Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma

Asthma Clinical Trial

Official title:

OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934801
• Other study ID #: RECHMPL19_0195
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: September 26, 2019

Study information

• Verified date: March 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A series of anonymous questionnaires will be administered to a panel of experts. Each questionnaire administered results in a body of information that is re-presented to the experts before performing the next round. Initial brainstorming questionnaires are open in nature, and are used to generate statements that individual experts would like to see evaluated by their peers. Subsequent ranking questionnaires require that each expert rank each statement according to a pre-defined likert scale. Serial ranking questionnaires are administered electronically and continue until stopping rules are met, or the maximum number of allowed rounds is achieved (capped at three rounds for the present study).

Experts are recruited by invitation or response to open call (see eligibility criteria and url at the end of this declaration.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Brainstorming 1
Expert recommendation statements will be collected for peer evaluation.
• Ranking Round 1
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
• Ranking Round 2
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
• Ranking Round 3
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.

Locations

Country	Name	City	State
France	Carey Suehs	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Association Jean Baptiste Desbrest, AstraZeneca

Country where clinical trial is conducted

France, 

References & Publications (2)

Suehs CM, Bourdin A. Tapering of Oral Corticosteroids for the Treatment of Asthma. Arch Bronconeumol. 2021 Feb 17. pii: S0300-2896(21)00054-5. doi: 10.1016/j.arbres.2021.01.029. [Epub ahead of print] English, Spanish. — View Citation

Suehs CM, Menzies-Gow A, Price D, Bleecker ER, Canonica GW, Gurnell M, Bourdin A; Oral Corticosteroids Tapering Delphi Expert Panel. Expert Consensus on the Tapering of Oral Corticosteroids for the Treatment of Asthma: A Delphi Study. Am J Respir Crit Car — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The number of statements meeting the stopping rule after ranking round 1.	When >= 70% of the expert panel indicates the same score for a given statement, no subsequent rounds of ranking for that statement will be performed.	Approximately month 5
Secondary	The number of statements meeting the stopping rule after ranking round 2.	When >= 70% of the expert panel indicates the same score for a given statement, no subsequent rounds of ranking for that statement will be performed.	Approximately month 5
Secondary	The number of statements meeting the stopping rule after ranking round 3.	When >= 70% of the expert panel indicates the same score for a given statement, no subsequent rounds of ranking for that statement will be performed.	Approximately month 5

External Links

•   Description The OCS Tapering Delphi study on the Open Science Framework.