Sliding Scale Insulin vs Basal-Bolus Insulin Therapy in Long-Term Care: A 21-Day Randomized Controlled Trial Comparing Efficacy, Safety and Feasibility.

INTRODUCTION: Sliding scale insulin (SSI) therapy remains a common means of insulin therapy in long-term care (LTC) for the management of type 2 diabetes mellitus, despite current recommendations not supportive of the form of therapy today. Lack of randomized trial data on the efficacy and safety of basal-bolus insulin (B-BI) therapy in nursing home residents may have precluded this form of insulin administration in the LTC setting. Our study is a comparison of the efficacy of SSI (control) and B-BI (intervention) therapies during a 21-day intervention trial in older nursing home residents. METHODS: Fourteen LTC facilities in the US participated; 110 residents with type 2 diabetes volunteered to participate; 35 failed inclusion criteria, 75 signed informed written consent, and 11 were discharged to home/hospital or withdrew consent; data from 64 participants are reported. Recent fasting blood glucose (FBG), hemoglobin A1c, and chemistries were obtained. Four glucose readings (prior to breakfast, lunch, dinner, and bedtime), oral antiglycemic drug, and insulin doses and changes, and all adverse events/serious adverse events, both those related to glucose control [hypoglycemic (<70 mg/dL) and hyperglycemic (>200 mg/dL) episodes] and those unrelated, were recorded daily. Patients were randomized to either remain on SSI or be shifted to the B-BI group. RESULTS: Nursing home residents 80 ± 8 (standard deviation) years, 66% female participated; Control and Intervention participants had similar age, gender, race distributions, comorbidity, and 3-day average pretrial FBG levels (all P > .05). At study end, B-BI volunteers had significantly lower 3-day average FBG levels vs pretrial (P = .0231) while SSI participants had no change in 3-day average FBG (P > .05). During the trial, participants from both groups had similar rates of hypoglycemia, hyperglycemia, other adverse events, and hospitalizations (serious adverse events) unrelated to glucose control (all P > .05). CONCLUSIONS: B-BI therapy produced significantly lower average FBG levels after 21 days compared with SSI therapy; both groups had similar rates of hypo- and hyperglycemia. Switching to B-BI therapy is feasible, safe, and effective in the LTC setting.

The role of cognitive impairment in the use of the Diskus inhaler.

BACKGROUND AND PURPOSE: Drugs delivered by metered-dose inhalers and dry powder inhalers (DPIs) are a mainstay in the treatment of chronic lung disease; however, previous studies suggest cognitive impairment hinders proper use of inhalers. The purpose of this study was to determine the relationship between the score on the Mini-Mental State Exam (MMSE) and the ability of nursing facility residents to complete the steps required for proper use of a multiunit-dose DPI (Diskus). METHODS: Nursing facility residents who had never used a multiunit-dose DPI (Diskus), who scored between 10 and 24 inclusive on the MMSE, and who were able to hold a breath for 10 seconds were recruited for an observational study to test their ability to use a placebo-loaded Diskus when supervised and assisted by personnel trained in the proper use the Diskus. Ability to use the DPI was assessed by the Diskus Evaluation Rating Scale (DERS), an instrument developed specifically for this study. Possible scores on the DERS ranged from 0 to 19, with a score of 0 indicating no limitations in any of the steps involved in using the Diskus and 19 indicating inability to do any of the steps after 3 supervised attempts. RESULTS: Forty Diskus-naïve nursing facility residents (86 ± 9 years of age; 32 women) with MMSE scores between 10 and 24 inclusive and the ability to hold a breath for 10 seconds were enrolled in the study. Mean MMSE scores were 17.4 ± 4.2, whereas the mean score on the DERS was 5.1 ± 3.2 (range 1-16). After controlling for age, gender, and education, a significant inverse relationship was noted between scores on the MMSE and the DERS such that for every 1-point increase on the MMSE, the subject's DERS score decreased by 0.345 points (P = .003). Overall, 38 of the 40 subjects with MMSE scores between 10 and 24 inclusive were able to use the Diskus successfully. CONCLUSION: For MMSE scores, the better the performance on the MMSE, the better the performance on the DERS. More important, 95% of the subjects in this study could use the Diskus successfully when properly supervised. In contrast to earlier studies, these findings suggest that a multiunit-dose DPI can be prescribed as one component of the regimen for chronic lung disease in patients with substantial cognitive impairment.

