National Clinical Guideline Template
Interim Guidance for Guideline Development Groups for the drafting of full version National Clinical Guidelines
National Clinical Effectiveness Committee
May 2014

The following document contains interim guidance regarding the preparation of NCEC approvedfull version National Clinical Guidelines for Department of Health publication

Checklist May 2014

  • NCEC approved guidelines should be provided in line with the template provided in the NCEC Guideline Development Manual (2013[1]). Following final approval of the guideline by the NCEC the Clinical Effectiveness Unit, Department of Health will manage typesetting, preparation for web publication and launch of document in collaboration with the guideline development group. All documentation should be provided in word format.
  • Guidelines will be published in the NCEC format and colours to provide for easy recognition by the public, clinicians and service providers of National Clinical Guidelines approved by the Minister for Health. Examples of published guidelines, guideline summaries and leaflets are available at
  • Guideline Development Groups will be asked to read and sign off final typeset document prior to publication.
  • Box 1 outlines essential checks that guideline development groups should complete prior to submitting the final approved guideline for typesetting.
  • The remainder of this document has the preferred NCEC guideline full version National Clinical Guideline template that can be used by the Guideline Development Group(GDG) to populate with their recommendations and findings.
  • A summary National Clinical Guideline document is also available from the NCEC for completion by the GDG.
  • The appendices outlined in the template below can be supplemented by any additional appendices as determined by the GDG and relevant content expertise.
  • More information on the process for NCEC approval can be found in the following framework: National Clinical Effectiveness Committee Framework for Endorsement of National Clinical Guidelines

Box 1: Summary Checklist for completion of a National Clinical Guideline

Complete
Yes/No
  1. Recommendations
/ List who is responsible for implementation of recommendation. This may differ according to the location where care is provided (e.g. hospital versus community setting).
Provide grade of recommendation beside each recommendation.
Check for difference between recommendations and practical guidance.
  1. Guideline editing
/ Check:
-For typographical and grammatical errors.
-Type font used is Century Gothic, Size 11 for body of text.
-The type font of paragraphs is justified throughout.
-Technical aspects for accuracy e.g. double check dosages and therapies recommended.
-Consistency of terminology.
-Use of capitals throughout guideline and summary document.
-All main and section headings only capitalise the first word.
-All abbreviations have been listed.
-References are in line with Harvard method. Ideally the reference software Endnote should be utilised.
-Web links are active in both text and references.
-Numbering of sections and cross reference with table of contents.
-Any cross-referencing in and between documents is accurate.
-Website links are live and current.
-Appendices are listed numerically (1, 2, 3, etc.)
-The colour scheme is as presented in the template document below.
  1. Summary guideline
/ A short summary of the guideline should be presented using the template provided by the NCEC.
  1. Leaflets
/ A patient and a clinician leaflet should be developed for publication as appropriate.
  1. Copyright or permissions
/ Permissions for use of all diagrams etc. should be sought and copies of permissions provided to the DoH.
  1. Disclaimers
/ Include disclaimers as required.
  1. Logos
/ Supply any additional logos required.
  1. Implementation monitoring
/ Identified KPIs (guideline implementation and guideline impact)which are suitable for incorporation in HSE Quality and Patient Safety Accountability Framework or HSE Service Plan or other as appropriate.
  1. Abbreviations
/
  • Guideline Development Group (GDG) is the term to be used for the group developing the guideline.
  • National Clinical Guideline is the term to be used when referring to the guideline in the document.
  • The full version National Clinical Guideline is how the main document should be referred to.
  • The summary National Clinical Guideline is how the summary document should be referred to.

  1. Alignment
/ The GDG should ensure that their National Clinical Guideline aligns with approved National Clinical Guidelines.

Copyright and publication

Copyright of a National Clinical Guideline approved by NCEC and published by the Department of Health lies with the Department of Health. However, the Department of Health acknowledges the work and ownership of any material developed by the Guideline Development Group (GDG). The GDG are requested to consult the Department of Health in advance of any proposed publication. The Department of Health will have twenty (20) working days to review and comment on the proposed publication, during which they may, acting reasonably:

i. recommend changes; and/or

ii. require the removal of any confidential information and/or proprietary information owned by the Department; and/or

iii. request the removal of any material which, in the opinion of the Department, is of a sensitive nature.

Reference must be made to the full title of the published National Clinical Guideline including ISSN and web address of on Department of Health website in all subsequent papers or publications.

<Title>

National Clinical Guideline No. X

1

Guideline Development Group

<who is involved and context of members>

<GDG logos etc>

Using this National Clinical Guideline

<intended user group>

<intended audience>

<Where the guideline is available>

<How does the guideline fit in the context of the current healthcare agenda, in terms of the clinical programmes>

<Key acknowledgements and thanks>

<signature of the GDG Chair>

Reference of National Clinical Guideline

<National Clinical Guideline should be referenced as follows:

Department of Health. <Title> National Clinical Guideline No. X. Month. Year. ISSN>

National Clinical Effectiveness Committee (NCEC)

<purpose and mission statement to be added by NCEC>

Disclaimer

<Example:Healthcare staff should use clinical judgement, medical and nursing knowledge in applying the guidance above and give due regard to individual circumstances presented by each patient/resident and available resources.

