Cover page

GDG <<add title>>

National Clinical Guideline No. X

[Template - full version]

Notes: CEU actions are marked in red. GDG actions are highlighted in yellow and content write up is flagged in blue italics. Font style is Calibri 12 and justified.

CEU/Design: Insert DOH logo

Intro pages

This National Clinical Guideline has been developed by the <GDG insert name> Guideline Development Group (GDG), within the HSE National Clinical Programme <GDG insert if/as relevant>.

CEU: Additional text above may apply for commissioned guidelines. In such cases, additional text will state that – “The NCEC was requested by the Minister for Health to commission this guideline arising from a significant patient safety/policy matter”.

Using this National Clinical GuidelineThis National Clinical Guideline applies to < GDG insert patient group and setting>. It does not apply to < GDG add as relevant>. This National Clinical Guideline is relevant to all healthcare professionals working in < GDG insert as relevant settings>.

Disclaimer NCEC National Clinical Guidelines do not replace professional judgment on particular cases, whereby the clinician or health professional decides that individual guideline recommendations are not appropriate in the circumstances presented by an individual patient, or whereby an individual patient declines a recommendation as a course of action in their care or treatment plan. In these circumstances the decision not to follow a recommendation should be appropriately recorded in the patient’s healthcare record.

Published by

Published by: The Department of Health, Block 1 Miesian Plaza, 50-58 Lower Baggot Street, Dublin 2, D02 XW14, Ireland Tel: +353 (1) 6354000www.health.gov.ieISSN 2009-6259.© Department of Health, CEU add month and year

Citation text CEUDepartment of Health (yyyy). Title (NCEC National Clinical Guideline No. XX). Available at: http://health.gov.ie/national-patient-safety-office/ncec/

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Users of NCEC National Clinical Guidelines must ensure they have the current version (hardcopy or softcopy) by checking the relevant section in the National Patient Safety Office on the Department of Health website: https://www.gov.ie/en/collection/c9fa9a-national-clinical-guidelines/Whilst every car has been taken to ensure that all information contained in this publication is correct, the Department of Health cannot accept responsibility for any errors or omissions which may have occurred.

CEU - this top section left intentionally blank for addition of logos. GDG must provide all the required logos (high definition images sized at 100% and the d.p.i. should be 300. JPGS, TIFFS and EPS are the required format. They must be sent by email as JPEG files. Examples HSE Clinical/National Programmes, Colleges or other. Their use must be appropriate and be reflected in the accompanying sentence immediately below. If logo is not self explanatory, additional text should be added.

Intro pages

Membership of the Guideline Development Group (GDG)The GDG was chaired by < GDG insert name and full titles>. This National Clinical Guideline is supported by< GDG insert as relevant, e.g. colleges and HSE divisions/Clinical Programmes> .

Membership nominations were sought from a variety of clinical and non-clinical backgrounds so as to be representative of all key stakeholders within the < GDG add sector as relevant>. GDG members included those involved in clinical practice, education, administration, research methodology and 2 persons representing patients and the public, < GDG continue as relevant>.

GDG add names of all members of GDG starting with Chair to the table below and next page if needed. Note that any other groups and contributors such as Steering group/Clinical Advisory Group names along with groups terms of reference must be added to appendices.

Name Job title and affiliation

<< name >> (Chair)

<< name >>

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Intro pages

(CEU)Credits The role of the NCEC is to prioritise, quality assure and recommend clinical guidelines to the Chief Medical Officer for endorsement by the Minister for Health. It is intended through Ministerial endorsement that full implementation of the guideline will occur through the relevant service plans.

The NCEC and the Department of Health acknowledge and recognise the Chair and members of the Guideline Development Group (GDG) for development of the guideline. The NCEC and Department of Health wish to express thanks and sincere gratitude to all persons contributing to this National Clinical Guideline; especially those that give of their time on a voluntary basis.

Acknowledgments <<from the Chair>>

Sample text only below

The Chair of the GDG, <insert name and title> wishes to acknowledge <<individual names and their individual contribution as appropriate >> as contributors to the development of NCG. Ms A and Dr B submitted the guideline proposal to the NCEC. Drs E, F and G successfully submitted the proposal/guideline for NCEC prioritisation. Mr X and Dr Y agreed the scope and developed the clinical questions. Drs P and Q of ABC university carried out the search for evidence and systematic review (as applicable). Dr F and Mrs X from University XYZ conducted the budget impact analysis. Drs E, prepared the implementation plan, Ms F and G successfully submitted the proposal/guideline for NCEC quality assurance. All authors approved the final guideline.

