Health Knowledge, Attitudes, Practice Clinical Trial
Official title:
Two Alternatives Versus Usual GRADE-SoF Tables to Improve Understanding in the Presentation of Systematic Review Results: a Three-arm Randomized Controlled Trial
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 control non-inferiority trial is
to investigate the understanding of information presented in three different SoF tables: a
new current GRADE-SoF table, a new alternative GRADE-SoF table, and EPC-SoF table with
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.
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.
Status | Not yet recruiting |
Enrollment | 702 |
Est. completion date | June 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - systematic review authors - researchers, - clinical practice guideline developers, - policy-makers, - end-users, - knowledge transfer organizations Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Canada,
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, J Schünemann H. 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 Jan 11. pii: S0895-4356(15)00583-1. doi: 10.1016/j.jclinepi.2015.12.007. [Epub ahead of print] — View Citation
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, Schünemann 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. — View Citation
Langendam M, Carrasco-Labra A, Santesso N, Mustafa RA, Brignardello-Petersen R, Ventresca M, Heus P, Lasserson T, Moustgaard R, Brozek J, Schünemann HJ. Improving GRADE evidence tables part 2: a systematic survey of explanatory notes shows more guidance is needed. J Clin Epidemiol. 2016 Jan 11. pii: S0895-4356(15)00584-3. doi: 10.1016/j.jclinepi.2015.12.008. [Epub ahead of print] — View Citation
Santesso N, Carrasco-Labra A, Langendam M, Brignardello-Petersen R, Mustafa RA, Heus P, Lasserson T, Opiyo N, Kunnamo I, Sinclair D, Garner P, Treweek S, Tovey D, Akl EA, Tugwell P, Brozek JL, Guyatt G, Schünemann HJ. Improving GRADE evidence tables part 3: detailed guidance for explanatory footnotes supports creating and understanding GRADE certainty in the evidence judgments. J Clin Epidemiol. 2016 Jan 12. pii: S0895-4356(15)00582-X. doi: 10.1016/j.jclinepi.2015.12.006. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Understanding of key findings survey | Understanding is defined as the correct comprehension of key findings. The investigators will frame seven multiple-choice questions about key concepts in the table with five response alternatives for each question and only one correct answer. The investigators will compare the proportion of correct answers between groups per question. Qualitative information will be analyzed using this approach since this topic has not been tested before in a trial. | 30 minutes | No |
Secondary | Accessibility of information survey | Accessibility of information. This outcome considers four items: 1) how easy it is to find critical information in the table; 2) how easy it is to understand the information; 3) whether the information is presented in a way that is helpful for decision-making; and 4) the overall accessibility of information. These four items will be measured by presenting participants with three statements for which they have to indicate the degree of agreement: 'It was easy to find the information about the effects'; 'It was easy to understand the information', 'The information is presented in a way that would help me making a decision', and 'Overall accessibility of information'. Agreement will be measured using a Likert scale asking the participant to consider the three above items together. For all the measures, the investigators will compare the means per group for each item. | 30 minutes | No |
Secondary | Satisfaction survey | Satisfaction. The investigators will ask participants which formatting features are the most satisfactory. For example, in Table B, the investigators will include a column with information about the number needed to treat (NNT). The purpose of this column is to give participants alternative information to assist with the interpretation of the absolute risk reduction ('Do you think that the NNT should be included as available information instead of the anticipated absolute effects difference in future versions of SoF tables?'). It will be measured as a dichotomous outcome and the investigators will compare proportions per group. | 30 minutes | No |
Secondary | Preference survey | Preference. Participants will answer the question: 'Between Table A (the current GRADE SoF table), Table B (the alternative GRADE SoF table) or Table C (EPC SoF table), which table do you prefer?' It will be measured using a rank of three: 1st choice, 2nd choice, and 3rd choice, and it will be treated as an ordinal outcome. To ensure a correct answer to this outcome, the randomization will be ended. The investigators will measure the preference for one of three tables at the end of the questionnaire. | 30 minutes | No |
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