[redactions made under s47F of the FOI Act]
From:
Clinical Guidelines
Sent:
Wednesday, 8 April 2020 9:37 PM
To:
Cc:
Mark Bellgrove
Subject:
RE: ADHD Guidelines [SEC=OFFICIAL]
Attachments:
_methodological_review_template_version_1_131118 (10)_AD.docx; progress_report_template_
140911 (1).pdf; public_consultation_-_information_for_developers_v6 (8).pdf
Dear
Just a quick note to provide you with some general information about the approval process.
Most of this information you’re probably familiar with but I thought I might go over it in case
anything is new since the last time you submitted a guideline for approval. I will also touch
base closer to the time that the requirements are due.
To be approved a guideline must meet the
NHMRC guideline standard and follow the
Procedures and requirements for meeting the NHMRC standard for guidelines.
NHMRC Council Meetings
Although there are changes to other NHMRC Committees due to the COVID-19 pandemic, we
understand the Council meetings will still go ahead as planned. The planned dates for 2021 are
11 March and 17 June. The third date for 2021 is to be advised and is most likely to be held in
October or November.
Council will be asked to consider the guideline recommendations only and the public
consultation report. All other material (the full guidelines, the technical and administrative
reports etc) will still need to be submitted to NHMRC and may be examined by Council if it
requests it. We will ask that someone from the guideline development group be available, in
person or by video, to answer any questions Council members may have. If Council are happy
then formal confirmation of CEO approval of your guidelines will be sent no more than three
weeks after the meeting.
Progress report
I have attached the progress report template for you to complete and return to NHMRC – this
is should be done 3-6 months before public consultation begins.
Public consultation
I have attached the NHMRC advice on public consultation for you. The main thing to stress is
the importance of sending the draft guidelines to all CEOs, Secretaries or Directors General of
state and territory health departments, explicitly inviting them to make a response. This step
mitigates the risk of the states and territories voicing concerns later on when it is too late to
change the guidelines, and also helps reassure members of council representing states and
territories. We also advise individual NHMRC council members about public consultation and
invite them to make a submission in their individual capacities.
Expert Peer Review Names
I would appreciate you providing me with the names of six people whom we can approach to
provide expert peer review of the draft guidelines, so that we can contact them well ahead of
time. They should be experts in part or all of the guidelines’ subject matter, not involved in
their development and preferably a mix of both international and Australian experts. NHMRC
will also independently source a similar number of experts (noting that the response rate for
timely expert review is usually poor, so the more people who are approached the greater the
possibility of getting reviews back in the required time).
1
Methodological Review
Please find attached a methodological review template for you to complete and submit to
NHMRC together with the draft guideline. You will see the template asks you to identify
whereabouts in the guideline various pieces of information can be found.
As ever we would appreciate a heads up if the guidelines are likely to be controversial or if
Commonwealth ministers are likely to be lobbied because of anything in them.
Happy to discuss anything here if you need more information. Have a great Easter break and
stay well.
Kind regards,
Sally
Sally Wright
Project Officer, Clinical Practice Guidelines
Research Translation
National Health and Medical Research Council
xxxxx.xxxxxx@xxxxx.xxx.xx
+61 03 8866 0411
Hours: Tue - Fri
nhmrc.gov.au
I acknowledge the Traditional Custodians of the lands around Australia and pay my respects to Elders past and
present.
From:
Sent: Wednesday, 12 February 2020 3:43 PM
To: Clinical Guidelines <xxxxxxxxxxxxxxxxxx@xxxxx.xxx.xx>
Subject: Re: ADHD Guidelines [SEC=OFFICIAL]
Hi Sally,
2
From:
Sent: Thursday, 23 January 2020 11:06 AM
To: Clinical Guidelines <xxxxxxxxxxxxxxxxxx@xxxxx.xxx.xx>
Subject: Re: ADHD Guidelines [SEC=OFFICIAL]
Hi Sally,
My apologies for such a delayed response. I hope you had a lovely festive season.
In response to your points:
Yes, please do email me and perhaps also cc xxxx.xxxxxxxxx@xxxxxx.xxx. Thank you I can
do this.
Is that component of the guidelines for guidelines now available or was it the public
consultation that I saw? If not publicly available, I would love to keep a copy.
Engaging Aboriginal and Torres Strait Islander people in guideline development module is
available to the public via the public consultation document. This version will stay online
until any changes are made to it as a result of the consultation. The Equity and Stakeholder
Engagement modules may also have some useful information on engaging ATSI people.
The conflict of interest module is available on the Guideline for Guidelines website here.
In terms of dates, we are running a little behind so we will attempt to meet the original Feb
2021 and June 2021 but I will know in the next few months if we are unlikely to. We will
likely do a 30 day public consultation. Thank you. I’ll touch base again in a few months’
time.
We have just completed the public consultation on the questions and are meeting today to
discuss next steps and compilation of the guideline group that will prioritise and PICO the
questions that have been consolidated. Thank you for the update. Good luck with your next
steps.
Apologies again. Best wishes,
4
Research Translation
National Health and Medical Research Council
xxxxx.xxxxxx@xxxxx.xxx.xx
+61 03 8866 0411
nhmrc.gov.au
[Logo-inline-tagline-purple]
I acknowledge the Traditional Custodians of the lands around
Australia and pay my respects to Elders past and present.
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6
NHMRC: Methodological review template
Using the 2011 NHMRC Standard to assess clinical practice guidelines
For Guideline Developers
NHMRC: Methodological review template
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
1
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
For Guideline Developers
The details you provide in this document, are submit ed to the appointed Methodological Reviewer for your
guideline, to assist them in locating the information relevant to each requirement. The instructions for
completing this document are listed below.
DO…
• Complete the
Guideline title and
Guideline developer details on page 3.
• Complete location details of information relevant to each mandatory requirement in the space indicated
below.
MANDATORY REQUIREMENTS: Example
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
A.1
The organisation/s
Must appear in guideline and
Yes / No
responsible for developing
can also appear in
and publishing the guideline
administrative report
is/are named.
Document(s); section; page(s)
Comment:
INSERT DETAILS HERE
• Developers are encouraged to meet the desirable requirements to improve guideline quality and
implementability. Where detail is available insert as per the mandatory requirements otherwise insert the
text n/a.
DESIRABLE REQUIREMENTS: Example
Location of the information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
A.2.1 The amount and percentage To appear in administrative
Yes / No
of total funding received from report
each funding source is
Document(s); section; page(s)
Comment:
stated.
INSERT DETAILS OR THE
TEXT N/A HERE
DON’T…
• Complete the
Documents reviewed on page 3.
• Complete
Section 1 (pages 4-5)
• Complete the
Information page or the
Competing Interest Statement (pages 6-7).
• Complete the column al ocated to the Methodological reviewer in
Section 2.
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
2
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
NHMRC: Methodological review template
Using the 2011 NHMRC standard to assess clinical practice guidelines
Guideline title
(developer to
complete)
Guideline developer
(developer to
complete)
Documents reviewed
(reviewer to complete)
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
3
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
1.1 Guideline details
(reviewer to complete)
1.2 Summary rating
(reviewer to complete)
It is considered that this guideline (meets and exceeds, meets, partly meets or does not meet) the
requirements set out in the
Procedures and requirements for meeting the 2011 NHMRC standard for clinical
practice guidelines as detailed in Section 1.3 of this report.
Meets and exceeds requirements
Al mandatory requirements were fulfil ed and are fully described and supported by the
descriptions in the documents supplied. In addition, some desirable requirements have also
been achieved.
Meets requirements
All mandatory requirements were fulfil ed and are fully described and supported by the
descriptions in the documents supplied.
Partly meets requirements
Some mandatory requirements were met, but other mandatory requirements of the 2011
NHMRC standard failed to be met.
Does not meet requirements
Most mandatory requirements in the 2011 NHMRC standard were not met.
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
4
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
1.3 Section ratings
(reviewer to complete)
Requirement
Rating
e.g. Summary description of requirement
e.g.
Provide rating and recommended action (if any) Ratings:
• Meets and exceeds requirements
• Meets mandatory requirements
• Partly meets mandatory requirements
• Does not meet mandatory requirements
A Governance and stakeholder involvement
B Scope and purpose
C Evidence review
D Guideline recommendations
E Guideline structure and style
F Public consultation
G Dissemination and implementation of guidelines
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
5
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Information (reviewer to complete)
The areas where the guidelines do not meet the 2011 NHMRC standard, are not applicable, or could not be
assessed against the requirements set out in the
Procedures and requirements for meeting the 2011 NHMRC
standard for clinical practice guidelines are described in detail in the following report.
Areas where the guidelines fail to meet the requirements in the
Procedures and requirements for meeting the
2011 NHMRC standard for clinical practice guidelines are:
Requirement
Issue
List requirement
Describe issue or gap in guideline
Areas where additional information or clarification is required are:
Requirement
Additional information sought
List requirement
Describe issue or gap and suggested information to be sought from developer
In addition, there are a number of other points highlighted in this report where changes could be considered
but are not essential in order to meet the
Procedures and requirements for meeting the 2011 NHMRC
standard for clinical practice guidelines (the requirements listed as desirable)
Requirement
Additional information sought
List requirement
Provide summary of comments and suggestions.
Use statements such as “developer may wish to consider” or “the NHMRC
may wish to seek further advice from the developer on”
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
6
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Competing interest statement by methodological reviewer
The reviewers <insert name> have received no funding or support from the developers of this guideline and
have had no direct contact with the developers of this guideline.
Name of reviewer
Signature of reviewer
Date
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
7
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
2. Detailed review of the guideline
Section A: Governance and stakeholder involvement
The guideline has been developed with multidisciplinary involvement, which takes into account perspectives
of a range of health professionals to which the topic relates, including consumer perspectives. The developer
of the guideline is clearly stated (including the funders), the process to recruit working party members is
published and details of all members are available including description of competing interest management
processes and competing interest statements.
MANDATORY REQUIREMENTS: Governance and stakeholder involvement
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
A.1
The organisation/s
Must appear in guideline and
Yes / No
responsible for developing
can also appear in
and publishing the guideline
administrative report
is/are named.
Document(s); section; page(s)
Comment:
Please cut and paste relevant
sections of guideline or
administrative report (noting
location and page of information)
to inform comments (if
appropriate).
If the answer is NO, provide
examples to il ustrate the issue.
A.2
Sources of funding for
Must appear in guideline and
Yes / No
guideline development,
can also appear in
publication and dissemination administrative report
are stated.
Document(s); section; page(s)
Comment:
A.3
A multidisciplinary group that Must appear in guideline and
Yes / No
includes end-users, relevant
can also appear in
disciplines and clinical
administrative report
experts is convened to
Document(s); section; page(s)
Comment:
develop the purposes, scope
and content of the guideline,
and the process and criteria
for selecting member are
described.
A.4
Consumers participate in the Must appear in administrative
Yes / No
guideline development, and
report
the processes employed to
Document(s); section; page(s)
Comment:
recruit, involve and support
consumer participants are
described.
A.5
A complete list of all the
Must appear in guideline and
Yes / No
people involved in the
can also appear in
guideline development
administrative report
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
8
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
MANDATORY REQUIREMENTS: Governance and stakeholder involvement
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
process is provided, including
Document(s); section; page(s)
Comment:
the following information for
each person:
• name
• profession or discipline
• organisational affiliation
and
• their role in the guideline
development process.
A.6
Potential competing interests Must appear in administrative
Yes / No
are identified, managed and
report
documented, and a
Document(s); section; page(s)
Comment:
competing interest
declaration is completed by
each member of the
guideline development group.
A.7
A list of organisations
Must appear in guideline and
Yes / No
formal y endorsing the
can also appear in
guideline is provided.
administrative report
Document(s); section; page(s)
Comment:
DESIRABLE REQUIREMENTS: Governance and stakeholder involvement
Location of the information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
A.2.1 The amount and percentage To appear in administrative
Yes / No
of total funding received from report
each funding source is
Document(s); section; page(s)
Comment:
stated.
A.4.1 The guideline development
To appear in administrative
Yes / No
process includes participation report
by representatives of
Document(s); section; page(s)
Comment:
Aboriginal and Torres Strait
Islander peoples and
cultural y and linguistically
diverse communities (as
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
9
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
DESIRABLE REQUIREMENTS: Governance and stakeholder involvement
Location of the information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
appropriate to the clinical
need and context), and the
processes employed to
recruit, involve and support
these participants are
described.
OVERALL ASSESSMENT FOR SECTION A: Governance and stakeholder involvement
(reviewer to complete, select one option)
• Meets and exceeds requirements
• Meets mandatory requirements
• Partly meets mandatory requirements
• Does not meet mandatory requirements
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
10
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Section B: Scope and purpose
The research question/issue/problem motivating the guideline is clearly stated, and the intended audience
and health care setting is made explicit.
MANDATORY REQUIREMENTS: Scope and purpose
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
B.1
The purpose of the guideline Must appear in guideline and
Yes / No
is stated, including the
can also appear in technical
clinical questions (see
report
Requirement C.1), issue or
Document(s); section; page(s)
Comment:
problems the guideline
Please cut and paste relevant
addresses.
sections of guideline or
administrative report (noting
location and page of information)
to inform comments (if
appropriate).
If the answer is NO, provide
examples to il ustrate the issue.
B.2
The health care setting to
Must appear in guideline
Yes / No
which the recommendations
Document(s); section; page(s)
Comment:
apply is described, 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
Must appear in guideline
Yes / No
the guideline are clearly
Document(s); section; page(s)
Comment:
defined, and any relevant
exceptions are identified.
B.4
The population to which the
Must appear in guideline
Yes / No
guideline recommendations
Document(s); section; page(s)
Comment:
wil apply is defined (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 Must appear in guideline
Yes / No
and Torres Strait Islander
Document(s); section; page(s)
Comment:
peoples (such as particular
risks, treatment
considerations or
sociocultural considerations)
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
11
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
MANDATORY REQUIREMENTS: Scope and purpose
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
are identified and described.
DESIRABLE REQUIREMENTS: Scope and purpose
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
B.5.1 Issues relevant to special-
To appear in guideline
Yes / No
needs groups such as
Document(s); section; page(s)
Comment:
cultural y and linguistically
diverse communities or
groups with low
socioeconomic status (e.g.
particular risks, treatment
considerations or
sociocultural considerations)
are identified and described.
Overal assessment for Section B: Scope and purpose
(reviewer to complete, select one option)
• Meets and exceeds requirements
• Meets mandatory requirements
• Partly meets mandatory requirements
• Does not meet mandatory requirements
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
12
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Section C: Evidence Review
The evidence on which the recommendation/s rely is reviewed to the standard of the 2011 NHMRC standard
and the NHMRC Toolkit publications
How to review the evidence: systematic identification and review of the
scientific literature, and
How to use the evidence: assessment and application of scientific evidence.
MANDATORY REQUIREMENTS: Evidence review
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
C.1
Clinical questions addressed Must appear in guideline and
Yes / No
by the guideline are stated in must appear in the technical
a structured and consistent
report
format to define the
Document(s); section; page(s)
Comment:
boundaries of the topic, i.e.
Please cut and paste relevant
by specifying the relevant
sections of guideline or
population, intervention/s
administrative report (noting
(e.g. treatment/s or
location and page of information)
diagnostic test/s),
to inform comments (if
comparator/s and outcomes
appropriate).
measured.
If the answer is NO, provide
examples to il ustrate the issue.
C.2
Systematic searches for
Must appear in technical report
Yes / No
evidence are undertaken and
Document(s); section; page(s)
Comment:
the search strategy is
documented, including the
search terms and databases
searched.
C.3
The population groups
Must appear in technical report
Yes / No
specified in the search
Document(s); section; page(s)
Comment:
strategy include Aboriginal
and Torres Strait Islander
peoples and any population
subgroups that have been
identified (see Requirement
B.4 and B.5).
C.4
The publication period
Must appear in technical report
Yes / No
covered by the searches is
Document(s); section; page(s)
Comment:
stated, and the latest date is
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
Must appear in technical report
Yes / No
criteria used to select studies
Document(s); section; page(s)
Comment:
for appraisal are described.
C.6
For each clinical question,
Must appear in technical report
Yes / No
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
13
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
MANDATORY REQUIREMENTS: Evidence review
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
the developer has provided
Document(s); section; page(s)
Comment:
an evidence table, 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 wil
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,
Must appear in technical report
Yes / No
the developer has provided
Document(s); section; page(s)
Comment:
an evidence statement 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
recommendations or
GRADE).
C.8
For each recommendation,
Must appear in guideline
Yes / No
the developer has provided
Document(s); section; page(s)
Comment:
an evidence summary, 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
Must appear in guideline
Yes / No
future update of the guideline
Document(s); section; page(s)
Comment:
is identified.
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
14
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
DESIRABLE REQUIREMENTS: Evidence review
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
C.3.1 The population groups
To appear in technical report
Yes / No
specified in the search
Document(s); section; page(s)
Comment:
strategy include groups such
as 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
To appear in technical report
Yes / No
search terms to identify
Document(s); section; page(s)
Comment:
evidence related to
consumers’ perceptions and
experiences.
C.3.3 Dependent on the guideline
To appear in technical report
Yes / No
scope, the search strategy is
Document(s); section; page(s)
Comment:
designed to identify 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
To appear in technical report
Yes / No
search terms to identify
Document(s); section; page(s)
Comment:
evidence related to cost
effectiveness and resource
implications of practice.
C.8.1 If gaps in the evidence are
To appear in guideline
Yes / No
identified during the evidence
Document(s); section; page(s)
Comment:
review, these are described
in the guideline and areas for
further research are noted.
OVERALL ASSESSMENT FOR SECTION C: Evidence Review
(reviewer to complete)
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
15
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Section D: Guideline recommendations
The evidence on which the recommendation/s rely is clearly identifiable, and the strength of
recommendation/s matches the strength of evidence. The recommendations are specific, unambiguous and
clearly describe the action to be taken.
MANDATORY REQUIREMENTS: Guideline recommendations
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
D.1
The wording of
Must appear in guideline
Yes / No
recommendations is specific,
Document(s); section; page(s)
Comment:
unambiguous, clearly
Please cut and paste relevant
describes the action/s to be
sections of guideline or
taken by users and matches
administrative report (noting
the strength of the body of
location and page of information)
evidence according to an
to inform comments (if
NHMRC-approved method
appropriate).
(NHMRC grades for
recommendations or
If the answer is NO, provide
GRADE).
examples to il ustrate the issue.
D.2
The wording of
Must appear in guideline
Yes / No
recommendations is writ en
Document(s); section; page(s)
Comment:
in plain English and is
consistent throughout the
guideline.
D.3
For each evidence-based
Must appear in guideline
Yes / No
recommendation, the
Document(s); section; page(s)
Comment:
supporting references are
listed and the grade of
recommendation is indicated
according to an NHMRC-
approved method (NHMRC
grades for recommendations
or GRADE).
D.4
Recommendations
Must appear in guideline
Yes / No
formulated in the absence of
Document(s); section; page(s)
Comment:
quality evidence (where a
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 Must appear in guideline
Yes / No
included in the guideline,
Document(s); section; page(s)
Comment:
where the subject matter is
outside of the scope of
search strategy, are clearly
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
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16
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
MANDATORY REQUIREMENTS: Guideline recommendations
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
labelled as such. The
preferred term for this type of
recommendation is a practice
point.
D.6
The method used to arrive at Must appear in administrative
Yes / No
consensus-based
report and can also appear in
recommendations or practice guideline
points (Requirements D.4
Document(s); section; page(s)
Comment:
and D.5) (e.g. voting or
formal methods, such as
Delphi) is documented.
D.7
Areas of major debate about Must appear in guideline
Yes / No
the evidence and the
Document(s); section; page(s)
Comment:
recommendations are
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 Must appear in guideline
Yes / No
of the body of evidence
Document(s); section; page(s)
Comment:
reviewed are described in the
guideline text and areas of
uncertainty are
acknowledged.
D.9
The guideline acknowledges Must appear in guideline
Yes / No
current national guidelines
Document(s); section; page(s)
Comment:
approved by NHMRC or
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
Must appear in guideline
Yes / No
any recommendation/s
Document(s); section; page(s)
Comment:
specifying intervention/s that
are not available or restricted
in Australia, the text clearly
indicates this, and the
developer has consulted the
relevant authority/ies (see
Requirements F.3).
D.11
Where evidence is identified
Must appear in guideline
Yes / No
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
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17
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
MANDATORY REQUIREMENTS: Guideline recommendations
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
showing that Aboriginal and
Document(s); section; page(s)
Comment:
Torres Strait Islander 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
Must appear in guideline
Yes / No
effects) and benefits of each
Document(s); section; page(s)
Comment:
recommended intervention
and its alternatives are
described in the guideline
text and the rationale for the
recommendation is
explained.
D.13
Any safety, legal or potential Must appear in guideline
Yes / No
misuse issues related to the
Document(s); section; page(s)
Comment:
clinical recommendations are
identified and described in
the guideline text.
D.14
The potential impact of each Must appear in guideline
Yes / No
recommendation on clinical
Document(s); section; page(s)
Comment:
practice or outcomes is
described in the text.
D.15
The guideline and
Must appear in administrative
Yes / No
recommendations have been report
assessed by at least two
Document(s); section; page(s)
Comment:
reviewers, independent of the
guideline development
process, using the AGREE II
instrument
DESIRABLE REQUIREMENTS: Guideline recommendations
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
D.2.1 Recommendations are
To appear in guideline
Yes / No
formulated using consistent
Document(s); section; page(s)
Comment:
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
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18
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
DESIRABLE REQUIREMENTS: Guideline recommendations
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
grammar, syntax and
wordings, so they can readily
be adapted for electronic
implementation strategies
(e.g. electronic decision
support systems and
automatic data col ection).
D.8.1 Recommendations that are
To appear in guideline
Yes / No
likely to be affected by new
Document(s); section; page(s)
Comment:
evidence after the 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
To appear in guideline
Yes / No
that deviate from current
Document(s); section; page(s)
Comment:
practice are identified.
D.9.2 The resource implications
To appear in guideline
Yes / No
and cost effectiveness of any
Document(s); section; page(s)
Comment:
recommended practice,
compared with current or
established practice, are
explicitly stated in the
guideline text.
D.11.1 Where evidence is identified
To appear in guideline
Yes / No
showing that sociocultural
Document(s); section; page(s)
Comment:
factors (including ethnicity,
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
To appear in guideline
Yes / No
efficacy and harm are stated
Document(s); section; page(s)
Comment:
for each management option
where evidence is available,
e.g. expressed as number
needed to treat (NNT),
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
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19
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
DESIRABLE REQUIREMENTS: Guideline recommendations
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
number needed to screen
(NNS), or number needed to
harm (NNH) as relevant to
the recommendation.
D.13.1 Ethical issues are considered To appear in guideline
Yes / No
when formulating the
Document(s); section; page(s)
Comment:
recommendations and any
such issues identified and
described.
D.16
If evidence for
To appear in guideline
Yes / No
complementary and
Document(s); section; page(s)
Comment:
alternative medicine options
is identified, 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
To appear in guideline
Yes / No
evidence for a
Document(s); section; page(s)
Comment:
complementary and
alternative medicine/therapy
commonly used in practice,
this is explicitly stated in the
guideline text.
D.18
Recommendations that
To appear in guideline
Yes / No
consider consumer self-
Document(s); section; page(s)
Comment:
management options are
included, where relevant.
D.19
Recommendations
To appear in guideline
Yes / No
emphasise consumer and
Document(s); section; page(s)
Comment:
carer involvement in
treatment and care decisions,
where relevant.
OVERALL ASSESSMENT FOR SECTION D: Guideline recommendations
(reviewer to complete, select one option)
• Meets and exceeds requirements
• Meets mandatory requirements
• Partly meets mandatory requirements
• Does not meet mandatory requirements
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
20
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Section E: Guideline structure and style
The layout of the Guideline is well designed with a table of contents and summary pages providing access to
key information. The Guideline is writ en in plain English with a reading age appropriate to the specified target
audience.
MANDATORY REQUIREMENTS: Guideline structure and style
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
E.1
The guideline includes a title Must appear in guideline
Yes / No
page listing:
Document(s); section; page(s)
Comment:
(i) the date of publication
Please cut and paste relevant
(ii) the authorship
sections of guideline or
(organisation or individuals)
administrative report (noting
(ii ) the publisher
location and page of information)
(iv) copyright information
to inform comments (if
including the copyright holder
appropriate).
(v) address for requesting
permission to reproduce
If the answer is NO, provide
material in the text
examples to il ustrate the issue.
(vi) the ISBN number
(vi ) a preferred citation for
the guideline publication.
E.2
The guideline is easy to
Must appear in guideline
Yes / No
navigate and includes a table
Document(s); section; page(s)
Comment:
of contents.
E.3
The guideline includes a brief Must appear in guideline
Yes / No
(e.g. 1-page) plain English
Document(s); section; page(s)
Comment:
summary.
E.4
The guideline includes an
Must appear in guideline
Yes / No
executive summary that lists
Document(s); section; page(s)
Comment:
all recommendations and
their grade using an
NHMRC-approved method
(NHMRC grades for
recommendations or
GRADE).
E.5
A glossary of technical terms, Must appear in guideline
Yes / No
acronyms and abbreviations
Document(s); section; page(s)
Comment:
is provided, and terms are
used consistently throughout
the guideline.
E.6
Where medicines are
Must appear in guideline
Yes / No
mentioned in the guideline,
Document(s); section; page(s)
Comment:
generic names are used and
brand names are avoided.
E.7
The document design and
Must appear in guideline
Yes / No
layout enables
Document(s); section; page(s)
Comment:
recommendations to be
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
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21
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
MANDATORY REQUIREMENTS: Guideline structure and style
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
identified easily within the
text.
E.8
References in the text are
Must appear in guideline
Yes / No
clearly identified and the
Document(s); section; page(s)
Comment:
citations clearly listed.
For electronic references, the
source location (e.g. website
address) and date accessed
is stated.
E.9
Chapter and heading levels
Must appear in guideline
Yes / No
are consistent, clearly
Document(s); section; page(s)
Comment:
distinguishable by the
document design and layout,
and assist with the navigation
throughout each topic of the
guideline.
