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Severe aortic stenosis is a disease affecting the heart valves with a growing prevalence in Europe and globally. Transcatheter aortic valve implantation (TAVI) is a treatment for this condition, which is an alternative to open heart surgery, using a less invasive ('keyhole') approach. Around 70% of the specialist
TAVI centres in the UK, which offer this procedure, employ a specialist TAVI nurse. However, many of these roles are not on substantive contracts and some of these nurses may be working under heavy burdens given the number of procedures performed by the centre. York Health Economics Consortium (YHEC) has undertaken a project to assess the potential value that specialist TAVI nurses bring to the patient pathway within the NHS, based on information obtained from TAVI nurses at seven hospitals in the UK.
BACKGROUND: Differentiating between bacterial and viral lower respiratory tract infections (LRTIs) presents a challenge for clinicians. This impacts patient management and treatment decisions, meaning patients with suspected viral infections often receive unnecessary antibiotics. The objective of this care pathway analysis (CPA) was to establish the potential positioning of a new test (MeMed BV) in the LRTI pathway in UK Emergency Departments (EDs).
MATERIALS: Semi-structured interviews of clinicians with experience in the diagnosis and management of LRTIs and budget holders were undertaken via Zoom. Thematic analysis and qualitative synthesis were conducted.
RESULTS: Ten clinicians, three budget holders, and one diagnostic adoption specialist were interviewed between July and August 2023. Based on the clinicians' feedback, we developed a flow-diagram of the main decision points in the current diagnostic pathway for LRTIs and a separate diagram including the new test. From the interviews, the main variations between hospitals were the timing of blood draw and availability of diagnostic point-of-care tests (POCTs). Clinicians made recommendations about the unmet clinical needs (e.g. reducing people going to EDs for LRTI unnecessarily and identifying bacterial infections likely to deteriorate); new test positioning (at the beginning of the pathway to identify patients for further testing and antibiotic prescriptions); and potential barriers to adoption (e.g. cost of the test and pipetting constraints). They also discussed evidence requirements (e.g. need for UK outcome data and cost effectiveness compared with the current standard of care); further technical development with associated benefits (e.g. finger prick version of the test for children); and potential value propositions (e.g. reduction of ED waiting times and admissions while waiting for test results in the most severe population with uncertain diagnoses). Budget holders advised on the process for test adoption: clinical and laboratory staff are key decision makers, with POCTs processed through clinicians and laboratory tests through the laboratory team. A business case is needed on a hospital-by-hospital basis.
CONCLUSIONS: The analysis provides useful information to inform evidence generation and test implementation. Since CPA is an iterative process, value propositions and test positioning need further refinement and validation through clinical studies, economic assessments, and clinical opinion elicitation.
Respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD), are common in England with the worst respiratory outcomes observed in the most deprived areas. There is limited published research to establish whether the rate of oral corticosteroid (OCS) prescribing for asthma and COPD is linked to levels of deprivation. This study carried out a multivariable regression analysis of publicly available data and found that deprivation is associated with a statistically significant increase in the proportion of patients receiving an OCS prescription for asthma or COPD at a GP practice level (p < 0.001). The model estimated that the proportion of prescriptions is 1.88% (95% CI 1.83% to 1.92%) and 2.84% (95% CI 2.70% to 2.98%) for the least deprived GP practice and the most deprived GP practice, respectively. This study lays the groundwork for future research using individual patient level data to consider the impact of variation in OCS prescribing rates.
BACKGROUND: There is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population.
METHODS: A two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses.
RESULTS: TAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses.
CONCLUSIONS: Based on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population.
The Consolidated Standards of Reporting Trials extension for Artificial Intelligence interventions (CONSORT-AI) was published in September 2020. Since its publication, several randomised controlled trials (RCTs) of AI interventions have been published but their completeness and transparency of reporting is unknown. This systematic review assesses the completeness of reporting of AI RCTs following publication of CONSORT-AI and provides a comprehensive summary of RCTs published in recent years. 65 RCTs were identified, mostly conducted in China (37%) and USA (18%). Median concordance with CONSORT-AI reporting was 90% (IQR 77-94%), although only 10 RCTs explicitly reported its use. Several items were consistently under-reported, including algorithm version, accessibility of the AI intervention or code, and references to a study protocol. Only 3 of 52 included journals explicitly endorsed or mandated CONSORT-AI. Despite a generally high concordance amongst recent AI RCTs, some AI-specific considerations remain systematically poorly reported. Further encouragement of CONSORT-AI adoption by journals and funders may enable more complete adoption of the full CONSORT-AI guidelines.
