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

Introduction: The latest COPD epidemiology survey in China estimated that there were 99 million potential COPD patients in the country, the majority of whom are undiagnosed. Screening for COPD in primary care settings is of vital importance for China, but it is not known which strategy would be the most suitable for adoption in primary care. Studies have been conducted to test the accuracy of questionnaires, expiratory peak flow meters, and microspirometers to screen for COPD, but no studies have directly evaluated and compared the effectiveness and cost-effectiveness of these methods in the Chinese setting.

Methods and analysis: We present the protocol for a multicenter cross-sectional study, to be conducted in 8 community hospitals from 4 cities amongst Chinese adults aged 40 years or older to investigate the effectiveness and cost-effectiveness of different case finding methods for COPD, and determine the test performance of individual and combinations of screening tests and strategies in comparison with quality diagnostic spirometry. Index tests are screening questionnaires (CDQ, CAPTURE, symptom-based questionnaire, COPD-SQ), microspirometer and peak flow. Each participant will complete all of these tests in one assessment. The primary analysis will compare the performance of a screening questionnaire with a handheld device. Secondary analyses will include the comparative performance of each index test, as well as a comparison of strategies where we use a screening questionnaire and a handheld device. Approximately 2000 participants will be recruited over 9-12 months.

Ethics and dissemination: The study has been approved by Peking University Hospital and University of Birmingham. All study participants will provide written informed consent. Study results will be published in appropriate journal and presented at national and international conferences, as well as relevant social media and various community/stakeholder engagement activities.

Trial registration: ISRCTN13357135.