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MJA 209 (7 Suppl) • 1 October 2018
Translation and implementation of the Australian-led PCOS guideline
Translation and implementation of the
Australian-led PCOS guideline: clinical summary
and translation resources from the International
Evidence-based Guideline for the Assessment
and Management of Polycystic Ovary Syndrome
Helena J Teede1,2, Marie L Misso1,2, Jacqueline A Boyle1,2, Rhonda M Garad1,2, Veryan McAllister1,3, Linda Downes1,2, Melanie Gibson1,2, Roger
J Hart1,4, Luk Rombauts5, Lisa Moran1,2, Anuja Dokras6, Joop Laven7, Terhi Piltonen8, Raymond J Rodgers1,9, Mala Thondan10, Michael F
Costello1,11, Robert J Norman1,9, on behalf of the International PCOS Network
1 National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash and Adelaide Universities, Melbourne, VIC. 2 Monash Centre for Health Research and
Implementation, Monash Public Health and Preventive Medicine, Monash University and Monash Health, Melbourne, VIC. 3 Polycystic Ovary Syndrome Association of Australia, Sydney,
NS W. 4 University of Western Australia, Perth, WA. 5 Department of Obstetrics and Gynaecology, Monash University, Melbourne, VIC. 6 Obstetrics and Gynecology, University of Pennsylvania,
Philadelphia, PA, USA. 7 Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, Netherlands. 8 Obstetrics and
Gynecology, PEDEGO Research Unit, Medical Research Centre, Oulu University Hospital, Oulu, Finland. 9 Robinson Research Institute, University of Adelaide and Fertility SA, Adelaide, SA. 10 Harp
Family Medical Centre, Melbourne, VIC. 11 UNSW Sydney, Sydney, NSW. helena.teedee@monash.edu • doi: 10.5694/mja18.00656
Abstract
Introduction: We have developed the first international
evidence-based guideline for the diagnosis and management
of polycystic ovary syndrome (PCOS), with an integrated
translation program incorporating resources for health
professionals and consumers. The development process
involved an extensive Australian-led international and
multidisciplinary collaboration of health professionals and
consumers over 2 years. The guideline is approved by the
National Health and Medical Research Council and aims to
support both health professionals and women with PCOS in
improving care, health outcomes and quality of life. A robust
evaluation process will enable practice benchmarking and
feedback to further inform evidence-based practice. We
propose that this methodology could be used in developing
and implementing guidelines for other women’s health
conditions and beyond.
Main recommendations: The recommendations cover
the following broad areas: diagnosis, screening and risk
assessment depending on life stage; emotional wellbeing;
healthy lifestyle; pharmacological treatment for non-fertility
indications; and assessment and treatment of infertility.
Changes in management as a result of this guideline:
• Diagnosis:
▪▪ when the combination of hyperandrogenism and
ovulatory dysfunction is present, ultrasound examination
of the ovaries is not necessary for diagnosis of PCOS in
adult women;
▪▪ requires the combination of hyperandrogenism and
ovulatory dysfunction in young women within 8 years of
menarche, with ultrasound examination of the ovaries
not recommended, owing to the overlap with normal
ovarian physiology; and
▪▪ adolescents with some clinical features of PCOS, but
without a clear diagnosis, should be regarded as “at risk”
and receive follow-up assessment.
• Screening for metabolic complications has been refined and
incorporates both PCOS status and additional metabolic
risk factors.
• Treatment of infertility: letrozole is now first line treatment
for infertility as it improves live birth rates while reducing
multiple pregnancies compared with clomiphene citrate.
Polycystic ovary syndrome (PCOS) aects 8–13% of reproductive
age women, with around 21% of Indigenous women aected.1,2
Clinically, reproductive features are prominent and underpin
PCOS diagnosis.3 The Roerdam diagnostic criteria are based on
two of three features: oligo- or anovulation, hyperandrogenism
(clinical or biochemical) and polycystic ovaries on ultrasound,
after exclusion of other causes (Box 1).3 Aetiology includes
genetic causes, in utero hormone exposure and lifestyle factors
(Box 2).4,5 PCOS is an endocrine disorder underpinned by
insulin resistance and hyperandrogenism.5,6 It is associated
with signicant metabolic features including increased rates
of gestational diabetes and type 2 diabetes mellitus as well as
an increase in cardiovascular risk factors (Box 2).7 PCOS has
signicant psychological impact with increased depression and
anxiety and impaired quality of life (Box 2).8,9 There is also an
increased rate of weight gain and prevalence of obesity in PCOS,
increasing severity of the condition, causing considerable concern
for those aected and mandating aention to healthy lifestyle.10
Obtaining a timely PCOS diagnosis is challenging for women,
with many experiencing delays with multiple dierent doctors
involved.11-13 Inadequate information provision and lack of
satisfaction with care has been reported, especially in areas such
as psychological features, lifestyle and prevention. Doctors often
focus on individual features of PCOS such as infertility, rather
than taking a broader approach to care.13 There is also potential
for overdiagnosis, including when isolated polycystic ovarian
morphology on ultrasound is incorrectly equated with PCOS.
Access to timely, accurate diagnosis and information provision
needs signicant improvement.
