Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001686190
Ethics application status
Approved
Date submitted
20/11/2019
Date registered
2/12/2019
Date last updated
25/01/2023
Date data sharing statement initially provided
2/12/2019
Date results information initially provided
17/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung function test impact on Clinical decision making and Quality of life in children (LoCQ) Study
Scientific title
The impact of lung function testing (spirometry) on clinical decision making and quality of life in children, a single centre randomised controlled trial (RCT).
Secondary ID [1] 299735 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LoCQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory disorders 315079 0
Asthma 315400 0
PBB/Bronchiectasis 322337 0
Condition category
Condition code
Respiratory 313419 313419 0 0
Asthma
Respiratory 313420 313420 0 0
Other respiratory disorders / diseases
Public Health 313696 313696 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is spirometry. Both the intervention and control groups will have spirometry with bronchodilator testing using the Queensland Children’s Hospital standard practice guide. This standard practice guide follows American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria for lung function testing in children (Miller MR, et al. Standardisation of spirometry. The European respiratory journal. 2005;26(2):319-38; Beydon N, et al. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. American journal of respiratory and critical care medicine. 2007;175(12):1304-45)

In this standard guide each child performs at least 3 acceptable manoeuvres, including
o Good start of forceful exhalation without hesitation or gradual onset
o Smooth flow of spirograms without artefacts
o At least 3 seconds of exhalation showing plateau of lung volume
o At least 2 manoeuvres which have FVC and FEV1 repeatability, not more than 10% or 100 ml of difference
These standards ensure acceptability, reproducibility and fidleity of the intervention. Further the spirometers are calibrated daily before use.
The intervention will be one single session of 15-30 minutes for each participant enrolled in the study. All spirometry testing will be administered by experienced paediatric respiratory scientists in a tertiary hospital laboratory.

The intervention group sees the doctor with the spirometry report. The control group sees the doctor without the spirometry report. The control group then sees the doctor again a second time with the spirometry report.
Intervention code [1] 315999 0
Diagnosis / Prognosis
Comparator / control treatment
While both groups will perform spirometry, the intervention group will have the spirometry results at the first consultation with doctor and the control group will not.
Control group
Active

Outcomes
Primary outcome [1] 321896 0
Our primary outcome is the proportion of children with any change in clinical decision making (diagnosis and management) and change scores between groups. This consists of a-priori list that consists of (i) any change in diagnosis based on 2 categories (disease and severity) and (ii) management based on 4 categories (medication, investigation, follow-up schedule and education). Change in each category is dichotomised as ‘yes’ or ‘no’. Each ‘yes’ scores one point, so the range in change score is 0 to a maximum of 6 (2 points from change in diagnosis and 4 points from change in management).
Timepoint [1] 321896 0
After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group
Secondary outcome [1] 376619 0
Change of the patient-reported outcome measure scores (State-Trait Anxiety Inventory ± Parent-Proxy QoL for paediatric chronic cough) from baseline
Timepoint [1] 376619 0
After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group
Secondary outcome [2] 376620 0
Opinions relating to the benefit of integrating spirometry into clinical practice assessed by 10-point Likert scales
Timepoint [2] 376620 0
At the end of clinic visit for both groups
Secondary outcome [3] 405156 0
Degree of diagnosis certainty (definite, probable or doubtful)
Timepoint [3] 405156 0
After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group

Eligibility
Key inclusion criteria
• A child with parents/guardians in attendance and able to provide written consent.
• A child aged from 4 to 18 years, who can perform acceptable spirometry
• Parent/guardian that is able to complete QoL questionnaires
• A child whose physician is willing to being part of the LoCQ Study
Minimum age
4 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Previously enrolled
• Contraindication for spirometry including dyspnoea, pneumothorax, haemoptysis, vital signs instability, lung cyst or bleb, and recent chest/eye surgery (<3 weeks)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will not be concealed from those involved in the clinical care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated permuted block 2-6 size, randomisation sequence generated by an external statistician, will be used. Children will be stratified by status (new/review), and cough condition (cough present/absent).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We wish to detect a significant difference in the proportion of children with any change in clinical decision making between the intervention and control groups. We assume the proportion in the population is 30% (Ho: p = 0.30). To find 45% proportion of children with any change (alternative p = 0.45) with 5% significance (alpha = 0.05, two-sided) and 90% power (power = 0.90), we require outcome data from 105 children (rounded up to 106 children).

