Search

Aims: Severe hypoglycaemia among people with diabetes who use insulin can be a life‐threatening complication if left untreated. Although glucagon has been approved for treatment of hypoglycaemia since the 1960s, it has been underutilized. We aimed to understand the perceptions of people with diabetes and their caregivers about glucagon. Methods: We conducted in‐depth, one‐on‐one telephone interviews with people with diabetes and their caregivers in the United States. The interviews included questions around general awareness of glucagon, reasons for owning or not owning glucagon, and suggestions for improving understanding of glucagon as treatment for severe hypoglycaemia. Initial synopsis and inductive codebook schema were used to analyse the responses by two independent researchers. Themes were developed from the codes, and codes were re‐mapped back to the themes. Results: There were 60 dyads of people with diabetes and their caregivers (N = 120). Four themes developed from the interviews: (1) for most participants, the stated reasons for not owning or renewing a prescription for glucagon included unawareness of the medication, its advantages and its value; (2) misperceptions about glucagon occurred frequently; (3) caregivers often lacked confidence in administering reconstituted injectable glucagon; and (4) education and training from healthcare providers about glucagon would be welcomed. Conclusions: This study emphasizes the need for healthcare providers to discuss hypoglycaemia prevention and events at each clinical visit, including the use of glucagon in the case of severe hypoglycaemia. Healthcare providers are encouraged to assess the knowledge of people with diabetes and their caregivers regarding treatment and prevention of hypoglycaemia. [ABSTRACT FROM AUTHOR]

SUMMARY: Background: Renal replacement therapies (RRT) other than in‐centre haemodialyses are underutilised by African Americans with end‐stage renal disease (ESRD) even though they are associated with reduced costs, morbidity and mortality as well as improved quality of life for patients. Objectives: To understand African American patients' knowledge of RRT options and how patient, provider and system‐factors contribute to knowledge and preferences. Participants' interviews were conducted at the University of Chicago Medical Center with African American patients with chronic kidney disease (CKD). The final analysis included 28 interviews; 22 patients had CKD not yet on dialysis or having received a transplant, while 6 had reached ESRD and were receiving treatment for kidney failure. Approach Transcripts were uploaded into NVivo8 for coding. Thematic analysis was used for data interpretation. Results: Four themes were identified: (1) limited knowledge of home modalities and deceased donor options, (2) CKD patients gave little thought to choosing RRT options, (3) CKD patients relied on doctors for treatment decisions, and (4) while patients reported knowledge of living kidney donation transplants (LKDT), it did not translate to receiving an LKDT. Conclusion: African Americans face significant knowledge and access barriers when deciding on their RRT treatment. Even patients with advanced CKD were still in the early stages of RRT selection. Understanding the knowledge gaps and barriers patients face will inform our subsequent intervention to educate and motivate patients to increase CKD self‐care and improve communication between patients, their families and their providers about different RRT treatments. [ABSTRACT FROM AUTHOR]

Objective: To examine the impact of Section 1115 waivers on Medicaid coverage and opioid agonist therapy (OAT) utilization among substance use treatment admissions.Data Source: Treatment Episode Data Set-Admissions (TEDS-A) (2001-2012).Study Design: We examined effects of 1115 waiver implementation on proportions of substance use treatment admissions with Medicaid and receiving OAT, using random intercept linear regression.Principal Findings: 1115 waiver implementation was associated with an average of a 6 percentage point increase in proportion of all admissions with Medicaid, and 4 percentage point increase among opioid outpatient admissions. Implementation was not associated with change in proportion of opioid outpatient admissions receiving OAT.Conclusions: 1115 waivers influence Medicaid coverage among substance use treatment admissions. The findings improve our understanding of how state policies impact substance use treatment utilization. [ABSTRACT FROM AUTHOR]

Background: The severe forms of thalassemia are the most common inherited anemias managed with regular blood transfusion therapy. Transfusion policies and complications are critical to quality of life and survival, but there is a lack of standardized care.Study Design and Methods: A survey of 58 items was completed in 2016 by 11 centers in California, Washington, Oregon, Nevada, and Arizona providing long-term care for thalassemia. The questionnaire addressed demographic information, transfusion practices and complications, and educational needs.Results: The centers followed 717 patients with β-thalassemia (314, 43.8%) or α-thalassemia (394, 55%). One-third (34.7%) of patients were transfusion-dependent. Indications and goals of transfusion therapy differed between centers. Prestorage leukoreduction was universal, while routine irradiation of units was limited to one site. Red blood cell antigen phenotype was determined before the first transfusion and patients received Rh/Kell-matched units. However, more than half of the transfused patients had received blood at multiple hospitals within or outside the United States. Alloantibodies were seen in 16.9% of transfused group, but management of such patients was variable. Unusual or emerging transfusion-transmitted pathogens were not observed. Multiple educational needs were recognized, with iron overload as the biggest challenge; the approach to iron chelation varied within the group.Conclusion: This study identified many patients not included in earlier surveys limited to major national centers, suggesting that the thalassemia population in the United States is vastly underestimated. Lack of evidence-based guidelines is a barrier to optimal care, which should be addressed through regional consortia of thalassemia centers. [ABSTRACT FROM AUTHOR]

