Developing your guidelines

After the scoping period is complete, the next step in the process is to start formulating and developing your guidelines. This involves:

• Writing review questions
• Collecting evidence
• Performing evidence reviews
• Doing literature searches and calls for evidence
• Writing recommendations
• Identifying opportunities for shared decision making
• Formulating research recommendations
• Developing your guidelines

Writing review questions

When it comes to writing review questions for each of your focus areas, NICE recommends using a framework to make sure your review questions are specific and well structured. A commonly used framework is known as PICO, which stands for population, intervention, comparator and outcome:

Population: Which population are you interested in? Are there subgroups that need to be considered?

Intervention: Which intervention, treatment or approach are you assessing?

Comparators: Are there alternative(s) to the intervention being considered? If so, what are these (for example, other interventions, standard active comparators, usual care or placebo)? The comparator can be no intervention/standard care.

Outcome: Which outcomes should be used to assess how well the intervention is working in different healthcare settings? What is important for people using services?

Your review questions should address each aspect of the PICO framework. The NICE website offers guidance and helpful examples on using PICO to develop review questions

Collect evidence to answer the review questions

According to NICE, any recommendation made in a medical guideline must be based on the ‘best available evidence’. But how do you actually gather this evidence?

Types of evidence:

First, it is important to understand different types of evidence (visit chapter 4 of the NICE guidance for more information):

Scientific evidence: Scientific evidence can be based on objective medical research, or it can be ‘context-sensitive’, meaning it looks at what works in real-life situations (such as social science). It can be quantitative (e.g. a measurement that proves a particular diagnostic test is better than another), or qualitative (e.g. experiences of people using services).

Colloquial evidence: Expert testimony from members of the committee or a group of people using services. This can be used to complement scientific evidence or provide missing information on the context.

Other evidence: Other sources of evidence may include reports, audits, ongoing research projects, and standard operating procedures.

Evidence quality

Some types of evidence are more reliable than others. For instance, a randomised-controlled clinical trial is a much more thorough way of testing the effect of a particular drug than a case study. Guidelines should therefore state not only what their recommendations are, but also how reliable the evidence is, so that healthcare professionals can make well-informed decisions for their patients.

One method for assessing the quality of evidence is using GRADE tables. Find out more about how GRADE works on the Grade Working Group website.

Ways of collecting evidence

Evidence can be collected for your medical guideline in the following ways:

• Literature search (for scientific evidence): A literature review is ‘a summary of the evidence from several studies, with conclusions about the findings’ (NICE glossary). The aim of a literature review is to understand the current state of knowledge on a given subject – in our case, the scientific knowledge about a disease in a ‘thorough, transparent and reproducible’ way. NICE shares advice about the sources to search and how to develop strategies for a systematic review on their website.
• Call for evidence from stakeholders (for colloquial evidence): Healthcare professionals, researchers and patients/carers may be able to contribute additional evidence. For instance, researchers may be aware of ongoing research related to a new intervention or service; doctors may know about the off-label use of medicines; and patients/carers can contribute their experiences using services.
  NICE states that confidential information (such as research results that haven’t yet been published) must be kept to a minimum and should be stored carefully. Evidence related to health inequalities should also be captured – for instance, if patients of different ages or backgrounds struggle to access existing interventions. Records from the evidence searches should be kept to ensure the process for identifying the evidence base is transparent and reproducible.

Section 7 of the NICE guidance gives advice on incorporating economic evaluation. This is a key part of the NICE process, but is outside the remit of this basic guide. If you would like to learn more about this area, feel free to check out our introductory guide to health economics here.

Section 8 of the NICE guidance shares how to link to other existing guidance, such as NICE technology appraisal guidance.

Plan the evidence review

Once you’ve understood the types of evidence you can collect and the ways you can collect it, you should plan how you will collect evidence to answer your review questions. You can formalise this plan in a ‘review protocol’, which will help you and your committee to think through the different stages of evidence collection (literature searches and calls for evidence) for each review question.

According to NICE, searches should take place across a mixture of databases, websites and other sources depending on the subject of the review question and the type of evidence sought. It is important to ensure all relevant literature is included, but there should be clear reasons for including particular sources.

You can find a template for a review protocol in section 4.5 on the NICE website. It includes an explanation of the context, each PICO element, and the searches to be conducted. It also includes a search protocol (a strategy for performing literature reviews, which is important for making sure the study is robust), which you can find out more about in section 5.2 on the NICE website.

Perform the literature searches and calls for evidence

Section 5.3 of the NICE guidance lists a number of sources that could be used for different review questions, such as CENTRAL, EMBASE and MEDLINE. This section also gives advice on devising a search strategy and identifying search terms.

Section 5.5 of the NICE guidance gives advice for calls for evidence. Information received from registered stakeholders, relevant organisations or individuals in response to a call for evidence should be recorded systematically and, if possible, cross-checked against evidence identified through database searching.

As previously mentioned, all evidence collected should be rated for its quality. One method for assessing the quality of evidence is using GRADE tables. Find out more about how GRADE works on the Grade Working Group website.