Prevention of venous thromboembolism in long term care: results of a multicenter educational intervention using clinical practice guidelines: part 2 of 2 (an AMDA Foundation project).

INTRODUCTION: Implementation of prophylaxis for venous thomboembolism (VTE) through risk assessment based on clinical practice guidelines (CPGs) is variably adopted in long term care facilities (LTCF). Current guidelines recommend venous thromboembolism prophylaxis (VTE-P) following risk assessment, individualized to patient status. In LTCF, differing comorbidity, life-expectancy, ethical, and quality-of-life issues may warrant a unique approach. This article examines VTE-P practices in LTCF before and after educational intervention to bring practice patterns consistent with CPGs. METHODS: Phase 1 (preceding article in this issue) identified current practice to assess risk and implement VTE-P (17 geographically diverse LTCFs, 3260 total beds). Phase 2 (educational intervention using CPGs) and Phase 3 (outcomes) reexamined VTE-P at the same 17 centers. RESULTS: The frequency of indications for VTE-P and contraindications to anticoagulation were similar during Phases 1 and 3 (all P > .05). In Phase 3, use of aspirin alone decreased more than 50% (P < .0005), whereas use of compression devices increased (P < .0005). Regression models predicted no relationship between any indication or contraindication and VTE-P in Phase 1 (all P > .05) but identified significant relationships between indication and contraindications and VTE-P in Phase 3 (P = .022 to P < .0005), suggesting adequate understanding of current CPGs following education as the basis for improved VTE-P. CONCLUSIONS: The study confirms the presence of significant comorbidity in LTC residents, many with indications for VTE-P, some with contraindications for anticoagulation. Following educational intervention, more residents received VTE-P, influenced by risk-benefit ratio favoring treatment. These findings suggest that even a modest educational intervention significantly improves provider knowledge pertinent to risk assessment consistent with CPG and more appropriate VTE-P.

Prevention of venous thromboembolism: practice patterns in 17 geographically diverse long term care facilities in the United States: part 1 of 2 (an AMDA Foundation project).

INTRODUCTION: Current guidelines recommend antithrombotic prophylaxis for venous thromboembolism (VTE) using risk assessment, factoring contraindications. This report represents a summary of current practice patterns to prevent VTE in long term care as Phase 1 of a 3-phase educational intervention study. PHASE 1 PARTICIPANTS: Participants were 376 new admissions/readmissions (77 ± 12 [SD] years; 67% female) from 17 geographically diverse long term care facilities (3260 total beds). MEASUREMENTS: The process describes current VTE prophylaxis (VTE-P) practices; a companion article describes the educational intervention (Phase 2) and outcome (Phase 3). Phase 1 data were collected on use of nonpharmacological measures and antithrombotic drugs for VTE-P between July and September 2009. RESULTS: Indications for VTE-P were evident in 85% of new admissions, of which two-thirds received VTE-P. Contraindications for anticoagulation were observed in 54.8% of admissions, including quality of life or patient/caregiver wishes. Logistic regression analysis predicted no relationship between any indication for or any contraindication to VTE-P and use of VTE-P, suggesting an inadequate understanding of current clinical practice guidelines. CONCLUSIONS: Residents of long term care have significant comorbidity that poses risk for VTE; although many received VTE-P, contraindications were common, warranting individualized considerations. The likelihood of VTE-P was greatest following orthopedic surgery, severe trauma, and medical illness.

Chronic kidney disease staging in nursing home and community older adults: does the choice of cockcroft-gault, modification of diet in renal disease study, or the chronic kidney disease epidemiology collaboration initiative equations matter?

