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Predictive validity and gender differences in a biopsychosocial model of violence risk assessment in acute psychiatry.
Eriksen, BMS, Færden, A, Lockertsen, Ø, Bjørkly, S, Roaldset, JO
Psychiatry research. 2018;:270-280
Abstract
Current violence risk assessment methods seem to have reached an upper limit of accuracy. More comprehensive biopsychosocial models may improve on existing methods. Research on gender differences concerning risk factors of violence is scarce and inconclusive. In this prospective study from an acute psychiatric ward, all patients admitted from March 2012 to March 2013 were included. Predictive validity and potential gender differences in a biopsychosocial model of violence risk assessment consisting of a psychosocial checklist (Violence risk screening-10, V-RISK-10), a patient's self-report risk scale (SRS), total cholesterol (TC) and high-density lipoprotein cholesterol (HDL) were examined in an inpatient (N = 348) and a 3-months follow-up (N = 101) sample. Overall increases in explained variances and predictive values were small and non-significant compared to V-RISK-10 alone. In the inpatient sample, HDL contributed significantly to the model for men but not for women. In the follow-up sample, SRS contributed significantly for the whole sample. Results indicated that the biopsychosocial model we tested partially improved accuracy of violence risk assessments in acute psychiatry and that gender differences may exist.
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Impact of a Shared Decision Making Intervention on Health Care Utilization: A Secondary Analysis of the Chest Pain Choice Multicenter Randomized Trial.
Schaffer, JT, Hess, EP, Hollander, JE, Kline, JA, Torres, CA, Diercks, DB, Jones, R, Owen, KP, Meisel, ZF, Demers, M, et al
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2018;(3):293-300
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Abstract
BACKGROUND Patients at low risk for acute coronary syndrome are frequently admitted for observation and cardiac testing, resulting in substantial burden and cost to the patient and the health care system. OBJECTIVES The purpose of this investigation was to measure the effect of the Chest Pain Choice (CPC) decision aid on overall health care utilization as well as utilization of specific services both during the index emergency department (ED) visit and in the subsequent 45 days. METHODS This was a planned secondary analysis of data from a pragmatic multicenter randomized trial of shared decision making in adults presenting to the ED with chest pain who were being considered for observation unit admission for cardiac stress testing or coronary computed tomography angiography. The trial compared an intervention group engaged in shared decision making facilitated by the CPC decision aid to a control group receiving usual care. Hospital-level billing data were used to measure utilization for the index ED visit and during the following 45 days. Patients in both groups also were asked to keep a diary recording health care utilization over the same 45-day period. Outcomes assessed included length of time in the ED and observation, ED visits, office visits, hospitalizations, testing, imaging, and procedures. RESULTS Of the 898 patients included in the original trial, we were able to contact 834 (92.9%) patients for 45-day health care diary review. There was no difference in patient-reported health care utilization between the study arms. Hospital-level billing data were obtained for all 898 (100%) patients. During the initial ED visit the length of stay (LOS) was similar, and there was no difference in the frequency of observation unit admission between study arms. However, the mean observation unit LOS was 95 minutes (95% confidence interval [CI] = 40.8-149.8) shorter in the CPC arm and the mean number of tests was lower in the CPC arm (decrease in 19.4 imaging studies per 100 patients, 95% CI = 15.5-23.3). When evaluating the entire encounter and follow-up period, the intervention arm underwent fewer tests (decrease in 125.6 tests per 100 patients, 95% CI = 29.3-221.6). More specifically, there were fewer advanced cardiac imaging tests completed (25.8 fewer per 100 patients, 95% CI = 3.74-47.9) in the intervention arm. CONCLUSIONS Shared decision making in low-risk chest pain can lead to decreased diagnostic testing without worsening outcomes measured over 45 days.
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Treatment choices for the glycaemic management of patients with type 2 diabetes and chronic kidney disease: Analysis of the SAIL patient linked dataset.
