What is the Economic Cost of Providing an All Wales Postpartum Haemorrhage Quality Improvement Initiative (OBS Cymru)? A Cost-Consequences Comparison with Standard Care.

BACKGROUND AND OBJECTIVE: A postpartum haemorrhage quality improvement initiative (the Obstetric Bleeding Strategy for Wales [OBS Cymru]), including about 60,000 maternities, was adopted across Wales (2017-2018). We performed a cost-consequences analysis to inform ongoing provision and wider uptake. METHODS: Analysis was based on primary data from the All Wales postpartum haemorrhage database, with a UK National Health Services perspective, a time horizon from delivery until hospital discharge and no discounting. Costs were based on UK published sources with viscoelastic haemostatic assay costs provided by the OBS Cymru national team. Mean costs per eligible patient (postpartum haemorrhage > 1000 mL) were calculated for OBS Cymru, using the early implementation period as a comparator. Modelling allowed comparisons of three scenarios (two predefined and one post hoc) and implementation in different sizes of maternity unit. RESULTS: All analyses demonstrated consistent savings in blood products, critical care and haematology time, and also a reduced occurrence of massive postpartum haemorrhage (> 2500 mL). Incremental postnatal length of stay varied between scenarios, substantially impacting on total costs. Mean incremental cost of OBS Cymru, compared with standard care, across Wales was £18.41 per patient (postpartum haemorrhage > 1000 mL) or - £10.66 if the length of stay was excluded. Modelling a maternity unit of 5000 births per annum, OBS Cymru incurred an incremental cost of £9.53 per patient with postpartum haemorrhage > 1000 mL. CONCLUSIONS: OBS Cymru reduces the occurrence of massive postpartum haemorrhage, need for transfusions, quantity of blood products and intensive care. In medium-to-large maternity units (>3000 maternities per annum), the OBS Cymru intervention approaches cost neutrality compared to standard care.

Episcissors-60 for Mediolateral Episiotomy: Evaluation of Clinical and Economic Evidence to Inform NICE Medical Technologies Guidance.

Obstetric anal sphincter injury (OASI) occurs in 2.9% of all vaginal births in the UK and can result in faecal incontinence. Where there is a clinical need for episiotomy, OASI can be minimised by accurate selection of the optimum angle of mediolateral episiotomy. Episcissors-60 are adapted surgical scissors incorporating a guide-limb to help achieve an accurate angle of mediolateral episiotomy. The ability of Episcissors-60 to reduce OASI by preventing inaccurate visual estimates of episiotomy angles was considered by the National Institute of Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme (MTEP). NICE concluded that Episcissors-60 shows promise for mediolateral episiotomy both in terms of clinical effectiveness and potential cost savings, but that there was not enough evidence to support routine adoption into the NHS at this time. NICE MTG47 recommends that key gaps in the evidence including patient-reported outcomes and the addition of Episcissors-60 to care bundles be addressed through research with specific focus on potential equality considerations.

Improving the time to ileostomy closure following an anterior resection for rectal cancer in the UK.

AIM: Delayed closure of ileostomy following an anterior resection for rectal cancer in the UK is common. The aims of this study were (i) to investigate the variation in patient pathways between hospitals, (ii) to identify the key learning points from units with the shortest time to closure and (iii) to develop guidance for a pathway to minimize delay in ileostomy closure. METHOD: This was a mixed methods study. Thirty-eight colorectal units in the UK completed a short online survey. Nine colorectal units in Wales filled in an additional, expanded version of the survey. Semi-structured interviews were performed with clinicians from the six best performing units in terms of timely ileostomy closure. The optimal pathway suggested is based on the best evidence available and the Association of Coloproctology of Great Britain and Ireland guidelines. RESULTS: Qualitative analysis revealed that 5% of units (n = 2) have a local target time for ileostomy closure. Of all units, 90% (n = 34) would consider implementing a pathway if guidelines were developed. In-depth interviews highlighted the importance of a multidisciplinary approach, a dedicated coordinator to facilitate timely booking, and consensus on whether closure should be performed before or after adjuvant chemotherapy. CONCLUSION: There is a lack of national guidance in timing of contrast studies and ileostomy closure. Key aspects to consider are better information at consent regarding stoma closure timing, a dedicated person to track patients and the planning of contrast studies at discharge from initial surgery. With a dedicated approach closure of ileostomy within 10-12 weeks is feasible for most units.

gammaCore for Cluster Headaches: A NICE Medical Technologies Guidance.

