Wade Harrison1, Francois Angoulvant2,3, Samantha House4,5, Vincent Gajdos6,7, Shawn L Ralston8,5. 1. Department of Pediatrics, Primary Children's Hospital and University of Utah, Salt Lake City, Utah. 2. Service d'accueil des urgences pédiatriques, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 3. Epidémiologie Clinique et Évaluation Économique Appliquées aux Populations Vulnérables, Institut National de la Santé et de la Recherche Médicale, Paris, France. 4. Children's Hospital at Dartmouth-Hitchcock, Lebanon, New Hampshire. 5. Department of Pediatrics, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire. 6. Service de Pédiatrie, Antoine Béclère University Hospital, Assistance Publique-Hôpitaux de Paris, Clamart, France; and. 7. Centre for Research in Epidemiology and Population Health, Villejuif, France. 8. Children's Hospital at Dartmouth-Hitchcock, Lebanon, New Hampshire; shawn.l.ralston@dartmouth.edu.
Abstract
: media-1vid110.1542/5799873875001PEDS-VA_2018-1144Video Abstract BACKGROUND AND OBJECTIVES: Meta-analyses of nebulized hypertonic saline (HS) for acute viral bronchiolitis have yielded disparate conclusions. Trial sequential analysis (TSA) is a novel method designed to account for potential sources of error in conventional meta-analysis. We sought to use TSA to determine if the existing literature base is sufficient to draw firm conclusions about the effectiveness of HS in bronchiolitis. METHODS: We used the cohort of studies identified in previously published conventional meta-analyses. Included studies were those in which authors compared treatment with HS versus normal saline (or supportive care) in children with bronchiolitis to reduce hospital length of stay (LOS) or hospitalizations. TSA results are used to provide a required information size and monitoring boundaries for statistical significance. RESULTS: For the LOS outcome, 17 studies including 1866 patients analyzed in which authors used conventional meta-analysis reveal a statistically significant benefit (mean difference = -0.41 days; 95% confidence interval = -0.07 to -0.75); however, TSA suggests that those conclusions are premature because of failure to reach the adequate information size of 2665 individuals. For the risk of hospitalization outcome, 8 studies including 1728 patients analyzed in which authors used conventional meta-analysis reveal a reduction in the relative risk of hospitalization (relative risk = 0.86; 95% confidence interval = 0.76 to 0.98); however, TSA suggests these conclusions are premature because of failure to reach the adequate information size of 4770. Both LOS and hospitalization results from conventional meta-analysis would be considered potentially false-positives by TSA. CONCLUSIONS: TSA reveals that concluding benefit from HS for children with bronchiolitis potentially represents type I error.
: media-1vid110.1542/5799873875001PEDS-VA_2018-1144Video Abstract BACKGROUND AND OBJECTIVES: Meta-analyses of nebulized hypertonicsaline (HS) for acute viral bronchiolitis have yielded disparate conclusions. Trial sequential analysis (TSA) is a novel method designed to account for potential sources of error in conventional meta-analysis. We sought to use TSA to determine if the existing literature base is sufficient to draw firm conclusions about the effectiveness of HS in bronchiolitis. METHODS: We used the cohort of studies identified in previously published conventional meta-analyses. Included studies were those in which authors compared treatment with HS versus normal saline (or supportive care) in children with bronchiolitis to reduce hospital length of stay (LOS) or hospitalizations. TSA results are used to provide a required information size and monitoring boundaries for statistical significance. RESULTS: For the LOS outcome, 17 studies including 1866 patients analyzed in which authors used conventional meta-analysis reveal a statistically significant benefit (mean difference = -0.41 days; 95% confidence interval = -0.07 to -0.75); however, TSA suggests that those conclusions are premature because of failure to reach the adequate information size of 2665 individuals. For the risk of hospitalization outcome, 8 studies including 1728 patients analyzed in which authors used conventional meta-analysis reveal a reduction in the relative risk of hospitalization (relative risk = 0.86; 95% confidence interval = 0.76 to 0.98); however, TSA suggests these conclusions are premature because of failure to reach the adequate information size of 4770. Both LOS and hospitalization results from conventional meta-analysis would be considered potentially false-positives by TSA. CONCLUSIONS:TSA reveals that concluding benefit from HS for children with bronchiolitis potentially represents type I error.
Authors: Ravinder Claire; Christian Gluud; Ivan Berlin; Tim Coleman; Jo Leonardi-Bee Journal: BMC Med Res Methodol Date: 2020-11-30 Impact factor: 4.615
Authors: Martin J Flores; MaTais Caldwell; Kalysa D Passmore; Megan Denney; James M Carr; Kerri Carr; Jeremy M Carr Journal: Can J Respir Ther Date: 2022-02-08