Back to resultsAccessibility of the World Health Organization's eTB Catalogue of Recommendations
Primary Purpose
Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
eTB Catalogue of Recommendations (eTB)
World Health Organization Tuberculosis Website (WHO TB)
Sponsored by
About this trial
This is an interventional health services research trial for Tuberculosis focused on measuring GRADE, Guidelines, Recommendations, Recommendation Mapping, Evidence Mapping
Eligibility Criteria
Inclusion Criteria:
- Stakeholders who consider themselves to be users or potential users of tuberculosis (TB) recommendations will be eligible for participation. For the purposes of this trial, a user is defined as someone who has previously accessed TB guidelines, recommendations or policy advice, and a potential user is someone who plans to access TB guidelines, recommendations, or policy advice in the future.
- Participants may be part of any group that has a stake in TB, including the public, healthcare providers, policymakers, or researchers. Participants may be from either low- and middle-income countries (LMIC) or high-income countries (HIC).
- They may also vary in levels of education and previous TB work experience.
Exclusion Criteria:
- Individuals involved in eTB catalogue development.
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
eTB Catalogue of Recommendation (eTB)
World Health Organization Tuberculosis Website (WHO TB)
Arm Description
New eTB catalogue of recommendations website (eTB).
Current method of accessing tuberculosis (TB) recommendations using World Health Organization (WHO) website (WHO TB).
Outcomes
Primary Outcome Measures
Accessibility of Information on a Seven-Point Likert Scale
The primary outcome is the accessibility of information on the eTB catalogue compared to the current WHO TB guidelines. Accessibility is defined as the ability to access and use information. This outcome considers the four following domains: (1) how easy is it to find the information (2) how easy is it to understand the information (3) whether the presentation of this information facilitates decision-making (4) overall accessibility of information. These domains will be measured using a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree). The statements will be: 'It was easy to find the information', 'it was easy to understand the information', 'the information was presented in a way that would help me make a decision', and 'this website was easy to navigate'. The investigators will calculate mean composite values of these four domains for the primary outcome of accessibility, and present the four individual domains as secondary outcomes.
Secondary Outcome Measures
Satisfaction on a Seven-Point Likert Scale
Satisfaction is defined as a stakeholder's impression of catalogue presentation. This outcome considers the three following domains: (1) home page presentation (2) recommendation list presentation (3) individual recommendation presentation.
These domains will be measured using a seven-point Likert-scale (1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied). The questions will be: 'how satisfied are you with presentation of the home page?', and 'how satisfied are you with the presentation of the list of recommendations?', and 'how satisfied are you with the presentation of this individual recommendation?'. The investigators will compare means between the intervention and control groups for each domain.
Understanding with Multiple Choice Questions
Understanding is defined as the correct comprehension of findings. This outcome will be measured using three multiple-choice questions with four choices and one correct answer. There will be an additional option to select 'not found'. The questions will be: 'what is the recommendation strength?', 'what is the certainty of the evidence?' and 'on which page does the evidence to decision (EtD) table for this recommendation start?'. The proportion of correct responses will be compared between groups.
Preference on a Seven-Point Likert-Scale
Preference is defined as a greater liking of one platform over the other. Participants will be provided with a demonstration of both platforms. They will subsequently answer the question 'between the WHO Tuberculosis Guidelines (current website), and the eTB Guidelines (alternative website), which do you prefer?'. This response will be measured on a Likert-scale (1 = strongly prefer WHO TB, 2 = prefer WHO TB, 3 = somewhat prefer WHO TB, 4 = same preference for WHO TB and eTB, 5 = somewhat prefer eTB, 6 = prefer eTB, 7 = strongly prefer eTB). The means will be compared between the intervention and control groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04745897
Brief Title
Accessibility of the World Health Organization's eTB Catalogue of Recommendations
Official Title
Comparing the Accessibility of the World Health Organization's Tuberculosis Guidelines to the eTB Catalogue of Recommendations: A Two-Arm Superiority Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
August 29, 2021 (Actual)
Study Completion Date
August 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The World Health Organization's Global Tuberculosis Programme (WHO-GTB) issues evidence-informed guideline recommendations on tuberculosis (TB). These recommendations are used by decision-makers, guideline developers and other stakeholders. In an effort to improve the accessibility and usability of these recommendations, a new eTB catalogue of recommendations has been developed. This study aims to compare the accessibility of the new eTB catalogue to the earlier method of accessing recommendations directed through the general WHO website.
