In the article cited above, funding information was inadvertently omitted for authors Paul Aveyard and Susan A. Jebb. The following text has been added: "P.A. is an NIHR senior investigator. P.A. and S.A.J. are funded by NIHR Oxford Biomedical Research Centre, NIHR Oxford Health Biomedical Research Centre, and NIHR Oxford and Thames Valley Applied Research Collaboration." The authors apologize for the omission. The online version of the article (https://doi.org/10.2337/dc23-2019) has been updated to correct the error.
OBJECTIVE: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. METHODS: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. RESULTS: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. CONCLUSIONS: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.
OBJECTIVE: In premenopausal individuals, vaginal microbiota diversity and lack of Lactobacillus dominance are associated with greater mucosal inflammation, which is linked to a higher risk of cervical dysplasia and infections. It is not known if the association between the vaginal microbiota and inflammation is present after menopause, when the vaginal microbiota is generally higher-diversity and fewer people have Lactobacillus dominance. METHODS: This is a post hoc analysis of a subset of postmenopausal individuals enrolled in a randomized trial for treatment of moderate-severe vulvovaginal discomfort that compared vaginal moisturizer, estradiol, or placebo. Vaginal fluid samples from 0, 4, and 12 weeks were characterized using 16S rRNA gene sequencing (microbiota) and MesoScale Discovery (vaginal fluid immune markers: IL-1b, IL-1a, IL-2, IL-6, IL-18, IL-10, IL-9, IL-13, IL-8, IP10, MIP1a, MIP1b, MIP3a). Global associations between cytokines and microbiota (assessed by relative abundance of individual taxa and Shannon index for alpha, or community, diversity) were explored, adjusting for treatment arm, using linear mixed models, principal component analysis, and Generalized Linear Mixed Model + Microbiome Regression-based Kernel Association Test (GLMM-MiRKAT). RESULTS: A total of 119 individuals with mean age of 61 years were included. At baseline, 29.5% of participants had a Lactobacillus-dominant vaginal microbiota. Across all timepoints, alpha diversity (Shannon index, P = 0.003) was highly associated with immune markers. Individual markers that were associated with Lactobacillus dominance were similar to those observed in premenopausal people: IL-10, IL-1b, IL-6, IL-8 (false discovery rate [FDR] < 0.01), IL-13 (FDR = 0.02), and IL-2 (FDR = 0.09). Over 12 weeks, change in alpha diversity was associated with change in cytokine concentration (Shannon, P = 0.018), with decreased proinflammatory cytokine concentrations observed with decreasing alpha diversity. CONCLUSIONS: In this cohort of postmenopausal individuals, Lactobacillus dominance and lower alpha diversity were associated with lower concentrations of inflammatory immune markers, as has been reported in premenopausal people. This suggests that after menopause lactobacilli continue to have beneficial effects on vaginal immune homeostasis, despite lower prevalence.
Despite successful suppression of plasma HIV replication by antiretroviral therapy (ART), some women living with HIV (WLHIV) can still experience genital HIV shedding (discordant shedding). Female genital tract (FGT) microbiome and virome dynamics during long-term ART in WLHIV are poorly understood but might contribute to discordant HIV shedding, as the microbiome and virome are known to influence FGT health. To understand FGT microbial communities over time during ART usage and discordant shedding, we characterized the microbiome and virome in 125 cervicovaginal specimens collected over two years in 31 WLHIV in Lima, Peru. Intrapersonal bacterial microbiome variation was higher in HIV shedders compared to non-shedders. Cervicovaginal virome composition changed over time, particularly in non-shedders. Specifically, anellovirus relative abundance was inversely associated with ART duration and CD4 counts. Our results suggest that discordant HIV shedding is associated with FGT microbiome instability, and immune recovery during ART influences FGT virome composition.
