Echocardiographic Evaluation of Pulmonary Embolism: A Review.

Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States. Appropriate risk stratification is an important component of the initial evaluation for acute management of these patients. Echocardiography plays a crucial role in the risk stratification of patients with PE. In this literature review, we describe the current strategies in risk stratification of patients with PE using echocardiography and the role of echocardiography in the diagnosis of PE.

Real-world evaluation of the clinical safety and efficacy of fluticasone/formoterol FDC via the Revolizer® in patients with persistent asthma in India.

The combination of inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABAs) is widely used for the management of asthma. This prospective, open-label, non-comparative, observational, 24-week multicentre study is the first real-world study from India to compare the efficacy and safety of fixed-dose combination of fluticasone/formoterol (Maxiflo® 100/6 mcg or 250/6 mcg) capsules via the Revolizer® device in patients with persistent asthma. The primary efficacy analyses included mean change in Asthma Control Test (ACT™) at 4, 8, 16 and 24 weeks. Secondary efficacy analyses included mean change in morning and evening peak expiratory flow rate (PEFR) at the end of 4, 8, 16 and 24 weeks, number of patients having symptom-free days and nights at the end of 4, 8, 16 and 24 weeks, the number and severity of exacerbations over 24 weeks and response to the Usability Preference Satisfaction Confidence questionnaire after 1 week. Overall, 385 (of 401; 96.01%) enrolled patients completed the study. The mean change in ACT™ score was 6.7 ± 3.71 (95% CI: 6.32, 7.06; p < 0.0001) at week 24. The ACT™ score at weeks 4, 8 and 16 showed progressive and statistically significant increase from baseline. A statistically significant improvement in morning and evening PEFR at weeks 4, 8, 16 and 24 was reported. The proportion of patients experiencing symptom-free days and nights continuously increased from baseline to week 24. A good safety profile over the 24-week period was observed. The Revolizer® device was preferred by 94.26% patients over their current device. Fluticasone propionate/formoterol fumarate FDC capsules administered via a single-dose dry powder inhaler ([DPI], (Revolizer®) offers a novel, well-tolerated and effective treatment option for the long-term management of asthma.

Personal exposures to particulate matter <2.5 µm in mass median aerodynamic diameter (PM2.5) pollution during the burning of six most commonly used firecrackers in India.

INTRODUCTION: Diwali or the festival of lights is the most popular festival celebrated in India when firecrackers are burnt by almost every household for 3 days. Levels of ambient air pollution are reported to be very high during the Diwali festival in India. In this study, we aimed to measure and compare the personal exposure levels to particulate matter <2.5 µm in mass median aerodynamic diameter (PM2.5) during burning of six of the most commonly used firecracker types in India. METHODS: Sparklers, ground spinners, flower pots, pulpuls, a garland of 1000 sounding crackers, and snake tablets were burnt outdoors in an open area during the late evening hours. Minute by minute PM2.5levels were measured at a distance and height from where they are normally burnt using Thermo pDR 1200, USA, and a set of five such experiments were conducted to examine the variability between the firecrackers. RESULTS: When measured at a distance and height from where they are normally burnt, the burning of snake tablets produced the highest peak level of PM2.5 (64,500 mcg/m3), followed by a garland of 1000 sounding crackers (38,540 mcg/m3), pulpuls (28,950 mcg/m3), sparklers (10,390 mcg/m3), ground spinners (9490 mcg/m3) and flower pots (4860 mcg/m3). CONCLUSION: Burning of firecrackers produce extremely high levels of personal exposure to PM2.5 levels that are likely to have significant short-term and long-term adverse health effects. The initiative taken by the Supreme Court of India in 2017 to ban the sale of firecrackers seems to be a step in the right direction to reduce the adverse health impacts in the community.

Factors influencing severity of community-acquired pneumonia.

INTRODUCTION: Community-acquired pneumonia (CAP) is a common cause of morbidity and mortality in India. There is a need to understand the risk factors associated with severity of CAP in our population. This study was part of the international global initiative for methicillin-resistant Staphylococcus aureus (MRSA) pneumonia study to evaluate MRSA. METHODS: A total of 100 consecutive cases of pneumonia admitted to the Department of Pulmonary Medicine in a tertiary care hospital were recruited in the study during March-July 2015. The severity of pneumonia was assessed based on the CURB-65 score. Individuals with pneumonia and CURB-65 score >2 were compared with subjects with CURB-65 score ≤2. Individuals were also evaluated for the causative organism and its resistance pattern with specific reference to the presence of MRSA. RESULTS: Mean age of patients was 54.03 years, 66% were men. Patients were managed either in the intensive care unit (42%) or wards/high dependency unit (58%), 22% needed noninvasive ventilation and 18% needed mechanical ventilation within 24 h of admission. On multivariate analysis, prior respiratory infection (within last 1 year), obesity (body mass index >30), and alcoholism, old age (>60 years) were independently associated risk factors for severe pneumonia. There were no cases of MRSA. In 34% of cases, organisms could be identified. Most common organisms were Klebsiella (8%), influenza (8%), and Pseudomonas (5%). CONCLUSION: Prior respiratory infection, obesity, alcoholism, and old age (>60 years) were observed to be important risk factors for severe CAP. Prospective studies should evaluate effect of weight reduction and cessation of alcohol consumption on recurrences of pneumonia in this population and on the severity of pneumonia.