Min, T, Davies, GI, Rice, S, Chess, J, Stephens, JW
Diabetes & metabolic syndrome. 2018;(2):123-127
Abstract
AIMS: Chronic kidney disease (CKD) is common in type 2 diabetes and limits the treatment choices for glycaemic control. Our aim was to examine real-world prescribing for managing hyperglycaemia in the presence of CKD. METHODS The SAIL (Secure Anonymised Information Linkage) databank was used to examine prescribing during the period from the 1st of January to 30th December 2014. CKD was defined as:- none or mild CKD, eGFR ≥60mL/min/1.73m2; moderate CKD eGFR <60mL/min/1.73m2; and severe CKD eGFR <30mL/min/1.73m2 or requiring dialysis. RESULTS We identified 9585 subjects who received any form of glucose lowering therapy (8363 had no/mild CKD; 1137 moderate CKD; 85 severe CKD). There was a linear association between insulin use and CKD severity with approximately 54% of those with severe CKD receiving insulin. Sulphonylureas use did not differ among the CKD groups and was approximately 40%. Metformin showed a linear decrease across the groups, however approximately 21% in the severe CKD group received metformin. The use of dipeptidyl peptidase 4 inhibitors (DPP-4i) was approximately 20% and did not differ among groups. The DPP-4 inhibitor choice was:- 1% vildagliptin, 9% saxagliptin, 58% sitagliptin, and 32% linaglitpin. With respect to sitagliptin and saxagliptin, 72% and 62% received an inappropriately high dose in the setting of CKD. CONCLUSIONS We observed that a considerable proportion of patients with type 2 diabetes and CKD were receiving metformin and non dose-adjusted DPP-4 inhibitors. Careful consideration of medication use and dosaging is required in the setting of CKD and type 2 diabetes.
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Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy-A Randomized, Double-blind, Placebo-controlled Clinical Trial.
Murtola, TJ, Syvälä, H, Tolonen, T, Helminen, M, Riikonen, J, Koskimäki, J, Pakarainen, T, Kaipia, A, Isotalo, T, Kujala, P, et al
European urology. 2018;(6):697-701
Abstract
We tested whether intervention with atorvastatin affects the prostate beneficially compared with placebo in men with prostate cancer in a randomized clinical trial. A total of 160 statin-naïve prostate cancer patients scheduled for radical prostatectomy were randomized to use 80mg atorvastatin or placebo daily from recruitment to surgery for a median of 27 d. Blinding was maintained throughout the trial. In total, 158 men completed the follow-up, with 96% compliance. Overall, atorvastatin did not significantly lower tumor proliferation index Ki-67 or serum prostate-specific antigen (PSA) compared with placebo. In subgroup analyses, after a minimum of 28 d of atorvastatin use, Ki-67 was 14.1% lower compared with placebo (p = 0.056). Among high-grade cases (International Society of Urological Pathology Gleason grade 3 or higher), atorvastatin lowered PSA compared with placebo: median change -0.6 ng/ml; p = 0.024. Intraprostatic inflammation did not differ between the study arms (p = 0.8). Despite a negative overall result showing no effect of statins on Ki67 or PSA overall, in post hoc exploratory analyses, there appeared to be benefit after a minimum duration of 28 d. Further studies are needed to verify this. PATIENT SUMMARY Cholesterol-lowering atorvastatin does not lower prostate cancer proliferation rate compared with placebo overall, but exploratory analyses suggest a benefit in longer exposure.
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Balanced Crystalloids versus Saline in Critically Ill Adults.
Semler, MW, Self, WH, Wanderer, JP, Ehrenfeld, JM, Wang, L, Byrne, DW, Stollings, JL, Kumar, AB, Hughes, CG, Hernandez, A, et al
The New England journal of medicine. 2018;(9):829-839
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BACKGROUND Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes. METHODS In a pragmatic, cluster-randomized, multiple-crossover trial conducted in five intensive care units at an academic center, we assigned 15,802 adults to receive saline (0.9% sodium chloride) or balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) according to the randomization of the unit to which they were admitted. The primary outcome was a major adverse kidney event within 30 days - a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) - all censored at hospital discharge or 30 days, whichever occurred first. RESULTS Among the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P=0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P=0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P=0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P=0.60). CONCLUSIONS Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction than the use of saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SMART-MED and SMART-SURG ClinicalTrials.gov numbers, NCT02444988 and NCT02547779 .).
