Real-World, Non-Interventional, Observational Study to Evaluate Effectiveness and Tolerability of Acotiamide Hydrochloride Hydrate in Treatment of Functional Dyspepsia

Abstract

Introduction

Functional dyspepsia (FD) is a highly prevalent condition which reduces patients' quality of life (QoL) and imparts a significant economic burden on the healthcare system. Acotiamide is a novel prokinetic agent useful in treatment of FD, and this study evaluated the effectiveness of acotiamide hydrochloride hydrate in management of FD over a 4-week period in a real-world setting.

Methods

This study was a prospective, observational, real-world data collection of 132 patients (85 male, 47 female) over 18 years of age diagnosed with FD as per Rome III criteria and treated with acotiamide for 4 weeks at a gastroenterology unit of a medical school in India. Those receiving prokinetics and cholinergic drugs, having any structural lesion on endoscopy, with coexisting irritable bowel syndrome and having heartburn in the past 12 weeks were excluded. Primary outcome was responders based on overall treatment efficacy (OTE) recorded on a seven-point Likert scale for postprandial distress syndrome (PDS; postprandial fullness, early satiety and upper abdominal bloating), epigastric pain syndrome (EPS; upper abdominal pain and upper abdominal discomfort) and associated symptoms (nausea, vomiting and excessive belching) at the end of 2 and 4 weeks. Secondary outcomes were elimination of symptoms of PDS, QoL assessed on the Short-Form Nepean Dyspepsia Index (SFNDI) questionnaire and clinical safety after 2 and 4 weeks.

Results

The responder rates with acotiamide at 2 and 4 weeks were 51.5% and 65.9%, respectively, for PDS. Similarly, the responder rates for EPS were 31.8% and 41.7%, respectively, at 2 weeks and 4 weeks. The responder rates for associated symptoms of nausea, vomiting and excessive belching were respectively 18.2%, 17.4% and 16.7% at 2 weeks and 18.2%, 17.4% and 18.2% at 4 weeks. Symptom elimination rates were 9.8% and 18.9% for postprandial fullness, 12.9% and 22.0% for early satiety, and 18.9% and 24.2% for abdominal bloating at 2 and 4 weeks, respectively. Significant improvement (p < 0.0001) in the SFNDI total scores from 25.91 (5.00) at 2 weeks to 23.76 (4.84) at 4 weeks were found at 4 weeks compared to 2 weeks. A total of 7 (5.30%) patients reported mild adverse events which were dizziness (4), headache (3) and nausea (1).

Conclusion

The current study demonstrates that treatment with acotiamide improves symptoms, QoL and is well tolerated in Indian patients with FD.

Trial Registration

Clinical Trial Registry of India, CTRI/2017/11/010421.

Funding

Dr. Reddy's Laboratories, India.

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The sweet disease [Humanities]

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If Canada needs more doctors, why hasnt medical school enrolment increased? [News]

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What are the long-term effects of smoked marijuana on lung health? [Commentary]

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A patient with polytrauma, hypothermia and cardiac arrest after delayed mountain rescue [Letters]

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Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial [Research]

BACKGROUND:

Parents have reported that they want to learn how to reduce pain in infants during vaccinations. Our objective was to compare different levels of intensity of postnatal education about pain mitigation on parental self-reported use of interventions at future infant vaccinations.

METHODS:

We conducted a longitudinal, 3-group parallel, add-on, randomized controlled trial on the postnatal ward of a hospital. New mothers, unaware of the hypothesis, were randomly assigned to 1 of 3 intervention groups and 3 follow-up groups (i.e., 9 groups, 3 x 3). The 3 intervention groups were control (general immunization information), pain pamphlet (pain mitigation information), and pain pamphlet and pain video (pain mitigation information). Both pain mitigation education groups also received general immunization information. The 3 follow-up groups were 2-, 4- and 6-month infant vaccinations. Mothers reported use of breastfeeding, sucrose and topical anesthetics during infant vaccinations in a telephone survey.

RESULTS:

Of 3420 participants, follow-up was available for 2549 (75%): 36.1%, 34.2% and 29.7% reported on pain mitigation practices at 2-, 4- and 6-month vaccinations, respectively (p = 0.9). Maternal characteristics did not differ (p > 0.05): mean age, 33.6 years; 58% were primipara. Utilization of any intervention (breastfeeding, sucrose or topical anesthetics) was 53.2%, 61.4% and 63.0% for control, pain pamphlet, and pain pamphlet and pain video groups, respectively (p < 0.001); both pain education groups had higher utilization than the control group, but did not differ from one another. Uptake differed among intervention groups at 2 and 4 months but not at 6 months.

INTERPRETATION:

Hospital-based postnatal education increased parental use of pain interventions at infant vaccinations and can be added to existing education.

Trial registration:

ClinicalTrials.gov, no. NCT01937143.

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How should we act on the social determinants of health? [Commentary]

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Managing HIV infection in patients older than 50 years [Review]

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Symptom of cultural narcissism [Letters]

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Diagnosing ovarian cancer [Practice]

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Doctors call for change in union tactics in health care strikes [News]

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Progressive multifocal leukoencephalopathy unmasked by antiretroviral therapy for HIV [Practice]

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Acute care model of addiction treatment not enough for substance abuse [News]

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PACAP deficiency as a model of aging

Abstract

Dysregulation of neuropeptides may play an important role in aging-induced impairments. In the long list of neuropeptides, pituitary adenylate cyclase–activating polypeptide (PACAP) represents a highly effective cytoprotective peptide that provides an endogenous control against a variety of tissue-damaging stimuli. PACAP has neuro- and general cytoprotective effects due to anti-apoptotic, anti-inflammatory, and antioxidant actions. As PACAP is also a part of the endogenous protective machinery, it can be hypothesized that the decreased protective effects in lack of endogenous PACAP would accelerate age-related degeneration and PACAP knockout mice would display age-related degenerative signs earlier. Recent results support this hypothesis showing that PACAP deficiency mimics aspects of age-related pathophysiological changes including increased neuronal vulnerability and systemic degeneration accompanied by increased apoptosis, oxidative stress, and inflammation. Decrease in PACAP expression has been shown in different species from invertebrates to humans. PACAP-deficient mice display numerous pathological alterations mimicking early aging, such as retinal changes, corneal keratinization and blurring, and systemic amyloidosis. In the present review, we summarize these findings and propose that PACAP deficiency could be a good model of premature aging.

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Breast Implant-Associated Anaplastic Large Cell Lymphoma

Abstract

Purpose of Review

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a recently recognised malignancy of T lymphocytes exclusively associated with textured breast implants. This review aims to evaluate existing theories regarding the epidemiology, pathogenesis, clinical evaluation and management of the disease.

Recent Findings

The true incidence of BIA-ALCL is difficult to define. Prevailing pathogenic theories recognise the interplay between textured implants, Gram-negative bacteria, host genetics (e.g. JAK/STAT, p53) and time. Patients typically present with a delayed seroma and less commonly with a capsular mass or systemic disease at an average of 8–10 years after implantation. BIA-ALCL staging has evolved from a "liquid tumour" model to a "solid tumour" classification. For localised disease, surgery involving complete capsulectomy and implant removal is the cornerstone of treatment. For more advanced disease, treatment includes surgery followed by chemotherapy (combination anthracycline-based), radiotherapy and the antibody drug conjugate (brentuximab vedotin).

Summary

The interplay between the Gram-negative biofilm, implant texturing, genetic mutations and time has been implicated in pathogenesis of BIA-ALCL. The identification of a putative infectious cause is not unique to lymphomagenesis. Future research, investigating BIA-ALCL genetic mutations and immunological modulation with Gram-negative biofilm in BIA-ALCL models is warranted.

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Pirfenidone for Treating Idiopathic Pulmonary Fibrosis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Abstract

The National Institute for Health and Care Excellence (NICE) published guidance on the use of pirfenidone (Esbriet^®, Roche) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in 2013. NICE decided to review existing guidance following publication of an additional clinical trial, and invited the manufacturer of pirfenidone to submit evidence of its clinical and cost effectiveness for the treatment of mild to moderate IPF when compared with best supportive care (BSC) or nintedanib; nintedanib was a comparator only for moderate IPF. An independent Evidence Review Group (ERG) critiqued the company submission and this paper summarises their report and subsequent NICE guidance. The key clinical effectiveness evidence was based on three randomised controlled trials (RCTs) and an open-label extension study. Supportive data were provided from two additional RCTs conducted in Japan, while one additional open-label study was included for safety outcomes. Meta-analysis of the three key RCTs found pirfenidone to be effective at reducing disease progression compared with placebo, but statistically significant differences were not identified in all of the RCTs. A statistically significant reduction in all-cause mortality was only demonstrated when pooling data across studies. The treatment effects of pirfenidone and nintedanib were broadly similar, based on an indirect comparison using network meta-analysis, although they have slightly different adverse event profiles. There remains considerable uncertainty in the cost-effectiveness estimates for pirfenidone versus BSC, particularly due to uncertainty regarding the duration of treatment effect and the method used to implement the stopping rule within the economic model.

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Cognitive Deficits in Multiple Sclerosis: Recent Advances in Treatment and Neurorehabilitation

Abstract

Purpose of review

This article highlights recent progress in research on treatment and neurorehabilitation of cognitive impairment in multiple sclerosis (MS) including pharmacological interventions, physical exercise, and neuropsychological rehabilitation, both in conventional and technology-assisted settings.

Recent findings

The most consistent evidence in terms of improvement or preservation of circumscribed cognitive scores in MS patients comes from moderately sampled randomized clinical trials on multimodal approaches that combine conventional or computerized neuropsychological training with psychoeducation or cognitive behavioral therapy. Disease-modifying treatments also appear to have beneficial effects in preventing or attenuating cognitive decline, whereas there is little evidence for agents such as donepezil or stimulants. Finally, physical exercise may yield some cognitive improvement in MS patients.

Summary

Despite substantial and often promising research efforts, there is a lack of validated and widely accepted clinical procedures for cognitive neurorehabilitation in MS. Development of such approaches will require collaborative efforts towards the design of interventions that are fundamentally inspired by cognitive neuroscience, potentially guided by neuroimaging, and composed of conventional neuropsychological training and cognitive behavioral therapy as well as physical exercise and therapeutic video games. Subsequently, large-scale validation will be needed with meaningful outcome measures reflecting transfer to everyday cognitive function and maintenance of training effects.

