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Background Polycystic ovary syndrome (PCOS) is a complex and multi-faceted endocrine disorder that affects 5–20% of women. Literature is limited regarding potentially differing PCOS phenotypes among women around the world. Objective To use Flo app technology to understand the multifaceted characteristics of PCOS across several countries and identify contributing risk factors to the development of this condition. Study design Flo is a widely used female health and wellbeing app with period tracking functionality that provides a globally representative and medically unbiased perspective on PCOS symptomatology. A chatbot dialog on PCOS was subsequently administered on the Flo application (app) to users from 142 countries (with at least 100 respondents) who have the app running in English during September–October 2019. Results For analyses, we selected the five countries with the greatest number of respondents: US ( n  = 243,238), UK ( n  = 68,325), India ( n  = 40,092), Philippines ( n  = 35,131), and Australia ( n  = 29,926). Bloating was the most frequently reported symptom among PCOS-positive women and appeared to be the main predictor of PCOS in our model (odds ratio 3·76 [95% CI 3·60–3·94]; p  < 0·0001). Additional top predictors of PCOS are high blood cholesterol and glucose levels. As BMI increased, the percentage of women who reported a physician-confirmed PCOS diagnosis also increased. However, women in India did not follow this trend. Conclusion Our findings are based on the largest known PCOS dataset and indicate that symptoms are more complex than previously understood. The most frequently reported symptoms (bloating, facial hirsutism, irregular cycles, hyperpigmentation, and baldness) are broader than those included in the Rotterdam criteria. Future work should reevaluate and refine the criteria utilized in PCOS diagnosis.

IntroductionAlthough studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients.Methods and analysisKAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid–base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8–51.5) min.Ethics and disseminationThe study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion.Trial registration numberNCT04040296.

PurposeTo better understand the beliefs about a causal role of emotional stress maintained by women seeking fertility care.MethodsA cross-sectional, self-administered survey was distributed to fertility care patients at an academic fertility center in Illinois. Of 5000 consecutive patients, 1460 completed the survey and were included in the study sample.ResultsMembers of our sample (N = 1460) were between 20 and 58 years (mean = 36.2, SD = 4.4). Most respondents were White (72.2%), were in a heterosexual relationship (86.8%), and felt that their physician understood their cultural background (79.4%). Of the sample, 28.9% believed emotional stress could cause infertility, 69.0% believed emotional stress could reduce success with fertility treatment, and 31.3% believed that emotional stress could cause a miscarriage, with evidence of significant racial differences. Less than a quarter (23.8%) of the sample believed emotional stress had no impact on fertility. Lower household income and educational attainment were associated with a greater belief in emotional stress as a causative factor in reproduction with regard to infertility, fertility treatment, and miscarriage.ConclusionThe majority of women seeking fertility care believe emotional stress could reduce the success of fertility treatment. Furthermore, beliefs about emotional stress and reproduction significantly differ based on race/ethnicity, income, and education. Particular attention should be paid to specific groups of women who may more likely not be aware of the lack of a proven biological relationship between emotional stress and reproduction.

BackgroundComprehensive medication management (CMM) programs optimize the effectiveness and safety of patients’ medication regimens, but CMM may be underutilized. Whether healthcare claims data can identify patients appropriate for CMM is not well-studied.AimDetermine the face validity of a claims-based algorithm to prioritize patients who likely need CMM.MethodWe used claims data to construct patient-level markers of “regimen complexity” and “high-risk for adverse effects,” which were combined to define four categories of claims-based CMM-need (very likely, likely, unlikely, very unlikely) among 180 patient records. Three clinicians independently reviewed each record to assess CMM need. We assessed concordance between the claims-based and clinician-review CMM need by calculating percent agreement as well as kappa statistic.ResultsMost records identified as ‘very likely’ (90%) by claims-based markers were identified by clinician-reviewers as needing CMM. Few records within the ‘very unlikely’ group (5%) were identified by clinician-reviewers as needing CMM. Interrater agreement between CMM-based algorithm and clinician review was moderate in strength (kappa = 0.6, p < 0.001).ConclusionClaims-based pharmacy measures may offer a valid approach to prioritize patients into CMM-need groups. Further testing of this algorithm is needed prior to implementation in clinic settings.

