Clinical trial NCT03934801: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma
Official title: OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Association Jean Baptiste Desbrest
name: AstraZeneca
First posted: 2019-05-02
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.)

Eligibility criteria: 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

Primary outcomes:
measure: The number of recommendation statements achieving positive consensus
timeFrame: Approximately month 5
measure: The number of recommendation statements achieving negative consensus
timeFrame: Approximately month 5
measure: The number of recommendation statements achieving consensus for neutrality
timeFrame: Approximately month 5
Secondary outcomes:
measure: The number of statements meeting the stopping rule after ranking round 1.
timeFrame: Approximately month 5
measure: The number of statements meeting the stopping rule after ranking round 2.
timeFrame: Approximately month 5
measure: The number of statements meeting the stopping rule after ranking round 3.
timeFrame: Approximately month 5
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Carey Suehs
Study officials:
affiliation: Association Jean Baptiste Desbrest
name: Carey Suehs, PhD
role: STUDY_DIRECTOR
References:
citation: Suehs CM, Bourdin A. Tapering of Oral Corticosteroids for the Treatment of Asthma. Arch Bronconeumol (Engl Ed). 2021 Feb 17:S0300-2896(21)00054-5. doi: 10.1016/j.arbres.2021.01.029. Online ahead of print. No abstract available. English, Spanish.
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 Care Med. 2021 Apr 1;203(7):871-881. doi: 10.1164/rccm.202007-2721OC.