Benchmarking the performance of a low-cost magnetic resonance control system at multiple sites in the open MaRCoS community.

PURPOSE: To describe the current properties and capabilities of an open-source hardware and software package that is being developed by many sites internationally with the aim of providing an inexpensive yet flexible platform for low-cost MRI. METHODS: This article describes three different setups from 50 to 360 mT in different settings, all of which used the MaRCoS console for acquiring data, and different types of software interface (custom-built GUI or Pulseq overlay) to acquire it. RESULTS: Images are presented both from phantoms and in vivo from healthy volunteers to demonstrate the image quality that can be obtained from the MaRCoS hardware/software interfaced to different low-field magnets. CONCLUSIONS: The results presented here show that a number of different sequences commonly used in the clinic can be programmed into an open-source system relatively quickly and easily, and can produce good quality images even at this early stage of development. Both the hardware and software will continue to develop, and it is an aim of this article to encourage other groups to join this international consortium.

Improvement of Inpatient Psychiatric Facility Quality Reporting program measure: Screening for metabolic disorders through pharmacy collaborative practice agreement.

BACKGROUND: Second-generation antipsychotics are associated with lower risks of extrapyramidal symptoms, including tardive dyskinesia. However, many second-generation antipsychotics are associated with metabolic adverse effects, including weight gain, impaired blood glucose control, and hyperlipidemia. Metabolic monitoring for patients prescribed antipsychotic medication is 1 of several measures of the Centers for Medicare & Medicaid Services' Inpatient Psychiatric Facility Quality Reporting program. Screening for metabolic disorders (SMD) must be obtained within the previous 365 days before the hospital discharge date. National data suggest that compliance with this measure is low. OBJECTIVE: To improve compliance of metabolic monitoring by 20% while ensuring that the quality improvement interventions did not cause any unintended adverse effects on other aspects of our system. PRACTICE DESCRIPTION: This quality initiative was conducted at a large, 2000-bed academic medical center with approximately 80 inpatient psychiatric beds. PRACTICE INNOVATION: To improve the metabolic screening rates, a pharmacist collaborative practice agreement (CPA) was established as part of a quality improvement project. Previously, there were no formal processes at the institution to ensure that appropriate laboratory tests were conducted. EVALUATION METHODS: Using an uncontrolled before-and-after design, SMD data were gathered from 6 months before and 6 months after CPA implementation. Pearson chi-square test or Fisher exact test were used to compare the pre- and postintervention groups in this quasi-experimental design. RESULTS: Compared with the preintervention period, compliance of SMD monitoring increased by 21.2% in the postintervention phase-from 69.2% to 90.4% (P < 0.001). CONCLUSION: The empowerment of clinical pharmacists with a CPA significantly improved guideline-concordant metabolic monitoring of antipsychotics. These findings may have significant impact on the approach to the safe use of these essential psychotropic medications and provide a framework for other inpatient mental health facilities to optimally use the skills of their interdisciplinary team.

The effect of mirabegron on energy expenditure and brown adipose tissue in healthy lean South Asian and Europid men.

AIM: To compare the effects of cold exposure and the ß3-adrenergic receptor agonist mirabegron on plasma lipids, energy expenditure and brown adipose tissue (BAT) activity in South Asians versus Europids. MATERIALS AND METHODS: Ten lean Dutch South Asian (aged 18-30 years; body mass index [BMI] 18-25 kg/m2 ) and 10 age- and BMI-matched Europid men participated in a randomized, double-blinded, cross-over study consisting of three interventions: short-term (~ 2 hours) cold exposure, mirabegron (200 mg one dose p.o.) and placebo. Before and after each intervention, we performed lipidomic analysis in serum, assessed resting energy expenditure (REE) and skin temperature, and measured BAT fat fraction by magnetic resonance imaging. RESULTS: In both ethnicities, cold exposure increased the levels of several serum lipid species, whereas mirabegron only increased free fatty acids. Cold exposure increased lipid oxidation in both ethnicities, while mirabegron increased lipid oxidation in Europids only. Cold exposure and mirabegron enhanced supraclavicular skin temperature in both ethnicities. Cold exposure decreased BAT fat fraction in both ethnicities. After the combination of data from both ethnicities, mirabegron decreased BAT fat fraction compared with placebo. CONCLUSIONS: In South Asians and Europids, cold exposure and mirabegron induced beneficial metabolic effects. When combining both ethnicities, cold exposure and mirabegron increased REE and lipid oxidation, coinciding with a higher supraclavicular skin temperature and lower BAT fat fraction.

