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National Clinical Guideline Proposal Template

Guidance for Guideline Development Groups for the preparation of a proposal for National Clinical

Guidelines

National Clinical Effectiveness CommitteeTemplate Version 3 - Sept 2015

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<Organisational Logos as appropriate>

<Title>Proposal to develop as a National Clinical Guideline

Guideline Proposal

<Month Year of submission>

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The following document contains guidance regarding the preparation of a proposal to develop National Clinical Guidelines (NCGs). It will be used in the prioritisation process and be submitted to the NCEC for consideration.

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Notice of IntentIt is recommended that a Notice of Intent is submitted prior to completion of a guidelines proposal.

A notice of intent is notice provided by a GDG of a guideline in development likely to be submitted to NCEC. The notice of intent will be published on the NCEC website. It allows information to be shared with stakeholders who have an interest in a clinical area, in order for them to communicate with each other and to prevent the possible duplication of effort where a number of stakeholders are undertaking work in the same area. This notification neither commits the GDG to submit their guideline to NCEC, nor does it indicate that the guideline will be prioritised or endorsed by NCEC.

Useful Resources This template should be used in conjection with the documents:

- NCEC Preliminary Prioritisation Process National Clinical Guidelines (March 2015)*- NCEC Clinical Guideline Developers Manual (2013)- HIQA and NCEC National Quality Assurance Criteria for Clinical Guidelines Version

2. (April 2015)*These documents are currently being updated.

Further resources, including procedures and published guidelines, are available at http://health.gov.ie/patient-safety/ncec/

General GuidanceConsideration should be given on the appropriate time in the guideline development process to submit a proposal. It is recommended that proposals are submitted as soon as there is sufficient information to allow prioritisation. They should outline the methodological approach and resources the GDG plan to use, where known.

At the proposal stage, it is accepted that a Guideline Development Group (GDG) may not yet be established. However, the proposal should contain as much information as possible about work undertaken to date on forming a GDG and any future plans to progress this should the guideline be prioritised.

Depending on the topic, guideline proposals may have different volumes of information in each section of the proposal. A submission must be made under each priorisitation criteria to indicate it has been considered by the proposer and/or organisational sponsor.

The proposer should use judgement to determine what and how much information is required under each criteria to faciliate the prioritisation process. It is important to note that reviewers are not subject experts. Abbreviations should be explained on first use in the text. A glossary of abbreviations and/or definitions may be provided if the proposer considers it useful for the prioritisation process.

http://health.gov.ie/patient-safety/ncec/

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Submission of Final ProposalCompleted proposals should be submitted at least six weeks prior to the date of the relevant committee meeting. Contact the Clinical Effectiveness Unit for dates.

Electronic (soft copy) submissions of both proposal and supporting documentation are preferred. If possible, pdf format should be used. However, if soft copies are not possible, please annotate any documents listed as “paper only”.

Please submit final document and any supporting information via email to [email protected] Paper documents can be posted or delivered by hand to:

Clinical Effectiveness Unit, CMO Office, Department of Health, Hawkins House, Dublin D02 VW90.

Completion of TemplateThe following should be completed:

- Boxes 1, 2 and 3 consider governance and contain key details of the proposed guidelines and the proposer and/or organisational sponsor and/or GDG.

- Box 4 provides space to outline the context of the proposed guideline in the Irish healthcare context.

- Box 5 which outlines essential checks that the proposer should complete prior to submitting the final proposal.

- Box 6 which contains the required information for the prioritisation process.

It is important to note that the questions listed under each heading are prompts only. An answer for each question may not be available. They are provided here as an aid only. In particular, it may be difficult to answer questions under criteria 3 and 4 at the proposal stage. However, proposers are encouraged to submit any information they have that may contribute to these criteria. Baseline data should be reported where known.

Supporting documentation may be submitted and should be listed in the appropriate section of box 6 under the relevant criteria.

Example(s) of possible tools to assist in implementation of NCG may be submitted as supporting documents and should be highlighted in the last section of box 6.

References should be provided in line with the Harvard method format and listed in the appropriate section on box 6. Where relevant, include details of policy documents and/or reports which inform the topic.

Note: information need only be inserted once. It is appopriate to refer back to previous sections to avoid repetition.

