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Trials. 2015 Apr 16;16:164. doi: 10.1186/s13063-015-0649-6.

Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial.

Author information

  • 1Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. alonsocarrascolabra@gmail.com.
  • 2Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Universidad de Chile, Santiago, Chile. alonsocarrascolabra@gmail.com.
  • 3Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. rominabp@gmail.com.
  • 4Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile. rominabp@gmail.com.
  • 5Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. santesna@mcmaster.ca.
  • 6Pontificia Universidad Católica de Chile, Santiago, Chile. ignacio.neumann@gmail.com.
  • 7Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. ramustafa@gmail.com.
  • 8Departments of Medicine/Nephrology and Biomedical & Health Informatics, University of Missouri, Kansas City, MO, USA. ramustafa@gmail.com.
  • 9Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. mbuagbawl@yahoo.com.
  • 10OSTEBA, Basque Office for Health Technology Assessment, Ministry for Health, Basque Government, Donostia-San Sebastián, Spain. itzi.etxe@gmail.com.
  • 11Department of Medicine, Hofstra North Shore LIJ School of Medicine, Manhasset, NY, USA. cdestio@NSHS.edu.
  • 12Department of Medicine, Hofstra North Shore LIJ School of Medicine, Manhasset, NY, USA. lmccullagh@NSHS.edu.
  • 13Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. palonso@santpau.cat.
  • 14Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau-CIBER of Epidemiology and Public Health (CIBERESP-IIB Sant Pau), Barcelona, Spain. palonso@santpau.cat.
  • 15German Cochrane Center, Medical Center - University of Freiburg, Freiburg, Germany. meerpohl@cochrane.de.
  • 16Department of Medicine, Innlandet Hospital Trust-division, Gjøvik, Norway. per.vandvik@gmail.com.
  • 17Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. brozekj@mcmaster.ca.
  • 18Department of Medicine, McMaster University, Hamilton, ON, Canada. brozekj@mcmaster.ca.
  • 19Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. ea32@aub.edu.lb.
  • 20American University of Beirut, Beirut, Lebanon. ea32@aub.edu.lb.
  • 21Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Medical Center, University of Amsterdam, Meibergdreef, Amsterdam, The Netherlands. p.m.bossuyt@amc.uva.nl.
  • 22Center for Academic Mental Health, School of Social and Community Medicine, University of Bristol, Bristol, UK. Rachel.Churchill@ccdan.org.
  • 23The Norwegian Branch of the Nordic Cochrane Center, Oslo, Norway. Claire.Glenton@kunnskapssenteret.no.
  • 24Norwegian Knowledge Center for the Health Services, Oslo, Norway. Claire.Glenton@kunnskapssenteret.no.
  • 25The Norwegian Branch of the Nordic Cochrane Center, Oslo, Norway. sarah@rosenbaum.no.
  • 26Norwegian Knowledge Center for the Health Services, Oslo, Norway. sarah@rosenbaum.no.
  • 27Department of Medicine, Faculty of Medicine, University of Ottawa, K1H 8 M5, Ottawa, ON, Canada. Tugwell.BB@uOttawa.ca.
  • 28Bruyère Research Institute, University of Ottawa, Ottawa, ON, Canada. Vivian.Welch@uottawa.ca.
  • 29Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. guyatt@mcmaster.ca.
  • 30Department of Medicine, McMaster University, Hamilton, ON, Canada. guyatt@mcmaster.ca.
  • 31Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. schuneh@mcmaster.ca.
  • 32Department of Medicine, McMaster University, Hamilton, ON, Canada. schuneh@mcmaster.ca.

Abstract

BACKGROUND:

Systematic reviews represent one of the most important tools for knowledge translation but users often struggle with understanding and interpreting their results. GRADE Summary-of-Findings tables have been developed to display results of systematic reviews in a concise and transparent manner. The current format of the Summary-of-Findings tables for presenting risks and quality of evidence improves understanding and assists users with finding key information from the systematic review. However, it has been suggested that additional methods to present risks and display results in the Summary-of-Findings tables are needed.

METHODS/DESIGN:

We will conduct a non-inferiority parallel-armed randomized controlled trial to determine whether an alternative format to present risks and display Summary-of-Findings tables is not inferior compared to the current standard format. We will measure participant understanding, accessibility of the information, satisfaction, and preference for both formats. We will invite systematic review users to participate (that is clinicians, guideline developers, and researchers). The data collection process will be undertaken using the online 'Survey Monkey' system. For the primary outcome understanding, non-inferiority of the alternative format (Table A) to the current standard format (Table C) of Summary-of-Findings tables will be claimed if the upper limit of a 1-sided 95% confidence interval (for the difference of proportion of participants answering correctly a given question) excluded a difference in favor of the current format of more than 10%.

DISCUSSION:

This study represents an effort to provide systematic reviewers with additional options to display review results using Summary-of-Findings tables. In this way, review authors will have a variety of methods to present risks and more flexibility to choose the most appropriate table features to display (that is optional columns, risks expressions, complementary methods to display continuous outcomes, and so on).

TRIALS REGISTRATION:

NCT02022631 (21 December 2013).

PMID:
25873338
[PubMed - indexed for MEDLINE]
PMCID:
PMC4416250
Free PMC Article
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