Emily Van Meter

An evaluation of edge effects in nutritional accessibility and availability measures: a simulation study

BackgroundThis paper addresses the statistical use of accessibility and availability indices and the effect of study boundaries on these measures. The measures are evaluated via an extensive simulation based on cluster models for local outlet density. We define outlet to mean either food retail store (convenience store, supermarket, gas station) or restaurant (limited service or full service restaurants). We designed a simulation whereby a cluster outlet model is assumed in a large study window and an internal subset of that window is constructed. We performed simulations on various criteria including one scenario representing an urban area with 2000 outlets as well as a non-urban area simulated with only 300 outlets. A comparison is made between estimates obtained with the full study area and estimates using only the subset area. This allows the study of the effect of edge censoring on accessibility measures.ResultsThe results suggest that considerable bias is found at the edges of study regions in particular for accessibility measures. Edge effects are smaller for availability measures (when not smoothed) and also for short range accessibilityConclusionsIt is recommended that any study utilizing these measures should correct for edge effects. The use of edge correction via guard areas is recommended and the avoidance of large range distance-based accessibility measures is also proposed.

Dose-finding clinical trial design for ordinal toxicity grades using the continuation ratio model: an extension of the continual reassessment method.

Background  Various dose-finding clinical trial designs, including the continual reassessment method (CRM), dichotomize toxicity outcomes based on prespecified dose-limiting toxicity (DLT) criteria. This loss of toxicity information is particularly inefficient due to the small sample sizes in phase I trials, especially when Common Terminology Criteria for Adverse Events (CTCAE v4.0) are an established ordinal toxicity grading classification already used in the clinical practice. Purpose  The purpose of this simulation study is to incorporate ordinal toxicity grades as specified by CTCAE v4.0 using a continuation ratio (CR) model in the likelihood-based CRM. Methods  This simulation study compares the CR model design to the dichotomous CRM as well as an ordinal CRM that implements the proportional odds (PO) model. We compare six scenarios for model performance based on various safety and efficiency criteria and consider a range of dose–toxicity relationship models, including CR models, PO models, and models that violate the PO assumption. Results  The ordinal CRM performs as well as the dichotomous CRM in all scenarios considered, especially in situations where the starting dose is overly toxic, the ordinal designs show slight improvement in the estimation of the maximum tolerated dose (MTD) and fewer median patients exposed to excessively toxic dose levels as compared to the binary CRM. We also find slight discrepancies in the performance between the PO model and CR model; however, the differences were not substantial enough to strongly recommend one model over the other. Limitations  The CR model design does require slightly more input from clinical investigators prior to the start of the trial as compared to the dichotomous CRM. Investigators must specify the distribution of toxicity grades at the expected dose levels for a 10% and 90% DLT rate in this CR design. However, an R package will help with the implementation of this ordinal design. Conclusions  While the ordinal designs did not perform significantly better than the binary counterpart, we were able to incorporate maximal toxicity information available into a feasible dose-finding design without compromising overall design performance.

Post-hematopoietic stem cell transplant immunization practices in the Pediatric Blood and Marrow Transplant Consortium†

A survey of National Marrow Donor Program transplant centers in 1995 demonstrated a wide range of immunization practices in post‐hematopoietic stem cell transplant (HSCT) recipients, which led to the 2000 Centers for Disease Control and Prevention (CDC) recommendations for vaccination after HSCT. We surveyed the principal investigators of the Pediatric Blood and Marrow Transplant Consortium (PBMTC) to identify immunization practice patterns after HSCT and assess compliance with the 2000 CDC guidelines.

