When Does Quality Improvement (QI) Become Research? A Practical Guide for UK Clinicians

Introduction

Many clinicians in the NHS embark on projects aimed at enhancing patient care, improving processes, or identifying best practice. While the intent is always positive, correctly categorising these activities – as Quality Improvement (QI), clinical audit, service evaluation, or formal research – is fundamental.

Misclassification can lead to inappropriate governance oversight, ethical breaches, delays, or even render valuable work unpublishable. This resource aims to demystify these distinctions, offering a practical framework for UK clinicians to navigate project categorisation effectively.

Why this topic matters

Correct categorisation ensures that your project adheres to the appropriate ethical, regulatory, and organisational frameworks. In the UK, this is particularly important due to stringent requirements from bodies such as the Health Research Authority (HRA), Research Ethics Committees (REC), and local NHS Trust governance structures. Key reasons why this distinction is critical include:

• Ethical Oversight: Research involving patients or their data typically requires formal REC approval to protect participants, whereas QI, audit, and service evaluation often fall under local clinical governance.
• Regulatory Compliance: The Medicines for Human Use (Clinical Trials) Regulations 2004 and the UK Policy Framework for Health and Social Care Research define what constitutes research and its associated legal obligations.
• Resource Allocation: Research often requires dedicated funding, staff, and time, distinct from operational QI activities.
• Publication and Dissemination: Academic journals often have strict requirements regarding ethical approval and methodology, which differ significantly between QI projects and formal research studies.
• Professional Development: Understanding these distinctions is a core competency for trainees and consultants, particularly for ARCP requirements and career progression.

Practical explanation

Let’s break down the definitions and key differentiating factors for Quality Improvement, Clinical Audit, Service Evaluation, and Research.

Clinical Audit

Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against explicit criteria. Where they do not meet the criteria, changes are implemented to bridge the gap and new audits are undertaken to confirm improvement. It typically compares current practice against a pre-defined standard, often derived from NICE guidelines, Royal College recommendations, or local protocols (e.g., “Are 95% of patients with suspected sepsis receiving antibiotics within one hour, as per local protocol and national guidance?”).

• Purpose: To assess adherence to standards and improve care within existing practice.
• Scope: Focuses on current practice and existing patients, aiming to confirm compliance or identify where improvements are needed.
• Methodology: Often uses retrospective data collection or observation against pre-set criteria.
• Ethical Review: Typically falls under local clinical governance. No REC approval is usually required, but local audit department registration is standard.

Service Evaluation

Service evaluation is designed to judge the current care provided, to describe the existing service, and to make recommendations for future service provision. It aims to answer the question “What standard does this service achieve?” rather than “Does this service meet a given standard?” (clinical audit) or “What new knowledge can be discovered?” (research). An example might be “How many patients attending the acute medical unit are subsequently discharged on the same day?” or “What is the average length of stay for emergency general surgery patients?”

• Purpose: To assess the effectiveness, efficiency, or acceptability of an existing service, without testing a hypothesis or generalising findings.
• Scope: Describes or measures current service delivery.
• Methodology: Can involve surveys, interviews, or collection of routine service data. No intervention or change is being tested.
• Ethical Review: Generally falls under local clinical governance. No REC approval is usually required, but local governance review is appropriate.

Quality Improvement (QI)

Quality Improvement is a systematic approach to making changes to how care is delivered, with the aim of improving patient outcomes, experience, or system efficiency. Unlike audit, which measures against a standard, or evaluation, which describes a service, QI actively tests and implements changes. It often uses methodologies like the Plan-Do-Study-Act (PDSA) cycle. An example could be “Implementing a new handover proforma to reduce critical information omissions.”

• Purpose: To achieve specific, measurable improvements in healthcare delivery through iterative cycles of change.
• Scope: Focused on specific local problems or processes within a defined service.
• Methodology: Iterative cycles (e.g., PDSA), rapid testing of changes, data collection to monitor impact.
• Ethical Review: Typically falls under local clinical governance. No REC approval is usually required, provided it is part of routine practice improvement and does not introduce novel interventions for research purposes. However, local QI teams and governance departments should be consulted.

Research

Research is the attempt to derive generalisable new knowledge by addressing clearly defined questions using systematic and rigorous methods. It seeks to answer questions like “Does intervention X improve outcome Y?” or “What is the causal link between A and B?” The key differentiator is the intent to generate new knowledge that can be generalised beyond the immediate population or setting. This includes clinical trials, epidemiological studies, qualitative studies asking about lived experience to inform broader understanding, and health services research that tests new models of care.

• Purpose: To generate new knowledge, test hypotheses, or answer questions that are generalisable.
• Scope: Often designed to be generalisable to broader populations or different settings.
• Methodology: Rigorous, pre-defined protocols, often involving randomisation, control groups, or complex statistical analyses.
• Ethical Review: Requires full ethical review by an NHS Research Ethics Committee (REC) and HRA approval in the UK. This is a legally mandated requirement for most health research.

