How to develop a CHI Clinical Guideline

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How to develop a CHI Clinical Guideline

Clinical practice guidelines ('guidelines') are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. In addition, guidelines can play an important role in health policy formation and have evolved to cover topics across the health care continuum (e.g., health promotion, screening, diagnosis).

The potential benefits of guidelines are only as good as the quality of the guidelines themselves.

Appropriate methodologies and rigorous strategies in the guideline development process are important for the successful implementation of the resulting recommendations. The quality of guidelines can be extremely variable and some often fall short of basic standards.

AGREE II

The Appraisal of Guidelines for REsearch & Evaluation (AGREE) Instrument was developed to address the issue of variability in guideline quality. To that end, the AGREE instrument is a tool that assesses the methodological rigour and transparency in which a guideline is developed.

Additionally, the AGREE II tool provides a methodological strategy for the development of guidelines and informs what information, and how information, ought to be presented.

The CHI Clinical Guidelines Committee has chosen to use this tool as the framework for the development and presentation of jointly developed clinical guidelines.

The AGREE II consists of 23 key items organized within 6 domains followed by 2 global rating items ("Overall Assessment"). Each domain captures a unique dimension of guideline quality.

Compliance with the specific items will be achieved and demonstrated by following the prescribed development process, using the recommended guideline format and completing the supporting documentation.

Our primary goal is to promote and support the development of local guidelines, therefore, we accept that certain items or domains may not be applicable to a particular guideline e.g Domain 6. Whilst we insist on a minimum standard with regard to the depth of the supporting literature search, we acknowledge local resource limitations and support a pragmatic approach where appropriate. For example, if SIGN have developed a guideline that members of the local development group are satisfied meets their exact requirements, it should be adopted, rather than "re-inventing the wheel".

We do, however, insist that the scope of the literature search performed and the data sources used to support a recommendation be recorded.

In order to ensure that guideline developers are fully appraised of what is required and can avail of local supports, it is imperative that the lead author meet with the CHI Clinical Guidelines Committee prior to embarking on a guideline's development and completes the"Preliminary outline of a proposed new or replacement guideline" form.

We will use the attached checklist to ensure the guideline is necessary, appropriately researched and valid for our population:

Title: Guidelines are listed in alphabetical order. Create the title accordingly.

Example:

Asthma: Management of Severe and Life-Threatening Disease
not 'Management of the patient with asthma ......'etc

Domain 1: Scope and Purpose

Item 1: Aim: In this section the overall objective(s) of the guideline is (are) specifically described

The aim will be stated explicitly in the final guideline.

Example:

Aim

"The aim of this document is to provide a guideline for the management of children with a severe and life-threatening exacerbation of asthma"

Item 2: Specific Health Questions:

Specific health questions will not be listed in the final guideline but should be submitted prior to the preliminary meeting with the CHI Clinical Guidelines Committee on the form "Preliminary outline of a proposed new or replacement guideline" This will permit an informed decision to be reached regarding the utility of the proposed new guideline and aid in clarifying which stakeholders must be engaged with. It will also form the basis of the literature search.

Example:

Specific Health Questions which this guideline will address (this will help to focus your literature review):

What are the features of severe or life threatening asthma?

What are the criteria for referral to PICM?

What are the PICU admission criteria for those with status asthmaticus?

What is the recommended bronchodilator regime? What is the role of non-invasive ventilation?

What is the role of Heliox?

What are the indications for intubation?

What is the recommended strategy for intubation?

What is the recommended ventilation strategy for those invasively ventilated?

What is the role of inhalational anaesthetics?

When should I consider ECLS?



Item 3: Target Patient Population:

The target patient population will be stated explicitly in the final guldeline.

Example:

Target Patient Population

"This evidence summary applies to children aged 2 to 16yrs with acute severe or life threatening exacerbation of asthma. It does not deal with the management of those children with less severe disease. It does not deal with the management of bronchiolitis."

Domain 2: Stakeholder involvement

Item 4: The guideline development group should include individuals from all the relevant professional groups.

Item 5: The views and preferences of the target population (patients, public, etc.) should be sought where appropriate.

Compliance with Items 4 and 5 will be recorded on the accompanying "Development group member's signature sheet". All listed group members are required to sign this sheet to acknowledge their input into the development process and their agreement with the content of the final draft.

