Australia leading the world: The journey of the PCOS Guideline
The story behind the release of the first International Guideline on the assessment and management of polycystic ovary syndrome (PCOS) (2018) really began about a decade ago. In 2008 Professor Helena Teede, a clinical endocrinologist, was becoming increasingly concerned about the inadequate standard of care provided to women with PCOS. Many of her patients relayed harrowing stories of difficulties getting a diagnosis, about the lack of information and support and, of enduring traumatic and costly fertility treatment.
Helena decided to do something about this. She formed The PCOS National Australian Alliance (The Alliance) who delivered the first national PCOS Guideline (2011). The Alliance would eventually be scaled-up to include globally renowned experts from seven continents and produce the first international PCOS Guideline (2018).
However, perhaps the most extraordinary part of the PCOS guideline journey is how from humble beginnings, an Australian research team led the world in creating an innovative, responsive formula for the development of evidence-based guidelines. Professor Teede and her team galvanised an international network of experts, generated an unprecedented level of collaboration between consumers, multidisciplinary health professionals and academics to deliver the first PCOS international guideline. And, along the way created a research roadmap advancing research and knowledge in PCOS that is distinguished by a comprehensive, global translation and evaluation program, delivering benefits to women with PCOS across the world.
History of initial Australian alliance and guideline
Polycystic ovary syndrome, or PCOS, is an endocrine or hormonal disorder involving excess levels of the hormones insulin and androgen, causing the common clinical features of the condition:
- excess facial and body hair, acne or scalp hair loss
- impaired ovulation or egg development in the ovaries leading to irregular cycles, reduced fertility and pregnancy complications
- increased risk of weight gain, diabetes and other metabolic features
- increased anxiety, depression and reduced quality of life.
Prior to the development of first PCOS Guideline (2011) the health care system was failing to meet the needs of women with PCOS.
“PCOS is a multi-faceted condition, with reproductive, metabolic and psychological features which often means diagnosis is delayed, treatment is often not holistic and opportunities for prevention, treatment and improved health outcomes including in infertility and pregnancy health are missed,” Professor Teede.
Despite the high prevalence of PCOS (1 in 8 women), many women went undiagnosed and were forced to ‘doctor shop’ until they found one with the knowledge and expertise to make a diagnosis. This often took an average of two years and up to two to three doctors. Women were often told they were unlikely to have children and likely to develop male type characteristics such as facial hair and then given little ongoing care.
They were commonly not informed about psychological issues such as depression and anxiety possibility related to the social stigma and poor body image reported by women due to the masculinising traits of PCOS.
In addition to the personal costs, the lack of effective treatments for PCOS cost the health system between $4 million to $1.16 billion (USA based figures) related to diabetes, obesity, and infertility treatments.
Also, health care practitioners reported feeling confused and ill equipped to manage PCOS.
Ultimately, in response to the unmet needs of women for consistent, evidence-based care The PCOS National Australian Alliance called on the Government to fund the development of the first Guideline.
A united voice-collaborative advocacy
The PCOS National Australian Alliance established in 2008 was comprised of twenty-five national, interdisciplinary and cross-sectoral leaders from: research, medical specialities (endocrinology, gynaecology), allied health, primary care practitioners, NGOs, research translation organisations, consumers.
The vision of the Alliance was to: improve the lives of Australian women with PCOS through education, research and evidence-based healthcare. It provided leadership and exercised its influence to: promote research and to support consistent, evidence-based, multidisciplinary service provision.
The Alliance leveraged expert and evidence informed collaborative advocacy through the formation of a united, representative voice to effectively engage with Government. Consequently, a large Federal Australian Government grant funded the first PCOS evidence-based Guideline and an extensive research translation program.
