Understanding Audit, Quality Improvement, Service Evaluation, and Research

Why this topic matters

Correctly categorising a project from its inception is fundamental for several reasons:

• Governance and Ethics: Each category has specific ethical and governance requirements. Research, for instance, typically requires formal ethical approval from an NHS Research Ethics Committee (REC), while audit and QI projects usually do not, instead relying on local governance frameworks. Misclassification can result in delays, non-compliance, or even invalidation of findings.
• Resource Allocation: Understanding the project type helps appropriately allocate resources, including staff time, funding, and access to data.
• Dissemination and Publication: The standards for reporting and publishing vary. Research is often published in peer-reviewed journals, whereas audit and QI are commonly presented internally, at local or national conferences, or in specialist reports.
• Learning and Development: For trainees, accurately understanding these distinctions is important for portfolio building, demonstrating competence in various domains, and preparing for career progression.
• Impact and Validity: Ensuring the right methodology and oversight maximises the project's impact and the validity of its conclusions.

Practical explanation

While sharing common tools and approaches (like data collection, analysis, and presentation), the key differentiators lie in their primary intention and the generalisability of their findings.

Clinical Audit

Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through a 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 explicit criteria, changes are implemented, and further monitoring is used to confirm improvement in care.

• Purpose: To measure current practice against a defined standard (e.g., NICE guidance, Royal College guidelines, local protocols) to identify if care is being delivered as intended and to drive local improvement. It directly influences current patient care within the service being audited.
• Methodology: Typically involves identifying a standard, collecting data on current practice, analysing the data, identifying gaps, implementing changes, and re-auditing.
• Governance: Generally falls under local clinical governance frameworks. Does not usually require NHS REC approval, but requires local audit department registration and approval.
• Generality of Findings: Findings are typically specific to the local service or department.

Quality Improvement (QI)

Quality Improvement (QI) is a systematic approach to making changes to healthcare processes and outcomes. It often uses specific methodologies (e.g., PDSA cycles – Plan-Do-Study-Act, Lean, Six Sigma) to test and implement changes on a smaller scale before wider adoption.

• Purpose: To continuously improve the quality, safety, effectiveness, efficiency, and patient-centredness of healthcare services. It's about 'how' to improve, often iteratively.
• Methodology: Iterative cycles of change (e.g., PDSA), rapid prototyping, driver diagrams, run charts. Focuses on 'learning by doing' and gradual improvement.
• Governance: Falls under local clinical governance frameworks. Usually does not require NHS REC approval, but local QI leads or governance teams should be notified and approve the project. Often part of ongoing service delivery.
• Generality of Findings: Primarily aimed at local improvement. While methods can be shared, specific results are often context-dependent.

Service Evaluation

Service evaluation is an activity that aims to judge the effectiveness of a service, to clarify whether and how it works, what it achieves, and how it can be improved. It is undertaken to produce information for local use to guide the ongoing development of the service.

• Purpose: To assess the value, effectiveness, or impact of a new or existing service, intervention, or pathway on a local population. It seeks to understand if a service is meeting its objectives and how it can be enhanced. Often involves gathering stakeholder feedback.
• Methodology: Can be diverse, including surveys, interviews, focus groups, observational studies, or analysis of existing administrative data. It doesn't typically compare specific interventions and doesn't aim to establish generalisable knowledge beyond the evaluated service.
• Governance: Falls under local clinical governance. Does not require NHS REC approval if solely for local service improvement purposes and does not involve randomisation or testing unproven interventions. Local R&D or governance sign-off is often required.
• Generality of Findings: Specific to the service being evaluated, though findings can inform similar services elsewhere.

Research

Research is the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.

• Purpose: To answer a scientific question with the intent of generating new knowledge that is generalisable beyond the immediate study population. This often involves testing hypotheses, comparing interventions, or understanding disease mechanisms.
• Methodology: Rigorous, pre-defined protocols, often involving randomisation, control groups, blinding, and validated outcome measures. Statistical power calculations are common.
• Governance: Requires formal NHS Research Ethics Committee (REC) approval, sponsorship (e.g., by an NHS Trust or university), and registration with relevant bodies (e.g., NIHR, Clinical Trials Registry). Often has intensive data governance and patient consent requirements.
• Generality of Findings: Aims for findings that are generalisable to wider populations and contribute to the broader scientific literature.

