NICE process and methods

1 Introduction

1 Introduction

1.1

The foundation of NICE guidance is the synthesis of evidence primarily through the process of systematic reviewing and, if appropriate, modelling and cost effectiveness decision analysis. The results of these analyses are then discussed by independent committees. These committees include NHS staff, healthcare professionals, social care practitioners, commissioners and providers of care, patients, service users and carers, industry and academics. Stakeholders have the opportunity to comment on draft recommendations before they are finalised. Not only does this process explicitly describe the evidence base, it also identifies where there are gaps, uncertainties or conflicts in the existing evidence.

1.2

Many of these uncertainties, although interesting to resolve, are unlikely to affect people's care or NICE's ability to produce guidance. However, if these uncertainties may have an effect on NICE's recommendations it is important for NICE to liaise with the research community to ensure they are addressed. NICE does this by making recommendations for research, which are communicated to researchers and funders. At the time guidance is issued, NICE's staff and committees have a thorough understanding of the current evidence and valuable insights into uncertainties that need to be resolved. It is important that these are capitalised on.

1.3

To undertake its national role effectively, NICE needs to ensure that:

  • the process of developing the research recommendations is robust, transparent and involves stakeholders

  • we identify research priorities

  • we make all research recommendations clearly identifiable in the guidance

  • the research recommendations provide the information necessary to support research commissioning

  • the research recommendations are available to researchers and funders by promoting them (for example through the research recommendations database)

  • the research recommendations are relevant to current practice

  • we communicate well with the research community.

1.4

This process and methods guide has been developed to help guidance‑producing centres make research recommendations. It describes a step-by-step approach to identifying uncertainties, formulating research recommendations and research questions, prioritising them and communicating them to the NICE Science Policy and Research (SP&R) team, researchers, and funders. It has been developed based on the SP&R team's interactions with research funders and researchers, as well as with guidance developers.

1.5

NICE works closely with the National Institute for Health Research (NIHR) Evaluation, Trials and Studies Coordinating Centre (NETSCC) to prioritise research recommendations. NICE and NETSCC interaction includes an annual meeting to review progress on carrying out and funding research from NICE research recommendations (both those given NICE key priority designation and those identified from the research recommendations database directly). This includes monitoring progress and the total spend on all research activities directly related to NICE research recommendations.

1.7

The NICE SP&R team also liaises with other researchers and research funders to make them aware of the most important uncertainties or resulting research recommendations that are prioritised during guidance production. This includes national organisations such as the UK Research Councils and research charities (for example, Cancer Research UK), and industry.

1.8

The process used to develop final research recommendations may vary between NICE guidance‑producing centres and is described in the process or methods manuals for each type of guidance.

Figure 1: The role of research recommendations in the guidance production cycle

1.9

Creating research recommendations is part of the guidance production cycle (evidence synthesis through to funding opportunities, surveillance decisions and updating guidance), see figure 1. Guidance producers (including those conducting systematic reviews and producing economic models) should:

  • identify any uncertainties that may affect people's care or NICE's ability to produce guidance

  • develop research recommendations using an appropriate technique to frame research question development, for example PICO (population, intervention, comparator, outcome) or EPICOT (evidence, population, intervention, comparator, outcome, time)

  • undertake consultation on research recommendations integral to the guidance (see the programmes' process or methods guides)

  • review whether research has addressed the gaps or uncertainties as part of the guidance review and update cycle.