First National PCOS EBG (2011)
In 2011, the first national PCOS Guideline was developed using internationally agreed methods for the development of evidence-based Guidelines. Multidisciplinary committees included a Project Board, PCOS Australian Alliance Strategic Advisory Group and four Guideline development groups were established, largely drawn from Alliance members and the consumer advocacy group Polycystic Ovary Association of Australia (POSAA). These groups determined the clinical questions that provided the structure of the Guideline and informed the extensive evidence search and synthesis and, subsequently, determined the clinical practice and research recommendations. Consumers were engaged in all phases of the PCOS project from design, development and implementation and were active contributors within a distributed decision making environment.
Key knowledge and evidence gaps were identified as:
- The natural history of PCOS, its features and complications
- Optimal models of care
- Optimal lifestyle interventions (specifically aiming to increase engagement
- Adherence and sustainability) and
- Optimal fertility interventions including the role of bariatric surgery for improving fertility in PCOS.
The Alliance published the Australian National Health and Medical Research Council (NHMRC) approved PCOS Guideline in 2011. The rigorously developed Guideline was well received internationally by the leading research bodies such as the UK National Institute for Health and Care Excellence (NICE), the US National Institute of Health (NIH) and the World Health Organisation (WHO) who collaboratively adapted it.
Following publication the PCOS Guideline (2011) was subject to an extensive national translation and dissemination program. The program reached over 5,000 primary care practitioners, over 3,000 allied health professionals and indirectly reached up to 28,000 general practitioners, 10,000 nurses, 8,000 allied health care professionals. In addition, through a range of targeted dissemination strategies the project reached up to 2 million health consumers and dissemination of 30,000 health education products. Evaluation data demonstrated significant health professional and consumer engagement, directly impacting rates of early diagnosis, consumer driven demand for high quality and responsive services, and synergistic impacts across a range of sectors.
However, whilst the PCOS guideline and translation program were successful in informing evidence-base practice, it became clear through the development process that many research gaps were yet to be addressed. It was therefore decided by the Alliance leaders to apply for a PCOS-focused centre of research excellence.
Centre of Research Excellence in PCOS
Centres of Research Excellence are large-scale collaborative initiatives bringing together high-level expertise and resources focused on a priority health area. The PCOS Centre of Research Excellence (2015-19) was established to address identified gaps in evidence, translation, practitioner capacity, service integration, equity and sustainability. The vision of the CRE continues to be to improve PCOS diagnosis, capture prevention opportunities, optimise management, and improve overall quality of life of affected women and their families. It was crucial to the formation of an unprecedented international collaboration on PCOS.
The PCOS CRE has held two annual general meetings that provided opportunities for international and Australian researchers to discuss and review their collaborative work. The highly esteemed Professor Bart Fauser in his capacity as the Chair of the CRE International Advisory board provided this reflection on the 2018 meeting held in Melbourne.
“It has been a great pleasure to be invited to attend this important internal review meeting…To be surrounded by around 50 colleagues with a profound research interest in PCOS has been a real treat. The open and friendly atmosphere made the event even more enjoyable. Indeed, the CRE guidelines will dominate PCOS care and research for the years to come, and you can all be proud for getting this all together with so many players around the world.”
The scaling up of a strong national leadership and governance model to an international level
The Australian Alliance was expanded to include internationally recognised leaders in their fields who together developed of the first International Evidence-based Guideline on the Assessment and Management of PCOS (2018). The collaboration that included 37 societies and consumer groups from 71 countries, 70 experts, health professional and women with PCOS met 20 times over a 15-month period and were guided by the expertise of Dr Marie Misso. Strong governance was ability provided by Linda Downes who holds the role as project manager.
The drivers for the development of the International PCOS guideline were:
- To update the evidence which is needed every five years
- To extend the guideline to new areas including pregnancy risk and care and infertility management
- To extend the guideline internationally
Some of the key outcomes of this Guideline include:
- Accurate and timely diagnosis in young women
- Avoidance of expensive, unnecessary diagnostic testing
- Increased focus on prevention, lifestyle and emotional wellbeing to improve quality of life
- Improved options for cheaper and safer fertility management
- Appropriate and judicious use of expensive, higher risk IVF treatments and
- Greater uptake of PCOS evidence-based models of care.
