Abstract
BackgroundBlood for transfusion is a frequently used clinical intervention, and is also a costly and limited resource with risks. Many transfusions are given to stable and non-bleeding patients despite no clear evidence of benefit from clinical studies. Audit and feedback (A&F) is widely used to improve the quality of healthcare, including appropriate use of blood. However, its effects are often inconsistent, indicating the need for coordinated research including more head-to-head trials comparing different ways of delivering feedback. A programmatic series of research projects, termed the ‘Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE’ (AFFINITIE) programme, aims to test different ways of developing and delivering feedback within an existing national audit structure.MethodsThe evaluation will comprise two linked 2×2 factorial, cross-sectional cluster-randomised controlled trials. Each trial will estimate the effects of two feedback interventions, ‘enhanced content’ and ‘enhanced follow-on support’, designed in earlier stages of the AFFINITIE programme, compared to current practice. The interventions will be embedded within two rounds of the UK National Comparative Audit of Blood Transfusion (NCABT) focusing on patient blood management in surgery and use of blood transfusions in patients with haematological malignancies. The unit of randomisation will be National Health Service (NHS) trust or health board. Clusters providing care relevant to the audit topics will be randomised following each baseline audit (separately for each trial), with stratification for size (volume of blood transfusions) and region (Regional Transfusion Committee). The primary outcome for each topic will be the proportion of patients receiving a transfusion coded as unnecessary. For each audit topic a linked, mixed-method fidelity assessment and cost-effectiveness analysis will be conducted in parallel to the trial.DiscussionAFFINITIE involves a series of studies to explore how A&F may be refined to change practice including two cluster randomised trials linked to national audits of transfusion practice. The methodology represents a step-wise increment in study design to more fully evaluate the effects of two enhanced feedback interventions on patient- and trust-level clinical, cost, safety and process outcomes.Trial registrationhttp://www.isrctn.com/ISRCTN15490813
Highlights
Blood for transfusion is a frequently used clinical intervention, and is a costly and limited resource with risks
In England, the National Health Service Blood and Transplant (NHSBT) National Comparative Audit (NCA) programme has supported a series of national audits designed to assess whether blood components are used appropriately and safely across clinical specialties [7]
This group agrees upon audit standards against which clinical practice will be compared, the data to be collected and the findings and recommendations to be included in feedback reports
Summary
Trial-based economic evaluation is not feasible as no unique set of patients is identified at the start of the trial and followed until study completion. Modelling is required to simulate costs and outcomes associated with each option. The models will combine decision tree and Markov approaches and will simulate the main hypothesised costs and effects. These include the costs associated with each intervention, changes in unnecessary transfusions and associated adverse events, plus changes in practice that were introduced to facilitate the change in transfusions. The trials will provide data on the impact of the interventions on transfusions and transfusion-associated adverse events. Data from published studies, expert clinical opinion, SHOT and the BSMS will be used to estimate the probabilities, costs, utilities and survival of transfusionrelated adverse events. No transfer of endpoint data or cleaning has yet occurred
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