Common pitfalls

• Misclassifying projects: The most common pitfall. For example, presenting a service evaluation as an audit or trying to conduct research without REC approval. When in doubt, consult your local audit, QI, or R&D department.
• Lack of clear objectives: Not defining the primary aim early enough can blur the lines between categories and lead to scope creep or confusion about governance.
• Ignoring local governance: Even for audit and QI, ensuring local department registration and approval is vital. This streamlines data access, ensures departmental awareness, and provides a record of activity.
• Poor documentation: Regardless of category, maintaining clear records of methodology, data, and outcomes is essential for reproducibility, reporting, and learning.
• Insufficient stakeholder engagement: Failing to involve relevant staff, patients, or departments early on can lead to resistance or irrelevant findings.
• Over-promising generalisability: Presenting local audit or QI findings as broadly applicable research without the appropriate methodology or governance can be misleading.

Step-by-step guidance for project classification

When embarking on a new project, consider these questions sequentially:

1. What is the primary purpose?

   • Is it to see if we are meeting a standard (audit)?
   • Is it to understand if a service is working and how to improve it, specific to our local context (service evaluation)?
   • Is it to make iterative, small-scale changes to improve a process or outcome (QI)?
   • Is it to generate new, generalisable knowledge that seeks to answer a broader scientific question (research)?

2. Does it involve patients?

   • If identifiable patient data is used, what is the legal basis for access and processing? GDPR and Caldicott principles apply across all categories.
   • Does it involve changing clinical care or randomising patients to different treatments/diagnostic pathways without established evidence?

3. Are we testing an unproven intervention or hypothesis?

   • If yes, it is likely research, especially if aiming for generalisable results.

4. Are we solely assessing existing practice against established standards or evaluating how an existing service functions?

   • This points towards audit or service evaluation.

5. Who will benefit from the results?

   • Only our local team/service (audit, QI, service evaluation)?
   • The wider scientific and medical community (research)?

Once you have provisional answers, always consult your local clinical audit, quality improvement, R&D, or governance departments. They are the authoritative bodies within your organisation for definitive project classification and approval.

Example in clinical practice

Consider a project aiming to improve the management of sepsis in an NHS Trust.

• Clinical Audit: The team might review a sample of patient records to see what percentage of patients with suspected sepsis received antibiotics within one hour of presentation, comparing this against the Trust's sepsis pathway standard. If compliance is low, they might implement an intervention (e.g., a new bedside prompt) and then re-audit.
• Quality Improvement: Using PDSA cycles, the team might test several small changes: for example, refining the electronic prescribing system prompt based on nurse feedback, trying a new handover tool, or integrating a 'sepsis huddle' into ward rounds. They would monitor impact on adherence to the sepsis bundle over short cycles.
• Service Evaluation: After implementing a new 'Sepsis Response Team', the team might evaluate its effectiveness. This could involve surveying staff on their perception of the team's usefulness, analysing time to specialist review, and looking at patient length of stay or readmission rates for sepsis, specifically to inform the ongoing funding and structure of that specific team.
• Research: A research project might compare two different national sepsis pathways in a randomised controlled trial across multiple Trusts to see which leads to better patient outcomes (e.g., mortality, ICU admission rates), generating evidence that could inform national guidelines.

How Lazomis can help

Lazomis provides structured tools and templates that can support your projects, regardless of their classification:

• Project Planning Templates: Our templates can guide you through defining objectives, methodologies, and clear timelines, helping to solidify your project's scope and category from the outset.
• Data Collection Forms: Develop customisable forms for robust data collection, essential for both audit and research, ensuring consistency and accuracy.
• Reporting and Dashboard Tools: Visualise your data effectively for audit reports, QI presentations, or service evaluation findings, making complex information accessible to stakeholders. This supports dissemination, a key component of all project types.
• Collaboration Features: Share project plans, data, and findings securely with your local audit, QI, or R&D departments for review and approval, streamlining governance processes.
• Knowledge Base: Access relevant guidance and best practice resources to ensure your project aligns with national standards and local policies.

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