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Nuclease Therapy Improves Severe Fatigue in Primary Sjögren's Syndrome: A Randomized Clinical Trial.
No full textOBJECTIVE
To assess the safety and efficacy of RSLV-132, an RNase Fc fusion protein in a phase II randomized, double-blind, placebo-controlled clinical trial in patients with primary Sjögren's syndrome (pSS).
METHODS
Thirty patients were randomized to receive intravenous RSLV-132 or placebo, weekly for two weeks then every two weeks for twelve weeks. Eight subjects received placebo and twenty received RSLV-132, 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI), EULAR Sjögren's syndrome patient reported index (ESSPRI), FACIT fatigue (FACIT-F), and profile of fatigue (ProF), and the digit symbol substitution test (DSST).
RESULTS
Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST. This improvement was correlated with increased expression of selected interferon-inducible genes.
CONCLUSION
Administration of RSLV-132 improved severe fatigue in pSS patients as determined by four independent measures of fatigue
Bringing into focus treatment limitation and DNACPR decisions: How COVID-19 has changed practice.
No full textBACKGROUND
The COVID-19 pandemic has introduced further challenges into Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) decisions. Existing evidence suggests success rates for CPR in COVID-19 patients is low and the risk to healthcare professionals from this aerosol-generating procedure complicates the benefit/harm balance of CPR.
METHODS
The study is based at a large teaching hospital in the United Kingdom where all DNACPR decisions are documented on an electronic healthcare record (EHR). Data from all DNACPR/TEAL status forms between 1st January 2017 and 30th April 2020 were collected and analysed. We compared patterns of decision making and rates of form completion during the 2-month peak pandemic phase to an analogous period during 2019.
RESULTS
A total of 16,007 forms were completed during the study period with a marked increase in form completion during the COVID-19 pandemic. Patients with a form completed were on average younger and had fewer co-morbidities during the COVID-19 period than in March-April 2019. Several questions on the DNACPR/TEAL forms were answered significantly differently with increases in patients being identified as suitable for CPR (23.8% versus 9.05%; p < 0.001) and full active treatment (30.5% versus 26.1%; p = 0.028). Whilst proportions of discussions that involved the patient remained similar during COVID-19 (95.8% versus 95.6%; p = 0.871), fewer discussions took place with relatives (50.6% versus 75.4%; p < 0.001).
CONCLUSION
During the COVID-19 pandemic, the emphasis on senior decision making and conversations around ceilings of treatment appears to have changed practice, with a higher proportion of patients having DNACPR/TEAL status documented. Understanding patient preferences around life-sustaining treatment versus comfort care is part of holistic practice and supports shared decision making. It is unclear whether these attitudinal changes will be sustained after COVID-19 admissions decrease
Conservative management of oesophageal soft food bolus impaction.
No full textBACKGROUND
Impaction of a soft food bolus in the oesophagus causes dysphagia and regurgitation. If the bolus does not pass spontaneously, then the patient is at risk of aspiration, dehydration, perforation, and death. Definitive management is with endoscopic intervention, recommended within 24 hours. Prior to endoscopy, many patients undergo a period of observation, awaiting spontaneous disimpaction, or may undergo enteral or parenteral treatments to attempt to dislodge the bolus. There is little consensus as to which of these conservative strategies is safe and effective to be used in this initial period, before resorting to definitive endoscopic management for persistent impaction.
OBJECTIVES
To evaluate the efficacy of non-endoscopic conservative treatments in the management of soft food boluses impacted within the oesophagus.
SEARCH METHODS
We searched the following databases, using relevant search terms: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and CINAHL. The date of the search was 18 August 2019. We screened the reference lists of relevant studies and reviews on the topic to identify any additional studies.
SELECTION CRITERIA
We included randomised controlled trials of the management of acute oesophageal soft food bolus impaction, in adults and children, reporting the incidence of disimpaction (confirmed radiologically or clinically by return to oral diet) without the need for endoscopic intervention. We did not include studies focusing on sharp or solid object impaction.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane.
