Clinical trial NCT04745897: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: GRADE
Guidelines
Recommendations
Recommendation Mapping
Evidence Mapping
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 244
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Accessibility of Information on a Seven-Point Likert Scale
timeFrame: Duration of survey (approximately 10 minutes)
Secondary outcomes:
measure: Satisfaction on a Seven-Point Likert Scale
timeFrame: Duration of survey (approximately 10 minutes)
measure: Understanding with Multiple Choice Questions
timeFrame: Duration of survey (approximately 10 minutes)
measure: Preference on a Seven-Point Likert-Scale
timeFrame: Duration of survey (approximately 10 minutes)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Holger J Schunemann, MD, PhD
role: STUDY_CHAIR
affiliation: McMaster University
name: Micayla N Matthews, BHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Tamara Lotfi, MD, MPH
role: STUDY_DIRECTOR
References: