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1.  Timeliness of immunizations of children in a Medicaid primary care case management managed care program. 
OBJECTIVE: This study assessed the timeliness of immunization for children in a Medicaid managed care primary care case management program controlling for patient and provider predictors of immunization status. METHODS: Using administrative data and patient medical records, up-to-date (UTD) and age appropriate immunization (AAI) status were reviewed for 5598 children. The 4:3:1 immunization series (four diphtheria, pertussis, tetanus vaccinations; three polio vaccinations; and one measles, mumps, rubella vaccination) was the standard. RESULTS: Childhood immunization rates were low when assessed using strict adherence to vaccination recommendations. At age 18 months, 28.3% were classified as UTD, and 6.3% were classified as AAI. Compared to children not up-to-date, UTD children were more likely to have public rather than private providers, to have had older mothers, and less likely to have been African American. Among UTD children, AAI children were more likely to reside in urban areas. CONCLUSIONS: Low-income children continue to be under-immunized, even under a managed care initiative. Health care providers and child health advocates need to continue pressure for programs that will increase adherence to nationally recommended guidelines.
PMCID: PMC2594144  PMID: 12392047
2.  Timeliness of Immunizations of Children in a Medicaid Primary Care Case Management Managed Care Program 
Objective.
This study assessed the timeliness of immunization for children in a Medicaid managed care primary care case management program controlling for patient and provider predictors of immunization status.
Methods.
Using administrative data and patient medical records, up-to-date (UTD) and age appropriate immunization (AAI) status were reviewed for 5,598 children. The 4:3:1 immunization series (4 diphtheria, pertussis, tetanus vaccinations; 3 polio vaccinations; and one measles, mumps, rubella vaccination) was the standard.
Results.
Childhood immunization rates were low when assessed using strict adherence to vaccination recommendations. At age 18 months, 28.3% were classified as UTD, and 6.3% were classified as AAI. Compared to children not up-to-date, UTD children were more likely to have public rather than private providers, to have had older mothers, and less likely to have been African-American. Among UTD children, AAI children were more likely to reside in urban areas.
Conclusions.
Low-income children continue to be under-immunized, even under a managed care initiative. Health care providers and child health advocates need to continue pressure for programs that will increase adherence to nationally recommended guidelines.
PMCID: PMC2568310
Medicaid; managed care; immunization; children
3.  Decline in Diarrhea Mortality and Admissions after Routine Childhood Rotavirus Immunization in Brazil: A Time-Series Analysis 
PLoS Medicine  2011;8(4):e1001024.
A time series analysis by Manish Patel and colleagues shows that the introduction of rotavirus vaccination in Brazil is associated with reduced diarrhea-related deaths and hospital admissions in children under 5 years of age.
Background
In 2006, Brazil began routine immunization of infants <15 wk of age with a single-strain rotavirus vaccine. We evaluated whether the rotavirus vaccination program was associated with declines in childhood diarrhea deaths and hospital admissions by monitoring disease trends before and after vaccine introduction in all five regions of Brazil with varying disease burden and distinct socioeconomic and health indicators.
Methods and Findings
National data were analyzed with an interrupted time-series analysis that used diarrhea-related mortality or hospitalization rates as the main outcomes. Monthly mortality and admission rates estimated for the years after rotavirus vaccination (2007–2009) were compared with expected rates calculated from pre-vaccine years (2002–2005), adjusting for secular and seasonal trends. During the three years following rotavirus vaccination in Brazil, rates for diarrhea-related mortality and admissions among children <5 y of age were 22% (95% confidence interval 6%–44%) and 17% (95% confidence interval 5%–27%) lower than expected, respectively. A cumulative total of ∼1,500 fewer diarrhea deaths and 130,000 fewer admissions were observed among children <5 y during the three years after rotavirus vaccination. The largest reductions in deaths (22%–28%) and admissions (21%–25%) were among children younger than 2 y, who had the highest rates of vaccination. In contrast, lower reductions in deaths (4%) and admissions (7%) were noted among children two years of age and older, who were not age-eligible for vaccination during the study period.
Conclusions
After the introduction of rotavirus vaccination for infants, significant declines for three full years were observed in under-5-y diarrhea-related mortality and hospital admissions for diarrhea in Brazil. The largest reductions in diarrhea-related mortality and hospital admissions for diarrhea were among children younger than 2 y, who were eligible for vaccination as infants, which suggests that the reduced diarrhea burden in this age group was associated with introduction of the rotavirus vaccine. These real-world data are consistent with evidence obtained from clinical trials and strengthen the evidence base for the introduction of rotavirus vaccination as an effective measure for controlling severe and fatal childhood diarrhea.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Diarrheal disease, usually caused by infectious agents, is the second major cause of death in children aged under five years. As highlighted in a recent PLoS Medicine series, access to clean water and improved sanitation is the key to the primary prevention of diarrheal illnesses. Yet despite the targets of Millennium Development Goal 7 to half the number of people without access to clean water or improved sanitation by 2015, over one billion people worldwide do not currently have access to clean water and over two billion do not currently have access to improved sanitation.
Since enteric viruses are primarily transmitted directly from one person to another, they cannot be controlled completely by improvements in sanitation. Therefore, although not replacing the urgent need to provide access to clean water and improved sanitation for all, vaccination programs that protect young children against some infections that cause diarrhea, such as rotavirus, which accounts for one-third of all child deaths caused by diarrhea, are a pragmatic way forward. As large clinical trials have shown the safety and efficacy of rotavirus vaccines in population settings, in July 2009, the World Health Organization recommended including rotavirus vaccines into every country's national immunization programs.
Why Was This Study Done?
Although the protective effect of rotavirus vaccines has been assessed in various high-, middle-, and low-income settings, for reasons that remain unclear, the efficacy of live, oral rotavirus vaccines appears to be dependent on geographical location and correlated to the socioeconomic status of the population. Because of these concerns, evaluating the health impact of large-scale rotavirus vaccine programs and ensuring their equity in a real-world setting (rather than in clinical trial conditions) is important.
Therefore, the researchers addressed this issue by conducting this study to evaluate the effect of rotavirus vaccination on mortality and hospital admissions for diarrhea due to all causes among young children in the five regions of Brazil. The researchers chose to do this study in Brazil because of the high incidence of diarrhea-related deaths and hospital admissions and because five years ago, in July 2006, the Brazilian Ministry of Health introduced the single-strain rotavirus vaccine simultaneously in all 27 states through its national immunization program—allowing for “before” and “after” intervention analysis.
What Did the Researchers Do and Find?
The researchers obtained data on diarrheal deaths and hospital admissions in children aged under five years for the period 2002–2005 and 2007–2009 and data on rotavirus vaccination rates. The researchers got the data on diarrhea deaths from the Brazilian Mortality Information System—the national database of information collected from death certificates that covers 90% of all deaths in Brazil. The data on hospital admissions came from the electronic Hospital Information System of Brazil's Unified Health System (Sistema Unico de Saúde, SUS)—the publicly funded health-care system that covers roughly 70% of the hospitalizations and includes information on all admissions (from public hospitals and some private hospitals) authorized for payment by the Unified Health System. The researchers got regional rotavirus vaccination coverage estimates for 2007–2009 from the information department of the Ministry of Health, and estimated coverage of the two doses of oral rotavirus vaccine by taking the annual number of second doses administered divided by the number of infants in the region.
In 2007, an estimated 80% of infants received two doses of rotavirus vaccine, and by 2009, this proportion rose to 84% of children younger than one year of age. The researchers found that in the three years following the introduction of rotavirus vaccination, diarrhea-related mortality rates and admissions among children aged under five years were respectively 22% and 17% lower than expected, with a cumulative total of 1,500 fewer diarrhea deaths and 130,000 fewer admissions. Furthermore, the largest reductions in deaths and admissions were among children who had the highest rates of vaccination (less than two years of age), and the lowest reductions were among children who were not eligible for vaccination during the study period (aged 2–4 years).