Any feedback on the template should be provided by completing Form A at the end of the document. This will be used to review this template and inform changes.

Box 1: Proposed National Clinical Guideline Governance ArrangementsInsert details as requested.

Clinical question underconsiderationWorking Title of Clinical Guideline

Scope of Proposed Guideline

Disease or clinical areaPopulation (please tick all that apply and add additional

information, e.g. age ranges, as appropriate) AdultPaediatricNeonatesObstetricsCare of the ElderlyOther (please detail)

Service (please tick all that apply and add additional information as appropriate) Primary CareSecondary CareDisability CareSocial CareMental HealthPopulation HealthAcute HospitalsLong Stay ResidentialOther (Please detail)

User Groups (Please detail)

Additional areasincluded

(Please detail)

Additional areas excluded

(Please detail)

Organisation Name- Development

Organisation Name– Implementation

Affiliation to HSE National or Clinical Programme(tick box)

Yes No

(Please detail)

Contact Name

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Contact Address

Contact Telephone NumberContact Email AddressDate of Proposal SubmissionForm of Submission(tick box)

Email Paper copy

Signature

Box 2: Details of Proposed Guideline Development GroupList names, titles and roles of all members of the proposed GDG.

Name Title Role

Box 3: Details of Additional Project Collaboration or SupportList names, titles and roles of any further individual offering collaboration or project support to the proposed guideline.

Name Title Organisation

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Box 4: Background Information and Proposed Timeline

Insert definitions if required to provide context to the information in the proposal.

Insert background information to show the role of the proposed clinical guideline in the Irish health care context. This should include a brief description aimed at the non-specialist of where the guideline will fit in the care pathway. If relevant, it may be useful to include a brief description on what is currently in place.

Insert names and references for key documents that support the proposed guideline within the Irish health service context. This may include service plans, standards and national reports.

Insert proposed timeline for guideline development. Specific dates are not required but an outline of the estimated project stages and associated time periods should be provided.

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Box 5: Summary Checklist for completion of a Proposal for a National Clinical GuidelineTick box as appopriate. Further comment may be inserted under each question is needed.

CompleteYes/No

1. Definition Is this a Clinical Guideline as per NCEC definition?

See NCEC Clinical Guideline Developers manual (2013)*

2. Template Has the NCEC Clinical Guideline Proposal Template been utilised?

Download from http://health.gov.ie/patient-safety/ncec/resources-and-learning/ncec-processes-and-templates/

3. Prioritisation Criteria

Have the NCEC Prioritisation Criteria have been addressed in this proposal?

See NCEC Preliminary Prioritisation Process National Clinical Guidelines (March 2015)

4. Guidance documents

Have the following documents been considered by the GDG?- NCEC Preliminary Prioritisation Process National Clinical

Guidelines (March 2015)- NCEC Clinical Guideline Developers manual (2013)*- HIQA and NCEC National Quality Assurance Criteria for

Clinical Guidelines Version 2 (April 2015)- NCEC Framework for Endorsement of National Clinical

Guidelines (April 2015)

*These documents are currently being updated.

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http://health.gov.ie/patient-safety/ncec/resources-and-learning/ncec-processes-and-templates/

http://health.gov.ie/patient-safety/ncec/resources-and-learning/ncec-processes-and-templates/

Box 6: Prioritisation Criteria The NCEC has identified 7 criteria for prioritisation. Descriptors for each criteria are included. Please provide a statement below with regard to each of the criteria.

It is important to note that the questions listed under each heading are prompts only. An answer for each question may not be available. They are provided here as an aid only. In particular, it may be difficult to answer questions under criteria 3 and 4 at the proposal stage. However, proposers are encouraged to submit any information they have that may contribute to these criteria.

Proposers should also explicitly state how they plan to approach the process and refer to any supporting documents or guidance that they may use. If the guideline will contribute to the achievement of improved healthcare as recommended by national standards or reports, such documents should be specified and the specific recommendations highlighted.

Proposers are requested to include subheadings where relevant under each criteria and to number these according to the criteria number e.g. 1.1, 1.2, 1.3 etc. These sections can then be cross referenced under other criteria to avoid the need to repeat information.