Intention-to-treat analyses will be used. For our primary outcome, the difference between groups will be compared using Chi-Square test for the proportion of children with any change in diagnosis and management. T-test or Mann-Whitney U test will be used depending on normality of the data to determine the difference of change scores.

For secondary outcomes, inter-group differences will be determined by T-test or Mann-Whitney if not normally distributed. Change in outcomes within the control group after review of spirometry will be assessed by McNemar test, paired T-test or Wilcoxon Signed Rank test. 10-point Likert scales will be reported as mean with SD or median with P25-P75. Degree of diagnostic certainty will be reported as frequency.

In the control group only, changes in the primary outcome and secondary outcomes [1] and [3], compared at timepoints before and after the spirometry is presented will also be analysed using statistical methods as discussed above.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2020
Actual
17/03/2020
Date of last participant enrolment
Anticipated
31/03/2022
Actual
17/02/2022
Date of last data collection
Anticipated
31/03/2022
Actual
17/02/2022
Sample size
Target
106
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15114 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 28408 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304207 0
University
Name [1] 304207 0
Cough, Asthma & Airways Research Group, Queensland University of Technology
Country [1] 304207 0
Australia
Primary sponsor type
Individual
Name
Dr Wicharn Boonjindasup
Address
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country
Australia
Secondary sponsor category [1] 304438 0
None
Name [1] 304438 0
Address [1] 304438 0
Country [1] 304438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304672 0
Children's Health Queensland Hospital and Health Service
Ethics committee address [1] 304672 0
Level 7, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, Queensland, 4101
Ethics committee country [1] 304672 0
Australia
Date submitted for ethics approval [1] 304672 0
14/10/2019
Approval date [1] 304672 0
20/11/2019
Ethics approval number [1] 304672 0
HREC/19/QCHQ/58722

Summary
Brief summary
The low utility of lung function testing in clinical practice, despite its importance, is not surprising as to date there are no randomised controlled trials (RCT) that have assessed the benefits in routine clinical practice. This RCT will assess the benefit of spirometry, in all paediatric respiratory conditions, which may lead to a change in routine clinical practice. If this study shows that spirometry has a positive impact on clinical decision making and quality of life, this evidence will encourage the use of spirometry as an important clinical assessment tool in both tertiary and primary care practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97806 0
Dr Wicharn Boonjindasup
Address 97806 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country 97806 0
Australia
Phone 97806 0
+61 730697280
Fax 97806 0
Email 97806 0
[email protected]
Contact person for public queries
Name 97807 0
Dr Wicharn Boonjindasup
Address 97807 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country 97807 0
Australia
Phone 97807 0
+61 730697280
Fax 97807 0
Email 97807 0
[email protected]
Contact person for scientific queries
Name 97808 0
Dr Wicharn Boonjindasup
Address 97808 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country 97808 0
Australia
Phone 97808 0
+61 730697280
Fax 97808 0
Email 97808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, after de-identification
When will data be available (start and end dates)?
Immediately following publication, ending 5 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal and obtain an approval from the Human Research Ethics Commitee
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18060Study protocolBoonjindasup W, Marchant JM, McElrea MS, Yerkovich ST, Masters IB, Chang AB. Impact of using spirometry on clinical decision making and quality of life in children: protocol for a single centre randomised controlled trial. BMJ Open. 2021 Sep 21;11(9):e050974. doi: 10.1136/bmjopen-2021-050974. PMID: 34548360; PMCID: PMC8458340.  
18061Statistical analysis plan  [email protected]
18062Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378687-(Uploaded-16-01-2023-03-28-38)-Basic results summary.docx
Plain language summaryNo 1. Research question Does routine spirometry impa... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of using spirometry on clinical decision making and quality of life in children: Protocol for a single centre randomised controlled trial.2021https://dx.doi.org/10.1136/bmjopen-2021-050974
EmbaseClinical determinants for State-Trait Anxiety Inventory of the parents of children with respiratory problems.2024https://dx.doi.org/10.1002/ppul.26702
EmbaseDoes routine spirometry impact on clinical decisions and patient-related outcome measures of children seen in respiratory clinics: an open-label randomised controlled trial.2023https://dx.doi.org/10.1136/bmjresp-2022-001402
N.B. These documents automatically identified may not have been verified by the study sponsor.