Center Protocols

The Peru Center of Excellence at the Universidad Peruana Cayetano Heredia (UPCH) enacted three protocols:

Protocol 1
Addressing geographical variation in the progression of non-communicable diseases in Peru

Protocol 2
Feasibility intervention trial of two types of improved cookstoves in three developing countries

Protocol 3
Lung ultrasound as a point-of-care diagnostic approach for pneumonia outcomes in improved cook stove intervention trials

Objectives

Protocol 1
To investigate the geographical variation in cardiovascular disease risk factors and disease incidence. To estimate the disease burden and influence of outdoor and indoor air pollution on chronic obstructive pulmonary disease.

Protocol 2
To perform a community-based feasibility trial with two types of improved cookstoves with a chimney in rural households.

Protocol 3
To determine the feasibility of lung ultrasound as a point-of-care diagnostic approach to improve the specificity of pneumonia diagnosis in young children from developing countries.

Background

Protocol 1
Peru, like many Latin American countries, has undergone a rapid epidemiological transition. As a result, the prevalence and risk factors of non-communicable diseases are changing. Understanding the effects of urbanization on the development of non-communicable diseases is an important public health challenge. However, there is a paucity of country-specific information regarding non-communicable disease burden and risk factors, especially in disadvantaged populations in Peru.

Both cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) are non-communicable diseases that pose a public health burden. A previous study showed a difference between cardiovascular risk factors among rural and urban populations. In many developing countries, the burden of COPD can be attributed to biomass fuel exposure. Globally, approximately 50% of all households and 90% of rural households use solid fuels as the main domestic source of energy; women and children having greater exposure than men. Furthermore, living at altitude may modify disease risk, since the anatomy and physiology of the respiratory system, and exposure to biomass fuel is different than at sea level. This protocol was initiated to investigate CVD risk factors and COPD burden in populations living in areas of differing urbanization, indoor and outdoor pollutions levels, and altitudes.

Protocol 2
More than half of the world’s population uses solid fuels indoors, particularly wood and coal, for cooking and home heating. Incomplete combustion of these materials results in the production of hazardous by-products that directly affect respiratory health. The World Health Organization (WHO) has identified indoor combustion of biomass solid fuels as one of the leading risk factors for disease burden worldwide. In 2000, more than 1.6 million deaths were attributed to biomass fuel smoke. Women and children tend to have the highest exposure to indoor air pollution because they spend the majority of the day inside or near the house. Biomass fuel exposure has been associated with an increased risk of respiratory infections including pneumonia, lung cancer, COPD, cardiovascular events, low birth weight and all-cause mortality in both adults and children.

Improved cookstoves increase the completeness of combustion and vent hazardous biomass products to the exterior of the house through a chimney, reducing exposure to biomass fuels. This protocol was initiated to determine if the use of an improved cookstove improves respiratory symptoms and lung function of the main cook in the household.

Protocol 3
Acute lower respiratory infection (ALRI) is the leading cause of death in children under 5 years of age. Pneumonia alone is responsible for killing 1.6 million children worldwide. Young children exposed to biomass fuel smoke are two times more likely to develop ALRI than those who are not exposed. The WHO developed a case management algorithm that relies solely on symptoms of shortness of breath or cough, an elevated respiratory rate, and chest indrawing for the diagnosis of pneumonia and administration of antibiotics and/or referral in resource-poor areas. This approach has a high rate of misclassification for pneumonia. A promising alternative for detection of pediatric pneumonia is lung ultrasound. Ultrasound has the advantage of gathering information from multiple angles and the ability to detect air-fluid differences that are present with pneumonia. This protocol was initiated to assess the feasibility of conducting ultrasound assessments as a point-of-care approach for the diagnosis of pneumonia in resource poor settings with a heavy burden of indoor air pollution.

Participants

Protocol 1
Eligible participants were aged 35 years and older and living in one of the three selected sites at the time of the study. Exclusion criteria included pregnancy and mobility problems. Additional exclusion criteria, such as high blood pressure, were applied only for spirometry. The Microbiome sub-study included participants with and without COPD who were current smokers or who were regularly exposed to biomass fuel smoke.

