INTEGRATE: Using routinely-collected healthcare data to inform clinical guidance and improve population health

Background The National Institute for Health and Care Excellence (NICE) is a global leader in developing guidelines for clinical care. However, there are areas of important need where treatment recommendations cannot be made due to lack of robust evidence to inform them (what should we do?). In the UK we are fortunate to have a wealth of routinely-collected healthcare data that is used by approved researchers in a safe and anonymised manner. It can be used to study important health questions such as the effects and safety of prescribed drugs, which may be particularly important when there is little evidence from randomised trials. However, at present routine healthcare data is little used to develop guidelines about the effects of drugs as there is concern that the results are less robust than that from randomised trials. However, there could be benefits to using this data: it is immediately available, low cost to analyse, and provides evidence about drug effects in the whole population rather than those included in trials. In addition, at present NICE do not monitor the uptake and effects of their guidelines (does what we do work?). Not assessing use of guidelines by healthcare workers means that we cannot understand or improve differences in uptake between men and women, among different ethnic groups, people with different income levels and between regions of England. This could lead to reduced health benefits and higher healthcare costs (how can we do better?). Aims and objectives The aim of the INTEGRATE study is to work in partnership with NICE to address these questions by identifying whether evidence from routinely-collected healthcare data can inform and increase the impact of clinical guidance produced by NICE. The objectives are to: Create early robust evidence where randomised trials are lacking. Assess the extent of implementation of guidance and variations in care. Determine the health and economic impact of implementation or non-uptake. Methods Workstream A: Using routinely-collected data to inform guideline development In this workstream we will jointly plan a series of three research studies. I will then analyse each using a scientific approach that treats the data as if it was a clinical trial. At the end of each study we will review what has been learnt to help improve the methods for the next one. By the end of the project we will jointly develop a framework to help NICE decide when routinely-collected data is helpful to address uncertainty in the future. Workstream B: Using routinely-collected data to assess and evaluate guideline impact Having jointly decided on a recent NICE guideline to study I will use routine healthcare data to identify what proportion of patients who should receive a drug are being offered it, looking in detail at whether this varies by sex, ethnicity, income and region. These results will feed into efforts to improve uptake of guidance in areas of need. I will then go on to study whether the guideline has led to improved health and to lower healthcare costs. Patient and Public Involvement Through our current research programme, we have developed a diverse and inclusive online patient and public advisory group. We will seek volunteers from this group to join the INTEGRATE steering group to help with all stages of the project including development of future research questions, interpretation of findings, providing feedback on plain English summaries and other methods of dissemination. Dissemination The impact of the INTEGRATE project will be to improve how NICE use evidence from routine data to develop and implement guidelines, strengthening their work into the future and with potential cost-efficiencies and benefits for the health of the population.