Modelling distributions of Aedes aegypti and Aedes albopictus using climate, host density and interspecies competition.

Florida faces the challenge of repeated introduction and autochthonous transmission of arboviruses transmitted by Aedes aegypti and Aedes albopictus. Empirically-based predictive models of the spatial distribution of these species would aid surveillance and vector control efforts. To predict the occurrence and abundance of these species, we fit a mixed-effects zero-inflated negative binomial regression to a mosquito surveillance dataset with records from more than 200,000 trap days, representative of 53% of the land area and ranging from 2004 to 2018 in Florida. We found an asymmetrical competitive interaction between adult populations of Aedes aegypti and Aedes albopictus for the sampled sites. Wind speed was negatively associated with the occurrence and abundance of both vectors. Our model predictions show high accuracy (72.9% to 94.5%) in validation tests leaving out a random 10% subset of sites and data since 2017, suggesting a potential for predicting the distribution of the two Aedes vectors.

Implementing and Evaluating a Mentor Training to Improve Support for Early-Career Scholars in Tobacco Regulatory Science.

INTRODUCTION: To implement and evaluate a blended online and in-person training to help mentors of early-career researchers appreciate the complexities of Tobacco Regulatory Science (TRS), refine TRS mentoring skills, and become acquainted with resources for providing effective guidance to TRS mentees. METHODS: TRS mentors engaged in a two-part pilot test of the training program. Authors evaluated both the online and in-person training using retrospective pre-post evaluations, which measure learning at the conclusion of a training program, and post-program focus groups. Twenty learners completed the online training, and 16 learners attended the in-person training module. Nine participants completed evaluations for the online module, and 12 participants completed evaluations for the in-person module. RESULTS: Program assessments revealed that participants found that the training achieved its overall goals. The majority of respondents (87.5%) rated the online portion of the training as valuable. For the in-person training, participants reported statistically significant improvements regarding confidence in: helping mentees to identify skills and training to effectively pursue TRS, assisting mentees in weighing career trajectories, and guiding mentees in conducting research responsive to TRS regulatory priorities. CONCLUSIONS: The novel mentoring program was well received by faculty seeking to strengthen skills for mentoring early-career TRS researchers to navigate the complex landscape of TRS, explore diverse funding opportunities, and discern potential career trajectories. It provided unique content to address issues outside the traditional tobacco research training curriculum and offered specific information on regulatory policies, priorities, and opportunities. IMPLICATIONS: This research documents the deployment and evaluation of a blended online and in-person training program for investigators mentoring early-career researchers working in TRS. Our assessment discovered that participants found the training to be valuable to their overall mentoring objectives. The training comprises a novel curriculum for investigators engaged in mentoring early-career researchers in a unique field, thus filling a deficit in the published literature by presenting a curriculum that has been customized to the unique needs of TRS mentors.

Quality Assessment of Tumor Size Data Collection for Pancreatic and Breast Cancer in SEER.

BACKGROUND AND OBJECTIVES: In 2017, the Surveillance, Epidemiology, and End Results (SEER) program piloted a reactive quality audit plan (r-QAP) to analyze Collaborative Stage (CS) tumor size in breast and pancreatic cancer. Preevaluation objectives were to establish procedures and analytic scope for SEER quality audits, cutoffs for data completeness/accuracy, and key decision checkpoints. METHODS: Tumor size data between 2004-2014 were selected from SEER registries for pancreatic and breast cancers, and initially assessed by site and registry for completeness. Further exploration was undertaken via cross tabulation in SEER with the American Joint Committee on Cancer (AJCC) 6th edition derived T data item to evaluate discrepancies between these closely related variables. RESULTS: For both cancer sites, completeness improved between 2004 and 2014, with the proportion of known tumor size values increasing from 60.6% to 79.2% in pancreatic cancer and from 94.0% to 95.9% in breast cancer. Tumor size plausibility categories were established wherein any tumor over 100 mm for pancreatic cancer or over 200 mm for breast cancer were considered highly unlikely. Only 2% of pancreas tumors and 0.1% of breast tumors were implausibly large per site-specific cutoffs. Less than 2% of all tumor size values were potentially discrepant in cross-tabulation with AJCC 6th edition derived T for each site. CONCLUSIONS: Most tumor size values appear to fall within acceptable ranges based on r-QAP activities, and implausibly large tumor size values are rare. Different natural histories and clinical presentation for pancreatic and breast cancer illustrate the need for site-specific cutoffs. Our results indicate that there are no major quality issues in the SEER research database for the CS tumor size data item in either pancreatic or breast cancer.

Mentoring for Success in Tobacco Regulatory Science: A Qualitative Study.

