More Than a Health Fair: Preventive Health Care During COVID-19 Vaccine Events.

Background: During the initial phase of the COVID-19 pandemic, facilities transformed some medical care to virtual appointments. There was a subsequent decline in chronic disease screening and management, as well as cancer screening rates. Observations: COVID-19 vaccine events offered an opportunity to provide face-to-face preventive care to veterans, and mobile vaccine events enabled us to reach rural veterans. In this quality improvement project, we partnered with state and community organizations to reach veterans at large vaccine events, as well as in rural sites and homeless housing. The program resulted in the successful provision of preventive care to 115 veterans at these events, with high follow-up for recommended medical care. In all, 404 clinical reminders were completed and 10 new veterans were enrolled for health care. Important clinical findings included an invasive colorectal cancer, positive HIV point-of-care test, diabetic retinal disease, uncontrolled hypertension, and depression. Conclusions: Vaccine events offer a venue for chronic disease screening, referral, and cancer screening.

Is There a Relationship Between Facility Peer Review Findings and Quality in the Veterans Health Administration?

Background: The aim of clinical peer review (PR) is to improve facility health care quality. However, prior authors have shown that PR may be biased, have rater reliability concerns, or be used for punitive reasons. It is important to determine whether facility PR processes are related to objective facility quality of care. Methods: We collected proportion of PR findings that "most experienced and competent clinicians may have managed the case differently" or "most experienced and competent clinicians would have managed the case differently" as an objective measure of facility PR processes and outcomes. We correlated these with facility quality metrics for 2019. Results: PR findings were not associated with facility quality metrics but were strongly associated with previous year findings. Conclusions: This study describes a potentially new source of bias in PR and demonstrates that objective facility outcomes are not related to individual PR findings.

Relative effectiveness of booster vs. 2-dose mRNA Covid-19 vaccination in the Veterans Health Administration: Self-controlled risk interval analysis.

OBJECTIVE: To estimate relative effectiveness of the booster mRNA Covid-19 vaccination versus the 2-dose primary series for both Delta and Omicron variants with self-controlled study design. METHODS: We used the Veterans Health Administration (VHA) Corporate Data Warehouse to identify U.S. Veterans who received the 2-dose primary mRNA Covid-19 vaccine series and a mRNA Covid-19 booster, and who had a positive SARS-CoV-2 test during the Delta (9/23/2021-11/30/2021) or Omicron (1/1/22-3/19/22) predominant period. Among them, we conducted a self-controlled risk interval (SCRI) analysis to compare odds of SARS-CoV-2 infection during a booster exposure interval versus a control interval. Exposures were a control interval (days 4-6 post-booster vaccination, presumably prior to gain of booster immunity), and booster exposure interval (days 14-16 post-booster vaccination, presumably following gain of booster immunity). Cases had a positive PCR or antigen SARS-CoV-2 test. Separately for Delta and Omicron periods, we used conditional logistic regression to calculate odds ratios (OR) of a positive test for the booster versus control interval and calculated relative effectiveness of booster versus 2-dose primary series as (1-OR)*100. The SCRI approach implicitly controlled for time-fixed confounders. RESULTS: We found 42 individuals with a positive SARS-CoV-2 test in the control interval and 14 in the booster exposure interval during the Delta period, and 141 and 70, respectively, in the Omicron period. For the booster versus 2-dose primary series, the odds of infection were 70% (95 %CI: 42%, 84%) lower during the Delta period and 54% (95 %CI: 38%, 66%) lower during Omicron. In sensitivity analyses among those with prior Covid-19 history, and age stratification, ORs were similar to the main analysis. CONCLUSIONS: Booster vaccination was more effective relative to a 2-dose primary series during the Delta and Omicron predominant periods, and the relative effectiveness was consistent across age groups.

Key Opportunities to Replace, Reduce, and Refine Regulatory Fish Acute Toxicity Tests.

Fish acute toxicity tests are conducted as part of regulatory hazard identification and risk-assessment packages for industrial chemicals and plant protection products. The aim of these tests is to determine the concentration which would be lethal to 50% of the animals treated. These tests are therefore associated with suffering in the test animals, and Organisation for Economic Co-operation and Development test guideline 203 (fish, acute toxicity) studies are the most widely conducted regulatory vertebrate ecotoxicology tests for prospective chemical safety assessment. There is great scope to apply the 3Rs principles-the reduction, refinement, and replacement of animals-in this area of testing. An expert ecotoxicology working group, led by the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research, including members from government, academia, and industry, reviewed global fish acute test data requirements for the major chemical sectors. The present study highlights ongoing initiatives and provides an overview of the key challenges and opportunities associated with replacing, reducing, and/or refining fish acute toxicity studies-without compromising environmental protection. Environ Toxicol Chem 2020;39:2076-2089. © 2020 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

The IMPROVE Guidelines (Ischaemia Models: Procedural Refinements Of in Vivo Experiments).

