Disparities in parental distress in a multicenter clinical trial for pediatric acute lymphoblastic leukemia.

BACKGROUND: Parent psychological distress during childhood cancer treatment has short- and long-term implications for parent, child, and family well-being. Identifying targetable predictors of parental distress is essential to inform interventions. We investigated the association between household material hardship (HMH), a modifiable poverty-exposure defined as housing, food, or utility insecurity, and severe psychological distress among parents of children aged 1-17 years with acute lymphoblastic leukemia (ALL) enrolled on the multicenter Dana-Farber ALL Consortium Trial 16-001. METHODS: This was a secondary analysis of parent-reported data. Parents completed an HMH survey within 32 days of clinical trial enrollment (T0) and again at 6 months into therapy (T1). The primary exposure was HMH at T0 and primary outcome was severe parental distress at T0 and T1, defined as a score greater than or equal to 13 on the Kessler-6 Psychological Distress Scale. Multivariable models were adjusted for ALL risk group and single parent status. RESULTS: Among 375 evaluable parents, one-third (32%; n = 120/375) reported HMH at T0. In multivariable analyses, T0 HMH was associated with over twice the odds of severe psychological distress at T0 and T1 HMH was associated with over 5 times the odds of severe distress at T1. CONCLUSIONS: Despite uniform clinical trial treatment of their children at well-resourced pediatric centers, HMH-exposed parents-compared with unexposed parents-experienced statistically significantly increased odds of severe psychological distress at the time of their child's leukemia diagnosis, which worsened 6 months into therapy. These data identify a high-risk parental population who may benefit from early psychosocial and HMH-targeted interventions to mitigate disparities in well-being.

Feasibility of oncology clinical trial-embedded evaluation of social determinants of health.

Social determinants of health (SDoH) are associated with stark disparities in cancer outcomes, but systematic SDoH data collection is virtually absent from oncology clinical trials. Trial-based SDoH data are essential to ensure representation of marginalized populations, contextualize outcome disparities, and identify health-equity intervention opportunities. We report the feasibility of a pediatric oncology multicenter therapeutic trial-embedded SDoH investigation. Among 448 trial participants, 392 (87.5%) opted-in to the embedded SDoH study; 375 (95.7%) completed baseline surveys, with high longitudinal response rates (88.9-93.1%) over 24 months. Trial-embedded SDoH data collection is feasible and acceptable and must be consistently included within future oncology trials.

PediCARE: Development of a poverty-targeted intervention for pediatric cancer.

BACKGROUND: Poverty is associated with inferior psychosocial outcomes, higher rates of relapse, and decreased overall survival in children with cancer. Despite this, there are few evidence-based, poverty-targeted interventions and none specific to pediatric oncology. To address this gap, we developed and refined the Pediatric Cancer Resource Equity (PediCARE) intervention, a household material hardship (HMH) targeted intervention providing transportation and groceries to pediatric oncology families. METHODS: This was a single-arm pilot study conducted at a single, large, tertiary pediatric cancer center. Newly diagnosed patients with HMH-exposure were directly assigned to receive PediCARE for a total of three months. Quantitative and qualitative approaches were used to evaluate its acceptability and to rapidly refine the intervention. RESULTS: Nine families (100% of those approached) consented to enrollment with no attrition over the three-month study period. Families were highly satisfied with the intervention and recommended participation to others. All of the families utilized the grocery delivery component of PediCARE, and seven utilized the transportation component. Qualitative participant feedback was used to rapidly refine the intervention including logistics of intervention delivery, and dose of intervention components. CONCLUSION: PediCARE, a poverty-targeted intervention, was highly acceptable to pediatric oncology families. The intervention was refined in real-time utilizing quantitative and qualitative feedback. Next steps include intervention evaluation in a randomized, controlled feasibility study.

Derivation and validation of risk groups in patients with osteosarcoma utilizing regression tree analysis.

