Publications by authors named "William Checkley"

258 Publications

Previous tuberculosis disease as a risk factor for chronic obstructive pulmonary disease: a cross-sectional analysis of multicountry, population-based studies.

Thorax 2021 Dec 1. Epub 2021 Dec 1.

Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA

Background: Risk factors for COPD in high-income settings are well understood; however, less attention has been paid to contributors of COPD in low-income and middle-income countries (LMICs) such as pulmonary tuberculosis. We sought to study the association between previous tuberculosis disease and COPD by using pooled population-based cross-sectional data in 13 geographically diverse, low-resource settings.

Methods: We pooled six cohorts in 13 different LMIC settings, 6 countries and 3 continents to study the relationship between self-reported previous tuberculosis disease and lung function outcomes including COPD (defined as a postbronchodilator forced expiratory volume in one second (FEV)/forced vital capacity (FVC) below the lower limit of normal). Multivariable regressions with random effects were used to examine the association between previous tuberculosis disease and lung function outcomes.

Results: We analysed data for 12 396 participants (median age 54.0 years, 51.5% male); 332 (2.7%) of the participants had previous tuberculosis disease. Overall prevalence of COPD was 8.8% (range 1.7%-15.5% across sites). COPD was four times more common among those with previous tuberculosis disease (25.7% vs 8.3% without previous tuberculosis disease, p<0.001). The adjusted odds of having COPD was 3.78 times higher (95% CI 2.87 to 4.98) for participants with previous tuberculosis disease than those without a history of tuberculosis disease. The attributable fraction of COPD due to previous tuberculosis disease in the study sample was 6.9% (95% CI 4.8% to 9.6%). Participants with previous tuberculosis disease also had lower prebronchodilator Z-scores for FEV (-0.70, 95% CI -0.84 to -0.55), FVC (-0.44, 95% CI -0.59 to -0.29) and the FEV:FVC ratio (-0.63, 95% CI -0.76 to -0.51) when compared with those without previous tuberculosis disease.

Conclusions: Previous tuberculosis disease is a significant and under-recognised risk factor for COPD and poor lung function in LMICs. Better tuberculosis control will also likely reduce the global burden of COPD.
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http://dx.doi.org/10.1136/thoraxjnl-2020-216500DOI Listing
December 2021

LPG stove and fuel intervention among pregnant women reduce fine particle air pollution exposures in three countries: Pilot results from the HAPIN trial.

Environ Pollut 2021 Dec 21;291:118198. Epub 2021 Sep 21.

Berkeley Air Monitoring Group, Berkeley, CA, USA. Electronic address:

The Household Air Pollution Intervention Network trial is a multi-country study on the effects of a liquefied petroleum gas (LPG) stove and fuel distribution intervention on women's and children's health. There is limited data on exposure reductions achieved by switching from solid to clean cooking fuels in rural settings across multiple countries. As formative research in 2017, we recruited pregnant women and characterized the impact of the intervention on personal exposures and kitchen levels of fine particulate matter (PM) in Guatemala, India, and Rwanda. Forty pregnant women were enrolled in each site. We measured cooking area concentrations of and personal exposures to PM for 24 or 48 h using gravimetric-based PM samplers at baseline and two follow-ups over two months after delivery of an LPG cookstove and free fuel supply. Mixed models were used to estimate PM reductions. Median kitchen PM concentrations were 296 μg/m at baseline (interquartile range, IQR: 158-507), 24 μg/m at first follow-up (IQR: 18-37), and 23 μg/m at second follow-up (IQR: 14-37). Median personal exposures to PM were 134 μg/m at baseline (IQR: 71-224), 35 μg/m at first follow-up (IQR: 23-51), and 32 μg/m at second follow-up (IQR: 23-47). Overall, the LPG intervention was associated with a 92% (95% confidence interval (CI): 90-94%) reduction in kitchen PM concentrations and a 74% (95% CI: 70-79%) reduction in personal PM exposures. Results were similar for each site. CONCLUSIONS: The intervention was associated with substantial reductions in kitchen and personal PM overall and in all sites. Results suggest LPG interventions in these rural settings may lower exposures to the WHO annual interim target-1 of 35 μg/m. The range of exposure contrasts falls on steep sections of estimated exposure-response curves for birthweight, blood pressure, and acute lower respiratory infections, implying potentially important health benefits when transitioning from solid fuels to LPG.
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http://dx.doi.org/10.1016/j.envpol.2021.118198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8593210PMC
December 2021

Defining hypoxaemia from pulse oximeter measurements of oxygen saturation in well children at low altitude in Bangladesh: an observational study.

BMJ Open Respir Res 2021 Nov;8(1)

Division of Pulmonary and Critical Care, Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.

Background: WHO defines hypoxaemia, a low peripheral arterial oxyhaemoglobin saturation (SpO), as <90%. Although hypoxaemia is an important risk factor for mortality of children with respiratory infections, the optimal SpO threshold for defining hypoxaemia is uncertain in low-income and middle-income countries (LMICs). We derived a SpO threshold for hypoxaemia from well children in Bangladesh residing at low altitude.

Methods: We prospectively enrolled well, children aged 3-35 months participating in a pneumococcal vaccine evaluation in Sylhet district, Bangladesh between June and August 2017. Trained health workers conducting community surveillance measured the SpO of children using a Masimo Rad-5 pulse oximeter with a wrap sensor. We used standard summary statistics to evaluate the SpO distribution, including whether the distribution differed by age or sex. We considered the 2.5th, 5th and 10th percentiles of SpO as possible lower thresholds for hypoxaemia.

Results: Our primary analytical sample included 1470 children (mean age 18.6±9.5 months). Median SpO was 98% (IQR 96%-99%), and the 2.5th, 5th and 10th percentile SpO was 91%, 92% and 94%. No child had a SpO <90%. Children 3-11 months had a lower median SpO (97%) than 12-23 months (98%) and 24-35 months (98%) (p=0.039). The SpO distribution did not differ by sex (p=0.959).

Conclusion: A SpO threshold for hypoxaemia derived from the 2.5th, 5th or 10th percentile of well children is higher than <90%. If a higher threshold than <90% is adopted into LMIC care algorithms then decision-making using SpO must also consider the child's clinical status to minimise misclassification of well children as hypoxaemic. Younger children in lower altitude LMICs may require a different threshold for hypoxaemia than older children. Evaluating the mortality risk of sick children using higher SpO thresholds for hypoxaemia is a key next step.
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http://dx.doi.org/10.1136/bmjresp-2021-001023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8565559PMC
November 2021

Resources and Geographical Access to Care for Severe Pediatric Pneumonia in Four Resource-Limited Settings.

