Mapeamento de escalas que avaliam mania em protocolos de estudos clínicos de intervenções farmacológicas no transtorno bipolar
Data
2023-11-23
Autores
Macedo, Gabriel Oliveira Martins de 
Orientadores
Melo, Daniela Oliveira de
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: Os Estudos Clínicos Randomizados (ECR) são ferramentas para os profissionais da clínica se basearem e tomar as melhores decisões em relação a intervenções para seus pacientes. Para que o ECR cumpra seu papel, é importante que sejam elencados desfechos clinicamente relevantes. Os desfechos mais relevantes para uma condição podem ser determinados com o emprego do Core Outcome Set Standards for Development (COS-STAD). Alguns desfechos precisam ser mensurados com o emprego de escalas validadas. O Transtorno Bipolar (TB) é uma condição que varia em sintomas e não há marcadores fisiológicos padronizados para seu diagnóstico, logo, existem escalas de avaliação propostas em literatura para as diferentes fases da doença que demandam pouco tempo para serem aplicadas, facilitando a avaliação de melhora, resposta ou remissão dentro de um ECR. Nesse estudo, foi proposto o mapeamento de escalas na avaliação de TB, com foco em mania, em protocolos de ECR registrados na plataforma clinicaltrials.gov. Materiais e Métodos: Foi realizada uma busca por protocolos de ECR na plataforma clinicaltrials.gov, empregando os termos “Bipolar disorder OR bipolar”. Para cada protocolo foram extraídos e organizados em uma planilha de Microsoft Excel® os dados para que fossem identificados os desfechos e as escalas empregadas em sua mensuração, quando aplicável. Com as informações organizadas, foi possível quantificar a frequência de proposta de uso de cada escala de avaliação focada na avaliação da mania. Resultados: Nos 247 protocolos de ECR incluídos, identificou- se 1.594 desfechos, onde 1.197 dos desfechos poderiam empregar escalas em sua avaliação, mas 93 (7,7%) desses não informaram a escala utilizada. Nos 1.174 desfechos que reportaram a escala empregada, a frequência de relato mostrou que a mais frequente foi a CGI-BP com 230 (38,53%) desfechos, seguida por YMRS (202 ; 33,83%) e MADS com 163 (27,30%) desfechos. BRMS e CARS-M foram usadas em 1 (0,9%) desfecho. Discussão e Conclusão: Nesse estudo, a maioria dos desfechos incluídos em protocolos de ECR descreviam qual escala empregariam, no entanto não avaliamos a completude do relato sobre a mensuração e interpretação da escala. Embora a plataforma clinicaltrials.gov seja a maior, pode ter havido perda de protocolos não registrados nessa plataforma, o que limita as conclusões. Um maior volume de desfechos que usavam CGI-BP e YMRS já era esperado devido à abrangência da escala CGI-BP e o fato de YMRS já ser conhecido como a escala mais utilizada para avaliar mania.
Introduction: Randomized Clinical Trials (RCTs) are tools for clinicians to base their decisions on and make the best interventions for their patients. In order for RCTs to fulfill their role, it is important to identify clinically relevant outcomes. The most relevant outcomes for a condition can be determined using the Core Outcome Set Standards for Development (COS-STAD). Some outcomes need to be measured using validated scales. Bipolar Disorder (BD) is a condition that varies in symptoms, and there are no standardized physiological markers for its diagnosis. Therefore, assessment scales proposed in the literature for the different phases of the disease that require little time to be applied exist, facilitating the evaluation of improvement, response, or remission within an RCT. In this study, we proposed the mapping of scales for assessing BD, with a focus on mania, in RCT protocols registered on the clinicaltrials.gov platform. Materials and Methods: A search for RCT protocols was conducted on the clinicaltrials.gov platform using the terms "Bipolar disorder OR bipolar". For each protocol, the data were extracted and organized in a Microsoft Excel® spreadsheet to identify the outcomes and scales employed in their measurement, when applicable. With the organized information, it was possible to quantify the frequency of proposed use for each mania assessment scale. Results: In the 247 included RCT protocols, 1,594 outcomes were identified, of which 1,197 outcomes could employ scales for their assessment, but 93 (7.7%) did not report the scale used. Among the 1,174 outcomes that reported the employed scale, the reporting frequency showed that the most common scale was the CGI-BP with 230 (38,53%) outcomes, followed by YMRS (202; 33.83%) and MADS with 163 (27.30%) outcomes. BRMS and CARS-M were used in 1 (0.17%) outcome. Discussion and Conclusion: In this study, the majority of outcomes included in RCT protocols described which scale they would employ; however, we did not evaluate the completeness of the reporting on the measurement and interpretation of the scale. Although the clinicaltrials.gov platform is the largest, there may have been a loss of protocols not registered on this platform, which limits the conclusions. A higher volume of outcomes using CGI-BP and YMRS was expected due to the comprehensiveness of the CGI-BP scale and the fact that YMRS is already known as the most widely used scale for assessing mania.
Introduction: Randomized Clinical Trials (RCTs) are tools for clinicians to base their decisions on and make the best interventions for their patients. In order for RCTs to fulfill their role, it is important to identify clinically relevant outcomes. The most relevant outcomes for a condition can be determined using the Core Outcome Set Standards for Development (COS-STAD). Some outcomes need to be measured using validated scales. Bipolar Disorder (BD) is a condition that varies in symptoms, and there are no standardized physiological markers for its diagnosis. Therefore, assessment scales proposed in the literature for the different phases of the disease that require little time to be applied exist, facilitating the evaluation of improvement, response, or remission within an RCT. In this study, we proposed the mapping of scales for assessing BD, with a focus on mania, in RCT protocols registered on the clinicaltrials.gov platform. Materials and Methods: A search for RCT protocols was conducted on the clinicaltrials.gov platform using the terms "Bipolar disorder OR bipolar". For each protocol, the data were extracted and organized in a Microsoft Excel® spreadsheet to identify the outcomes and scales employed in their measurement, when applicable. With the organized information, it was possible to quantify the frequency of proposed use for each mania assessment scale. Results: In the 247 included RCT protocols, 1,594 outcomes were identified, of which 1,197 outcomes could employ scales for their assessment, but 93 (7.7%) did not report the scale used. Among the 1,174 outcomes that reported the employed scale, the reporting frequency showed that the most common scale was the CGI-BP with 230 (38,53%) outcomes, followed by YMRS (202; 33.83%) and MADS with 163 (27.30%) outcomes. BRMS and CARS-M were used in 1 (0.17%) outcome. Discussion and Conclusion: In this study, the majority of outcomes included in RCT protocols described which scale they would employ; however, we did not evaluate the completeness of the reporting on the measurement and interpretation of the scale. Although the clinicaltrials.gov platform is the largest, there may have been a loss of protocols not registered on this platform, which limits the conclusions. A higher volume of outcomes using CGI-BP and YMRS was expected due to the comprehensiveness of the CGI-BP scale and the fact that YMRS is already known as the most widely used scale for assessing mania.