Alex Aregbesola1,2, Allison Gates3, Amanda Coyle4, Shannon Sim3, Ben Vandermeer3, Megan Skakum4, Despina Contopoulos-Ioannidis5, Anna Heath6,7, Lisa Hartling3, Terry P Klassen4,8. 1. The Children's Hospital Research Institute of Manitoba, 513-715 McDermot Avenue, John Buhler Research Centre, Winnipeg, Manitoba, R3E 3P4, Canada. alex.aregbesola@umanitoba.ca. 2. Department of Pediatrics and Child Health, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada. alex.aregbesola@umanitoba.ca. 3. Department of Pediatrics and the Alberta Research Centre for Health Evidence (ARCHE), University of Alberta, Edmonton, Canada. 4. The Children's Hospital Research Institute of Manitoba, 513-715 McDermot Avenue, John Buhler Research Centre, Winnipeg, Manitoba, R3E 3P4, Canada. 5. Department of Pediatrics, Division of Infectious Diseases, Stanford University School of Medicine and Meta Research Innovation Center at Stanford (METRICS), Stanford, CA, USA. 6. The Hospital for Sick Children and the University of Toronto, Toronto, ON, Canada. 7. University College London, London, UK. 8. Department of Pediatrics and Child Health, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.
Abstract
BACKGROUND: There is an unresolved debate about the reliability of the interpretation of P value. Some investigators have suggested that an alternative Bayesian method is preferred in conducting health research. As randomized-controlled trials (RCTs) are important in generating research evidence, we decided to investigate the extent, if any, the inferential statistical framework in published RCTs in child health research have changed over 10 years. We aim to examine the change in P value and Bayesian analysis in RCTs in child health research papers published from 2007 to 2017. METHODS: We will search the Cochrane Central Register of Controlled Trials (Wiley) to identify relevant citations. We will leverage a pre-existing sample of child health RCTs published in 2007 (n=300) used in our previous study of reporting quality of pediatric RCTs. Using the same strategy and study selection methods, we will identify a comparable random sample of child health RCTs published in 2017 (n=300). Eligible studies will include RCTs in health research among individuals aged 21 years and below. One reviewer will select studies for inclusion and extract the data and another reviewer will verify these. Disagreements will be resolved by a discussion between reviewers or by involving another reviewer. We will perform a descriptive analysis of 2007 and 2017 samples and analyze the results using both the frequentist and Bayesian methods. We will present specific characteristics of the clinical trials from 2007 and 2017 in tabular and graphical forms. We will report the difference in the proportion of P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. Clustering around P values of significance, if observed, will be reported. DISCUSSION: This review will present the difference in the proportion of trials that reported on P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. The implications for future clinical research will be discussed and this research work will be published in a peer-reviewed journal. This review has the potential to help inform the need for a change in the methodological approach from the null hypothesis significance test to Bayesian methods. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework https://osf.io/aj2df.
BACKGROUND: There is an unresolved debate about the reliability of the interpretation of P value. Some investigators have suggested that an alternative Bayesian method is preferred in conducting health research. As randomized-controlled trials (RCTs) are important in generating research evidence, we decided to investigate the extent, if any, the inferential statistical framework in published RCTs in child health research have changed over 10 years. We aim to examine the change in P value and Bayesian analysis in RCTs in child health research papers published from 2007 to 2017. METHODS: We will search the Cochrane Central Register of Controlled Trials (Wiley) to identify relevant citations. We will leverage a pre-existing sample of child health RCTs published in 2007 (n=300) used in our previous study of reporting quality of pediatric RCTs. Using the same strategy and study selection methods, we will identify a comparable random sample of child health RCTs published in 2017 (n=300). Eligible studies will include RCTs in health research among individuals aged 21 years and below. One reviewer will select studies for inclusion and extract the data and another reviewer will verify these. Disagreements will be resolved by a discussion between reviewers or by involving another reviewer. We will perform a descriptive analysis of 2007 and 2017 samples and analyze the results using both the frequentist and Bayesian methods. We will present specific characteristics of the clinical trials from 2007 and 2017 in tabular and graphical forms. We will report the difference in the proportion of P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. Clustering around P values of significance, if observed, will be reported. DISCUSSION: This review will present the difference in the proportion of trials that reported on P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. The implications for future clinical research will be discussed and this research work will be published in a peer-reviewed journal. This review has the potential to help inform the need for a change in the methodological approach from the null hypothesis significance test to Bayesian methods. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework https://osf.io/aj2df.
Authors: Allison Gates; Lisa Hartling; Ben Vandermeer; Patrina Caldwell; Despina G Contopoulos-Ioannidis; Sarah Curtis; Ricardo M Fernandes; Terry P Klassen; Katrina Williams; Michele P Dyson Journal: J Pediatr Date: 2017-11-21 Impact factor: 4.406
Authors: David Moher; Larissa Shamseer; Mike Clarke; Davina Ghersi; Alessandro Liberati; Mark Petticrew; Paul Shekelle; Lesley A Stewart Journal: Syst Rev Date: 2015-01-01