RESUMO
OBJECTIVES: We planned to synthesize evidence examining the potential efficacy and safety of performing physical rehabilitation and/or mobilization (PR&M) in adult patients receiving extracorporeal life support (ECLS). DATA SOURCES: We included any study that compared PR&M to no PR&M or among different PR&M strategies in adult patients receiving any ECLS for any indication and any cannulation. We searched seven electronic databases with no language limitations. STUDY SELECTION AND DATA EXTRACTION: Two reviewers, independently and in duplicate, screened all citations for eligibility. We used the Cochrane Risk of Bias 2 and Cochrane Risk Of Bias In Non-randomized Studies of Interventions tools to assess individual study risk of bias. Although we had planned for meta-analysis, this was not possible due to insufficient data, so we used narrative and tabular data summaries for presenting results. We assessed the overall certainty of the evidence for each outcome using the Grading of Recommendations Assessment, Development, and Evaluation framework. DATA SYNTHESIS: We included 17 studies that enrolled 996 patients. Most studies examined venovenous extracorporeal membrane oxygenation (ECMO) and/or venoarterial ECMO as a bridge to recovery in the ICU. We found an uncertain effect of high-intensity/active PR&M on mortality, duration of mechanical ventilation, ICU length of stay, hospital length of stay, or quality of life compared with low-intensity/passive PR&M in patients receiving ECLS (very low certainty due to very serious imprecision). There was similarly an uncertain effect on safety events including clinically important bleeding, spontaneous intracerebral hemorrhage, limb ischemia, accidental decannulation, or ECLS circuit dysfunction (very low certainty due to very serious risk of bias and imprecision). CONCLUSIONS: Based on the currently available summary of evidence, there is an uncertain effect of high-intensity/active PR&M on patient important outcomes or safety in patients receiving ECLS. Despite indirect data from other populations suggesting potential benefit of high-intensity PR&M in the ICU; further high-quality randomized trials evaluating the benefits and risks of physical therapy and/or mobilization in this population are needed.
Assuntos
Oxigenação por Membrana Extracorpórea , Humanos , Oxigenação por Membrana Extracorpórea/métodos , Modalidades de Fisioterapia , Deambulação Precoce/métodos , Tempo de InternaçãoRESUMO
OBJECTIVE: To discuss the strengths and limitations of ventilator-free days and to provide a comprehensive discussion of the different analytic methods for analyzing and interpreting this outcome. METHODS: Using simulations, the power of different analytical methods was assessed, namely: quantile (median) regression, cumulative logistic regression, generalized pairwise comparison, conditional approach and truncated approach. Overall, 3,000 simulations of a two-arm trial with n = 300 per arm were computed using a two-sided alternative hypothesis and a type I error rate of α = 0.05. RESULTS: When considering power, median regression did not perform well in studies where the treatment effect was mainly driven by mortality. Median regression performed better in situations with a weak effect on mortality but a strong effect on duration, duration only, and moderate mortality and duration. Cumulative logistic regression was found to produce similar power to the Wilcoxon rank-sum test across all scenarios, being the best strategy for the scenarios of moderate mortality and duration, weak mortality and strong duration, and duration only. CONCLUSION: In this study, we describe the relative power of new methods for analyzing ventilator-free days in critical care research. Our data provide validation and guidance for the use of the cumulative logistic model, median regression, generalized pairwise comparisons, and the conditional and truncated approach in specific scenarios.
Assuntos
Cuidados Críticos , Respiração Artificial , Humanos , Cuidados Críticos/métodos , Respiração Artificial/mortalidade , Modelos Logísticos , Fatores de Tempo , Simulação por Computador , Desmame do Respirador/métodosRESUMO
ABSTRACT Objective: To discuss the strengths and limitations of ventilator-free days and to provide a comprehensive discussion of the different analytic methods for analyzing and interpreting this outcome. Methods: Using simulations, the power of different analytical methods was assessed, namely: quantile (median) regression, cumulative logistic regression, generalized pairwise comparison, conditional approach and truncated approach. Overall, 3,000 simulations of a two-arm trial with n = 300 per arm were computed using a two-sided alternative hypothesis and a type I error rate of α = 0.05. Results: When considering power, median regression did not perform well in studies where the treatment effect was mainly driven by mortality. Median regression performed better in situations with a weak effect on mortality but a strong effect on duration, duration only, and moderate mortality and duration. Cumulative logistic regression was found to produce similar power to the Wilcoxon rank-sum test across all scenarios, being the best strategy for the scenarios of moderate mortality and duration, weak mortality and strong duration, and duration only. Conclusion: In this study, we describe the relative power of new methods for analyzing ventilator-free days in critical care research. Our data provide validation and guidance for the use of the cumulative logistic model, median regression, generalized pairwise comparisons, and the conditional and truncated approach in specific scenarios.
RESUMO Objetivo: Discutir os pontos fortes e as limitações dos dias livres de ventilador e fornecer uma discussão abrangente dos diferentes métodos analíticos para analisar e interpretar esse desfecho. Métodos: Por meio de simulações, avaliou-se o poder de diferentes métodos analíticos, a saber: regressão quantílica (mediana), regressão logística cumulativa, comparação generalizada entre pares, abordagem condicional e abordagem truncada. No total, foram computadas 3.000 simulações de um estudo de dois braços com n = 300 por braço, usando uma hipótese alternativa bilateral e uma taxa de erro tipo I de α = 0,05. Resultados: Ao considerar o poder, a regressão mediana não teve bom desempenho em estudos em que o efeito do tratamento foi impulsionado principalmente pela mortalidade. A regressão mediana teve desempenho melhor em situações com efeito fraco na mortalidade, mas forte na duração, somente na duração e na mortalidade e duração moderadas. Verificou-se que a regressão logística cumulativa produziu um poder semelhante ao do teste de soma de postos de Wilcoxon em todos os cenários, sendo a melhor estratégia nos cenários de mortalidade e duração moderadas, mortalidade fraca e duração forte, e apenas duração. Conclusão: Neste estudo, descrevemos o poder relativo de novos métodos para analisar os dias livres de ventilador em estudos de cuidados intensivos. Nossos dados fornecem validação e orientação quanto ao uso do modelo logístico cumulativo, regressão mediana, comparações generalizadas entre pares e a abordagem condicional e truncada em cenários específicos.