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Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment.
No full textPURPOSE
To develop an agreed set of outcomes known as a core outcome set (COS) for Non-Infectious Uveitis of the Posterior Segment (NIU-PS) clinical trials.
DESIGN
Mixed-methods study design comprising a systematic review and qualitative study followed by a two round Delphi exercise and face-to-face consensus meeting.
PARTICIPANTS
Key stakeholders including: patients diagnosed with NIU-PS; their caregivers; healthcare professionals involved in decision-making for patients with NIU-PS including ophthalmologists, nurse practitioners and policymakers/commissioners.
METHODS
A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a two-round Delphi exercise of stakeholders rating the importance of outcomes on a nine-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of 'include', 'exclude' or 'for discussion' that were taken forward to a face-to-face consensus meeting of key stakeholders at which the final COS was agreed.
MAIN OUTCOME MEASURE
Items recommended for inclusion in the COS for NIU-PS RESULTS: A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting of which 7/15 were agreed for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, Health Related Quality of Life (HRQoL), treatment side effects and disease control.
CONCLUSION
This study builds on international work across the clinical trials community and our qualitative research to construct the world's first COS for NIU-PS. The COS provide a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce non-informative research. Some of the outcomes identified do not yet have internationally agreed methods for measurement and should be the subject of future international consensus development.
TRIAL REGISTRATION
The study was registered with COMET (http://comet-initiative.org/studies/details/640)
Perioperative blood transfusion is not an independent predictor for worse outcomes in retroperitoneal sarcoma surgery.
No full textBACKGROUND
Surgery for retroperitoneal soft tissue sarcoma (RPS) is technically challenging, often requiring perioperative red blood cell transfusion (PBT). In other cancers, controversy exists regarding the association of PBT and oncologic outcomes. No study has assessed this association in primary RPS, or identified factors associated with PBT.
METHODS
Data was collected on all resected primary RPS between 2006 and 2020 at The Ottawa Hospital (Canada) and University Hospital Birmingham (United Kingdom). 'PBT' denotes transfusion given one week before surgery until discharge. Multivariable regression (MVA) identified clinicopathologic factors associated with PBT and assessed PBT association with oncologic outcomes. Surgical complexity was measured using resected organ score (ROS) and patterns of resection.
RESULTS
192 patients were included with 98 (50.8%) receiving PBT. Median follow-up was 38.2 months. High tumour grade (OR 2.20, P = 0.048), preoperative anemia (OR 2.78, P = 0.020), blood loss >1000 mL (OR 4.89, P = 0.004) and ROS >2 (OR 2.29, P = 0.026) were associated with PBT on MVA. A direct linear relationship was observed between higher ROS and increasing units of PBT (β = 0.586, P = 0.038). Increasingly complex patterns of resection were associated with increasing odds of PBT. PBT was associated with severe post-operative complications (P = 0.008) on MVA. Univariable association between PBT and 5-year disease-free or overall survival was lost upon MVA.
CONCLUSIONS
Surgical complexity and high tumour grade are potentially related to PBT. Oncologic outcomes are not predicted by PBT but are better explained by tumour grade which subsequently may increase surgical complexity. Strategies to reduce PBT should be considered in primary RPS patients
The first modified Delphi consensus statement on sleeve gastrectomy.
No full textINTRODUCTION
Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG.
METHODS
We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus.
RESULTS
The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE.
CONCLUSION
A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic
Sternal closure with single compared with double or figure-of-8 wires in obese patients post cardiac surgery.
No full textOBJECTIVES
Sternal instability and wound infections are major causes of morbidity following cardiac surgery, which is further amplified in high risk patients that include diabetics and patients with high body mass index (BMI). We compare the different outcomes of different sternal wire closure techniques following median sternotomy for cardiac surgery in obese patients.
METHODS
A comprehensive electronic literature search was undertaken according to PRISMA guidelines from inception to July 2020 to identify all published data comparing single wire sternal closure to either double wire or figure-of-8 techniques following median sternotomy for cardiac surgery in obese patients, defined as a BMI ≥ 30.
RESULTS
Eight studies met the final inclusion criteria; single wire versus double wire sternal closure (n = 2) and single wire versus figure-of-8 wire closure (n = 6). Higher rate of sternal instability was noted in single wire versus double wire closure (22/150 [14.7%] patients vs. 6/150 [4%] patients, p = 0.003, odd ratio [OR] 0.25 [95% confidence interval [CI] 0.10-0.63]). Similarly, sternal instability was higher in single wire vs figure-of-8 wire closure technique (33/2422 [1.3%] vs. 11/8035 [0.1%], p = 0.04 OR 0.30 [95% CI, 0.09-0.96]), respectively.
