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Feasibility study and evaluation of expert opinion on the semi-automated meta-analysis and the conventional meta-analysis.
Ajiji, Priscilla; Cottin, Judith; Picot, Cyndie; Uzunali, Anil; Ripoche, Emmanuelle; Cucherat, Michel; Maison, Patrick.
Afiliação
  • Ajiji P; Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), 143 Boulevard Anatole France, 93200, Saint Denis, France.
  • Cottin J; EA 7379, Faculté de Santé, Université Paris-Est Créteil, Créteil, France.
  • Picot C; Service Hospitalo-Universitaire de Pharmacotoxicologie, Hospices Civils de Lyon, Lyon, France.
  • Uzunali A; Service Hospitalo-Universitaire de Pharmacotoxicologie, Hospices Civils de Lyon, Lyon, France.
  • Ripoche E; Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), 143 Boulevard Anatole France, 93200, Saint Denis, France.
  • Cucherat M; Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), 143 Boulevard Anatole France, 93200, Saint Denis, France.
  • Maison P; Service Hospitalo-Universitaire de Pharmacotoxicologie, Hospices Civils de Lyon, Lyon, France.
Eur J Clin Pharmacol ; 78(7): 1177-1184, 2022 Jul.
Article em En | MEDLINE | ID: mdl-35501476
ABSTRACT

PURPOSE:

To assess the feasibility and acceptance of the semi-automated meta-analysis (SAMA). The objectives are twofold, namely (1) to compare expert opinion on the quality of protocols, methods, and results of one conventional meta-analysis (CMA) and one SAMA and (2) to compare the time to execute the CMA and the SAMA.

METHODS:

Experts evaluated the protocols and manuscripts/reports of the CMA and SAMA conducted independently on the safety of metronidazole in pregnancy. Expert opinion was collected using AMSTAR 2 checklist. Time spent was recorded using case report forms.

RESULTS:

The overall scores of the opinion of all experts for protocols, methods, and results for SAMA (6.75) and CMA (6.87) were not statistically different (p = 0.88). The experts' confidence in the results of each MA was 7.89 ± 1.17 and 8.11 ± 0.92, respectively. The time to completion was 14 working days for SAMA and 24.7 for CMA. MA tasks such as calculation of effect estimates, subgroup/sensitivity analysis, and publication bias investigation required no investment in time for SAMA.

CONCLUSION:

In conclusion, our study demonstrated the feasibility of SAMA and suggests acceptance for risk assessment by an expert committee. Our results suggest that SAMA reduces the time required for a MA without altering expert confidence in the methodological and scientific rigor. As our study was limited to one example, the generalization of our results requires confirmation by other studies.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Prova Pericial Tipo de estudo: Systematic_reviews Limite: Female / Humans / Pregnancy Idioma: En Revista: Eur J Clin Pharmacol Ano de publicação: 2022 Tipo de documento: Article País de afiliação: França

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Prova Pericial Tipo de estudo: Systematic_reviews Limite: Female / Humans / Pregnancy Idioma: En Revista: Eur J Clin Pharmacol Ano de publicação: 2022 Tipo de documento: Article País de afiliação: França