Análise dos desfechos de eficácia/efetividade das intervenções terapêuticas dos ensaios clínicos randomizados de lesões por pressão em adultos: pesquisa sistemática.
Carregando...
Data
2019-02-28
Autores
Título da Revista
ISSN da Revista
Título de Volume
Editor
Universidade Estadual Paulista (Unesp)
Resumo
Introdução: as úlceras por pressão ou lesões por pressão (LPPs) têm alta incidência, principalmente nas unidades hospitalares. Ensaios clínicos randomizados (ECRs) de intervenções terapêuticas para LPP devem incluir uma descrição clara dos desfechos e resultados para aumentar a transparência, replicabilidade e melhorar a construção da evidência científica. Objetivos: avaliar a completude das descrições dos desfechos de intervenções terapêuticas em ECRs de pacientes adultos com LPP, descrevendo a frequência de ECRs com desfechos primários relatados, métodos de medição ou ferramentas usadas para avaliar os desfechos e os resultados dos desfechos relatados. Métodos: foi realizada pesquisa sistemática dos ECRs publicados no período de janeiro de 2006 a abril de 2018 nas bases de dados: PubMed, Cochrane, Cinahl, Embase, Lilacs, Scopus e Web of Science. O processo de seleção dos estudos foi realizado em duas etapas de triagem: título e resumo, e revisão do texto completo, sempre por dois pesquisadores de forma independente. A completude do desfecho foi avaliada de acordo com cinco critérios: domínio, medida específica, métrica específica ou formato dos dados de resultado que foram usados para análise, método de agregação e tempo que foi utilizado para análise. A qualidade dos resultados do desfecho foi classificada como completa, incompleta ou não reportada. Conduzimos uma análise descritiva do número, tipo e graus de especificação dos desfechos nos ECRs incluídos. A frequência das categorias em cada domínio dos desfechos também foi relatada. Resultados: sessenta estudos foram incluídos para análise. Foram relatados 242 desfechos e 40 ECRs (66,7%) apresentaram 65 desfechos primários, os quais eram, principalmente, do tipo intermediário/substituto (81,5%). O principal desfecho avaliado nos ECRs foi a redução da área da úlcera (38%) e apenas 21,1% dos resultados dos desfechos foram relatados de forma completa. Verificou-se que mais da metade dos desfechos (61,6%) tiveram pontuação máxima de 5 na avaliação da completude do desfecho. O elemento menos descrito é o método de agregação dos dados (71,9%). Apenas 48,3% dos desfechos com técnica especificada tinham referência ou validação da mesma. Os desfechos relatados de forma mais incompleta foram associados a estudos com ano de publicação mais antigo, menor tamanho amostral, revistas com fatores de impactos menores e patrocinados pela indústria. Conclusões: houve uma heterogeneidade de desfechos nos ECR em LPP, a maioria deles foram substitutos ou intermediários e quase 40% dos estudos descreveram os desfechos de forma incompleta. Os resultados relatados também estavam, em sua grande maioria, incompletos, dificultando a análise do efeito da intervenção nos desfechos propostos. Estes resultados caracterizam que a descrição dos desfechos e de seus resultados nos ECRs de LPPs precisam ser melhor relatados para aumentar a clareza dos estudos e das evidências científicas.