OBJECTIVE: To compare the chronic kidney disease (CKD) stages derived from GFR estimates using 3 different formulae in a sample of older adults from the community and long term care settings. PARTICIPANTS: Data from 1535 older, hospitalized patients (2000-2008) were collected; individuals were hospitalized for acute illness unrelated to renal function. MEASUREMENTS: Patient demographics, pertinent medical history, and routine laboratory test results were collected. Estimate of glomerular filtration rate and creatinine clearance values were determined by the Cockcroft-Gault, Modification of Diet in Renal Disease Study, and Chronic Kidney Disease Epidemiology Collaboration equations. RESULTS: The Cockcroft-Gault equation generated significantly lower mean estimate of glomerular filtration rate values than either Modification of Diet in Renal Disease Study or Chronic Kidney Disease Epidemiology Collaboration equations in the total sample (P < .0005) and in a subset of patients diagnosed as renal insufficiency (P < .00005). Using the 3 formulae produced a significant disconnect in CKD staging resulting in the potential for different recommendations for monitoring and management across formulae (National Kidney Foundation Guidelines) (P < .0005). When stratified by age, the 3 equations produce nearly identical glomerular filtration rate estimates in patients younger than 70 years (P = .989) but significantly different glomerular filtration rate estimates in patients from 70 to 104 years (P < .0005). CONCLUSIONS: The Cockcroft-Gault equation systematically provides lower (more severe) estimates of renal function than the Modification of Diet in Renal Disease Study and Chronic Kidney Disease Epidemiology Collaboration equation in patients older than 70 years. However, significant differences in CKD staging derived from estimate of glomerular filtration rate or creatinine clearance were not observed in adults from 59 to 69 years of age. These findings do not validate one formula over the others, but demonstrate that disparities exist; it may be prudent to use the same formula over time in a given patient to monitor changes in renal function.

Warfarin: implementing its safe use in hospitalized patients from nursing homes and community through a performance improvement initiative.

INTRODUCTION: Warfarin is increasingly used to prevent thromboembolism but adverse drug events (ADEs) are common. The National Safety Goals (3E) 2008 recommend that institutions develop processes to monitor the safe use of warfarin. Despite these guidelines, adverse events (bleeding) are common. This initiative, in an academic hospital, tracked warfarin use before and after using a PI process aimed at improving safe use of warfarin in hospitalized adults. METHODS: Retrospective (PRE-initiative, September-December 2007) and prospective (POST-initiative, January-December 2008) data were collected on in-hospital and prior warfarin use, demographics, medical history, initial and in-hospital warfarin maintenance dosing, hematocrit, International Normalized Ratio (INR), hepatic and renal function and adverse events related to warfarin use. Education on the appropriate use of warfarin was provided through formal and informal sessions and during daily hand-off sessions. RESULTS: A total of 308 patients receiving oral warfarin were examined (mean age 70 ± 17(SD) years, 47% males, 36% from nursing homes). Age, sex ratios, and place of residence were similar PRE- versus POST-initiative. Overall initial and maintenance warfarin doses were significantly lower POST-initiative (P = .0129 and P = .0319, respectively) and these decreases occurred exclusively in patients with supratherapeutic INR levels (>3.0). During the POST-period, the prevalence of high INR levels and bleeding events during hospitalization also decreased significantly (P = .015 and P < .0005, respectively). Finally, concomitant use of anticoagulant and/or antiplatelet drugs was significantly decreased POST-initiative (P = .028). CONCLUSIONS: Most hospitalized patients (PRE- and POST-) presented with INRs in the sub- or supratherapeutic ranges (<2 and >3, respectively), requiring warfarin dose adjustments. Education through this initiative resulted in significantly lower average maintenance doses of warfarin, less use of concomitant anticoagulant or antiplatelet drugs, fewer supratherapeutic range INRs, and fewer adverse events during warfarin therapy. Education through a PI initiative is a simple and effective means to implement safer use of warfarin in the in-hospital setting.

Serum lutein response is greater from free lutein than from esterified lutein during 4 weeks of supplementation in healthy adults.

BACKGROUND: Current data suggest great variability in serum response following lutein ingestion from various sources. OBJECTIVE: To compare the relative serum response during supplementation with free lutein (fL) and lutein esters (Le). METHODS: 72 volunteers (23-52 years; body mass index [BMI] >20 and <30 kg/m2; baseline serum lutein <20 µg/dL [<352 nmol/L]) were identified. Subjects, matched for gender, age, and BMI, were randomly assigned to the fL or Le group. fL and Le capsules contained 12.2 mg of free lutein or 27 mg of lutein ester (equivalent to 13.5 mg free lutein), respectively. Fasting blood was obtained at baseline and after 7, 14, 21, and 28 days of supplementation. Supplements were consumed with standard portions of dry, ready-to-eat cereal and 2% cow's milk. RESULTS: Absolute changes in serum lutein, per mg daily dose, were significantly greater in fL vs. Le after 21 days (p  =  0.0012) and remained so after 28 days (p  =  0.0011) of supplementation. Serum lutein Area Under the Curve [AUC((day 0-28))] response was 17% greater for fL vs. Le (p  =  0.0187). Regression models were used and determined that (1) baseline serum lutein levels and (2) the form of lutein ingested (fL > Le) influence the serum lutein response during supplementation, while subject age, gender, BMI, and serum lipids do not affect serum response. CONCLUSIONS: These results suggest that the relative serum lutein response will be significantly greater from supplements containing free lutein than from supplements containing lutein esters. These findings should be useful for future clinical trials exploring the effectiveness of lutein supplementation in the prevention of or protection against age-related macular degeneration and/or cataracts.