The external review carried out by Dr J is acknowledged. We would like in addition to thank Mr D for his editorial support during preparation for publication.

A full list of members of the Guideline Development Group is available in the previous page/s.

<GDG add electronic signature and date >

Signed by the Chair(s) __________________________________ Date: _________________

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Intro pages

National Clinical Guidelines Providing standardised clinical care to patients in healthcare is challenging. This is due to a number of factors, among them diversity in environments of care and complex patient presentations. It is self-evident that safe, effective care and treatment are important in ensuring that patients get the best outcomes from their care.

The Department of Health is of the view that supporting evidence-based practice, through the clinical effectiveness framework, is a critical element of the health service to deliver safe and high quality care. The National Clinical Effectiveness Committee (NCEC) is a Ministerial committee set up in 2010 as a key recommendation of the report of the Commission on Patient Safety and Quality Assurance (2008). The establishment of the Commission was prompted by an increasing awareness of patient safety issues in general and high profile health service system failures at home and abroad.

The NCEC on behalf of the Department of Health has embarked on a quality assured National Clinical Guideline development process linked to service delivery priorities. Furthermore, implementing National Clinical Guidelines sets a standard nationally, to enable healthcare professionals to deliver safe and effective care and treatment while monitoring their individual, team and organisation’s performance.

The aim of these National Clinical Guidelines is to reduce unnecessary variations in practice and provide an evidence base for the most appropriate healthcare in particular circumstances. As a consequence of Ministerial mandate, it is expected that NCEC National Clinical Guidelines are implemented across all relevant services in the Irish healthcare setting.

The NCEC is a partnership between key stakeholders in patient safety. NCEC’s mission is to provide a framework for national endorsement of clinical guidelines and clinical audit to optimise patient and service user care. The NCEC has a remit to establish and implement processes for the prioritisation and quality assurance of clinical guidelines and clinical audit so as to recommend them to the Minister for Health to become part of a suite of National Clinical Guidelines and National Clinical Audit. The aim of the suite of National Clinical Guidelines is to provide guidance and standards for improving the quality, safety and cost-effectiveness of healthcare in Ireland. The implementation of these National Clinical Guidelines will support the provision of evidence-based and consistent care across Irish healthcare services.

NCEC Terms of Reference

1. Provide strategic leadership for the national clinical effectiveness agenda.2. Contribute to national patient safety and quality improvement agendas.3. Publish standards for clinical practice guidance.4. Publish guidance for National Clinical Guidelines and National Clinical Audit.5. Prioritise and quality assure National Clinical Guidelines and National Clinical Audit.6. Commission National Clinical Guidelines and National Clinical Audit.7. Align National Clinical Guidelines and National Clinical Audit with implementation levers.8. Report periodically on the implementation and impact of National Clinical Guidelines and

the performance of National Clinical Audit.9. Establish sub-committees for NCEC workstreams.10. Publish an annual report.

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Intro pages

Table of contents Page

Section 1: National Clinical Guideline recommendations1.1 Summary of recommendations

Section 2: Development of this National Clinical Guideline2.1 Background2.2 Clinical and financial impact of condition/disease/topic2.3 Rationale for this National Clinical Guideline2.4 Aim and objectives2.5 Guideline scope2.6 Conflict of interest statement2.7 Sources of funding

2.8

Guideline methodologyStep 1: Formulate the key questionsStep 2: Search methodologyStep 3: Screen and appraise the evidenceStep 4: Develop and grade the recommendations

2.9 Consultation summary2.10 External review2.11 Implementation2.12 Monitoring and audit2.13 Plan to update this National Clinical Guideline

Section 3: National Clinical Guideline3.1 Key questions and evidence statements3.2 Summary budget impact analysis

Section 4: Appendices1 Guideline Development Group terms of reference2 Literature search strategy3 Evidence tables4 Consultation report

5Economic assessment

Part A: Economic evidence summaryPart B: Budget impact analysis

6 Implementation plan7 Supporting tools8 Monitoring and audit9 Glossary of terms and abbreviations

10 <insert as needed>References

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Intro pages

List of tables page123

List of figures page123

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Main body – sections 1-4

Section 1. National Clinical Guideline recommendations

1.1 Summary of recommendationsSummary list of all recommendations in table format see below. Sub-headings may be inserted if needed to group recommendations into categories depending on the type of intervention. Include details of grading systems used for assessment of certainty and grading of evidence.