Objective: To examine whether medical homes have heterogeneous effects in different subpopulations, leveraging the interpretations from a variety of statistical techniques.Data Sources/study Setting: Secondary claims data from the NC Medicaid program for 2004-2007. The sample included all adults with diagnoses of schizophrenia, bipolar disorder, or major depression who were not dually enrolled in Medicare or in a nursing facility.Study Design: We modeled a number of monthly service use, adherence, and expenditure outcomes using fixed effects, generalized estimating equation with and without inverse probability of treatment weights, and instrumental variables analyses.Data Collection: Data were received from the Carolina Cost and Quality Initiative.Principal Findings: The four estimation techniques consistently revealed generally positive associations between medical homes and access to primary care, specialty mental health care, greater medication adherence, slightly lower emergency room use, and greater expenditures. These findings were consistent across all three major severe mental illness diagnostic groups. Some heterogeneity in effects were noted, especially in preventive screening.Conclusions: Expanding access to primary care-based medical homes for people with severe mental illness may not save money for insurance providers, due to greater access for important outpatient services with little cost offset. Health services research examining more of the treatment heterogeneity may contribute to more realistic projections about medical homes outcomes. [ABSTRACT FROM AUTHOR]

Objective: To develop and validate rates of potentially preventable emergency department (ED) visits as indicators of community health.Data Sources: Agency for Healthcare Research and Quality, Healthcare Cost and Utilization Project 2008-2010 State Inpatient Databases and State Emergency Department Databases.Study Design: Empirical analyses and structured panel reviews.Methods: Panels of 14-17 clinicians and end users evaluated a set of ED Prevention Quality Indicators (PQIs) using a Modified Delphi process. Empirical analyses included assessing variation in ED PQI rates across counties and sensitivity of those rates to county-level poverty, uninsurance, and density of primary care physicians (PCPs).Principal Findings: ED PQI rates varied widely across U.S. communities. Indicator rates were significantly associated with county-level poverty, median income, Medicaid insurance, and levels of uninsurance. A few indicators were significantly associated with PCP density, with higher rates in areas with greater density. A clinical and an end-user panel separately rated the indicators as having strong face validity for most uses evaluated.Conclusions: The ED PQIs have undergone initial validation as indicators of community health with potential for use in public reporting, population health improvement, and research. [ABSTRACT FROM AUTHOR]

Each year approximately 13,000 Veterans transition to maintenance dialysis, mostly in the traditional form of thrice-weekly hemodialysis from the start. Among >6000 dialysis units nationwide, there are currently approximately 70 Veterans Affairs (VA) dialysis centers. Given this number of VA dialysis centers and their limited capacity, only 10% of all incident dialysis Veterans initiate treatment in a VA center. Evidence suggests that, among Veterans, the receipt of care within the VA system is associated with favorable outcomes, potentially because of the enhanced access to healthcare resources. Data from the United States Renal Data System Special Study Center "Transition-of-Care-in-CKD" suggest that Veterans who receive dialysis in a VA unit exhibit greater survival compared with the non-VA centers. Substantial financial expenditures arise from the high volume of outsourced care and higher dialysis reimbursement paid by the VA than by Medicare to outsourced providers. Given the exceedingly high mortality and abrupt decline in residual kidney function (RKF) in the first dialysis year, it is possible that incremental transition to dialysis through an initial twice-weekly hemodialysis regimen might preserve RKF, prolong vascular access longevity, improve patients' quality of life, and be a more patient-centered approach, more consistent with "personalized" dialysis. Broad implementation of incremental dialysis might also result in more Veterans receiving care within a VA dialysis unit. Controlled trials are needed to examine the safety and efficacy of incremental hemodialysis in Veterans and other populations; the administrative and health care as well as provider structure within the VA system would facilitate the performance of such trials. [ABSTRACT FROM AUTHOR]

Background and Aims Global payment and accountable care reform efforts in the United States may connect more individuals with substance use disorders (SUD) to treatment. We tested whether such changes instituted under an Alternative Quality Contract (AQC) model within the Blue Cross Blue Shield of Massachusetts' (BCBSMA) insurer increased care for individuals with SUD. Design Difference-in-differences design comparing enrollees in AQC organizations with a comparison group of enrollees in organizations not participating in the AQC. Setting Massachusetts, USA. Participants BCBSMA enrollees aged 13-64 years from 2006 to 2011 (3 years prior to and after implementation) representing 1 333 534 enrollees and 42 801 SUD service users. Measurements Outcomes were SUD service use and spending and SUD performance metrics. Primary exposures were enrollment into an AQC provider organization and whether the AQC organization did or did not face risk for behavioral health costs. Findings Enrollees in AQC organizations facing behavioral health risk experienced no change in the probability of using SUD services (1.64 versus 1.66%; P = 0.63), SUD spending ($2807 versus $2700; P = 0.34) or total spending ($12 631 versus $12 849; P = 0.53), or SUD performance metrics (identification: 1.73 versus 1.76%, P = 0.57; initiation: 27.86 versus 27.02%, P = 0.50; engagement: 11.19 versus 10.97%, P = 0.79). Enrollees in AQC organizations not at risk for behavioral health spending experienced a small increase in the probability of using SUD services (1.83 versus 1.66%; P = 0.003) and the identification performance metric (1.92 versus 1.76%; P = 0.007) and a reduction in SUD medication use (11.84 versus 14.03%; P = 0.03) and the initiation performance metric (23.76 versus 27.02%; P = 0.005). Conclusions A global payment and accountable care model introduced in Massachusetts, USA (in which a health insurer provided care providers with fixed prepayments to cover most or all of their patients' care during a specified time-period, incentivizing providers to keep their patients healthy and reduce costs) did not lead to sizable changes in substance use disorder service use during the first 3 years following its implementation. [ABSTRACT FROM AUTHOR]

