Title: Effectiveness and cost-effectiveness of serum B-type natriuretic peptide (BNP or NT-BNP) testing and monitoring in patients with heart failure (HF) in primary and secondary care.
Funder: Department of Health (England)

Abstract: Our proposed research project has three components: STUDY 1: We propose to conduct a full systematic review of the published evidence and identify all randomised controlled trials (RCTs) on the clinical effectiveness of BNP-guided therapy versus standard care (symptom-guided therapy) for patients with heart failure (HF). We will update an existing (unpublished) individual patient data (IPD) meta-analysis of these RCTs to determine whether BNP-guided therapy is effective in patients with HF and test whether the effectiveness of BNP-guided therapy varies in subgroups of interest pre-specified by the expert clinicians in the team. These subgroup analyses will identify who would benefit the most from such monitoring (as specified in the brief). In view of the fact that we may be unable to obtain IPD from all RCT study authors we will also update an aggregate data meta-analysis to compare with the results of the IPD meta-analysis. We are aware that the IPD are unlikely to provide adequate parameter estimates for the cost-effectiveness model because the RCTs are heterogeneous have highly selected populations and have all been conducted outside the UK and (with one exception) only in hospital settings. STUDY 2: We propose to supplement the IPD meta-analysis with analyses of a cohort of patients with HF which is geographically representative of patients with HF being managed in primary and secondary care in the UK. We will create the cohort by linking data from the Clinical Practice Research Datalink (CPRD) the UK National Heart Failure Audit (NHFA) Hospital Episode Statistics (HES) and Office of National Statistics (ONS) mortality register. These data will allow us to profile the longitudinal care pathway for a representative sample of HF patients from diagnosis through treatment to outcome. This cohort will provide realistic population-based parameter estimates to populate the cost-effectiveness model. In addition we will attempt to distinguish groups of patients who have never had BNP testing who have been tested to diagnose HF or who have been tested in order to guide treatment. If we are successful in doing this we will also estimate the effectiveness of BNP testing / monitoring in subgroups of interest pre-specified by the expert clinicians in the team (e.g. type of HF (left ventricular systolic dysfunction vs. preserved ejection fraction) presence vs. absence of major comorbidity at diagnosis etc.) which cannot be estimated from the IPD meta-analysis because some subgroups have been excluded from the trials. STUDY 3: We will develop a lifetime cost-effectiveness model to evaluate the cost per Quality Adjusted Life Year (QALY) gained by BNP monitoring versus standard care in patients with HF managed in primary or secondary care using efficacy data derived from STUDY 1 and resource use data derived from STUDY 2 to inform key parameters of the model. Separate analyses will be conducted for pre-specified patient subgroups shown to respond differently to BNP monitoring (e.g. patients > 75 years) by either STUDY 1 or STUDY 2.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CARDIOVASCULAR