New Alternative Formats vs Standard of SoF Tables. Non-inferiority Controlled Trial

NCT02022631 | Completed

• 1 other identifier: MIF_aim1RCT1
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats. The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system. The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C). Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized. Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.

Conditions

GRADE Approach; Summary of Findings Table; Cochrane Collaboration

Outcome Measures

Primary Outcomes (1)

• Understanding of key findings

  Investigators will frame multiple-choice questions about key concepts in the table with five response alternatives for each question and only one correct answer. Then, investigators will compare the proportion of correct answers between groups per question

  30 minutes

Secondary Outcomes (3)

• Accessibility of information

  30 minutes

• Overall satisfaction

  30 minutes

• Preference

  30 minutes

Study Arms (2)

Alternative SoF

EXPERIMENTAL

Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B). In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same. The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e. supplementary data as risk difference).

Other: Alternative summary of findings table format

Current SoF

ACTIVE COMPARATOR

Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B). In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same. The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e. supplementary data as risk difference).

Other: Current summary of findings table format

Interventions

Alternative summary of findings table format OTHER

Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B). In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same. The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e. supplementary data as risk difference).

Alternative SoF

Current summary of findings table format OTHER

Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B). In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same. The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e. supplementary data as risk difference).

Current SoF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cochrane review users
• Authors of systematic reviews
• Health professionals
• Guideline developers
• Researchers

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (2)

• Carrasco-Labra A, Brignardello-Petersen R, Santesso N, Neumann I, Mustafa RA, Mbuagbaw L, Etxeandia Ikobaltzeta I, De Stio C, McCullagh LJ, Alonso-Coello P, Meerpohl JJ, Vandvik PO, Brozek JL, Akl EA, Bossuyt P, Churchill R, Glenton C, Rosenbaum S, Tugwell P, Welch V, Garner P, Guyatt G, Schunemann HJ. Improving GRADE evidence tables part 1: a randomized trial shows improved understanding of content in summary of findings tables with a new format. J Clin Epidemiol. 2016 Jun;74:7-18. doi: 10.1016/j.jclinepi.2015.12.007. Epub 2016 Jan 11.

  PMID: 26791430 DERIVED

• Carrasco-Labra A, Brignardello-Petersen R, Santesso N, Neumann I, Mustafa RA, Mbuagbaw L, Ikobaltzeta IE, De Stio C, McCullagh LJ, Alonso-Coello P, Meerpohl JJ, Vandvik PO, Brozek JL, Akl EA, Bossuyt P, Churchill R, Glenton C, Rosenbaum S, Tugwell P, Welch V, Guyatt G, Schunemann H. 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. Trials. 2015 Apr 16;16:164. doi: 10.1186/s13063-015-0649-6.

  PMID: 25873338 DERIVED

Related Links

• Related Info
• Related Info

Study Officials

• Holger Schünemann, MD, MSc, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Alonso Carrasco-Labra, DDS, MSc

  McMaster University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)