Applying an Implementation Science Approach to Genomic Medicine Workshop Summary (2016) / Chapter Skim
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4 Generating Evidence During Implementation
4 Generating Evidence During Implementation
Pages 31-42
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From page 31... ...
screening was rapidly integrated into clinical care and therefore is an interesting genetic test deployment to study. However, lessons could be learned from the obstacles encoun tered after introducing cffDNA screening, such as how to increase patient and provider knowledge about the strengths and limitations of the test.
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From page 32... ...
PROGRAMS FOR ENROLLING PATIENTS AND TRACKING CANCER TREATMENT Cancer treatment can be both compelling and frustrating for clinicians because of the high number of new drugs currently being approved, said Edward Kim, the Donald S Kim Distinguished Chair for Cancer Research at the Levine Cancer Institute in the Carolinas HealthCare System.
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From page 33... ...
In addition to patient accrual challenges, clinical researchers must also plan for sample collection, regulatory approval, and communication with providers, Kim noted. To address the challenge of low enrollment rates and to foster awareness of clinical trials, the Carolinas HealthCare System has launched a proprietary system called EAPathways.
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From page 34... ...
The Levine Cancer Institute is participating in the Targeted Agent and Profiling Utilization Registry (TAPUR) study with ASCO, the Cancer Research Consortium of West Michigan, the Michigan Cancer Research Consortium, and the University of Michigan.1 The primary objectives of the TAPUR study are to describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs and to facilitate access to those drugs for patients with advanced solid tumors, B cell, non-Hodgkin lymphoma, or malignant melanomas with a known genomic variant.
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From page 35... ...
Changing physician and health system workflows, the use of decision support for relaying new complex diagnostic information, the influence of reimbursement, and the development of an evidence base are challenges faced in many health care implementation scenarios. Other areas -- such as the return of results to patients and family members and the interpretation of data -- are more specific to the field of genomics, observed Kimmel.
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From page 36... ...
The network includes six genomic medicine demonstration projects and a central coordinating center. The subjects of the demonstration projects range from detailed family histories to pharmacogenetics to monogenic diabetes.
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From page 37... ...
IGNITE also has shown that many, but not all, aspects of implementation are generic across projects. For example, one of the IGNITE Network projects is systematically collecting information on all of the barriers to implementation identified across all of the sites, with the barriers being rated by the sites according to how specific they are to genomics.
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From page 38... ...
CELL-FREE DNA SCREENING FOR ANEUPLOIDY Unbiased clinical effectiveness data is very important for implementing new clinical practices, and translation needs to be evidence-based instead of just rapid, said Mary Norton, a professor of obstetrics, gynecology, and reproductive sciences and the David E Thorburn, M.D., and Kate McKee Thorburn Endowed Chair in Perinatal Medicine and Genetics at the University of California, San Francisco.
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From page 39... ...
Several major professional societies have published statements on cffDNA screening for fetal aneuploidy, and the general observation, Norton said, is that conventional screening methods are the most appropriate first line test. Any patient may choose cffDNA screening, according to these statements, but patients should be counseled appropriately regarding the limitations and benefits (ACOG, 2015)
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From page 40... ...
The lower risk the patient is, the less likely a positive result is to be a true positive, Norton said. For example, a study of 109 consecutive cases of women who had abnormal cffDNA screening results followed by diagnostic testing yielded a true positive or positive predictive value of 67 percent, with the performance higher for Down syndrome than for other less common chromosome abnormalities (Wang et al., 2015)
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From page 41... ...
This would require convening all of the stakeholders, including regulators, policy and practice leaders, fiscal intermediaries, payers, clinical leaders in the systems, and so on. Companies that produce genomic tests could get together with clinicians to develop standardized formats for delivering test results.
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