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IntroductionStatistical literacy is essential in clinical and translational science (CTS). Statistical competencies have been published to guide coursework design and selection for graduate students in CTS. Here, we describe common elements of graduate curricula for CTS and identify gaps in the statistical competencies.MethodsWe surveyed statistics educators using e-mail solicitation sent through four professional organizations. Respondents rated the degree to which 24 educational statistical competencies were included in required and elective coursework in doctoral-level and master's-level programs for CTS learners. We report competency results from institutions with Clinical and Translational Science Awards (CTSAs), reflecting institutions that have invested in CTS training.ResultsThere were 24 CTSA-funded respondents representing 13 doctoral-level programs and 23 master's-level programs. For doctoral-level programs, competencies covered extensively in required coursework for all doctoral-level programs were basic principles of probability and hypothesis testing, understanding the implications of selecting appropriate statistical methods, and computing appropriate descriptive statistics. The only competency extensively covered in required coursework for all master's-level programs was understanding the implications of selecting appropriate statistical methods. The least covered competencies included understanding the purpose of meta-analysis and the uses of early stopping rules in clinical trials. Competencies considered to be less fundamental and more specialized tended to be covered less frequently in graduate courses.ConclusionWhile graduate courses in CTS tend to cover many statistical fundamentals, learning gaps exist, particularly for more specialized competencies. Educational material to fill these gaps is necessary for learners pursuing these activities.

IntroductionStatistical literacy is essential in clinical and translational science (CTS). Statistical competencies have been published to guide coursework design and selection for graduate students in CTS. Here, we describe common elements of graduate curricula for CTS and identify gaps in the statistical competencies.MethodsWe surveyed statistics educators using e-mail solicitation sent through four professional organizations. Respondents rated the degree to which 24 educational statistical competencies were included in required and elective coursework in doctoral-level and master's-level programs for CTS learners. We report competency results from institutions with Clinical and Translational Science Awards (CTSAs), reflecting institutions that have invested in CTS training.ResultsThere were 24 CTSA-funded respondents representing 13 doctoral-level programs and 23 master's-level programs. For doctoral-level programs, competencies covered extensively in required coursework for all doctoral-level programs were basic principles of probability and hypothesis testing, understanding the implications of selecting appropriate statistical methods, and computing appropriate descriptive statistics. The only competency extensively covered in required coursework for all master's-level programs was understanding the implications of selecting appropriate statistical methods. The least covered competencies included understanding the purpose of meta-analysis and the uses of early stopping rules in clinical trials. Competencies considered to be less fundamental and more specialized tended to be covered less frequently in graduate courses.ConclusionWhile graduate courses in CTS tend to cover many statistical fundamentals, learning gaps exist, particularly for more specialized competencies. Educational material to fill these gaps is necessary for learners pursuing these activities.