No.. Recommendation *Grade/level124678

*Add a footnote to refer reader to relevant section later in the guideline (that explains grading/levels of evidence used.

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Main body – sections 1-4

Section 2: Development of the National Clinical Guideline

2.1 Background Provide an overview of epidemiology of condition/burden of disease/topic. Preference for Irish figures, if using International try to extrapolate to the Irish context.

2.2 Clinical and financial impact of condition/disease/topicProvide a summary of the clinical and financial impact of the disease/condition National, European and International.

2.3 Rationale for this National Clinical GuidelineExplain why this national guideline is required. Include also any National, European and International policy/strategy.

2.4 Aim and objectives State the outcomes that this guideline aims to achieve, potential health impact of the guideline, with details of specific health benefits and health intent.

2.5 Guideline scope List the target population, target audience/settings, inclusions, exclusions and other as appropriate.

2.6 Conflict of interest statement Include a statement on how conflict of interests were managed in general (in line with current NCEC Conflicts of Interest Policy). If any conflicts were declared, include a description of how the conflicts were managed.

2.7 Sources of funding Declare sources of funding if any.

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Main body – sections 1-4

2.8 Guideline methodology Include a broad description of methodology using the 4 steps below. Refer to NCEC Guideline Developers Manual.

Step 1: Formulate the key questions Provide a general overview of how the GDG prepared, prioritised and finalised the key questions. Refer reader to the appendices for the full list of key questions in PICO, PIPOH or other relevant format.

Step 2: Search methodology Provide a general outline of the search strategy (clinical, grey and economic), dates of searches, limits applied. Refer the reader to the relevant appendices for search strategy. Provide details of where the full literature review is available i.e. website.

Step 3: Screen and appraise the evidence Include a description of how the literature was screened and refer readers to appendices if needed.Include a description of how the literature was appraised and refer readers to appendices as required.

Step 4: Develop and grade the recommendations Provide information on how the recommendations were developed and what grading / level of evidence was used.

2.9 Consultation summary Outline the nature and extent of stakeholder consultation undertaken.

2.10 External reviewInclude members of external review group; their relevant expertise outlined; the process by which they were selected; their direct input to be outlined.

2.11 ImplementationProvide a short summary of the proposed implementation plan and how it will be monitored and or measured. Full text to be included as an appendix. You must include the following statement: “Funding for guideline implementation is subject to service planning and estimates process”.

2.12 Monitoring and audit Provide a summary of proposed audit and monitoring plan. Full text to be included as an appendix.

2.13 Plan to update this National Clinical Guideline Provide details of the plan to update this national clinical guideline in line with NCEC policy.

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Main body – sections 1-4

Section 3: National Clinical Guideline

3.1 Key questions and evidence statements State key question and repeat for every question (PICO or similar format). If there are a large number of key questions they may be added as PICO tables in an appendix.

Key question 1 Q: Full question: <<insert text>>

P (Population) <<insert P>>I (Intervention) <<insert I>>C (Comparison/control) <<insert C>>O (Outcome) <<insert O>>

Evidence statement Evidence summary for key question 1. Include evidence at the highest level available for this question i.e. if level 1 evidence available, no need to include levels 3-4 in the summary. Include evidence which matches the P-I-C-O of the question.Insert other sub-headings as appropriate e.g. benefits and harms, quality of evidence, values & preferences, resource use.

Recommendation <<1>><insert recommendation>Quality/level of evidence: + Strength of recommendation:

Good practice point (if applicable)<insert >

The following are responsible for implementation of recommendation <<1>><<Free text>>

3.2 Summary budget impact analysisProvide a budget impact analysis (BIA) summary, and refer the reader to the full economic assessment in the appendices. The recommended structure for your one page summary is to use the following subheadings:

OverviewAdd overview.

Key findings relating to costsAdd key findings relating to costs.

Key findings relating to benefitsAdd key findings relating to benefits.

ConclusionAdd conclusion.

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Appendices

Section 4: Appendices

Appendix 1: Guideline Development Group terms of reference Note the names of GDG membership is shown at the intro pages. This appendix is for their terms of reference and also to add all other groups as relevant e.g. clinical advisory group/steering group etc.

GDG Terms of Reference <insert>

External Reviewers<Names, titles and organisations>

Conflict of interest declarationsList conflict of interest details as relevant for GDG, external reviewers and steering group or other as relevant – if these are few and listed in section 2, this section of the appendix may not be required.

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Appendices

Appendix 2: Literature search strategy

Provide details of the literature search strategy

Figure X Flow chart of included and excluded studies

Use a graphic to represent numbers of included and excluded studies.