BACKGROUND: For patients with osteosarcoma, apart from stage and primary site, we lack reliable prognostic factors for risk stratification at diagnosis. There is a need for further defined, discrete prognostic groups using presenting clinical features. METHODS: We analyzed a cohort of 3069 patients less than 50 years of age, diagnosed with primary osteosarcoma of the bone between 1986 and 2013 from the Surveillance, Epidemiology, and End Results (SEER) database. Patients were randomly split into test and validation cohorts. Optimal cut points for age, tumor size, and grade were identified using classification and regression tree analysis. Manual recursive partitioning was used to identify discrete prognostic groups within the test cohort. These groups were applied to the validation cohort, and overall survival was analyzed using Cox models, Kaplan Meier methods, and log-rank tests. RESULTS: After applying recursive partitioning to the test cohort, our initial model included six groups. Application of these groups to the validation cohort resulted in four final groups. Key risk factors included presence of metastases, tumor site, tumor grade, age, and tumor size. Patients with localized axial tumors were identified as having similar outcomes to patients with metastases. Age and tumor size were only prognostically important in patients with extremity tumors when assessed in the validation cohort. CONCLUSIONS: This analysis supports prior reports that patients with axial tumors are a high-risk group, and demonstrates the importance of age and tumor size in patients with appendicular tumors. Biologic and genetic markers are needed to further define subgroups in osteosarcoma.

Development of a Comprehensive Trauma Training Curriculum for the Resource-Limited Environment.

OBJECTIVE: The goal of this project was to create a multitiered trauma training curriculum that was designed specifically for the low-resource setting. DESIGN: We developed 2 courses designed to teach principles and skills necessary for trauma care. The first course, "Emergency Ward Management of Trauma (EWMT)," is designed to teach interns the initial assessment and stabilization of trauma patients in the emergency ward. The second course for mid-level surgical residents, "Surgical Techniques and Repairs in Trauma for the Low-resource Environment" (STaRTLE), is a cadaver-based operative trauma course designed to teach surgical exposures and techniques. The courses were rolled out at Mbarara Regional Referral Hospital in the low-income country of Uganda. Precourse and postcourse tests and surveys were administered. SETTING: This study took place at Mbarara Regional Referral Hospital (MRRH). This is a hospital in southwest Uganda with a subspecialty care, a medical school, nursing school, and multiple residency programs. PARTICIPANTS: Students in the EWMT course were interns at MRRH. After 1 year of training, most of these interns will become medical officers as the only provider at a district hospital in Uganda. The students in the STARTLE course were second-year residents in the general surgery program at MRRH. RESULTS: Scores on knowledge based tests improved significantly with both courses. Survey results from the EWMT course suggest that participants feel better prepared to care for the injured patient (median Likert [IQR]: 5.0 [5.0-5.0]) and that their practice improved (5.0 [5.0-5.0]). Similarly, following the STaRTLE course we found participants felt significantly more comfortable with performing 20 of the 22 operative procedures taught. CONCLUSIONS: These courses represent a feasible, cost-effective, and resource appropriate trauma education curriculum that if standardized and implemented may improve trauma care and outcomes in the resource-limited setting.

Data Improvement Through Simplification: Implications for Low-Resource Settings.

BACKGROUND: The focus of many data collection efforts centers on creation of more granular data. The assumption is that more complex data are better able to predict outcomes. We hypothesized that data are often needlessly complex. We sought to demonstrate this concept by examination of the American Society of Anesthesiologists (ASA) scoring system. METHODS: First, we created every possible consecutive two, three and four category combinations of the current five category ASA score. This resulted in 14 combinations of simplified ASA. We compared the predictive ability of these simplified scores for postoperative outcomes for 2.3 million patients in the NSQIP database. Individual model performance was assessed by comparing receiver operator characteristic (ROC) curves for each model with the standard ASA. RESULTS: Two of our 4-category models and one of our 3-category models had ability to predict all outcomes equivalent to standard ASA. These results held for all outcomes and on all subgroups tested. The performance of the three best performing simplified ASA scores were also equivalent to the standard ASA score in the univariate analysis and when included in a multivariate model. CONCLUSIONS: It is assumed that the most granular data and use of the largest number of variables for risk-adjusted predictions will increase accuracy. This complexity is often at the expense of utility. Using the single best predictor in surgical outcomes research, we have shown this is not the case. In this example, we demonstrate that one can simplify ASA into a 3-category variable without losing any ability to predict outcomes.

Validation of an Electronic Surgical Outcomes Database at Mbarara Regional Referral Hospital, Uganda.