OBJECTIVES: Our study explores the experiences of early career and senior scientists regarding mentorship and career trajectories in tobacco regulatory science (TRS). METHODS: We conducted 22 phone interviews with early career and senior tobacco regulatory scientists from July 2015 to January 2016. All interviews were conducted using a structured interview guide and analyzed using a thematic approach by 2 independent coders. RESULTS: TRS presents specific opportunities and challenges to scientists due to its focused goal of informing tobacco regulation. An understanding of US Food and Drug Administration (FDA) research priorities and how science can inform tobacco regulation are essential for effective mentorship in TRS. Careers in TRS can be pursued in various academic and non-academic professional roles; both offer the distinct ability to conduct science that impacts public policy. Early career and senior scientists identified the importance and challenge of providing broad training across the diverse disciplines of TRS. CONCLUSIONS: Effective mentorship in TRS requires that mentors possess an in-depth understanding of the scientific, regulatory, and legislative processes inherent to tobacco regulatory policy-making. A training program for mentors specific to TRS has the potential to meet diverse professional needs of mentors and mentees aiming to impact tobacco policy.

Defining Tobacco Regulatory Science Competencies.

INTRODUCTION: In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel's work to develop core TRS domains and competencies. METHODS: The Panel developed the list of domains and competencies using a semistructured Delphi method divided into four phases occurring between November 2013 and August 2015. RESULTS: The final proposed list included a total of 51 competencies across six core domains and 28 competencies across five specialized domains. CONCLUSIONS: There is a need for continued discussion to establish the utility of the proposed set of competencies for emerging TRS curricula and to identify the best strategies for incorporating these competencies into TRS training programs. Given the field's broad multidisciplinary nature, further experience is needed to refine the core domains that should be covered in TRS training programs versus knowledge obtained in more specialized programs. IMPLICATIONS: Regulatory science to inform the regulation of tobacco products is an emerging field. The paper provides an initial list of core and specialized domains and competencies to be used in developing curricula for new and emerging training programs aimed at preparing a new cohort of scientists to conduct critical TRS research.

Comparison of risedronate to alendronate and calcitonin for early reduction of nonvertebral fracture risk: results from a managed care administrative claims database.

OBJECTIVE: Recent randomized clinical trials have shown that risedronate reduces the risk of nonvertebral fractures and clinical vertebral fractures within 6 months of initiating treatment. The objective of the current study was to determine whether this early antifracture effect could be demonstrated in nonvertebral fractures for risedronate and other osteoporosis therapies in an observational administrative claims database. METHODS: A proprietary administrative claims database was used to identify managed care members who received a new prescription for risedronate, alendronate, or nasal calcitonin from July 1, 2000, to December 31, 2001. Patient records were analyzed for the incidence of nonvertebral fractures (clavicle, humerus, wrist, pelvis, hip, and leg) in the first 6 and 12 months following initiation of treatment. A Cox proportional hazards regression model was used to estimate relative risk (RR) of fracture at 6 and 12 months. RESULTS: In the 6-month analysis, 774 patients (11%) received calcitonin, 5,307 (75%) received alendronate, and 1,000 (14%) received risedronate. Twelve-month data were available for a subset (71%) of patients (656 calcitonin [13%], 3,716 alendronate [74%], and 652 risedronate [13%]). Most were women (93%); mean age was similar for alendronate and risedronate, and nasal calcitonin patients were about 3 years older, on average. Risedronate and alendronate patients were more likely to have used estrogen, while nasal calcitonin patients were more likely to have been hospitalized and had higher use of concomitant medications and more physician visits. Relative risks were adjusted for these differences. Risedronate and alendronate patients were similar with respect to these indicators of general health status. In the 6-month analysis, nonvertebral fractures were observed in 2.2% of patients receiving nasal calcitonin, 1.4% of patients receiving alendronate, and 0.6% of patients receiving risedronate. The adjusted RR reduction was 69% for risedronate versus calcitonin (RR = 0.31; 95% CI, 0.12 to 0.81; P = 0.02), 54% for risedronate versus alendronate (RR = 0.46; 95% CI, 0.20 to 1.06; P = 0.07), and 26% for alendronate versus calcitonin (RR = 0.74; 95% CI, 0.43 to 1.27; P = 0.28). In the 12-month analysis, nonvertebral fracture rates were 2.9% for nasal calcitonin, 2.4% for alendronate, and 0.9% for risedronate patients. The adjusted RR reduction was 75% for risedronate versus calcitonin (RR = 0.25; 95% CI, 0.10 to 0.64; P<0.01), 59% for risedronate versus alendronate (RR = 0.41; 95% CI, 0.18 to 0.94; P = 0.04), and 25% for alendronate versus calcitonin (RR = 0.75; 95% CI, 0.45 to 1.25; P = 0.27). CONCLUSIONS: This analysis of medical and pharmacy claims contained in an administrative database confirms the early fracture reduction with risedronate that was shown in randomized clinical trials. Risedronate was more effective than calcitonin in reducing the risk of nonvertebral fractures within the first 6 months of treatment. Risedronate was more effective than either calcitonin or alendronate in reducing the risk of nonvertebral fractures within 12 months of treatment.

