Comparison of a portable, pneumotach flow-sensor-based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients-a randomized, crossover study.

BACKGROUND: Spirofy™ is India's first portable, pneumotach flow-sensor-based digital spirometer developed to diagnose asthma and chronic obstructive pulmonary disease (COPD). In this study, we compared the performance of the Spirofy™ device with that of the Vitalograph Alpha Touch™ spirometer in measuring the lung capacities of healthy individuals, asthmatics, and COPD patients. We also assessed the inter-device variability between two Spirofy™ devices. METHODS: In a randomized, three-way crossover, open-label study, we measured the differences in forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) between the Spirofy™ and Vitalograph Alpha Touch™ spirometers. A proportion of the FEV1/FVC ratio distribution of < 0.7 was used to compare the diagnostic accuracies of the Spirofy™ with Vitalograph™ Alpha Touch™ spirometers. RESULTS: Ninety subjects participated in this study. The mean ± SD FVC values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 2.60 ± 1.05 L, 2.64 ± 1.04 L, and 2.67 ± 1.04 L, respectively. The mean ± SD FEV1 values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 1.87 ± 0.92 (L), 1.88 ± 0.92 (L), and 1.93 ± 0.93 (L), respectively. A significant positive correlation was found between the FVC and FEV1 values recorded by Vitalograph Alpha Touch™, Spirofy™ 1, and Spirofy™ 2. As compared to Vitalograph Alpha Touch™, the Spirofy™ device showed good sensitivity (97%), specificity (90%), and overall accuracy (93.3%) at an FEV1/FVC ratio < 0.7. No inter-device variability was observed between the two Spirofy™ devices. CONCLUSION: Spirofy™ is a portable and easy-to-use device and is as accurate as the standard Vitalograph Alpha Touch™ spirometer for the diagnosis of COPD and asthma. TRIAL REGISTRATION: CTRI/2021/09/036492 (Clinical Trials Registry - India).

Gaps in asthma diagnosis and treatment in low- and middle-income countries.

Low- and middle-income countries (LMICs) contribute to a major proportion of asthma morbidity and mortality globally, even though the prevalence is higher in high income countries. Mortality due to asthma is avoidable and patients should be able to live a near normal life. There are factors that influence overall disease prevalence and poor health outcomes due to asthma in LMICs. This article summarizes the gaps in asthma diagnosis and management in LMICs. The gaps are diverse. Each challenge needs to be addressed through policy decisions, upgrade of infrastructure, knowledge and skills for early diagnosis and correct management among health care providers, both clinicians and paramedics. Healthcare accessibility and affordability are genuine challenges, and the public healthcare system needs to be geared up to address these at primary and tertiary levels. Mass education of the population through national level government initiatives is needed to help bridge the sociocultural gaps.

Is underuse of Inhaled Corticosteroids for Asthma in India contributing to 42% of global asthma deaths?

Background: : According to the 2019 Global Burden of Disease (GBD) report, India contributes to an estimated 12.9% of global asthma cases (34.3 million) but a disproportionate 42.3% of all global asthma deaths. Also, asthma causes 4.83 million disability-adjusted life years (DALYs) annually in India, four times more than China, which ranks second. Hypothesis: : We hypothesised that this disproportionate increase in asthma deaths and suffering in India could be due to the under-use of inhaled corticosteroids. Methods: : Using the estimated number of asthma cases in each state and union territory in India (34.3 million) from the 2019 GBD data, we calculated the expected sales of inhaled corticosteroids (ICS) for asthmatics in India. We assumed that 10% of asthmatics have mild intermitted disease and thus need only 4 units of ICS pMDI per year. The remaining 90% should ideally use 12 units of ICS pMDI or equivalent DPI. We also assumed that 30% of ICS sales in India would be accounted for by the 38 million COPD patients. State-wise actual sales of ICS in India were obtained from IQVIA. Results: : The total amount of ICS sales in India for asthma obtained from IQVIA was 26.4 million versus the 384.16 million expected sales, which is only 6.8% of the required estimated sales. Moreover, when we correlated state-wise actual sales of ICS in India versus asthma mortality and DALYs (per 100,000 population), we found a significant negative correlation (R = -0.56; P < 0.001 for asthma deaths and R = -0.61; P < 0.001 for asthma DALYs). Impact and Future Direction: : Policy-makers, health care providers, public health researchers, asthma sufferers and the people at large need to take cognizance of our findings and undertake appropriate measures, such as creating awareness and ensuring availability and regular use of ICS by asthmatics in India.

