[redactions made under s47F of the FOI Act]
From:
Duggan, Geraint
Sent:
Thursday, 21 March 2019 3:06 PM
To:
Mark Bellgrove
Cc:
Clinical Guidelines
Subject:
RE: ADHD clinical guidelines [SEC=UNCLASSIFIED]
Attachments:
Procedures & Requirements.pdf
Hi Mark
It was good to talk to you yesterday. As promised here is some follow up information.
1. What do NHMRC approved guidelines look like?
NHMRC has developed a national clinical practice guidelines portal which hosts evidence based guidelines, both
NHMRC approved and not approved . If you use the advanced search function you can filter by ‘NHMRC
approved’ which will give you a list of the currently approved (
i.e. <5 years old) guidelines. I particularly draw
your attention to the Hip and knee osteoarthritis guideline which contains a large number of recommendations
against commonly used but ineffective treatments, and the National stroke guidelines which were developed
using MagicApp and are published on that platform, which is one of the best examples of living guidelines and
which are supported by a sophisticated national clinical audit program.
2. What do I have to do to develop an NHMRC approved guideline?
You will need to meet the NHMRC Guideline development standards and the
Procedures and requirements for
meeting the 2011 NHMRC standard for clinical practice guidelines (attached). The latter is a step by step guide of
what to do. In addition NHMRC has developed a ‘Guidelines for Guidelines’ online resource ‐ a modular guide to
meeting some of the NHMRC standards. I would encourage you to become familiar with the overall content but
you may find the Identifying and managing conflicts of interest, Consumer involvement, Organisation and
budgeting, Guideline development group and Adapt, adopt or start from scratch modules helpful now as you
plan your guideline.
3. Training and staffing
As we discussed NHMRC advocates the use of GRADE for guideline development. Training is provided through
one of two approved training centres in Melbourne (Monash) and Adelaide (Joanna Briggs Institute). Both are
recommended.
To recruit methodologists and writers you may wish to get the advice of Cochrane Australia (which may be able
to help Monash affiliated projects, or at least give you advice). You could also look through recent NHMRC
approved guidelines to identify the methodologists used in guidelines you like. Unfortunately NHMRC cannot
recommend individuals or businesses for guideline developers seeking NHMRC approval.
4. Register your guideline
Once you are ready to start the preparatory work you should register your guideline on the NHMRC Guidelines
in development register, checking the box indicating that you will seek NHMRC approval. This will trigger a
formal request to the NHMRC CEO to accept the guideline onto our work plan. You should include as much
information as possible when you register, noting it will be posted on a public facing website.
I hope this is helpful. Please get in touch if you need more information.
Regards
Geraint
1
xxxx.xxxxxxxxx@xxxxxx.xxx
Australian ADHD Professionals Association Inc
Inaugural President
www.ausadhd.com.au
ORCID: orcid.org/0000-0003-0186-8349
http://www.monash.edu.au/research/profiles/profile.html?sid=1985044&pid=6456
M
m
m
http://www.monash.edu/neuro-institute/
I acknowledge the Traditional Owners and Custodians of the lands on which I live and work and pay my respect to Elders both past and
present
--
PROFESSOR MARK A. BELLGROVE
Director of Research, Institute of Cognitive and Clinical Neurosciences
National Health and Medical Research Council (NHMRC) Senior Research Fellow
Monash Institute of Cognitive and Clinical Neurosciences
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Australia
xxxx.xxxxxxxxx@xxxxxx.xxx
Australian ADHD Professionals Association Inc
Inaugural President
www.ausadhd.com.au
3
ORCID: orcid.org/0000-0003-0186-8349
http://www.monash.edu.au/research/profiles/profile.html?sid=1985044&pid=6456
M
m
m
http://www.monash.edu/neuro-institute/
I acknowledge the Traditional Owners and Custodians of the lands on which I live and work and pay my respect to Elders both past and
present
4
Electronic document
© Commonwealth of Australia 2011
This work is copyright. You may download, display, print and reproduce the whole or part of this
work in unaltered form for your own personal use or, if you are part of an organisation, for internal
use within your organisation, but only if you or your organisation do not use the reproduction for
any commercial purpose and retain this copyright notice and all disclaimer notices as part of that
reproduction. Apart from rights to use as permitted by the
Copyright Act 1968 or allowed by this
copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or
any part of this work in any way (electronic or otherwise) without first being given the specific
written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction
and rights are to be sent to Strategic Communications, National Health and Medical Research Council,
GPO Box 1421, Canberra ACT 2600 or via email to xxxxx.xxxxxxxxxxxx@xxxxx.xxx.xx.
ISBN Online: 1864964642
This document replaces
NHMRC standards and procedures for externally developed guidelines (2007).
This document will apply to all externally developed clinical practice guidelines for which intention
to seek NHMRC approval is registered on or after 1 January 2011.
Preferred citation
National Health and Medical Research Council.
Procedures and requirements for meeting the 2011
NHMRC standard for clinical practice guidelines. Melbourne: National Health and Medical Research
Council; 2011.
Revision history
The following table describes a summary of the changes made to this document since original
publication.
Version
Date
Amendment notes
1
May 2011
First publication
1.1
January 2012
Minor formatting corrections
Contact:
National Health and Medical Research Council
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
GPO Box 1421
Canberra ACT 2601
Ph: 61 2 6217 9000
Fax: 61 2 6217 9100
Email: xxxxx@xxxxx.xxx.xx
Website: www.nhmrc.gov.au
NHMRC Reference code: CP133
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table of contents
table of contents
How to contact NHMRC
1
About NHMRC approval
1
1. Introduction
2
Purpose
2
Scope
3
Before starting guideline development
4
2. Procedures for seeking NHMRC approval
6
Summary
6
Document preparation
8
Stage 1 Register intention to seek NHMRC approval
9
Stage 2 Develop guideline in accordance with NHMRC requirements
10
Stage 3 Release draft guideline for public consultation
11
Stage 4 Submit final draft guideline
13
Stage 5 Publish approved clinical practice guideline
14
3. Requirements for meeting the NHMRC standard
16
Introduction
16
A. Governance and stakeholder involvement
16
B. Scope and purpose
17
C. Evidence review
18
D. Guideline recommendations
19
E. Guideline structure and style
21
F. Public consultation
22
G. Dissemination and implementation of guidelines
23
Abbreviations and special terms used
24
References
29
List of tables and figures
Box 1.1
Summary of NHMRC standard for clinical practice guidelines
2
Box 1.2
Summary of what has changed
4
Box 1.3
NHMRC resources for guideline developers
5
Table 2.1 Summary of procedures to seek NHMRC approval of clinical practice guidelines
6
Table 2.2 Summary of documents required for NHMRC approval of clinical practice guidelines
8
ii
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How to contact NHMRC
Email: xxxxxxxxxxxxxxxxxx@xxxxx.xxx.xx
Telephone: 03 8866 0400
At any time please contact NHMRC to:
• provide updates on the timeline for development of a clinical practice guideline seeking
NHMRC approval
• ask for more information, including dates of NHMRC Council meetings to facilitate timing of
guideline submission for consideration for approval
• submit documents as required
• enquire about a guideline submission.
Information on clinical practice guidelines developed for use in Australian health care settings
can be accessed through the Clinical Practice Guidelines Portal www.clinicalguidelines.gov.au.
Proposed clinical practice guidelines should be listed on Guidelines in Development Register:
www.clinicalguidelines.gov.au/in-development/register.
About NHMRC approval
NHMRC approval of a clinical practice guideline is generally valid for a maximum of five years, and
applies only to the version of the guideline that was approved by NHMRC. Subsequent versions
must be resubmitted for approval.
Approval of an externally developed clinical practice guideline indicates that NHMRC considers that
the guideline is based on the systematic identification and synthesis of the best available scientific
evidence and makes clear recommendations for health professionals practising in Australia.
NHMRC will only approve guidelines that meet all the mandatory requirements listed in Part 3 of
this document. Developers are encouraged to meet the desirable requirements to improve guideline
quality and implementability.
Guidelines with NHMRC approval are recognised in Australia and internationally as representing
current medical knowledge and best practice in health care.
More information
Resources for developers of clinical practice guidelines and up-to-date information about the approval
process is available at www.nhmrc.gov.au/guidelines/developers.htm.
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introduction
1. introduction
The National Health and Medical Research Council (NHMRC) has a statutory responsibility to
provide leadership in the development of high-quality clinical practice guidelines in Australia.
Under Section 14A of the Commonwealth National Health and Medical Research Council
(NHMRC) Act 19921, NHMRC can also approve selected clinical practice guidelines developed
by other organisations.
As part of this role, NHMRC sets standards in clinical practice guideline development (outlined in
Box 1.1). Clinical practice guidelines should be based on the systematic identification and synthesis
of the best available scientific evidence and make clear recommendations for health professionals
practising in an Australian health care setting. The NHMRC requirements for developing clinical
practice guidelines are designed to ensure that this standard is upheld.
The
Procedures and requirements for meeting the 2011 NHMRC standard for clinical practice
guidelines replace those described in
NHMRC standards and procedures for externally developed
guidelines (2007). The new procedures and requirements draw on Australian and international best
practice and incorporate dimensions from internationally validated guideline appraisal instruments.2-4
This document applies to all new and revised clinical practice guidelines seeking NHMRC approval
from 1 January 2011. Key changes to the approval process are outlined in Box 1.2.
Box 1.1 Summary of NHMRC standard for clinical practice guidelines
To meet the NHMRC standard, clinical practice guidelines must:
• provide guidance on a clearly defined clinical problem based on an identified need
• be developed by a multidisciplinary group that includes relevant experts, end users and consumers
affected by the clinical practice guideline
• include a transparent process for declaration and management of potential conflicts of interest by
each member of the guideline development group
• be based on the systematic identification and synthesis of the best available scientific evidence
• make clear and actionable recommendations in plain English for health professionals practising in an
Australian health care setting
• be easy to navigate for end-users
• undergo a process of public consultation and independent external clinical expert review
• incorporate a plan for dissemination including issues for consideration in implementation
Purpose
The purposes of this document are to:
• describe the NHMRC standard for clinical practice guidelines
• outline the procedures for NHMRC approval of clinical practice guidelines developed by
external organisations (Part 2)
• set out the requirements that must be met in the preparation of clinical practice guidelines
to ensure that the NHMRC standard is upheld (Part 3).
Further information, including forms and templates for aspects of the approval process, are
available at http://www.nhmrc.gov.au/guidelines/information-guideline-developers.
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introduction
Scope
Target users
This information is provided for developers of clinical practice guidelines who intend to seek
NHMRC approval. Ideally, it should be read
before beginning the process of developing a clinical
practice guideline. This document may also be useful to funders of clinical practice guidelines
who wish to be informed by the NHMRC standard.
NHMRC will consider for approval guidelines that have been produced under the auspices of
expert organisationsi including medical colleges, peak bodies representing medical specialists,
medical special interest associations, professional societies, public or private health organisations,
non-government agencies and federal or state government agencies.
The NHMRC does not consider for approval clinical practice guidelines:
• developed and issued by individuals who are not officially sponsored or supported by one of
the above types of organisations
• developed, published or funded by industry groups (or organisations whose main source of
funding is derived from industry groups) with a financial interestii in the guideline clinical area.
Types of guidelines to which this document applies
These procedures and requirements apply to clinical practice guidelines developed for national
use within Australia and published in full-text format.
New editions of previously published clinical practice guidelines seeking NHMRC approval
(whether or not they were previously approved by NHMRC) should also follow the
Procedures and
requirements for meeting the 2011 NHMRC standard for clinical practice guidelines (2011), each
time they are revised to include new clinical evidence. This document does not apply to guidelines
published only in a web-based format with frequent, rapid updating.
i
For an overview of the types of organisations that have developed NHMRC-approved guidelines, visit the NHMRC Clinical
Practice Guidelines Portal (www.clinicalguideline.gov.au) and in the 'Browse by' field choose 'NHMRC approved' from
the menu.
ii Information about conflict of interest is currently under development by NHMRC.
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introduction
Box 1.2 Summary of what has changed
Procedures and requirements for meeting the 2011 NHMRC standard for clinical practice guidelines (2011)
replaces
NHMRC standards and procedures for externally developed guidelines (2007
). Developers should
note the following key differences:
• All clinical practice guidelines seeking NHMRC approval must now register on the Guidelines in
Development Register (www.clinicalguidelines.gov.au/in-development) at the beginning of the process
(Part 2: Procedures, Stage 1). Early notification prior to commencement will enable NHMRC to
process this request and notify developers in a timely manner. Developers should ensure that timing
of registration will enable them to submit progress reports at required intervals.
• All clinical practice guidelines approved by NHMRC must now include a brief (1-page) plain English
summary (Part 3: Requirements, E.3).
• Developers are now required to circulate the public consultation draft to relevant government
agencies, including the Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory
Committee (PBAC) and Medical Services Advisory Committee (MSAC), and to the Director-
General, Chief Executive or Secretary of each Australian health department (state, territory and
Commonwealth) as part of the public consultation process.
• Developers are now required to identify and consult with key professional organisations (such
as specialty colleges) and consumer organisations that will be involved in, or affected by, the
implementation of the clinical recommendations of the guideline.
• Developers are now required to engage at least 2 reviewers, who must be independent of the
guideline development process, to assess the guideline using the AGREE II instrument3, 5 prior to
submission of the final draft guideline to NHMRC for approval. This enables the assessment of
guidelines against internationally accepted appraisal instruments (Part 3: Requirements, D.15).
• Developers will be asked to nominate up to 6 potential reviewers who are clinical experts in area/s
covered by the guideline and are independent of the guideline development process. NHMRC will engage
independent clinical expert reviewers as part of the approval process (Part 2: Procedures, Stage 4).
• As part of the public consultation process, NHMRC will notify NHMRC Council Members that the
public consultation draft is available for their comment as individuals or on behalf of their jurisdictions
(Part 2: Procedures, Stage 2).
• The NHMRC Guidelines Assessment Register (GAR) program has ceased. Guideline developers are
now responsible for accessing methodological expertise (Part 1: Introduction, Expertise and resources).
Before starting guideline development
Expertise and resources
Guideline development is a complex, lengthy and resource-intensive task. It is the responsibility
of the developer organisation to ensure that the resources required (financial support, access to
clinical and methodological expertise, and project management and administrative capacity) have
been considered and secured prior to commencement.
During guideline development, NHMRC staff are available to provide developers with further
information or clarification of the NHMRC standard. Developers are strongly advised to access
methodological expertise, in addition to and separate from clinical or content expertise, to assist
them in the systematic identification, appraisal and interpretation of clinical evidence.
In addition, NHMRC resources (Box 1.3) have been published to provide further guidance for
developers. These resources are scheduled for revision by NHMRC from 2011.
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introduction
Box 1.3. NHMRC resources for guideline developers
A guide to the development, evaluation and implementation of clinical practice guidelines (1999)
This publication includes the accompanying handbooks:
How to review the evidence: systematic identification and review of scientific literature (2000)
How to present the evidence for consumers: preparation of consumer publications (2000)
How to prepare and present evidence-based information for consumers of health services: a literature review (1999)
How to put evidence into practice: implementation and dissemination strategies (2000)
How to use the evidence: assessment and application of scientific evidence (2000)
How to compare the costs and benefits: evaluation of the economic evidence (2001)
Using socioeconomic evidence in clinical practice guidelines (2003)
These publications are available at http://www.nhmrc.gov.au/guidelines/resources-guideline-developers
Managing timelines
Indicative times taken for NHMRC to respond at each stage of the approval process are summarised
in Table 2.1 in Part 2. Developers are requested to make an accurate estimate of the guideline
development timelines and key milestones (public consultation and submission of the final draft
guideline for consideration for approval) at the beginning of the development process. It is the
developer’s responsibility to notify NHMRC if the timelines change during the development
process. Delays may affect eligibility for consideration of the final draft guideline for approval
(Part 2: Procedures, Stage 2: Providing a timetable of key milestones).
Version control
A clinical practice guideline seeking NHMRC approval should not be disseminated, prior to
approval, other than for public consultation purposes. Drafts circulated for this purposes should
be clearly marked as such.
For administrative purposes, the final draft guideline should be submitted electronically as plain
text (e.g. Word document, rich text format document or PDF). Developers should be aware that
amendments may be requested by NHMRC prior to approval.
Guideline implementation
NHMRC recognises that implementation of guideline recommendations is critical for clinical
practice improvement. It should be considered throughout the development of the guideline.
In practice, however, many organisations that develop clinical practice guidelines do not have a
role in implementation, or do not have access to funding to implement guideline recommendations.
Often, the working group responsible for developing the guideline recommendations is not the
same group responsible for implementation.
