About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03934801

Recruitment Status Completed

First Posted May 2, 2019

Last update posted March 25, 2021

Study Description

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.

  • Condition or Disease:Asthma
  • Intervention/Treatment: Other: Ranking Round 1
    Other: Brainstorming 1
    Other: Ranking Round 2
    Other: Ranking Round 3
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 140 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: September 2019
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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

Contacts and Locations
Contacts
Locations

France
Carey Suehs
Montpellier

Sponsors and Collaborators

University Hospital, Montpellier

Association Jean Baptiste Desbrest

AstraZeneca

Investigators

Study Director: Carey Suehs, PhD Association Jean Baptiste Desbrest

More Information