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Norway Atrocities Raise Challenges About Europe's Far-Right (7/29)
Last week's atrocities in Norway were an act of far-right violence on a scale unknown in Western Europe in the post-World War II era, and they have scalded European politics with sudden fear about the possible extreme consequences of anti-Muslim populist rhetoric.
The spread of anti-Islamic attitudes among the European electorate and the entry of small far-right wing movements into national parliaments alongside mainstream political parties have increasingly challenged mainstream leaders' ability to champion Europe's social cohesion and traditional values such as toleration and to mobilize strong consensus on difficult decisions shaping the EU to meet its economic and international challenges, according to Garret Martin in European Affairs.
The fall-out of the savage massacres in Norway on the course of European politics will take time to become clear. The left in Europe – which has traditionally seen itself as the rampart against racism – is out of power in major countries, including Britain, France, Germany and Italy – and is struggling to revitalize its cause, or at least to reframe the passionate debate over immigration. As far as the right is concerned, those mainstream political parties could find it more difficult to accept support from the far-right parties after the events in Norway, the New York Times reports.
Far-right leaders were quick to distance themselves from the Norwegian killer's acts – a move which undoubtely eased some of mainstream right's concerns about their current and future political cooperation with far-right parties. Geert Wilders of the Dutch Freedom Party said the killer was a "violent and sick character;" France's Marine Le Pen, leader of the anti-immigrant National Front, said that the Norwegian slaughter "is the work of a lone lunatic who must be ruthlessly punished;" the killings were condemned by the Danish People's Party, the Sweden Democrats and the True Finns, all of them anti-immigrant and nationalist parties represented in the national parliaments of Denmark, Sweden and Finland – all countries considered to be open and progressive Nordic societies like Norway.
Norway's atrocity is an unfathomable step beyond the anti-immigrant stance of these political movements, but the murderer's purported views against the "Islamization of Western Europe" echo the core theme of anti-immigration parties gaining ground across the EU. From Sweden to Italy, populist politicians have won votes and influence with the message that Europe is letting in too many people – especially Muslims – who they claim do not accept Western values, who cause crime and unemployment and undue strains on social services. The rise of the populist right is pressuring mainstream political leaders to accommodate extremist views and demands in all these countries. This New York Times article adds some nuance to this statement, portraying how mainstream parties in Sweden have sought to compete with nationalist parties – the Sweden Democrats – in part by co-opting some of their core themes.
Norway is an oil-rich exception to these pressures on jobs or living standards. But even in this small, well-off country, populism has grown alongside recent immigration trends giving Norway a 12 percent population of (largely Muslim) immigrants and their children. Extremists often blame governments in this and other Nordic countries for being too liberal – "too lax," they would say – in their attitudes toward this influx. A rare counter-attack against extremist movements occurred in Sweden some five years ago when all the countries' newspapers published the same special issues carrying photographs of the leading Swedish neo-Nazis in hopes that they would be stigmatized and marginalized in their communities.
Now the shock of events may trigger a European backlash against toleration of islamophobic propaganda and racism. But the political fall-out will be complex. It may include sterner penal attitudes: many European justice systems have shunned the harsh punishments meted out in U.S. courts for political violence. In fact, there are some grim similarities between Norway's "long wolf" mass-killer and home-grown, right-wing American psychopaths who have carried out atrocities in the U.S. in recent decades. The Norwegian terrorist apparently learned some of his violent ideology and even bomb-making techniques from American extremists on the web. For Europeans, part of the shock from Norway comes from a realization that the ideological violence they abhorred in American life has germinated in Europe, too – that "it can happen here."
Certainly, leaders at all levels in Europe and the U.S. will undergo soul-searching about the rise of the far-right in the EU and the dangers of populism. Current counter-terrorism efforts by European governments have focused on possible Islamic attacks, but now Europe's police agency, Europol, has announced a 50-man taskforce to look into non-Islamist threats of homegrown terrorism.
Voicing the initial reactions of many Europeans from beyond his own left-leaning group, Norwegian writer Aslak Sira Myhre said that the mayhem must shake Europeans into reacting against anti-Islamic extremism that has often been dismissed as marginal. He notes that the killer was a fellow Norwegian who until 2005 had been an active member of a populist party that was a growing rightwing force in Norwegian democratic politics. He left them and sought his ideology instead among the community of anti-Islamist groups on the internet. Now, the Norwegian writer wrote in an Oslo paper, "all Western leaders have the same problem within their own borders. Will they now wage war on homegrown rightwing extremism? On Islamophobia and racism?"
The author praised Norwegian Prime Minister Jens Stoltenberg for his response to the outrage: Our answer to the attack should be more democracy and more openness, he said, adding that "there is good reason to be proud [of Norway's leaders]. Contrasting this reaction to America's bellicose reaction to the 9/11 attacks, he said that Norway should follow the examples of Britain and Spain in their measured responses to attacks they suffered from Muslim extremists. But, he said, "after the most dreadful experience in Norway since the Second World War, we need to go further. We need to use this incident to strike a blow against the intolerance, racism and hatred that is growing, not just in Norway and not just in Scandinavia but throughout Europe." His words foreshadow lengthy processes to come of political debate and leadership challenges.
-- By European Affairs


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Recommendations From the International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome
Helena J. Teede; Marie L. Misso; Michael F. Costello; Anuja Dokras; Joop Laven; Lisa Moran; Terhi Piltonen; Robert J. Norman; on behalf of the International PCOS
Hum Reprod. 2018;33(9):1602-1618.
What Does This Mean for Adolescents and Women With PCOS?
Study Question: What is the recommended assessment and management of women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise and consumer preference?
Summary Answer: International evidence-based guidelines, including 166 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of women with PCOS.
What Is Known Already: Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated. Diagnosis of PCOS remains controversial, and assessment and management are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist.
Study Design, Size, Duration: International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Appraisal of Guidelines for Research and Evaluation (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength.
Participants/Materials, Setting, Methods: Governance included a six continent international advisory and a project board, five guideline development groups, and consumer and translation committees. Extensive health professional and consumer engagement informed guideline scope and priorities. Engaged international society-nominated panels included pediatrics, endocrinology, gynecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, public health and other experts, alongside consumers, project management, evidence synthesis and translation experts. In total, 37 societies and organizations covering 71 countries engaged in the process. Twenty face-to-face meetings over 15 months addressed 60 prioritized clinical questions involving 40 systematic and 20 narrative reviews. Evidence-based recommendations were developed and approved via consensus voting within the five guideline panels, modified based on international feedback and peer review, with final recommendations approved across all panels.
Main Results and the Role of Chance: The evidence in the assessment and management of PCOS is generally of low to moderate quality. The guideline provides 31 evidence based recommendations, 59 clinical consensus recommendations and 76 clinical practice points all related to assessment and management of PCOS. Key changes in this guideline include: (i) considerable refinement of individual diagnostic criteria with a focus on improving accuracy of diagnosis; (ii) reducing unnecessary testing; (iii) increasing focus on education, lifestyle modification, emotional wellbeing and quality of life; and (iv) emphasizing evidence based medical therapy and cheaper and safer fertility management.
Limitations, Reasons for Caution: Overall evidence is generally low to moderate quality, requiring significantly greater research in this neglected, yet common condition, especially around refining specific diagnostic features in PCOS. Regional health system variation is acknowledged and a process for guideline and translation resource adaptation is provided.
Wider Implications of the Findings: The international guideline for the assessment and management of PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program.
Study Funding/Competing Interest(s): The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine. Guideline development group members did not receive payment. Travel expenses were covered by the sponsoring organizations. 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/medicine/sphpm/mchri/pcos/guideline in the Register of disclosures of interest. Of named authors, Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Laven declared grants from Ferring, Euroscreen and personal fees from Ferring, Euroscreen, Danone and Titus Healthcare. Prof. Norman has declared a minor shareholder interest in an IVF unit. The remaining authors have no conflicts of interest to declare. The guideline was peer reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREE-II criteria, and underwent methodological review. This guideline was approved by all members of the guideline development groups and was submitted for final approval by the NHMRC.
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting reproductive aged women, with a prevalence of between 8 and 13% depending on the population studied and definitions used (Teede et al., 2010; Azziz et al., 2016). PCOS is complex with reproductive, metabolic and psychological features (Teede et al., 2010; Azziz et al., 2016). Clinical practice in the assessment and management of PCOS is inconsistent, with key evidence practice gaps, whilst women internationally have highlighted delayed diagnosis and dissatisfaction with care (Teede et al., 2014; Dokras et al., 2017; Gibson-Helm, et al., 2017). Current guidelines either are limited in breadth, do not follow rigorous best practice in development, have not involved consumers, or are outdated (Teede et al., 2011; Legro et al., 2013; Conway et al., 2014; Goodman et al., 2015; Balen et al., 2016), resulting in inconsistent guidance for clinicians and women alike. To address these identified gaps, here we summarize the development process and recommendations from the first international evidence-based guideline for the assessment and management of PCOS, bringing together extensive consumer engagement and international collaboration with leading societies and organizations, multidisciplinary experts, and primary care representatives. In this process, the guideline development groups (GDG) unanimously supported the Rotterdam diagnostic criteria (Group, 2004) for adult women.
