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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-08-21

Brief Summary

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Background: Summary of Findings (SoF) tables have been developed to present results of systematic reviews in a concise and explicit format. Adopted by many review groups including the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ), and the GRADE Working Group; SoF tables provide succinct, transparent, and easily interpretable judgments about the certainty of evidence and magnitude of effects. Currently, there are three different SoF formats in use. This study aims to compare SoF table formats in terms of understanding, accessibility, satisfaction, and preference with systematic review users.

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.

Detailed Description

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Objective: Summary of Findings (SoF) tables present results of systematic reviews in a concise and explicit format. Adopted by many review groups including the Cochrane Collaboration, and the Agency for Healthcare Research and Quality (AHRQ). Optimal understanding of SoF table may be influenced by the type of information being conveyed and objectives or preferences of the end user. This study aims to compare three SoF table formats in terms of understanding, accessibility, satisfaction, and preference with systematic review users.

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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Research Report

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Group Type EXPERIMENTAL

Current GRADE SoF table

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Alternative GRADE SoF table

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

EPC SoF table

Intervention Type OTHER

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

Intervention Type OTHER

Alternative GRADE SoF table

The alternative GRADE SoF table format will be developed from a user-testing survey.

Intervention Type OTHER

EPC SoF table

For the EPC SoF table, the investigators will use one of their format which was recently published

Intervention Type OTHER

Other Intervention Names

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Table A Table B Table C

Eligibility Criteria

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Inclusion Criteria

Participants will be eligible if they consider themselves as systematic review users. For the purpose of this trial, systematic review users will be defined as researchers, clinical practice guideline developers, policy-makers, or knowledge transfer professionals. Participants who declare dedicating more than 70% of their time during last year to conducting research (for example, methodologists, epidemiologists, statisticians) will be classified as researchers. Participants who declare having participated in at least one systematic review or clinical practice guideline during the last two years will be classified as clinical practice guideline developers. Knowledge transfer professionals, who declare working in a dynamic and iterative process that includes synthesis, dissemination, exchange and ethically sound application of knowledge to improve the health care system, during last two years, will be classified as knowledge transfer professionals. Finally, participants who declare being responsible for or involved in formulating policies in the last year, especially in politics, will be classified as policy-makers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Grading of Recommendations Assessment, Development and Evaluation working group

UNKNOWN

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Canada

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.

Reference Type RESULT
PMID: 25721570 (View on PubMed)

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/

Reference Type RESULT
PMID: 24967474 (View on PubMed)

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.

Reference Type RESULT
PMID: 26791430 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29362242 (View on PubMed)

Related Links

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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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