Research ethics training in Peru: a case study.

With the rapidly increasing number of health care professionals seeking international research experience, comes an urgent need for enhanced capacity of host country institutional review boards (IRB) to review research proposals and ensure research activities are both ethical and relevant to the host country customs and needs. A successful combination of distance learning, interactive courses and expert course instructors has been applied in Peru since 2004 through collaborations between the U.S. Naval Medical Research Center Detachment, the University of Washington and the Department of Clinical Bioethics of the National Institutes of Health to provide training in ethical conduct of research to IRB members and researchers from Peru and other Latin American countries. All training activities were conducted under the auspices of the Peruvian National Institute of Health (INS), Ministry of Health. To date, 927 people from 12 different Latin American countries have participated in several of these training activities. In this article we describe our training model.

Supporting the creation of new institutional review boards in developing countries: the U.S. Naval Medical Research Center Detachment experience.

The U.S. Naval Medical Research Center Detachment (NMRCD) has worked in Peru since 1983, conducting research on diseases of military importance in large part by interacting with multiple research partners across the scientific community of Central America and South America. Over the years, NMRCD has had research collaborations in Guatemala, Nicaragua, Costa Rica, Belize, Honduras, Suriname, Venezuela, Colombia, Ecuador, Bolivia, Chile, Uruguay, Paraguay, and Argentina. In addition to the various infectious diseases research collaborations, NMRCD has supported capacity building for research ethics and the creation of new institutional review boards. This article describes the contributions of NMRCD to research ethics training in Central America and South America, with specific emphasis on the support given to the creation of new institutional review boards.

Prevalence of bacterial vaginosis among young women in low-income populations of coastal Peru.

The goal of this study was to determine the prevalence of bacterial vaginosis (BV) in Peruvian women from socioeconomically deprived populations and to determine the association between BV and risk factors for sexually transmitted diseases (STDs). Women were administered an epidemiologic survey to determine sexual risk behaviour and they provided biological samples to test for BV and STDs. The prevalence of BV was high (27%) and was significantly associated with having a bacterial STD or trichomoniasis. Age, marital status, and a history of sex work, but not of sexual experience, frequency of intercourse, and unprotected intercourse, were associated with BV. As BV may be a marker for STDs, screening for STDs should be performed in individuals with BV to promote early detection and treatment of co-infecting sexually transmitted pathogens.

Multidrug-resistant tuberculosis in bone marrow transplant recipient.

Multidrug-resistant tuberculosis (TB) is an increasing problem worldwide, however only three cases have been previously described in transplant recipients, especially involving lung and heart transplant. We describe a case of multidrug-resistant TB in an allogenic bone marrow transplant recipient with good response to second-line therapy.

Resultados de la aplicación de neurolépticos de depósito en pacientes psicóticos del Hospital "Víctor Larco Herrera" 2002-2003 / Results of the application of antipsychotics of deposit in psychotics patients of the Hospital

El Programa de Neurolépticos de Acción prolongada (NAP) es único en su género en el país. Nació con el propósito de evitar las recaídas y posteriores hospitalizaciones y evitar la larga permanencia de pacientes psicóticos en el Hospital "Víctor Larco Herrera". Si bien estos propósitos se mantuvieron, el programa necesitó de una reorganización que mejorase sus procesos. En la actualidad, el número de pacientes casi llega a los 500 y a pesar de que el sistema hospitalario aún acoge la idea de los programas organizados y sistematizados y no haberse desenvuelto al óptimo de su capacidad, el Programa NAP ha demostrado su eficiencia al conseguir con pocos recursos, una organización y un equipo cohesionado, disminuir los modos y frecuencias de aplicación, elevar el cumplimiento, disminuir las hospitalizaciones y contribuir a crear más conciencia de enfermedad en sus pacientes. Esperamos que en el futuro se creen en nuestro Hospital más programas que sistematicen y especialicen la atención en beneficio de los pacientes que acuden a él.

Acute mountain sickness, dehydration, and bicarbonate clearance: preliminary field data from the Nepal Himalaya.

BACKGROUND: In 1999, Basnyat et al. published preliminary data demonstrating an inverse correlation between hydration status and acute mountain sickness during an epidemiological study performed in the vicinity of Mount Everest. To expand on these findings, we have re turned to the Langtang area of the Nepal Himalaya to perform more specific studies of altitude illness related to dehydration and hypoxemia using urine studies, pulse oximetry, and physical examination. HYPOTHESIS: Dehydration will incite physiological changes aimed at the preservation of vascular volume homeostasis characterized by the production of sodium and water sparing hormones. As sodium is reabsorbed in the kidney, bicarbonate anion is also reabsorbed resulting in insufficient bicarbonate anion excretion by the kidney leading to an incomplete compensation for altitude induced hypocapnic alkalosis and the development of clinical disease. METHODS: Estimates of intravascular volume (urine specific gravity), oxygen saturation (pulse oximetry), urinary bi carbonate excretion (urine pH), and AMS (Lake Louise Score) were collected from Hindu pilgrims at 4243 m during an annual sacred festival at Lake Gosinkunda. RESULTS: Worsening altitude illness approx imated by increasing Lake Louise Score was associated with increasing urine specific gravity (p = 0.043), decreasing oxygen saturation (p = 0.020), and decreasing urine pH (p = 0.040) after rapid ascent to 4243 m. CONCLUSIONS: Worsening altitude illness, indicated by increasing Lake Louise score, was associated with increasing measures of dehydration, hypoxemia, and urine acidity.