Recommendations may not be appropriate in all circumstances and the decision to adopt specific recommendations should be made by the practitioner taking into account the individual circumstances presented by each patient/resident and available resources. Therapeutic options should be discussed with xxx on a case-by-case basis as necessary.>

Table of Contents

Section 1: Background

1.1 Need for National Clinical Guideline/revised National Clinical Guideline

1.2 Clinical and financial impact of condition/disease/topic

1.3 Overview of epidemiology of condition/disease/topic

1.4 Aim of National Clinical Guideline

1.5 Scope of National Clinical Guideline, target population and target audience

1.6 Guideline Development Group

1.7 Methodology and literature review

1.8 Grading of recommendations

1.9 External review

1.10 Procedure for update of National Clinical Guideline

1.11ImplementationofNational Clinical Guideline

1. 12 Roles and responsibilities

1.13 Audit criteria

SECTION 2. National Clinical Guideline recommendations

2.1 National recommendations.

2.2 <Content specific recommendations>

2.2.1 <Sub-headings>

Section 3: Appendices and References

Appendix X: Guideline Development Group; Terms of reference, membership, conflicts of interest and contribution of members to the guideline.

Appendix X : Summary of tools to assist in Implementation of National Clinical Guideline

Appendix X: Literature review

Appendix X: Details of consultation process

Appendix X: Glossary of terms andabbreviations

Appendix X: Budget impact assessment

References

Section 1: Background

1.1 Need for National ClinicalGuideline/revised National Clinical Guideline

1.2 Clinical and financial impact of condition/disease/topic

1.3Overview of epidemiology of condition/disease/topic

1.4Aimof National Clinical Guideline

1.5Scope of National Clinical Guideline, target population and target audience

1.6Guideline Development Group

<overview of types of members>

<sections each member was responsible for drafting>

<conflict of interests if any, declared and if necessary a description of how this conflict of interest was managed.

<sources of funding if any, declared>

1.7Methodology and literature review

<General overview of these processes such as times and dates of meetings and any consultations with groups other than the GDG>

<Full methodology to be described in appendix section>

1.8Grading of recommendations

<Outline of grading structure used – refer to the NCEC Guideline Devlopement Manual for guidance>

1.9 External review

<Members of external review group>

<their relevant expertise outlined>

<the process by which they were contacted>

<their direct input to be outlined>

1.10 Procedure for update of National Clinical Guideline

<Details of procedure for update>

1.11ImplementationofNational Clinical Guideline

An overview of what is required for the Implementation of this National Clinical Guideline>

<Key groups responsible for various sections of implementation

1. 12 Roles and responsibilities

<Roles and responsibilities outlined for:

Organisational responsibility

Other healthcare staff>

1.13 Audit criteria

To ensure that this guideline positively impacts on patient care, it is important that implementation is audited. Audit is recommended to support continuous quality improvement in relation to the implementation of the National Clinical Guideline.

<Key audit criteria need to be outlined>

SECTION 2.National Clinical Guideline recommendations

<summary of National recommendations

Section / Subsectionif relevant / Recommendation Number
<High level recommendations>
<Other more section specific recommendations>

2.1 National recommendations.

<high level recommendations>

Recommendation X

<insert recommendation>

Grade xx

2.2<Content specific recommendations>

2.2.1 <Sub-headings>

The following are responsible for implementation of recommendation X:

CEO/General Manager of healthcare facility…etc.>

Recommendation X

<insert recommendation>

Grade X

Practical Guidance

<insert for above recommendation>

Rationale

<if any for the above recommendation/practical guidance.

Note:This section may not apply if there is a stated adaptation process that makes reference back to the original adapted guideline>

The following are responsible for implementation of recommendation X:

Healthcare facility Senior Management Team (e.g. CEO, Director of Nursing/Midwifery, Clinical Director and Director of Finance) and all healthcare staff…etc.>

Recommendation X

Grade X

Practical Guidance

<insert for above recommendation>

Rationale

<if any for the above recommendation/practical guidance.

Note:This section may not apply if there is a stated adaptation process that makes reference back to the original guideline>

Section 3: Appendices and References

Appendix X: Guideline Development Group; Terms of reference, membership, conflicts of interest and contribution of members to National Clinical Guideline.

Terms of Reference

Membership and Conflicts of Interest

Chair:

Members:

Conflicts of Interest

Contributions

Additional Contributions and Review

Appendix X : Summary of tools to assist in Implementation ofNational Clinical Guideline

Appendix X: Literature review

The review should be carried out using a robust methodology. The NCEC Guideline Development Manual outlines the steps necessary to carry out a systematic literature review to support clinical guideline development and should be used as a reference guide when completing this literature review.

Proposed Search strategy

The scope of the literature search should encompass national and international research. A full audit trail for articles with bibliographical detail should be included.

In the first instance a search for relevant clinical guidelines should be carried out and if any are found, their quality should be appraised using the “rigour of development” domain as described by the National Quality Assurance Criteria for Clinical Guidelines (HIQA,2011).