What Do These Findings Mean?
These findings suggest that the introduction of rotavirus vaccination in all areas of Brazil is associated with reduced diarrhea-related deaths and hospital admissions in children aged under five years. These real-world impact data are consistent with the clinical trials and strengthen the evidence base for rotavirus vaccination as an effective measure for controlling severe and fatal childhood diarrhea.
These findings have important global policy implications. In middle-income countries, such as Brazil, that are not eligible for financial support from donors, the potential reductions in admissions and other health-care costs will be important for cost-effectiveness considerations to justify the purchase of these still relatively expensive vaccines.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001024
PLoS Medicine has published a series on water and sanitation
More information is available from the World Health Organization on diarrheal illness in children
More information is available about rotavirus vaccines from the World Health Organization, the US Centers for Disease Control and Prevention, and the Rotavirus Vaccine Program
doi:10.1371/journal.pmed.1001024
PMCID: PMC3079643  PMID: 21526228
4.  Insurance Gaps Among Vulnerable Children in the United States, 1999–2001 
Pediatrics  2005;116(5):1155-1161.
Objective
To quantify the number of children who experience gaps in insurance coverage and to determine whether vulnerable subgroups of children experience noteworthy lapses in insurance coverage.
Methods
We analyzed nationally representative data from 24 149 children sampled in the 1999–2001 Medical Expenditure Panel Survey linked to the 1997–1999 National Health Interview Survey. Vulnerable subgroups of children included children with chronic conditions, those from ethnic/racial minorities, and those living in poverty. On the basis of cumulative annual monthly insurance coverage status, each child fell into 1 of 3 groups: continuous coverage, uninsured, or gaps in coverage. Using SAS-callable SUDAAN, we conducted multivariate ordinal logistic regression model to quantify the likelihood of having gaps in coverage for vulnerable subgroups of children.
Results
From 1999 to 2001, we found that > 9 million American children annually had gaps in coverage and that 5 to 6 million children annually were uninsured for the entire year. Sixty percent of children experienced gaps of at least 4 months, and > 40% of all publicly and privately insured children had coverage gaps. After accounting for relevant covariates, children with chronic conditions were just as likely as other children to have gaps in coverage or be uninsured; Hispanic children were most likely to have insurance gaps or be uninsured; and children from poor and near-poor families were 4 to 5 times more likely to have lapsed coverage than children from high-income families. Poverty and maternal education were the strongest factors associated with lapsed coverage.
Conclusions
Unstable health insurance is an underrecognized problem for children, including those with chronic conditions. Because unstable insurance coverage can lead to inadequate health care utilization and poor child health outcomes, strategies to promote stable insurance coverage merit serious consideration.
doi:10.1542/peds.2004-2403
PMCID: PMC1370262  PMID: 16264003
chronic conditions; health insurance; medically under-served; health insurance coverage gaps; ethnic disparity; TANF, Temporary Assistance to Needy Families; MEPS, Medical Expenditure Panel Survey; HC, Household Component; MPC, Medical Provider Component; IC, Insurance Component; NHIS, National Health Interview Survey
5.  Factors associated with underimmunization at 3 months of age in four medically underserved areas. 
Public Health Reports  2004;119(5):479-485.
OBJECTIVE: Risk factors for underimmunization at 3 months of age are not well described. This study examines coverage rates and factors associated with under-immunization at 3 months of age in four medically underserved areas. METHODS: During 1997-1998, cross-sectional household surveys using a two-stage cluster sample design were conducted in four federally designated Health Professional Shortage Areas. Respondents were parents or caregivers of children ages 12-35 months: 847 from northern Manhattan, 843 from Detroit, 771 from San Diego, and 1,091 from rural Colorado. A child was considered up-to-date (UTD) with vaccinations at 3 months of age if documentation of receipt of diphtheria-tetanus-pertussis, polio, haemophilus influenzae type B, and hepatitis B vaccines was obtained from a provider or a hand-held vaccination card, or both. RESULTS: Household response rates ranged from 79% to 88% across sites. Vaccination coverage levels at 3 months of age varied across sites: 82.4% in northern Manhattan, 70.5% in Detroit, 82.3% in San Diego, and 75.8% in rural Colorado. Among children who were not UTD, the majority (65.7% to 71.5% per site) had missed vaccines due to missed opportunities. Factors associated with not being UTD varied by site and included having public or no insurance, >/=2 children living in the household, and the adult respondent being unmarried. At all sites, vaccination coverage among WIC enrollees was higher than coverage among children eligible for but not enrolled in WIC, but the association between UTD status and WIC enrollment was statistically significant for only one site and marginally significant for two other sites. CONCLUSIONS: Missed opportunities were a significant barrier to vaccinations, even at this early age. Practice-based strategies to reduce missed opportunities and prenatal WIC enrollment should be focused especially toward those at highest risk of underimmunization.
doi:10.1016/j.phr.2004.07.005
PMCID: PMC1497657  PMID: 15313111
6.  Impact of health insurance status on vaccination coverage in children 19-35 months old, United States, 1993-1996. 
Public Health Reports  2004;119(2):156-162.
OBJECTIVES: To show how health insurance (privately and publicly insured, insured and uninsured) relates to vaccination coverage in children 19-35 months old, and how this can be used to better target public health interventions. METHODS: The National Health Interview Survey (NHIS) gathers information on the health and health care of the U.S. non-institutionalized population through household interviews. The authors combined immunization and health insurance supplements from the 1993 through 1996 NHIS, and classified children 19-35 months old by their immunization and insurance status. Results were compared using both bivariate and multivariate analyses, and the backwards stepwise selection method was used to build multivariate logistic regression models. RESULTS: Uninsured children tended to have lower vaccination coverage than those who had insurance, either private or public. Among those with insurance, publicly insured children had lower vaccination coverage than privately insured children. Backwards stepwise regression retained insurance status, metropolitan statistical area, and education of responsible adult family member as major predictors of immunization. Factors considered but not retained in the final model included child race/ethnicity, family poverty index, and region of country. CONCLUSIONS: Insurance status was a critical predictor of vaccination coverage for children ages 19-35 months. After controlling for confounders, the uninsured were about 24% less likely to receive all recommended shots than the insured and, among the insured, those with public insurance were about 24% less likely to receive all recommended vaccines than those with private insurance.
PMCID: PMC1497610  PMID: 15192902
7.  Uninsurance among Children Whose Parents Are Losing Medicaid Coverage: Results from a Statewide Survey of Oregon Families 
Health Services Research  2008;43(1 Pt 2):401-418.
Context
Thousands of adults lost coverage after Oregon's Medicaid program implemented cost containment policies in March 2003. Despite the continuation of comprehensive public health coverage for children, the percentage of uninsured children in the state rose from 10.1 percent in 2002 to 12.3 percent in 2004 (over 110,000 uninsured children). Among the uninsured children, over half of them were likely eligible for public health insurance coverage.
Research Objective
To examine barriers low-income families face when attempting to access children's health insurance. To examine possible links between Medicaid cutbacks in adult coverage and children's loss of coverage.
Data Source/Study Setting
Statewide primary data from low-income households enrolled in Oregon's food stamp program.
Study Design
Cross-sectional analysis. The primary predictor variable was whether or not any adults in the household recently lost Medicaid coverage. The main outcome variables were children's current insurance status and children's insurance coverage gaps.
Data Collection
A mail-return survey instrument was designed to collect information from a stratified, random sample of households with children presumed eligible for publicly funded health insurance programs.
