Analysis of a National Programme for Selective Internal Radiation Therapy for Colorectal Cancer Liver Metastases.

AIMS: Patients with chemotherapy-refractory colorectal cancer liver metastases have limited therapeutic options. Selective internal radiation therapy (SIRT) delivers yttrium 90 microspheres as a minimally invasive procedure. This prospective, single-arm, observational, service-evaluation study was part of National Health Service England Commissioning through Evaluation. METHODS: Patients eligible for treatment had histologically confirmed carcinoma with liver-only/liver-dominant metastases with clinical progression during or following oxaliplatin-based and irinotecan-based chemotherapy. All patients received SIRT plus standard of care. The primary outcome was overall survival; secondary outcomes included safety, progression-free survival (PFS) and liver-specific PFS (LPFS). RESULTS: Between December 2013 and March 2017, 399 patients were treated in 10 centres with a median follow-up of 14.3 months (95% confidence interval 9.2-19.4). The median overall survival was 7.6 months (95% confidence interval 6.9-8.3). The median PFS and LPFS were 3.0 months (95% confidence interval 2.8-3.1) and 3.7 months (95% confidence interval 3.2-4.3), respectively. During the follow-up period, 143 patients experienced an adverse event and 8% of the events were grade 3. CONCLUSION: Survival estimates from this pragmatic study show clinical outcomes attainable in the National Health Service comparable with previously published data. This study shows the value of a registry-based commissioning model to aid national commissioning decisions for highly specialist cancer treatments.

Vision Amniotic Leak Detector (ALD) to Eliminate Amniotic Fluid Leakage as a Cause of Vaginal Wetness in Pregnancy: A NICE Medical Technology Guidance.

In prelabour rupture of membranes (PROM) or preterm PROM the amniotic membranes rupture prior to labour. Where this is not overt a speculum examination is undertaken to confirm diagnosis. The Vision Amniotic Leak Detector (ALD) is a panty liner that can diagnose amniotic fluid as a cause of vaginal wetness. It was evaluated by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme. The sponsor (CommonSense Ltd) identified five studies, of which three were deemed within scope by the External Assessment Centre (EAC). Two of these three used an inappropriate comparator. The EAC recalculated the diagnostic accuracy of Vision ALD using speculum examination as the comparator: sensitivity of 97% (95% CI 93-99%), negative predictive value of 96% (95% CI 92-98%). A negative result would therefore allow patients to be discharged with confidence. In the sponsor's cost-consequence model only patients with a positive Vision ALD result would have a speculum examination, producing a cost saving of around £10 per patient. The EAC felt that some costs were unjustified and the model did not include infection outcomes or use in a community setting. The EAC revised the sponsor's model and found the results were most sensitive to clinician costs. Vision ALD was associated with savings of around £15-£25 per patient when administration in lower-cost community healthcare avoided a referral to a higher-cost secondary-care centre. NICE published guidance MTG15 in July 2013 recommending that the case for adopting Vision ALD was supported by the evidence.

The ScanTrainer obstetrics and gynaecology ultrasound virtual reality training simulator: A cost model to determine the cost viability of replacing clinical training with simulation training.

The aim of this study was to produce an economic cost model comparing the use of the Medaphor ScanTrainer virtual reality training simulator for obstetrics and gynaecology ultrasound to achieve basic competence, with the traditional training method. A literature search and survey of expert opinion were used to identify resources used in training. An executable model was produced in Excel. The model showed a cost saving for a clinic using the ScanTrainer of £7114 per annum. The uncertainties of the model were explored and it was found to be robust. Threshold values for the key drivers of the model were identified. Using the ScanTrainer is cost saving for clinics with at least two trainees per year to train, if it would take at least six lists to train them using the traditional training method and if a traditional training list has at least two fewer patients than a standard list.

Fractal dimensions of laser doppler flowmetry time series.

Laser Doppler flowmetry (LDF) provides a non-invasive method of assessing cutaneous perfusion. As the microvasculature under the probe is not defined the measured flux cannot be given absolute units, but the technique has nevertheless proved valuable for assessing relative changes in perfusion in response to physiological stress. LDF signals normally show pronounced temporal variability, both as a consequence of the pulsatile nature of blood flow and local changes in dynamic vasomotor activity. The aim of the present study was to investigate the use of methods of nonlinear analysis in characterizing temporal fluctuations in LDF signals. Data were collected under standardised conditions from the forearm of 16 normal subjects at rest, during exercise and on recovery. Surrogate data was then generated from the original time series by phase randomization. Dispersional analysis demonstrated that the LDF data was fractal with two distinct scaling regions, thus allowing the calculation of a fractal dimension which decreased significantly from 1.23 +/- 0.09 to 1.04 +/- 0.02 during exercise. By contrast, dispersional analysis of the surrogate data showed no scaling region.