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Barrett-Lee P.,Velindre Hospital | Casbard A.,University of Cardiff | Abraham J.,Velindre Hospital | Hood K.,University of Cardiff | And 7 more authors.
The Lancet Oncology | Year: 2014

Background: Bisphosphonates are routinely used in the treatment of metastatic bone disease from breast cancer to reduce pain and bone destruction. Zoledronic acid given by intravenous infusion has been widely used, but places a substantial logistical burden on both patient and hospital. As a result, the use of oral ibandronic acid has increased, despite the absence of comparative data. In the ZICE trial, we compared oral ibandronic acid with intravenous zoledronic acid for the treatment of metastatic breast cancer to bone. Methods: This phase 3, open-label, parallel group active-controlled, multicentre, randomised, non-inferiority phase 3 study was done in 99 UK hospitals. Eligibility criteria included at least one radiologically confirmed bone metastasis from a histologically confirmed breast cancer. Patients with ECOG performance status 0 to 2 and clinical decision to treat with bisphosphonates within 3 months of randomisation were randomly assigned to receive 96 weeks of treatment with either intravenous zoledronic acid at 4 mg every 3-4 weeks or oral ibandronic acid 50 mg daily. Randomisation (1:1) was done via a central computerised system within stratified block sizes of four. Randomisation was stratified on whether patients had current or planned treatment with chemotherapy; current or planned treatment with hormone therapy; and whether they had a previous skeletal-related event within the last 3 months or had planned radiotherapy treatment to the bone or planned orthopaedic surgery due to bone metastases. The primary non-inferiority endpoint was the frequency and timing of skeletal-related events over 96 weeks, analysed using a per-protocol analysis. All active (non-withdrawn) patients have now reached the 96-week timepoint and the trial is now in long-term follow-up. The trial is registered with ClinicalTrials.gov, number NCT00326820. Findings: Between Jan 13, 2006, and Oct 4, 2010, 705 patients were randomly assigned to receive ibandronic acid and 699 to receive zoledronic acid; three patients withdrew immediately after randomisation. The per-protocol analysis included 654 patients in the ibandronic acid group and 672 in the zoledronic acid group. Annual rates of skeletal-related events were 0·499 (95% CI 0·454-0·549) with ibandronic acid and 0·435 (0·393-0·480) with zoledronic acid; the rate ratio for skeletal-related events was 1·148 (95% CI 0·967-1·362). The upper CI was greater than the margin of non-inferiority of 1·08; therefore, we could not reject the null hypothesis that ibandronic acid was inferior to zoledronic acid. More patients in the zoledronic acid group had renal toxic effects than in the ibandronic acid group (226 [32%] of 697 vs 172 [24%] of 704) but rates of osteonecrosis of the jaw were low in both groups (nine [1%] of 697 vs five [<1%] of 704). The most common grade 3 or 4 adverse events were fatigue (97 [14%] of 697 patients allocated zoledronic acid vs 98 [14%] of 704 allocated ibandronic acid), increased bone pain (92 [13%] vs 86 [12%]), joint pain (42 [6%] vs 38 [5%]), infection (33 [5%] vs 24 [3%]), and nausea or vomiting (38 [5%] vs 41 [6%]). Interpretation: Our results suggest that zoledronic acid is preferable to ibandronic acid in preventing skeletal-related events caused by bone metastases. However, both drugs have acceptable side-effect profiles and the oral formulation is more convenient, and could still be considered if the patient has a strong preference or if difficulties occur with intravenous infusions. Funding: Roche Products Ltd (educational grant), supported by National Institute for Health Research Cancer Network, following endorsement by Cancer Research UK (CRUKE/04/022). © 2014 Elsevier Ltd.