Principal Findings
Over 10 percent of children in the study population eligible for publicly funded health insurance programs were uninsured, and over 25 percent of these children had gaps in insurance coverage during a 12-month period. Low-income children who were most likely to be uninsured or have coverage gaps were Hispanic; were teenagers older than 14; were in families at the higher end of the income threshold; had an employed parent; or had a parent who was uninsured. Fifty percent of the uninsured children lived in a household with at least one adult who had recently lost Medicaid coverage, compared with only 40 percent of insured children (p=.040). Similarly, over 51 percent of children with a recent gap in insurance coverage had an adult in the household who lost Medicaid, compared with only 38 percent of children without coverage gaps (p<.0001). After adjusting for ethnicity, age, household income, and parental employment, children living in a household with an adult who lost Medicaid coverage after recent cutbacks had a higher likelihood of having no current health insurance (OR 1.44, 95 percent CI 1.02, 2.04), and/or having an insurance gap (OR 1.79, 95 percent CI 1.36, 2.36).
Conclusions
Uninsured children and those with recent coverage gaps were more likely to have adults in their household who lost Medicaid coverage after recent cutbacks. Although current fiscal constraints prevent many states from expanding public health insurance coverage to more parents, states need to be aware of the impact on children when adults lose coverage. It is critical to develop strategies to keep parents informed regarding continued eligibility and benefits for their children and to reduce administrative barriers to children's enrollment and retention in public health insurance programs.
doi:10.1111/j.1475-6773.2007.00764.x
PMCID: PMC2323132  PMID: 18199193
Insurance coverage; health care access; primary health care; Medicaid; children's health care
8.  Insurance Coverage and Financial Burden for Families of Children with Special Health Care Needs 
Objective
To examine the role of insurance coverage in protecting families of children with special health care needs (CSHCN) from the financial burden associated with care.
Methods
Data from the 2001 National Survey of Children with Special Health Care Needs were analyzed. We built two multivariate regression models using “work loss/cut back” and “experiencing financial problems” as the dependent variables and insurance status as the primary independent variable of interest while adjusting for income, race/ethnicity, functional limitation/severity, and other sociodemographic predictors.
Results
Approximately 29.9 % of CSHCN live in families where their condition led parents to report cutting back on work or stopping work completely. Families of 20.9 % of CSHCN reported experiencing financial difficulties due to the child’s condition. Insurance coverage significantly reduced the likelihood of families experiencing financial problems at every income level. The proportion of families experiencing financial problems was reduced from 35.7 to 23.0 % for the poor and 44.9 to 24.5 % for low-income families with continuous insurance coverage (p<0.01 for both comparisons). Similarly, the proportion of parents having to cut back or stop work was reduced from 42.8 to 35.9 % for the poor (p<0.05) and 43.5 to 33.9 % for low-income families (p<0.01).
Conclusions
Continuous health insurance coverage provides protection from financial burden and hardship for families of CSHCN in all income groups. This evidence is supportive of policies designed to promote universal coverage for CSHCN. However, many poor and low-income families continue to experience work loss and financial problems despite insurance coverage. Hence, health insurance should not be viewed as a solution in itself, but instead as one element of a comprehensive strategy to provide financial safety for families with CSHCN.
doi:10.1016/j.ambp.2006.04.009
PMCID: PMC1557643  PMID: 16843251
Children with Special Health Care Needs(CSHCN); health insurance; Medicaid; poverty status; National Survey of CSHCN; CSHCN, children with special health care needs; SCHIP, State Children’s Health Insurance
9.  Uninsured Children and Adolescents with Insured Parents 
Context
Millions of US children lack health insurance coverage. Efforts to expand children’s insurance often focus on extending public coverage to uninsured parents. Less is known about the uninsured children whose parents already have coverage.
Objective
To identify predictors of uninsurance among US children with insured parents.
Design/Setting
Cross-sectional and full-year analyses of pooled 2002-2005 data from the nationally-representative Medical Expenditure Panel Survey (MEPS).
Participants
All children under age 19 in four yearly MEPS files with positive full-year weights who had at least one parent residing in the same household (unweighted total number = 39,710).
Main Outcome Measure
Cross-sectional and full-year uninsurance among children with at least one insured parent.
Results
Cross-sectionally, over 3.3 percent of US children were uninsured with at least one insured parent (unweighted total number = 1,380, weighted average yearly population of approximately 2.3 million children). In multivariable analyses, children experiencing this discordant pattern of family coverage were more likely Hispanic (odds ratio [OR] 1.58; 95% confidence interval [CI], 1.23 to 2.03) compared to white, non-Hispanic; low and middle income (OR 2.02; 95% CI, 1.42 to 2.88; and OR 1.48; 95% CI, 1.09 to 2.03, respectively) compared to high income; from single-parent homes (OR 1.99; 95% CI 1.59 to 2.49) compared to children living with two married parents; and living with parents who had less than a high school education (OR 1.44; 95% CI 1.10 to 1.89) compared to those with at least one parent who had completed high school. Children whose parents had public coverage were less likely to be uninsured (OR 0.64; 95% CI 0.43 to 0.96) compared to those whose parents reported private health insurance. These predictors remained significant in full-year analyses. Similar patterns of vulnerability were also found among a subset of uninsured children with privately-covered parents.
Conclusions
Predictors of uninsurance among children with at least one insured parent included: having low and middle household incomes, being of Hispanic origin, having parents who did not complete high school, and living in a single-parent household. Having a parent covered by only public insurance was associated with better children’s coverage rates.
doi:10.1001/jama.2008.516
PMCID: PMC3116514  PMID: 18940977
health insurance; discontinuous health insurance coverage; access to healthcare; SCHIP; child health; health policy
10.  Usual Source of Care and Unmet Need Among Vulnerable Children: 1998–2006 
Pediatrics  2009;123(2):e214-e219.
OBJECTIVE
The purpose of this work was to identify the proportions of publicly (Medicaid and State Child Health Insurance Program) insured and uninsured children who did not identify a usual source of care from 1998 to 2006, spanning the State Children’s Health Insurance Program (1997 to present) and the President’s Health Center Initiative (2002 to present), and to characterize unmet medical need as it relates to insurance and a usual source of care for publicly insured and uninsured children.
METHODS
We conducted a secondary data analysis of multiple years of the National Health Interview Survey. We identified the proportion of publicly insured and uninsured children aged 0 to 17 years who did not identify a usual source of care and stratified according to the site of care. We described the odds of reporting an unmet medical need according to insurance status and usual source of care, compared with privately insured children with a usual source of care. Sample weights were used to derive national estimates.
RESULTS
From 1998 through 2006, there were significant increases in the proportions of children enrolled in Medicaid (16.7%–24.5%) and the State Child Health Insurance Program (2.0%–5.3%). The proportion of uninsured children has remained stable from 2002 to 2006 at ~10%. However, the proportion of uninsured reporting no usual source of care increased from 17.8% to 23.3%. Hispanic children had significant increases in the proportions of the uninsured and reporting no usual source of care by 2006. Hispanics constituted the largest proportion in both groups. Uninsured children and children without a usual source of care reported the highest odds of unmet need. Among the insured, publicly insured children had twice the odds of reporting an unmet need compared with privately insured children.
CONCLUSIONS
During the State Child Health Insurance Program and the President’s Health Center Initiative, growing proportions of uninsured children reported no usual source of care. Unmet medical need was the highest for the uninsured and those without a usual source of care. These findings suggest that initiatives designed to improve access to care must combine broadened insurance coverage with enhanced access to usual sources of care.
doi:10.1542/peds.2008-2454
PMCID: PMC2787198  PMID: 19171573
usual source of care; Medicaid; SCHIP; uninsured; children; health center
11.  Childhood vaccination in informal urban settlements in Nairobi, Kenya: Who gets vaccinated? 
BMC Public Health  2011;11:6.