BACKGROUND: Accurate, complete and sustainable methods of tracking patients and outcomes in low-resource settings are imperative as we launch efforts to improve surgical care globally. The Surgical services QUality Assessment Database (SQUAD) at the Mbarara Regional Referral Hospital in Uganda is one of very few electronic surgical databases in a low-resource setting. We evaluated the completeness and accuracy of SQUAD. METHODS: Data were prospectively collected on 20 of the most clinically relevant variables captured by SQUAD for all general surgery patients admitted to MRRH over a two-week period. Patients were followed until discharge, death or hospital day 30; whichever occurred first. These data were compared to that in SQUAD for the same time period for completeness and accuracy. RESULTS: Of 186 unique patients seen over the two-week period, 172 (92.5%) were captured by SQUAD. The capture rate was greater than 86% for each of the 20 variables evaluated, except American Society of Anesthesiologists score, which had a 69% capture rate. Regarding accuracy, there was almost perfect agreement for 16/20 variables (all k > 0.81), substantial agreement for 2/20 variables (k 0.63, 0.73) and moderate agreement for the remaining 2/20 variables (k 0.43, 0.48) between SQUAD and the prospectively collected data. CONCLUSION: SQUAD is an electronic surgical database that has been implemented and sustained in a low-resource setting. For the 20 variables evaluated, the data within SQUAD are highly complete and accurate. This database may serve as a model for the development of additional surgical databases in low-resource environments.

Out-of-pocket payment for surgery in Uganda: The rate of impoverishing and catastrophic expenditure at a government hospital.

BACKGROUND AND OBJECTIVES: It is Ugandan governmental policy that all surgical care delivered at government hospitals in Uganda is to be provided to patients free of charge. In practice, however, frequent stock-outs and broken equipment require patients to pay for large portions of their care out of their own pocket. The purpose of this study was to determine the financial impact on patients who undergo surgery at a government hospital in Uganda. METHODS: Every surgical patient discharged from a surgical ward at a large regional referral hospital in rural southwestern Uganda over a 3-week period in April 2016 was asked to participate. Patients who agreed were surveyed to determine their baseline level of poverty and to assess the financial impact of the hospitalization. Rates of impoverishment and catastrophic expenditure were then calculated. An "impoverishing expense" is defined as one that pushes a household below published poverty thresholds. A "catastrophic expense" was incurred if the patient spent more than 10% of their average annual expenditures. RESULTS: We interviewed 295 out of a possible 320 patients during the study period. 46% (CI 40-52%) of our patients met the World Bank's definition of extreme poverty ($1.90/person/day). After receiving surgical care an additional 10 patients faced extreme poverty, and 5 patients were newly impoverished by the World Bank's definition ($3.10/person/day). 31% of patients faced a catastrophic expenditure of more than 10% of their estimated total yearly expenses. 53% of the households in our study had to borrow money to pay for care, 21% had to sell possessions, and 17% lost a job as a result of the patient's hospitalization. Only 5% of our patients received some form of charity. CONCLUSIONS AND RELEVANCE: Despite the government's policy to provide "free care," undergoing an operation at a government hospital in Uganda can result in a severe economic burden to patients and their families. Alternative financing schemes to provide financial protection are critically needed.

Surgical volume and postoperative mortality rate at a referral hospital in Western Uganda: Measuring the Lancet Commission on Global Surgery indicators in low-resource settings.

BACKGROUND: The Lancet Commission on Global Surgery recommends that every country report its surgical volume and postoperative mortality rate. Little is known, however, about the numbers of operations performed and the associated postoperative mortality rate in low-income countries or how to best collect these data. METHODS: For one month, every patient who underwent an operation at a referral hospital in western Uganda was observed. These patients and their outcomes were followed until discharge. Prospective data were compared with data obtained from logbooks and patient charts to determine the validity of using retrospective methods for collecting these metrics. RESULTS: Surgical volume at this regional hospital in Uganda is 8,515 operations/y, compared to 4,000 operations/y reported in the only other published data. The postoperative mortality rate at this hospital is 2.4%, similar to other hospitals in low-income countries. Finding patient files in the medical records department was time consuming and yielded only 62% of the files. Furthermore, a comparison of missing versus found charts revealed that the missing charts were significantly different from the found charts. Logbooks, on the other hand, captured 99% of the operations and 94% of the deaths. CONCLUSION: Our results describe a simple, reproducible, accurate, and inexpensive method for collection of the Lancet Commission on Global Surgery variables using logbooks that already exist in most hospitals in low-income countries. While some have suggested using risk-adjusted postoperative mortality rate as a more equitable variable, our data suggest that only a limited amount of risk adjustment is possible given the limited available data.