Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma
OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study
1 other identifier
observational
30
1 country
1
Brief Summary
The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2019
CompletedSeptember 4, 2019
September 1, 2019
6 months
March 25, 2019
September 3, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
The number of recommendation statements achieving positive consensus
When \>= 70% of the expert panel indicates either "agree" or "strongly agree" for a given statement, a positive consensus has been met.
Approximately month 5
The number of recommendation statements achieving negative consensus
When \>= 70% of the expert panel indicates either "disagree" or "strongly disagree" for a given statement, a positive consensus has been met.
Approximately month 5
The number of recommendation statements achieving consensus for neutrality
When \>= 70% of the expert panel indicates "neutral" for a given statement, a consensus for neutrality has been met.
Approximately month 5
Secondary Outcomes (3)
The number of statements meeting the stopping rule after ranking round 1.
Approximately month 5
The number of statements meeting the stopping rule after ranking round 2.
Approximately month 5
The number of statements meeting the stopping rule after ranking round 3.
Approximately month 5
Study Arms (1)
The expert panel
Participation in this study will be proposed to a group of experts, including pulmonologists, endocrinologists, allergists, paediatricians and rheumatologists. Additionally, patient advocacy organization representatives will also be invited. Experts meeting eligibility criteria (see section below) are invited to participate. Further details are available via the URL link at the end of this declaration.
Interventions
Expert recommendation statements will be collected for peer evaluation.
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
Eligibility Criteria
The expert panel may include pulmonologists, endocrinologists, allergists, paediatricians and rheumatologists. Additionally, patient advocacy organization representatives will also be invited. Potential experts may respond to open invitation via the link at the end of this study registration.
You may qualify if:
- The expert is either a pulmonologist/respiratory disease specialist, an allergist, an endocrinologist, a paediatrician, a rheumatologist or a patient advocacy organisation representative
- All clinicians involved must manage patients on a weekly basis and have clinical experience in managing disease following oral corticosteroid withdrawal/tapering.
- Patient advocacy organization representatives must represent a relevant patient group (and provide contact information for their group)
You may not qualify if:
- Currently employed by a pharmaceutical company, or will have such employment in the upcoming 12 months
- Ownership in a pharmaceutical company or any other conflict of interest with the present study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Association Jean Baptiste Desbrestlead
- AstraZenecacollaborator
- University Hospital, Montpelliercollaborator
Study Sites (1)
Association Jean Baptiste Desbrest
Montpellier, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carey Suehs, PhD
Association Jean Baptiste Desbrest
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2019
First Posted
April 2, 2019
Study Start
April 1, 2019
Primary Completion
September 26, 2019
Study Completion
September 26, 2019
Last Updated
September 4, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Anonymized data will be shared on an appropriate public platform at the time of publication.
Anonymized data will be shared on an appropriate public platform at the time of publication.