3 Process for developing quality standards

3.1 Developing a topic overview

This section should be read in conjunction with the interim process guide for a more proportionate approach to quality standard development

The NICE quality standards team develops a topic overview for each quality standard, based on the referred topic. The overview describes core elements of the standard, such as the population and condition or services to be covered, and lists the key source guidance that will be used to underpin the quality statements. Key source guidance is typically NICE guidance. If other guidance is used it should meet NICE's accreditation criteria. If there are some gaps in the areas of care that could potentially be covered within a quality standard, this is highlighted in the overview.

The topic overview is published on the NICE website along with advance notice of the topic development schedule and consultation phases.

At publication of the topic overview, NICE requests written submissions from QSAC specialist committee members and stakeholders (see section 4 on stakeholder involvement) asking them to:

identify key areas for quality improvement, including emergent areas of practice that may be considered to be developmental
highlight any national or routine indicators and performance measures
provide examples of published information on current practice (such as, reports of variation in care or service provision, safety concerns, evaluations of compliance with source guidance, or experiences of people using services) to support the identified areas for quality improvement
express interest in being a supporting organisation.

Submissions should be made on the form provided and received by NICE within 2 weeks of the request.

Where relevant, the NHS England and Improvement Patient Safety Team submits information on safety issues within a particular topic. This feedback is submitted either in a form or full patient safety report.

The NICE quality standards team then drafts a summary report of stakeholder comments and prepares a briefing paper on proposed areas for quality improvement. The briefing paper describes relevant guidance, policy context and current practice relating to each area for quality improvement, and includes relevant safety issues, standards and indicators currently in use (for example, in national audits) and related quality standards where applicable.

3.2 Prioritising areas for quality improvement

This section should be read in conjunction with the interim process guide for a more proportionate approach to quality standard development.

At the first QSAC meeting for each topic, the topic overview, the summary report of stakeholder comments and the briefing paper is presented to the QSAC. The relevant national clinical or policy lead may also be invited to give an overview, which is considered expert testimony by the QSAC members. Additional topic expert advisers may also be invited to present testimony relating to any published current practice submissions.

The QSAC then agrees prioritised areas of care or service provision for which quality statements and measures should be developed. Quality statements will describe either enhanced or developmental practice.

Areas prioritised for quality statements describing enhanced practice should:

be areas of care where there is evidence or committee consensus that there is variation in the delivery of care (in particular aspects of care or services that are not widely provided and/or not considered to be standard practice, but that are feasible to provide)
focus on key requirements for high-quality care or service provision that are expected to contribute to improving the experience of care or services as well as their safety and effectiveness
be measurable and therefore suitable for development as quality measures.

Areas prioritised for quality statements describing developmental practice will, like all quality statements, be underpinned by NICE or NICE-accredited guidance. A developmental quality statement should also:

represent an emergent area of cutting-edge service delivery or technology currently being carried out by a minority of providers and indicating outstanding performance
need specific, significant changes to be put in place, such as redesign of services or new equipment
have the potential to be widely adopted over time to drive improvement in outcomes.

In addition, for quality statements describing both enhanced and developmental practice the following aspects should be considered:

experiences of people using services
safety of people using services
equality
resource impact.

At the first QSAC meeting, the committee is provided with a summary of any resource implications identified in the guideline costing reports, including cost savings that have not been suggested by stakeholders. The committee is asked to ensure that, where possible, potential costs are balanced with potential cost savings. The Guideline Resource and Implementation Panel (GRIP) has been established to review estimates of resource impact and workforce implications of guidelines and consider the timing of resource impact by financial year. Where available, the QSAC will be provided with an implementation statement on affordability and workforce implications for the guidelines reviewed by the GRIP.

Particular attention should be given to any areas where there is potential to significantly improve quality and productivity. Quality improvement areas prioritised by the QSAC are validated as meeting the criteria above by the NICE quality standards team.

If there is no source guidance available for a particular area of care or service provision, the QSAC may use a placeholder statement to indicate that the area was agreed to be a priority for quality improvement but could not be included as a quality statement because of a lack of underpinning guidance. A placeholder statement indicates the need for evidence-based guidance to be developed.

After the first QSAC meeting, the NICE quality standards team produces a concise set of quality statements and measures for the agreed areas, with advice from the QSAC specialist committee members. The QSAC chair approves the quality statements and measures before they are approved by NICE for consultation.

3.3 Developing statements and measures

A fundamental principle of quality standard development is that the statements should be based on NICE guidance or NICE-accredited guidance. In many instances NICE guidance is the basis for the quality statements and measures.

Recommendations from NICE or NICE-accredited guidance are considered to be statements of 'best practice' care or service provision. They address aspects of care or services that are:

considered essential by regulatory bodies or
established practice for which there is evidence that the majority of practitioners have implemented the recommendation or
good or effective practice for which there is evidence that the majority of practitioners have not implemented the recommendation.