Background
Recent trends in global vaccination coverage have shown increases with most countries reaching 90% DTP3 coverage in 2008, although pockets of undervaccination continue to persist in parts of sub-Saharan Africa particularly in the urban slums. The objectives of this study were to determine the vaccination status of children aged between 12-23 months living in two slums of Nairobi and to identify the risk factors associated with incomplete vaccination.
Methods
The study was carried out as part of a longitudinal Maternal and Child Health study undertaken in Korogocho and Viwandani slums of Nairobi. These slums host the Nairobi Urban Health and Demographic Surveillance System (NUHDSS) run by the African Population and Health Research Centre (APHRC). All women from the NUHDSS area who gave birth since September 2006 were enrolled in the project and administered a questionnaire which asked about the vaccination history of their children. For the purpose of this study, we used data from 1848 children aged 12-23 months who were expected to have received all the WHO-recommended vaccinations. The vaccination details were collected during the first visit about four months after birth with follow-up visits repeated thereafter at four month intervals. Full vaccination was defined as receiving all the basic childhood vaccinations by the end of 24 months of life, whereas up-to-date (UTD) vaccination referred to receipt of BCG, OPV 1-3, DTP 1-3, and measles vaccinations within the first 12 months of life. All vaccination data were obtained from vaccination cards which were sighted during the household visit as well as by recall from mothers. Multivariate models were used to identify the risk factors associated with incomplete vaccination.
Results
Measles coverage was substantially lower than that for the other vaccines when determined using only vaccination cards or in addition to maternal recall. Up-to-date (UTD) coverage with all vaccinations at 12 months was 41.3% and 51.8% with and without the birth dose of OPV, respectively. Full vaccination coverage (57.5%) was higher than up-to-date coverage (51.8%) at 12 months overall, and in both slum settlements, using data from cards. Multivariate analysis showed that household assets and expenditure, ethnicity, place of delivery, mother's level of education, age and parity were all predictors of full vaccination among children living in the slums.
Conclusions
The findings show the extent to which children resident in slums are underserved with vaccination and indicate that service delivery of immunization services in the urban slums needs to be reassessed to ensure that all children are reached.
doi:10.1186/1471-2458-11-6
PMCID: PMC3024932  PMID: 21205306
12.  Role of SCHIP in Serving Children with Special Health Care Needs 
Health Care Financing Review  2006;28(2):53-64.
The purpose of this article is to provide new information about two policy issues: (1) Is the State Children's Health Insurance Program (SCHIP) an important source of health insurance for children with special health care needs (CSHCN? and (2) Does SCHIP provide CSHCN with better access to care, compared with other insurance coverage? Using the 2001 National Survey of CSHCN, we found that a limited fraction of CSHCN were eligible for SCHIP while a relatively small proportion of SCHIP-eligible CSHCN were uninsured. Access to care for CSHCN under SCHIP was better than those SCHIP-eligible but uninsured, and similar to those income-eligible for SCHIP but privately insured.
PMCID: PMC4194983  PMID: 17427845
13.  Vaccination coverage and its determinants among migrant children in Guangdong, China 
BMC Public Health  2014;14:203.
Background
Guangdong province attracted more than 31 million migrants in 2010. But few studies were performed to estimate the complete and age-appropriate immunization coverage and determine risk factors of migrant children.
Methods
1610 migrant children aged 12–59 months from 70 villages were interviewed in Guangdong. Demographic characteristics, primary caregiver’s knowledge and attitude toward immunization, and child’s immunization history were obtained. UTD and age-appropriate immunization rates for the following five vaccines and the overall series (1:3:3:3:1 immunization series) were assessed: one dose of BCG, three doses of DTP, OPV and HepB, one dose of MCV. Risk factors for not being UTD for the 1:3:3:3:1 immunization series were explored.
Results
For each antigen, the UTD immunization rate was above 71%, but the age-appropriate immunization rates for BCG, HepB, OPV, DPT and MCV were only 47.8%, 45.1%, 47.1%, 46.8% and 37.2%, respectively. The 1st dose was most likely to be delayed within them. For the 1:3:3:3:1 immunization series, the UTD immunization rate and age-appropriate immunization rate were 64.9% and 12.4% respectively. Several factors as below were significantly associated with UTD immunization. The primary caregiver’s determinants were their occupation, knowledge and attitude toward immunization. The child’s determinants were sex, Hukou, birth place, residential buildings and family income.
Conclusions
Alarmingly low immunization coverage of migrant children should be closely monitored by NIISS. Primary caregiver and child’s determinants should be considered when taking measures. Strategies to strengthen active out-reach activities and health education for primary caregivers needed to be developed to improve their immunization coverage.
doi:10.1186/1471-2458-14-203
PMCID: PMC3938078  PMID: 24568184
Up-to-date; Age-appropriate immunization; Immunization coverage; Risk factor; Migrant children
14.  The pot calling the kettle black: the extent and type of errors in a computerized immunization registry and by parent report 
BMC Pediatrics  2014;14:1.
Background
Accurate classification of children’s immunization status is essential for clinical care, administration and evaluation of immunization programs, and vaccine program research. Computerized immunization registries have been proposed as a valuable alternative to provider paper records or parent report, but there is a need to better understand the challenges associated with their use. This study assessed the accuracy of immunization status classification in an immunization registry as compared to parent report and determined the number and type of errors occurring in both sources.
Methods
This study was a sub-analysis of a larger study which compared the characteristics of children whose immunizations were up to date (UTD) at two years as compared to those not UTD. Children’s immunization status was initially determined from a population-based immunization registry, and then compared to parent report of immunization status, as reported in a postal survey. Discrepancies between the two sources were adjudicated by review of immunization providers’ hard-copy clinic records. Descriptive analyses included calculating proportions and confidence intervals for errors in classification and reporting of the type and frequency of errors.
Results
Among the 461 survey respondents, there were 60 discrepancies in immunization status. The majority of errors were due to parent report (n = 44), but the registry was not without fault (n = 16). Parents tended to erroneously report their child as UTD, whereas the registry was more likely to wrongly classify children as not UTD. Reasons for registry errors included failure to account for varicella disease history, variable number of doses required due to age at series initiation, and doses administered out of the region.
Conclusions
These results confirm that parent report is often flawed, but also identify that registries are prone to misclassification of immunization status. Immunization program administrators and researchers need to institute measures to identify and reduce misclassification, in order for registries to play an effective role in the control of vaccine-preventable disease.
doi:10.1186/1471-2431-14-1
PMCID: PMC3880846  PMID: 24387002
Immunization; Vaccination; Immunization status; Immunization information system (IIS); Registry; Parent report; Misclassification
15.  Maternal determinants of pediatric preventive care utilization among blacks and whites. 
OBJECTIVE: We assessed maternal characteristics that were predictive of preventive care utilization among children 0-5 years and compared black-white differences in preventive care usage. METHOD: We used the 1996-2000 series of public use files from the Medical Expenditure Panel Survey (MEPS). Receipt of preventive care was defined as up-to-date immunization coverage of the child and at least one dental visit during the year. RESULTS: A total of 10,525 children were analyzed consisting of 2,090 blacks (19.9%) and 8,435 whites (80.1%). Black mothers were in general older and less educated. Black households were larger in size and contained a greater number of children. Black mothers earned, on average, much less than their white counterparts even though they tended to be more frequently employed than whites. Despite similar levels of insurance coverage for both racial groups, the overwhelming majority of white mothers were privately insured (73.2%), in contrast to only about half of blacks with private insurance coverage [54.3% (p < 0.0001)]. Overall, the level of pediatric preventive services utilization was a paltry 15.4%. Children of black mothers were significantly less likely to receive preventive care than whites (OR = 0.78; 95% CI = 0.64-0.94). Other determinants of preventive care use were maternal age, insurance coverage, education and family size. Older, educated mothers with insurance coverage and reduced family size were more likely to have their children immunized and have dental visits. CONCLUSION: Maternal characteristics are important markers that indicate the risk for underutilization of pediatric preventive care. A particularly important finding with policy implication is the observation that maternal insurance coverage enhances pediatric preventive care use. Health policy planners may consider parallel insurance coverage of both the child and the mother in order to enhance receipt of preventive health services by the child.
