Quantifying the Cost of Shigella Diarrhea in the Enterics for Global Health (EFGH) Shigella Surveillance Study.

Background: Comparative costs of public health interventions provide valuable data for decision making. However, the availability of comprehensive and context-specific costs is often limited. The Enterics for Global Health (EFGH) Shigella surveillance study-a facility-based diarrhea surveillance study across 7 countries-aims to generate evidence on health system and household costs associated with medically attended Shigella diarrhea in children. Methods: EFGH working groups comprising representatives from each country (Bangladesh, Kenya, Malawi, Mali, Pakistan, Peru, and The Gambia) developed the study methods. Over a 24-month surveillance period, facility-based surveys will collect data on resource use for the medical treatment of an estimated 9800 children aged 6-35 months with diarrhea. Through these surveys, we will describe and quantify medical resources used in the treatment of diarrhea (eg, medication, supplies, and provider salaries), nonmedical resources (eg, travel costs to the facility), and the amount of caregiver time lost from work to care for their sick child. To assign costs to each identified resource, we will use a combination of caregiver interviews, national medical price lists, and databases from the World Health Organization and the International Labor Organization. Our primary outcome will be the estimated cost per inpatient and outpatient episode of medically attended Shigella diarrhea treatment across countries, levels of care, and illness severity. We will conduct sensitivity and scenario analysis to determine how unit costs vary across scenarios. Conclusions: Results from this study will contribute to the existing body of literature on diarrhea costing and inform future policy decisions related to investments in preventive strategies for Shigella.

The economic impact of childhood acute gastroenteritis on Malawian families and the healthcare system.

OBJECTIVES: This prospective cohort study sought to estimate health system and household costs for episodes of diarrhoeal illness in Malawi. SETTING: Data were collected in two Malawian settings: a rural health centre in Chilumba and an urban tertiary care hospital in Blantyre. PARTICIPANTS: Children under 5 years of age presenting with diarrhoeal disease between 1 January 2013 and 21 November 2014 were eligible for inclusion. Illnesses attributed to other underlying causes were excluded, as were illnesses commencing more than 2 weeks prior to presentation. Complete data were collected on 514 cases at both the time of the initial visit to the participating healthcare facility and 6 weeks after discharge. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was the total cost of an episode of illness. Costs to the health system were gathered from chart review (drugs and diagnostics) and actual hospital expenditure (staff and facility costs). Household costs, including lost income, were obtained by interview with the parents/guardians of patients. RESULTS: Total costs in 2014 US$ for rural inpatient, rural outpatient, urban inpatient and urban outpatient were $65.33, $8.89, $60.23 and $14.51, respectively (excluding lost income). Mean household contributions to these costs were 15.8%, 9.8%, 21.3% and 50.6%. CONCLUSION: This study found significant financial burden from childhood diarrhoeal disease to the healthcare system and to households. The latter face the risk of consequent impoverishment, as the study demonstrates how the costs of seeking treatment bring the income of the majority of families in all income strata below the national poverty line in the month of illness.

Measuring indirect effects of rotavirus vaccine in low income countries.

Widespread introduction of rotavirus vaccines has led to major reductions in the burden of rotavirus gastroenteritis worldwide. Vaccine effectiveness is diminished, however, in low income countries, that harbour the greatest burden of rotavirus attributed morbidity and mortality. Indirect effects of rotavirus vaccine (herd immunity and herd protection) could increase population level impact and improve vaccine cost effectiveness in such settings. While rotavirus vaccine indirect effects have been demonstrated in high and middle income countries, there are very little data from low income countries where force of infection, population structures and vaccine schedules differ. Targeted efforts to evaluate indirect effects of rotavirus vaccine in low income countries are required to understand the total impact of rotavirus vaccine on the global burden of rotavirus disease.

Cost-Effectiveness of Monovalent Rotavirus Vaccination of Infants in Malawi: A Postintroduction Analysis Using Individual Patient-Level Costing Data.