MAIN RESULTS
We identified 890 unique records through the electronic searches. We excluded 809 clearly irrelevant records and retrieved 81 records for further assessment. We subsequently included one randomised controlled trial that met the eligibility criteria, which was conducted in four Swedish centres and randomised 43 participants to receive either intravenous diazepam followed by glucagon, or intravenous placebos. The effect of the active substances compared with placebo on rates of disimpaction without intervention is uncertain, as the numbers from this single study were small, and the rates were similar (38% versus 32%; risk ratio 1.19, 95% confidence interval 0.51 to 2.75, P = 0.69). The certainty of the evidence using GRADE for this outcome is low. Data on adverse events were lacking.
AUTHORS' CONCLUSIONS
There is currently inadequate data to recommend the use of any enteral or parenteral treatments in the management of acute oesophageal soft food bolus impaction. There is also inadequate data regarding potential adverse events from the use of these treatments, or from potential delays in definitive endoscopic management. Caution should be exercised when using any conservative management strategies in these patients
Reviewing the Recent Developments in Idiopathic Intracranial Hypertension.
No full textThere is increasing evidence and appreciation of idiopathic intracranial hypertension (IIH) in medicine. The pathological processes underlying raised intracranial pressure are being studied, with new insights found in both hormonal dysregulation and the metabolic neuroendocrine axis. These will potentially lead to novel therapeutic targets for IIH. The first consensus guidelines have been published on the investigation and management of adult IIH, and the International Headache Society criteria for headache attributable to IIH have been modified to reflect our evolving understanding of IIH. Randomized clinical trials have been published, and a number of studies in this disease area are ongoing
Impact of Right Ventricular Dysfunction on Mortality in Patients Hospitalized with COVID-19 according to Race.
No full textBackground
Epidemiological studies suggest that black, Asian and minority ethnic (BAME) patients may be at risk of worse outcomes from Coronavirus-19 (COVID-19) but the pathophysiological drivers for this association are unknown. This study sought to investigate the relationship between findings on echocardiography, mortality and race in COVID-19 pneumonia.
Methods
This was a multicenter, retrospective, observational study including 164 adults (61±13years; 78% male; 36% BAME) hospitalized with COVID-19 undergoing echocardiography between March 16 and May 9, 2020 at 3 days (IQR 2 - 5) from admission. The primary outcome was all-cause mortality.
Results
After a median follow up of 31 days (IQR 14 - 42 days), 58 (35%) patients had died. The right ventricle (RV) was dilated in 62 (38%) patients, and 58 (35%) patients had RV systolic dysfunction. Only 2 (1%) patients had left ventricular (LV) dilatation and 133 (81%) had normal or hyperdynamic LV systolic function. Reduced tricuspid annulus planar systolic excursion was associated with elevated D-dimer (ρ = -0.18, p = 0.025) and high-sensitivity cardiac Troponin (ρ = -0.30, p < 0.0001). Reduced RV systolic function (HR, 1.80; 95% CI, 1.05 - 3.09; p = 0.032) was an independent predictor of all-cause mortality after adjustment for demographic and clinical risk factors. Comparing white and BAME individuals, there were no differences in echocardiography findings, biomarkers or mortality.
Conclusions
In patients hospitalized with COVID-19 pneumonia, reduced RV systolic function is prevalent and associated with all-cause mortality. There is however, no racial variation in the early findings on echocardiography, biomarkers or mortality
Letter to Burns in Response to Letter to the Editor in response to the impact of serum zinc normalization on clinical outcomes in severe burn patients (Article in Press) by Olsen, Coffey and Porter et al.
No full text
Reducing Implant Infection in Orthopaedics (RIIiO): Results of a Pilot Study Comparing the Influence of Forced Air and Resistive Fabric Warming Technologies on Post-Operative Infections following Orthopaedic Implant Surgery.
No full textBACKGROUND
Active warming during surgery prevents perioperative hypothermia but the effectiveness and post-operative infection rates may differ between warming technologies. We report results of a pilot study in patients over the age of 65 undergoing hemiarthroplasty following fractured neck of femur.
