ung function test impact on Clinical decision making and Quality of life in children (LoCQ) Study

Not Applicable

Completed

• Conditions: Respiratory disorders; Asthma; PBB/Bronchiectasis; Respiratory - Asthma; Respiratory - Other respiratory disorders / diseases; Public Health - Health service research

• Registration Number: ACTRN12619001686190
• Lead Sponsor: Dr Wicharn Boonjindasup

Brief Summary

1. Research question Does routine spirometry impact on clinical decisions and patient-related outcome measures of children seen in pulmonology clinics? 2. Background information Spirometry is recommended as an adjunct test in many respiratory practice guidelines. However, there is a paucity of high-quality evidence to support the routine use of spirometry in children. 3. Participant characteristics Children able to perform reliable spirometry with parent/guardian in attendance 4. Key results Using spirometry with clinical review significantly altered doctors’ clinical decisions, especially in follow-up schedule and patient education; and improved patient-reported outcome measures. 5. Limitations This is a non-blinded study. The study was undertaken in a specialist children hospital, so data may not be applicable in other settings. In addition, findings are limited to a single timepoint assessment, and could not determine long term outcomes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Study Completion: 2022-02-17
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 106

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group]

Secondary Outcome Measures

Name	Time	Method
Change of the patient-reported outcome measure scores (State-Trait Anxiety Inventory ± Parent-Proxy QoL for paediatric chronic cough) from baseline<br>[After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group];Opinions relating to the benefit of integrating spirometry into clinical practice assessed by 10-point Likert scales[At the end of clinic visit for both groups];Degree of diagnosis certainty (definite, probable or doubtful)<br>[After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group]