Background Survival rates in pediatric oncology have improved dramatically, in part due to high patient participation in clinical trials. Although racial/ethnic inequalities in clinical trial participation have been reported in adults, pediatric data and studies comparing participation rates by socio-demographic characteristics are scarce. The goal of this study was to assess differences in research protocol participation for childhood cancer by age, sex, race/ethnicity, parental language, cancer type and insurance status. Procedure Data on enrollment in any protocol, biospecimen, or therapeutic protocols were collected and analyzed for newly diagnosed pediatric patients with cancer from 2008–2012 at Rady Children’s Hospital. Results Among the 353 patients included in the analysis, 304 (86.1%) were enrolled in any protocol. Enrollment in biospecimen and therapeutic protocols was 84.2% (261/310) and 81.1% (206/254), respectively. Logistic regression analyses revealed significant enrollment underrepresentation in any protocol for Hispanics compared to Non-Hispanic whites (81% vs. 91%; Odds Ratio [OR], 0.43; 95% Confidence Interval [CI], 0.21–0.90; p=0.021) and among children of Spanish-speaking vs. English-speaking parents (78% vs. 89%; OR, 0.45; 95%CI, 0.23–0.87; p=0.016). Compared to patients aged 0–4 years, significant underrepresentation was also found among patients 15–21 years old (92% vs.72%; OR, 0.21; 95% CI, 0.09–0.48; p<0.001). Similar trends were observed when analyzing enrollment in biospecimen and therapeutic protocols separately. Conclusions There was significant underrepresentation in protocol participation for Hispanics, children of Spanish-speaking parents, and patients ages 15–21. Research is urgently needed to understand barriers to research participation among these groups underrepresented in pediatric oncology clinical trials.
Adult cancer disparities have been documented for decades and continue to persist despite clinical advancements in cancer prevention, detection, and treatment. Pediatric cancer survival has improved significantly in the United States for the past 5 decades to over 80%; however, disparate outcomes among children and adolescents with cancer still affect many populations in the United States and globally, including racial and ethnic minorities, populations with low socioeconomic status, and residents of underserved areas. To achieve equitable outcomes for all children and adolescents with cancer, it is imperative that concerted multilevel approaches be carried out to understand and address health disparities and to ensure access to high-quality cancer care. Addressing social determinants of health, such as removing barriers to health care access and ensuring access to social supports, can reduce pediatric cancer disparities. Nevertheless, public health policy, health system interventions, and innovative delivery of evidence-based services are critically needed. Partnerships among patients, caregivers, and health care providers, and among health care, academic, and governmental institutions, have a pivotal role in reducing cancer disparities and improving outcomes in the 21st century.
The analysis of inflammatory cytokines and chemokines produced during Hepatitis C virus (HCV) infection has advanced our understanding of viral-host interactions and identified predictors of treatment response. Administration of interferons (IFN) made it difficult to interpret biomarkers of immune activation during treatment. Direct acting antiviral (DAA) regimens without IFN are now being used to treat HCV with excellent efficacy. To gain insight into HCV-host interactions occurring before, during and after HCV treatment we performed a case-control study that measured serial plasma levels of IP-10, MCP-1, MIP-1β, and IL-18 in 131 patients with chronic HCV treated with sofosbuvir (SOF) plus ribavirin (RBV). A linear regression analysis using baseline factors identified strong positive associations between elevated ALT and pre-treatment IP-10 and between the presence of cirrhosis and elevated pre-treatment IL-18. Mean IP-10, MCP-1, MIP-1β and IL-18 levels all decline on therapy but display different dynamics late in treatment and following cessation of therapy. On treatment IP-10 and MIP-1β levels were significantly higher in individuals who achieved sustained virologic response (SVR). Logistic regression analyses examining treatment response in all patients demonstrated significant associations between higher baseline MIP-1β levels and smaller decreases in MIP-1β early in treatment and SVR. Higher early MIP-1β levels were also significantly associated with SVR in subsets of patients with cirrhosis and individuals with GT3 infection, two factors associated with decreased responsiveness to treatment. Conclusion: Our study shows that changes in IP-10 levels mirror HCV RNA suggesting IP-10 is an indicator of innate immune viral recognition. MIP-1β levels remained elevated in GT2/3 patients who achieved SVR suggesting differential immune activation in those who respond to SOF/RBV therapy and a potential role in predicting treatment responses.
Background The U.S. National Healthcare Safety Network (NHSN) has provided a definition of mucosal barrier injury–associated, laboratory-confirmed bloodstream infection (MBI-LCBI) to improve infection surveillance. To date there is little information about its impact in pediatric oncology centers in low- to middle-income countries. Objectives To determine the impact of the definition on the rate of central line-associated bloodstream infection (CLABSI) and compare the clinical characteristics of MBI vs. non-MBI LCBI cases. Methods We retrospectively applied the NHSN definition to all CLABSIs recorded at a pediatric oncology center in Tijuana, Mexico, from January 2011 through December 2014. CLABSI events were re-classified according to the MBI-LCBI definition. Clinical characteristics and outcomes of MBI and non-MBI CLABSIs were compared. Results Of 55 CLABSI events, 44% (24/55) qualified as MBI-LCBIs; all were MBI-LCBI subcategory 1 (intestinal flora pathogens). After the number of MBI-LCBI cases was removed from the numerator, the CLABSI rate during the study period decreased from 5.72 to 3.22 infections per 1,000 central line days. Patients with MBI-LCBI were significantly younger than non-MBI-LCBI patients (P=0.029) and had a significantly greater frequency of neutropenia (100% vs. 39%, P=0.001) and chemotherapy exposure (87% vs. 58%, P=0.020) and significantly longer median hospitalization (34 vs. 23 days, P=0.008). Conclusion A substantial proportion of CLABSI events at our pediatric cancer center met the MBI-LCBI criteria. Our results support separate monitoring and reporting of MBI and non-MBI– -LCBIs in low- to middle-income countries to allow accurate detection and tracking of preventable (non-MBI) bloodstream infections.