1 Diagnosis of polycystic ovary syndrome
Adapted from Teede et al.9
Adult
women
Adolescents
Rotterdam diagnostic criteria require two of:
1. Oligo- or anovulation;
2. Clinical and/or biochemical hyperandrogenism;
3. Polycystic ovaries;
after exclusion of other aetiologies
Diagnostic criteria require:
1. Oligo- or anovulation: and,
2. Clinical and/or biochemical hyperandrogenism;
after exclusion of other aetiologies
Ultrasound is not recommended in diagnosis <8 years
post menarche
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MJA 209 (7 Suppl) • 1 October 2018
Supplement
Clinically, there is considerable variation in care and evidence
of confusion around diagnostic criteria.11,14 Researchers are
frustrated with inadequate priority and funding in PCOS,
especially given the prevalence, disease and economic burden.15
These challenges are exacerbated by inconsistent guideline
quality and recommendations. Past guidelines have not
followed recommended rigorous development processes, have
not involved diverse health professionals including primary
care providers, have not engaged women aected by PCOS, are
country specic or, as in the case of the 2011 Australian PCOS
guidelines,9 are now out of date. In this context, PCOS is a clear
priority area for updated, consistent rigorously co-developed
guidelines, translation resources and health professional and
consumer support.16
The National Health and Medical Research Council (NHMRC)
funded a Centre of Research Excellence to address current gaps.
Through a multidisciplinary national alliance and international
network, including primary care providers and women with
PCOS, we have developed the International evidence-based
guideline for the assessment and management of polycystic ovary
syndrome 2018 and co-designed an extensive range of translation
resources (Box 3).16
The guideline addresses:
screening, diagnostic assessment, risk assessment and life
stage (Algorithm 1);
prevalence, screening, diagnostic assessment and treatment
of emotional wellbeing (Algorithm 2);
lifestyle (Algorithm 3);
pharmacological treatment for non-fertility indications
(Algorithm 4); and
assessment and treatment of infertility (Algorithm 5).
Diverse PCOS features are considered, including reproductive
(hyperandrogenism, anovulation, infertility), metabolic
(insulin resistance, impaired glucose tolerance, gestational
and type 2 diabetes, adverse cardiovascular risk proles) and
psychological features (increased anxiety and depression and
worsened quality of life).17 The guideline recognises variable
presentation across the lifespan; ethnicity, which has an impact
on dermatological and metabolic
features; and cultural factors aecting
experiences of women with PCOS.
The guideline abstract is provided
in Box 4 and the full guideline is
available at hps://www.monash.
edu/medicine/sphpm/mchri/pcos.
Guideline development
process and methods
The guideline and translation
program were developed through the
integration of clinical perspectives,
the preferences of women and
the best available evidence.
International society-nominated
panels included consumers and
experts in the elds of paediatrics,
endocrinology, gynaecology, primary
care, reproductive endocrinology,
psychiatry, psychology, dietetics,
exercise physiology, public health,
project management and evidence
synthesis translation. Governance
included an international advisory
and a project board, ve guideline
development groups, and consumer and translation commiees.
The NHMRC Australian Centre for Research Excellence in PCOS
co-funded the guideline in partnership with the European
Society of Human Reproduction and Embryology and the
American Society for Reproductive Medicine. Thirty-seven
organisations across 71 countries collaborated to address 60
prioritised clinical questions based on 40 systematic and 20
narrative reviews, generating 166 recommendations. Methods
met NHMRC standards and procedures for externally developed
guidelines18 and are outlined in the full guideline and Box 5.19
These involved rigorous systematic review, training, online
communication and face-to-face meetings to discuss the evidence
and apply the Grading of Recommendations, Assessment,
Development, and Evaluation (GRADE) framework. Evidence
quality, feasibility, acceptability, cost, implementation and
ultimately recommendation strength were agreed across the
panel. Convened commiees from partner and collaborating
organisations provided peer review and the guideline was
approved by the NHMRC.20-22
Women with PCOS and health professionals as the end users
played a fundamental role in developing the guideline and
resources. Stakeholder engagement and processes for guideline
and translation resource development are outlined in Box 5.19 A
summary of the recommendations is published elsewhere.20-22
The MJA has also published an editorial accompanying this
supplement.23
In this supplement, we aim to optimise translation and
implementation of the guideline (Box 4) by providing a brief clinical
summary in the Australian context, noting key changes in practice,
and by supporting health care providers, especially those in primary
care, with co-designed, practical information, tools and consumer
resources to improve outcomes and quality of life for women with
PCOS (Box 3). We also highlight implications for Aboriginal and
Torres Strait Islander women who are at high risk of PCOS.
The guideline is underpinned by a robust evaluation process
which will enable practice benchmarking and feedback data to
be collected to guide further alignment with evidence-based care.
Downloads of the guideline and its resources will be monitored;
focus groups and surveys will measure awareness in consumers
and knowledge and practice change by health professionals. This
2 Aetiology and clinical manifestations of polycystic ovary syndrome
Adapted from Teede et al.9
Genetics
Androgens
Hirsutism
Acne
Diabetes
Metabolic syndrome
Cardiovascular risk
Insulin
Ovarian follicles
Anovulation
Oestrogen
Menstrual disturbances
Sub fertility
Psycho-social issues: body image, self esteem, depression, anxiety
Lifestyle
In utero hormonal exposures
Obesity exacerbates hormonal changes
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MJA 209 (7 Suppl) • 1 October 2018
Translation and implementation of the Australian-led PCOS guideline
information will then be compared with data that were collected
before the guideline release, to measure change.
This strategic international approach involved strong partnership
between consumers, multidisciplinary health professionals,
academics and professional societies and we propose that this
is transferable to other women’s health conditions and beyond.
