To determine whether CT-based cerebral small vessel disease (SVD) biomarkers are associated with 6-month functional outcome after intracerebral hemorrhage (ICH) and whether these biomarkers improve ...the performance of the preexisting ICH prediction score.
We included 864 patients with acute ICH from a multicenter, hospital-based prospective cohort study. We evaluated CT-based SVD biomarkers (white matter hypodensities WMH, lacunes, brain atrophy, and a composite SVD burden score) and their associations with poor 6-month functional outcome (modified Rankin Scale score >2). The area under the receiver operating characteristic curve (AUROC) and Hosmer-Lemeshow test were used to assess discrimination and calibration of the ICH score with and without SVD biomarkers.
In multivariable models (adjusted for ICH score components), WMH presence (odds ratio OR 1.52, 95% confidence interval CI 1.12-2.06), cortical atrophy presence (OR 1.80, 95% CI 1.19-2.73), deep atrophy presence (OR 1.66, 95% CI 1.17-2.34), and severe atrophy (either deep or cortical) (OR 1.94, 95% CI 1.36-2.74) were independently associated with poor functional outcome. For the revised ICH score, the AUROC was 0.71 (95% CI 0.68-0.74). Adding SVD markers did not significantly improve ICH score discrimination; for the best model (adding severe atrophy), the AUROC was 0.73 (95% CI 0.69-0.76). These results were confirmed when lobar and nonlobar ICH were considered separately.
The ICH score has acceptable discrimination for predicting 6-month functional outcome after ICH. CT biomarkers of SVD are associated with functional outcome, but adding them does not significantly improve ICH score discrimination.
ClinicalTrials.gov Identifier: NCT02513316.
Abstract Purpose We investigated whether clinicians’ explicit and implicit ethnic/racial bias is related to black and Latino patients’ perceptions of their care in established clinical relationships. ...Methods We administered a telephone survey to 2,908 patients, stratified by ethnicity/race, and randomly selected from the patient panels of 134 clinicians who had previously completed tests of explicit and implicit ethnic/racial bias. Patients completed the Primary Care Assessment Survey, which addressed their clinicians’ interpersonal treatment, communication, trust, and contextual knowledge. We created a composite measure of patient-centered care from the 4 subscales. Results Levels of explicit bias were low among clinicians and unrelated to patients’ perceptions. Levels of implicit bias varied among clinicians, and those with greater implicit bias were rated lower in patient-centered care by their black patients as compared with a reference group of white patients ( P = .04). Latino patients gave the clinicians lower ratings than did other groups ( P <.0001), and this did not depend on the clinicians’ implicit bias ( P = .98). Conclusions This is among the first studies to investigate clinicians’ implicit bias and communication processes in ongoing clinical relationships. Our findings suggest that clinicians’ implicit bias may jeopardize their clinical relationships with black patients, which could have negative effects on other care processes. As such, this finding supports the Institute of Medicine's suggestion that clinician bias may contribute to health disparities. Latinos’ overall greater concerns about their clinicians appear to be based on aspects of care other than clinician bias.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Abstract Background Allergic rhinitis affects 10 to 40% of the population. It reduces quality of life, school and work performance, and is a frequent reason for office visits in general practice. ...Medical costs are large but avoidable costs associated with lost work productivity are even larger than those incurred by asthma. New evidence has accumulated since the last revision of the Allergic Rhinitis and its Impact on Asthma – ARIA guidelines in 2010 prompting its update. Objective To provide a targeted update of the ARIA guidelines. Methods The ARIA guideline panel identified new clinical questions and selected questions requiring an update. We performed systematic reviews of health effects and the evidence about patient values and preferences, and resource requirements (up to June 2016). We followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence-to-decision frameworks to develop recommendations. Results The 2016 revision of the ARIA guidelines provides updated and new recommendations about the pharmacological treatment of allergic rhinitis. It specifically addresses the relative merits of using oral H1-antihistamines, intranasal H1-antihistamines, intranasal corticosteroids, and leukotriene receptor antagonists either alone or their combination. The ARIA guideline panel provides specific recommendations for the choice of treatment, the rationale for the choice, and discusses specific considerations that clinicians and patients may want to review in order to choose the management most appropriate for an individual patient. Conclusions Appropriate treatment of allergic rhinitis may improve patients’ quality of life, school and work productivity. ARIA recommendations support patients, their caregivers, and health care providers in choosing the optimal treatment.
Silent cerebral ischemia (SCI) has been reported in 14% of cases after catheter ablation of atrial fibrillation (AF) with radiofrequency (RF) energy and discontinuation of warfarin before AF ablation ...procedures.
The purpose of this study was to determine whether periprocedural anticoagulation management affects the incidence of SCI after RF ablation using an open irrigated catheter.