In recognition of this, a set of requirements are included in Part 3: Requirements, G. It is a
mandatory requirement that clinical practice guidelines seeking NHMRC approval must, as a
minimum, contain a plan for dissemination of the guideline (Requirement G.1) and should
highlight key guideline recommendations that are most likely to lead to improvements in health
outcomes for consideration in implementation (Requirement G.2). It is a desirable requirement
(Requirement G.3) that, where possible, a plan for implementing the guideline is also provided.
NHMRC requires that a document with the dissemination and /or implementation plan along with
the key recommendations for implementation is submitted as a separate document to the main
body of the clinical practice guideline for consideration of approval at Stage 4. NHMRC approval
will cover the full guideline, but not the specific activities or the identified key recommendations
contained within the dissemination or implementation plan. It will be the guideline developer’s
responsibility to liaise with the relevant authorities to put these activities into action.
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Procedures for seeking NHMRc approval
2. Procedures for seeking NHMRc approval
Summary
The procedures are described as five stages in the following section. The responsibilities of the
guideline developer and NHMRC at each stage are summarised in Table 2.1.
TaBle 2.1. Summary of procedures to seek NHMRC approval of clinical practice guidelines
STAGE
WHAT THE DEVELoPER MuST Do
WHAT NHMRC WILL Do
Stage 1.
As soon as possible:
Register
intention to
Notify NHMRC of the intention to seek
Formally advise developer, in writing,
seek NHMRC
NHMRC approval via the Guidelines in
of the CEO’s decision whether to
approval
Development Register.
consider the guideline for approval.
NB. Developers should ensure that the timing
Normally this takes 2–4 weeks from
of registration of their guideline will enable
date of registration, unless the CEO
them to submit progress report/s at the
seeks advice from Council.
required intervals (see Stage 2).
Notify AHMAC if NHMRC agrees
to consider guideline
MILESToNE: NHMRC AGREES To CoNSIDER GuIDELINE FoR APPRoVAL
Stage 2.
As soon as possible:
Develop
guideline in
Submit timeline of key milestones. An accurate
Acknowledge the proposed timeline
accordance
estimate of date for planned public consultation
in writing.
with NHMRC
is required.
requirements
3–6 months before planned public consultation period:
Submit progress report (including nominations
Inform developer in writing if any major
of potential clinical expert reviewers).
issues or gaps in the development
Address any issues identified by NHMRC
process are identified (4–8 weeks from
within one month from receipt of response to
receipt of progress report).
progress report.
At any time:
Notify NHMRC in writing if timelines change.
Advise developer of any updates
as required.
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Procedures for seeking NHMRc approval
STAGE
WHAT THE DEVELoPER MuST Do
WHAT NHMRC WILL Do
Stage 3.
Confirm the start date of the public consultation
Notify Council members of the public
Release draft
period with NHMRC 2 weeks prior to the
consultation period and how to access
guideline
publication of the first notice of public consultation.
the draft.
for public
Provide the draft guideline and details of public
Request that Council members who
consultation
consultation, including dates, web links and
wish to provide comments as individuals†
submission requirements to NHMRC five days prior
do so directly to developer during the
the start date of the public consultation period.
specified public consultation period.
Release draft guideline for public consultation in
Encourage Council members to seek
accordance with requirements (Refer to Part 3:
advice from their jurisdictions or other
F. Public consultation).
expert sources within their networks,
Provide draft guideline to relevant stakeholders,
as they see fit.
including TGA, PBAC and MSAC, the Director-
General, Chief Executive or Secretary of state,
territory and Commonwealth departments of
health, and key professional organisations (such
as specialty colleges) and consumer organisations
that will be involved in or affected by the
implementation of guideline recommendations.
Document and address all comments received
during public consultation.
Notify NHMRC of intended date for submission
of final guideline draft for approval (at least
2 months prior to submission date).
Stage 4.
Submit final draft guideline to NHMRC for approval
Arrange independent methodological
Submit final
(at least two months prior to the Council meeting
and clinical expert review of final draft
draft guideline
at which developer requests the final draft guideline
of guideline.
to be considered).*
Consider methodological and clinical
Address any issues raised by reviewers as
expert reviewers’ comments. Seek
requested by NHMRC.
further information from developer
Address any issues raised at or prior to Council
in preparation of papers for Council
meeting.
consideration (if required).
Inform developer in writing whether
the guideline is approved by NHMRC
(up to 4 weeks after Council meeting).
MILESToNE: NHMRC APPRoVES GuIDELINE
Stage 5.
Publish and disseminate guideline within 16 weeks
Inform developer of the NHMRC
Publish
of date of NHMRC approval, in accordance with
publishing obligations and requirements.
approved
NHMRC publishing requirements.
Once published, assess guideline for
clinical practice
inclusion on Clinical Practice Guidelines
guideline
Portal§ and announce in NHMRC
publications (NHMRC Tracker6 and
NICS Update7).
AHMAC: Australian Health Ministers Advisory Council
CEO: NHMRC Chief Executive Officer
Council: Council of the NHMRC
MSAC: Medical Services Advisory Committee
PBAC: Pharmaceutical Benefits Advisory Committee
TGA: Therapeutic Goods Administration
Contact details for these agencies are available from NHMRC.
* Developers should approach NHMRC to request information on upcoming Council Meeting dates.
† Comments submitted at this Stage represent those of individual Council members and/or their jurisdictions,
and not those of the NHMRC Council.
§ All clinical practice guidelines produced in Australia are assessed prior to inclusion on the NHMRC Clinical
Practice Guidelines Portal (www.clinicalguidelines.gov.au/about.php).
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Procedures for seeking NHMRc approval
Document preparation
It is the responsibility of the guideline developer to document all processes and to demonstrate
how they meet the NHMRC mandatory requirements for approval. A list of documents required
for submission to NHMRC is summarised in Table 2.2.
TaBle 2.2. Summary of documents required for NHMRC approval of clinical practice guidelines
DoCuMENT NAME
DESCRIPTIoN
SuBMISSIoN TIME
Progress report
Provides details of aspects of the guideline
Approximately 6 months
development process. The developer must submit
(and not later than 3 months)
a progress report to confirm the intention to
before the draft guideline is
seek NHMRC approval (progress report template
released for public consultation.
available at http://www.nhmrc.gov.au/guidelines/
If the timeline is altered due to
resources-guideline-developers).
delays in guideline development,
NHMRC may request further
progress reports.
Draft guideline
Draft guideline with content intended for use in
Public consultation draft and
clinical setting.
final draft versions required.
Technical report
A record of the evidence review process
Submitted with final draft
(refer to Part 3: Requirements for the
for approval.
information to be included).
Should also be made available
with public consultation draft.
Administrative report
Non-technical information relating to process
Submitted with final draft
of guideline development (refer to Part 3:
for approval.
Requirements for the information to be included).
May also be made available
with public consultation draft.
Dissemination plan
A document separate from the main guideline
Submitted with final draft
document which contains, at a minimum, details
or approval.
of the dissemination plan for the guideline.
Should also be made available
This document should also highlight key guideline
with public consultation draft.
recommendations that are most likely to lead
to improvements in health outcomes, for
consideration in implementation.
Public consultation
Documents details of public consultation
Submitted with final draft
submissions summary
submissions and guideline developer responses
or approval.
(further information on public consultation is
available at: http://www.nhmrc.gov.au/guidelines/
resources-guideline-developers).
For NHMRC administrative purposes, developers must submit documents electronically in plain text
(e.g. DOC, PDF or rich text format). Once approved, developers may choose to publish their final
guideline in print, electronic or interactive online formats.
The information that is required to be included in the guideline (including appendices), the
administrative report and the technical report is detailed in Part 3: Requirements. All information
in the technical and administrative reports must be readily accessible to the public when the
guideline is published (Part 3: Requirements E.11–E.12).
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Procedures for seeking NHMRc approval
Stage 1. Register intention to seek NHMRC approval
Registration
The NHMRC Guidelines in Development Register (www.clinicalguidelines.gov.au/in-development)
provides a central point of reference for Australian clinical practice guidelines that are planned or
under development. It is designed to reduce duplication of effort and foster greater collaboration
between guideline developers. The Guidelines in Development Register also acts as the entry point
for developers of clinical practice guidelines to identify their intention to seek NHMRC approval of
their final draft guideline.
