Scunthorpe, United Kingdom
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Lee S.M.,University College London | Khan I.,University College London | Upadhyay S.,Scunthorpe General Hospital | Lewanski C.,Charing Cross Hospital | And 15 more authors.
The Lancet Oncology | Year: 2012

Background: Many patients with advanced non-small-cell lung cancer (NSCLC) receive only active supportive care because of poor performance status or presence of several comorbidities. We investigated whether erlotinib improves clinical outcome in these patients. Methods: TOPICAL was a double-blind, randomised, placebo-controlled, phase 3 trial, done at 78 centres in the UK. Eligibility criteria were newly diagnosed, pathologically confirmed NSCLC; stage IIIb or IV; chemotherapy naive; no symptomatic brain metastases; deemed unsuitable for chemotherapy because of poor (≥2) Eastern Cooperative Oncology Group performance status or presence of several comorbidities, or both; and estimated life expectancy of at least 8 weeks. Patients were randomly assigned (by phone call, in a 1:1 ratio, stratified by disease stage, performance status, smoking history, and centre, block size 10) to receive oral placebo or erlotinib (150 mg per day) until disease progression or unacceptable toxicity. Investigators, clinicians, and patients were masked to assignment. The primary endpoint was overall survival. Analyses were by intention to treat, and prespecified subgroup analyses included development of a rash due to erlotinib within 28 days of starting treatment. This study is registered, number ISRCTN 77383050. Findings: Between April 14, 2005, and April 1, 2009, we randomly assigned 350 patients to receive erlotinib and 320 to receive placebo. We followed up patients until March 31, 2011. 657 patients died; median overall survival did not differ between groups (erlotinib, 3·7 months, 95% CI 3·2-4·2, vs placebo, 3·6 months, 3·2-3·9; unadjusted hazard ratio [HR] 0·94, 95% CI 0·81-1·10, p=0·46). 59% (178 of 302) of patients assigned erlotinib and who were assessable at 1 month developed first-cycle rash, which was the only independent factor associated with overall survival. Patients with first-cycle rash had better overall survival (HR 0·76, 95% CI 0·63-0·92, p=0·0058), compared with placebo. Compared with placebo, overall survival seemed to be worse in the group that did not develop first-cycle rash (1·30, 1·05-1·61, p=0·017). Grade 3 or 4 diarrhoea was more common with erlotinib than placebo (8% [28 of 334] vs 1% [four of 313], p=0·0001), as was high-grade rash (23% [79 of 334] vs 2% [five of 313], p<0·0001); other adverse events were much the same between groups. Interpretation: Patients with NSCLC who are deemed unsuitable for chemotherapy could be given erlotinib. Patients who develop a first-cycle rash should continue to receive erlotinib, whereas those who do not have a rash after 28 days should discontinue erlotinib, because of the possibility of decreased survival. Funding: Cancer Research UK, Roche. © 2012 Elsevier Ltd.


Mannan A.,Scunthorpe General Hospital | Smith T.O.,University of East Anglia | Sagar C.,Scunthorpe General Hospital | London N.J.,Harrogate District Hospital | Molitor P.J.A.,Scunthorpe General Hospital
Orthopaedics and Traumatology: Surgery and Research | Year: 2015

Aim: A systematic review and meta-analysis of clinical studies assessing alignment outcomes in patient-specific instrumented (PSI) knee arthroplasty was conducted. Materials and methods: PRISMA compliant data was extracted from literature databases up to January 2014. Results: Twenty-six studies met the inclusion criteria, reporting a total of 1792 knees. Twenty-three studies reported alignment outcomes in the coronal plane, 11 in the sagittal plane. In all but three series, MRI was the preoperative imaging modality. Range of mean postoperative alignment (hip-knee-ankle [HKA] angle) was 176.5 to 181.70. The proportion of three degrees of outliers showed an overall mean of 18.6%. In total, fifteen studies compared alignment outcomes between standard and PSI. From these, four studies showed significantly higher accuracy of coronal plane alignment with PSI (HKA angle). Meta-analysis of seven high-quality comparative studies demonstrated no significant increased accuracy in postoperative mechanical axis (HKA angle) with PSI. Subgroup meta-analysis of both femoral and tibial rotation was not feasible due to a low number of inclusive high-quality series. Conclusions: PSI knee arthroplasty is shown not to confer increased accuracy in reconstituting the postoperative mechanical axis. Further studies are required to demonstrate both clinical and radiological alignment outcomes in PSI knee arthroplasty with focus upon tibial and femoral rotation. Level of evidence: Level 2-meta-analysis. © 2015 Elsevier Masson SAS.


