Process Manual - Dietitians Association of Australia

Transcription

A review of the evidence to address targeted
questions to inform the revision of the
Australian dietary guidelines 2009
Process manual
Associate Professor Peter Williams, PhD, FDAA (Research Leader)
Associate Professor Margaret Allman-Farrinelli, PhD, AdvAPD (Research Leader)
Professor Clare Collins, PhD, FDAA (Research Leader)
Dr Janelle Gifford, PhD, AdvAPD (Project Officer)
Annette Byron, MPH, APD (Project Manager)
Dietitians Association of Australia
ABN 34 008 521 480
Acknowledgements
ADA Evidence Analysis Manual, Steps in the ADA Evidence Analysis Process, 2008. © American Dietetic
Association. Pages 43–48 reprinted with permission.
© Copyright 2011 Dietitians Association of Australia
A review of the evidence to address targeted questions to inform the revision of the Australian dietary guidelines 2009:
Process Manual
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This manual may be used for the purposes of private study, research, criticism or review , as permitted under the
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Any reproduction made of the information or material must include a copy of the original copyright and disclaimer
notices as set out here.
Contents
Introduction
1
Section 1
Overall process
2
Section 2
Data extraction
3
Section 3
Quality assessment
16
Section 4
Forming a Body of Evidence statement
17
Section 5
Creating citation lists
18
Section 6
NHMRC submitted literature
21
Section 7
Submitting documents to the Project Officer
22
Section 8
Appendices
23
Appendix 1
Reviewers‘ Tips
23
Appendix 2
Search strategy for Systematic Literature Review to Update the Dietary Guidelines
24
Appendix 3
Decision tree for study selection
53
Appendix 4
Example body of evidence chapter: Fruit
54
Appendix 5
Sample Data Extraction – RCT
56
Appendix 6
Sample Data Extraction – Review
58
Appendix 7
NHMRC Levels of Evidence
61
Appendix 8
NHMRC explanatory notes on effect size
64
Appendix 9
NHMRC explanatory notes on relevance of evidence
65
Appendix 10
Guide to filling out the Quality Criteria Checklist
66
Appendix 11
How to assess the body of evidence and formulate recommendations
73
Appendix 12
NHMRC citations inclusions/exclusions proforma
77
Section 9
References
78
Dietitians Association of Australia A review of the evidence to address targetedquestions to inform the revision of the Australian
dietary guidelines 2009
Introduction
The Review of the evidence to address targeted questions to inform the revision of the Australian dietary
guidelines was a complex undertaking of the Dietitians Association of Australia under contract to the
National Health and Medical Research Council (NHMRC) with contributions from more than thirty
Australian Accredited Practising Dietitians/academic reviewers in diverse locations. Training,
communication and implementation of common process and tools for this project was crucial to a high
quality review. This manual was developed by the Review Leadership Team with the assistance of the
Project Officer and Project Manager for the purpose of guiding the people undertaking the review and to
provide a common point of reference over the duration of the project. The manual evolved as the process
was developed and fine-tuned and was shaped by feedback from reviewers to the Review Leadership
Team and from NHMRC Dietary Guidelines Working Committee (DGWC).
The Review Leadership Team wish to acknowledge and thank the team of reviewers and the
DGWC/NHMRC for their assistance and support.
Introduction
1
A review of the evidence to address targetedquestions to inform the revision of the Australian dietary guidelines 2009
Section 1 Overall process
Figure 1 gives an overview of the review process for systematic and umbrella reviews.
Figure 1
Review process
Data
Extraction
Quality
Assessment
Body of Evidence
Matrix
·
·
·
Receive Endnote Libraries from librarian
Identify studies for inclusion in review
Extract data into data extraction spreadsheet
·
Use modified ADA Checklist/spreadsheet for Quality Assessment – enter
assessment of all papers on the one spreadsheet
·
Summarise data extraction and quality assessment into the summary of
included studies
Collate results from the summary into the Overall Rating of the Body of
Evidence spreadsheet.
·
·
Table of Evidence
Statements
·
Research Leadership team to review the Body of Evidence Matrix and
recommendation statements for consistency with the evidence
Send all required documents to the Project Officer
Recommendations for
NHMRC
Reviewers‘ tips have been developed and included in Appendix 1 in order to assist with questions that
may arise as reviewers work through the process.
2
Section 1 Overall process
Section 2 Data extraction
2.1
EndNote libraries and identifying studies for inclusion
The first step of the review process is to identify a set of articles for inclusion in the review. To do this
1.
2.
3.
4.
You will receive an EndNote (VX4, Thomson Reuters, New York, NY, USA) database with all the
references retrieved using the project search strategy.
The EndNote database needs to be customised to include several fields unique to the review
(see 2.1.1).
You will need to cull (identify) articles for retrieval/non-retrieval, inclusion/exclusion. You will need to
record several related keys in customised fields (see 2.1.2).
Retrieve the final included articles for data extraction and quality rating.
Steps 2–3 are outlined below as well as instructions on searching using customised fields.
2.1.1 Customising your EndNote database
There are several customised fields within EndNote that will be used to store information for reference and
searching for this review. These fields are:
·
Study/Review/Other
·
Retrieve/Not Retrieve
·
Not Retrieve Reason
·
Include/Exclude
·
Exclude Reason
·
Inclusion – Population Subgroup
·
Inclusion – Outcome Condition
We need you to use these customised fields for consistency across the review process and for ease of
searching in reporting on this information.
For you to use the customised fields within your EndNote database, you will need to import an XML file
with the formatted reference template for journal articles. The process for importing the XML file is (also
see ―notes‖ at the end of this section if you can‘t locate the EndNote files referred to here):
Backup Current XML file for safety
·
for XP it is located at: Documents and Settings\[your name]\Application Data\EndNote
·
for Vista it is located at: [your name]\AppData\Roaming\EndNote
·
find the file RefTypeTable.xml and rename to RefTypeTableOriginal.xml
For EndNote X1 (Windows XP)
·
Save the attached file to your USB or disk
·
Open your EndNote library.
·
Click on Edit\Preferences, then click on Reference Types
·
Click on Import, and import the saved XML file.
·
This will overwrite the current file of the same name, so all your future libraries will use this.
For EndNote X (Windows XP)
·
Save the attached file to your disk at the following location: Documents and Settings\[your
name]\Application Data\EndNote
·
Open your EndNote library.
For EndNote X (Windows Vista)
·
Save the attached file to your disk at the following location: [your name]\AppData\Roaming\EndNote
3
A review of the evidence to address targetedquestions to inform the revision of the Australian dietary guidelines 2009 Dietitians
Association of Australia
·
Open your EndNote library as above.
Notes
·
If you can‘t find your EndNote files, they may be ―hidden‖. Try following these steps to display hidden
files and folders.
1.
2.
3.
In Documents and Settings or subfolders as required, open Folder Options.
Click the View tab.
Under Advanced settings, click Show hidden files and folders, and then click OK.
·
Reviewers will need to consistently use the same version of EndNote on the same computer OR
implement the same steps on PCs in use for the review in order to pick up the customised fields – the
XML file is not transferred with the EndNote library across PCs or versions of EndNote on the same
PC.
·
In order to view the customisations, the reference type must be ―journal article‖. Reviewers will need to
alter this if individual references have come through as a different reference type.
4
2.1.2 Culling articles
The process for culling papers is shown in Figure 2 below and notes on process and documentation at
each step follow.
Figure 2
Process for culling articles contributing to body of evidence statements and required documentation
Process
Documentation
Search Information
Topic search
Step 1
Step 2
Step 3
Step 4
Step 5
· Appendix: Search strategy from librarian
· Topic Chapter: Search summary paragraph from
reviewer
Classify
Retrieve / Not
Retrieve
· Statistics Flowchart: add total number obtained
from search
Retrieve
CLASSIFY
Include / Exclude
Not Retrieve
CLASSIFY
Note reason for
non-retrieval
Include
Note population
Subgroup and
Outcome
Exclude
Note reason for
exclusion
Include/Exclude
· Statistics Flowchart: add number included and
excluded, and reason for exclusion
· Data Extraction: one data extraction sheet (tab) for
each included study within one excel spreadsheet
for each topic
· Summary of Included Studies: Summarise results
of all included studies.
Include
CLASSIFY
Include in BOE /
Not include in BOE
Include in BOE
Create BOE for
each outcome
Retrieve/Not Retrieve
· Statistics Flowchart: add number retrieved and not
retrieved, and reason for non-retrieval
· Quality Criteria Checklist: One spreadsheet (tab)
for each included study within one Excel
spreadsheet for each topic.
Not include in BOE
Include in BOE/not include in BOE
· Statistics Flowchart: add number included in BOE,
not included in BOE and reason for non-inclusion in
BOE
· Citation list included studies not in BOE: Extract
citation list for I studies
· Citation list all excluded studies: Extract citation
list for I and E studies.
Include in BOE
· BOE and Summary of Included Studies: one Excel
file for each BOE
· Topic Chapter: For each BOE statement include
statement with consistent wording as specified,
grade, BOE matrix, summary paragraph, reference
list
5
Step 1
·
·
·
Record in the field Study/Review/Other one of the following:
S
if the article is a study
R
if the article is a review
O
if the article is neither a study nor a review
The decision to not retrieve an article should be based on obvious exclusion criteria in the abstract.
Where there is doubt, retrieve the article. When reviewing abstracts, each study should be recorded in
the Retrieve/Not Retrieve field as
R
if the study is to be retrieved
N
if the study is not to be retrieved
If classified as N reason(s) for non-retrieval should be recorded in the field Not Retrieve Reason as
(Note: there may be several reasons for a single study to be excluded but only one reason code need
be given)
NS
Not a study (e.g. editorial)
NP
Not a relevant population (e.g. animal study, particular disease group)
NO
Not a relevant outcome (i.e. the study does not report any of the defined outcomes e.g.
risk of chronic disease, environmental impacts, social equity and health and well bring OR
e.g. RCTs that studied the effects of isolated extracts were excluded as NO: e.g. betaglucan (rather than whole oats); isoflavones (rather than soy).
Dup
Article is a duplicate of another article already identified for retrieval
XS
Cross-sectional study
Step 2
·
When reviewing full articles that have been retrieved, apply exclusion criteria and record one of the
following in the Include/Exclude field:
I
if the article is to be included in the review
E
if the article is to be excluded from the review
Step 3
·
If the article has been excluded record one of the following as a reason for exclusion in the Exclude
Reason field:
(Note: there may be several reasons for a single study to be excluded but only one reason code need
be given)
6
NS
Not a study (e.g. editorial)
NP
Not a relevant population (e.g. animal study, particular disease group)
NO
Not a relevant outcome (i.e. the study does not report any of the defined
outcomes e.g. risk of chronic disease, environmental impacts, social equity and
health and wellbeing) OR e.g. RCTs that studied the effects of isolated extracts
were excluded as NO: e.g. beta-glucan (rather than whole oats); isoflavones
(rather than soy).
Dup
Article is a duplicate of another article already identified for retrieval
XS
Cross-sectional study
<5 studies
less than 5 studies – cannot form BOE
inc in review
where a single study is already covered by an included review article
·
If the article has been included, a code needs to be recorded in the Inclusion – Population Subgroup
and the Inclusion – Outcome Condition fields:
1.