Most in vivo models of ischaemic stroke target the middle cerebral artery and a spectrum of stroke severities, from mild to substantial, can be achieved. This review describes opportunities to improve the in vivo modelling of ischaemic stroke and animal welfare. It provides a number of recommendations to minimise the level of severity in the most common rodent models of middle cerebral artery occlusion, while sustaining or improving the scientific outcomes. The recommendations cover basic requirements pre-surgery, selecting the most appropriate anaesthetic and analgesic regimen, as well as intraoperative and post-operative care. The aim is to provide support for researchers and animal care staff to refine their procedures and practices, and implement small incremental changes to improve the welfare of the animals used and to answer the scientific question under investigation. All recommendations are recapitulated in a summary poster (see supplementary information).

ICU Deaths in Patients With Advanced Cancer.

BACKGROUND: A significant number of advanced cancer admissions to the intensive care unit (ICU) are inappropriate in that they do not result in prolonged survival. No clear consensus criteria for reasonable admissions of advanced cancer patients have been developed. METHOD: We established four criteria for reasonable admissions to ICU in patients who suffered from advanced, incurable cancer: post procedure complication, recent notification of cancer, ECOG performance status of 0-1, and life expectancy of more than 6 months. Based on these criteria, we reviewed the charts of all patients who died in the ICU at the University of Tennessee Health Science Center (UTHSC) affiliated Veteran's Affairs Medical Center between 10/2005 and 10/2010. We identified patients with advanced, incurable cancer and performed an in depth review of their charts. RESULTS: In the 421 charts of patients who died in our ICU between October 2005 and October 2010 we identified 52 patients admitted to the ICU with advanced, incurable cancer. 14 patients were diagnosed with cancer one month or less prior to admission. 21 patients had ECOG performance status of 0-1. 14 patients had life expectancy of more than 6 months and 8 patients were admitted for post procedure complication. 47% of patients who did not satisfy any of our reasonable admission criteria had APDs. CONCLUSIONS: Incorporating proposed admission criteria in ICU admission guidelines may prevent 37% of inappropriate, advanced cancer admissions to the ICU. A simple increase in numbers of APDs would not likely change significantly the numbers of inappropriate ICU admissions.

Advancing the 3Rs in regulatory ecotoxicology: A pragmatic cross-sector approach.

The ecotoxicity testing of chemicals for prospective environmental safety assessment is an area in which a high number of vertebrates are used across a variety of industry sectors. Refining, reducing, and replacing the use of animals such as fish, birds, and amphibians for this purpose addresses the ethical concerns and the increasing legislative requirements to consider alternative test methods. Members of the UK-based National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) Ecotoxicology Working Group, consisting of representatives from academia, government organizations, and industry, have worked together over the past 6 y to provide evidence bases to support and advance the application of the 3Rs in regulatory ecotoxicity testing. The group recently held a workshop to identify the areas of testing, demands, and drivers that will have an impact on the future of animal use in regulatory ecotoxicology. As a result of these discussions, we have developed a pragmatic approach to prioritize and realistically address key opportunity areas, to enable progress toward the vision of a reduced reliance on the use of animals in this area of testing. This paper summarizes the findings of this exercise and proposes a pragmatic strategy toward our key long-term goals-the incorporation of reliable alternatives to whole-organism testing into regulations and guidance, and a culture shift toward reduced reliance on vertebrate toxicity testing in routine environmental safety assessment. Integr Environ Assess Manag 2016;12:417-421. © 2015 SETAC.

Poor health, but not fracture and fall risk, is associated with nonattendance at bone mineral density screening.

BACKGROUND: Bone mineral density screening identifies women at risk for fracture. Nonattendance at screening is associated with subsequent hip fracture. Determining reasons for nonattendance may help in the designing of methods to improve screening. METHODS: We hypothesize that nonattenders may report poorer health and have a higher risk of fracture and fall. Women were randomly chosen from a list of people scheduled for a screening dual x-ray absorptiometry (DXA) scan. We used a validated telephone survey to calculate osteoporosis, fracture, and fall risk scores. Women answered questions about their health and medical conditions. RESULTS: Of 263 women contacted, 226 (86%) women agreed to participate; 145 participants completed a dual-energy x-ray absorptiometry scan and 81 women failed to attend. Women who did not attend screening were more likely to report a serious medical condition (59.3% vs 46.9%; P = 0.09). Nonattenders were more likely to report their health as fair or poor (51.9% vs 33.8%; P = 0.01). There were no differences for osteoporosis, fall, and fracture risks. CONCLUSIONS: Failure to attend osteoporosis screening is associated with significant health problems and poor self-rated health. Improving point of care access may increase the amount of osteoporosis screening among women with multiple comorbidities.

