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1.
Anim Cogn ; 25(5): 1109-1131, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36018473

RESUMO

Dolphins gain information through echolocation, a publicly accessible sensory system in which dolphins produce clicks and process returning echoes, thereby both investigating and contributing to auditory scenes. How their knowledge of these scenes contributes to their echoic information-seeking is unclear. Here, we investigate their top-down cognitive processes in an echoic matching-to-sample task in which targets and auditory scenes vary in their decipherability and shift from being completely unfamiliar to familiar. A blind-folded adult male dolphin investigated a target sample positioned in front of a hydrophone to allow recording of clicks, a measure of information-seeking and effort; the dolphin received fish for choosing an object identical to the sample from 3 alternatives. We presented 20 three-object sets, unfamiliar in the first five 18-trial sessions with each set. Performance accuracy and click counts varied widely across sets. Click counts of the four lowest-performance-accuracy/low-discriminability sets (X = 41%) and the four highest-performance-accuracy/high-discriminability sets (X = 91%) were similar at the first sessions' starts and then decreased for both kinds of scenes, although the decrease was substantially greater for low-discriminability sets. In four challenging-but-doable sets, number of clicks remained relatively steady across the 5 sessions. Reduced echoic effort with low-discriminability sets was not due to overall motivation: the differential relationship between click number and object-set discriminability was maintained when difficult and easy trials were interleaved and when objects from originally difficult scenes were grouped with more discriminable objects. These data suggest that dolphins calibrate their echoic information-seeking effort based on their knowledge and expectations of auditory scenes.


Assuntos
Golfinho Nariz-de-Garrafa , Golfinhos , Ecolocação , Masculino , Animais , Comportamento de Busca de Informação
2.
Dev Psychopathol ; 34(1): 37-54, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-33283694

RESUMO

Children of mothers with serious mental health difficulties are at increased risk of developing mental health difficulties themselves in their own lifetime. Specialist interventions delivered in perinatal mental health services offer an opportunity to support the infant's development and long-term mental health. This review aimed to systematically evaluate the shared elements of successful perinatal mental health interventions that underpin improved outcomes for infants whose mothers experience perinatal mental health difficulties. Nine electronic databases were searched comprehensively for relevant controlled studies of perinatal mental health interventions, and a narrative synthesis undertaken to assess whether statistically significant benefits were noted. Sixteen studies, trialing 19 interventions, were analyzed using a narrative approach and grouped according to reported effectiveness. Eight interventions demonstrated significant improvements in infant outcomes and/or mother-infant relationship outcomes and were used to inform the analysis of the included interventions' components. While the interventions identified were diverse, there were common components which potentially underpin successful interventions for infants whose mothers are experiencing mental health difficulties, including: facilitation of positive Mother×Infant interactions; helping mothers to understand their infant's perspective or inner world; and the use of video feedback.


Assuntos
Saúde Mental , Mães , Criança , Desenvolvimento Infantil , Feminino , Humanos , Lactente , Mães/psicologia , Gravidez
3.
J Womens Health (Larchmt) ; 30(4): 533-538, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33217253

RESUMO

Background: Study to describe the degree of menopausal palpitation distress and its demographic, clinical, symptom, and quality-of-life (QOL) correlates. Analysis of existing, baseline, data from peri- and postmenopausal women, 42 to 62 years of age, who participated in the Menopause Strategies-Finding Lasting Answers for Symptoms and Health (MsFLASH) clinical trials testing interventions for vasomotor symptoms (n = 759). Up to 46.8% of menopausal women report having palpitations, yet the symptom is relatively understudied. Little is known about palpitation distress or its correlates. Materials and Methods: Degree of distress from "heart racing or pounding" was self-reported over the past two weeks as "not at all," "a little bit," "moderately," "quite a bit," or "extremely." Other measures included self-report forms, clinic-verified body mass index (BMI), vasomotor symptom diaries, and validated symptom and QOL tools. Results: The percentage who reported palpitation distress was 19.6%, 25.2%, and 33.5% in the three trials or 25.0% overall. In multivariate analysis, the odds of reporting palpitation distress was lower in past smokers (odds ratio [OR] = 0.59 [95% confidence interval (CI) 0.38-0.90]) and current smokers (OR = 0.48 [0.27-0.87]) relative to never-smokers and lower with every 5 kg/m2 higher BMI (OR = 0.82 [0.69-0.98]).The odds of reporting palpitation distress was higher with every five point more severe insomnia (OR = 1.28 [1.05-1.54]), five point worse depressive symptoms (OR = 1.47 [1.11-1.95]), five point worse perceived stress (OR = 1.19 [1.01-1.39]), and one point worse menopausal QOL (OR = 1.29 [1.06-1.57]). Conclusions: Menopausal palpitation distress is common and associated with demographic, clinical, symptom, and QOL factors. Findings can be used for screening in clinical practice and to justify additional research on this understudied symptom.


Assuntos
Qualidade de Vida , Distúrbios do Início e da Manutenção do Sono , Feminino , Fogachos/epidemiologia , Humanos , Menopausa , Autorrelato
5.
Menopause ; 27(10): 1126-1136, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32701665

RESUMO

OBJECTIVE: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected menopause-related quality of life (QOL) measures. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects on menopause-related QOL relative to control in women with VMS. METHODS: We pooled individual-level data from 1,005 peri- and postmenopausal women with 14 or more VMS/week across the four RCTs. Interventions included escitalopram 10 to 20 mg/d; yoga/aerobic exercise; 1.8 g/d omega-3-fatty acids; oral 17-beta-estradiol 0.5 mg/d; venlafaxine XR 75 mg/d; and cognitive behavioral therapy for insomnia (CBT-I). Outcomes measures were the Menopause-specific Quality of Life scale and its subscales. RESULTS: Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control. The largest improvement in the vasomotor subscale was observed with estradiol (-1.2 points), with more modest but significant effects seen with escitalopram, yoga, and CBT-I. Significant improvements in the psychosocial subscale were observed for escitalopram, venlafaxine, and CBT-I. For the physical subscale, the greatest improvement was observed for CBT-I and exercise, whereas for the sexual subscale, the greatest improvement was observed for CBT-I, with yoga and estradiol demonstrating smaller effects. CONCLUSIONS: These results suggest that for menopause-related QOL, women have a variety of treatment strategies to choose from and can select an approach based on most bothersome symptoms and individual preferences.


Assuntos
Qualidade de Vida , Yoga , Citalopram , Feminino , Fogachos/tratamento farmacológico , Humanos , Menopausa
6.
J Diabetes Complications ; 34(8): 107586, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32546421

RESUMO

Oscillating glucose levels can increase oxidative stress and may contribute to ß-cell dysfunction. We tested the hypothesis that increased glycemic variability contributes to ß-cell dysfunction by experimentally altering glucose variability with controlled diets varying in glycemic index (GI). Fifty-two adults with prediabetes received a 2-week moderate GI (GI = 55-58) control diet followed by randomization to a four-week low GI (LGI: GI < 35) or high GI (HGI HI > 70) diet. Those on the HGI diet were randomized to placebo or the antioxidant N-acetylcysteine (NAC). Participants underwent blinded CGMS, fasting oxidative stress markers and an intravenous glucose tolerance test to estimate ß-cell function (disposition index: DI). On the control diet, DI was inversely correlated with SD glucose (r = -0.314, p = 0.03), but neither DI nor glucose variability were associated with oxidative stress markers. The LGI diet decreased SD glucose (Control 0.96 ±â€¯0.08 vs. LGI 0.79 ±â€¯0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ±â€¯0.06 vs. HGI 1.06 ±â€¯0.07, p = 0.03). Neither DI nor oxidative stress markers changed after the LGI or HGI diets. NAC had no effect on DI, glucose variability or oxidative stress markers. We conclude small changes in glucose variability induced by dietary GI in adults with pre-diabetes are unlikely to contribute to ß-cell dysfunction.


Assuntos
Glicemia/metabolismo , Dieta , Índice Glicêmico , Células Secretoras de Insulina/fisiologia , Estresse Oxidativo/fisiologia , Estado Pré-Diabético/sangue , Acetilcisteína/uso terapêutico , Adulto , Biomarcadores/metabolismo , Feminino , Sequestradores de Radicais Livres/uso terapêutico , Teste de Tolerância a Glucose , Carga Glicêmica , Humanos , Masculino , Pessoa de Meia-Idade , Estado Pré-Diabético/fisiopatologia
7.
Am J Obstet Gynecol ; 223(1): 99.e1-99.e9, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31954158

RESUMO

BACKGROUND: Vulvovaginal symptoms, which include dryness, irritation, and pain with intercourse, are common among postmenopausal women and are associated with impaired sexual functioning and quality of life. Previous assessment of treatment strategies for these symptoms has been limited by a lack of sensitive patient-centered outcome measures that assess symptom impact on functional and quality-of-life domains. OBJECTIVE: We aimed to (1) examine change in the impact of postmenopausal vulvovaginal symptoms on multiple aspects of well-being and functioning in relation to vaginal estradiol and moisturizer treatment and (2) guide meaningful interpretation of scores on a structured-item questionnaire measure of condition-specific impact. STUDY DESIGN: Data were drawn from postmenopausal women who were enrolled in the Menopause Strategies: Finding Lasting Answers for Symptoms and Health Vaginal Health Trial (a 12-week, double-blind, placebo-controlled randomized trial of treatment for vulvovaginal symptoms) who were assigned to vaginal 10-µg estradiol tablet plus placebo gel (n=98), vaginal moisturizer plus placebo tablet (n=97), or dual placebo (n=94). At baseline and 12-week follow up, participants completed the Day-to-Day Impact of Vaginal Aging questionnaire to assess the impact of vaginal symptoms on 4 domains (activities of daily living, emotional well-being, sexual functioning, and body image), each on a 0-4 point scale. Day-to-Day Impact of Vaginal Aging sensitivity to change was assessed by the examination of the associations between change in Day-to-Day Impact of Vaginal Aging domain scores and vulvovaginal symptom severity from baseline to 12 weeks with analysis of covariance. Within-woman and between-group minimal clinically important improvement was assessed with the use of an anchor-based approach that relates change in Day-to-Day Impact of Vaginal Aging domain scores with self-reported benefit from treatment. RESULTS: Participants in all treatment arms (n=289) demonstrated reduced impact of vulvovaginal symptoms on all domains of well-being and functioning as assessed by Day-to-Day Impact of Vaginal Aging at 12-week follow up, with no significant differences in improvement between women who were assigned to either estradiol tablet or vaginal moisturizer compared with placebo. For all Day-to-Day Impact of Vaginal Aging domains, mean impact scores were reduced when participants reported symptom improvement (-0.3 to -0.8 point change in Day-to-Day Impact of Vaginal Aging scores for <2-point symptom severity change vs -0.4 to -1.6 point change in Day-to-Day Impact of Vaginal Aging scores for 2+ point symptom severity change; all P<.001). Minimal clinically important change in Day-to-Day Impact of Vaginal Aging domain scale scores, which are anchored to self-reported meaningful benefit from treatment at 12 weeks, ranged from -0.4 to -1.3 (within-woman) and -0.2 to -0.7 (between-group). Observed change and minimal clinically important difference were largest for the sexual functioning domain. CONCLUSION: The impact of vulvovaginal symptoms on day-to-day activities, sexual function, emotional well-being, and body image may be improved with low-dose vaginal estradiol, moisturizer, or topical placebo. The Day-to-Day Impact of Vaginal Aging questionnaire demonstrates sensitivity to change with treatment of vulvovaginal symptoms, particularly Day-to-Day Impact of Vaginal Aging scales that focus on symptom impact on sexual functioning and body image. Minimal clinically important improvement in the impact of vulvovaginal symptoms as measured by the Day-to-Day Impact of Vaginal Aging can be defined with the use of these measures.


