NICE, the UK body that decides what treatments the NHS should use, often cannot issue guidance because the gold-standard randomised trial evidence simply does not exist. This project will test whether the vast amounts of data the NHS already collects—prescriptions, diagnoses, demographics—can fill those gaps and tell doctors what actually works. The problem is twofold. First, without trial evidence, NICE stays silent on many common clinical decisions, leaving patients and clinicians guessing. Second, even when NICE does issue guidance, no one systematically checks whether it is being followed, or whether certain groups—by ethnicity, sex, or income—are being left behind. That blind spot wastes money and worsens health inequalities. If successful, this research will give NICE a practical framework to use routine NHS data for both creating guidance and tracking its uptake. That could mean faster, cheaper answers to urgent clinical questions, and a system that spots and corrects disparities in care as they emerge. The ultimate change is invisible to patients but vital: a smarter, more responsive guidance machine that quietly improves population health without waiting years for a trial.
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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 development After 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 impact After 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.
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