“We occupy a world of medical societies, which often collaborate by sometimes compete…One of these (areas) in which they compete is the development of clinical practice guidelines…(However) the development of the PCOS clinical practice guideline by the group out of Monash University in Australia…is truly a novel and remarkable development whose impact is not yet realisable…” Professor Rick Legro, Penn State College of Medicine, Pennsylvania.
It is estimated that about 85% of research is wasted. Clinical Guidelines are no exception and are more likely to gather dust on the bookshelf than influence health care practice.
However, Professor Helena Teede and her team were determined to translate evidence to practice in a timely manner. To achieve this, research translation, led by Dr Rhonda Garad, was built into the research design with all collaborators signing up as active participants in the Guideline translation as well as the research process.
The research translation of the PCOS international Guideline targets a broad audience and uses best-practice knowledge translation principles.
The specific aims of the translation program are to:
- Build the capability of health professionals to deliver high-quality, evidence-based assessment and management of PCOS
- Augment the health literacy of PCOS health consumers
- Improve early diagnosis rates and health outcomes, and,
- Promote best-practice evidence-based PCOS models of care.
All translation outputs are guided by the following principles:
- Informed by the needs and preferences of women with PCOS
- Co-created and attuned to the needs of end-users, and
- Are multi-faceted, multi-modal and refined to the communication channels of end-users.
Central to the translation and dissemination program is the active engagement of over 37 partner and collaborator organisations and leading engaged health experts who leverage their extensive reach and influence to promote the PCOS Guideline uptake. Leading consumer groups internationally and translation organisations are strongly engaged with, and committed to the Guideline translation and impact. In addition, the translation program is supported by a comprehensive evaluation framework measuring international impacts and outcomes.
The following translation resources were informed by extensive consultation with end-users:
- Co-designed practice algorithms promoting evidence-based practice covering (Assessment and
diagnosis, emotional wellbeing, lifestyle management, pharmacology and fertility)
- Consumer info-graphs to increase consumer PCOS related health literacy and enhance self-management (Covering self-diagnosis, emotional wellbeing, lifestyle management, pharmacology and fertility)
- Co-designed digital booklets catering to low and medium health literacy levels
- A consumer booklet co-designed with and for Aboriginal and Torres Strait Islander women
- An internationally accessible, accredited health professional learning module hosted on the UK based Futurelearn platform
- The first innovative consumer PCOS App (AskPCOS) providing comprehensive evidence-based PCOS health information, a self-diagnostic function, a Question Prompt List (QPL) to optimise health practitioner engagement and a commonly asked questions list (See Xie et al. in this series).
To monitor impact the Guideline translation program is supported by an extensive evaluation framework. The framework includes an international, collaborative data hub collecting data from PCOS services aligned with the Guideline recommendations and includes benchmarking and feedback to guide further alignment with evidence-based care (funded by Government and the National Health and Medical Research Council). In addition, iatrics will monitor downloads of the Guideline and resources. Finally, focus groups and surveys will measure knowledge and awareness in consumers and health professionals with results compared to large-scale data (3500 participants) collected prior to the Guideline release.
All translation products can be accessed here.
The Guideline has had significant impact since its release in July 2018 that can be seen in the impact graphic below.
The international PCOS Guideline has delivered a body of work to progress awareness, quality of care and improved health outcomes for women with PCOS through collaboration, Guideline development and research translation.
However, perhaps the most important outcome from this process is the development of a new roadmap for large-scale international collaboration.
“This strategic approach with strong partnerships between consumers, multidisciplinary health professionals, academics and professional societies is transferable to other women’s health conditions and beyond and would reduce duplication of effort and promote consistency of care. Once completed Guidelines can be adapted to regional health settings based on population needs, health systems and resource availability,” Professor Rick Legro.