Comparison of Three Summary of Finding Tables to Improve Understanding in the Presentation of Systematic Review Results
NCT ID: NCT02813941
Last Updated: 2018-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
178 participants
INTERVENTIONAL
2018-01-08
2018-08-21
Brief Summary
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Methods: The primary objective of this three-arm randomized controlled non-inferiority trial is to investigate whether an alternative GRADE-SoF table, or EPC-SoF table, is noninferior to the current GRADE-SoF table in the understanding of information presented to systematic review users. Researchers, clinical practice guideline developers, policy-makers, end-users, or knowledge transfer will be recruited. Data will be collected electronically at baseline and after randomization. Noninferiority would be declared if the difference in the proportion of participants who understand the information displayed in the alternative SoF table is 10% or less.
Discussion: This study aims to assess the understanding, accessibility, satisfaction, and preference between three SoF tables for displaying summary evidence from health-related outcomes. The results of this study will provide important knowledge to understand what information should be included in SoF tables in systematic reviews.
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Detailed Description
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Methods: The primary objective of this three-arm randomized controlled non-inferiority trial is to investigate whether an alternative GRADE-SoF table or EPC-SoF table is noninferior to the current GRADE-SoF table in the understanding of the information presented to systematic review users, particularly for descriptive findings. Researchers, clinical practice guideline developers, policy-makers, or knowledge transfer professionals will be recruited. Data will be collected electronically at baseline and after randomization. Noninferiority would be declared if the difference in the proportion of participants who understand the information displayed in the alternative SoF table is 10% or less.
Ethics and Dissemination: The Hamilton Integrated Research Ethics Board (HiREB) reviewed this protocol. The findings from this study will be disseminated through a publication in a peer-reviewed journal.
Strengths and limitations of this study
* This is a randomized controlled trial that uses a GRADE Summary of Finding (SoF) table evaluated in another randomized controlled trial with a positive accomplishment of understanding the information displayed on it.
* This is the first time that GRADE SoF tables will be evaluated, in terms of understanding descriptive findings with a select part of a SoF table adapted by an EPC center to convey information on multiple comparisons efficiently.
* This will test understanding of presentation of findings from only a single comparison and will not test understanding of a complex body of evidence.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Alternative GRADE SoF table
Two SoF tables (alternative GRADE SoF table and EPC SoF table) will be used in this randomized controlled non-inferiority trial as an intervention. The alternative GRADE SoF table format will be developed from a user-testing survey.
Current GRADE SoF table
The current GRADE SoF table will be the common comparator for the other two SoF tables
EPC SoF table
For the EPC SoF table, the investigators will use one of their format which was recently published.
Alternative GRADE SoF table
The alternative GRADE SoF table format will be developed from a user-testing survey.
Current GRADE SoF table
The current GRADE SoF table will be the common comparator for the other two SoF tables
EPC SoF table
For the EPC SoF table, the investigators will use one of their format which was recently published
Interventions
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Current GRADE SoF table
The current GRADE SoF table will be the common comparator for the other two SoF tables
Alternative GRADE SoF table
The alternative GRADE SoF table format will be developed from a user-testing survey.
EPC SoF table
For the EPC SoF table, the investigators will use one of their format which was recently published
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
Yes
Sponsors
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Grading of Recommendations Assessment, Development and Evaluation working group
UNKNOWN
Agency for Healthcare Research and Quality (AHRQ)
FED
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Holger J Schunemann, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Department of Clinical Epidemiology & Biostatistics
Locations
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Department of Health Research Methods, Evidence and Impact
Hamilton, Ontario, Canada
Countries
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References
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Berkman ND, Lohr KN, Ansari MT, Balk EM, Kane R, McDonagh M, Morton SC, Viswanathan M, Bass EB, Butler M, Gartlehner G, Hartling L, McPheeters M, Morgan LC, Reston J, Sista P, Whitlock E, Chang S. Grading the strength of a body of evidence when assessing health care interventions: an EPC update. J Clin Epidemiol. 2015 Nov;68(11):1312-24. doi: 10.1016/j.jclinepi.2014.11.023. Epub 2014 Dec 20.
Feltner C, Jones CD, Cene CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJL, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional Care Interventions To Prevent Readmissions for People With Heart Failure [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 May. Report No.: 14-EHC021-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK209241/
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.
Yepes-Nunez JJ, Morgan RL, Mbuagbaw L, Carrasco-Labra A, Chang S, Hempel S, Shekelle P, Helfand M, Baldeh T, Schunemann HJ. Two alternatives versus the standard Grading of Recommendations Assessment, Development and Evaluation (GRADE) summary of findings (SoF) tables to improve understanding in the presentation of systematic review results: a three-arm, randomised, controlled, non-inferiority trial. BMJ Open. 2018 Jan 23;8(1):e015623. doi: 10.1136/bmjopen-2016-015623.
Related Links
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Online survey
Other Identifiers
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MIF1-II
Identifier Type: -
Identifier Source: org_study_id
NCT02732028
Identifier Type: -
Identifier Source: nct_alias
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