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The market for technology that tracks ovulation to promote conception is rapidly expanding in the United States, targeting the growing audience of technologically proficient, reproductive-age female consumers. In this narrative review, 23 different, nonprescription wearables and devices designed to help women track their fertile window were identified as currently, commercially available in the United States. The majority of these utilize measurements of basal body temperature or combinations of various urinary hormones. This clinical opinion characterizes the scant available research validating the accuracy of these technologies. It further examines research oversight, discusses the utility of these wearables and devices to consumers, and considers these technologies through an equity lens. The discussion concludes with a call for innovation, describing promising new technologies that not only harness unique physiologic parameters to predict ovulation, but also focus on cost-effectiveness with the hope of increasing access to these currently costly devices and wearables.
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BACKGROUND: Persistent pregnancies of unknown location are defined by abnormally trending serum human chorionic gonadotropin with nondiagnostic ultrasound. There is no consensus on optimal management. OBJECTIVE: This study aimed to assess the cost-effectiveness of 3 primary management strategies for persistent pregnancies of unknown location: (1) expectant management, (2) empirical 2-dose methotrexate, and (3) uterine evacuation followed by methotrexate, if indicated. STUDY DESIGN: This was a prospective economic evaluation performed concurrently with the Expectant versus Active Management for Treatment of Persistent Pregnancies of Unknown Location multicenter randomized trial that was conducted from July 2014 to June 2019. Participants were randomized 1:1:1 to expectant management, 2-dose methotrexate, or uterine evacuation. The analysis was from the healthcare sector perspective with a 6-week time horizon after randomization. Costs were expressed in 2018 US dollars. Effectiveness was measured in quality-adjusted life years and the rate of salpingectomy. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were generated. Sensitivity analyses were performed to assess the robustness of the analysis. RESULTS: Methotrexate had the lowest mean cost ($875), followed by expectant management ($1085) and uterine evacuation ($1902) (P=.001). Expectant management had the highest mean quality-adjusted life years (0.1043), followed by methotrexate (0.1031) and uterine evacuation (0.0992) (P=.0001). The salpingectomy rate was higher for expectant management than for methotrexate (9.4% vs 1.2%, respectively; P=.02) and for expectant management than for uterine evacuation (9.4% vs 8.1%, respectively; P=.04). Uterine evacuation, with the highest costs and the lowest quality-adjusted life years, was dominated by both expectant management and methotrexate. In the base case analysis, expectant management was not cost-effective compared with methotrexate at a willingness to pay of $150,000 per quality-adjusted life year given an incremental cost-effectiveness ratio of $175,083 per quality-adjusted life year gained (95% confidence interval, -$1,666,825 to $2,676,375). Threshold analysis demonstrated that methotrexate administration would have to cost $214 (an increase of $16 or 8%) to favor expectant management. Moreover, expectant management would be favorable in lower-risk patient populations with rates of laparoscopic surgical management for ectopic pregnancy not exceeding 4% of pregnancies of unknown location. Based on the cost-effectiveness acceptability curves, the probability of expectant management being cost-effective compared with methotrexate at a willingness to pay of $150,000 per quality-adjusted life year gained was 50%. The results were dependent on the cost of surgical intervention and the expected rate of methotrexate failure. CONCLUSION: The management of pregnancies of unknown location with a 2-dose methotrexate protocol may be cost-effective compared with expectant management and uterine evacuation. Although uterine evacuation was dominated, expectant management vs methotrexate results were sensitive to modest changes in treatment costs of both methotrexate and surgical management.
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Abortivos não Esteroides , Análise Custo-Benefício , Metotrexato , Anos de Vida Ajustados por Qualidade de Vida , Conduta Expectante , Humanos , Feminino , Gravidez , Metotrexato/uso terapêutico , Metotrexato/economia , Conduta Expectante/economia , Abortivos não Esteroides/uso terapêutico , Abortivos não Esteroides/economia , Abortivos não Esteroides/administração & dosagem , Adulto , Estudos Prospectivos , Gravidez Ectópica/terapia , Gravidez Ectópica/economia , Gonadotropina Coriônica/uso terapêutico , Gonadotropina Coriônica/economia , Análise de Custo-EfetividadeRESUMO
Vital signs monitoring is a fundamental component of ensuring the health and safety of women and newborns during pregnancy, labor, and childbirth. This monitoring is often the first step in early detection of pregnancy abnormalities, providing an opportunity for prompt, effective intervention to prevent maternal and neonatal morbidity and mortality. Contemporary pregnancy monitoring systems require numerous devices wired to large base units; at least five separate devices with distinct user interfaces are commonly used to detect uterine contractility, maternal blood oxygenation, temperature, heart rate, blood pressure, and fetal heart rate. Current monitoring technologies are expensive and complex with implementation challenges in low-resource settings where maternal morbidity and mortality is the greatest. We present an integrated monitoring platform leveraging advanced flexible electronics, wireless connectivity, and compatibility with a wide range of low-cost mobile devices. Three flexible, soft, and low-profile sensors offer comprehensive vital signs monitoring for both women and fetuses with time-synchronized operation, including advanced parameters such as continuous cuffless blood pressure, electrohysterography-derived uterine monitoring, and automated body position classification. Successful field trials of pregnant women between 25 and 41 wk of gestation in both high-resource settings (n = 91) and low-resource settings (n = 485) demonstrate the system's performance, usability, and safety.
