Predictors of Need for Critical Care Support, Adverse Events, and Outcome after Stroke Thrombolysis.

BACKGROUND: Results from trials and international registries exhibit heterogeneity regarding safety, efficacy, markers of prognosis, and markers of the need for critical care support after intravenous thrombolysis (IVT) for strokes. The purpose of our study was to indentify such markers after performance of comparisons among patients who received thrombolysis in our intensive care unit. MATERIALS AND METHODS: Our study included 124 patients who received IVT in accordance with international criteria. Outcome measures of univariate and regression analyses resulted from comparisons between groups of patients with or without the need for critical care support (advanced life support and neurocritical care interventions), groups of patients developing or not developing primary adverse events (symptomatic intracranial hemorrhage [SICH] and/or Death and/or Serious systemic bleeding and/or New stroke) and groups of patients with different main outcome variables (mortality, functional independence at 3 months). RESULTS: Our results suggested that higher severity scores (Simplified Acute Physiology Score II, National Institutes of Health Stroke Scale) correlated with the need for critical care support, primary adverse events, and main outcome variables, whereas older age was significantly associated with fewer adverse events. Hyperlipidemia, symptom-to-needle time, and vascular disease were associated with functional capacity at 3 months, whereas diabetes mellitus and vascular disease correlated with the need for critical care support. CONCLUSION: Patients' age, hyperlipidemia, presence of vascular disease, Simplified Acute Physiology Score II (a novel marker), and National Institutes of Health Stroke Scale at 2 hours and at 7 days are independent predictors of the need for critical care support, adverse events, and clinical outcomes after thrombolysis.

Proportion of published primary health care protocols with published results in subsequent papers was decreasing.

OBJECTIVES: We assessed the proportion of primary health care (PHC) randomized controlled trial (RCT) protocols published in peer-reviewed journals that published results in subsequent papers in peer-reviewed journals; and whether this proportion changed over time. STUDY DESIGN AND SETTING: We searched (last update June 2019) for RCTs published in peer-reviewed journals reporting primary outcome results for 620 protocols that were published up to 2014 and were retrieved in PubMed. We recorded the absolute number and the proportion of protocols with published results per year; and estimated whether the proportion changed over time. RESULTS: Of the 620 published protocols, 525 (85%) disseminated their results through a published RCT by June 2019. The number of published protocols was increasing over time especially after 2001. However, the proportion of protocols per year with published results in subsequent papers was decreasing over time after 2002. Specifically, the proportion ranged from 86% to 96% for protocols published until 2010 while for those published from 2011 onward ranged from 76% to 86%. Mean time from protocol to results publication was 39 months (95% CI 37, 41). CONCLUSION: Almost one-sixth of PHC trial protocols published in peer-reviewed journals did not publish their results in subsequent papers.