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Lessons from the SWITCH trial: changing glucocorticoids in the management of metastatic castration-resistant prostate cancer (mCRPC)

Lessons from the SWITCH trial: changing glucocorticoids in the management of metastatic castration-resistant prostate cancer (mCRPC)

Lessons from the SWITCH trial: changing glucocorticoids in the management of metastatic castration-resistant prostate cancer (mCRPC), Published online: 22 October 2018; doi:10.1038/s41416-018-0239-y

Lessons from the SWITCH trial: changing glucocorticoids in the management of metastatic castration-resistant prostate cancer (mCRPC)

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Human papillomavirus type 16 genomic variation in women with subsequent in situ or invasive cervical cancer: prospective population-based study

Human papillomavirus type 16 genomic variation in women with subsequent in situ or invasive cervical cancer: prospective population-based study

Human papillomavirus type 16 genomic variation in women with subsequent in situ or invasive cervical cancer: prospective population-based study, Published online: 22 October 2018; doi:10.1038/s41416-018-0311-7

Human papillomavirus type 16 genomic variation in women with subsequent in situ or invasive cervical cancer: prospective population-based study

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Assessment of Pain Management, Acceptance of Illness, and Adjustment to Life with Cancer in Patients with Nonmuscle Invasive Bladder Cancer

Purpose. According to the European Association of Urology bladder cancer is the seventh most commonly diagnosed malignancy in the world's male population. Despite its high incidence, papers evaluating psychological state in those patients' group are lacking. The purpose of the study was to evaluate pain management, disease acceptance, and adjustment to cancer in homogenous group of patients diagnosed with nonmuscle-invasive bladder cancer (NMIBC). Methods. Group of 252 male patients who were scheduled for NMIBC treatment were prospectively evaluated. Patients fulfilled Acceptance of Illness Scale (AIS), Mini-Mental Adjustment to Cancer (Mini-MAC) and Coping Strategies (CSQ) questionnaires before treatment introduction. Results. Highest CSQ score was achieved by the coping self-statements subscale (mean=18,37). The catastrophizing subscale score was the lowest (mean=11,24). Place of residence affected results of CSQ statement about pain control. Catastrophizing and coping self-statements strategies were associated with matrimonial status. In the Mini-MAC questionnaire the fighting spirit way of coping had the highest (21,73) and the helplessness-hopelessness subscale had the lowest mean value (13,3). Matrimonial status was strongly associated with anxious preoccupation, fighting spirit, and helplessness – hopelessness way of coping. The mean AIS test score was 28.8. AIS result was influenced by patient's marital status, yet not by education, place of residence, nor any clinical factor. Conclusions. In the examined group, the level of acceptance of the disease reached values that were slightly higher than the average. It indicated a fairly good adaptation to cancer. Among the methods of coping with cancer, the constructive style is definitely dominant with a high intensity of the fighting spirit strategy. The destructive style of cancer coping reached low values with a low intensity of helplessness/hopelessness strategy. From pain coping strategies, self-statements and praying/hoping were the most commonly chosen ways, whereas catastrophizing was the rarest. Many associations between various questioners' results were also observed.

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Complementary Role of the Computed Biomodelling through Finite Element Analysis and Computed Tomography for Diagnosis of Transcatheter Heart Valve Thrombosis

Introduction. The TAVR procedure is associated with a substantial risk of thrombosis. Current guidelines recommend catheter-based aortic valve implantation for prohibitive-high-risk patients with severe aortic valve stenosis but acknowledge that the aetiology and mechanism of thrombosis are unclear. Methods. From 2015 to 2018, 607 patients with severe aortic valve stenosis underwent either self-expandable or balloon-expandable catheter-based aortic valve implantation at our institute. A complementary study was designed to support computed tomography as a predictor of complications using an advanced biomodelling process through finite element analysis (FEA). The primary evaluation of study was the thrombosis of the valve at 12 months. Results. At 12 months, 546 patients had normal valvular function. 61 patients had THVT while 6 showed thrombosis and dislodgement with deterioration to NYHA Class IV requiring rehospitalization. The FEA biomodelling revealed a strong link between solid uncrushed calcifications, delayed dislodgement of TAVR and late thrombosis. We observed an interesting phenomenon of fibrosis/calcification originating at the level of the misplaced valve, which was the primary cause of coronary obstruction. Conclusion. The use of cardiac CT and predictive biomodelling should be integrated into routine practice for the selection of TAVR candidates and as a predictor of negative outcomes given the lack of accurate investigations available. This would assist in effective decision-making and diagnosis especially in a high-risk cohort of patients.

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Prognostic Value of Frailty for Older Patients with Heart Failure: A Systematic Review and Meta-Analysis of Prospective Studies

Objective. Numerous studies have investigated the prognostic role of frailty in elderly patients with heart failure (HF), but the limited size of the reported studies has resulted in continued uncertainty regarding its prognostic impact. The aim of this study was to integrate the findings of all available studies and estimate the impact of frailty on the prognosis of HF by performing a systematic review and meta-analysis. Methods. PubMed, Embase, Cochrane, and Web of Science databases were searched from inception to November 2017 to identify eligible prospective studies. The Newcastle-Ottawa Scale (NOS) was used to evaluate study quality. The association between frailty and HF outcomes was reviewed. Overall hazard ratios (HRs) for the effects of frailty on all-cause mortality were pooled using a fixed-effect model and publication bias was evaluated using funnel plots. Results. A total of 10 studies involving 3033 elderly patients with HF were included in the systematic review and meta-analysis. All eligible studies indicated that frailty was of prognostic significance for HF patients. The HRs for the effects of frailty on all-cause mortality were 1.70 (95% confidence interval (CI): 1.41–2.04), based on the pooling of six studies that provided related data. However, publication bias was observed among the studies. Conclusions. Frailty has a high prevalence among older patients with HF. Elderly HF patients with frailty have a poorer prognosis than those without frailty. Further studies are now required to implement the use of frailty assessment tools and explore effective interventions for frailty in older HF patients.

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Travel beyond Clinical Uses of Fiber Reinforced Composites (FRCs) in Dentistry: A Review of Past Employments, Present Applications, and Future Perspectives

The reinforcement of resins with short or long fibers has multiple applications in various engineering and biomedical fields. The use of fiber reinforced composites (FRCs) in dentistry has been described in the literature from more than 40 years. In vitro studies evaluated mechanical properties such as flexural strength, fatigue resistance, fracture strength, layer thickness, bacterial adhesion, bonding characteristics with long fibers, woven fibers, and FRC posts. Also, multiple clinical applications such as replacement of missing teeth by resin-bonded adhesive fixed dental prostheses of various kinds, reinforcement elements of dentures or pontics, and direct construction of posts and cores have been investigated. In orthodontics, FRCs have been used also for active and passive orthodontic applications, such as anchorage units, en-masse movement units, and postorthodontic tooth retention. FRCs have been extensively tested in the literature, but today the advances in new technologies involving the introduction of nanofillers or new fibers along with understanding the design principles of FRC devices open new fields of research for these materials both in vitro and in vivo. The present review describes past and present applications of FRCs and introduces some future perspectives on the use of these materials.

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Acupoint Therapy on Diabetes Mellitus and Its Common Chronic Complications: A Review of Its Mechanisms

Acupoint therapy is one of the therapeutic means in Traditional Chinese Medicine (TCM) concerning acupoints and meridians, including manual acupuncture, electroacupuncture, moxibustion, external application, acupoint injection, and catgut embedding. In the treatment of diabetes and its common chronic complications, acupoint therapy has proved to have specific curative effect and notable advantages. Single or combined with western medicine, it has superior efficacy and less side effects than western medicine alone. Studying its mechanism can provide experimental basis for clinical treatment. Relevant researches in the recent 5 years mainly focused on the mechanism of electroacupuncture, point injection, catgut embedding, etc. in the treatment of diabetes and common diabetic complications such as neuropathy, nephropathy, and hepatopathy. The possible theories involve the regulation of nerve conduction, signal pathways, hormone level, protein expression, oxidative stress level, structure restoration, etc. The most studied acupoints are Zusanli (ST36), Shenshu (BL23), Sanyinjiao (SP6), Yishu (EX-B3), and Zhongwan (CV12). However, most of the studies have been based on diabetes model rats rather than clinical trials. Moreover, the mechanism of acupoint therapy treating other chronic complications like diabetic retinopathy and that of other effective methods like pressing ear with beans, auricular points plaster therapy, and external application remain unclear. Therefore, this aspect still awaits further research.

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N-Acetylcysteine for the Treatment of Psychiatric Disorders: A Review of Current Evidence

N-acetylcysteine, a sulphur-containing amino acid for the treatment of paracetamol overdose and chronic obstructive pulmonary disease, is a widely available off-the-shelf oral antioxidant supplement in many countries. With the potential to modulate several neurological pathways, including glutamate dysregulation, oxidative stress, and inflammation that can be beneficial to the brain functions, N-acetylcysteine is being explored as an adjunctive therapy for many psychiatric conditions. This narrative review synthesises and presents the current evidence from systematic reviews, meta-analyses, and latest clinical trials on N-acetylcysteine for addiction and substance abuse, schizophrenia, obsessive-compulsive and related disorders, and mood disorders. Good evidence exists to support the use of N-acetylcysteine as an adjunct treatment to reduce the total and negative symptoms of schizophrenia. N-acetylcysteine also appears to be effective in reducing craving in substance use disorders, especially for the treatment of cocaine and cannabis use among young people, in addition to preventing relapse in already abstinent individuals. Effects of N-acetylcysteine on obsessive-compulsive and related disorders, as well as on mood disorders, remain unclear with mixed reviews, even though promising evidence does exist. Larger and better-designed studies are required to further investigate the clinical effectiveness of N-acetylcysteine in these areas. Oral N-acetylcysteine is safe and well tolerated without any considerable adverse effects. Current evidence supports its use as an adjunctive therapy clinically for psychiatric conditions, administered concomitantly with existing medications, with a recommended dosage between 2000 and 2400 mg/day.

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Bacterial Extracellular DNA Production Is Associated with Outcome of Prosthetic Joint Infections

In a retrospective study the association of the production of extracellular DNA (eDNA) in biofilms of clinical staphylococcal isolates from 60 patients with prosthetic joint infection (PJI) and the clinical outcome were investigated. Data from a previous study on eDNA production determined in 24-hour biofilms of staphylococcal isolates (Staphylococcus aureus n=30, Staphylococcus epidermidis n=30) was correlated with the patients' clinical outcome after 3 and 12 months. Statistical analysis was performed using either the Spearman's rank correlations test or the t-test. eDNA production of S. epidermidis in 24-hour biofilms correlated with the patients' outcome 'not cured' after 12 months. For S. aureus no such correlation was detected. Thus, eDNA may be a virulence factor of S. epidermidis. Quantification of eDNA production as a surrogate marker for biofilm formation might be a potential predictive marker for the management of PJI.