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Monitorização Fisiológica/instrumentação , Gravidez/fisiologia , Dispositivos Eletrônicos Vestíveis , Tecnologia sem Fio/instrumentação , Feminino , Recursos em Saúde , Frequência Cardíaca Fetal , Humanos , Contração Uterina , Sinais VitaisRESUMO
INTRODUCTION: More than 40,000 children undergo surgical interventions annually for the treatment of congenital heart defects. Intraoperative and postoperative vital sign monitoring is a cornerstone of pediatric care. METHODS: A single-arm prospective observational study was performed. Pediatric patients undergoing a procedure with a planned admission to the Cardiac Intensive Care Unit at Lurie Children's Hospital (Chicago, IL) were eligible for enrollment. Participant vital signs were monitored using standard equipment and an FDA-cleared experimental device (ANNE® ) consisting of a wireless patch positioned at the suprasternal notch and index finger or foot. The primary goal of the study was to assess real-world feasibility of wireless sensors in pediatric patients with congenital cardiac defects. RESULTS: A total of 13 patients were enrolled, ranging in age from 4 months to 16 years with a median age of 4 years. Overall, 54% (n = 7) were female and the most common anomaly in the cohort was an atrial septal defect (n = 6). The mean admission length was 3 days (range 2-6), resulting in more than 1000 h of vital sign monitoring (⟩60,000 data points). Bland-Altman plots were generated for heart rate and respiratory rate to assess beat-to-beast differences between the standard equipment and the experimental sensors. CONCLUSIONS: Novel, wireless, flexible sensors demonstrated comparable performance to standard monitoring equipment in a cohort of pediatric patients with congenital cardiac heart defects undergoing surgery.
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Cardiopatias Congênitas , Sinais Vitais , Humanos , Criança , Feminino , Pré-Escolar , Masculino , Cardiopatias Congênitas/cirurgia , Cardiopatias Congênitas/diagnóstico , Frequência Cardíaca , Taxa Respiratória , HospitalizaçãoRESUMO
PURPOSE: To study the impact of undergoing an embryo transfer during the week of daylight savings time transition on live birth rates. METHODS: We performed a retrospective observational cohort study of patients undergoing embryo transfer at an academic infertility practice during the week of spring or fall daylight savings time transition (cases), or the 2 weeks preceding and following the daylight savings transition (controls) between 2015 and 2021. The primary exposure was completion of an embryo transfer during the week of daylight savings time transition. The primary outcome was a comparison of live birth rate per embryo transfer among individuals undergoing an embryo transfer during the week of daylight savings time (DST) transition and those who did not. RESULTS: A total of 309 embryo transfers occurred during the week of daylight savings transition and 1242 embryo transfers occurred in the control group outside of the daylight savings transition week. The live birth rate after embryo transfer during DST transition weeks was 39.2% (121/309) compared to 40.8% (507/1242) (p = 0.59). When restricting the analysis to individuals (age > 37 years), the live birth rate after embryo transfer during DST transition week was 23.5% (24/102) compared to 34.8% (149/429) (p = 0.03). This difference persisted in the mixed-effects regression model demonstrating that after adjusting for relevant covariates, embryo transfer during DST transition weeks resulted in a 45% decrease in the odds of achieving a live birth. CONCLUSION: Daylight savings time transition may be associated with less favorable outcomes after embryo transfer among an older infertile patient population. Future work is needed to prospectively examine the influence of circadian rhythm disruption on reproductive outcomes.