Radiation-induced reductions in transporter mRNA levels parallel reductions in intestinal sugar transport.

More than a century ago, ionizing radiation was observed to damage the radiosensitive small intestine. Although a large number of studies has since shown that radiation reduces rates of intestinal digestion and absorption of nutrients, no study has determined whether radiation affects mRNA expression and dietary regulation of nutrient transporters. Since radiation generates free radicals and disrupts DNA replication, we tested the hypotheses that at doses known to reduce sugar absorption, radiation decreases the mRNA abundance of sugar transporters SGLT1 and GLUT5, prevents substrate regulation of sugar transporter expression, and causes reductions in sugar absorption that can be prevented by consumption of the antioxidant vitamin A, previously shown by us to radioprotect the testes. Mice were acutely irradiated with (137)Cs gamma rays at doses of 0, 7, 8.5, or 10 Gy over the whole body. Mice were fed with vitamin A-supplemented diet (100x the control diet) for 5 days prior to irradiation after which the diet was continued until death. Intestinal sugar transport was studied at days 2, 5, 8, and 14 postirradiation. By day 8, d-glucose uptake decreased by approximately 10-20% and d-fructose uptake by 25-85%. With increasing radiation dose, the quantity of heterogeneous nuclear RNA increased for both transporters, whereas mRNA levels decreased, paralleling reductions in transport. Enterocytes of mice fed the vitamin A supplement had > or = 6-fold retinol concentrations than those of mice fed control diets, confirming considerable intestinal vitamin A uptake. However, vitamin A supplementation had no effect on clinical or transport parameters and afforded no protection against radiation-induced changes in intestinal sugar transport. Radiation markedly reduced GLUT5 activity and mRNA abundance, but high-d-fructose diets enhanced GLUT5 activity and mRNA expression in both unirradiated and irradiated mice. In conclusion, the effect of radiation may be posttranscriptional, and radiation-damaged intestines can still respond to dietary stimuli.

An escalating dose regimen of pegylated interferon and ribavirin in HCV cirrhotic patients referred for liver transplant.

BACKGROUND: To lessen the severity of recurrent hepatitis C virus (HCV) postliver transplantation (post-LT) by treating HCV patients with cirrhosis, we assessed the safety and efficacy of an escalating dose pegylated interferon (PEG-IFN)/ribavirin protocol in pre-LT patients. METHODS: Ninety patients were treated with 90 microg PEG-IFN alpha-2a and 400 mg ribavirin and advanced to 180 microg and 800 to 1200 mg, respectively, over 8 weeks. RESULTS: Mean age was 55.3 years. Thirty-four percent of patients received prior interferon treatment, 77% had genotype 1 or 4. Mean Child's score was 6.7 and model for end-stage liver disease 11.2; 49% reached full-dose PEG-IFN and 85% ribavirin, 18% required dose reduction, 33% stopped treatment because of adverse effects, 9% had deterioration of liver function, and 7% died. Follow-up of 9.6 months showed sustained virological response in 13% of patients. The rate of serious complications was 16.3% in Child's class A, 48% in B, and 100% in C (P=0.005). Serum albumin was a significant predictor for worsening liver function (P=0.007). CONCLUSIONS: Using an escalating dose regimen of PEG-IFN alpha-2a and ribavirin, we achieved only a 13% sustained virological response in HCV cirrhotic pre-LT patients with an accompanying 9% risk of worsening liver function and 7% risk of death.

Vitamin C treatment reduces elevated C-reactive protein.

