Dose adjustment for normal eating (DAFNE) - an audit of outcomes in Australia.
ABSTRACT To audit and describe the effects of participation in the Dose Adjustment for Normal Eating (DAFNE) course on clinical outcomes in people with type 1 diabetes mellitus (T1DM).
Audit of clinical outcomes before and 1 year after DAFNE training for 145 people with T1DM who participated in courses at seven Australian diabetes centres between February 2005 and March 2007. Participants had been diagnosed with T1DM at least 1 year before and were beyond the "honeymoon phase", with glycated haemoglobin (HbA(1c)) < 12% and no severe diabetes complications. They were aged over 17 years and able to understand written and spoken English.
A 5-day structured education program covering T1DM management with an emphasis on unrestricted diet, precise carbohydrate estimation and prandial insulin dosing using insulin-to-carbohydrate ratios.
Glycaemic control (HbA(1c) levels), weight, severe hypoglycaemia, and quality of life scores on general (Hospital Anxiety and Depression) and diabetes-specific (Problem Areas in Diabetes) scales.
Mean HbA(1c) fell from 8.2% to 7.8% (95% CI for change, - 0.5% to - 0.2%; P < 0.0001) and weight from 75.1 to 74.2 kg (95% CI for change, - 1.6 to - 0.2 kg; P = 0.012). Severe hypoglycaemia was less frequent after DAFNE training (P = 0.0001). Quality of life improved (P < 0.0001 for both scales).
One year after participation in the DAFNE program of structured education, people with T1DM showed improved glycaemic control, reduced incidence of severe hypoglycaemia, slightly reduced weight and improved quality of life. The DAFNE course offers one means of improving clinical outcomes in T1DM.
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ABSTRACT: AimAdvanced carbohydrate counting, a systematic method for insulin bolus calculation, is recommended in the management of Type 1 diabetes. The aim of this systematic review was to summarize all available evidence from randomized and observational studies of the effects of advanced carbohydrate counting on glycaemic control (HbA1c), psychosocial measures, weight and hypoglycaemic events in patients of all age groups with Type 1 diabetes on a basal–bolus insulin regimen.Methods An electronic search of Scopus, MEDLINE and The Cochrane Library conducted in January 2013 identified 27 relevant articles. Six were randomized controlled trials and 21 were observational studies. Large heterogeneity existed across studies with regard to study design and patient populations. Reporting of statistical measures was insufficient to serve as a basis for a meta-analysis.ResultsOverall, the studies demonstrated a positive trend in change in HbA1c after introduction of advanced carbohydrate counting. Reductions in HbA1c ranged from 0.0 to 17 mmol/mol (0.0–1.6%). Most psychosocial measures improved; however, only few improvements were clinically considered relevant. Both weight gain and reduction were registered, but most studies found no significant weight changes. The majority of studies assessing the incidence of hypoglycaemic events found a significant reduction in the event rate and none reported an increase in the incidence.Conclusions In summary, the currently available literature does not provide sufficient evidence to definitively determine the effects of advanced carbohydrate counting on HbA1c, psychosocial measures, weight or hypoglycaemic events. Nevertheless, the method still appears preferable to other insulin dosing procedures, which justifies continued use and inclusion of advanced carbohydrate counting in clinical guidelines.This article is protected by copyright. All rights reserved.Diabetic Medicine 03/2014; · 3.24 Impact Factor
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ABSTRACT: The Dose Adjustment for Normal Eating (DAFNE) programme of intensive insulin therapy for type 1 diabetes provides a structured educational intervention to improve glycemic control, reduce hypoglycemia and improve quality of life. Enhancement of self-management skills is a key element of DAFNE and patients acquire detailed skills in insulin dose adjustment. Following DAFNE training, patients report improved confidence in their ability to manage their own insulin dosing, but generally still seek and require the assistance of health professionals when making substantial changes to their insulin regimens. Some DAFNE trained patients may be able to assist their peers in aspects of diabetes management within a group environment, but widespread introduction of the expert patient/peer educator role in the self-management of type 1 diabetes, in particular related to insulin dose management, would require formal and detailed evaluation, preferably in randomized controlled clinical trials, before being introduced into routine clinical practice.Diabetes & metabolism journal 04/2014; 38(2):87-91.
