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Treatment of unresectable locally advanced pancreatic cancer with percutaneous irreversible electroporation (IRE) following initial systemic chemotherapy (LAP-PIE) trial: study protocol for a feasibility randomised controlled trial.
No full textBACKGROUND
Approximately 30% of patients with pancreas cancer have unresectable locally advanced disease, which is currently treated with systemic chemotherapy. A new treatment option of irreversible electroporation (IRE) has been investigated for these patients since 2005. Cohort studies suggest that IRE confers a survival advantage, but with associated, procedure-related complications. Selection bias may account for improved survival and there have been no prospective randomised trials evaluating the harms and benefits of therapy. The aim of this trial is to evaluate the feasibility of a randomised comparison of IRE therapy with chemotherapy versus chemotherapy alone in patients with locally advanced pancreatic cancer (LAPC).
METHODS AND ANALYSIS
Eligible patients with LAPC who have undergone first-line 5-FluoroUracil, Leucovorin, Irinotecan and Oxaliplatin chemotherapy will be randomised to receive either a single session of IRE followed by (if indicated) further chemotherapy or to chemotherapy alone (standard of care). Fifty patients from up to seven specialist pancreas centres in the UK will be recruited over a period of 15 months. Trial follow-up will be 12 months. The primary outcome measure is ability to recruit. Secondary objectives include practicality and technical success of treatment, acceptability of treatment to patients and clinicians and safety of treatment. A qualitative study has been incorporated to evaluate the patient and clinician perspective of the locally advanced pancreatic cancer with percutaneous irreversible electroporation trial. It is likely that the data obtained will guide the structure, the primary outcome measure, the power and the duration of a subsequent multicentre randomised controlled trial aimed at establishing the clinical efficiency of pancreas IRE therapy. Indicative procedure-related costings will be collected in this feasibility trial, which will inform the cost evaluation in the subsequent study on efficiency.
ETHICS AND DISSEMINATION
The protocol has received approval by London-Brent Research Ethics Committee reference number 21/LO/0077.Results will be analysed following completion of trial recruitment and follow-up. Results will be presented to international conferences with an interest in oncology, hepatopancreaticobiliary surgery and interventional radiology and be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ISRCTN14986389
Delivery of drinking, eating and mobilising (DrEaMing) and its association with length of hospital stay after major noncardiac surgery: observational cohort study.
No full textBACKGROUND
Enhanced recovery pathways are associated with improved postoperative outcomes. However, as enhanced recovery pathways have become more complex and varied, compliance has reduced. The 'DrEaMing' bundle re-prioritises early postoperative delivery of drinking, eating, and mobilising. We investigated relationships between DrEaMing compliance, postoperative hospital length of stay (LOS), and complications in a prospective multicentre major surgical cohort.
METHODS
We interrogated the UK Perioperative Quality Improvement Programme dataset. Analyses were conducted in four stages. In an exploratory cohort, we identified independent predictors of DrEaMing. We quantified the association between delivery of DrEaMing (and its component variables) and prolonged LOS in a homogenous colorectal subgroup and assessed generalisability in multispecialty patients. Finally, LOS and complications were compared across hospitals, stratified by DrEaMing compliance.
RESULTS
The exploratory cohort comprised 22 218 records, the colorectal subgroup 7230, and the multispecialty subgroup 5713. DrEaMing compliance was 59% (13 112 patients), 60% (4341 patients), and 60% (3421), respectively, but varied substantially between hospitals. Delivery of DrEaMing predicted reduced odds of prolonged LOS in colorectal (odds ratio 0.51 [0.43-0.59], P<0.001) and multispecialty cohorts (odds ratio 0.47 [0.41-0.53], P<0.001). At the hospital level, complications were not the primary determinant of LOS after colorectal surgery, but consistent delivery of DrEaMing was associated with significantly shorter LOS.
CONCLUSIONS
Delivery of bundled and unbundled DrEaMing was associated with substantial reductions in postoperative LOS, independent of the effects of confounder variables. Consistency of process delivery, and not complications, predicted shorter hospital-level LOS. DrEaMing may be adopted by perioperative health systems as a quality metric to support improved patient outcomes and reduced LOS
Risk factors associated with COVID-19 severity among patients on maintenance haemodialysis: a retrospective multicentre cross-sectional study in the UK.
No full textOBJECTIVES
To assess the applicability of risk factors for severe COVID-19 defined in the general population for patients on haemodialysis.
SETTING
A retrospective cross-sectional study performed across thirty four haemodialysis units in midlands of the UK.
PARTICIPANTS
All 274 patients on maintenance haemodialysis who tested positive for SARS-CoV-2 on PCR testing between March and August 2020, in participating haemodialysis centres.
EXPOSURE
The utility of obesity, diabetes status, ethnicity, Charlson Comorbidity Index (CCI) and socioeconomic deprivation scores were investigated as risk factors for severe COVID-19.
