Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial

Abstract

Objective: The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care. Methods: The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia. Conclusion: According to the trial’s best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results. ClinicalTrials.gov registration: NCT03920501

Effect of Telemedicine Support for Intraoperative Anaesthesia Care on Postoperative Outcomes: The TECTONICS Randomised Clinical Trial

“…A cluster-randomised trial of TCC with a lower risk of bias will be available soon. 27 The only randomised trial of TCC of which we are aware found effects on protocol adherence but not patient outcomes. 5 Importantly, because of the (nearly) patient level randomisation and contamination from shared clinicians, our analysis of TECTONICS does not capture benefits to outcomes due to overall improvements in protocol adherence, discussed below.…”

Challenges and limitations of using ventilator-free days as an outcome in critical care trials

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The use of ventilator-free days (VFDs) as an outcome measure is increasingly popular in critical care research. (1)(2)(3) This composite outcome simultaneously reflects patient survival and the time not spent on mechanical ventilation (MV) within a specified timeframe, which usually extends from randomization up to Day 28. For patients who do not survive this period, VFDs are recorded as zero.Composite outcomes, such as those combining death, myocardial infarction, or stroke, are commonly used in fields such as cardiology due to their ability to enhance the statistical power of clinical trials while focusing on patient-relevant events.

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“…The use of ventilator-free days (VFDs) as an outcome measure is increasingly popular in critical care research. (1)(2)(3) This composite outcome simultaneously reflects patient survival and the time not spent on mechanical ventilation (MV) within a specified timeframe, which usually extends from randomization up to Day 28. For patients who do not survive this period, VFDs are recorded as zero.…”