Kaura V.,Scunthorpe General Hospital | Bonner S.,James Cook University
Trends in Anaesthesia and Critical Care | Year: 2012

Subarachnoid haemorrhage (SAH) results in the release of numerous cerebral biomarkers into the cerebrospinal fluid (CSF) and the systemic circulation. Multiple biomarkers have been identified and it has been postulated that some of these may be used in the early identification and diagnosis of the condition, its sequelae, as well as for determining the prognosis. This article reviews the current knowledge base that exists regarding the biomarker expression associated with SAH and the evidence behind their potential use in early diagnosis and identification of complications. Finally the importance of developing validated biomarkers to optimise clinical management of this common life threatening condition is discussed. © 2011 Elsevier Ltd.


Delicata M.,Northern General Hospital | Banerjee A.,Scunthorpe General Hospital
BMJ Case Reports | Year: 2015

We present an interesting case of Legionnaires' disease masquerading as acute pyelonephritis, with complete absence of respiratory symptoms on admission. A 45-year-old man was diagnosed with Legionnaires' disease 2 days after presenting to hospital with dysuria and right loin pain. He became critically unwell during the hospital admission, with headache, uncontrolled fever, breathlessness, decreasing oxygen saturations and increasing oxygen requirements. A CT pulmonary angiography demonstrated right upper lobar consolidation and Legionella urinary antigen was positive. He was treated with ciprofloxacin and rifampicin and made a full recovery. Copyright 2015 BMJ Publishing Group. All rights reserved.


Penston J.,Scunthorpe General Hospital
Journal of Evaluation in Clinical Practice | Year: 2011

Much of medical research involves large-scale randomized controlled trials designed to detect small differences in outcome between the study groups. This approach is believed to produce reliable evidence on which the management of patients is based. But can we be sure that the demonstration of a small, albeit statistically significant, difference is sufficient to infer the presence of a causal relationship between the drug and the outcome? A study is claimed to have internal validity when other explanations for the observed difference - namely, inequalities between the groups, bias in the assessment of the outcome and chance - have been excluded. Despite the various processes that are put into place - including, for example, randomization, allocation concealment, double-blinding and intention-to-treat analysis - it remains doubtful whether the groups are equal in terms of all factors relevant to the outcome and whether bias has been excluded. As for the exclusion of chance, not only may inappropriate statistical tests be used, but also frequentist statistics has been subjected to serious criticisms in recent years that further bring internal validity into question. But the problems do not end with the flaws in internal validity. The philosophical basis of large-scale randomized controlled trials and epidemiological studies is unsound. When examined closely, many obstacles emerge that threaten the inference from a small, statistically significant difference to the presence of a causal relationship between the drug and the outcome. Given the influence of statistics-based research on the practice of medicine, it is of the utmost importance that the flaws in this methodology are brought to the fore. © 2011 Blackwell Publishing Ltd.


Richards E.,Scunthorpe General Hospital | Vijh R.,Scunthorpe General Hospital
Breast | Year: 2011

Claims for poor cosmetic outcome account for a large proportion of breast care malpractice litigation in the UK. Detailed analysis of such claims has not been conducted. We sought to analyse National Health Service Litigation Authority (NHSLA) data pertaining to breast care over the period September 2005-April 2008, focussing on claims for poor cosmetic outcome. Data from a medical indemnity organisation detailing similar claims in the private sector were also analysed. Comparison of the NHSLA data with previously obtained NHSLA data (May 1995-September 2005) demonstrated an upward trend in claims for poor cosmetic outcome. The majority of claimants for poor cosmesis had benign disease and the vast majority of claimants with breast malignancy had undergone breast reconstruction. The majority of claims for poor cosmetic outcome were against plastic surgeons. This was more marked in the private sector data than in the NHSLA data, reflecting their workload. © 2010 Elsevier Ltd.


