Pulmonary arterial hypertension trials put to the test: Using the fragility index to assess trials robustness.

BACKGROUND: Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. The Fragility Index (FI) is a tool to assess the robustness of RCT results. FI was validated for dichotomous outcomes and recent work expanded its use to continuous outcomes. Studying the robustness of RCTs in Pulmonary Arterial Hypertension (PAH) treatments is crucial due to the severity and mortality risks associated with this rare condition. OBJECTIVES: Analyze FI and Fragility quotient (FQ) of significant primary outcomes in PAH RCTs and study FI correlation with sample size and journal impact factor. METHODS: FI and FQ calculation followed by Spearman correlation to assess the correlation between FI and sample size, and FI and impact factor. RESULTS: The median sample size of the 21 trials was 202 patients (IQR 106-267), with 6 trials reporting primary outcomes as dichotomous and 15 reporting continuous primary outcomes. The median FI was 10 (IQR 3-20), and the median FQ was 0.044 (0.026-0.097). A moderate correlation was found between FI and sample size, with r = 0.56; P = 0.008 and FI and journal impact factor (r=0.50; P=0.019). The FI for continuous outcomes was similar to that for dichotomous outcomes. CONCLUSIONS: This study represents the first analysis of the FI and FQ of PAH treatment RCTs, and expands the use of FI to continuous outcomes in this context. The moderate correlation between FI and sample size suggests that increasing sample size alone is partially correlated to a higher FI. The similarity between FI for continuous and dichotomous outcomes supports the broader use of FI in PAH RCTs.

Outcomes and prognostic factors of decompensated pulmonary hypertension in the intensive care unit.

BACKGROUND: Patients with acute decompensation of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) admitted to intensive care unit (ICU) have high in-hospital mortality. We hypothesized that pulmonary hypertension (PH) severity, measured by a simplified version of European Society of Cardiology/European Respiratory Society (ESC/ERS) risk assessment, and the severity of organ dysfunction upon ICU admission, measured by sequential organ failure assessment score (SOFA) were associated with in-hospital mortality in decompensated patients with PAH and CTEPH. We also described clinical and laboratory variables during ICU stay. METHODS: Observational study including adults with decompensated PAH or CTEPH with unplanned ICU admission between 2014 and 2019. Multivariate logistic regression models were used to evaluate the association of ESC/ERS risk assessment and SOFA score with in-hospital mortality. ESC/ERS risk assessment and SOFA score were included in a decision tree to predict in-hospital mortality. RESULTS: 73 patients were included. In-hospital mortality was 41.1%. ESC/ERS high-risk group (adjusted odds ratio = 95.52) and SOFA score (adjusted odds ratio = 1.80) were associated with in-hospital mortality. The decision tree identified four groups with in-hospital mortality between 8.1% and 100%. Nonsurvivors had a lower central venous oxygen saturation, higher arterial lactate and higher brain natriuretic peptide in the end of first week in the ICU. CONCLUSIONS: High-risk on a simplified version of ERS/ESC risk assessment and SOFA score upon ICU admission are associate with in-hospital mortality. A decision tree based on ESC/ERS risk assessment and SOFA score identifies four groups with in-hospital mortality between 8.1% and 100%.

Implementation of Tele-ICU during the COVID-19 pandemic.

OBJECTIVE: To describe the implementation of a Tele-ICU program during the COVID-19 pandemic, as well as to describe and analyze the results of the first four months of operation of the program. METHODS: This was a descriptive observational study of the implementation of a Tele-ICU program, followed by a retrospective analysis of clinical data of patients with COVID-19 admitted to ICUs between April and July of 2020. RESULTS: The Tele-ICU program was implemented over a four-week period and proved to be feasible during the pandemic. Participants were trained remotely, and the program had an evidence-based design, the objective being to standardize care for patients with COVID-19. More than 100,000 views were recorded on the free online platforms and the mobile application. During the study period, the cases of 326 patients with COVID-19 were evaluated through the program. The median age was 60 years (IQR, 49-68 years). There was a predominance of males (56%). There was also a high prevalence of hypertension (49.1%) and diabetes mellitus (38.4%). At ICU admission, 83.7% of patients were on invasive mechanical ventilation, with a median PaO2/FiO2 ratio < 150. It was possible to use lung-protective ventilation in 75% of the patients. Overall, in-hospital mortality was 68%, and ICU mortality was 65%. CONCLUSIONS: Our Tele-ICU program provided multidisciplinary training to health care professionals and clinical follow-up for hundreds of critically ill patients. This public health care network initiative was unprecedented and proved to be feasible during the COVID-19 pandemic, encouraging the creation of similar projects that combine evidence-based practices, training, and Tele-ICU.

Peliosis hepatis and systemic lupus erythematosus: A rare condition identified by magnetic resonance imaging.

Peliosis hepatis is a rare benign disorder characterized by the presence of multiple cavities filled with blood with no preferential localization in the liver parenchyma. It may be related to several etiologic conditions, especially infections and toxicity of immunosuppressive drugs. To our knowledge, there are only three articles reporting the association between peliosis hepatis and systemic lupus erythematosus. In this report, we describe a case of this rare condition, highlighting the importance of magnetic resonance imaging. A short review of this subject is also presented.

Peliosis hepatis and systemic lupus erythematosus: A rare condition identified by magnetic resonance imaging / Peliose hepática e lúpus eritematoso sistêmico: uma rara condição identificada pela ressonância nuclear magnética

Summary Peliosis hepatis is a rare benign disorder characterized by the presence of multiple cavities filled with blood with no preferential localization in the liver parenchyma. It may be related to several etiologic conditions, especially infections and toxicity of immunosuppressive drugs. To our knowledge, there are only three articles reporting the association between peliosis hepatis and systemic lupus erythematosus. In this report, we describe a case of this rare condition, highlighting the importance of magnetic resonance imaging. A short review of this subject is also presented.

Resumo Peliose hepática é uma patologia benigna rara caracterizada pela presença de múltiplas cavidades preenchidas por sangue sem localização preferencial no parênquima do fígado. Pode estar relacionada a uma série de condições etiológicas, dentre elas doenças infecciosas e toxicidade por drogas imunossupressoras. Para nosso conhecimento, existem apenas três artigos que abordam a associação entre peliose hepática e lúpus eritematoso sistêmico. Neste relato, descrevemos um caso desta rara condição, destacando a importância da ressonância magnética. Uma breve revisão sobre o tema é apresentada.