OBJECTIVE: The 'Deadly RED' project primarily aimed to improve culturally competent care to reduce the number of First Nations patients presenting to a Queensland ED who 'Take own leave' (TOL). The secondary aim was to evaluate the implementation project. METHODS: A pre/post-test quasi experimental study design using mixed methods was co-designed with adherence to Indigenous research considerations. Quantitative analysis of First Nations presentations before and after Deadly RED implementation was performed using SPSS. Qualitative analysis of transcribed research yarns in NVIVO was coded and themed for analysis. Staff experiences and perspectives were collated using electronically distributed surveys and process audits were performed. RESULTS: A total of 1096 First Nations presentations June to August 2021 and 1167 in the matched 2022 post-implementation period were analysed. Significantly more patients were recorded as TOL post-implementation (13.0% pre vs 21.3% post) and representations rates were unchanged. Forty-six staff surveyed identified improvements in all parameters including cultural appropriateness and quality of care. Qualitative analysis of 85 research yarns revealed themes migrated to increasingly acceptable, accessible, and usable care. Notably, 45% of the First Nation's patients recorded as TOL self-reported that their treatment was complete. The study was feasible as 80% of packs distributed and 73% follow-up screening after TOL. CONCLUSIONS: The Deadly RED evaluation revealed significant discrepancies in the reported data points of TOL and the 'story' of the First Nations persons experience of appropriate and completed care. Staff awareness and cultural capability improved significantly, and yarning allowed knowledge translation and improvements in communication which contributed to a better healthcare experience for First Nations patients attending our ED.
BACKGROUND: Prevalence of self-harm In England is rising, however contact with statutory services remains relatively low. There is growing recognition of the potential role voluntary, community and social enterprise sector (VCSE) organisations have in the provision of self-harm support. We aimed to explore individuals' experiences of using these services and the barriers and facilitators to accessing support. METHODS: Qualitative, online interviews with 23 adults (18+) who have accessed support from VCSE organisations for self-harm in the Yorkshire and the Humber region were undertaken. Interviews were audio recorded and transcribed verbatim. Thematic analysis was undertaken using NVivo software. RESULTS: Participants described how a lack of service flexibility and the perception that their individual needs were not being heard often made them less likely to engage with both statutory and VCSE organisations. The complexity of care pathways made it difficult for them to access appropriate support when required, as did a lack of awareness of the types of support available. Participants described how engagement was improved by services that fostered a sense of community. The delivery of peer support played a key role in creating this sense of belonging. Education and workplace settings were also viewed as key sources of support for individuals, with a lack of mental health literacy acting as a barrier to access in these environments. CONCLUSIONS: VCSE organisations can play a crucial role in the provision of support for self-harm, however, pathways into these services remain complex and links between statutory and non-statutory services need to be strengthened. The provision of peer support is viewed as a crucial component of effective support in VCSE organisations. Further supervision and training should be offered to those providing peer support to ensure that their own mental health is protected.
Mental Health , Self-Injurious Behavior , Adult , Humans , Feedback , Qualitative Research , England/epidemiology , Self-Injurious Behavior/epidemiology , Self-Injurious Behavior/prevention & control , Self-Injurious Behavior/psychology
Based on the vulnerability-stress model and coping theory, this study of 1920 people in Scotland investigated how sex, age, occupational factors, anxiety, depression and maladaptive coping behaviours are associated with cardiovascular health. Structural equation modelling and serial Sobel mediation tests were conducted. Anxiety was associated with past arrhythmia, whereas depression was associated with past heart attacks, stroke and angina. Females reported more anxiety, past arrhythmia, confectionary and alcohol consumption, whereas males had more heart attacks. Confectionary consumption was associated with past arrhythmia, and alcohol consumption was associated with past heart attacks. Being older was associated with depression, past stroke, arrhythmia and alcohol consumption. Being younger was associated with anxiety and smoking. Depression and smoking mediated the relationship between type of working and cardiovascular health history, potentially because of socioeconomic factors. Clinicians can use these results to advise clients about cardiovascular risks associated with anxiety, depression, demographics and health-related coping behaviours.