BACKGROUND: Rotavirus vaccination reduces childhood hospitalization in Africa, but cost-effectiveness has not been determined using real-world effectiveness and costing data. We sought to determine monovalent rotavirus vaccine cost-effectiveness in Malawi, one of Africa's poorest countries and the first Gavi-eligible country to report disease reduction following introduction in 2012. METHODS: This was a prospective cohort study of children with acute gastroenteritis at a rural primary health center, a rural first referral-level hospital and an urban regional referral hospital in Malawi. For each participant we itemized household costs of illness and direct medical expenditures incurred. We also collected Ministry of Health vaccine implementation costs. Using a standard tool (TRIVAC), we derived cost-effectiveness. RESULTS: Between 1 January 2013 and 21 November 2014, we recruited 530 children aged <5 years with gastroenteritis. Costs did not differ by rotavirus test result, but were significantly higher for admitted children and those with increased severity on Vesikari scale. Adding rotavirus vaccine to the national schedule costs Malawi $0.42 per dose in system costs. Vaccine copayment is an additional $0.20. Over 20 years, the vaccine program will avert 1 026 000 cases of rotavirus gastroenteritis, 78 000 inpatient admissions, 4300 deaths, and 136 000 disability-adjusted-life-years (DALYs). For this year's birth cohort, it will avert 54 000 cases of rotavirus and 281 deaths in children aged <5 years. The program will cost $10.5 million and save $8.0 million in averted healthcare costs. Societal cost per DALY averted was $10, and the cost per rotavirus case averted was $1. CONCLUSIONS: Gastroenteritis causes substantial economic burden to Malawi. The rotavirus vaccine program is highly cost-effective. Together with the demonstrated impact of rotavirus vaccine in reducing population hospitalization burden, its cost-effectiveness makes a strong argument for widespread utilization in other low-income, high-burden settings.

Potential barriers to healthcare in Malawi for under-five children with cough and fever: a national household survey.

Failure to access healthcare is an important contributor to child mortality in many developing countries. In a national household survey in Malawi, we explored demographic and socioeconomic barriers to healthcare for childhood illnesses and assessed the direct and indirect costs of seeking care. Using a cluster-sample design, we selected 2,697 households and interviewed 1,669 caretakers. The main reason for households not being surveyed was the absence of a primary caretaker in the household. Among 2,077 children aged less than five years, 504 episodes of cough and fever during the previous two weeks were reported. A trained healthcare provider was visited for 48.0% of illness episodes. A multivariate regression model showed that children from the poorest households (p = 0.02) and children aged > 12 months (p = 0.02) were less likely to seek care when ill compared to those living in wealthier households and children of higher age-group respectively. Families from rural households spent more time travelling compared to urban households (68.9 vs 14.1 minutes; p < 0.001). In addition, visiting a trained healthcare provider was associated with longer travel time (p < 0.001) and higher direct costs (p < 0.001) compared to visiting an untrained provider. Thus, several barriers to accessing healthcare in Malawi for childhood illnesses exist. Continued efforts to reduce these barriers are needed to narrow the gap in the health and healthcare equity in Malawi.

Rotavirus vaccines: entering a new stage of deployment.

PURPOSE OF REVIEW: Rotavirus is the single most important cause of severe diarrhoea in infants and young children. This review provides updated information concerning three rotavirus vaccines that are being evaluated and introduced globally. RECENT FINDINGS: Two large, phase III clinical trials, each involving more than 60,000 infants in both developing and developed countries, demonstrated that both RotaTeq (Merck & Co., Whitehouse Station, New Jersey, USA), the pentavalent human-bovine reassortant vaccine, and Rotarix (GlaxoSmithKine Biologicals, Rixensart, Belgium), the monovalent live-attenuated human rotavirus vaccine, are safe with respect to intussusception when the first dose is administered between 6 and 12 weeks of age, and that both vaccines are 90-95% efficacious in preventing severe rotavirus gastroenteritis including hospitalization. The bovine (UK)-human rotavirus reassortant tetravalent (BRV-TV) vaccine, developed at the National Institutes of Health (USA), was licensed for local production in several developing countries. SUMMARY: Rotavirus vaccines are entering a new stage of deployment toward the goal of reducing morbidity and mortality attributed to rotavirus infection in developing countries, and hospitalizations and emergency visits caused by rotavirus in developed countries. High vaccine prices appear to offset cost savings, and may make policymakers even in wealthy countries hesitate to introduce a rotavirus vaccine into their childhood immunization programmes.

