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1.

Background

Intracranial abscesses are rare and life-threatening conditions that typically originate from direct extension from nearby structures, hematogenous dissemination or following penetrating cerebral trauma or neurosurgery.

Findings

A 36-year-old male presented to our emergency department with complaints of left eye swelling, headache and drowsiness. On physical exam, the patient was febrile and his left upper eyelid was markedly swollen with fluctuance and drainage. Maxillofacial computed tomography was obtained to evaluate for orbital pathology but revealed bifrontal brain abscesses.

Conclusions

Brain abscesses should be considered in the differential diagnosis for patients who present with the classic triad of headache, fever and neurological deficit.
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2.

Objective

To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.

Design

Prospective randomized trial

Setting

Tertiary care university affiliated critical care unit.

Patients

All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.

Interventions

Patients were randomized to receive either enteral olanzapine or haloperidol.

Measurements

Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.

Main results

Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.

Conclusions

Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.
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3.

Introduction

Patients and care providers came up with the idea of an educational tool for patients with chronic pain

Methodology

The educational sessions were developed over a five-year period, with four meetings per year.

Results

“Kit KAD” answers the problems faced by patients in pain in everyday life. The “Kit KAD” offers tools and session leaders and can be used by any team trained in PTE (patient therapeutic education).

Conclusion

The “Kit KAD” group, assisted on methodology by the Eastern region UTEP (Transversal Patient therapeutic Education Unit), created an innovative educational tool for patients in chronic pain.
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4.

Aims

Create an educational program in chronic pain (EPCP).

Material and methods

We used a four-step process to create the EPCP tailored to patient’s needs.

Results

Five groups of patients can benefit from the program annually. Based on their own assessment, patients stated that their knowledge of chronic pain improved between 2.8 to 24%. The satisfaction with the EPCP was 8.67/10.

Conclusion

Our EPCP helps patients gain and maintain the skills they need to best manage their lives with a chronic pain.
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5.

Introduction

Antibiotics have traditionally been classified as bactericidal or bacteriostatic. Azithromycin belongs to the parent class of macrolides that are characteristically bacteriostatic. Some evidence suggests that this mol-ecule demonstrates bactericidal kill and has concentration-dependent effects. This study tests the hypothesis that azithromycin demonstrates a bactericidal, concentration-dependent antibiotic effect at concentrations corresponding to and exceeding published tear and conjunctival levels.

Methods

The antibacterial activity of different concentrations of azithromycin 1% in DuraSite® (AzaSite®; Inspire Pharmaceuticals Inc, Durham, NC, USA) was evaluated using a kinetics-of-kill model. Recent conjunctivitis isolates of Staphylococcus aureus, Streptococcus pneumoniae or Haemophilus influenzae were exposed to four concentrations of azithromycin (100, 250, 500 and 750 μg/ml). Starting concentrations were similar to the maximum concentrations (Cmax) that have been demonstrated in conjunctiva (83 μg/g) and tears (288 μg/ml) following topical ocular administration. The percentage of surviving bacteria at 30 and 60 minutes following exposure to each concentration were determined.

Results

Azithromycin failed to demonstrate bactericidal activity (i.e. a 3-log reduction in surviving bacteria) against S. aureus, S. pneumoniae or H. influenzae. Furthermore, the rate and extent of antibacterial activity with azithromycin did not change with higher concentrations, even at the highest tested concentration of 750 μg/ml.

Conclusion

Similar to the parent macrolide class, azithromycin demonstrates bacteriostatic activity against common conjunctival pathogens up to the maximum tested concentration of 750 μg/ml (i.e. 2.6-times and 9-times published Cmax tear and conjunctival concentration, respectively). Azithromycin’s bacteriostatic effects and prolonged elimination half-life will likely lead to a corresponding increase in the emergence of macrolide-resistant isolates.
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6.

Introduction

Ambulatory practices that actively partner with patients and families in quality improvement (QI) report benefits such as better patient/family interactions with physicians and staff, and patient empowerment. However, creating effective patient/family partnerships for ambulatory care improvement is not yet routine. The objective of this paper is to provide practices with concrete evidence about meaningfully involving patients and families in QI activities.

Methods

Review of literature published from 2000–2015 and a focus group conducted in 2014 with practice advisors.

Results

Thirty articles discussed 26 studies or examples of patient/family partnerships in ambulatory care QI. Patient and family partnership mechanisms included QI committees and advisory councils. Facilitators included process transparency, mechanisms for acting on patient/family input, and compensation. Challenges for practices included uncertainty about how best to involve patients and families in QI. Several studies found that patient/family partnership was a catalyst for improvement and reported that partnerships resulted in process improvements. Focus group results were concordant.