Prevalence, time trends and treatment practices of asthma in India: the Global Asthma Network study.

Objective: The objective of this subanalysis of data from centres across urban areas in India of the Global Asthma Network (GAN) was to study 1) the prevalence of symptoms of asthma in children and adults, 2) the change in prevalence of asthma and its trigger factors since the International Study of Asthma and Allergies in Childhood (ISAAC), and 3) current asthma treatment practice. Methods: In this cross-sectional, multicentre, school-based and self-administered questionnaire, responses from children aged 6-7 years and 13-14 years, and their respective parents, were analysed. Results: The GAN Phase I study included 20 084 children in the 6-7-year age group, 25 887 children in the 13-14-year age group and 81 296 parents. The prevalence of wheeze in the previous 12 months was 3.16%, 3.63% and 3.30% in the three groups, respectively. In comparison to the ISAAC studies, there was a significant reduction in the prevalence of current wheeze (p<0.001). Bivariate analysis revealed a significant reduction in the prevalence of trigger factors. Almost 82% of current wheezers and 70% of subjects with symptoms of severe asthma were not clinically diagnosed as having asthma. The daily use of inhaled corticosteroids (ICS) was less than 2.5% in subjects with current wheeze and those with symptoms of severe asthma but less than 1% used daily ICS when asthma remained undiagnosed. Conclusion: The prevalence of current wheeze and its causal factors showed a significant reduction compared to previous ISAAC studies. Among subjects with current wheeze and symptoms of severe asthma, the problem of under-diagnosis and under-treatment was widespread.

Global Asthma Network Phase I, India: Results for allergic rhinitis and eczema in 127,309 children and adults.

Background: The Global Asthma Network phase I study in India aimed to study the prevalence, time trends, and associated risk factors of allergic rhinitis and eczema among 6-7-year-old, and 13-14-year-old school children and their parents. Objectives: The objective of the study was to understand the current prevalence and associated risk factors of Allergic Rhinitis and Eczema in India among 6-7-year-olds, 13-14-year-olds and in their parents/guardians for newer directions to health care providers, policy makers and academicians. Methods: Cross-sectional, multicenter study using self- and parent-administered questionnaire among randomly selected school children aged 6 to 7 years from 8 centers and 13 to 14 years from 9 centers and their respective parents/guardians across India. Results: Prevalence of allergic rhinitis (AR) (%, 95% CI) among 20,084 6-7-year-olds (children), 25,887 13-14-year-olds (adolescents), and 81,296 adults/parents was 7.7% (7.4%-8.1%), 23.5% (23.0%-24.1%), and 9.8% (9.55%-9.96%) and that of eczema was 2.5% (2.3%-2.7%), 3.5% (3.27%-3.71%), and 9.9% (9.7%-10.1%), respectively. Among 6-7-year-olds, AR and eczema showed a significantly (P < .001) declining time trend since the International Study of Asthma and Allergies in school children phase III in 2002-2003. Among 13-14-year-olds, AR (P < .01) but not eczema showed a significant temporal decline. Coexisting atopic condition, parental history of atopy, and some environmental factors consistent with previous studies were significant risk factors among children and adolescents. AR or eczema in either parent strongly predicted the same atopic condition among their adolescent offspring. Among adults, coexisting atopic condition was the strongest predictor of either AR or eczema. Conclusions: There is a slight declining time trend of AR and eczema in India over 2 decades among children and adolescents. Nearly 10% of Indian adults suffer from AR and eczema. Although genetic factors had the strongest association for AR and eczema among all age groups, certain early-life and environmental exposures need consideration to devise preventative strategies.

COPD awareness in the urban slums and rural areas around Pune city in India.

COPD is the second leading cause of death and disability adjusted life years (DALYs) in India, yet, it remains poorly recognized. We aimed to study the level of awareness of COPD in urban slums of Pune city in India and its neighboring rural areas. All male and female subjects above the age of 30 years residing in 13 randomly selected slums of Pune city (total population of 3000) and 7 randomly selected neighboring rural villages (total population of 3000) were invited to participate in this cross-sectional community survey. After obtaining written informed consent, 13 trained community health workers (CHWs) administered a questionnaire that captured their level of awareness of COPD. Of the 6000 subjects approached, 5420 residents (mean age ± SD = 48.0 ± 13.5 years; 38% males) consented and answered all questions. The number of people who had ever heard the word COPD was 49/5420 [0.9% (0.6-1.1%); 0.7% (0.5-1.3%) of the urban slum dwellers and 1.15% (0.5-1.3%) of rural residents]. Among those who had never heard the word COPD (n = 5371), when asked what was the name of the disease caused by long-term tobacco smoking, 38% said cancer, 16.7% said asthma, and 4.4% said TB. Among those who had heard the word COPD (n = 49), 6.1% said it was a disease of the heart, and 61% attributed COPD to smoke and dust pollution and 20% to tobacco smoking. The level of awareness of COPD in the Indian community is extremely low, highlighting the need to have nationwide mass awareness programs in India.