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The Influence of Pin Deviation on the Fracture Correction and the Fixator Adjustment with Sensitivity and Kinematic Analysis

Fracture correction is important orthopedics operation and can be performed by unilateral external fixator. Due to pin deviations being inevitable during the operation, searching the impacts of pin deviation on the fracture correction and fixator joint adjustment are important. This study puts forward evaluation index with sensitivity analysis for investigating the impact of three orientation deviations and three position deviations on fracture correction. Meanwhile, based on a clinical case from a 28-year-old female, the influence of pin deviation on the adjustment of fixator joints was analyzed by inverse kinematic method. Different pin deviations have different sensitivity; the sensitivity of orientation deviation is relatively larger than position deviation. The existence of pin deviation will result in the change of the adjustment value of fixator joints. In addition, the experiments of seven situations were established to verify the analytical results. This study revealed the sensitivity of different pin deviations which can also be used to predict the adjustment value of fixator joints and the accuracy of fracture correction. This research also helps to reduce operation time and decrease damage to soft tissue by reducing the frequency of inserting pins.

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Antiviral resistance of stem cells

Xianfang Wu | Andrew C Kwong | Charles M Rice

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Human papillomavirus type 16 genomic variation in women with subsequent in situ or invasive cervical cancer: prospective population-based study

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Lessons from the SWITCH trial: changing glucocorticoids in the management of metastatic castration-resistant prostate cancer (mCRPC)

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Transdermal Measurement of Glomerular Filtration Rate in Mice

Here we describe a protocol to measure glomerular filtration rate (GFR) in conscious, freely moving mice using a transdermal GFR monitor.

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Gene Expression Analysis of Endothelial Cells Exposed to Shear Stress Using Multiple Parallel-plate Flow Chambers

Here, a workflow for the culture and gene expression analysis of endothelial cells under fluid shear stress is presented. Included is a physical arrangement for simultaneously housing and monitoring multiple flow chambers in a controlled environment and the use of an exogenous reference RNA for quantitative PCR.

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Pore-scale Imaging and Characterization of Hydrocarbon Reservoir Rock Wettability at Subsurface Conditions Using X-ray Microtomography

This protocol is presented to characterize the complex wetting conditions of an opaque porous medium (hydrocarbon reservoir rock) using three-dimensional images obtained by X-ray microtomography at subsurface conditions.

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Contrast-Matching Detergent in Small-Angle Neutron Scattering Experiments for Membrane Protein Structural Analysis and Ab Initio Modeling

This protocol demonstrates how to obtain a low-resolution ab initio model and structural details of a detergent-solubilized membrane protein in solution using small-angle neutron scattering with contrast-matching of the detergent.

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A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Prophylactic Effect of Traditional Chinese Medicine Supplementing Qi and Hemostasis Formula on Gastrointestinal Bleeding after Percutaneous Coronary Intervention in Patients at High Risks

Objective. To evaluate the clinical efficacy of traditional Chinese medicine (TCM) supplementing Qi and hemostasis formula on gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) and thus find out the optimal therapeutic regimen to reduce incidence of GI bleeding without increase of major adverse cardiovascular events (MACEs). Methods. In the randomized, double-blinded, controlled trial, 117 participants who underwent PCI were enrolled and evenly distributed into treatment arm (59) and control arm (58). Numerous end points were assessed including the primary endpoint of GI bleeding and MACEs and secondary endpoint of thromboelastogram (TEG) (mainly MAadp, inhibition of ADP, and inhibition of AA) and TCM syndrome score during the follow-up phase of 90 days. Results. Incidence of bleeding including GI bleeding and MACE did not differ significantly between two arms (28.82% in treatment arm versus 24.44% in control). However, on both days 30 and 90, TCM treatment remarkably reduced the TCM syndrome total score with notable alteration (P

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The Evaluation of the Relationship between sTREM-1, VEGF-B, and VEGF Gene Expression Levels with Disease Activity of Behçet’s Patients

Background. There is no specific marker that shows the disease activity in Behçet's disease. Aim. In this study, we aimed to investigate VEGF-B and VEGF gene expressions and sTREM-1 levels in association with the activation of Behçet's disease. Study Design. Case-control study. Methods. Clinical features of patients who applied in the rheumatology clinic and were diagnosed with BD according to the international working group's criteria were investigated. 30 healthy volunteers and 30 patients in the active period according to the EBDCAF scoring were studied. VEGF-B and VEGF gene expressions and sTREM-1 levels were studied in the serum samples of the patients and the control subjects. Results. The VEGF-B expressions and sTREM-1 levels were higher in the BD than those in the healthy group, but this difference did not reach statistical significance. VEGF gene expression was statistically significant (). Behçet's disease patients with oral aphthae, genital ulcer, eye, joint, vascular, skin, and neurological involvement were analyzed separately as subgroups. We find that VEGF gene expression level of Behçet's disease patients with joint involvement (arthritis/arthralgia) and also VEGF-B and VEGF gene expression of Behçet's disease with vascular involvement (DVT/thrombophlebitis) were significantly higher (,). Each subgroup was analyzed with the control group. We determined that VEGF gene expression in all subgroups was significantly higher than that in the control group. At the same time, VEGF-B levels of patients with genital ulcer and vascular involvement (DVT/thrombophlebitis) were significantly higher than those in the control group. Conclusion. VEGF-B and VEGF gene expressions can be activity indicators for BD. In addition, this study shows that new treatment options should be explored for Behçet's disease patients with joint and vascular involvement. In the following years, new treatment methods are needed to investigate for revealing the role of the etiopathogenesis of BD and the activation and prognosis of VEGF by examining this study and providing much more participation. In our study group, the sTREM-1 levels were high but the results did not reach statistical significance. More studies are needed with larger groups in order the highlight the exact role of STREM-1 in Behçet's disease.

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UBE2D1 RNA Expression Was an Independent Unfavorable Prognostic Indicator in Lung Adenocarcinoma, but Not in Lung Squamous Cell Carcinoma

In this study, we investigated the potential prognostic value of ubiquitin-conjugating enzyme E2D1 (UBE2D1) RNA expression in different histological subtypes of non-small-cell lung cancer (NSCLC). A retrospective study was performed by using molecular, clinicopathological, and survival data in the Cancer Genome Atlas (TCGA)—Lung Cancer. Results showed that both lung adenocarcinoma (LUAD) () and lung squamous cell carcinoma (LUSC) () tissues had significantly elevated UBE2D1 RNA expression compared to the normal tissues ( and , respectively). UBE2D1 RNA expression was significantly higher in LUAD than in LUSC tissues. Increased UBE2D1 RNA expression was independently associated with shorter OS (HR: 1.359, 95% CI: 1.031–1.791, ) and RFS (HR: 1.842, 95% CI: 1.353–2.508, ) in LUAD patients, but not in LUSC patients. DNA amplification was common in LUAD patients (88/551, 16.0%) and was associated with significantly upregulated UBE2D1 RNA expression. Based on these findings, we infer that UBE2D1 RNA expression might only serve as an independent prognostic indicator of unfavorable OS and RFS in LUAD, but not in LUSC.

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Simultaneous Determination of Phenolic Compounds in Leptadenia pyrotechnica (Forssk.) Decne. by Using High-Performance Liquid Chromatography (HPLC-DAD-UV)

During the present study, an endeavor has been made to produce a simple, rapid, and simultaneous method for determination of phenolic compounds by using high-performance liquid chromatography in aerial parts of Leptadenia pyrotechnica (Forssk.) Decne. collected from the Indian Thar Desert. The optimized process was used for the quantification of ten phenolic compounds. The chromatographic separation was accomplished on an Atlantis T3 column at 25°C with isocratic elution. A mixture of acetonitrile and water was used as the mobile phase at a flow rate of 0.8 mL/min. The linear regression examination data for the calibration plots displayed a good linear relationship with r2 > 0.999 in the concentration range of 2–20 µL. In the methanolic extracts of the whole plant of L. pyrotechnica, the content of caffeic acid (3.3%) was reported to be the highest concentration.

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Horses or zebras: a delayed diagnosis of meralgia paraesthetica

Description  

A 75-year-old woman presented with a 3-week history of escalating nocturnal neuropathic pain affecting her left thigh. This pain was described as sharp and 'shooting' in nature, primarily in the upper outer part of her thigh, with a severity of '10/10' at its worst. She had a medical history of osteoarthritis, hypercholesterolaemia, paroxysmal atrial fibrillation, a complete left bundle branch block with normal cardiac function and intestinal metaplasia for which she was undergoing regular endoscopic surveillance. She provided a strong family history of malignancy, with colorectal cancer in her sister, ovarian cancer in her mother, oesophageal cancer in her father, and lung and prostate cancer in her brother. Of note, in this time she had not experienced any trauma, fevers, fatigue, altered bowel habits, or weight loss.

The clinical exam revealed loss of the ankle reflex on the left side despite reinforcement but no other discernible neurological deficit....

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Hidden diagnosis behind viral infection: the danger of anchoring bias

Anchoring bias is one of the most common diagnostic biases that may lead to closed-minded thinking and could result in unnecessary tests, inappropriate patient management and even misdiagnosis. A 4-year-old boy was brought to the emergency department because of shaking chills. On the basis of bilateral swollen preauricular areas, high level of serum amylase and the prevalence of mumps, he initially received a diagnosis of mumps in spite of the shaking chills. However, blood culture turned out to be positive for two different kinds of bacteria. The patient finally received a diagnosis of polymicrobial bacteraemia resulting from suppurative appendicitis. We must consider and rule out bacteraemia in the differential diagnosis for patients who present with shaking chills, even in the presence of symptoms or information consistent with a more common viral infection such as mumps. In addition, intra-abdominal infection should be ruled out in the presence of polymicrobial enterobacteriaceae bacteraemia.

https://ift.tt/2NRbyCE

Sleep-related eating disorder with mirtazapine

Sleep-related eating disorder (SRED) is classified within parasomnia and is characterised by recurrent episodes of abnormal, dysfunctional eating during sleep. This report describes a case of SRED in a 19-year-old woman admitted to the psychiatric ward with worsening anxiety, low mood and suicidal ideation. She was started on low-dose mirtazapine for mood stabilisation and, following an incremental increase to 30 mg, she developed nocturnal binge eating of which she retained only partial memory on waking. She developed adverse health consequences as a result of these recurrent episodes. The subject's symptoms were relieved rapidly following reduction of the dose of mirtazapine back to 15 mg.

https://ift.tt/2Oy1fsi

A novel KIF5B-ALK fusion in a child with an atypical central nervous system inflammatory myofibroblastic tumour

