Essential factors of safety and efficacy of assistive products: a scoping review
DOI:
https://doi.org/10.11606/issn.2317-0190.v32i4a245841Keywords:
Persons with Disabilities, Self-Help Devices, Safety, EfficacyAbstract
Objective: To identify the essential factors of safety and efficacy of assistive products in order to support government actions regarding the production, dispensing, and surveillance of these products. Method: The present study was commissioned by the Brazilian Health Regulatory Agency (ANVISA) to support evidence-informed decision-making within the agency. As this is a technical product aimed to support evidence-informed decion making, within a short timeframe, the method of a rapid response was adopted. The review was guided by a research question developed using the PCC acronym (Population, Concept, and Context): "What are the essential factors related to the safety and efficacy of assistive products?" Searches were conducted in Clinical Trials, the International Clinical Trials Registry Platform (ICTRP), and the Brazilian Clinical Trials Registry (REBEC). Results: A total of 539 records were identified across the three included databases, and two records were excluded as duplicates. At the end of the selection process, 485 records were excluded for not meeting the eligibility criteria, and 52 studies were included. Conclusion: Based on the included records, it was possible to identify and categorize 241 efficacy factors. The results were organized into an outcome matrix, with information described by product type and category. The same was done for safety factors, which appeared in a much smaller number of assessments. Regarding the context of the studies, it is worth noting the small proportion of studies from low- and middle-income countries, as well as the number of studies conducted in the Brazilian setting – only two, both from the University of São Paulo.
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References
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