A Case Study on Reviewing Specialist Services Commissioning in Wales: TAVI for Severe Aortic Stenosis.

The Welsh Health Specialised Services Committee (WHSSC) is responsible for planning, commissioning and funding specialised healthcare in Wales. Investment in new technologies or services is based on clinical and economic evidence, using a consistent and transparent process. This is accomplished in three stages. The first stage is the preparation of a rapid evidence review. This then informs the development or update of the relevant Commissioning Policy. The final stage is to prioritise the Commissioning Policy recommendations against all other new services and interventions, to inform WHSSC's annual commissioning intentions. In 2017, a review was conducted of the WHSSC Commissioning Policy for transcatheter aortic valve implantation for severe aortic stenosis. Prior to this only high-risk patients were eligible for transcatheter aortic valve implantation. The rapid evidence review identified three randomised controlled trials and two economic analyses relevant to the decision problem. Transcatheter aortic valve implantation was generally found to be more expensive and more effective than medical management or surgical aortic valve replacement, with incremental cost-effectiveness ratios around £10,500-£36,000 for inoperable groups and £17,000-£24,000 in high-risk groups. The rapid evidence review, expert advice and stakeholder feedback informed the revision process of the Commissioning Policy for transcatheter aortic valve implantation. This recommended the addition of patients unsuitable for surgical aortic valve replacement and the removal of explicit risk scoring. This recommendation was subject to the prioritisation process (carried out annually). The updated transcatheter aortic valve implantation recommendation was ranked second out of 23 technologies and services competing for additional WHSSC funding. The WHSSC Integrated Commissioning Plan for specialised services in Wales (2019) therefore included funding to support the new criteria for transcatheter aortic valve implantation treatment.

In Wales, specialised health services are selected and funded at a national level by the Welsh Health Specialised Services Committee. Specialised services are provided for small numbers of patients, requiring highly specialised professionals or technologies. When the aortic heart valve becomes narrowed with disease it can be replaced with an artificial valve. This normally requires open surgery, which is risky for some patients, particularly those who are frail. Since 2012, the Welsh Health Specialised Services Committee have funded a less invasive procedure called TAVI (transcatheter aortic valve implantation) for patients who could have open surgery but at a high risk. In 2017, this policy needed updating, thus a new evidence review was conducted. This showed that patients at high risk from open surgery were more likely to survive if they underwent TAVI. Others, for whom open surgery was too risky, were also more likely to survive if they underwent TAVI instead of medication. However, TAVI tended to produce more vascular problems, such as blockages or damage to blood vessels. Transcatheter aortic valve implantation is generally more effective and more expensive than either drugs or open surgery in these patient groups, but is within cost-effectiveness limits often used in the UK National Health Service. As a result of the review, experts recommended that TAVI should be available to more patients, which would require greater levels of funding. Transcatheter aortic valve implantation was ranked as second out of 23 new or updated treatments competing for funding allocations. The Welsh Health Specialised Services Committee therefore published a new Commissioning Plan for TAVI in 2019 that now included patients who are considered too risky to undergo open surgery.

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.

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.