Objectives To estimate the prevalence of new initiation of long-acting opioids since introduction of national efforts to increase prescriber and public awareness on safe use of transdermal fentanyl patches. Design Cross-sectional. Setting U.S. nursing homes ( NHs). Participants Medicare-enrolled long-stay NH residents (N = 22,253). Measurements Minimum Data Set 3.0 was linked with Medicare enrollment, hospital claims, and prescription drug transaction data (January-December 2011) and used to determine the prevalence of new initiation of a long-acting opioid prescribed to residents in NHs. Results Of NH residents prescribed a long-acting opioid within 30 days of NH admission (n = 12,278), 9.4% (95% confidence interval = 8.9-9.9%) lacked a prescription drug claim for a short-acting opioid in the previous 60 days. The most common initial prescriptions of long-acting opioids were fentanyl patch (51.9% of opioid-naïve NH residents), morphine sulfate (28.1%), and oxycodone (17.2%). Conclusion New initiation of long-acting opioids-especially fentanyl patches, which have been the subject of safety communications-persists in NHs. [ABSTRACT FROM AUTHOR]

Naloxegol, a peripherally acting μ-opioid receptor antagonist, was recently approved in the United States for the treatment of opioid-induced constipation. This study evaluated the effects of CYP3A inhibition and induction on the pharmacokinetics, safety, and tolerability of naloxegol. Separate open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover studies of naloxegol (25 mg by mouth [PO]) in the absence or presence of the inhibitors ketoconazole (400 mg PO) and diltiazem extended release (240 mg PO), or the inducer rifampin (600 mg PO) were conducted in healthy volunteers. Area under the curve (AUC∞) for naloxegol was increased with coadministration of either ketoconazole (12.9-fold) or diltiazem (3.4-fold) and decreased by 89% with coadministration of rifampin compared with AUC∞ for naloxegol alone. Naloxegol was generally safe and well tolerated when given alone or coadministered with the respective CYP3A modulators; 1 subject discontinued because of elevations in liver enzymes attributed to rifampin. The exposure of naloxegol was affected substantially by ketoconazole, diltiazem, and rifampin, suggesting that it is a sensitive in vivo substrate of CYP3A4. [ABSTRACT FROM AUTHOR]

Objectives To evaluate frequency of use of two anti-dementia drug classes approved for treatment of symptoms, whether populations most likely to benefit are treated, and correlates of treatment initiation. Design Nationally representative cohort study. Setting Fee-for-service Medicare. Participants Elderly adults with dementia enrolled in Medicare Parts A, B, and D in 2009 (N = 433,559) and a subset with incident dementia (n = 185,449). Measurements Main outcome was any prescription fill for antidementia drugs (cholinesterase inhibitors (ChEIs) or memantine) within 1 year. Results Treatment with antidementia drugs occurred in 55.8% of all participants with dementia and 49.3% of those with incident dementia. There was no difference between ChEIs and memantine use according to dementia severity (measured as death within first year or living in residential care vs in a community setting) even though memantine is not indicated in mild disease. In incident cases, initiation of treatment was lower in residential care (relative risk (RR) = 0.82, 95% confidence interval (CI) = 0.81-0.83) and with more comorbidities (RR = 0.96, 95% CI = 0.96-0.96). Sixty percent of participants were managed in primary care alone. Seeing a neurologist (RR = 1.07, 95% CI = 1.06-1.09) or psychiatrist (RR = 1.17, 95% CI = 1.16-1.19) was associated with higher likelihood of treatment than seeing a primary care provider alone, and seeing geriatrician was associated with with lower likelihood (RR = 0.96, 95% CI = 0.93-0.99). Across the United States, the proportion of newly diagnosed individuals started on antidementia treatment varied from 32% to 66% across hospital referral regions. Conclusion Antidementia drugs are used less often in people with late disease, but there is no differentiation in medication choice. Although primary care providers most often prescribe antidementia medication without specialty support, differences in practice between specialties are evident. [ABSTRACT FROM AUTHOR]

