François Grolleau1,2, Gary S Collins3, Andrei Smarandache4, Romain Pirracchio, Clément Gakuba1,5, Isabelle Boutron, Jason W Busse6, P J Devereaux7, Yannick Le Manach2. 1. Department of Anesthesiology and Critical Care Medicine, CHU Caen Côte de Nacre, Caen, France. 2. Departments of Anesthesia & Clinical Epidemiology and Biostatistics, Michael DeGroote School of Medicine, Faculty of Health Sciences, McMaster University and the Perioperative Research Group, Population Health Research Institute, Hamilton, ON, Canada. 3. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, United Kingdom. 4. Michael G. DeGroote School of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada. 5. Normandie Univ, UNICAEN, INSERM, INSERM UMR-S U1237, 'Physiopathology and Imaging of Neurological Disorders' PhIND, Caen, France. 6. Departments of Anesthesia and Health Research Methods, Evidence & Impact, and the Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. 7. Departments of Medicine & Health Evidence and Impact, Michael DeGroote School of Medicine, Faculty of Health Sciences, McMaster University and the Perioperative Research Group, Population Health Research Institute, Hamilton, ON, Canada.
Abstract
OBJECTIVES: The Fragility Index, which represents the number of patients responsible for a statistically significant finding, has been suggested as an aid for interpreting the robustness of results from clinical trials. A small Fragility Index indicates that the statistical significance of a trial depends on only a few events. Our objectives were to calculate the Fragility Index of statistically significant results from randomized controlled trials of anesthesia and critical care interventions and to determine the frequency of distorted presentation of results or "spin". DATA SOURCES: We systematically searched MEDLINE from January 01, 2007, to February 22, 2017, to identify randomized controlled trials exploring the effect of critical care medicine or anesthesia interventions. STUDY SELECTION: Studies were included if they randomized patients 1:1 into two parallel arms and reported at least one statistically significant (p < 0.05) binary outcome (primary or secondary). DATA EXTRACTION: Two reviewers independently assessed eligibility and extracted data. The Fragility Index was determined for the chosen outcome. We assessed the level of spin in negative trials and the presence of recommendations for clinical practice in positive trials. DATA SYNTHESIS: We identified 166 eligible randomized controlled trials with a median sample size of 207 patients (interquartile range, 109-497). The median Fragility Index was 3 (interquartile range, 1-7), which means that adding three events to one of the trials treatment arms eliminated its statistical significance. High spin was identified in 42% (n = 30) of negative randomized controlled trials, whereas 21% (n = 20) of positive randomized controlled trials provided recommendations. Lower levels of spin and recommendations were associated with publication in journals with high impact factors (p < 0.001 for both). CONCLUSIONS: Statistically significant results in anesthesia and critical care randomized controlled trials are often fragile, and study conclusions are frequently affected by spin. Routine calculation of the Fragility Index in medical literature may allow for better understanding of trials and therefore enhance the quality of reporting.
OBJECTIVES: The Fragility Index, which represents the number of patients responsible for a statistically significant finding, has been suggested as an aid for interpreting the robustness of results from clinical trials. A small Fragility Index indicates that the statistical significance of a trial depends on only a few events. Our objectives were to calculate the Fragility Index of statistically significant results from randomized controlled trials of anesthesia and critical care interventions and to determine the frequency of distorted presentation of results or "spin". DATA SOURCES: We systematically searched MEDLINE from January 01, 2007, to February 22, 2017, to identify randomized controlled trials exploring the effect of critical care medicine or anesthesia interventions. STUDY SELECTION: Studies were included if they randomized patients 1:1 into two parallel arms and reported at least one statistically significant (p < 0.05) binary outcome (primary or secondary). DATA EXTRACTION: Two reviewers independently assessed eligibility and extracted data. The Fragility Index was determined for the chosen outcome. We assessed the level of spin in negative trials and the presence of recommendations for clinical practice in positive trials. DATA SYNTHESIS: We identified 166 eligible randomized controlled trials with a median sample size of 207 patients (interquartile range, 109-497). The median Fragility Index was 3 (interquartile range, 1-7), which means that adding three events to one of the trials treatment arms eliminated its statistical significance. High spin was identified in 42% (n = 30) of negative randomized controlled trials, whereas 21% (n = 20) of positive randomized controlled trials provided recommendations. Lower levels of spin and recommendations were associated with publication in journals with high impact factors (p < 0.001 for both). CONCLUSIONS: Statistically significant results in anesthesia and critical care randomized controlled trials are often fragile, and study conclusions are frequently affected by spin. Routine calculation of the Fragility Index in medical literature may allow for better understanding of trials and therefore enhance the quality of reporting.
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