Before proposing a new clinical practice guideline, it is the responsibility of guideline developers to
undertake a formal needs analysis to inform the guideline scope. This should draw on information
listed in the NHMRC Clinical Practice Guidelines Portal and Register (www.clinicalguidelines.gov.au),
and include an assessment of burden of disease and identification of the clinical problem (including
variation in clinical practice).
All developer organisations intending to seek NHMRC approval of clinical practice guidelines should
register proposed guidelines on the NHMRC Guidelines in Development Register before starting the
development process (www.clinicalguidelines.gov.au/in-development/registration-form).
NHMRC will notify developers when their proposed clinical practice guidelines have been listed on
the NHMRC Guidelines in Development Register.
IMPORTANT
Early notification prior to commencement will enable NHMRC to process this request and notify
developers in a timely manner. Developers should ensure that the timing of registration of a guideline
seeking NHMRC approval will enable progress report submission timelines to be met.
Initial assessment of eligibility for approval consideration
Following registration, NHMRC will assess the scope of the proposed clinical practice guideline
to determine whether the registered guideline will be considered by NHMRC for approval.
The final decision on whether to agree to consider a guideline for approval is made by the
NHMRC’s Chief Executive Officer (CEO). The CEO may choose to seek further advice from
NHMRC Council before making this decision. NHMRC will formally advise the developer, in
writing, of the CEO’s decision.
Only guidelines intended to apply nationally will be considered for approval. NHMRC will not
consider for approval guidelines developed for a specific local context or health service.
If the CEO declines to consider a guideline for approval, a reason will be stated.
When a guideline is accepted to be considered for NHMRC approval, NHMRC will routinely
notify the Australian Health Ministers Advisory Council (AHMAC) to give state and territory health
departments advance notice of current guidelines in development seeking NHMRC approval.
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Procedures for seeking NHMRc approval
Stage 2. Develop guideline in accordance with
NHMRC requirements
Provide a timetable of key milestones
When beginning the guideline development process, it is essential that the developer determines
an accurate estimate of when the guideline will be released for public consultation, as well as an
estimate of the final submission date.
At any time in the development process the developer must notify NHMRC if the dates of public
consultation or final submission change, to allow the planned NHMRC-commissioned review
process to be adjusted. At any time NHMRC may request more information from developer,
if appropriate.
A realistic and accurate timeline is crucial, as it is a mandatory requirement (Part 3: Requirement C4)
that the systematic review is current and includes evidence published within:iii
• 12 months of the date on which the draft guideline is released for public consultation
• 20 months of the date on which the final draft guideline is submitted to NHMRC for approval.
IMPORTANT
Estimates of timelines for public consultation and final submission must be as accurate as possible.
Delays may affect eligibility for consideration of the final draft guideline for approval.
Evidence review
Each guideline should be based on a systematic review and critical appraisal of the current scientific
literature (Part 3: Requirements, C). Further guidance on evidence review, including
NHMRC levels
of evidence and grades for recommendations for developers of clinical practice guidelines (2009), is
available at http://www.nhmrc.gov.au/guidelines/resources-guideline-developers.
Progress report
To confirm the intention to seek NHMRC approval for a clinical practice guideline, the developer
must submit the first progress report approximately six months (and not later than three months)
before the draft guideline is released for public consultation (progress report template available at
http://www.nhmrc.gov.au/guidelines/resources-guideline-developers). NHMRC will inform the
developer in writing if any major issues or gaps in the development process are identified within
4–8 weeks from receipt of the progress report.
If delays in guideline development occur that alter the timeframes for the public consultation
and/or final submission dates, further progress reports may be requested by NHMRC.
At this time developers will also be requested to nominate potential clinical expert reviewers
for the final assessment at Stage 4. Guidance for developers on identifying appropriate
potential clinical expert reviewers is available from
http://www.nhmrc.gov.au/guidelines/resources-guideline-developers.
iii This is to ensure that evidence base used to support guideline recommendations is within two years of the publication date
of the guideline.
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Procedures for seeking NHMRc approval
other documents the developer must prepare during Stage 2
In addition to the draft guideline, the draft technical and administrative reports
(see Part 2: Document preparation) must be prepared during this stage.
The technical report must be submitted with final draft for approval. It should also be made
available with public consultation draft.
The administrative report must also be submitted with final draft for approval. It may also be
made available with the public consultation draft.
Stage 3. Release draft guideline for public consultation
Publishing a notice of public consultation
In accordance with Section 14A of the
NHMRC Act 1992 (Cwlth)1 and
NHMRC Regulations 2006
(Cwlth)8,developers seeking NHMRC approval must publish a notice inviting public submissions
on the draft guideline for a minimum period of 30 days (Part 3: Requirements F.1). In summary:
• The developer must publish a notice in at least one major national daily newspaper.
The developer may also publish a notice in any other way the organisation or group of
organisations considers appropriate.
• The notice must contain a summary of the draft guidelines and state where copies of the draft
guidelines could be obtained. Developers should ensure that this public consultation draft
guideline is clearly marked to indicate its draft status.
• The notice must identify the last day the developer will accept submissions, which must be,
at a minimum, 30 days after the notice is first published.
Further detail regarding requirements for public consultation, including a suggested format
for the consultation notice, is available at:
http://www.nhmrc.gov.au/guidelines/resources-guideline-developers.
The developer may also undertake additional consultation at this time or at any time during
guideline development.
Developers may wish to use additional methods to publicise their public consultation period
(including media releases or public events).
If the public consultation draft refers to NHMRC approval, it must clearly indicate that the guideline
has not yet been approved by NHMRC and that approval, if granted, would apply to the final draft that
is yet to be submitted for consideration following any amendments made after public consultation.
Before public consultation, developers should contact NHMRC (see How to Contact NHMRC) for
advice on the permitted wording of references to NHMRC and NHMRC approval.
Notifying NHMRC of public consultation
Developers are requested to confirm the start date of the public consultation period with NHMRC
two weeks prior to the publication of the first notice of public consultation.
Developers are requested liaise with the NHMRC staff to ensure the draft guideline and details
of public consultation, including dates, web links and submission requirements are provided to
NHMRC five days prior to the start date of the public consultation period.
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Procedures for seeking NHMRc approval
When the draft clinical practice guideline is released for public consultation, NHMRC will notify
Council members. Council members will be encouraged to consider the public consultation draft as
individuals and/or seek expert advice from their jurisdictions or other expert sources within their
networks, as they see fit. Comments and feedback from a Council member will be submitted the
directly to the developer during the specified public consultation period.
Advice from relevant authorities
The guideline developer is required to send a public consultation draft guideline to the Director-
General, Chief Executive or Secretary of each state, territory and Commonwealth health department.
The guideline developer is also required to send a public consultation draft guideline to relevant
government agencies, including Therapeutic Goods Administration (TGA), the Pharmaceutical
Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC),
specifically highlighting recommendations in the draft clinical guideline that are relevant to these
agencies (Part 3: Requirements, D.10 and F.3). These may include recommendations that:
• specify interventions that are not available or restricted in Australia (e.g. the use of medicines that
are not registered by the TGA or are outside registered indications, or the use or medicines that
are not listed for reimbursement by the PBS)
• require, or would be supported by, a change in service delivery (e.g. services for which patients
and practitioners are not reimbursed through the Medicare Benefits Schedule).
Contact details for these agencies are available from NHMRC.
Consulting with other stakeholders
The guideline developers is required to identify and consult with key professional organisations
that will be involved in, or affected by, the implementation of the clinical recommendations of
the guideline. This may include specialist colleges whose members are target users, or which
will disseminate the guideline to members, and foundations whose interest area/s are covered
by the guideline.
The guideline developer is required to identify and consult with key consumer organisations that
will be affected by the guideline.
After public consultation
The developer must document all the submissions lodged in response to the public consultation
notice and record them in a summary table that sets out each comment received and a justification
as to why each comment resulted in an amendment of the guideline or not. Information on
preparing a public consultation submissions summary is available at:
http://www.nhmrc.gov.au/guidelines/resources-guideline-developers.
Where advice has been specifically sought from relevant authorities and any other stakeholders,
all responses (including nil response) should be documented and the resulting amendments or
other actions clearly stated in the public consultation submissions summary table.
The public consultation submissions summary must be submitted to NHMRC with the final draft
guideline at Stage 4. The final draft submitted for approval should include all amendments and
changes made as a result of the public consultation comments.
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Procedures for seeking NHMRc approval
Stage 4. Submit final draft guideline
Developers must notify NHMRC of the intended date for submission of the final draft guideline
for approval at least two months prior to the intended submission date. Developers can request
information from NHMRC (How to Contact NHMRC) on upcoming Council meeting dates.