CONCLUSION
There is benefit in the use of either double or figure-of-8 sternal wire closure techniques over single wire closure in terms of sternal instability. However, as the studies were limited, larger scale comparative studies are required to provide a solid evidence base for choosing the optimal sternal closure technique in this high risk group of patients
Transthoracic echocardiography of hypertrophic cardiomyopathy in adults: a practical guideline from the British Society of Echocardiography.
No full textHypertrophic cardiomyopathy (HCM) is common, inherited and characterised by unexplained thickening of the myocardium. The British Society of Echocardiography (BSE) has recently published a minimum dataset for transthoracic echocardiography detailing the core views needed for a standard echocardiogram. For patients with confirmed or suspected HCM, additional views and measurements are necessary. This guideline, therefore, supplements the minimum dataset and describes a tailored, stepwise approach to the echocardiographic examination, and echocardiography's position in the diagnostic pathway, before advising on the imaging of disease complications and invasive treatments
Disease burden and economic impact of diagnosed non-alcoholic steatohepatitis (nash) in five european countries in 2018: A cost-of-illness analysis.
No full textBACKGROUND AND AIMS
Non-alcoholic steatohepatitis (NASH) is a chronic disease that can progress to end-stage liver disease (ESLD). A large proportion of early-stage NASH patients remain undiagnosed compared to those with advanced fibrosis, who are more likely to receive disease management interventions. This study estimated the disease burden and economic impact of diagnosed NASH in the adult population of France, Germany, Italy, Spain and the United Kingdom (UK) in 2018.
METHODS
The socioeconomic burden of diagnosed NASH was estimated using cost-of-illness methodology applying a prevalence approach to estimate the number of adults with NASH and the attributable economic and wellbeing costs. Given undiagnosed patients do not incur costs in the study, the probability of diagnosis is central to cost estimation. The analysis was based on literature review, databases and consultation with clinical experts, economists and patient groups.
RESULTS
The proportion of adult NASH patients with a diagnosis ranged from 11.9% to 12.7% across countries, which increased to 38.8% to 39.1% for advanced fibrosis (F3 to F4 compensated cirrhosis). Total economic costs were €8,548-19,546M. Of these, health system costs were €619-1,292M. Total wellbeing costs were €41,536-90,379M. The majority of the undiagnosed population (87.3% to 88.2% of total prevalence) was found to have early stage NASH which, left untreated, may progress to more resource consuming ESLD over time.
CONCLUSIONS
This study found the majority of economic and wellbeing costs of NASH are experienced in late disease stages. Earlier diagnosis and care of NASH patients could reduce future healthcare costs
Does insulin resistance influence neurodegeneration in non-diabetic Alzheimer's subjects?
No full textBACKGROUND
Type 2 diabetes is a risk factor for Alzheimer's disease (AD), and AD brain shows impaired insulin signalling. The role of peripheral insulin resistance on AD aetiopathogenesis in non-diabetic patients is still debated. Here we evaluated the influence of insulin resistance on brain glucose metabolism, grey matter volume and white matter lesions (WMLs) in non-diabetic AD subjects.
METHODS
In total, 130 non-diabetic AD subjects underwent MRI and [18F]FDG PET scans with arterial cannula insertion for radioactivity measurement. T1 Volumetric and FLAIR sequences were acquired on a 3-T MRI scanner. These subjects also had measurement of glucose and insulin levels after a 4-h fast on the same day of the scan. Insulin resistance was calculated by the updated homeostatic model assessment (HOMA2). For [18F]FDG analysis, cerebral glucose metabolic rate (rCMRGlc) parametric images were generated using spectral analysis with arterial plasma input function.
RESULTS
In this non-diabetic AD population, HOMA2 was negatively associated with hippocampal rCMRGlc, along with total grey matter volumes. No significant correlation was observed between HOMA2, hippocampal volume and WMLs.
CONCLUSIONS
In non-diabetic AD, peripheral insulin resistance is independently associated with reduced hippocampal glucose metabolism and with lower grey matter volume, suggesting that peripheral insulin resistance might influence AD pathology by its action on cerebral glucose metabolism and on neurodegeneration