MAIN OUTCOMES AND MEASURES
Severe COVID-19, defined as requiring supplemental oxygen or respiratory support, or a C reactive protein of ≥75 mg/dL (RECOVERY trial definitions), and its association with obesity, diabetes status, ethnicity, CCI, and socioeconomic deprivation.
RESULTS
63.5% (174/274 patients) developed severe disease. Socioeconomic deprivation associated with severity, being most pronounced between the most and least deprived quartiles (OR 2.81, 95% CI 1.22 to 6.47, p=0.015), after adjusting for age, sex and ethnicity. There was no association between obesity, diabetes status, ethnicity or CCI with COVID-19 severity. We found no evidence of temporal evolution of cases (p=0.209) or clustering that would impact our findings.
CONCLUSION
The incidence of severe COVID-19 is high among patients on haemodialysis; this cohort should be considered high risk. There was strong evidence of an association between socioeconomic deprivation and COVID-19 severity. Other risk factors that apply to the general population may not apply to this cohort
British Association of Dermatologists guidelines for the management of adults with delusional infestation 2022.
No full textDynamic susceptibility-contrast magnetic resonance imaging with contrast agent leakage correction aids in predicting grade in pediatric brain tumours: a multicenter study.
No full textBACKGROUND
Relative cerebral blood volume (rCBV) measured using dynamic susceptibility-contrast MRI can differentiate between low- and high-grade pediatric brain tumors. Multicenter studies are required for translation into clinical practice.
OBJECTIVE
We compared leakage-corrected dynamic susceptibility-contrast MRI perfusion parameters acquired at multiple centers in low- and high-grade pediatric brain tumors.
MATERIALS AND METHODS
Eighty-five pediatric patients underwent pre-treatment dynamic susceptibility-contrast MRI scans at four centers. MRI protocols were variable. We analyzed data using the Boxerman leakage-correction method producing pixel-by-pixel estimates of leakage-uncorrected (rCBV) and corrected (rCBV) relative cerebral blood volume, and the leakage parameter, K. Histological diagnoses were obtained. Tumors were classified by high-grade tumor. We compared whole-tumor median perfusion parameters between low- and high-grade tumors and across tumor types.
RESULTS
Forty tumors were classified as low grade, 45 as high grade. Mean whole-tumor median rCBV was higher in high-grade tumors than low-grade tumors (mean ± standard deviation [SD] = 2.37±2.61 vs. -0.14±5.55; P<0.01). Average median rCBV increased following leakage correction (2.54±1.63 vs. 1.68±1.36; P=0.010), remaining higher in high-grade tumors than low grade-tumors. Low-grade tumors, particularly pilocytic astrocytomas, showed T1-dominant leakage effects; high-grade tumors showed T2*-dominance (mean K=0.017±0.049 vs. 0.002±0.017). Parameters varied with tumor type but not center. Median rCBV was higher (mean = 1.49 vs. 0.49; P=0.015) and K lower (mean = 0.005 vs. 0.016; P=0.013) in children who received a pre-bolus of contrast agent compared to those who did not. Leakage correction removed the difference.
CONCLUSION
Dynamic susceptibility-contrast MRI acquired at multiple centers helped distinguish between children's brain tumors. Relative cerebral blood volume was significantly higher in high-grade compared to low-grade tumors and differed among common tumor types. Vessel leakage correction is required to provide accurate rCBV, particularly in low-grade enhancing tumors
Acute-on-chronic liver failure: A 20-year retrospective review of a tertiary paediatric liver centre.
No full textAIM
Acute-on-chronic liver failure (ACLF) is an acute deterioration of pre-existing chronic liver disease related to a precipitating event. We characterised paediatric ACLF at Birmingham Children's Hospital (BCH) utilising European Association of Liver Disease CLIF criteria, including prevalence, triggers and outcomes.
METHODS
All BCH patients from 2000 to 2020 with CLD who underwent initial liver transplant or died on the transplant waiting list or whilst too unwell to be listed were reviewed.
RESULTS
From 2000 to 2020, 24 (4%) children with ACLF were identified. Death occurred in 18 (75%). Transplant occurred in 9 (36%), 3 of which died. ACLF triggers were sepsis organism negative 11 (46%), sepsis organism positive 8 (33%) and GI bleed 5 (17%). Bilirubin at the time of transplant/death in those with ACLF who lived compared with those who died was 529 umol/L (381) versus 665 (210) (p=0.38), creatinine 138 umol/L (147) versus 67 (46) (p=0.41), PT 33 sec (14) versus (32 (15) (p = 0.72), Grade 3, 4 hepatic encephalopathy 1 (17%) versus 10 (56%) (p = 0.17), vasopressor use 1 (17%) versus 17 (94%) (p = 0.001) and ventilation 3 (50%) versus 17 (94%) (p = 0.035).