Objective: To examine the association between non-adherence to clinical practice guidelines (CPGs) and time to return to work (RTW) for patients with workplace injuries.Data Sources/study Setting: Secondary analysis of medical billing and disability data for 148,199 for shoulder and back injuries from a workers' compensation insurer.Study Design: Cox proportional hazard regression is used to estimate the association between time to RTW and receipt of guideline-discordant care. We test the robustness of our findings to an omitted confounding variable.Data Collection: Collected by the insurer from the time an injury was reported, through recovery or last follow-up.Principal Findings: Receiving guideline-discordant care was associated with slower RTW for only some guidelines. Early receipt of care, and getting less than the recommended amount of care, were correlated with faster RTW. Excessive physical therapy, bracing, and injections were associated with slower RTW.Conclusions: There is not a consistent relationship between performance on CPGs and RTW. The association between performance on CPG and RTW is difficult to measure in observational data, because analysts cannot control for omitted variables that affect a patient's treatment and outcomes. CPGs supported by observational studies or randomized trials may have a more certain relationship to health outcomes. [ABSTRACT FROM AUTHOR]

Background: Patients with heart failure and preserved ejection fraction (HFpEF) have a poor prognosis, and no therapies have been proven to improve outcomes. It has been proposed that heart failure, including HFpEF, represents overlapping syndromes that may have different prognoses. We present an exploratory study of patients enrolled in the Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE) using latent class analysis (LCA) with validation using the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM)-Preserved study to identify HFpEF subgroups.Methods and Results: In total, 4113 HFpEF patients randomized to irbesartan or placebo were characterized according to 11 clinical features. The HFpEF subgroups were identified using LCA. Event-free survival and effect of irbesartan on the composite of all-cause mortality and cardiovascular hospitalization were determined for each subgroup. Subgroup definitions were applied to 3203 patients enrolled in CHARM-Preserved to validate observations regarding prognosis and treatment response. Six subgroups were identified with significant differences in event-free survival (P < 0.001). Clinical profiles and prognoses of the six subgroups were similar in CHARM-Preserved. The two subgroups with the worst event-free survival in both studies were characterized by a high prevalence of obesity, hyperlipidaemia, diabetes mellitus, anaemia, and renal insufficiency (Subgroup C) and by female predominance, advanced age, lower body mass index, and high rates of atrial fibrillation, valvular disease, renal insufficiency, and anaemia (Subgroup F).Conclusion: Using a data-driven approach, we identified HFpEF subgroups with significantly different prognoses. Further development of this approach for characterizing HFpEF subgroups is warranted. [ABSTRACT FROM AUTHOR]

Objectives To compare the effectiveness of chemotherapy in prolonging survival according to age in breast and colon cancer. Design Retrospective cohort study with a matched cohort analysis based on the conditional probability of receiving chemotherapy. Setting The 16 Surveillance, Epidemiology, and End Results ( SEER) areas from the SEER- Medicare linked database. Participants Women diagnosed with Stage I to IIIa hormone receptor-negative breast cancer (n = 14,440) and 26,893 men and women with Stage III colon cancer (n = 26,893) aged 65 and older in 1992 to 2009. Measurements The main exposure was the receipt of chemotherapy, and the main outcome was mortality. Results In women with breast cancer aged 65 to 69, the risk of all-cause mortality was statistically significantly lower in those who received chemotherapy than in those who did not in the entire cohort (hazard ratio ( HR) = 0.70, 95% confidence interval ( CI) = 0.57-0.88) and in a propensity-matched cohort ( HR = 0.82, 95% CI = 0.70-0.96) after adjusting for measured confounders. These patterns were similar in participants aged 70 to 74 and 75 to 79, but in women aged 80 to 84 and 85 to 89, risk of all-cause mortality was no longer significantly lower in those receiving chemotherapy in the entire and matched cohorts, except that, in a small number of women who received doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), risk of mortality was significantly lower for those aged 80 to 84. Chemotherapy appeared to be effective in all ages from 65 through 84 in participants with Stage III colon cancer. For example, in those aged 85 to 89, chemotherapy was significantly associated with lower risk of mortality in the entire cohort ( HR = 0.79, 95% CI = 0.67-0.92) and the matched cohort ( HR = 0.79, 95% CI = 0.66-0.95). Conclusion The effectiveness of chemotherapy decreased with age in participants with breast cancer, in whom chemotherapy appears to be effective until age 79 except for the doxorubicin-cyclophosphamide combination, which was effective in participants aged 80 to 84. In individuals with Stage III colon cancer, chemotherapy appears to be effective to age 89. These findings were consistent with those of randomized clinical trials. [ABSTRACT FROM AUTHOR]

Objectives To better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X- ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X- ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration: ClinicalTrials.Gov NCT00393055. [ABSTRACT FROM AUTHOR]

