Title: INTEGRATE: Using routinely-collected healthcare data to inform clinical guidance and improve population health
Funder: Department of Health and Social Care

Abstract: Background Clear health guidance informed by robust evidence can improve the health of populations. 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 clinical need where robust randomised evidence to inform guidance does not exist and recommendations for care (what should we do?) are not made. Despite the focus on generating high-quality guidance, at present uptake and impact of guidance is not directly measured (does what we do work?). Not assessing guidance implementation leads to an inability to understand and address disparities by sex, ethnicity, socioeconomic status and region, leading to lost economic benefits from improved health (how can we do better?).The COVID pandemic has created new collaborations and I have worked with partners from NICE over the last year to provide evidence to address urgent research questions. In the INTEGRATE study I will build on this partnership to answer co-produced research questions using cutting-edge epidemiological methods in the unique wealth of routinely-collected data available in England to provide specific and timely evidence to address evidence gaps and inform implementation.Aims and objectives The aim is to determine if evidence generated from routinely-collected 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. Develop a framework to support NICE in adopting observational evidence into clinical guidance.Methods Workstream A: Using routinely-collected data to inform guideline developmentAfter initial scoping meetings we will complete three cycles of answering distinct research questions using a target-trial approach in primary care data. Shared learning in each cycle will iteratively improve knowledge leading to a framework for incorporation of routine evidence into NICE clinical guidance.Workstream B: Using routinely-collected data to assess and evaluate guideline impactAfter collaborative identification of suitable recent NICE guidance, we will use repeated cross-sectional studies in primary care data to describe changes in individual level-prescribing over time after guideline launch, focusing on disparities in prescribing by sex, ethnicity, socioeconomic status and region. These results will feedback to targeted efforts to improve uptake of guidance in areas of need. We will go on to quantify the health and economic benefits of uptake in a cohort study.Timelines for delivery The learning-systems approach in Workstream A will lead to co-development of knowledge throughout the cycles of research projects, culminating in the final framework for incorporation of routine evidence into NICE guidance in year five. Workstream B will run concurrently over three years.Anticipated impact and dissemination Individual studies will directly inform clinical guidelines as well as producing stand-alone outputs. The ultimate impact will be to improve how NICE will use evidence from routine data for guideline development and implementation, strengthening their work into the future and with potential cost-efficiencies and benefits for the health of the population.

Lay abstract: 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 developmentIn 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 impactHaving 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 InvolvementThrough 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.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: GENERIC HEALTH RELEVANCE