CONCLUSION
Acute-on-chronic liver failure whilst infrequent has high rates of mortality. The use of vasopressors and ventilation is more frequent in those who die from ACLF
Development and Validation of the Anaphylaxis Quality of Life Scale for Adults.
No full textBACKGROUND
Anaphylaxis is a severe and potentially life-threatening allergic reaction that can have a detrimental impact on quality of life (QoL). There are no validated scales to measure the impact of anaphylaxis on QoL of adults.
OBJECTIVE
The aim of this study was to develop and assess the reliability and validity of a QoL scale for adults with anaphylaxis (Anaphylaxis Quality of Life Scale for Adults [A-QoL-Adults]).
METHODS
All participants were recruited from a specialist allergy clinic and had a confirmed diagnosis of anaphylaxis (as per the World Allergy Organization diagnostic criteria) to food, drugs, venom, or latex or had spontaneous anaphylaxis. Interviews were conducted with 13 adults; data were analyzed using thematic analysis to extract items for a QoL scale. A prototype QoL scale was then completed by 115 participants alongside validated scales to measure generic QoL (World Health Organization Quality of Life Scale [Brief Version] [WHOQoL BREF]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), and stress (Perceived Stress Scale [PSS]).
RESULTS
The A-QoL-Adults scale has 21 items demonstrating excellent internal reliability (Cronbach α = 0.96). Factor analysis produced 3 subscales: Emotional Impact; Social Impact; and Limitations on Life. Each has excellent internal reliability (0.92, 0.92, and 0.91, respectively). Poorer anaphylaxis-related QoL (total A-QoL-Adults score and subscale scores) correlated significantly with poorer general QoL and greater anxiety, depression, and stress (all P < .01 with medium-to-large effect sizes).
CONCLUSIONS
The A-QoL-Adults scale is a reliable measure of QoL in adults with anaphylaxis and shows good construct validity. It will offer health care professionals a means to further understand the impact of anaphylaxis on adult patients and could help direct and monitor allergy management and the need for further psychological intervention
WSES/GAIS/WSIS/SIS-E/AAST global clinical pathways for patients with skin and soft tissue infections.
No full textSkin and soft-tissue infections (SSTIs) encompass a variety of pathological conditions that involve the skin and underlying subcutaneous tissue, fascia, or muscle, ranging from simple superficial infections to severe necrotizing infections.Together, the World Society of Emergency Surgery, the Global Alliance for Infections in Surgery, the Surgical Infection Society-Europe, The World Surgical Infection Society, and the American Association for the Surgery of Trauma have jointly completed an international multi-society document to promote global standards of care in SSTIs guiding clinicians by describing reasonable approaches to the management of SSTIs.An extensive non-systematic review was conducted using the PubMed and MEDLINE databases, limited to the English language. The resulting evidence was shared by an international task force with different clinical backgrounds
A systematic review and meta-analysis comparing the use of hook plates and superior plates in the treatment of displaced distal clavicle fractures.
No full textINTRODUCTION
Non-operative treatment of displaced distal clavicle fractures results in high non-union and yet there is no consensus on superior treatment modality. While there are a number of different techniques available for fixation, hook plate (HP) has been used most commonly. A number of modern techniques, including superior plate (SP), have shown less complications but equivocal union rate and shoulder function. The aim of this systematic review and meta-analysis is to compare the outcome of HP fixation with superior plate in surgical fixation of displaced distal clavicle fractures.
PATIENTS AND METHODS
A review of the online databases MEDLINE and Embase was conducted on 15 January 2021 according to PRISMA guidelines. The review was registered prospectively in the PROSPERO database. Clinical studies reporting union rate, complications and shoulder function were included. The studies were appraised using the Methodological Index for Non-Randomized Studies (MINORS) tool.
RESULTS
The search strategy identified 42 studies eligible for inclusion with a total of 1,261 patients. These included 17 hook-plate case series (n = 573), 18 superior plate case series, of which 6 used SP alone (n = 223) and 12 SP and simultaneous CCLR case series (n = 189), and 7 studies comparing HP and SP (n = 276). The overall complication rate was significantly higher with HP when compared to SP [(32.7% vs 12.7%; OR 6.31 (95% CI: 2.67-14.91)]. The overall union rates in the case series appeared comparable in the current SR; HP 96.4%, SP 96.9% and SP with simultaneous CCLR 97.9%. Shoulder function was most commonly assessed using CM score and the mean ranged from 83.8 to 97.2 in HP, 89 to 98 in SP group and 90.6 to 97.6 in SP with CCLR. Meta-analysis of CM score failed to show a significant difference for HP versus SP (pooled weighted mean difference was 2.67 (95% CI: - 0.09 to 5.43) with a trend to favour SP fixation.
CONCLUSION
The current review has demonstrated that HP, SP alone or with CCLR all offer excellent union rate and appear to provide comparative functional outcomes. However, HP is associated with significantly higher complication rates