Rotavirus infection in Saudi Arabia.

BACKGROUND: Human rotavirus, an important causative agent of severe gastroenteritis in infants and young children worldwide, leads to high morbidity in both developing and developed countries, including Saudi Arabia, and high mortality in developing countries. Effective control depends upon an accurate understanding of disease burden and the relative importance of circulating serotypes. METHODS: We examined the epidemiology and disease burden of rotavirus in Saudi Arabia through a review of 22 published studies of rotavirus and the aetiology of diarrhoea carried out from 1982 to 2003. RESULTS: The prevalence of rotavirus infection ranged between 10% to 46% with a median of 30%. Most cases were among children less than 2 years of age, and particularly in the first year of life. There were significant differences in seasonality within Saudi Arabia, with increased infection during winter in some cities and during summer in others. G1 was the predominant serotype followed by G4, G3 and G2, in 4 studies where strains had been G-typed. The prevalence of nontypeable strains ranged from 11.0% to 31.3%. No data were available on P types. Results of electropherotyping in 4 studies revealed that the long electropherotype was predominant. CONCLUSION: Rotavirus is an important cause of severe diarrhoea in Saudi children. However, the available data on rotavirus strains in circulation are limited and there is an urgent need for up-to-date and comprehensive studies to evaluate rotavirus strains in circulation and identify unusual types that could be incorporated into future vaccines.

A critical time for rotavirus vaccines: a review.

Universal introduction of rotavirus vaccines into childhood immunization programs is expected to substantially reduce the mortality from rotavirus gastroenteritis in developing countries (currently estimated at 702,000 annual deaths among children less than 5 years of age). In addition, it is expected to virtually eliminate hospitalizations due to rotavirus gastroenteritis in developed countries. Two rotavirus vaccines, Rotarix (GlaxoSmithKline Biologicals, Belgium) and RotaTeq (Merck & Co., USA) have recently completed Phase III clinical trials, each involving more than 60,000 children. Both vaccines appear safe with respect to intussusception, and are highly efficacious in preventing severe gastroenteritis due to rotavirus strains carrying predominantly serotype G1. The monovalent human rotavirus vaccine Rotarix, possessing serotype P1A[8],G1, is being first introduced into developing countries, whereas the pentavalent bovine-human reassortant rotavirus vaccine RotaTeq, comprising G-types G1, G2, G3, G4 and P-type P1A[8], will be initially introduced into the USA and Europe. Current disease burden estimates and economic justification will be required wherever the vaccines are introduced. Confirmation of the safety of both vaccines will require extensive postlicensure evaluation in which it will be key to assure adherence to administration of the first dose of either vaccine before 3 months of age. Assessment of the ability of each vaccine to provide protection against an increasingly diverse population of rotavirus strains will crucially depend on continuous global strain surveillance. Finally, efforts to improve existing rotavirus vaccines and to develop alternative vaccines should continue, so as to ensure that the prerotavirus vaccine era is consigned to a historical context.

Rotavirus vaccines: development, current issues and future prospects.

The potential benefit of safe and effective rotavirus vaccination in reducing morbidity and especially mortality from rotavirus gastroenteritis among children in developing countries has long been recognised. More recently, the focus of attention shifted to developed countries, where cost-effectiveness analyses justified the routine introduction of rotavirus vaccines into childhood immunisation schedules. The recent withdrawal in the U.S.A. of the first licensed rotavirus vaccine (the tetravalent rhesus reassortant rotavirus vaccine), following investigation into reports of intussusception among a number of vaccinees, has directed attention once more towards rotavirus vaccine use in developing countries. However, issues relating to vaccine safety, efficacy, and cost, remain to be overcome before widespread introduction of rotavirus vaccines can be anticipated.