Cluster headaches are excruciating attacks of pain that can last between 15 min and 3 h. Cluster headaches can be episodic, where patients have long pain-free intervals between attacks, or chronic, where they do not. As part of the Medical Technologies Evaluation Programme, the UK National Institute for Health and Care Excellence (NICE) considered the clinical effectiveness and cost impact of gammaCore (electroCore), a handheld, patient-controlled device used to treat and prevent cluster headache. gammaCore is a non-invasive vagus nerve stimulator, the aim of which is to modify pain signals by stimulating the vagus nerve through the skin of the neck. Evidence suggests that gammaCore reduces the intensity and frequency of cluster headaches and that the addition of gammaCore to standard care is cost saving. Therefore, the guidance published by NICE in December 2019 recommends routine adoption of gammaCore into the UK national health service. However, the guidance noted that gammaCore does not work for everyone and recommended that treatment with gammaCore should stop after 3 months in patients whose symptoms do not improve.

Effects of the Argus II Retinal Prosthesis System on the Quality of Life of Patients With Ultra-Low Vision Due to Retinitis Pigmentosa: Protocol for a Single-Arm, Mixed Methods Study.

BACKGROUND: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients' quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England's Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. OBJECTIVE: The aim of this study was to assess the effect of the Argus II device on patient's daily activities and quality of life. METHODS: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users' experiences with the procedure, the device, and rehabilitation. The effect of the device on patients' functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. RESULTS: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. CONCLUSIONS: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants' quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17436.

Curos™ Disinfection Caps for the Prevention of Infection When Using Needleless Connectors: A NICE Medical Technologies Guidance.

Central line-associated bloodstream infections (CLABSIs) are primary, laboratory confirmed bloodstream infections in patients with a central line within 48 h of symptom onset. Catheter-related bloodstream infection (CRBSI) is a more specific term used when the cause of infection has been confirmed by catheter tip cultures. CLABSIs and CRBSIs occur as a result of bacteraemia originating from intravenous catheters. Bloodstream infections are associated with increased length of stay, mortality and increased cost in treatment. The ability of Curos™, a disinfecting cap for needleless connectors of vascular access lines, to prevent bloodstream infections was considered by the National Institute of Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme (MTEP). Curos is a single-use device that contains a foam that is impregnated with 70% isopropyl alcohol; use of Curos is claimed to avoid the need to manually disinfect needleless connectors. Curos disinfection caps may contribute to the prevention of CLABSIs and CRBSIs as part of a bundle of infection prevention processes; however, the evidence for Curos is limited in both quantity and quality and may not be generalisable to National Health Service (NHS) practice. Therefore, the guidance published by NICE in May 2019 recommended further research to address uncertainties regarding the clinical benefits of using Curos.

First steps in PROMs and PREMs collection in Wales as part of the prudent and value-based healthcare agenda.

PURPOSE: Patients are experts in their own health and should be treated as equal partners in their care. Patient-reported outcome measures (PROMs) are an effective way of gathering patient feedback and can facilitate effectiveness and cost-effectiveness analysis to improve decision making and service improvement. The PROMs, PREMs & Effectiveness Programme was initiated in 2016 and aimed to develop an electronic platform to facilitate collection of PROMs and Patient-reported experience measures (PREMs) from secondary care patients across Wales. METHODS: We worked with all Health Boards in Wales, the NHS Wales Informatics Service (NWIS), and Cedar (a healthcare technology research centre) to identify and meet technical requirements to develop a platform which is fit for purpose. Patient groups were included throughout the development to gather feedback and for extensive testing. Clinical teams helped identify the most appropriate tools, with licences, translations and electronic formatting issues being managed centrally. RESULTS: The developed platform is integrated with patient administration systems minimising the need for manual input, with processes in place to allow automatic collection triggers according to nationally agreed schedules. We have over 30 nationally agreed PROMs 'pathways' with over 110,000 PROMs collected to date. Responses are fed back to clinicians via the electronic patient record and to each health board via feeds to the national data warehouse, making data easily accessible to different teams, maximising use and application. DISCUSSION: The national platform has provided a co-ordinated approach to PROMs collection in Wales, offering an effective means of communicating with patients outside the traditional clinic visit.