Assuntos
Estradiol/administração & dosagem , Estrogênios/administração & dosagem , Pós-Menopausa , Doenças Vaginais/diagnóstico , Doenças Vaginais/tratamento farmacológico , Doenças da Vulva/diagnóstico , Doenças da Vulva/tratamento farmacológico , Idoso , Autoavaliação Diagnóstica , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Avaliação de Resultados da Assistência ao Paciente , Qualidade de Vida , Avaliação de Sintomas , Comprimidos , Doenças Vaginais/etiologia , Doenças da Vulva/etiologia
8.
Menopause ; 27(4): 473-484, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31977667

RESUMO

OBJECTIVE: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health clinical trials network was funded by the National Institutes of Health to find new ways to alleviate the most common, bothersome menopausal symptoms by designing and conducting multiple concurrent clinical intervention studies, accommodating a wide scope of populations and intervention strategies. METHODS: Trials were conducted in Boston, Indianapolis, Minneapolis, Oakland, Philadelphia, and Seattle, with the Data Coordinating Center in Seattle, and were designed with standardized eligibility criteria and endpoints. Primary outcomes focused on vasomotor symptoms, sleep quality and insomnia symptoms, and vaginal symptoms. Secondary outcomes included quality of life, sexual function, and mood. RESULTS: We completed five randomized clinical trials and three ancillary studies, testing nine interventions in over 1,300 women and collecting nearly 16,000 bio-specimens. Escitalopram, venlafaxine hydrochloride extended release, and low-dose estradiol diminished hot flashes by approximately 50% as compared with a 30% decrease by placebo. No benefits on vasomotor symptoms were observed with yoga or exercise compared with usual activity, nor with omega-3 supplementation compared with placebo. Cognitive behavioral therapy for insomnia reduced self-reported insomnia symptoms and improved overall sleep quality compared with menopause education control. We did not find significant benefit from a vaginal estradiol tablet or a vaginal moisturizer compared with placebo tablet and gel in diminishing the severity of vaginal symptoms. CONCLUSIONS: The MsFLASH trials contributed substantially to our understanding of bothersome menopausal symptom treatment. It is important that clinicians counseling women about available treatment options consider all therapies-both nonhormonal and hormonal.


Assuntos
Menopausa , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Idoso , Feminino , Fogachos/terapia , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Disfunções Sexuais Fisiológicas/terapia , Distúrbios do Início e da Manutenção do Sono/terapia , Doenças Vaginais/tratamento farmacológico
9.
JAMA Intern Med ; 179(12): 1699-1706, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31609397