PMCID: PMC2569499  PMID: 16035577
16.  Reasons for Unmet Need for Child and Family Health Services among Children with Special Health Care Needs with and without Medical Homes 
PLoS ONE  2013;8(12):e82570.
Objectives
Medical homes, an important component of U.S. health reform, were first developed to help families of children with special health care needs (CSHCN) find and coordinate services, and reduce their children’s unmet need for health services. We hypothesize that CSHCN lacking medical homes are more likely than those with medical homes to report health system delivery or coverage problems as the specific reasons for unmet need.
Methods
Data are from the 2005-2006 National Survey of Children with Special Health Care Needs (NS-CSHCN), a national, population-based survey of 40,723 CSHCN. We studied whether lacking a medical home was associated with 9 specific reasons for unmet need for 11 types of medical services, controlling for health insurance, child’s health, and sociodemographic characteristics.
Results
Weighted to the national population, 17% of CSHCN reported at least one unmet health service need in the previous year. CSHCN without medical homes were 2 to 3 times as likely to report unmet need for child or family health services, and more likely to report no referral (OR= 3.3), dissatisfaction with provider (OR=2.5), service not available in area (OR= 2.1), can’t find provider who accepts insurance (OR=1.8), and health plan problems (OR=1.4) as reasons for unmet need (all p<0.05).
Conclusions
CSHCN without medical homes were more likely than those with medical homes to report health system delivery or coverage reasons for unmet child health service needs. Attributable risk estimates suggest that if the 50% of CSHCN who lacked medical homes had one, overall unmet need for child health services could be reduced by as much as 35% and unmet need for family health services by 40%.
doi:10.1371/journal.pone.0082570
PMCID: PMC3858312  PMID: 24340042
17.  The role of insurance in the achievement of universal coverage within a developing country context: South Africa as a case study 
BMC Public Health  2012;12(Suppl 1):S5.
Background
Achieving universal coverage as an objective needs to confront the reality of multiple mechanisms, with healthcare financing and provision occurring in both public and private settings. South Africa has both large and mature public and private health systems offering useful insights into how they can be effectively harmonized to optimise coverage. Private healthcare in South Africa has also gone through many phases and regulatory regimes which, through careful review, can help identify potential policy frameworks that can optimise their ability to deepen coverage in a manner that complements the basic coverage of public arrangements.
Research question
Using South Africa as a case study, this review examines whether private health systems are susceptible to regulation and therefore able to support an extension and deepening of coverage when complementing a pre-existing publicly funded and delivered health system?
Methods
The approach involves a review of different stages in the development of the South African private health system and its response to policy changes. The focus is on the time-bound characteristics of the health system and associated policy responses and opportunities. A distinction is consequently made between the early, largely unregulated, phases of development and more mature phases with alternative regulatory regimes.
Results
The private health system in South Africa has played an important supplementary role in achieving universal coverage throughout its history, but more especially in the post-Apartheid period. However, the quality of this role has been erratic, influenced predominantly by policy vacillation.
The private system expanded rapidly during the 1980s mainly due to the pre-existence of a mature health insurance system and a weakening public hospital system which could accommodate and facilitate an increased demand for private hospital services. This growth served to expand commercial interest in health insurance, in the form of regulated medical schemes, which until this point took the form of non-commercial occupational (employer-based) schemes. During the 1980s government acquiesced to industry lobbies arguing for the deregulation of health insurance from 1989, with an extreme deregulation occurring in 1994, evidently in anticipation of the change of government associated with the democratic dispensation. Dramatic unintended consequences followed, with substantial increases in provider and funder costs coinciding with uncontrolled discrimination against poor health risks.
Against significant industry opposition, including legal challenges, partial re-regulation took effect from 2000 which removed the discretion of schemes to discriminate against poor health risks. This included: the implementation of a strong regulator of health insurance; the establishment of one allowable vehicle able to provide health insurance; open enrolment, whereby schemes could not refuse membership applications; mandatory minimum benefit requirements; and a prohibition on setting contributions or premiums on the basis of health status. After a two-year lag, dramatically reduced cost trends and contributions became evident. Aside from generally tighter regulation across a range of fronts, this appears related to the need for schemes to compete more on the basis of healthcare provider costs than demographic risk profiles. Despite an incomplete reform improved equitable coverage and cost-containment was nevertheless achieved.
A more complete regulatory regime is consequently likely to deepen coverage by: further stabilising and even decreasing costs; enhanced risk pooling; and access for low income groups. This would occur if South Africa: improved the quality of free public services, thereby creating competitive constraints for medical schemes; introduced risk-equalisation, increasing the pressure on schemes to compete on the cost and quality of coverage rather than their risk profile; and through the establishment of improved price regulation.
Conclusions
The objective of universal coverage can be seen in two dimensions, horizontal extension and vertical deepening. Private systems play an important role in deepening coverage by mobilising revenue from income earners for health services over-and-above the horizontal extension role of public systems and related subsidies. South Africa provides an example of how this natural deepening occurs whether regulated or unregulated. It also demonstrates how poor regulation of mature private systems can severely undermine this role and diminish achievements below attainable levels of social protection. The mature South African system has demonstrated its sensitivity to regulatory design and responds rapidly to changes both positive and negative. When measures to enhance risk pooling are introduced, coverage is expanded and becomes increasingly fair and sustainable. When removed, however, the system becomes less stable and fair as costs rise and people with poor health status are systematically excluded from cover. This susceptibility to regulation therefore presents an opportunity to policymakers to achieve social protection objectives through the strategic management of markets rather than exclusively through less responsive systems based on tax-funded direct provision. This is especially relevant as private markets for healthcare are inevitable, with policy discretion reduced to a choice between functional or dysfunctional regimes.
doi:10.1186/1471-2458-12-S1-S5
PMCID: PMC3381693  PMID: 22992410
18.  Out-of-Pocket Financial Burden for Low-Income Families with Children: Socioeconomic Disparities and Effects of Insurance 
Health Services Research  2005;40(6 Pt 1):1722-1736.
Objective
To determine whether socioeconomic disparities exist in the financial burden of out-of-pocket (OOP) health care expenditures for families with children, and whether health insurance coverage decreases financial burden for low-income families.
Data Source
The Household Component of the 2001 Medical Expenditure Panel Survey.
Study Design
Cross-sectional family-level analysis. We used bivariate statistics to examine whether financial burden varied by poverty level. Multivariate regression models were used to assess whether family insurance coverage was associated with level of financial burden for low-income families. The main outcome was financial burden, defined as the proportion of family income spent on OOP health care expenditures, including premiums, for all family members.
Data Collection/Extraction
We aggregated annual OOP expenditures for all members of 4,531 families with a child <18 years old. Family insurance coverage was categorized as follows: (1) all members publicly insured all year, (2) all members privately insured all year, (3) all members uninsured all year, (4) partial coverage, or (5) mix of public and private with no uninsured periods.
Principal Findings
A regressive gradient was noted for financial burden across income groups, with families with incomes <100 percent of the Federal Poverty Level (FPL) spending a mean of $119.66 OOP per $1,000 of family income and families with incomes 100–199 percent FPL spending $66.30 OOP per $1,000, compared with $37.75 for families with incomes >400 percent FPL. For low-income families (<200 percent FPL), there was a 785 percent decrease in financial burden for those with full-year public coverage compared with those with full-year private insurance (p<.001).