Implementation of high-throughput non-invasive prenatal testing for fetal RHD genotype testing in England: Results of a cross-sectional survey of maternity units and expert interviews.

BACKGROUND: Previously, routine antenatal anti-D prophylaxis (RAADP) was administered to all RhD-negative mothers to reduce the risk of sensitisation in the UK's National Health Service (NHS). If the baby is RhD-negative, RAADP is not required. In 2016, the UK National Institute for Health and Care Excellence (NICE) recommended non-invasive prenatal testing (NIPT) for fetal RHD genotype as a cost-effective option to guide RAADP. OBJECTIVES: To evaluate the implementation of high-throughput NIPT for fetal RHD genotype in maternity units in England by addressing research recommendations from the NICE. These were to reduce uncertainty around the resource use and cost of staff training, management of samples and results and record-keeping, as well as resultant changes to antenatal or post-partum care and performance of NIPT. METHODS: A cross-sectional survey was developed and sent to clinicians at 39 English NHS Trusts in May 2018. Qualitative interviews with seven individuals were conducted to explore missing or contraindicatory data. Qualitative findings were supplemented with NIPT test results (April 2017 to February 2019) from English hospitals. RESULTS: Staff reported that training took up to 30 minutes. There were no extra costs associated with sample management or additional appointments. Extra time required for record-keeping and management of test results was balanced later in the patient pathway. The antenatal pathway was not changed in the Trusts surveyed. The survey revealed that four post-partum scenarios were being used within English NHS Trusts. The frequency of inconclusive NIPT results was 4.3%. CONCLUSION: NIPT for fetal RHD genotype can be implemented without consuming substantial extra resources through incorporation into an existing patient pathway.

iFuse Implant System for Treating Chronic Sacroiliac Joint Pain: A NICE Medical Technology Guidance.

Treatment and management of sacroiliac joint pain is often non-surgical, involving packages of care that can include analgesics, physiotherapy, corticosteroid injections and radiofrequency ablation. Surgical intervention is considered when patients no longer respond to conservative management. The iFuse Implant System is placed across the sacroiliac joint using minimally invasive surgery, stabilising the joint and correcting any misalignment or weakness that can cause chronic pain. The iFuse system was evaluated in 2018 by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme (MTEP). Clinical evidence for iFuse suggests improved pain, Oswestry disability index (ODI) and quality of life compared to non-surgical management. The company (SI-Bone®) submitted two cost models indicating that iFuse was cost saving compared with open surgery and non-surgical management. Clinicians advised that non-surgical management was the most appropriate comparator and Cedar (a health technology research centre) made changes to the model to test the impact of higher acquisition and procedure costs. Cedar found iFuse to be cost incurring by approximately £560 per patient at 7 years. During the consultation period, the company reduced the cost of some iFuse consumables, and Cedar extended the time horizon to test the assumption that iFuse would become cost saving over time. These changes indicated that iFuse becomes cost saving at 8 years (approximately £129 per patient), after which the cost saving continues to increase. NICE published guidance in October 2018 recommending that the case for adoption of the iFuse system in the UK National Health Service (NHS) was supported by the evidence.

Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial.

BACKGROUND: Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO2) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO2 for insufflation, can reduce the risk of perioperative hypothermia. OBJECTIVE: The aim is to determine if insufflation with warmed, humidified CO2 using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. METHODS: The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. RESULTS: The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. CONCLUSIONS: The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14533.