Such an approach can reduce duplication of eort and promote
consistency of care and focus on provision of useful, accessible
and meaningful resources to support both health professionals
and people aected by a variety of conditions.24
Screening, diagnostic assessment, risk
assessment and life stage (Algorithm 1)
We aim to improve accuracy and to simplify
and facilitate timely diagnosis, while avoiding
overdiagnosis, especially in adolescents. The guideline
endorses the consensus-based Roerdam diagnostic
criteria3,20 for adult women and supports them with
best available evidence. Algorithm 1 (hps://www.
monash.edu/__data/assets/pdf_file/0018/1411641/
Algorithm-1-20180618.pdf) highlights the rened
diagnostic criteria in adolescents, which require
both hyperandrogenism and irregular cycles, with
ultrasound now not recommended for diagnosis within
8 years of menarche, owing to overlap with normal
reproductive physiology. Adolescents with clinical
features but not a clear diagnosis are deemed “at risk”,
with follow-up assessment recommended. Diagnostic
features are rened, including irregular cycles, clinical
and biochemical hyperandrogenism, and polycystic
ovarian morphology. Exclusion of thyroid disease
(thyroid-stimulating hormone), hyperprolactinemia
(prolactin) and non-classic congenital adrenal
hyperplasia (17-hydroxyprogesterone) is
recommended, with further evaluation in patients with
amenorrhea and more severe clinical features including
consideration of hypogonadotropic hypogonadism,
Cushing disease or androgen-producing tumours. The
guideline recognises that PCOS is an insulin-resistant
and metabolic disorder; tests for insulin resistance,
however, lack accuracy and should not be incorporated
into the diagnostic criteria for PCOS at this time. Anti-
Müllerian hormone is likewise not recommended for
diagnosis at this time.
Complication screening is recommended in PCOS.
Cardiovascular risk factor screening is updated
and simplied, including monitoring weight and
weight change, assessing body mass index, family
history, ethnicity, smoking status, blood pressure
and glycaemic status in all patients with PCOS, and
waist circumference and lipid proles in those with
additional risk factors. Frequency and type of testing
are guided by presence of both PCOS and other risk
factors. Obstructive sleep apnoea and endometrial
cancer risk are also addressed.
Prevalence, screening, diagnostic
assessment and treatment of emotional
wellbeing (Algorithm 2)
Algorithm 2 (hps://www.monash.edu/__data/assets/
pdf_le/0004/1411645/Algorithm-2.pdf) highlights
the increased prevalence of psychological features in
PCOS, including anxiety and depressive symptoms,
psycho-sexual dysfunction, eating disorders and
disordered eating, and adverse impact on body
image. The importance of these issues for women
is recognised, along with the resulting signicant
impairment of quality of life. It is vital to ascertain and focus on
the individual areas of most importance to women with PCOS.
Appropriate screening is recommended based on risk, along
with consideration of PCOS features that may have an impact
on treatment.
In models of care, identication of priority areas for the
individual with PCOS is paramount to enable targeted treatment
that improves quality of life. Primary care providers are well
positioned to assess, provide care and coordination and, if
needed, refer to ensure that care is targeted to need and priority.
3 Resources for women and health professionals to support
evidence-based care in polycystic ovary syndrome (PCOS)
Resources for health professionals
Algorithm 1 Screening, diagnostic assessment, risk assessment and
life stage
https://www.monash.edu/__data/assets/pdf_
file/0018/1411641/Algorithm-1-20180615.pdf
Algorithm 2 Prevalence, screening, diagnostic assessment and
treatment of emotional wellbeing
https://www.monash.edu/__data/assets/pdf_
file/0004/1411645/Algorithm-2.pdf
Algorithm 3 Lifestyle
https://www.monash.edu/__data/assets/pdf_
file/0008/1411649/Algorithm-3.pdf
Algorithm 4 Pharmacological treatment for non-fertility indications
https://www.monash.edu/__data/assets/pdf_
file/0019/1411651/Algorithm-4-20180801.pdf
Algorithm 5 Fertility treatment
https://www.monash.edu/__data/assets/pdf_
file/0003/1411653/Algorithm-5-20180619.pdf
Online programs Webinars, interviews with experts and women with PCOS
Certificate programs Online (fee-paying education programs)
GP Tool and care plan Outline of PCOS for GPs to be used during the
consultation
https://www.monash.edu/__data/assets/pdf_
file/0003/1411662/PCOS-GP-Tool-20180622.pdf;
https://www.monash.edu/medicine/sphpm/mchri/pcos/
resources/practice-tools-for-health-practitioners
Resources for women
Infographic 1 What is PCOS and do I have it?
https://www.monash.edu/__data/assets/pdf_
file/0009/1410858/PCOS-Quiz.pdf
Infographic 2 Lifestyle and PCOS
https://www.monash.edu/__data/assets/pdf_
file/0006/1410855/PCOS-and-Lifestyle-Management.pdf
Infographic 3 Emotional wellbeing and PCOS
https://www.monash.edu/__data/assets/pdf_
file/0004/1410853/PCOS-and-Emotional-Well-being.pdf
Infographic 4 PCOS medical treatment
https://www.monash.edu/__data/assets/pdf_
file/0020/1410860/PCOS-Treatment.pdf
Infographic 5 Fertility and PCOS
https://www.monash.edu/__data/assets/pdf_
file/0005/1410854/PCOS-and-Fertility.pdf
Video series A series of videos delivered by experts on all aspects of PCOS
Mobile app Available on Apple iTunes and Google platforms —
multilingual options in development
Written resources Fact sheets, e-resources, booklets and tools available online
Online programs Webinars and online resources and presentations
Question prompt list Question list embedded in the app or available stand-
alone to improve interaction between women with PCOS
and their health professionals
All resources are available at https://www.monash.edu/medicine/sphpm/mchri/pcos
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MJA 209 (7 Suppl) • 1 October 2018
Supplement
4 Abstract from the International evidence-based guideline
for the assessment and management of polycystic ovary
syndrome 2018
Objective: To develop and translate rigorous, comprehensive evidence-
based diagnosis, assessment and treatment guidelines, to improve the
lives of women with polycystic ovary syndrome (PCOS) worldwide.