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Long-term treatment with pegvisomant: observations from 2090 acromegaly patients in ACROSTUDY.
Buchfelder, M, van der Lely, AJ, Biller, BMK, Webb, SM, Brue, T, Strasburger, CJ, Ghigo, E, Camacho-Hubner, C, Pan, K, Lavenberg, J, et al
European journal of endocrinology. 2018;(6):419-427
Abstract
Objectives ACROSTUDY is an international, non-interventional study of acromegaly patients treated with pegvisomant (PEGV), a growth hormone receptor antagonist and has been conducted since 2004 in 15 countries to study the long-term safety and efficacy of PEGV. This report comprises the second interim analysis of 2090 patients as of May 12, 2016. Methods Descriptive analyses of safety, pituitary imaging and outcomes on PEGV treatment up to 12 years were performed. Results Prior to starting PEGV, 96% of patients had reported surgery, radiation, medical therapy or any combinations of those. At start of PEGV, 89% of patients had IGFI levels above the upper limit of normal (ULN). The percentage of patients with normal IGFI levels increased from 53% at year 1 to 73% at year 10, and the average daily dose of PEGV increased from 12.8 mg (year 1) to 18.9 mg (year 10). A total of 4832 adverse events (AEs) were reported in 1137 patients (54.4%), of which 570 were considered treatment related in 337 patients (16.1%). Serious AEs were reported in 22% of patients, of which 2.3% were considered treatment related. Locally reported MRIs showed most patients (72.2%) had no change in tumor size relative to the prior scan; 16.8% had a decrease, 6.8% an increase and 4.3% both. In patients with normal liver tests at PEGV start, an ALT or AST elevation of >3× ULN at any time point during their follow-up was reported in 3%. Conclusions This second interim analysis confirms that long-term use of PEGV is an effective and safe treatment in patients with acromegaly.
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Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).
Colin-Ramirez, E, Ezekowitz, JA, ,
American heart journal. 2018;:87-96
Abstract
BACKGROUND Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF. METHODS The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients. CONCLUSIONS The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.
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A bundled quality improvement program to standardize clinical blood pressure measurement in primary care.
Boonyasai, RT, Carson, KA, Marsteller, JA, Dietz, KB, Noronha, GJ, Hsu, YJ, Flynn, SJ, Charleston, JM, Prokopowicz, GP, Miller, ER, et al
Journal of clinical hypertension (Greenwich, Conn.). 2018;(2):324-333
Abstract
We evaluated use of a program to improve blood pressure measurement at 6 primary care clinics over a 6-month period. The program consisted of automated devices, clinical training, and support for systems change. Unannounced audits and electronic medical records provided evaluation data. Clinics used devices in 81.0% of encounters and used them as intended in 71.6% of encounters, but implementation fidelity varied. Intervention site systolic and diastolic blood pressure with terminal digit "0" decreased from 32.1% and 33.7% to 11.1% and 11.3%, respectively. Improvement occurred uniformly, regardless of sites' adherence to the measurement protocol. Providers rechecked blood pressure measurements less often post-intervention (from 23.5% to 8.1% of visits overall). Providers at sites with high protocol adherence were less likely to recheck measurements than those at low adherence sites. Comparison sites exhibited no change in terminal digit preference or repeat measurements. This study demonstrates that clinics can apply a pragmatic intervention to improve blood pressure measurement. Additional refinement may improve implementation fidelity.
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A Prospective, Open-Label Study Evaluating Adjunctive Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Psoriasis Patients With Inadequate Response to Biologic Therapy.