Description  

An 11-year-old girl presented with global developmental delay. As part of her routine work-up for her developmental disability, MRI of the brain was performed and demonstrated a contrast-enhancing lesion with reduced diffusivity in the right parietal lobe (figure 1). A stereotactic robotic-assisted needle biopsy revealed microglial proliferation and lymphocytic inflammation, indicating potential microglioma or gliofibroma; however, a more definitive diagnosis was not established given the limited tissue. Early repeat MRI showed areas of progression, and gross total resection was performed. The pathology demonstrated a moderately cellular proliferation of spindle cells with scattered mitotic figures, and a mixed inflammatory infiltrate of scattered lymphocytes, plasma cells and eosinophils (figure 2A). The areas of nodular spindle cell proliferation were diffusely immunopositive for CD68 and negative for CD30, CD34, smooth muscle actin, desmin, S100, CD1a, CD117, CD3, CD20, CD15, synaptophysin, glial fibrillary acidic protein (GFAP) and leucocyte...

https://ift.tt/2NSjrYk

Plasmablastic lymphoma masquerading solitary plasmacytoma in an immunocompetent patient

We report a case of a middle-aged woman who initially presented with a painful solitary destructive lesion at fifth lumbar vertebra. The initial diagnosis of plasma cell neoplasm was made based on limited histological information obtained from fragmented tissue sample. Clinicopathological findings were consistent with a solitary plasmacytoma, and she was treated with definitive radiotherapy. A month after completing radiotherapy, she was found to have multiple liver lesions. Subsequent liver biopsy confirmed plasmablastic lymphoma (PBL). She was treated with multiple lines of chemo/immunotherapy regimens with limited or no response. She died of progression of liver lesions causing hepatic failure 16 months post diagnosis. Because of its rarity and heterogeneous presentations, PBL could easily be overlooked clinically and pathologically in immunocompetent patients. Diagnosis of PBL should be considered when there is coexpression of myeloma and lymphoma immune markers.

https://ift.tt/2Oy19AW

Coronary artery ectasia in Crohns disease

Coronary artery ectasia (CAE) can be ascribed, in the majority of cases, to coronary atherosclerosis. Nevertheless, the presence of isolated ectatic lesions without obstructive coronary artery disease and the association of CAE with several autoimmune diseases characterised by systemic vascular involvement suggest that the pathogenesis of CAE may extend beyond coronary atherosclerosis. We herein report the case of a 56-year-old male patient with Crohn's disease and isolated CAE, who has been found positive for IgM and IgA antiendothelial cell antibodies, and discuss a potential pathogenic mechanism.

https://ift.tt/2NSjqne

Common diagnosis at an unusual age - pulmonary oedema in a toddler

Description 

A 15-month-old toddler presented to the emergency department (ED) with a history of fatigue, rhinitis and reduced oral intake. The medical history was remarkable for diarrhoea (Enterohaemorrhagic Escherichia coli (EHEC), Shiga toxin) positive haemolytic uremic syndrome (D⁺-HUS) 3 months ago with microangiopathic haemolytic anaemia, thrombocytopenia, renal failure and hypertension. When HUS was diagnosed, he had a blood pressure of 117/82 mm Hg, anuria over 18 hours and a platelet count of 110x10⁹/L with fragmentocytes on blood film without evidence of complement dysfunction. The patient had come off dialysis after 1 month with persistent impaired renal function (peak creatinine 300 µmol/L, on discharge 205 µmol/L, estimated glomerular filtration rate (eGFR) 10 and 15 mL/min/1.73 m², respectively). He was on regular amlodipine, calcitriol and sodium bicarbonate. Parents reported normal urine output. Clinical examination showed respiratory rate 62/min, no recessions, heart rate 154/min, blood pressure 122/98 mm Hg, pulse oximetry 100% and normal temperature. Lung auscultation revealed bilateral inferior...

https://ift.tt/2OCpqWM

Dysphagia unveiling systemic immunoglobulin light-chain amyloidosis with multiple myeloma

Dysphagia is an uncommon presentation of systemic immunoglobulin light-chain (AL) amyloidosis with multiple myeloma (MM). Gastrointestinal (GI) involvement usually manifests with altered motility, malabsorption or bleeding. Furthermore, patients identified with GI amyloidosis, without previous diagnosis of a plasma cell disorder, are extremely rare. We report an elderly woman who presented with acute on chronic cardiac dysfunction, sick sinus syndrome and acute renal failure. While admitted, she developed intermittent dysphagia to both solids and liquids. Oesophagogastroduodenoscopy showed ulcerations of oesophagus and duodenum. Biopsies revealed focal amyloid deposition, stained with Congo red. Renal biopsy revealed amyloid deposition in renal arterioles. She underwent a bone marrow biopsy confirming MM, represented by more than 15% plasma cell population. She was started on treatment for heart failure, induction chemotherapy for MM and percutaneous gastrostomy tube for feeding. However, she continued to deteriorate, eventually opting for hospice, and ultimately died 2 days after discharge from hospital.

https://ift.tt/2NR6tu1

Intraoperative Descemets membrane detachment in a case of phacomorphic glaucoma

A 60-year-old female patient with phacomorphic glaucoma underwent initial medical management to control the intraocular pressure (IOP). After 48 hours, a stable IOP was achieved and subsequently the patient was planned for phacoemulsification followed by intraocular lens implantation. There was initial difficulty while reconstructing the corneal wounds; however, phacoemulsification and IOL implantation were uneventful but during viscoelastic removal, an inadvertent Descemet's membrane detachment involving the central cornea was noted. Postoperatively corneal oedema persisted till 1 week, following which there was a gradual improvement with topical antibiotics, steroids and hyperosmotic agents. At the end of 6 months, the best corrected visual acuity was 20/25 with a central corneal thickness of 580 µm without any need for additional endothelial replacement surgery.

https://ift.tt/2OyQAxA

Persistent cervical lymphadenitis in a patient with prior thyroid cancer attributed to Kikuchi-Fujimoto disease

We describe a 50-year-old woman with a history of thyroid cancer who presented with bilateral cervical and submandibular lymphadenopathy, low-grade fevers, and increasing fatigue. The patient underwent lymph node fine-needle aspiration, which showed no evidence of metastatic or lymphoproliferative disease. This procedure was complicated by a parapharyngeal abscess and cellulitis. She was treated unsuccessfully with various courses of antibiotics, but briefly responded to short courses of steroids. As her cervical lymphadenopathy returned, she underwent an excisional lymph node biopsy, which demonstrated caseating granulomatous lymphadenitis. Extensive review of systems, physical examination, laboratory and imaging studies demonstrated no evidence of malignancy, infection or systemic lupus erythematosus . Our patient was clinically diagnosed with Kikuchi-Fujimoto disease and successfully treated with prednisone tapered over 3 months. She remains in clinical remission.

https://ift.tt/2NRbxyA

Treatment response in osmotic demyelination syndrome presenting as severe parkinsonism, ptosis and gaze palsy

Osmotic demyelination syndrome commonly affects the pons and infrequently involves the extrapontine region. We report a patient with severe hyponatraemia who developed osmotic demyelination syndrome as a consequence of rapid sodium correction. The condition manifested as acute severe parkinsonism, bilateral ptosis and gaze impairment. MRI revealed typical features of central pontine and extrapontine myelinolysis. The patient improved gradually after treatment with a combination of levodopa, intravenous immunoglobulin and dexamethasone. However, it is important to emphasise that the improvement of neurological symptoms is not necessarily causal with these experimental therapies.

https://ift.tt/2OAkTE5

Abdominal compartment syndrome: the importance of urinary catheter placement in measuring intra-abdominal pressure

Description  

A 27-year-old man with a background of alcohol excess presented to the surgical assessment unit (SAU) with abdominal pain. On clinical examination, he was tender in his epigastric and left-upper quadrant. The blood results of note were a white cell count of 21x10⁹/L, C reactive protein 332 mg/L and amylase 812 U/L. He deteriorated quite quickly on the SAU with agitation, type 1 respiratory failure and hypotension. He required intubation and ventilation, and to be started on vasopressors. A CT of his abdomen and pelvis showed features in keeping with necrotising pancreatitis with a collection in the lesser sac (figure 1). He was managed conservatively in the intensive care unit with vasopressors, intravenous fluids, nasogastric feeds and antimicrobials.

Figure 1

CT scan of abdomen and pelvis showing features of necrotising pancreatitis.

On day 2, he developed increasing abdominal distension. His intra-abdominal pressure...

https://ift.tt/2NSmEal

Spontaneous renal artery dissection masquerading as urinary tract infection

Spontaneous renal artery dissection is a rare clinical entity, and symptoms vary from non-specific abdominal pain to life-threatening hypertension. A 44-year-old woman with no significant medical history initially presented with symptoms suggestive of urinary tract infection which did not respond to antibiotic therapy. Imaging revealed right renal infarction resulting from focal spontaneous renal artery dissection, which was managed conservatively. CT angiography is the preferred imaging modality for the diagnosis of this condition. Treatment options include medical management of hypertension with or without anticoagulation, endovascular intervention and surgical revascularisation depending on the presentation and the extent of the vascular and renal parenchymal involvement. This case emphasises the need to have high index of suspicion for uncommon diagnoses in patients who present with common symptoms but do not respond to empiric therapy.

https://ift.tt/2OAkSQx

Acute mechanical duodenal obstruction due to giant hydronephrosis: an unusual cause of acute abdomen

Giant hydronephrosis (GH) is a rare clinical entity with about 600 cases and defined as the adult renal pelvis containing greater than 1 L of fluid, or at least 1.6% of the body weight or kidney occupying the hemiabdomen. The pelvic-ureteric junction (PUJ) obstruction is the most frequent cause of GH. We thus report a case of massive abdominal distension due to GH secondary to PUJ obstruction who presented with acute duodenal obstruction due to extrinsic compression and was managed with percutaneous nephrostomy followed by open nephrectomy.

https://ift.tt/2NTwFnT

Baerveldt-XEN persistent proximal occlusion: solving new problems with old answers

A 51-year-old woman was referred with uncontrolled intraocular pressure (IOP) despite maximal medical IOP-lowering therapy. Her background included several failed glaucoma filtering surgeries, including aqueous drainage devices. Considering the need to perform surgery in a patient with both scarred conjunctiva and corneal endothelial deficiency, a surgical technique combining cornea-friendly XEN stent connected to a large-plate Baerveldt glaucoma implant was undertaken. Unfortunately, XEN implants obstructed twice during the early postoperative period. As further XEN replacements were unfeasible, there was the need to bridge the gap between the Baerveldt tube and the anterior chamber. An easy accessible, cheap 22G angiocatheter segment was used for this purpose. With a follow-up of 6 months, there were no postoperative complications nor loss of efficiency, with IOP of 7 mmHg. Tube extension using angiocatheter is a viable, cost-effective option in these difficult cases, saving the surgeon from having to explant and replace the entire implant.

https://ift.tt/2OyQztw

Atypical histopathology findings in presumed epibulbar cysticercosis

Description 

A 20-year-old young man presented with a painless epibulbar mass noted suddenly over the medial side of right eye (RE) 1 month back. Systemic history was insignificant and there was no history of trauma. On examination, visual acuity was 20/20 in both eyes (B/E) with no limitation of ocular movements. On examination, a mass lesion measuring about 1 cm in its longest dimension was noted over the medial side of the RE, with no apparent compression effect (figure 1). Overlying conjunctiva was mildly oedematous and congested. The posterior extent of the mass could not be appreciated. Rest of the anterior and posterior segment examination of BE was within normal limits.