Objectives To ascertain predictors of initiation of brand-name versus generic narrow therapeutic index ( NTI) drugs. Design Retrospective cohort study. Setting Data from CVS Caremark were linked to Medicare claims and to U.S. census data. Participants Individuals aged 65 and older who initiated an NTI drug in 2006 and 2007 (N = 36,832). Measurements Demographic, health service utilization, and geographic predictors of whether participants initiated a generic or brand-name version of their NTI drug were identified using logistic regression. Results Overall, 30,014 (81.5%) participants started on a generic version of their NTI drug. The most commonly initiated NTI drugs were warfarin (n = 17,790; 48%), levothyroxine (n = 10,779; 29%), and digoxin (n = 6,414; 17%). Older age (odds ratio ( OR) = 1.12, 95% confidence interval ( CI) = 1.02-1.22 comparing aged ≥85 with 65-74), higher burden of comorbidity ( OR = 1.05, 95% CI = 1.04-1.07 for each 1-point increase in comorbidity score), and prior use of any generic drug ( OR = 1.55, 95% CI = 1.29-1.87) were positively associated with generic drug initiation. Independent of other predictors, residing in the census block group with the highest generic use was positively associated with greater odds of generic NTI drug initiation ( OR = 1.24, 95% CI = 1.14-1.35 compared with the lowest quintile). Conclusion Demographic, health service utilization, and geographic characteristics are important determinants of whether individuals initiate treatment with a brand-name or generic NTI drug. These factors may contribute to disparities in care and highlight potential targets for educational campaigns. [ABSTRACT FROM AUTHOR]

Purpose Farmworkers frequently live in rural areas and experience high rates of depressive symptoms. This study examines the association between elevated depressive symptoms and health care utilization among Latino farmworkers. Methods Data were obtained from 2,905 Latino farmworkers interviewed for the National Agricultural Workers Survey. Elevated depressive symptoms were measured using the Center for Epidemiologic Studies Depression short-form. A dichotomous health care utilization variable was constructed from self-reported use of health care services in the United States. A categorical measure of provider type was constructed for those reporting use of health care. Results Over 50% of farmworkers reported at least 1 health care visit in the United States during the past 2 years; most visits occurred in a private practice. The odds of reporting health care utilization in the United States were 45% higher among farmworkers with elevated depressive symptoms. Type of provider was not associated with depressive symptoms. Women were more likely to seek health care; education and family relationships were associated with health care utilization. Conclusions Latino farmworkers who live and work in rural areas seek care from private practices or migrant/Community Health Clinics. Farmworkers with elevated depressive symptoms are more likely to access health care. Rural health care providers need to be prepared to recognize, screen, and treat mental health problems among Latino farmworkers. Outreach focused on protecting farmworker mental health may be useful in reducing health care utilization while improving farmworker quality of life. [ABSTRACT FROM AUTHOR]

Background and Objective Beta-lactam antibiotics prescribed in periodontal therapy are vulnerable to degradation by bacterial β-lactamases. This study evaluated the occurrence of β-lactamase-positive subgingival bacteria in chronic periodontitis subjects of USA origin, and assessed their in vitro resistance to metronidazole at a breakpoint concentration of 4 μg/mL. Material and Methods Subgingival plaque specimens from deep periodontal pockets with bleeding on probing were removed from 564 adults with severe chronic periodontitis before treatment. The samples were transported in VMGA III and then plated onto: (i) nonselective enriched Brucella blood agar ( EBBA) and incubated anaerobically for 7 d; and (ii) selective trypticase soy-bacitracin-vancomycin ( TSBV) and incubated for 3 d in air + 5% CO2. At the end of the incubation periods, the bacterial test species were identified and quantified. Specimen dilutions were also plated onto EBBA plates supplemented with 2 μg/mL of amoxicillin, a combination of 2 μg/mL of amoxicillin plus 2 μg/mL of the β-lactamase inhibitor clavulanic acid, or 4 μg/mL of metronidazole, followed by anaerobic incubation for 7 d. Bacterial test species presumptively positive for β-lactamase production were identified by growth on EBBA primary isolation plates supplemented with amoxicillin alone and no growth on EBBA primary isolation plates containing both amoxicillin plus clavulanic acid. A subset of such isolates was subjected to nitrocefin-based chromogenic disk testing to confirm the presence of β-lactamase activity. In vitro resistance to 4 μg/mL of metronidazole was noted when growth of test species occurred on metronidazole-supplemented EBBA culture plates. Results Two-hundred and ninety-four (52.1%) of the study subjects yielded β-lactamase-producing subgingival bacterial test species, with Prevotella intermedia/nigrescens, Fusobacterium nucleatum and other Prevotella species most frequently identified as β-lactamase-producing organisms. Of the β-lactamase-producing bacterial test species strains recovered, 98.9% were susceptible in vitro to metronidazole at 4 μg/mL. Conclusion The occurrence of β-lactamase-positive subgingival bacterial species in more than half of the subjects with severe chronic periodontitis raises questions about the therapeutic potential of single-drug regimens with β-lactam antibiotics in periodontal therapy. The in vitro effectiveness of metronidazole against nearly all recovered β-lactamase-producing subgingival bacterial species further supports clinical periodontitis treatment strategies involving the combination of systemic amoxicillin plus metronidazole. [ABSTRACT FROM AUTHOR]

