Clinical Guideline

Development GUIDELINES

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 The following document contains interim guidance regarding the preparation of
NCEC approved full 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 http://health.gov.ie/patient-safety/ncec/national-clinical-guidelines/

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

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http://health.gov.ie/wp-content/uploads/2014/03/ncec_guideline_development_manual_january13.pdf
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 Complet
e
Yes/No
1. Recommendatio List who is responsible for implementation of recommendation. This
ns 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.
2. Guideline Check:
editing - 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.
3. Summary A short summary of the guideline should be presented using the
guideline template provided by the NCEC.
4. Leaflets A patient and a clinician leaflet should be developed for publication
as appropriate.
5. Copyright or Permissions for use of all diagrams etc. should be sought and copies
permissions of permissions provided to the DoH.
6. Disclaimers Include disclaimers as required.
7. Logos Supply any additional logos required.
8. Implementation Identified KPIs (guideline implementation and guideline impact)
monitoring which are suitable for incorporation in HSE Quality and Patient Safety
Accountability Framework or HSE Service Plan or other as
appropriate.
9. 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.
10. Alignment The GDG should ensure that their National Clinical Guideline aligns
with approved National Clinical Guidelines.

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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.

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<Title>
National Clinical Guideline No. X

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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>

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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.>

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Table of Contents

SECTION 1: BACKGROUND 7
1.1 Need for National Clinical Guideline/revised National Clinical Guideline 7
1.2 Clinical and financial impact of condition/disease/topic 7
1.3 Overview of epidemiology of condition/disease/topic 7
1.4 Aim of National Clinical Guideline 7
1.5 Scope of National Clinical Guideline, target population and target audience 7
1.6 Guideline Development Group 7
1.7 Methodology and literature review 7
1.8 Grading of recommendations 7
1.9 External review 7
1.10 Procedure for update of National Clinical Guideline 7
1 . 1 1 Implementation of National Clinical Guideline 7
1. 12 Roles and responsibilities 7
1.13 Audit criteria 8

SECTION 2. NATIONAL CLINICAL GUIDELINE RECOMMENDATIONS 9

2.1 National recommendations. 9
2.2 <Content specific recommendations> 9
2.2.1 <Sub-headings> 9

SECTION 3: APPENDICES AND REFERENCES 11

Appendix X: Guideline Development Group; Terms of reference, membership,
conflicts of interest and contribution of members to the guideline. 11
Appendix X : Summary of tools to assist in Implementation of National Clinical
Guideline 12
Appendix X: Literature review 12
Appendix X: Details of consultation process 13
Appendix X: Glossary of terms and abbreviations 14
Appendix X: Budget impact assessment 15
References 18

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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

<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>

1.7 Methodology 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>

1.8 Grading 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 . 1 1 Implementation of National 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
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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>

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SECTION 2. National Clinical Guideline recommendations
<summary of National recommendations>

Section Subsection <if relevant> Recommendatio

n 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 facilityetc.>

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:

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

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

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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

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

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Date
Patients and
members of
the public
External
review

Clinical
leaders and
healthcare
managers
National
committees
Professional
groups

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Appendix X: Glossary of terms and abbreviations

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

Key message

<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 Database and 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 of National 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 592852
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-benefit analysis or hospital costs or medical costs or quality-
26 of-life).sh.
(econom$ or cost or costly or costing or costed or price or prices or pricing 1046158
or priced or discount or discounts or discounted or discounting or
expenditure
or expenditures or budget$ or afford$ or pharmacoeconomic or
27 pharmaco-
(cost$ adj1 economic$).ti,ab.
(util$ or effective$ or efficac$ or benefit$ or consequence$ or 212069
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
28 charges).ti,ab.
(decision adj1 (tree$ or analy$ or model$)).ti,ab. 20279
29 ((value or values or valuation) adj2 (money or monetary or life or lives or 8947
costs or cost)).ti,ab.
30 (qol or qoly or qolys or hrqol or qaly or qalys or qale or qales).ti,ab. 63557
31 (sensitivity analys$s or quality-adjusted life year$ or quality adjusted life 11826
year$ or quality-adjusted life expectanc$ or quality adjusted life
32 expectanc$).ti,ab.
(unit cost or unit-cost or unit-costs or unit costs or drug cost or drug 45098
costs or hospital costs or health-care costs or health care cost or
medical cost or medical costs).ti,ab.
33 (decision adj1 (tree$ 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 YES
reproduce any external
materials/publications NO
used in this National
Clinical Guideline?

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 YES
completion of a National
Clinical Guideline? NO
What did you find worked
well?

In your opinion, what areas

of the template could be
improved?