Plasma C-reactive protein (CRP) is an inflammatory biomarker that predicts cardiovascular disease. Lowering elevated CRP with statins has reduced the incidence of cardiovascular disease. We investigated whether vitamin C or E could reduce CRP. Healthy nonsmokers (N=396) were randomized to three groups, 1000 mg/day vitamin C, 800 IU/day vitamin E, or placebo, for 2 months. Median baseline CRP was low, 0.85 mg/L. No treatment effect was seen when all participants were included. However, a significant interaction was found, indicating that treatment effect depends on baseline CRP concentration. Among participants with CRP indicative of elevated cardiovascular risk (> or =1.0 mg/L), vitamin C reduced the median CRP by 25.3% vs placebo (p=0.02) (median reduction in the vitamin C group, 0.25 mg/L, 16.7%). These effects are similar to those of statins. The vitamin E effect was not significant. In summary, treatment with vitamin C but not vitamin E significantly reduced CRP among individuals with CRP > or =1.0 mg/L. Among the obese, 75% had CRP > or =1.0 mg/L. Research is needed to determine whether reducing this inflammatory biomarker with vitamin C could reduce diseases associated with obesity. But research on clinical benefits of antioxidants should limit participants to persons with elevations in the target biomarkers.

Vitamin C in plasma is inversely related to blood pressure and change in blood pressure during the previous year in young Black and White women.

BACKGROUND: The prevalence of hypertension and its contribution to cardiovascular disease risk makes it imperative to identify factors that may help prevent this disorder. Extensive biological and biochemical data suggest that plasma ascorbic acid may be such a factor. In this study we examined the association between plasma ascorbic acid concentration and blood pressure (BP) in young-adult women. METHODS: Participants were 242 Black and White women aged 18-21 yr from the Richmond, CA, cohort of the National Heart, Lung and Blood Institute Growth and Health Study. We examined the associations of plasma ascorbic acid with BP at follow-up year 10, and with change in BP during the previous year. RESULTS: In cross-sectional analysis, plasma ascorbic acid at year 10 was inversely associated with systolic BP and diastolic BP after adjusting for race, body mass index, education, and dietary intake of fat and sodium. Persons in the highest one-fourth of the plasma ascorbic acid distribution had 4.66 mmHg lower systolic BP (95% CI 1.10 to 8.22 mmHg, p = 0.005) and 6.04 mmHg lower diastolic BP (95% CI 2.70 to 9.38 mmHg, p = 0.0002) than those in the lowest one-fourth of the distribution. In analysis of the change in BP, plasma ascorbic acid was also inversely associated with change in systolic BP and diastolic BP during the previous year. While diastolic blood pressure among persons in the lowest quartile of plasma ascorbic acid increased by 5.97 mmHg (95% CI 3.82 to 8.13 mmHg) from year 9 to year 10, those in the highest quartile of plasma vitamin C increased by only 0.23 mmHg (95% CI -1.90 to +2.36 mmHg) (test for linear trend: p < 0.0001). A similar effect was seen for change in systolic BP, p = 0.005. CONCLUSION: Plasma ascorbic acid was found to be inversely associated with BP and change in BP during the prior year. The findings suggest the possibility that vitamin C may influence BP in healthy young adults. Since lower BP in young adulthood may lead to lower BP and decreased incidence of age-associated vascular events in older adults, further investigation of treatment effects of vitamin C on BP regulation in young adults is warranted.

The risk of developing lung cancer associated with antioxidants in the blood: ascorbic acids, carotenoids, alpha-tocopherol, selenium, and total peroxyl radical absorbing capacity.