This comprehensive evidence-based guideline builds on prior high-quality guidelines and culminates from a rigorous, Appraisal of Guidelines for Research and Evaluation-II (AGREE-II)-compliant, evidence-based guideline development process. It provides a single source of international evidence-based recommendations (EBR) to guide clinical practice with the opportunity for adaptation in relevant health systems. Together with an extensive translation program, the aim is to reduce worldwide variation in care and promote high-quality service provision to improve health outcomes and quality of life in women with PCOS. The guidelines are supported by a multifaceted international translation program with co-designed resources to enhance the skills of health professionals and empower women with PCOS, with an integrated comprehensive evaluation program.
Hum Reprod. 2018;33(9):1602-1618. © 2018 Oxford University Press
Table I. Categories of recommendations in the PCOS guideline.
EBR Evidence-based recommendations are made where evidence is sufficient to inform a recommendation made by the guideline development group.
CCR Clinical consensus recommendations are made in the absence of adequate evidence on PCOS. These are informed by evidence in other populations and are made by the guideline development group, using rigorous and transparent processes.
CPP Clinical practice points are made where evidence was not sought and are made where important clinical issues arose from discussion of evidence-based or clinical consensus recommendations.
Table II. Quality (certainty) of evidence categories.*
High ⊕⊕⊕⊕ Very confident that the true effect lies close to that of the estimate of the effect.
Moderate ⊕⊕⊕○ Moderate confidence in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low ⊕⊕○○ Limited confidence in the effect estimate: the true effect may be substantially different from the estimate of the effect.
Very Low ⊕○○○ Very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
*Adapted from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) (GRADE working group).
Table III. Recommendations and practice points. © Monash University on behalf of the NHMRC Centre for Research Excellence in PCOS, 2018.
Category (see Table I for definition)
GRADE and quality
1. Screening, diagnostic assessment, risk assessment and life-stage
Irregular cycles and ovulatory dysfunction
CCR Irregular menstrual cycles are defined as:
Normal in the first year post menarche as part of the pubertal transition
1 to <3 years post menarche: <21 or >45 days
3 years post menarche to perimenopause: <21 or >35 days or <8 cycles per year
1 year post menarche >90 days for any one cycle
Primary amenorrhea by age 15 or >3 years post thelarche (breast development)
When irregular menstrual cycles are present a diagnosis of PCOS should be considered and assessed according to the guidelines
CCR In an adolescent with irregular menstrual cycles, the value and optimal timing of assessment and diagnosis of PCOS should be discussed with the patient, taking into account diagnostic challenges at this life stage and psychosocial and cultural factors ****
CPP For adolescents who have features of PCOS but do not meet diagnostic criteria, an 'increased risk' could be considered and reassessment advised at or before full reproductive maturity, 8 years post menarche. This includes those with PCOS features before combined oral contraceptive pill (COCP) commencement, those with persisting features and those with significant weight gain in adolescence.
CPP Ovulatory dysfunction can still occur with regular cycles and if anovulation needs to be confirmed serum progesterone levels can be measured. _
Biochemical hyperandrogenism
EBR Calculated free testosterone, free androgen index or calculated bioavailable testosterone should be used to assess biochemical hyperandrogenism in the diagnosis of PCOS. **** ⊕⊕○○
EBR High-quality assays such as liquid chromatography–mass spectrometry (LCMS) and extraction/chromatography immunoassays, should be used for the most accurate assessment of total or free testosterone in PCOS. *** ⊕⊕○○
EBR Androstenedione and dehydroepiandrosterone sulfate (DHEAS) could be considered if total or free testosterone are not elevated; however, these provide limited additional information in the diagnosis of PCOS. *** ⊕⊕○○
CCR Direct free testosterone assays, such as radiometric or enzyme-linked assays, preferably should not be used in assessment of biochemical hyperandrogenism in PCOS, as they demonstrate poor sensitivity, accuracy and precision.
CPP Reliable assessment of biochemical hyperandrogenism is not possible in women on hormonal contraception, due to effects on sex hormone-binding globulin and altered gonadotrophin-dependent androgen production. _
CPP Where assessment of biochemical hyperandrogenism is important in women on hormonal contraception, drug withdrawal is recommended for months or longer before measurement, and contraception management with a non-hormonal alternative is needed during this time. _
CPP Assessment of biochemical hyperandrogenism is most useful in establishing the diagnosis of PCOS and/or phenotype where clinical signs of hyperandrogenism (in particular hirsutism) are unclear or absent. _
CPP Interpretation of androgen levels needs to be guided by the reference ranges of the laboratory used, acknowledging that ranges for different methods and laboratories vary widely. Normal values are ideally based on levels from a well phenotyped healthy control population or by cluster analysis of a large general population considering age and pubertal specific stages. _
CPP Where androgen levels are markedly above laboratory reference ranges, other causes of biochemical hyperandrogenism need to be considered. History of symptom onset and progression is critical in assessing for neoplasia, however, some androgen-secreting neoplasms may only induce mild to moderate increases in biochemical hyperandrogenism. _
Clinical hyperandrogenism
CCR A comprehensive history and physical examination should be completed for symptoms and signs of clinical hyperandrogenism, including acne, alopecia, and hirsutism and, in adolescents, severe acne and hirsutism. ****
CCR Health professionals should be aware of the potential negative psychosocial impact of clinical hyperandrogenism. Reported unwanted excess hair growth and/or alopecia should be considered important, regardless of apparent clinical severity. ****
CCR Standardized visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥4–6 indicating hirsutism, depending on ethnicity, acknowledging that self-treatment is common and can limit clinical assessment. (See recommendations on ethnic variation.) ****
CCR The Ludwig visual score is preferred for assessing the degree and distribution of alopecia. ****
CPP There are no universally accepted visual assessments for evaluating acne.
CPP The prevalence of hirsutism is the same across ethnicities, yet the mFG cut-off scores for defining hirsutism and the severity of hirsutism varies by ethnicity. _
CPP As ethnic variation in vellus hair density is notable, over-estimation of hirsutism may occur if vellus hair is confused with terminal hair; only terminal hairs need to be considered in pathological hirsutism, with terminal hairs clinically growing >5 mm in length if untreated, varying in shape and texture and generally being pigmented. _
Ultrasound and polycystic ovarian morphology (PCOM)
CCR Ultrasound should not be used for the diagnosis of PCOS in those with a gynecological age of <8 years (<8 years after menarche), due to the high incidence of multi-follicular ovaries in this life stage. ****
CCR The threshold for PCOM should be revised regularly with advancing ultrasound technology, and age-specific cut off values for PCOM should be defined. ****
CCR The transvaginal ultrasound approach is preferred in the diagnosis of PCOS, if sexually active and if acceptable to the individual being assessed. ****
CCR Using endovaginal ultrasound transducers with a frequency bandwidth that includes 8 MHz, the threshold for PCOM on either ovary, a follicle number per ovary of ≥20 and/or an ovarian volume ≥10 ml on either ovary, ensuring no corpora lutea, cysts or dominant follicles are present. ***
CPP If using older technology, the threshold for PCOM could be an ovarian volume ≥10 ml on either ovary. _
CPP In patients with irregular menstrual cycles and hyperandrogenism, an ovarian ultrasound is not necessary for PCOS diagnosis; however, ultrasound will identify the complete PCOS phenotype. _
CPP In transabdominal ultrasound reporting is best focused on ovarian volume with a threshold of ≥10 ml, given the difficulty of reliably assessing follicle number with this approach. _
CPP Clear protocols are recommended for reporting follicle number per ovary and ovarian volume on ultrasound. Recommended minimum reporting standards include:
• Last menstrual period
• Transducer bandwidth frequency
• Approach/route assessed
• Total follicle number per ovary measuring 2–9 mm
• Three dimensions and volume of each ovary
• Reporting of endometrial thickness and appearance is preferred; 3-layer endometrial assessment may be useful to screen for endometrial pathology
• Other ovarian and uterine pathology, as well as ovarian cysts, corpus luteum, dominant follicles ≥10 mm _
CPP There is a need for training in careful and meticulous follicle counting per ovary, to improve reporting. _
Anti-Müllerian hormone (AMH)
EBR Serum AMH levels should not yet be used as an alternative for the detection of PCOM or as a single test for the diagnosis of PCOS. *** ⊕⊕○○
CPP There is emerging evidence that with improved standardization of assays and established cut off levels or thresholds based on large scale validation in populations of different ages and ethnicities, AMH assays will be more accurate in the detection of PCOM. _
Ethnic variation
CCR Health professionals should consider ethnic variation in the presentation and manifestations of PCOS, including:
• A relatively mild phenotype in Caucasians
• Higher body mass index (BMI) in Caucasian women, especially in North America and Australia
• More severe hirsutism in Middle Eastern, Hispanic and Mediterranean women
• Increased central adiposity, insulin resistance, diabetes, metabolic risks and acanthosis nigricans in South East Asians and Indigenous Australians
• Lower BMI and milder hirsutism in East Asians
• Higher BMI and metabolic features in Africans ****
Menopause life stage
CCR Postmenopausal persistence of PCOS could be considered likely with continuing evidence of hyperandrogenism. ***
CCR A diagnosis of PCOS postmenopause could be considered if there is a past diagnosis of PCOS, a long-term history of irregular menstrual cycles and hyperandrogenism and/or PCOM, during the reproductive years. ***
CPP Postmenopausal women presenting with new-onset, severe or worsening hyperandrogenism including hirsutism, require investigation to rule out androgen-secreting tumors and ovarian hyperthecosis. _
Cardiovascular disease risk (CVD)
CCR All those with PCOS should be offered regular monitoring for weight changes and excess weight, in consultation with and where acceptable to the individual woman. Monitoring could be at each visit or at a minimum 6–12 monthly, with frequency planned and agreed between the health professional and the individual. ****
CCR Weight, height and ideally waist circumference should be measured and BMI calculated with the following considered:
• BMI categories and waist circumference should follow World Health Organization guidelines, also noting ethnic and adolescent ranges.