Consecutive patients undergoing RF ablation for AF without warfarin discontinuation and receiving heparin bolus before transseptal catheterization (group I, n = 146) were compared with a group of patients who had protocol deviation in terms of maintaining the therapeutic preprocedural international normalized ratio (patients with subtherapeutic INR) and/or failure to receive pretransseptal heparin bolus infusion and/or ≥2 consecutive ACT measurements <300 seconds (noncompliant population, group II, n = 134) and with a group of patients undergoing RF ablation with warfarin discontinuation bridged with low molecular weight heparin (group III, n = 148). All patients underwent preablation and postablation (within 48 hours) diffusion magnetic resonance imaging.
SCI was detected in 2% of patients (3/146) in group I, 7% (10/134) in group II, and 14% (21/148) in group III (P <.001). “Therapeutic INR” was strongly associated with a lower prevalence of postprocedural silent cerebral ischemia (SCI). Multivariable analysis demonstrated nonparoxysmal AF (odds ratio 3.8, 95% confidence interval 1.5–9.7, P = .005) and noncompliance to protocol (odds ratio 2.8, 95% confidence interval 1.5–5.1, P <.001 to be significant predictors of ischemic events.
Strict adherence to an anticoagulation protocol significantly reduces the prevalence of SCI after catheter ablation of AF with RF energy.
Background Uniforms are potential reservoirs for hospital organisms, potentially reinfecting the hands of health care workers (HCWs). The study aimed to determine the association between the ...bacterial contamination of HCWs' hands and uniforms (white coats and scrubs). Methods HCWs working in 5 intensive care units had cultures obtained from their hands and uniforms (white coats or scrubs). Pathogens were defined as any gram-negative bacilli, Staphylococcus aureus , and enterococci. Results Bacterial growth was detected on 103 hands (86%); 13 (11%) grew S aureus , 7 (6%) grew Acinetobacter spp, 2 (2%) grew enterococci, and 83 (70%) grew only skin flora. The presence of pathogens on the hands was associated with a greater likelihood of the presence of pathogens on white coats (κ = 0.81; P < .001), but not on scrubs (κ = 0.31; P = .036). Similarly, the presence of Acinetobacter on HCWs' hands was associated with a greater likelihood of Acinetobacter contamination of white coats (κ = 0.70; P < .001), but not of scrubs (κ = 0.36; P = .024). Conclusions Contamination of provider's hands with pathogens or Acinetobacter baumannii was associated with contamination of white coats. This association was not observed between hands and scrubs, however.
Background Moderate-to-severe allergic rhinitis (AR) is a challenge to treat, with many patients using multiple therapies and achieving limited symptom control. More effective therapies must be ...developed and tested in well-controlled, randomized, prospective studies with a direct comparison to current standards. Objectives The aim of these studies was to investigate the efficacy of MP29-02 (a novel formulation of azelastine and fluticasone propionate FP) in patients with moderate-to-severe seasonal allergic rhinitis (SAR) and to compare its efficacy with 2 first-line therapies (ie, intranasal azelastine and intranasal FP) in this population. Methods Three thousand three hundred ninety-eight patients (≥12 years old) with moderate-to-severe SAR were enrolled into 3 multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trials (MP4002 NCT00651118, MP4004 NCT00740792, and MP4006 NCT00883168). Each trial was conducted for 14 days during different allergy seasons. The primary efficacy variable was the sum of the morning and evening change from baseline in reflective total nasal symptom score (range, 0-24) over the treatment period. Outcomes for the meta-analysis included efficacy according to disease severity and time to response in relevant responder criteria. Results In the meta-analysis MP29-02 reduced the mean reflective total nasal symptom score from baseline (−5.7 SD, 5.3) more than FP (−5.1 SD, 4.9, P < .001), azelastine (−4.4 SD, 4.8, P < .001), or placebo (−3.0 SD, 4.2, P < .001). This benefit was observed from the first day of assessment, with improvement in each individual nasal symptom, even in the patients with the most severe disease. MP29-02 achieved response consistently days earlier and showed greater efficacy in patients with moderate-to-severe rhinitis than FP and azelastine. Conclusions MP29-02 represents a novel therapy that demonstrated superiority to 2 first-line therapies for AR. Patients with moderate-to-severe SAR achieved better control, and their symptoms were controlled earlier with MP29-02 than with recommended medications according to guidelines.
