Research Report 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, Noninferiority Trial
| NCT number | NCT02813941 |
| Other study ID # | MIF1-II |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 8, 2018 |
| Est. completion date | August 21, 2018 |
| Verified date | August 2018 |
| Source | McMaster University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 178 |
| Est. completion date | August 21, 2018 |
| Est. primary completion date | June 1, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Department of Health Research Methods, Evidence and Impact | Hamilton | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| McMaster University | Agency for Healthcare Research and Quality (AHRQ), Grading of Recommendations Assessment, Development and Evaluation working group |
Canada,
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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, Tugwel — View Citation
Feltner C, Jones CD, Cené 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 Re — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Understanding of information (questionnaire) | Investigators will frame multiple-choice questions about key concepts in the table with five response alternatives for each question and only one correct answer. Then, investigators will compare the proportion of correct answers between groups per question | 30 minutes | |
| Secondary | Accessibility of information (questionnaire) | 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. | 30 minutes | |
| Secondary | Satisfaction (questionnaire) | It will be measured using a 7-point Likert scale with 3 anchors: 1= strongly dissatisfied, 4= neither satisfied nor dissatisfied, 7= strongly satisfied, and it will be treated as a continuous outcome. Investigators will compare the means per group. | 30 minutes | |
| Secondary | Preference (questionnaire) | 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. | 30 minutes |