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

September 3, 2019 updated by: Association Jean Baptiste Desbrest

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Association Jean Baptiste Desbrest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The expert panel

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately month 5
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.
Approximately month 5
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.
Approximately month 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately month 5
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.
Approximately month 5
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.
Approximately month 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Jean Baptiste Desbrest

Collaborators

AstraZeneca
University Hospital, Montpellier

Investigators

  • Study Director: Carey Suehs, PhD, Association Jean Baptiste Desbrest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

September 26, 2019

Study Completion (Anticipated)

September 26, 2019

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JDB-Delphi-201903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be shared on an appropriate public platform at the time of publication.

IPD Sharing Time Frame

Anonymized data will be shared on an appropriate public platform at the time of publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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