Figure 1

(A) Clinical photograph shows the epibulbar cystic lesion over medial side of the eye ball (arrows). (B) Sonography shows a cystic lesion with a hyperdense echo within its cavity that is seen as connected...

https://ift.tt/2NTnqUP

Impending cardiac tamponade as a primary presentation of Hashimotos thyroiditis

Description 

A 37-year-old woman with a history of psoriatic arthritis presented to the emergency department with back pain radiating to the upper abdomen for 1 week with no other associated symptoms. Physical examination revealed normal vital signs, mild enlargement of the thyroid gland, jugular venous distension and distant heart sounds. Laboratory results revealed elevated thyroid-stimulating hormone at 134.76 U/mL, decreased free T4 at 0.27 ng/dL and T3 at 1.7 ng/dL. Testing for cyclic citrullinated peptide antibody, antinuclear antibody and rheumatoid factor was negative. ECG showed sinus rhythm at 63 beats per minute and low-voltage complexes. Chest X-ray showed cardiomegaly. CT of the abdomen and pelvis revealed an incidental large pericardial effusion and no remarkable abdominal pathology. Echocardiography confirmed large pericardial effusion with an early tamponade physiology (figure 1).

Figure 1

(A) Echocardiogram (ECHO) apical four chamber view showing right ventricular wall collapse with surrounding large pericardial effusion. (B) ECHO parasternal short-axis...

https://ift.tt/2OEsTEc

Neurosyphilis concurrently involving eye and ear

Description 

A 42-year-old woman presented to our hospital with a 2-month history of bilateral decreased and blurry vision accompanying mild photophobia. She had had several episodes of unsafe sex and was diagnosed with secondary syphilis 10 months prior. Despite the diagnosis, she did not undergo any treatment for the infection. An ophthalmological examination revealed bilateral macular oedema, suggesting the development of uveitis (figure 1A,B). Laboratory data for complete blood counts and chemistry were unremarkable, but there were elevations of rapid plasma reagin (RPR) test and Treponema pallidum haemagglutination test (TPHA) titres, at 1:32 and 1:5120, respectively, leading to the diagnosis of ocular syphilis. Screening tests for hepatitis B virus, hepatitis C virus and HIV yielded negative findings. Further cerebrospinal fluid examination indicated a complication of neurosyphilis, with a mildly elevated white cell count (0.013x10⁹/L), protein level (49 mg/dL), and positive RPR (1:4) and TPHA (1:320) titres. The...

https://ift.tt/2NTwEQR

Generalised nevus flammeus, episcleral capillary malformation and glaucoma

Description 

A 35-year-old woman presented with no vision, redness, pain and photophobia in the left eye (LE) since 4 months. This was associated with left-sided headache and vomiting too. She had history of poor vision in LE since 2–3 years, and had been treated with topical antiglaucoma medication. There was no significant family history. On examination, visual acuity was 6/6 in right eye (RE) and no perception of light in LE. Intraocular pressure (IOP) was measured as 14 mm Hg in RE and >60 mm Hg in LE. Slit lamp evaluation revealed conjunctival congestion, corneal oedema, fully dilated pupil and white cataract in LE (figure 1). Gonioscopy was within normal limits. RE ocular examination did not reveal any significant anomaly. RE pupil did not show any consensual response, while LE pupil was fixed. Systemic workup revealed nevus flammeus (NF) over the face involving both periocular regions but more...

https://ift.tt/2OF4izf

Cutaneous pseudolymphoma secondary to gabapentin

Description 

A middle-aged woman presented with a 'pimple that won't heal'. She stated that it slowly enlarged over her left cheek for 6 months. She denied any symptoms of itchiness nor pain. She previously tried topical metronidazole for 6 weeks without improvement. She used acetaminophen and ibuprofen on occasion for 10 years to combat her migraine headaches, plus her neurologist recently initiated her on gabapentin. The patient noted that her presenting problem started 3 weeks after she initiated the gabapentin. Throughout this period of time, she also continued to take ibuprofen approximately three times weekly. She denied using any other medicines. Additionally, she denied a bug bite to her left cheek. On examination, a single dime-sized, non-scaly plaque with slight erythema was located on her left cheek (figure 1). The rest of her skin exam was unremarkable. A single punch biopsy revealed a dermal mixed infiltrate consisting of predominantly...

https://ift.tt/2NQ9sCV

The PIPc Study--application of indicators of potentially inappropriate prescribing in children (PIPc) to a national prescribing database in Ireland: a cross-sectional prevalence study

Objectives

Evidence is limited regarding the quality of prescribing to children. The objective of this study was to apply a set of explicit prescribing indicators to a national pharmacy claims database (Primary Care Reimbursement Service) to determine the prevalence of potentially inappropriate prescribing in children (PIPc) in primary care.

Primary and secondary outcomes measures

To determine the overall prevalence of potentially inappropriate prescribing (PIP) in children in primary care. To examine the prevalence of PIPc by gender.

Design and setting

Cross-sectional study. Application of indicators of commission of PIP and omission of appropriate prescribing to a national prescribing database in Ireland.

Participants

Eligible children <16 years of age who were prescribed medication in 2014.

Results

Overall prevalence of PIPc by commission was 3.5% (95% CI 3.5% to 3.6%) of eligible children <16 years of age who were prescribed medication in 2014. Overall prevalence of PIPc by omission was 2.5% (95% CI 2.5% to 2.6%) which rose to 11.5% (95% CI 11.4% to 11.7%) when prescribing of spacer devices for children with asthma was included. The most common individual PIPc by commission was the prescribing of carbocisteine to children (3.3% of eligible children). The most common PIPc by omission (after excluding spacer devices) was failure to prescribe an emollient to children prescribed greater than one topical corticosteroid (54% of eligible children). PIPc by omission was significantly higher in males compared with females (relative risk (RR) 1.3; 95% CI 1.0 to 1.7) but no different for PIPc by commission (RR 1.0; 95% CI 0.7 to 1.6).

Conclusion

This study shows that the overall prevalence of PIP in children is low, although results suggest room for improved adherence to asthma guidelines.

https://ift.tt/2q4JMsI

Protocol for a multicentre, prospective cohort study of practice patterns and clinical outcomes associated with emergency department sedation for mechanically ventilated patients: the ED-SED Study

Introduction

In mechanically ventilated patients, sedation strategies are a major determinant of outcome. The emergency department (ED) is the earliest exposure to mechanical ventilation for hundreds of thousands of patients annually in the USA. The one retrospective study that exists regarding ED sedation for mechanically ventilated patients showed a strong association between deep sedation in the ED and worse clinical outcomes. This finding suggests that the ED may be an optimal location to study the impact of early sedation on outcome, yet a lack of prospective studies represents a knowledge gap in this arena. This protocol describes a prospective observational study aimed at further characterising ED sedation practices and assessing the relationship between ED sedation and clinical outcomes. An association between ED sedation and clinical outcomes across multiple sites would suggest the need for changes in the current sedation strategies used in the ED, and provide evidence for future interventional studies in this field.

Methods and analysis

This is a multicentre, prospective cohort study testing the hypothesis that deep sedation in the ED is associated with worse clinical outcomes. A cohort of over 300 mechanically ventilated ED patients will be included. The primary outcome is ventilator-free days, and secondary outcomes include hospital mortality, incidence of acute brain dysfunction and lengths of stay. Multivariable linear regression will test the hypothesis that deep sedation in the ED is associated with a decrease in ventilator-free days.

Ethics and dissemination

Approval of the study by the Institutional Review Board (IRB) at each participating site has been obtained prior to data collection on the first patient. This work will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at scientific meetings and data sharing with other investigators through academically established means.

https://ift.tt/2R3oKq4

Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2)

Introduction

Concurrent chemoradiation is the standard therapy for patients with local advanced oesophageal carcinoma unsuitable for surgery. Paclitaxel is an active agent against oesophageal cancer and it has been proved as a potent radiation sensitiser. There have been multiple studies evaluating paclitaxel-based chemoradiation in oesophageal cancer, of which the results are inspiring. However, which regimen, among cisplatin (TP), carboplatin (TC) or fluorouracil (TF) in combination with paclitaxel concurrent with radiotherapy, provides best prognosis with minimum adverse events is still unknown and very few studies focus on this field. The purpose of this study is to confirm the priority of TF to TP or TF to TC concurrent with radiotherapy in terms of overall survival and propose a feasible and effective plan for patients with local advanced oesophageal cancer.

Methods and analysis

ESO-Shanghai 2 is a three-arm, multicenter, open-labelled, randomised phase III clinical trial. The study was initiated in July 2015 and the duration of inclusion is expected to be 4 years. The study compares two pairs of regimen: TF versus TP and TF versus TC concurrent with definitive radiotherapy for patients with oesophageal squamous cell carcinoma (OSCC). Patients with histologically confirmed OSCC (clinical stage II, III or IVa based on the sixth Union for International Cancer Control-tumour, node, metastasis classification) and without any prior treatment of chemotherapy, radiotherapy or surgery against oesophageal cancer will be eligible. A total of 321 patients will be randomised and allocated in a 1:1:1 ratio to the three treatment groups. Patients are stratified by lymph node status (N0, N1, M1a). The primary endpoint is overall survival and the secondary endpoint is progression-free survival and adverse events.

Ethics and dissemination

This trial has been approved by the Fudan University Shanghai Cancer Centre Institutional Review Board. Trial results will be disseminated via peer reviewed scientific journals and conference presentations.

Trial status

The trial was initiated in July 2015 and is currently recruiting patients in all of the participating institutions above.

Trial registration number

NCT02459457.

https://ift.tt/2R54xQO

International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)

Introduction

A critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments.

Methods and analysis

This phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study.

Ethics and dissemination

This study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

https://ift.tt/2q4RTFM

Appraising the quality standard underpinning international clinical practice guidelines for the selection and care of vascular access devices: a systematic review of reviews

Objective

Catheter-related bloodstream infections are one of the most important adverse events for patients. Evidence-based practice embraces interventions to prevent and reduce catheter-related bloodstream infections in patients. At present, a growing number of guidelines exist worldwide. The purpose of the study was to assess clinical practice guidelines for peripheral and central venous access device care and prevention of related complications.