Appendix 3: Evidence tables Provide a table of evidence for each key question. Refer to the NCEC guideline developers manual for sample of headings to use.

Appendix 4: Consultation report

List names of stakeholder/ organisations invited to contribute and noted those that responded (table below can be used). Outline also the process for stakeholder consultation and any changes made as a result.

DatePatients groupsExternal review

Clinical Programmes and healthcare divisionsNational committeesProfessional groups

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Appendices

Appendix 5: Economic assessment Where a commissioned review is used to inform the guideline, the report can be an annex and remain a standalone document (separate to this guideline). Remember the summary BIA remains part of the main guideline.

Part A: Economic evidence summary

Report completed by…

Introduction

MethodsMethodology, including the search strategy …

Table X: Economic Filter ID Search Hits

6 *Economics/

7 *Economics, Medical/

8 *Economics, Pharmaceutical/

9 exp "Costs and Cost Analysis"/

10 exp Health Care Costs/

11 exp decision support techniques/

12 exp models, economic/

13 markov chains.sh.

14 montecarlo method.sh.

15 uncertainty.sh.

16 quality of life.sh.

17 quality-adjusted life years.sh.

18 exp health economics/

19 exp economic evaluation/

20 exppharmacoeconomics/

21 exp economic aspect/

22 quality adjusted life year/

23 quality of life/

24 exp "costs and cost analyses"/

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-benefit analysis or hospital costs or medical costs or quality-of-life).sh.

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 expenditureor expenditures or budget$ or afford$ or pharmacoeconomic or pharmaco- economic$).ti,ab.

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Appendices

27 (cost$ adj1 (util$ or effective$ or efficac$ or benefit$ or consequence$ oranaly$ 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.

28 (decision adj1 (tree$ or analy$ or model$)).ti,ab.

29 ((value or values or valuation) adj2 (money or monetary or life or lives or costs or cost)).ti,ab.

30 (qol or qoly or qolys or hrqol or qaly or qalys or qale or qales).ti,ab.

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.

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.

33 (decision adj1 (tree$ or analy$ or model$)).ti,ab.

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Figure X Flow chart of included and excluded studies for economic literature review

Use a graphic to represent numbers of studies.

Economic literature review results

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.

Part B: Budget impact analysis

A well-structured budget impact analysis (BIA) report should be provided. It should be transparent, all assumptions clearly stated, and all gaps identified. A good BIA will have an introduction, main results and conclusion.

The introduction should provide a general overview of what is included in the BIA. It should clearly outline which recommendations are examined in the BIA and which were considered similar to current practice. It should describe how the main section will be structured, for instance, stating if certain recommendations are grouped together.

How best to structure the main results section will depend on the guideline. However, these general points are worth following:

It is best to start with the direct costs of implementation then follow with the potential cost savings from improved outcomes.

Outline any areas where it is not clear how the budget might be impacted – it is better to be transparent about gaps than to ‘hide’ them.

Create one table which pulls all estimated costs together at the end of your main results. Include any estimated savings from improved outcomes and unknown areas. Sample table is here <link from E-learning module>

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Appendices

A short conclusion should summarise the findings and highlight any major gaps in the BIA.

Appendix 6: Implementation plan Insert the logic model and detailed implementation plan to include actions; persons responsible and timelines for implementation of each recommendation. Include also dissemination of the guideline and actions to facilitate implementation. Templates for implementation plans can be found on the NCEC webpages.

Appendix 7: Supporting tools List the supporting tools for this guideline, for example, weblinks or details of patient information leaflets, elearning and related services.

Appendix 8: Monitoring and audit Insert details of proposed audit and monitoring plan . KPIs and audit criteria should be prepared. Include audit tools and other arrangements as appropriate. Consider existing data collection mechanisms where available or other types of data collection such as patient satisfaction/patient experience surveys, evaluation, quality indicators and research.

Appendix 9: Glossary of terms and abbreviations Definitions within the context of this document<if any>

AbbreviationsAll abbreviations in the document must be stated and listed in alphabetical order, using the table below.

The following abbreviations are used in this document:GDG Guideine Development GroupNCEC National Clinical Effectiveness Committee

Appendix 10: <insert title >

Add as many additional appendices to meet the requirements of your specific guideline.

References

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Appendices

Version HistoryDate Version Details

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Appendices

May 2014 1 NewAug 2017 2 Updated table of contents and Introductory pages (GDG, credits and

acknowledgements etc.Oct 2019 3 Updated new DOH address

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