Risk factors for burns in children: crowding, poverty, and poor maternal education.

OBJECTIVE: To characterize the presentation of burns in children and risk factors associated with their occurrence in a developing country as a basis for future prevention programs. DESIGN: Case-control study. SETTING: Burn unit of the National Institute of Child Health (Instituto Nacional de Salud del Niño) in Lima, Peru. METHODS: A questionnaire was administered to all consenting guardians of children admitted to the burns (cases) and general medicine (controls) units during a period of 14 months. Guardians of patients were questioned regarding etiology of the injury, demographic and socioeconomic data. RESULTS: 740 cases and controls were enrolled. Altogether 77.5% of the cases burns occurred in the patient's home, with 67.8% in the kitchen; 74% were due to scalding. Most involved children younger than 5 years. Lack of water supply (odds ratio (OR) 5.2, 95% confidence interval (CI) 2.1 to 1 2.3), low income (OR 2.8, 95% CI 2.0 to 3.9), and crowding (OR 2.5, 95%CI 1.7 to 3.6) were associated with an increased risk. The presence of a living room (OR 0.6, 95% CI 0.4 to 0.8) and better maternal education (OR 0.6, 95% CI 0.5 to 0.9) were protective factors. CONCLUSIONS: To prevent burns interventions should be directed to low socioeconomic status groups; these interventions should be designed accordingly to local risk factors.

The efficacy of bismuth subsalicylate in the treatment of acute diarrhoea and the prevention of persistent diarrhoea.

UNLABELLED: A controlled, randomized, double-blind study in Bangladeshi children (ages 4-36 mo) with acute diarrhoea was undertaken to determine whether bismuth subsalicylate (BSS) would prevent the development of persistent diarrhoea (PD) in young children. The children were randomized to two groups: 226 were given liquid oral BSS, (as Pepto-Bismol), 100 mg/kg/d for 5 d; 225 were given placebo of identical appearance. On admission to the study, the two groups were comparable both clinically and microbiologically. Rotavirus was found in 56% of all the children, and enterotoxigenic E. coli in 31% of a subsample studied. Children treated with BSS had less severe and less prolonged illness than those treated with placebo (p = 0.057). There was, however, no difference in the development of PD between the two groups (8% and 11%). Unexpectedly, patients treated with BSS gained significantly more weight (2.3%) than those treated with placebo (0.5%; p < 0.001) during the course of the study. No toxicity of BSS was detected. CONCLUSION: Treatment with BSS had a modest therapeutic effect on acute diarrhoea, as has been previously demonstrated, but with no suggestion of a therapeutic effect on the prevention of persistent diarrhoea in this group of patients.

Natural history of infection with Bartonella bacilliformis in a nonendemic population.

An investigation was performed after an outbreak of bartonellosis in a region of Peru nonendemic for this disorder. Symptoms of acute and chronic bartonellosis were recorded. Serological analysis was performed on 55% of the affected population (554 individuals), 77.5% of whom demonstrated previous infection with Bartonella bacilliformis. The attack rate of Oroya fever was 13.8% (123 cases); the case-fatality rate was 0.7%. The attack rate of verruga peruana was 17.6%. A new specific immunostain was developed and used to confirm the presence of B. bacilliformis in the biopsied skin lesions. Most seropositive individuals (56%) were asymptomatic. The symptoms that were associated with prior infection, as determined by Western blot, included fever (37.2% of the seropositive vs. 17.2% of the seronegative population; P<.001), bone and joint pain (27% vs. 9%; P<.001), headache (27% vs. 12.3%; P <.001), and skin lesions described as verruga peruana (26.8% vs. 4.9%; P<.001). Our findings suggest that infection with B. bacilliformis causes a broad spectrum of disease that is significantly milder in severity than that frequently reported.

Gallstone disease in Peruvian coastal natives and highland migrants.