Conclusions
Socioeconomic disparities exist in the financial burden of OOP health care expenditures for families with children. For low-income families, full-year public coverage provides significantly greater protection from financial burden than full-year private coverage.
doi:10.1111/j.1475-6773.2004.00421.x
PMCID: PMC1361224  PMID: 16336545
Financial burden; family coverage; health care costs; health care financing/insurance/premiums; socioeconomic disparities
19.  Does private insurance adequately protect families of children with mental health disorders? 
Pediatrics  2009;124(Suppl 4):S399-S406.
Objective
Although private insurance typically covers many health care costs, the challenges faced by families caring for a sick child are substantial. These challenges may be more severe for CSHCN with mental illnesses than for other special needs children. Our objective is to determine whether families of privately insured children needing mental health care face different burdens than other families in caring for their children.
Patients and Methods
We use the 2005–2006 National Survey of Children with Special Health Care Needs (NS-CSHCN) to study privately insured children ages 6–17. We compare CSHCN with mental health care needs (N=4,918) to three groups: children with no SHCN (N=2,346), CSHCN with no mental health care needs (N=16,250), and CSHCN with no mental health care need but a need for other specialty services (N=7,902). The latter group is a subset of CSHCN with no mental health care need. We use weighted logistic regression and study outcomes across four domains: financial burden, health plan experiences, labor market and time effects, and parent experience with services.
Results
We find that families of children with mental health care needs face significantly greater financial barriers, have more negative health plan experiences, and are more likely to reduce their labor market participation to care for their child than other families.
Conclusions
Families of privately insured CSHCN needing mental health care face a higher burden than other families in caring for their children. Policies are needed to aid these families in obtaining affordable, high quality care for their children.
doi:10.1542/peds.2009-1255K
PMCID: PMC2805472  PMID: 19948605
mental health; health care services; CSHCN
20.  Immunization Milestones: A More Comprehensive Picture of Age-Appropriate Vaccination 
A challenge facing immunization registries is developing measures of childhood immunization coverage that contain more information for setting policy than present vaccine series up-to-date (UTD) rates. This study combined milestone analysis with provider encounter data to determine when children either do not receive indicated immunizations during medical encounters or fail to visit providers. Milestone analysis measures immunization status at key times between birth and age 2, when recommended immunizations first become late. The immunization status of a large population of children in the Oregon ALERT immunization registry and in the Oregon Health Plan was tracked across milestone ages. Findings indicate that the majority of children went back and forth with regard to having complete age-appropriate immunizations over time. We also found that immunization UTD rates when used alone are biased towards relating non-UTD status to a lack of visits to providers, instead of to provider visits on which recommended immunizations are not given.
doi:10.1155/2010/916525
PMCID: PMC2874993  PMID: 20508852
21.  The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial 
PLoS Medicine  2011;8(5):e1000437.
In a cluster randomized trial, Beth Kangwana and colleagues find that provision of subsidized packs of the malaria therapy artemether-lumefantrine to shops more than doubled the proportion of children with fever who received drugs promptly.
Background
It has been proposed that artemisinin-based combination therapy (ACT) be subsidised in the private sector in order to improve affordability and access. This study in western Kenya aimed to evaluate the impact of providing subsidized artemether–lumefantrine (AL) through retail providers on the coverage of prompt, effective antimalarial treatment for febrile children aged 3–59 months.
Methods and Findings
We used a cluster-randomized, controlled design with nine control and nine intervention sublocations, equally distributed across three districts in western Kenya. Cross-sectional household surveys were conducted before and after the delivery of the intervention. The intervention comprised provision of subsidized packs of paediatric ACT to retail outlets, training of retail outlet staff, and community awareness activities. The primary outcome was defined as the proportion of children aged 3–59 months reporting fever in the past 2 weeks who started treatment with AL on the same day or following day of fever onset. Data were collected using structured questionnaires and analyzed based on cluster-level summaries, comparing control to intervention arms, while adjusting for other covariates. Data were collected on 2,749 children in the target age group at baseline and 2,662 at follow-up. 29% of children experienced fever within 2 weeks before the interview. At follow-up, the percentage of children receiving AL on the day of fever or the following day had risen by 14.6% points in the control arm (from 5.3% [standard deviation (SD): 3.2%] to 19.9% [SD: 10.0%]) and 40.2% points in the intervention arm (from 4.7% [SD: 3.4%] to 44.9% [SD: 11.7%]). The percentage of children receiving AL was significantly greater in the intervention arm at follow-up, with a difference between the arms of 25.0% points (95% confidence interval [CI]: 14.1%, 35.9%; unadjusted p = 0.0002, adjusted p = 0.0001). No significant differences were observed between arms in the proportion of caregivers who sought treatment for their child's fever by source, or in the child's adherence to AL.
Conclusions
Subsidizing ACT in the retail sector can significantly increase ACT coverage for reported fevers in rural areas. Further research is needed on the impact and cost-effectiveness of such subsidy programmes at a national scale.
Trial Registration
Current Controlled Trials ISRCTN59275137 and Kenya Pharmacy and Poisons Board Ethical Committee for Clinical Trials PPB/ECCT/08/07.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Malaria is a major global public-health problem. Half the world's population is at risk of this mosquito-borne parasitic disease, which kills a million people (mainly children living in sub-Saharan Africa) every year. Although several parasites cause malaria, Plasmodium falciparum is responsible for most of these deaths. For the past 50 years, the main treatments for malaria have been drugs such as sulfadoxine–pyrimethamine and chloroquine. Unfortunately, parasitic resistance to these inexpensive "monotherapies" is now widespread and there has been an upsurge in the illness and death caused by P. falciparum. To combat this increase, the World Health Organization (WHO) now recommends artemisinin-based combination therapy (ACT) for first-line treatment of P. falciparum malaria in all regions with drug-resistant malaria. In ACT, artemisinin derivatives (new, fast-acting antimalarial drugs) are used in combination with another antimalarial to reduce the chances of P. falciparum becoming resistant to either drug.
Why Was This Study Done?
Despite WHO's recommendation, ACT use in many developing countries remains low partly because of its high retail price. To increase the affordability of and access to ACT, the Global Fund to Fight AIDS, Tuberculosis and Malaria is planning to run an ACT subsidy mechanism called the “Affordable Medicines Facility – malaria” (AMF-m). Using money provided by various donors, the Global Fund aims to reduce the private sector retail costs of ACT to those of monotherapies by making "copayments" directly to ACT manufacturers. Phase I of the AMF-m is already being implemented in pilots in several countries, but there are few data on the likely impact of private sector ACT subsidies on the coverage of prompt, effective treatment at the community level. In this cluster randomized controlled trial, the researchers investigate the impact of an intervention package that includes ACT subsidies on malaria treatment of young children in a high malaria transmission area of western Kenya. In a cluster randomized controlled trial, groups of patients rather than individual patients are randomly assigned to receive a test or control intervention, and the outcomes in different clusters are compared.
What Did the Researchers Do and Find?
The researchers randomly assigned 18 rural sublocations (the lowest administrative level in Kenya) to receive the intervention—the provision of subsidized packs of the ACT artemether-lumefantrine (AL) to retail outlets, retail staff training, and community awareness activities—or to act as controls. The researchers collected data about recent fever (a symptom of malaria) in children aged 3–59 months and its treatment with AL from randomly selected households in the intervention and control sublocations 4 months before and 8 months after roll-out of the intervention. At follow-up, 19.9% of children in the control arm received AL within 24 hours of fever developing compared to 5.3% of children at baseline (a 14.5% point rise). In the intervention arm, the percentage of children receiving AL within 24 hours of fever developing increased from 4.7% at baseline to 44.9% at follow-up (a 40.2% point rise). Moreover, the proportion of children receiving AL in the intervention arm was significantly greater than in the control arm (that is, unlikely to have happened by chance). Put another way, the intervention more than doubled the proportion of children with fever who received AL promptly.