Final draft guidelines should be submitted at least two months prior the Council meeting at
which developers request the draft guideline to be considered.
For example, developers who wish their guideline to be considered at a Council meeting scheduled
for 1 July must notify NHMRC on or earlier than 1 March of their intention to submit. Developers
must also submit the final draft guideline no later than 1 May.
Documents to be submitted at final draft stage
For administrative purposes, the final draft guideline should be submitted electronically as plain
text (e.g. a Word document, rich text format document or PDF). Developers may choose to publish
their final guideline in print, electronic or interactive online formats.
Developers should be aware that amendments to the final draft guideline may be requested by
NHMRC. Accordingly, the final draft guideline should be marked to indicate its draft status. Before
being considered for approval by NHMRC, the final draft guideline should not be circulated, other
than for purposes of review by the writing group or guideline committee.
The following documents must be submitted with the final draft guideline:
• the technical report (described in Part 2: Procedures, Document Preparation)
• the administrative report (described in Part 2: Procedures, Document Preparation)
• the public consultation submissions summary (described in Stage 3)
• the dissemination plan (and implementation plan, if one has been developed) (described in
Part 2: Procedures, Document Preparation).
Guideline reviews prior to Council consideration for approval
NHMRC will initiate independent methodological and clinical expert reviews of the final
draft guideline.
Independent methodological review
The purpose of the independent methodological review is to assess the draft clinical practice
guideline and related process documentation to determine whether the development process
undertaken was appropriate to meet the NHMRC standard (i.e. NHMRC processes have been
adhered to and NHMRC requirements have been met). Independent methodological reviewers
will have expertise in evidence review methodology and guideline development. These reviewers
will be selected by NHMRC after determining that they have no current or prior association with
the guideline development process.
Independent clinical expert review
The purpose of the independent clinical expert review is to evaluate the appropriateness of the
clinical recommendations, based on an overview of the body of evidence.
NHMRC will select clinical expert reviewers with:
• appropriate clinical content expertise
• no current or prior association with guideline development process
• no affiliations with the developer organisation or funding bodies.
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Procedures for seeking NHMRc approval
Clinical expert reviewers will be asked to consider whether:
• the appropriate evidence been identified and reviewed in line with the scope and clinical
questions posed by this guideline
• the risks and potential harms of recommendations been fully considered in the context of
clinical practice, including any medicolegal implications
• other relevant guidelines exist on the same topic (including Australian guidelines, international
guidelines or other well-referenced guidance) and, if so, whether these are in conflict with
recommendations made in the guideline. If such conflicts are identified, the clinical expert
reviewers will consider whether the new guideline recommendations are justified by current
evidence and their rationale is clearly explained.
To streamline the time taken for NHMRC to engage appropriate clinical expert reviewers,
developers are requested to nominate 6 potential clinical expert reviewers and provide a list
of these with their progress report submitted at Stage 2. Guidance for developers on identifying
appropriate potential clinical expert reviewers is available at:
http://www.nhmrc.gov.au/guidelines/resources-guideline-developers.
After review
NHMRC may request amendments, clarification or further documentation as a result of reviewer
comments prior to consideration by Council. This may need to occur quickly to meet timelines for
Council meetings, and will be negotiated with developers individually, where appropriate.
Council and CEO will consider the final draft guideline and associated documentation along
with the independent clinical expert and methodological reviewers’ reports. The Chair of the
multidisciplinary group convened to develop the guideline may be invited to attend the Council
session to address any outstanding issues raised.
NHMRC may request additional amendments to the guideline prior to approval.
NHMRC will formally notify the guideline developer of the CEO’s decision in writing up to four
weeks after the Council meeting. If approved, NHMRC approval will be valid for a maximum of
five years unless otherwise stipulated. Approval may be for a shorter period in clinical areas in
which new evidence is emerging rapidly.
When NHMRC approval is declined
If a final draft guideline is not approved, NHMRC will advise the developer of the reasons for the
decision. Any further matters arising, including matters relating to the reasons for refusal may be
addressed to the CEO of the NHMRC for further consideration within 1 month of this notification.
Stage 5. Publish approved clinical practice guideline
Publishing obligations and requirements for NHMRC approved guidelines
After a clinical practice guideline is approved, NHMRC will inform the developer of publishing
obligations. These include use of the mandatory NHMRC statement of approval and NHMRC logo.
Guidelines developed by external organisations and approved by NHMRC may not be represented
as developed or published by NHMRC. For example, a developer organisation may not use
the expression ‘an NHMRC guideline’ or ‘NHMRC recommendations’ when promoting NHMRC
approved clinical practice guidelines.
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Procedures for seeking NHMRc approval
Developers should contact NHMRC (How to Contact NHMRC) to request further information
on the publishing requirements following approval (including the use of the NHMRC logo and
approval statement), and not proceed to printing or final layout until this had been addressed.
The developer must publish the clinical practice guideline within 16 weeks of the date of approval
stated in the official notification. Following this, NHMRC will publish an approval announcement in
NHMRC Tracker6 subscription service and NICS Update7 newsletter and provide information on the
NHMRC website for readers on how to obtain the guideline and associated documents. All clinical
practice guidelines produced in Australia, including NHMRC approved externally developed clinical
practice guidelines, are assessed prior to inclusion on the NHMRC Clinical Practice Guidelines
Portal (www.clinicalguidelines.gov.au).
The NHMRC will not assume any responsibility for the publication or dissemination of externally
developed guidelines beyond what is stipulated above.
Companion publications
Developers may choose to develop companion documents, based on the evidence found in the
guideline document, for consumers and health care professionals such as general practitioners and
nurses. It is recommended that the intended audience of the companion documents should be
involved in its development and that the draft documents be focus-tested with appropriate target
user groups prior to finalisation.9
NHMRC does not provide approval for companion documents. Developers should not display the
NHMRC logo or approval statement on companion documents.
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Requirements for meeting the NHMRc standard
3. Requirements for meeting the
NHMRc standard
Introduction
This section sets out all the requirements that a guideline developer must fulfil before a clinical
practice guideline will be considered for NHMRC approval. Developers should familiarise
themselves with all the requirements before beginning the guideline development process.
The tables in this section indicate where each requirement must be documented as a minimum.
NHMRC will only approve guidelines that meet
all of the conditions listed as “mandatory”. Developers
are encouraged to meet the desirable requirements to improve guideline quality and implementability.
IMPORTANT
NHMRC will only approve guidelines that meet
all of the requirements listed as “mandatory”.
Developers are encouraged to meet the desirable requirements to improve guideline quality
and implementability.
A. Governance and stakeholder involvement
REquIREMENT
DoCuMENTED IN:
Mandatory
The guideline/development process must meet all the fol owing conditions:
a.1
The organisation/s responsible for developing and publishing the guideline
Must be in Guideline
is/are named.
but can also be in
Administrative report
a.2
Sources of funding for guideline development, publication and dissemination
Must be in Guideline
are stated.
but can also be in
Administrative report
a.3 A multidisciplinary group that includes end-users, relevant disciplines and clinical
Must be in Guideline
experts is convened to develop the purposes, scope and content of the guideline,
but can also be in
and the process and criteria for selecting member are described.
Administrative report
a.4 Consumers participate in the guideline development, and the processes employed
Administrative report
to recruit, involve and support consumer participants are described.
a.5 A complete list of all the people involved in the guideline development process is
Must be in Guideline
provided, including the following information for each person: name, profession or
but can also be in
discipline, organisational affiliation and role in the guideline development process.
Administrative report
a.6 Potential competing interests are identified, managed and documented, and a
Administrative report
competing interest declaration is completed by each member of the guideline
development group.
a.7
A list of organisations formally endorsing the guideline is provided.
Must be in Guideline
but can also be in
Administrative report
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Requirements for meeting the NHMRc standard
REquIREMENT
DoCuMENTED IN:
Desirable
The guideline/development process should meet the fol owing conditions, where applicable:
a.2.1 The amount and percentage of total funding received from each funding source is
Administrative report
stated.
a.4.1 The guideline development process includes participation by representatives of
Administrative report
Aboriginal and Torres Strait Islander peoples and culturally and linguistically diverse
communities (as appropriate to the clinical need and context), and the processes
employed to recruit, involve and support these participants
are described.iv
B. Scope and purpose
REquIREMENT
DoCuMENTED IN:
Mandatory
The guideline/development process must meet all the fol owing conditions:
B.1
The purpose of the guideline is stated, including the clinical questions
Must be in Guideline
(see Requirement C.1), issue or problems the guideline addresses.
but can also be in
Technical report
B.2
The health care setting to which the recommendations apply is described,
Guideline
including the health system level (e.g. primary care, acute care) and clinical stage
(e.g. whether the guideline covers prevention, screening, assessment, treatment,
rehabilitation or monitoring).
