دورية أكاديمية
Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia.
| العنوان: | Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia. |
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| المؤلفون: | Araújo YG; Universidade Federal de São João del Rei, Divinópolis, MG, Brazil., Paolinelli JPV; Universidade Federal de São João del Rei, Divinópolis, MG, Brazil., Pichitelli JSD; Universidade Federal de São João del Rei, Divinópolis, MG, Brazil., Rios DRA; Universidade Federal de São João del Rei, Divinópolis, MG, Brazil., Baldoni NR; Universidade de Itaúna, Itaúna, MG, Brazil., Baldoni AO; Universidade Federal de São João del Rei, Divinópolis, MG, Brazil. |
| المصدر: | Einstein (Sao Paulo, Brazil) [Einstein (Sao Paulo)] 2022 May 06; Vol. 20, pp. eAO6859. Date of Electronic Publication: 2022 May 06 (Print Publication: 2022). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Instituto de Ensino e Pesquisa Albert Einstein Country of Publication: Brazil NLM ID: 101281800 Publication Model: eCollection Cited Medium: Internet ISSN: 2317-6385 (Electronic) Linking ISSN: 16794508 NLM ISO Abbreviation: Einstein (Sao Paulo) Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: São Paulo, SP : Instituto de Ensino e Pesquisa Albert Einstein |
| مواضيع طبية MeSH: | Hemophilia A*/drug therapy, Blood Coagulation Factors ; Brazil ; Humans ; Product Labeling ; Treatment Outcome |
| مستخلص: | Objective: To identify and analyze the quality of scientific evidence from clinical efficacy studies present in the package inserts of coagulation factors, used in the treatment of hemophilia A and B. Methods: Documentary study developed in two stages. The first stage consisted of identifying the medicine packages inserts electronically registered in the Brazilian Health Regulatory Agency, and analyzing the availability of the bibliographic references cited therein. This analysis was conducted in the PubMed, SciELO, Google Scholar, and Web of Science databases. The second step was the analysis of the methodological quality of the efficacy studies. Two trained researchers used the Cochrane Collaboration Risk of Bias version 5.1.0 tools for methodological quality analysis, and Review Manager 5.4 software to generate the risk of bias graph. Results: Of the 17 medicines listed, 7 had referenced package inserts. Of these, 10 studies were eligible for analysis of methodological quality. More than half of the analyzed studies did not control for selection, performance, and detection bias. A total of 100% controlled attrition and reporting biases, and 50% had a high risk of conflict of interest. Conclusion: The biases present are significant and may have influenced the overestimation of the effects of the outcomes of each of the studies. |
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| المشرفين على المادة: | 0 (Blood Coagulation Factors) |
| تواريخ الأحداث: | Date Created: 20220511 Date Completed: 20220516 Latest Revision: 20240827 |
| رمز التحديث: | 20240827 |
| مُعرف محوري في PubMed: | PMC9071259 |
| DOI: | 10.31744/einstein_journal/2022AO6859 |
| PMID: | 35544898 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2317-6385 |
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| DOI: | 10.31744/einstein_journal/2022AO6859 |