Antibiotic Prescription, Organisms and its Resistance Pattern in Patients Admitted to Respiratory ICU with Respiratory Infection in Mysuru.

AIM OF STUDY: Respiratory infections account for significant morbidity, mortality and expenses to patients getting admitted to ICU. Antibiotic resistance is a major worldwide concern in ICU, including India. It is important to know the antibiotic prescribing pattern in ICU, organisms and its resistance pattern as there is sparse data on Indian ICUs. MATERIALS AND METHODS: We conducted a prospective study from August 2015 to February 2016. All patients getting admitted to RICU with respiratory infection who were treated with antibiotics were included into study. Demographic details, comorbidities, Clinco-pathological score (CPI) on day1 and 2 of admission, duration of ICU admission, number of antibiotics used, antibiotic prescription, antimicrobial resistance pattern of patients were collected using APRISE questionnaire. RESULTS: During study period 352 patients were screened and 303 patients were included into study. Mean age was 56.05±16.37 and 190 (62.70%) were men. Most common diagnosis was Pneumonia (66%). Piperacillin-tazobactam was most common empirical antibiotic used. We found 60% resistance to piperacillin-tazobactam. Acinetobacter baumanii was the most common organism isolated (29.2%) and was highly resistant to Carbapenem (60%). Klebsiella pneumoniae was resistant to Amikacin (45%), piperacillin (55%) and Ceftazidime (50%). CONCLUSION: Piperacillin-tazobactam was the most common antibiotic prescribed to patients with respiratory infection admitted to ICU. More than half of patients (60%) had resistance to the empirical antibiotic used in our ICU, highlighting the need for antibiogram for each ICU. Thirty six percent of patient had prior antibiotic use and had mainly gram negative organisms with high resistance to commonly used antibiotics.

Challenges in recruitment and retention of clinical trial subjects.

BACKGROUND: Successful recruitment of patients is known to be one of the most challenging aspects in conduct of randomized controlled trials. Inadequate patient retention during conduct of trial affects conclusive results. OBJECTIVE: To assess the level of challenges faced by Indian investigators in recruitment and retention of trial subjects. METHODS: We developed a survey questionnaire on challenges encountered by investigators in subject recruitment and retention which was hosted on a web portal. RESULTS: Seventy-three investigators from India participated in the survey. The frequently encountered challenges in subject recruitment were complexity of study protocol (38%), lack of awareness about clinical trials in patients (37%), and sociocultural issues related to trial participation (37%). About 63% of participants strongly agreed that creating a positive awareness about clinical trials among people through press and media, having a dedicated clinical research coordinator for trial (50.7%), and designing a recruitment strategy prior to study initiation (46.6%) would enhance recruitment. Almost 50.7% of participants agreed that interacting with medical community in vicinity of the study site and educating patients about clinical trials during routine outpatient department visits (46.6%) would enhance recruitment. Experiencing a serious adverse event, subject's fear for study procedures (47%) and side effects (44%) were thought to have a moderate effect on subject retention. CONCLUSION: Our survey has put forth factors related to negative publicity by media, lack of patient education about clinical trials; complex study designs are barriers to clinical trial recruitment in India. It is essential to devise innovative and effective strategies focusing on education of public and mass media about clinical research in India.

Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators.

