Research ReportNCT02813941
Comparison of Three Summary of Finding Tables to Improve Understanding in the Presentation of Systematic Review Results
A study testing Current GRADE SoF table, Alternative GRADE SoF table and EPC SoF table in people with Research Report, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Research Report
- What is being tested?
- Current GRADE SoF table, Alternative GRADE SoF table and EPC SoF table
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2018to 21 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Health Research Methods, Evidence and Impact
Hamilton, Ontario, L8S 4K1
About this study
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
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.
Read the 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.
- Conditions
- Research Report
- Being tested
- Current GRADE SoF table, Alternative GRADE SoF table, EPC SoF table
- Keywords
- Randomized controlled trial, Systematic review, Summary of finding tables, GRADE, AHRQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current GRADE SoF tableOther
Also called Table A
The current GRADE SoF table will be the common comparator for the other two SoF tables
Alternative GRADE SoF tableOther
Also called Table B
The alternative GRADE SoF table format will be developed from a user-testing survey.
EPC SoF tableOther
Also called Table C
For the EPC SoF table, the investigators will use one of their format which was recently published
| Study group | Role | What they receive |
|---|---|---|
| Alternative GRADE SoF table | Experimental | 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. Receives: Other: Current GRADE SoF table |
| EPC SoF table | Experimental | For the EPC SoF table, the investigators will use one of their format which was recently published. Receives: Other: Alternative GRADE SoF table |
| Current GRADE SoF table | Active comparator | The current GRADE SoF table will be the common comparator for the other two SoF tables Receives: Other: EPC SoF table |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (3)
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start8 Jan 2018
- Primary completion1 Jun 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Research ReportStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Grading of Recommendations Assessment, Development and Evaluation working group, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Holger J Schunemann, MD, MSc, PhD, Principal investigator, McMaster University, Department of Clinical Epidemiology & Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813941
- Sponsor's protocol ID
- MIF1-II
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no individual patient data shared from this study.
Publications
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.
PubMed 25721570Feltner 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/
PubMed 24967474Carrasco-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.
PubMed 26791430Yepes-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.
PubMed 29362242
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02813941
- Acronym / sponsor ID
- MIF1-II
- Conditions
- Research Report
- Keywords
- Randomized controlled trial, Systematic review, Summary of finding tables, GRADE, AHRQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Grading of Recommendations Assessment, Development and Evaluation working group, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alternative GRADE SoF table | Experimental | Other: Current GRADE SoF tableTwo 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. |
| EPC SoF table | Experimental | Other: Alternative GRADE SoF tableFor the EPC SoF table, the investigators will use one of their format which was recently published. |
| Current GRADE SoF table | Active comparator | Other: EPC SoF tableThe current GRADE SoF table will be the common comparator for the other two SoF tables |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current GRADE SoF tableAlso: Table AThe current GRADE SoF table will be the common comparator for the other two SoF tables | Other | Alternative GRADE SoF table |
| Alternative GRADE SoF tableAlso: Table BThe alternative GRADE SoF table format will be developed from a user-testing survey. | Other | EPC SoF table |
| EPC SoF tableAlso: Table CFor the EPC SoF table, the investigators will use one of their format which was recently published | Other | Current GRADE SoF table |
Primary outcome
Understanding of information (questionnaire)
Time frame: 30 minutes
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
3 secondary outcomes
Accessibility of information (questionnaire)
Time frame: 30 minutes
Satisfaction (questionnaire)
Time frame: 30 minutes
Preference (questionnaire)
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Results publication: PubMed 25721570Berkman 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.
- Results publication: PubMed 24967474Feltner 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/
- Results publication: PubMed 26791430Carrasco-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.
- Derived from this study: PubMed 29362242Yepes-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.
- Online surveyLink provided by the sponsor.
- Individual participant dataSharing planned: No. There will be no individual patient data shared from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger J Schunemann, MD, MSc, PhD principal investigator
McMaster University, Department of Clinical Epidemiology & Biostatistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current GRADE SoF table, Alternative GRADE SoF table and EPC SoF table in people with Research Report, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding of information (questionnaire) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813941, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.