There is a critical need for objective data about receipt of preventive healthcare screenings that are not subject to self-response bias. However, no available evidence indicates which methods are effective for obtaining retrospective medical record data for women with intellectual disabilities ( ID) receiving care in the community. This article describes a procedure for obtaining retrospective medical record data for 199 women with ID who took part in a community-based, multisite, randomized controlled trial of a health education intervention. Data were analyzed to determine rates of correct physician identification and physician response rates during the 2006-2009 study periods. To assess accuracy in identifying physicians and response rates over time, Mc Nemar's test of paired proportions for dependent samples was used. Physician identification varied over time with correct identification being highest in more recent years. The majority of practices responded to our requests for medical record data; however, response rates and item completion rates were highest for the most recent data, with rates declining significantly for data from earlier years. Obtaining retrospective medical record data from community-based medical practices is possible, but difficult. Therefore, researchers should budget resources to accommodate a lengthy process with extensive follow-up. Researchers interested in older medical data face additional challenges in obtaining complete records. [ABSTRACT FROM AUTHOR]

Aim In this multicentre cross-sectional study we aimed to identify whether self-management ability and healthcare service delivery factors were related to preventable conditions [urinary tract infections (UTIs), pressure ulcers] and healthcare utilization [emergency room (ER) visits, hospitalizations] specifically in a sample of young adults with myelomeningocele. Background Spina bifida is one of the most common congenital birth defects, affecting over 166 000 individuals living in the USA. Participants completed a questionnaire comprised of a self-report measure of healthcare services (Patient Assessment of Chronic Illness Care), recent healthcare utilization and preventable medical conditions. A structured clinical interview [Adolescent Self-Management and Independence Scale 2 (AMIS)] was administered to assess self-management. Multiple linear regression models were run to explore individual and combined effects of the AMIS, Patient Assessment of Chronic Illness Care, condition severity variables (shunted hydrocephalus, lesion level) and demographic factors in explaining variability in ER visits, hospitalizations, UTIs and pressure ulcers. Results Higher number of UTIs were associated with no history of shunting, lower educational levels, higher employment levels and lower AMIS scores (adjusted R2 = 0.774, P = 0.002). Higher number of ulcers was associated with higher motor level and higher educational level (adjusted R2 = 0.378, P = 0.017). Higher number of hospitalizations was associated with higher number of wounds and lower AMIS scores (adjusted R2 = 0.544, P = 0.012). A significant model for ER visits was not identified. Conclusions Initiatives aimed at improving self-management skills or providing support for skin and bladder care may be warranted for those with high levels of motor impairment or lower educational levels. Better detection of wounds may be seen in those with higher employment levels. Spina bifida is a complex condition, but one whose most prevalent concomitant secondary conditions may be preventable through simple measures that improve self-management and through health educational initiatives targeted to specific patient groups. [ABSTRACT FROM AUTHOR]

Objective: Given the paucity of information available regarding standardized ratings of depression symptoms in bipolar manic states, and in particular those in older adults, we explored depression ratings in symptomatic participants in a multicenter study of treatment of bipolar I disorder in late life.Methods: Baseline data was obtained from the first 100 patients enrolled in an NIMH-funded, 9-week, randomized, double-blind RCT comparing treatment with lithium or valproate in patients of age 60 years and older with Type I Bipolar mania or hypomania. This multi-site study was conducted at six academic medical centers in the United States and enrolled inpatients and outpatients with a total Young Mania Rating Scale (YMRS) score of 18 or greater. Depressive symptoms were evaluated with the Hamilton Depression Rating Scale (HAM-D) and the Montgomery-Asberg Depression Rating Scale (MADRS). The criterion for at least moderate bipolar depressive symptoms was the European College of Neuropsychopharmacology (ECNP) Consensus Meeting definition of HAM-D 17 total score >20.Results: Eleven percent of patients had mixed symptoms defined by depression scale severity according to ECNP criterion. In the overall sample, total scores on the two depression scales were highly correlated. Total YMRS scores of this mixed symptom group were similar to the remainder of the sample.Conclusions: These preliminary findings suggest that moderate to severe depressive symptoms occur in about one in ten bipolar manic elders. Future studies are needed to further evaluate symptom profiles, clinical correlates, and treatments for bipolar older adults with combined manic and depressive symptoms. [ABSTRACT FROM AUTHOR]

Overweight and obese people appear to be at greater risk of suboptimal vitamin and mineral status compared with people of a healthy weight. Nutrients most affected include vitamin D, vitamin B, carotenoids, folate, vitamin C and iron. The reasons are unknown but may be caused by poor diets, increased requirements or obesity-related changes to nutrient absorption, excretion or metabolism, or a combination of these. Sequestration of fat-soluble vitamins by adipose tissues is also a major factor. Although dietary assessment in obese populations is hampered by under-reporting, there is evidence that dietary patterns characterised by energy-dense, processed foods are more common in groups with a higher body mass index. Dieting practices, bariatric surgery and the use of anti-obesity drugs may compound the risk of nutrient inadequacy, although sustained weight loss helps to improve vitamin D status. A poor nutrient status could accentuate the risk of chronic diseases already experienced by overweight people on account of their excessive fat mass. There is evidence that the use of dietary supplements can improve nutrient status and have a favourable impact on disease risk markers such as lipid profiles and insulin resistance. Whether currently dieting or not, overweight people may benefit from safeguarding vitamin and mineral adequacy by taking a multi-nutrient supplement alongside an increased intake of nutrient-rich foods. [ABSTRACT FROM AUTHOR]