Detailed Description
This is a two-arm superiority randomized controlled trial. The primary objective is to compare the accessibility of information between the eTB catalogue (intervention) and WHO TB (comparison). Secondary outcomes include understanding of the information, satisfaction of catalogue presentation, and preference toward the catalogue. Current and potential users of TB recommendations will be recruited. Data will be collected using a survey with demographic questions and subsequent 1:1 randomization to the intervention. Superiority will be declared if the mean difference in accessibility is 0.5 or greater for the intervention arm on the seven-point Likert scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
GRADE, Guidelines, Recommendations, Recommendation Mapping, Evidence Mapping
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eTB Catalogue of Recommendation (eTB)
Arm Type
Experimental
Arm Description
New eTB catalogue of recommendations website (eTB).
Arm Title
World Health Organization Tuberculosis Website (WHO TB)
Arm Type
Active Comparator
Arm Description
Current method of accessing tuberculosis (TB) recommendations using World Health Organization (WHO) website (WHO TB).
Intervention Type
Other
Intervention Name(s)
eTB Catalogue of Recommendations (eTB)
Intervention Description
eTB Catalogue of Recommendations (eTB)
Intervention Type
Other
Intervention Name(s)
World Health Organization Tuberculosis Website (WHO TB)
Intervention Description
World Health Organization Tuberculosis Website (WHO TB)
Primary Outcome Measure Information:
Title
Accessibility of Information on a Seven-Point Likert Scale
Description
The primary outcome is the accessibility of information on the eTB catalogue compared to the current WHO TB guidelines. Accessibility is defined as the ability to access and use information. This outcome considers the four following domains: (1) how easy is it to find the information (2) how easy is it to understand the information (3) whether the presentation of this information facilitates decision-making (4) overall accessibility of information. These domains will be measured using a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree). The statements will be: 'It was easy to find the information', 'it was easy to understand the information', 'the information was presented in a way that would help me make a decision', and 'this website was easy to navigate'. The investigators will calculate mean composite values of these four domains for the primary outcome of accessibility, and present the four individual domains as secondary outcomes.
Time Frame
Duration of survey (approximately 10 minutes)
Secondary Outcome Measure Information:
Title
Satisfaction on a Seven-Point Likert Scale
Description
Satisfaction is defined as a stakeholder's impression of catalogue presentation. This outcome considers the three following domains: (1) home page presentation (2) recommendation list presentation (3) individual recommendation presentation.
These domains will be measured using a seven-point Likert-scale (1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied). The questions will be: 'how satisfied are you with presentation of the home page?', and 'how satisfied are you with the presentation of the list of recommendations?', and 'how satisfied are you with the presentation of this individual recommendation?'. The investigators will compare means between the intervention and control groups for each domain.
Time Frame
Duration of survey (approximately 10 minutes)
Title
Understanding with Multiple Choice Questions
Description
Understanding is defined as the correct comprehension of findings. This outcome will be measured using three multiple-choice questions with four choices and one correct answer. There will be an additional option to select 'not found'. The questions will be: 'what is the recommendation strength?', 'what is the certainty of the evidence?' and 'on which page does the evidence to decision (EtD) table for this recommendation start?'. The proportion of correct responses will be compared between groups.
Time Frame
Duration of survey (approximately 10 minutes)
Title
Preference on a Seven-Point Likert-Scale
Description
Preference is defined as a greater liking of one platform over the other. Participants will be provided with a demonstration of both platforms. They will subsequently answer the question 'between the WHO Tuberculosis Guidelines (current website), and the eTB Guidelines (alternative website), which do you prefer?'. This response will be measured on a Likert-scale (1 = strongly prefer WHO TB, 2 = prefer WHO TB, 3 = somewhat prefer WHO TB, 4 = same preference for WHO TB and eTB, 5 = somewhat prefer eTB, 6 = prefer eTB, 7 = strongly prefer eTB). The means will be compared between the intervention and control groups.
Time Frame
Duration of survey (approximately 10 minutes)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Stakeholders who consider themselves to be users or potential users of tuberculosis (TB) recommendations will be eligible for participation. For the purposes of this trial, a user is defined as someone who has previously accessed TB guidelines, recommendations or policy advice, and a potential user is someone who plans to access TB guidelines, recommendations, or policy advice in the future.
Participants may be part of any group that has a stake in TB, including the public, healthcare providers, policymakers, or researchers. Participants may be from either low- and middle-income countries (LMIC) or high-income countries (HIC).
They may also vary in levels of education and previous TB work experience.
Exclusion Criteria:
Individuals involved in eTB catalogue development.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger J Schunemann, MD, PhD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Micayla N Matthews, BHSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamara Lotfi, MD, MPH
Organizational Affiliation
McMaster University
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://tuberculosis.evidenceprime.com/
Description
eTB Catalogue of Recommendations
Learn more about this trial
Accessibility of the World Health Organization's eTB Catalogue of Recommendations
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