RESUMO

Importance: To control spending, the Centers for Medicare & Medicaid Services reduced Medicare fee-for-service (FFS) payments for noninvasive cardiac tests (NCTs) performed in provider-based office settings (ambulatory offices not administratively affiliated with hospitals) starting in 2005. Contemporaneously, payments for hospital-based outpatient testing increased. The association between differential payments by site and test location is unknown. Objectives: To quantify trends in differential Medicare FFS payments for NCTs performed in hospital-based and provider-based settings, determine the association between the hospital-based outpatient testing to provider-based office testing payment ratio and the proportion of hospital-based NCTs, and to examine trends in test location between Medicare FFS and 3 Medicare Advantage health maintenance organizations for which Centers for Medicare & Medicaid Services payments do not depend on testing location. Design, Setting, and Participants: This observational claims-based study used Medicare FFS claims from 1999 to 2015 (5% random sample) and Medicare Advantage claims from 3 large health maintenance organizations (2005-2015) among Medicare FFS beneficiaries aged 65 years or older and a health maintenance organization control group. Statistical analysis was performed from May 1, 2017, to July 15, 2019. Exposures: The weighted mean payment ratio of Medicare FFS hospital-based outpatient testing to provider-based office testing for outpatient NCTs. Main Outcomes and Measures: Proportion of outpatient NCTs performed in the hospital-based setting and Medicare FFS costs. Results: The data included a mean of 1.72 million patient-years annually in Medicare FFS (mean age, 75.2 years; 57.3% female in 2015) and a mean of 142 230 patient-years annually in the managed care control group (mean age, 74.8 years; 56.2% female in 2015). The Medicare payment ratio of FFS hospital-based outpatient testing to provider-based office testing increased from 1.05 in 2005 to 2.32 in 2015. The FFS hospital-based outpatient testing proportion increased from 21.1% in 2008 to 43.2% in 2015 and was correlated with the payment ratio (correlation coefficient with a 1-year lag, 0.767; P < .001). In contrast, the hospital-based outpatient testing proportion for the control group declined from 16.6% in 2008 to 15.2% in 2015 (correlation coefficient, -0.024, P = .95). The estimated extra costs owing to tests shifting to the hospital-based outpatient setting in the Medicare FFS group was $661 million in 2015, including $161 million in patient out-of-pocket costs. Conclusions and Relevance: In settings in which reimbursement depends on test location, increasing hospital-based payments correlated with greater proportions of outpatient NCTs performed in the hospital-based outpatient setting. Site-neutral payments may offer an incentive for testing to be performed in the more efficient location.


Assuntos
Técnicas de Diagnóstico Cardiovascular/economia , Idoso , Instituições de Assistência Ambulatorial/economia , Feminino , Custos de Cuidados de Saúde , Gastos em Saúde , Humanos , Masculino , Medicare , Mecanismo de Reembolso , Estados Unidos
10.
Clin Trials ; 16(5): 476-480, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31055949

RESUMO

BACKGROUND: The MsFLASH (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) Network recruited into five randomized clinical trials (n = 100-350) through mass mailings. The fifth trial tested two interventions for postmenopausal vulvovaginal symptoms (itching, pain, irritation, dryness, or pain with sex) and thus required a high level of sensitivity to privacy concerns. For this trial, in addition to mass mailings we pilot tested a social media recruitment approach. We aimed to evaluate the feasibility of recruiting healthy midlife women with bothersome vulvovaginal symptoms to participate in the Vaginal Health Trial through Facebook advertising. METHODS: As part of a larger advertising campaign that enrolled 302 postmenopausal women for the 12-week randomized, double-blind, placebo-controlled Vaginal Health Trial from April 2016 to February 2017, Facebook advertising was used to recruit 25 participants. The target population for recruitment by mailings and by Facebook ads included women aged 50-70 years and living within 20 miles of study sites in Minneapolis, MN and Seattle, WA. Design of recruitment letters and Facebook advertisements was informed by focus group feedback. Facebook ads were displayed in the "newsfeed" of targeted users and included a link to the study website. Response rates and costs are described for both online ads and mailing. RESULTS: Facebook ads ran in Minneapolis for 28 days and in Seattle for 15 days, with ads posted and removed from the site as needed based on clinic flow and a set budget limit. Our estimated Facebook advertising reach was over 200,000 women; 461 women responded and 25 were enrolled at a cost of US$14,813. The response rate per estimated reach was 0.22%; costs were US$32 per response and US$593 per randomized participant. The social media recruitment results varied by site, showing greater effectiveness in Seattle than in Minneapolis. We mailed 277,000 recruitment letters; 2166 women responded and 277 were randomized at a cost of US$98,682. The response rate per letter sent was 0.78%; costs were US$46 per response and US$356 per randomized participant. Results varied little across sites. CONCLUSION: Recruitment to a clinical trial testing interventions for postmenopausal vaginal symptoms is feasible through social media advertising. Variability in observed effectiveness and costs may reflect the small sample sizes and limited budget of the pilot recruitment study.


Assuntos
Publicidade/ética , Seleção de Pacientes , Mídias Sociais/instrumentação , Publicidade/economia , Publicidade/métodos , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Projetos Piloto , Pós-Menopausa , Ensaios Clínicos Controlados Aleatórios como Assunto , Doenças Vaginais
11.
Am J Perinatol ; 36(10): 1045-1053, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30500961

RESUMO

OBJECTIVE: Women with prediabetes are identified from screening for overt diabetes in early pregnancy, but the clinical significance of prediabetes in pregnancy is unclear. We examined whether prediabetes in early pregnancy was associated with risks of adverse outcomes. STUDY DESIGN: We conducted a retrospective cohort study of pregnant women enrolled in Kaiser Permanente Washington from 2011 to 2014. Early pregnancy hemoglobin A1C (A1C) values, covariates, and outcomes were ascertained from electronic medical records and state birth certificates. Women with prediabetes (A1C of 5.7-6.4%) were compared with those with normal A1C levels (<5.7%) for risk of gestational diabetes mellitus (GDM) and other outcomes including preeclampsia, primary cesarean delivery, induction of labor, large/small for gestational age, preterm birth, and macrosomia. We used modified Poisson's regression to calculate adjusted relative risks (RRs) and 95% confidence intervals (CIs). RESULTS: Of 7,020 women, 239 (3.4%) had prediabetes. GDM developed in 48% of prediabetic women compared with 11% of women with normal A1C levels (adjusted RR: 2.8, 95% CI: 2.4-3.3). Prediabetes was not associated with all other adverse maternal and neonatal outcomes. CONCLUSION: Prediabetes in early pregnancy is a risk factor for GDM. Future research is needed to elucidate whether early intervention may reduce this risk.


Assuntos
Diabetes Gestacional , Hemoglobinas Glicadas/análise , Estado Pré-Diabético/complicações , Gravidez/sangue , Adolescente , Adulto , Feminino , Macrossomia Fetal , Humanos , Hipoglicemia/etiologia , Recém-Nascido , Doenças do Recém-Nascido/etiologia , Modelos Logísticos , Resultado da Gravidez , Nascimento Prematuro , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
12.
Obstet Gynecol ; 132(4): 859-867, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30130344

RESUMO

OBJECTIVE: To compare perinatal outcomes before and after a clinical guideline change from a two-step to a one-step approach to screening for gestational diabetes mellitus (GDM). METHODS: We conducted a before-after cohort study of women with singleton live birth deliveries within Kaiser Permanente Washington, a mixed-model health plan in Washington state. We used Kaiser Permanente Washington electronic health data and linked birth certificates. We compared outcomes before (January 2009-March 2011) and after (April 2012-December 2014) the guideline change among women who received prenatal care from health care providers internal to Kaiser Permanente Washington (n=4,977 before, n=6,337 after). We made the same comparison among women who received prenatal care from external health care providers (not exposed to the guideline change; n=3,386 before, n=4,454 after) to control for time trends unrelated to the guideline change. Adjusted relative risks and 95% CIs were estimated using Poisson generalized estimating equations. RESULTS: After the guideline change, receipt of the one-step approach became widespread among women cared for by Kaiser Permanente Washington internal providers (87%), and use of insulin increased 3.7-fold from 1.2% to 4.4%. Among women cared for by Kaiser Permanente Washington internal providers, GDM increased from 6.9% to 11.4%, induction of labor from 25.2% to 28.6%, neonatal hypoglycemia from 1.3% to 2.0%, and outpatient nonstress testing from 134.6 to 157.0 test days per 100 women. After accounting for background trends in outcomes (based on the women cared for by external providers), the guideline change was associated with increased incidence of GDM (relative risk [RR] 1.41, 95% CI 1.17-1.69), labor induction (RR 1.20, 95% CI 1.09-1.32), neonatal hypoglycemia (RR 1.77, 95% CI 1.14-2.75), and nonstress testing (RR 1.12, 95% CI 1.02-1.24% per 100 women). There was no association with other outcomes including cesarean delivery or macrosomia. CONCLUSION: Adopting the one-step approach was associated with a 41% increase in the diagnosis of GDM without improved maternal or neonatal outcomes.


Assuntos
Diabetes Gestacional/diagnóstico , Adulto , Estudos de Coortes , Feminino , Humanos , Recém-Nascido , Guias de Prática Clínica como Assunto , Gravidez , Resultado da Gravidez , Adulto Jovem
13.
JAMA Intern Med ; 178(5): 681-690, 2018 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-29554173

RESUMO

Importance: Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of 2 commonly recommended treatments. Objective: To compare the efficacy of a low-dose vaginal estradiol tablet and a vaginal moisturizer, each vs placebo, for treatment of moderate-to-severe postmenopausal vulvovaginal symptoms. Design, Setting, and Participants: This 12-week multicenter randomized clinical trial enrolled postmenopausal women with moderate to severe symptoms of vulvovaginal itching, pain, dryness, irritation, or pain with penetration. Interventions: Vaginal 10-µg estradiol tablet (daily for 2 weeks, then twice weekly) plus placebo gel (3 times a week) (n = 102) vs placebo tablet plus vaginal moisturizer (n = 100) vs dual placebo (n = 100). Main Outcomes and Measures: The main outcome was decrease in severity (0-3) of most bothersome symptom (MBS) between enrollment and 12 weeks. Additional measures included a composite vaginal symptom score, Female Sexual Function Index (FSFI) score (2-36), modified Female Sexual Distress Score-Revised item 1, treatment satisfaction and meaningful benefit, Vaginal Maturation Index, and vaginal pH. Results: The 302 women had a mean (SD) age of 61 (4) years and were primarily white (267 [88%]), college educated (200 [66%]), and sexually active (245 [81%]). Most women (294 [97%]) provided data for the primary analysis. The most commonly reported MBS was pain with vaginal penetration (182 [60%]), followed by vulvovaginal dryness (63 [21%]). Mean baseline MBS severity was similar between treatment groups: estradiol, 2.4 (95% CI, 2.3 to 2.6); moisturizer, 2.5 (95% CI, 2.3 to 2.6); placebo, 2.5 (95% CI, 2.4 to 2.6). All treatment groups had similar mean reductions in MBS severity over 12 weeks: estradiol, -1.4 (95% CI, -1.6 to -1.2); moisturizer, -1.2 (95% CI, -1.4 to -1.0); and placebo, -1.3 (95% CI, -1.5 to -1.1). No significant differences were seen between estradiol (P = .25) or moisturizer (P = .31) compared with placebo. Mean total FSFI improvement was similar between estradiol (5.4; 95% CI, 4.0 to 6.9) and placebo (4.5; 95% CI, 2.8 to 6.1) (P = .64), and between moisturizer (3.1; 95% CI, 1.7 to 4.5) and placebo (P = .17). Conclusions and Relevance: Our results suggest that neither prescribed vaginal estradiol tablet nor over-the-counter vaginal moisturizer provides additional benefit over placebo vaginal tablet and gel in reducing postmenopausal vulvovaginal symptoms. Trial Registration: clinicaltrials.gov Identifier: NCT02516202.


Assuntos
Estradiol/administração & dosagem , Estrogênios/administração & dosagem , Pós-Menopausa , Cremes, Espumas e Géis Vaginais/administração & dosagem , Doenças Vaginais/tratamento farmacológico , Vulva/efeitos dos fármacos , Administração Intravaginal , Feminino , Géis , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento
14.
ISME J ; 12(7): 1631-1641, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29434315

RESUMO

The mechanisms by which obesity increases cancer risk are unclear, but some lines of evidence suggest that gut microbial communities (GMC) may contribute to chronic inflammation in obese individuals through raised systemic levels of lipopolysaccharides (LPS). We evaluated associations of the GMC in stool with plasma LPS-binding protein (LBP, a measure of LPS) and C-reactive protein (CRP) concentrations in 110 premenopausal women in the United States. Diet was assessed using 3-day food records and GMCs were evaluated using pyrosequencing of the 16S rRNA gene. OTUs were identified at 97% sequence similarity. Taxonomic classification and functional genes were imputed from 16S rRNA genes, and alpha and beta diversity were assessed using the Shannon index and MRPP, respectively. Multivariable linear regression analysis was used to assess the relation between LBP, specific bacterial genera identified with indicator species analysis, and CRP. Dietary fat intake, particularly saturated fat, and CRP were positively associated with increased LBP. GMC beta diversity, but not alpha diversity, was statistically significantly different between groups using unweighted Unifrac. Several taxa, particularly those in the Clostridia class, were more prevalent in women with low LBP, while Bacteroides were more prevalent in those with high LBP. Genes associated with gram-negative cell wall material synthesis were also associated with LBP and CRP. In contrast, Phascolarctobacterium was associated with lower concentrations of LBP and CRP. We found distinct differences between tertiles of LBP regarding the diversity and composition of the microbiome, as well as differences in functional genes that potentially activate LBP.


Assuntos
Bactérias/isolamento & purificação , Proteínas de Transporte/sangue , Microbioma Gastrointestinal , Glicoproteínas de Membrana/sangue , Pré-Menopausa/sangue , Proteínas de Fase Aguda , Adulto , Bactérias/classificação , Bactérias/genética , Proteína C-Reativa/metabolismo , DNA Bacteriano/genética , Fezes/microbiologia , Feminino , Humanos , Pessoa de Meia-Idade , Filogenia , RNA Ribossômico 16S/genética
15.
Menopause ; 25(5): 500-507, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29206774

RESUMO

OBJECTIVE: The aim of the study was to identify associations between improvement in genitourinary symptoms of menopause (GSM) and vaginal microbiota, vaginal glycogen, and serum estrogen. METHODS: Thirty postmenopausal women enrolled in a hot flash treatment trial (oral estradiol vs venlafaxine vs placebo) who reported GSM and provided vaginal swabs at 0, 4, and 8 weeks were studied. Bacterial communities were characterized using deep sequencing targeting the 16S rRNA gene V3-V4 region. Participants selected a most bothersome genitourinary symptom (dryness, discharge, pain, itch/burn, or inability to have sex) and rated severity on a 10-point scale at baseline and 8 weeks. Vaginal glycogen and serum estradiol and estrone were measured at enrollment and 8 weeks. Comparisons according to improvement in most bothersome symptom (MBS) were made using χ, Wilcoxon signed-rank test, or Hotelling's t test. RESULTS: Of 30 participants, 21 (70%) had improvement in MBS over the 8-week study and 9 (30%) had no improvement or worsening of MBS. A higher proportion of women receiving estradiol or venlafaxine reported improvement in MBS (88%, 78%) compared with placebo (54%; P = 0.28). MBS improvement was associated with Lactobacillus-dominant vaginal microbiota at enrollment (57% vs 22%, P = 0.08). Vaginal glycogen, serum estradiol, and estrone significantly increased in women whose MBS improved. CONCLUSIONS: A larger proportion of women whose MBS improved had a Lactobacillus dominant microbiota at enrollment than those who had no improvement during the trial, though this difference was not statistically significant. Larger trials are needed to determine whether vaginal microbiota modify or mediate treatment responses in women with GSM.


