Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,709
- 试验地点
- 3
- 主要终点
- Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools
研究概览
简要总结
This study will test how well short questionnaires, with and without a simple breathing test called 'peak flow', can identify people with COPD compared to the gold-standard diagnostic test called spirometry. We will test this in 10,500 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our case-finding intervention at scale.
详细描述
The investigators will determine whether case-finding for COPD can be facilitated using 5-item questionnaires with and without a measurement of Peak-Flow. The investigators hypothesise that 5-item questionnaires will be a valid case-finding tool for COPD in LMIC and will be acceptable and feasible for use in these settings.
- Clinical Aim: Determine the diagnostic accuracy of the case-finding questionnaires with and without PEF.
- Implementation Aim: Assess the appropriateness, acceptability and feasibility of using questionnaires and PEF to identify COPD cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health.
The design of the intervention will be informed by formative work prior to commencement of the main study.
Study fieldworkers will enroll and screen a randomly-selected age- and sex-stratified population sample of adults aged ≥40 years; a total of 10,500 between the following three countries in the catchment areas of existing community census areas in Bhaktapur (Nepal), Lima (Peru), and Nakaseke (Uganda).
The investigators will report the sensitivity, specificity and positive predictive value of the case-finding questionnaire, with and without PEF, in relation to a gold standard COPD diagnosis made at spirometry (post-bronchodilator FEV1/VC ratio <LLN, with a history of significant respiratory exposure to tobacco smoke or biomass). The investigators will construct ROC curves to visualise trade-offs in sensitivity and specificity across a range of questionnaire cut off values.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants aged ≥40 years
- •Full-time resident in the area (living in area > 6 months)
- •Able to perform adequate quality spirometry
- •Capable of providing informed consent
排除标准
- •Pregnancy (self-reported)
- •Currently has active pulmonary TB or is taking medications for pulmonary TB
结局指标
主要结局
Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools
时间窗: 12 months
Sensitivity, Specificity and Positive Predictive Value of the case-finding questionnaires with and without peak-expiratory flow (PEF), compared to spirometry.
次要结局
- Health Economics(12 months)
- Fidelity - Spirometry Quality Control Failures(12 months)
- Process Evaluation - Actual number of participants recruited against target.(12 months)
- Fidelity - Proportion of Questionnaires with Missing Data Fields(12 months)