Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health Workshop Summary (2009) / Chapter Skim
Currently Skimming:
2 Generating Evidence for Decision Making
2 Generating Evidence for Decision Making
Pages 3-12
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 3... ...
County of Los Angeles Department of Public Health Decisions affecting health care must be acceptable and legitimate to the people they will affect, Teutsch began. The legitimization of health policy decisions requires prospective agreement about the evidentiary standards that will be used.
|
From page 4... ...
There is harms because less is known about the technology, but also the potential for increased benefits by providing the technology sooner to those who may need it. Requiring a lower evidentiary bar means a greater dependence on models and expert opinion.
|
From page 5... ...
Then evidence reviewers should synthesize data from studies as well as desired economic information. With quantitative scientific evidence in hand, the decision makers should also consider budget constraints, values and preferences, equity issues, acceptability, and other contextual issues before making a decision.
|
From page 6... ...
Clinical effectiveness and cost ally assessed in relationship to therapeutic or diagnostic alternatives. A matrix, such as the one under development by America's Health Insurance Plans, can be useful to help payers compare two technologies with regard to net benefit and certainty (Figure 2-3)
|
From page 7... ...
The framework lays out proposed evidentiary standards for clinical applications as a function of treatment goals and acceptable regret. Considering the various goals of treatment -- including cancer prevention in healthy individuals, palliative therapies, procedures that offer incremental improvement in terms of survival, or curative measures -- how much certainty is needed before a technology should be used?
|
From page 8... ...
portrait below Effective Quality Intervention Assurance (Benefit) Natural History Clinical Pilot Sensitivity Prevalence Trials Clinical Specificity PPV NPV Ethical, Legal, & Disorder Social Implications & Health (safeguards & impediments)
|
From page 9... ...
A good single RCT may be adequate, but less strong. The list then covers other study designs that are progressively less desirable, such as controlled trials that are not randomized, or cohort studies, with case series or expert opinion being the least desirable form of evidence.
|
From page 10... ...
Decision-Factor Matrix In the end, Teutsch said, a systematic process is needed to ensure fairness and reasonableness in decision making. This process includes: clear "rules of the road" for the technology developers, patient advocacy groups, and others; a deliberative process incorporating both quantitative and qualitative or contextual information; transparency; and an appeals processes so that when other issues arise, they can be addressed, and the decision changed where appropriate.
|
From page 11... ...
Figure 5 R01538 vector, editable DISCUSSION Wylie Burke, M.D., Ph.D. Moderator A question was asked as to whether the appeals process mentioned by Teutsch would address passive challenges, such as a need for change identified as a result of horizon scanning, as well as active challenges.
|
From page 12... ...
Another participant expressed concern about the decision matrixes considering low efficacy and harm as if they were similar in impact, and suggested that a distinction be made. Teutsch said the vocabulary varies, but in his perspective, efficacy refers to benefits, and effectiveness refers to the balance of the benefits and potential harms.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.