• Consideration should be given for Asian and high-risk ethnic groups including recommended monitoring of waist circumference. ****
CCR All women with PCOS should be assessed for cardiovascular risk factors and global CVD risk. ****
CCR If screening reveals CVD risk factors including obesity, cigarette smoking, dyslipidemia, hypertension, impaired glucose tolerance, and lack of physical activity, women with PCOS should be considered at increased risk of CVD. ****
CCR Overweight and obese women with PCOS, regardless of age, should have a fasting lipid profile (cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride level at diagnosis). Thereafter, frequency of measurement should be based on the presence of hyperlipidemia and global CVD risk. ****
CCR All women with PCOS should have blood pressure measured annually, or more frequently based on global CVD risk. ****
CPP Health professionals need to be aware that CVD risk in women with PCOS remains unclear pending high-quality studies, however prevalence of CVD risk factors is increased, warranting consideration of screening. _
CPP Consideration needs to be given to the significant differences in CVD risk across ethnicities (See Ethnic variation) when determining frequency of risk assessment. _
Gestational diabetes, impaired glucose tolerance and type 2 diabetes
CCR Health professionals and women with PCOS should be aware that, regardless of age, the prevalence of gestational diabetes, impaired glucose tolerance and type 2 diabetes (5-fold in Asia, 4-fold in the Americas and 3-fold in Europe) are significantly increased in PCOS, with risk independent of, yet exacerbated by, obesity. ****
CCR Glycemic status should be assessed at baseline in all women with PCOS. Thereafter, assessment should be every one to three years, influenced by the presence of other diabetes risk factors. ****
CCR An oral glucose tolerance test (OGTT), fasting plasma glucose or HbA1c should be performed to assess glycemic status. In high-risk women with PCOS (including a BMI > 25 kg/m2 or in Asians >23 kg/m2, history of impaired fasting glucose, impaired glucose tolerance or gestational diabetes, family history of diabetes mellitus type 2, hypertension or high-risk ethnicity), an OGTT is recommended. ****
CCR A 75-g OGTT should be offered in all women with PCOS preconception when planning pregnancy or seeking fertility treatment, given the high risk of hyperglycemia and the associated comorbidities in pregnancy. If not performed preconception, an OGTT should be offered at <20 weeks gestation, and all women with PCOS should be offered the test at 24–28 weeks gestation. ****
Obstructive sleep apnea (OSA)
CCR Screening should only be considered for OSA in PCOS to identify and alleviate related symptoms, such as snoring, waking unrefreshed from sleep, daytime sleepiness and the potential for fatigue to contribute to mood disorders. Screening should not be considered with the intention of improving cardiometabolic risk, with inadequate evidence for metabolic benefits of OSA treatment in PCOS and in general populations. ****
CCR A simple screening questionnaire, preferably the Berlin tool, could be applied and if positive, referral to a specialist considered. ***
CPP A positive screen raises the likelihood of OSA, however, it does not quantify symptom burden and alone does not justify treatment. If women with PCOS have OSA symptoms and a positive screen, consideration can be given to referral to a specialist center for further evaluation. _
CCR Health professionals and women with PCOS should be aware of a 2- to 6-fold increased risk of endometrial cancer, which often presents before menopause; however, absolute risk of endometrial cancer remains relatively low. ***
CPP Health professionals require a low threshold for investigation of endometrial cancer in women with PCOS or a history of PCOS, with investigation by transvaginal ultrasound and/or endometrial biopsy recommended with persistent thickened endometrium and/or risk factors including prolonged amenorrhea, abnormal vaginal bleeding or excess weight. However, routine ultrasound screening of endometrial thickness in PCOS is not recommended. _
CPP Optimal prevention for endometrial hyperplasia and endometrial cancer is not known. A pragmatic approach could include COCP or progestin therapy in those with cycles longer than 90 days. _
2. Prevalence, screening, diagnostic assessment and treatment in emotional wellbeing
CCR Health professionals and women should be aware of the adverse impact of PCOS on quality of life. ****
CCR Health professionals should capture and consider perceptions of symptoms, impact on quality of life and personal priorities for care to improve patient outcomes. ****
CPP The PCOS quality of life tool (PCOSQ), or the modified PCOSQ, may be useful clinically to highlight PCOS features causing greatest distress, and to evaluate treatment outcomes on women's subjective PCOS health concerns. _
Depressive and anxiety symptoms, screening and treatment
CCR Health professionals should be aware that in PCOS, there is a high prevalence of moderate to severe anxiety and depressive symptoms in adults; and a likely increased prevalence in adolescents. ****
CCR Anxiety and depressive symptoms should be routinely screened in all adolescents and women with PCOS at diagnosis. If the screen for these symptoms and/or other aspects of emotional wellbeing is positive, further assessment and/or referral for assessment and treatment should be completed by suitably qualified health professionals, informed by regional guidelines. ****
CCR If treatment is warranted, psychological therapy and/or pharmacological treatment should be offered in PCOS, informed by regional clinical practice guidelines. ****
CPP The optimal interval for anxiety and depressive symptom screening is not known. A pragmatic approach could include repeat screening using clinical judgment, considering risk factors, comorbidities and life events. _
CPP Assessment of anxiety and or depressive symptoms involves assessment of risk factors, symptoms and severity. Symptoms can be screened according to regional guidelines, or by using simple stepwise approaches (see full guideline for details). _
CPP Where pharmacological treatment for anxiety and depression is offered in PCOS, the following need consideration:
• Caution is needed to avoid inappropriate treatment with antidepressants or anxiolytics. Where mental health disorders are clearly documented and persistent, or if suicidal symptoms are present, treatment of depression or anxiety need to be informed by clinical regional practice guidelines.
• Use of agents that exacerbate PCOS symptoms, including weight gain, need careful consideration. _
CPP Factors including obesity, infertility and hirsutism need consideration along with use of hormonal medications in PCOS, as they may independently exacerbate depressive and anxiety symptoms and other aspects of emotional wellbeing. _
Psychosexual function
CCR All health professionals should be aware of the increased prevalence of psychosexual dysfunction and should consider exploring how features of PCOS, including hirsutism and body image, impact on sex life and relationships in PCOS. ****
CCR If psychosexual dysfunction is suspected, tools such as the Female Sexual Function Index can be considered. ****
CCR Health professionals and women should be aware that features of PCOS can impact on body image. ***
CPP Negative body image, can be screened according to regional guidelines or by using a stepped approach (see full guideline for details). _
Eating disorders and disordered eating
CCR All health professionals and women should be aware of the increased prevalence of eating disorders and disordered eating associated with PCOS. **
CCR If eating disorders and disordered eating are suspected, further assessment, referral and treatment, including psychological therapy, could be offered by appropriately trained health professionals, informed by regional guidelines or by using a stepped approach (see full guideline for details). **
Information resources, models of care, cultural and linguistic considerations
CCR Information and education resources for women with PCOS should be culturally appropriate, tailored and high-quality, should use a respectful and empathetic approach, and promote self-care and highlight peer support groups. ****
CCR Information and education resources for healthcare professionals should promote the recommended diagnostic criteria, appropriate screening for comorbidities, and effective lifestyle and pharmacological management. ****
CCR PCOS information should be comprehensive, evidence-based and inclusive of the biopsychosocial dimensions of PCOS across the life-span. ****
CCR Women's needs, communication preferences, beliefs and culture should be considered and addressed through provision of culturally and linguistically appropriate co-designed resources and care. ****
CPP Interdisciplinary care needs to be considered for those with PCOS where appropriate and available. Primary care is generally well placed to diagnose, screen and coordinate interdisciplinary care. _
CPP Care needs to be person centered, address women's priorities and be provided in partnership with those with PCOS and where appropriate, their families. _
CPP Guideline dissemination and translation including multimodal education tools and resources is important, with consultation and engagement with stakeholders internationally. _
3. Lifestyle
Effectiveness of lifestyle interventions
CCR Healthy lifestyle behaviors encompassing healthy eating and regular physical activity should be recommended in all those with PCOS to achieve and/or maintain healthy weight and to optimize hormonal outcomes, general health and quality of life across the life course. ****
EBR Lifestyle intervention (preferably multicomponent including diet, exercise and behavioral strategies) should be recommended in all those with PCOS and excess weight, for reductions in weight, central obesity and insulin resistance. *** ⊕⊕○○
CPP Achievable goals such as 5–10% weight loss in those with excess weight yields significant clinical improvements and is considered successful weight reduction within 6 months. Ongoing assessment and monitoring is important during weight loss and maintenance in all women with PCOS. _
CPP SMART (Specific Measurable, Achievable, Realistic and Timely) goal setting and self-monitoring can enable achievement of realistic lifestyle goals. _
CPP Psychological factors such as anxiety and depressive symptoms, body image concerns and disordered eating, need consideration and management to optimize engagement and adherence to lifestyle interventions. _
CPP Health professional interactions around healthy lifestyle, including diet and exercise, need to be respectful, patient-centered and to value women's individualized healthy lifestyle preferences and cultural, socioeconomic and ethnic differences. Health professionals need to also consider personal sensitivities, marginalization and potential weight-related stigma. _
CPP Adolescent and ethnic-specific BMI and waist circumference categories need to be considered when optimizing lifestyle and weight. _
CPP Healthy lifestyle may contribute to health and quality of life benefits in the absence of weight loss. _
CPP Healthy lifestyle and optimal weight management appears equally effective in PCOS as in the general population and is the joint responsibility of all health professionals, partnering with women with PCOS. Where complex issues arise, referral to suitably trained allied health professionals needs to be considered. _
CPP Ethnic groups with PCOS who are at high cardiometabolic risk require greater consideration in terms of healthy lifestyle and lifestyle intervention (see Ethnic Variation). _
CCR Lifestyle interventions could include behavioral strategies such as goal-setting, self-monitoring, stimulus control, problem solving, assertiveness training, slower eating, reinforcing changes and relapse prevention, to optimize weight management, healthy lifestyle and emotional wellbeing in women with PCOS. ****
CPP Comprehensive health behavioral or cognitive behavioral interventions could be considered to increase support, engagement, retention, adherence and maintenance of healthy lifestyle and improve health outcomes in women with PCOS. _
CCR A variety of balanced dietary approaches could be recommended to reduce dietary energy intake and induce weight loss in women with PCOS and overweight and obesity, as per general population recommendations. ****
CCR General healthy eating principles should be followed for all women with PCOS across the life course, as per general population recommendations. ****
CPP To achieve weight loss in those with excess weight, an energy deficit of 30% or 500–750 kcal/day (1200–1500 kcal/day) could be prescribed for women, also considering individual energy requirements, body weight and physical activity levels. _
CPP In women with PCOS, there is no or limited evidence that any specific energy equivalent diet type is better than another, or that there is any differential response to weight management intervention, compared to women without PCOS. _
CPP Tailoring of dietary changes to food preferences, allowing for a flexible and individual approach to reducing energy intake and avoiding unduly restrictive and nutritionally unbalanced diets, are important, as per general population recommendations. _
Exercise intervention
CCR Health professionals should encourage and advise the following for prevention of weight gain and maintenance of health:
• In adults from 18–64 years, a minimum of 150 min/week of moderate intensity physical activity or 75 min/week of vigorous intensities or an equivalent combination of both, including muscle strengthening activities on 2 non-consecutive days/week
• In adolescents, at least 60 min of moderate to vigorous intensity physical activity/day, including those that strengthen muscle and bone at least 3 times weekly
• Activity be performed in at least 10-min bouts or around 1000 steps, aiming to achieve at least 30 min daily on most days. ***
CCR Health professionals should encourage and advise the following for modest weight-loss, prevention of weight-regain and greater health benefits:
• A minimum of 250 min/week of moderate intensity activities or 150 min/week of vigorous intensity or an equivalent combination of both, and muscle strengthening activities involving major muscle groups on 2 non-consecutive days/week.
• Minimized sedentary, screen or sitting time. ***
CPP Physical activity includes leisure time physical activity, transportation such as walking or cycling, occupational work, household chores, games, sports or planned exercise, in the context of daily, family and community activities. Daily, 10 000 steps is ideal, including activities of daily living and 30 min of structured physical activity or around 3000 steps. Structuring of recommended activities need to consider women's and family routines as well as cultural preferences _
CPP Realistic physical activity SMART (Specific, Measureable, Achievable, Relevant, Time limited) goals could include 10 min bouts, progressively increasing physical activity 5% weekly, up to and above recommendations. _
CPP Self-monitoring including with fitness tracking devices and technologies for step count and exercise intensity, could be used as an adjunct to support and promote active lifestyles and minimize sedentary behaviors. _
Obesity and weight assessment
CCR Health professionals and women should be aware that women with PCOS have a higher prevalence of weight gain and obesity, presenting significant concerns for women, impacting on health and emotional wellbeing, with a clear need for prevention. ***
CCR All those with PCOS should be offered regular monitoring for weight changes and excess weight (see Cardiovascular Disease Risk). ****
CPP When assessing weight, related stigma, negative body image and/or low self-esteem need to be considered and assessment needs to be respectful and considerate. Beforehand, explanations on the purpose and how the information will be used and the opportunity for questions and preferences needs to be provided, permission sought and scales and tape measures adequate. Implications of results need to be explained and where this impacts on emotional wellbeing, support provided. _
CPP Prevention of weight gain, monitoring of weight and encouraging evidence-based and socio-culturally appropriate healthy lifestyle is important in PCOS, particularly from adolescence. _
4. Pharmacological treatment for non-fertility indications
Pharmacological treatment principles in PCOS
CPP Consideration of the individual's personal characteristics, preferences and values is important in recommending pharmacological treatment. _
CPP When prescribing pharmacological therapy in PCOS, benefits, adverse effects and contraindications in PCOS and general populations need to be considered and discussed before commencement. _
CPP COCPs, metformin and other pharmacological treatments are generally off label# in PCOS. However, off label use is predominantly evidence-based and is allowed in many countries. Where it is allowed, health professionals need to inform women and discuss the evidence, possible concerns and side effects of treatment. _
CPP Holistic approaches are required and pharmacological therapy in PCOS needs to be considered alongside education, lifestyle and other options including cosmetic therapy and counseling. _
Combined oral contraceptive pills (COCPs)
EBR The COCP alone should be recommended in adult women with PCOS for management of hyperandrogenism and/or irregular menstrual cycles. **** ⊕⊕○○
EBR The COCP alone should be considered in adolescents with a clear diagnosis of PCOS for management of clinical hyperandrogenism and/or irregular menstrual cycles. *** ⊕⊕○○
EBR The COCP could be considered in adolescents who are deemed 'at risk' but not yet diagnosed with PCOS, for management of clinical hyperandrogenism and irregular menstrual cycles. *** ⊕⊕○○
EBR Specific types or dose of progestins, estrogens or combinations of COCP cannot currently be recommended in adults and adolescents with PCOS and practice should be informed by general population guidelines. *** ⊕⊕○○
CCR The 35 μg ethinyloestradiol plus cyproterone acetate preparations should not be considered first line in PCOS as per general population guidelines, due to adverse effects including venous thromboembolic risks. *
CPP When prescribing COCPs in adults and adolescents with PCOS:
• Various COCP preparations have similar efficacy in treating hirsutism.
• The lowest effective estrogen doses (such as 20–30 μg of ethinyloestradiol or equivalent), and natural estrogen preparations are preferred, balancing efficacy, metabolic risk profile, side effects, cost and availability.
• The generally limited evidence on effects of COCPs in PCOS needs to be appreciated with practice informed by general population guidelines (World Health Organization Guidelines).
• The relative and absolute contraindications and side effects of COCPs need to be considered and be the subject of individualized discussion.
• PCOS specific risk factors such as high BMI, hyperlipidemia and hypertension need to be considered. _
Combined oral contraceptive pills in combination with metformin and/or anti-androgen pharmacological agents
EBR In combination with the COCP, metformin should be considered in women with PCOS for management of metabolic features where COCP and lifestyle changes do not achieve desired goals. **** ⊕⊕○○
EBR In combination with the COCP, metformin could be considered in adolescents with PCOS and BMI ≥ 25 kg/m2 where COCP and lifestyle changes do not achieve desired goals. **** ⊕⊕○○
CPP In combination with the COCP, metformin may be most beneficial in high metabolic risk groups including those with diabetes risk factors, impaired glucose tolerance or high-risk ethnic groups. _
EBR In combination with the COCP, antiandrogens should only be considered in PCOS to treat hirsutism, after 6 months or more of COCP and cosmetic therapy have failed to adequately improve symptoms. ** ⊕⊕○○
CCR In combination with the COCP, antiandrogens could be considered for the treatment of androgen-related alopecia in PCOS. **
CPP In PCOS, antiandrogens must be used with effective contraception, to avoid male fetal undervirilisation. Variable availability and regulatory status of these agents is notable and for some agents, potential liver toxicity requires caution. _
EBR Metformin in addition to lifestyle, could be recommended in adult women with PCOS, for the treatment of weight, hormonal and metabolic outcomes. *** ⊕⊕○○
EBR Metformin in addition to lifestyle, should be considered in adult women with PCOS with BMI ≥ 25 kg/m2 for management of weight and metabolic outcomes. *** ⊕⊕○○
EBR Metformin in additional to lifestyle, could be considered in adolescents with a clear diagnosis of PCOS or with symptoms of PCOS before the diagnosis is made. *** ⊕⊕○○
CPP Metformin may offer greater benefit in high metabolic risk groups including those with diabetes risk factors, impaired glucose tolerance or high-risk ethnic groups (see Ethnic variation). _
CPP Where metformin is prescribed the following need to be considered:
• Adverse effects, including gastrointestinal side-effects that are generally dose dependent and self-limiting, need to be the subject of individualized discussion.
• Starting at a low dose, with 500 mg increments 1–2 weekly and extended release preparations may minimize side effects.
• Metformin use appears safe long term, based on use in other populations, however, ongoing requirement needs to be considered and use may be associated with low vitamin B12 levels.
• Use is generally off label and health professionals need to inform women and discuss the evidence, possible concerns and side effects. _
Anti-obesity pharmacological agents
CCR Anti-obesity medications in addition to lifestyle, could be considered for the management of obesity in adults with PCOS after lifestyle intervention, as per general population recommendations. _
CPP For anti-obesity medications, cost, contraindications, side effects, variable availability and regulatory status need to be considered and pregnancy needs to be avoided whilst taking these medications. _
Anti-androgen pharmacological agents
EBR Where COCPs are contraindicated or poorly tolerated, in the presence of other effective forms of contraception, antiandrogens could be considered to treat hirsutism and androgen-related alopecia. *** ⊕○○○
CPP Specific types or doses of antiandrogens cannot currently be recommended with inadequate evidence in PCOS. _
EBR Inositol (in any form) should currently be considered an experimental therapy in PCOS, with emerging evidence on efficacy highlighting the need for further research. *
⊕○○○
CPP Women taking inositol and other complementary therapies are encouraged to advise their health professional. _
5. Assessment and treatment of infertility
Assessment of factors that may affect fertility, treatment response or pregnancy outcomes
CPP Factors such as blood glucose, weight, blood pressure, smoking, alcohol, diet, exercise, sleep and mental, emotional and sexual health need to be optimized in women with PCOS, to improve reproductive and obstetric outcomes, aligned with recommendations in the general population. Refer to Lifestyle, Emotional Wellbeing and Diabetes risk sections. _
CPP Monitoring during pregnancy is important in women with PCOS, given increased risk of adverse maternal and offspring outcomes. _
CCR In women with PCOS and infertility due to anovulation alone with normal semen analysis, the risks, benefits, costs and timing of tubal patency testing should be discussed on an individual basis. ***
CCR Tubal patency testing should be considered prior to ovulation induction in women with PCOS where there is suspected tubal infertility. ***
Ovulation induction principles
CPP The use of ovulation induction agents, including letrozole, metformin and clomiphene citrate is off label in many countries. Where off label use of ovulation induction agents is allowed, health professionals need to inform women and discuss the evidence, possible concerns and side effects. _
CPP Pregnancy needs to be excluded prior to ovulation induction. _
CPP Unsuccessful, prolonged use of ovulation induction agents need to be avoided, due to poor success rates. _
EBR Letrozole should be considered first line pharmacological treatment for ovulation induction in women with PCOS with anovulatory infertility and no other infertility factors to improve ovulation, pregnancy and live birth rates. **** ⊕⊕○○
CPP Where letrozole is not available or use is not permitted or cost is prohibitive, health professionals can use other ovulation induction agents. _
CPP Health professionals and women need to be aware that the risk of multiple pregnancy appears to be less with letrozole, compared to clomiphene citrate. _
Clomiphene citrate and metformin
EBR Clomiphene citrate could be used alone in women with PCOS with anovulatory infertility and no other infertility factors to improve ovulation and pregnancy rates. *** ⊕○○○
EBR Metformin could be used alone in women with PCOS, with anovulatory infertility and no other infertility factors, to improve ovulation, pregnancy and live birth rates, although women should be informed that there are more effective ovulation induction agents. *** ⊕⊕⊕○
EBR Clomiphene citrate could be used in preference, when considering clomiphene citrate or metformin for ovulation induction in women with PCOS who are obese (BMI is ≥30 kg/m2) with anovulatory infertility and no other infertility factors. *** ⊕⊕○○
EBR If metformin is being used for ovulation induction in women with PCOS who are obese (BMI ≥ 30 kg/m2) with anovulatory infertility and no other infertility factors, clomiphene citrate could be added to improve ovulation, pregnancy and live birth rates. *** ⊕⊕○○
EBR Clomiphene citrate could be combined with metformin, rather than persisting with clomiphene citrate alone, in women with PCOS who are clomiphene citrate-resistant, with anovulatory infertility and no other infertility factors, to improve ovulation and pregnancy rates. *** ⊕⊕○○
CPP The risk of multiple pregnancies is increased with clomiphene citrate use and therefore monitoring needs to be considered. _
Gonadotrophins
EBR Gonadotrophins could be used as second line pharmacological agents in women with PCOS who have failed first line oral ovulation induction therapy and are anovulatory and infertile, with no other infertility factors. *** ⊕⊕○○
EBR Gonadotrophins could be considered as first line treatment, in the presence of ultrasound monitoring, following counseling on cost and potential risk of multiple pregnancy, in women with PCOS with anovulatory infertility and no other infertility factors. *** ⊕⊕○○
EBR Gonadotrophins, where available and affordable, should be used in preference to clomiphene citrate combined with metformin therapy for ovulation induction, in women with PCOS with anovulatory infertility, clomiphene citrate-resistance and no other infertility factors, to improve ovulation, pregnancy and live birth rates. **** ⊕⊕⊕○
EBR Gonadotrophins with the addition of metformin could be used rather than gonadotrophin alone, in women with PCOS with anovulatory infertility, clomiphene citrate-resistance and no other infertility factors, to improve ovulation, pregnancy and live birth rates. *** ⊕⊕⊕○
EBR Either gonadotrophins or laparoscopic ovarian surgery could be used in women with PCOS with anovulatory infertility, clomiphene citrate-resistance and no other infertility factors, following counseling on benefits and risks of each therapy. **** ⊕⊕⊕○
CPP Where gonadotrophins are prescribed, considerations include:
• Cost and availability.
• Expertise required for use in ovulation induction.
• Degree of intensive ultrasound monitoring required.
• Lack of difference in clinical efficacy of available gonadotrophin preparations.
• Low dose gonadotrophin protocols optimize monofollicular development.
• Risk and implications of potential multiple pregnancy. _
CPP Gonadotrophin induced ovulation is only triggered when there are fewer than three mature follicles and needs to be canceled if there are more than two mature follicles with the patient advised to avoid unprotected intercourse. _
CCR Pharmacological anti-obesity agents should be considered an experimental therapy in women with PCOS for the purpose of improving fertility, with risk to benefit ratios currently too uncertain to advocate this as fertility therapy. *
EBR Laparoscopic ovarian surgery could be second line therapy for women with PCOS, who are clomiphene citrate resistant, with anovulatory infertility and no other infertility factors. *** ⊕⊕○○
CCR Laparoscopic ovarian surgery could potentially be offered as first line treatment if laparoscopy is indicated for another reason in women with PCOS with anovulatory infertility and no other infertility factors. ***
CPP Risks need to be explained to all women with PCOS considering laparoscopic ovarian surgery. _
CPP Where laparoscopic ovarian surgery is to be recommended, the following need to be considered:
• Comparative cost.
• Intra-operative and post-operative risks are higher in women who are overweight and obese.
• There may be a small associated risk of lower ovarian reserve or loss of ovarian function.
• Periadnexal adhesion formation may be an associated risk. _
CCR Bariatric surgery should be considered an experimental therapy in women with PCOS, for the purpose of having a healthy baby, with risk to benefit ratios currently too uncertain to advocate this as fertility therapy. *
CPP If bariatric surgery is to be prescribed, the following need to be considered:
• The need for a structured weight management program involving diet, physical activity and interventions to improve psychological, musculoskeletal and cardiovascular health to continue post-operatively.
• Perinatal risks such as small for gestational age, premature delivery, possibly increased infant mortality.
• Potential benefits such as reduced incidence of large for gestational age fetus and gestational diabetes.
• Recommendations for pregnancy avoidance during periods of rapid weight loss and for at least 12 months after bariatric surgery with appropriate contraception.
If pregnancy occurs, the following need to be considered:
• Awareness and preventative management of pre-and post-operative nutritional deficiencies is important, ideally in a specialist interdisciplinary care setting.
• Monitoring of fetal growth during pregnancy. _
CCR In the absence of an absolute indication for IVF ± ICSI), women with PCOS and anovulatory infertility could be offered IVF as third line therapy where first or second line ovulation induction therapies have failed. ***
CPP In women with anovulatory PCOS, the use of IVF is effective and when elective single embryo transfer is used, multiple pregnancies can be minimized. _
CPP Women with PCOS undergoing IVF ± ICSI therapy need to be counseled prior to starting treatment including on:
• Availability, cost and convenience.
• Increased risk of ovarian hyperstimulation syndrome.
