Qualidade metodológica de diretrizes clínicas internacionais: houve melhora ao longo do tempo?
Data
2023-01-30
Autores
Silva, Lucas Caetano Araújo 
Orientadores
Melo, Daniela Oliveira de
Tipo
Dissertação de mestrado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: A saúde baseada em evidências é uma alternativa para promover tomada de decisão que considere os melhores e mais atualizados estudos científicos, a fim de orientar especialistas na prática clínica. As diretrizes clínicas (DC) são documentos que sintetizam as evidências e as traduzem em recomendações usuais para a saúde. Tem sido observada uma quantidade maior de DC desde o início do século XXI, ainda que nem sempre com rigor metodológico. A segunda versão do Appraisal of Guidelines for Research & Evaluation (AGREE-II) é o instrumento mais conhecido e usado pelo mundo para avaliação da qualidade metodológica de DC, mas seu uso deve ser adequado. Objetivo: Analisar a evolução da qualidade metodológica das DC ao longo do tempo relatada em estudos que reportaram cuidados mínimos na aplicação do AGREE-II. Métodos: Foi realizada revisão sistemática, sendo conduzidas buscas nas bases de dados Medline (via Pubmed), Embase, Cochrane Library e Lilacs, em 12 de junho de 2020. Dos estudos elegíveis, extraíram-se dados de características das DC, como ano de publicação, instituição elaboradora, região/país de origem, área clínica e os resultados das avaliações para cada domínio do AGREE-II, bem como nota geral, se disponível. Foi conduzida análise estatística com teste de Kruskal-Wallis (α=0,05) para avaliação da evolução da qualidade ao longo do tempo para todas as DC e para subgrupos desses documentos, de acordo com região de origem, instituição elaboradora e área clínica. Resultados e Discussão: Um total de 3.211 DC foram avaliadas nos 186 estudos incluídos. Para 23 DC, não foi possível identificar ano de publicação, fazendo que com a análise da qualidade ao longo do tempo compreendesse resultados da avaliação com AGREE-II para 3.188 DC, publicadas entre 1977 e 2020. Observou-se melhora da qualidade das DC para todos os domínios e para o escore geral do AGREE-II, a qual foi confirmada estatisticamente pela diferença significativa dos resultados dos escores medianos comparados entre os períodos de anos utilizados, com p<0,001 em todos os casos. Contudo, os domínios 2 (envolvimento das partes interessadas), 3 (rigor de desenvolvimento) e 5 (aplicabilidade) tiveram mediana dos escores no período final de análise próxima ou abaixo de 50%. A qualidade foi maior ao longo do tempo em todos os domínios somente para DC provenientes da América do Norte e Europa (p≤0,001), inclusive quando excluídos os resultados para DC de instituições com maior tradição na elaboração desses documentos (p<0,05). A melhora também foi observada quando analisadas separadamente as DC de acordo com o grupo elaborador: governos (p<0,001), sociedades profissionais (p<0,001) e grupos de pesquisa (p<0,001, exceto no domínio 5). Quando a qualidade das DC foi avaliada em subgrupos de 20 diferentes áreas clínicas, apenas para duas delas foi observada aumento de qualidade metodológica em todos os domínios do AGREE-II: neurologia (p<0,001) e ginecologia (p<0,001). Conclusão: Houve melhora na qualidade metodológica das DC publicadas ao longo do tempo tanto no geral, quanto para vários dos subgrupos analisados. Apesar disso, principalmente para os domínios 2, 3 e 5, ainda há oportunidade para melhoria observando as medianas calculadas, que permanecem aquém do desejado.
