OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The number of recommendation statements achieving positive consensus
研究概览
简要总结
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.
详细描述
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.)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
The number of recommendation statements achieving positive consensus
时间窗: 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.
The number of recommendation statements achieving negative consensus
时间窗: 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.
The number of recommendation statements achieving consensus for neutrality
时间窗: Approximately month 5
When \>= 70% of the expert panel indicates "neutral" for a given statement, a consensus for neutrality has been met.
次要结局
- The number of statements meeting the stopping rule after ranking round 1.(Approximately month 5)
- The number of statements meeting the stopping rule after ranking round 2.(Approximately month 5)
- The number of statements meeting the stopping rule after ranking round 3.(Approximately month 5)