• Options to reduce the risk of ovarian hyperstimulation. _
CCR Urinary or recombinant follicle stimulation hormone can be used in women with PCOS undergoing controlled ovarian hyperstimulation for IVF ± ICSI, with insufficient evidence to recommend specific follicle stimulating hormone (FSH) preparations. _
CCR Exogenous recombinant luteinizing hormone treatment should not be routinely used in combination with follicle stimulating hormone therapy in women with PCOS undergoing controlled ovarian hyperstimulation for IVF ± ICSI. _
EBR A gonadotrophin releasing hormone antagonist protocol is preferred in women with PCOS undergoing an IVF ± ICSI cycle, over a gonadotrophin releasing hormone agonist long protocol, to reduce the duration of stimulation, total gonadotrophin dose and incidence of ovarian hyperstimulation syndrome (OHSS). *** ⊕⊕○○
CPP Human chorionic gonadotrophin is best used at the lowest doses to trigger final oocyte maturation in women with PCOS undergoing an IVF ± ICSI cycle to reduce the incidence of OHSS. _
CPP Triggering final oocyte maturation with a gonadotropin-releasing hormone (GnRH) agonist and freezing all suitable embryos could be considered in women with PCOS having an IVF/ICSI cycle with a GnRH antagonist protocol and at an increased risk of developing OHSS or where fresh embryo transfer is not planned. _
CPP In IVF ± ICSI cycles in women with PCOS, consideration needs to be given to an elective freeze of all embryos. _
EBR Adjunct metformin therapy could be used before and/or during follicle stimulating hormone ovarian stimulation in women with PCOS undergoing a IVF ± ICSI therapy with a GnRH agonist protocol, to improve the clinical pregnancy rate and reduce the risk of OHSS. *** ⊕⊕○○
CCR In a GnRH agonist protocol with adjunct metformin therapy, in women with PCOS undergoing IVF ± ICSI treatment, the following could be considered:
• Metformin commencement at the start of GnRH agonist treatment.
• Metformin use at a dose of between 1000 and 2550 mg daily.
• Metformin cessation at the time of the pregnancy test or menses (unless the metformin therapy is otherwise indicated).
• Metformin side-effects (see metformin section in this table). _
CPP In IVF ± ICSI cycles, women with PCOS could be counseled on potential benefits of adjunct metformin in a GnRH antagonist protocol to reduce risk of ovarian hyperstimulation syndrome (see above for metformin therapy considerations). _
CPP The term in vitro maturation (IVM) treatment cycle is applied to 'the maturation in vitro of immature cumulus oocyte complexes collected from antral follicles' (encompassing both stimulated and unstimulated cycles, but without the use of a human gonadotrophin trigger). _
CCR In units with sufficient expertise, IVM could be offered to achieve pregnancy and livebirth rates approaching those of standard IVF ± ICSI treatment without the risk of OHSS for women with PCOS, where an embryo is generated, then vitrified and thawed and transferred in a subsequent cycle. **
EBR = evidence based recommendation; CCR = clinical consensus recommendation; CPP = clinical practice point. Evidence quality: ⊕⊕⊕⊕ = high quality; ⊕⊕⊕○ = moderate quality; ⊕⊕○○ = low quality and ⊕○○○ = very low quality evidence. ****Strong recommendation for the option; ***Conditional recommendation for the option; **Conditional recommendation for either the option or the comparison; *Conditional recommendation against the option. Note: Off-label prescribing occurs when a drug is prescribed for an indication, a route of administration, or a patient group that is not included in the approved product information document for that drug by the regulatory body. Prescribing off-label is often unavoidable and common, and does not mean that the regulatory body has rejected the indication, but more commonly there has not been a submission to request evaluation of the indication or that patient group for any given drug.
GRADE working group. Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines.
© International evidence-based guideline for the assessment and management of polycystic ovary syndrome 2018, Helena Teede et al. Monash University (monash.edu/medicine/sphpm/mchri/pcos), 2018, by permission of Monash University, on behalf of the NHMRC Centre for Research Excellence in PCOS. This image/content is not covered by the terms of the Creative Commons licence of this publication. For permission to reuse, please contact the rights holder.
Helena J. Teede1,2,3,*, Marie L. Misso1,2,3, Michael F. Costello4, Anuja Dokras5, Joop Laven6, Lisa Moran1,2,3, Terhi Piltonen7, and Robert J. Norman1,2,8, on behalf of the International PCOS§
1National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash University, Melbourne, Victoria, Australia 2National Health and Medical Research Council Centre for Research Excellence in PCOS, University of Adelaide, Adelaide, South Australia, Australia 3Monash Centre for Health Research and Implementation, Monash Public Health and Preventive Medicine, Monash University and Monash Health, Melbourne, Victoria, Australia 4School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia 5Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA 6Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, The Netherlands 7Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Centre, Oulu University Hospital, Oulu, Finland 8Robinson Research Institute, University of Adelaide and Fertility SA, Adelaide, South Australia, Australia
§Participants of the International PCOS Network are listed in the Appendix.
*Correspondence address
Locked Bag 29, Clayton, 3168 Victoria, Australia. E-mail: helena.teede@monash.edu
Authors' roles
Professor Teede, Professor Norman and all listed authors, were members of the project board, and coordinated GDG activities from prioritizing clinical questions, providing clinical input into evidence synthesis, chairing the GDG process and GRADE framework application, finalizing recommendations, responding to feedback and endorsing the guideline. Helena Teede was the guideline development and translation lead and engaged with all GDG meetings, overseeing the process. Joop Laven, Anuja Dokras, Lisa Moran, Terhi Piltonen and Michael Costello chaired the GDGs. Marie Misso led the guideline development and evidence synthesis processes. Robert Norman was the PCOS Centre for Research Excellence co-director, the deputy chair of the International advisory board and the deputy chair of two GDG's. All other authors, were actively engaged as guideline development group, consumer, translation or international advisory board members or members of the evidence synthesis and translation team, contributed to the article, prioritizing clinical questions, discussing recommendations until voting and consensus, responses to external peer review and approval of the final recommendations across all GDGs.
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/medicine/sphpm/mchri/pcos/guideline in the Register of disclosures of interest. Of named authors, Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Laven declared grants from Ferring, Euroscreen and personal fees from Ferring, Euroscreen, Danone and Titus Healthcare. Prof. Norman has declared a minor shareholder interest in an IVF unit. The remaining authors have no conflicts of interest to declare.
International PCOS Network
Marianne Andersen, Odense University Hospital, Denmark
Ricardo Azziz, State University of New York System Administration, USA
Adam Balen, Leeds Teaching Hospitals, UK
Estifanos Baye, Monash Centre for Health Research and Implementation, Australia
Jacqueline Boyle, Monash Centre for Health Research and Implementation, Australia
Leah Brennan, Australian Catholic University, Australia
Frank Broekmans, University Medical Centre Utrecht, Netherlands
Preeti Dabadghao, Sanjay Gandhi Postgraduate Institute of Medical Sciences, India
Luigi Devoto, University of Chile, Faculty of Medicine, Chile
Didier Dewailly, University of Lille, France
Linda Downes, Monash Centre for Health Research and Implementation, Australia
Bart Fauser, University Medical Center Utrecht, Netherlands Stephen Franks, Imperial College, London, UK
Rhonda M. Garad, Monash Centre for Health Research and Implementation, Australia
Melanie Gibson-Helm, Monash University, Australia
Cheryce Harrison, Monash Centre for Health Research and Implementation, Australia
Roger Hart, The University of Western Australia, Australia Rachel Hawkes, Verity, UK
Angelica Hirschberg, Karolinska Institutet, Sweden
Kathleen Hoeger, University of Rochester, USA
Femke Hohmann, Huisartsenpraktijk Hohmann & De Vet, Rotterdam, Netherlands
Samantha Hutchison, Monash Health Centre for Research Implementation, Australia
Anju Joham, Monash Centre for Health Research and Implementation, Australia
Louise Johnson, Victorian Assisted Reproductive Treatment Authority, Australia
Cailin Jordan, Genea Hollywood Fertility, Australia
Jayashri Kulkarni, Monash Alfred Psychiatry Research Centre, Australia
Richard S. Legro, Penn State College of Medicine, Hershey, PA, USA
Rong Li, Peking University Third Hospital, China
Marla Lujan, Cornell University, USA
Jaideep Malhotra, Rainbow Hospital, India
Darren Mansfield, Monash University and Monash Health, Australia
Kate Marsh, Northside Nutrition & Dietetics, Australia
Veryan McAllister, Polycystic Ovary Syndrome Association Australia, Australia
Edgar Mocanu, Royal College of Surgeons, Rotunda Hospital, Dublin 1, Ireland
Ben W. Mol, Monash University, Australia
Ernest Ng, Department of Obstetrics & Gynaecology, The University of Hong Kong, Hong Kong
Sharon Oberfield, Columbia University Medical Center, USA
Sasha Ottey, The PCOS Challenge: The National Polycystic Ovary Syndrome Association, USA
Alexia Peña, The Robinson Research Institute at the University of Adelaide, Australia
Jie Qiao, Peking University Third Hospital, China
Leanne Redman, Pennington Biomedical Research Center, USA
Raymond Rodgers, The Robinson Research Institute at the University of Adelaide, Australia
Luk Rombauts, Department of Obstetrics and Gynecology, Monash University, Australia
Daniela Romualdi, Fondazione Policlinico Universitario Agostino Gemelli, Rome
Duru Shah, Gynaecworld, India
Jane Speight, Deakin University, Australia
Poli Mara Spritzer, Federal University of Rio Grande Do Sul, Brazil
Elisabet Stener-Victorin, Karolinska Institutet, Sweden Nigel Stepto, Victoria University, Australia
Juha S. Tapanainen, University of Helsinki, Helsinki University Hospital, Finland
Eliza C. Tassone, Monash Centre for Health Research and Implementation, Australia
Shakila Thangaratinam, BARC (Barts Research Centre for Women's Health) Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK
Mala Thondan, Harp Family Medical Centre, Australia
Chii-Ruey Tzeng, Taipei Medical University Hospital, Taiwan Zephne van der Spuy, University of Cape Town, South Africa
Eszter Vanky, Dept. of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Norway
Maria Vogiatzi, Children's Hospital of Philadelphia, University of Pennsylvania, USA
Angela Wan, Monash Centre for Health Research and Implementation, Australia
Chandrika Wijeyaratne, Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Colombo, Sri Lanka
Selma Witchel, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh, USA
Jane Woolcock, Women's and Children's Hospital Adelaide, Australia
Bulent O. Yildiz, Hacettepe University School of Medicine, Ankara, Turkey
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text:
The Only Known Footage Of The Titanic
This incredible Titanic footage is your only chance to glimpse the doomed ship in action -- and see the waters where it sank.