Participants: Extensive health professional and patient engagement
informed guideline priority areas. International Society-nominated
panels included consumers, paediatrics, endocrinology, gynaecology,
primary care, reproductive endocrinology, psychiatry, psychology,
dietetics, exercise physiology, public health, project management,
evidence synthesis and translation experts.
Evidence: Best practice evidence-based guideline development
involved extensive evidence synthesis and the Grading of
Recommendations, Assessment, Development, and Evaluation
(GRADE) framework covered evidence quality, feasibility, acceptability,
cost, implementation and ultimately recommendation strength.
Process: Governance included an international advisory board from
six continents, a project board, five guideline development groups with
63 members, consumer and translation committees. The Australian
Centre for Research Excellence in PCOS, funded by the National Health
and Medical Research Council (NHMRC), partnered with European
Society of Human Reproduction and Embryology and the American
Society for Reproductive Medicine. Thirty seven organisations across 71
countries collaborated with 23 face to face international meetings over
15 months. Sixty prioritised clinical questions involved 40 systematic
and 20 narrative reviews, generating 166 recommendations and
practice points. Convened Committees from partner and collaborating
organisations provided peer review and the guideline was approved by
the NHMRC.
Conclusions: We endorse the Rotterdam PCOS diagnostic criteria in
adults (two of clinical or biochemical hyperandrogenism, ovulatory
dysfunction, or polycystic ovaries on ultrasound) and where irregular
menstrual cycles and hyperandrogenism are present, highlight
that ultrasound is not necessary in diagnosis. Within eight years of
menarche, both hyperandrogenism and ovulatory dysfunction are
required, with ultrasound not recommended. Ultrasound criteria are
tightened with advancing technology. Anti-Müllerian hormone levels
are not yet adequate for diagnosis. Once diagnosed, assessment and
management includes reproductive, metabolic and psychological
features. Education, self-empowerment, multidisciplinary care
and lifestyle intervention for prevention or management of excess
weight are important. Depressive and anxiety symptoms should be
screened, assessed and managed with the need for awareness of
other impacts on emotional wellbeing. Combined oral contraceptive
pills are firstline pharmacological management for menstrual
irregularity and hyperandrogenism, with no specific recommended
preparations and general preference for lower dose preparations.
Metformin is recommended in addition or alone, primarily for metabolic
features. Letrozole is first-line pharmacological infertility therapy; with
clomiphene and metformin having a role alone and in combination.
In women with PCOS and anovulatory infertility, gonadotrophins are
second line. In the absence of an absolute indication for IVF, women
with PCOS and anovulatory infertility, could be offered IVF third line
where other ovulation induction therapies have failed. Overall evidence
is low to moderate quality, requiring significant research expansion in
this neglected, yet common condition. Guideline translation will be
extensive including a multilingual patient mobile application and health
professional training.
Reproduced with permission from the author Helena Teede on behalf of
Monash University, which holds the copyright: https://www.monash.edu/__
data/assets/pdf_file/0004/1412644/PCOS-Evidence-Based-Guideline.pdf
Ethnic and cultural dierence and life stage need consideration.
Care should address short and long term psychological features
and be mindful of how reproductive and metabolic features may
aect psychological wellbeing.
Lifestyle (Algorithm 3)
Algorithm 3 (hps://www.monash.edu/__data/assets/pdf_
le/0008/1411649/Algorithm-3.pdf) highlights that healthy
lifestyle and prevention of excess weight gain are critical for all
women with PCOS from adolescence. Lifestyle interventions are
similarly eective in women with and without PCOS, and are
rst line treatment in the majority of women with PCOS who
are overweight. Modest weight loss of 5–10% of body weight
is recommended to improve PCOS features, primarily through
caloric restriction. No specic diet oers greater benet in PCOS.
Exercise recommendations are made for weight maintenance,
health and weight loss. Incorporating behavioural strategies
such as goal seing, self-monitoring, stimulus control, problem
solving, assertiveness training, slower eating, reinforcing
changes and relapse prevention are recommended to improve
adherence and ecacy.
Pharmacological treatment for non-fertility
indications (Algorithm 4)
Algorithm 4 (hps://www.monash.edu/__data/assets/
pdf_le/0019/1411651/Algorithm-4-20180801.pdf) outlines
recommendations regarding pharmacological treatment for non-
fertility indications. Combined oral contraceptive pills (COCPs)
continue to be recommended as rst line medical treatment for
hyperandrogenism and regulation of menstrual cycles in PCOS.
COCP ecacy is largely related to hepatic-mediated oestrogenic
eects on sex hormone-binding globulin, which in turn decrease
free testosterone levels. Other forms of hormonal contraception
are less eective in this regard. COCP use for 6–12 months
reduces androgens and hirsutism. Mood impacts have not been
shown in PCOS; however, general population studies have noted
COCP impact on libido and mood. No one preparation has been
shown to be superior in PCOS, with all COCP agents increasing
sex hormone-binding globulin and improving clinical outcomes.
Based on general population data, COCPs are recommended at
the lowest eective oestrogen dose balancing ecacy, metabolic
risk prole, side eects, costs and availability, and 35 mg
ethinyl estradiol preparations are not recommended rst line
treatment. Where COCPs and lifestyle changes fail in meeting
treatment goals, metformin, as an insulin sensitiser, may assist in
prevention of weight gain and improvement in metabolic features.
Metformin improves body mass index, cyclicity, androgen
levels and metabolic features, has demonstrated ecacy in
combination with lifestyle modication, and is recommended in
addition to lifestyle intervention, not as a substitute. Low dose
therapy is recommended initially, with subsequent titration to
reduce the mild and self-limiting gastrointestinal side eects.
Anti-androgens in PCOS have limited evidence and are only
recommended for hirsutism when at least 6 months of COCPs
with cosmetic therapy have failed. Bariatric surgery can improve
clinical features; however, registry studies demonstrate concerns
around pregnancy outcomes and should only be considered in
PCOS after lifestyle therapy fails.