Polycystic ovary syndrome (PCOS) is known to affect 6%-12% of women of reproductive age in the United States. PCOS is a heterogeneous condition associated with menstrual cycle irregularity and androgen excess. Though many women with PCOS have a BMI classified as overweight or obese, information is limited on how specific symptoms and BMI mediate PCOS diagnoses in the general population. A questionnaire on PCOS-related symptoms and previous PCOS diagnosis was available to Flo users during one month (2019). Women aged 18-44 years seeking to track their cycle or to conceive, who were not pregnant, on active contraception or in stabilization mode after pregnancy, and had Flo app running in English met the study inclusion criteria. Participant characteristics including age and BMI were also collected from Flo app users during the sign-up process. All users in the study had agreed to the use of their de-identified and aggregated data for research purposes. The differences in clinical manifestation of PCOS symptoms between BMI groups were analyzed. Of US users with BMI data in the whole cohort, 8,808 women reported having physician-diagnosed PCOS, 5,551 women reported not having a PCOS diagnosis, and 58,478 reported that they had not been checked for PCOS. Of women with PCOS, 19.5% were normal weight (BMI 18.5-24.9), 19.7% were overweight (BMI 25.0-29.9), 20.4% were obese (30.0-34.9), 17.8% were severly obese (BMI 35.0-39.9), and 21.0% were morbidly obese (BMI 40+). The most common symptoms among PCOS positive women were bloating (38.7%), hirsutism (38.2%), and irregular cycle (26.0%). A direct relationship exists between BMI and having PCOS, as the percentage of PCOS in obese, severely obese, and morbidly obese BMI groups was higher (1.37, 1.87, and 2.12 times, respectively) than in the whole cohort. Similarly, among women who report acne, skin hyperpigmentation, bloating, hirsutism, heavy menses, baldness, family history of PCOS, high cholesterol, irregular cycle, and inability to conceive for > 1 year, there is a direct relationship between BMI and the percentage of women with PCOS. Moreover, when identifying symptoms and findings serving as strong predictors of a positive PCOS diagnosis, hirsutism, high glucose, and high levels of both cholesterol and glucose were the top symptoms and findings for women with BMI 18.5-34.9. Hirsutism, high glucose, and inability to conceive for > 1 year were the strongest predictors of PCOS for women with BMI 35+. Among all users with hirsutism, the percentage of women with PCOS increased 3.65 times compared to the whole cohort, making it the strongest predictor of PCOS. Understanding BMI patterns as they relate to PCOS symptoms allows for better understanding the pathophysiology of PCOS. Among women with PCOS in the United States, changes in BMI are associated with variations in the many symptoms of PCOS.

Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disorder associated with menstrual irregularity and androgen excess. The worldwide prevalence of PCOS among women of reproductive age ranges from 5-20%. Mobile menstrual cycle apps, such as Flo, provide an opportunity to gather data on the characteristics of PCOS in a globally representative and medically unbiased population. The objective of this study was to report PCOS symptomatology relative to country in order to better characterize PCOS and its differing phenotypes among users around the world. A questionnaire on PCOS related symptoms and previous PCOS diagnosis was available to Flo users during one month (2019). The geographical location of the user was estimated based on the IP address. Study inclusion criteria included women aged 18-44 years seeking to track their cycle or to conceive, who were not pregnant, on active contraception, or in stabilization mode after pregnancy and had Flo app running in English. All users in the study had agreed to the use of their de-identified and aggregated data for research purposes.The highest number of Flo app users who completed the PCOS questionnaire were coming from the following top 5 countries: United States (US) (n=240,732), United Kingdom (UK) (n=67,696), India (n=40,171), the Philippines (n=35,097), and Australia (n=28,946). The percentage of self-reported PCOS in these countries was 14.4% with higher percentages in India, the Philippines, and Australia (22.6%, 20.0%, 15.9, respectively) and lower in the US and UK (12.2% and 13.71%, respectively). In the US, UK, and Australia, the most common self-reported symptoms of PCOS positive women were bloating, hirsutism, and irregular cycles. In India and the Philippines, the most common symptoms of women with PCOS were bloating, baldness, and irregular cycles. Hirsutism, high glucose and high levels of both cholesterol and glucose are the three top symptoms increasing the probability of PCOS in all studied countries. The percentage of self-reported PCOS increases 3.04 times among users that reported hirsutism compared to all users that positively responded to the PCOS self-assessment question. Probability of PCOS among users that report hirsutism increases 3.85 times for Australia and 4.24 times for India. Australia and India had higher percentages of self-reported PCOS among those who reported experiencing nearly all PCOS related symptoms. Using Flo’s software, we are able to determine that geographic location has an effect on the phenotypic presentation of PCOS. Understanding the distribution of PCOS symptomology around the world will help to better characterize PCOS and improve diagnosis and treatment on both an individual and global scale.