The Economic Value of MR-Imaging for Uveal Melanoma.

OBJECTIVE: Uveal melanoma (UM) is the most common primary intra-ocular tumour. Treatment is determined by tumour size and location. Generally, smaller tumours are eligible for brachytherapy unless they are located close to posterior pole. Larger tumours are enucleated or undergo proton beam therapy (PBT), which is more expensive than brachytherapy and less available. Accuracy of tumour size determination is critical for accurate planning and delivery of treatment, particularly to ensure tumour coverage, critical structure sparing, and for the choice of treatment modality. This is particularly the case for tumour dimensions that are close to the cut-off point for a specific type of treatment: in the case of the brachytherapy protocol at our institution, 6-8 mm. Ultrasound is conventionally used, but magnetic resonance imaging (MRI) has recently become an additional available tool. Although more expensive, it enables more accurate measurements and is particularly useful in combination with clinical fundus examination, fundus photography and ultrasound. Our aim in this paper was to determine the economic value of MRI for UM treatment. METHODS: We retrospectively analysed 60 patients' MRI scans acquired as part of a study or for clinical care. For each patient, we assessed whether the extra cost of an MRI generated economic benefit or change in optimal treatment. RESULTS: MRI indicated a smaller tumour prominence than US in 10% of patients with intermediate tumour size, resulting in a change from PBT to brachytherapy. The costs of MRI, €200-€1000, are significantly lower than the higher costs of PBT compared to brachytherapy, €24,000 difference. In addition, the annual total economic burden of severe vision impairment associated with eye removal is €10,000. Furthermore, for patients where ultrasound was impossible due to previous surgery, MRI enabled eye-preserving treatment. CONCLUSION: An additional MRI for specific patients with UM improves economic value as it enables less expensive treatment in a sufficient percentage of patients to compensate for the MRI costs. Value is increased in terms of quality of care as it enables for some a treatment option which spares more vision.

Implications for medication dosing for transgender patients: A review of the literature and recommendations for pharmacists.

PURPOSE: Transgender patients face considerable healthcare disparities. Improved means of recognizing transgender patients and understanding their medical needs is important to provide optimal care. The electronic medical record (EMR) of our health system allows for differentiation of gender identity, legal sex, and sex at birth. With EMR recognition of transgender patients, a recommendation for estimating creatinine clearance (CLcr) and ideal body weight (IBW) was needed to standardize medication dosing. SUMMARY: The literature was reviewed for evidence on the effect of gender-affirming hormone therapy on serum creatinine concentration and lean body mass. Findings informed a recommendation for drug dosing based on CLcr and IBW in transgender patients. Four studies that reported the effect of hormone therapy on biometric laboratory values were found. Three studies reported that values of transgender patients more closely resembled the standard values of their gender identity vs sex at birth after hormone therapy; 1 study reported a range of values that more closely resembled those associated with sex at birth while still overlapping with values associated with gender identity. Consequently, it was recommended that pharmacists dose medications based on CLcr and IBW calculations consistent with gender identity after a patient has been on hormone therapy for 6 months or longer. CONCLUSION: Providing optimal care to transgender patients includes considering the effect of gender-affirming hormone therapy on overall physiology. Consistently using the appropriate CLcr and IBW calculations for each patient ensures safe and effective care. Additional studies are needed to confirm the effect of hormone therapy on renal clearance and lean body mass.

3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT.

BACKGROUND: Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy. OBJECTIVES: To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations. DESIGN: An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial. SETTING: A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand. PARTICIPANTS: Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum. INTERVENTIONS: The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months. MAIN OUTCOME MEASURES: The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient. RESULTS: Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n = 3035; 6-month analysis, n = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114; p-value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years (p < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4-6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. CONCLUSIONS: The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019-20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre - Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).

Patients diagnosed with bowel cancer are likely to have surgery to remove the tumour. Patients diagnosed with a more advanced stage of the disease are then likely to be offered what is known as adjuvant chemotherapy ­ chemotherapy to kill any cancer cells that have already spread but cannot be seen. Adjuvant chemotherapy is usually given over 6 months using two medicines known as oxaliplatin and fluoropyrimidine. This chemotherapy has side effects of diarrhoea, nausea and vomiting, and it reduces the numbers of cells in the blood. It can also damage nerves, which causes discomfort, numbness and tingling; in some cases, this can go on for years. These side effects are more likely to develop with longer treatment. This study looked at whether or not shortening the time over which patients were given oxaliplatin and fluoropyrimidine chemotherapy reduced its effectiveness. In this large study of over 6000 patients, half of the patients were allocated by chance to be treated for 3 months and the other half to be treated for 6 months. Reducing the time that patients had chemotherapy from 6 months to 3 months did not make the treatment less effective. When patients treated with chemotherapy over 3 months were compared with those treated over 6 months, 77% of patients in both groups were well with no detectable disease 3 years after surgery. Patients were less likely to get side effects with 3-month chemotherapy. In particular, the chance of persistent long-term nerve damage was lower, resulting in patients with 3-month chemotherapy having better health-related quality of life. Overall, the study showed that 3-month adjuvant chemotherapy for patients with bowel cancer is as effective as 6-month adjuvant chemotherapy and causes fewer side effects.