Quality statements are derived from guidance recommendations where there is evidence that there are gaps in the implementation of the recommendation, where there is inappropriate variation in the implementation of the recommendation or where the recommendation represents an emergent area of practice. The statements therefore cover areas where quality can be improved, and where quality statements and measures could be used to support quality improvement initiatives.

The NICE or NICE-accredited guidance used to underpin quality standards can be topic-specific or concern treatment commonly used in the management of the topic under consideration (such as safety guidance).

3.4 Drafting the quality standard

A quality standard is made up of quality statements and associated quality measures.

A set of quality statements is drafted based on the agreed prioritised areas for quality improvement and derived from the source guidance.

Wording the quality statements

Statements usually place the person at the centre of the care or service requirement, for example 'People with [a requirement for social care] are offered…' or 'People with [condition] are offered…'. The statements should promote choice and involvement in decision-making for people using services. However, if the quality statement is addressing service delivery the responsible organisation may be the focus of the statement, for example '[a particular service/organisation] provides…'.

Each quality statement should specify 1 concept or requirement for high-quality care or service provision (for example, a single intervention, action or event). Where appropriate, in exceptional circumstances, 2 concepts or requirements for high-quality care or service provision may be allowed when they are closely linked (for example, if treatment or service options are dependent on the results of prior assessment) and individual statements describing these would lack clarity. Quality statements should not contain 2 or more unlinked or loosely linked concepts.

Although each quality standard describes markers of high-quality, cost-effective care or service provision that, when delivered collectively, should contribute to improving people's experience of care or services as well as their safety and effectiveness, there may be individual outcomes that can be attributed to specific statements. These individual outcomes are specified in the quality standard. Most quality statements consist of 1 sentence.

Developing the quality measures

Quality measures are drafted after the wording of the quality statements has been agreed. They address the structure of care or services, process of care or service provision and, if appropriate, outcome of care or service provision.

The majority of measures are likely to be process measures because few outcome measures can be attributed to a single quality statement or used at local level to reliably assess the quality of care or service provision and allow comparisons between providers. Where an outcome can be attributed to a single statement and can be used at a local level, it will be included as a quality measure.

All quality measures related to processes are expressed as a numerator and a denominator that define a proportion (numerator/denominator). The numerator is a subset of the denominator population. For example, if the quality measure is:

'the proportion of people identified as approaching the end of life who receive information on social, practical and emotional support available'

the numerator and denominator are:

numerator – the number in the denominator receiving information on social, practical and emotional support available.
denominator – the number of people identified as approaching the end of life.

The numerator does not include people receiving information on social, practical and emotional support available who are not identified as approaching the end of life.

Any timeframes specified in the measure are also specified in the statement. The exception to this is when timeframes vary according to different circumstances or characteristics of people using services. In such cases, descriptions such as 'timely' may be used in the quality statement, with specific timeframes being outlined in the measure and/or supporting definitions. For example, methods and follow-up schedules for surveillance after colorectal cancer vary. The quality statement is:

'People free from disease after treatment for colorectal cancer are offered regular surveillance.'

The surveillance methods and follow-up intervals in the NICE guidance are specified in the measures.

The timeframes are taken directly from underpinning NICE or NICE-accredited guidance, or based on the expert advice and opinion of the QSAC.

3.5 Consultation

This section should be read in conjunction with the interim process guide for a more proportionate approach to quality standard development

After the QSAC chair, on behalf of the QSAC and NICE, has agreed the draft quality standard, stakeholders are invited to comment on it through a formal consultation via the NICE website. The consultation period is 4 weeks. General feedback and comments on individual quality statements are accepted. Stakeholders may also be invited to respond to specific questions such as which quality statements are most important and why, whether there are important areas of care or service provision that are not included and if the proposed measures are appropriate. See section 4 for more information on stakeholder involvement.

Comments received from non-registered stakeholders and individuals are reviewed by the committee but are not included in the summary prepared by the NICE quality standards team. These comments are not made available on the NICE website.

Comments received after the deadline for submission will not be considered formally.

Field testing

For some quality standards, the QSAC may request that field testing is commissioned, for example, in settings or services where quality standards are new. Any request for field testing will be considered and approved, as appropriate, by the NICE quality standards team.

The aim of field testing is to examine the relevance, utility, acceptability, clarity and potential impact of the draft quality standards with:

providers, professionals, commissioners and managers
organisations representing the interests of people using services and carers.

Field testing is primarily a qualitative exercise; a range of views are needed and it can involve a number of methods. The NICE quality standards team considers the choice of methods carefully, taking into account the topic, the groups involved and other relevant issues. Methods may include the use of groups, one-to-one or paired in-depth interviews or surveys. In some cases – for example, if a range of groups are involved – a combination of approaches may be used. Field testing takes place during the consultation stage.