Common pitfalls

• Mission Creep: A QI project, initially focused on local improvement, might evolve into something that generates generalisable knowledge, inadvertently becoming research without the necessary ethical approvals.
• Lack of Consultation: Failing to consult with local audit/QI departments, R&D offices, or the HRA's online decision tools can lead to misclassification and subsequent problems.
• Retrospective Data for Research: Using routinely collected data for audit or QI is common. However, if that data is subsequently analysed to generate new, generalisable knowledge (e.g., identifying risk factors for a condition not previously established), it may cross into research.
• Introducing Novel Interventions: If a 'QI' project introduces a new intervention that has not been previously evaluated or is intended to contribute to a body of generalisable evidence about that intervention, it is likely research, particularly if it involves randomisation or blinding.
• Publication Intent: If the primary intent for publication is to influence broader clinical practice or contribute to a general body of knowledge, the project is more likely to be research.

Step-by-step approach for project categorisation

Follow these steps to help correctly classify your project:

1. Define your project's primary aim: Is it to improve a local process, measure adherence to a standard, describe an existing service, or generate new, generalisable knowledge?
2. Use the HRA decision tool: The Health Research Authority provides a comprehensive online tool on their website (www.hra.nhs.uk/planning-and-improving-research/what-is-research/is-my-project-research/) to help determine if your project is research. This is the definitive guidance in the UK.
3. Consult your local R&D/Governance Office: Always discuss your project with your Trust’s Research & Development (R&D) department, clinical governance, or audit lead. They have local knowledge and will help interpret national guidance in your context.
4. Consider the audience for your findings: If you intend to publish in a journal that seeks research-grade evidence to influence wider practice, then research classification is more likely.
5. Look for key indicators of research:
   • Is there a formal hypothesis being tested?
   • Is there a control arm or systematic comparison against a non-standard intervention?
   • Are you introducing a novel intervention (drug, device, or clinical pathway) with the intent of evaluating its general effectiveness?
   • Is patient consent being sought for something beyond routine clinical care?
   • Does the project involve randomisation or blinding?
   • Is the primary intention to generate findings that are generalisable?

Example in clinical practice

Imagine a project aimed at reducing catheter-associated urinary tract infections (CAUTIs) on a ward.

• Scenario 1 (Clinical Audit): The team reviews patient notes to see if staff are adhering to the established Trust protocol for catheter insertion and care. Findings show poor compliance. This is an audit because it measures adherence to an existing standard.
• Scenario 2 (Quality Improvement): Based on the audit, the team implements a new 'catheter care bundle' with staff training and regular prompts. They use PDSA cycles, monitoring CAUTI rates and compliance over several months. This is QI because it involves iterative testing and implementation of changes to improve a specific local outcome.
• Scenario 3 (Service Evaluation): The Trust leadership wants to understand the current burden of CAUTIs across all wards, the average length of stay attributable to CAUTIs, and current catheterisation rates. They collect aggregated, anonymised data. This is service evaluation as it describes an existing service and its outcomes.
• Scenario 4 (Research): A pharmaceutical company approaches the Trust to conduct a trial comparing a new antimicrobial-coated catheter against standard catheters to see if it significantly reduces CAUTI rates across multiple NHS sites. This study involves randomisation, power calculations, and aims to generate generalisable evidence on the new catheter's efficacy. This is research.

This resource supports, but does not replace, clinical judgement. Local policy, formulary and specialist advice should be followed.

How Lazomis can help

Lazomis provides structured tools and frameworks that can support both QI and clinical audit projects, helping you maintain clarity and rigour. For example:

• Lazomis QI Project Setup: Guides you through defining project aims, identifying measures, and planning intervention cycles, helping to clearly articulate the intent of your project.
• Lazomis Data Collection Templates: Offers standardised templates for collecting data, ensuring consistency and making analysis more straightforward, which is beneficial for both audit and QI. This can help prevent 'mission creep' towards undeclared research by focusing on process and outcome measures relevant to your improvement goals.
• Lazomis Reporting Dashboards: Visualise your data in real-time, allowing for immediate feedback on the impact of your interventions for QI or adherence rates for audit. This supports the 'Study' phase of PDSA cycles.
• Documentation and Archiving: Lazomis helps you document all aspects of your project, from initial registration with local governance to final reports and dissemination plans. Thorough documentation is essential regardless of classification and is often a prerequisite for publication.

While Lazomis cannot classify your project for you, its organised approach to project management and data handling enables a transparent and auditable workflow, making it easier to present your project to local governance teams and demonstrate its adherence to appropriate classifications.