Design

Systematic review of clinical practice guidelines: We conducted a search of the literature published from 2005 to 2018 using Medline/PubMed, Embase, CINAHL, Ovid, ScienceDirect, Scopus and Web of Science. We also evaluated grey literature sources and websites of organisations that compiled or produced guidelines. Guideline quality was assessed with the Appraisal of Guidelines for Research and Evaluation, Second Edition tool by three independent reviewers. Cohen's kappa coefficient was used to evaluate the concordance between reviewers.

Results

We included seven guidelines in the evaluation. The concordance between observers was substantial, K=0.6364 (95% CI 0.0247 to 1.2259). We identified seven international guidelines, which scored poorly on crucial domains such as applicability (medium 39%), stakeholder involvement (medium 65%) and methodological rigour (medium 67%). Guidelines by Spanish Health Ministry and UK National Institute for Health and Care Excellence presented the highest quality.

Conclusions

It is crucial to critically evaluate the validity and reliability of clinical practice guidelines so the best, most context-specific document is selected. Such choice is a necessary prior step to encourage and support health organisations to transfer research results to clinical practice. The gaps identified in our study may explain the suboptimal clinical impact of guidelines. Such low adoption may be mitigated with the use of implementation guides accompanying clinical documents.

https://ift.tt/2R54uEC

Influence of social determinants of health on patients with advanced lung cancer: a prospective cohort study

Introduction

Socioeconomic factors with an influence on human health are known as social determinants of health (SDH). There are some SDH studies in patients with lung cancer, but important exposures such as social isolation and loneliness have not been adequately investigated. This study will assess the influence of SDH, particularly social isolation and loneliness, on patients with advanced lung cancer in Japan.

Methods and analysis

The inclusion criteria for this prospective cohort study will be as follows: a diagnosis of advanced lung cancer; unsuitability for curative surgery; and willingness to participate. The primary outcome will be the initial choice of treatment and the secondary outcomes will be overall survival, changes in disease staging or performance status, route to diagnosis and place of death. The exposures will be social isolation, loneliness, employment, insurance type, education and dementia. The study enrolment period will be 1 year and the follow-up duration will be 2 years. The log-rank test will be used to compare overall survival between patients when grouped according to the study exposures and multivariate analysis will be performed using Cox proportional hazards regression. The X² test will be used to compare the initial treatment, changes in disease stage and place of death, and logistic regression will be used for multivariate analysis of these factors. A p value <0.05 will be considered statistically significant.

Ethics and dissemination

This study has been approved by the Institutional Review Board at Hyogo Prefectural Amagasaki General Medical Center (No 29-164). A manuscript summarising the outcome of this study will be submitted to a peer-reviewed journal and the data will be presented at conferences.

Trial registration number

UMIN000031810.

https://ift.tt/2q4TVFV

Understanding the needs and experiences of people with young onset dementia: a qualitative study

Aim

Despite an estimated 40 000 people diagnosed with young onset dementia (YOD) in the UK, there is a general lack of awareness of the condition when compared with late onset dementia. The aim of this study was to explore the experiences and needs of people living with YOD (younger than 65 years) and gain an understanding of the issues that impact on them.

Setting

Participants' homes, support group premises or university rooms.

Participants

14 people with a diagnosis of YOD from a northern UK city.

Design

Semistructured, in-depth interviews were audio recorded, transcribed and analysed cross-sectionally following principles of interpretative phenomenological analysis.

Results

Four superordinate themes are reported on 'process of diagnosis', 'the impact of living YOD', 'needs of people with YOD' and 'living well with YOD'. Nine subordinate themes captured participant experiences of developing cognitive difficulties, after being diagnosed with YOD, and subsequently living with the condition. Key issues that emerging included a lack of general awareness of YOD; how this can delay help seeking; commonalities in prediagnosis trajectories; retrospective understanding of prediagnosis symptom patterns; the difficulties of obtaining a firm diagnosis; the importance of face-to-face support and difficulties associated with daily living. Participants also described the emotional and psychological impact of the condition and the importance of formal and informal support networks.

Conclusions

People who have a diagnosis of YOD regard themselves as distinct from older people with dementia. Despite similar symptoms, the context in which they experience the condition creates a range of distinct psychosocial concerns not commonly well addressed by health and social care services. As awareness of YOD continues to grow, the development (or adaptation) of services that take into account the idiosyncratic needs of people with YOD should be addressed.

https://ift.tt/2R551q6

ATTIRE: Albumin To prevenT Infection in chronic liveR failurE: study protocol for an interventional randomised controlled trial

Introduction

Circulating prostaglandin E₂ levels are elevated in acutely decompensated cirrhosis and have been shown to contribute to immune suppression. Albumin binds to and inactivates this immune-suppressive lipid mediator. Human albumin solution (HAS) could thus be repurposed as an immune-restorative drug in these patients.

This is a phase III randomised controlled trial (RCT) to verify whether targeting a serum albumin level of ≥35 g/L in hospitalised patients with decompensated cirrhosis using repeated intravenous infusions of 20% HAS will reduce incidence of infection, renal dysfunction and mortality for the treatment period (maximum 14 days or discharge if <14 days) compared with standard medical care.

Methods and analysis

Albumin To prevenT Infection in chronic liveR failurE stage 2 is a multicentre, open-label, interventional RCT. Patients with decompensated cirrhosis admitted to the hospital with a serum albumin of <30 g/L are eligible, subject to exclusion criteria. Patients randomised to intravenous HAS will have this administered, according to serum albumin levels, for up to 14 days or discharge. The infusion protocol aims to increase serum albumin to near-normal levels.

The composite primary endpoint is: new infection, renal dysfunction or mortality within the trial treatment period. Secondary endpoints include mortality at up to 6 months, incidence of other organ failures, cost-effectiveness and quality of life outcomes and time to liver transplant. The trial will recruit 866 patients at more than 30 sites across the UK.

Ethicsanddissemination

Research ethics approval was given by the London-Brent research ethics committee (ref: 15/LO/0104). The clinical trials authorisation was issued by the medicines and healthcare products regulatory agency (ref: 20363/0350/001–0001). The trial is registered with the European Medicines Agency (EudraCT 2014-002300-24) and has been adopted by the National Institute for Health Research (ISRCTN 14174793). This manuscript refers to version 6.0 of the protocol. Results will be disseminated through peer-reviewed journals and international conferences. Recruitment of the first participant occurred on 25 January 2016.

https://ift.tt/2q4JMcc

Mixed-methods evaluation of the Perioperative Medicine Service for High-Risk Patients Implementation Pilot (POMSHIP): a study protocol

Introduction

Perioperative complications have a lasting effect on health-related quality of life and long-term survival. The Royal College of Anaesthetists has proposed the development of perioperative medicine (POM) services as an intervention aimed at improving postoperative outcome, by providing better coordinated care for high-risk patients. The Perioperative Medicine Service for High-risk Patients Implementation Pilot was developed to determine if a specialist POM service is able to reduce postoperative morbidity, failure to rescue, mortality and cost associated with hospital admission. The service involves individualised objective risk assessment, admission to a postoperative critical care unit and follow-up on the surgical ward by the POM team. This paper introduces the service and how it will be evaluated.

Methods and analysis of the evaluation

A mixed-methods evaluation is exploring the impact of the service. Clinical effectiveness of the service is being analysed using a 'before and after' comparison of the primary outcome (the PostOperative Morbidity Score). Secondary outcomes will include length of stay, validated surveys to explore quality of life (EQ-5D) and quality of recovery (Quality of Recovery-15 Score). The impact on costs is being analysed using 'before and after' data from the Patient-Level Information and Costing System and the National Schedule of Reference Costs. The perceptions and experiences of staff and patients with the service, and how it is being implemented, are being explored by a qualitative process evaluation.

Ethics and dissemination

The study was classified as a service evaluation. Participant information sheets and consent forms have been developed for the interviews and approvals required for the use of the validated surveys were obtained. The findings of the evaluation are being used formatively, to make changes in the service throughout implementation. The findings will also be used to inform the potential roll-out of the service to other sites.

https://ift.tt/2R54i8m

Late-life suicidal behaviours among new users of antidepressants: a prospective population-based study of sociodemographic and gender factors in those aged 75 and above

Objective

To investigate sociodemographic and gender factors associated with suicide and suicide attempts among new users of antidepressants aged 75 and above.

Design

Register-based cohort study.

Setting

National population-based cohort of Swedish residents aged ≥75 years.

Participants

185 225 patients who initiated antidepressant medication between 1 January 2007 and 31 December 2013 were followed until 31 December 2014.

Main outcome measures

Suicide and suicide attempts. Fine and Gray regression models were used to analyse the sociodemographic factors (age, country of birth, marital status, education level, last occupation, income and social allowance) associated with suicidal behaviours in the entire cohort and by gender.

Results

During follow-up, 295 suicides and 654 suicide attempts occurred. Adjusted sub-hazard ratios (aSHRs) for suicide were lower among older age groups (aSHR 0.73, 95% CI 0.53 to 0.99 for those 85–89 years; and aSHR 0.53, 95% CI 0.33 to 0.86 for those ≥90 years). A similar pattern was observed for suicide attempts. Suicide attempts were more common among those born in foreign countries (aSHR 1.58, 95% CI 1.16 to 2.15 for those born in another Nordic country; and aSHR 1.43, 95% CI 1.06 to 1.93 for those born in non-Nordic countries). In the gender-stratified analyses, being single or divorced, and born in another Nordic country was associated with a higher risk of suicide among men. Educational and occupational history and being born in a non-Nordic country influenced risk of suicidal behaviours in women.

Conclusion

Suicidal behaviours occurred more commonly among new users who were 'younger' old adults and those with foreign background, suggesting that those groups might require greater support when initiating antidepressant therapy. Our findings suggest the need for gender-specific, multifaceted approaches to the prevention of suicidal behaviours in late life.

https://ift.tt/2q1jaJi

Nutritional impact on Immunological maturation during Childhood in relation to the Environment (NICE): a prospective birth cohort in northern Sweden

Introduction

Prenatal and neonatal environmental factors, such as nutrition, microbes and toxicants, may affect health throughout life. Many diseases, such as allergy and impaired child development, may be programmed already in utero or during early infancy. Birth cohorts are important tools to study associations between early life exposure and disease risk. Here, we describe the study protocol of the prospective birth cohort, 'Nutritional impact on Immunological maturation during Childhood in relation to the Environment' (NICE). The primary aim of the NICE cohort is to clarify the effect of key environmental exposures—diet, microbes and environmental toxicants—during pregnancy and early childhood, on the maturation of the infant's immune system, including initiation of sensitisation and allergy as well as some secondary outcomes: infant growth, obesity, neurological development and oral health.