Am J Respir Crit Care Med 2021 Oct 18. Epub 2021 Oct 18.

Johns Hopkins University, 1466, Division of Pulmonary and Critical Care, School of Medicine, Baltimore, Maryland, United States;

Rationale: Pneumonia is the leading cause of death in children worldwide. Identifying and appropriately managing severe pneumonia in a timely manner improves outcomes. Little is known about the readiness of healthcare facilities to manage severe pediatric pneumonia in low-resource settings.

Objectives: As part of the Household Air Pollution Intervention Network (HAPIN) trial, we sought to identify healthcare facilities that were adequately resourced to manage severe pediatric pneumonia in Jalapa, Guatemala (J-GUA); Puno, Peru (P-PER); Kayonza, Rwanda (K-RWA); and Tamil Nadu, India (T-IND). We conducted a facility-based survey of available infrastructure, staff, equipment, and medical consumables. Facilities were georeferenced and a road network analysis was performed.

Measurements And Main Results: Of the 350 healthcare facilities surveyed, 13% had adequate resources to manage severe pneumonia, 37% had pulse oximeters, and 44% had supplemental oxygen. Mean (±SD) travel time to an adequately-resourced facility was 41±19 minutes in J-GUA, 99±64 minutes in P-PER, 40±19 minutes in K-RWA, and 31±19 minutes in T-IND. Expanding pulse oximetry coverage to all facilities reduced travel time by 44% in J-GUA, 29% in P-PER, 29% in K-RWA, and 11% in T-IND (all p<0.001).

Conclusions: Most healthcare facilities in low-resource settings of the HAPIN study area were inadequately resourced to care for severe pediatric pneumonia. Early identification of cases and timely referral is paramount. The provision of pulse oximeters to all health facilities may be an effective approach to identify cases earlier and refer them for care and in a timely manner. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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http://dx.doi.org/10.1164/rccm.202104-1013OCDOI Listing
October 2021

The Effectiveness of High-Flow Nasal Cannula in Coronavirus Disease 2019 Pneumonia: A Retrospective Cohort Study.

Crit Care Med 2021 Sep 22. Epub 2021 Sep 22.

Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD. Department of Applied Mathematics and Statistics, Johns Hopkins University, Baltimore, MD. Division of Biostatistics and Bioinformatics at The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.

Objectives: High-flow nasal cannula is widely used in acute hypoxemic respiratory failure due to coronavirus disease 2019, yet data regarding its effectiveness is lacking. More evidence is needed to guide patient selection, timing of high-flow nasal cannula initiation, and resource allocation. We aimed to assess time to discharge and time to death in severe coronavirus disease 2019 in patients treated with high-flow nasal cannula compared with matched controls. We also evaluated the ability of the respiratory rate-oxygenation ratio to predict progression to invasive mechanical ventilation.

Design: Time-dependent propensity score matching was used to create pairs of individuals who were then analyzed in a Cox proportional-hazards regression model to estimate high-flow nasal cannula's effect on time to discharge and time to death. A secondary analysis excluded high-flow nasal cannula patients intubated within 6 hours of admission. A Cox proportional-hazards regression model was used to assess risk of invasive mechanical ventilation among high-flow nasal cannula patients stratified by respiratory rate-oxygenation.

Setting: The five hospitals of the Johns Hopkins Health System.

Patients: All patients who were admitted with a laboratory-confirmed diagnosis of coronavirus disease 2019 were eligible for inclusion.

Interventions: None.

Measurements And Main Results: High-flow nasal cannula was associated with longer median time to discharge: 10.6 days (interquartile range, 7.1-15.8 d) versus 7.8 days (interquartile range, 4.9-12.1 d). Respiratory rate-oxygenation index performed poorly in predicting ventilation or death. In the primary analysis, there was no significant association between high-flow nasal cannula and hazard of death (adjusted hazard ratio, 0.79; 95% CI, 0.57-1.09). Excluding patients intubated within 6 hours of admission, high-flow nasal cannula was associated with reduced hazard of death (adjusted hazard ratio, 0.67; 95% CI, 0.45-0.99).

Conclusions: Among unselected patients with severe coronavirus disease 2019 pneumonia, high-flow nasal cannula was not associated with a statistically significant reduction in hazard of death. However, in patients not mechanically ventilated within 6 hours of admission, high-flow nasal cannula was associated with a significantly reduced hazard of death.
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http://dx.doi.org/10.1097/CCM.0000000000005309DOI Listing
September 2021

Impact of national introduction of ten-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in Bangladesh: Case-control and time-trend studies.

Vaccine 2021 09 28;39(40):5794-5801. Epub 2021 Aug 28.

Child Health Research Foundation, Dhaka, Bangladesh.

Background: Bangladesh introduced the ten-valent pneumococcal conjugate vaccine (PCV10) into its national immunization program in March 2015 creating an opportunity to assess the real-world impact of PCV on invasive pneumococcal disease (IPD).

Methods: Between January 2014 and June 2018, children aged 3-35 months in three rural sub-districts of Sylhet district of Bangladesh were visited every two months to collect morbidity and care-seeking data. Children attending sub-district hospitals with pneumonia, meningitis, or sepsis were assessed for IPD after obtaining informed consent. Blood and cerebrospinal fluid were collected from enrolled children to isolate pneumococcus using culture and molecular test. Children who were age-eligible to receive the PCV and had pneumococcus isolated were enrolled as cases. Four age and sex-matched clinic and community controls were selected for each case within one to two weeks of case identification. Data on immunization status and confounders were collected. PCV coverage was estimated using vaccine coverage surveys. Case-control and incidence trend analyses were conducted to assess the impact of PCV on IPD.

Results: The community cohort yielded 217,605 child years of observations and 154,773 sick child-visits to study hospitals. Pneumococcus was isolated from 44 children who were age-eligible to receive PCV; these children were enrolled as cases. The cases were matched with 166 community- and 150 clinic-controls. The matched case-control analyses using community-controls showed 83% effectiveness (95% CI: 1.57-97.1%) and clinic controls showed 90% effectiveness (95% CI: -26.0% to 99.1%) of PCV in preventing IPD. Incidence trend analysis estimated vaccine effectiveness at 80.1% (95% CI: 38.4, 93.6).

Conclusion: PCV in this pediatric population in Bangladesh was highly effective in preventing IPD.
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http://dx.doi.org/10.1016/j.vaccine.2021.08.068DOI Listing
September 2021

Characterization of Air Pollution Exposures as Risk Factors for Tuberculosis Infection.

