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Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair.
Paparella, D, Di Mauro, M, Bitton Worms, K, Bolotin, G, Russo, C, Trunfio, S, Scrofani, R, Antona, C, Actis Dato, G, Casabona, R, et al
The Journal of thoracic and cardiovascular surgery. 2016;(5):1302-8.e1
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Abstract
OBJECTIVE To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. METHODS Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). RESULTS No differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P = .50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P = .01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P = .02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. CONCLUSIONS Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial.
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Qualitative study of telemonitoring of blood glucose and blood pressure in type 2 diabetes.
Hanley, J, Fairbrother, P, McCloughan, L, Pagliari, C, Paterson, M, Pinnock, H, Sheikh, A, Wild, S, McKinstry, B
BMJ open. 2015;(12):e008896
Abstract
OBJECTIVES To explore the experiences of patients and professionals taking part in a randomised controlled trial (RCT) of blood glucose, blood pressure (BP) and weight telemonitoring in type 2 diabetes supported by primary care, and identify factors facilitating or hindering the effectiveness of the intervention and those likely to influence its potential translation to routine practice. DESIGN Qualitative study adopting an interpretive descriptive approach. PARTICIPANTS 23 patients, 6 nurses and 4 doctors who were participating in a RCT of blood glucose and BP telemonitoring. A maximum variation sample of patients from within the trial based on age, sex and deprivation status of the practice was sought. SETTING 12 primary care practices in Scotland and England. METHOD Data were collected via recorded semistructured interviews. Analysis was inductive with themes presented within an overarching thematic framework. Multiple strategies were employed to ensure that the analysis was credible and trustworthy. RESULTS Telemonitoring of blood glucose, BP and weight by people with type 2 diabetes was feasible. The data generated by telemonitoring supported self-care decisions and medical treatment decisions. Motivation to self-manage diet was increased by telemonitoring of blood glucose, and the 'benign policing' aspect of telemonitoring was considered by patients to be important. The convenience of home monitoring was very acceptable to patients although professionals had some concerns about telemonitoring increasing workload and costs. CONCLUSIONS Telemonitoring of blood glucose, BP and weight in primary care is a promising way of improving diabetes management which would be highly acceptable to the type of patients who volunteered for this study. TRIAL REGISTRATION NUMBER ISRCTN71674628; Pre-results.
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Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: protocol for a pilot randomised controlled trial.
Sewell, DA, Hammersley, VS, Devereux, G, Robertson, A, Stoddart, A, Weir, C, Worth, A, Sheikh, A
Trials. 2013;:173
Abstract
BACKGROUND Over recent decades there has been a substantial increase in asthma and allergic disease especially in children. Given the high prevalence, and the associated high disease burden and costs, there is a need to identify effective strategies for the primary prevention of asthma and allergy. A recent systematic review of the literature found strong supportive epidemiological evidence for a protective role of the Mediterranean diet, which now needs to be confirmed through formal experimental studies. This pilot trial in pregnant women aims to establish recruitment, retention and acceptability of a dietary intervention, and to assess the likely impact of the intervention on adherence to a Mediterranean diet during pregnancy. METHODS/DESIGN This study was a pilot, two-arm, randomised controlled trial in a sample population of pregnant women at high risk of having a child who will develop asthma or allergic disease. DISCUSSION The work ultimately aims to contribute to improving health outcomes through seeking to reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable in informing the subsequent planned large-scale, parallel group, randomised controlled trial.
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Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial.
