Diagnostic Evidence Co-operative Newcastle

The clinical utility of a risk assessment tool combining NEWS (National Early Warning Score) and mid-regional pro-adrenomedullin (MR-proADM) for the disposition planning of acutely ill patients The NIHR Diagnostic Evidence Co-operative (DEC) Newcastle is working with Thermo Fisher Scientific to evaluate the clinical performance and budget impact of their MR-proADM Kryptor assay.

Clinical requirement / unmet need / challenge Patients admitted to an acute medical assessment unit by referral from their GP, or the emergency department, will typically have their National Early Warning Score (NEWS) taken. This score summarises key parameters including heart rate, blood pressure, and temperature, into a single number. Higher NEWS indicates a greater risk of deterioration. However, some patients with low scores will deteriorate unexpectedly, and the NEWS is therefore not sufficiently predictive. Additionally, patients with chronic obstructive pulmonary disease (COPD), and other chronic conditions, may have a consistently elevated baseline NEWS. In these patients, the NEWS predicts a higher risk of deterioration, and indicates requirement of a higher level of monitoring or care than may actually be necessary.

The opportunity The mid-regional fragment of pro-adrenomedullin (MR-proADM) is a stable part of the molecule adrenomedullin (ADM) and is found in plasma after ADM degradation. Studies have shown the plasma level of MR-proADM to be predictive of severity of illness in sepsis and respiratory infections, and it may also predict survival in patients with COPD or heart failure. Thermo Fisher Scientific has therefore developed an assay which detects the MR-proADM level in plasma, which may have potential for use alongside the NEWS for more accurate predictions.

www.newcastle.dec.nihr.ac.uk | [email protected] |

@NIHR_DEC_Ncl

The NIHR Diagnostic Evidence Co-operative Newcastle is delivered in partnership between Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University

How we addressed the challenge The highly active Assessment Suite at the Royal Victoria Infirmary of Newcastle upon Tyne Hospitals NHS Foundation Trust was the ideal location to investigate the predictive power of MRproADM. Dr Ashley Price (Consultant in Infectious Diseases) was keen to be involved and took on the role of Chief Investigator. In his role as Professor of Respiratory Medicine, John Simpson (Director, NIHR DEC Newcastle) took on a co-investigatory role. Between them, and Dr Michael Power (Deputy Director, NIHR DEC Newcastle), and with statistical support from Dr Deborah Stocken (Senior Lecturer in Clinical Trials and Biostatistics, Institute of Health and Society, Newcastle University), a study was designed. The study aimed to identify if a prediction model based on NEWS plus MR-proADM would improve the quantification and categorisation of the risks of clinically important deterioration, across timescales ranging from 24 hours to 30 days from admission. It also sought to assess the budget impact of adoption of such a decision aid into acute medical assessment units of NHS Trusts.

Progress to date With a small team of enthusiastic research nurses, the study recruited its first patient in September 2015. They used recruitment documentation generated by the DEC’s Work Packet System, and stored the data in its linked data capture system. Coordination and study support was provided by Rachel O’Leary (Research Scientist, NIHR DEC

Newcastle) and Ray Waters (Project Manager, NIHR DEC Newcastle). The study reached its recruitment target of 300 participants in December 2015. Collection of follow-up data is ongoing for the last patients recruited, and a period of data cleaning and checking will follow. The scripts for computational analysis are being finalised, and once the final dataset is available, statistical analysis will be carried out by Dr Sara Graziadio (Research Scientist, NIHR DEC Newcastle), and health economic analysis will be carried out by Dr Joy Allen (IVD Evaluation Methodologist, NIHR DEC Newcastle). The NIHR DEC Newcastle will also work with the clinical research team, and other relevant clinical stakeholders, to develop a decision aid incorporating NEWS and MR-proADM, for the accurate prediction of deterioration risk in patients admitted to acute medical assessment units. Following the analysis, a publication will be drafted for submission to a high quality open access journal.

Future work and impact If the results from this study indicate that MRproADM is a good complement to the NEWS, in predicting the deterioration risk and subsequent outcome of patients admitted to acute medical assessment units, further studies would be justified. The impact in the future could include fewer adverse events as a result of unexpected deterioration, the accurate stratification of patients into high or low risk, and the associated budget impact of assigning resources accordingly.

www.newcastle.dec.nihr.ac.uk | [email protected] |

@NIHR_DEC_Ncl

The NIHR Diagnostic Evidence Co-operative Newcastle is delivered in partnership between Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University