What Do These Findings Mean?
These findings show that in the rural areas of Kenya included in this study, the provision of subsidized ACT in the private retail sector can significantly increase the coverage of prompt and effective treatment of fever in children with ACT; the increase in ACT coverage in the control arm probably reflects improved availability of AL in public-health facilities. However, these findings may not be generalizable to other settings and, because the design of this trial and that of the planned AMF-m roll-out are somewhat different (through AMF-m, subsidized drugs will be available to all age groups, for example), these results must be used with caution when trying to predict the outcome of AMF-m. Most importantly, the tested intervention only achieved prompt ACT uptake in 44.9% of children with fever, somewhat lower than the target of 80% set by the Roll Back Malaria Partnership. Thus, although the provision of subsidized ACTs is likely to improve ACT coverage, additional strategies to increase the prompt use of ACT need to be identified.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000437.
Information is available from the World Health Organization on malaria (in several languages); the 2010 World Malaria Report provides details of the current global malaria situation
The US Centers for Disease Control and Prevention provide information on malaria (in English and Spanish)
Information is available from the Roll Back Malaria Partnership on the global control of malaria including fact sheets about ACT and about malaria in Kenya, and information on AMF-m
The Global Fund to Fight AIDS, Tuberculosis and Malaria, an international financing institution that invests the world's money to save lives, also has information on fighting malaria and on the AMF-m (in several languages)
MedlinePlus provides links to additional information on malaria (in English and Spanish)
doi:10.1371/journal.pmed.1000437
PMCID: PMC3104978  PMID: 21655317
22.  Removing the Age Restrictions for Rotavirus Vaccination: A Benefit-Risk Modeling Analysis 
PLoS Medicine  2012;9(10):e1001330.
A modeling analysis conducted by Manish Patel and colleagues predicts the possible number of rotavirus deaths prevented, and number of intussusception deaths caused, by use of an unrestricted rotavirus schedule in low- and middle-income countries.
Background
To minimize potential risk of intussusception, the World Health Organization (WHO) recommended in 2009 that rotavirus immunization should be initiated by age 15 weeks and completed before 32 weeks. These restrictions could adversely impact vaccination coverage and thereby its health impact, particularly in developing countries where delays in vaccination often occur.
Methods and Findings
We conducted a modeling study to estimate the number of rotavirus deaths prevented and the number of intussusception deaths caused by vaccination when administered on the restricted schedule versus an unrestricted schedule whereby rotavirus vaccine would be administered with DTP vaccine up to age 3 years. Countries were grouped on the basis of child mortality rates, using WHO data. Inputs were estimates of WHO rotavirus mortality by week of age from a recent study, intussusception mortality based on a literature review, predicted vaccination rates by week of age from USAID Demographic and Health Surveys, the United Nations Children's Fund (UNICEF) Multiple Indicator Cluster Surveys (MICS), and WHO-UNICEF 2010 country-specific coverage estimates, and published estimates of vaccine efficacy and vaccine-associated intussusception risk. On the basis of the error estimates and distributions for model inputs, we conducted 2,000 simulations to obtain median estimates of deaths averted and caused as well as the uncertainty ranges, defined as the 5th–95th percentile, to provide an indication of the uncertainty in the estimates.
We estimated that in low and low-middle income countries a restricted schedule would prevent 155,800 rotavirus deaths (5th–95th centiles, 83,300–217,700) while causing potentially 253 intussusception deaths (76–689). In contrast, vaccination without age restrictions would prevent 203,000 rotavirus deaths (102,000–281,500) while potentially causing 547 intussusception deaths (237–1,160). Thus, removing the age restrictions would avert an additional 47,200 rotavirus deaths (18,700–63,700) and cause an additional 294 (161–471) intussusception deaths, for an incremental benefit-risk ratio of 154 deaths averted for every death caused by vaccine. These extra deaths prevented under an unrestricted schedule reflect vaccination of an additional 21%–25% children, beyond the 63%–73% of the children who would be vaccinated under the restricted schedule. Importantly, these estimates err on the side of safety in that they assume high vaccine-associated risk of intussusception and do not account for potential herd immunity or non-fatal outcomes.
Conclusions
Our analysis suggests that in low- and middle-income countries the additional lives saved by removing age restrictions for rotavirus vaccination would far outnumber the potential excess vaccine-associated intussusception deaths.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Rotavirus causes severe diarrhea and vomiting. It is responsible for a large number of hospitalizations among young children in developed countries (an estimated 60,000 hospitalizations per year in the US in 2005, for example). In poor countries, rotavirus is a major cause of death in children under five. In 1998, the first rotavirus vaccine, called RotaShield, was approved in the US by the Food and Drug Administration. Shortly after the vaccine became widely used, doctors noticed a small increase in a problem called intussusception among the vaccinated infants. Intussusception is a rare type of bowel obstruction that occurs when the bowel telescopes in on itself. Prompt treatment of intussusception normally leads to full recovery, but some children with the condition need surgery, and when the disease is left untreated it can be fatal. Because intussusception is a serious condition and because very few children die from rotavirus infection in the United States, the US authorities stopped recommending vaccination with RotaShield in 1999. The manufacturer withdrew the vaccine from the market shortly thereafter.
Since then, two new vaccines (named Rotarix and RotaTeq) have been developed. Before they were approved in the US and elsewhere, they were extensively tested for any adverse side effects, especially intussusception. No increase in the risk for intussusception was found in these studies, and both are now approved and recommended for vaccination of infants around the world.
Why Was This Study Done?
Since 2006, hundreds of thousands of infants have been vaccinated with Rotarix or RotaTeq, with safety being closely monitored. Some countries have reported a small increase in intussusception (one to four additional cases per 100,000 vaccinated infants, compared with one per 2,000 of cases that occur in unvaccinated children). This increase is much lower than the one seen previously with RotaShield. In response to these findings, authorities in the US and other developed countries as well as the World Health Organization declared that the benefits of the vaccine outweigh the risks of the small number of additional intussusception cases in both developed and poor countries. However, because older infants have a higher risk of naturally occurring intussusception, they decided that the course of vaccination (three oral doses for Rotarix and two for RotaTeq) should be initiated before 15 weeks of age and completed before the age of 32 weeks. This is usually not a problem in countries with easy access to health facilities. However, in many poor countries where delays in infant vaccination are common, giving the vaccine only to very young children means that many others who could benefit from its protection will be excluded. In this study, the researchers examined the risks and benefits of rotavirus vaccination in poor countries where most of the rotavirus deaths occur. Specifically, they looked at the benefits and risks if the age restrictions were removed, with a particular emphasis on allowing infants to initiate rotavirus immunization even if they arrive after 15 weeks of age.
What Did the Researchers Do and Find?
The researchers used the most recent estimates for how well the vaccines protect children in Africa and Asia from becoming infected with rotavirus, how many deaths from rotavirus infection can be avoided by vaccination, how many additional cases of intussusception will likely occur in vaccinated children, and what proportion of children would be excluded from rotavirus vaccination because they are too old when they come to a health facility for their infant vaccination. They then estimated the number of rotavirus deaths prevented and the number of intussusception deaths caused by vaccination in two scenarios. The first one (the restricted scenario) corresponds to previous guidelines from WHO and others, in which rotavirus vaccination needs to be initiated before 15 weeks and the full series completed before 32 weeks. The second one (called the unrestricted scenario) allows rotavirus vaccination of children alongside current routinely administered vaccines up to three years of age, recognizing that most children receive their vaccination by 1 year of life.
The researchers estimated that removing the age restriction would prevent an additional 154 rotavirus deaths for each intussusception death caused by the vaccine. Under the unrestricted scenario, roughly a third more children would get vaccinated, which would prevent an additional approximately 47,000 death from rotavirus while causing approximately 300 additional intussusception deaths.