Effectiveness of a primary care practice intervention for increasing colorectal cancer screening in Appalachian Kentucky

OBJECTIVE This report describes findings from a randomized controlled trial of an intervention to increase colorectal cancer (CRC) screening in primary care practices in Appalachian Kentucky. METHODS Sixty-six primary care practices were randomized to early or delayed intervention groups. The intervention was provided at practices using academic detailing, a method of education where providers receive information on a specific topic through personal contact. Data were collected in cross-sectional surveys of medical records at baseline and six months post-intervention. RESULTS A total of 3844 medical records were reviewed at baseline and 3751 at the six-month follow-up. At baselines, colonoscopy was recommended more frequently (43.4%) than any other screening modality, followed by fecal occult blood testing (18.0%), flexible sigmoidoscopy (0.4%), and double-contrast barium enema (0.3%). Rates of documented screening results were higher for all practices at the six-month follow-up for colonoscopy (31.8% vs 29.6%) and fecal occult blood testing (12.2% vs 11.2%). For early intervention practices that recommended screening, colonoscopy rates increased by 15.7% at six months compared to an increase of 2.4% in the delayed intervention practices (p=.01). CONCLUSIONS Using academic detailing to reach rural primary care providers with a CRC screening intervention was associated with an increase in colonoscopy.

Cervical Cancer Screening: Exploring Appalachian Patients’ Barriers to Follow-Up Care

This article describes a community-based Patient Navigation (PN) project conducted to identify potential barriers to seeking follow-up cervical cancer care in southeastern Kentucky. Patient navigators (PNs) were placed in cervical cancer programs within county public health departments where they interviewed patients about their perceived barriers to seeking follow-up care after receiving a positive Pap test result. Participants identified various potential barriers at three levels: the individual/personal level, the health care system level and the community/environmental level. One identified barrier that was unique to this study was a lack of consistency between follow-up recommendations and follow-up guidelines for patients under age 21. Implications are discussed.

Inconsistencies Between Medical Records and Patient-Reported Recommendations for Follow-Up After Abnormal Pap Tests

PURPOSE Adherence with recommended follow-up after an abnormal Pap test is a critical step in the prevention of cervical cancer. Here, we focused on identifying inconsistencies between self-reported and health department record recommendations for follow-up. METHODS Self-reported recommendations for follow-up were collected by questionnaire from 519 women with abnormal Pap tests in rural Appalachia as part of a trial of the efficacy of patient navigation. Health department medical records were reviewed to collect healthcare provider recommendations. Measures of inconsistency (discordance) were calculated for overall recommendations and each of three particular follow-up recommendations: repeat Pap test, referral for further tests, and other gynecologist referral. RESULTS The inconsistencies between the recommendation from the health department records and self-reports ranged from 15.0% (repeat Pap test) to 35.3% (gynecologist referral). Inconsistencies were most common among women with a history of abnormal Pap tests and those with more severe initial results. Recommendations for repeat Pap tests were correctly reported most often when the women recalled receiving a letter stating the results. Of greatest concern were the inconsistencies regarding recommendations for referral to a gynecologist. The more severe the Pap test result, the greater the odds of inaccurate self-reports of receiving a referral to a gynecologist for follow-up, p<0.001. CONCLUSIONS Clinicians should be aware that patients with a history of abnormal results and severe Pap test abnormalities are at risk of misreporting recommendations for follow up.

Effectiveness of an Intervention for Adherence to Follow-up Recommendations for Abnormal Pap Tests in Appalachian Kentucky

OBJECTIVE In collaboration with rural county health departments (CHDs), we developed a patient navigation intervention to increase adherence to follow-up recommendations for women with abnormal Pap tests. METHODS Local women were recruited, trained and placed in CHDs. Navigation was tailored to the follow-up care recommended. Effectiveness was evaluated in a quasi-experimental trial that included 13 intervention CHDs and 13 comparison group CHDs. Participants were enrolled from September 2008 through July 2010. RESULTS A total of 478 participants were enrolled. The proportion that received recommended follow-up care was greater in the intervention CHDs (91.6%) than in the comparison group CHDs (80.8%) (p = .01). CONCLUSIONS These results suggest that development of policy to promote navigation with rural health care delivery systems has great potential to improve patient outcomes.