BACKGROUND: Matrix metalloprotease 9 (MMP-9) is associated with inflammation and lung remodeling in chronic obstructive pulmonary disease (COPD). We hypothesized that elevated circulating MMP-9 represents a potentially novel biomarker that identifies a subset of individuals with COPD with an inflammatory phenotype who are at increased risk for acute exacerbation (AECOPD). METHODS: We analyzed Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS) and Genetic Epidemiology of COPD (COPDGene) cohorts for which baseline and prospective data were available. Elevated MMP-9 was defined based on >95th percentile plasma values from control (non-COPD) sample in SPIROMICS. COPD subjects were classified as having elevated or nonelevated MMP-9. Logistic, Poisson, and Kaplan-Meier analyses were used to identify associations with prospective AECOPD in both cohorts. RESULTS: Elevated MMP-9 was present in 95/1,053 (9%) of SPIROMICS and 41/140 (29%) of COPDGene participants with COPD. COPD subjects with elevated MMP-9 had a 13%-16% increased absolute risk for AECOPD and a higher median (interquartile range; IQR) annual AECOPD rate (0.33 [0-0.74] versus 0 [0-0.80] events/year and 0.9 [0.5-2] versus 0.5 [0-1.4] events/year for SPIROMICS and COPDGene, respectively). In adjusted models within each cohort, elevated MMP-9 was associated with increased odds (odds ratio [OR], 1.71; 95%CI, 1.00-2.90; and OR, 3.03; 95%CI, 1.02-9.01), frequency (incidence rate ratio [IRR], 1.45; 95%CI, 1.23-1.7; and IRR, 1.24; 95%CI, 1.03-1.49), and shorter time-to-first AECOPD (21.7 versus 31.7 months and 14 versus 21 months) in SPIROMICS and COPDGene, respectively. CONCLUSIONS: Elevated MMP-9 was independently associated with AECOPD risk in 2 well-characterized COPD cohorts. These findings provide evidence for MMP-9 as a prognostic biomarker and potential therapeutic target in COPD. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01969344 (SPIROMICS) and NCT00608764 (COPDGene). FUNDING: This work was funded by K08 HL123940 to JMW; R01HL124233 to PJC; Merit Review I01 CX000911 to JLC; R01 (R01HL102371, R01HL126596) and VA Merit (I01BX001756) to AG. SPIROMICS (Subpopulations and Intermediate Outcomes in COPD Study) is funded by contracts from the NHLBI (HHSN268200900013C, HHSN268200900014C,HHSN268200900015C HHSN268200900016C, HHSN268200900017C, HHSN268200900018C, HHSN268200900019C, and HHSN268200900020C) and a grant from the NIH/NHLBI (U01 HL137880), and supplemented by contributions made through the Foundation for the NIH and the COPD Foundation from AstraZeneca/MedImmune; Bayer; Bellerophon Therapeutics; Boehringer-Ingelheim Pharmaceuticals Inc.; Chiesi Farmaceutici; Forest Research Institute Inc.; GlaxoSmithKline; Grifols Therapeutics Inc.; Ikaria Inc.; Novartis Pharmaceuticals Corporation; Nycomed GmbH; ProterixBio; Regeneron Pharmaceuticals Inc.; Sanofi; Sunovion; Takeda Pharmaceutical Company; and Theravance Biopharma and Mylan. COPDGene is funded by the NHLBI (R01 HL089897 and R01 HL089856) and by the COPD Foundation through contributions made to an Industry Advisory Board composed of AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Pfizer, Siemens, and Sunovion.

Employ a novel testing method to assess Multi Directional Impact Protection System (MIPS) helmet technology on rotational velocity and acceleration during head impact. An optimization study was completed utilizing a 50th percentile male Hybrid III anthropomorphic test device (ATD). Helmets included expanded polystyrene foam (EPS) and two different MIPS helmets (MIPS 1, MIPS 2). A 24.38-m-long elevated track with rails and a motorized sled was utilized to replicate a fall from approximately 2.13 m. The sled was set to a speed of 20.92 kph, where a tripping mechanism induced rotation in the ATD from the sled and onto a sand surface. During impact of the ATD with the sand surface, head kinematics were measured using resultant acceleration (peak G's), duration of impact (ms), and rotational velocity (rad/s). A total of three trials for each helmet did not demonstrate a significant difference between the EPS vs. MIPS 1 group with, peak (G's) for resultant acceleration (p = 0.100), duration (ms) for resultant acceleration, (p = 0.100), peak (G's) for rotational velocity, (p = 0.700), and duration (ms) for rotational velocity (p = 0.700). Similarly, the EPS vs. MIPS 2 testing demonstrated no significant differences between the MIPS 2 helmet compared to the EPS helmet, with resultant acceleration (p = 0.400), duration acceleration (p = 0.200), rotational velocity (p = 0.400) and duration velocity (p = 0.400). However, when the MIPS helmet data were pooled, and the EPS helmet data were compared, a statistically significant difference in the duration of acceleration was found (p = 0.048). Current testing uses a helmeted head form which is dropped or rolled from a prescribed height. These methods discount the loading placed on the neck and head through the angular momentum of the body. Our novel testing method did not find significant differences between the helmet types in diminishing peak rotational forces to the brain; however, our data suggests that MIPS helmet liners may reduce duration of impact. The reduction of acceleration duration could indicate less rotation of the neck, due to the dampening of these forces by the MIPS liners. [ABSTRACT FROM AUTHOR]