They also calculated some best- and worst-case scenarios. The worst-case scenario assumed a much higher risk of intussusception for children receiving their first dose after 15 weeks of life than what has been seen anywhere, and also that an additional 20% of children with intussusception would die from it than what was already assumed in their routine scenario (again, a higher number than seen in reality). In addition, it assumes a lower protection from rotavirus death for the vaccine than has been observed in children vaccinated so far. In this pessimistic case, the number of rotavirus deaths prevented was 24 for each intussusception death caused by the vaccine.
What Do These Findings Mean?
If one accepts that deaths caused by a vaccine are not fundamentally different from deaths caused by a failure to vaccinate, then these results show that the benefits of lifting the age restriction for rotavirus vaccine clearly outweigh the risks, at least when only examining mortality outcomes. The calculations are valid only for low-income countries in Africa and Asia where both vaccination delays and deaths from rotavirus are common. The risk-benefit ratio will be different elsewhere. There are also additional risks and benefits that are not included in the study's estimates. For example, early vaccination might be seen as less of an urgent priority when this vaccine can be had at a later date, leaving very young children more vulnerable. On the other hand, when many children in the community are vaccinated, even the unvaccinated children are less likely to get infected (what is known as “herd immunity”), something that has not been taken into account in the benefits here. The results of this study (and its limitations) were reviewed in April 2012 by WHO's Strategic Advisory Group of Experts. The group then recommended that, while early vaccination is still strongly encouraged, the age restriction on rotavirus vaccination should be removed in countries where delays in vaccination and rotavirus mortality are common so that more vulnerable children can be vaccinated and deaths from rotavirus averted.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001330.
The World Health Organization provides information on rotavirus
Wikipedia has information on rotavirus vaccine and intussusception (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US Centers for Disease Control and Prevention rotavirus vaccination page includes a link to frequently asked questions
PATH Rotavirus Vaccine Access and Delivery has timely, useful updates on status of rotavirus vaccines globally
doi:10.1371/journal.pmed.1001330
PMCID: PMC3479108  PMID: 23109915
23.  Transitions from Private to Public Health Coverage among Children: Estimating Effects on Out-of-Pocket Medical Costs and Health Insurance Premium Costs 
Health Services Research  2011;46(3):840-858.
Objective
To assess the effects of transitions from private to public health insurance by children on out-of-pocket medical expenditures and health insurance premium costs.
Data Sources
Data are drawn from the 1996 and 2001 panels of the Survey of Income and Program Participation. We construct a nationally representative, longitudinal sample of children, ages 0–18, and their families for the period 1998–2003, a period in which states raised public health insurance eligibility rates for children.
Study Design
We exploit the Survey of Income and Program Participation's longitudinal design to identify children in our sample who transition from private to public health insurance. We then use a bootstrapped instrumental variable approach to estimate the effects of these transitions on out-of-pocket expenditures and health insurance premium costs.
Principal Findings
Children who transition from private to public coverage are relatively low-income, are disproportionately likely to live in single-mother households, and are more likely to be Black or of Hispanic origin. Child health status is highly predictive of transitions. We estimate that these transitions provide a cash-equivalent transfer of nearly U.S.$1,500 annually for families in the form of reduced out-of-pocket and health insurance premium costs.
Conclusions
Transitions from private to public health coverage by children can bring important social benefits to vulnerable families. This suggests that instead of being a net societal cost, such transitions may provide an important social benefit.
doi:10.1111/j.1475-6773.2010.01238.x
PMCID: PMC3097405  PMID: 21306364
Medicaid; State Children's Health Insurance Program; health insurance; crowd-out; medical expenses; Survey of Income and Program Participation
24.  Identifying Children with Special Health Care Needs in the National Health Interview Survey: A New Resource for Policy Analysis 
Health Services Research  2004;39(1):53-72.
Objective
To test the feasibility of using the National Health Interview Survey (NHIS) to identify children with chronic illness through a noncategorical approach, as exemplified by the Children with Special Health Care Needs (CSHCN) screener. The ability to use the NHIS to identify CSHCN will permit analyses of the effects of welfare reform and public insurance eligibility expansions during the late 1990s on CSHCN.
Data Sources
The NHIS from 1997, 1999, and 2000. The NHIS is an ongoing household survey representative of the civilian, noninstitutionalized population of the United States.
Study Design
Survey items were selected from the NHIS and thresholds designated to replicate the content and logic of the CSHCN screener. The screener asks explicit questions concerning an elevated need for, or use of health care services, and about limitations in activity, both caused by a chronic health condition. The algorithm created was applied to the pooled 1999–2000 NHIS to generate national prevalence estimates. Multivariate logistic regression was estimated to determine the effect of having particular demographic characteristics on the likelihood of being identified as CSHCN. Log odds ratios were compared to those from earlier NHIS-based estimates and from a pretest of the CSHCN screener.
Principal Findings
An estimated 12 percent of noninstitutionalized children aged 0 through 17 have a chronic condition that results in elevated service use or limitations in normal activity. This estimate is sensitive to inclusion of children with a broader array of less serious or shorter-term conditions. The estimated effects of child characteristics on the likelihood of being identified as having special health needs are similar but not identical to other algorithms that have been used to identify CSHCN.
Conclusions
It is feasible to use existing questions in the NHIS to identify a population of CSHCN that is substantially similar to children identified through other algorithms or through use of a screening instrument imbedded in a household survey. The availability of this algorithm will permit use of the NHIS for important analyses of the effects of welfare reform and public insurance expansions on children with special health care needs.
doi:10.1111/j.1475-6773.2004.00215.x
PMCID: PMC1360994  PMID: 14965077
Children; chronic illness; measurement; CSHCN screener
25.  Who Can't Pay for Health Care? 
BACKGROUND
In an era of rising health care costs, many Americans experience difficulty paying for needed health care services. With costs expected to continue rising, changes to private insurance plans and public programs aimed at containing costs may have a negative impact on Americans' ability to afford care.
OBJECTIVES
To provide estimates of the number of adults who avoid health care due to cost, and to assess the association of income, functional status, and type of insurance with the extent to which people with health insurance report financial barriers.
RESEARCH DESIGN
Cross-sectional observational study using data from the Commonwealth Fund 2001 Health Care Quality Survey, a nationally representative telephone survey.
PARTICIPANTS
U.S. adults age 18 and older (N=6,722).
MEASURES
Six measures of avoiding health care due to cost, including delaying or not seeking care; not filling prescription medicines; and not following recommended treatment plan.
RESULTS
The proportion of Americans with difficulty affording health care varies by income and health insurance coverage. Overall, 16.9% of Americans report at least 1 financial barrier. Among those with private insurance, the poor (28.4%), near poor (24.3%), and those with functional impairments (22.9%) were more likely to report avoiding care due to cost. In multivariate models, the uninsured are more likely (OR, 2.3; 95% CI, 1.7 to 3.0) to have trouble paying for care. Independent of insurance coverage and other demographic characteristics, the poor (OR, 3.6; 95% CI, 2.1 to 4.6), near poor (OR, 2.1; 95% CI, 1.9 to 3.7), and middle-income (OR, 1.8; 95% CI, 1.3 to 2.5) respondents as well as those with functional impairments (OR, 1.6; 95% CI, 1.3 to 2.0) are significantly more likely to avoid care due to cost.
CONCLUSIONS
Privately and publicly insured individuals who have low incomes or functional impairments encounter significant financial barriers to care despite having health insurance. Proposals to expand health insurance will need to address these barriers in order to be effective.
doi:10.1111/j.1525-1497.2005.0087.x
PMCID: PMC1490134  PMID: 15987324
health care affordability; insurance coverage; low-income populations; functional impairment

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