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MJA • Volume 192 Number 11 • 7 June 2010
The Medical Journal of Australia ISSN:
0025-729X 7 June 2010 192 11 637-640
©The Medical Journal of Australia 2010
tralia since February 2005. These involve a
5-day (Monday to Friday over 1 week)
outpatient program of structured education
in diabetes self-management for groups of
six to eight people with T1DM, with an
emphasis on insulin dose adjustment using
a flexible dietary intake and detailed estima-
tion of dietary carbohydrate intake. Insulin-
to-carbohydrate ratios and corrective insulin
doses form the basis of prandial insulin
A national “OzDAFNE” collaborative
coordinates training and accreditation of
centres and ensures standardised, high-
quality delivery of the DAFNE course in
Australia. The dietary elements of DAFNE
have been adapted to Australian food
choices and nutritional analysis, but the core
curriculum is consistent with the UK pro-
gram. Collection of audit data (before and
1 year after DAFNE training) from partici-
pants is an agreed condition of membership
of the OzDAFNE collaborative. This is
funded through each centre’s existing
This report presents outcome data for the
cohort of people with T1DM who partici-
pated in DAFNE courses in Australia
between February 2005 and March 2007.
any people with type 1 diabetes
mellitus (T1DM) struggle with the
everyday challenge of attempting
to achieve near-normal glycaemia while
avoiding hypoglycaemia. The Dose Adjust-
ment for Normal Eating (DAFNE) program
of structured education for people with
T1DM,1 developed in the United Kingdom
by adapting a German diabetes teaching and
treatment program,2 offers one potential
approach to managing this problem.
Reported benefits of DAFNE training
include improved overall glycaemic control,
reduced hypoglycaemia and improved qual-
ity of life.1,2
DAFNE courses have been offered in Aus-
Clinical data collection
Pre-specified inclusion criteria for DAFNE
training included confirmation of T1DM at
least 12 months previously; being in the
post-“honeymoon phase”; glycated haemo-
globin (HbA1c) level <12%; age over 17
years; and ability to understand written and
spoken English. To be included in this study,
we required participants to have HbA1c lev-
els recorded both before and after DAFNE
training. De-identified clinical data from
people undergoing DAFNE training were
collected at seven specialist (secondary/terti-
ary) diabetes centres and community diabe-
tes organisations and entered into a secure
web-based database. The OzDAFNE data-
base was locked on 31 March 2008.
Participants agreed to the use of their de-
identified collective data for quality assurance
purposes, but no formal consent form was
used. The data collection and reporting pro-
cess was reviewed by the Mater Health Serv-
ices Human Research Ethics Committee and
the study was exempted as a quality assur-
ance activity, consistent with National Health
and Medical Research Council guidelines.3
Data items included participants’ demo-
graphics, anthropometric data, history of
diabetes and its complications, biochemical
variables and scores from two measures of
quality of life — the Hospital Anxiety and
Depression Scale (HADS)4 and the Problem
Areas in Diabetes (PAID) Scale5 — which
have been validated in people with diabetes.
The HADS is used to assess both anxiety and
depressive symptoms. From a possible total
score of 21 over both domains, scores <7
are considered normal, 8–10 suggestive of
anxiety or depression, and ?11 indicative
of a probable mood disorder. The PAID
score covers a range of emotional states
frequently reported in diabetes. These data
were collected within 1 month of beginning
and 1 year after participation in the DAFNE
program. Biochemical variables were ana-
lysed using routine methods at each local
DAFNE centre, without standardisation
Dose adjustment for normal eating (DAFNE) —
an audit of outcomes in Australia
H David McIntyre, Brigid A Knight, Dianne M Harvey, Marina N Noud, Virginia L Hagger and Kristen S Gilshenan
Objective: To audit and describe the effects of participation in the Dose Adjustment for
Normal Eating (DAFNE) course on clinical outcomes in people with type 1 diabetes
Design, setting and participants: Audit of clinical outcomes before and 1 year after
DAFNE training for 145 people with T1DM who participated in courses at seven
Australian diabetes centres between February 2005 and March 2007. Participants had
been diagnosed with T1DM at least 1 year before and were beyond the “honeymoon
phase”, with glycated haemoglobin (HbA1c) <12% and no severe diabetes
complications. They were aged over 17 years and able to understand written and spoken
Intervention: A 5-day structured education program covering T1DM management with
an emphasis on unrestricted diet, precise carbohydrate estimation and prandial insulin
dosing using insulin-to-carbohydrate ratios.
