Clinical trial NCT02813941: Comparison of Three Summary of Finding Tables to Improve Understanding in the Presentation of Systematic Review Results
Official title: Two Alternatives Versus Usual GRADE-SoF Tables to Improve Understanding in the Presentation of Systematic Review Results: A Three-arm, Randomized, Controlled, Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Research Report
Keywords: Randomized controlled trial
Systematic review
Summary of finding tables
GRADE
AHRQ
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Grading of Recommendations Assessment, Development and Evaluation working group
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2016-06-27
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Understanding of information (questionnaire)
timeFrame: 30 minutes
Secondary outcomes:
measure: Accessibility of information (questionnaire)
timeFrame: 30 minutes
measure: Satisfaction (questionnaire)
timeFrame: 30 minutes
measure: Preference (questionnaire)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Department of Health Research Methods, Evidence and Impact
state: Ontario
Study officials:
affiliation: McMaster University, Department of Clinical Epidemiology & Biostatistics
name: Holger J Schunemann, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.