B.3. The intended end users of the guideline are clearly defined, and any relevant
Guideline
exceptions are identified.
B.4
The population to which the guideline recommendations will apply is defined
Guideline
(e.g. children, adolescents, adults or older adults) and population subgroups for
which specific information is required are identified and described.
B.5
Issues relevant to Aboriginal and Torres Strait Islander peoples (such as particular
Guideline
risks, treatment considerations or sociocultural considerations) are identified
and described.
Desirable
The guideline/development process should meet the fol owing conditions, where applicable:
B.5.1 Issues relevant to special-needs groups such as culturally and linguistically
Guideline
diverse communities or groups with low socioeconomic status (e.g. particular
risks, treatment considerations or sociocultural considerations) are identified
and described.
iv This is currently a desirable requirement due to insufficient best practice models for engagement with these groups. When
appropriate guidance on how to meet this requirement has been developed it is intended that this will become mandatory.
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Requirements for meeting the NHMRc standard
C. Evidence review
REquIREMENT
DoCuMENTED IN:
Mandatory
The guideline/development process must meet all the fol owing conditions:
C.1
Clinical questions addressed by the guideline are stated in a structured and
Technical report
consistent format to define the boundaries of the topic, i.e. by specifying
Guideline
the relevant population, intervention/s (e.g. treatment/s or diagnostic test/s),
comparator/s and outcomes measured.
C.2. Systematic searches for evidence are undertaken and the search strategy is
Technical report
documented, including the search terms and databases searched.
C.3. The population groups specified in the search strategy include Aboriginal and
Technical report
Torres Strait Islander peoples and any population subgroups that have been
identified (see Requirement B.4 and B.5).
C.4. The publication period covered by the searches is stated, and the latest date is
Technical report
within 12 months of the first day of public consultation and within 20 months
of submission of the final draft guideline to NHMRC for approval.
C.5. The inclusion and exclusion criteria used to select studies for appraisal
Technical report
are described.
C.6. For each clinical question, the developer has provided an evidence table,
Technical report
which summarises the systematic assessment and critical appraisal of all
studies that meet the inclusion criteria (i.e. the body of evidence on which a
recommendation will be based). Each evidence table should include information
on study design, outcomes, level of evidence, the findings of meta-analysis
(if performed) and other relevant information.
C.7
For each clinical question, the developer has provided an evidence statement
Technical report
form, which documents the synthesis and evaluation of the body of evidence to
determine the grade of each recommendation, according to an NHMRC-approved
method (NHMRC grades for recommendations10 or GRADE11).
C.8
For each recommendation, the developer has provided an evidence summary,
Guideline
which briefly states the outcomes of each clinical studies on which the
recommendation was based, their level of evidence and reference details.
C.9 A recommended date for future update of the guideline is identified.
Guideline
Desirable
The guideline/development process should meet the fol owing conditions, where applicable:
C.3.1 The population groups specified in the search strategy include groups such as
Technical report
culturally and linguistically diverse communities or other groups for whom specific
sociocultural factors (including ethnicity, gender, age, disability, socioeconomic status
and location) in treatment or prevention outcomes should be considered.
C.3.2 Search strategies include search terms to identify evidence related to consumers’
Technical report
perceptions and experiences.
C.3.3 Dependent on the guideline scope, the search strategy is designed to identify
Technical report
evidence for all relevant alternatives for screening, prevention, diagnosis or
treatment of the condition addressed by the guideline, including relevant
complementary and alternative medicine approaches.
C.3.4 Search strategies include search terms to identify evidence related to cost
Technical report
effectiveness and resource implications of practice.
C.8.1 If gaps in the evidence are identified during the evidence review, these are
Guideline
described in the guideline and areas for further research are noted.
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Requirements for meeting the NHMRc standard
D. Guideline recommendations
REquIREMENT
DoCuMENTED IN:
Mandatory
The guideline/development process must meet all the fol owing conditions:
D.1
The wording of recommendations is specific, unambiguous, clearly describes
Guideline
the action/s to be taken by users and matches the strength of the body of
evidence.10-11
D.2
The wording of recommendations is written in plain English and is consistent
Guideline
throughout the guideline.
D.3
For each evidence-based recommendation, the supporting references are listed
Guideline
and the grade of recommendation is indicated according to an NHMRC-approved
method (NHMRC grades for recommendations10 or GRADE11).
D.4
Recommendations formulated in the absence of quality evidence (where a
Guideline
systematic review of the evidence was conducted as part of the search strategy)
are clearly labelled as such. The preferred term for this type of recommendation is
a consensus-based recommendation.
D.5
Any further recommendations included in the guideline, where the subject matter
Guideline
is outside of the scope of search strategy, are clearly labelled as such. The preferred
term for this type of recommendation is a practice point.
D.6
The method used to arrive at consensus-based recommendations or practice
Must be in Administrative
points (Requirements D.4 and D.5) (e.g. voting or formal methods, such as Delphi) report but can also be
is documented.
in Guideline
D.7
Areas of major debate about the evidence and the recommendations are
Guideline
identified and the various significant viewpoints are outlined in the guideline
text (even if the guideline development working group members eventually
reached a decision).
D.8
The strengths and limitations of the body of evidence reviewed are described in
Guideline
the guideline text and areas of uncertainty are acknowledged.
D.9
The guideline acknowledges current national guidelines approved by NHMRC or
Guideline
endorsed by major authorities, and any deviations from these are explicitly noted
in the guideline text and the rationale provided.
D.10 Where a guideline makes any recommendation/s specifying intervention/s that
Guideline
are not available or restricted in Australia,v the text clearly indicates this, and the
developer has consulted the relevant authority/ies (see Requirements F.3).
D.11 Where evidence is identified showing that Aboriginal and Torres Strait Islander
Guideline
peoples or other population groups have specific treatment or prevention
outcomes, this evidence is clearly identified and considered in the formulation
of the recommendations.
D.12 The harms (risks or side effects) and benefits of each recommended intervention
Guideline
and its alternatives are described in the guideline text and the rationale for the
recommendation is explained.
D.13 Any safety, legal or potential misuse issues related to the clinical recommendations
Guideline
are identified and described in the guideline text.
D.14 The potential impact of each recommendation on clinical practice or outcomes is
Guideline
described in the text.
v Such as the use of medicines that are not registered by the Therapeutic Goods Administration or outside registered indications,
the use of medicines that are not listed for reimbursement by the Pharmaceutical Benefits Scheme, or services for which
patients and practitioners are not reimbursed through the Medicare Benefits Schedule.
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Requirements for meeting the NHMRc standard
REquIREMENT
DoCuMENTED IN:
D.15 The guideline and recommendations have been assessed by at least two
Administrative report
reviewers, independent of the guideline development process, using the
AGREE II instrument.3, 5
Desirable
The guideline/development process should meet the fol owing conditions, where applicable:
D.2.1 Recommendations are formulated using consistent grammar, syntax and
Guideline
wordings, so they can readily be adapted for electronic implementation strategies
(e.g. electronic decision support systems and automatic data collection).
D.8.1 Recommendations that are likely to be affected by new evidence after the
Guideline
guideline has been approved (e.g. major clinical trials underway at the time
of guideline publication) are identified and the implications for the guideline
recommendations are explained in the guideline text.
D.9.1 Clinical recommendations that deviate from current practice are identified.
Guideline
D.9.2 The resource implications and cost effectiveness of any recommended practice,
Guideline
compared with current or established practice, are explicitly stated in the
guideline text.
D.11.1 Where evidence is identified showing that sociocultural factors (including ethnicity,
Guideline
gender, age, disability, socioeconomic status and location) affect treatment or
prevention outcomes (see Requirement C.3.1), this evidence is clearly identified
and considered in the formulation of the recommendations.
D.12.1 Absolute measures of both efficacy and harm are stated for each management
Guideline
option where evidence is available, e.g. expressed as number needed to treat
(NNT), number needed to screen (NNS), or number needed to harm (NNH)
as relevant to the recommendation.