Main outcome measures: Glycaemic control (HbA1c levels), weight, severe
hypoglycaemia, and quality of life scores on general (Hospital Anxiety and Depression)
and diabetes-specific (Problem Areas in Diabetes) scales.
Results: Mean HbA1c fell from 8.2% to 7.8% (95% CI for change, −0.5% to −0.2%;
P<0.0001) and weight from 75.1 to 74.2kg (95% CI for change, −1.6 to −0.2kg; P=0.012).
Severe hypoglycaemia was less frequent after DAFNE training (P=0.0001). Quality of life
improved (P<0.0001 for both scales).
Conclusions: One year after participation in the DAFNE program of structured
education, people with T1DM showed improved glycaemic control, reduced incidence
of severe hypoglycaemia, slightly reduced weight and improved quality of life. The
DAFNE course offers one means of improving clinical outcomes in T1DM.
MJA 2010; 192: 637–640
638MJA • Volume 192 Number 11 • 7 June 2010
Data items were tested for normality of
distribution using the Shapiro–Wilk test and
results verified by examining Q-Q plots.
Normally distributed data were analysed
primarily using paired t tests and are
reported as mean ± SD or mean difference
(95% confidence interval). Non-normally
distributed data were analysed using the
Wilcoxon signed rank test and are reported
as median (interquartile range). Statistical
comparisons were by unpaired t tests for
continuous variables. Categorical results are
reported as frequencies (%) and were ana-
lysed using the χ2 test or Fisher exact test.
Exact P values are noted unless P is less than
0.0001. Statistica, version 8.0 (StatSoft,
Tulsa, Okla, USA) was used for all analyses.
Baseline data for 446 DAFNE course partici-
pants were recorded in the system. Of these,
272 had completed DAFNE training at least
1 year before the locking of the database
and were eligible for inclusion. One-hundred
and fifty-five people had at least some
recorded data 1 year after training, and 145
(53%) had HbA1c levels recorded both
before and after DAFNE training. These 145
people form the cohort for this report. The
number of participants with data recorded
varies for different characteristics. Baseline
characteristics of the people included and
excluded from this study are presented in
Box 1. Only the frequency of diabetic
peripheral neuropathy varied significantly
between these two groups. Nearly all of our
final cohort (97%) were white. Participants’
mean body mass index (BMI) was in the
overweight range. Twenty-eight per cent had
known complications of diabetes.
Major clinical outcomes
Mean HbA1c levels for the whole cohort
fell from 8.2% to 7.8% (95% CI for
change, −0.5% to −0.2%; P<0.0001), and
the change in HbA1c varied according to
baseline glycaemic control, being greater for
participants with HbA1c levels in the highest
quartile before DAFNE training (Box 2).
Thirty-four per cent of participants (48/
143) reported severe hypoglycaemic events
(defined as an episode requiring the assist-
ance of a third party) in the year before they
undertook DAFNE training (Box 1), with 13
people reporting more than four events.
Overall, severe hypoglycaemic events were
less frequent in the 12 months after DAFNE
training (P<0.0001). The distribution of
severe hypoglycaemic events was markedly
skewed at baseline, with the remaining 66%
of participants (95/143) reporting no events
in the previous year.
The change in number of severe hypogly-
caemic events per year confirms an overall
improvement after DAFNE training (Box 3).