Methods and analysis

The NICE cohort will recruit about 650 families during mid-pregnancy. The principal inclusion criterion will be planned birth at the Sunderby Hospital in the north of Sweden, during 2015–2018. Questionnaires data and biological samples will be collected at 10 time-points, from pregnancy until the children reach 4 years of age. Samples will be collected primarily from mothers and children, and from fathers. Biological samples include blood, urine, placenta, breast milk, meconium, faeces, saliva and hair. Information regarding allergic heredity, diet, socioeconomic status, lifestyle including smoking, siblings, pet ownership, etc will be collected using questionnaires. Sensitisation to common allergens will be assessed by skin prick testing and allergic disease will be diagnosed by a paediatrician at 1 and 4 years of age. At 4 years of age, the children will also be examined regarding growth, neurobehavioural and neurophysiological status and oral health.

Ethics and dissemination

The NICE cohort has been approved by the Regional Ethical Review Board in Umeå, Sweden (2013/18-31M). Results will be disseminated through peer-reviewed journals and communicated on scientific conferences.

https://ift.tt/2R6EUz2

Disclosure of payments by pharmaceutical companies to healthcare professionals in the UK: analysis of the Association of the British Pharmaceutical Industrys Disclosure UK database, 2015 and 2016 cohorts

Objectives

To analyse the section of Disclosure UK that pertains to healthcare professionals (HCPs) in order to provide insight into the database's structure and content and suggest ways to improve its transparency.

Design and participants

Cohort study of drug companies and HCPs in the 2015 and 2016 versions of Disclosure UK.

Results

Companies report transfers of value (ToVs) to named HCPs or, where an HCP declines to consent, in aggregate. Only a limited number of variables describe the recipient HCP and the ToV, precluding refined analyses. In 2015, 107 companies reported 54 910 ToVs worth 50 967 728. In 2016, 109 companies reported ToVs but spending decreased by 7.3%. The spending was concentrated: the top 10 spenders reported about 50% of the total value, with consultancy-related payments comprising over 70%, and the rest being costs for events. In 2015, 55.5% (30 478) of ToVs worth 24 428 619 (47.9%) were disclosed at the individual HCP level, increasing to 64.5% (32 407) and 28 145 091 (59.2%) in 2016. Despite increased individual-level disclosure in 2016, the median number of ToVs reported by each company at the individual level was only 57.7%, with 25% of companies reporting less than 38.6%. We found little agreement (62%–48% in 2015 and 46%–30% in 2016) between HCP consent rates that we calculated based on information in the database and those provided by companies.

Conclusions

Key deficiencies in Disclosure UK include: insufficient information on payments and recipients, a relatively low HCP consent rate for individual-level disclosure, differences in consent rates across companies and payment types, and reporting ambiguities or inconsistencies. We employ these findings to develop recommendations for improving transparency, including an easily interpretable consent rate statistic that allows for comparison across years, firms and countries. If deficiencies remain unresolved, the UK should consider introducing legislation requiring mandatory disclosure to allow for adequate tracking of industry payments.

https://ift.tt/2q0KuY9

Moderation of alcohol consumption as a recommendation in European hypertension management guidelines: a survey on awareness, screening and implementation among European physicians

Objectives

Moderation of alcohol consumption is included as a class I, level of evidence A recommendation in the current European guidelines for the management of hypertension. We investigated its awareness and self-reported implementation among European physicians across different specialties and workplaces.

Design and setting

A cross-sectional survey study conducted in two annual German meetings (German Society of Cardiology and the German Society of Internal Medicine) and two annual European meetings (European Society of Hypertension and European Society Cardiology) in 2015.

Participants

1064 physicians attending the European meetings were interviewed including 52.1% cardiologists, 29.2% internists and 8.8% general practitioners.

Main outcome measures

Physician screening of alcohol consumption, awareness and self-implementation of the recommendation of the current European guidelines about moderation of alcohol consumption for the management of hypertension.

Results

Overall, 81.9% of physicians reported to generally quantify alcohol consumption in patients with hypertension. However, only 28.6% and 14.5% of participants reported screening alcohol consumption in their patients with newly detected or treatment-resistant hypertension. Physicians recommended a maximum alcohol intake of 13.1±11.7 g/day for women (95% CI 12.3 to 13.8) and 19.9±15.6 g/day for men (95% CI 18.8 to 20.9). In case of moderate to high alcohol consumption, 10.3% would manage only hypertension without addressing alcohol consumption, while 3.7% of the physicians would do so in case of alcohol dependence (p<0.001).

Conclusions

The average amount of alcohol intake per day recommended by European physicians in this survey was in agreement with the guidelines. The low number of physicians that screen for alcohol consumption in patients with newly detected and with treatment-resistant hypertension indicates an important deficit in the management of hypertension.

https://ift.tt/2R5Om5H

Emergency hospital care for adults with suspected seizures in the NHS in England 2007-2013: a cross-sectional study

Aims

To quantify the frequency, characteristics, geographical variation and costs of emergency hospital care for suspected seizures.

Design

Cross-sectional study using routinely collected data (Hospital Episode Statistics).

Setting

The National Health Service in England 2007–2013.

Participants

Adults who attended an emergency department (ED) or were admitted to hospital.

Results

In England (population 2011: 53.11 million, 41.77 million adults), suspected seizures gave rise to 50 111 unscheduled admissions per year among adults (≥18 years). This is 47.1% of unscheduled admissions for neurological conditions and 0.71% of all unscheduled admissions. Only a small proportion of admissions for suspected seizures were coded as status epilepticus (3.5%) and there were a very small number of dissociative (non-epileptic) seizures. The median length of stay for each admission was 1 day, the median cost for each admission was £1651 ($2175) and the total cost of all admissions for suspected seizures in England was £88.2 million ($116.2 million) per year. 16.8% of patients had more than one admission per year. There was significant geographical variability in the rate of admissions corrected for population age and gender differences and some areas had rates of admission which were consistently higher than the average.

Conclusions

Our data show that suspected seizures are the most common neurological cause of admissions to hospital in England, that readmissions are common and that there is significant geographical variability in admission rates. This variability has not previously been reported in the published literature. The cause of the geographical variation is unknown; important factors are likely to include prevalence, deprivation and clinical practice and these require further investigation. Dissociative seizures are not adequately diagnosed during ED attendances and hospital admissions.

https://ift.tt/2q1s1KS

Decision-making on the location of care of the elderly: protocol for a systematic review of qualitative studies

Introduction

The elderly must take part in the management of their own health. One of the aspects they should be able to decide on is the place where they want to live. The aim of this review is to synthetise qualitative evidence in order to understand how decisions are made on the location of care of the elderly.

Methods and analysis

Systematic review of qualitative studies. Six databases have been consulted: Web of Science, PubMed, Scopus, CINAHL Complete, PsycINFO and SciELO Citation Index (from the beginning to 29 November 2017). The inclusion criteria will be: studies that deal with the decision-making process on the location of care of the elderly (already experienced by the participants), original studies, qualitative or mixed-method studies and studies written in English or Spanish. The obtained results will be exported to the Zotero bibliography manager. The references will be reviewed by title and abstract and, later, the complete texts will be reviewed for their inclusion. A tool created for this study will be used to extract the data. The quality will be assessed with Critical Appraisal Skills Programme Español. The data synthesis will be carried out using the constant comparative method. All this process will be performed independently by two reviewers. Enhancing transparency in reporting the synthesis of qualitative research has been used to draw up this protocol.

Ethics and dissemination

This protocol did not require ethical approval, since it is a protocol for a systematic review. The plans to disseminate our results include publishing a research paper in a high-impact journal in our study area. Also, if possible, our results will be presented in scientific conferences. Besides, the obtained results will complement and discuss the doctoral thesis of one of the authors of the review.

PROSPERO registration number

CRD42018084826.

https://ift.tt/2R50gfX

Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH): study protocol of a prospective before-after effectiveness-implementation study

Introduction

Although the majority of older patients admitted to a cardiology unit present with at least one geriatric syndrome, guidelines on managing heart disease often do not consider the complex needs of frail older patients. Geriatric co-management has demonstrated potential to improve functional status, and reduce complications and length of stay, but evidence on the effectiveness in cardiology patients is lacking. This study aims to determine if geriatric co-management is superior to usual care in preventing functional decline, complications, mortality, readmission rates, reducing length of stay and improving quality of life in older patients admitted for acute heart disease or for transcatheter aortic valve implantation, and to identify determinants of success for geriatric co-management in this population.

Methods and analysis

This prospective quasi-experimental before-and-after study will be performed on two cardiology units of the University Hospitals Leuven in Belgium in patients aged ≥75 years. In the precohort (n=227), usual care will be documented. A multitude of implementation strategies will be applied to allow for successful implementation of the model. Patients in the after cohort (n=227) will undergo a comprehensive geriatric assessment within 24 hours of admission to stratify them into one of three groups based on their baseline risk for developing functional decline: low-risk patients receive proactive consultation, high-risk patients will be co-managed by the geriatric nurse to prevent complications and patients with acute geriatric problems will receive an additional medication review and co-management by the geriatrician.

Ethics and dissemination

The study protocol was approved by the Medical Ethics Committee UZ Leuven/KU Leuven (S58296). Written voluntary (proxy-)informed consent will be obtained from all participants at the start of the study. Dissemination of results will be through articles in scientific and professional journals both in English and Dutch and by conference presentations.

Trial registration number

NCT02890927.

https://ift.tt/2q2WSXu

Protocol for a randomised, double-blind, placebo-controlled trial to explore the effect of tramadol in the prevention of postpartum depression (ETPPD)

Introduction

Postpartum depression is one of the most commonly experienced psychological disorders for women patients undergoing caesarean section, which accounts for about one-third of puerpera worldwide. Tramadol, a commonly used analgesic with an inhibitory effect on the reuptake of norepinephrine and serotonin, is an effective and well-tolerated agent for analgesia after caesarean section. Based on the role of changes in the postpartum levels of serotonin and norepinephrine in postpartum depression, we speculated that postoperative intravenous analgesia using tramadol may decrease the incidence of postpartum depression for caesarean patients. Therefore, this trial aimed to explore the effect of tramadol in the prevention of postpartum depression.