D.13.1 Ethical issues are considered when formulating the recommendations and any
Guideline
such issues identified and described.
D.16 If evidence for complementary and alternative medicine options is identified,
Guideline
the risks and benefits of these are stated in the guideline text and appropriate
recommendations included.
D.17 If there is a lack of rigorous evidence for a complementary and alternative
Guideline
medicine/therapy commonly used in practice, this is explicitly stated in the
guideline text.
D.18 Recommendations that consider consumer self-management options are
Guideline
included, where relevant.
D.19 Recommendations emphasise consumer and carer involvement in treatment
Guideline
and care decisions, where relevant.
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Requirements for meeting the NHMRc standard
E. Guideline structure and style
REquIREMENT
DoCuMENTED IN:
Mandatory
The guideline/development process must meet all the fol owing conditions:
e.1
The guideline includes a title page listing:
Guideline
(i) the date of publication
(ii) the authorship (organisation or individuals)
(iii) the publisher
(iv) copyright information including the copyright holder
(v) address for requesting permission to reproduce material in the text
(vi) the ISBN numbervi
(vii) a preferred citation for the guideline publication.
e.2
The guideline is easy to navigate and includes a table of contents.
Guideline
e.3
The guideline includes a brief (e.g. 1-page) plain English summary.
Guideline
e.4
The guideline includes an executive summary that lists all recommendations
Guideline
and their grade using an NHMRC-approved method (NHMRC grades for
recommendations10 or GRADE11).
e.5
A glossary of technical terms, acronyms and abbreviations is provided, and terms
Guideline
are used consistently throughout the guideline.
e.6
Where medicines are mentioned in the guideline, generic namesvii are used and
Guideline
brand names are avoided.
e.7
The document design and layout enables recommendations to be identified easily
Guideline
within the text.
e.8
References in the text are clearly identified and the citations clearly listed.
Guideline
For electronic references, the source location (e.g. website address) and date
accessed is stated.
e.9
Chapter and heading levels are consistent, clearly distinguishable by the document
Guideline
design and layout, and assist with the navigation throughout each topic of the
guideline.
e.10 The guideline information is sequenced in a logical manner which is applicable to
Guideline
the intended end user.
e.11 The technical report is either (i) included in the guideline document, or (ii) provided
Guideline
in a readily accessible location, such as a website, which is indicated in the guideline.
e.12 The administrative report is either (i) included in the guideline document, or
Guideline
(ii) provided in a readily accessible location, such as a website, which is indicated
in the guideline
.
vi International Standard Book Numbers (ISBN) are obtained from an ISBN Agency and can only be obtained when the final
document is available. Details available from the National Library of Australia: http://www.nla.gov.au/services/ISBN.html
vii If use of the generic name (recommended international non-proprietary name) does not provide sufficient clarity for users,
developers should consult NHMRC before final approval stage.
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Requirements for meeting the NHMRc standard
REquIREMENT
DoCuMENTED IN:
Desirable
The guideline/development process should meet the fol owing conditions, where applicable:
e.2.1 An index is included.
Guideline
e.2.2 If the guideline is published in PDF format, bookmarks are provided to facilitate
Guideline
navigation.
e.2.3 If the guideline is published as a web page, hyperlinks are provided to facilitate
Guideline
navigation.
e.3.1 Plain English is used for all guideline text.
Guideline
e.4.1 A summary of recommendations is available as a separate document, and the
Guideline
guideline text states where to obtain this document.
e.7.1 The design of the guideline (printed or electronic) is suitable for people with
Guideline
visual impairment.viii
F. Public consultation
REquIREMENT
DoCuMENTED IN:
Mandatory
The guideline/development process must meet all the fol owing conditions:
F.1
The process for public consultation on the draft guideline complies with Section 14A
Administrative report
of the Commonwealth
National Health and Medical Research Council Act 19921 and
accompanying regulations8.
F.2
Details of submissions received during public consultation and the response of
Public consultation
the guideline development working group to the submissions (including whether, why submissions summary
and how the guideline was altered) are provided as a separate document to
the NHMRC.
F.3
During the public consultation period, the developer has undertaken and documented Administrative report
consultation with:
Public consultation
– the Director-General, Chief Executive or Secretary of each state, territory and
submissions summary
Commonwealth health department
– relevant authority/iesix, when a guideline makes any recommendation/s specifying
interventions that are not available or restricted in Australia (see Requirement D.10).
F.4
The developer has identified and consulted with key professional organisations (such
Administrative report
as specialty colleges) and consumer organisations that will be involved in, or affected
Public consultation
by, the implementation of the clinical recommendations of the guideline.
submissions summary
Desirable
The guideline/development process should meet the fol owing conditions, where applicable:
F.2.1 A version of the public consultation submissions summary is publicly available, with
Administrative report
submissions de-identified.
viii Refer to Vision Australia (http://www.visionaustralia.org.au/info.aspx?page=1845&template=PrintReg).
ix Such as the use of medicines that are not registered by the Therapeutic Goods Administration or outside registered indications,
the use of medicines that are not listed for reimbursement by the Pharmaceutical Benefits Scheme, or services for which
patients and practitioners are not reimbursed through the Medicare Benefits Schedule.
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Requirements for meeting the NHMRc standard
G. Dissemination and implementation of guidelines
REquIREMENT
DoCuMENTED IN:
Mandatory
The guideline/development process must meet all the fol owing conditions:
G.1 A plan for the dissemination of the guideline is submitted as a separate document
Dissemination plan
from the clinical practice guideline.
G.2 Key recommendations that are most likely to lead to improvements in health
Dissemination plan
outcomes are highlighted for consideration in implementation.
Desirable
The guideline/development process should meet the fol owing conditions, where applicable:
G.3 A practical implementation plan is provided as a separate document, based on
Implementation plan
considerations of the Australian health care context and identification of appropriate
(may be part of
organisation/s where the key recommendations may be directed.
dissemination plan)
G.4 Resources to support implementation of the guidelines are developed, such as
Guideline
summaries and other tools for different health care professionals, and the guideline
indicates where these can be obtained.
G.5 Accompanying consumer information is provided.
Guideline
G.6 Versions of the plain English summary and consumer information are available in
Guideline
different languages, if appropriate.
G.7 Suggestions for local adaptation and adoption of the guideline are provided.
Guideline
G.8 Measures are developed for determining the extent to which key guideline
Guideline
recommendations are implemented.
G.9 An evaluation strategy is developed and described to assess the extent to which
Guideline
guideline recommendations are adopted into routine practice.
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abbreviations
abbreviations and special terms used
Administrative report
A report containing non-technical information about the
guideline development process that must be made available
to the public and NHMRC, but which is not required for
inclusion in the guideline document. This report will include
information such as a list of contributors, conflict of interest
declaration and statement of funding (as detailed in Part 3:
Requirements). The means by which this report can be
accessed (electronic and/or in print) must be provided within
the guideline.
AHMAC
Australian Health Ministers Advisory Council
(http://www.ahmac.gov.au).
Body of evidence
All studies identified for each clinical question by the
systematic literature search which meet the specified
inclusion criteria.
Clinical practice guideline/s
Statements that include recommendations intended to
optimise patient care that are informed by a systematic
review of evidence and an assessment of the benefits and
harms of alternative care options.12
Clinical practice
The performance of health professionals’ within any health
care setting.
Consumers
Members of the population using a specified health service
or receiving a specified type of health care. Consumers
can include patients and potential patients, carers and
organisations representing consumers’ interests. As a
member of a committee, steering group or similar, consumer
representatives voice the consumer perspective and takes
part in the decision-making process on behalf of consumers.
Complementary medicine/s
Complementary medicines (also known as ‘traditional’,
‘integrative’ or ‘alternative’ medicines’) include vitamin,
mineral, herbal, aromatherapy and homoeopathic products.
Refer to Schedule 14 of the Commonwealth
Therapeutic
Goods Regulations 1990 for a list of the type of substances
or products covered by the term ‘complementary’. Active
complementary medicine substances are defined in Section
52F of the Commonwealth
Therapeutic Goods Act 1989.
Essentially, if the substance is a designated active ingredient
that has an established identity and tradition of use, it is a
complementary medicine substance.
Companion document
A secondary publication directly adapted or derived from a
clinical practice guideline as guidance for a particular group
(e.g. patients or a particular health professional discipline),
such as a consumer version of a guideline, clinical practice
algorithm or summary publication.
