Evaluating screening strategies for identifying undiagnosed COPD in China: a Breathe Well project

Conditions

Chronic obstructive pulmonary disease Respiratory COPD

Zihan Pan, Andy Dickens, Chunhua Chi, Xia Kong, Alexandra Enocson et al. (23 authors)

BMJ Open2021-09-0126 citations

10.1136/bmjopen-2021-051811

Study to evaluate the effectiveness and cost-effectiveness of different screening strategies for identifying undiagnosed COPD among residents (≥40 years) in four cities in China: protocol for a multicentre cross-sectional study on behalf of the Breathe Well group

Zihan Pan, Andy Dickens, Chunhua Chi, Xia Kong, Alexandra Enocson et al. (10 authors)

BMJ Open2020-11-017 citations

10.1136/bmjopen-2019-035738

Interventions

Current interventions as of 30/04/2019: The study will use a paired design, with all participants receiving the index tests and reference test during the same study assessment. The stu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 28/01/2020: 1. Aged =40 years 2. Residing in the catchment areas of the participating community health centres or their satellite offices _____ Previous inclusion criteria as of 30/04/2019: 1. Aged =40 years 2. Residing in the catchment areas of the participating community health centres _____ Previous inclusion criteria: 1. Aged =40 years 2. Residing in the catchment areas of the participating community centres

Exclusion criteria

Exclusion criteria: 1. Unable to do spirometry (e.g. dementia, lack of teeth or otherwise cannot make a good seal) 2. Contraindicated for spirometry (chest infection in the last 3 weeks, coughing up blood in the last month, severe angina, uncontrolled high blood pressure, pneumothorax or history in the last 3 months of tuberculosis, heart attack, detached retina, or surgery on chest/abdomen/brain/ears/eyes 3. Currently pregnant/breastfeeding 4. Previous adverse reaction to salbutamol

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 30/04/2019: 1. Pre-bronchodilator peak flow assessed using a USPE peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE, CDQ, a symptom-based questionnaire and selected items from the COPD-SQ on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the end of the study Previous primary outcome measures: 1. Pre-bronchodilator peak flow assessed using a KOKA PEF-3 peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE and COPD Diagnostic Questionnaire (CDQ) questionnaires, plus a revised version of the International Primary Care Airways Guidelines (IPAG) questionnaire (Zhang et al 2016) on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the the end of the study	—

Measure

Time frame

Current primary outcome measures as of 30/04/2019: 1. Pre-bronchodilator peak flow assessed using a USPE peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE, CDQ, a symptom-based questionnaire and selected items from the COPD-SQ on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the end of the study Previous primary outcome measures: 1. Pre-bronchodilator peak flow assessed using a KOKA PEF-3 peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE and COPD Diagnostic Questionnaire (CDQ) questionnaires, plus a revised version of the International Primary Care Airways Guidelines (IPAG) questionnaire (Zhang et al 2016) on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the the end of the study

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Secondary

Measure	Time frame
1. Test performance of screening strategies, using a combination of spirometry data and clinical confirmation to define COPD 2. Test performance of screening strategies, using an FEV1/FVC ratio of <0.7 to define COPD 3. Optimal cut-points for the screening tests, assessed by repeating primary analyses while applying different thresholds to the questionnaires, peak flow and microspirometry tests to indicate possible COPD. All analyses will be conducted once data collection has closed.	—

Measure

Time frame

1. Test performance of screening strategies, using a combination of spirometry data and clinical confirmation to define COPD 2. Test performance of screening strategies, using an FEV1/FVC ratio of <0.7 to define COPD 3. Optimal cut-points for the screening tests, assessed by repeating primary analyses while applying different thresholds to the questionnaires, peak flow and microspirometry tests to indicate possible COPD. All analyses will be conducted once data collection has closed.

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Countries

China

Contacts

Public ContactZihan Pan

panzihan@yeah.net+8618701291196

Outcome results

None listed