Teriparatide is safe and effectively increases bone biomarkers in institutionalized individuals with osteoporosis.

Institutionalized adults with severe developmental disabilities have a high rate of minimal trauma and appendicular fracture. There is little information about osteoporosis treatment in this population. In this efficacy and safety study, men and women with severe developmental disabilities and osteoporosis received 20 mcg teriparatide subcutaneously daily for 18-24 months. Markers of bone formation [procollagen type 1 intact N-terminal propeptide (P1NP)] and resorption [C-telopeptide (CTx)] were measured at three-month intervals. Serum calcium was measured at two-week intervals for 12 weeks and thereafter at three-month intervals. Twenty-seven individuals received at least one injection. The incidence of hypercalcemia was 11.1% but was persistent and led to medication discontinuation in only one participant. Biomarkers of bone formation increased rapidly, doubling by three months. At 12 months, P1NP and CTx remained elevated from baseline; P1NP had risen from 66.95 +/- 83.71 microg/l (mean +/- SD) to 142.42 +/- 113.85 microg/l (P = 0.05), and CTx had increased from 0.377 +/- 0.253 to 1.016 +/- 1.048 ng/ml (P = 0.01). The majority of participants had an increase in P1NP of over 10 microg/l. In conclusion, teriparatide is safe and effective in developmentally disabled institutionalized adults. Serial calcium measurements are warranted, particularly during the first three months of therapy.

Does a history of non-vertebral fracture identify women without osteoporosis for treatment?

BACKGROUND: Postmenopausal women with a prior fracture have an increased risk for future fracture. Whether a history of non-vertebral fracture defines a group of women with low bone mass but without osteoporosis for whom alendronate would prevent new non-vertebral fracture is not known. SUBJECTS AND METHODS: Secondary analysis of data from the Fracture Intervention Trial (FIT). Of 2,785 postmenopausal women with a T-score at the femoral neck between -1 and -2.5 and without prevalent radiographic vertebral deformity, 880 (31.6%) reported experiencing a fracture after 45 years of age. Women were randomized to placebo or alendronate (5 mg/day years for the first 2 years and 10 mg/day thereafter) and were followed for an average of 4.2 +/- 0.5 years. Incident non-vertebral fractures were confirmed by x-rays and radiology reports. RESULTS: In the placebo arm, a self-report of prior fracture identified women with a 1.5-fold (hazard ratio [RH] 1.46, 95% C.I. 1.04-2.04) increased risk for incident non-vertebral fracture. However, there was no evidence that the effect of alendronate differed across subgroups of women with (RH 1.26 for alendronate vs placebo, 95% C.I. 0.89-1.79) and without prior fracture (RH 1.02 for alendronate vs placebo, 95% C.I. 0.76-1.38; P = 0.37 for interaction). CONCLUSION: Assessing a clinical risk factor, prior non-vertebral fracture, did not identify women with low bone mass for whom alendronate reduced future non-vertebral fracture risk.

Preliminary findings: 25(OH)D levels and PTH are indicators of rapid bone accrual in pubertal children.

OBJECTIVE: The objective of this study was to evaluate the role of serum levels of 25(OH)D and PTH on the accumulation of whole body bone mass in a cohort of children. METHODS: This was a longitudinal study (1.98 +/- 0.07 y) of sixty-nine children (89% Caucasian, 44% male) enrolled in a calcium supplementation trial. Bone area, bone mineral content (BMC) and density (BMD) of the whole body and radius were assessed using a QDR 2000 (Hologic, Inc) dual energy x-ray absorptiometer. Serum PTH and 25(OH)D were measured using radioimmunoassays. RESULTS: Vitamin D stores were inversely related gain in bone area (p < 0.002), BMC (p < 0.002) BMD (p < 0.027), as well as to PTH levels (p < 0.0001). Compared to those with adequate vitamin D stores (>34 ng/ml), those who had consistently low vitamin D stores (18 ng/ml) had a 8% larger gain in bone area (p < 0.05); 11% in BMC (p < 0.05) and no differences in gain in BMD; after adjusting for baseline bone measurements, race, gender, season measured, Tanner stage, and calcium intake. CONCLUSIONS: High normal PTH with low-normal 25(OH)D stores and moderate to high calcium intake may be beneficial to accruing larger bone size and BMC during puberty.