OBJECTIVE: To understand preferences for features of weight loss programs among adults with or at risk of type 2 diabetes in the U.K. RESEARCH DESIGN AND METHODS: We conducted a discrete choice experiment with 3,960 U.K. adults living with overweight (n = 675 with type 2 diabetes). Preferences for seven characteristics of weight loss programs were analyzed. Simulations from choice models using the experimental data predicted uptake of available weight loss programs. Patient groups comprising those who have experience with weight loss programs, including from minority communities, informed the experimental design. RESULTS: Preferences did not differ between individuals with and without type 2 diabetes. Preferences were strongest for type of diet. Healthy eating was most preferred relative to total diet replacement (odds ratio [OR] 2.24; 95% CI 2.04-2.44). Individual interventions were more popular than group interventions (OR 1.40; 95% CI 1.34-1.47). Participants preferred programs offering weight loss of 10-15 kg (OR 1.37; 95% CI 1.28-1.47) to those offering loss of 2-4 kg. Online content was preferred over in-person contact (OR 1.24; 95% CI 1.18-1.30). There were few differences in preferences by gender or ethnicity, although weight loss was more important to women than to men, and individuals from ethnic minority populations identified more with programs where others shared their characteristics. Modeling suggested that tailoring programs to individual preferences could increase participation by â¼17 percentage points (68% in relative terms). CONCLUSIONS: Offering a range of weight loss programs targeting the preferred attributes of different patient groups could potentially encourage more people to participate in weight loss programs and support those living with overweight to reduce their weight.
Diabetes Mellitus, Type 2 , Weight Reduction Programs , Male , Adult , Humans , Female , Diabetes Mellitus, Type 2/therapy , Overweight/therapy , Ethnicity , Minority Groups
Recurrent infectious vaginitis can lead to significant morbidity, patient frustration, and health care costs. The most common causes are bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC); however, other infectious and noninfectious etiologies should be considered in patients with recurrent symptoms. A detailed history and physical examination with appropriate testing at the time of symptoms is critical to establishing a correct diagnosis. Management options for recurrent BV and VVC are limited. Complex cases including those with atypical symptoms, negative testing for common causes, refractory symptoms despite appropriate therapy or recurrences during suppressive therapy will require referral to specialist care.
Candidiasis, Vulvovaginal , Vaginosis, Bacterial , Female , Humans , Vaginosis, Bacterial/diagnosis , Vaginosis, Bacterial/drug therapy , Vaginosis, Bacterial/microbiology , Candidiasis, Vulvovaginal/diagnosis , Candidiasis, Vulvovaginal/drug therapy , Primary Health Care
This review summarizes our current understanding of associations of the postmenopausal vaginal microbiome with genitourinary syndrome of menopause. We review the normal postmenopausal microbiota, examine the association of the microbiome with vulvovaginal symptoms, describe microbial communities associated with physical and laboratory findings, and report the impact of different treatments for genitourinary syndrome of menopause on microbiota and symptom improvement. Postmenopausal vaginal symptoms have an underlying pathophysiology that has not been fully elucidated. Estrogen treatment may not be sufficient to relieve symptoms of vaginal discomfort in all postmenopausal individuals. In addition, other interventions targeted at changing the microbiota or pH do not consistently improve symptom severity.