Objectives: The objective was to describe the emergency department (ED) resource burden of the spring 2009 H1N1 influenza pandemic at U.S. children's hospitals by quantifying observed-to-expected utilization. Methods: The authors performed an ecologic analysis for April through July 2009 using data from 23 EDs in the Pediatric Health Information System (PHIS), an administrative database of widely distributed U.S. children's hospitals. All ED visits during the study period were included, and data from the 5 prior years were used for establishing expected values. Primary outcome measures included observed-to-expected ratios for ED visits for all reasons and for influenza-related illness (IRI). [ABSTRACT FROM AUTHOR]

Objectives: Acute gastroenteritis is a very common emergency department (ED) diagnosis accounting for greater than 1.5 million outpatient visits and 200,000 hospitalizations annually among children in the United States. Although guidelines exist to assist clinicians, they do not clearly address topics for which evidence is new or limited, including the use of antiemetic agents, probiotics, and intravenous (IV) fluid rehydration regimens. This study sought to describe the ED treatments administered to children with acute gastroenteritis and to compare management between Canadian and U.S. physicians practicing pediatric emergency medicine (PEM). Methods: Members of PEM research networks located in Canada and the United States were invited to participate in a cross-sectional, Internet-based survey. Participants were included if they are attending physicians and provide care to patients < 18 years of age in an ED. Results: In total, 235 of 339 (73%) eligible individuals responded. A total of 103 of 136 Canadian physicians (76%) report initiating oral rehydration therapy (ORT) in children with moderate dehydration, compared with 44 of 94 (47%) of their U.S. colleagues (p < 0.001). The latter more often administer antiemetic agents to children with vomiting (67% vs. 45%; p = 0.001). American physicians administer larger IV fluid bolus volumes (p < 0.001) and over shorter time periods (p = 0.001) and repeat the fluid boluses more frequently (p < 0.001). Probiotics are routinely recommended by only 35 of 230 respondents (15%). Conclusions: The treatment of pediatric gastroenteritis varies by geographic location and differs significantly between Canadian and American PEM physicians. Oral rehydration continues to be underused, particularly in the United States. Probiotic use remains uncommon, while ondansetron administration has become routine. Children frequently receive IV rehydration, with the rate and volume administered being greater in the United States. [ABSTRACT FROM AUTHOR]

Background: Relatively few studies have examined gender differences in the effectiveness of specific behavioral or pharmacologic treatment of alcohol dependence. The aim of this study is to assess whether there were gender differences in treatment outcomes for specific behavioral and medication treatments singly or in combination by conducting a secondary analysis of public access data from the national, multisite NIAAA-sponsored COMBINE study. Methods: The COMBINE study investigated alcohol treatment among 8 groups of patients (378 women, 848 men) who received medical management (MM) with 16 weeks of placebo, naltrexone (100 mg/day), acamprosate (3 g/day), or their combination with or without a specialist-delivered combined behavioral intervention. We examined efficacy measures separately for men and women, followed by an overall analysis that included gender and its interaction with treatment condition in the analyses. These analyses were performed to confirm whether the findings reported in the parent trial were also relevant to women, and to more closely examine secondary outcome variables that were not analyzed previously for gender effects. Results: Compared to men, women reported a later age of onset of alcohol dependence by approximately 3 years, were significantly less likely to have had previous alcohol treatment, and drank fewer drinks per drinking day. Otherwise, there were no baseline gender differences in drinking measures. Outcome analyses of 2 primary (percent days abstinent and time to first heavy drinking day) and 2 secondary (good clinical response and percent heavy drinking days) drinking measures yielded the same overall pattern in each gender as that observed in the parent COMBINE study report. That is, only the naltrexone by behavioral intervention interaction reached or approached significance in women as well as in men. There was a naltrexone main effect that was significant in both men and women in reduction in alcohol craving scores with naltrexone-treated subjects reporting lower craving than placebo-treated subjects. Conclusions: This gender-focused analysis found that alcohol-dependent women responded to naltrexone with COMBINE's Medical Management, similar to the alcohol-dependent men, on a wide range of outcome measures. These results suggest that clinicians can feel comfortable prescribing naltrexone for alcohol dependence in both men and women. In this study, it is also notable that fewer women than men reported receiving any alcohol treatment prior to entry into the COMBINE study. Of note, women tend to go to primary health care more frequently than to specialty substance abuse programs for treatment, and so the benefit we confirm for women of the naltrexone and MM combination has practical implications for treating alcohol-dependent women. [ABSTRACT FROM AUTHOR]

