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

Completed

• Conditions: Asthma
• Interventions: Other: Brainstorming 1; Other: Ranking Round 1; Other: Ranking Round 2; Other: Ranking Round 3

• Registration Number: NCT03934801
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed 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.)

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-02
• Primary Completion: 2019-09-26
• Study Completion: 2019-09-26
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The expert panel	Ranking Round 2	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.
The expert panel	Brainstorming 1	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.
The expert panel	Ranking Round 1	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.
The expert panel	Ranking Round 3	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.

Primary Outcome Measures

Name	Time	Method
The number of recommendation statements achieving positive consensus	Approximately month 5	When \>= 70% of the expert panel indicates either "agree" or "strongly agree" for a given statement, a positive consensus has been met.
The number of recommendation statements achieving consensus for neutrality	Approximately month 5	When \>= 70% of the expert panel indicates "neutral" for a given statement, a consensus for neutrality has been met.
The number of recommendation statements achieving negative consensus	Approximately month 5	When \>= 70% of the expert panel indicates either "disagree" or "strongly disagree" for a given statement, a positive consensus has been met.

Secondary Outcome Measures

Name	Time	Method
The number of statements meeting the stopping rule after ranking round 1.	Approximately month 5	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.
The number of statements meeting the stopping rule after ranking round 2.	Approximately month 5	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.
The number of statements meeting the stopping rule after ranking round 3.	Approximately month 5	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.

Trial Locations

Locations (1)

Carey Suehs; 🇫🇷 Montpellier, France