Background: Polycystic ovary syndrome (PCOS) is a complex and multi-faceted endocrine disorder that affects 5-20% of women. Literature is limited regarding potentially differing PCOS phenotypes among women around the world. Therefore, we used Flo app technology to understand the multifaceted characteristics of PCOS across several countries and identify contributing risk factors to the development of this condition. Methods: Flo is a widely used female health and wellbeing app with period tracking functionality that provides a globally representative and medically unbiased perspective on PCOS symptomatology. A chatbot dialog on PCOS was subsequently administered on the Flo application (app) to users from 142 countries (with at least 100 respondents) who have the app running in English during September-October 2019. Results: For analyses, we selected the five countries with the greatest number of respondents: US (n=243,238), UK (n=68,325), India (n=40,092), Philippines (n=35,131), and Australia (n=29,926). Bloating was the most frequently reported symptom among PCOS-positive women and appeared to be the main predictor of PCOS in our model (odds ratio 3·76 [95% CI 3·60-3·94]; p<0·0001). Additional top predictors of PCOS are high blood cholesterol and glucose levels. As BMI increased, the percentage of women who reported a physician-confirmed PCOS diagnosis also increased. However, women in India did not follow this trend. Conclusions: Our findings are based on the largest known PCOS dataset and indicate that symptoms are more complex than previously understood. The most frequently reported symptoms (bloating, facial hirsutism, irregular cycles, hyperpigmentation, and baldness) are broader than those included in the Rotterdam criteria. Future work should reevaluate and refine the criteria utilized in PCOS diagnosis.

Inequalities in maternal and newborn health persist in many high-income countries, including for women of refugee background. The Bridging the Gap partnership programme in Victoria, Australia, was designed to find new ways to improve the responsiveness of universal maternity and early child health services for women and families of refugee background with the codesign and implementation of iterative quality improvement and demonstration initiatives. One goal of this 'whole-of-system' approach was to improve access to antenatal care. The objective of this paper is to report refugee women's access to hospital-based antenatal care over the period of health system reforms. The study was designed using an interrupted time series analysis using routinely collected data from two hospital networks (four maternity hospitals) at 6-month intervals during reform activity (January 2014 to December 2016). The sample included women of refugee background and a comparison group of Australian-born women giving birth over the 3 years. We describe the proportions of women of refugee background (1) attending seven or more antenatal visits and (2) attending their first hospital visit at less than 16 weeks' gestation compared over time and to Australian-born women using logistic regression analyses. In total, 10% of births at participating hospitals were to women of refugee background. Refugee women were born in over 35 countries, and at one participating hospital, 40% required an interpreter. Compared with Australian-born women, women of refugee background were of similar age at the time of birth and were more likely to be having their second or subsequent baby and have four or more children. At baseline, 60% of refugee-background women and Australian-born women attended seven or more antenatal visits. Similar trends of improvement over the 6-month time intervals were observed for both populations, increasing to 80% of women at one hospital network having seven or more visits at the final data collection period and 73% at the other network. In contrast, there was a steady decrease in the proportion of women having their first hospital visit at less than 16 weeks' gestation, which was most marked for women of refugee background. Using an interrupted time series of observational data over the period of improvement is limited compared with using a randomisation design, which was not feasible in this setting. Accurate ascertainment of 'harder-to-reach' populations and ongoing monitoring of quality improvement initiatives are essential to understand the impact of system reforms. Our findings suggest that improvement in total antenatal visits may have been at the expense of recommended access to public hospital antenatal care within 16 weeks of gestation.

