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Point of Care Spirometry Study
Participant Information Sheet
Study Title:
Impact of POC spirometry on diagnosis of Obstructive Airways Diseases in clinical practice.
India contributes to a high proportion of deaths and disability adjusted life years to the global mortality and morbidity of Asthma and COPD. Underdiagnosis and misdiagnosis of asthma and COPD are major reasons for the huge burden of obstructive airways diseases in our country. A major reason for underdiagnosis is underutilization of Spirometry-the gold standard for diagnosis of asthma and COPD. Of all the reasons for underutilization of Spirometry, lack of availability and non-affordability have been cited as the major reasons by doctors. With newer indigenously developed spirometers, accessibility and affordability are being addressed by industry partners. It is important to understand whether using these point of care spirometers is adding value to the quality of healthcare by improving the diagnosis of asthma and COPD in clinical settings. Hence, we are conducting this study called as ‘Point of care spirometry study’.
We compliment you on your decision to purchase a point of care spirometer. We have received your contact details from the Cipla team which is helping you procure the spirometer. We would like to invite you to participate in the ‘Point of care Spirometry Study’ which is being conducted among 50 Chest Physicians and General Physicians in India who are about to procure the spirometers. You have been selected by a process of convenient sampling. We will be trying to understand whether adding a point of care spirometer helps diagnose a greater number of patients of asthma and COPD.
The study will require your online participation and will use a web application for questionnaires and data collection. It will involve:
- One-time initial short questionnaire about your demographics and your practice.
- Daily record of each patient visiting your clinic with respiratory symptoms, using a very short questionnaire about symptoms and diagnosis for 1 month.
- After you have procured your spirometer, you will need to complete the training in spirometry procedure and interpretation provided by CREST.
- After training, once again a daily record of each patient visiting your clinic with respiratory symptoms using the same brief questionnaire as pre-spirometer month will have to be maintained for 1 month.
- Call from the CREST team for monitoring purposes.
- One-time feedback questionnaire at the end of 1 month post spirometry records.
We will be grateful if you could spare this time from your busy schedule and participate in the study. Your responses will be totally anonymous, and your identity will not be disclosed to anyone. Your participation is entirely voluntary, but we would really appreciate your inputs and insights.
This study is submitted to the Royal Pune independent Ethics Committee, Pune for approval for all states in India. The study has also been uploaded on the site of the Clinical Trials Registry of India. The registration number is awaited. This survey is being conducted in collaboration with Cipla Ltd. as our logistics partner.
We thank the Cipla Team member in advance who has brought this survey to you. Your participation is completely voluntary. You will not be paid any money for your participation. However, you will be getting the training in Spirometry as well as hand holding for quality assurance, interpretation and troubleshooting for procedure from CREST. After the study is completed, you will be given a certificate of participation in this important study from CREST and your contribution will be acknowledged in the publication as part of the Point of Care Spirometry Study Group.
Feel free to contact the investigator, Dr. Monica Barne on 9922933131 for any query/clarification. This is an investigator-initiated survey sponsored by Cipla Ltd.