Regulation of medicines and medical devices: contrasts and similarities.

In recent times, there has been an unprecedented level of public interest and active debate regarding the regulation of medical devices. This is in light of the topical, rather dissimilar, incidents involving poly-implant-prothèse (PIP) breast and metal-on-metal hip implants. Although medicines and devices are regulated under European Union (EU) law, the regulatory regimes are very different and some have argued that features of the pharmaceutical regime should be applied to medical devices in the current review of the medical devices directives. Both medicines and certain devices need to have an assessment of their risks and benefits before being used in patients, and undergo subsequent monitoring for adverse events. However, there are significant differences between these two groups in terms of the number of products, the pattern of innovation and development, and the types of adverse events that arise from their use. This review will summarise the key issues through a comparison of how both are regulated and monitored.

Republished: instigating change: trainee doctors' perspective.

In the 21st century, the core skills of trainee doctors are evolving as clinicians, leaders and innovators. Leadership skills are an essential tool for all doctors and need to be an integral part of their training and learning as set out in the General Medical Council's Good Medical Practice. It is essential to develop these skills at an early stage and continually improve them. A group of junior doctors participated in a pilot programme for leadership with the aim of executing a quality improvement (QI) project. This article describes our experiences of both the course itself and the project undertaken by our group. As part of the process of implementing change, we faced a number of challenges which contributed to our learning. These have been explored as well as potential ways to overcome them to enable the swift and smooth development of future QI projects. Using an example of a QI project looking at handover, this article demonstrates how a trainee doctor can implement their project for both professional and institutional improvement.

A national UK survey of radiology trainees special interest choices: what and why?

OBJECTIVES: A national survey was designed to better understand factors influencing special interest choices, future aspirations of UK radiology trainees and perceptions of breast radiology. METHODS: A SurveyMonkey questionnaire was developed and distributed to all radiology trainees in the UK through the British Institute of Radiology, RCR Junior Radiologists Forum and by directly contacting UK training schemes as well as by social media between December 2015 and January 2016. RESULTS: From 21 training schemes across the UK, 232 responses were received. Over half entered radiology after foundation training and 62% were ST1-3; one-fifth of trainees intended to leave the NHS. The most popular special interests were musculoskeletal (18%), abdominal imaging (16%) and neuroradiology (13%). Gynaecological and oncological imaging proved to be the least popular. Strong personal interest, a successful rotation during training, a mix of imaging modalities, direct impact on patient care and job prospects were the most popular factors influencing career choice. Research and potential for private income were the least influential factors. Respondents detailed their perceptions of breast radiology, selecting an awareness of career prospects (41%) and a better trainee experience (36%) as factors that would increase their interest in pursuing it as a career. CONCLUSION: Understanding the factors that influence special interest choice is essential to addressing the alarming staffing shortfalls that will befall certain radiology special interests. Addressing trainee's preconceptions and improving the trainee experience are key to attracting trainees to breast radiology. Advances in knowledge: This is the first survey of its kind in the UK literature designed to evaluate special interest career choices and the factors that influence those among radiology trainees.

Updates on the diagnosis and treatment of prostate cancer.

Prostate cancer is the second most prevalent cancer in males worldwide and the commonest cancer in males in the UK. The recent updates on the diagnosis and treatment of prostate cancer were discussed at a multidisciplinary day event organized by the British Institute of Radiology and held in London in November 2016. This day covered the use of the prostate-specific antigen biomarker and of advanced imaging techniques such as multiparametric and whole-body MRI, choline positron emission tomography/CT and gallium-labelled prostate-specific membrane antigen for the detection of prostate cancer. In addition, the results of several trials assessing the management of the disease were discussed, in particular the Prostate Cancer Intervention Versus Observation Trial and Prostate Testing for Cancer and Treatment trials which evaluated the gain of intervention vs observation, and four randomized controlled trials comparing hypofractionated and standard radiotherapy regimen. Further to this event, this commentary highlights the topical issues relating to recently published guidelines and to trials for the management of prostate cancer where these were discussed.

