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Covariate Adjustment Tutorials

List of Case Studies

Simulated MISTIE III Data: Minimally Invasive Surgery for Intracranial Hemorrhage

The Minimally Invasive Surgery with Thrombolysis in Intracerebral haemorrhage Evacuation trial was a Phase III trial evaluating the safety and efficacy of minimally invasive surgery with Alteplase for ICH removal compared to standard-of-care medical management for individuals with intracranial hemorrhage. Outcomes were measured at 30, 180, and 365-days post-randomization using the Modified Rankin Scale (MRS). Survival was also assessed, with patients administratively censored on the date of their final MRS assessment. It was hypothesized that the surgical intervention would reduce mortality and improve functional outcomes as measured by the Modified Rankin Scale (MRS).

CTN 0003 - Suboxone (Buprenorphine/Naloxone) Taper: A Comparison of Two Schedules

CTN03 was a phase III two arm trial to assess tapering schedules of the drug buprenorphine, a pharmacotherapy for opioid dependence. At the time of the study design, there was considerable variation in tapering schedules in practice, and a knowledge gap in terms of the best way to administer buprenorphine to control withdrawal symptoms and give the greatest chance of abstinence at the end of treatment. It was hypothesized that a longer taper schedule would result in greater likelihood of a participant being retained on study and providing opioid-free urine samples at the end of the drug taper schedule. Participants were randomized 1:1 to a 7-day or 28-day taper using stratified block randomization across 11 sites in 10 US cities. Randomization was stratified by the maintenance dose of buprenorphine at stabilization: 8, 16, or 24 mg.

CTN 0030 - Prescription Opioid Addiction Treatment Study (POATS)