Abstract Background Quantitative assessment of postsurgical knee motion provides sensitive measurements, but results are technical and may not be meaningful to patients. Although several ...knee-specific instruments exist, no patient-reported outcome (PRO) measure correlates function with improved stability, motion, satisfaction, and confidence. Objective To address both the above limitations by developing a PRO measure to assess the phenomenon of a “normal” knee after primary total knee arthroplasty (TKA). Methods A draft conceptual model linking the impact of clinical mechanics to hypothesized functional outcomes was generated after a literature review of available assessment tools. Participants aged 18 to 80 years having undergone TKA within the past 10 to 18 months were identified and screened by clinical sites to participate in phase 1 focus groups or phase 2 in-depth interviews. Participants were asked to describe their TKA experiences, including how their knee feels now, followed by cognitive debriefing of Patient’s Knee Implant Performance (PKIP) draft items. Results Phase 1 results indicated that concepts of confidence, stability, and satisfaction in patients’ replacement knee when performing certain activities were distinct and important in the patients’ assessment of their TKA. Phase 2 efforts yielded a final version of the PKIP measure containing nine items assessing the broader concepts of stability, confidence, and satisfaction in association with activities. Presurgical and postsurgical versions of the measure were created. Conclusions Results of this qualitative study support use of the PKIP as a complementary PRO measure to assess performance after primary TKA. Psychometric evaluation of the PKIP is planned.
Topical hemostatic agents are used in conjunction with conventional procedures to reduce blood loss. They are often used in cardiothoracic surgery, which is particularly prone to bleeding risks. ...Variation in their use exists because detailed policy and practice guidelines reflecting the current medical evidence have not been developed to promote best surgical practice in this setting. To address this need, the Society for the Advancement of Blood Management convened an International Hemostatic Expert Panel. This article reviews the available literature and sets out evidence-based recommendations for the use of topical hemostatic agents in cardiothoracic surgery.
Abstract Background In the PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) trial that evaluated patients with nonvalvular ...atrial fibrillation (NVAF), left atrial appendage (LAA) occlusion was noninferior to warfarin for stroke prevention, but a periprocedural safety hazard was identified. Objectives The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy. Methods This randomized trial further assessed the efficacy and safety of the Watchman device. Patients with NVAF who had a CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes mellitus, and previous stroke/transient ischemic attack) score ≥2 or 1 and another risk factor were eligible. Patients were randomly assigned (in a 2:1 ratio) to undergo LAA occlusion and subsequent discontinuation of warfarin (intervention group, n = 269) or receive chronic warfarin therapy (control group, n = 138). Two efficacy and 1 safety coprimary endpoints were assessed. Results At 18 months, the rate of the first coprimary efficacy endpoint (composite of stroke, systemic embolism SE, and cardiovascular/unexplained death) was 0.064 in the device group versus 0.063 in the control group (rate ratio 1.07 95% credible interval (CrI): 0.57 to 1.89) and did not achieve the prespecified criteria noninferiority (upper boundary of 95% CrI ≥1.75). The rate for the second coprimary efficacy endpoint (stroke or SE >7 days’ postrandomization) was 0.0253 versus 0.0200 (risk difference 0.0053 95% CrI: –0.0190 to 0.0273), achieving noninferiority. Early safety events occurred in 2.2% of the Watchman arm, significantly lower than in PROTECT AF, satisfying the pre-specified safety performance goal. Using a broader, more inclusive definition of adverse effects, these still were lower in PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial than in PROTECT AF (4.2% vs. 8.7%; p = 0.004). Pericardial effusions requiring surgical repair decreased from 1.6% to 0.4% (p = 0.027), and those requiring pericardiocentesis decreased from 2.9% to 1.5% (p = 0.36), although the number of events was small. Conclusions In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE >7 days’ post-procedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety has significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy.
Abstract Objectives The aim of this study was to evaluate the incidence and clinical implications of leaks (acute incomplete occlusion, early and late reopenings) following LAA ligation with the ...LARIAT device. Background Percutaneous LAA ligation with the LARIAT device may represent an alternative for stroke prevention in high-risk patients with atrial fibrillation with contraindications to oral anticoagulation. Methods This was a retrospective, multicenter study of 98 consecutive patients undergoing successful LAA ligation with the LARIAT device. Leaks were defined as the presence of flow as evaluated by transesophageal echocardiography (TEE). TEE was performed during the procedure, at 6 and 12 months, and after thromboembolic events. Results Leaks were detected in 5 (5%), 14 (15%), and 19 (20%) patients at the 3 time points. During follow-up, 5 patients developed neurological events (4 strokes and 1 transient ischemic attack). Two occurred early (1 fatal stroke and 1 stroke with multiple recurrences in the following months), and TEE was not repeated after the events. The remaining 3 occurred late (after 6 months) and were associated with small leaks (<5 mm). In 2 of 3 cases, such a small leak was missed by the standard evaluation on 2-dimensional TEE, being evident only with the aid of 3-dimensional imaging. Conclusions Incomplete occlusion of the LAA after LARIAT ligation is relatively common and may be associated with thromboembolic events. Proper long-term surveillance with careful TEE should be considered to detect leaks, which can be managed with either resumption of oral anticoagulation or percutaneous transcatheter closure.
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