Eight per cent (11/137) of participants
reported an increase in frequency of severe
hypoglycaemia in the year after DAFNE
training. This group had a longer duration
of diabetes, but did not differ in any of the
other baseline characteristics. Twenty-eight
percent (39/137) reported a decrease in
frequency of severe hypoglycaemia. Eighty-
three of 87 people who reported no change
in hypoglycaemia frequency had not experi-
enced severe hypoglycaemia in the year
before DAFNE training.
Participants’ mean weight had fallen by
0.9kg 12 months after DAFNE participation
(95% CI for change, −1.6 to −0.2kg; P=
0.012) (Box 4).
Assessment using the PAID and HADS
questionnaires showed that participants’
quality of life had improved 1 year after
DAFNE training. The median PAID score
before DAFNE training was 25, typical for
an unselected outpatient population.5 This
decreased to 16.25 (consistent with
improved quality of life) 1 year after DAFNE
training, corresponding to a small-to-mod-
erate effect size (Box 4). Before training,
participants’ PAID scores were highest for
questions relating to hypoglycaemia, the
future risk of complications, and guilt and
anxiety for getting “off track” with diabetes
management. The greatest reductions after
training were seen in these areas and in
concerns regarding food and eating.
The median scores for both HADS ques-
tionnaires showed small to moderate reduc-
tions after DAFNE training (Box 4). At the
12-month follow-up, a greater proportion of
participants showed scores in the normal
and mid ranges, with fewer having scores
that are likely to indicate a mood disorder.
Our audit of clinical outcomes suggests that
the DAFNE program benefits people with
1 Comparison of baseline characteristics of participants in the DAFNE program
who were included and excluded from this study
With follow-up HbA1c level*
Without follow-up HbA1c
recorded Mean (SD)P
Duration of diabetes
No. (%) No. (%)
in previous year
Ketoacidosis in previous
145 8 (6%)1248 (6%) 0.31
BMI=body mass index. DAFNE=Dose Adjustment for Normal Eating. HbA1c=glycated haemoglobin.
*Participants for whom HbA1c levels were recorded before and 1 year after DAFNE training (included in this
study). †Participants for whom HbA1c levels were only available before DAFNE training (excluded from this
study). ‡Defined as an episode requiring the assistance of a third party.
MJA • Volume 192 Number 11 • 7 June 2010
T1DM in Australia. The results are broadly
consistent with those reported in the UK
DAFNE randomised controlled trial1 and in a
large-scale German audit series.6 The UK trial
reported a larger (about 1%) mean reduction
in HbA1c levels, but it had recruited patients
with poor glycaemic control and a mean
HbA1c level of 9.3% at baseline. Consistent
with our findings, the German audit
described differences in HbA1c reduction
according to baseline HbA1c quartile.
The landmark Diabetes Control and
Complications Trial (DCCT)7 offered the
first clear evidence that improved glycaemic
control in T1DM improves clinical (in par-
ticular, microvascular) outcomes, but both
the DCCT8 and a subsequent meta-analysis9
suggested that HbA1c reduction must inevi-
tably be accompanied by an increase in
severe hypoglycaemia. This, in addition to
the weight gain associated with intensive
therapy,7 has served to discourage many
people with diabetes, and their treating doc-
tors, from attempting more intensive glycae-
However, both our data and the UK and
German reports1,6 demonstrate that it is
possible to lower HbA1c levels without these
unwanted effects using the DAFNE struc-
tured education program. We suggest that
these benefits may derive from the very
detailed 5-day program of patient education
that comprises the DAFNE course and from
the less stringent glycaemic targets used in
DAFNE. While the DCCT program was
largely doctor-, dietitian- and nurse-driven,
with prescription of dietary regimens, and
insulin doses adjusted by clinicians, DAFNE
promotes self-management with dietary
flexibility and self-titration of insulin doses.
Type 1 diabetes is a profoundly vexatious
chronic disease for many people, as it
involves complex juggling of insulin doses
according to food intake, glucose concentra-
tions, exercise and other, often apparently
random, factors on an unremitting daily
basis. This clearly can impair quality of life.
