Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial.

BACKGROUND: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. METHODS/DESIGN: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. CONCLUSIONS: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. TRIAL REGISTRATION: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Nil.

Lung infarction secondary to infected pulmonary arterial thrombosis in a patient with Eisenmenger's syndrome.

A case is presented where a patient with Eisenmenger's syndrome is successfully treated for infection of chronic pulmonary arterial thrombosis with good effect. The evidence for antibiotic and anticoagulant therapy in this patient group is discussed.

A Scoping Review of mHealth Interventions for Secondary Prevention of Stroke: Implications for Policy and Practice.

Secondary prevention is a major priority for those living with stroke and may be improved through the use of mobile Health (mHealth) interventions. While evidence for the effectiveness of mHealth interventions for secondary prevention of stroke is growing, little attention has been given to the translation of these interventions into real-world use. In this review, we aimed to provide an update on the effectiveness of mHealth interventions for secondary prevention of stroke, and investigate their translation into real-world use. Four electronic databases and the gray literature were searched for randomized controlled trials of mHealth interventions for secondary prevention of stroke published between 2010 and 2023. Qualitative and mixed-methods evaluations of the trials were also included. Data were extracted regarding study design, population, mHealth technology involved, the intervention, and outcomes. Principal researchers from these trials were also contacted to obtain further translational information. From 1151 records, 13 randomized controlled trials and 4 evaluations were identified; sample sizes varied widely (median, 56; range, 24-4298). Short message service messages (9/13) and smartphone applications (6/13) were the main technologies used to deliver interventions. Primary outcomes of feasibility of the intervention were achieved in 4 trials, and primary outcomes of changes in risk factors, lifestyle behaviors, and adherence to medication improved in 6 trials. Only 1 trial had a hard end point (ie, stroke recurrence) as a primary outcome, and no significant differences were observed between groups. There was evidence for only 1 intervention being successfully translated into real-world use. Further evidence is required on the clinical effectiveness of mHealth interventions for preventing recurrent stroke, and the associated delivery costs and cost-effectiveness, before adoption into real-world settings.