Inclusion – Population Subgroup codes:
I0
if the study population includes those age 0–6 months
I7
if the study population includes those aged 7–12 months
C1
if the study population includes those aged 1–3 years
C4
if the study population includes those aged 4–8 years
B9
if the study population includes those aged 9–13 years who are male
B14
G9
if the study population includes those aged 9–13 years who are female
G14
M19
M31
M51
M65
if the study population includes those age 65+ years who are male
W19
W31
W51
W65
if the study population includes those age 65+ years who are female
P14
if the study population includes pregnant women aged 14–18 years
P19
P31
L14
if the study population includes lactating women aged 14–18 year
L19
if the study population includes lactating women aged 19–30 years
L31
if the study population includes lactating women aged 31–50 years
7
Inclusion – Outcome Condition codes:
2.
Ob
if the study measures risk of obesity
CVD
if the study measures risk of CVD
St
if the study measures risk of stroke
T2D
if the study measures risk of Type 2 Diabetes
Ca
if the study measures risk of cancers
HT
if the study measures risk of hypertension
COPD if the study measures risk of chronic obstructive pulmonary disease
Eye
if the study measures risk of eye diseases
Bo
if the study measures risk of bone diseases
Dl
if the study measures risk of dental diseases
Me
if the study measures risk of mental illness
En
if the study measures environmental impacts (over the life of the food, i.e. production,
packaging, distribution, consumption, waste products)
SE
if the study measures outcomes related to social equity.
HWB
if the study measures outcomes related to health and wellbeing (e.g. life expectancy,
DALY/QALYS)
Oth
if the outcome is included for outcomes in Appendix 2 (Table 2), but is not specific for the
question of interest.
Step 4
·
Although a study may meet inclusion criteria, Body of Evidence (BOE) statements can only be made if
the volume of evidence exists to support it. BOE statements will be formed according to the volume of
evidence indicated in the Decision Tree (Appendix C in the SLR Project Plan; see Appendix 3). At least
five individual studies are needed to form a BOE statement. For all studies that remain after these
criteria update the Include/Exclude field in the EndNote database to IBOE. Possible values in the
Include/Exclude field are now E, I, or IBOE.
·
Remove individual studies from the Summary of Included Studies where they are also referenced in an
included systematic review. This is so they are not counted twice and is a request from NHMRC.
Modify the Include/Exclude field in the EndNote database to E (for exclude) and modify the Exclude
Reason field to Dup.
Step 5
·
Complete the BOE matrix (see Section 4).
·
Form a BOE statement based on all the IBOE studies (see Section 4).
·
Write a summary paragraph.
·
Create a citation list for all studies contributing to the BOE statement (see Section 4).
Documentation/files to be submitted
Refer also to process diagram at the beginning of this section.
·
Data Extraction File – one Excel File with one tab for each study.
·
Summary of Included Studies – one Excel File for each of: Reviews, RCTs & Case Controls, All
other studies.
·
Quality Criteria Checklist – one Excel File with one tab for each study.
·
BOE and Summary of Included Studies – one Excel File for each BOE statement. Within each file
there should be one tab for the BOE statement/grading/matrix, and one tab for the summary of studies
contributing to the BOE statement. For the Summary of Included Studies ensure:

8
all cells are filled. Include ―n/a‖ in cells where applicable and do not leave any blank.

Add the reference number from EndNote in square brackets in the first row after the author name
and year i.e. Bloggs et al. 2006 [9999] or Bloggs & Cloggs 2006 [9999].

Add all the reference numbers related to the BOE under the BOE grading.
·
Topic Chapter – one word document modelled on the Fruit topic (Appendix 4) including a summary
search paragraph, the work found in the BOE tab in each of the BOE and Summary of Included
Studies files (above), summary paragraph for each BOE statement, reference list for each BOE
statement (see Creating Citation Lists).
·
NHMRC Literature Table (See Section 6)
·
Submit documents (see Section 7)
2.1.3 Searching using customised fields
Searching customised fields will be needed to provide statistics to the NHMRC on the review process. A
search on customised fields can be conducted by clicking on References/Search References to find the
references with all the search keys entered in the preceding section. However the search fields are still
named ―Custom 1–7‖ and not the names allocated to the customised fields. To search on the customised
fields reviewers need to be aware that:
·
Custom 1=Study/Review/Other
·
Custom 2=Retrieve/Not Retrieve
·
Custom 3=Not Retrieve Reason
·
Custom 4=Include/Exclude
·
Custom 5=Exclude Reason
·
Custom 6=Inclusion – Population Subgroup
·
Custom 7=Inclusion – Outcome Condition
9
2.2
Data extraction and summary of included studies
Three spreadsheets have been provided for data extraction. These are for Randomised Controlled Trials
and Case-Control Studies, Reviews, and All Other Studies. Refer to Figure 3 for an example showing the
spreadsheet for Randomised Controlled Trials and Case-Control Studies.
Figure 3
Data extraction template for randomised controlled trials and case-control studies
The worksheets are as follows:
·
Overall Rating BOE (Body of Evidence). This is to be filled in last (see Section 4).
·
Summary of Inc Studies. This may be filled in as you go OR after you have completed data extraction
for all studies. It may be more efficient to fill it out for each study as you go. This worksheet has been
based on guidance provided by the NHMRC1 and has associated notes modified for the current review.
These are found in Table 1. Please refer to these notes as you are working through the data extraction
process.
·
nameYYYYa. This will be the name of the third tab when the data extraction table first comes to you.
Rename the tab with the First Author, Year (and letter a–z if the author has published more than one
study in the same year). This worksheet has been based on guidance provided by the NHMRC1 and
has associated notes modified for the current review. These are found in Tables 2 (for Randomised
Controlled Trials and Case-Control Studies) and 3 (for Reviews). Please refer to these notes as you
are working through the data extraction process. Also note that drop-down menus have been provided
for the rows Level of Evidence, Study Design, Allocation, Clinical Importance, and Relevance to assist
with your selection of these fields. Examples of data extraction for an RCT and a Review can be found
in Appendices 5 and 6 respectively.
·
Template. You will need to create a new worksheet for each study that is included. To do this, click on
the ―Insert worksheet tab at the bottom of the worksheet (or F11). Click on the Template tab, place
your cursor in the top left hand corner of the spreadsheet (to the left of column A and above row 1),
right-click and select copy. Move to the newly inserted worksheet, click on the top left hand corner of
the spreadsheet (to the left of column A and above row 1), right-click and select paste. Rename the tab
of your new sheet with the First Author, Year (and letter a–z if the author has published more than one
study in the same year). Please ensure you follow the copy/paste process outlined here as data
10
validation lists for the drop-down menus are contained (hidden) within the sheet outside the table rows.
The drop down menus will not function unless the entire worksheet is copied.
11
Table 1
Data extraction notes for summary worksheet
Data Extraction Notes
[1]
Authors, e.g. Smith et al (1999)
[2]
Type of study (RCT, case-control, etc)
[3]
As per the NHMRC levels of evidence, provided at p. 8 of the NHMRC toolkit publication: How to use the
evidence: assessment and application of scientific evidence. See Appendix 7.
[4]
Intervention (e.g. treatment with a pharmaceutical agent, surgery, a dietary supplement, psychotherapy)
and comparator(s).
[5]
Number of participants in each group
[6]
Brief information relevant to the particular study (e.g. participants, methods, outcomes, length of follow up)
[7]
Assessment (in words) of the overall quality of the study. Is the study quality good enough that you have
confidence in the results?
[8]
Size of the summary measure (or point estimate) plus the 95% CI (confidence interval) and/or P-value
[9]
The words corresponding to the appropriate rating from the scale provided at p. 23 of the NHMRC toolkit
publication: How to use the evidence: assessment and application of scientific evidence. See Appendix 8.
[10]
The words corresponding to the appropriate rating from the scale provided at p. 28 of the NHMRC toolkit
publication: How to use the evidence: assessment and application of scientific evidence. See Appendix 9.
Table 2
Data extraction notes for randomised controlled trials and case-control studies
[1]
Full reference citation details
[2]
Details of how the study was funded or other relevant affiliations of the authors (designed to expose
potential conflicts of interest, such as drug company funding for the drug being trialed)
[3]
The study type (eg RCT, case-control study, cohort study), with additional detail where relevant
[4]
As per the NHMRC levels of evidence, provided at pg. 8 of the NHMRC toolkit publication: How to use the
evidence: assessment and application of scientific evidence. Appendix 7.
[5]
Country/setting (eg hospital, primary care, hospice)
[6]
Provide detail on the intervention. This will generally be a therapeutic procedure such as treatment with a
pharmaceutical agent, surgery, a dietary supplement, a dietary change or psychotherapy. Some other
interventions are less obviously categorised as interventions, such as early detection (screening) and
patient educational materials. The key characteristic is that a person or their environment is manipulated in
the hope of benefiting that person or reducing harm. Particular reference should be made to any
differences from Australian current practice. Key factors in the dietary intervention can be listed here if it is
helpful in giving better context of the study.
[7]
Number of participants enrolled in the intervention/treatment group
[8]
The intervention (eg drug, therapy, placebo) used as a comparison in the study. There may be more than
one comparator. Particular reference should be made to any differences from Australian current practice.
[9]
Number of participants enrolled in the comparison/control group(s)
12
Table 2
Data extraction notes for randomised controlled trials and case-control studies (continued)
[10]
Any factors that may confound/influence the results and/or the external validity (see below) of the results
(e.g. mean age, mean BMI, sex, co-morbidities, obesity, existing medications, previous surgery). List all
potential confounders since these relate to study quality. Give baseline data where relevant.
[11]
Length of follow-up of the participants. Note that this is follow-up after study completion.
[12]
The outcomes studied (list all outcomes in terms of primary and secondary outcomes). Indicate which
outcomes are relevant to the review/guidelines inclusion criteria. Copy EndNote inclusion code here. Also
note whether the outcome is a primary or secondary outcome in the study of interest.
[13]
The method used to assign patients to treatment or control groups (eg coin toss, random number table,
computer-generated random numbers, sealed envelopes). Also indicate whether the allocation list was
concealed (e.g. computerised random number generation, administered from a central trial office, assigned
locally)
[14]
The results of the group analysis, noting any clinically or statistically significant differences between the
groups at study inception
[15]
Whether the participants, outcome assessors and (if different) investigators were blinded to the group
allocation. Insert Y/N/NR/NC (for yes/no/not reported/not clear). To add further detail/comment on blinding,
add a comment by right click on the cell and ―insert comment‖
[16]
(a) Indicate whether, aside from the experimental treatment, the groups were treated and measured the
same. Insert Y/N/NR/NC (for yes/no/not reported/not clear); (b) N/NR (for no/not reported) OR overall
number; (c) actual intake achieved by the intervention group (as opposed to the planned intervention
intake)
[17]
The proportion of participants that were followed up and whether all participants were analysed according
to the group to which they were initially allocated, regardless of whether or not they dropped out, fully
complied with the treatment, or crossed over and received the other treatment (‗intention to treat analysis‘ ITT)
[18]
Summarise the quality rating using the ADA assessment tool, and if necessary add further assessment (in
words) of the overall quality of the study. Is the study quality good enough that you have confidence in the
results?
[19]
The outcome relevant for this entry in the database (Note: more than one table may be required if there
are several outcomes relevant to different clinical questions/guidelines)
[20]
For binary outcomes, show numbers of patients with the outcome. For continuous outcomes, show means
± standard deviations; or medians and interquartile ranges
[21]
For binary outcomes, show numbers of patients with the outcome. For continuous outcomes, show means
± standard deviations; or medians and interquartile ranges. Add number of columns as needed , e.g. 3-arm
trials
[22]
Absolute and relative measures of effect and measure of variability eg risk differences (absolute risk
reduction or absolute risk increase), mean differences, relative risk, odds ratio
[25]
95% confidence interval (CI) for all measures, if available, otherwise use P-value (be explicit on what
comparison the P-value relates to)
[23]
A measure of benefit, when the treatment increases the probability of a good event. The number needed to
treat to benefit (NNT) = the number of participants who must receive the treatment to create one additional
improved outcome in comparison with the control treatment; calculated as 1/absolute benefit increase,
rounded up to the next highest whole number
[25]
13
Table 2
Data extraction notes for randomised controlled trials and case-control studies (continued)
[24]
A measure of harm, when the treatment increases the risk of specified adverse outcomes of a condition or
reduces the probability of a good event. The number needed to treat to harm (NNH) = the number of
patients who, if they receive the treatment, would lead to one additional person being harmed compared
with patients who receive the control treatment; calculated as 1/absolute risk increase, rounded up to the
next highest whole number
[25]
[26]
Insert the words corresponding to the appropriate rating from the scale provided at p. 23 of the NHMRC
toolkit publication: How to use the evidence: assessment and application of scientific evidence
[27]
Insert the words corresponding to the appropriate rating from the scale provided at p. 28 of the NHMRC
toolkit publication: How to use the evidence: assessment and application of scientific evidence
[28]
Information on any adverse events mentioned in the study
[29]
Are the patients in the study so different from those being considered for the guideline that the results may
not be applicable to them? i.e. is the study generalisable? Insert Y/N
[30]
Will the potential benefits outweigh any potential harms of treatment in the guideline population? i.e. is the
study applicable? Insert Y/N
[31]
Add your overall comments regarding the interpretation or implications of this study. This should include
―flags‖ or questions for the Review Leadership Team. Comments on the actual intake achieved should be
included here.
[32]
Statement on main conclusion. This can be copied from the study or a summary statement
14
Table 3
Data extraction notes for reviews
[1]
Full reference citation details
[2]
Details of how the study was funded or other relevant affiliations of the authors (designed to expose
potential conflicts of interest, such as drug company funding for the drug being trialed)
[3]
The study type (e.g. systematic review, meta-analysis, systematic review of cohort, meta-analysis of
cohort), with additional detail where relevant
[4]
As per the NHMRC levels of evidence, provided at p. 8 of the NHMRC toolkit publication: How to use the
evidence: assessment and application of scientific evidence. Appendix 7.
[5]
Date range of search
[6]
Total number of studies included in the review
[7]
Total number of participants included in review from all studies
[8]
Gender (insert M,F, or M+F), Country/Region, age range, plus characteristics considered to be important
by the reviewer. Range of exposure should be a summary of exposures i.e. minimum exposure of all
studies and maximum exposure of all studies.
[9]
The outcomes studied (list all outcomes in terms of primary and secondary outcomes). Indicate which
outcomes are relevant to the review/guidelines inclusion criteria. Copy EndNote inclusion code here. Also
note whether the outcome is a primary or secondary outcome.
[10]
Range of length of follow-up of the participants. Note that this is follow-up after study completion.
[11]
List all databases included in the search for studies.
[12]
Statistical tests/methods used to analyse and summarise data.
[13]
Summarise the quality rating using the ADA assessment tool, and if necessary add further assessment (in
words) of the overall quality of the study. Is the study quality good enough that you have confidence in the
results?
[14]
Copy and paste the main/relevant results table from the pdf of the review. Within the pdf, choose
Tools/Select&Zoom/Snapshot Tool to copy, then paste into this row of the Excel document. The size of the
selected table may need to be reduced and the Excel row height may need to be expanded to fit the table.
[15]
Are the patients in the review so different from those being considered for the guideline that the results
may not be applicable to them? i.e. is the review generalisable? Insert Y/N
[16]
Will the potential benefits outweigh any potential harms of treatment in the guideline population? i.e. is the
review applicable? Insert Y/N
[17]
Add your overall comments regarding the interpretation or implications of this review. This should include
―flags‖ or questions for the Review Leadership Team. Comments on the actual intake achieved should be
included here.
[18]
Statement on main conclusion. This can be copied from the study or a summary statement.
15
Section 3 Quality assessment
The ADA Quality Assessment Checklist will be used for quality assessment for Primary Studies (S
questions) and Reviews (U questions). Worksheets with both checklists are housed in an Excel
spreadsheet (note the tabs at the base of the spreadsheet). This will be sent to reviewers separately.
Guidance on how to answer the questions can be found in Appendix 10.
Perform the following steps for Primary Studies:
1.
2.
3.
4.
5.
Enter first author, year in Row 4
Enter a sequential reference number in Row 5
Answer questions 1, 2, 4–10 as y or n (yes or no)
Answer question 3 as y, n or na (yes, no or not applicable)
Using criteria in Rows 19–21, rate the paper in Row 18 as n, 0, or p (negative, neutral or positive).
Questions 2, 3, 6 and 7 are grouped/shaded and counts of ―y‖ and ―n‖ are automated and included at
the bottom of the spreadsheet for ease of assessment.
Perform the following steps for Review Studies:
1.
2.
3.
4.
16
Enter first author, year in Row 4
Enter a sequential reference number in Row 5
Answer questions 1–10 as y or n (yes or no)
Using criteria in Rows 19–21, rate the paper in Row 18 as n, 0, or p (negative, neutral or positive).
Questions 1–4 are shaded and counts of ―y‖ and ―n‖ are automated and included at the bottom of the
spreadsheet for ease of assessment.
Section 3 Description of key components of nutrition and dietetic services
Section 4 Forming a Body of Evidence statement
1.
2.
Fill in the Body of Evidence matrix in the Excel spreadsheet
For statement based on Level II intervention studies, the evidence statement will take the following
form:
Consumption of [x food] reduces/increases [insert outcome]
E.g. In individuals with elevated BP, a median reduction in salt of 4.6g/day 78mmol sodium/day)
reduces blood pressure by around 5mmHg for systolic and 2.7mmHg for diastolic BP)
3.
When the body of evidence statement is informed by Level III evidence, form the Body of Evidence
statement using the following consistent wording:
a.
Where there is an association and no quantification:
Consumption of [x food] is associated with [reduced risk of/increased risk of]
[insert outcome]
b.
Where there is an association and quantification:
Consumption of [insert amount in serves/g/mL as appropriate] [insert
frequency] of [x food] is associated with [reduced risk of/increased risk of]
[insert outcome]
c.
Where there is no association late BOE statement submissions were worded as follows:
Consumption of [x food] is not associated with [insert outcome]
For BOE statements submitted prior to November 2009, general wording of the evidence
statement was in the direction expected (even if there were no clear outcome). For example it
would be expected that fruit intake would be beneficial so wording of the statement would be
Consumption of fruit is not associated with reduced risk of cancer
NOT
Consumption of fruit is not associated with increased risk of cancer
Wording of statements over the different submissions will be aligned for consistency for the final
submission.
4.
5.
6.
Grade the statement according to the NHMRC system (see Appendix 11). Generally:
·
Grade A required Excellent for both evidence base and consistency
·
Grade B requires Excellent or Good for both evidence base and consistency
·
Grade C requires Good or Satisfactory for both evidence base and consistency
·
Grade D requires Satisfactory or Poor for both evidence base and consistency
Note: when evaluating the consistency and clinical impact of contradictory evidence, much more
weight should be given to meta-analysis results than to individual additional studies, and the reasoning
for final judgements should be explained in the text under evidence tables.
Where dose response ranges are given in the BOE statement but there are many studies underpinning
the statement, include the lowest and highest doses from the selection of papers supporting the
statement (the lowest and highest number do not need to come from the same paper.
Section 4 Forming a Body of Evidence statement
17
Section 5 Creating citation lists
5.1
Format for citation lists
A special Output Style for EndNote has been developed (file name Author–Date SLR.ens). This is in the
format required for NHMRC as follows in alphabetical Author–Date sequence, for example:
Affinito, P., Palomba, S., Bonifacio, M., Fontana, D., Izzo, R., Trimarco, B., & Nappi, C. 2001,
―Effects of hormonal replacement therapy in postmenopausal hypertensive patients‖, Maturitas,
vol. 40, no. 1, pp. 75–83.
To use the Output Style file in EndNote:
1.
2.
3.
Ensure EndNote is closed.
Save the Author–Date SLR.ens file in C drive/program files/EndNote X1/Styles
When you open EndNote click on Edit/Output Styles and click on Author–Date SLR
You will need to create a citation list for:
1.
2.
3.
Included studies (to be included in the BOE in the Topic Chapter (See Appendix 4)
Included studies not included in the BOE (to be included in the Topic Chapter (See Appendix 4)
All retrieved but excluded studies
5.2
Creating citation lists for included and excluded studies
Create the citation lists as follows:
1.
For included studies contributing to the BOE
a.
Figure 4
b.
c.
d.
18
Go to the References tab and select Search References (Figure 4)
Searching references
Under the References
tab, select Search
References
Under Search, type IBOE
Under In, select Custom 4
Click on the Search tab at the bottom of the screen (Figure 5)
Figure 5
Searching for IBOE references
Under Search,
type IBOE
Under In, type
Custom 4
Click on
Search
e.
f.
2.
3.
Export the references as per instructions in Section 5.3.
Create the heading Included Studies at the top of the file.
For included studies not contributing to the BOE, repeat the above steps, except put I under Search
instead of IBOE. Use the heading Included Studies (not contributing to BOE).
For all studies NOT contributing to the BOE, repeat the above steps except
a.
b.
c.
d.
e.
under Search, type I.
under Search in the second field down, type E
under Search in the second field down, type IBOE
Under In in the second field down, select Custom 4
for the Boolean conditions select Or in the first field and Not for the second, and search (Figure 6).
19
Figure 6
Searching for all excluded references
Under Search, type
I
Under Search, type
E
Under Search,
type IBOE
under In, type
Custom 4
type Or for
first condition
type Not for
second
condition
click on
Search
f.
g.
5.3
1.
2.
Export the references as per instructions in Section 5.3.
Create the heading Excluded Studies at the top of the resulting file.
Exporting your file
Ensure the Output Style customised for this project (Author–Date SLR) has been chosen.
To export your file, select File/Export and save your file as in rich text format (rtf), NOT text format (txt).
Figure 7
Exporting your file
Under File, select
Export
3.
Format paragraphs within the file as follows:
a.
b.
20
Ensure Author-Date SLR
has been selected as the
output style
no indentation
6pt after each paragraph
Section 6 NHMRC submitted literature
NHMRC Dietary Guidelines Working Committee submitted some literature to be considered in the review.