Conclusion

This paper describes emergent mechanisms and processes that ambulatory care practices use to partner with patients and families in QI including outcomes, facilitators, and challenges.

Funding

Gordon and Betty Moore Foundation.
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7.

Introduction

Blinatumomab is a bispecific T cell-engaging antibody construct indicated for adult patients with relapsed/refractory (R/R) Ph(?) B-precursor acute lymphoblastic leukemia (ALL), an aggressive disease with poor prognosis. A phase 2 single-arm clinical study showed that 43% of patients achieved CR/CRh within two cycles and approximately 20% of patients receiving blinatumomab were still alive after 2 years.

Methods

The objective of the current analysis was to estimate long-term survival of patients receiving blinatumomab beyond the observed time period in the clinical study using a large historical observational dataset. Conditional survival probabilities of blinatumomab-treated patients beyond month 60 were assumed to be the same as the US general population.

Results

At month 60, the estimated proportion of blinatumomab-treated patients alive was more than double that of historical patients (12.6% vs 5.4%). The mean overall survival was 76.1 months for blinatumomab patients and 39.8 months for historical patients. Sensitivity analyses including additional follow-up data from the clinical study showed consistent results.

Conclusions

These findings suggest that blinatumomab provides substantial overall survival benefit to patients with (R/R) Ph(?) B-precursor ALL compared with salvage chemotherapy.

Funding

Amgen.

Trial Registration

ClinicalTrials.gov identifier NCT01466179 and NCT02003612.
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8.

Objectives

1) to assess the prevalence of hepatitis C virus (HCV) infection in a population of acute psychiatric in-patients; 2) to find out relationships between HCV comorbidity and clinical features of psychiatric patients.

Methods

Prospective observational study in a 6-year period.

Results

2396 cases (1492 patients) were admitted in the considered period. Forty-two patients (2.8%) were affected by HCV infection. HCV infection was more frequent in patients with less years of education, lower social class, lower last year best Global Assessment of Functioning score, more hostile or violent behavior in hospital, with a lifetime history of previous suicide attempt, and with substance-related disorders.

Conclusion

HCV infection in psychiatric patients constitutes a major threat to the health of psychiatric patients and is related with unfavorable social background, worse global functioning, hostile or violent behavior, substance-related disorders. It appears also to be a significant risk of suicidal behavior.
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9.

Background

Resting state magnetic resonance imaging allows studying functionally interconnected brain networks. Here we were aimed to verify functional connectivity between brain networks at rest and its relationship with thalamic microstructure in migraine without aura (MO) patients between attacks.

Methods

Eighteen patients with untreated MO underwent 3 T MRI scans and were compared to a group of 19 healthy volunteers (HV). We used MRI to collect resting state data among two selected resting state networks, identified using group independent component (IC) analysis. Fractional anisotropy (FA) and mean diffusivity (MD) values of bilateral thalami were retrieved from a previous diffusion tensor imaging study on the same subjects and correlated with resting state ICs Z-scores.

Results

In comparison to HV, in MO we found significant reduced functional connectivity between the default mode network and the visuo-spatial system. Both HV and migraine patients selected ICs Z-scores correlated negatively with FA values of the thalamus bilaterally.

Conclusions

The present results are the first evidence supporting the hypothesis that an abnormal resting within networks connectivity associated with significant differences in baseline thalamic microstructure could contribute to interictal migraine pathophysiology.
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10.

Objective

To study the clinical effect of body mass index (BMI) in the optimal time of weaning from sequential invasive-noninvasive mechanical ventilation (MV) by treating severity chronic obstructive pulmonary disease (COPD) patients.

Methods

94 patients with severity COPD were divided into the control group (BMI<21) and the study group (BMI>21). These two groups were treated by similar symptomatic therapies such as mechanical ventilation, antibacterial, antispasmodic, relieving asthma, antitussive, expectorant, correction of electrolyte imbalance and acid-base balance disorders, strengthen nutritional support, etc.

Results

Compared with the control group, the study group had shorter duration of invasive mechanical ventilation, non-invasive mechanical ventilation time, total mechanical ventilation time, total hospital stay (P<0.01). There are significant differences between these two groups in re-intubation rate, VAP occurred in the number of case, hospital mortality rate in 28 days (P<0.05).