BACKGROUND: In a previous study, we found that gallstones were a common occurrence in the high altitude villages of the Peruvian Andes. AIMS: To determine if high altitude (> or = 1500 m) is a contributing risk factor for gallstone disease. METHODS: We conducted a cross sectional study in a periurban community in Lima, Peru, and compared the prevalence of gallstone disease between coastal natives, highland (Sierra) natives and Sierra natives who had migrated to the coast. We also compared the prevalence rates from this study with those from a previous study conducted at high altitude. We examined 1534 subjects >15 years of age for gallstone disease. Subjects were interviewed for the presence or absence of risk factors. RESULTS: Gallstone disease was more common in females (16.1 cases per 100, 95% CI 13.8-18.2) than in males (10.7 per 100, 95% CI 8.0-13.4). Females had a greater risk of gallstone disease, especially if they had used oral contraception and/or had four or more children. The age adjusted prevalence was not significantly different between coastal natives, Sierra migrants, and Andean villagers. The prevalence of gallstone disease was not associated with time since migration or with having native Sierra parents. After adjusting for other risk factors, Sierra natives who migrated to the coast had a lower prevalence of gallstone disease than coastal natives (odds ratio 0.74, 95% CI 0.58-0.94). CONCLUSIONS: This study indicates that high altitude is not a positive risk factor for gallstone disease and confirms that this disease is common in Peruvians, which may be attributable to Peruvian-Indian ethnicity.

A placebo-controlled trial of Lactobacillus GG to prevent diarrhea in undernourished Peruvian children.

OBJECTIVE: Lactobacillus GG (L-GG), an acid- and bile-resistant strain that colonizes the intestinal mucosa, has been used to manage diarrhea in children. Our objective was to evaluate the prophylactic use of L-GG to prevent diarrhea in children at high risk from a developing country in a randomized, placebo-controlled trial. STUDY DESIGN: Two hundred four undernourished children 6 to 24 months old from an indigent peri-urban Peruvian town received either L-GG or placebo in flavored gelatin once daily, 6 days a week, for 15 months. Episodes of diarrhea were documented by daily home visits, and diagnostic studies were done in a subset of cases. Recovery of L-GG in stool from subjects and from family contacts was examined. RESULTS: Subjects in the L-GG group had significantly fewer episodes of diarrhea (5.21 episodes diarrhea/child/year ['ecy'] L-GG group, 6. 02 ecy placebo group; P =.028). The decreased incidence of diarrhea in the L-GG group was greatest in the 18- to 29-month age group (P =. 004) and was largely limited to nonbreastfed children (Breastfed: 6. 59 ecy L-GG, 6.32 ecy placebo, P =.7; Nonbreastfed: 4.69 ecy L-GG, 5. 86 ecy placebo, P =.005). The duration of diarrhea episodes and the causes of diarrhea were similar in both groups, except adenovirus was more common in the placebo group. CONCLUSION: L-GG supplementation may be useful as a prophylactic measure to control diarrhea in undernourished children at increased risk, especially nonbreastfed children in the toddler age group.

PIP: This article features a placebo-controlled trial of Lactobacillus GG (L-GG) for diarrhea prevention in undernourished children in Peru. The purpose of the study was to evaluate the use of L-GG as prophylactic treatment for diarrhea. The study population included 204 undernourished children aged 6-24 months, 99 of which were on L-GG and 105 on placebo. Subjects were followed by daily home visits to document diarrhea episodes and diagnostic studies were conducted. Results revealed that children receiving L-GG experienced fewer episodes of diarrhea, which were more pronounced among 18-29 month old children and largely limited to non-breast-fed children. Moreover, the duration of diarrhea episodes and its causes were similar in both groups, except that adenovirus was detected more frequently in the placebo group. In conclusion, L-GG supplementation would decrease diarrhea incidence in high-risk children.

Seasonal change in nutritional status among young children in an urban shanty town in Peru.

Seasonal variation in nutritional status among young children has been described in rural populations, but in few urban settings. We examined seasonality in 7 years of nutritional surveillance data from an urban shanty town near Lima, Peru, where children 0-35 months old were measured at intervals of 4-5 months. We compared nutritional status by month, using generalized estimating equations to account for the intercorrelations among measurements of the same person at different times. The periodicity of the seasonal variation was found to fit a model in which the month of the year was sine-transformed, and this sine-transformed model was used to examine possible interactions with age, sex and year of examination. A total of 38,626 measurements was available from 11,333 children. In late winter, mean weight-for-height was an estimated 0.38 Z score higher than in late summer. The seasonal effect occurred at all ages, in both sexes, and in each year of surveillance. The amplitude was greatest for children 6-23 months old. The summer trough in weight-for-height was lower in 1989 than in other years; children who experienced this summer low had lower mean height-for-age in subsequent years. The seasonal variation in nutritional status may be related to differences in dietary intake, or to the higher prevalence of bacterial diarrhoea in summer than in winter. The more marked drop in weight-for-height in 1989 and subsequent trough in height-for-age may be related to political and economic changes than adversely affected food access in Peru.