ToolCAP: Novel Tools to improve management of paediatric Community-Acquired Pneumonia - a randomized controlled trial- Statistical Analysis Plan
Abstract
The ToolCAP cohort study is a prospective, observational, multi-site platform study designed to collect harmonized, high-quality clinical, imaging, and biological data on children with IMCI-defined pneumonia in low- and middle-income countries (LMICs). The primary objective is to inform the development and validation of diagnostic and prognostic tools, including lung ultrasound (LUS), point-of-care biomarkers, and AIbased models, to improve pneumonia diagnosis, management, and antimicrobial stewardship. This statistical analysis plan (SAP) outlines the analytic strategy for describing the study population, assessing the performance of candidate diagnostic tools, and enabling data sharing in support of secondary research questions and AI model development. Children under 12 years presenting with suspected pneumonia are enrolled within 24 hours of presentation and undergo clinical assessment, digital auscultation, LUS, and optional biological sampling. Follow-up occurs on Day 8 and Day 29 to assess outcomes including recovery, treatment response, and complications. The SAP details variable definitions, data management strategies, and pre-specified analyses, including descriptive summaries, sensitivity and specificity of diagnostic tools against clinical reference standards, and exploratory subgroup analyses.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Severe clinical outcomes of COVID-19 associated with proton pump inhibitors: a nationwide cohort study with propensity score matching
- Levofloxacin-Induced Tendon Rupture: A Case Report and Review of the Literature
- Association between cord blood 25-hydroxyvitamin D concentrations and respiratory tract infections in the first 6 months of age in a Korean population: a birth cohort study (COCOA)
- Neuroprotective Effects of Epicatechin against Oxidative Stress-Induced Cognitive Impairment: A Systematic Review and Meta-Analysis
- Quality evaluation and in vitro interaction studies between levofloxacin 250mg and diclofenac sodium 50mg tablets
- Molecular Epidemiology of mcr-1 -Positive Polymyxin B-Resistant Escherichia coli Producing Extended-Spectrum β-Lactamase (ESBL) in a Tertiary Hospital in Shandong, China
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.