Ryan, D, Price, D, Musgrave, SD, Malhotra, S, Lee, AJ, Ayansina, D, Sheikh, A, Tarassenko, L, Pagliari, C, Pinnock, H
BMJ (Clinical research ed.). 2012;:e1756
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OBJECTIVE To determine whether mobile phone based monitoring improves asthma control compared with standard paper based monitoring strategies. DESIGN Multicentre randomised controlled trial with cost effectiveness analysis. SETTING UK primary care. PARTICIPANTS 288 adolescents and adults with poorly controlled asthma (asthma control questionnaire (ACQ) score ≥ 1.5) from 32 practices. INTERVENTION Participants were centrally randomised to twice daily recording and mobile phone based transmission of symptoms, drug use, and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring. MAIN OUTCOME MEASURES Changes in scores on asthma control questionnaire and self efficacy (knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)) at six months after randomisation. Assessment of outcomes was blinded. Analysis was on an intention to treat basis. RESULTS There was no significant difference in the change in asthma control or self efficacy between the two groups (ACQ: mean change 0.75 in mobile group v 0.73 in paper group, mean difference in change -0.02 (95% confidence interval -0.23 to 0.19); KASE-AQ score: mean change -4.4 v -2.4, mean difference 2.0 (-0.3 to 4.2)). The numbers of patients who had acute exacerbations, steroid courses, and unscheduled consultations were similar in both groups, with similar healthcare costs. Overall, the mobile phone service was more expensive because of the expenses of telemonitoring. CONCLUSIONS Mobile technology does not improve asthma control or increase self efficacy compared with paper based monitoring when both groups received clinical care to guidelines standards. The mobile technology was not cost effective. TRIAL REGISTRATION Clinical Trials NCT00512837.
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Phase II efficacy and pharmacogenomic study of Selumetinib (AZD6244; ARRY-142886) in iodine-131 refractory papillary thyroid carcinoma with or without follicular elements.
Hayes, DN, Lucas, AS, Tanvetyanon, T, Krzyzanowska, MK, Chung, CH, Murphy, BA, Gilbert, J, Mehra, R, Moore, DT, Sheikh, A, et al
Clinical cancer research : an official journal of the American Association for Cancer Research. 2012;(7):2056-65
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PURPOSE A multicenter, open-label, phase II trial was conducted to evaluate the efficacy, safety, and tolerability of selumetinib in iodine-refractory papillary thyroid cancer (IRPTC). EXPERIMENTAL DESIGN Patients with advanced IRPTC with or without follicular elements and documented disease progression within the preceding 12 months were eligible to receive selumetinib at a dose of 100 mg twice daily. The primary endpoint was objective response rate using Response Evaluation Criteria in Solid Tumors. Secondary endpoints were safety, overall survival, and progression-free survival (PFS). Tumor genotype including mutations in BRAF, NRAS, and HRAS was assessed. RESULTS Best responses in 32 evaluable patients out of 39 enrolled were 1 partial response (3%), 21 stable disease (54%), and 11 progressive disease (28%). Disease stability maintenance occurred for 16 weeks in 49%, 24 weeks in 36%. Median PFS was 32 weeks. BRAF V600E mutants (12 of 26 evaluated, 46%) had a longer median PFS compared with patients with BRAF wild-type (WT) tumors (33 versus 11 weeks, respectively, HR = 0.6, not significant, P = 0.3). The most common adverse events and grades 3 to 4 toxicities included rash, fatigue, diarrhea, and peripheral edema. Two pulmonary deaths occurred in the study and were judged unlikely to be related to the study drug. CONCLUSIONS Selumetinib was well tolerated but the study was negative with regard to the primary outcome. Secondary analyses suggest that future studies of selumetinib and other mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK; MEK) inhibitors in IRPTC should consider BRAF V600E mutation status in the trial design based on differential trends in outcome.
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A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis.
Avery, AJ, Rodgers, S, Cantrill, JA, Armstrong, S, Cresswell, K, Eden, M, Elliott, RA, Howard, R, Kendrick, D, Morris, CJ, et al
Lancet (London, England). 2012;(9823):1310-9
Abstract
BACKGROUND Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention. METHODS In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to researchers and statisticians involved in processing and analysing the data. The allocation was not masked to general practices, pharmacists, patients, or researchers who visited practices to extract data. [corrected]. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; β blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299. FINDINGS 72 general practices with a combined list size of 480,942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38-0·89); a β blocker if they had asthma (0·73, 0·58-0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34-0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months. INTERPRETATION The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records. FUNDING Patient Safety Research Portfolio, Department of Health, England.