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BACKGROUND: It is often unclear whether systematic reviews and primary studies are de-signed to elucidate the efficacy or effectiveness of interventions. This may compromise the use of the information in clinical or policy decisions. OBJECTIVE: This overview aimed to evaluate the methodological profiles of studies on fibromyalgia pharmacotherapy in terms of the quality and nature of the interventions (efficacy versus effective-ness). METHODS: The protocol was registered in the International Prospective Register of Systematic Re-views database. Seven databases were searched for relevant publications. Systematic reviews inves-tigating the effectiveness or efficacy of fibromyalgia pharmacotherapy were included. Methodolog-ical quality was investigated using A MeaSurement Tool to Assess Systematic Reviews (AM-STAR), and efficacy andeffectiveness were evaluated using Rating of Included Trials on the Effica-cy-effectiveness Spectrum (RITES). RESULTS: In this overview, 4,107 studies were initially identified. 8 systematic reviews and 34 prima-ry studies remained after overlaps were removed. Of the eight systematic reviews, 4.76% (n=3) and 7.93% (n=5) were of moderate and high quality, respectively. An analysis of systematic reviews clearly showed the criteria "participants characteristics" and "trial setting" with the most frequent answers as scales 1 and 2 (strong emphasis on efficacy or rather strong emphasis on efficacy), re-spectively. RITES analysis revealed that the most frequent response was "strong emphasis on effi-cacy" in 68% (92/136) of primary studies. CONCLUSION: This analysis showed, in both systematic reviews and primary studies, a predominantly strong emphasis on efficacy, suggesting the need for methodological quality improvement in future studies, especially those designed to provide evidence related to effectiveness. The protocol for this overview has been registered in the International Prospective Register of Sys-tematic Reviews (PROSPERO; CRD42018095943).
Assuntos
Fibromialgia , Humanos , Fibromialgia/tratamento farmacológico , Revisões Sistemáticas como AssuntoRESUMO
Introduction: Adverse drug reactions (ADR) are a problem for healthcare systems worldwide. Pediatric patients constitute a vulnerable group with regard to ADRs. However, although pediatric patients are at increased risk for these reactions, there is little progress on ADR detection methods in this group.Areas covered: In this systematic search, performed according to PRISMA statements, we selected studies, published in PubMed/Medline databases; Scopus; LILACS; Web of Science; Embase and Cochrane Library until April, 2020, on ADRs in hospitalized pediatric patients.Expert opinion: The increase of pediatric drug safety data is essential to the improvement of childcare. Health services must continuously stimulate educational programs focused on ADR detection tools to minimize the barriers and raise awareness among professionals. Therefore, it is necessary to consider that each method has advantages and disadvantages and must be analyzed in detail to be implemented according to the peculiarities of each practice scenario. Triggers tools (active method) correlated with electronic medical notes seems a good strategy for ADR identification, whether pediatric parameters are well checked and adapted with each age group. In any event, combined methods will add data to identification and clearer ADR assessment.