How is the evidence for safety and effectiveness evaluated in the nomination for exclusions?
By: Fabian Hernández
Researcher in Health Economics
One of the criteria established in Law 1751 of 2015 for the determination of exclusions is the lack of evidence on safety and clinical effectiveness, or that the results of comparative studies show that its clinical effectiveness is inferior compared to other available alternatives.
One of the criteria established in Law 1751 of 2015 for the determination of exclusions is the lack of evidence on safety and clinical effectiveness, or that the results of comparative studies show that its clinical effectiveness is inferior compared to other available alternatives. To evaluate this, the IETS will form a technical-scientific analysis group that will issue a concept on the nomination.
It should be added that any actor in the health system can nominate a technology.
The evaluating group then poses a PICOT question that will guide the extraction of information from the evidence provided by the nominator or the performance of a new rapid review of the literature (not necessarily systematic).
The evidence submitted by the nominator will be evaluated using the Cochrane Collaboration risk of bias assessment tools for systematic reviews (RoBIS), clinical trials (RoB), cohort studies and case-control (ROBINS-I), Axis tool for cross-sectional studies and / or QUADAS 2 tool for diagnostic test studies. If the evidence presents a high risk of bias, or the evaluating group considers the need for a meta-analysis, a de novo review will be carried out following the guidelines of the IETS methodological manual.
One of the main criteria that the evaluating group takes into account to carry out a meta-analysis is the homogeneity of the populations, that is, that the participants in each of the studies to be included have similar characteristics, in order to reduce bias. in the end result.
Once the evidence synthesis has been carried out, the group will issue a concept on the efficacy and safety of the nominated technology that, together with the opinions collected from associations of potentially affected patients, will be evaluated by the Ministry of Health to make a decision.
To learn more about this process, we recommend that you consult Resolution 330 of 2017