Examination of resource use and clinical interventions associated with chronic kidney disease in a managed care population.

BACKGROUND: The management of chronic kidney disease (CKD) is multifaceted, including monitoring, early diagnosis, and treatment of comorbidities such as diabetes, hypoalbuminemia, and anemia, and initiating timely procedures in preparation for dialysis such as vascular access placement. Presumably, optimal care provided to patients during the predialysis phase will produce a significant impact on morbidity and mortality outcomes. OBJECTIVE: A retrospective analysis was conducted to assess specific factors that may be associated with optimal quality of care for CKD patients during the predialysis phase. METHODS: Health care resource utilization and the occurrence of interventions associated with optimal predialysis care were evaluated with claims data. Predialysis erythropoietin (EPO) therapy, nephrology referrals, and nutritional supplement administration were all examined during the 12 months prior to dialysis. RESULTS: Medical and pharmacy claims from a managed care database were analyzed for 1,936 incident dialysis patients. Of these, 48.7% did not have any interventions associated with optimal care. Only a minority of patients received prescription iron preparations (6.8%), vitamin D (4.0%), and phosphate binders (7.7%). A total of 20.8% patients had a vascular access placement, and 29.8% were in the care of a nephrologist during this same time period. Only 10.5% received predialysis EPO, yet more than 40% were diagnosed with anemia. Of the EPO users, however, 72.4% were also receiving other interventions to appropriately manage CKD. CONCLUSION: These claims-documented results suggest that the lack of EPO use in predialysis patients in a managed care plan may predict overall suboptimal treatment of these patients. There is an apparent need for the proactive management of CKD in a managed care plan to potentially redistribute or reduce health care resource utilization while improving patient outcomes.

Health care resource utilization and the impact of anemia management in patients with chronic kidney disease.

BACKGROUND: Limited information exists on resource utilization patterns and overall patient management of chronic kidney disease (CKD) before the initiation of dialysis therapy. METHODS: A retrospective claims analysis from January 1997 to December 1999 was conducted using a managed care database on 1,936 incident dialysis patients, examining the 12 months preceding dialysis initiation to evaluate whether managed care patients with CKD are receiving expected interventions and appropriate management of CKD. RESULTS: Mean age was 66.8 years, 46% were women, 91.2% had claims for facility services, 97.6% had claims for professional services, and 95.7% had claims for outpatient pharmacy, with mean costs per patient of $26,204, $9,623, and $1,503, respectively. Sixty-two percent of patients were hospitalized, averaging 1.3 admissions annually ($14,818/admission; average, 7.8 d/admission). Despite high overall resource use, treatments for preparation for dialysis therapy, appropriate tests, and nutritional supplements (eg, phosphate binders, B-complex combinations, and vitamins with iron) were administered infrequently. Comorbid conditions, such as anemia (47.4%) and diabetes (53%), were appropriately addressed with erythropoietin (10.5%) and angiotensin-converting enzyme inhibitors (38%) in only a minority of cases. In preparation for dialysis therapy, only 20.8% underwent a vascular access procedure. CONCLUSION: Although patients consumed significant amounts of resources during the 12 months before dialysis initiation, many were not using expected resources for the appropriate management of CKD. A number of opportunities exist to improve predialysis care through better management of these conditions.

Exploring the methodological challenges of investigating comparison groups with different underlying characteristics: a case study.

OBJECTIVE: To examine challenges in forming accurate conclusions from claims data when comparing different patient groups, and to stress the need to adjust for confounding variables through application of statistical methods. METHODS: Patients who were 60 or older and began amlodipine or felodipine in 1997 or 1998 were identified from a proprietary managed care claims database. Patients had 6 months of medical and outpatient pharmacy benefits coverage before and after initiating therapy. They were stratified on varying degrees of hypertension severity and on all-condition clinical complexity, and quantified with a proprietary Burden of Illness (BOI) score, defined as the expected resource use for the patient.s combined conditions during the 6 months before therapy. RESULTS: Of the 17,667 patients, 10,469 (59.3%) were female. The 12,389 amlodipine users were similar in age to felodipine users (n=5,278), 73 versus 74, respectively. More amlodipine users were assigned to the 2 most clinically complex quintiles of the BOI distribution (45.5% to 26.9%), with 24.3% of patients in the top quintile (9.7% for felodipine) and twice the prevalence of ischemic heart disease/angina (42.4% versus 19.4%). High-severity hypertension was found among 33.6% of amlodipine users, contrasted with 17.9% for felodipine. A significant difference in the mean average daily dose (ADD) between the amlodipine (5.93 mg) and felodipine (5.8 mg) groups (P=0.0007) was noted. CONCLUSION: These results stress the importance of assessing the impact of potentially confounding variables and the need to address differing patient characteristics through either risk adjustment or stratification in making head-to-head comparisons.