NCEC Framework for Endorsement of National Clinical Guidelines

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National Clinical Effectiveness Committee

Framework for Endorsement of National Clinical Guidelines

April 2013

Version 4


Table of Contents

Page

1. Introduction / 2
2. Definition Clinical Guideline / 2
3. NCEC Principles / 3
4. Scope of Framework / 3
5. Roles and Responsibilities / 4
6. Process for Endorsement of National Clinical Guidelines (8 Steps) / 5
7. NCEC Communication with Clinical Guideline Development Groups / 14
8. NCEC Appeals Process / 14
Appendix 1 Checklist for Submission of Clinical Guideline to NCEC / 15
Appendix 2 Clinical Guideline Template and Prompts / 17

Abbreviations

HIQA / Health and Information Quality Authority
NCEC / National Clinical Effectiveness Committee

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NCEC Framework for Endorsement of National Clinical Guidelines

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1. Introduction to NCEC

On 23rd September 2010, the Patient Safety First initiative was launched in response to recommendations of the Report of the Commission on Patient Safety and Quality Assurance – Building a Culture of Patient Safety (2008). A key component of the Patient Safety First initiative is the National Framework for Clinical Effectiveness. The purpose of this framework is to provide formal structures and processes to support clinical effectiveness. Clinical effectiveness involves a number of processes, but primary among these are (i) the development or adaptation and use of clinical guidelines to support evidence-based practice and (ii) the use of clinical audit to improve patient care and outcomes.

Clinical guidelines can improve health outcomes, reduce variation in practice, improve quality of clinical decisions, influence health service policy and inform service users and the public about the service they should be receiving.

The oversight of the National Framework for Clinical Effectiveness is provided by the National Clinical Effectiveness Committee (NCEC). The NCEC is a partnership between key stakeholders in patient safety. The NCEC mission is to provide a framework for national endorsement of clinical guidelines and audit to optimise patient care. The NCEC Terms of Reference are to:

- Apply criteria for the prioritisation of clinical guidelines and audit for the Irish health system

- Apply criteria for quality assurance of clinical guidelines and audit for the Irish health system

- Disseminate a template on how a clinical guideline and audit should be structured, how audit will be linked to the clinical guideline and how and with what methodology it should be pursued

- Recommend clinical guidelines and national audit, which have been quality assured against these criteria, for Ministerial endorsement within the Irish health system

- Facilitate with other agencies the dissemination of endorsed clinical guidelines and audit outcomes to front-line staff and to the public in an appropriate format

- Report periodically on the implementation of endorsed clinical guidelines.

2. Definition of Clinical Guideline

The term ‘clinical guideline’ has synonyms that may elsewhere be considered to be broadly interchangeable. These include ‘guideline’, ‘health guideline’, ‘clinical practice guideline’, ‘evidence-based guideline’, ‘evidence-based guidance’ and ‘guidance’. For the purpose of consistency, the NCEC will use the term ‘clinical guideline’ in its work. The following identifies the specific meaning that should be inferred for this term.

Clinical guidelines are systematically developed statements, based on a thorough evaluation of the evidence, to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances, across the entire clinical spectrum.

3. NCEC Principles

The NCEC mission is to provide a framework for national endorsement of clinical guidelines and audit to optimise patient care. The NCEC draws on international guideline development methodology and the expertise of established guideline development groups where available.

It is recognised that the NCEC, and the health system as a whole, is likely to be able to effectively implement and monitor only a small number of national clinical guidelines each year. Not all clinical guidelines will be submitted for national endorsement and clinical guideline development groups should continue to develop clinical guidelines in response to the needs of their own organisations. However, once a national clinical guideline is endorsed it will supersede any other guidelines on that topic. The Report of the Commission on Patient Safety and Quality Assurance – Building a Culture of Patient Safety (2008) identifies that national clinical guidelines will have a significant impact on the strategic direction of health services in Ireland and will influence the allocation of resources and configuration of services in the future.