Low-field MRI: An MR physics perspective.

Historically, clinical MRI started with main magnetic field strengths in the ∼0.05-0.35T range. In the past 40 years there have been considerable developments in MRI hardware, with one of the primary ones being the trend to higher magnetic fields. While resulting in large improvements in data quality and diagnostic value, such developments have meant that conventional systems at 1.5 and 3T remain relatively expensive pieces of medical imaging equipment, and are out of the financial reach for much of the world. In this review we describe the current state-of-the-art of low-field systems (defined as 0.25-1T), both with respect to its low cost, low foot-print, and subject accessibility. Furthermore, we discuss how low field could potentially benefit from many of the developments that have occurred in higher-field MRI. In the first section, the signal-to-noise ratio (SNR) dependence on the static magnetic field and its impact on the achievable contrast, resolution, and acquisition times are discussed from a theoretical perspective. In the second section, developments in hardware (eg, magnet, gradient, and RF coils) used both in experimental low-field scanners and also those that are currently in the market are reviewed. In the final section the potential roles of new acquisition readouts, motion tracking, and image reconstruction strategies, currently being developed primarily at higher fields, are presented. Level of Evidence: 5 Technical Efficacy Stage: 1 J. Magn. Reson. Imaging 2019.

SCOT: a comparison of cost-effectiveness from a large randomised phase III trial of two durations of adjuvant Oxaliplatin combination chemotherapy for colorectal cancer.

BACKGROUND: The Short Course Oncology Therapy (SCOT) study is an international, multicentre, non-inferiority randomised controlled trial assessing the efficacy, toxicity, and cost-effectiveness of 3 months (3 M) versus the usually given 6 months (6 M) of adjuvant chemotherapy in colorectal cancer. METHODS: In total, 6088 patients with fully resected high-risk stage II or stage III colorectal cancer were randomised and followed up for 3-8 years. The within-trial cost-effectiveness analysis from a UK health-care perspective is presented using the resource use data, quality of life (EQ-5D-3L), time on treatment (ToT), disease-free survival after treatment (DFS) and overall survival (OS) data. Quality-adjusted partitioned survival analysis and Kaplan-Meier Sample Average Estimator estimated QALYs and costs. Probabilistic sensitivity and subgroup analysis was undertaken. RESULTS: The 3 M arm is less costly (-£4881; 95% CI: -£6269; -£3492) and entails (non-significant) QALY gains (0.08; 95% CI: -0.086; 0.230) due to a better significant quality of life. The net monetary benefit was significantly higher in 3 M under a wide range of monetary values of a QALY. The subgroup analysis found similar results for patients in the CAPOX regimen. However, for the FOLFOX regimen, 3 M had lower QALYs than 6 M (not statistically significant). CONCLUSIONS: Overall, 3 M dominates 6 M with no significant detrimental impact on QALYs. The results provide the economic case that a 3 M treatment strategy should be considered a new standard of care.

The need for a prescribing competency framework to address the burden of complex polypharmacy among multiple long-term conditions.

The original requirement for a competency framework for prescribers was to identify the essential skills for non-medical prescribers. However, core prescribing competencies are relevant to any prescriber. The new, revised version is especially relevant for doctors/physicians. Doctors are the most frequent prescribers - prescribing is the most common therapeutic intervention. The quantity and complexity of medicine use is increasing through multiple treatment strategies/pathways for multiple comorbidities, resulting in polypharmacy - especially with long-term conditions. This is against a background of the ongoing introduction of new drugs with novel mechanisms of action with increased risks of adverse effects, compounded by drug-drug and disease-drug interactions. This has increased the need for monitoring and follow-up, including identification and management of poor adherence. It is challenging for doctors to maintain safe and effective prescribing and train other doctors and non-medical prescribers within the multidisciplinary team. The prescribing competency framework provides a systematic approach to support doctors to prescribe safely and effectively. It can be used by medical schools to teach prescribing, including preparation for the prescribing safety assessment; by F1/F2 doctors to support prescribing in early years; as part of prescribing quality improvement initiatives and as a continuing professional development framework in general practice or acute care settings.

