Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale.
研究概览
简要总结
This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD).
The primary objective of the Delphi study is to aid the interpretation of respiratory oscillometry in clinical practice amongst adult patients with asthma or COPD. This will be achieved by obtaining expert consensus on:
- Which parameters are used in clinical practice for impulse oscillometry (IOS) and for forced oscillation technique (FOT) devices.
- What cut-offs can be used for each parameter to guide clinical practice in the management of adult patients with asthma and COPD.
This study is based on the Delphi methodology. The Delphi study will comprise of four rounds, one brainstorming round, to formulate the consensus survey, and three rounds to attempt to obtain consensus.
In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to participants in the Delphi study electronically using SurveyLet, an online survey platform. Participants will respond anonymously to the survey questions, indicating their level of agreement or disagreement with each statement or question. Participants will be given 4 weeks to complete each round of the Delphi study.
Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds). Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds.
详细描述
Study procedures:
The Delphi study will comprise of four rounds, one brainstorming round and three rounds to attempt to obtain consensus.
A series of anonymous questionnaires will be administered to a panel of experts and respiratory specialists familiar with oscillometry testing.
Phase one: Brainstorming to develop survey questionnaire.
The initial brainstorming questionnaire will be developed by the Steering Committee, based on the published literature and clinical practice. The brainstorming questionnaire will be circulated to a selected group of respiratory specialists who are known experts in respiratory oscillometry for refinement and testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Respiratory specialist in active clinical practice ≥ 12 months.
- •Use respiratory oscillometry ≥ 2 tests per week
排除标准
- •Only use respiratory oscillometry when participating in clinical trials
- •Employee or stockholder of pharmaceutical company
- •Employee or stockholder of oscillometry manufacturer
- •Employee or stockholder of tobacco/vaping companies.
结局指标
主要结局
Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale.
时间窗: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Participants are asked to rank in order of clinical importance the different respiratory oscillometry parameters (R5, R20, X5, AX, R5-R20, delta X5) from 1 to 6 Consensus is achieved when ≥ 70% of the participants give the same ranking order within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their ranking again.
Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, AX, R5-R20) to define an abnormal test result as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)
时间窗: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Cut-off values used to define abnormality are proposed for each parameter (R5, X5, AX, and R5-R20) and the participants/experts are asked for their level of agreement with the proposed cut-off value being assessed. An example of the type of statement used for this component of the survey is as follows: For R5, a result with a z-score \> 1.64 is considered abnormal. A. Agree Strongly B. Agree Moderately C. Agree Slightly D. Disagree Slightly E. Disagree Moderately F. Disagree Strongly Consensus is achieved when ≥ 70% of the participants give the same level of agreement for each statement within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their level of agreement again.
次要结局
- Identification of cut-off values used for oscillometry parameters (R5, X5, AX, R5-R20) to define a significant clinical change between visits as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)(When consensus is achieved within an individual Delphi round or through to study end, up to 1 year)
- Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, and AX) to define a bronchodilator response as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)(When consensus is achieved within an individual Delphi round or through to study end, up to 1 year)