Criteria 1 Patient Safety IssueConsider the following:

a) What is the patient safety issue?b) Who is affected?c) How are they affected?d) Does the issue have national implications?e) What are the risks associated with this issue if not addressed?f) How can it be addressed?g) Is there potential for quality improvement in the area?

Response to Criteria 1

Additional Information for Criteria 1 (if relevant), including details of supporting documents

References and Data Sources for Criteria 1

Criteria 2 Burden of Clinical Topic**Includes disease/condition/circumstance etc.Consider the following:

a) What is the incidence/prevalence of clinical topic (disease/condition/circumstance)?b) The population (patients, public, etc.) to whom the guideline is meant to apply is

specifically described?

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c) What is the associated mortality and morbidity?d) What are the rates of relapse, re-admission and complications?e) Is there reduced quality of life?f) Is there patient dissatisfaction?



References for Criteria 2

Criteria 3 Evidence AnalysisConsider the following:

a) 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

b) Is there detail of the search methods and evidence rating?c) Are recommendations graded based on the quality of evidence with an explicit link

between the recommendations and supporting evidence?d) 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 4 Economic ImpactWhile 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.Consider the following:

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

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a. Have the resource implications of implementing the guideline been considered?b. Have the resources required for any initial set up or roll out phase been

considered?c. Have the cost of these resources to the publicly-funded system been estimated?

b) Are there potential cost savings to be realised if the guideline is implemented?a. Are there any potential cost savings due to changes in the use of resources?b. Have the benefits from improved outcomes been quantified and the associated

costs or savings been estimated?c) Is there national or international cost-effectiveness evidence to support implementing

the guideline?a. Is a summary of the cost-effectiveness evidence presented? Is this generalisable

or relevant to the Irish healthcare setting?b. Has this evidence been gathered using systematic searching methods and are

these methods documented?Response to Criteria 4



Criteria 5 Variability in PracticeConsider the following:

a) Are there gaps between current clinical practice and evidence-based practice?b) Are significant variations in practice evident?c) What is the associated risk of the variance from best practice?d) Would reducing variation incur beneficial effects for patients?e) Would reducing variation reduce avoidable morbidity and/or mortality?f) To what extent is there a high risk impact for the health system?g) Are there high frequency risk factors (avoidable and inherent)?




Criteria 6 Potential for Improved HealthConsider the following:

a) The overall objective of the guideline is specifically described with the expected benefit V3. Sept 2015. of 14

or outcome of the guideline clearly outlinedb) Is there potential for improved health outcomes?c) What is the extent of potential improved quality of life?d) What is the extent of potential improved quality of care?e) Is there potential for health promotion at population health level?f) Is there potential for disease prevention at population health level?g) Will the clinical guideline reduce the extent of avoidable injury?h) Will the clinical guideline reduce inequalities in health?i) What are the potential short and long-term health outcomes taking into account the

strength of evidence associated with each?j) Is there a maximum likelihood of benefit and minimum harm?k) Will the clinical guideline reduce symptoms, avoid or delay need for other therapies or

reduce disease progression?l) Will the clinical guideline support the implementation of national health policy?m) Will the clinical guideline improve patient safety?




Criteria 7 Clinical Guideline ImplementationConsider the following:

a) What is the feasibility of implementation of the clinical guideline?b) What are the facilitators to the guideline application?c) Are there any significant barriers to implementation of the clinical guideline?d) What is the resource impact for implementation of the clinical guideline?e) How acceptable will the clinical guideline be to relevant stakeholders (consumers and

clinicians)? Did the clinical Guideline Development Group include individuals from all the relevant professional groups, methodological experts and intended users for example healthcare professionals, hospital managers etc.?

f) Is there a degree of urgency for implementation of the clinical guideline?g) What is likelihood of the clinical guideline implementation strategy being successful?h) How accessible will the clinical guideline be?



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Any additional comment you wish to make

Summary of possible tools to assist in implementation of National Clinical Guideline (if relevant)

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This form is not part of the proposal template.

Form AFeedback from GDG user on National Clinical Guideline Proposal Template

Did you find the provision of a template useful for the preparation of a proposal for a National Clinical Guideline?

YES

NOWhat did you find worked well?

In your opinion, what areas of the template could be improved?

Please return feedback form to [email protected]

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