Am J Respir Crit Care Med 2021 11;204(10):1130-1131

Division of Pulmonary and Critical Care.

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http://dx.doi.org/10.1164/rccm.202107-1795EDDOI Listing
November 2021

Challenges in the Implementation of Chronic Obstructive Pulmonary Disease Guidelines in Low- and Middle-Income Countries: An Official American Thoracic Society Workshop Report.

Ann Am Thorac Soc 2021 08;18(8):1269-1277

There is a substantial burden of chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), in low- and middle-income countries (LMICs). LMICs have particular challenges in delivering cost-effective prevention, diagnosis, and management of COPD. Optimal care can be supported by effective implementation of guidelines. This American Thoracic Society workshop considered challenges to implementation of COPD guidelines in LMICs. We make 10 specific recommendations: ) relevant organizations should provide LMIC-specific COPD management guidance; ) patient and professional organizations must persuade policy-makers of the importance of lung function testing programs in LMICs; ) healthcare education and training should emphasize the early-life origins of COPD; ) urgent action is required by governments to reduce airborne exposures, including exposures to tobacco smoke and indoor and outdoor air pollution; ) guidance for COPD in LMICs should explicitly link across Essential Medicine Lists and the World Health Organization package of essential noncommunicable disease interventions for primary health care in low-resource settings and should consider availability, affordability, sustainability, and cost-effective use of medicines; ) the pharmaceutical industry should work to make effective COPD and tobacco-dependence medicines globally accessible and affordable; ) implementation of locally adapted, cost-effective pulmonary rehabilitation programs should be an international priority; ) the World Health Organization Global Action Plan for the Prevention and Control of Noncommunicable Diseases should specify how improvements in respiratory health will be achieved; ) research funders should increase the proportion of funding allocated to COPD in LMICs; and ) the respiratory community should leverage the skills and enthusiasm of earlier-career clinicians and researchers to improve global respiratory health.
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http://dx.doi.org/10.1513/AnnalsATS.202103-284STDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513652PMC
August 2021

Acceptability of patient-centered hypertension education delivered by community health workers among people living with HIV/AIDS in rural Uganda.

BMC Public Health 2021 07 7;21(1):1343. Epub 2021 Jul 7.

Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, USA.

Background: The prevalence of hypertension is increasing among people living with HIV/AIDS (PLWHA) in low- and middle-income countries (LMICs). However, knowledge of the complications and management of hypertension among PLWHA in Uganda remains low. We explored the acceptability of implementing hypertension (HTN) specific health education by community health workers (CHWs) among PLWHA in rural Uganda.

Methods: We conducted a qualitative study consisting of 22 in-depth interviews (14 PLWHA/HTN and 8 CHWs), 3 focus group discussions (FGDs), 2 with PLWHA/HTN and 1 with CHWs from Nakaseke district, Uganda. Participants were interviewed after a single session interaction with the CHW. Data were transcribed from luganda (local language) into English and analyzed using thematic analysis. We used Sekhon's model of acceptability of health Interventions to explore participants' perceptions.

Results: Participants believed CHWs utilized easy-to-understand, colloquial, non-technical language during education delivery, had a pre-existing rapport with the CHWs that aided faster communication, and had more time to explain illness than medical doctors had. Participants found the educational material (PocketDoktor™) to be simple and easy to understand, and perceived that the education would lead to improved health outcomes. Participants stated their health was a priority and sought further disease-specific information. We also found that CHWs were highly motivated to carry out the patient-centered education. While delivering the education, CHWs experienced difficulties in keeping up with the technical details regarding hypertension in the PocketDoktor™, financial stress and patient questions beyond their self-perceived skill level and experience. PLWHA/HTN had challenges accessing the health facility where the intervention was delivered and preferred a household setting.

Conclusions: Hypertension patient-centered education delivered by CHWs using the PocketDoktor™ was acceptable to PLWHA and hypertension in Nakaseke area in rural, Uganda. There is need for further studies to determine the cost implications of delivering this intervention among PLWHA across LMIC settings.
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http://dx.doi.org/10.1186/s12889-021-11411-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264981PMC
July 2021

Altered IgA Response to Gut Bacteria Is Associated with Childhood Asthma in Peru.

J Immunol 2021 07 30;207(2):398-407. Epub 2021 Jun 30.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD

Alterations in gut microbiota in early life have been associated with the development of asthma; however, the role of gut bacteria or the IgA response to gut bacteria in school-aged children with asthma is unclear. To address this question, we profiled the microbial populations in fecal and nasal swab samples by 16S rRNA sequencing from 40 asthma and 40 control children aged 9-17 y from Peru. Clinical history and laboratory evaluation of asthma and allergy were obtained. Fecal samples were analyzed by flow cytometry and sorted into IgA and IgA subsets for 16S rRNA sequencing. We found that the fecal or nasal microbial 16S rRNA diversity and frequency of IgA fecal bacteria did not differ between children with or without asthma. However, the α diversity of fecal IgA bacteria was decreased in asthma compared with control. Machine learning analysis of fecal bacterial IgA-enrichment data revealed loss of IgA binding to the , , and taxa in children with asthma compared with controls. In addition, this loss of IgA binding was associated with worse asthma control (Asthma Control Test) and increased odds of severe as opposed to mild to moderate asthma. Thus, despite little to no change in the microbiota, children with asthma exhibit an altered host IgA response to gut bacteria compared with control participants. Notably, the signature of altered IgA responses is loss of IgA binding, in particular to members of spp., which is associated with greater severity of asthma.
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http://dx.doi.org/10.4049/jimmunol.2001296DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8516662PMC
July 2021

Inequities in air pollution exposure and gaps in air quality monitoring.

J Allergy Clin Immunol 2021 07 21;148(1):64-66. Epub 2021 Apr 21.

Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Md; Center for Global Non-Communicable Diseases, Johns Hopkins University, Baltimore, Md; Program in Global Disease Epidemiology and Control, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md. Electronic address:

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http://dx.doi.org/10.1016/j.jaci.2021.04.014DOI Listing
July 2021

A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings.

BMC Med Res Methodol 2021 04 12;21(1):68. Epub 2021 Apr 12.

Division of International Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, USA.

Rationale: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk.

Objectives: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial conducted in rural, low-resource settings, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize the integrity of reseach aims while minimizing infection risk based on the latest scientific understanding of the virus.

Methods: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. National and local government recommendations provided the minimum safety guidelines for our work.

Results: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential viral aerosolization while performing the activity. For each activity, one of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities that can potentially aerosolize the virus are deemed the highest risk.