Quantitative assessment of the effects of high-permittivity pads in 7 Tesla MRI of the brain.

The use of high-permittivity materials has been shown to be an effective method for increasing transmit and receive sensitivity in areas of low-signal intensity in the brain at high field. Results in this article show that the use of these materials does not increase the intercoil coupling for a phased array receive coil, does not have any detrimental effects on the B(0) homogeneity within the brain, and does not affect the specific absorption rate distribution within the head. Areas of the brain close to the pads exhibit significant increases (>100%) in transmit field efficiency, but areas further away show a less pronounced (~10%) decrease due to the homogenization of the transmit field and the loss introduced by the dielectric pads.

Quantitative assessment of left ventricular function in humans at 7 T.

The purpose of this study was to determine the ability of 7 T cardiac magnetic resonance imaging (MRI) to quantitatively assess left ventricular volumes, mass, and function from cine short-axis series and left ventricular diastolic filling from velocity-encoded MRI in 10 healthy volunteers. As comparative "gold standard," the corresponding measures obtained at 1.5 T were taken. Left ventricular volumes, function, and mass were obtained by manual image segmentation. Trans-mitral flow graphs were obtained from 2D one-directional through-plane velocity-encoded MRI planned at the mitral valve in end-systole. Imaging at 7 T MRI was successful in 80% of the examinations. Assessment of left ventricular volumes, function, and mass at 7 T showed good agreement with 1.5 T (no significant differences between variables describing volumes, function, and mass with intraclass correlation coefficients ranging from 0.77 to 0.96). Trans-mitral stroke volume and the ratio between early and atrial peak filling rate showed strong agreement at both field strengths (no significant differences between stroke volumes and filling ratios with intraclass correlation coefficients 0.92 for stroke volumes and 0.77 for peak filling ratios). In conclusion, this study shows that assessing left ventricular volumes, function, and flow is feasible at 7 T MRI and that standardized MRI protocols provide similar quantitative results when compared with 1.5 T MRI.

Experimental and numerical assessment of MRI-induced temperature change and SAR distributions in phantoms and in vivo.

It is important to accurately characterize the heating of tissues due to the radiofrequency energy applied during MRI. This has led to an increase in the use of numerical methods to predict specific energy absorption rate distributions for safety assurance in MRI. To ensure these methods are accurate for actual MRI coils, however, it is necessary to compare to experimental results. Here, we report results of some recent efforts to experimentally map temperature change and specific energy absorption rate in a phantom and in vivo where the only source of heat is the radiofrequency fields produced by the imaging coil. Results in a phantom match numerical simulation well, and preliminary results in vivo show measurable temperature increase. With further development, similar methods may be useful for verifying numerical methods for predicting specific energy absorption rate distributions and in some cases for directly measuring temperature changes and specific energy absorption rate induced by the radiofrequency fields in MRI experiments.

Assessment of beliefs in the effectiveness of acupuncture for treatment of psychiatric symptoms.

OBJECTIVES: Research has demonstrated that beliefs or expectancies can exert a powerful influence on treatment and/or drug effects. As patients participate in more complementary and/or alternative treatments for psychiatric conditions, it is important to assess the role of belief or expectancy on response to nontraditional treatment approaches. The Acupuncture Beliefs Scale was developed to assess belief in the efficacy of acupuncture for both physical and psychiatric symptoms and conditions. Development and psychometric properties of the scale are described. DESIGN AND SUBJECTS: Research personnel solicited statements regarding the potential experience and effects of acupuncture. These items were collapsed into a set of 36 items, with some rotated to avoid response bias. Outpatients diagnosed with bipolar disorder and undergraduates completed the scale (n = 118). RESULTS: The scale yielded excellent internal consistency (coefficient alpha = 0.97), and item-total score correlations between 0.37 and 0.83. Principal component analysis with a varimax rotation revealed three significant and meaningful factors that were consistent across both subject groups. Factors appeared to capture general endorsement of acupuncture treatment, beliefs in the scientific value and credibility of acupuncture treatment, and beliefs about the procedures and physical experience of acupuncture. CONCLUSIONS: The Acupuncture Beliefs Scale is a 36-item self-report scale that may be useful for measurement of beliefs in the effectiveness of acupuncture treatment.