Yttrium-90 Transarterial Radioembolization for Chemotherapy-Refractory Intrahepatic Cholangiocarcinoma: A Prospective, Observational Study.

PURPOSE: To evaluate the safety and efficacy of yttrium-90 transarterial radioembolization (TARE) for the treatment of unresectable, chemotherapy-refractory intrahepatic cholangiocarcinoma (ICC). METHODS: A prospective, observational study was carried out in 10 centers between 2013 and 2017. TARE plus standard care was delivered to patients with unresectable, chemotherapy-refractory or chemotherapy-intolerant ICC. Primary outcome was overall survival. Secondary outcomes included safety, progression-free survival (PFS), and liver-specific progression-free survival (LPFS). RESULTS: Sixty-one patients were treated with TARE. Patients were 53% male; median age was 64 years; 91% had performance status 0/1; 92% had received prior chemotherapy; and 59% had no extrahepatic disease. Median follow-up was 13.9 months (95% confidence interval [CI], 9.6-18.1). Overall survival was 8.7 months (95% CI, 5.3-12.1), and 37% of patients survived to 12 months. PFS was 2.8 months (95% CI, 2.6-3.1), and LPFS was 3.1 months (95% CI, 1.3-4.8). One severe complication (abdominal pain) occurred at the time of the TARE procedure. Thirty patients experienced a total of 49 adverse events, of which 8% were grade ≥3; most common were grade 1-2 fatigue and abdominal pain. A total of 77 abnormal laboratory value events were recorded, of which 4% were grade ≥3. CONCLUSIONS: Patients with advanced ICC have limited therapeutic options and a poor prognosis. This prospective study examined the survival of patients with unresectable, chemotherapy-refractory primary ICC treated with TARE in real-world practice. The results demonstrate that this treatment merits further investigation in this patient cohort in a larger study, including collection of patient-reported outcomes.

Quality of life benefits from arrhythmia ablation: A longitudinal study using the C-CAP questionnaire and EQ5D.

AIMS: To investigate long-term efficacy of cardiac ablation for symptomatic arrhythmia by gathering generic and arrhythmia-related quality of life data using patient-reported outcome measures before and after ablation. METHODS: Consecutive patients undergoing cardiac ablation procedures at three sites in the United Kingdom were enrolled (n = 561). Data were collected at baseline, at 8-16 weeks, and 12 months after the ablation with responses from 390 patients received at all three time points. Nonparametric tests were used to identify any changes in patient outcomes due to nonnormal data. RESULTS: There were significant improvements in symptom severity, impact on life scores, EQ-5D-5L indices, and visual analogue score (VAS) scores at pre- versus 3 months and at preablation versus 1 year. Impact on life score showed additional improvement at 1 year versus 3 months, while improvements in symptom severity, EQ-5D-5L indices, and VAS scores continued to be maintained between 3 months and 1 year. CONCLUSION: Cardiac ablation provides patients with arrhythmias relief from symptoms, and results in an improvement in quality of life. Improvements observed at 3 months are maintained at 1 year follow-up.

Questions remain regarding the long-term efficacy of cardiac ablation. We enrolled 561 consecutive patients undergoing ablation procedures at three UK sites. Data were collected at baseline, and at 3 and 12 months. Improvement in symptoms was reported following treatment, with patients continuing to maintain or show continued improvement at 1 year.

Thopaz+ Portable Digital System for Managing Chest Drains: A NICE Medical Technology Guidance.