Conclusions: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we were able to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our staff, participants, local communities, and funders. This framework can be tailored to other research studies conducted in similar settings during the current pandemic, as well as potential future outbreaks with similar transmission dynamics. The trial is registered with clinicaltrials.gov NCT02944682 on October 26. 2016 .
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http://dx.doi.org/10.1186/s12874-021-01232-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040756PMC
April 2021

Differences between cigarette smoking and biomass smoke exposure: An in silico comparative assessment of particulate deposition in the lungs.

Environ Res 2021 06 3;197:111116. Epub 2021 Apr 3.

Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, USA; Program in Global Disease Epidemiology and Control, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA.

Cigarette smoking and biomass smoke are the two main environmental risk factors of chronic obstructive pulmonary disease (COPD) worldwide. However, it remains unclear why these exposures result in two different disease phenotypes. In this study, we assessed the lung deposition from biomass and cigarette smoke exposures and examined whether differences due to inherently different particle size distributions and inhalation conditions may contribute to the differences between biomass- and tobacco-related COPD phenotypes. Using high-fidelity three-dimensional computational fluid-particle dynamics in a representative upper airway geometry, coupled to one-dimensional models of the lower airways, we computed total deposited doses and examined regional deposition patterns based on exposure data from a randomized control trial in Peru and from the literature for biomass and mainstream cigarette smoke, respectively. Our results showed that intrathoracic deposition was higher in cigarette smoking, with 36.8% of inhaled biomass smoke particles and 57.7% of cigarette smoke particles depositing in the intrathoracic airways. We observed higher fractions of cigarette smoke particles in the last few airway generations, which could explain why cigarette smoking is associated with more emphysema than biomass smoke exposure. Mean daily deposited dose was two orders of magnitude higher in cigarette smoking. Lobar distributions of the deposited dose also differed, with the left lower and right upper lobes receiving the highest doses of biomass and cigarette smoke particles, respectively. Our findings suggest that the differences between biomass- and tobacco-related COPD could, at least in part, be due to differences in total and regional lung deposition of biomass and cigarette smoke.
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http://dx.doi.org/10.1016/j.envres.2021.111116DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8187290PMC
June 2021

Ultrasound Core Laboratory for the Household Air Pollution Intervention Network Trial: Standardized Training and Image Management for Field Studies Using Portable Ultrasound in Fetal, Lung, and Vascular Evaluations.

Ultrasound Med Biol 2021 06 1;47(6):1506-1513. Epub 2021 Apr 1.

Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Department of Medicine, Washington University in St. Louis, Missouri, USA.

Ultrasound Core Laboratories (UCL) are used in multicenter trials to assess imaging biomarkers to define robust phenotypes, to reduce imaging variability and to allow blinded independent review with the purpose of optimizing endpoint measurement precision. The Household Air Pollution Intervention Network, a multicountry randomized controlled trial (Guatemala, Peru, India and Rwanda), evaluates the effects of reducing household air pollution on health outcomes. Field studies using portable ultrasound evaluate fetal, lung and vascular imaging endpoints. The objective of this report is to describe administrative methods and training of a centralized clinical research UCL. A comprehensive administrative protocol and training curriculum included standard operating procedures, didactics, practical scanning and written/practical assessments of general ultrasound principles and specific imaging protocols. After initial online training, 18 sonographers (three or four per country and five from the UCL) participated in a 2 wk on-site training program. Written and practical testing evaluated ultrasound topic knowledge and scanning skills, and surveys evaluated the overall course. The UCL developed comprehensive standard operating procedures for image acquisition with a portable ultrasound system, digital image upload to cloud-based storage, off-line analysis and quality control. Pre- and post-training tests showed significant improvements (fetal ultrasound: 71% ± 13% vs. 93% ± 7%, p < 0.0001; vascular lung ultrasound: 60% ± 8% vs. 84% ± 10%, p < 0.0001). Qualitative and quantitative feedback showed high satisfaction with training (mean, 4.9 ± 0.1; scale: 1 = worst, 5 = best). The UCL oversees all stages: training, standardization, performance monitoring, image quality control and consistency of measurements. Sonographers who failed to meet minimum allowable performance were identified for retraining. In conclusion, a UCL was established to ensure accurate and reproducible ultrasound measurements in clinical research. Standardized operating procedures and training are aimed at reducing variability and enhancing measurement precision from study sites, representing a model for use of portable digital ultrasound for multicenter field studies.
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http://dx.doi.org/10.1016/j.ultrasmedbio.2021.02.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054758PMC
June 2021

24-hour ambulatory blood pressure monitoring and hypertension related risk among HIV-positive and HIV-negative individuals: cross sectional study findings from rural Uganda.

J Hum Hypertens 2021 Mar 25. Epub 2021 Mar 25.

Non-Communicable Diseases (NCD) Theme, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.

Hypertension is diagnosed and treated based on blood pressure (BP) readings obtained in the clinic setting. Positive HIV status is associated with a higher prevalence of abnormal diurnal BP patterns, diagnosed with ambulatory BP monitoring rather than the conventional method of BP measurement. Little is known about ambulatory BP profiles in people living with HIV (PLHIV) in low-income countries, especially within sub-Saharan Africa. In this study, we compared 24-h ambulatory BP profiles of 140 HIV-positive individuals vs. profiles in 166 HIV negative individuals living in rural Uganda. HIV was well-controlled, with all HIV seropositive participants reporting use of anti-retroviral therapy, and ~123 (88%) having undetectable viral load. Most participants reported ART use duration of less than 10 years. Compared to HIV negative participants, HIV positive participants had lower median 24-h systolic BP (110.4 mmHg (IQR: 105.7, 118.7) vs 117.7 mmHg (IQR: 110.8, 129.8), p < 0.001), and 24-h diastolic BP (69.2 mmHg (IQR: 65.0, 74.9) vs. 71.9 mmHg (IQR: 67.2, 78.1), p = 0.004). Adjusted results showed greater percentage systolic nocturnal dipping among PLHIV compared to HIV negative individuals (difference = 2.70 (IQR: 0.94, 4.47), p < 0.05). Results of the adjusted Poisson regression suggested lower prevalence of 24-h and night hypertension among HIV positives compared to HIV negative, but were not statistically significant. Our data suggest that continuous 24-h BP measurements are lower in PLHIV on ART compared to HIV negative individuals.
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http://dx.doi.org/10.1038/s41371-020-00464-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8463623PMC
March 2021

Household air pollution and blood markers of inflammation: A cross-sectional analysis.

