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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03934801
Enrollment
140
Registered
2019-05-02
Start date
2019-04-01
Completion date
2019-09-26
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.)

Interventions

Expert recommendation statements will be collected for peer evaluation.

OTHERRanking Round 1

Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.

OTHERRanking Round 2

Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.

OTHERRanking Round 3

Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.

Sponsors

Association Jean Baptiste Desbrest
CollaboratorOTHER
AstraZeneca
CollaboratorINDUSTRY
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of recommendation statements achieving positive consensusApproximately month 5When \>= 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 negative consensusApproximately month 5When \>= 70% of the expert panel indicates either disagree or strongly disagree for a given statement, a positive consensus has been met.
The number of recommendation statements achieving consensus for neutralityApproximately month 5When \>= 70% of the expert panel indicates neutral for a given statement, a consensus for neutrality has been met.

Secondary

MeasureTime frameDescription
The number of statements meeting the stopping rule after ranking round 1.Approximately month 5When \>= 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 5When \>= 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 5When \>= 70% of the expert panel indicates the same score for a given statement, no subsequent rounds of ranking for that statement will be performed.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026