Title: Are the Blood Testing Schedules within Chemotherapy Treatment Protocols Optimal for Patient Care?
Funder: Department of Health and Social Care

Abstract: Background Over the past decade the numbers of patients receiving chemotherapy has increased. This growth has led to many chemotherapy delivering services to adapt patient pathways in order to reduce patient waiting time and maximise capacity. Patients receiving chemotherapy require a toxicity review prior to chemotherapy administration, including haematology testing and a scoring of adverse effects. Myelosuppression is a common chemotherapy toxicity that can present as low levels of neutrophils, platelets and haemoglobin. Criteria for the period between haematological testing and chemotherapy administration is not evidence based, but commonly set in chemotherapy procedures as a seventy two- hour period. This period is referred to as the validity period. Many patients with common cancers have haematological tests and chemotherapy on different days, there are many occasions when the seventy-two hour period will pass and a repeat blood test will be taken. This causes delays to patients on the day of chemotherapy, as the blood test will need to be reviewed prior to treatment. The vesicant or irritant effects of some of the common chemotherapy agents mean that extracting blood is often challenging and can cause anxiety and distress to patients. In addition there are costs to patients, their carers and the health service.The study is of importance to ensure that blood testing is not duplicated unnecessarily in patients undergoing chemotherapy treatment.Aims and objectives The aim of the study is to evaluate whether the validity period that are currently used within chemotherapy guidelines are optimal for chemotherapy patients in routine clinical practice. The achievable objectives are: 1) To retrospectively analyse data from electronic chemotherapy prescribing records, from multiple NHS sites, where multiple blood tests have been performed at earlier time points to 72 hours and again within the 72 hour period. From this the proportion of patients that that received an unnecessary blood test will be calculated. 2) To develop and validate a risk model for five chemotherapy regimens (Validity Blood Assessment (VBA) model) to enable clinicians to confidently extend validity periods for these protocols as appropriate.Methods A retrospective cohort study from approximately 10,000 chemotherapy treatment episodes will be conducted. The results will be used to develop and validate the VBA model. Four major cancer centres in England have agreed to collaborate in this research. Data on five chemotherapy protocols for three different types of cancer (breast, colorectal and lymphoma) will be collected and used in the development of the model using the STATA software. The whole dataset will be used to estimate the probability of a patient suffering an unexpected myelopsuppression, if a previous sample indicated otherwise, prior to chemotherapy. Variables on potential predictors for an unexpected myelosuppression have been derived from a literature review. These will be initially analysed by univariable analysis to understand their associations with outcome. A multivariable logistic regression model will be developed using these predictors. The model will be validated both internally and then externally using new data from London based hospitals. Following this, a small single site evaluation will test the use of any model in clinical practice. The results from this will be a guide to future real-time testing. Project Outputs It is envisaged that guidance can be developed using the model. The model would guide and evidence based guideline to appropriate validity periods for different patient groups. The model developed within the research would enable clinicians extend validity periods when appropriate and minimising blood testing for commonly used chemotherapy protocols. The research may result in a financial saving for both patients and the NHS.

Lay abstract: This research aims to provide the evidence currently lacking for chemotherapy blood testing schedules. Evidence that will directly improve the care to many patients. A large volume of data is available, where electronic prescribing is used. The data will be used to both develop and validate a model that will guide the schedules of blood testing during chemotherapy.Background Over the past decade chemotherapy patient numbers have grown. This growth has led to many NHS services that deliver chemotherapy to change patient pathways (i.e. the route that individual patients take through their processes of care), in order to reduce patient waiting times and maximise capacity. Patients receiving chemotherapy receive a safety check before chemotherapy can be given. Bone marrow suppression (a decrease in the production of blood cells) is a common side effect of chemotherapy that is monitored via a blood test.A seventy two hour period is commonly written into chemotherapy policies as an appropriate period between having a blood test and receiving chemotherapy. This is referred to as a validity period. It is not well understood what the ideal validity period or window is between having a blood test and receiving treatment. Patients that receive treatment for common cancers such as breast, lung and bowel will commonly have blood tests on a separate day to their chemotherapy, to avoid long waits. There are occasions when this seventy two hour period will pass after a blood test is taken and before chemotherapy treatment. This will result in patients receiving a further blood test on the day of chemotherapy. For many patients this may be unnecessary and the additional test can impact patients in many ways. This study aims to assess whether the validity period of seventy two hours is actually appropriate for patients in routine clinical practice. Methods Using chemotherapy electronic prescribing data for approximately 10,000 treatment episodes, a risk model will be developed for commonly used chemotherapy treatments. The data will be from four English cancer hospitals. The data will be used to establish firstly the proportion of patients that did receive an unnecessary duplicate blood test before receiving chemotherapy. The developed model will enable the understanding of a safe validity period and also the understanding of patients groups that actually may need additional testing. Patient and Public Involvement Patients and carers have helped in the development of this research proposal. A panel of patients and carers will be directly involved in managing the research by giving advice, that will shape the research at defined time points. The representatives will also help with guiding dissemination, to patients and carers. This will ensure that information that is shared is appropriate. Project OutputsFindings of the research will be presented to patients, carers and relevant NHS professional groups that may drive further work in the area and change in practice. An international collaborator will aid dissemination outside the UK. Dissemination will be via conferences and freely accessed journals. As the study is multicentre, collaborators at other sites will help share any new knowledge learned and provide rapid adoption to any changes in practice if required. Adoption of the findings may result in economic savings to both the NHS and to patients and their carers. The proposed research, has potential to have real impact on patients and the NHS service by:Providing evidence based guidance to blood testing schedulesProviding an understanding of the patients that are at an increased risk of bone marrow suppressionIncreasing data science research in an area that is currently lacking.

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