Indoor Air 2021 09 22;31(5):1509-1521. Epub 2021 Mar 22.

Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.

Household air pollution (HAP) from biomass stoves is a leading risk factor for cardiopulmonary outcomes; however, its toxicity pathways and relationship with inflammation markers are poorly understood. Among 180 adult women in rural Peru, we examined the cross-sectional exposure-response relationship between biomass HAP and markers of inflammation in blood using baseline measurements from a randomized trial. We measured markers of inflammation (CRP, IL-6, IL-10, IL-1β, and TNF-α) with dried blood spots, 48-h kitchen area concentrations and personal exposures to fine particulate matter (PM ), black carbon (BC), and carbon monoxide (CO), and 48-h kitchen concentrations of nitrogen dioxide (NO ) in a subset of 97 participants. We conducted an exposure-response analysis between quintiles of HAP levels and markers of inflammation. Markers of inflammation were more strongly associated with kitchen area concentrations of BC than PM . As expected, kitchen area BC concentrations were positively associated with TNF-α (pro-inflammatory) concentrations and negatively associated with IL-10, an anti-inflammatory marker, controlling for confounders in single- and multi-pollutant models. However, contrary to expectations, kitchen area BC and NO concentrations were negatively associated with IL-1β, a pro-inflammatory marker. No associations were identified for IL-6 or CRP, or for any marker in relation to personal exposures.
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http://dx.doi.org/10.1111/ina.12814DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8380676PMC
September 2021

Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial.

Trials 2021 Mar 16;22(1):213. Epub 2021 Mar 16.

Makerere University Lung Institute, Makerere College of Health Sciences, Kampala, Uganda.

Background: COPD is a leading cause of death globally, with the majority of morbidity and mortality occurring in low- and middle-income country (LMIC) settings. While tobacco-smoke exposure is the most important risk factor for COPD in high-income settings, household air pollution from biomass smoke combustion is a leading risk factor for COPD in LMICs. Despite the high burden of biomass smoke-related COPD, few studies have evaluated the efficacy of pharmacotherapy in this context. Currently recommended inhaler-based therapy for COPD is neither available nor affordable in most resource-limited settings. Low-dose theophylline is an oral, once-a-day therapy, long used in high-income countries (HICs), which has been proposed for the management of COPD in LMICs in the absence of inhaled steroids and/or bronchodilators. The Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD) trial investigates the clinical efficacy and cost-effectiveness of low-dose theophylline for the management of biomass-related COPD in a low-income setting.

Methods: LODOT-BCOPD is a randomized, double-blind, placebo-controlled trial to test the efficacy of low-dose theophylline in improving respiratory symptoms in 110 participants with moderate to severe COPD in Central Uganda. The inclusion criteria are as follows: (1) age 40 to 80 years, (2) full-time resident of the study area, (3) daily biomass exposure, (4) post-bronchodilator FEV/FVC below the 5th percentile of the Global Lung Initiative mixed ethnic reference population, and (5) GOLD Grade B-D COPD. Participants will be randomly assigned to receive once daily low-dose theophylline (200 mg ER, Unicontin-E) or placebo for 52 weeks. All participants will receive education about self-management of COPD and rescue salbutamol inhalers. We will measure health status using the St. George's Respiratory Questionnaire (SGRQ) and quality of life using the EuroQol-5D (EQ-5D) at baseline and every 6 months. In addition, we will assess household air pollution levels, serum inflammatory biomarkers (fibrinogen, hs-CRP), and theophylline levels at baseline, 1 month, and 6 months. The primary outcome is change in SGRQ score at 12 months. Lastly, we will assess the cost-effectiveness of the intervention by calculating quality-adjusted life years (QALYs) from the EQ-5D.

Trial Registration: ClinicalTrials.gov  NCT03984188 . Registered on June 12, 2019 TRIAL ACRONYM: Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD).
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http://dx.doi.org/10.1186/s13063-021-05163-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7962083PMC
March 2021

Genome-wide association study of asthma, total IgE, and lung function in a cohort of Peruvian children.

J Allergy Clin Immunol 2021 Dec 10;148(6):1493-1504. Epub 2021 Mar 10.

Division of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, Md. Electronic address:

Background: Genetic ancestry plays a role in asthma health disparities.

Objective: Our aim was to evaluate the impact of ancestry on and identify genetic variants associated with asthma, total serum IgE level, and lung function.

Methods: A total of 436 Peruvian children (aged 9-19 years) with asthma and 291 without asthma were genotyped by using the Illumina Multi-Ethnic Global Array. Genome-wide proportions of indigenous ancestry populations from continental America (NAT) and European ancestry from the Iberian populations in Spain (IBS) were estimated by using ADMIXTURE. We assessed the relationship between ancestry and the phenotypes and performed a genome-wide association study.

Results: The mean ancestry proportions were 84.7% NAT (case patients, 84.2%; controls, 85.4%) and 15.3% IBS (15.8%; 14.6%). With adjustment for asthma, NAT was associated with higher total serum IgE levels (P < .001) and IBS was associated with lower total serum IgE levels (P < .001). NAT was associated with higher FEV percent predicted values (P < .001), whereas IBS was associated with lower FEV values in the controls but not in the case patients. The HLA-DR/DQ region on chromosome 6 (Chr6) was strongly associated with total serum IgE (rs3135348; P = 3.438 × 10) and was independent of an association with the haplotype HLA-DQA1∼HLA-DQB1:04.01∼04.02 (P = 1.55 × 10). For lung function, we identified a locus (rs4410198; P = 5.536 × 10) mapping to Chr19, near a cluster of zinc finger interacting genes that colocalizes to the long noncoding RNA CTD-2537I9.5. This novel locus was replicated in an independent sample of pediatric case patients with asthma with similar admixture from Brazil (P = .005).

Conclusion: This study confirms the role of HLA in atopy, and identifies a novel locus mapping to a long noncoding RNA for lung function that may be specific to children with NAT.
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http://dx.doi.org/10.1016/j.jaci.2021.02.035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8429514PMC
December 2021

Training physicians in India to interpret pediatric chest radiographs according to World Health Organization research methodology.

Pediatr Radiol 2021 Jul 11;51(8):1322-1331. Epub 2021 Mar 11.

Department of International Health, International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Background: Chest radiography is the standard for diagnosing pediatric lower respiratory infections in low-income and middle-income countries. A method for interpreting pediatric chest radiographs for research endpoints was recently updated by the World Health Organization (WHO) Chest Radiography in Epidemiological Studies project. Research in India required training local physicians to interpret chest radiographs following the WHO method.

