lunes, 30 de abril de 2012

Building the evidence base for decision making in ... [Genet Med. 2012] - PubMed - NCBI

Building the evidence base for decision making in ... [Genet Med. 2012] - PubMed - NCBI

Genet Med. 2012 Apr 19. doi: 10.1038/gim.2012.16. [Epub ahead of print]

Building the evidence base for decision making in cancer genomic medicine using comparative effectiveness research.

Source

Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA.

Abstract

The clinical utility is uncertain for many cancer genomic applications. Comparative effectiveness research (CER) can provide evidence to clarify this uncertainty. The aim of this study was to identify approaches to help stakeholders make evidence-based decisions and to describe potential challenges and opportunities in using CER to produce evidence-based guidance. We identified general CER approaches for genomic applications through literature review, the authors' experiences, and lessons learned from a recent, seven-site CER initiative in cancer genomic medicine. Case studies illustrate the use of CER approaches. Evidence generation and synthesis approaches used in CER include comparative observational and randomized trials, patient-reported outcomes, decision modeling, and economic analysis. Significant challenges to conducting CER in cancer genomics include the rapid pace of innovation, lack of regulation, and variable definitions and evidence thresholds for clinical and personal utility. Opportunities to capitalize on CER methods in cancer genomics include improvements in the conduct of evidence synthesis, stakeholder engagement, increasing the number of comparative studies, and developing approaches to inform clinical guidelines and research prioritization. CER offers a variety of methodological approaches that can address stakeholders' needs and help ensure an effective translation of genomic discoveries.Genet Med advance online publication 19 April 2012.
PMID:
22516979
[PubMed - as supplied by publisher]

Stakeholder assessment of the evidence for cancer ... [Genet Med. 2012] - PubMed - NCBI

Stakeholder assessment of the evidence for cancer ... [Genet Med. 2012] - PubMed - NCBI

Genet Med. 2012 Apr 5. doi: 10.1038/gim.2012.3. [Epub ahead of print]

Stakeholder assessment of the evidence for cancer genomic tests: insights from three case studies.

Source

Center for Medical Technology Policy, Baltimore, Maryland, USA.

Abstract

Purpose:Insufficient evidence on the net benefits and harms of genomic tests in real-world settings is a translational barrier for genomic medicine. Understanding stakeholders' assessment of the current evidence base for clinical practice and coverage decisions should be a critical step in influencing research, policy, and practice.Methods:Twenty-two stakeholders participated in a workshop exploring the evidence of genomic tests for clinical and coverage decision making. Stakeholders completed a survey prior to and during the meeting. They also discussed if they would recommend for or against current clinical use of each test.Results:At baseline, the level of confidence in the clinical validity and clinical utility of each test varied, although the group expressed greater confidence for epidermal growth factor receptor mutation and Lynch syndrome testing than for Oncotype DX. Following the discussion, survey results reflected even less confidence for Oncotype DX and epidermal growth factor receptor mutation testing, but not for Lynch syndrome testing. The majority of stakeholders would consider clinical use for all three tests, but under the conditions of additional research or a shared clinical decision-making approach.Conclusion:Stakeholder engagement in unbiased settings is necessary to understand various perspectives about evidentiary thresholds in genomic medicine. Participants recommended the use of various methods for evidence generation and synthesis.Genet Med advance online publication 5 April 2012.
PMID:
22481130
[PubMed - as supplied by publisher]

Comparative effectiveness research and genomic med... [Genet Med. 2009] - PubMed - NCBI

Comparative effectiveness research and genomic med... [Genet Med. 2009] - PubMed - NCBI

Genet Med. 2009 Oct;11(10):707-11.

Comparative effectiveness research and genomic medicine: an evolving partnership for 21st century medicine.

Source

Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia 3033, USA. mkhoury@cdc.gov

Abstract

The American Recovery and Reinvestment Act has provided resources for comparative effectiveness research that will lead to evidence-based decisions about health and health care choices. Some have voiced concerns that evidence-based comparative effectiveness research principles are only relevant to "average" patients and not as much to individuals with unique combinations of genes, exposures and disease outcomes, intrinsic to genomic medicine. In this commentary, we argue that comparative effectiveness research and genomic medicine not only can and should coexist but also they will increasingly benefit from each other. The promise and success of genomic medicine will depend on rigorous comparative effectiveness research to compare outcomes for genome-based applications in practice to traditional non-genome-based approaches. In addition, the success of comparative effectiveness research will depend on developing new methods and clinical research infrastructures to integrate genome-based personalized perspectives into point of care decisions by patients and providers. There is a need to heal the apparent schism between genomic medicine and comparative effectiveness research to enhance knowledge-driven practice of medicine in the 21st century.
PMID:
19752739
[PubMed - indexed for MEDLINE]

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Lunes 30 de ABRIL de 2012
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