The California Technology Assessment Forum uses the five criteria listed below to determine if a medical technology improves health outcomes and is safe and effective.
- The technology must have final approval from the appropriate government regulatory bodies.
- The scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes.
Evidence about the effectiveness will be graded as follows, according to the criteria proposed by Cook, et al. (Cook DJ, et al. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest, 1992; 4 (suppl): 305S-311S).
Level 1: Randomized trials that had enough power to demonstrate a statistically significant health outcome;
Level 2: Randomized trials with results that were not statistically significant but where a larger trial might have shown a clinically important difference;
Level 3: Nonrandomized concurrent cohort comparisons between contemporaneous patients;
Level 4: Nonrandomized historical cohort comparisons between current patients and former patients (from the same institution or from the literature);
Level 5: Case series without control subjects.Evidence from Level 1 studies are the preferred basis for deciding whether this criterion is met.
In the absence of Level 1 studies, technologies may meet this criterion if, overall, Level 2-4 studies indicate that:
a. The technology provides substantial benefits to important health outcomes, and b. The new technology has been shown to be safer or more beneficial than existing technologies or alternative treatments in comparative studies.
In general, technologies will not be approved based on evidence from Level 5 studies (case series without controls). - The technology must improve the net health outcomes.
- The technology must be as beneficial as any established alternatives.
- The improvement must be attainable outside the investigational settings.
Get more details about our technology assessment criteria.
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