Objective: To describe the methodology for training Indian physicians and evaluate the training's effectiveness.

Materials And Methods: Twenty-nine physicians (15 radiologists and 14 pediatricians) from India were trained by two WHO Chest Radiography in Epidemiological Studies members over 3 days in May 2019. Training materials were adapted from WHO Chest Radiography in Epidemiological Studies resources. Participants followed WHO methodology to interpret 60 unique chest radiographs before and after the training. Participants needed to correctly classify ≥80% of radiographs for primary endpoint pneumonia on the post-training test to be certified to interpret research images. We analyzed participant performance on both examinations.

Results: Twenty-six of 29 participants (89.7%) completed both examinations. The average score increased by 9.6% (95% confidence interval [CI] 5.0-14.1%) between examinations (P<0.001). Participants correctly classifying ≥80% of images for primary endpoint pneumonia increased from 69.2% (18/26) on the pretraining to 92.3% (24/26) on the post-training examination (P=0.003). The mean scores of radiologists and pediatricians on the post-training examination were not statistically different (P=0.43).

Conclusion: Our results demonstrate this training approach using revised WHO definitions and tools was successful, and that non-radiologists can learn to apply these methods as effectively as radiologists. Such capacity strengthening is important for enabling research to support national policy decision-making in these settings. We recommend future research incorporating WHO chest radiograph methodology to consider modelling trainings after this approach.
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http://dx.doi.org/10.1007/s00247-021-04992-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8266794PMC
July 2021

Association between Blood Pressure and HIV Status in Rural Uganda: Results of Cross-Sectional Analysis.

Glob Heart 2021 02 10;16(1):12. Epub 2021 Feb 10.

Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, Maryland, US.

Introduction: The association between HIV status and hypertension is not well described within sub-Saharan Africa. We examined prevalence and risk factors for hypertension among HIV positive and negative individuals living in a rural district of Uganda.

Methods: We conducted a cross-sectional analysis in two concurrent cohorts of 600 HIV negative and 721 HIV seropositive individuals aged ≥35 years.

Results: Of the 721 HIV positive participants, 59.8% were women and the median age was 44.3 years, while for HIV negative individuals, 55% were women and the median age was 47.8 years. Over 90% of HIV positive individuals were on antiretroviral treatment. The prevalence of hypertension (≥140/≥90 mmHg) was 33.5% in HIV negative individuals and 23.9% in HIV positive individuals. Age (adjusted OR = 1.05, 95% CI 1.03 to 1.06) and BMI (adjusted OR = 1.08, 95% CI 1.05 to 1.12) were associated with higher odds of hypertension. Having HIV was associated with lower odds of hypertension (adjusted OR = 0.66, 95% CI 0.50 to 0.88), lower systolic blood pressure (-5.1 mmHg, 95% CI: -7.4 to -2.4) and lower diastolic blood pressure (-4.0 mmHg, 95% CI: -5.6 to -2.5). We did not observe differences in the odds of hypertension by CD4 count, viral load or ART among HIV positive individuals in this sample.

Conclusions: Hypertension was prevalent in one third of HIV negative individuals and in one fourth of HIV positive patients. While access to health information among individuals attending HIV clinics may explain observed differences, more research is needed to understand plausible biological and social mechanisms that could explain lower blood pressure among people living with HIV in Uganda.
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http://dx.doi.org/10.5334/gh.858DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880004PMC
February 2021

Pragmatic Recommendations for the Management of Acute Respiratory Failure and Mechanical Ventilation in Patients with COVID-19 in Low- and Middle-Income Countries.

Am J Trop Med Hyg 2021 Jan 13. Epub 2021 Jan 13.

3Department of Intensive Care, Amsterdam University Medical Centers, Location 'Academic Medical Center', Amsterdam, The Netherlands.

Management of patients with severe or critical COVID-19 is mainly modeled after care for patients with severe pneumonia or acute respiratory distress syndrome (ARDS) from other causes, and these recommendations are based on evidence that often originates from investigations in resource-rich intensive care units located in high-income countries. Often, it is impractical to apply these recommendations to resource-restricted settings, particularly in low- and middle-income countries (LMICs). We report on a set of pragmatic recommendations for acute respiratory failure and mechanical ventilation management in patients with severe/critical COVID-19 in LMICs. We suggest starting supplementary oxygen when SpO2 is persistently lower than 94%. We recommend supplemental oxygen to keep SpO2 at 88-95% and suggest higher targets in settings where continuous pulse oximetry is not available but intermittent pulse oximetry is. We suggest a trial of awake prone positioning in patients who remain hypoxemic; however, this requires close monitoring, and clear failure and escalation criteria. In places with an adequate number and trained staff, the strategy seems safe. We recommend to intubate based on signs of respiratory distress more than on refractory hypoxemia alone, and we recommend close monitoring for respiratory worsening and early intubation if worsening occurs. We recommend low-tidal volume ventilation combined with FiO2 and positive end-expiratory pressure (PEEP) management based on a high FiO2/low PEEP table. We recommend against using routine recruitment maneuvers, unless as a rescue therapy in refractory hypoxemia, and we recommend using prone positioning for 12-16 hours in case of refractory hypoxemia (PaO2/FiO2 < 150 mmHg, FiO2 ≥ 0.6 and PEEP ≥ 10 cmH2O) in intubated patients as standard in ARDS patients. We also recommend against sharing one ventilator for multiple patients. We recommend daily assessments for readiness for weaning by a low-level pressure support and recommend against using a T-piece trial because of aerosolization risk.
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http://dx.doi.org/10.4269/ajtmh.20-0796DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957237PMC
January 2021

Development and Validity Assessment of a Chronic Obstructive Pulmonary Disease Knowledge Questionnaire in Low- and Middle-Income Countries.

Ann Am Thorac Soc 2021 08;18(8):1298-1305

University College London Respiratory, University College London, London, United Kingdom.