Although quality of life was not markedly
abnormal in our cohort at baseline, all meas-
ures did improve after participation in the
DAFNE course. The reasons for this may
include reduced hypoglycaemia,10 improved
self-management skills and confidence, and
building a relationship with the health pro-
fessional team, as well as the supportive
environment and sharing of experiences of
the “diabetic life” which, anecdotally, are
always part of the DAFNE group dynamic.
Some limitations of our data should be
noted. All data items were collected in a
routine clinical environment, without stand-
ardised assays, dedicated staff or uniform
data collection systems.
People with T1DM participating in
DAFNE may not be representative of the
population of people with T1DM as a whole.
However, the mean baseline HbA1c level and
BMI for our cohort were very similar to
reported values for the cohort of T1DM
patients who participated in the 2006 Aus-
tralian National Diabetes Information Audit
and Benchmarking survey of patients
attending specialist diabetes clinics in Aus-
tralia (HbA1c, 8.1% ±1.6%; BMI,
26.2 ±4.5kg/m2).11 The distribution of
HADS scores in our cohort at baseline was
also similar to that reported in a UK cohort
of adults with T1DM.4 The reasons why
2 Change in participants’ HbA1c
levels 1 year after DAFNE
DAFNE=dose adjustment for normal eating.
HbA1c=glycated haemoglobin. *Absolute
change in mean HbA1c (95% CI) (HbA1c post
DAFNE− HbA1c pre DAFNE), categorised by
baseline HbA1c quartile group. Quartile ranges:
Q1, 6.2%–7.4%; Q2, 7.5%–8.1%; Q3, 8.2%–9.0%;
Pre-DAFNE HbA1c quartile
Change in HbA1c (post DAFNE − pre DAFNE)
3 Change in self-reported
frequency* of severe
hypoglycaemia† among DAFNE
DAFNE=dose adjustment for normal eating.
*Comparing the year following DAFNE training
with the year before DAFNE training. †Defined as
an episode requiring the assistance of a third
−4 to −1
1 to 4
Change in severe hypoglycaemia (events/year)
Number of particpants
4 Major clinical outcomes for participants 1 year after DAFNE training (n=145)
1 year after
(− 0.5% to − 0.2%)
(− 1.6 to − 0.2)
Weight (kg) 75.1 (13.8)74.2 (13.4)
variablesMedian (IQR) Median (IQR)P
episodes previous year
HADS — anxiety score
HADS — depression score
PAID — total score
0 (0–1)0 (0–0) 0.0001
DAFNE=dose adjustment for normal eating. HADS=Hospital Anxiety and Depression Scale.4
HbA1c=glycated haemoglobin. IQR=interquartile range. PAID=Problem Areas in Diabetes Scale.5
*Mean and 95% CIs shown for change in HbA1c and weight (post DAFNE − pre DAFNE). †P values are for
comparison of pre- versus post-DAFNE results.
640MJA • Volume 192 Number 11 • 7 June 2010
some participants did not attend for data
collection 1 year after DAFNE training are
not known, but these participants do not
appear to differ in terms of baseline clinical
characteristics from those who did attend.
This audit reports outcomes on a pre- and
post-intervention basis, with no control
group to assess changes over time without
the intervention. However, such data are
available from the UK DAFNE study1 and
our results are consistent with other pub-
Structured patient education has been
endorsed as a routine part of diabetes man-
agement by the National Institute for Clini-
cal Excellence in the UK,12 with DAFNE
being recognised as one program suitable for
people with T1DM. Cost modelling in the
UK has suggested that DAFNE is cost-sav-
ing, due to reduced diabetic complications,
rather than just cost-effective.13 Other struc-
tured education courses, such as the
Empowerment program developed and con-
ducted in Newcastle, Australia,14 and flexi-
ble insulin therapy teaching courses in
Basel, Switzerland,15 have also shown bene-
fits, including reduced hypoglycaemia and
improved quality of life, although reduc-
tions in HbA1c levels have not always been
shown, perhaps due to differing participant
Despite the positive outcomes of DAFNE
in Australia, funding for this type of inten-
sive, structured education program remains
difficult to secure. Limited support for
group education is available to people with
type 2 diabetes.16 However, the current
Medicare Benefits Schedule rebate of $16.00
per group service (Item 81105) is clearly
inadequate to fund an intensive education
program, and T1DM is excluded. Many
OzDAFNE centres have been charging no or
minimal fees for the DAFNE course. This
allows some people with T1DM to access
the program, but limits the number of
courses that centres are able to provide.