Methods and analysis

A randomised double-blind placebo-controlled trial will be performed and 1230 singleton parturients will be randomised to receive patient-controlled intravenous analgesia with tramadol or hydromorphone, or patient-controlled epidural analgesia with ropivacaine. The primary outcome of this trial will be the incidence of postpartum depression at 4 weeks after the caesarean section, together with the collection of the relevant data during hospitalisation and at 3 months after the caesarean section. Subgroup data according to the preoperative depression score will be analysed. Demographic characteristics, postoperative analgesic effects and postoperative recovery score will also be summarised and presented.

Ethics and dissemination

The current trial protocol was approved by the Institutional Ethics Committee of Xinqiao Hospital (ID: 2017–026), Third Military Medical University, Chongqing, China. The results of this trial will be disseminated at scientific meetings and in a peer-reviewed journal.

Trial registration number

NCT03309163; Pre-results.

https://ift.tt/2RamehZ

Trends in the socioeconomic patterning of overweight/obesity in India: a repeated cross-sectional study using nationally representative data

Objectives

We aimed to examine trends in prevalence of overweight/obesity among adults in India by socioeconomic position (SEP) between 1998 and 2016.

Design

Repeated cross-sectional study using nationally representative data from India collected in 1998/1999, 2005/2006 and 2015/2016. Multilevel regressions were used to assess trends in prevalence of overweight/obesity by SEP.

Setting

26, 29 and 36 Indian states or union territories, in 1998/99, 2005/2006 and 2015/2016, respectively.

Participants

628 795 ever-married women aged 15–49 years and 93 618 men aged 15–54 years.

Primary outcome measure

Overweight/obesity defined by body mass index >24.99 kg/m².

Results

Between 1998 and 2016, overweight/obesity prevalence increased among men and women in both urban and rural areas. In all periods, overweight/obesity prevalence was consistently highest among higher SEP individuals. In urban areas, overweight/obesity prevalence increased considerably over the study period among lower SEP adults. For instance, between 1998 and 2016, overweight/obesity prevalence increased from approximately 15%–32% among urban women with no education. Whereas the prevalence among urban men with higher education increased from 26% to 34% between 2005 and 2016, we did not observe any notable changes among high SEP urban women between 1998 and 2016. In rural areas, more similar increases in overweight/obesity prevalence were found among all individuals across the study period, irrespective of SEP. Among rural women with higher education, overweight/obesity increased from 16% to 25% between 1998 and 2016, while the prevalence among rural women with no education increased from 4% to 14%.

Conclusions

We identified some convergence of overweight/obesity prevalence across SEP in urban areas among both men and women, with fewer signs of convergence across SEP groups in rural areas. Efforts are therefore needed to slow the increasing trend of overweight/obesity among all Indians, as we found evidence suggesting it may no longer be considered a 'diseases of affluence'.

https://ift.tt/2q46HEU

Assessment of patient centredness through patient-reported experience measures (ASPIRED): protocol of a mixed-methods study

Introduction

The impact of patient centredness (PC) in healthcare has grown over the years. However, conceptualisations of PC are heterogeneous. Existing patient-reported measures of PC have shown inconsistencies and shortcomings. This impedes the comparison of results across studies. To foster PC, it is important to know which dimensions matter most to patients and to be able to measure its current extent from the patients' perspective. This study aims (1) to assess relevance of dimensions of PC from the patients' perspective, (2) to develop and psychometrically test a core set of patient-reported experience measures (PREMs) assessing PC and (3) to investigate the feasibility of implementation of this core set in routine healthcare.

Methods and analysis

A mixed-methods approach will be used. In phase 1, 200 patients will assess the relevance of the dimensions of PC in a Delphi study using a plain language description. In phase 2, the core set of PREMs will be developed through literature reviews, focus groups, key informant interviews and content validity ratings. The core set will be tested psychometrically in a cross-sectional study with 2000 inpatient and outpatients with different chronic conditions (ie, cancer, cardiovascular diseases, mental disorders and musculoskeletal disorders). In phase 3, the feasibility of implementation of the core set will be assessed through semistructured interviews with healthcare practitioners after piloting in routine care. Furthermore, an expert workshop will be held on how to foster implementation.

Ethics and dissemination

The study will be carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association and principles of good scientific practice. The study was approved by the Ethics Committee of the Medical Association Hamburg, Germany (study ID: PV5724). The study results will be disseminated in scientific journals and through collaboration partners and plain language press releases.

https://ift.tt/2R6yxMe

Validation of a non-invasive method for the early detection of metabolic syndrome: a diagnostic accuracy test in a working population

Objectives

A non-invasive method for the early detection of metabolic syndrome (NIM-MetS) using only waist-to-height ratio (WHtR) and blood pressure (BP) has recently been published, with fixed cut-off values for gender and age. The aim of this study was to validate this method in a large sample of Spanish workers.

Design

A diagnostic test accuracy to assess the validity of the method was performed.

Setting

Occupational health services.

Participants

The studies were conducted in 2012–2016 on a sample of 60 799 workers from the Balearic Islands (Spain).

Interventions

The NCEP-ATP III criteria were used as the gold standard. NIM-MetS has been devised using classification trees (the ² automatic interaction detection method).

Main outcome measures

Anthropometric and biochemical variables to diagnose MetS. Sensitivity, specificity, validity index and Youden Index were determined to analyse the accuracy of the diagnostic test (NIM-MetS).

Results

With regard to the validation of the method, sensitivity was 54.7%, specificity 94.9% and the Validity Index 91.2%. The cut-off value for WHtR was 0.54, ranging from 0.51 (lower age group) to 0.56 (higher age group). Variables more closely associated with MetS were WHtR (area under the curve (AUC)=0.85; 95% CI 0.84 to 0.86) and systolic BP (AUC=0.79; 95% CI 0.78 to 0.80)). The final cut-off values for the non-invasive method were WHtR ≥0.56 and BP ≥128/80 mm Hg, which includes four levels of MetS risk (very low, low, moderate and high).

Conclusions

The analysed method has shown a high validity index (higher than 91%) for the early detection of MetS. It is a non-invasive method that is easy to apply and interpret in any healthcare setting. This method provides a scale of MetS risk which allows more accurate detection and more effective intervention.

https://ift.tt/2q1uh4W

Galangin and Pinocembrin from Propolis Ameliorate Insulin Resistance in HepG2 Cells via Regulating Akt/mTOR Signaling

Insulin resistance has a critical role in type 2 diabetes. The aim of this study was to investigate the effect of pinobanksin, galangin, chrysin, and pinocembrin from propolis on insulin resistance. Our study shows that galangin and pinocembrin can ameliorate insulin resistance; on the contrary, pinobanksin and chrysin are ineffective. Galangin and pinocembrin treatments substantially increase glucose consumption and glycogen content by enhancing the activities of hexokinase and pyruvate kinase. Galangin treatment with 80 μM increased hexokinase and pyruvate kinase activities by 21.94% and 29.12%, respectively. Moreover, we hypothesize that galangin and pinocembrin may have a synergistic effect on the improvement of insulin resistance via Akt/mTOR signaling pathway, through distinctly upregulating the phosphorylation of IR, Akt, and GSK3β and remarkably downregulating the phosphorylation of IRS. Most notably, this is the first study to our knowledge to investigate pinocembrin about the alleviation of insulin resistance. Our results provide compelling evidence for the depth development of propolis products to ameliorate insulin resistance.

https://ift.tt/2S7C91v

Efficacy of Second-Look Ultrasound with MR Coregistration for Evaluating Additional Enhancing Lesions of the Breast: Review of the Literature

Contrast enhanced magnetic resonance imaging (CE-MRI) has acquired a central role in the field of diagnosis and evaluation of breast cancer due to its high sensitivity; on the other hand, MRI has shown a variable specificity because of the wide overlap between the imaging features of benign and malignant lesions. Therefore, when an additional breast lesion is identified at CE-MRI, a second look with targeted US is generally performed because it provides additional information to further characterise the target lesion and makes it possible to perform US-guided biopsies which are costless and more comfortable for patients compared with MRI-guided ones. Nevertheless, there is not always a correspondence between CE-MR findings and targeted US due to several factors including different operator's experience and position of patients. A new technique has recently been developed in order to overcome these limitations: US with MR coregistration, which can synchronise a sonography image and the MR image with multiplanar reconstruction (MPR) of the same section in real time. The aim of our study is to review the literature concerning the second look performed with this emerging and promising technique, showing both advantages and limitations in comparison with conventional targeted US.

https://ift.tt/2CV7uAb

Robustness of biomarker determination in breast cancer by RT-qPCR: impact of tumor cell content, DCIS and non-neoplastic breast tissue

Tissue heterogeneity in formalin-fixed paraffin-embedded (FFPE) breast cancer specimens may affect the accuracy of reverse transcription quantitative real-time PCR (RT-qPCR). Herein, we tested the impact of ti...

https://ift.tt/2Cwy7ur

Repeated mutKRAS ctDNA measurements represent a novel and promising tool for early response prediction and therapy monitoring in advanced pancreatic cancer

Abstract

Background

The presence of mutated KRAS (^mutKRAS ctDNA) in plasma samples has been consistently shown to be a negative prognostic indicator in pancreatic cancer (PC). Only small pilot studies have evaluated the value of serial ^mutKRAS ctDNA-measurements in PC.

Patients and methods

The aim of the present study was to explore the potential of repeated ^mutKRAS ctDNA measurements for response prediction and therapy monitoring in advanced PC patients. We used the BEAMing technology to determine levels of ^mutKRAS ctDNA, CA 19-9, CEA and CYFRA 21-1 in 284 plasma samples of 54 patients with advanced PC receiving gemcitabine-based chemotherapy. Absolute levels and kinetics of ^mutKRAS ctDNA, CA 19-9, CEA and CYFRA 21-1 were correlated to radiological response, progression-free and overall survival.

Results

^mutKRAS ctDNA was present in a majority of advanced PC patients (n = 36/54, 67%) and indicated tissue KRAS mutation status with a high sensitivity (75%) and specificity (100%). The presence of ^mutKRAS ctDNA, as well as higher levels of CA 19-9, CEA and CYFRA 21-1 before initiation of the first-line chemotherapy, was significantly correlated to an adverse overall survival. During therapy, changes in ^mutKRAS ctDNA levels were more rapid and pronounced than changes in protein-based tumor markers. A decrease in ^mutKRAS ctDNA levels during therapy was an early indicator of response to therapy, while there was no significant correlation between kinetics of CA 19-9, CEA or CYFRA 21-1 and response to chemotherapy during the first four weeks of treatment. Repeated ^mutKRAS ctDNA measurements during follow-up appeared to be superior to protein-based tumor markers in detecting progressive disease (sensitivity: 83%, specificity: 100%).

Conclusion

^mutKRAS ctDNA kinetics appear to be a powerful and highly specific tool in early response prediction and therapy monitoring of advanced PC patients receiving chemotherapy.

https://ift.tt/2SbDfcS