On April 14, 1912 at 11:40 p.m., the Titanic struck an iceberg in the North Atlantic. By 2:24 a.m., the ship had reached the ocean floor. Twelve days earlier, when the massive vessel left dock for its first sea trial, nobody knew anything.
Yet that morning of the first sea trial, with a camera capturing what is now the only extant footage of the ship, the Titanic looked as massive and robust as the world thought it would be. Today, for 63 seconds captured by that camera, we can see the ship alive, drifting upright in the water, smoke pluming from its stacks.
Beyond those 63 seconds, this contemporary newsreel, which premiered just six days after the ship sank (an incredibly fast turnaround for 1912), shows us the ship's captain soon before the launch as well as two of the other ships that participated in the Titanic's rescue mission.
Finally, in perhaps the most haunting touch, the newsreel displays footage of the icy waters near where the Titanic sank (although there is much debate about just how near). In context, it's hard not to see the icebergs captured here — still and white though they are — as more than a little menacing.
Next, if you enjoyed this Titanic footage, check out some astounding Titanic facts you've never heard before. Then see James Cameron and National Geographic's fully accurate CGI recreation of how the Titanic sank. And discover five sunken ships even more fascinating than the Titanic. Finally, read up on the Titanic 2 replica ship to launch in 2020.
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For the past eight nights, our house has been silent. Our son has gone to bed and woken up without a seizure, without a sound. For the last few months, he has a string of seizures in the early morning, echoing their call throughout the house. But for just over a week, shortly after starting the ketogenic diet, his seizures had stopped, and I had just begun to forget that sound. I had just begun to stop expecting that sound.
But then, a day after he moved back in to his own bedroom, a sound carried up the stairs and down the hall. At first, I thought it was my wife singing in the bedroom, or the call of the fans rumbling through the hockey game on the television. But after my wife shut the door, and after I muted the television, the sound once again filled the room. Down in his room, our son was having more seizures.
I got ready for bed and headed down to his room. Our monitors are still not here, and as much as our bodies resent the lack of sleep that came with having him staying in our bed, I wasn't ready to trust that his seizures were temporary and that they wouldn't cluster. So I found a space in the corner of his twin bed, and I laid with my son until he fell asleep. I listened as he had another handful of seizures, and another few in the early morning.
Although we are still very much struggling with some lingering issues during the day, I was eager to return to a quiet house at night and to a restful sleep. I was ready to assume that the noise I heard at night was my wife watching some terrible show on CBS or a drunken neighbor stumbling home after a night out. But for now, I must still keep that part of my brain active that can pick up every sound and distinguish Madam Secretary from a myoclonic seizure, from knowing which is damaging a brain in my house and which is just a seizure.
There are days like today when I wonder if I will ever sleep soundly again. I wonder whether I will over not worry that every sound I hear is my son having a seizure and whether I need to rush down to his room to make sure he has recovered. Living on the edge, all day and all night long, is taking a toll.
There is so much uncertainty, so much to react to, so much to be cautious about. But I am hopeful for the day when the worst thing that I will hear at night is another show on CBS.


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CMS Issues Updated Open Payments FAQs
By Katie Pawlitz, Vicki Tankle, Sarah Cummings Stewart & Ryan Pate on 13 April 2022
CMS recently issued updated Open Payments Frequently Asked Questions (FAQs). The FAQs are revised periodically to reflect the most up to date program requirements. This latest revision both added and removed FAQs, and also included some general edits.
The following FAQs were added: #2014, #2015, #2016, #2017, #2018, #2019, #2020, #2021 and #2022. Each new FAQ is reproduced in full below. They provide additional guidance regarding topics such as archived reporting years, salaries paid to covered recipients, reporting of device identifiers, valuing long-term device loans, debt forgiveness, and the definition of Nurse Practitioner.
Additionally, the following FAQs have been removed from the FAQ document "due to being no longer applicable, redundant with another FAQ, or of low utility" (according to CMS):
#8161 (describing non-reportable educational materials),
#8360 (clarifying the retraction or resubmission of entire reports, or corrections, retractions or additions to a group of records),
#8972 (confirming that CMS will not issue advisory opinions exempting applicable manufacturers or applicable group purchasing organizations from reporting requirements),
#8978 (regarding manufacturers of dental alloys),
#9002 (regarding dental schools affiliated with universities and health care institutions not listed on CMS' teaching hospital list),
#9130 (explaining the removal of research as a nature of payment category),
#9134 (clarifying whether Federal, state, and local taxes withheld from a physician owner or inventory are considered reportable payments or other transfers of value),
#10246 and #11002 (answering why CMS changed certain aspects of the Finale Rule at Part 403, subpart I),
#11638 (regarding payments to a continuing education organization),
#12368 (regarding the calculation of the number of payments received by a physician),
#12394 (describing how CMS will ensure Open Payments information remains user-friendly for consumers),
#22569 (identifying the content required for reporting ownership and investment interests).
Even now, almost a decade after the Open Payments program final rule was first implemented, questions continue to arise regarding the types of payments and transfers of value that are reportable and how companies must report them. These updated FAQs certainly provide helpful guidance as companies navigate federal transparency obligations, but additional questions may remain.
Reed Smith will continue monitoring developments involving the Open Payments program. Please reach out to the authors of this post or the Reed Smith attorneys with whom you regularly work for more information or guidance on these changes.
Full Text of New FAQs
FAQ #2014
Question: What is the process for archiving data? Why are only the most recent seven years of data available on the Open Payments Search Tool?
Answer: Data publication occurs for 5 years from the time the program year data is first published. After a program year reaches its fifth full year (including data publication and data refresh) of publication, the program year is closed and archived. "Closed" means that the specific program year will no longer be eligible for edits and no new records may be submitted. Archiving is completed based on the program year of the record, so for example, if a Program Year 2021 record is updated in 2023, it will still be archived with Program Year 2021 records. Following the closing of a program year, it is archived. Archived program years are not displayed or searchable on the Open Payments Search Tool. Archived program years are available for download via the Open Payments Archived Dataset Download page.
Final Rule Changes
Question: At the start of Program Year 2021, why did changes occur, and what were they, to the nature of payment categories?
Answer: At the start of Program Year 2021, CMS's Open Payments team made several reporting changes in response to feedback that CMS received from industry stakeholders. These changes were made in an effort to: 1) reduce ambiguity when reporting payments classified as forgiven debts; 2) accurately reflect the value long-term medical supply or device loans; 3) capture acquisition-related transactions such as buyout payments made to covered recipients in relation to the acquisition of a company in which the covered recipient has an ownership interest; and 4) simplify the reporting of payments related to medical education.
The changes made were that the two medical education Nature of Payment categories, "Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing medical education program" and "Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program" were consolidated to the single category of "Medical education programs." Further, the following additional Nature of Payments categories were added: "Debt forgiveness," "Long-term medical supply or device loan," and "Acquisitions."
Data Submission / Attestation
Question: Should reporting entities report the salary paid to covered recipients who are on the payroll?
Answer: The salary paid to a bona fide employee of the reporting entity is not required to be reported. The final rule states that "covered recipient means— (1) Any physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or certified nurse-midwife who is not a bona fide employee of the applicable manufacturer that is reporting the payment." An employee is an individual who is considered to be "employed by" or an "employee" of an entity if the individual would be considered to be an employee of the entity under the usual common law rules applicable when determining the employer-employee relationship (as applied for purposes of section 3121(d)(2) of the Internal Revenue Code of 1986).
Question: How should a long-term medical supply or device loan be valued?
Answer: CMS does not dictate how the valuation of a device loan is set. The reporting entity should make a reasonable determination. Reporting entities are encouraged to use the assumptions document for the purpose of explaining reporting methodologies and noting any unique reporting circumstances when completing data submissions.
Question: Should the entire Universal Device Identifier (UDI) of the device be provided, i.e., expiry and lot number, or is just the general UDI sufficient?
Answer: In the Open Payments System, only the DI portion of the UDI needs to be reported. This is mentioned in the instructions document which states that if the device has a unique device identifier (UDI), then the device identifier (DI) portions of it must be reported, as applicable. This is a new field labelled as "Primary Device Identifier" in the Open Payments System on the Associated Related Products page. The Primary DI information is available in the reference data "List of Medical Device or Medical Supply Names and Primary Device Identifier," which is available for download on the Open Payments Resources page.
