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).

Perspectives of Patients With Chronic Respiratory Diseases and Medical Professionals on Pulmonary Rehabilitation in Pune, India: Qualitative Analysis.

BACKGROUND: Chronic respiratory diseases (CRDs) contribute significantly to morbidity and mortality worldwide and in India. Access to nonpharmacological options, such as pulmonary rehabilitation (PR), are, however, limited. Given the difference between need and availability, exploring PR, specifically remotely delivered PR, in a resource-poor setting, will help inform future work. OBJECTIVE: This study explored the perceptions, experiences, needs, and challenges of patients with CRDs and the potential of and the need for PR from the perspective of patients as well as medical professionals involved in the referral (doctors) and delivery (physiotherapists) of PR. METHODS: In-depth qualitative semistructured interviews were conducted among 20 individuals diagnosed with CRDs and 9 medical professionals. An inductive thematic analysis approach was used as we sought to identify the meanings shared both within and across the 2 participant groups. RESULTS: The 20 patients considered lifestyle choices (smoking and drinking), a lack of physical activity, mental stress, and heredity as the triggering factors for their CRDs. All of them equated the disease with breathlessness and a lack of physical strength, consulting multiple doctors about their physical symptoms. The most commonly cited treatment choice was an inhaler. Most of them believed that yoga and exercise are good self-management strategies, and some were performing yoga postures and breathing exercises, as advised by friends or family members or learned from a televised program or YouTube videos. None of them identified with the term "pulmonary rehabilitation," but many were aware of the exercise component and its benefits. Despite being naive to smartphone technology or having difficulty in reading, most of them were enthusiastic about enrolling in an application-based remotely delivered digital PR program. The 9 medical professionals were, however, reluctant to depend on a PR program delivered entirely online. They recommended that patients with CRDs be supported by their family to use technology, with some time spent with a medical professional during the program. CONCLUSIONS: Patients with CRDs in India currently manage their disease with nonguided strategies but are eager to improve and would benefit from a guided PR program to feel better. A home-based PR program, with delivery facilitated by digital solutions, would be welcomed by patients and health care professionals involved in their care, as it would reduce the need for travel, specialist equipment, and setup. However, low digital literacy, low resource availability, and a lack of expertise are of concern to health care professionals. For India, including yoga could be a way of making PR "culturally congruent" and more successful. The digital PR intervention should be flexible to individual patient needs and should be complemented with physical sessions and a feedback mechanism for both practitioners as well as patients for better uptake and adherence.

Doxycycline for the prevention of progression of COVID-19 to severe disease requiring intensive care unit (ICU) admission: A randomized, controlled, open-label, parallel group trial (DOXPREVENT.ICU).

BACKGROUND: After admission to hospital, COVID-19 progresses in a substantial proportion of patients to critical disease that requires intensive care unit (ICU) admission. METHODS: In a pragmatic, non-blinded trial, 387 patients aged 40-90 years were randomised to receive treatment with SoC plus doxycycline (n = 192) or SoC only (n = 195). The primary outcome was the need for ICU admission as judged by the attending physicians. Three types of analyses were carried out for the primary outcome: "Intention to treat" (ITT) based on randomisation; "Per protocol" (PP), excluding patients not treated according to randomisation; and "As treated" (AT), based on actual treatment received. The trial was undertaken in six hospitals in India with high-quality ICU facilities. An online application serving as the electronic case report form was developed to enable screening, randomisation and collection of outcomes data. RESULTS: Adherence to treatment per protocol was 95.1%. Among all 387 participants, 77 (19.9%) developed critical disease needing ICU admission. In all three primary outcome analyses, doxycycline was associated with a relative risk reduction (RRR) and absolute risk reduction (ARR): ITT 31.6% RRR, 7.4% ARR (P = 0.063); PP 40.7% RRR, 9.6% ARR (P = 0.017); AT 43.2% RRR, 10.8% ARR (P = 0.007), with numbers needed to treat (NTT) of 13.4 (ITT), 10.4 (PP), and 9.3 (AT), respectively. Doxycycline was well tolerated with not a single patient stopping treatment due to adverse events. CONCLUSIONS: In hospitalized COVID-19 patients, doxycycline, a safe, inexpensive, and widely available antibiotic with anti-inflammatory properties, reduces the need for ICU admission when added to SoC.

Short-acting ß2-agonists over-prescription in patients with asthma: an Indian subset analysis of international SABINA III study.

OBJECTIVE: The SABINA (SABA use IN Asthma) program was initiated to describe short-acting ß2-agonists (SABA) prescription patterns and assess the impact of its over-prescription on exacerbation risk and asthma control. We evaluated SABA prescription patterns in patients with asthma in the Indian cohort of SABINA III. METHODS: This multi-centre, observational, cross-sectional study included retrospective and real-time electronic data collection. Data were extracted from medical records of patients with asthma (aged >12 years) having >3 consultations with the same healthcare practitioners between March 2019 and January 2020. The data included prescriptions of SABA and other asthma treatments and over-the-counter (OTC) purchases of SABA. SABA prescriptions were categorized by the number of SABA canisters prescribed in the 12 months preceding the study visit. RESULTS: A total of 510 patients with asthma were included from specialist care (mean age 49.1 years; 57.65 females), with 8.2% classified with mild asthma and 91.8% with moderate-to-severe asthma. SABA as monotherapy and add-on to maintenance therapy was prescribed to 4.5% (n = 23) and 44.9% (n = 229) of patients, respectively. While ICS monotherapy and ICS/LABA were prescribed to 5.1% (n = 26) and 93.3% (n = 476) of patients, respectively. SABA was found to be over-prescribed (≥3 SABA canisters/year) among 23.9% of patients (n = 122). Additionally, 8% of patients (n = 41) purchased SABA OTC without prescription. CONCLUSIONS: Nearly one-fourth of patients with asthma in India were over-prescribed SABA. Educational programmes targeted at national and regional levels should be expanded to raise greater asthma awareness and encourage the adoption of guideline-directed asthma treatment plans among healthcare practitioners.