Background: pressure ulcer or pressure injuries (PI) have a high incidence, mainly in hospital units. Randomized controlled trials (RCTs) of therapeutic interventions for PI should include a clear description of outcomes and results to increase transparency, replicability and improve the construction of scientific evidence. Objectives: the primary objective of this study is to evaluate the completeness of the descriptions of outcomes of therapeutic interventions in RCTs in adult PI patients. Secondary objectives are: to describe the frequency of RCTs with reported primary outcomes, measurement methods, or tools used to assess outcomes and results of reported outcomes. Methods: a systematic research of RCTs published between January 2006 and April 2018 was carried out in the data bases: PubMed, Cochrane, Cinahl, Embase, Lilacs, Scopus and Web of Science. The selection process of the studies was carried out in two stages of screening: title and abstract, and review of the full text, always by two researchers independent. The completeness of the outcome was evaluated according to five criteria: domain, specific measure, specific metric or format of the outcome data that was used for analysis, aggregation method and time that was used for analysis. The quality of the results of the outcome was classified as complete, incomplete or unreported. We conducted a descriptive analysis of the number, type, and degree of specification of outcomes in the included RCTs. The frequency of categories in each domain of outcomes has also been reported. Results: sixty studies were included for analysis. A total of 242 outcomes were reported and 40 RCTs (66.7%) had 65 primary outcomes, which were mainly of the intermediate/substitute type (81.5%). The main outcome evaluated in the RCTs was the reduction of the ulcer area (38%) and only 21.1% of the results of the outcomes were reported completely. It was found that more than half of the outcomes (61.6%) had a maximum score of 5 in completeness assessment of the outcome. The least described element is the data aggregation method (71.9%). Only 48.3% of the outcomes with specified technique had reference or validation of the same. The most incompletely reported outcomes were associated with studies with older year of publication, smaller sample size, journals with smaller impact factors, and industry sponsored. Conclusions: there was a heterogeneity of RCT outcomes in PI, most of them were substitutes or intermediates, and almost 40% of the studies incompletely described the outcomes. The results reported were also, for the most part, incomplete, making it difficult to analyze the effect of the intervention on the proposed outcomes. These results characterize that the description of the outcomes and their results in the RCTs of PIs need to be better reported to increase the clarity of the studies and the scientific evidence.
Background: pressure ulcer or pressure injuries (PI) have a high incidence, mainly in hospital units. Randomized controlled trials (RCTs) of therapeutic interventions for PI should include a clear description of outcomes and results to increase transparency, replicability and improve the construction of scientific evidence. Objectives: the primary objective of this study is to evaluate the completeness of the descriptions of outcomes of therapeutic interventions in RCTs in adult PI patients. Secondary objectives are: to describe the frequency of RCTs with reported primary outcomes, measurement methods, or tools used to assess outcomes and results of reported outcomes. Methods: a systematic research of RCTs published between January 2006 and April 2018 was carried out in the data bases: PubMed, Cochrane, Cinahl, Embase, Lilacs, Scopus and Web of Science. The selection process of the studies was carried out in two stages of screening: title and abstract, and review of the full text, always by two researchers independent. The completeness of the outcome was evaluated according to five criteria: domain, specific measure, specific metric or format of the outcome data that was used for analysis, aggregation method and time that was used for analysis. The quality of the results of the outcome was classified as complete, incomplete or unreported. We conducted a descriptive analysis of the number, type, and degree of specification of outcomes in the included RCTs. The frequency of categories in each domain of outcomes has also been reported. Results: sixty studies were included for analysis. A total of 242 outcomes were reported and 40 RCTs (66.7%) had 65 primary outcomes, which were mainly of the intermediate/substitute type (81.5%). The main outcome evaluated in the RCTs was the reduction of the ulcer area (38%) and only 21.1% of the results of the outcomes were reported completely. It was found that more than half of the outcomes (61.6%) had a maximum score of 5 in completeness assessment of the outcome. The least described element is the data aggregation method (71.9%). Only 48.3% of the outcomes with specified technique had reference or validation of the same. The most incompletely reported outcomes were associated with studies with older year of publication, smaller sample size, journals with smaller impact factors, and industry sponsored. Conclusions: there was a heterogeneity of RCT outcomes in PI, most of them were substitutes or intermediates, and almost 40% of the studies incompletely described the outcomes. The results reported were also, for the most part, incomplete, making it difficult to analyze the effect of the intervention on the proposed outcomes. These results characterize that the description of the outcomes and their results in the RCTs of PIs need to be better reported to increase the clarity of the studies and the scientific evidence.
Descrição
Palavras-chave
Úlcera por pressão., Ensaio clínico randomizado., Desfecho de tratamento., Revisão, Pressure ulcer, Randomized clinical trial, Treatment outcome, Review