The Thopaz+ portable digital system was evaluated by the Medical Technologies Advisory Committee (MTAC) of the National Institute for Health and Care Excellence (NICE). The manufacturer, Medela, submitted a case for the adoption of Thopaz+ that was critiqued by Cedar, on behalf of NICE. Due to a lack of clinical evidence submitted by the manufacturer, Cedar carried out its own literature search. Clinical evidence showed that the use of Thopaz+ led to shorter drainage times, a shorter hospital stay, lower rates of chest drain re-insertion and higher patient satisfaction compared to conventional chest drainage when used in patients following pulmonary resection. One comparative study of the use of Thopaz+ in patients with spontaneous pneumothorax was identified and showed shorter drainage times and a shorter length of hospital stay compared to conventional drainage. No economic evidence was submitted by the manufacturer, but a simple decision tree model was included. The model was improved by Cedar and showed a cost saving of £111.33 per patient when Thopaz+ was used instead of conventional chest drainage in patients following pulmonary resection. Cedar also carried out a sub-group analysis of the use of Thopaz+ instead of conventional drainage in patients with pneumothorax where a cost saving of £550.90 was observed. The main cost driver for the model and sub-group analysis was length of stay. The sub-group analysis was based on a single comparative study. However, the MTAC received details of an unpublished audit of Thopaz+ which confirmed its efficacy in treating patients with pneumothorax. Thopaz+ received a positive recommendation in Medical Technologies Guidance 37.

ReCell® Spray-On Skin System for Treating Skin Loss, Scarring and Depigmentation after Burn Injury: A NICE Medical Technology Guidance.

The gold standard treatment for deep burns is an autologous skin graft; in larger burns this may be meshed to increase the area covered. However, long-term aesthetic and functional outcomes of graft scars may be poor. ReCell® is a medical device that processes skin samples in the operating theatre into a cell suspension to be sprayed or dripped onto a wound. It is claimed to improve healing and scar appearance. This device was evaluated by the National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme. Two groups were defined: ReCell compared to conventional dressings in shallower burns, and meshed grafts plus ReCell compared to meshed grafts alone in larger deeper burns. The manufacturer's clinical evidence submission included three papers and eight conference abstracts. The External Assessment Centre (EAC) excluded two of these and added seven abstracts. In general, the evidence did not fit the defined groups, but suggested that ReCell was clinically comparable to skin grafts for partial thickness burns; however, ReCell is not used in this way in the UK. The manufacturer submitted an economic model in which ReCell treatment of partial thickness burns reduced the requirement for later skin grafts. This indicated that ReCell alone was cost saving in comparison to conventional dressings. The EAC indicated that this model was clinically inappropriate, but data were not available to populate a new model. NICE Medical Technologies Guidance 21 recommended that additional research was needed to address the uncertainties regarding the potential benefits of ReCell.

Peristeen Transanal Irrigation System to Manage Bowel Dysfunction: A NICE Medical Technology Guidance.

The Peristeen transanal irrigation system is intended to allow people with bowel dysfunction to flush out the lower part of the bowel as part of their bowel management strategy. Peristeen was the subject of an evaluation by the National Institute for Health and Care Excellence, through its Medical Technologies Evaluation Programme, for the management of bowel dysfunction. The company, Coloplast, submitted a case for adoption of the technology, claiming that the technology improves the severity of chronic constipation or faecal incontinence and improves quality of life for people with bowel dysfunction. Other claimed benefits included reduced frequency of UTIs, stoma surgery and hospitalisation rates, as well as reduced costs. The submission was critiqued by Cedar. The clinical evidence assessed included one randomised controlled trial, and 12 observational studies for adults and 11 studies for children. Although there are limitations in the evidence, the assessed studies show some improvement in outcomes for patients who choose to continue using Peristeen. The committee heard from patient experts that Peristeen had improved their lives and allowed them increased independence. The submitted economic evidence had numerous flaws, however following Cedar's changes to the model, and additional sensitivity analysis, the use of Peristeen was judged unlikely to be cost incurring compared with standard bowel care. The Peristeen transanal irrigation system received a positive recommendation in Medical Technologies Guidance 36.

Requirements for the collection of electronic PROMS either "in clinic" or "at home" as part of the PROMs, PREMs and Effectiveness Programme (PPEP) in Wales: a feasibility study using a generic PROM tool.