Objectives: To describe maternal exposure to tobacco in the three months before conception and throughout pregnancy, examine risk factors associated with tobacco exposure in pregnancy and smoking cessation, assess use of pharmacotherapy for smoking cessation and evaluate birth outcomes by smoking status.Design: A cohort of women from a multi-site United States study were asked retrospectively about their exposure to tobacco.Population: The study population was comprised of 4,667 mothers of non-malformed control infants who participated in the National Birth Defects Prevention Study from 1997 to 2003.Methods: Using computer-assisted telephone interview responses from this population-based sample, we assessed patterns of maternal smoking and exposure to environmental tobacco smoke (ETS) as well as use of pharmacotherapy for quitting smoking during pregnancy.Results: Overall, 961 (20.6%) mothers reported any smoking and 1,401 (30.0%) reported any exposure to ETS at home or work during the three months before conception through pregnancy. Of the 961 smokers, 512 (53.3%) reportedly quit smoking before or during pregnancy, including 379 (74% of quitters) in the first trimester, and 420 (43.7%) continued to smoke throughout the pregnancy. Only 2.1% of smokers reportedly used pharmacotherapy to quit smoking anytime from three months before conception through pregnancy. Low birthweight and preterm delivery rates were lowest among offspring of non-smokers and highest in offspring of those who continued to smoke throughout pregnancy.Conclusions: About one-half of mothers who reported preconceptional smoking quit before or during pregnancy. Use of pharmacotherapy to quit smoking during pregnancy was not common. [ABSTRACT FROM AUTHOR]

The National Institute on Drug Abuse's Clinical Trials Network (CTN) aims to improve addiction treatment in the United States in part through technology transfer. Given the importance of clinicians in the technology transfer process, this research compares 561 CTN-affiliated and 1,745 non-CTN counselors' ratings of buprenorphine acceptability. CTN-affiliated counselors reported significantly greater acceptability than non-CTN counselors. This difference was not explained by controlling for counselor characteristics, but was completely attenuated by measures of buprenorphine-specific training and buprenorphine implementation. These data suggest that the CTN's impact on counselor attitudes may be attributed to the greater exposure to buprenorphine received by CTN-affiliated counselors. [ABSTRACT FROM AUTHOR]

Objective: To assess the impacts of the characteristics of quality improvement (QI) teams and their environments on team success in designing and implementing high quality, enduring depression care improvement programs in primary care (PC) practices.Study Setting/data Sources: Two nonprofit managed care organizations sponsored five QI teams tasked with improving care for depression in large PC practices. Data on characteristics of the teams and their environments is from observer process notes, national expert ratings, administrative data, and interviews.Study Design: Comparative formative evaluation of the quality and duration of implementation of the depression improvement programs developed by Central Teams (CTs) emphasizing expert design and Local Teams (LTs) emphasizing participatory local clinician design, and of the effects of additional team and environmental factors on each type of team. Both types of teams depended upon local clinicians for implementation.Principal Findings: The CT intervention program designs were more evidence-based than those of LTs. Expert team leadership, support from local practice management, and support from local mental health specialists strongly influenced the development of successful team programs. The CTs and LTs were equally successful when these conditions could be met, but CTs were more successful than LTs in less supportive environments.Conclusions: The LT approach to QI for depression requires high local support and expertise from primary care and mental health clinicians. The CT approach is more likely to succeed than the LT approach when local practice conditions are not optimal. [ABSTRACT FROM AUTHOR]

Background: Vitamin C has long been a candidate for modulating periodontal disease. Studies of scorbutic gingivitis and the effects of vitamin C on extracellular matrix and immunologic and inflammatory responses provide a rationale for hypothesizing that vitamin C is a risk factor for periodontal disease.Methods: We evaluated the role of dietary vitamin C as a contributing risk factor for periodontal disease utilizing the Third National Health and Nutrition Examination Survey (NHANES III) which is representative of the U.S. civilian, non-institutionalized population.Results: A sample of 12,419 adults (20 to 90+ years of age), with dental measurements and assessment of dietary information as well as demographic and medical histories were included in the studies. Dietary vitamin C was estimated by a 24-hour dietary record. Individuals with periodontal disease were arbitrarily defined as those who had mean clinical attachment levels of > or =1.5 mm. Using multiple logistic regression analysis, we found a relationship between reduced dietary vitamin C and increased risk for periodontal disease for the overall population (odds ratio [OR] = 1.19; 95% CI: 1.05 to 1.33). Current and former tobacco users who were taking less dietary vitamin C showed an increased risk of periodontal disease with OR of 1.28, 95% CI: 1.04 to 1.59 for former smokers, and an OR of 1.21, 95% CI: 1.02 to 1.43 for current tobacco users. There was a dose-response relationship between the levels of dietary vitamin C and periodontal disease with an OR of 1.30 for those taking 0 to 29 mg of vitamin C per day, to 1.16 for those taking 100 to 179 mg of vitamin C per day as compared to those taking 180 mg or more of vitamin C per day.Conclusion: Dietary intake of vitamin C showed a weak, but statistically significant, relationship to periodontal disease in current and former smokers as measured by clinical attachment. Those taking the lowest levels of vitamin C, and who also smoke, are likely to show the greatest clinical effect on the periodontal tissues. [ABSTRACT FROM AUTHOR]