The same inclusion/exclusion criteria employed in Section 2.1.2 Step 3 is to be applied. Reviewers are to
complete a table describing the results of this process as shown in Appendix 12.
Section 6 NHMRC submitted literature
21
Section 7 Submitting documents to the
Project Officer
Documents can be submitted by e-mail, post (on USB/CD/DVD), or using Dropbox (Dropbox Inc. Los Altos,
CA 94022. The Dropbox facility is free of charge up to 2GB and allows sharing of very large files without
the need for e-mailing and USB/DVD/CD. You can read about Dropbox here:
https://www.getdropbox.com/features.
If you wish to use Dropbox, notify the project officer and please follow these instructions:
1.
An invitation will be received from the Project Officer to join Dropbox.
a.
b.
c.
Download the program onto your PC; and
Create an account with your e-mail address.
In your "My Documents" or "Documents" folder on your PC you will notice a new box called "My
Dropbox".
2.
The Project Officer will add names of reviewers to a share file their specific question and each reviewer
will receive an e-mail saying that they have been invited to share this Folder. You should just need to
click the link provided in the e-mail to access the folder. The folder contains individual folders for each
question.
3.
In the My Dropbox folder on your PC, find the folder for your question and copy the relevant documents
into this folder.
Please do not delete or change what is inside your My Dropbox folder. This changes versions of the
same file on all PCs that share the folder.
22
Section 4 Workforce planning
Section 8 Appendices
Appendix 1
Reviewers‘ Tips
Retrieval/Non-Retrieval
·
Individual articles referenced within systematic reviews that are included in the review should not be
retrieved.
·
In the ―reason for non-retrieval‖ field, code irrelevant papers in EndNote as N and then NS, NP or NO
as appropriate.
Inclusion/Exclusions
·
Include studies on food and exclude studies on nutrients or food components delivered in a different
form. Trials where fats and oils are administered in capsule form can be included.
·
Include studies if the amount of food (dose) is not included in the study as this still informs about the
effect of the food.
·
Include studies where subjects have a health condition (e.g. hyperinsulinaemia/obesity/CHD/
hypercholesterolaemia) if these subjects happen to be part of the study group and the condition is not
a focus of the study. If the study is about effect of food/nutrient on the disease state, then exclude it...
Inclusion Codes
·
Report baseline age group for longitudinal studies in the inclusion code.
·
Outcomes that are important but not in the inclusion list should be coded as ―Oth‖ in the Inclusion
Outcome Condition. Restrict the use of ―Oth‖ as an outcome code (―Inclusion - Outcome Condition‖) to
outcomes already included in Table 2 (Appendix 2) of Process Manual.
Data Extraction
·
Do not calculate results between groups in the outcomes [19] of the Data Extraction Table for RCTs
and Case Controls.
·
Where there are multiple outcomes for data extraction, results should be entered in whichever way is
easiest for the reviewer to understand, for example outcome and age group within population or
population and age group within outcome etc.
23
Appendix 2
Search strategy for Systematic Literature Review to Update the Dietary Guidelines
Table A2.1 Table of search questions and keywords for population, intervention, comparator, and outcome
Question
S.1.1
Population
Intervention
Comparator
Outcome
Includes:
General population in the following
subgroups:
·
Infants 0–6 months
·
Infants 7–12 months
·
Children 1–3 years
·
Children 4–8 years
·
Boys 9–13 years
·
Boys 14–18 years
·
Girls 9–13 years
·
Girls 14–18 years
·
Men 19–30 years
·
Men 31–50 years
·
Men 51–65 years
·
Men >65 years
·
Women 19–30 years
·
Women 31–50 years
·
Women 51–65 years
·
Women >65 years
·
Pregnant women 14–18 years
·
·
·
Lactating women 14–18 years
·
·
See Table 1 Fruit
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
Systematic literature review – assessing the primary
literature
Fruit
In these population groups, does a particular intake of fruit
affect the risk of [each condition listed in Table 2]?
For each of the topics under S1.1 use the same question
format. In this example search for fruit for each intervention
inclusions and exclusions (Table 1), according to each
population group for all outcomes as listed in separate outcome
table (Table 2).
Includes:
· Fruit as a food
and juice in total
· Fruit as a food
only
Excludes:
·
·
24
Serious medical conditions
Elite athletes
Table A2.1 Table of search questions and keywords for population, intervention, comparator, and outcome (continued)
S.1.1
(cont.)
Question
Population
Intervention
Comparator
Outcome
Vegetables
As for S1.1 Fruit
See Table 1
Vegetables
Level of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
No red meat or
one intake level of
red meat
compared to
higher intake of
red meat
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
‗In these population groups, does a particular intake of
vegetables affect the risk of [each condition listed in Table 2]?‘
What is the association between intake of vegetables and risk
of [each condition listed in Table 2]?
Meat
‗In these population groups, does a particular intake of meat
affect the risk of [each condition listed in Table 2]?‘
Can absorb S.1.6 into this question but need to answer dose in
wording, i.e. specific quantity of meat and related beneficial or
detrimental effect.
NB look at
vegetables as a
food and juice in
total and as a food
only.
As for S1.1 Fruit
See Table 1 Meat
25
S.1.1
(cont.)
Question
Population
Intervention
Comparator
Outcome
Dairy (cheese, milks and yoghurt)
As for S1.1 Fruit
See Table 1 Dairy
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
As for S1.1 Fruit
See Table 1
Cereals/grains
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
‗In these population groups, does a particular intake of dairy
Cereals/grains
cereals/grains affect the risk of [each condition listed in Table
2]?‘
26
and
Compare cereals
high or low in
added sugar
S.1.1
(cont.)
Question
Population
Intervention
Comparator
Outcome
Legumes
As for S1.1 Fruit
See Table 1
Legumes
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
As for S1.1 Fruit
See Table 1 Nuts
and seeds
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
legumes affect the risk [each condition listed in Table 2]?‘
Nuts and seeds
‗In these population groups, does a particular intake of nuts
and seeds affect the risk of [each condition listed in Table 2]?‘
27
S.1.1
(cont.)
Question
Population
Intervention
Comparator
Outcome
Fish
As for S1.1 Fruit
See Table 1 Fish
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
As for S1.1 Fruit
See Table 1
Poultry
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
‗In these population groups, does a particular intake of fish
Poultry
‗In these population groups, does a particular intake of poultry
28
S.1.1
(cont.)
Question
Population
Intervention
Comparator
Outcome
Eggs
As for S.1.1 Fruit
See Table 1 Eggs
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
As for S1.1 Fruit
See Table 1
Fat/oil
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
‗In these population groups, does a particular intake of eggs
Fat/oil
‗In these population groups, does a particular intake of fat/oil
Try clustering for
some outcomes
29
S.1.1
(cont.)
Question
Population
Intervention
Comparator
Outcome
Salt/sodium
As for S.1.1 Fruit
See Table 1
Salt/sodium
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
As for S.1.1 Fruit
See Table 1
Sugars
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
salt/sodium affect the risk of [each condition listed in Table 2]?‘
Move this question to the umbrella review only but identify
amount of salt because salt assessed in Kids Eat Kids Play.
Sugars
‗In these population groups, does a particular intake of sugars
Consider whether S1.7 can be absorbed into S1.1
30
S.1.1
(cont.)
Question
Population
Intervention
Comparator
Outcome
Beverages (including water)
As for S1.1 Fruit
See Table 1
Beverages
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
As for S1.1 Fruit
See Table 1
Alcohol
Levels of
consumption
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
beverages affect the risk of [each condition listed in Table 2]?‘
Alcohol
‗In these population groups, does a particular intake of alcohol
31
S.1.1
(cont.)
Question
Population
Social distribution of dietary intake
See Table 2 Social equity
Intervention
Looking for amounts of foods to inform Core Food Group
modelling.
Comparator
Outcome
High and low
intakes for major
food groups
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
Includes:
· Other
· Dietary patterns
· Food groups
· Whole foods
· Food
components
· Beverages.
See Table 2
Environmental
impacts
Limit studies to Australia. Narrative reviews likely to be most
relevant.
Include data gaps in report to NHMRC.
S.1.2
What are the greenhouse gas emissions, water use and
biodiversity implications of different dietary patterns, food
groups, whole groups, food components and beverages?
What is the relative greenhouse gas production and water use
of different dietary patterns, food groups, whole foods, food
components and beverages?
Search strategy to include studies from 1980 onwards. Include
Australian and international studies.
32
Includes:
· General population.
Excludes:
· People with serious medical
conditions.
Includes:
· Dietary patterns
· Food groups
· Whole foods
· Food
components
· Beverages.
S.1.3
Question
Population
Intervention
What factors lead to children adopting appropriate life course
food consumption and dietary patterns?
Includes:
· General population
· Children aged 4–18 years
· Overweight children
Includes:
· Parenting,
Environment
· Education
experience
· Geographical
mapping
· School based
interventions
· Food
interventions
· Behavioural
interventions
· Body image
· Eating with
family
· Psychosocial
functioning
· Self-esteem
· Perceived
dietary
competence
· Health beliefs
· Parental control
of eating
· Economic
factors
· Socioeconomic
status
· Food insecurity
· Marketing
methods
· Advertising
Exclude studies with less than 12 month follow-up.
Excludes:
· People with serious medical
conditions.
Comparator
Outcome
Includes:
· Health
· Diet quality
· Diet variety
· BMI
· Fruit and
vegetables
(Table 2)
· Sugar
sweetened
beverages
(Table 2)
· High fat foods
· Life course food
consumption
and dietary
patterns, for
example food
consumption
and dietary
patterns in
childhood and
adulthood.
33
S.1.4
Question
Population
Intervention
What are the economic, physical and psycho-social barriers
and the enablers to different population groups achieving diets
consistent with the dietary guidelines?
Includes:
Includes:
· Income –
personal and
household
· Social
disadvantage
· Poverty
· Food prices
· Food costs
· Access
· Rural
· Urban
· Geographic
· Transport
· Urban planning
· Psychosocial
Education
· Language
· Migrant status
Mental health
state
· Addictions
· Family situation
(living alone/
married/single)
Limit studies primarily to those from Australia from 2003.
If not many RCT, go down cascade of evidence.
General population, in the
following subgroups:
· Infants;
· Children;
· Adolescents;
· Adults;
· Older adults;
· Pregnant and lactating women;
· Low socioeconomic status
groups;
· Aboriginals and Torres Strait
Islanders;
· Culturally and linguistically
diverse groups; and
· People living in rural and remote
areas.
Excludes:
· Those with serious medical
conditions
34
Comparator
Outcome
Includes:
· Eating patterns
· Consistency of
diet with the
Dietary
Guidelines for
Australian
Adults (2003)
and the Dietary
Guidelines for
Children and
Adolescents
incorporating
the Infant
Feeding
Guidelines for
Health Workers
(2003)
S.1.5
Question
Population
Intervention
Comparator
Outcome
What is the most appropriate age to introduce solid foods to
infants?