Assuntos
Microbiota , Pós-Menopausa , Vagina/microbiologia , Doenças Vaginais/microbiologia , Antidepressivos de Segunda Geração/uso terapêutico , Atrofia , Dispareunia/tratamento farmacológico , Estradiol/sangue , Estradiol/uso terapêutico , Estrogênios/sangue , Estrogênios/uso terapêutico , Feminino , Glicogênio/análise , Humanos , Lactobacillus/isolamento & purificação , Estudos Longitudinais , Pessoa de Meia-Idade , Inquéritos e Questionários , Vagina/efeitos dos fármacos , Doenças Vaginais/tratamento farmacológico , Cloridrato de Venlafaxina/uso terapêutico , Doenças da Vulva/tratamento farmacológico
16.
Sleep ; 41(1)2018 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-29165623

RESUMO

Study Objectives: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects relative to control in women with comparably severe insomnia symptoms and VMS. Methods: We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ≥ 12, and ≥14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10-20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8-12 weeks of treatment. Results: CBT-I produced the greatest reduction in ISI from baseline relative to control at -5.2 points (95% CI -7.0 to -3.4). Effects on ISI were similar for exercise at -2.1 and venlafaxine at -2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at -2.7 points (-3.9 to -1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. Conclusions: This study's findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.


Assuntos
Antidepressivos de Segunda Geração/uso terapêutico , Citalopram/uso terapêutico , Terapia Cognitivo-Comportamental/métodos , Estradiol/uso terapêutico , Terapia por Exercício/métodos , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Sono/efeitos dos fármacos , Cloridrato de Venlafaxina/uso terapêutico , Método Duplo-Cego , Exercício Físico , Ácidos Graxos Ômega-3/sangue , Feminino , Fogachos/fisiopatologia , Humanos , Meditação , Menopausa/fisiologia , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Placebos/uso terapêutico , Autorrelato , Distúrbios do Início e da Manutenção do Sono/fisiopatologia , Yoga
17.
Menopause ; 24(10): 1160-1166, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28640154

RESUMO

OBJECTIVE: To examine associations between the composition of the vaginal microbiota and genitourinary menopausal symptoms, serum estrogen, and vaginal glycogen. METHODS: For this cross-sectional study, 88 women aged 40 to 62 years, enrolled in a hot flash treatment trial, provided vaginal swabs and a blood sample at enrollment. Bacterial communities were characterized using 16S rRNA PCR and deep sequencing targeting the V3-V4 region. Quantities of Lactobacillus crispatus and Lactobacillus iners were measured using qPCR. Self-reported genitourinary symptoms included: presence and severity of individual symptoms and identification of most bothersome symptom. Glycogen was measured fluorometrically in swab eluate. Serum estradiol (E2) and estrone (E1) were measured by liquid chromatography/mass spectrometry. Associations between bacteria, symptoms, glycogen, and serum estrogens were tested by linear regression or Wilcoxon signed-rank test, adjusted for multiple comparisons. Comparisons between groups used Kruskall-Wallis or Fisher's exact test. RESULTS: Of the 88 women, 33 (38%) had a majority of Lactobacillus species, whereas 58 (66%) had any Lactobacillus detected. Over half (53%) reported at least one vulvovaginal symptom (most commonly dryness), but symptoms were not associated with the presence of Lactobacillus species. Women with Lactobacillus-dominant communities had higher unconjugated serum estrone, but no difference in vaginal glycogen levels, compared with those with non-Lactobacillus-dominant communities. Higher serum E2 and E1 were not associated with either higher vaginal glycogen or detection of individual genera. CONCLUSIONS: Presence of Lactobacillus-dominant vaginal microbiota was not associated with fewer vulvovaginal symptoms. Serum estrone was higher in women with Lactobacillus dominance, but vaginal-free glycogen was not associated with composition of the vaginal microbiota.


Assuntos
Menopausa , Microbiota , Vagina/microbiologia , Doenças Vaginais/microbiologia , Adulto , Biomarcadores/análise , Estudos Transversais , Estradiol/sangue , Estrona/sangue , Feminino , Glicogênio/análise , Fogachos/microbiologia , Humanos , Lactobacillus/isolamento & purificação , Pessoa de Meia-Idade , Autorrelato
18.
Menopause ; 24(8): 877-885, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28509814

RESUMO

OBJECTIVES: To conduct psychometric analyses to condense the Hot Flash-Related Daily Interference Scale (HFRDIS) into a shorter form termed the Hot Flash Interference (HFI) scale; evaluate cut-points for both scales; and establish minimally important differences (MIDs) for both scales. METHODS: We analyzed baseline and postrandomization patient-reported data pooled across three randomized trials aimed at reducing vasomotor symptoms (VMS) in 899 midlife women. Trials were conducted across five MsFLASH clinical sites between July 2009 and October 2012. We eliminated HFRDIS items based on experts' content validity ratings and confirmatory factor analysis, and evaluated cut-points and established MIDs by mapping HFRDIS and HFI to other measures. RESULTS: The three-item HFI (interference with sleep, mood, and concentration) demonstrated strong internal consistency (alphas of 0.830 and 0.856), showed good fit to the unidimensional "hot flash interference factor," and strong convergent validity with HFRDIS scores, diary VMS, and menopausal quality of life. For both scales, cut-points of mild (0-3.9), moderate (4-6.9), and severe (7-10) interference were associated with increasing diary VMS ratings, sleep, and anxiety. The average MID was 1.66 for the HFRDIS and 2.34 for the HFI. CONCLUSIONS: The HFI is a brief assessment of VMS interference and will be useful in busy clinics to standardize VMS assessment or in research studies where response burden may be an issue. The scale cut-points and MIDs should prove useful in targeting those most in need of treatment, monitoring treatment response, and interpreting existing and future research findings.