BACKGROUND: The patient-reported outcome measures (PROMs), patient-reported experience measure (PREMs) and Effectiveness Programme (PPEP) launched with the aim of supporting all National Health Service Wales (NHS Wales) organisations to collect PROMs and PREMs across a range of conditions. The aim is to collect generic and condition-specific PROMs and PREMs electronically from every secondary care patient in Wales to provide a measure that can be used to determine the clinical and cost-effectiveness of treatments and services. This study reports on the experience of the PPEP in developing an electronic platform suitable for large-scale data collection, storage, analysis and reporting and identifies the problems encountered and solutions implemented using a generic PROM survey as an example. METHODS: The generic PROM survey is available in English and Welsh and consists of a consent section and three components: the EQ-5D-5L tool, the Work Productivity and Activity Impairment (WPAI) tool and a number of "about you" questions. The "about you" questions are designed to assess factors which may affect patient health and outcomes such as information on height, weight, smoking history, exercise levels and alcohol consumption. A dedicated PROM database was built, and links between the e-PROM platform and other key clinical databases within NHS Wales were developed. RESULTS: Pilot testing of the unvalidated sections of the generic electronic PROM found that most of the questions were well understood and easy to answer: however, feedback suggested some improvements and changes were required, specifically around questions relating to alcohol and exercise.Electronic PROM collection has been initiated in six of the seven health boards in Wales and at-home collection initiated in three health boards. More than 9300 patients have completed a PROM survey. Early results from one Health Board show that patients took approximately 10 min to complete the questionnaire with most patients answering an average of 94.7% of the questions. CONCLUSIONS: Successful implementation of a PROM collection programme is dependent on a number of factors including close collaboration with clinicians, analysts, IT specialists and patients to ensure that any electronic system of PROM collection is fit for purpose and user friendly both for patients and clinicians.

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study).

OBJECTIVES: To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP). PATIENTS AND METHODS: As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK-ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post-procedure, and complication data post-PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non-inferiority analysis on propensity-score-matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire-based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK-ROPE study database. RESULTS: The results showed that PAE was clinically effective, producing a median 10-point IPSS improvement from baseline at 12 months post-procedure. PAE did not appear to be as effective as TURP, which produced a median 15-point IPSS score improvement at 12 months post-procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality-of-life (QoL) improvement, there was no evidence of PAE being non-inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post-procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non-target embolization that presented as self-limiting penile ulcers. Additional patient-reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy-one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights. CONCLUSION: Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone-beam computed tomography is encouraged to improve operator confidence and minimize non-target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients' symptoms, requirements and anatomical variation.

ENDURALIFE-Powered Cardiac Resynchronisation Therapy Defibrillator Devices for Treating Heart Failure: A NICE Medical Technology Guidance.

ENDURALIFE™-powered cardiac resynchronisation therapy defibrillator (CRT-D) devices were the subject of an evaluation by the National Institute for Health and Care Excellence, through its Medical Technologies Evaluation Programme, for the treatment of heart failure. Boston Scientific (manufacturer) submitted a case for the adoption of the technology, claiming that it has a longer battery life resulting in a longer time to CRT-D replacement. Other claimed benefits were fewer complications associated with replacement procedures, fewer hospital admissions, less time spent in hospital and reduced demand on cardiology device implantation rooms. The submission was critiqued by Cedar, an external assessment centre. The submitted clinical evidence showed that ENDURALIFE-powered devices implanted during the period 2008-2010 were superior, in terms of longevity, to other devices at that time. Submitted economic evidence indicated that, because of a reduction in the need for replacement procedures, ENDURALIFE-powered devices were cost saving when compared to comparator devices. Cedar highlighted uncertainty of the applicability of the clinical evidence to devices marketed today. The Medical Technologies Advisory Committee noted that this was unavoidable due to the follow-up time required to study battery life. Clinical experts noted that increased battery life is an important patient benefit. However, centres use devices from multiple manufacturers to negate pressure on clinical services in the event of a major device recall. The clinical and economic evidence showed benefits to the patient, and further analysis requested by the committee suggested that ENDURALIFE-powered CRT-Ds may save between £2120 and £5627 per patient over 15 years through a reduction in the need for replacement procedures. ENDURALIFE-powered CRT-D devices received a positive recommendation in Medical Technologies Guidance 33.