Assessment and treatment of infertility (Algorithm 5)
Algorithm 5 (hps://www.monash.edu/__data/assets/
pdf_le/0003/1411653/Algorithm-5-20180619.pdf) outlines
recommendations on pre-conception care and infertility
management. While infertility assessment and management
require specialist care, optimisation of psychological health,
lifestyle intervention and provision of evidence-based resources
to inform women on infertility treatment recommendations are
well placed in primary care. The key change recommended in
the guideline is the use of letrozole as rst line pharmacological
treatment in PCOS-associated and anovulatory infertility.
Compared with clomiphene citrate, letrozole improves live
birth rate, with a reduced rate of multiple pregnancy. However,
in Australia, this involves o-label prescription and requires
explanation and consent from the patient. Clomiphene citrate is
recommended alone or combined with metformin. Metformin can
be used alone, recognising lower success rates than other agents.
When rst line therapy has failed, exogenous gonadotrophins
in women with clomiphene citrate-resistant PCOS are generally
recommended second line, as is laparoscopic ovarian drilling.
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MJA 209 (7 Suppl) • 1 October 2018
Translation and implementation of the Australian-led PCOS guideline
Importantly, in vitro fertilisation is indicated for women with
PCOS and anovulation, after failure to respond to first and
second line ovulation induction, or if there are other factors
contributing to infertility. Algorithm 5 provides a detailed
explanation regarding drug choice, based on clinical and
other factors.
General practice tool, care plan and consumer
resources to support care
Tools and resources have been developed with and for general
practitioners, including a GP tool and care plan template to
support decision making and evidence-based care in clinical
practice (hps://www.monash.edu/medicine/sphpm/mchri/
pcos/resources/practice-tools-for-health-practitioners). A
key component of the range of consumer tools, developed in
partnership with consumers, is the PCOS app (AskPCOS). This
is the rst evidence-based PCOS app that has a range of unique
features (eg, a comprehensive repository of information,
question prompt list) to increase PCOS-related health
literacy. GPs and other health professionals are the preferred
source of consumer information, yet there is a clear need for
complementary, additional, high quality, evidence-based
resources for aected women. Such resources are accessible by
searching “Monash PCOS” in your Web browser, or see Box
3 for direct links to the guideline resources for women and
health professionals. These resources address demonstrated
gaps, including inadequate and generally poor quality existing
information, to support clinical care and improve knowledge,
consumer engagement and health outcomes.
Considerations for Aboriginal and Torres Strait
Islander women
Given the higher prevalence and more severe clinical features of
PCOS in Aboriginal and Torres Strait Islander women,2,25 early
diagnosis and management are vital to prevent and manage
the reproductive, metabolic and psychological features of
PCOS. This must be undertaken in a culturally appropriate and
respectful manner.
In diagnosis, high quality ultrasound access may be challenging,
as Aboriginal and Torres Strait Islander women are more likely
to live in remote locations.26 The reduced guideline focus on
ultrasound in PCOS diagnosis may assist here. Regarding
screening for features of PCOS, Aboriginal and Torres Strait
Islander women have increased risks of obesity, type 2 diabetes,
5 Guideline development process
GDG = guideline development group. *Time points and tasks where prioritisation of engagement from GDG
is required.
Reproduced with permission from Misso and Teede.19
Disseminate,
implement,
update
(steps 16 - 18
up to 6 months)
Formulate
guidance
(3 months)
Systematic
review of
evidence
(6 months - 1 year)
Establish
GDG and
scope
(up to 6 months)
22. Revise and update
21. Evaluate
20. Implement
19. Disseminate*
18. Obtain endorsements
17. Public consulation
16. Finalise guideline
content
15. Write narrative
clinical context*
14. Reach consensus
among GDG*
13. GRADE
recommendation(s)*
12. Draft
recommendation(s)*
11. Synthesise evidence
1. Create multidiciplinary guideline
development group including consumers
2. Scope and define topics*
3. Identify and prioritise clinical questions*
4. Define PICO*
5. Identify existing guidelines to adapt
If <5 years and high quality, skip to
step 13 to adapt for local use
If >5 years and high quality,
update
6. Systematically search for evidence
7. Identify and select evidence*
8. Appraise methodological quality of
included studies
9. Extract data
10. Synthesise data
dyslipidaemia and mental health disorders,
independent of PCOS.27 They are more
likely to be overweight or obese at all ages,
with obesity contributing around 16% of the
disparity in health burden.28 Diabetes is a key
cause of mortality and disability-adjusted life-
years in Aboriginal and Torres Strait Islander
women,28 and PCOS amplies these risks,
making screening more critical.
Lifestyle management is the rst line treatment
for PCOS and associated complications.
However, access to culturally appropriate
care, services and lifestyle programs is
suboptimal, because socio-economic factors,
as well as lack of access to healthy food
for those living in remote locations, create
barriers to modifying lifestyle. Improving
this situation is likely to require broader
community and government action. There
is lile information about exercise among
Aboriginal and Torres Strait Islander women.
However, low participation rates in sports, less in women than
men, have been noted.28 Facilitators of engagement include
having a group, family, community or team focus, choice of
activities and realistic goal aainment.29,30 Overall, we anticipate
that the lifestyle recommendations in the guideline will be broadly
applicable to Aboriginal and Torres Strait Islander women, but
we acknowledge the socio-economic and geographical barriers
and the need for adaptation to engage this population, especially
in rural and remote locations.