Bagel, J, Zapata, J, Nelson, E
Journal of drugs in dermatology : JDD. 2018;(8):845-850
Abstract
OBJECTIVE To assess the effectiveness and safety of combining calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam with biologic therapies for patients with plaque psoriasis who have not obtained an adequate response with biologic therapy. METHODS This was a prospective, open-label, single-arm study of patients with chronic plaque-type psoriasis (body surface area [BSA] ≤5%) who were being treated with biologic agents for ≥24 weeks. All patients received once-daily Cal/BD foam for 4 weeks, followed by twice-weekly use on consecutive days for 12 weeks (maintenance regimen). The end points were assessed at weeks 4 and 16, and included the Physician's Global Assessment (PGA), BSA, PGA×BSA, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM)-9. Safety evaluations included assessments of local skin reactions and adverse events (AEs). RESULTS Enrolled were 25 patients (18 men and 7 women; mean age, 53 ± 11 years). Patients had significant disease activity despite being on stable biologic therapy (median values: BSA, 3%; PGA, 3; PGA×BSA, 8). At weeks 4 and 16 versus baseline, adjunctive therapy with Cal/BD foam significantly improved PGA score (1 vs 1 vs 3; P less than .01), BSA involvement (1% vs 1% vs 3%; P less than .01), and PGA×BSA measure (1 vs 1 vs 8; P less than .01). Most patients achieved treat-to-target criteria for BSA ≤1% and PGA ≤1 at week 4 (both 76%) and week 16 (both 68%) versus 12% and 4%, respectively, at baseline. Quality of life was improved at both weeks 4 and 16, with high treatment satisfaction. Overall, adjunctive Cal/BD foam was safe and well-tolerated, with no serious AEs. CONCLUSIONS Adjunctive therapy with Cal/BD foam was associated with an improvement of every measure of disease activity in patients with inadequate response to biologics, an effect that was maintained throughout the study. The majority of patients achieved treat-to-target goals. J Drugs Dermatol. 2018;17(8):845-850.
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A pragmatic controlled trial to prevent childhood obesity within a risk group at maternity and child health-care clinics: results up to six years of age (the VACOPP study).
Mustila, T, Raitanen, J, Keskinen, P, Luoto, R
BMC pediatrics. 2018;(1):89
Abstract
BACKGROUND Obesity in childhood appears often during the toddler years. The prenatal environment influences obesity risk. Maternal gestational diabetes, the child's diet, and physical activity in the first few years have an important role in subsequent weight gain. A study was conducted to evaluate effectiveness of a primary health-care lifestyle counselling intervention in prevention of childhood obesity up to 6 years of age. METHODS The study was a controlled pragmatic trial to prevent childhood obesity and was implemented at maternity and child health-care clinics. The participants (n = 185) were mothers at risk of gestational diabetes mellitus with their offspring born between 2008 and 2010. The prenatal intervention, started at the end of the first trimester of pregnancy, consisted of counselling on diet and physical activity by municipal health-care staff. The intervention continued at yearly appointments with a public health-nurse at child health-care clinics. The paper reports the offspring weight gain results for 2-6 years of age. Weight gain up to 6 years of age was assessed as BMI standard deviation scores (SDS) via a mixed-effect linear regression model. The proportion of children at 6 years with overweight/obesity was assessed as weight-for-height percentage and ISO-BMI. Priority was not given to power calculations, because of the study's pragmatic nature. RESULTS One hundred forty seven children's (control n = 76/85% and intervention n = 71/56%) weight and height scores were available for analysis at 6 years of age. There was no significant difference in weight gain or overweight/obesity proportions between the groups at 6 years of age, but the proportion of children with obesity in both groups was high (assessed as ISO-BMI 9.9% and 11.8%) relative to prevalence in this age group in Finland. CONCLUSION As the authors previously reported, the intervention-group mothers had lower prevalence of gestational diabetes mellitus, but a decrease in obesity incidence before school age among their offspring was not found. The authors believe that an effective intervention should start before conception, continuing during pregnancy and the postpartum period through the developmentally unique child's first years. TRIAL REGISTRATION ClinicalTrials.gov NCT00970710 . Registered 1 September 2009. Retrospectively registered.