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临床试验/ACTRN12619001686190
ACTRN12619001686190已完成未知

The impact of lung function testing (spirometry) on clinical decision making and quality of life in children, a single centre randomised controlled trial (RCT).

Dr Wicharn Boonjindasup0 个研究点目标入组 106 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
106

研究概览

简要总结

  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.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
4 Years 至 18 Years(—)
性别
All

入选标准

  • •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

排除标准

  • •Previously enrolled
  • •Contraindication for spirometry including dyspnoea, pneumothorax, haemoptysis, vital signs instability, lung cyst or bleb, and recent chest/eye surgery (<3 weeks)

研究者

发起方
Dr Wicharn Boonjindasup

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