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abbreviations
Consensus-based
Recommendations formulated by the guideline development
recommendations
group, using a consensus-reaching process, in the absence
of high-quality evidence (where a systematic review of
the evidence was conducted as part of the guideline
search strategy).
Council
The Council of the NHMRC, as established under Section 20
the Commonwealth
National Health and Medical Research
Council Act 1992.1 The functions of the Council are to provide
advice to the NHMRC Chief Executive Officer and perform
other functions conferred on it.
Desirable requirement
Requirements which developers are encouraged to meet to
improve guideline quality and implementability.
Evidence-based
Recommendations formulated by the guideline development
recommendation
group based on high-quality evidence and graded according
to an NHMRC-approved method (where a systematic review
of the evidence was conducted as part of the guideline
search strategy).
Evidence summary
A summary prepared for each clinical practice guideline
recommendation, which briefly summarises the body of
evidence on which the recommendation was based, including
outcomes, level of evidence and reference citation of clinical
studies. http://www.nhmrc.gov.au/guidelines/resources-
guideline-developers
Evidence tables
A table prepared for each clinical question addressed by a
clinical practice guideline, which summarises the systematic
assessment and critical appraisal of all studies that meet
inclusion criteria (i.e. the body of evidence on which a
recommendation will be based). Each evidence table should
include information on study design, outcomes, level of
evidence, the findings of meta-analysis (if performed) and
other relevant information. http://www.nhmrc.gov.au/
guidelines/resources-guideline-developers
Evidence statement form
A form summarising the development group’s synthesis of
the body of evidence for each clinical question, taking into
account factors relating to the evidence base, consistency,
clinical impact, generalisability and applicability of the body
of evidence, which is used to support the formulation and
grading of recommendations. An example of this form is
found at Attachment 1 of
NHMRC levels of evidence and
grades for recommendations for guideline developers (2009).10
External guideline
An organisation, other than NHMRC, that is responsible for
developer (Developer)
developing a clinical practice guideline (previously referred
to as a third-party developer).
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abbreviations
Final draft guideline
The draft clinical practice guideline that is submitted to
NHMRC for consideration for approval after addressing
issues raised at public consultation stage. Developers should
be aware that amendments to the final draft guideline may
be requested by NHMRC and thus it should be marked to
indicate its draft status. A final draft guideline should not be
circulated for clinical use prior to consideration by NHMRC
for approval.
Grade of recommendation
A rating assigned to a clinical practice recommendation
according to the strength of the evidence on which it is based.
The NHMRC-preferred system for grading recommendations
is described in
NHMRC levels of evidence and grades for
recommendations for developers of guidelines (2009)10,
where the overall grade of the recommendation based on
consideration of the rating for each individual component
of the body of evidence.
GRADE
The Grading of Recommendations Assessment, Development
and Evaluation system11, which is an international system
for grading evidence when developing clinical practice
guidelines.
Health professionals
Any health workers who provide health care and related
medical services, including doctors, nurses, Aboriginal health
workers and allied health professionals.
Independent clinical
An NHMRC-commissioned evaluation of draft clinical practice
expert review
guidelines by experts in the relevant clinical area/s, who were
not involved in the guideline development process.
Independent
An NHMRC-commissioned evaluation of draft clinical practice
methodological review
guideline and related process documentation (including
technical reports and administrative reports) by an expert in
evidence review methodology and guideline development
who was not involved in the guideline development process.
Level/s of evidence
A numerical rating assigned to a piece of published clinical
evidence, that reflects the risk of bias in its study design.
The NHMRC-preferred system for grading evidence is
described in
NHMRC levels of evidence and grades for
recommendations for developers of guidelines (2009).
Mandatory requirement
Requirements that must be met to obtain NHMRC approval.
MBS
Medicare Benefits Schedule (http://www.health.gov.au/
internet/mbsonline/publishing.nsf/Content/Medicare-
Benefits-Schedule-MBS-1)
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abbreviations
MSAC
Medical Services Advisory Committee (http://www.msac.gov.
au). This committee advises the Australian Minister for Health
and Ageing on evidence relating to the safety, effectiveness
and cost-effectiveness of new medical technologies and
procedures, in order to inform Australian Government
decisions about public funding for new, and in some cases
existing, medical procedures.
NHMRC
National Health and Medical Research Council.
PBAC
Pharmaceutical Benefits Advisory Committee (http://www.
health.gov.au/internet/main/publishing.nsf/Content/
health-pbs-general-listing-committee3.htm), an independent
statutory body established on 12 May 1954 under section 101
of the Commonwealth
National Health Act (1953) to make
recommendations and give advice to the Minister about which
drugs and medicinal preparations should be made available as
pharmaceutical benefits.
PBS
Pharmaceutical Benefits Schedule (http://www.pbs.gov.au).
Practice points
Points of guidance included in the guideline used to support
evidence-based recommendations, where the subject matter
is outside of the scope of search strategy, and which were
formulated based on expert opinion using a consensus
process.
Procedures
A set of tasks which must be carried out by developers
seeking NHMRC approval of clinical practice guidelines.
Public consultation draft
The interim version of the draft clinical practice guideline that
guideline
is released for public consultation. Developers should ensure
that this public consultation draft guideline is clearly marked
to indicate its draft status.
Requirements
The set of conditions necessary for meeting the NHMRC
standard for clinical practice guidelines.
Standard (NHMRC
The NHMRC standard for high quality clinical practice
standard)
guidelines (i.e. that clinical practice guidelines are based on
the systematic identification and synthesis of the best available
scientific evidence and make clear recommendations for
health professionals practising in an Australian health care
setting). This standard is met by fulfilling all the mandatory
requirements set out in this document.
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abbreviations
Technical report
A report containing information about the evidence review
and recommendation formulation process used in the
guideline development that must be made available to the
public, but which is not required for inclusion in the main
guideline document. This report will include information such
as research questions, literature search strategies, evidence
evaluation methodologies and evidence tables (as detailed in
Part 3: Requirements). The means by which this report can
be accessed (electronic and/or in print) must be provided
within the guideline.
TGA
Therapeutic Goods Administration (http://www.tga.gov.au).
The TGA carries out a range of assessment and monitoring
activities to ensure therapeutic goods available in Australia are
of an acceptable standard with the aim of ensuring that the
Australian community has access, within a reasonable time,
to therapeutic advances.
User (end users)
The specific group or range of health workers for whom the
clinical practice guidelines are intended, to inform their work
in a health setting.
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References
References
1. Commonwealth of Australia
National Health and Medical Research Council Act (1992).
Available from: http://www.comlaw.gov.au/Details/C2006C00354.
2. A guide to the development, implementation and evaluation of clinical practice guidelines:
NHMRC; 1999 [cited 2011 March]. Available from:
http://www.nhmrc.gov.au/publications/synopses/cp30syn.htm.
3. Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. The AGREE
Collaboration; 2010 [cited 2011 March]; Available from:
http://www.agreetrust.org/resource-centre/agree-ii/.
4. Shiffman RN, Dixon J, Brandt C, Essaihi A, Hsiao A, Michel G, et al. The GuideLine
Implementability Appraisal (GLIA): development of an instrument to identify obstacles to
guideline implementation. BMC medical informatics and decision making. 2005;5:23.
5. Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument: Training tools.
The AGREE Collaboration; 2010 [cited 2011 March]; Available from:
http://www.agreetrust.org/resource-centre/training/.
6. NHMRC Tracker. Available from: http://www.nhmrc.gov.au/media/newsletters.
7. NICS Update. National Health and Medical Research Council; Available from:
http://www.nhmrc.gov.au/media/newsletters/nics-updates/all.
8. National Health and Medical Research Council Regulations 2006. Available from:
http://www.austlii.edu.au/au/legis/cth/num_reg/nhamrcr2006n353o2006534.
9. How to present the evidence for consumers: preparation of consumer publications: NHMRC;
2000 [cited 2011 March]. Available from:
http://www.nhmrc.gov.au/publications/synopses/cp66syn.htm.
10. NHMRC levels of evidence and grades for recommendations for developers of guidelines:
NHMRC; 2009 [cited 2011 March]. Available from:
http://www.nhmrc.gov.au/ files nhmrc/file/guidelines/evidence statement form.pdf.
11. Guyatt G, Oxman A, Vist G, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE:
an emerging consensus on rating quality of evidence and strength of recommendations.
BMJ. 2008;336(7650):924-6.
12. Institute of Medicine (IOM). Clinical Practice Guidelines We Can Trust. Washington,
DC: The National Academies Press; 2011.
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