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