Conclusions

It is difficult to wean successfully from sequential mechanical ventilation for severity COPD patients (BMI<21), so BMI as one of important reference index can be used to estimate the optimal time for weaning from sequential mechanical ventilation for severity COPD patients.
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11.

Purpose

The aim of this study was to investigate the multidetector computed tomography (MDCT) features of strangulated ileus caused by epiploic appendix of the sigmoid colon.

Methods

We retrospectively evaluated MDCT images of four patients who underwent surgery in our hospital between 2011 and 2014. Patients were aged from 66 to 79 years, and two were female.

Results

Closed loop obstruction of the small bowel was confirmed in all patients. A fatty peritoneal band around the orifice of the ileus was detected in two patients, but was equivocal in the other two patients. Traction of the sigmoid colon toward the hilum of the closed loop of the small bowel was obvious in three patients.

Conclusion

When traction of the sigmoid colon is detected in MDCT in a case of closed loop obstruction of the small bowel, strangulated ileus caused by an epiploic appendix should be considered in the differential diagnosis.
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12.

Background

The study was performed to reveal the effect of an individualized personal outpatient therapy program, based on a multidisciplinary assessment, on pain and health-related quality of life in patients with chronic pain.

Methods

Fifty patients were prospectively evaluated before and 3 months after establishment of an individualized outpatient therapy program. Health-related quality of life, pain and pain-related disability, depression and motivation to adopt self-management of chronic pain were assessed. Therapy adherence was tested with a structured interview.

Results

Only marginal improvements were observed in terms of pain and health-related quality of life. Therapy adherence varied between the different therapies.

Conclusions

An individualized personal outpatient therapy program has only marginal effects on pain and health-related quality of life in patients with chronic pain.
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13.

Objective

To investigate the effect of enteral Synbiotic 2000 FORTE® (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically ill patients.

Design

Prospective, randomised, double blind, placebo controlled trial.

Setting

Tertiary referral centre, general Adult Intensive Care Unit (ICU).

Patients and participants

259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled.

Intervention

All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE® (twice a day) or a cellulose-based placebo for a maximum of 28 days.

Measurements and results

Treatment group (n = 130) was well matched with placebo group (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively.

Conclusions

Enteral administration of Synbiotic 2000 FORTE® has no statistically significant impact on the incidence of VAP in critically ill patients.
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14.

Background

Disseminated intravascular coagulation (DIC) is associated with high mortality in patients with sepsis. Several studies reporting that recombinant human soluble thrombomodulin (rhTM) reduced mortality in sepsis patients. This retrospective cohort study aimed to evaluate the efficacy of rhTM for patients with mild coagulopathy compared with those with severe coagulopathy.

Methods

We evaluated about 90-day mortality and SOFA score. SOFA score was also evaluated for the following components: respiratory, cardiovascular, hepatic, renal and coagulation.

Results

All 69 patients were diagnosed with sepsis, fulfilled Japanese Association for Acute Medicine criteria for DIC, and were treated with rhTM. Patients were assigned to either the mild coagulopathy group (did not fulfill the International Society on Thrombosis and Haemostasis overt DIC criteria) or the severe coagulopathy group (fulfilled overt DIC criteria). The 90-day mortality was significant lower in severe coagulopathy group than mild coagulopathy group (P?=?0.029). Although the SOFA scores did not decrease in the mild coagulopathy group, SOFA scores decreased significantly in the severe coagulopathy group. Furthermore the respiratory component of the SOFA score significant decreased in severe coagulopathy group compared with mild coagulopathy group.

Conclusions

rhTM administration may reduce mortality by improving organ dysfunction especially for respiratory in septic patients with severe coagulopathy.
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15.

Introduction

The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied in mainly Caucasian patients. The present interim analysis aimed to evaluate the 72-week safety of DMF in Japanese patients with RRMS.

Methods

Safety data of Japanese subjects enrolled in the 24-week randomised, double-blind, placebo-controlled APEX study (Part I) and its following open-label extension (Part II) were analysed at 72 weeks from the beginning of Part I. In Part I, subjects were randomised to DMF treatment or matching placebo while all subjects received DMF treatment during Part II. Adverse events (AEs) reported throughout the study period were recorded.