Proctor R.D.,Royal Cornwall Hospitals NHS Trust | Rofe C.J.,University of Southampton | Bryant T.J.C.,University of Southampton | Hacking C.N.,University of Southampton | Stedman B.,University of Southampton
Clinical Radiology | Year: 2013

Autoimmune pancreatitis (AIP) remains one of the rarer forms of pancreatitis but has become increasingly well recognized and widely diagnosed as it is an important differential, particularly due to the dramatic response to appropriate therapy. It is now best considered as part of a multisystem disease and the notion of "IgG4-related systemic sclerosing disease" has become widely recognized as the number of extra-pancreatic associations of AIP grows. More recently AIP has been classified into two subtypes: lymphoplasmacytic sclerosing pancreatitis (LPSP) and idiopathic duct-centric pancreatitis (IDCP) with distinct geographical, age and sex distributions for the two subtypes, in addition to different pathological characteristics. The role of imaging is crucial in AIP and should be considered in conjunction with clinical, serological, and histopathological findings to make the diagnosis. Radiologists are uniquely placed to raise the possibility of AIP and aid the exclusion of significant differentials to allow the initiation of appropriate management and avoidance of unnecessary intervention. Radiological investigation may reveal a number of characteristic imaging findings in AIP but appearances can vary considerably and the focal form of AIP may appear as a pancreatic mass, imitating pancreatic carcinoma. This review will illustrate typical and atypical appearances of AIP on all imaging modes. Emphasis will be placed on the imaging features that are likely to prove useful in discriminating AIP from other causes prior to histopathological confirmation. In addition, examples of relevant differential diagnoses are discussed and illustrated. © 2012 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.


Gunawardene A.R.,Royal Cornwall Hospitals NHS Trust | Chant H.,Royal Cornwall Hospitals NHS Trust
Annals of the Royal College of Surgeons of England | Year: 2014

Temporal artery biopsy is considered the gold standard investigation of giant cell arteritis and is recommended in suspected cases despite a sensitivity of 81-91%. This review highlights the potential risk of facial nerve injury during temporal artery biopsy and introduces recent advances in the emerging role of imaging modalities. When these non-invasive techniques are used in conjunction with American College of Rheumatology scoring, which includes clinical features and biochemical test results, temporal artery biopsy may be avoided in selected cases.


Brown A.S.,Royal Cornwall Hospitals NHS Trust
Clinical Governance | Year: 2011

Purpose - Risk management is becoming an increasingly important topic in healthcare. The dangers of conducting clinical trials were brought to the attention of the public by the media in 2006 with the TGN1412 phase 1 clinical trial. Clinical trials are however important for the development of new drugs. There are a number of gatekeepers for the safety of trials but risk assessment is now becoming an important aspect. This paper aims to focus on clinical trials. Design/methodology/approach - A new risk assessment tool was developed to collect data relating to the contributory factors and control measures associated with clinical trials. The responses to a series of 29 questions are then scored to inform a risk rating for the clinical trial Practical implications - The theoretical model was converted into a Microsoft Excel spreadsheet with drop down boxes for the responses to the questions. Research management staff have found the tool simple and quick to use. A printout of the assessment can be placed in the study folder as evidence. Highlighted risks are then flagged up to the organisation's corporate risk register and an action plan developed. Originality/value - The tool has been utilised to assess risks of all research projects from educational studies such as MSc, PhD to medical device trials and drug trials. Furthermore it has assessed risks in the acute, primary care and mental health sectors. © 2011 Emerald Group Publishing Limited. All rights reserved.


Wells J.C.K.,University College London | Sharp G.,Royal Cornwall Hospitals NHS Trust | Steer P.J.,Imperial College London | Leon D.A.,London School of Hygiene and Tropical Medicine
PLoS ONE | Year: 2013

Background:Ethnic groups differ significantly in adult physique and birth weight. We aimed to improve understanding of maternal versus paternal contributions to ethnic differences in birth weight, by comparing the offspring of same-ethnic versus mixed-ethnic unions amongst Europeans and South Asian Indians in the UK.Methodology and principal findings:We used data from the UK Office for National Statistics Longitudinal Study (LS) and the Chelsea and Westminster Hospital (CWH), London. In the combined sample at all gestational ages, average birth weight of offspring with two European parents was significantly greater than that of offspring with two Indian parents [Δ = 344 (95% CI 329, 360) g]. Compared to offspring of European mothers, the offspring of Indian mothers had lower birth weight, whether the father was European [Δ = -152 (95% CI -92, -212) g] or Indian [Δ = -254 (95% -315, -192) g]. After adjustment for various confounding factors, average birth weight of offspring with European father and Indian mother was greater than that of offspring with two Indian parents [LS: Δ = 249 (95% CI 143, 354) g; CWH: Δ = 236 (95% CI 62, 411) g]. Average birth weight of offspring with Indian father and European mother was significantly less than that of offspring with two European parents [LS: Δ = -117 (95% CI -207, -26) g; CWH: Δ = -83 (-206, 40) g].Conclusions/Significance:Birth weight of offspring with mixed-ethnic parentage was intermediate between that of offspring with two European or two Indian parents, demonstrating a paternal as well as a maternal contribution to ethnic differences in fetal growth. This can be interpreted as demonstrating paternal modulation of maternal investment in offspring. We suggest long-term nutritional experience over generations may drive such ethnic differences through parental co-adaptation. © 2013 Wells et al.