NCEC guidance and tools can be used by any clinical guideline development group regardless of whether they are submitting their clinical guidelines for national endorsement.

NCEC documentation will be reviewed regularly, especially after the first year, and it is likely to evolve over time with experience and changing requirements of the healthcare system. All NCEC documentation and resources are available at

4. Scope of Framework

What is this document and who is it for?

The aim of this framework document is to describe the steps required in order for clinical guidelines to be endorsed as national clinical guidelines. This document is primarily for clinical guideline development groups and organisations sponsoring the development of clinical guidelines.

What does it cover?

This document describes:

  1. Roles and responsibilities of NCEC, clinical guideline development groups and other bodies
  2. Steps for clinical guideline development groups to submit clinical guidelines to the NCEC
  3. Screening and prioritisation criteria utilised by the NCEC in deciding which clinical guidelines to prioritise
  4. Quality assurance criteria that the NCEC uses in appraising a clinical guideline
  5. The communications that will occur between NCEC and clinical guideline development groups.

What does it not cover?

This document does not describe how to develop a clinical guideline. NCEC Draft Clinical Guideline Development Manual (May 2012) and other relevant resources to support clinical guideline development groups are available on the NCEC website

5. Roles and Responsibilities

The roles of Clinical Guideline Development Groups are to:

- develop clinical guidelines[1]

- facilitate clinical guideline dissemination and use in clinical audit with relevant stakeholders

- submit clinical guidelines to NCEC if seeking national endorsement.

It is appropriate for clinical guideline development to be led/sponsored by any group or organisation. This could include:

- Disciplines such as medicine, nursing, health and social care professionals

- Training bodies and facilities

- Public and private healthcare providers.

It is the responsibility of Clinical Guideline Development Groups to utilise a robust clinical guideline development process. This requires clinical guideline development groups to have appropriate clinical and methodological expertise along with multidisciplinary and patient representation.

The roles of the NCEC are to prioritise, appraise and endorse clinical guidelines to be part of a suite of national clinical guidelines, and with other stakeholders to facilitate their dissemination and use in clinical audit. Over time, the NCEC hopes to be in a position to increasingly provide support for clinical guideline development groups.

It is the responsibility of the NCEC to use transparent and robust processes in the screening, prioritisation and quality assurance of submitted clinical guidelines. Members of the NCEC are responsible for ensuring that the views of the stakeholders that they represent are taken into consideration in the development and implementation of a national suite of clinical guidelines and to facilitate the implementation of national guidelines in their organisations. In order to achieve this, the NCEC is made up of a large group of stakeholders:

Clinical Indemnity Scheme
Dublin Academic Teaching Hospitals
Department of Health
Forum of Irish Postgraduate Medical Training Bodies[2]
Forum of Professional Regulatory Bodies
Health Information and Quality Authority
Health Service Executive
Independent Hospitals Association of Ireland / Irish Association of Directors of Nursing and Midwifery
Irish College of General Practitioners
Mental Health Commission
National Cancer Control Programme
Patient Representative Groups
Private Health Insurers
Therapy Professions Committee

The role of the Minister for Health is to endorse national clinical guidelines that have been recommended by the NCEC.

Step 1 Submission of Clinical Guidelines to the NCEC

Clinical guideline development groups should submit clinical guidelines being proposed for national endorsement by the Minister for Health in both electronic (PDF via email) and paper hard copy to: NCEC Office, Chief Medical Officer Division, Department of Health, Hawkins House, Dublin 2

Receipt of clinical guidelines will be acknowledged.

Documentation for inclusion for submission of clinical guidelines

Clinical guideline development groups must include the following documentation in their submission to NCEC:

  1. Checklist for submission of clinical guidelines (Appendix 1)
  1. Clinical Guideline (See Appendix 2 for preferred format of presentation of clinical guidelines)

Documentation for consideration prior to submission of clinical guidelines

Clinical guideline development groups should give consideration to the information that the NCEC will require in order to complete the review process.

