Desfechos propostos em protocolos de estudos clínicos que avaliam opções de tratamento farmacológico da mania
Data
2022-12-19
Autores
Silva, Raquel Lustosa da 
Orientadores
Melo, Daniela Oliveira de
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: Um processo importante do planejamento dos protocolos de estudos
clínicos é a seleção dos desfechos, pois é por meio deles que se avaliam o quanto
os tratamentos podem ou não contribuir para a melhora ou cura dos pacientes. O
clinicaltrials.gov é o principal repositório de protocolos de estudos clínicos e foi
através dele que foram mapeados os desfechos relacionados ao transtorno bipolar
(TB) presentes neste estudo. Objetivo: O objetivo desse estudo foi mapear os
desfechos propostos para avaliar mania em protocolos de estudos clínicos com
intervenções farmacológicas para o transtorno bipolar. Materiais e Métodos: Foi
realizada uma busca, em 21 de dezembro de 2021, na plataforma clinicaltrials.gov
por protocolos de estudos clínicos de fase 3 que avaliavam intervenções
farmacológicas para o TB. Desses protocolos foram extraídas as informações sobre
os cinco primeiros desfechos propostos (fase da doença/manifestação, escala,
tempo de seguimento e medida do desfecho). Para os protocolos que incluíam pelo
menos um desfecho relacionado à mania ou qualquer episódio de humor, foram
analisados a frequência de cada desfecho de interesse e a frequência de uso de
escalas. Resultados: Foram incluídos 241 protocolos de estudo clínico na análise
dos dados, resultando na identificação de 806 desfechos. Dos 806, 225 avaliavam
desfechos de interesse, relacionados à mania (182; 80,89%) ou qualquer episódio
de humor (43; 19,11%). Dos 225 desfechos de interesse, 135 (60,00%) avaliavam a
melhora clínica do paciente em relação ao quadro de mania e 37 (16,40%)
avaliavam a ocorrência de recaída. Adicionalmente, somente 27 (12,00%) dos 225
desfechos de interesse não descreveram o uso de uma escala. A escala mais
utilizada para avaliação dos desfechos foi a Young Mania Rating Scale – YMRS
(111; 49,33%). Discussão e Conclusão: Na grande maioria dos desfechos, foi
empregado escala na avaliação. A YMRS foi a escala mais utilizada, demonstrando
preferência por essa análise. Dessa forma, tem sido frequente o uso dessas
ferramentas, o que torna a avaliação do desfecho mais clara e objetiva, facilitando a
comparação e análise dos tratamentos farmacológicos. A melhora clínica foi a
avaliação mais frequente, o que demanda que os protocolos estabeleçam não
apenas escalas, mas também critérios claros sobre o que é considerado melhora
clinicamente relevante, ou seja, interpretação dos resultados.
Introduction: An important process in the planning of clinical trial protocols is the selection of outcomes, as it is through them that the extent to which treatments may or may not contribute to the improvement or cure of patients is assessed. Clinicaltrials.gov is the main repository of clinical trial protocols and it was through it that the outcomes related to bipolar disorder (BD) present in this study were mapped. Objective: The aim of this study was to map the proposed outcomes to evaluate mania in clinical trial protocols with pharmacological interventions for bipolar disorder. Materials and Methods: A search was performed on December 21, 2021, on the clinicaltrials.gov platform for phase 3 clinical trial protocols that evaluated pharmacological interventions for BD. Informations about the first five proposed outcomes was extracted from these protocols (disease/manifestation stage, scale, time frame and outcome measure). For protocols that included at least one outcome related to mania or any mood episode, the frequency of each outcome of interest and the frequency of use of scales were analyzed. Results: A total of 241 clinical trial protocols were included in the data analysis, resulting in the identification of 806 outcomes. Of the 806, 225 assessed outcomes of interest related to mania (182; 80.89%) or any mood episode (43; 19.11%). Of the 225 outcomes of interest, 135 (60.00%) assessed the patient's clinical improvement in relation to the manic condition and 37 (16.40%) assessed the occurrence of relapse. Additionally, only 27 (12.00%) of the 225 outcomes of interest did not describe the use of a scale. The most used scale for evaluating the outcomes was the Young Mania Rating Scale - YMRS (111; 49.33%). Discussion and Conclusion: In the vast majority of outcomes, a scale was used in the assessment. The YMRS was the most used scale, demonstrating a preference for this analysis. Thus, the use of these tools has been frequent, which makes the evaluation of the outcome clearer and more objective, facilitating the comparison and analysis of pharmacological treatments. The clinical improvement was the most frequent assessment, which demands that protocols establish not only scales, but also clear criteria on what is considered clinically relevant improvement, that is, interpretation of results.
Introduction: An important process in the planning of clinical trial protocols is the selection of outcomes, as it is through them that the extent to which treatments may or may not contribute to the improvement or cure of patients is assessed. Clinicaltrials.gov is the main repository of clinical trial protocols and it was through it that the outcomes related to bipolar disorder (BD) present in this study were mapped. Objective: The aim of this study was to map the proposed outcomes to evaluate mania in clinical trial protocols with pharmacological interventions for bipolar disorder. Materials and Methods: A search was performed on December 21, 2021, on the clinicaltrials.gov platform for phase 3 clinical trial protocols that evaluated pharmacological interventions for BD. Informations about the first five proposed outcomes was extracted from these protocols (disease/manifestation stage, scale, time frame and outcome measure). For protocols that included at least one outcome related to mania or any mood episode, the frequency of each outcome of interest and the frequency of use of scales were analyzed. Results: A total of 241 clinical trial protocols were included in the data analysis, resulting in the identification of 806 outcomes. Of the 806, 225 assessed outcomes of interest related to mania (182; 80.89%) or any mood episode (43; 19.11%). Of the 225 outcomes of interest, 135 (60.00%) assessed the patient's clinical improvement in relation to the manic condition and 37 (16.40%) assessed the occurrence of relapse. Additionally, only 27 (12.00%) of the 225 outcomes of interest did not describe the use of a scale. The most used scale for evaluating the outcomes was the Young Mania Rating Scale - YMRS (111; 49.33%). Discussion and Conclusion: In the vast majority of outcomes, a scale was used in the assessment. The YMRS was the most used scale, demonstrating a preference for this analysis. Thus, the use of these tools has been frequent, which makes the evaluation of the outcome clearer and more objective, facilitating the comparison and analysis of pharmacological treatments. The clinical improvement was the most frequent assessment, which demands that protocols establish not only scales, but also clear criteria on what is considered clinically relevant improvement, that is, interpretation of results.