NICE process and methods

Appendix: Interim process statement for a more proportionate approach to quality standard development

Appendix: Interim process statement for a more proportionate approach to quality standard development

Introduction

To support the changing needs and objectives of all parts of the health and care system, NICE is transforming to ensure its guidance remains relevant, timely, useable and effective. To achieve these aims, the methods and processes that underpin NICE's guidance need to evolve.

This appendix describes the interim process changes that NICE will use over the next 24 months to support proportionate approaches to the development and maintenance of NICE quality standards. It should be read alongside the relevant sections of the NICE quality standards process guide.

The interim process may be applied in the following situations:

  • The health and care system needs a new or updated quality standard faster than the current process can deliver.

  • The nature and extent of update needed to an existing quality standard does not justify the resource use associated with the full development process.

  • To support the integration and/or incorporation of selected quality standards into NICE guidelines.

The changes outlined will be monitored and reviewed.

  • NICE will use the interim process in selected quality standard topics over the next 24 months. This stage will inform a full update of the quality standard process guide.

  • The updated quality standard process guide will be consulted on following the usual process for manual updates. This will then be finalised and published.

We welcome comments on the content of this statement. These should be addressed to qualitystandards@nice.org.uk .

A proportional approach to how we develop and update existing quality standards

As well as utilising our existing processes for quality standard development, we are introducing more proportionate, agile and responsive approaches where appropriate as described in the introduction.

Key areas in the current process guide, where NICE may decide, to adopt a more proportionate approach are:

  • Developing a topic overview (see section 3.1)

  • Changes to committee decision making outside of formal meetings, including:

  • Consultation (see section 3.5)

  • Use of external guidance to support the development of quality standards.

Developing a topic overview

Where a proportional approach to topic engagement is applicable due to the narrower scope of a topic, the following options may be used:

  • Reducing the topic engagement comment period to 5 working days

  • Limiting topic engagement to topic specific professional and patient organisations and topic experts.

  • Holding a workshop with topic specific professional and patient organisations and topic experts.

In such instances, minutes/a record of the workshop would be taken and published on the NICE website.

Changes to committee decision making outside of formal meetings

Prioritising areas for quality improvement:

Where a proportionate approach is required to prioritise areas for quality improvement, a working group may be convened in place of a full quality standards advisory committee (QSAC) meeting. The working group will have the same remit as the full QSAC.

The working group will be chaired by an existing NICE committee chair. Membership of the working group will be drawn from:

  • professional and lay representation from the QSAC committee; the number of QSAC representatives may vary in accordance with the needs of the topic.

  • guideline committee professional and patient expert representatives.

  • additional external professional and patient expertise will be invited where appropriate.

The needs of the working group are such that an appropriate spread of members' experience and expertise should be represented at each meeting. If, in the view of the chair, the spread of experience and expertise is inappropriate for the business under consideration, the meeting may be suspended or adjourned until a later date.

Decisions of the group will normally be arrived at by a consensus of those members present. If the working group concludes that it cannot make a decision on the quality standard content this will result in a full committee meeting.

Where a working group has been convened in place of a full committee meeting to agree prioritised areas of care, the same group will be convened to review the full set of consultation comments.

Reviewing consultation feedback

In some instances, such as where consultation comments demonstrate a high degree of agreement with the draft quality standard, neither a full committee meeting, nor a working group will be convened to review the consultation comments. The committee will instead review the consultation comments and share any feedback with the NICE team and the chair via email.

If the committee chair concludes that further committee input is required to refine the quality standard based on the consultation comments, this will result in either a full committee meeting or a working group meeting with a subset of the committee.

Utilisation of the guideline committee (GC)

The guideline committee may be utilised to prioritise areas for quality improvement and review consultation feedback, in place of a full quality standards advisory committee (QSAC) meeting. In these instances, appropriate training will be provided to the professional and lay guideline committee members to ensure they are able to prioritise areas for quality improvement. Representation from the QSAC committee will be agreed as required for the development of the Quality Standard; the number of QSAC representatives may vary in accordance with the needs of the topic.

This approach may be undertaken as part of a testing and refining process to incorporate quality standard statements into NICE guidelines, and will support NICE's ambitions to integrate NICE guidance, making it easier for users to find all guidance about a condition.

Consultation: A flexible public consultation for registered stakeholders

Where a proportionate approach to consultation is required, NICE may reduce or extend the length of the consultation comment period depending on the extent of change to the existing content or the potential impact on the system. The minimum consultation period will be no less than 15 working days; advance notice of a consultation will always be given

Standing down of existing quality standards

If feedback from the health and care system indicates a quality standard is no longer adding value, such as when the quality standard has been superseded by statutory requirements, a quality standard may be suitable to be stood down and removed from the quality standards library. This could be applicable to quality standards which are published, in development or awaiting development. Initial approval will be sought from an associate director in the Centre for Guidelines Directorate and the Centre for Guidelines Deputy Director before moving to a process of formal un-referral.

Formal un-referral will be sought following discussions with the endorsing body (Department of Health and Social Care or NHS England) before the quality standard is presented to the NICE Guidance Executive for final approval. Following agreement from the Guidance Executive, the quality standard will be stood down and removed from the NICE website.

Use of external guidance to support the development of quality standards

Quality standards are evidence-based and underpinned by NICE guidance or other sources of high-quality evidence.

With the approval of the Guidance Executive, high quality external guidance, such as guidance from royal colleges or international guideline developers, may be used to support the development of NICE quality standards.