3.6 Reviewing consultation feedback

This section should be read in conjunction with the interim process guide for a more proportionate approach to quality standard development

A summary of the consultation comments, prepared by the NICE quality standards team, and the full set of consultation comments are shared with the QSAC. The QSAC then meets to review the comments, and if undertaken the field testing report, and the quality standard is refined with input from the QSAC chair and members.

3.7 Validation and consistency checking

The revised quality standard then undergoes a process of internal quality assurance, consistency checking and approval by an associate director or a programme director in the NICE quality standards team who has not been directly involved in the development of the quality standard. This quality assurance considers both the process and content of the quality standard (including issues raised during the development of the quality standard). Independent technical comments provided by a technical adviser at NICE are also considered. During this stage there is ongoing discussion with the QSAC chair, and QSAC members as appropriate, to agree changes to the quality standard. The quality standard is edited by the publishing team before being presented to the NICE Guidance Executive for final approval before publication.

Guidance Executive

When considering a quality standard for publication, the NICE Guidance Executive assesses whether it:

addresses areas relevant to the topic overview
follows the agreed process and methods
is consistent with other related quality standards
promotes equality and avoids unlawful discrimination
is cogent and follows the agreed template.

If a major issue is identified by the NICE Guidance Executive, further work may be needed by the NICE quality standards team, the QSAC chair and the QSAC as appropriate. The NICE Guidance Executive does not comment at other stages during the development of a quality standard.

3.8 Publication

Once approved by the NICE Guidance Executive, the final quality standard is published on the NICE website.

Registered stakeholders are notified on the day of publication by an email containing a link to the quality standard.

3.9 Reviewing published quality standards

Quality standards are regularly reviewed. For each published quality standard an initial review decision is made by the Health and Social Care Directorate. There are 3 possible review decisions:

Alignment of the quality standard to updated source guidance.
Full update if more comprehensive amendments are required to reflect changes in the areas for quality improvement, new NICE or NICE-accredited guidance or new national priorities.
No changes necessary.

A summary of the review (including initial review decisions) is presented to Guidance Executive for approval. This is then published on the NICE website and stakeholders are notified.

Where possible this review process will be timed to align with the process for agreeing the annual quality standards work programme with the bodies that commission the NICE quality standards, including NHS England and Improvement and the Department of Health and Social Care.

3.10 Aligning to new and updated guidance

New and updated NICE and NICE-accredited source guidance is monitored continually through the year to identify the need to align published quality standards.

The quality standards team liaises with the NICE guidance team or NICE-accredited organisation undertaking the source guidance update to stay up-to-date with progress during development. During guidance consultation, the potential impact of the update on the quality standard is assessed by the quality standards technical team and any potential changes to the quality standard are noted. The findings of this assessment are shared with selected members of the guideline development group involved in updating the relevant guidance for validation and then the final decision on alignments is taken by Guidance Executive.

Wherever possible, alignments to quality standards will be published at the same time as the updated guidance. Other NICE teams are informed so any relevant support products are amended accordingly and republished at the same time.

If the assessment of the updated guidance finds that no changes are necessary, this decision is published on the quality standard web page within 2 weeks of Guidance Executive approval.

3.11 Full updates

The quality standards team carries out a regular review of all quality standards published to identify whether a full update is needed.

The review looks at the following areas to determine the impact on each quality standard:

feedback on changes in the areas for quality improvement
priority areas identified by NHS England and Improvement, Public Health England and the Department of Health and Social Care.

Also, at any time, interested persons or organisations can suggest a quality standard is updated by emailing qualitystandards@nice.org.uk. All comments will be considered as part of the review process.

Following the decision that a quality standard needs a full update, it will usually be considered as part of the process for agreeing the annual quality standards work programme with the bodies that commission the NICE quality standards, including NHS England and Improvement, the Department of Health and Social Care and Public Health England. A small number of full updates will be agreed as part of NICE's annual work programme with the relevant commissioners.

A full update of a quality standard follows the same process as the development of a new quality standard. The updated quality standard replaces the original quality standard.

Amendments in exceptional circumstances

Amendments to address exceptional circumstances (such as safety concerns, withdrawal of drugs or interventions and significant changes to legislation) are assessed separately on a case-by-case basis in line with NICE policy.

Correcting errors in published quality standards

Corrections or changes to a published quality standard will be made if an error:

puts people using services at risk, or impacts on their care or
damages NICE's reputation or
significantly affects the meaning of the standard.

If it is necessary to correct an error in a published quality standard, we will follow NICE's internal policy for dealing with errors. The individual or organisation who reported the error will be contacted in writing, and we will explain our rationale for the decisions and actions taken.

Quality standards: process guide

NICE process and methods