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.

Detecting deterioration in patients with chronic disease using telemonitoring: navigating the 'trough of disillusionment'.

OBJECTIVES: To examine the evidence base for telemonitoring designed for patients who have chronic obstructive pulmonary disease and heart failure, and to assess whether telemonitoring fulfils the principles of monitoring and is ready for implementation into routine settings. DESIGN: Qualitative data collection using interviews and participation in a multi-path mapping process. PARTICIPANTS: Twenty-six purposively selected informants completed semi-structured interviews and 24 individuals with expertise in the relevant clinical and informatics domains from academia, industry, policy and provider organizations and participated in a multi-path mapping workshop. RESULTS: The evidence base for the effectiveness of telemonitoring is weak and inconsistent, with insufficient cost-effectiveness studies. When considered against an accepted definition of monitoring, telemonitoring is found wanting. Telemonitoring has not been able so far to ensure that the technologies fit into the life world of the patient and into the clinical and organizational milieu of health service delivery systems. CONCLUSIONS: To develop effective telemonitoring for patients with chronic disease, more attention needs to be given to agreeing the central aim of early detection and, to ensure potential implementation, engaging a wide range of stakeholders in the design process, especially patients and clinicians.

Designing and implementing telemonitoring for early detection of deterioration in chronic disease: defining the requirements.

Patients with chronic disease may suffer frequent acute deteriorations and associated increased risk of hospitalisation. Earlier detection of these could enable successful intervention, improving patients' well-being and reducing costs; however, current telemonitoring systems do not achieve this effectively. We conducted a qualitative study using stakeholder interviews to define current standards of care and user requirements for improved early detection telemonitoring. We determined that early detection is not a concept that has informed technology or service design and that telemonitoring is driven by the available technology rather than by users' needs. We have described a set of requirements questions to inform the design and implementation of telemonitoring systems and suggested the research needed to develop successful early detection telemonitoring. User-centred design and genuine interdisciplinary approaches are needed to create solutions that are fit for purpose, sustainable and address the real needs of patients, clinicians and healthcare organisations.

Bridging two translation gaps: a new informatics research agenda for telemonitoring of chronic disease.

OBJECTIVE: To propose a research agenda that addresses technological and other knowledge gaps in developing telemonitoring solutions for patients with chronic diseases, with particular focus on detecting deterioration early enough to intervene effectively. DESIGN: A mixed methods approach incorporating literature review, key informant, and focus group interviews to gain an in-depth, multidisciplinary understanding of current approaches, and a roadmapping process to synthesise a research agenda. RESULTS: Counter to intuition, the research agenda for early detection of deterioration in patients with chronic diseases is not only primarily about advances in sensor technology but also much more about the problems of clinical specification, translation, and interfacing. The ultimate aim of telemonitoring is not fully agreed between the actors (patients, clinicians, technologists, and service providers). This leads to unresolved issues such as: (1) How are sensors used by patients as part of daily routines? (2) What are the indicators of early deterioration and how might they be used to trigger alerts? (3) How should alerts lead to appropriate levels of responses across different agencies and sectors? CONCLUSION: Attempts to use telemonitoring to improve the care of patients with chronic diseases over the last two decades have so far failed to lead to systems that are embedded in routine clinical practice. Attempts at implementation have paid insufficient attention to understanding patient and clinical needs and the complex dynamics and accountabilities that arise at the level of service models. A suggested way ahead is to co-design technology and services collaboratively with all stakeholders.