What are clinical practice guidelines?

Clinical practice guidelines (CPGs) are evidence-based recommendations intended to assist healthcare practitioners in making informed decisions about patient care. These guidelines are typically developed by professional organisations or government agencies, and based on a systematic review of the available medical literature.

The goal of clinical practice guidelines is to promote the delivery of high-quality, evidence-based care consistent with the latest research findings, and to improve patient outcomes. They are designed to help:

• Healthcare providers make decisions about appropriate diagnostic and treatment approaches using strong recommendations.
• Inform healthcare policy makers.

Clinical practice guidelines can cover a wide range of healthcare topics, from disease management and prevention to surgical techniques and rehabilitation. They may be developed for use in primary care settings, specialty care settings, or inpatient settings, and may be tailored to specific patient populations or medical conditions.

What is included in a clinical practice guideline?

A clinical practice guideline is designed to provide a clear and concise summary of the best available scientific evidence and expert opinions on a particular clinical topic. They are developed and shared by healthcare improvement bodies including the National Institute for Health and Care Excellence (NICE) in England, and SIGN, in Scotland.  To facilitate this, guidelines typically include several key elements.

• An introduction or overview: describing the overall goals and objectives of the guideline, and identifies the target audience (such as primary care physicians, specialists, nurses, and so on). It also goes through the methodology used to develop the guideline, including the search strategy for identifying relevant literature, the criteria used to select and evaluate the evidence, and the process used to develop and grade evidence.
• Recommendations: presenting the specific guideline recommendations for clinical practice based on the available evidence. Recommendations may be organised by clinical condition, patient population, or type of intervention, and may include specific details about the timing, dosage, and duration of treatment. Some organisations, such as NICE, include recommendations in the overview section of the guidance.
• Tools and resources: providing guidance on how to implement the recommendations in clinical practice, including strategies for monitoring and evaluating the effectiveness of the guideline.
• Evidence review: a summary of the available evidence  used to develop the guideline, including its quality and strength, and any limitations or gaps in the evidence base. It will also include references, listing the sources of evidence used to develop the guideline, such as primary research studies, systematic reviews, and meta-analysis.

What is the process for developing a clinical practice guideline?

The guideline development process will vary between different health services and organisations, but typically involves several key steps.

Form a guideline development group

The first step is to form a group responsible for developing the guideline. This group may include clinicians, researchers, patient representatives, and other relevant stakeholders.

Within NICE, this group will include a committee, registered stakeholders, and NICE staff and contractors.

Define the scope and purpose

The next step in clinical practice guideline development is to outline the guideline’s purpose, including the clinical question or topic it will address, the target audience, and its scope and goals.

Within NICE, guidelines are developed according to seven core principles.

1. The guideline is based on the best available evidence of what works, and what it costs.
2. The guideline is developed by independent and unbiased committees of experts, from across a range of health and social care professions.
3. All committees include at least two lay members (people with personal experience of using health or care services, including carers, or from a community affected by the guideline).
4. Regular consultation allows organisations and individuals to comment on our recommendations.
5. Once published, all NICE guidelines are regularly checked, and updated in the light of new evidence or intelligence if necessary.
6. NICE is committed to advancing equality and diversity, reducing inequalities and ensuring that the NICE's principles reflect the values of society.
7. Processes, methods, and policies remain up‑to‑date.

Conduct a systematic review of the evidence

The guideline development group then conducts a systematic review of the available evidence on the clinical question or topic, using a standardised and rigorous methodology to evaluate the quality and strength of the evidence.

Develop the recommendations

Based on the results of the systematic review, the guideline development group will develop a set of evidence-based recommendations for clinical practice, taking into account factors such as the quality of the evidence, the balance of benefits and harms, and the values and preferences of patients.

The draft guideline is then shared, reviewed, and revised with feedback from key stakeholders and multidisciplinary experts. 

Implement the guideline

Once the guideline is completed, it is shared with healthcare professionals and other stakeholders. Its dissemination means it can now be embedded in clinical practice.

Update the guideline as needed

The guideline development group will also work to establish a process for regularly updating the guideline. This may occur as new, relevant evidence emerges, clinical practice changes, or if an appraisal of guidelines occurs.

What is a systematic review?

A systematic review is a rigorous and comprehensive approach to identifying, evaluating, and synthesising the available evidence on a particular clinical question or topic. These reviews often form the foundation for developing clinical practice guidelines.

The process of conducting a systematic review can involve several key steps.

1. Defining the research question: clearly define the question or topic of interest, and specify the inclusion and exclusion criteria for the studies to be included in the review.
2. Conducting a literature search: systematically search for all relevant studies in the published literature, using predefined search strategies and databases.
3. Screening and selecting studies: screen and evaluate the studies identified in the literature search against the inclusion and exclusion criteria, and select the most relevant studies and observational studies for inclusion in the review.
4. Extracting data: extract data from the literature review from the selected studies and organise into tables or other summary formats.
5. Evaluating the quality of the evidence: evaluate the evidence’s quality, using established criteria, such as the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) framework, to assess the strength and certainty of the evidence.
6. Synthesising the evidence: synthesise and summarise the evidence in a meaningful way. This synthesis also helps ensure the evidence is useful for clinical decision-making.

What are the benefits of using clinical guidelines?

Clinical guidelines support evidence-based medicine and can ensure consistent, standardised care within health services, with better patient outcomes, preventive healthcare, and efficient use of resources.

According to an article by academics such as Steven H Woolf and Jeremy Grimshaw, Potential benefits, limitations, and harms of clinical guidelines, the principal benefit of guidelines is to improve the quality of care received by patients:

“For patients (and almost everyone else in health care), the greatest benefit that could be achieved by guidelines is to improve health outcomes,” the article states. “Guidelines that promote interventions of proven benefit and discourage ineffective ones have the potential to reduce morbidity and mortality and improve quality of life, at least for some conditions.”

What are the limitations of clinical practice guidelines?

Clinical practice guidelines, while intended to be evidence-based and objective, are not infallible. They may be influenced by the biases of the guideline development group or by the limitations of the available research. It is important for healthcare practitioners to critically evaluate guidelines in light of their own clinical expertise and the unique needs of each patient. 

It is also important to evaluate:

the applicability, acceptability, and appropriateness of research evidence and study design

• any conflicts of interest within committees
• the strength of recommendations
• quality and level of evidence.
• clinical questions around health outcomes
• cost-effectiveness
• patient preferences and permissions
• critical appraisals around the feasibility of the recommendations
• any external reviews that grade working group recommendations
• peer reviews, controlled trials, and any other available data to support the strength of the recommendations.

Help develop clinical practice guidelines

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