A hospital-based cluster-randomized controlled trial of free influenza vaccination before hospital discharge compared to routine care in patients with heart failure (PANDA II): Statistical Analysis Plan
Shan, S.; Billot, L.; Du, X.; Dong, J.; Anderson, C. S.
Show abstract
The PANDA II trial aims to evaluate whether a free influenza vaccination program for patients hospitalized in China with acute heart failure provides benefits compared to current routine practice of no influenza vaccination. It is designed as a two-arm, parallel, cluster-crossover randomized trial of 122 hospitals conducted over three influenza seasons. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variable collected in the trial. The primary outcome is a composite of all-cause mortality and re-admission to hospital within a 12- month period after the initial 30-day post-discharge period. The primary analysis will include all recruited participants analysed according to the intervention allocated to the hospital during their enrolment period. It will consist in an individual-level hierarchical logistic regression adjusted for the effect of the period and for clustering by hospital using both a random hospital effect and a random hospital-period effect. The effect of the influenza vaccination program will be estimated as an odds ratio and 95% confidence interval. Sensitivity analyses will include covariate adjustments as well as a cluster-level analysis and subgroup analyses according to eight pre-specified subgroups.
Matching journals
The top 2 journals account for 50% of the predicted probability mass.
Similar papers in this journal
- Real-world effects of ACE inhibitors and Angiotensin Receptor Blockers: protocol for an emulation study of the ONTARGET trial using electronic health records 95%
- The association between influenza vaccination, all-cause mortality and cardiovascular mortality: a protocol for a living systematic review and prospective meta-analysis 95%
- Apple Watch and Withings Evaluation of Symptoms, Treatment, and Rhythm in those Undergoing Cardioversion (AWE STRUCk): A Pragmatic Randomized Controlled Trial 94%
Similar papers in this journal
- External validation of a claims-based model to predict left ventricular ejection fraction class in patients with heart failure 94%
- Laboratory-confirmed respiratory viral infection triggers for acute myocardial infarction and stroke: systematic review protocol 94%
- Safety and effectiveness of RBD-specific polyclonal equine F(ab′)2 fragments for the treatment of hospitalized patients with severe Covid-19 disease: a retrospective cohort study 94%
Similar papers in this journal
- Statistical Analysis Plan for the Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN): a study protocol for a stepped-wedge cluster randomized controlled trial 95%
- Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): Statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial 94%
- Decision support system to evaluate VENTilation in the Acute Respiratory Distress Syndrome (DeVENT study) – Trial Protocol 94%
Similar papers in this journal
- The HEART-GP strategy for ruling out acute coronary syndrome in out-of-hours primary care: a diagnostic accuracy trial protocol 92%
- The IGNITE Trial: Participant Recruitment Lessons Prior to SARS-CoV-2 92%
- A Retrospective Analysis of Serious Adverse Events and Deaths in US-Based Lifestyle Clinical Trials for Cognitive Health 91%
Similar papers in this journal
- The Proportion of Randomized Controlled Trials That Inform Clinical Practice: A Longitudinal Cohort Study of Trials Registered on ClinicalTrials.gov 92%
- Multicenter preclinical studies as an innovative method to enhance translation: a systematic review of published studies 91%
- Systematic analysis of electronic health records identifies drugs reducing risk of COVID-19 hospitalization and severity 90%
"Similar papers" are the closest papers from that journal in the model's embedding space. They show what the match is built on, but the ranking comes mostly from a classifier over the whole training set, not from these examples alone.