E.10 The guideline information is
Must appear in guideline
Yes / No
sequenced in a logical
Document(s); section; page(s)
Comment:
manner which is applicable to
the intended end user.
E.11 The technical report is either Must appear in guideline
Yes / No
(i) included in the guideline
Document(s); section; page(s)
Comment:
document, or (i ) provided in
a readily accessible location,
such as a website, which is
indicated in the guideline.
E.12 The administrative report is
Must appear in guideline
Yes / No
either (i) included in the
Document(s); section; page(s)
Comment:
guideline document, or
(i ) provided in a readily
accessible location, such as
a website, which is indicated
in the guideline.
DESIRABLE REQUIREMENTS: Guideline structure and style
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
E.2.1 An index is included.
To appear in guideline
Yes / No
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22
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
DESIRABLE REQUIREMENTS: Guideline structure and style
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
Document(s); section; page(s)
Comment:
E.2.2 If the guideline is published in To appear in guideline
Yes / No
PDF format, bookmarks are
Document(s); section; page(s)
Comment:
provided to facilitate
navigation.
E.2.3 If the guideline is published
To appear in guideline
Yes / No
as a web page, hyperlinks
Document(s); section; page(s)
Comment:
are provided to facilitate
navigation.
E.3.1 Plain English is used for all
To appear in guideline
Yes / No
guideline text.
Document(s); section; page(s)
Comment:
E.4.1 A summary of
To appear in guideline
Yes / No
recommendations is
Document(s); section; page(s)
Comment:
available as a separate
document, and the guideline
text states where to obtain
this document.
E.7.1 The design of the guideline
To appear in guideline
Yes / No
(printed or electronic) is
Document(s); section; page(s)
Comment:
suitable for people with visual
impairment.
OVERALL ASSESSMENT FOR SECTION E: Guideline structure and style
(reviewer to complete, select one option)
• Meets and exceeds requirements
• Meets mandatory requirements
• Partly meets mandatory requirements
• Does not meet mandatory requirements
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
23
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Section F: Public consultation
The public consultation on the draft version of the guideline has been undertaken and the public consultation
process complies with Section 14A of the
NHMRC Act 1992. The developer has consulted with Director-
General/CMO of each State Health Department, relevant authorities, key professional organisations and
consumers. Details of the public submission received during public consultation and responses from the
guideline developer are clearly documented and supplied as a separate document to NHMRC.
MANDATORY REQUIREMENTS: Public consultation
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative or information relating to the
technical report including page requirement.
number/s).
Guideline developer to
Methodological reviewer to
complete
complete
F.1
The process for public
Must appear in administrative
Yes / No
consultation on the draft
report
guideline complies with
Document(s); section; page(s)
Comment:
Section 14A of the
Please cut and paste relevant
Commonwealth
National
sections of guideline or
Health and Medical Research
administrative report (noting
Council Act 1992 and
location and page of information)
accompanying regulations.
to inform comments (if
appropriate).
If the answer is NO, provide
examples to il ustrate the issue.
F.2
Details of submissions
Must appear in the public
Yes / No
received during public
consultations submissions
consultation and the
summary
response of the guideline
Document(s); section; page(s)
Comment:
development working group
to the submissions (including
whether, why and how the
guideline was altered) are
provided as a separate
document to the NHMRC.
F.3
During the public consultation Must appear in the
Yes / No
period, the developer has
administrative report and the
undertaken and documented public consultation
consultation with:
submissions summary
- the Director-General, Chief
Document(s); section; page(s)
Comment:
Executive or Secretary of
each state, territory and
Commonwealth health
department
- relevant authority/ies, 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 Must appear in the
Yes / No
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24
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
MANDATORY REQUIREMENTS: Public consultation
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative or information relating to the
technical report including page requirement.
number/s).
Guideline developer to
Methodological reviewer to
complete
complete
and consulted with key
administrative report and the
professional organisations
public consultation
(such as specialty colleges)
submissions summary
and consumer organisations
Document(s); section; page(s)
Comment:
that wil be involved in, or
affected by, the
implementation of the clinical
recommendations of the
guideline.
DESIRABLE REQUIREMENTS: Public consultation
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative or information relating to the
technical report including page requirement.
number/s).
Guideline developer to
Methodological reviewer to
complete
complete
F.2.1 A version of the public
To appear in administrative
Yes / No
consultation submissions
report
summary is publicly
Document(s); section; page(s)
Comment:
available, with submissions
de-identified.
OVERALL ASSESSMENT FOR SECTION F: Public consultation
(reviewer to complete)
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25
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Section G: Dissemination and implementation of guidelines
A dissemination and/or implementation plan is submitted as set out in the NHMRC Toolkit publication
How to
put the evidence into practice: implementation and dissemination strategies. Specifical y, key
recommendations likely to lead to improvements in health outcomes are highlighted for consideration in
implementation.
MANDATORY REQUIREMENTS: Dissemination and implementation of guidelines
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
G.1
A plan for the dissemination
Must appear in dissemination
Yes / No
of the guideline is submit ed
plan
as a separate document from
Document(s); section; page(s)
Comment:
the clinical practice guideline.
Please cut and paste relevant
sections of guideline or
administrative report (noting
location and page of information)
to inform comments (if
appropriate).
If the answer is NO, provide
examples to il ustrate the issue.
G.2
Key recommendations that
Must appear in dissemination
Yes / No
are most likely to lead to
plan
improvements in health
Document(s); section; page(s)
Comment:
outcomes are highlighted for
consideration in
implementation.
DESIREABLE REQUIREMENTS: Dissemination and implementation of guidelines
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
G.3
A practical implementation
To appear in Implementation
Yes / No
plan is provided as a
plan (may also be part of
separate document, based
dissemination plan)
on considerations of the
Document(s); section; page(s)
Comment:
Australian health care
context and identification of
appropriate organisation/s
where the key
recommendations may be
directed.
G.4
Resources to support
To appear in guideline
Yes / No
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26
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
DESIREABLE REQUIREMENTS: Dissemination and implementation of guidelines
Location of information
Notes pertaining to assessment of
relevant to each requirement
requirement or location of
(i.e. guideline, administrative
information relating to the
or technical report including
requirement.
page number/s).
Guideline developer to
Methodological reviewer to
complete
complete
implementation of the
Document(s); section; page(s)
Comment:
guidelines are developed,
such as summaries and other
tools for dif erent health care
professionals, and the
guideline indicates where
these can be obtained.
G.5
Accompanying consumer
To appear in guideline
Yes / No
information is provided.
Document(s); section; page(s)
Comment:
G.6
Versions of the plain English To appear in guideline
Yes / No
summary and consumer
Document(s); section; page(s)
Comment:
information are available in
dif erent languages, if
appropriate.
G.7
Suggestions for local
To appear in guideline
Yes / No
adaptation and adoption of
Document(s); section; page(s)
Comment:
the guideline are provided.
G.8
Measures are developed for
To appear in guideline
Yes / No
determining the extent to
Document(s); section; page(s)
Comment:
which key guideline
recommendations are
implemented.
G.9
An evaluation strategy is
To appear in guideline
Yes / No
developed and described to
Document(s); section; page(s)
Comment:
assess the extent to which
guideline recommendations
are adopted into routine
practice.
OVERALL ASSESSMENT FOR SECTION G: Dissemination and implementation of guidelines
(reviewer to complete, select one option)
• Meets and exceeds requirements
• Meets mandatory requirements
• Partly meets mandatory requirements
• Does not meet mandatory requirements
NHMRC: METHODOLOGICAL REVIEW TEMPLATE – USING THE 2011 STANDARD TO ASSESS CLINICAL PRACTICE GUIDELINES
<INSERT GUIDELINE TITLE>
27

VERSION: 2 | EFFECTIVE DATE: 10/02/14
PROGRESS REPORT TEMPLATE
To confirm the intention to seek the National Health and
5. Describe the processes to be used for declaration and
Medical Research Council (NHMRC) approval for a clinical
management of competing interests for all people involved in
practice guideline, the developer must submit a progress report
the guideline development process.
approximately 6 months (and not later than 3 months) before
6. Describe the processes that will be/are being used to ensure
the draft guideline is released for public consultation. NHMRC
consumer perspectives are incorporated in the guideline.
will inform the developer in writing if any major issues or gaps in
the development process are identified within 4- 8 weeks from
7. List the organisations (if any) that will be approached to
receipt of the progress report.
endorse the guideline.
Scope and purpose
The progress report should be submitted
electronically to NHMRC at:
8. List the clinical research questions which are being
xxxxxxxxxxxxxxxxxx@xxxxx.xxx.xx
addressed by the guideline that inform the evidence review.
9. List the population groups to which the guideline
Please ensure the full guideline title is included
recommendations will apply and any population subgroups
at the start of the progress report. The progress
for whom specific information may be required (such as risks
report should not exceed 15 pages in length.
or treatment considerations).
10. List any issues (such as particular risks, treatment
If delays occur in the guideline development which alter the
considerations or sociocultural considerations) identified as
timeframes for the public consultation and/or final submission
relevant to Aboriginal and Torres Strait Islander peoples or any
dates, further progress reports may be requested by NHMRC.
other groups (eg culturally and linguistically diverse (CALD)
groups) which will be considered as part of the guideline
Governance and stakeholders
scope, and describe how these issues have been addressed
in the evidence review and formulation of recommendations.
1. List the key organisation or organisations responsible for
development and publication of the guideline.
Evidence review
2. List the sources of all funding for the development of the
11. List the names of the evidence experts who will be involved in
guideline and its publication.
the search and appraisal of the literature (if not provided at 4).
3. Describe the processes for ensuring editorial independence
12. List the publication date cut points (as month/year) for
from funders.
all evidence searches, including any differences if multiple
4. List all the people involved in the guideline development
searches were completed as part of the evidence
process (including discipline/expertise, organisational
review process.
affiliation and role in the guideline development process).
| PAGE 1 of 2
Recommendations
Dissemination and implementation
13. List the types of recommendations which have been or
18. List the organisations/agencies who will be responsible
will be derived from the clinical questions. For example,
for the implementation of the final guideline.
these may include recommendations based on a systematic
19. Provide a summary of the dissemination plan for the
evidence review, recommendations developed where a
final guideline.
systematic evidence review was conducted and low quality
or no evidence was identified (and consensus processes may
20. List the tools and resources that will be developed to
have been used) and recommendations developed to provide
accompany the guidelines.
additional information to support recommendations where a
Key dates
systematic evidence review was not conducted (sometimes
called practice points or points of note).
21. Provide the start and end dates for the public consultation
14. Describe the process which will be used to reach expert or
period.
group consensus in the development of recommendations.
22. Provide the intended submission date of the final draft
guideline for NHMRC approval.
Consultation
General
15. Indicate whether any recommendations will specify the use
of medicines or services that are currently not available or
23. Summarise any difficulties or delays which have been
restricted in Australia, and how the relevant authority/ies will
encountered in progressing the development of the
be consulted.
guideline to date.
16. List any organisations/individuals that will be specifically
24. Provide details of any controversial or contentious issues
approached to provide comment on the guideline.
associated with the guideline content or development process.
17. Describe the processes that are in place to collaborate with
organisations that are producing/have produced advice
in related areas. For example they may be involved in the
review of evidence, review of drafts, and/ or notified when
potentially conflicting recommendations are proposed.
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VERSION: 3 | EFFECTIVE DATE: 16/12/2016
VERSION: 2 | EFFECTIVE DATE: 10/02/14
PUBLIC CONSULTATION INFORMATION FOR
GUIDELINE DEVELOPERS SEEKING NHMRC APPROVAL
OF THEIR GUIDELINE
The National Health and Medical Research Council Act 1992 (the
•
a statement that the draft guideline will be submitted to
NHMRC Act) allows the National Health and Medical Research
NHMRC for its approval under section 14A of the NHMRC
Council (NHMRC) to approve clinical practice guidelines
Act
developed by external organisations. NHMRC approval indicates
that these guidelines are of a high quality, based on the best
•
instructions on how to make a submission, where a copy
available scientific evidence and developed to rigorous standards
of the draft guideline can be obtained and the closing date
including public consultation.
(which must be at least 30 days from the first date of
publishing the notice)
This information document is written for guideline developers
seeking NHMRC approval of their clinical practice guideline
•
your contact details such as a telephone number and/or
and provides you with information about NHMRC’s public
mailing address for alternative methods of submissions.
consultation requirements.
While NHMRC no longer requires you to advertise public
consultation in a national newspaper, you may wish to use other
Notifying NHMRC of public consultation methods such as media releases and public events, and you may
wish to undertake additional consultation at any time during the
Guideline developers must liaise with their nominated NHMRC
guideline’s development.
project officer to ensure the draft guideline and details of
public consultation, including dates, web links and submission
NHMRC will support your public consultation by publishing a
requirements are provided to NHMRC at least five days prior to
notice on the NHMRC website, in the NHMRC Health Tracker
the start date of the public consultation period.
email newsletter and through an email alert to subscribers of the
NHMRC public consultation subscription service.
Releasing your guideline for public
NHMRC will also advise its Council Members of the release
consultation
of your guideline for public consultation; they will be invited to
provide comments directly to you in their individual capacity.
The NHMRC Act requires that externally developed guidelines
are released for public consultation for a minimum of 30 days,
You may also wish to consider providing your guideline
and requires developers to invite submissions and to have regard
electronically in more than one format.
to all submissions received.
As developer you must publish a consultation notice on a publicly
accessible website which includes the following information:
•
the developer’s name and logo
•
the name of the draft guideline/guidelines
Contacting specific groups during
•
an overview of the submissions received, including
public consultation
the number of submissions, the types of individuals or
organisations from whom submissions were received and
recurring themes in submissions (including any potential
Where guidelines include specific recommendations about
contentious issues and how they were addressed)
interventions that are restricted or not available in Australia, and
which require (or would be supported by) a change in service
•
an overview of main decisions taken in response to
delivery, you should send a public consultation draft guideline
submission comments.
to relevant government agencies, such as the Therapeutic
Goods Administration (TGA), the Pharmaceutical Benefits
2. A list of the submissions and corresponding responses,
Advisory Committee (PBAC) and the Medical Services Advisory
rebuttals or changes made to the guideline by the developer,
Committee (MSAC). Your covering correspondence should
organised either thematically or to correspond with sections of
specifically highlight the recommendation(s) in question.
the guideline.
At the public consultation stage you should identify and consult
•
It is suggested that any responses (including nil responses)
with key organisations that will be involved in, or affected by, the
where advice has been sought from relevant authorities and
implementation of the clinical recommendations of the guideline.
key organisations are documented and clearly highlighted in
This may include:
the public consultation submissions table.
•
specialist colleges whose members are target users, or
If the public consultation report you send to NHMRC contains
which will disseminate the guideline to members
de-identified public consultation submissions please provide an
additional list of the organisations that have provided comment
•
organisations with an interest in the guideline topic
at public consultation.
(including consumer organisations).
For further information please contact your NHMRC project
In addition you are asked to notify and invite submissions from
officer via xxxxxxxxxxxxxxxxxx@xxxxx.xxx.xx or call 02 6217 9000.
the Consumers Health Forum of Australia.
Draft guideline and references to
NHMRC
Developers should ensure that the public consultation
draft guideline is clearly marked to indicate its draft status.
Developers should ensure that if references to NHMRC approval
are made within the guideline, these should clearly state that
the draft guideline is proposed for submission to the NHMRC
for approval under section 14A of the NHMRC Act 1992.
Developers should seek advice from their NHMRC project officer
regarding references to NHMRC or NHMRC approval in their
guideline by contacting xxxxxxxxxxxxxxxxxx@xxxxx.xxx.xx.
Collation of public consultation
submissions
When collating public consultation submission it is suggested
that the following information is included:
1. A summary of the consultation process:
•
dates of consultation and where details of the public
consultation were published
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Document Outline
- 6b_methodological_review_template_version_1_131118 (10)_AD.pdf