Monitoring of inhaler use at home with a smartphone video application in a pilot study.

Inhalation therapy is the basis of the pharmacological management of asthma and COPD. Most patients are trained on the correct use of inhalers by health professionals but after that do patients continue to take them correctly at home remains largely unknown. Video recording of the inhalation technique using a smartphone can be used to evaluate the inhaler technique at home. Through this pilot study, we aimed to understand whether inhaler training given to patients in the outpatient clinic translates into good inhalation practices at home by a video application platform using a smartphone. We recruited 70 newly diagnosed asthma and COPD patients and a pulmonologist trained them to use their inhaler until they were able to use it correctly. Videos of inhaler use were captured by a relative or a friend at home and then sent to an independent reviewer via WhatsApp on Days 1, 7, 14 and 28 (±2). Each step of the inhaler technique was evaluated based on a predetermined checklist with a rating scale of 0 to 10 (10 for all steps done correctly). Out of 70 patients recruited, 30 (42%) sent all videos. We found that, although all patients performed all the steps correctly in the clinic, none of them performed all steps correctly at home even on Day 1 itself of the inhaler use. On Day 1, the steps score reduced from 10 to 6.9 with a downward trend until Day 28. The most common mistakes from Day 1 onwards were incorrect inspiratory flow rates and not gargling after the inhaler use. Also, most patients showed partially effective inhalation as per our scoring method. Remote video monitoring of inhaler use in the home environment is possible with a mobile video application that gives us a better insight into the most common inhaler mistakes performed by patients at home. Inhaler errors start appearing immediately on Day 1 after the training, and incorrect inspiratory flow rates and forgetting to do gargles are common errors. Early detection of inhaler errors at home may be possible through this method.

Symptoms and medical conditions in 204 912 patients visiting primary health-care practitioners in India: a 1-day point prevalence study (the POSEIDON study).

BACKGROUND: India has one of the highest disease burdens in the world. A better understanding of what ails India will help policy makers plan appropriate health-care services and infrastructure development, design medical education curricula, and identify health research priorities that are relevant to the needs of the country. The POSEIDON study aimed to record the prevalence of symptoms and medical conditions for which patients visit a primary health-care practitioner in India. METHODS: We randomly selected 12 000 general practitioners, general physicians, and paediatricians from 880 cities and towns and invited them to record demographic details, symptoms, and medical conditions for every patient they saw on Feb 1, 2011. A further 1225 practitioners volunteered to participate and their responses were included. We did simple descriptive analyses of prevalence rates and used χ(2) tests to study comorbid associations. Through application of systems biology methods, we visualised inter-relations between organ involvement of diseases and symptoms and deciphered how these associations change with age and gender. FINDINGS: We included responses from 7400 health-care practitioners, which represented data for 204 912 patients, who presented with 554 146 reasons for visit. Fever (35·5%) was the most common presenting symptom. More than half of all patients presented with respiratory symptoms across all age groups and regions of India. Other common presentations were digestive system symptoms (25%), circulatory symptoms (12·5%), skin complaints (9%), and endocrine disorders (6·6%). Hypertension (14·52%), obstructive airways diseases (14·51%), and upper respiratory tract infections (12·9%) were the most common diagnoses reported. Of note was that 21·4% of all patients with hypertension reported by the primary health-care practitioners were younger than 40 years. Anaemia was the fourth most common disease reported by these health-care practitioners and was most common in women of menstrual age living outside metro cities. INTERPRETATION: The POSEIDON study provides insight into the reasons that patients visit primary health-care practitioners in India; our results highlight important social and medical challenges in the developing world. FUNDING: Chest Research Foundation, Council of Scientific and Industrial Research-Institute of Genomics and Integrated Biology (CSIR-IGIB), and Cipla Ltd.