Includes:
· Breast fed 4/12 to 6/12
· Breast fed around 6/12 to 8/12
· Infant formula fed 4/12 to 6/12
· Infant formula fed around 6/12 to
8/12
· Children
Introduction of
solid foods
(subgroups of
different foods,
method of
introduction,
method of
preparation)
a) Introduction of
solid foods at
different ages;
Risk of:
·
·
Does the introduction of solid foods at different ages change
the risk to the infant of developing allergic syndromes, for
example eczema, wheezing, gastro intestinal tract
symptoms?
- Which solids?
- How many different foods?
- Effect of method of introduction – one at a time, length of
time for one food, length of time before another food is
introduced, mixed food products?
- Effect of method of preparation of solids – cooked, mixed
with breastmilk, infant formula or cow‘s milk?
Does the earlier introduction of solids result in:
- Decreased breastmilk production for the lactating mother?
- Increased risk of overweight and/or obesity over the short
term and long term for the infant?
- Increased morbidity and mortality over the short term and
long term for the infant?
·
b) Comparison of
different types
of foods;
c) Comparison of
different
methods of
introduction;
and
d) Comparison of
different
methods of
preparation of
solids.
·
·
·
The infant
developing
allergic
syndromes, for
example
eczema,
wheezing,
gastro intestinal
tract symptoms;
Reduction of
breastmilk
production;
Overweight
and/or obesity
over the short
term and long
term for the
infant; and
Morbidity and
mortality over
the short term
and long term
for the infant.
35
S.1.6
Question
Population
Intervention
Comparator
Outcome
Is there a dose response relationship between consuming red
meat (not including processed meat as red meat) and an
increased risk of cancer?
Includes:
Table 1 Meat
No red meat or
small amount or
more serves red
meat compared to
another dose of
red meat.
See Table 2
Cancer
Can be absorbed into S.1.1 but need to identify the doseresponse.
subgroups:
· Infants;
· Children;
· Adolescents;
· Adults;
· Older adults; and
· Pregnant and lactating women.
Compare different
cooking methods
Excludes:
Those with serious medical
conditions
S.1.7
Is there a dose response relationship of sucrose or other
refined sugars in foods or beverages on body weight indices
over the long term (1 year +)?
This may also be able to be absorbed into S.1.1
Includes:
subgroups:
· Infants;
· Children;
· Adolescents;
· Adults;
Includes:
· Sucrose or other
refined sugars in
foods and
beverages
(Table 1)
· Sugar as a
marker of food
type
Different doses of
sucrose or other
refined sugars.
See Table 2
Obesity
Excludes:
conditions
36
S.1.8
Question
Population
Intervention
Comparator
Outcome
What is the effect of sugar sweetened beverages (including
those sweetened with high fructose corn syrup) on total energy
intake, body weight indices and dental health in the diet? Is
there a difference between fruit juice, flavoured milk and other
beverages?
Includes:
Includes:
subgroups:
· Infants;
· Children;
· Adolescents;
· Adults;
Sugar sweetened
beverages (see
Table 1), including
beverages
sweetened with
intrinsic and added
sugars, for
example:
For body weight
question:
Includes:
· Total energy
intake
· See Table 2
Obesity
· See Table 2
Dental health
Excludes:
conditions
·
·
·
·
Soft drink;
Fruit juice;
Flavoured milk;
and
Other sugar
containing
beverages
(including high
fructose corn
syrup
sweetened
beverages).
Excludes:
· Sugar
sweetened
foods
Sugar sweetened
beverages
compared to
beverages without
sugar, e.g. water
and diet drinks, or
compared to other
types of sugarsweetened
beverage
(including high
fructose corn
syrup sweetened
beverages). (See
Table 1)
For dental health
question:
Sugar sweetened
beverages
compared to
beverages without
sugar with at least
equal acidity or
compared to other
types of sugarsweetened
beverage
(including high
fructose corn
syrup sweetened
beverages).
37
S.1.9
Question
Population
Intervention
Comparator
Outcome
What are the health benefits of grain-based foods (including
bread, breakfast cereals, oats, pasta and rice) in both refined
and wholegrain forms?
Includes:
Includes:
· Table 1
Cereals/grains
· Excludes:
treatment eg
oats for
cholesterol
Wholegrain forms
compared with
refined forms.
Includes:
Risk of chronic
diseases listed in
Table 2
Is there an association between intake of grain based foods in
both refined and wholegrain forms and reduced risk of
disease?
Does the health benefit/risk of disease differ between refined
grain and wholegrain forms?
subgroups:
· Infants;
· Children;
· Adolescents;
· Adults;
Excludes:
·
S.1.10
Is there an association between specific or subgroups of fruits
and vegetables, for example brassica vegetables, tomatoes,
cruciferous vegetables and citrus etc, and:
·
·
·
·
·
·
·
·
·
·
·
38
Obesity;
Cardio Vascular Disease (including hyperlipidemias);
Stroke;
Diabetes;
Cancer;
Hypertension;
Chronic Obstructive Pulmonary Disease;
Eye health;
Bone health;
Dental health; and
Mental health.
Table 2 Health
and wellbeing
Table 2 Obesity
Those with serious medical
conditions
Includes:
subgroups:
· Infants;
· Children;
· Adolescents;
· Adults;
Excludes:
conditions
See Table 1
Subgroups of fruits
and vegetables
Low versus high
consumption of
specific or
subgroups of fruits
and vegetables.
See Table 2
Outcomes for
Obesity, CHD,
Stroke, Type 2
Diabetes, Cancer,
Hypertension,
Chronic
obstructive
pulmonary
disease, Eye
health, Bone
health, Dental
health, Mental
health, Other
Table A2.2 Umbrella review – a systematic review of systematic reviews (including assessing the quality of the reviews to determine whether the conclusions are subject to
bias)
Question
U.1.1
Population
What dietary patterns, food groups including:
·
·
·
·
·
·
·
·
Fruit;
Vegetables;
Meat;
Dairy (cheese, milks and
yoghurt);
Cereals/grains;
Legumes;
Nuts and seeds;
Fish;
·
·
·
·
·
·
·
Poultry;
Eggs;
Fat/oil;
Salt/sodium;
Sugars;
Beverages (including
water); and
Alcohol
·
Health and wellbeing (Life Expectancy/ DALY/QALYs);
and
Reduced risk of chronic diseases including:
- Obesity;
- Cardio Vascular Disease
(including
hyperlipidemias);
- Stroke;
- Diabetes;
- Cancer;
- Hypertension;
Vulnerable populations
including:
·
·
·
·
And whole foods and food components (not nutrients) are
associated with:
·
Includes:
General population
- Chronic Obstructive
Pulmonary Disease;
- Eye health;
- Bone health;
- Dental health; and
- Mental health;
·
Low socioeconomic
status groups;
Aboriginals and Torres
Strait Islanders;
Culturally and
linguistically diverse
groups; and
People living in rural and
remote areas.
Intervention
See Table 1 Dietary
patterns, food groups
Comparator
Consumption high in one
type of dietary pattern,
food group, whole foods
Consider processed and and food component
other meat, and processed compared to a different
meat separately
consumption of a dietary
pattern, food group, whole
foods and food
component.
Outcome
See Table 2 Outcomes for
Obesity, CHD, Stroke,
Type 2 Diabetes, Cancer,
Hypertension, Chronic
obstructive pulmonary
disease, Eye health, Bone
health, Dental health,
Mental health, Other
Excludes:
Those with serious
medical conditions
in the general population and vulnerable groups including
low socioeconomic status, Aboriginals and Torres Strait
Islanders and culturally and linguistically diverse groups,
and those living in rural and remote areas, without serious
disease?
Emphasis on whole dietary patterns, not single foods as
S.1.1.
39
bias) (continued)
U.1.2
Question
Population
Intervention
What is the inter-relationship between dietary patterns,
food groups, whole foods, food components and
beverages and environmental sustainability?
Includes:
· General population.
e) Dietary patterns, food
groups, whole foods,
food components and
beverages; and
a) Dietary patterns, food
groups, whole foods,
food components and
beverages; and
f) Environmental
sustainability, for
example ecological
footprint, water
quality, natural
resources, air quality,
soil quality and
underlying fish stocks
b) Environmental
sustainability –
agriculture and
fisheries
What is the impact of climate change and other aspects
of environmental degradation on the capacity to sustain
production in Australia of food groups, whole foods, food
components and beverages?
Focus on Australian food and agricultural industry, not
international.
Category 2 S2.1 is not covered in contract. However,
when analysing material for U1.2 the reviewer will look
at the material from the environment on food perspective
and provide a narrative summary of anything which is
found.
40
Comparator
Outcome
bias) (continued)
U.1.3
Question
Population
What are the most recent data on dietary patterns and
intakes of foods and food components (including
nutrients) in Australia? How does the data vary across
age/sex groups in the general population and vulnerable
groups including low socioeconomic status, Aboriginals
and Torres Strait Islanders and culturally and
linguistically diverse groups, and those living in rural and
remote areas?
Includes:
General population in
the following subgroups:
· Infants;
· Children;
· Adolescents;
· Adults;
· Older adults;
· Pregnant and lactating
women;
· Low socioeconomic
status groups;
· Aboriginals and Torres
Strait Islanders;
· Culturally and
groups; and
· People living in rural
and remote areas.
From these, what are the normal ranges of intakes of
different key food groups in different Australian
populations?
How much physical activity is needed at each age to
balance energy intake for reducing metabolism.
Include studies from 1995 onwards
Intervention
Comparator
Outcome
Includes:
· Dietary patterns
· Food intakes
· Food components
Nutrients
Excludes:
· Those with serious
medical conditions.
41
bias) (continued)
U.1.4
Question
Population
Intervention
Comparator
Outcome
What is the relationship between dietary intake and
physical activity in promoting health and wellbeing?
Includes:
General population in
the following subgroups:
Balance of food intake
and physical activity
used to maintain healthy
body weight, maintain
muscle strength and
support normal growth
and development.
Unbalanced levels of
food intake and physical
activity.
Includes:
· Measures of health
· DALY, QALY, body
weight, muscle
strength, growth and
development in
children, life
expectancy, morbidity,
and mortality.
· Are there outcomes
more relevant to the
question than those
given – these don‘t
seem related to the
question
Not breastfeeding.
See Table 2
Infants;
Children;
· Adolescents;
· Adults;
· Pregnant and lactating
women.
Excludes:
·
·
·
U.1.5
What are the benefits of breastfeeding (partial and
exclusive) and the risks of not breastfeeding (any and
exclusive), to infants and mothers, both in the short term
and long term?
Include studies from 1988 onwards.
42
Two types of physical
activity – to maintain
muscle strength and
prevent obesity
Those with serious
medical conditions
Includes:
· Aboriginals & Torres
Strait Islander
· CALD
· Lactating women
· Mothers
· Infants
· Postpartum
· Perinatal
Breastfeeding – look at
literature and advise on
short term and long
term.
Risk of exposure to
nicotine and alcohol;
breastfeeding, breast
milk, human milk,
colostrum, lactation,
infant formula, artificial
feeding, breastfeeding
initiation, breastfeeding
duration, exclusive
breastfeeding, partial
breastfeeding, weaning
bias) (continued)
U.1.6
Question
Population
Intervention
What nutritional factors are important in optimising
pregnancy outcomes?