The parameters, i.e., population, interventions, comparisons, and outcomes (PICOs) are to be presented along with the review methodology, including the search strategy, detailed search terms and methods for quality appraisal and evidence synthesis that were used.

Evidence tables should be presented and the rationale behind the particular grade chosen for each of the recommendations should be clearly presented.>

Appendix X: Details of consultation process

Date
Patients and members of the public
External review
Clinical leaders and healthcare managers
National committees
Professional groups

1

AppendixX: Glossary of termsandabbreviations

Definitions within the context of this document

<if any>

Abbreviations

<all abbreviations in the document must be stated>

Appendix 11: Budget impact assessment

Economic Impact Report

<Report completed by…>

Economic literature review results

The GDG should undertake a literature search for evidence of clinical and cost effectiveness, cost and resource impact, including primary (research studies) and secondary (reviews and economic evaluations) sources. The literature sources that will be searched should be specified in the search strategy and should include relevant resources, such as trial/guideline registries and relevant citation databases (e.g. Medline, EMBASE, Database of Abstracts of Reviews of Effects (DARE), NHS Economic Evaluation Database, Health Technology Assessment Databaseand Cochrane Database of Systematic Reviews). The economic literature review can be undertaken using the same search terms as derived from the clinical literature review but with the economic filter applied.

Budget impact ofNational Clinical Guideline

Scope of the budget-impact analysis

Overall cost implications

Possible additional cost implications of the National Clinical Guideline

Methods

The search strategy …>

Table 4 Economic Filter

ID / Search / Hits
6 / *Economics/ / 21479
7 / *Economics, Medical/ / 21559
8 / *Economics, Pharmaceutical/ / 5872
9 / exp "Costs and Cost Analysis"/ / 400064
10 / exp Health Care Costs/ / 224939
11 / exp decision support techniques/ / 64779
12 / exp models, economic/ / 102782
13 / markov chains.sh. / 8346
14 / montecarlo method.sh. / 35519
15 / uncertainty.sh. / 10158
16 / quality of life.sh. / 308452
17 / quality-adjusted life years.sh. / 5950
18 / exp health economics/ / 564180
19 / exp economic evaluation/ / 190553
20 / exppharmacoeconomics/ / 160770
21 / exp economic aspect/ / 1047120
22 / quality adjusted life year/ / 15615
23 / quality of life/ / 308452
24 / exp "costs and cost analyses"/ / 168352
25 / (economic impact or economic value or pharmaco-economics or health care cost or economic factors or cost analysis or economic analysis or cost or cost- effectiveness or cost effectiveness or costs or health care cost or cost savings or cost-benefitanalysis or hospital costs or medical costs or quality-of-life).sh. / 592852
26 / (econom$ or cost or costly or costing or costed or price or prices or pricing or priced or discount or discounts or discounted or discounting or expenditure
or expenditures or budget$ or afford$ or pharmacoeconomic or pharmaco- economic$).ti,ab. / 1046158
27 / (cost$ adj1 (util$ or effective$ or efficac$or benefit$or consequence$ or
analy$ or minimi$ or saving$ or breakdown or lowering or estimate$ or variable$ or allocation or control or illness or sharing or life or lives or affordabl$ or instrument$ or technolog$ or day$ or fee or fees or charge or charges).ti,ab. / 212069
28 / (decision adj1 (tree$ or analy$ or model$)).ti,ab. / 20279
29 / ((value or values or valuation) adj2 (money or monetary or life or lives or costs or cost)).ti,ab. / 8947
30 / (qol or qoly or qolys or hrqol or qaly or qalys or qale or qales).ti,ab. / 63557
31 / (sensitivity analys$s or quality-adjusted life year$ or quality adjusted life year$ or quality-adjusted life expectanc$ or quality adjusted life expectanc$).ti,ab. / 11826
32 / (unit cost or unit-cost or unit-costs or unit costs or drug cost or drug costs or hospital costs or health-care costs or health care cost or medical cost or medical costs).ti,ab. / 45098
33 / (decision adj1 (tree$ or analy$ or model$)).ti,ab. / 20279
34 / or/6-33 / 2377303

Figure X Flow chart of excluded studies for economic literature review

<use a graphic to represent numbers of excluded studies>

References for budget impact assessment

<Endnote>

<Harvard Style>

<Journal in Italics>

References

<Endnote>

<Harvard Style>

<Journal in Italics>

Form A

Permissions Form for Guideline Development Groups

Have all permissions been granted to reproduce any external materials/publications used in this National Clinical Guideline? / YES

NO
Please include evidence of all permissions requested by the GDG to reproduce external materials/publications used in this National Clinical Guideline.
Signature of Chair of GDG to verify that relevant permission have been sought. / ______
Date:______

This form is not part of the guideline template.

Form B

Feedback from GDG user of Summary National Clinical Guideline Template

Did you find the provision of a template useful for the completion of a National Clinical Guideline? / YES

NO
What did you find worked well?
In your opinion, what areas of the template could be improved?

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