Willis H.,Royal Cornwall Hospitals NHS Trust
Emergency Medicine Journal | Year: 2012

A short cut review was carried out to establish ultrasonography was as good as radiography at detecting fracture clavicles in children. 580 papers were found using the reported searches, of which 5 presented the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these best papers are tabulated. It is that ultrasonography is sensitive at detecting clavicular fractures in children.


Roberts N.,Royal Cornwall Hospitals NHS Trust | Bradley B.,Royal Cornwall Hospitals NHS Trust | Williams D.,Royal Cornwall Hospitals NHS Trust
Annals of the Royal College of Surgeons of England | Year: 2014

INTRODUCTION: Electronic patient reported outcome measures (PROMs) enable real time reporting back to the patient and medical team, comparison between similar patient cohorts and long-term cost effective outcome measurement. The primary objective of this three-phase pilot study was to measure uptake using a web-based PROM system following the introduction of two separate process improvements. METHODS: Eighty consecutive new elective orthopaedic patients in a single surgeon's practice were recruited for the study. Patients in Group 1 (n=26) received only a letter reminding them to complete a symptom score. Those in Group 2 (n=31) also received a reminder SMS (short message service) message via their mobile or home telephone and those in Group 3 (n=23) also had access to a tablet computer in clinic. RESULTS: The mean patient age in Group 1 was 55 years (range: 24-80 years), in Group 2 it was 60 years (range: 23-85 years) and in Group 3 it was 58 years (range: 37-78 years) (p>0.05). Overall, 79% of patients had internet access, and 35% of Group 1, 55% of Group 2 and 74% of Group 3 recorded an electronic PROM score (p=0.02). In Group 3, 94% of patients listed for an operation completed an electronic PROM score (p=0.006). CONCLUSIONS: Collecting PROM data effectively in everyday clinical practice is challenging. Electronic collection should meet that challenge and improve healthcare delivery but it is in its infancy. This pilot study shows that the combination of an SMS reminder and access to a Wi-Fi enabled tablet computer in the clinic setting enabled 94% of patients listed for an operation to complete a score on a web-based clinical outcomes system. Additional staff training and telephone call reminders may further improve uptake.


Brown A.S.,Royal Cornwall Hospitals NHS Trust
Nurse researcher | Year: 2010

The safe and competent use of complex medical devices requires training for healthcare staff, and external assurance standards require hospital trusts to provide evidence of such training. This paper describes a novel, non-confrontational approach to obtaining this information, using syringe drivers as an example.


Newton H.,Royal Cornwall Hospitals NHS Trust
British Journal of Health Care Management | Year: 2013

The cost of managing patients with chronic wounds is rising and accounts for 3% of the total NHS budget. Despite significant advances in wound management over the last 35 years there remains little evidence of standardised practices across the country. The management of wounds is continually viewed as a challenging and costly area of practice. The challenges arise from the increasing complexity of acute and chronic wounds, which are affected by patients multiple comorbidities, resistant bacteria and an aging population. There is also a plethora of dressings available in the market place today which despite providing a wide choice can be confusing and costly if inappropriately used. This article will explore the principles of wound healing, highlighting key factors that can impact on outcomes. The main types of wound dressings will also be discussed.


Newton H.,Royal Cornwall Hospitals NHS Trust
Wounds UK | Year: 2010

Tackling healthcare-associated infections (HAIs) such as meticillin-resistant Staphylococcus aureus (MRSA) continues to be a key safety issue. As a result of surveillance, it was reported that the author's trust, a secondary care provider, had a poor rating for MRSA bacteraemias. From April 2008 to March 2009, 12 patients developed a bacteraemia that through root cause analysis was found to be associated with their wound. This article describes the strategic and educational plan developed to address this trust-wide issue and its impact in reducing wound-associated MRSA bacteraemias. It also acknowledges the resulting changes in clinical practice.

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