Includes:
· Aboriginals & Torres
Strait Islander
· CALD
· Lactating women
· Mothers
· Infants
· Postpartum
· Perinatal
Includes:
· diet
· dietary intake
· food
· food habits
· eating patterns
· food patterns
· diet quality
· diet variety
· diet score
· alcohol
· caffeine
· nutrients
· vitamins
· minerals
· Supplements
- Folic acid
- Iron
- Calcium
- Iodine
- Vitamin D
- Fluoride
Will need to include a statement re. supplements – look
at what NZ used in their DG
Comparator
Outcome
See Table 2
43
bias) (continued)
U.1.7
Question
Population
Intervention
What nutritional factors are important in optimising
breastfeeding outcomes?
Includes:
·
General population
·
Aboriginals &
Torres Strait
Islander
·
CALD
·
Lactating women
·
Mothers
·
Infants
·
Postpartum
·
Perinatal
Includes:
·
Diet
·
Dietary intake
·
Food
·
Food habits
·
Eating patterns
·
Food patterns
·
Diet quality
·
Diet variety
·
Diet score
Will need to include a statement re. supplements – look
at what NZ used in their DG
U.1.8
How does the processing, preparation and cooking of
food, including:
Frozen/ canned/ dried/ juice; and
Cooking methods, for example boiling, stir frying,
roasting, microwaving, steaming etc;
change the bioavailability/nutritional value of the food,
food safety and environmental impact?
·
·
What is the impact of processing on nutritional value,
food safety and bioavailability? (intervention =
processing)
What is the impact of transporting and packaging food
on the environment? (interventions = packaging and
transport)
What is the impact of processing on food safety in rural
and remote areas, and in locations of lower
socioeconomic status. (interventions = processing,
transport and market access (mode of purchase)).
44
Includes:
·
Food processing
·
Food preparation
Cooking
·
Frozen food
·
Canned food
·
Dried food
·
Juice
·
Cooking method
·
Boiling
·
Stir frying
·
Roasting
·
Microwaving
·
Steaming
·
Grilling
·
Industrial food production
·
Food service and Food
manufacturing
·
Domestic cooking
Includes fruit, vegetables,
milk, grains, meat, fish and
poultry.
Comparator
Outcome
See Table 2
Methods of
processing,
preparation and
cooking of methods
compared against
each other.
Includes:
·
Bioavailability
·
Nutritional value
·
Biologically active
substances
·
Food safety
·
Environmental
impact
Table A2.3 Narrative review – comprehensive review of the literature
Question
N.1.1
What current and past national food selection guides are
used/have been used in Australia?
N.1.2
What are the major national food selection guides currently
used internationally?
N.1.3
What methods have been used to develop national food
selection guides?
N.1.4
What indices and references are used for the assessment of
body weight, growth rates and obesity in children in Australia?
What are the current opinions on which indices and references
are best?
N.1.5
What are the appropriate food safety processes, for example in
food preparation and storage, to maintain a safe food supply
for individuals and groups of individuals, including children and
adults?
Population
Intervention
Comparator
Outcome
Restrict to studies of healthy
children
Include pregnant women
45
Category 2
Table A2.4 Systematic literature review – assessing the primary literature
S.2.6
Question
Population
Intervention
Comparator
Outcome
What is the dose response relationship between different types
of milk intake and weight change in adults?
May be able to be a subset of S.1.1.
Includes:
· General adult population,
Dose of milk
intake (cow‘s milk,
goat‘s milk,
sheep‘s milk, soy
milk, full fat,
reduced fat, low
fat, flavoured milk,
almond milk and
rice milk, sugar
sweetened).
One type of milk
compared to
another type of
milk,
See Table 2
Obesity
Excludes:
conditions
· Excludes pregnant and lactating
women.
and
compare different
levels of milk
consumption.
Includes: liquid
milk
Excludes: cheese,
yoghurt
46
Table A2.5 Key words for interventions (food terms) for question S1.1, S1.6, S1.7, S1.10, U1.1
Vegetables
Meat
Poultry
Dairy
Fat/oil
Fish
Includes:
· Raw
· Cooked
· Canned
· Juice
· Dried
· pastes (eg tomato
paste)
· potato
· corn on the cob
Includes:
· all or part of the muscle
of any meat (cattle,
sheep, goat, buffalo,
kangaroo, camel, deer,
goat, pig rabbit).
· Different cooking
methods (grilling, frying,
braising, roasting,
baking, broiling,
stewing)
Includes:
· carcass muscle only of
chicken, duck, turkey
and other avian foods).
Includes:
· Cow, goat, sheep milk
· skim, full fat, low fat
· Milk
· Yogurt
· Cheese
· Custard
Includes:
· coconut cream
· cream
· butter
· lard
· dripping
· copha
· oils
· sesame oil
· margarines
Includes:
· Fish (fresh, frozen,
tinned, dried, smoked)
· Seafood
· fin fish
· shellfish
· crustaceans
· fish fingers
Excludes:
· Powders
· Extracts
· sauces based on
vegetables
· soups
· potato/vegetable crisps,
soy and soy products,
legumes
· seaweed
Excludes:
· Offal
· processed meat
products (such as ham)
meat alternatives (such
as TVP)
· mixed foods including
meat (such as pies)
Excludes:
· Offal
· processed meat
products (such turkey
roll,
· chicken nuggets),
· eggs
poultry (such as pies)
· paté
Excludes:
· ice confection
· icecream
· cream
· sour cream
· butter
· eggs
· added CLA
· A1 & A2 milk
Excludes:
· designer fats (e.g.
MCT/CLA/diacyl glycerol
phytosterol margarine)
· fish oil supplements,
phytosterol margarine
Excludes:
· Processed seafood
products (such as crab
sticks)
fish (such as pies)
· fish oil supplements
· seaweed
47
Table A2.5 Key words for interventions (food terms) for question S1.1, S1.6, S1.7, S1.10, U1.1 (continued)
Fruit
Legumes
Eggs
Salt/sodium
Nuts and seeds
Alcohol
Includes:
· Raw
· Whole
· Canned
· Juice
· Dried
Includes:
· soy
· soy products (milk, tofu,
tempeh, yogurt etc)
Includes:
· fresh, dried, liquid,
frozen,
· cooked, e.g. omelette/
scrambled,
(predominately egg)
Includes:
· Sodium
· sodium chloride
· other salts including
sodium (eg sodium
bicarbonate)
· flavoured salts (such as
celery or chicken salt)
Includes:
· Peanuts
· nut butters
· tahini
Includes:
· Alcohol
· Alcoholic beverages
· Wine
· Beer
· Spirits
· Pre-mixed drinks
· Alcopop
Excludes:
· fruit extracts
· fruit flavoured drinks
· fruit flavoured
confectionery
· coconut
Excludes:
· Peanuts
· green peas
· green beans
Excludes:
· mixed dishes
· quiche
Excludes:
· Potassium salts
Excludes:
· Oils
· Coconut
· legumes
Excludes:
· Mouthwash
· Cooking essence
48
Cereals/grains
Sugars
Subgroups of fruits and
vegetables
Dietary patterns, food
groups
Beverages
Sugar sweetened
beverages
Includes:
· Whole or partially
processed grains (eg
rice, wheat, oats, corn,
barley)
· Breads
· breakfast cereals
(distinguish between
high and low added
sugar if possible)
· pasta and noodles
· flour
· polenta
· semolina
· bran
· wheatgerm
· corn cakes
· scones
· couscous
· pikelets
· crumpets
Includes:
· hexose
monosaccharides and
disaccharides, including
dextrose,
· fructose, sucrose and
lactose
· starch hydrolysate
glucose syrups,
maltodextrin and similar
products
· products derived at a
sugar refinery, including
brown sugar and
· molasses
· icing sugar
· invert sugar
· fruit sugar syrup;
· Glucose
· Galactose
· Maltose
· trehalose
· Xylose
· Sucrose
· Malt
· Sugar
· Honey
· Corn syrup
· High fructose corn syrup
(also consider colour, or
root vs leafy veg)
Includes:
· Fruit
· Vegetables
· Meat
· Dairy (cheese, milks and
yoghurt);
· Cereals/grains
· Legumes
· Nuts and seeds
· Fish
· Poultry
· Eggs
· Fat/oil
· Salt/sodium
· Sugars
· Beverages (including
water)
· Alcohol
· Whole foods
· food components
· diet
· dietary pattern
· local foods
· variety
· diet quality score
· dietary index
· food habits
· factor analysis
· cluster analysis
· principal component
Includes:
· water
· mineral water
· tap water
· soda water
· flavoured waters
· vitamin waters
· electrolyte replacement
drinks
· sports drinks
· energy drinks
· soft drinks
· artificially sweetened
drinks
· non-caloric soft drinks
· artificially sweetened
cordials
· non-caloric cordials
· tea
· iced teas
· flavoured teas
· coffee
· iced coffee
· coffee extracts
· chocolate drinks
· fruit juice
· fruit drinks
· fruit aides
· fruit punches
· low-calorie beverages
Includes:
· Flavoured waters
· Vitamin waters
· Electrolyte replacement
drinks
· Sports drinks
· Energy drinks
· Iced teas
· Iced coffee
· Chocolate drinks
· Fruit juice with added
sugar
· Fruit drink
· Fruit aides
· Fruit punches
· Flavoured milk
· Soft drinks
Excludes:
· corn on the cob
· cereal based products
with a significant amount
of added fat or sugar
(such as cakes,
pastries, pies or biscuits,
pancakes)
Includes:
· Fruit:
- Pome
- Berry
- Citrus
- Stone
- Tropical
- Other
· Vegetables:
- Potatoes
- Brassica/cruciferous
(inc cabbage,
cauliflower)
- Carrot and other root
- Leaf and stalk
- Tomato and products
(eg tomato paste)
- Other
Excludes:
· supplements of nutrients
or extracts
· fruit extracts
· fruit flavoured drinks
· fruit flavoured
confectionery
· coconut
· powders
· extracts
· sauces based on
49
Cereals/grains
(continued)
Sugars
(continued)
Wholegrain will be defined
as:
·
"the intact grain or the
dehulled, ground, milled,
cracked or flaked grain
where the constituents –
endosperm, germ and
bran – are present in such
proportions that represent
the typical ratio of those
fractions occurring in the
whole cereal, and includes
wholemeal"
Wholegrain Foods will be
defined as those
containing at least 51%
wholegrain (based on the
FDA definition to allow
wholegrain health claims)
50
·
·
·
·
·
·
·
·
·
·
Erythritol
Glycerol
Isomalt
Lactitol
Maltitol
Mannitol
Organic acids
Polydextrose
Sorbitol
D-Tagatose
Xylitol
Subgroups of fruits and
vegetables (continued)
·
·
·
·
·
vegetables
soups
potato/vegetable crisps
soy and soy products
legumes
seaweed
Dietary patterns, food
groups (continued)
·
·
·
analysis
DASH
Mediterranean diet
Beverages
(continued)
·
Sugar sweetened
beverages (continued)
flavoured milk drinks,
cow goat, soy
Excludes:
· alcohol
· alcoholic beverages
· liquid dietary
supplements
· liquid nutritional
supplements
· milk, whole
· milk, fat reduced
Excludes:
· non-nutritive sweeteners
Table A2.6 Keywords for outcomes for questions S1.1, S1.2, S1.10, U1.1, U1.5, U1.6, U1.7
CHD
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
heart disease
vascular disease
atheroma
atherosclerosis
arteriosclerosis
HDL
LDL
VLDL
cholesterol
hypercholesterolemia
coronary heart disease
lipoproteins
lipids
triacylglycerol
triglycerides
Cancer
(relate to ICD terminology)