AIM
To establish the recruitment and data management strategies needed for a full trial comparing post-operative infection rates associated with forced air versus resistive fabric warming.
METHODS
Participants were randomised 1:1 in permuted blocks to forced air or resistive fabric warming. Hypothermia was defined as a temperature of <36ºC at the end of surgery. Primary outcomes were the number of participants recruited and the number with definitive deep surgical site infections.
FINDINGS
515 participants were randomised at 6 sites over a period of 18 months. Follow-up was completed for 70.1%. Thirty-seven participants were hypothermic (7.5% in the FAW group; 9.7 % in the RFW group). The mean temperatures before anaesthesia and at the end of surgery were similar. For the primary clinical outcome, there were 4 deep surgical site infections in the forced air warming group and 3 in the resistive fabric warming group. All participants who developed a post-operative infection had antibiotic prophylaxis, a cemented prosthesis and were operated under laminar airflow; none were hypothermic. There were no serious adverse events related to warming.
CONCLUSION
Surgical site infections were identified in both groups. Progression from the pilot to the full trial is possible but will need to take account of the high attrition rate.
TRIAL REGISTRATION
ISRCTN 74612906 (http://www.isrctn.com/ISRCTN74612906)
Gastrectomy Alone or in Combination With Hepatic Resection in the Management of Liver Metastases From Gastric Cancer: A Systematic Review Using an Updated and Cumulative Meta-Analysis.
No full textBackground
Recent studies have demonstrated that hepatectomy in patients with synchronous hepatic gastric metastases may improve survival in certain patients. This study aimed to evaluate survival benefits of gastrectomy plus hepatectomy versus gastrectomy alone in patients with hepatic gastric metastases.
Methods
Studies were identified by a systematic search of Embase, PubMed, Cochrane Library, and Google Scholar databases. Traditional and cumulative meta-analyses were used to monitor the evidence over time.
Results
Eleven studies which included 861 patients compared gastrectomy plus hepatic resection in 349 patients with gastrectomy alone in 512 patients. Overall significantly better survival rates of 1, 2, 3, and 5 years were demonstrated for patients who underwent gastrectomy plus hepatic resection compared to patients who under underwent gastrectomy alone ((hazard ratio (HR) = 0.52 (0.39, 0.69), P < 0.001), (HR = 0.85 (0.74, 0.97), P = 0.01), (HR = 0.80 (0.72, 0.90), P = 0.003), (HR = 0.83 (0.78, 0.90), P < 0.001), respectively).
Conclusions
Carefully selected patients with hepatic gastric metastases may benefit from hepatic resection
Simultaneous, Delayed and Liver-First Hepatic Resections for Synchronous Colorectal Liver Metastases: A Systematic Review and Network Meta-Analysis.
No full textBackground
Systematic reviews and meta-analyses that compare simultaneous, delayed and liver-first approach for synchronous colorectal liver metastases have found no significant differences. The aim of this study was to determine the best treatment strategy on the basis of effect sizes and the probabilities of treatment ranking by using a network meta-analysis. Moreover, first-time pairwise and network meta-analyses were used to estimate the existing evidence, and their results were compared to detect any discrepancies between them.
Methods
Systematic review, pairwise meta-analysis and network meta-analysis were performed. The primary and secondary outcomes were 5-year overall survival and postoperative major morbidity, respectively.
Results
No significant differences in long-term survival and major morbidity were found amongst the three approaches. The hazard ratios (95% confidence interval) for 5-year overall survival for the simultaneous, delayed and liver-first approaches were 0.93 (0.69 - 1.24, P = 0.613), 0.97 (0.87 - 1.07, P = 0.596) and 0.90 (0.67 - 1.22, P = 0.499), respectively. Moreover, the liver-first approach with a surface under the cumulative ranking area score of 89% was ranked as the potentially best treatment option based on probabilities of treatment ranking.
Conclusions
On the basis of the relative ranking of treatments, the liver-first approach ranked first, followed by the delayed and simultaneous approaches. Therefore, a three-arm randomized controlled trial that compares the liver-first, simultaneous and delayed approaches needs to shed further light as to which is the best treatment option