Microbiota , Postmenopause , Female , Humans , Menopause , Vagina/pathology , Estrogens , Atrophy
ISSUE ADDRESSED: The Deadly RED redesign and implementation research aimed to improve take own leave (TOL) rates within a Queensland emergency department by providing a culturally competent care pathway. METHODOLOGY: A mixed methods pre/post evaluation of the feasibility, acceptability and usability of the Deadly RED pathway for First Nations patients presenting to ED was performed. This pathway combined early welcome and information sharing, introduction of screening and follow up for patients who TOL and enhanced access to alternative community healthcare. Yarning circles facilitated co-design of research protocols and tools while a purposefully designed research Yarn enhanced understanding of the 'story' of the people. Qualitative analysis of Yarns allowed deductive themes to be extracted. A Participatory Action Research (PAR) approach and Indigenous research methodology involving First Nations people in design, knowledge sharing and joint ownership of results was used. RESULTS: Common themes from the 85 yarns included the negative impact of long waiting times and positive impact from wholistic care. Unique themes identified included interpretation of waiting room placement and paracetamol prescription as a dismissal. Knowledge dissemination from yarning drove improvements in communications and processes to promote treatment completion resulting in elimination of these themes in post implementation yarns. Eighteen patients who had TOL were included in the post implementation yarns, however only eight of these believed that their treatment was incomplete. CONCLUSION: The use of yarning for consumer engagement has allowed deeper understanding of the reasons for TOL in First Nations emergency patients. The reciprocal knowledge sharing has guided targeted improvements in wholistic emergency care and communication resulting in First Nations patients feeling their care is complete even when the 'number' reports otherwise. SO WHAT?: Indigenous Research methodology including yarning with First Nations patients suggests alternative engagement methods to guide enhanced quality of care monitoring for ED presentations.
BACKGROUND: The gut microbiota in patients with inflammatory bowel disease are perturbed in both composition and function. The vaginal microbiome and its role in the reproductive health of women with inflammatory bowel disease is less well described. OBJECTIVE: We aim to compare the vaginal microbiota of women with inflammatory bowel disease to healthy controls. METHODS: Women with inflammatory bowel disease enrolled in a longitudinal cohort study provided self-collected vaginal swabs. Healthy controls underwent provider-collected vaginal swabs at routine gynecologic exams. All participants completed surveys on health history, vulvovaginal symptoms and gastrointestinal symptoms, if applicable. Microbiota were characterized by sequencing the V4 region of the 16S rRNA gene. Associations between patient characteristics and microbial community composition were evaluated by PERMANOVA and Principal Components Analysis. Lactobacillus dominance of the microbial community was compared between groups using chi-square and Poisson regression. RESULTS: The cohort included 54 women with inflammatory bowel disease (25 Ulcerative colitis, 25 Crohn's Disease) and 26 controls. A majority, 72 (90%) were White; 17 (31%) with inflammatory bowel disease and 7 (27%) controls were postmenopausal. The composition of the vaginal microbiota did not vary significantly by diagnosis or severity of inflammatory bowel disease but did vary by menopausal status (p = 0.042). There were no significant differences in Shannon Diversity Index between healthy controls and women with IBD in premenopausal participants. There was no difference in proportion of Lactobacillus dominance according to diagnosis in premenopausal participants. A subgroup of postmenopausal women with Ulcerative colitis showed a significant higher alpha diversity and a lack of Lactobacillus dominance in the vaginal microbiome. CONCLUSIONS: Menopausal status had a larger impact on vaginal microbial communities than inflammatory bowel disease diagnosis or severity.
Colitis, Ulcerative , Inflammatory Bowel Diseases , Microbiota , Humans , Female , RNA, Ribosomal, 16S/genetics , Longitudinal Studies , Microbiota/genetics , Vagina , Lactobacillus/genetics
There is growing evidence that language discordance between patients and their health care teams negatively affects quality of care, experience of care, and health outcomes, yet there is limited guidance on best practices for advancing equitable care for patients who have language barriers within obstetrics and gynecology. In this commentary, we present two cases of language-discordant care and a framework for addressing language as a critical lens for health inequities in obstetrics and gynecology, which includes a variety of clinical settings such as labor and delivery, perioperative care, outpatient clinics, and inpatient services, as well as sensitivity around reproductive health topics. The proposed framework explores drivers of language-related inequities at the clinician, health system, and societal level. We end with actionable recommendations for enhancing equitable care for patients experiencing language barriers. Because language and communication barriers undergird other structural drivers of inequities in reproductive health outcomes, we urge obstetrician-gynecologists to prioritize improving care for patients experiencing language barriers.