Results

Overall, 109 Japanese subjects completed 72 weeks of treatment. The incidence of AEs and serious AEs was 95% and 19%, respectively, in the DMF group compared with 84% and 18%, respectively, in the placebo group at 24 weeks. Common AEs (at least 5%) reported with treatment included nasopharyngitis, flushing, hot flush, gastrointestinal events, pruritus, rash, headache, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). AEs led to discontinuation of DMF in 5% of patients and included MS relapse, flushing, abdominal pain, liver disorder and increased ALT/AST. After an initial decrease from baseline of 17% in the DMF group at week 24, the mean lymphocyte counts stabilised and were maintained until week 72. No opportunistic/serious infections nor malignancies were reported with DMF treatment. The incidences of AEs, serious AEs, and discontinuation due to AEs were similar between the DMF and the placebo groups.

Conclusion

The 72-week safety profile of DMF in Japanese patients with RRMS was consistent with previous studies that enrolled mostly Caucasian patients, with a lower incidence of flushing and related symptoms and a lower reduction in the lymphocyte count compared with previous reports.

Trial Registration

ClinicalTrials.gov identifier NCT01838668.

Funding

Biogen Japan Ltd.
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16.

Background

The subjective state of health with respect to pain and psyche was surveyed utilizing validated pain questionnaires in patients undergoing special pain therapy and represents the basis for targeted treatment measures.

Objective

The purpose of this study was to investigate the possible distortion of answers due to social desirability of responses in chronic pain patients.

Material and methods

During two survey periods assessing patient satisfaction using both anonymized and personalized questionnaires, the effects arising from socially desirable response patterns were analyzed. The sample consisted of chronic pain patients being treated in an inpatient therapy setting.

Results

In both periods of observation no significant impact on the response behavior of chronic pain patients was found in personalized or anonymized questionnaires.

Conclusion

The results of the study suggest that the responses of chronic pain patients with respect to their subjective state of health are not influenced by social desirability. Thus, scoring systems such as the German pain questionnaire will not be influenced by social desirability in chronic pain patients and can therefore be used as a part of diagnostics and therapy planning.
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17.

Background

Self-directed and other violence as well as subsequent coercive interventions occur in a substantial proportion of patients with personality disorders during in-patient treatment. Different strategies may be required to reduce coercive interventions for patients of different diagnostic groups.

Methods

We specialised one of our acute admission wards in the treatment of personality disorders and adjustment disorders (ICD-10 F4 and F6). Patients are not transferred to other acute wards in case of suicidal or violent behaviour. Violent behaviour and coercive interventions such as seclusion or restraint were recorded in the same way as in the rest of the hospital. We recorded the percentage of subjects affected by diagnostic group and average length of an intervention in the year before and after the change in organisational structure.

Results

The total number of coercive interventions decreased by 85% both among patients with an F4 and those with an F6 primary diagnosis. Violent behaviours decreased by about 50%, the proportion of involuntary committed patients decreased by 70%.

Conclusion

The organisational change turned out to be highly effective without any additional cost of personnel or other resources.
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18.

Introduction

Systematic collection of patient-reported outcome measures (PROMs) during ambulatory clinic visits can enhance communication between patient and provider, and provide the ability to evaluate outcomes of care. Little is known about patient satisfaction of PROM data collection in routine clinical care. To evaluate patient reaction to the routine collection of PROMs in the ambulatory setting.

Methods

Before all ambulatory clinic visits at our neurological institute, patients electronically complete health status questionnaires. We administered an 8-question patient satisfaction survey to a sample of patients seen across the institute after their clinical visit.

Results

Of 343 patients approached, 323 agreed to participate. The majority responded that the questionnaire system was easy to use, was an appropriate length, and benefited their care overall (strongly agree or agree = 92.3%, 87.6%, and 77.3%, respectively). Provider review of the PROMs with the patient during the clinic visit was associated with significantly higher positive responses to all questions, even those regarding logistical aspects of the collection process. There were significant age and race differences in response to perceived benefit: those in the Black/other race category had a markedly lower probability of viewing the process favorably with increasing age.

Conclusions

Systematic collection of PROMs via an electronic questionnaire appears to be well accepted by patients. A minority of patients did not feel the questionnaire content applied to their appointment or that the system was a beneficial feature of the clinical practice. The provider can significantly improve the patient’s perception of PROM collection and the patient–physician encounter by reviewing the questionnaire results with the patient.
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19.

Introduction

Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients.

Methods

This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8.

Results

The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event.

Conclusion

This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG.

Funding

AbbVie Inc.
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20.

Background

Quetiapine causes less prolactin elevation and/or galactorrhoea than other atypical antipsychotics.

Case Presentation

Ms AB had galactorrhoea and raised prolactin levels at only 100 mg of quetiapine daily.

Conclusion

Low dose quetiapine can also cause galactorrhoea.
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