Although the data are unclear, it is likely that infertility rates
among Aboriginal and Torres Strait Islander women are at
least similar to the national prevalence (the limited reports
suggest they are actually higher) despite the younger age of
rst birth and increased total fertility rate.31,32 This emphasises
the need for early diagnosis and for prevention. Socio-economic
and geographic barriers may also aect uptake of medication
recommendations (eg, letrozole) or procedures (eg, laparoscopic
surgery). See also hp://www.naccho.org.au/wp-content/
uploads/1.National-guide-to-a-preventive-health-assessment-
for-Aboriginal-and-Torres-Strait-Islander-people-2.pdf.
Resources are currently in the co-development phase with
Aboriginal and Torres Strait Islander women.
Conclusion
The International evidence-based guideline on the assessment and
management of polycystic ovary syndrome 2018 has been rigorously
developed and informed by consumers, multidisciplinary health
professionals and leading PCOS experts from six continents. The
guideline is designed to address the needs of health professionals
in providing beer, timely care and improved outcomes for
women with PCOS, as well as enabling women to be more
informed and involved in their treatment.
The PCOS guideline and translation resources aim to accelerate
the delivery of consistent, evidence-based care across
Australia. GPs are well supported in the implementation of the
recommendations from the PCOS guideline by the provision
of the range of freely available practice tools, tailored to the
Australian context. GPs can also augment the PCOS-related
health literacy of consumers by directing them to the range of
consumer resources.
Collaborating authors: Estifanos Baye, Monash Centre for Health Research and
Implementation, Melbourne; Leah Brennan, Australian Catholic University, Melbourne;
Cheryce Harrison, Monash Centre for Health Research and Implementation, Melbourne;
Samantha Hutchison, Monash Health Centre for Research Implementation, Melbourne;
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MJA 209 (7 Suppl) • 1 October 2018
Supplement
Anju Joham, Monash Centre for Health Research and Implementation, Melbourne; Louise
Johnson, Victorian Assisted Reproductive Treatment Authority, Melbourne; Cailin Jordan,
Genea Hollywood Fertility, Perth; Jayashri Kulkarni, Monash Alfred Psychiatry Research Centre,
Melbourne; Darren Mansfield, Monash Health, Melbourne; Kate Marsh, Northside Nutrition
and Dietetics, Sydney; Ben W Mol, Monash University, Melbourne; Alexia Peña, Robinson
Research Institute, University of Adelaide, Adelaide; Raymond Rodgers, Robinson Research
Institute, University of Adelaide, Adelaide; Jane Speight, Deakin University, Geelong; Nigel
Stepto, Victoria University, Melbourne; Eliza C Tassone, Monash Centre for Health Research
and Implementation, Melbourne; Angela Wan, Monash University, Melbourne; Jane Woolcock,
Women’s and Children’s Hospital, Adelaide.
Acknowledgements: We gratefully acknowledge the contribution of the many women
with PCOS and health professionals who guided and contributed to this work. We thank our
funding, partner, engaged and collaborating organisations for their roles in prioritising topics
and identifying gaps, and contributing members for guideline development, providing peer
review and assisting with dissemination. We acknowledge those who independently assessed
the guideline against AGREEII criteria and completed methodological review, and those within
the NHMRC who managed the approval process. This guideline was approved by all members of
the guideline development groups and has been approved by the NHMRC.
Specifically, our funding, partner, collaborator and engaged organisations include:
• The NHMRC through the funded Centre for Research Excellence in Polycystic
Ovary Syndrome and the members of this Centre who coordinated this international
guideline effort.
• Our partner organisations which co-funded the guideline: the American Society
for Reproductive Medicine and the European Society of Human Reproduction and
Embryology.
• Our collaborating and engaged societies and consumer groups: Androgen Excess
and Polycystic Ovary Syndrome Society; American Pediatric Endocrine Society; Asia Pacific
Paediatric Endocrine Society; Asia Pacific Initiative on Reproduction; Australasian Paediatric
Endocrine Group; Australian Diabetes Society; British Fertility Society; Canadian Society of
Endocrinology and Metabolism; Dietitians Association Australia; Endocrine Society (US);
Endocrine Society Australia; European Society of Endocrinology; European Society for
Paediatric Endocrinology; Exercise and Sports Science Australia; Fertility Society Australia;
International Society of Endocrinology; International Federation of Fertility Societies;
International Federation of Gynaecology and Obstetrics; Italian Society of Gynaecology
and Obstetrics; Japanese Society for Paediatric Endocrinology; Latin American Society for
Paediatric Endocrinology; Nordic Federation of Societies of Obstetrics and Gynaecology;
PCOS Challenge; PCOS Society of India; Paediatric Endocrine Society; Polycystic Ovary
Association Australia; Royal Australasian College of Physicians; Royal Australian College
of General Practitioners; Royal Australian and New Zealand College of Obstetricians and
Gynaecologists; Royal College of Obstetricians and Gynaecologists (UK); South African
Society of Gynaecology and Obstetrics; Verity UK; Victorian Assisted Reproductive
Technology Association (VARTA).
• Our Australian translation partners: Jean Hailes for Women’s Health
and VARTA.
Funding: The guideline and translation program was primarily funded by the NHMRC
Centre for Research Excellence in PCOS grant (APP1078444) and partnership grant
(APP1133084). This funding was supported by a partnership with the European Society of
Human Reproduction and Embryology and the American Society for Reproductive Medicine.
Translation costs were supported by the NHMRC Centre for Research Excellence and
partnership grant. Jean Hailes for Women’s Health funded the cost of this MJA supplement.
Competing interests: Disclosures of conflicts of interest were declared at the outset
and updated throughout the guideline process, aligned with NHMRC guideline processes.
Full details of conflicts declared across the guideline development groups are available
at https://www-monash-edu.ezproxy.lib.monash.edu.au/medicine/sphpm/mchri/pcos/
guideline in the register of disclosures of interest.