The management of ventilated patients on intensive care has, at its core, a care bundle; an evidence based group of actions designed to reduce the risk of ventilator-associated pneumonia. One of these is the daily cessation of sedation medication to expedite weaning from ventilatory support. A reflection-on-action exercise was carried out when a spinally injured patient became physically active during a sedation hold. This was attributed to hyperactive delirium. The concern was the conflict between providing evidence based Intensive Care Unit (ICU) therapy care and maintaining spinal immobility.Reflection on this incident led to a literature search for guidance on the likelihood of delirium causing secondary spinal injury in patients with unstable fractures. There was plentiful research on delirium and its consequences but very little examining the link between spinal injury and delirium. In order to be able to provide evidence-based care to future trauma patients the research supporting spinal immobilisation was also examined.The research showed that compliance with ventilator care bundles reduced the risks of acquiring ventilator-associated pneumonia. Research surrounding spinal immobilisation was conflicting and there were no studies linking the consequences of immobilised patients experiencing hyperactive delirium.Through a case study approach the research was reviewed in relation to a particular patient and although literature was lacking some implications for practice could be identified to promote the best possible outcomes.Sedation cessation episodes are an essential part of patient care on intensive care. For spinally injured patients' these may need to be modified to sedation reductions to prevent sudden wakening and uncontrolled movement should the patient be experiencing hyperactive delirium. This case study clearly highlights the need for further research in this area as the consequences of both ventilator associated pneumonia and extending spinal injuries is costly for both patients and hospitals. © 2013 Elsevier Ltd.


Leonidou A.,Scunthorpe General Hospital | Cam N.B.,Scunthorpe General Hospital | Chambers I.R.,Scunthorpe General Hospital
Surgeon | Year: 2011

Introduction: Femoral neck fractures are an increasingly common injury in the elderly. Frequently these patients present taking Clopidogrel, an irreversible inhibitor of platelet aggregation. Although this is associated with an increased risk of intra-operative bleeding and also an increased risk of spinal haematoma where regional anaesthesia is employed, the recent SIGN (Scottish Intercollegiate Guidance Network) guidelines recommend that surgery should not be delayed. Methods: We conducted a retrospective review of consecutive patients admitted with femoral neck fractures between April 2008 and October 2009. Patients on Clopidogrel were identified and data including ASA grade, time to operation, medical co-morbidities, and post-admission complications were recorded. Comparative information from the National Hip Fracture Database was used. Results: 405 patients were included. 27 patients were taking Clopidogrel on admission and they were all ASA 3 or 4. Mean time to theatre was 8 days. Post-admission medical complications occurred in 7 patients (25.9%). A further 4 patients (14.8%) died, 3 of them post-operatively. From the study population a control group of 72 ASA 3 and 4 patients was further studied. The mean time to operation was 2.3 days. Post-admission medical complications occurred in 13 patients (18%) and 8 patients (11%) died post-operatively. The difference in the mortality and morbidity of these two groups was found to be statistically not significant. In 2009 the national mean time to operation was 2.19 days with an associated mortality rate of 8.67%. Discussion and conclusion: Patients receiving Clopidogrel have complex medical co-morbidities and a higher anaesthetic risk. Delaying operative management might be contributing to the increased rate of mortality and morbidity. In accordance with the SIGN guidelines we recommend early operative intervention in these high risk patients. © 2010 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland.


Morgan J.L.,Scunthorpe General Hospital | Vijh R.,Scunthorpe General Hospital
Breast | Year: 2013

Malpractice litigation involving the delivery of breast care has been evaluated in the United States of America (USA) but is a relatively new area of study in the United Kingdom (UK). We sought to study and evaluate the emerging trends in litigation claims in relation to breast disease with the National Health Service Litigation Authority (NHSLA) over the last 15 years, up to December 2010. © 2013 Elsevier Ltd.


Raychaudhuri M.,Scunthorpe General Hospital | Chew P.R.,University of Hull
Sexually Transmitted Infections | Year: 2012

A new pattern of disease caused by Panton-Valentine leukocidin (PVL)-positive strains of Staphylococcus aureus is emerging in the UK and worldwide. Community-associated methicillin-resistant S aureus (MRSA) is more likely to produce PVL, a pore-forming cytotoxin inducing leucocyte lysis, which often infects young healthy individuals. The worldwide emergence and continually increasing prevalence of community-acquired PVL-MRSA have recently attracted high-profile media attention and prompted concern regarding the transmissibility and virulence. This paper reports a case of genitourinary tract infection associated with PVL-positive community-associated MRSA in an immunocompetent young man.

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