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Chronic obstructive
pulmonary disease
·
·
·
emphysema
chronic obstructive
airways disease
sleep apnoea
Health and wellbeing
·
·
·
·
·
·
·
malignancy
neoplasm
carcinoma
breast cancer
prostate cancer
colon cancer
endometrial cancer
adenoma
polyps
colorectal cancer
oral cancer
pharyngeal cancer
lung cancer
oesophageal/esophageal cancer
gastric cancer /cancer of the
stomach
renal/ kidney cancer
ovarian cancer
cervical cancer
bladder cancer
skin cancer
melanoma
Life expectancy
DALY
QALYs
QoL
SF36
SF12
Malnutrition
Obesity
(interpret broadly)
·
·
·
·
·
·
·
·
·
·
·
Overweight
BMI
waist:hip ratio
WHR
waist circumference
weight gain
body weight
skinfold thickness
body size
lean body mass
body fat
energy expenditure
Mental health
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Eye Health
·
·
·
·
·
·
vision
blindness
cataract
glaucoma
macular degeneration
retinopathy
mental health
mental illness
mental hygiene
depression
depressive
symptoms
physiological
stresses
dementia
dementias
cognition
cognitive
impairment
schizophrenia
bipolar disorder
ADHD
MMA
Hypertension
·
·
·
blood pressure
systolic blood
pressure
diastolic blood
pressure
Social equity
·
·
·
·
·
·
·
·
·
·
·
·
·
social disadvantage
socioeconomic status
social gradient
household income
personal income
Indigenous
Aboriginals
Torres Strait Islanders
rural
poverty
low income
culturally and
groups
migrants
Bone health
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Other
·
·
·
·
·
constipation
inflammatory bowel
disease
immune function
hydration status
kidney stones
bone
bones
bone tissue
skeleton
osteoblasts
osteocytes
osteoclasts
bone matrix
bone density
bone mineral density
bone mineral content
bone resorption
bone loss
fracture
trabecular
cortical
osteoporosis
Stroke
·
·
·
·
·
CVA
cerebrovascular stroke
vascular accident
ischemia
TIA
51
Table A2.6 Keywords for outcomes for questions S1.1, S1.2, S1.10, U1.1, U1.5, U1.6, U1.7 (continued)
Environmental impacts
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Waste products
2
C0
Methane
Greenhouse gas
emissions
Water use
Biodiversity
Carbon footprints
Life cycle analysis
Environmental impact
Soil quality
Sustainability
Transport
Storage
Packaging
Food processing
Energy cost
Energy consumption
Nitrous oxide
Dental health
·
·
·
·
·
·
·
·
·
·
·
·
·
·
oral health
mouth disease
halitosis
tooth
dentition
tooth components
teeth
dental erosion
dental decay
caries
caries increments
DMFT
Gingival bleeding
% of surfaces with plaque
Type 2 Diabetes
·
·
·
·
·
·
·
·
·
·
·
·
glucose
insulin
insulin resistance
HbA1
glycemic index
glycaemia
insulinemia
GI
HOMA
QICKI
Metabolic syndrome
fructosamine
Pregnancy
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
52
Pregnancy
outcomes
Fertility rates
Birth weight
Preterm
delivery.
Weight gain in
pregnancy
Foetal alcohol
syndrome
Conception
Miscarriage
Spontaneous
abortion
Birth defect
Congenital
abnormality
Congenital
malformation
Neural tube
defect
Pregnancy
complications
Pregnancy
hypertension
Hypermesis
Foetal growth
Small for
gestation age
Pre-term
delivery
Breastfeeding
(infant harm & benefit)
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Infant nutrition
Infant bonding
Rates of infections infants
Allergy
Eczema
Risk of chronic disease
in adulthood
Smoking
Nicotine
Alcohol
Bonding
Infection
Immunity
Atopic
Type 2 diabetes
Overweight
Obesity
Breastfeeding
(maternal harm & benefit)
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Maternal discomfort;
Maternal bonding
Wellbeing
Mental health
DALY
QALY
SF36
SF12
maternal nutrition
Post-partum depression
Maternal weight loss
Pre-menopausal breast
cancer
Ovarian cancer.
Maternal overweight
Maternal obesity
Postpartum
Psycho-social
breastfeeding initiation
breastfeeding duration
breastfeeding success
Breastfeeding problems
Engorgement
Nipple
Type 2 diabetes
Gestational diabetes
Cancer
Appendix 3
Systematic review of systematic reviews
If <3 studies go to
systematic review
Systematic reviews
If <10 systematic go to
RCTs studies
Umbrella
Reviews
Randomised Controlled Trials (RCTs)
(Dietary Interventions)
- RCTs
- Pseudo RCTs
- Clustered RCTs
If <10 RCTs go to
observational studies
Systematic
Reviews
A comparative study with concurrent controls:
- Non-randomised, experimental trial
- Cohort study
- Case-control study
- Interrupted time series with a control group
A comparative study with concurrent controls:
- Historical control study
- Two or more single arm study
- Interrupted time series without a parallel control group
If <10 observational studes
go to ecological studies
Case series with either post-test or pre-test/post-test
outcomes
Ecological studies
Narrative
Reviews
Narrative/Qualitative Studies
Footnotes
1. Criteria to screen studies will be determined and applied on the following principles if large numbers of studies are identified
- Minimum number of subjects
- Length of study follow-up
- Characteristics of study i.e. limit on number of studies from the same research group which have similar content.
2. Key literature
- Key literature may include reports by government authorities, highly respected national and international health agencies
(Australia, UK, Europe, New Zealand, Canada, and USA), peer-reviewed systematic literature reviews or as provided by
the NHMRC. The preferred Tenderer will seek advice from the NHMRC and the Working Committee on key literature
to be included.
- Other reports or expert opinion will be for listing only, not review, and may be useful in identifying studies and
interpreting the findings
53
Appendix 4
Example body of evidence chapter: Fruit
Fruit
Search results
The initial search of the data bases included 3691 references for fruit and the specified disease outcomes.
The detailed search is included in Appendix 1. As there were 2,714 duplicates with the vegetable data base
the two were combined in one EndNote library and coded as one. In all 97 references concerning fruit and
vegetables had data extracted and 57 papers were used to form the body of evidence statements for fruit.
Sufficient evidence was found to make statements for fruit and cardiovascular disease, stroke, weight loss
and obesity, type 2 diabetes and a range of cancers including gastric, breast, lung, colorectal, oesophageal
and oral and nasopharyngeal, ovarian, endometrial and bladder cancer.
Fruit and coronary heart disease
Table A4.1 Body of Evidence and Statement for fruit and coronary heart disease
Does a particular intake of fruit affect the risk of coronary heart disease in adults?
Evidence
statement
Consumption of each additional daily serve of fruit is associated with a
reduced risk of coronary heart disease.
Grade
C
Component
Rating
Notes
Evidence Base
good
Level III evidence from two meta analyses each with 9 cohort studies (with most
studies in common and medium risk bias) 2 individual cohorts (with low risk bias)
and 1 case control (medium risk bias)
Consistency
good
Two meta analyses and one cohort protective but 1 case control increased risk
and other cohort describes protection when on a 40–55% energy from
carbohydrate but not higher or lower
Clinical impact
satisfactory
Meta analyses protective for each additional serve fruit (7%)
Generalisability
good
Populations from US Europe Japan
Applicability
good
Australian adults
The studies used to make the body of evidence statements are shown in the Table 1. The two meta
analyses are in agreement but have 6 of 9 studies in common, with most studies being from the USA. The
Japanese cohort study demonstrated a stronger association between fruit and cardiovascular disease. The
analysis of the Nurses Health and Male Health Professionals cohorts stratified by the percentage energy
from carbohydrate indicated that the protective effect is only found when carbohydrate intakes are between
40 and 55% energy. The hospital-based case control study showing that fruit increases the risk of acute
myocardial infarction was of a poorer quality because of the instrument used to measure fruit intake and
the bias in selection of controls.
References
Dauchet, L., Amouyel, P., Hercberg, S. & Dallongeville, J. 2006, "Fruit and vegetable consumption and risk
of coronary heart disease: a meta-analysis of cohort studies", Journal of Nutrition, vol. 136, no. 10, pp.
2588–93.
He, F. J., Nowson, C. A., Lucas, M. & MacGregor, G. A. 2007, "Increased consumption of fruit and
vegetables is related to a reduced risk of coronary heart disease: meta-analysis of cohort studies", Journal
of Human Hypertension, vol. 21, no. 9, pp. 717–28.
Joshipura, K. J., Hung, H.-C., Li, T. Y., Hu, F. B., Rimm, E. B., Stampfer, M. J., Colditz, G. & Willett, W. C.
2009, "Intakes of fruits, vegetables and carbohydrate and the risk of CVD", Public Health Nutrition, vol. 12,
no. 1, pp. 115–21.
Rastogi, T., Reddy, K. S., Vaz, M., Spiegelman, D., Willett, W. C., Stampfer, M. J. & Ascherio, A. 2004,
"Diet and risk of ischemic heart disease in India.[see comment]", American Journal of Clinical Nutrition, vol.
79, no. 4, pp. 582–92.
Takachi, R., Inoue, M., Ishihara, J., Kurahashi, N., Iwasaki, M., Sasazuki, S., Iso, H., Tsubono, Y. &
Tsugane, S. 2008, "Fruit and vegetable intake and risk of total cancer and cardiovascular disease: Japan
54
Public Health Center-Based Prospective Study", American Journal of Epidemiology, vol. 167, no. 1, pp. 59–
70.
55
Appendix 5
56
Sample Data Extraction – RCT
57
Appendix 6
58
Sample Data Extraction – Review
59
60
Appendix 7
NHMRC Levels of Evidence
From: NHMRC 2000, How to use the evidence: assessment and application of scientific evidence. http://nhmrc.gov.au/publications/categories/information.htm.
Retrieved 24 March 2009
61
*NOTE: See Table 1.2 below
62
xx
63
Appendix 8
NHMRC explanatory notes on effect size
The following tables are from p. 23:
NHMRC 2000, How to use the evidence: assessment and application of scientific evidence.
http://nhmrc.gov.au/publications/categories/information.htm
64
Appendix 9
NHMRC explanatory notes on relevance of evidence
The following table is from p. 28:
NHMRC 2000, How to use the evidence: assessment and application of scientific evidence.
http://nhmrc.gov.au/publications/categories/information.htm
65
Appendix 10
Guide to filling out the Quality Criteria Checklist
The following guide is from p. 43–48:
American Dietetic Association. 2008, Evidence Analysis Manual. Steps in the ADA Evidence Analysis
Process. Scientific Affairs and Research. Chicago2.