IntroductionIt is increasingly essential for medical researchers to be literate in statistics, but the requisite degree of literacy is not the same for every statistical competency in translational research. Statistical competency can range from 'fundamental' (necessary for all) to 'specialized' (necessary for only some). In this study, we determine the degree to which each competency is fundamental or specialized.MethodsWe surveyed members of 4 professional organizations, targeting doctorally trained biostatisticians and epidemiologists who taught statistics to medical research learners in the past 5 years. Respondents rated 24 educational competencies on a 5-point Likert scale anchored by 'fundamental' and 'specialized.'ResultsThere were 112 responses. Nineteen of 24 competencies were fundamental. The competencies considered most fundamental were assessing sources of bias and variation (95%), recognizing one's own limits with regard to statistics (93%), identifying the strengths, and limitations of study designs (93%). The least endorsed items were meta-analysis (34%) and stopping rules (18%).ConclusionWe have identified the statistical competencies needed by all medical researchers. These competencies should be considered when designing statistical curricula for medical researchers and should inform which topics are taught in graduate programs and evidence-based medicine courses where learners need to read and understand the medical research literature.

PurposeTo learn the size, composition, and scholarly output of biostatistics, epidemiology, and research design (BERD) units in U.S. academic health centers (AHCs).MethodEach year for four years, the authors surveyed all BERD units in U.S. AHCs that were members of the Clinical and Translational Science Award (CTSA) Consortium. In 2010, 46 BERD units were surveyed; in 2011, 55; in 2012, 60; and in 2013, 61.ResultsResponse rates to the 2010, 2011, 2012, and 2013 surveys were 93.5%, 98.2%, 98.3%, and 86.9%, respectively. Overall, the size of BERD units ranged from 3 to 86 individuals. The median FTE in BERD units remained similar and ranged from 3.0 to 3.5 FTEs over the years. BERD units reported more availability of doctoral-level biostatisticians than doctoral-level epidemiologists. In 2011, 2012, and 2013, more than a third of BERD units provided consulting support on 101 to 200 projects. A majority of BERD units reported that between 25% and 75% (in 2011) and 31% to 70% (in 2012) of their consulting was to junior investigators. More than two-thirds of BERD units reported their contributions to the submission of 20 or more non-BERD grant or contract applications annually. Nearly half of BERD units reported 1 to 10 manuscripts submitted annually with a BERD practitioner as the first or corresponding author.ConclusionsThe findings regarding BERD units provide a benchmark against which to compare BERD resources and may be particularly useful for institutions planning to develop new units to support programs such as the CTSA.

Given the increasing level and scope of biostatistics expertise needed at academic health centers today, we developed best practices guidelines for biostatistics units to be more effective in providing biostatistical support to their institutions, and in fostering an environment in which unit members can thrive professionally. Our recommendations focus on the key areas of: 1) funding sources and mechanisms; 2) providing and prioritizing access to biostatistical resources; and 3) interacting with investigators. We recommend that the leadership of biostatistics units negotiate for sufficient long-term infrastructure support to ensure stability and continuity of funding for personnel, align project budgets closely with actual level of biostatistical effort, devise and consistently apply strategies for prioritizing and tracking effort on studies, and clearly stipulate with investigators prior to project initiation policies regarding funding, lead time, and authorship.

RationaleCalcium/calmodulin-dependent protein kinase II (CaMKII) is activated in heart failure (HF) and can contribute to arrhythmias induced by β-adrenergic receptor-mediated sarcoplasmic reticulum calcium leak.ObjectiveTo evaluate the effect of CaMKII inhibition on ventricular tachycardia (VT) induction in conscious HF and naive rabbits.Methods and resultsNonischemic HF was induced by aortic insufficiency and constriction. Electrocardiograms were recorded in rabbits pretreated with vehicle (saline) or the CaMKII inhibitor KN-93 (300 μg/kg); VT was induced by infusion of increasing doses of norepinephrine (1.56-25 μg·kg⁻¹·min⁻¹) in naive (n = 8) and HF (n = 7) rabbits. With saline, median VT dose threshold in HF was 6.25 versus 12.5 μg·kg⁻¹·min⁻¹ norepinephrine in naive rabbits (P = 0.06). Pretreatment with KN-93 significantly increased VT threshold in HF and naive rabbits (median = 25 μg·kg⁻¹·min⁻¹, P < 0.05 vs. saline for both groups). Mean cycle length of VT initiation was shorter in HF (221 ± 20 milliseconds) than naive (296 ± 23 milliseconds, P < 0.05) rabbits with saline; this difference was not significant after treatment with KN-93.ConclusionsKN-93 significantly reduced arrhythmia inducibility and slowed initiation of VT, suggesting that CaMKII inhibition may have antiarrhythmic effects in the failing human heart.