A total of 3009 participants were enrolled. A subset of participants provided urine samples (Tumbes only), performed a 6-minute walk test, and/or provided sputum samples.

Protocol 2
Eligible participants were women aged 20-49 years old who identified as the main cook in a household that used a traditional cookstove indoors.

A total of 133 participants were enrolled.

Protocol 3
Eligible participants were aged > 2 months and < 3 years and met the WHO criteria for ALRI. Participants with no WHO criteria for ALRI were enrolled as controls.

A total of 378 participants were enrolled. 127 were controls, 82 had respiratory symptoms without clinical pneumonia, and 169 had clinical pneumonia by WHO criteria.

Design

Protocol 1
This was an observational study conducted at three sites in Peru, consisting of two phases. The sites included Lima (sea-level, highly urbanized, high levels of outdoor air pollution, low prevalence of biomass fuel use), Tumbes (sea-level, less urbanized, low levels of outdoor air pollution, high prevalence of biomass fuel use), and Puno (high-altitude, rural, low levels of outdoor air pollution, high prevalence of biomass fuel use). Phase 1 determined the prevalence of CVD risk factors, hypertension, diabetes, obesity, and COPD. Demographics and anthropometrics were obtained as well. Participants were also asked to complete several questionnaires. Phase 2 was follow-up at 20 and 40 months. Selected participants were asked to provide urine samples (Tumbes only), complete a 6-minute walk test, and/or provide sputum samples to be tested for lung microbiome.

The primary objectives were to compare the prevalence and risk factors of CVD and COPD, the rate of disease progression to hypertension and diabetes from a disease-free baseline status and the rate of lung function decline between populations.

Miranda JJ, Bernabe-Ortiz A, Smeeth L, Gilman RH, Checkley W; CRONICAS Cohort Study Group. Addressing geographical variation in the progression of non-communicable diseases in Peru: the CRONICAS cohort study protocol. BMJ Open. 2012;2(1):e000610. Published 2012 Jan 11. doi:10.1136/bmjopen-2011-000610

Protocol 2
This was a feasibility study conducted at three sites. The sites were located in Peru, Kenya, and Nepal. The study used a crossover design. All participants had a run-in observational period of 4 months with the traditional cookstove prior to randomization. Participants were then randomized to receive one type of the improved cookstove with a chimney for 4 months, followed by the other type of improved cookstove with a chimney for another 4 months. At baseline, sociodemographic information for each household, respiratory outcomes and other health data for the participating women, and cooking times and practices including the types of fuels used were collected. Cooking behavioral practices and compliance with improved cookstove use were assessed monthly. Respiratory and environmental measures were assessed at the mid-point of each 4-month period to minimize carry-over effects.

Protocol 3
This was an observational study conducted at two resource poor sites, one in Peru and the other in Nepal. Enrolled participants received bilateral lung ultrasonography performed by a physician trained on a standardized protocol. Parents of participants completed a questionnaire on symptoms, previous treatments, medical history, and demographics. Vital signs, respiratory findings, and ultrasound findings were also collected.

The primary outcome was to determine agreement between the WHO algorithm and lung consolidations identified by point-of-care ultrasound.

Conclusions

Protocol 3
The WHO algorithm disagreed with point-of-care ultrasound findings in more than one-third of children and had an overall low performance when compared with point-of-care ultrasound to identify lung consolidation. A paired approach with point-of-care ultrasound may improve case management in resource-limited settings.

Chavez MA, Naithani N, Gilman RH, et al. Agreement Between the World Health Organization Algorithm and Lung Consolidation Identified Using Point-of-Care Ultrasound for the Diagnosis of Childhood Pneumonia by General Practitioners. Lung. 2015;193(4):531-538. doi:10.1007/s00408-015-9730-x

Request Data

Please note that researchers must be registered on this site to submit a request, and you will be prompted to log in. If you are not registered on this site, you can do so via the Request button. Registration is quick, easy and free.