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Dexamethasone in Hospitalized Patients with Covid-19.
No full textBACKGROUND
Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.
METHODS
In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the final results of this assessment.
RESULTS
A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.92 to 1.55).
CONCLUSIONS
In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.)
The effect of Brexit on, and changes in, the European Union medical device regulations.
No full textWith the exit of the UK from the European Union and the European Union Regulation 201/745 coming into effect on 26 May 2021, the regulatory landscape for medical devices is undergoing a substantial change, the implications of which will be felt by those procuring and using medical devices in clinical settings. This article outlines the changes that clinicians, as users of medical devices, should be aware of in the immediate future
It is our clinical responsibility to recognise and treat delirium - in response to "Delirium in Burn Patients: Developing a Mobile Application for Assessment and Diagnosis".
No full textScapular Winging Secondary to Serratus Anterior Dysfunction: Analysis of Clinical Presentations and Etiology in a Consecutive Series of 96 Patients.
No full textBACKGROUND
This study aimed to establish the relative incidence of etiologies causing serratus anterior (SA) dysfunction in patients with proven abnormality on needle electromyography.
METHODS
This was a retrospective review of patients with scapular winging secondary to SA dysfunction. Each patient underwent a detailed clinical, radiological and neurophysiological assessment to arrive at the precise etiological diagnosis. Patients with atypical clinical features were referred for a neurologist's assessment. Hematological and genetic testing were requested at the discretion of the neurologist. A scapular winging severity score based on clinical signs was devised to aid clinical grading.
RESULTS
Between 2014 and 2020, a consecutive series of 108 patients with suspected SA dysfunction were assessed, of which 96 met the inclusion criteria. There were 34 females and 62 males with a mean age of 38 years (range 15-77). Winging affected the right scapulae in 69 patients, the left in 17 and were bilateral in 10. This was caused by a myopathic disorder in 12 (12%) patients. Eighty-four (88%) patients had a long thoracic nerve lesion, caused by cervical pathology (2), iatrogenic injury (2), trauma (33), and neuralgic amyotrophy (NA) (47). Among those with NA, winging resolved spontaneously within 3 years of onset in 22 patients (mean duration 16 months, range 3-36 months). No patients recovered fully if their duration of winging lasted longer than 3 years. Patients with palsy secondary to NA tended to have a worse severity of winging than those due to a traumatic cause (p=0.04).
CONCLUSION
NA accounted for approximately half of the patients with SA dysfunction, therefore it is essential to also consider the differentials of myopathy, trauma, iatrogenic injury and spinal pathology. We recommend the judicious employment of ancillary tests and a low threshold of referral to a neurologist, in order to arrive at the exact diagnosis to accurately guide patient treatment
Nephrotic syndrome secondary to alpha-1 antitrypsin deficiency.
No full textWe report a 64-year-old caucasian woman diagnosed with membranous nephropathy secondary to alpha-1 antitrypsin deficiency (AATD). AATD is a rare autosomal codominant genetic disorder. Its clinical manifestations are mostly observed in the lungs, with early-onset emphysema. Nephropathy due to AATD is still very rare and only a few cohort studies have been reported. It has been recognised that alpha-1 antitrypsin has a protective role in the kidneys which enhances the possibility of development of kidney failure, such as nephrotic syndrome, in cases of AATD. Further clinical investigation is needed to understand the relationship between the development of nephropathy, namely membranous nephropathy, and AATD
Systematic review of the use of translated patient-reported outcome measures in cancer trials.
No full textBACKGROUND
Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition.
METHODS
Protocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs.
RESULTS
Eighty-four trials met the inclusion criteria, only 14 (17%) (n = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies. Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified.
CONCLUSIONS
Greater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials
Cost-effectiveness of bariatric surgery versus community weight management to treat obesity-related idiopathic intracranial hypertension: evidence from a single-payer healthcare system.
No full textBACKGROUND
Idiopathic intracranial hypertension (IIH) is associated with significant morbidity, predominantly affecting women of childbearing age living with obesity. Weight loss has demonstrated successful disease-modifying effects; however, the long-term cost-effectiveness of weight loss interventions for the treatment of IIH has not yet been established.
OBJECTIVES
To estimate the cost-effectiveness of weight-loss treatments for IIH.
SETTING
Single-payer healthcare system (National Health Service, England).
METHODS
A Markov model was developed comparing bariatric surgery with a community weight management intervention over 5-, 10-, and 20-year time horizons. Transition probabilities, utilities, and resource use were informed by the IIH Weight Trial (IIH:WT), alongside the published literature. A probabilistic sensitivity analysis was conducted to characterize uncertainty within the model.
RESULTS
In the base case analysis, over a 20-year time horizon, bariatric surgery was "dominant," led to cost savings of £49,500, and generated an additional 1.16 quality-adjusted life years in comparison to the community weight management intervention. The probabilistic sensitivity analysis indicated a probability of 98% that bariatric surgery is the dominant option in terms of cost-effectiveness.
CONCLUSION
This economic modeling study has shown that when compared to community weight management, bariatric surgery is a highly cost-effective treatment option for IIH in women living with obesity. The model shows that surgery leads to long-term cost savings and health benefits, but that these do not occur until after 5 years post surgery, and then gradually increase over time
