Pesquisa sistemática dos ensaios clínicos aleatorizados pilotos e de viabilidade em dermatologia: análise quanto à adequação metodológica ao CONSORT Statement para estudos pilotos.
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2020-02-27
Autores
Magolbo, Natiara Grava
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Universidade Estadual Paulista (Unesp)
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Introdução: Estudos pilotos e de viabilidade são realizados em diversas áreas clínicas e têm importante papel no planejamento e desenvolvimento de ensaios clínicos aleatorizados (ECAs). Entretanto, na literatura existe grande número de ECAs declarados como pilotos e de viabilidade, mas não relatam claramente em seus objetivos e métodos quais itens são testados quanto aos processos e viabilidade e se são uma preparação para estudos maiores. Objetivos: avaliar a adequação dos relatos de ECAs denominados como pilotos ou de viabilidade publicados na área de dermatologia, em relação aos cincos pontos-chaves necessários para relato destes estudos e determinar quais são os fatores associados com adequação completa aos cincos pontoschaves. Métodos: pesquisa sistemática metodológica de ECAs pilotos e de viabilidade em dermatologia publicados no PubMed, no período de janeiro de 2012 a julho de 2018. Critérios de exclusão: protocolos, carta aos editores e estudos pilotos não aleatorizados. A extração de dados de cada artigo selecionado foi realizada por meio de uma planilha padronizada. Dois revisores extraíram os dados e qualquer desacordo foi resolvido através de consenso. Os estudos incluídos foram avaliados quanto sua adequação aos cincos pontos-chaves, os quais foram escolhidos pelos autores a partir do CONSORT Statement para estudos pilotos e de viabilidade, por considerarem que são itens fundamentais para um bom relato de ECA piloto e de viabilidade. Os cincos pontos-chaves são: i) se título ou resumo esclarece que se trata de um estudo piloto ou de viabilidade; ii) se os objetivos avaliam processos ou viabilidade; iii) se os desfechos descritos são relacionados aos processos ou viabilidade do estudo; iv) se houve critérios de sucesso para iniciar o estudo principal e v) se haverá progressão para o estudo principal. Resultados: identificaram-se 912 artigos com inclusão para análise de 206 ECAs. Entre os 206 estudos analisados, apenas 12 ECAs (5,8%) relataram os cincos pontos- chaves. O item mais relatado foi o título ou resumo indicando que se tratava de um estudo piloto ou de viabilidade e o menos relatado foi relacionado aos critérios de sucesso para progredir para um estudo principal. Vinte e sete ECAs (13%) relataram objetivos e desfechos adequados para estudo piloto e de viabilidade, sendo os principais a taxa de adesão e retenção, aceitabilidade de novas intervenções, taxa de recrutamento e número de participantes elegíveis. Os ECAs com relato completo dos cincos pontos-chaves foram publicados mais em revistas que endossam o CONSORT (OR 9,9; IC95% 1,2-81,7) e com desenho multicêntrico (OR 5,4; IC95% 1,2-23,6). Conclusão: há escassez de ECAs pilotos e de viabilidade adequadamente relatados em dermatologia. Poucos estudos relataram objetivos e desfechos que avaliaram processos e viabilidade para a progressão para um estudo futuro maior e os critérios de sucesso para esta progressão.