New Health Technologies: A UK Perspective Comment on "Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies".

New health technologies require development and evaluation ahead of being incorporated into the patient care pathway. In light of the recent publication by Lehoux et al who discuss the role of entrepreneurs, investors and regulators in providing value to new health technologies, we summarise the processes involved in making new health technologies available for use in the United Kingdom.

May-Thurner variant secondary to degenerative lumbar spondylolisthesis: a case report.

May-Thurner syndrome (MTS) is a rare condition in which patients develop iliofemoral deep venous thrombosis due to an anatomical variant in which the right common iliac artery overlies and compresses the left common iliac vein against the lumbar spine. We report a case of variant MTS, where vascular distortion secondary to spontaneous spinal arthrodesis of degenerative lumbar spondylolisthesis resulted in left common iliac vein compression and iliofemoral deep vein thrombosis. While the common complications of degenerative spondylolisthesis, such as spinal stenosis, are well described; the potential for pelvic vascular distortion secondary to anterior translation of the lumbar spine is not well recognized. The purpose in presenting this case is to describe the mechanism by which this variant of MTS occurs and highlight the need for vigilance for this unusual clinical entity.

Does a novel penalized likelihood reconstruction of 18F-FDG PET-CT improve signal-to-background in colorectal liver metastases?

PURPOSE: Iterative reconstruction algorithms are widely used to reconstruct positron emission tomography computerised tomography (PET/CT) data. Lesion detection in the liver by 18F-fluorodeoxyglucose PET/CT (18F-FDG-PET/CT) is hindered by 18F-FDG uptake in background liver parenchyma. The aim of this study was to compare semi-quantitative parameters of histologically-proven colorectal liver metastases detected by 18F-FDG-PET/CT using data based on a Bayesian penalised likelihood (BPL) reconstruction, with data based on a conventional time-of-flight (ToF) ordered subsets expectation maximisation (OSEM) reconstruction. METHODS: A BPL reconstruction algorithm was used to retrospectively reconstruct sinogram PET data. This data was compared with OSEM reconstructions. A volume of interest was placed within normal background liver parenchyma. Lesions were segmented using automated thresholding. Lesion maximum standardised uptake value (SUVmax), standard deviation of background liver parenchyma SUV, signal-to-background ratio (SBR), and signal-to-noise ratio (SNR) were collated. Data was analysed using paired Student's t-tests and the Pearson correlation. RESULTS: Forty-two liver metastases from twenty-four patients were included in the analysis. The average lesion SUVmax increased from 8.8 to 11.6 (p<0.001) after application of the BPL algorithm, with no significant difference in background noise. SBR increased from 4.0 to 4.9 (p<0.001) and SNR increased from 10.6 to 13.1 (p<0.001) using BPL. There was a statistically significant negative correlation between lesion size and the percentage increase in lesion SUVmax (p=0.03). CONCLUSIONS: This BPL reconstruction algorithm improved SNR and SBR for colorectal liver metastases detected by 18F-FDG-PET/CT, increasing the lesion SUVmax without increasing background liver SUV or image noise. This may improve the detection of FDG-avid focal liver lesions and the diagnostic performance of clinical 18F-FDG-PET/CT in this setting, with the largest impact for small foci.

In the spotlight: healthcare inspections as an opportunity for trainee clinicians to be the leaders of today.

There have been repeated calls from all quarters of healthcare for more clinicians to be leaders. The risks of not accepting this responsibility have been demonstrated by harrowing reports into failed care in England. Ambiguity persists over what clinical leadership encompasses, how it can be developed and how to inspire clinicians to practise it. A supportive organisational culture, dedicated resources and national support are needed to foster leadership skills among trainee clinicians. Here we discuss a possible blueprint based on the recent reviews of English NHS Trusts with high mortality rates for future initiatives in empowering medical and nursing trainees to learn from leaders and practise leadership skills.

