Study Synopsis

A.    Title:   Proportion of patients advised spirometry on visiting the respiratory OPD but     are unable to perform spirometry.

B.    Background: To confirm the diagnosis of various lung diseases, it is crucial to perform lung function tests. It also helps to identify the severity of the airflow obstruction and decide appropriate pharmacotherapy based on the severity. The response to the administered intervention can also be objectively monitored. Physicians have been using the conventional spirometer to diagnos e Obstructive Airways Diseases (OADs) for several decades now, but spirometry is not an easy test to perform as it requires patient effort and co-operation. In addition, spirometry cannot be performed in children below 5 years of age, elderly, pre operative and those who have cognitive and physical impairment. To overcome the challenges posed by the spirometer, the lung oscillometer can be used as an alternative in those patients who are unable to perform spirometry.

Lung Oscillometry is a non-invasive tool to diagnose obstructive airways diseases. It requires minimal patient co-operation unlike spirometry. Dubois et.al in the year 1956, developed the Forced Oscillometry technique (FOT), which worked on the principle of using single frequency sinusoidal sound waves generated by a loud-speaker and passed into the lungs during tidal breathing, to get a better insight in the functioning of the lung.

C.    Research Question: What is the proportion of patients advised spirometry on visiting   the respiratory OPD but are unable to perform Spirometry?

4. Aim of the Study:

·     To study the proportion of patients advised spirometry on visiting   the respiratory OPD but are unable to perform Spirometry

5. Study Design: Point prevalence, cross sectional observational study

F.     Sample Size: 300 patients; 10 breathe free educators; 10 doctors

G.   Study Population:

·     All patients, male and female (18 years and above) visiting the clinic for respiratory symptoms and are referred by the doctor to perform spirometry for the very first time

·     Breathe Free Educators/ managers at the respective centers who are performing spirometry.

·     Doctors who are referring for spirometry

H.   Study location: Centers across the country who have access to the breathe free educators (BFE)/ managers

I.      Data Collection variables/tools:

1.     Spirometry (pre and post)

2.     Questionnaire for spirometry technician

3.     Questionnairre for patients

4.     Questionnairre for doctors

5.     Peak flow meter (PEFR)

J.     Statistical Analysis Plan: The primary objective of this study is to report the proportion of patients visiting the respiratory OPD who are advised spirometry but are unable to perform the test. Analysis will be performed using simple descriptive statistics which mainly includes frequency and percentages for all categorical variables, and mean and standard deviation for continuous variables. Chi-square test will be used to explore associations.

For qualitative analysis, qualitative software will be used, and various themes will be identified.

11. Study Outcomes

·       Proportion of patients who performed spirometry.

·       Proportion of patients unable to perform spirometry.

·       Proportion of patients who refused to perform spirometry

·       Reasons for being unable to perform Spirometry.

·       Feedback of Breathe Free Educators on performing spirometry

·       Reasons why a doctor did not advice spirometry