What are the NICE Guidelines?
The National Institute for Health and Care Excellence (NICE) is a UK-based independent organization established in 1999 that develops evidence-based clinical guidelines to standardize healthcare quality and reduce practice variation across the National Health Service. 1
Core Mission and Scope
NICE was originally created to reduce variation in the availability and quality of healthcare delivered by the UK National Health Service. 1 In 2005, the mission expanded to include development of public health guidance aimed at preventing illness and promoting healthier lifestyles. 1
The organization's primary function includes:
- Development of clinical guidelines based on best available evidence to recommend appropriate treatment and care for people with specific diseases and conditions 1
- Production of evidence-based recommendations for health and care in England, Wales, and Northern Ireland 2, 3
- Establishment of standards for best practice within the National Health Service 3
Development Methodology
NICE guidelines are developed by multidisciplinary teams using rigorous systematic methodology that includes:
- Independent advisory committees comprising healthcare professionals, specialists, and lay members (patient representatives) 1, 2
- Rigorous systematic literature searches for evidence-based practice interventions 1
- Critical review and critique by content experts, patients, and caregivers 1
- Registered stakeholder consultation on draft scopes and draft guidelines, including organizations representing people whose care may be directly affected 2
- Health economic analysis to assess both clinical effectiveness and cost-effectiveness of interventions 2, 4
The technical teams supporting guideline development include project managers, information specialists, systematic reviewers, and health economists. 2
Evidence Review Process
NICE employs standardized systematic review protocols with the following characteristics:
- Comprehensive database searches including MEDLINE, EMBASE, CINAHL, PsycInfo, and the Cochrane Library 1
- Prespecified review protocols that define populations, interventions, reference standards, and target conditions 1
- Quality assessment of studies for methodological rigor, risk of bias, applicability to the UK, and clinical significance 1
- Consensus-based recommendations when evidence is insufficient or not strong enough to guide decisions 1
Scope and Output
As of May 2013, 160 guidelines had been developed and disseminated with another 65 in development. 1 The guidelines have received substantial attention from both clinical and lay audiences. 1
NICE selects a limited number of high-impact questions to be answered by evidence review, rather than covering topics exhaustively as professional society guidelines may do. 2 This focused approach differs from comprehensive disease-specific guidelines produced by international professional societies.
Key Distinguishing Features
NICE guidelines uniquely incorporate cost-effectiveness analysis alongside clinical effectiveness, which distinguishes them from many international professional society guidelines. 2, 4 This reflects their mandate to provide guidance for implementation within the UK's taxpayer-funded National Health Service. 4
The guidelines are designed for use across multiple healthcare settings including:
- Ambulance paramedics 1
- Emergency departments 1
- Primary care 1
- Secondary care 1
- Long-term residential care 1
Implementation Considerations
NICE guidelines are commonly used beyond the National Health Service, including by volunteers and private sector providers. 1 However, a key limitation is that NICE guidelines do not provide practical protocols for implementation of their recommendations, which can create challenges for operationalizing the guidance in clinical practice. 1
Implementation documents are published alongside guidelines to address cost implications and facilitate adoption. 1 For example, implementation of the chronic heart failure guideline showed projected net savings of £19,000 per 100,000 persons. 1
Important Caveats
NICE guidelines require regular review and updates as new evidence continually emerges that may affect recommendations. 1 Clinicians should remain alert to potential new advances not yet captured in published guidelines. 1
Current NICE guidelines face challenges with multimorbidity, as they are not designed to consider the cumulative impact of treatment recommendations on people with several conditions or to allow comparison of relative benefits and risks across multiple diseases. 5
Additionally, the evidence base underlying NICE primary care recommendations may not always be derived from primary care settings, with studies showing wide variation (26% to 80%) in the proportion of primary care-relevant recommendations actually based on primary care research. 6