The majority of the morbidity and mortality related to chronic obstructive pulmonary disease (COPD) occurs in low- and middle-income countries (LMICs). Despite the increasing burden of COPD, disease-specific knowledge among healthcare workers and patients in LMICs remains limited. COPD knowledge questionnaires (COPD-KQ) are valid and reliable tools to assess COPD knowledge and can be employed in settings with limited health literacy. To develop and assess the validity and reliability of a COPD-KQ among individuals with COPD in three LMIC settings. Twelve questions were generated by an expert team of 16 researchers, physicians, and public health professionals to create an LMIC-specific COPD-KQ. The content was based on previous instruments, clinical guidelines, focus-group discussions, and questionnaire piloting. Participants with COPD completed the questionnaire across three diverse LMIC settings before and 3 months after delivery of a standardized COPD-specific education package by a local community health worker trained to deliver the education to an appropriate standard. We used paired tests to assess improvement in knowledge after intervention. Questionnaire development initially yielded 52 items. On the basis of community feedback and expertise, items were eliminated and added, yielding a final 12-item questionnaire, with a maximum total score of 12. A total of 196 participants with COPD were included in this study in Nepal ( = 86), Peru ( = 35), and Uganda ( = 75). The mean ± standard deviation baseline score was 8.0 ± 2.5, and 3 months after education, the mean score was 10.2 ± 1.7. The community health worker-led COPD educational intervention improved COPD knowledge among community members by 2.2 points (95% confidence interval, 1.8-2.6 points;  = 10.9;  < 0.001). Internal consistency using Cronbach's α was 0.75. The LMIC COPD-KQ demonstrates face and content validity and acceptable internal consistency through development phases, suggesting a reliable and valid COPD education instrument that can be used to assess educational interventions across LMIC settings. Clinical trial registered with www.clinicaltrials.gov (NCT03365713).
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http://dx.doi.org/10.1513/AnnalsATS.202007-884OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513659PMC
August 2021

Use of liquefied petroleum gas in Puno, Peru: Fuel needs under conditions of free fuel and near-exclusive use.

Energy Sustain Dev 2020 Oct 7;58:150-157. Epub 2020 Sep 7.

Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

Reducing the burden of household air pollution could be achieved with exclusive adoption of cleaner fuels such as liquefied petroleum gas (LPG). However, we lack understanding of how much LPG is required to support exclusive use and how household characteristics affect this quantity. This paper used data from 90 participants in the Cardiopulmonary outcomes and Household Air Pollution (CHAP) trial in Puno, Peru who received free LPG deliveries for one year. Households with a mean of four members that cooked nearly exclusively (>98%) with LPG used an average of 19.1 kg (95% CI 18.5 to 19.6) of LPG per month for tasks similar to those done with the traditional biomass stove. LPG use per month was 0.5 kg higher for each additional pig or dog owned (p=0.003), 0.7 kg higher for each additional household member (p<0.001), 0.3 kg higher for households in the second-lowest compared to the lowest wealth quintile (p=0.01), and 1.1 kg higher if the household had previously received subsidized LPG (p=0.05). LPG use per month was 1.1 kg lower during the rainy season (p<0.001) and 1.7 kg lower during the planting season (p<0.001) compared to the cold and harvest seasons, despite the fact that LPG was not typically used for space heating. LPG use decreased by 0.05 kg per month over the course of one year after receiving the LPG stove (p=0.02). These results suggest that achieving exclusive LPG use in Puno, Peru requires that rural residents have affordable access to an average of two 10 kg LPG tanks per month. Conducting similar investigations in other countries could help policymakers set and target LPG subsidies to ensure that households have access to enough LPG to achieve exclusive LPG use and the potential health benefits.
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http://dx.doi.org/10.1016/j.esd.2020.07.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799435PMC
October 2020

Pragmatic Recommendations for Therapeutics of Hospitalized COVID-19 Patients in Low- and Middle-Income Countries.

Am J Trop Med Hyg 2020 Dec 29. Epub 2020 Dec 29.

Division of Pulmonary Allergy Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

The therapeutic options for COVID-19 patients are currently limited, but numerous randomized controlled trials are being completed, and many are on the way. For COVID-19 patients in low- and middle-income countries (LMICs), we recommend against using remdesivir outside of a clinical trial. We recommend against using hydroxychloroquine ± azithromycin or lopinavir-ritonavir. We suggest empiric antimicrobial treatment for likely coinfecting pathogens if an alternative infectious cause is likely. We suggest close monitoring without additional empiric antimicrobials if there are no clinical or laboratory signs of other infections. We recommend using oral or intravenous low-dose dexamethasone in adults with COVID-19 disease who require oxygen or mechanical ventilation. We recommend against using dexamethasone in patients with COVID-19 who do not require supplemental oxygen. We recommend using alternate equivalent doses of steroids in the event that dexamethasone is unavailable. We also recommend using low-dose corticosteroids in patients with refractory shock requiring vasopressor support. We recommend against the use of convalescent plasma and interleukin-6 inhibitors, such as tocilizumab, for the treatment of COVID-19 in LMICs outside of clinical trials.
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http://dx.doi.org/10.4269/ajtmh.20-1106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957231PMC
December 2020

Pragmatic Recommendations for Safety while Caring for Hospitalized Patients with Coronavirus Disease 2019 (COVID-19) in Low- and Middle-Income Countries.

Am J Trop Med Hyg 2020 Dec 22. Epub 2020 Dec 22.

Divisao de Pneumologia, Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.

Infection prevention and control measures to control the spread of COVID-19 are challenging to implement in many low- and middle-income countries (LMICs). This is compounded by the fact that most recommendations are based on evidence that mainly originates in high-income countries. There are often availability, affordability, and feasibility barriers to applying such recommendations in LMICs, and therefore, there is a need for developing recommendations that are achievable in LMICs. We used a modified version of the GRADE method to select important questions, searched the literature for relevant evidence, and formulated pragmatic recommendations for safety while caring for patients with COVID-19 in LMICs. We selected five questions related to safety, covering minimal requirements for personal protective equipment (PPE), recommendations for extended use and reuse of PPE, restriction on the number of times healthcare workers enter patients' rooms, hand hygiene, and environmental ventilation. We formulated 21 recommendations that are feasible and affordable in LMICs.
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http://dx.doi.org/10.4269/ajtmh.20-1128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957241PMC
December 2020

Effects of a Household Air Pollution Intervention with Liquefied Petroleum Gas on Cardiopulmonary Outcomes in Peru. A Randomized Controlled Trial.

Am J Respir Crit Care Med 2021 06;203(11):1386-1397

Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, Maryland.