Coinfusion of low-dose GLP-1 and glucagon in man results in a reduction in food intake.

Obesity is a growing epidemic, and current medical therapies have proven inadequate. Endogenous satiety hormones provide an attractive target for the development of drugs that aim to cause effective weight loss with minimal side effects. Both glucagon and GLP-1 reduce appetite and cause weight loss. Additionally, glucagon increases energy expenditure. We hypothesized that the combination of both peptides, administered at doses that are individually subanorectic, would reduce appetite, while GLP-1 would protect against the hyperglycemic effect of glucagon. In this double-blind crossover study, subanorectic doses of each peptide alone, both peptides in combination, or placebo was infused into 13 human volunteers for 120 min. An ad libitum meal was provided after 90 min, and calorie intake determined. Resting energy expenditure was measured by indirect calorimetry at baseline and during infusion. Glucagon or GLP-1, given individually at subanorectic doses, did not significantly reduce food intake. Coinfusion at the same doses led to a significant reduction in food intake of 13%. Furthermore, the addition of GLP-1 protected against glucagon-induced hyperglycemia, and an increase in energy expenditure of 53 kcal/day was seen on coinfusion. These observations support the concept of GLP-1 and glucagon dual agonism as a possible treatment for obesity and diabetes.

Instigating change: trainee doctors' perspective.

In the 21st century, the core skills of trainee doctors are evolving as clinicians, leaders and innovators. Leadership skills are an essential tool for all doctors and need to be an integral part of their training and learning as set out in the General Medical Council's Good Medical Practice. It is essential to develop these skills at an early stage and continually improve them. A group of junior doctors participated in a pilot programme for leadership with the aim of executing a quality improvement (QI) project. This article describes our experiences of both the course itself and the project undertaken by our group. As part of the process of implementing change, we faced a number of challenges which contributed to our learning. These have been explored as well as potential ways to overcome them to enable the swift and smooth development of future QI projects. Using an example of a QI project looking at handover, this article demonstrates how a trainee doctor can implement their project for both professional and institutional improvement.

Does use of intraoperative cell-salvage delay recovery in patients undergoing elective abdominal aortic surgery?

A best evidence topic in vascular surgery was written according to a structured protocol. The question addressed was whether the use of intraoperative cell-salvage (ICS) leads to negative outcomes in patients undergoing elective abdominal aortic surgery? Altogether 305 papers were found using the reported search, of which 10 were judged to represent the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers were tabulated. None of the 10 papers included in the analysis demonstrated that ICS use led to significantly higher incidence of cardiac or septic postoperative complications. Similarly, length of intensive treatment unit (ITU) or hospital stay and mortality in elective abdominal aortic surgery were not adversely affected. Indeed two trials actually show a significantly shorter hospital stay after ICS use, one a shorter ITU stay and another suggests lower rates of chest sepsis. Based on these papers, we concluded that the use of ICS does not cause increased morbidity or mortality when compared to standard practise of transfusion of allogenic blood, and may actually improve some clinical outcomes. As abdominal aortic surgery inevitably causes significant intraoperative blood loss, in the range of 661-3755 ml as described in the papers detailed in this review, ICS is a useful and safe strategy to minimise use of allogenic blood.

Toothache: an unlikely presentation of secondary breast malignancy.

An 81-year-old female presented to the maxillo-facial department with a 6-month history of left-sided toothache and upper lip and cheek numbness. She had previously undergone a right mastectomy for breast adenocarcinoma, followed 6 years later by left mastectomy with pneumonectomy for contralateral breast and lung metastases. Following buccal biopsies and MRI of the head and neck, the patient was referred to our head and neck team. The MRI showed a large left maxillary sinus mass and transnasal endoscopic biopsies under general anaesthesia of this confirmed distant breast carcinoma metastasis. The patient was discussed at the Head and Neck Multidisciplinary Team meeting. Further surgical resection was not thought appropriate and the patient has subsequently undergone curative dose radiotherapy to the face. She remains alive with symptom control 8 months following this presentation.