Two Alternatives Versus Usual GRADE-SoF Tables to Improve Understanding

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02732028
• Other study ID #: GRADESoFII
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2016
• Last updated: April 7, 2016
• Start date: April 2016
• Est. completion date: June 2017

Study information

• Verified date: April 2016
• Source: McMaster University
• Contact: Holger Schunemann, MD, MSc, PhD
• Phone: 9055259140
• Email: schuneh[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

Other:
• Alternative GRADE SoF table
These three tables will present the same clinical question of the review in terms of patients, setting, intervention, comparator, outcomes, and complementary information such as footnotes. The only differences between the current and alternative SoF tables 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 (e.g., number needed to treat).
• EPC SoF table
These three tables will present the same clinical question of the review in terms of patients, setting, intervention, comparator, outcomes, and complementary information such as footnotes. The only differences between the current and alternative SoF tables 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 (e.g., number needed to treat).
• Current GRADE SoF table
These three tables will present the same clinical question of the review in terms of patients, setting, intervention, comparator, outcomes, and complementary information such as footnotes. The only differences between the current and alternative SoF tables 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 (e.g., number needed to treat).

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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

Outcome

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