The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance.

As part of its Medical Technologies Evaluation Programme (MTEP), the National Institute for Health and Care Excellence (NICE) invited Neotract (manufacturer) to submit clinical and economic evidence for their prostatic urethral lift device, Urolift, for the relief of lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS BPH). The Urolift System uses implants to retract the prostatic lobe away from the urethral lumen. The clinical evidence used in the manufacturer's submission shows that Urolift is effective for the treatment of BPH. Urolift delivers a weighted mean International Prostate Symptom Score (IPSS) improvement of between 9.22 and 11.82 points. These Urolift improvements are greater than a published 'marked improvement' in IPSS score of 8.80. Comparison with randomised controlled trials (RCTs) of TURP (Transurethral Resection of Prostate) and HoLEP (Holmium Laser Enucleation of Prostate) show that Urolift does not yield better clinical outcomes from baseline compared to TURP and HoLEP in terms of IPSS, QoL (Quality of Life) and Qmax (maximum urinary flow). However, Urolift appears to have the advantage in terms of minimal and mild complications, and this may be of interest to patients and urologists. The economic case for Urolift was made using a very detailed and thorough de novo cost model. The base case posed by the manufacturer placed Urolift at almost cost-neutral (£3 cost incurring, based on 2014 prices) compared to TURP, and £418 cost incurring compared to HoLEP. In an additional scenario comparing day-case Urolift with in-patient TURP, the estimated per-patient savings with Urolift were £286 compared with monopolar TURP (mTURP) and £159 compared with bipolar TURP (BiTURP). NICE guidance MTG26 recommends that the case for adoption of Urolift was supported by the evidence, when implemented in a day-case setting.

The TURis System for Transurethral Resection of the Prostate: A NICE Medical Technology Guidance.

The transurethral resection in saline (TURis) system was notified by the company Olympus Medical to the National Institute of Health and Care Excellence's (NICE's) Medical Technologies Evaluation Programme. Following selection for medical technologies guidance, the company developed a submission of clinical and economic evidence for evaluation. TURis is a bipolar surgical system for treating men with lower urinary tract symptoms due to benign prostatic enlargement. The comparator is any monopolar transurethral resection of the prostate (mTURP) system. Cedar, a collaboration between Cardiff and Vale University Health Board, Cardiff University and Swansea University in the UK, acted as an External Assessment Centre (EAC) for NICE to independently critique the company's submission of evidence. Eight randomised trials provided evidence for TURis, demonstrating efficacy equivalent to that of mTURP for improvement of symptoms. The company presented meta-analyses of key outcome measures, and the EAC made methodological modifications in response to the heterogeneity of the trial data. The EAC analysis found that TURis substantially reduced the relative risks of transurethral resection syndrome (relative risk 0.18 [95 % confidence interval 0.05-0.62]) and blood transfusion (relative risk 0.35 [95 % confidence interval 0.19-0.65]). The company provided a de novo economic model comparing TURis with mTURP. The EAC critiqued the model methodology and made modifications. This found TURis to be cost saving at £70.55 per case for existing Olympus customers and cost incurring at £19.80 per case for non-Olympus customers. When an additional scenario based on the only available data on readmission (due to any cause) from a single trial was modelled, the estimated cost saving per case was £375.02 for existing users of Olympus electrosurgery equipment and £284.66 per case when new Olympus equipment would need to be purchased. Meta-analysis of eight randomised trials showed that TURis is associated with a statistically significantly reduced risk of transurethral resection syndrome and a reduced need for blood transfusion-two factors that may drive cost saving for the National Health Service. The clinical data are equivocal as to whether TURis shortens the hospital stay. Limited data from a single study suggest that TURis may reduce the rate of readmission after surgery. The NICE guidance supports adoption of the TURis technology for performing transurethral resection of the prostate in men with lower urinary tract symptoms due to benign prostatic enlargement.