BACKGROUND: Clinical research in India experienced dramatic changes with series of stringent guidelines introduced by regulatory authorities. These guidelines posed significant challenges for the clinical trial industry. OBJECTIVE: To assess the perceptions and opinion of Indian Investigators about the new regulatory guidelines. METHODS: We developed a survey questionnaire on recent regulatory guidelines which was hosted on a web portal. Seventy-three investigators from India participated in the survey. RESULTS: Central registration of Ethics Committees (ECs) was agreed by 90.1% participants, 76.8% participants agreed to compensation of subjects for study related Serious Adverse Events (SAE's). The compulsion to include government sites in clinical trials was not agreed by 49.3% participants while 21.2% agreed to it. Restriction on a number of trials per investigator was agreed by 49.3% of participants while 40.9% disagreed. Participants (50.7%) disagreed to the introduction of audio-video (AV) recording of informed consent, 36.6% agreed and 12.7% were neutral. DISCUSSION: Participants observed that post central registration; ECs have improved systems with adequate member composition, functional Standard Operating Procedures, and timely approvals. Participants agreed that compensation of study related SAE's would assure subject protection and safety. The introduction of AV consenting was strongly debated sighting sociocultural issues in the implementation of the same. CONCLUSION: Participants endorsed guidelines pertaining to the central registration of ECs, SAE related compensation. Restrictions on a number of trials per investigator and AV consenting were debated ardently. The response of the survey participants who are clinical trial investigators in India showed general acceptance, effectiveness and anticipated compliance to the new regulatory guidelines.

Indoor Particulate Matter < 2.5 µm in Mean Aerodynamic Diameter and Carbon Monoxide Levels During the Burning of Mosquito Coils and Their Association With Respiratory Health.

BACKGROUND: An estimated 700 million people suffer from mosquito-borne diseases worldwide. Various types of mosquito repellents are widely used to prevent mosquito bites. The objectives of this study were (1) to measure the indoor levels of particulate matter < 2.5 µm in mean aerodynamic diameter (PM2.5) and carbon monoxide (CO) during the burning of mosquito coils (MCs) and study the impact of indoor ventilation patterns; and (2) to study and compare the prevalence of respiratory ailments in homes using different types of mosquito repellents. METHODS: Indoor PM2.5 and CO levels were measured inside a bedroom during the burning of MCs keeping the window and/or door open/closed over a 6-h duration. A cross-sectional survey was conducted in three villages where 465 individuals were administered a questionnaire that captured demographic details, type and duration of mosquito repellents used, and prevalence of respiratory symptoms and diseases. RESULTS: Fifty-three percent of the subjects burned MCs on most days of the week, and 63% did so with their doors and windows closed. Burning of MCs produced very high levels of PM2.5 (1,031 µg/m(3) mean, 1,613 µg/m(3) peak) and CO (6.50 parts per million (ppm) mean, 10.27 ppm peak) when both the door and window were closed. These levels reduced by around 50% when the window was opened and > 95% when both the window and the door were opened. The prevalence rates of respiratory symptoms and diseases were higher in subjects using MCs, although not statistically significant. Those living in smaller homes and using MCs had significantly greater morbidity. CONCLUSIONS: Burning of MCs produces indoor levels of PM2.5 and CO that are higher than those reported during the burning of biomass fuels for cooking purposes and may be associated with respiratory morbidity.

Field testing of alternative cookstove performance in a rural setting of western India.

Nearly three billion people use solid fuels for cooking and heating, which leads to extremely high levels of household air pollution and is a major cause of morbidity and mortality. Many stove manufacturers have developed alternative cookstoves (ACSs) that are aimed at reducing emissions and fuel consumption. Here, we tested a traditional clay chulha cookstove (TCS) and five commercially available ACSs, including both natural draft (Greenway Smart Stove, Envirofit PCS-1) and forced draft stoves (BioLite HomeStove, Philips Woodstove HD4012, and Eco-Chulha XXL), in a test kitchen in a rural village of western India. Compared to the TCS, the ACSs produced significant reductions in particulate matter less than 2.5 µm (PM2.5) and CO concentrations (Envirofit: 22%/16%, Greenway: 24%/42%, BioLite: 40%/35%, Philips: 66%/55% and Eco-Chulha: 61%/42%), which persisted after normalization for fuel consumption or useful energy. PM2.5 and CO concentrations were lower for forced draft stoves than natural draft stoves. Furthermore, the Philips and Eco-Chulha units exhibited higher cooking efficiency than the TCS. Despite significant reductions in concentrations, all ACSs failed to achieve PM2.5 levels that are considered safe by the World Health Organization (ACSs: 277-714 µg/m³ or 11-28 fold higher than the WHO recommendation of 25 µg/m³).

Obesity and asthma: the role of environmental pollutants.

Air pollution is a well-known risk for lung diseases, including asthma. Growing evidences suggesting air pollution as a novel risk factor for the development of obesity. Several Epidemiological studies have ascertained an association between various ambient and indoor air pollutants and obesity by medium of endocrine disruptive chemicals that can disrupt the normal development and homeostatic controls over adipogenesis and energy balance and induce obesity. Several obesity-induced mechanisms have been proposed that increases this vulnerability of obese individuals to harmful effects of air pollution rendering them more susceptible to developing air-pollution driven incident asthma or worsening of already existing asthma.