BackgroundCurrent literature suggests that racial/ethnic minority survivors may be more likely than whites to experience economic hardship after a cancer diagnosis; however, little is known about such hardship.MethodsPatients with lung cancer (LC) and colorectal cancer (CRC) participating in the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium were surveyed approximately 4 months (baseline) and 12 months (follow-up) after diagnosis. Economic hardship at follow-up was present if participants 1) indicated difficulty living on household income; and/or 2) for the following 2 months, anticipated experiencing hardships (inadequate housing, food, or medical attention) or reducing living standards to the bare necessities of life. The authors tested whether African Americans (AAs) and Hispanics were more likely than whites to experience economic hardship controlling for sex, age, education, marital status, cancer stage, treatment, and economic status at baseline (income, prescription drug coverage).ResultsOf 3432 survivors (39.7% with LC, 60.3% with CRC), 14% were AA, 7% were Hispanic, and 79% were white. AAs and Hispanics had lower education and income than whites. Approximately 68% of AAs, 58% of Hispanics, and 44.5% of whites reported economic hardship. In LC survivors, the Hispanic-white disparity was not significant in unadjusted or adjusted analyses, and the AA-white disparity was explained by baseline economic status. In CRC survivors, the Hispanic-white disparity was explained by baseline economic status, and the AA-white disparity was not explained by the variables that were included in the model.ConclusionsEconomic hardship was evident in almost 1 in 2 cancer survivors 1 year after diagnosis, especially AAs. Research should evaluate and address risk factors and their impact on survival and survivorship outcomes.

It is very important for medical professionals and medical researchers to be literate in statistics. However, we have found that the degree of literacy that is required should not be identical for every statistical competency or even for every learner. We first begin by describing why the development, teaching, and assessment of statistical competencies for medical professionals and medical researchers are critical tasks. We next review our three substantial efforts at developing a comprehensive list of statistical competencies that can be used as a guide for what medical research learners should know about statistics, for curricular development, and for assessment of statistical education. We then summarize the origin and the inclusion of the statistical competency items. We follow this with a description of potential uses and applications of the statistical competencies to improve targeted learning for medical research learners. Finally, we discuss implications of the statistical competencies for undergraduate statistics education. [This work was funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award Program in collaboration with the University of Alabama at Birmingham (UL1 TR001417) and the Mayo Clinic (UL1 TR000135)].

BackgroundThe rates of physical inactivity and related cancer incidence and mortality are disproportionately high in the Deep South region in the United States, a rural, medically underserved region with a large African American population compared with the rest of the nation. Given this region’s lower rates of literacy and internet access, interactive voice response (IVR) system–automated telephone-based interventions have the potential to help overcome physical activity intervention barriers (literacy, internet access, costs, and transportation) but have yet to be extended to rural, underserved populations, such as in the Deep South. Thus, extensive formative research is being conducted to develop and beta test the Deep South IVR System–Supported Active Lifestyle intervention in preparation for dissemination in rural Alabama counties. ObjectiveThis paper aims to describe the design and rationale of an ongoing efficacy trial of the Deep South IVR System–Supported Active Lifestyle intervention. MethodsA two-arm randomized controlled trial will be conducted to compare a 12-month physical activity intervention versus a wait-list control condition in 240 underactive adults from 6 rural Alabama counties. The Deep South IVR System–Supported Active Lifestyle intervention is based on the Social Cognitive Theory and includes IVR-automated physical activity–related phone counseling (daily in months 0-3, twice weekly in months 4-6, and weekly in months 7-12) and support from local rural county coordinators with the University of Alabama O’Neal Comprehensive Cancer Center Community Outreach and Engagement Office. The primary outcome is weekly minutes of moderate- to vigorous-intensity physical activity (7-day physical activity recall; accelerometry) at baseline, 6 months, 12 months, and 18 months. Rural Active Living Assessments will be conducted in each rural county to assess walkability, assess recreational amenities, and inform future environment and policy efforts. ResultsThis study was funded in March 2019 and approved by the institutional review board of the University of Alabama at Birmingham in April 2019. As of February 2020, start-up activities (hiring and training staff and purchasing supplies) were completed. Study recruitment and assessments began in September 2020 and are ongoing. As of February 2021, a total of 43 participants have been enrolled in Dallas County, 42 in Sumter County, and 51 in Greene County. ConclusionsIVR-supported phone counseling has great potential for addressing physical activity barriers (eg, culture, literacy, cost, or transportation) and reducing related rural health disparities in this region. Trial RegistrationClinicalTrials.gov NCT03903874; https://clinicaltrials.gov/ct2/show/NCT03903874. International Registered Report Identifier (IRRID)DERR1-10.2196/29245