Question: Since the Primary Device Identifier (DI) is a unique 14-digit string that varies by different sizes and components even for the same brand name, do you have any guidelines for selecting which representative DI to assign to a brand name?
Answer: The reporting entity is responsible for determining the most appropriate DI for the record. In the Open Payments System, the Primary DI is validated against the reference data in the "List of Medical Device or Medical Supply Names and Primary Device Identifier." It is sufficient if the Primary DI and device/supply name match the information in the reference data stated in the List of Medical Device or Medical Supply Names and Primary Device Identifier. This reference data includes medical device and medical supply name and Primary Device Identifier information for all the medical devices and medical supplies listed annually through December 31st in the Food and Drug Administration (FDA) Global Unique Device Identification Database Directory (GUDID). An active list of devices is located on the Access GUDID website at https://accessgudid.nlm.nih.gov/download.
Question: Does CMS validate product brand names against device identifiers (DIs)? Will records fail if these do not match?
Answer: Open Payments System validation checks whether the combination of the Primary DI and the marketed name of the medical device/supply name match. Should the combination of the Primary DI and the medical device/supply name not match, and should the information not match what is given in the reference data "List of Medical Device or Medical Supply Names and Primary Device Identifier," the Open Payments System will return a warning to the user. The user may then correct the information or proceed with reporting the payment. The records will not fail and they are able to be sent to final submission despite the presence of a warning. Users will be able to submit the Primary DI data and validation starting in the Open Payments System beginning in calendar year 2022.
Question: For debt forgiveness, should a reporting entity report the full write-off amount, or, if given to a collection agency, only report the amount that is returned?
Answer: For any debt collection write-off, the entire amount written off should be reported regardless of whether a collection agency is involved.
Question: Is a Nurse Practitioner (NP) a type of advanced practice nurse? Do you have a formal definition of an NP?
Answer: The regulation at 42 C.F.R. §403.902 defines a nurse practitioner as a nurse practitioner who performs such services as such individual is legally authorized to perform (in the State in which the individual performs such services) in accordance with State law (or the State regulatory mechanism provided by State law), and who meets such training, education, and experience requirements (or any combination thereof) as the Secretary may prescribe in regulations. If the advanced practice nurse meets the requirements of a Nurse Practitioner (which might vary from state to state) in the Regulations at 42 CFR 403.902, then presumably they would qualify as a Nurse Practitioner. However, this will be an individual case-by-case determination.
Tags: Centers for Medicare & Medicaid Services Developments, Fraud and Abuse, Open Payments, Physician Payments, Regulatory Developments
Katie Pawlitz
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Vicki Tankle
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Sarah Cummings Stewart
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Ryan Pate
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Recent Medicare Advantage and Part D rule increases regulatory oversight on third party marketers
CMS Gives the IPO List the Godfather 3 Treatment


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Wilmington's Browntown residents rally for peace
The rally in Wilmington's Browntown comes a week after a deadly shooting on the 900 block of Brown St. in the neighborhood.
Wilmington's Browntown residents rally for peace The rally in Wilmington's Browntown comes a week after a deadly shooting on the 900 block of Brown St. in the neighborhood. Check out this story on delawareonline.com: https://delonline.us/1V6bzjN
Jenna Pizzi, The News Journal Published 3:30 p.m. ET Jan. 19, 2016 | Updated 7:46 a.m. ET Jan. 20, 2016
Mary Lou Robinson, of the immediate Browntown neighborhood, places flyers on doors in the Browntown neighborhood as she, Councilwoman Sherry Dorsey Walker, police officers and community members walk the neighborhood against violence in Browntown, specifically following the deadly shooting on the 900 block of Brown Street.(Photo: DOUG CURRAN/SPECIAL TO THE NEWS)
One person was killed, and four were injured in a shooting in Browntown on Jan. 11.
A community walk was held on Tuesday night.
Police have released few details about the shooting.
Wrapped in scarves, hats and gloves, a small group of Browntown residents in Wilmington braved cold weather and went door to door Tuesday night asking neighbors to take a stand against violence following a deadly shooting.
"We have come too far to let this incident go unchecked," said Bernadette Evans, who organizes the Browntown Block Captains in the neighborhood.
Evans and neighbors tucked bright-pink fliers into doors and mailboxes, letting people know that there are ways to safely cooperate with the police as they investigate the Jan. 11 shooting that left one dead.
"If we as residents want peace and safety, then we must decide that we are going to have it," the flier read. "Once we decide that living in fear of being the victim of gun violence is not an option, then we all must take action! When we as a community stand together and push back, then and only then will things change!"
Wilmington City Councilwoman Sherry Dorsey Walker said she helped organize the community walk because it's important that residents don't let gun violence and fear become the norm.
"We are trying our best as a community to stop these types of incidents from occurring and it's important to keep the momentum going by reminding ourselves that law-abiding citizens outnumber the criminals and we shall prevail," Dorsey Walker said.
DELAWAREONLINE
Wilmington's Browntown shooting victim named
The shooting, in the 900 block of Brown St., killed Ira Brown, a 20-year-old city resident, who was shot several times in the legs. Police have released few details about the incident, which they have described as a robbery gone wrong. A police spokeswoman said she would not release more information on Tuesday.
Also wounded by gunfire in the incident were a 51-year-old woman shot in the abdomen; a 28-year-old man shot in the leg; a 21-year-old man shot in the shoulder, leg and abdomen; and a 49-year-old man shot in the left hand and abdomen, according to authorities.
Evans on Tuesday said it was unsettling to hear about the shooting because her organization of block captains is looking out for neighbors and is building a strong community in the shadow of I-95.
"We try to keep Browntown quiet and safer," she said, which is why she wanted to pass out the fliers with words of encouragement and information about how to contact the police.
"This is actually a very quiet street," said Mary Lou Robinson, who lives across the street from the home where the shooting occurred.
Robinson said she wants to encourage her neighbors to find trust in police and report even small incidents as they happen because too often they wait until several days later to report a crime.
"People can trust the cops," Robinson said.
Residents also distributed information about how to contact police anonymously if they fear of retaliation for cooperating with law enforcement, Evans said.
"There are ways for them to reach out to the authorities," Evans said. "And we want to show our partnership with Wilmington Police because we have a good one."
Contact Jenna Pizzi at jpizzi@delawareonline.com or (302) 324-2837. Follow her on Twitter @JennaPizzi.
Shooting in Wilmington's Browntown section
Police respond Monday night to a shooting in the 900 block of Brown St. in Wilmington. JOHN J. JANKOWSKI JR./SPECIAL TO THE NEWS JOURNAL
Police respond to a shooting in Wilmington's Browntown section on Monday. JOHN J. JANKOWSKI JR./SPECIAL TO THE NEWS JOURNAL
Police investigate a shooting in the Browntown neighborhood of Wilmington on Jan. 11. A man was killed. JOHN J. JANKOWSKI JR./SPECIAL TO THE NEWS JOURNAL
Community shocked by Browntown shooting; 1 killed
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ABF Freight driver honored for helping trucker in Texas
An ABF Freight driver from New Mexico has been recognized for coming to the aid of a fellow trucker involved in a rollover accident in Texas.
The Truckload Carriers Association recently named Alfonso Archuleta, from Albuquerque, New Mexico, a Highway Angel for stopping to aid a FedEx driver whose double trailers overturned into a ditch.
TCA explains:
Early one morning in August, Archuleta was traveling on Highway 54 near Stratford, Texas. The sun was coming up, making things a bit hazy as it had just rained. Suddenly, he saw a truck up ahead, laid over on its side, in the ditch. It was a FedEx truck pulling a set of doubles that had passed him a bit earlier.
Alfonso ArchuletaArchuleta immediately pulled over and grabbed a pair of rubber gloves. "You never know what you're going to find," he said. He ran to check on the driver. "I asked him if he had any broken bones and he said no." At about the same time, an off-duty volunteer firefighter pulled up and helped Archuleta get the driver out of the truck. "The driver was really upset," he recalled. "He said he had just gotten over COVID and this was his first day back. He didn't know what had happened and must have blacked out."
Archuleta went to look at the back of the trailer to see if there were any hazmat placards. "He had corrosive on," he said. "We got the paperwork out to give to the fire department when they arrived and saw that he was hauling batteries."
Thankfully, the driver seemed to be okay. "He was just really upset that he turned the truck over," shared Archuleta. He tried to calm the driver. "I told him that as long as he was okay, not to worry about the truck." At that point, the volunteer firefighter said he would stay with the driver until first responders arrived so that Archuleta could get back on his route.
Archuleta said his father also drove a truck for a living. "As a little kid, I would do walk arounds with him to check the tires and inspect the vehicle," he recalled. "My dad was always a safe driver. I always stress to young drivers how it important it is to make sure you're as safe as you can be. It's important to share your knowledge. You learn it and you pass it along. Taking a little bit of time could save a life."
TCA has presented him with a certificate, patch, lapel pin, and truck decals. His employer has also received a letter acknowledging Archuleta as a Highway Angel.
Since the program's inception in August 1997, nearly 1,300 professional truck drivers have been recognized as Highway Angels for the exemplary kindness, courtesy, and courage they have displayed while on the job.
The program's Presenting Sponsor is EpicVue, and the Supporting Sponsor is DriverFacts.
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