Assuntos
Fogachos/psicologia , Menopausa , Psicometria , Qualidade de Vida , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Inquéritos e Questionários
19.
Maturitas ; 99: 37-42, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28364866

RESUMO

OBJECTIVE: Obesity can be a considerable health concern for peri- and post-menopausal women. Evidence suggests an association between the gut microbiome and obesity. The study objective was to evaluate the association between being overweight or obese and phenotypic markers of having an overall gut microbial environment not capable of metabolizing the isoflavone daidzein to equol or O-desmethylangolensin (ODMA). STUDY DESIGN: Cross-sectional study of 137 peri- and 218 post-menopausal women, aged 44-55 years, who consumed at least three servings per week of soy (source of daidzein). Equol and ODMA producers and non-producers were identified based on urinary concentrations of daidzein, equol and ODMA in a 24-h urine sample. MAIN OUTCOME MEASURES: Mean body mass index (BMI) and odds of obesity. RESULTS: Fifty-one women were ODMA non-producers and 226 were equol non-producers. The ODMA non-producer phenotype was positively associated with obesity (OR: 3.33, 95% CI: 1.53, 7.23), and mean BMI was significantly higher in non-producers (28.9kg/m2) than in producers (26.7kg/m2), after adjusting for age, ethnicity, and menopausal status. Positive associations with being obese were observed in both peri-menopausal (OR=3.92, 95% CI: 0.90, 17.0) and post-menopausal (OR=3.00, 95% CI: 1.22, 7.70) women. The equol non-producer phenotype was not associated with obesity (OR=1.13, 95% CI: 0.64, 1.98), and mean BMI was not significantly different between equol producers (27.3kg/m2) and non-producers (26.5kg/m2). CONCLUSIONS: These results suggest that the ODMA non-producer phenotype is associated with obesity in peri- and post-menopausal women. Further work is needed to confirm these observations in additional populations and to evaluate possible mechanisms.


Assuntos
Equol/biossíntese , Microbioma Gastrointestinal/fisiologia , Isoflavonas/biossíntese , Isoflavonas/metabolismo , Obesidade/microbiologia , Adulto , Índice de Massa Corporal , Estudos Transversais , Equol/urina , Etnicidade , Feminino , Humanos , Isoflavonas/urina , Pessoa de Meia-Idade , Obesidade/epidemiologia , Razão de Chances , Sobrepeso/epidemiologia , Sobrepeso/microbiologia , Perimenopausa , Pós-Menopausa
20.
Injury ; 48(5): 1031-1034, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28292519

RESUMO

INTRODUCTION: The management of blunt splenic injuries (BSI) has evolved toward strategies that avoid splenectomy. There is growing adoption of interventional radiology (IR) techniques in non-operative management of BSI, with evidence suggesting a corresponding reduction in emergency laparotomy requirements and increased splenic preservation rates. Currently there are no UK national guidelines for the management of blunt splenic injury. This may lead to variations in management, despite the reorganisation of trauma services in England in 2012. MATERIALS AND METHODS: A survey was distributed through the British Society of Interventional Radiologists to all UK members aiming to identify availability of IR services in England, radiologists' practice, and attitudes toward management of BSI. RESULTS: 116 responses from respondents working in 23 of the 26 Regional Trauma Networks in England were received. 79% provide a single dedicated IR service but over 50% cover more than one hospital within the network. All offer arterial embolisation for BSI. Only 25% follow guidelines. In haemodynamically stable patients, an increasing trend for embolisation was seen as grade of splenic injury increased from 1 to 4 (12.5%-82.14%, p<0.01). In unstable patients or those with radiological evidence of bleeding, significantly more respondents offer embolisation for grade 1-3 injuries (p<0.01), compared to stable patients. Significantly fewer respondents offer embolisation for grade 5 versus 4 injuries in unstable patients or with evidence of bleeding. CONCLUSION: Splenic embolisation is offered for a variety of injury grades, providing the patient remains stable. Variation in interventional radiology services remain despite the introduction of regional trauma networks.


Assuntos
Traumatismos Abdominais/terapia , Embolização Terapêutica , Radiologia Intervencionista , Baço/lesões , Centros de Traumatologia , Ferimentos não Penetrantes/terapia , Traumatismos Abdominais/complicações , Traumatismos Abdominais/diagnóstico por imagem , Embolização Terapêutica/métodos , Inglaterra/epidemiologia , Pesquisa sobre Serviços de Saúde , Humanos , Escala de Gravidade do Ferimento , Laparotomia/estatística & dados numéricos , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/estatística & dados numéricos , Baço/diagnóstico por imagem , Esplenectomia/estatística & dados numéricos , Ferimentos não Penetrantes/complicações , Ferimentos não Penetrantes/diagnóstico por imagem
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