Introduction: Evidence-based health is an alternative to promote decision-making that considers the best and most updated scientific studies, in order to guide specialists in clinical practice. Clinical practice guidelines (CPG) are documents that synthesize evidence and translate it into usual health recommendations. A larger amount of CPG has been observed since the beginning of the 21st century, although not always with methodological rigor. The second version of the Appraisal of Guidelines for Research & Evaluation (AGREE-II) is the best-known instrument used worldwide to assess the methodological quality of CPG, but its use must be appropriate. Objective: To analyze the evolution of the methodological quality of CPG over time described in studies that reported minimal criteria in the application of the AGREE-II. Methods: A systematic review was carried out, with searches conducted in Medline (via Pubmed), Embase, Cochrane Library and Lilacs databases, on June 12, 2020. From eligible studies, data were extracted on characteristics of CPG, such as year of publication, publishing institution, region/country of origin, clinical area and the results of the assessments for each AGREE-II domain, as well as the overall score, if available. Statistical analysis was performed with the Kruskal-Wallis’ test (α=0.05) to assess the evolution of quality over time for all CPG and for subgroups of these documents, according to region of origin, publishing institution and clinical area. Results and Discussion: A total of 3211 CPG were evaluated in the 186 included studies. For 23 CPG, it was not possible to identify the year of publication, so the analysis of quality over time was made from the results of the 3,188 CPG evaluated by AGREE-II and published between 1977 and 2020. There was an improvement in the quality of the CPG for all the domains and for the overall score, which was statistically confirmed by the significant difference in the results of the median scores compared between the periods of years used, with p-value<0.001 in all cases. Despite this, domains 2 (stakeholder involvement), 3 (rigor of development) and 5 (applicability) had median scores in the final period of analysis close to or below 50%. Quality was higher over time in all the domains only for CPG from North America and Europe (p≤0.001), even when excluding CPG results from institutions with a greater tradition in preparing these documents (p<0.05). The improvement was also observed when the CPG were analyzed separately according to the elaboration group: governments (p<0.001), professional societies (p<0.001) and research groups (p<0.001, except in domain 5). When the quality of CPG was evaluated in subgroups of 20 different clinical areas, only two of them showed an increase in methodological quality in all domains of the AGREE-II: neurology (p<0.001) and gynecology (p<0.001). Conclusion: There was an improvement in the methodological quality of the CPG published over time both for general analysis and for different analyzed subgroups. However, especially for domains 2, 3 and 5, there is still opportunity for improvement, looking at the calculated medians, which remained below the desired level.
Introduction: Evidence-based health is an alternative to promote decision-making that considers the best and most updated scientific studies, in order to guide specialists in clinical practice. Clinical practice guidelines (CPG) are documents that synthesize evidence and translate it into usual health recommendations. A larger amount of CPG has been observed since the beginning of the 21st century, although not always with methodological rigor. The second version of the Appraisal of Guidelines for Research & Evaluation (AGREE-II) is the best-known instrument used worldwide to assess the methodological quality of CPG, but its use must be appropriate. Objective: To analyze the evolution of the methodological quality of CPG over time described in studies that reported minimal criteria in the application of the AGREE-II. Methods: A systematic review was carried out, with searches conducted in Medline (via Pubmed), Embase, Cochrane Library and Lilacs databases, on June 12, 2020. From eligible studies, data were extracted on characteristics of CPG, such as year of publication, publishing institution, region/country of origin, clinical area and the results of the assessments for each AGREE-II domain, as well as the overall score, if available. Statistical analysis was performed with the Kruskal-Wallis’ test (α=0.05) to assess the evolution of quality over time for all CPG and for subgroups of these documents, according to region of origin, publishing institution and clinical area. Results and Discussion: A total of 3211 CPG were evaluated in the 186 included studies. For 23 CPG, it was not possible to identify the year of publication, so the analysis of quality over time was made from the results of the 3,188 CPG evaluated by AGREE-II and published between 1977 and 2020. There was an improvement in the quality of the CPG for all the domains and for the overall score, which was statistically confirmed by the significant difference in the results of the median scores compared between the periods of years used, with p-value<0.001 in all cases. Despite this, domains 2 (stakeholder involvement), 3 (rigor of development) and 5 (applicability) had median scores in the final period of analysis close to or below 50%. Quality was higher over time in all the domains only for CPG from North America and Europe (p≤0.001), even when excluding CPG results from institutions with a greater tradition in preparing these documents (p<0.05). The improvement was also observed when the CPG were analyzed separately according to the elaboration group: governments (p<0.001), professional societies (p<0.001) and research groups (p<0.001, except in domain 5). When the quality of CPG was evaluated in subgroups of 20 different clinical areas, only two of them showed an increase in methodological quality in all domains of the AGREE-II: neurology (p<0.001) and gynecology (p<0.001). Conclusion: There was an improvement in the methodological quality of the CPG published over time both for general analysis and for different analyzed subgroups. However, especially for domains 2, 3 and 5, there is still opportunity for improvement, looking at the calculated medians, which remained below the desired level.
Descrição
Citação
Silva, L.C.A. Qualidade metodológica de diretrizes clínicas internacionais: houve melhora ao longo dos anos? Diadema, 2023. 108 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Instituto de Ciências Ambientais, Químicas e Farmacêuticas, Universidade Federal de São Paulo, Diadema, 2023.