Gynecology , Health Equity , Obstetrics , Female , Pregnancy , Humans , Inpatients , Communication Barriers
The human vaginal microbiota is frequently dominated by lactobacilli and transition to a more diverse community of anaerobic microbes is associated with health risks. Glycogen released by lysed epithelial cells is believed to be an important nutrient source in the vagina. However, the mechanism by which vaginal bacteria metabolize glycogen is unclear, with evidence implicating both bacterial and human enzymes. Here we biochemically characterize six glycogen-degrading enzymes (GDEs), all of which are pullanases (PulA homologues), from vaginal bacteria that support the growth of amylase-deficient Lactobacillus crispatus on glycogen. We reveal variations in their pH tolerance, substrate preferences, breakdown products and susceptibility to inhibition. Analysis of vaginal microbiome datasets shows that these enzymes are expressed in all community state types. Finally, we confirm the presence and activity of bacterial and human GDEs in cervicovaginal fluid. This work establishes that bacterial GDEs can participate in the breakdown of glycogen, providing insight into metabolism that may shape the vaginal microbiota.
Amylases , Microbiota , Female , Humans , Vagina/microbiology , Bacteria/genetics , Bacteria/metabolism , Microbiota/physiology , Glycogen/metabolism
Vulvovaginal itching, a commonly reported symptom in postmenopausal women, may be because of the genitourinary syndrome of menopause but has a broad differential including dermatologic, infectious, and autoimmune causes. Comprehensive evaluation is important to avoid inappropriate treatments that may delay the correct diagnosis. In many cases, no clear cause can be identified, and the goal of management is simply to control symptoms.
Menopause , Postmenopause , Female , Humans , Syndrome , Pruritus/etiology , Pruritus/therapy
OBJECTIVE: The aim of the study is to describe the location, severity, and frequency of genitourinary symptoms in postmenopausal women enrolled in a randomized trial of treatment for vulvovaginal discomfort. METHODS: This is a post hoc analysis of enrollment responses for participants in the MsFLASH Vaginal Health Trial. Participants were asked about the severity (0-3), frequency (in days per week) and location (vulvar or vaginal) of itch, dryness, pain/soreness, irritation, as well as severity and frequency of pain with penetration, vaginal discharge, urinary incontinence, and urinary urgency. RESULTS: A total of 302 participants were enrolled, with a mean age of 60.9 ± 4.1 years. The mean number of moderate-severe vulvovaginal symptoms experienced by trial participants in the month before enrollment was 3.4 ± 1.5, with a range from 1 to 7. The most commonly reported symptom across all severity categories was vaginal dryness (285/302, 94%), but the one most frequently rated as severe was pain with vaginal penetration (121/302, 40%). Vaginal dryness was the symptom with highest frequency; 53% of participants with that symptom reported experiencing it ≥4 d/wk. For vaginal symptoms, 80% of participants (241/302) reported that at least one of these symptoms occurred during or after sex while only 43% (158/302) reported that at least one vulvar symptom occurred during or after sex. Urinary incontinence (202/302, 67%) and urinary frequency (128/302, 43%) were the two most commonly reported urinary issues. CONCLUSIONS: Our data highlight the complexity of genitourinary syndrome of menopause symptoms in quantity, severity, and frequency, suggesting that measuring distress, bother, or interference may be the most comprehensive measure.
Urinary Incontinence , Vaginal Diseases , Female , Humans , Middle Aged , Aged , Menopause , Vaginal Diseases/pathology , Vagina/pathology , Vulva/pathology , Urinary Incontinence/pathology , Atrophy/pathology
Cesarean section rates continue to rise globally, and C-sectioned infants are at a higher risk of adverse child outcomes. In this issue of Cell Host & Microbe, Zhou et al. report that vaginal microbial transfer (VMT) from birth mother to infant post-delivery may alter infant gut microbiota and improve neurodevelopment.
Gastrointestinal Microbiome , Female , Humans , Infant , Pregnancy , Cesarean Section , Mothers , Vagina