The following may be helpful to clinical guideline development groups:

  • NCEC DRAFT Clinical Guideline Development Manual (2012)
  • NCEC Modus Operandi (2011)
  • NCEC Clinical Guideline Screening and Prioritisation Criteria Version 2 (2012)
  • HIQA National Quality Assurance Criteria for Clinical Guidelines (2011)
  • Complete the Agree II Tutorial -

All NCEC documentation and resources are available at

HIQA documentation is available at

Dates for receipt of Clinical Guidelines

  • See

Please note, as this is a new process the length of time for a clinical guideline to conclude the NCEC processes from receipt of complete information from clinical guideline development groups to endorsement has not yet been established. The NCEC hopes to complete one cycle every 6 months, but this is dependent on a number of factors, both in NCEC and clinical guideline development groups. Furthermore, unlike other countries, the system being introduced in Ireland is dependent on the contribution of a variety of individuals for which this activity is in addition to their normal professional duties. Therefore it is likely that the NCEC will have the capacity to prioritise a maximum of three clinical guidelines to proceed to clinical guideline appraisal at each submission date. The NCEC will continuously review its processes which are likely to evolve over time with experience and changing requirements of the healthcare system.

Step 2 Clinical Guidelines Screening Process

Clinical guidelines submitted to the NCEC should have been recently developed or reviewed. Refer to NCEC Draft Clinical Guideline Development Manual (May 2012) on safetyfirst.ie for further detail.

The term ‘clinical guideline’ has synonyms that may elsewhere be considered to be broadly interchangeable. These include ‘guideline’, ‘health guideline’, ‘clinical practice guideline’, ‘evidence-based guideline’, ‘evidence-based guidance’ and ‘guidance’. For the purpose of consistency, the NCEC will use the term ‘clinical guideline’ in its work. The following identifies the specific meaning that should be inferred for this term.

Clinical guidelines are systematically developed statements, based on a thorough evaluation of the evidence, to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances, across the entire clinical spectrum.

NCEC will apply the following screening criteria that only those clinical guidelines that:

(a) Have been recently developed or reviewed, and

(b) Meet the NCEC definition of a clinical guideline will proceed to prioritisation.

The Chair of the NCEC will notify the clinical guideline development group in writing if the clinical guideline submission is not proceeding to prioritisation.

Step 3 Prioritisation of Clinical Guidelines

Screened clinical guidelines which meet NCEC screening criteria will proceed to prioritisation. The NCEC mission is to endorse national clinical guidelines, of which there will only be a small number endorsed each year.

  1. The NCEC prioritsation criteria will be used by NCEC to identify which submitted clinical guidelines should be prioritised for appraisal
  2. The NCEC prioritisation criteria may be used by NCEC to identify areas where a national clinical guideline is required.

At this time the NCEC will not be advising clinical guideline development groups on whether to proceed with guideline development on a particular topic. However, clinical guideline development groups could use the NCEC prioritisation criteria to inform their decision on whether to develop a clinical guideline for national endorsement.

The NCEC have identified six criteria of high importance for clinical guideline prioritisation. Consideration was given to the Irish context for clinical practice and general prioritisation criteria utilised by various agencies. A likert scale is associated with each criterion. Descriptors are provided for each criterion to assist clinical guideline development groups

and the NCEC. The prioritisation criteria descriptors will support a consistent approach for submission and prioritisation of clinical guidelines by NCEC. Refer to NCEC Clinical Guideline Screening and Prioritisation Criteria Version 2 (2012) for further detail.

Clinical guideline development groups should give consideration to each of the prioritisation criteria and provide the NCEC with specific information for each of the criteria as per Appendix 1 Checklist for Submission of Clinical Guidelines to NCEC.