In summary, our audit of people with
T1DM undergoing the DAFNE course dem-
onstrates clinical benefits similar to those
reported in other health care settings.
DAFNE provides one potential means of
improving glycaemic control and other
important health outcomes in people with
T1DM. We believe that OzDAFNE merits
consideration for more widespread availabil-
ity, predicated on more systematic funding.
David McIntyre has received speaker fees and
travel assistance from companies involved in provi-
sion of insulin/delivery systems for type 1 diabetes
care, including Novo Nordisk, Eli Lilly, sanofi-
aventis and Medtronic. He is a previous President
of the DAFNE Association of Australia Inc (now
delisted) and Director of a diabetes centre
involved in the provision of DAFNE courses, but
has derived no personal profit from this.
H David McIntyre, MBBS, FRACP, Head of
Mater Clinical School and Director1
Brigid A Knight, BSc, GradDipNutrDiet,
Dietitian and Diabetes Educator2
Dianne M Harvey, BSc, GradDipDietetics,
Dietitian and OzDAFNE Coordinator3
Marina N Noud, MNurs, DipEd, CDE, Clinical
Nurse Consultant, Diabetes and
Virginia L Hagger, MPH, RN-CDE, GradDipVet,
Health and Education Services Manager3
Kristen S Gilshenan, BMaths(Hons), BInfoTech,
Statistician, Mater Research Support Centre2
1 Endocrinology and Obstetric Medicine,
University of Queensland and Mater Health
Services, Brisbane, QLD.
2 Mater Health Services, Brisbane, QLD.
3 Diabetes Australia, Victoria, Melbourne, VIC.
1 DAFNE Study Group. Training in flexible, inten-
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dom in people with type 1 diabetes: dose
adjustment for normal eating (DAFNE) ran-
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2 Mühlhauser I, Bruckner I, Berger M, et al. Evalu-
ation of an intensified insulin treatment and
teaching programme as routine management
of type 1 (insulin-dependent) diabetes. The
Bucharest-Düsseldorf study. Diabetologia
1987; 30: 681-690.
3 National Health and Medical Research Council.
When does quality assurance in health care
require independent ethical review? Canberra:
4 Shaban MC, Fosbury J, Kerr D, Cavan DA. The
prevalence of depression and anxiety in adults
with Type 1 diabetes. Diabet Med 2006; 23:
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WH. Responsiveness of the Problem Areas In
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2003; 20: 69-72.
6 Sämann A, Mühlhauser I, Bender R, et al. Gly-
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with type 1 diabetes: a prospective implemen-
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7 Diabetes Control and Complications Trial
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ment of diabetes on the development and
progression of long-term complications in insu-
lin-dependent diabetes mellitus. N Engl J Med
1993; 329: 977-986.
8 Diabetes Control and Complications Trial
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1997; 46: 271-286.
9 Egger M, Davey Smith G, Stettler C, Diem P.
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10 Davis RE, Morrissey M, Peters JR, et al. Impact
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11 National Association of Diabetes Centres.
ANDIAB 2006 — Australian national diabetes
information audit and benchmarking. Final
report. Canberra: Australian Government
Department of Health and Ageing, 2007.
12 National Institute for Clinical Excellence. Guid-
ance on the use of patient-education models
for diabetes. (Technology appraisal guidance
60.) London: NICE, 2003.
13 Shearer A, Bagust A, Sanderson D, et al. Cost-
effectiveness of flexible intensive insulin man-
agement to enable dietary freedom in people
with Type 1 diabetes in the UK. Diabet Med
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14 Lowe J, Linjawi S, Mensch M, et al. Flexible
eating and flexible insulin dosing in patients
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16 Australian Government Department of Health
and Ageing. Medicare Benefits Schedule.
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(Received 28 May 2009, accepted 3 Feb 2010)