Skip to main content
OpenTrials
Completed

NCT Number: NCT03934801

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Carey Suehs

Montpellier, 34295, France

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brainstorming 1

Other

Expert recommendation statements will be collected for peer evaluation.

Ranking Round 1

Other

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

Ranking Round 2

Other

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

Ranking Round 3

Other

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

Primary outcomes

  1. The number of recommendation statements achieving positive consensus

    Time frame: 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.

  2. The number of recommendation statements achieving negative consensus

    Time frame: 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.

  3. The number of recommendation statements achieving consensus for neutrality

    Time frame: Approximately month 5

    When >= 70% of the expert panel indicates "neutral" for a given statement, a consensus for neutrality has been met.

Secondary outcomes

  1. The number of statements meeting the stopping rule after ranking round 1.

    Time frame: 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.

  2. The number of statements meeting the stopping rule after ranking round 2.

    Time frame: 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.

  3. The number of statements meeting the stopping rule after ranking round 3.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Association Jean Baptiste Desbrest
  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 2, 2019
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.