Approximately 40% of people worldwide are exposed to household air pollution (HAP) from the burning of biomass fuels. Previous efforts to document health benefits of HAP mitigation have been stymied by an inability to lower emissions to target levels. We sought to determine if a household air pollution intervention with liquefied petroleum gas (LPG) improved cardiopulmonary health outcomes in adult women living in a resource-poor setting in Peru. We conducted a randomized controlled field trial in 180 women aged 25-64 years living in rural Puno, Peru. Intervention women received an LPG stove, continuous fuel delivery for 1 year, education, and behavioral messaging, whereas control women were asked to continue their usual cooking practices. We assessed for stove use adherence using temperature loggers installed in both LPG and biomass stoves of intervention households. We measured blood pressure, peak expiratory flow (PEF), and respiratory symptoms using the St. George's Respiratory Questionnaire at baseline and at 3-4 visits after randomization. Intervention women used their LPG stove exclusively for 98% of days. We did not find differences in average postrandomization systolic blood pressure (intervention - control 0.7 mm Hg; 95% confidence interval, -2.1 to 3.4), diastolic blood pressure (0.3 mm Hg; -1.5 to 2.0), prebronchodilator peak expiratory flow/height (0.14 L/s/m; -0.02 to 0.29), postbronchodilator peak expiratory flow/height (0.11 L/s/m; -0.05 to 0.27), or St. George's Respiratory Questionnaire total score (-1.4; -3.9 to 1.2) over 1 year in intention-to-treat analysis. There were no reported harms related to the intervention. We did not find evidence of a difference in blood pressure, lung function, or respiratory symptoms during the year-long intervention with LPG. Clinical trial registered with www.clinicaltrials.gov (NCT02994680).
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http://dx.doi.org/10.1164/rccm.202006-2319OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8456540PMC
June 2021

Exposure contrasts associated with a liquefied petroleum gas (LPG) intervention at potential field sites for the multi-country household air pollution intervention network (HAPIN) trial in India: results from pilot phase activities in rural Tamil Nadu.

BMC Public Health 2020 Nov 26;20(1):1799. Epub 2020 Nov 26.

Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, 600116, India.

Background: The Household Air Pollution Intervention Network (HAPIN) trial aims to assess health benefits of a liquefied petroleum gas (LPG) cookfuel and stove intervention among women and children across four low- and middle-income countries (LMICs). We measured exposure contrasts for women, achievable under alternative conditions of biomass or LPG cookfuel use, at potential HAPIN field sites in India, to aid in site selection for the main trial.

Methods: We recruited participants from potential field sites within Villupuram and Nagapattinam districts in Tamil Nadu, India, that were identified during a feasibility assessment. We performed. (i) cross-sectional measurements on women (N = 79) using either biomass or LPG as their primary cookfuel and (ii) before-and-after measurements on pregnant women (N = 41), once at baseline while using biomass fuel and twice - at 1 and 2 months - after installation of an LPG stove and free fuel intervention. We involved participants to co-design clothing and instrument stands for personal and area sampling. We measured 24 or 48-h personal exposures and kitchen and ambient concentrations of fine particulate matter (PM2.5) using gravimetric samplers.

Results: In the cross-sectional analysis, median (interquartile range, IQR) kitchen PM2.5 concentrations in biomass and LPG using homes were 134 μg/m3 [IQR:71-258] and 27 μg/m3 [IQR:20-47], while corresponding personal exposures were 75 μg/m3 [IQR:55-104] and 36 μg/m3 [IQR:26-46], respectively. In before-and-after analysis, median 48-h personal exposures for pregnant women were 72 μg/m3 [IQR:49-127] at baseline and 25 μg/m3 [IQR:18-35] after the LPG intervention, with a sustained reduction of 93% in mean kitchen PM2.5 concentrations and 78% in mean personal PM2.5 exposures over the 2 month intervention period. Median ambient concentrations were 23 μg/m3 [IQR:19-27). Participant feedback was critical in designing clothing and instrument stands that ensured high compliance.

Conclusions: An LPG stove and fuel intervention in the candidate HAPIN trial field sites in India was deemed suitable for achieving health-relevant exposure reductions. Ambient concentrations indicated limited contributions from other sources. Study results provide critical inputs for the HAPIN trial site selection in India, while also contributing new information on HAP exposures in relation to LPG interventions and among pregnant women in LMICs.

Trial Registration: ClinicalTrials.Gov. NCT02944682 ; Prospectively registered on October 17, 2016.
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http://dx.doi.org/10.1186/s12889-020-09865-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690197PMC
November 2020

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic.

Res Sq 2020 Nov 12. Epub 2020 Nov 12.

National Institutes of Health.

Rationale: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk.

Objectives: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize integrity of reseach aims while minimizing infection risk based on the latest understanding of the virus.

Methods: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework.

Results: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential aerosolization while performing the activity. One of of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities which can potentially aerosolize the virus are deemed the highest risk.

Conclusions: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we can compare trial activities using the same criteria. This approach allows us to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our participants, local communities, and funders. The trial is registered with clinicaltrials.gov (NCT02944682).
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http://dx.doi.org/10.21203/rs.3.rs-103997/v1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668754PMC
November 2020

A Novel Case-Finding Instrument for Chronic Obstructive Pulmonary Disease in Low- and Middle-Income Country Settings.

Int J Chron Obstruct Pulmon Dis 2020 3;15:2769-2777. Epub 2020 Nov 3.

Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

Background: Low- and middle-income countries (LMICs) account for >90% of deaths and illness episodes related to COPD; however, this condition is commonly underdiagnosed in these settings. Case-finding instruments for COPD may improve diagnosis and identify individuals that need treatment, but few have been validated in resource-limited settings.

Methods: We conducted a population-based cross-sectional study in Uganda to assess the diagnostic accuracy of a respiratory symptom, exposure and functional questionnaire in combination with peak expiratory flow for COPD diagnosis using post-bronchodilator FEV/FVC z-score below the 5th percentile as the gold standard. We included locally relevant exposure questions and statistical learning techniques to identify the most important risk factors for COPD. We used 80% of the data to develop the case-finding instrument and validated it in the remaining 20%. We evaluated for calibration and discrimination using standard approaches. The final score, COLA (COPD in LMICs Assessment), included seven questions, age and pre-bronchodilator peak expiratory flow.

Results: We analyzed data from 1,173 participants (average age 47 years, 46.9% male, 4.5% with COPD) with acceptable and reproducible spirometry. The seven questions yielded a cross-validated area-under-the-curve [AUC] of 0.68 (95% CI 0.61-0.75) with higher scores conferring greater odds of COPD. The inclusion of peak expiratory flow and age improved prediction in a validation sample (AUC=0.83, 95% CI 0.78-0.88) with a positive predictive value of 50% and a negative predictive value of 96%. The final instrument (COLA) included seven questions, age and pre-bronchodilator peak expiratory flow.

Conclusion: COLA predicted COPD in urban and rural settings in Uganda has high calibration and discrimination, and could serve as a simple, low-cost screening tool in resource-limited settings.
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http://dx.doi.org/10.2147/COPD.S268076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7648534PMC
June 2021
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