Background: Pilot and feasibility studies are carried out in several clinical areas and have an important role in the planning and development of randomized clinical trials (RCTs). However, in the literature there are a large number of RCTs declared as pilots and viability, but not clearly related in their objectives and methods. What are the items tested with regard to processes and feasibility and if it is a preparation for larger studies. Objectives: to assess RCT’s suitability reports referred to as tests or feasibility of publication in the field of dermatology, in relation to the values of key keys used for study reports and wich are the factors associated with complete adequacy to the key points. Methods: systematic survey of dermatology pilot’s RCT published in PubMed from January 2012 to July 2018. Exclusion criteria: protocols, letter to editorials and non-randomized pilot studies. Data extraction from each selected article was performed using a standardized spreadsheet. Two reviewers extracted the data and any disagreements were resolved by consensus. The included studies were assessed as to their suitability for the five key points, which were chosen by the authors from the CONSORT Statement for pilot and feasibility studies, as they consider that they are fundamental items for a good report of pilot and feasibility RCTs. The five key points are: i) title or abstract indicating that it is a pilot study; ii) objectives attesting to viability; iii) outcomes that assess viability; iv) success criteria for starting the main study and v) whether there will be progression to the main study. Pilot RCTs were considered “true” when they presented viability objectives and outcomes. Results: 912 articles were identified, including 206 RCTs for analysis. Among the 206 studies analyzed, only 12 RCTs (5.8%) reported the five key points. The most reported item was the title or summary indicating that it was a pilot or feasibility study and the least reported was related to the success criteria to progress to a main study. Twenty-seven ECAs (13%) reported adequate objectives and outcomes for a pilot and feasibility study, the main ones being the adherence and retention rate, acceptability of new interventions, recruitment rate and number of eligible participants. RCTs with a complete report of the five key points were published more in magazines that endorse CONSORT (OR 9.9; 95% CI 1.2-81.7) and with a multicentric design (OR 5.4; 95% CI 1.2 -23.6). Conclusion: there is a shortage of pilot and viability RCTs adequately reported in dermatology. Few studies have reported objectives and outcomes that assessed processes and feasibility for progression to a larger future study and the success criteria for this progression.
Background: Pilot and feasibility studies are carried out in several clinical areas and have an important role in the planning and development of randomized clinical trials (RCTs). However, in the literature there are a large number of RCTs declared as pilots and viability, but not clearly related in their objectives and methods. What are the items tested with regard to processes and feasibility and if it is a preparation for larger studies. Objectives: to assess RCT’s suitability reports referred to as tests or feasibility of publication in the field of dermatology, in relation to the values of key keys used for study reports and wich are the factors associated with complete adequacy to the key points. Methods: systematic survey of dermatology pilot’s RCT published in PubMed from January 2012 to July 2018. Exclusion criteria: protocols, letter to editorials and non-randomized pilot studies. Data extraction from each selected article was performed using a standardized spreadsheet. Two reviewers extracted the data and any disagreements were resolved by consensus. The included studies were assessed as to their suitability for the five key points, which were chosen by the authors from the CONSORT Statement for pilot and feasibility studies, as they consider that they are fundamental items for a good report of pilot and feasibility RCTs. The five key points are: i) title or abstract indicating that it is a pilot study; ii) objectives attesting to viability; iii) outcomes that assess viability; iv) success criteria for starting the main study and v) whether there will be progression to the main study. Pilot RCTs were considered “true” when they presented viability objectives and outcomes. Results: 912 articles were identified, including 206 RCTs for analysis. Among the 206 studies analyzed, only 12 RCTs (5.8%) reported the five key points. The most reported item was the title or summary indicating that it was a pilot or feasibility study and the least reported was related to the success criteria to progress to a main study. Twenty-seven ECAs (13%) reported adequate objectives and outcomes for a pilot and feasibility study, the main ones being the adherence and retention rate, acceptability of new interventions, recruitment rate and number of eligible participants. RCTs with a complete report of the five key points were published more in magazines that endorse CONSORT (OR 9.9; 95% CI 1.2-81.7) and with a multicentric design (OR 5.4; 95% CI 1.2 -23.6). Conclusion: there is a shortage of pilot and viability RCTs adequately reported in dermatology. Few studies have reported objectives and outcomes that assessed processes and feasibility for progression to a larger future study and the success criteria for this progression.
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Palavras-chave
Dermatologia, Pesquisa metodológica, Estudos de viabilidade, Pilot study, Feasibility study, Dermatology