A captive audience: a pilot study of screening and counseling hospitalized women for fracture risk.

BACKGROUND: Innovative methods are needed to improve screening for osteoporosis, especially in women with multiple comorbid conditions. OBJECTIVES: Determine whether a fracture risk-screening program including a bedside calcaneal ultrasound is feasible in hospitalized women, and determine whether identification of fracture risks results in behavior change after discharge. DESIGN: Prospective uncontrolled feasibility study. SETTING: Five hundred twenty-eight bed academic hospital. PARTICIPANTS: One hundred three hospitalized women age 60 years or older. METHODS: A bedside calcaneal ultrasound was used to estimate bone mineral density. Clinical fracture risks were obtained via interview. The patient and primary care physician received personalized risk information and educational material. RESULTS: Of 103 eligible women, 59 (57%) agreed to undergo bedside screening and counseling. Of these 59 women, 49 (83%) had at least one major clinical risk factor for fracture. The median T-score was -2.5. Among the 42 women available for phone follow-up 2 months after hospital discharge, 34 (81%) reported after at least 1 recommendation to diminish fracture risk. CONCLUSION: A hospital-based osteoporosis screening program using calcaneal ultrasound is feasible and identifies women at risk of fracture. Feedback of low bone mineral density and fracture risk during hospitalization may promote behavior change to diminish fracture risk after discharge.

Correlates of use of antifracture therapy in older women with low bone mineral density.

BACKGROUND: Guidelines exist for treatment of low bone mineral density (BMD). Little is known about patient characteristics associated with use of treatment. OBJECTIVES: To determine patient-related correlates of medication use following screening dual x-ray absorptiometry (DXA) of older adults. DESIGN: Secondary analysis of a prospective cohort study. SETTING: Pittsburgh, PA and Memphis, TN. PARTICIPANTS: Community-dwelling women between the ages 70 and 79 years enrolled in the Health, Aging, and Body Composition (Health ABC) Study. MEASUREMENTS: Risk factors for fracture and BMD of the hip were assessed at baseline. Patients and their community physicians were supplied the results of the DXA scan. Prescription and over-the-counter medication use was collected at annual exams for 2 years. RESULTS: Of 1,584 women enrolled in Health ABC, 378 had an indication for antifracture therapy and were not receiving such treatment at baseline. By the second annual follow-up examination, prescription antiresorptive medication was reported in 49 (13.0%), whereas 65 (17.2%) received calcium and/or vitamin D supplementation. In adjusted models, the strongest predictor for use of any antifracture medicine was presence of osteoporosis [vs osteopenia, odds ratio (OR), 2.9 (1.7 to 4.7)], white race [OR, 2.6 (1.5 to 4.8)], and receipt of the flu shot [OR, 2.2 (1.3 to 3.8)]. Neither a history of falls nor prior fracture was associated with use of antifracture medications. CONCLUSION: Even when physicians of study participants were provided with DXA scan results, 70% of older high-functioning women with an indication for therapy did not start or remain on an antifracture therapy. Substantial room for improvement exists in fracture prevention following a diagnosis of low BMD-especially among women with a history of falls, prior fractures, and among black women.

Magnesium intake from food and supplements is associated with bone mineral density in healthy older white subjects.

OBJECTIVES: To determine whether magnesium intake from supplemental and dietary sources is associated with bone mineral density (BMD) in older men and women. DESIGN: Cross-sectional. SETTING: Memphis, Tennessee, and Pittsburgh, Pennsylvania. PARTICIPANTS: Two thousand thirty-eight older black and white men and women aged 70 to 79 at baseline enrolled in the Health, Aging and Body Composition Study. MEASUREMENTS: Dietary intake of magnesium was assessed using a semiquantitative food frequency questionnaire, and supplement data were collected based on a medication inventory. BMD of the whole body was obtained using a fan-beam densitometer. Additional covariates included age, body mass index (BMI), smoking status, alcohol use, physical activity, estrogen use, and supplemental calcium (Ca) and vitamin D use. RESULTS: In white, but not black, men and women, magnesium intake was positively associated with BMD of the whole body after adjustment for age, self-report of osteoporosis or fracture in adulthood, caloric intake, Ca and vitamin D intake, BMI, smoking status, alcohol intake, physical activity, thiazide diuretic use, and estrogen use in women (P=.05 for men and P=.005 for women). BMD was 0.04 g/cm2 higher in white women and 0.02 g/cm2 higher in white men in the highest than in the lowest quintile of magnesium intake. CONCLUSION: Greater magnesium intake was significantly related to higher BMD in white women and men. The lack of association observed in black women and men may be related to differences in Ca regulation or in nutrient reporting.