Introduction: Yearly more than 160,000 childhood cancer cases are diagnosed worldwide and around 90,000 die because of this disease. In Colombia, this represents the 2nd leading cause of childhood deaths for those more than one year old. Objective: To describe the occurrence and survival patterns of childhood cancer patients over the last 20 years in Cali. Methods:Information was obtained from the Cancer Population Registry in Cali and the Municipal Department of Health. The International Classification for childhood Cancer (ICCC) was used. Vital status data was obtained from MDH death certificates and hospital databases. Additionally, clinical records were reviewed and, in some cases, telephone contact was made to gather data. Follow-up was completed until December 31, 2011. Incident (IR) and mortality rates (MR) were estimated and adjusted for age. Life-tables were made to estimate overall survival. Results: Between 1977-2011 there were 2,311 cases of cancer identified in children less than 15 years of age. The IR and MR for Cali were found to be 141.2 and 55.6 per million of people per year. Leukemias, lymphomas, Central nervous system (CNS) tumors and soft tissue sarcomas showed IR´s of 60.1, 20.5, 25.7 and 9.4, respectively. 5-years OS was 48%, and showed an improvement from 24.9%±4.3 to 51.8%±4.6, compared 1992-96 vs 2002-06 periods. Conclusion: The IR found is comparable with those from affluent countries. Taking into account that pediatric cancer is curable in about 75-80% of the cases, an enormous challenge is presented to the Colombian health system: to improve current clinical results.
Survival rates for pediatric cancer have improved significantly over the past five decades, 1 mainly due to clinical trial (CT) participation. 2 Hispanic children have a significantly higher incidence of leukemia and lymphoma; however, Hispanics and African Americans have poorer 5-year overall survival rates than their non-Hispanic White (NHW) counterparts. 3-5 Lower survival rates are at least partially attributable to lower enrollment in CTs. 6 The National Institutes of Health Revitalization Act of 1993 mandated the inclusion of women and minorities in CTs. 7 However, to date, only 2% of approximately 10 000 National Cancer Institute (NCI) CTs have sufficient minority participants. 8 Despite the NCI's efforts to include minorities in research, Hispanics and African Americans are severely underrepresented compared to NHWs (1-7% and 15% vs 67%, respectively). 8 Enrollment rates in cancer CTs are even lower at 0.4-2.2% for Hispanics and 5.4% for African Americans, even at NCI-designated cancer centers. 8 Our work demonstrated that Hispanics are underrepresented in pediatric cancer research. 9 Consequently, cancer outcomes data are primarily based on data from NHWs, providing inadequate information to adequately assess treatment benefits for minorities.
Background Cancer is emerging as a major cause of childhood mortality in low-income and middle-income countries. In Mexico, cancer is the number one cause of death in children aged 5–14. Until recently, many children with cancer from Baja California, Mexico went untreated. We reasoned that an initiative inspired by the St. Jude Children’s Research Hospital (SJCRH) “twinning” model could successfully be applied to the San Diego–Tijuana border region. In 2008, a twinning project was initiated by Rady Children’s Hospital, SJCRH and the General Hospital Tijuana (GHT). Our aim was to establish a pediatric oncology unit in a culturally sensitive manner, adapted to the local health care system. Procedure An initial assessment revealed that despite existence of basic hospital infrastructure at the GHT, the essential elements of a pediatric cancer unit were lacking, including dedicated space, trained staff, and uniform treatment. A 5-year action plan was designed to offer training, support the staff financially, and improve the infrastructure. Results After seven years, accomplishments include the opening of a new inpatient unit with updated technology, fully-trained staff and a dedicated, interdisciplinary team. Over 700 children have benefited from accurate diagnosis and treatment. Conclusions Initiatives that implement long-term partnerships between institutions along the Mexican-North American border can be highly effective in establishing successful pediatric cancer control programs. The geographic proximity facilitated accelerated training and close monitoring of project development. Similar initiatives across other disciplines may benefit additional patients and synergize with pediatric oncology programs to reduce health disparities in underserved areas.
Key Points Question Are health literacy, contextual factors, or sociodemographic characteristics associated with parental perception of voluntariness during informed consent for pediatric leukemia clinical trials? Findings In this cross-sectional study that included 97 parents of children with newly diagnosed leukemia, lower perception of voluntariness was significantly associated with lower health literacy. Meaning Low health literacy may have a role in parents not making complete and meaningful informed decisions for their child’s participation in cancer clinical trials.
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