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Coeficiente de Natalidade , Infertilidade , Gravidez , Feminino , Humanos , Idoso , Adulto , Fertilização in vitro , Taxa de Gravidez , Estudos Retrospectivos , Transferência Embrionária/métodos , Nascido Vivo/epidemiologia , Infertilidade/epidemiologia , Infertilidade/terapiaRESUMO
Uterus transplantation (UTx) provides a new pathway to parenthood for patients with absolute uterine factor infertility. The application of reproductive technologies, such as in vitro fertilization, embryo cryopreservation, and frozen embryo transfers, for this unique population, is particularly nuanced and continually evolving. There are important pretransplant and posttransplant reproductive considerations for physicians and patients anticipating UTx. As with any rapidly evolving medical innovation, efforts to consolidate experiences and knowledge by centers offering UTx is paramount.
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Infertilidade Feminina , Criopreservação , Transferência Embrionária , Feminino , Fertilização in vitro , Humanos , Infertilidade Feminina/terapia , Útero/transplanteRESUMO
PURPOSE: To compare pregnancy and birth outcomes after frozen embryo transfers (FETs) among White, Black, and Asian women and evaluate the effect of patient, protocol, and cycle characteristics on success. METHODS: A retrospective chart review identified women who underwent an autologous FET at an academic fertility center between January 2013 and March 2020. RESULTS: White, Black, and Asian women completed 1,181 (71.7%), 230 (14.0%), and 235 (14.3%) cycles, respectively. Black women were significantly less likely to achieve a positive hCG level (AOR 0.66, 95% CI 0.49-0.90), clinical pregnancy (AOR 0.71, 95% CI 0.53-0.97), and live birth (AOR 0.65, 95% CI 0.47-0.89) compared to White women after adjusting for possible confounders. There were no differences in the aforementioned outcomes when looking at cycles completed by Asian versus White women. When comparing outcomes by endometrial preparation protocol, significant differences were seen amongst the three groups for live birth rates following natural cycle FETs (52.36%, 25.81%, and 44.19% for White, Black, and Asian women, respectively, p = 0.02), a difference not appreciated after programmed FETs. CONCLUSION: Black race is associated with significantly worse pregnancy and live birth rates following FET when compared to White race. Additionally, significant differences in live birth rates among White, Black, and Asian women exist following natural cycle FET versus programmed FET. These disparities in success are not only important for patient counseling, but also when determining management strategies to improve fertility rates among minority women.
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Criopreservação/estatística & dados numéricos , Transferência Embrionária/estatística & dados numéricos , Grupos Raciais/estatística & dados numéricos , Adulto , Coeficiente de Natalidade , Endométrio/fisiologia , Feminino , Humanos , Nascido Vivo , Masculino , Indução da Ovulação/estatística & dados numéricos , Gravidez , Taxa de Gravidez , Estudos RetrospectivosRESUMO
Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71% of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95% CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95% CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95% CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95% CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.
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Equipamentos e Provisões/efeitos adversos , Recall de Dispositivo Médico , United States Food and Drug Administration , Estados UnidosAssuntos
Dermatite Atópica , Dispositivos Eletrônicos Vestíveis , Adulto , Humanos , Prurido , Mãos , Extremidade SuperiorRESUMO
The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death. We defined a recall event as a group of unique Food and Drug Administration recalls that share a similar reason for recall and occurred within a 1-month time frame. In total, 7 class I recall events were identified encompassing 83 unique recalls affecting >88,000 medical devices in distribution. Recalls involved a broad range of devices used in women's health including diagnostic assays for chlamydia and gonorrhea, a laparoscopic tissue morcellator, and obstetrical/gynecological surgical kits. Four of 7 (57%) recall events were due to postmarketing problems such as improper packaging and labeling while the remaining 3 (43%) recalls were due to premarketing problems (eg, software issues). Additionally, 3 of 7 (43%) recall events were cleared via the 510(k) pathway, while the remaining were essentially exempt from any form of premarket approval. Two recall events involved sterility concerns of 71 surgical kits used in obstetrics and gynecological surgeries representing the majority of affected devices (78,423) in distribution. Class I medical device recalls are rare but serious events. Most recalled devices in women's health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.