Vitamin D, parathyroid hormone, and bone mass in adolescents.

This article provides a review of the evidence identifying the factors related to vitamin D status in adolescents. The prevalence of vitamin D deficiency based on 25-hydroxyvitamin D [25(OH)D] of <25 nmol/L ranges from 0 to 32% depending on the season measured and the latitude of the population assessed. The factors that have been reported to affect serum 25(OH)D in adolescents include ethnicity, gender, puberty stage, parathyroid hormone (PTH), dietary vitamin D intake, and sun exposure. Vitamin D supplementation studies are limited to small populations and with supplementation focused on winter months when sunlight may be inadequate. The effects of vitamin D status and supplementation on bone assessment provide varied results. Differences in study design, modalities of bone assessment, and stage of puberty could contribute to disparate findings. Overall, the results from the available literature provide more questions than answers concerning the role of vitamin D in bone accrual in adolescents.

Relationship between patient age and duration of physician visit in ambulatory setting: does one size fit all?

OBJECTIVES: To determine whether patient age, the presence of comorbid illness, and the number of prescribed medications influence the duration of a physician visit in an ambulatory care setting. DESIGN: A cross-sectional study of ambulatory care visits made by adults aged 45 and older to primary care physicians. SETTING: A probability sample of outpatient follow-up visits in the United States using the National Ambulatory Medical Care Survey (NAMCS) 2002 database. PARTICIPANTS: Of 28,738 physician visits in the 2002 NAMCS data set, there were 3,819 visits by adults aged 45 and older included in this study for analysis. MEASUREMENTS: The primary endpoint was the time that a physician spent with a patient at each visit. Covariates included for analyses were patient characteristics, physician characteristics, visit characteristics, and source of payment. Visit characteristics, including the number of diagnoses and the number of prescribed medications, the major diagnoses, and the therapeutic class of prescribed medications, were compared for different age groups (45-64, 65-74, and > or =75) to determine the complexity of the patient's medical conditions. Endpoint estimates were computed by age group and were also estimated based on study covariates using univariate and multivariate linear regression. RESULTS: The mean time+/-standard deviation spent with a physician was 17.9+/-8.5 minutes. There were no differences in the duration of visits between the age groups before or after adjustment for patient covariates. Patients aged 75 and older had more comorbid illness and were prescribed more medications than patients aged 45 to 64 and 65 to 74 (P<.001). Patients aged 75 and older were also prescribed more medications that require specific monitoring and counseling (warfarin, digoxin, angiotensin-converting enzyme inhibitors, diuretics, and levothyroxine) than were patients in other age groups (P<.001). Hypertension, coronary artery disease, atrial fibrillation, congestive heart failure, cerebrovascular disease, and transient ischemic attack were more common in patients aged 75 and older than in other age groups (P<.001). Despite these differences, there were no differences in unadjusted or adjusted duration of physician visit between the age groups. CONCLUSION: Although patients aged 75 and older had more medical conditions and were at higher risk for drug-related problems than younger patients, the duration of physician visits was similar across the age groups. These findings suggest that elderly patients may require a multidisciplinary approach to optimize patient care in the ambulatory setting.

QSource quality initiative. Reversing the diabetes epidemic in Tennessee.

This paper summarizes the results of a recent report on diabetes in Tennessee. Diabetes has reached epidemic proportions in Tennessee. In 2001, an estimated 7.7% of the population was diabetic, an increase from 5.8% a decade earlier. This increase is largely due to widespread unhealthy eating habits, physical inactivity, and associated obesity. The majority of diabetes is preventable and can be effectively treated through daily exercise and a healthy diet. Diabetes prevention efforts in Tennessee schools and communities, however, are grossly inadequate. Providers and payers underemphasize prevention. Since the causes of diabetes can be traced to childhood habits, early prevention is the key to reversing the diabetes epidemic. Immediate statewide action must be taken to promote daily exercise and decrease access to high-calorie, high-fat "junk" food in our schools and communities. Physicians, health professional organizations, health plans, government, churches, schools, and employers must work together to battle the diabetes epidemic through public education, community-wide health promotion programs, and efforts to improve quality of diabetes care for all Tennesseans.