Journal of Clinical Epidemiology
Journal of Clinical Epidemiology
5 years ago

Comparable outcomes among trial and non-trial participants in a clinical trial of antibiotics for childhood pneumonia: A retrospective cohort study

We compared characteristics and outcomes of children enrolled in a randomized controlled trial (RCT) comparing oral amoxicillin and benzyl penicillin for the treatment of chest indrawing pneumonia versus children who received routine care to determine the external validity of the trial results. Study Design and Setting We undertook a retrospective cohort study of children aged 2 – 59 months admitted in six Kenyan hospitals. Data for non-trial participants were extracted from inpatient records upon conclusion of the RCT. Mortality among trial versus non-trial participants was compared in multivariate models. Results 1709 children were included, of whom 527 were enrolled in the RCT and 1182 received routine care. History of a wheeze was more common among trial participants (35.4% versus 11.2%; p<0.01), while dehydration was more common among non-trial participants (8.6% versus 5.9%; p=0.05). Other patient characteristics were balanced between the two groups. Among those with available outcome data, 14/1140 (1.2%) non-trial participants died compared to 4/527 (0.8%) enrolled in the trial (adjusted odds ratio 0.7; 95% confidence interval 0.2 to 2.1). Conclusion Patient characteristics were similar and mortality was low among trial and non-trial participants. These findings support the revised World Health Organization treatment recommendations for chest indrawing pneumonia.

Publisher URL: www.sciencedirect.com/science

DOI: S0895435616307739

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.