NCEC Prioritisation Criteria / Likert Scale
1. / Burden of Clinical Topic* / High (5) Low (1)
2. / Evidence Analysis / Strong (5) Weak (1)
3. / Economic Impact / High (5) Low (1)
4. / Variability in Practice / Major (5) Minor (1)
5. / Potential for Addressing Health Issues / High (5) Low (1)
6. / Clinical Guideline Implementation / Strong (5) Weak (1)

*Includes disease/condition/circumstance etc.

NCEC Clinical Guideline Prioritisation Criteria Descriptors

Under the criteria below are a series of questions that are designed to assist guideline developers in addressing the issues. However, it is not anticipated that for each set of guidelines all questions need to be answered as some may be more relevant to certain guidelines than others.

Criteria 1 Burden of Clinical Topic

- What is the incidence/prevalence of clinical topic (disease/condition/circumstance)?

- The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described?

- What is the associated mortality and morbidity?

- What are the rates of relapse, re-admission and complications?

- Is there reduced quality of life?

- Is there patient dissatisfaction?

Criteria 2 Evidence Analysis

- Are clinical guideline recommendations based on an analysis of the evidence? This should preferably be a systematic review of high-quality randomised controlled clinical trials or well designed controlled studies that measure relevant outcomes demonstrating strong, clinically important beneficial public health effects?

- Is there detail of the search methods and evidence rating?

- Are recommendations graded based on the quality of evidence with an explicit link between the recommendations and supporting evidence?

- Has the clinical guideline been externally reviewed prior to its submission to the NCEC? Ideally the external review should provide commentary on the search strategy for the evidence review?

Criteria 3 Economic Impact

While there is often limited Irish data available on the economic impact of healthcare interventions, guideline developers should consider international evidence and make an effort to include some estimation or approximation of the cost-effectiveness, and any possible budget increases or savings, if the guideline is implemented.

- Would implementing this guideline have a substantial budget impact on the healthcare system?

  • Have the resource implications of implementing the guideline been considered?
  • Have the resources required for any initial set up or roll out phase been considered?
  • Have the cost of these resources to the publicly-funded system been estimated?

- Are there potential cost savings to be realised if the guideline is implemented?

  • Are there any potential cost savings due to changes in the use of resources?
  • Have the benefits from improved outcomes been quantified and the associated costs or savings been estimated?

- Is there national or international cost-effectiveness evidence to support implementing the guideline?

  • Is a summary of the cost-effectiveness evidence presented? Is this generalisable or relevant to the Irish healthcare setting?
  • Has this evidence been gathered using systematic searching methods and are these methods documented?

Criteria 4 Variability in Practice

- Are there gaps between current clinical practice and evidence-based practice?

- Are significant variations in practice evident?

- What is the associated risk of the variance from best practice?

- Would reducing variation incur beneficial effects for patients?

- Would reducing variation reduce avoidable morbidity and/or mortality?

- To what extent is there a high risk impact for the health system?

- Are there high frequency risk factors (avoidable and inherent)?

Criteria 5 Potential for Improved Health

- The overall objective of the guideline is specifically described with the expected benefit or outcome of the guideline clearly outlined

- Is there potential for improved health outcomes?

- What is the extent of potential improved quality of life?

- What is the extent of potential improved quality of care?

- Is there potential for health promotion at population health level?

- Is there potential for disease prevention at population health level?

- Will the clinical guideline reduce the extent of avoidable injury?

- Will the clinical guideline reduce inequalities in health?

- What are the potential short and long-term health outcomes taking into account the strength of evidence associated with each?

- Is there a maximum likelihood of benefit and minimum harm?

- Will the clinical guideline reduce symptoms, avoid or delay need for other therapies or reduce disease progression?

- Will the clinical guideline support the implementation of national health policy?

- Will the clinical guideline improve patient safety?

Criteria 6 Clinical Guideline Implementation

- What is the feasibility of implementation of the clinical guideline?

- What are the facilitators to the guideline application?