TuberculosisNCT04745897
Accessibility of the World Health Organization's eTB Catalogue of Recommendations
A study testing eTB Catalogue of Recommendations (eTB) and World Health Organization Tuberculosis Website (WHO TB) in people with Tuberculosis, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- eTB Catalogue of Recommendations (eTB) and World Health Organization Tuberculosis Website (WHO TB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2021to 29 Aug 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals involved in eTB catalogue development.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- eTB Catalogue of Recommendations (eTB), World Health Organization Tuberculosis Website (WHO TB)
- Keywords
- GRADE, Guidelines, Recommendations, Recommendation Mapping, Evidence Mapping
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eTB Catalogue of Recommendations (eTB)Other
eTB Catalogue of Recommendations (eTB)
World Health Organization Tuberculosis Website (WHO TB)Other
World Health Organization Tuberculosis Website (WHO TB)
| Study group | Role | What they receive |
|---|---|---|
| eTB Catalogue of Recommendation (eTB) | Experimental | New eTB catalogue of recommendations website (eTB). Receives: Other: eTB Catalogue of Recommendations (eTB) |
| World Health Organization Tuberculosis Website (WHO TB) | Active comparator | Current method of accessing tuberculosis (TB) recommendations using World Health Organization (WHO) website (WHO TB). Receives: Other: World Health Organization Tuberculosis Website (WHO TB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of survey (approximately 10 minutes)
Secondary outcomes (3)
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.
Measured: Duration of survey (approximately 10 minutes)
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.
Measured: Duration of survey (approximately 10 minutes)
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.
Measured: Duration of survey (approximately 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start26 Feb 2021
- Primary completion29 Aug 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holger J Schunemann, MD, PhD, Study chair, McMaster UniversityMicayla N Matthews, BHSc, Principal investigator, McMaster UniversityTamara Lotfi, MD, MPH, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745897
- Sponsor's protocol ID
- 7908
- Status last verified
- Dec 2021
- First submitted
- 4 Feb 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matthews M, Lotfi T, Santesso N, Loeb M, Mertz D, Chagla Z, Hajizadeh A, Piggott T, Dietl B, Schunemann HJ. Comparing the usability of the World Health Organization's conventional tuberculosis guidelines to the eTB recommendations map: A two-arm superiority randomised controlled trial. PLOS Glob Public Health. 2022 Oct 14;2(10):e0001166. doi: 10.1371/journal.pgph.0001166. eCollection 2022.
PubMed 36962671
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04745897
- Acronym / sponsor ID
- 7908
- Conditions
- Tuberculosis
- Keywords
- GRADE, Guidelines, Recommendations, Recommendation Mapping, Evidence Mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTB Catalogue of Recommendation (eTB) | Experimental | Other: eTB Catalogue of Recommendations (eTB)New eTB catalogue of recommendations website (eTB). |
| World Health Organization Tuberculosis Website (WHO TB) | Active comparator | Other: World Health Organization Tuberculosis Website (WHO TB)Current method of accessing tuberculosis (TB) recommendations using World Health Organization (WHO) website (WHO TB). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals involved in eTB catalogue development.
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 |
|---|---|---|
| eTB Catalogue of Recommendations (eTB)eTB Catalogue of Recommendations (eTB) | Other | eTB Catalogue of Recommendation (eTB) |
| World Health Organization Tuberculosis Website (WHO TB)World Health Organization Tuberculosis Website (WHO TB) | Other | World Health Organization Tuberculosis Website (WHO TB) |
Primary outcome
Accessibility of Information on a Seven-Point Likert Scale
Time frame: Duration of survey (approximately 10 minutes)
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.
3 secondary outcomes
Satisfaction on a Seven-Point Likert Scale
Time frame: Duration of survey (approximately 10 minutes)
Understanding with Multiple Choice Questions
Time frame: Duration of survey (approximately 10 minutes)
Preference on a Seven-Point Likert-Scale
Time frame: Duration of survey (approximately 10 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 13 Dec 2021.
- Derived from this study: PubMed 36962671Matthews M, Lotfi T, Santesso N, Loeb M, Mertz D, Chagla Z, Hajizadeh A, Piggott T, Dietl B, Schunemann HJ. Comparing the usability of the World Health Organization's conventional tuberculosis guidelines to the eTB recommendations map: A two-arm superiority randomised controlled trial. PLOS Glob Public Health. 2022 Oct 14;2(10):e0001166. doi: 10.1371/journal.pgph.0001166. eCollection 2022.
- eTB Catalogue of RecommendationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, PhD study chair
McMaster University
Micayla N Matthews, BHSc principal investigator
McMaster University
Tamara Lotfi, MD, MPH study director
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eTB Catalogue of Recommendations (eTB) and World Health Organization Tuberculosis Website (WHO TB) in people with Tuberculosis, 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 3 inclusion and 1 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 13 Dec 2021. 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?
Accessibility of Information on a Seven-Point Likert Scale (time frame: Duration of survey (approximately 10 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 NCT04745897, which also lists 1 linked publication.
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 13 Dec 2021.