In using the guide, please note:
·
for the current review, the Relevance questions have been excluded from the Dietary Guidelines
Review Process quality criteria assessment as they appear in the checklist since the process of
excluding studies assumes that all included studies are relevant;
·
answer ―y‖ OR ―n‖ and not ―yes‖ OR ―no‖ in the spreadsheet provided;
·
answer ―n‖, ―0‖ OR ―p‖ and not ―–―, ―0‖ OR ―+‖in the spreadsheet provided.
66
67
68
69
70
71
72
Appendix 11
How to assess the body of evidence and formulate
recommendations
From: Part B of NHMRC 2008, How to use the evidence: assessment and application of scientific
evidence3.
http://www.nhmrc.gov.au/guidelines/consult/consultations/add_levels_grades_dev_guidelines2.htm
. Retrieved 14 September 2009. It is recommended that reviewers utilise the tools within this document to
assist with understanding and undertaking the grading of the body of evidence.
This part of the document describes how to grade the ‗body of evidence‘ for each guideline
recommendation. The body of evidence considers the evidence dimensions of all the studies relevant to
that recommendation. To assist guideline developers, the NHMRC GAR consultants have developed an
approach for assessing the body of evidence and formulating recommendations. This will ensure that while
guidelines may differ in their purpose and formulation, their developmental processes are consistent, and
their recommendations are formulated in a consistent manner.
Consequently, the NHMRC Evidence Statement Form is intended to be used for each clinical question
addressed in a guideline. Before completing the form, each included study should be critically appraised
and the relevant data extracted and summarised as shown in the NHMRC standards and procedures for
externally developed guidelines (NHMRC 2007)4. This information assists in the formulation of the
recommendation, and in determining the overall grade of the ‗body of evidence‘ that supports that
recommendation.
The NHMRC Evidence Statement Form sets out the basis for rating five key components of the ‗body of
evidence‘ for each recommendation. These components are:
1.
2.
3.
4.
5.
The evidence base, in terms of the number of studies, level of evidence and quality of studies (risk of
bias).
The consistency of the study results.
The potential clinical impact of the proposed recommendation.
The generalisability of the body of evidence to the target population for the guideline.
The applicability of the body of evidence to the Australian healthcare context.
The first two components give a picture of the internal validity of the study data in support of efficacy (for an
intervention), accuracy (for a diagnostic test), or strength of association (for a prognosis or aetiological
question). The third component addresses the likely clinical impact of the proposed recommendation. The
last two components consider external factors that may influence the effectiveness of the proposed
recommendation in practice, in terms of the generalisability for the intended population and setting of the
proposed recommendation, and applicability to the Australian (or other local) health care system.
Definitions of the components of the evidence statement3
1.
Evidence base
The evidence base is assessed in terms of the quantity, level and quality (risk of bias) of the included
studies:
Quantity of evidence reflects the number of the studies that have been included as the evidence base for
each guideline (and listed in the evidence summary table or text). The quantity assessment also takes into
account the number of patients in relation to the frequency of the outcomes measured (ie the statistical
power of the studies). Small, underpowered studies that are otherwise sound may be included in the
evidence base if their findings are generally similar — but at least some of the studies cited as evidence
must be large enough to detect the size and direction of any effect. Alternatively, the results of the studies
could be considered in a meta-analysis to increase the power and statistical precision of the effect
estimate.
Level of evidence reflects the best study types for the specific type of question (see Table 1). The most
appropriate study design to answer each type of clinical question (intervention, diagnostic accuracy,
aetiology or prognosis) is level II evidence. Level I studies are systematic reviews of the appropriate level II
studies in each case. Study designs that are progressively less robust for answering each type of question
are shown at levels III and IV.
Quality of evidence reflects how well the studies were designed in order to eliminate bias, including how the
subjects were selected, allocated to groups, managed and followed up (see Part A, Dimensions of
evidence, and Table 2 for further information).
73
2.
Consistency
The consistency component of the ‗body of evidence‘ assesses whether the findings are consistent across
the included studies (including across a range of study populations and study designs). Ideally, for a metaanalysis of randomised studies, there should be a statistical analysis of heterogeneity showing little
statistical difference between the studies. However, given that statistical tests for heterogeneity are
underpowered, presentation of an I2 statistic as well as an appraisal of the reasons for the heterogeneity
between studies, would be useful. Heterogeneity between studies may be due to differences in the study
design, the quality of the studies (risk of bias), the population studied, the definition of the outcome being
assessed, as well as many other factors. Non-randomised studies may have larger estimates of effect as a
result of the greater bias in such studies; however, such studies may also be important for confirming or
questioning results from randomised trials in larger populations that may be more representative of the
target population for the proposed guideline.
3.
Clinical impact
Clinical impact is a measure of the potential benefit from application of the guideline to a population.
Factors that need to be taken into account when estimating clinical impact include:
·
the relevance of the evidence to the clinical question, the statistical precision and size of the effect
(including clinical importance) of the results in the evidence-base, and the relevance of the effect to the
patients, compared with other management options (or none)
·
the duration of therapy required to achieve the effect, and
·
the balance of risks and benefits (taking into account the size of the patient population concerned).
4.
Generalisability
This component covers how well the subjects and settings of the included studies match those of the
recommendation. Population issues that might influence the relative importance of recommendations
include gender, age or ethnicity, baseline risk, or the level of care (e.g. community or hospital). This is
particularly important for evidence from randomised controlled trials (RCTs), as the setting and entry
requirements for such trials are generally narrowly based and therefore may not be representative of all the
patients to whom the recommendation may be applied in practice. Confirmation of RCT evidence by
broader-based population studies may be helpful in this regard (see ‗2. Consistency‘).
In the case of studies of diagnostic accuracy, a number of additional criteria also need to be taken into
account, including the stage of the disease (eg early versus advanced), the duration of illness and the
prevalence of the disease in the study population as compared to the target population for the guideline.
5.
Applicability
This component addresses whether the evidence base is relevant to the Australian health care setting
generally, or to more local settings for specific recommendations (such as rural areas or cities).
Factors that may reduce the direct application of study findings to the Australian or more local settings
include organisational factors (e.g. availability of trained staff, clinic time, specialised equipment, tests or
other resources) and cultural factors (e.g. attitudes to health issues, including those that may affect
compliance with the recommendation).
How to use the NHMRC Evidence Statement Form
Step 1 — Rate each of the five components
Applying evidence in real clinical situations is not usually straightforward. Consequently guideline
developers find that the body of evidence supporting a recommendation rarely consists of entirely one
rating for all the important components (outlined above). For example, a body of evidence may contain a
large number of studies with a low risk of bias and consistent findings, but which are not directly applicable
to the target population or Australian healthcare context and have only a limited clinical impact.
Alternatively, a body of evidence may only consist of one or two randomised trials with small sample sizes
that have a moderate risk of bias but have a very large clinical impact and are directly applicable to the
Australian healthcare context and target population. The NHMRC evidence grading system is designed to
allow for this mixture of components, while still reflecting the overall body of evidence supporting a
guideline recommendation.
74
The components described above should be rated according to the matrix shown in Table 3. Enter the
results into the NHMRC Evidence Statement Form along with any further notes relevant to the discussions
for each component.
The Evidence Statement Form also provides space to enter any other relevant factors that were taken into
account by the guideline developers when judging the body of evidence and developing the wording of the
recommendation.
Step 2 — Prepare an evidence statement matrix
In the ‗Evidence statement matrix ‘ section of the form, summarise the guideline developers‘ synthesis of
the evidence relating to each component at the right hand side of the form, and fill in the evidence matrix at
the left hand side of the form. Each recommendation should be accompanied by this matrix as well as the
overall grade given to the recommendation (see Step 3). Developers should indicate dissenting opinions or
other relevant issues in the space provided under the evidence matrix.
Step 3 — Formulate a recommendation based on the body of evidence
Develop wording for the recommendation. This should address the specific clinical question and ideally be
written as an action statement. The wording of the recommendation should reflect the strength of the body
of evidence. Words such as ‗must‘ or ‗should‘ are used when the evidence underpinning the
recommendation is strong, and words such as ‗might‘ or ‗could‘ are used when the evidence body is
weaker.
Step 4 — Determine the grade for the recommendation
Determine the overall grade of the recommendation based on a summation of the rating for each
individual component of the body of evidence. A recommendation cannot be graded A or B unless the
evidence base and consistency of the evidence are both rated A or B.
NHMRC overall grades of recommendation are intended to indicate the strength of the body of evidence
underpinning the recommendation. This should assist users of the clinical practice guidelines to make
75
appropriate and informed clinical judgments. Grade A or B recommendations are generally based on a
body of evidence that can be trusted to guide clinical practice, whereas Grades C or D recommendations
must be applied carefully to individual clinical and organisational circumstances and should be interpreted
with care (see Table 4).
Implementing guideline recommendations
How the guideline will be implemented should be considered at the time that the guideline
recommendations are being formulated. Guidelines require an implementation plan that ensures
appropriate roll out, supports and evaluation of guideline effectiveness in improving practice, and guideline
uptake. The Evidence Statement Form asks developers to consider four questions related to the
implementation of each recommendation:
·
Will this recommendation result in changes in usual care?
·
Are there any resource implications associated with implementing this recommendation?
·
Will the implementation of this recommendation require changes in the way care is currently
organised?
·
Are the guideline development group aware of any barriers to the implementation of this
recommendation?
Conclusion
This paper outlines an approach piloted and refined over two years by NHMRC GAR consultants. This
approach reflects the concerted input of experience in assisting a range of guideline developers to develop
guidelines for a range of conditions and purposes. This approach provides a way forward for guideline
developers to appraise, classify and grade evidence relevant to the purpose of a guideline. With further
application of these levels and grades of evidence, modifications will inevitably be made to further improve
guideline development processes.
76
Appendix 12
NHMRC citations inclusions/exclusions proforma
NHMRC Submitted Citations Inclusions/Exclusions list
Incl
Supports
BOE?
Excl XS
Excl NP
Excl NO
Included
Already
Citation
Excl Not
In
Timefram
NS
Excl
e frame
[insert question number and topic here]
[insert full citation here]
Fill in Y or N in one column for each citation as follows:
·
Included already
BOE
Article was retrieved in the systematic search and was included in the
·
Excl not in timeframe
Article did not fit within the date range supplied by NHMRC
·
Other Exclusion codes
As defined and applied for main body of literature
·
Incl Supports BOE?
Y if the citation supports the BOE,N if it does not
77
Section 9 References
1. NHMRC 2000, How to use the evidence: assessment and application of scientific evidence.
http://nhmrc.gov.au/publications/categories/information.htm. Retrieved 24 March 2009.
2. American Dietetic Association. 2008, Evidence Analysis Manual. Steps in the ADA Evidence Analysis
Process. Scientific Affairs and Research. Chicago.
3. From: Part B of NHMRC 2008, How to use the evidence: assessment and application of scientific
evidence.
http://www.nhmrc.gov.au/guidelines/consult/consultations/add_levels_grades_dev_guidelines2.
htm. Retrieved 14 September 2009.
4. NHMRC 2007, NHMRC standards and procedures for externally developed guidelines.
http://www.nhmrc.gov.au/publications/synopses/nh56syn.htm. Retrieved 14 September 2009.
78
Section 9 References

Process Manual - Dietitians Association of Australia

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