Lung cancer cases diagnosed during the period 1975 through 1993 and matched controls were identified in the rosters of Washington County, Maryland residents who had donated blood for a serum bank in 1974 or 1989. Plasma from participants in the 1989 project was assayed for ascorbic acid; serum or plasma was assayed for participants in either project for alpha- and beta-carotene, cryptoxanthin, lutein/zeaxanthin, lycopene, alpha-tocopherol, selenium, and peroxyl radical absorption capacity. Among the total group of 258 cases and 515 controls, serum/plasma concentrations were significantly lower among cases than controls for cryptoxanthin, beta-carotene, and lutein/zeaxanthin with case-control differences of -25.5, -17.1, and -10.1%, respectively. Modest nonsignificant case-control differences in a protective direction were noted for alpha-carotene and ascorbic acid. There were only trivial differences for lycopene, alpha-tocopherol, selenium, and peroxyl radical absorption capacity. Findings are reported for males and females and for persons who had never smoked cigarettes, former smokers, and current smokers at baseline. These results and those from previous studies suggest that beta-carotene is a marker for some protective factor(s) against lung cancer; that cryptoxanthin, alpha-carotene, and ascorbic acid need to be investigated further as potentially protective factors or associates of a protective factor; and that lycopene, alpha-tocopherol, selenium, and peroxyl radical absorption capacity are unlikely to be associated with lung cancer risk. Until specific preventive factors are identified, the best protection against lung cancer is still the avoidance of airborne carcinogens, especially tobacco smoke; second best is the consumption of a diet rich in fruits and vegetables.

Associations of plasma carotenoids with risk factors and biomarkers related to cardiovascular disease in middle-aged and older women.

BACKGROUND: Cardiovascular disease (CVD) risk factors may potentially influence plasma concentrations of carotenoids. However, data on the association of plasma carotenoids with CVD related biomarkers are only limited. OBJECTIVE: We examined the cross-sectional association of plasma carotenoids with blood lipids, glycated hemoglobin (Hb A(1c)), and C-reactive protein (CRP) in middle-aged and older women initially free of CVD and cancer. DESIGN: Participants from 3 nested case-control studies in the Women's Health Study were pooled. Baseline plasma carotenoids, including alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, and lutein-zeaxanthin, blood lipids, Hb A(1c), and CRP were available for 2895 women. RESULTS: Women who were current smokers or obese had lower plasma concentrations of most carotenoids expect for lycopene. After adjusting for age, race, lifestyle factors, clinical factors, plasma total cholesterol, and dietary carotenoids, an increase of 30 mg/dL in LDL cholesterol was associated with a 17% increase in alpha-carotene, a 16% increase in beta-carotene, and an 8.5% increase in lycopene; an increase of 10 mg/dL in HDL cholesterol was associated with a 5.3% decrease in lycopene; an increase of 0.3% in Hb A(1c) was associated with a 1.4% increase in lycopene; and an increase of 2 mg/L in CRP was associated with a 1.3% decrease in beta-carotene (all P < 0.01). CONCLUSIONS: In middle-aged and older women free of CVD and cancer, plasma carotenoids were associated with smoking, obesity, LDL cholesterol, HDL cholesterol, Hb A(1c), and CRP. The associations differ among individual carotenoids, possibly reflecting metabolic effects of lifestyle and physiologic factors on plasma carotenoids, and may partially explain the inverse association of plasma carotenoids with CVD outcomes observed in epidemiologic studies.

Anemia: its impact on hospitalizations and length of hospital stay in nursing home and community older adults.

OBJECTIVE: To examine the association between anemia and its severity on hospitalizations and length of stay (LOS) in hospital in older adults. PARTICIPANTS: A cross-sectional sample of 590 adults from long term care facilities (NH) and community ambulatory care (C) in the Bronx, NY. MEASUREMENTS: Patient demographics, medical history, hospitalizations during an 18-month period, LOS per hospitalization, and laboratory parameters including hemoglobin (Hb) at enrollment and during hospitalization. RESULTS: Anemia and hospitalization occurred in 62% and 64% of the sample, respectively. NH residents were older (P = .0013), had fewer hospitalizations (P = .001) but similar rates of anemia, anemia severity, gender ratios and LOS per hospitalization as C subjects (all P > .05). Females were older (P = .0455), had fewer hospitalizations (P = .001) and more severe anemia than males (P < .0005). The likelihood of hospitalization increased 1) as anemia severity increased (P < .00005), 2) in African Americans (P = .002), 3) in males (P = .006), and 4) as anemia duration increased (P < .0005). Anemic patients had significantly longer total LOS days than non-anemic individuals (P < .00005); total LOS also increased as severity of anemia increased (P = .0022). CONCLUSIONS: Our findings suggest anemia, in particular chronic and severe anemia in older Americans is associated with an increased likelihood of hospitalizations and an increased LOS when hospitalized. The recognition and treatment of anemia in older adults has the potential to reduce hospitalizations and LOS and decrease overall health care costs to individuals and third party providers.