Background: Vancomycin loading doses are commonly used to quickly attain target serum concentrations; however, data supporting their effect on clinical patient outcomes is limited. In April 2020, our institution revised our pharmacist-driven vancomycin dosing protocol to reserve loading doses for hemodynamically unstable patients with suspected serious methicillin-resistant Staphylococcus aureus (MRSA) infections. Prior to the protocol update, all patients treated with vancomycin at our institution received a weight-based loading dose. The purpose of this study is to assess clinical efficacy and safety outcomes related to the use of vancomycin loading doses. Methods: A retrospective, quasi-experimental study was performed to compare clinical outcomes in adult patients treated with vancomycin for laboratory-confirmed MRSA infections. Patients who received vancomycin therapy prior to our institution's vancomycin dosing protocol revisions (pre-intervention) were compared to patients who received vancomycin after the revisions (post-intervention). The primary outcome was all-cause, inpatient mortality. Secondary outcomes included persistent signs and symptoms of infection ≥5 days after vancomycin initiation, switch to alternative anti-MRSA therapy, and nephrotoxicity. Results: A total of 122 patients (63 pre-intervention patients and 59 post-intervention patients) were included. Receipt of a vancomycin loading dose did not impact the rate of inpatient mortality (4.76%vs 6.78%; OR 1.46, 95% CI [0.31, 6.79]). All secondary outcomes were similar between the two groups, including persistent signs and symptoms of infection, switch to alternative anti-MRSA therapy, and nephrotoxicity. Conclusions: Routine use of vancomycin loading doses is not associated with improved outcomes in hemodynamically stable patients with MRSA infections. [ABSTRACT FROM AUTHOR]

BackgroundAs cancer care shifts from hospital to outpatient settings, the number of cancer caregivers continues to grow. However, little is known about the cancer caregiving experience. This gap in knowledge is especially evident for racially diverse caregivers.ObjectiveThis study, part of a multisite study of care recipients with either lung or colorectal cancer and their caregivers, examined the caregiving experiences of African American (AA) and white caregivers.MethodsCaregivers were identified by cancer patients in the Cancer Care Outcomes Research and Surveillance consortium. Caregivers completed a self-administered, mailed questionnaire that assessed their characteristics and experiences. Analysis of covariance was used to compare racial groups by objective burden and caregiving resources while controlling for covariates.ResultsDespite greater preparedness for the caregiving role (P = .006), AA caregivers reported more weekly hours caregiving than whites did (26.5 ± 3.1 vs 18.0 ± 1.7; P = .01). In later phases of caregiving, AAs reported having more social support (P = .02), spending more hours caregiving (31.9 ± 3.5 vs 16.9 ± 1.9; P < .001), and performing more instrumental activities of daily living on behalf of their care recipient (P = .021).ConclusionRacial differences in the caregiving experience exist.Implications for practiceNurses play a key role in educating cancer patients and their caregivers on how to effectively cope with and manage cancer. Because AA caregivers seem to spend more time in the caregiving role and perform more caregiving tasks, AA caregivers may benefit from interventions tailored to their specific caregiving experience.