Age adjusted hematopoietic stem cell transplant comorbidity index predicts survival in a T-cell depleted cohort

OBJECTIVES Allogeneic hematopoietic stem cell transplant (HCT) continues to evolve with the treatment in higher risk patient population. This practice mandates stringent update and validation of risk stratification prior to undergoing such a complex and potentially fatal procedure. We examined the adoption of the new comorbidity index (HCT-CI/Age) proposed by the Seattle group after the addition of age variable and compared it to the pre-transplant assessment of mortality (PAM) that already incorporates age as part of its evaluation criteria. METHODS A retrospective analysis of adult patients who underwent HCT at our institution from January 2010 through August 2014 was performed. Kaplan-Meiers curve, log-rank tests, Cox model and Pearson correlation was used in the analysis. RESULTS Of the 114 patients that underwent allogeneic transplant in our institution, 75.4% were ≥40 years old. More than 58% had a DLCO ≤80%. Although scores were positively correlated (correlation coefficient 0.43, p < 0.001), HCT-CI/Age more accurately predicted 2-year overall survival (OS) and non-relapse mortality (NRM) in patients with lower (0-4) and higher (5-7) scores (52% and 36% versus 24% and 76%, p = 0.004, 0.003 respectively). PAM score did not reach statistical significance for difference in OS nor NRM between the low (<24) and high-risk (≥24) groups (p = 0.19 for both). CONCLUSIONS Despite our small sample population, HCT-CI/Age was more discriminative to identify patients with poor outcome that might benefit from intensified management strategies or other therapeutic approaches rather than allogeneic HCT.

Abstract B14: Effectiveness of patient navigation for follow-up for abnormal pap tests in Appalachian Kentucky

Introduction. Residents of Appalachian Kentucky experiences significant cancer disparities. The population is characterized, in general, as largely rural with high poverty rates, high unemployment and limited access to health care. Lung and colorectal cancer incidence and mortality rates in this area are among the highest in the nation and although cervical cancer mortality has decreased over recent decades, data from the Surveillance, Epidemiology, and End Results (SEER) program reveals that mortality rates in Kentucky are substantially higher than the national average. In 2003, when this project began, the US cervical cancer mortality rate was 2.7 per 100,000 (95% confidence interval = 2.6-2.7). During the same period, the rate in Kentucky was 3.2 per 100,000 (2.9-3.6). In the 54 Appalachian counties in the state, the rate was even higher, 3.7 per 100,000 (3.5-4.0). Death from cervical cancer is preventable in nearly all cases with screening by the Pap test and adherence with recommendations to obtain follow-up care when abnormalities are detected. Methods. To address the problem of elevated cervical cancer incidence and mortality experienced by rural Appalachian women, a patient navigation intervention program was developed with the goal of increasing adherence with recommendations for follow-up for women with abnormal Pap test results. The intervention was implemented in partnership with county health departments. Intervention effectiveness was evaluated in a quasi-experimental trial that included intervention county health departments (n=13) that provided patient navigation services and a comparison group of county health departments (n=13) that provided usual care. Women with abnormal Pap test results were enrolled in the intervention group county health departments and patient navigation was tailored to the type of follow-up care recommended. Study outcome data were collected from medical records. Participants were enrolled from September 2008 through July 2010. A total of 774 medical record reviews are included in the analysis (230 women in intervention and 544 women in comparison county health departments). Recommendations for follow-up, which were based on the type of abnormality and the age of the patient, included returning to the health department to obtain a repeat Pap test or making an appointment with a community gynecologist under contract with the health department. Key Findings. The proportion of participants that received their recommended follow-up care was greater in the intervention group (91.6%) than in the comparison group (80.8%) (p=.01). The effect of the patient navigation intervention was strongest among women who received follow-up care from the health department as opposed to community gynecologists under contract with the health departments. Conclusions. The results demonstrate the effectiveness of the patient navigation intervention and also provide evidence suggesting that development of policy to promote integration of navigation with rural health care delivery systems has great potential to improve patient outcomes. Citation Format: Mark Dignan, Brent Shelton, Nancy E. Schoenberg, Carol R. White, Stacey A. Slone, Emily Van Meter, Frances J. Feltner, Gretchen Ely, Christopher DeSimone. Effectiveness of patient navigation for follow-up for abnormal pap tests in Appalachian Kentucky. [abstract]. In: Proceedings of the Thirteenth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2014 Sep 27-Oct 1; New Orleans, LA. Philadelphia (PA): AACR; Can Prev Res 2015;8(10 Suppl): Abstract nr B14.