To isolate and characterize bacteriophage lytic for the opportunistic pathogen Klebsiella oxytoca and their formulation into a range of solid dosage forms for in-vitro testing. We report the isolation, genomic and functional characterization of a novel bacteriophage lytic for Klebsiella oxytoca, which does not infect the closely related Klebsiella pneumoniae. This bacteriophage was formulated into suppositories and troches and shown to be released and lyse underlying Klebsiella oxytoca bacteria in an in-vitro model. These bacteriophage formulations were stable for at least 49 days at 4°C. The successful in-vitro assay of these formulations here suggests that they could potentially be tested in-vivo to determine whether such a therapeutic approach could modulate the gut microbiome, and control Klebsiella oxytoca overgrowth, during antibiotic therapy regimes. This study reports a novel bacteriophage specific for Klebsiella oxytoca which can be formulated into solid dosage forms appropriate for potential delivery in testing as a therapy to modulate gut microbiome during antibiotic therapies.

ObjectivesThe aim of this study was to report on the physical and mental health of migrant and refugee fathers participating in a population-based study of Australian children and their families.DesignCross-sectional survey data drawn from a population-based longitudinal study when children were aged 4–5 years.SettingPopulation-based study of Australian children and their families.Participants8137 fathers participated in the study when their children were aged 4–5 years. There were 131 (1.6%) fathers of likely refugee background, 872 (10.7%) fathers who migrated from English-speaking countries, 1005 (12.4%) fathers who migrated from non-English-speaking countries and 6129 (75.3%) Australian-born fathers.Primary outcome measuresFathers’ psychological distress was assessed using the self-report Kessler-6. Information pertaining to physical health conditions, global or overall health, alcohol and tobacco use, and body mass index status was obtained.ResultsCompared with Australian-born fathers, fathers of likely refugee background (adjusted OR(aOR) 3.17, 95% CI 2.13 to 4.74) and fathers from non-English-speaking countries (aOR 1.79, 95%CI 1.51 to 2.13) had higher odds of psychological distress. Refugee fathers were more likely to report fair to poor overall health (aOR 1.95, 95% CI 1.06 to 3.60) and being underweight (aOR 3.49, 95% CI 1.57 to 7.74) compared with Australian-born fathers. Refugee fathers and those from non-English-speaking countries were less likely to report light (aOR 0.25, 95% CI 0.15 to 0.43, and aOR 0.30, 95% CI 0.24 to 0.37, respectively) and moderate to harmful alcohol use (aOR 0.04, 95% CI 0.10 to 0.17, and aOR 0.14, 95% CI 0.10 to 0.19, respectively) than Australian-born fathers. Finally, fathers from non-English-speaking and English-speaking countries were less likely to be overweight (aOR 0.62, 95% CI 0.51 to 0.75, and aOR 0.84, 95% CI 0.68 to 1.03, respectively) and obese (aOR 0.43, 95% CI 0.32 to 0.58, and aOR 0.77, 95% CI 0.61 to 0.98, respectively) than Australian-born fathers.ConclusionFathers of refugee background experience poorer mental health and poorer general health than Australian-born fathers. Fathers who have migrated from non-English-speaking countries also report greater psychological distress than Australian-born fathers. This underscores the need for primary healthcare services to tailor efforts to reduce disparities in health outcomes for refugee populations that may be vulnerable due to circumstances and sequelae of forced migration and to recognise the additional psychological stresses that may accompany fatherhood following migration from non-English-speaking countries. It is important to note that refugee and migrant fathers report less alcohol use and are less likely to be overweight and obese than Australian-born fathers.