Michael Costello has declared shares in Virtus Health and past sponsorship from Merck
Serono for conference presentations. Joop Laven has received grants from Ferring
Pharmaceuticals and Euroscreen, and personal fees from Ferring Pharmaceuticals,
Euroscreen, Danone and Titus Health Care. Robert Norman is a minor shareholder
interest in an IVF unit. The remaining authors have no conflicts of interest to declare.
Provenance: Commissioned; externally peer reviewed. n
1 Bozdag G, Mumusoglu S, Zengin D, et al. The prevalence
and phenotypic features of polycystic ovary syndrome:
A systematic review and meta-analysis. Hum Reprod
2016; 31: 2841-2855.
2 Boyle JA, Cunningham J, O’Dea K, et al. Prevalence of
polycystic ovary syndrome in a sample of Indigenous
women in Darwin, Australia. Med J Aust 2012; 196:
62-66. https://www.mja.com.au/journal/2012/196/1/
prevalence-polycystic-ovary-syndrome-sample-
indigenous-women-darwin-australia
3 Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus
Workshop Group. Revised 2003 consensus on diagnostic
criteria and long‐term health risks related to polycystic
ovary syndrome. Hum Reprod 2004; 19: 41-47.
4 Tata B, Mimouni NEH, Barbotin A-L, et al. Elevated
prenatal anti-Müllerian hormone reprograms the fetus
and induces polycystic ovary syndrome in adulthood.
Nat Med 2018; 24: 834-846.
5 Diamanti-Kandarakis E, Dunaif A. Insulin resistance and
the polycystic ovary syndrome revisited: an update on
mechanisms and implications. Endocr Rev 2012; 33: 981-1030.
6 Stepto NK, Cassar S, Joham AE, et al. Women with
polycystic ovary syndrome have intrinsic insulin
resistance on euglycaemic-hyperinsulaemic clamp. Hum
Reprod 2013; 28: 777-784.
7 Moran LJ, Norman RJ, Teede HJ. Metabolic risk in PCOS:
phenotype and adiposity impact. Trends Endocrinol
Metab 2015; 26: 136-143.
8 Dokras A, Stener-Victorin E, Yildiz BO, et al. Androgen excess-
Polycystic Ovary Syndrome Society: position statement
on depression, anxiety, quality of life, and eating disorders
in polycystic ovary syndrome. Fertil Steril 2018; 109:
888-899.
9 Teede HJ, Misso ML, Deeks AA, et al. Assessment and
management of polycystic ovary syndrome: summary
of an evidence-based guideline. Med J Aust 2011;
195 (6 Suppl): S65-S110. https://www.mja.com.au/
journal/2011/195/6/assessment-and-management-
polycystic-ovary-syndrome-summary-evidence-based
10 Teede HJ, Joham AE, Paul E, et al. Longitudinal weight
gain in women identified with polycystic ovary syndrome:
results of an observational study in young women.
Obesity 2013; 21: 1526-1532.
11 Gibson-Helm M, Teede H, Dunaif A, Dokras A. Delayed
diagnosis and a lack of information associated with
dissatisfaction in women with polycystic ovary syndrome.
J Clin Endocrinol Metab 2017; 102: 604-612.
12 Teede H, Gibson-Helm M, Norman RJ, et al. Polycystic ovary
syndrome: perceptions and attitudes of women and primary
health care physicians on features of PCOS and renaming the
syndrome. J Clin Endocrinol Metab 2014; 99: E107-E111.
13 Gibson-Helm ME, Lucas IM, Boyle JA, Teede HJ. Women’s
experiences of polycystic ovary syndrome diagnosis. Fam
Pract 2014; 31: 545-549.
14 Dokras A, Saini S, Gibson-Helm M, et al. Gaps in knowledge
among physicians regarding diagnostic criteria and
management of polycystic ovary syndrome. Fertil Steril
2017; 107: 1380-1386.e1.
15 Brakta S, Lizneva D, Mykhalchenko K, et al. Perspectives on
Polycystic Ovary Syndrome: Is Polycystic Ovary Syndrome
Research Underfunded? J Clin Endocrinol Metab 2017; 102:
4421-4427.
16 Teede H, Legro R, Norman R. A vision for change in PCOS
through international collaboration. Semin Reprod Med
2018; in press.
17 Teede H, Deeks A, Moran L. Polycystic ovary syndrome: a
complex condition with psychological, reproductive and
metabolic manifestations that impacts on health across
the lifespan. BMC Med 2010; 8: 41.
18 National Health and Medical Research Council. 2016 NHMRC
Standards for Guidelines. https://www.nhmrc.gov.au/guidelines-
publications/information-guideline-developers/2016-nhmrc-
standards-guidelines (viewed Aug 2018).
19 Misso M, Teede H. Evidence based guideline (EBG)
development: a practical guide. In: Ilic D, editor. Knowledge
transfer: practices, types and challenges. New York: Nova
Publishers, 2012.
20 Teede HJ, Misso ML, Costello MF, at al. Recommendations
from the international evidence-based guideline for
the assessment and management of polycystic ovary
syndrome. Fertil Steril 2018; 110: 364-379.
21 Teede HJ, Misso ML, Costello MF, et al. Recommendations
from the international evidence-based guideline for the
assessment and management of polycystic ovary syndrome.
Clin Endocrinol (Oxf) 2018; doi: 10.1111/cen.13795[Epub ahead
of print].
22 Teede HJ, Misso ML, Costello MF, et al. Recommendations
from the international evidence-based guideline for
the assessment and management of polycystic ovary
syndrome. Hum Reprod 2018; doi: 10.1093/humrep/dey256
[Epub ahead of print].
