Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313372
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-26
Brief Title:
Interpreting Respiratory Oscillometry in Adult Asthma and COPD a Delphi Study
Sponsor:
Scius Healthcare Solutions Pty Ltd
Organization:
Scius Healthcare Solutions Pty Ltd
Study Overview
Official Title:
Interpreting Respiratory Oscillometry in Adult Asthma and COPD a Delphi Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
The expert panel will comprise of approximately 10 respiratory specialists who have published papers on respiratory oscillometry This brainstorming questionnaire will be open in nature and will allow all respondents to propose new statements as well as adjust the proposed statements that are to be evaluated by their peers
The results of the brainstorming round will be reviewed by the Steering Committee to finalise the questionnaire for the first round of the Delphi study
Phase two Attempting to achieve consensus
To obtain consensus three iterative rounds Rounds 1-3 will be undertaken In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to all participants in the Delphi study electronically using SurveyLet an online survey platform utilising the Delphi technique
The initial questionnaire for use in Round 1 will be the survey developed in the brainstorming round
There will be a range of statement types used to ascertain consensus including
Agreement with statements ranked using a six-point scale Agree Strongly Agree Moderately Agree Slightly Disagree Slightly Disagree Strongly Disagree Moderately
Agreement on importanceclinical utility of various oscillometry parameters using a ranking process
Agreement on defining values cut-offs for clinically relevant changes for the various oscillometry parameters
Participants will be encouraged to provide free text comments after each statement or question and these comments will be reviewed by the Steering Committee to determine if the questionnaire needs revision prior to the next survey round
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
Participants will be given 4 weeks to complete each round of the Delphi study During a Delphi study participants with a minority opinion can become discouraged and drop out of the study potentially resulting in an overestimation of consensus
At the commencement of the study participants will be sent an email with an encrypted personalised secure link to the study questionnaire This secure link means that each participant can only view their own data and the aggregated data shared in study rounds 2 and 3 No study participant nor the lead investigators can see the individual responses of any other participant Access to subsequent study rounds is also via the encrypted secure link or via the participant login into the SurveyLet platform
In this study consensus is achieved when 70 of the participants give the same answer for any question or statement
For questions and statements that are assessed using a 6-point agreement scale consensus is achieved when 70 of participants either
Agree Strongly or Agree Moderately
Agree Slightly or Disagree Slightly
Disagree Strongly or Disagree Moderately
For questions and statements that are assessed using a ranking process consensus is achieved when 70 of participants give that ranking
For questions and statements that are assessed using a defined value consensus is achieved when 70 of participants give the same value
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
The expert panel will comprise of approximately 10 respiratory specialists who have published papers on respiratory oscillometry This brainstorming questionnaire will be open in nature and will allow all respondents to propose new statements as well as adjust the proposed statements that are to be evaluated by their peers
The results of the brainstorming round will be reviewed by the Steering Committee to finalise the questionnaire for the first round of the Delphi study
Phase two Attempting to achieve consensus
To obtain consensus three iterative rounds Rounds 1-3 will be undertaken In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to all participants in the Delphi study electronically using SurveyLet an online survey platform utilising the Delphi technique
The initial questionnaire for use in Round 1 will be the survey developed in the brainstorming round
There will be a range of statement types used to ascertain consensus including
Agreement with statements ranked using a six-point scale Agree Strongly Agree Moderately Agree Slightly Disagree Slightly Disagree Strongly Disagree Moderately
Agreement on importanceclinical utility of various oscillometry parameters using a ranking process
Agreement on defining values cut-offs for clinically relevant changes for the various oscillometry parameters
Participants will be encouraged to provide free text comments after each statement or question and these comments will be reviewed by the Steering Committee to determine if the questionnaire needs revision prior to the next survey round
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
Participants will be given 4 weeks to complete each round of the Delphi study During a Delphi study participants with a minority opinion can become discouraged and drop out of the study potentially resulting in an overestimation of consensus
At the commencement of the study participants will be sent an email with an encrypted personalised secure link to the study questionnaire This secure link means that each participant can only view their own data and the aggregated data shared in study rounds 2 and 3 No study participant nor the lead investigators can see the individual responses of any other participant Access to subsequent study rounds is also via the encrypted secure link or via the participant login into the SurveyLet platform
In this study consensus is achieved when 70 of the participants give the same answer for any question or statement
For questions and statements that are assessed using a 6-point agreement scale consensus is achieved when 70 of participants either
Agree Strongly or Agree Moderately
Agree Slightly or Disagree Slightly
Disagree Strongly or Disagree Moderately
For questions and statements that are assessed using a ranking process consensus is achieved when 70 of participants give that ranking
For questions and statements that are assessed using a defined value consensus is achieved when 70 of participants give the same value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None