Item 6: Target Users:

The target users will be stated explicitly in the final guldeline.

Example:

Target Users

"This guide is directed at health-care professionals involved in the care of critically ill infants and children"

Domain 3: Rigour of development

Item 7: Systematic methods were used to search for evidence.

Item 8: The criteria for selecting the evidence are clearly described.

Compliance with Items 7 and 8 will be demonstrated through recording of the Search Strategy and Selecton Criteria on the "Literature Search Documentation form". This process will be faciliated by the librarians at each hospital's respective library.

Item 9: The strengths and limitations of the body of evidence are clearly described.

Item 10: The methods for formulating the recommendations are clearly described.

Item 11: The health benefits, side effects and risks have been considered in formulating the recommendations.

Item 12: There is an explicit link between the recommendations and the supporting evidence.

Compliance with the above items will be demonstrated by referencing the evidence supporting a particular recommendation and including a brief narrative regarding the robustness of that evidence and any caveats that may apply to the implementation of a particular recommendation.

Example:

"Inhalational Anaesthetics. Volatile anaesthetic agents exert a direct dilatory effect on airway smooth muscle and inhibit release of inflammatory mediators.They have been used to treat status asthmaticus since the 1930's. Their use in the paediatric population is supported by case series. Isoflurane delivered at 0.5 to 1.5% has been demonstrated to be effective and safe. Hypotension is common and pressor support is likely to be required."

Item 13: The guideline has been externally reviewed by experts prior to its publication.

External review will not be sought for guidelines designed for local implementation.

Item 14: A procedure for updating the guideline is provided.

The last reviewed / updated date is stated at the foot of the guideline. The suggestion timeline for review is 3 years.

Domain 4: Clarity of Presentation

This domain deals with the language, structure and format of the guideline.

Item 15: The recommendations are specific and unambiguous.

Item 16: The different options for management of the condition or health issue are clearly presented.

Item 17: Key recommendations are easily identifiable.

Compliance with the above items will be facilitated through the use of plain language and by following the standardized format. Flow diagrams should be provided where applicable.

Example: Asthma: Severe and Life Threatening

Flow diagram for Asthma: management of Severe & Life Threatening Disease

Domain 5: Applicability Description

This domain pertains to the likely barriers and facilitators to implementation, strategies to improve uptake, and cost implications of applying the guideline.

Item 18: The guideline describes facilitators and barriers to its application.

Item 19: The guideline provides advice and/or tools on how the recommendations can be put into practice.

Item 20: The potential resource implications of applying the recommendations have been considered.

Item 21: The guideline presents monitoring and/ or auditing criteria.

Compliance with Items 18, 20 and 21 will be achieved through completion of the relevant sections of the " Preliminary outline of a proposed new or replacement guideline " form.

Example:


Barriers to implementation and resource implications:

Logistics of delivery of inhalation anaesthetics in PICUAbsence of funding for respiratory ECLS. Absence of suitable cannulae and experience in delivery of Veno-Venous ECLS



Audit criteria (what are the endpoints which your guideline hopes to achieve)

Compliance rate (number of asthmatics admitted to PICU managed in accordance with the asthma guideline); intubation rate; ventilation days; length of stay; PICU mortality; all cause mortality

 

Compliance with Item 19 will be achieved via the inclusion of Companion Documents which may be linked to from the parent guideline document.

Example:


Companion Documents

- Nursing guideline on the set up and management of the AnaConDa Device (Anaesthetic Conserving Device)

Domain 6: Editorial Independence

This domain is concerned with the formation of recommendations not being unduly biased with competing interests.

The views of the funding body have not influenced the content of the guideline.
Competing interests of guideline development group members have been recorded and addressed.

It is anticipated that the collaborative nature of the guideline development process will go a large way towards ensuring balanced recommendations. Where any member of the development group has a real or potential conflict of interest, this must be brought to the attention of the HCGC at the earliest opportunity.

Links to:

- Preliminary outline of a Proposed New or Replacement Guideline pro forma

- CHI Clinical Guideline template

- CHI Flow diagram template

- CHI Clinical Guideline Literature Search Documentation pro forma

- CHI Clinical Guideline Development Group members signature sheet

- CHI Clinical Guideline Development Process - Step by Step