23 Norman R, Teede H. A new evidence-based guideline
for assessment and management of polycystic ovary
syndrome. Med J Aust 2018; 209: 299-300.
24 National Institutes of Health. NIH evidence-based
methodology workshop on Polycystic Ovary Syndrome:
executive summary. 3-5 Dec 2012. https://prevention-archive.
od.nih.gov/docs/programs/pcos/FinalReport.pdf (viewed
Aug 2018).
25 Davis SR, Knight S, White V, et al. Preliminary indication of a
high prevalence of polycystic ovary syndrome in indigenous
Australian women. Gynecol Endocrinol 2002; 16: 443-446.
26 Boyle J, Hollands G, Beck S, et al. Process evaluation of a
pilot evidence-based Polycystic Ovary Syndrome clinic in
the Torres Strait. Aust J Rural Health 2017; 25: 175-181.
27 Australian Bureau of Statistics. 4715.0 National Aboriginal
and Torres Strait Islander Health Survey, 2004-05.
Canberra: ABS, 2006. http://www.abs.gov.au/ausstats/
abs@.nsf/mf/4715.0/ (viewed Jan 2018).
28 Vos T, Barker B, Begg S, et al. Burden of disease and
injury in Aboriginal and Torres Strait Islander Peoples: the
Indigenous health gap. Int J Epidemiol 2009; 38: 470-477.
29 Hunt J, Marshall AL, Jenkins D. Exploring the meaning of, the
barriers to and potential strategies for promoting physical
activity among urban Indigenous Australians. Health
Promot J Aust 2008; 19: 102-108.
30 Thompson SJ, Giord SM, Thorpe L. The social and cultural
context of risk and prevention: food and physical activity in
an urban Aboriginal community. Health Educ Behav 2000; 27:
725-743.
31 Hancock H. Aboriginal women’s perinatal needs,
experiences and maternity services: a literature review to
enable considerations to be made about quality indicators.
Ngaanyatjarra Health Service, Dec 2006. https://www.
lowitja.org.au/sites/default/files/docs/Ngaanyatjarra-
Health-Service-Lit-Review.pdf (viewed Aug 2018).
32 Kildea S, Bowden FJ. Reproductive health, infertility and
sexually transmitted infections in Indigenous women in
a remote community in the Northern Territory. Aust N Z J
Public Health 2000; 24: 382-386.
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PCOS PRIMARY CARE PLAN
Patient and GP
identified problem
list
Patient problems
/ needs / relevant
conditions
Goals - changes to be achieved Required treatments and services including
patient actions
Arrangements for
treatments/services
(when, who, contact
details)
1. Priorities and education Education - PCOS resources: https://www.
monash.edu/medicine/sphpm/mchri/pcos and
AskPCOS app
Patient identified
priorities
Other identified
priorities
Patient's understanding
of their condition
Clear understanding of PCOS and
patient’s role in self- management
Education - PCOS resources
2. Lifestyle Education - PCOS resources
Nutrition Maintain general healthy diet Set joint agreed SMART goals for small achiev-
able changes
Patient to implement
GP to refer to dieti-
cian as required
Weight - prevention of
excess weight gain and
management of weight
loss as needed
Weight
Height
BMI
Target prevention of weight gain or
5-10% weight loss through caloric
restriction
Education - PCOS resources
Review 12 monthly for prevention and 1-2
monthly for weight loss
Patient to monitor
GP to monitor
GP to refer to dieti-
cian if needed
Physical activity Current exercise
Patient prioritised/agreed goals
Education - PCOS resources Patient to imple-
ment/ monitor
GP to monitor
Refer as needed
Smoking Cessation Smoking cessation strategy:
Consider: Quit, Medication
Patient to manage
GP to support
Alcohol intake Current
Target ▪≤ 1 standard drink per day
Patient education Patient to implement
GP to monitor/sup-
port
3. Metabolic features Education - PCOS resources
BP Target <130/80 Every 12 months GP to monitor
Lipids ̶ Check in PCOS
with BMI >25kg/m2
Under laboratory recommended
range
Fasting lipids at diagnosis and recheck based
on global CVD risk
GP to monitor
Glucose
routinely and
around pregnancy
Target prevention, regular screen-
ing, early detection and treatment
Assessed in all at baseline, then every 1-3
years, based on additional diabetes risk factors
Fasting plasma glucose or HbA1c ok in PCOS
alone, OGTT with additional risk factors.
OGTT for all with PCOS before and during
pregnancy
GP to monitor
Patient's name:
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4. Reproductive Education - PCOS resources
Menstrual regulation
and endometrial
protection
≥4 cycles per year (if not on
COCP/IUD)
Lifestyle + Medical treatment Patient and GP to
monitor
Hirsutism
Alopecia
Acne
Assess impact on QoL, meet
patients expectations and reduce
adverse patient impact
Cosmetic and/or treatment with COCP alone
for at least 6-12/12 first line
Patient and GP to
monitor
Fertility Target optimal fertility
Reassurance - Vast majority with
PCOS will have a family if desired
and no other infertility factors, but
many may need oral medication
support to do so. Rarely need IVF
Discuss early family initiation where possible
Prevent weight gain/manage excess weight
Preconception care
Further resources at
https://www.varta.org.au/
GP to reassure,
educate, support
lifestyle change
and refer for
management where
needed
5. Psychological Education and PCOS resources
Identify, support and
minimise psychological
impact
Screen clinically or use brief
psychological tool at https://www.
monash.edu/medicine/sphpm/
mchri/pcos
If positive on routine questions further
assess, treat PCOS features and manage
psychological issues
GP to refer
psychologist and or
additional treatment
as needed
6. Other
7. Medication
current
Medication
changes
List: Correct use of medication
Minimise side effects
Education and PCOS resources GP to review
compliance/side
effects
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