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Segurança de Equipamentos/estatística & dados numéricos , Ginecologia/instrumentação , Recall de Dispositivo Médico , Obstetrícia/instrumentação , Equipamentos e Provisões/classificação , Feminino , Humanos , Vigilância de Produtos Comercializados/normas , Fatores de Risco , Estados Unidos , United States Food and Drug Administration , Saúde da MulherRESUMO
Medical malpractice plaintiff firms play a central role in the prosecution of malpractice claims. There have been limited studies on the online advertising practices of plaintiff medical malpractice firms. The Martindale-Hubbell directory was used to identify all plaintiff medical malpractice firms in Suffolk County, Massachusetts. Each firm's website was individually mined for relevant data. Thirty-one unique medical malpractice law firms were identified. Seventy-seven percent of law firms advertised awards with the Martindale-Hubbell AV rating, AVVO, and Super Lawyer being the three most common. The second most common method of advertising was accomplished through descriptions of successful verdicts and settlements (61%). A total of 408 verdicts, settlements, and arbitrations collectively representing $1.4 billion dollars were advertised by all law firms. Median awarded values for verdicts was advertised as $4.5 million, while the median awarded values for settlements was $1.25 million. Defendants most commonly practiced obstetrics (18%), followed by primary care (14%). Law firms report treatment and diagnosis delay as the most common successful claim (50%), followed much further by misdiagnosis (8%), and communication error (4%). Our sample correlates with larger claims-based studies surrounding the most commonly sued specialties, however, median reported settlement and verdict values were significantly higher in our cohort. Considerations should be made to provide advertising guidelines for medical malpractice plaintiff firms.
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Publicidade , Erros de Diagnóstico/legislação & jurisprudência , Imperícia/legislação & jurisprudência , Estudos Transversais , Humanos , MassachusettsRESUMO
BACKGROUND: Melanoma is the most common cancer diagnosed for patients ages 25 to 29 years, the group with the highest birth rates in the United States. Oncofertility is a new field addressing the reproductive needs of patients with cancer facing fertility-threatening treatments. OBJECTIVE: We sought to assess gender-specific fertility risk for Food and Drug Administration (FDA)-approved melanoma therapies with a new risk category system. METHODS: We conducted a retrospective review of FDA, European Union, and Health Canada regulatory filings, along with previously published reports to grade fertility risk of systemic melanoma therapies. The proposed fertility risk category system is analogous to the FDA's A/B/C/D/X/N pregnancy-risk categories. RESULTS: For female patients, 58% of treatments represent a fertility risk (Category C and D), 33% have unknown risk (Category N), and 1 therapy (vemurafenib) did not show animal ovarian toxicity (Category B). For male patients, 33% represented a fertility risk (Category C and D), 50% of treatments had unknown risk (Category N), and 17% did not show animal testicular toxicity (Category B). LIMITATIONS: Data on fertility risk for melanoma therapies approved after 2009 are limited to preclinical animal studies. CONCLUSION: Dermatologists have an opportunity to discuss fertility preservation, make appropriate referrals, and steward registries on reproductive outcomes for patients with melanoma.
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Preservação da Fertilidade/métodos , Melanoma/diagnóstico , Melanoma/tratamento farmacológico , Neoplasias Cutâneas/diagnóstico , Neoplasias Cutâneas/tratamento farmacológico , Adolescente , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Canadá , Estudos de Coortes , Aconselhamento/organização & administração , União Europeia , Feminino , Humanos , Infertilidade Feminina/etiologia , Infertilidade Feminina/prevenção & controle , Infertilidade Masculina/etiologia , Infertilidade Masculina/prevenção & controle , Masculino , Melanoma/complicações , Gravidez , Estudos Retrospectivos , Medição de Risco , Neoplasias Cutâneas/complicações , Estados Unidos , United States Food and Drug Administration , Adulto JovemRESUMO
OBJECTIVE: Our objective was to examine the associations of total and trimester-specific gestational weight gain (GWG) rate with postpartum maternal weight and cardiometabolic risk. We hypothesized that first-trimester GWG would be most strongly associated with long-term maternal health. STUDY DESIGN: We studied 801 women enrolled during the first trimester of pregnancy in the Boston-area Project Viva cohort 1999 through 2002. At 3 years postpartum we measured maternal weight, waist circumference (WC), and systolic blood pressure (SBP) and collected fasting blood from a subset. At 7 years postpartum we again measured weight and WC. We used multivariable linear regression to evaluate relations of total and trimester-specific GWG rate with weight change (vs self-reported prepregnancy weight) and WC at each time point, stratified by prepregnancy weight, as well as associations with SBP and insulin resistance at 3 years. RESULTS: Median age at enrollment was 34.0 years (range, 16.4-44.9); 65% were white. Mean (SD) total GWG rate was 0.38 (0.14) kg/wk. Women gained weight faster during the second (0.47 [0.19] kg/wk) and third (0.44 [0.22] kg/wk) trimesters than the first (0.22 [0.22] kg/wk). Total and first-trimester GWG rate were most strongly associated with postpartum weight change. Among normal-weight women, each 1-SD increase in total and first-trimester GWG rate corresponded with 0.85 (95% confidence interval [CI], 0.07-1.63) kg and 2.08 (1.32-2.84) kg greater weight change at 3 and 7 years postpartum, respectively, but there was not strong evidence of association for either second- (-0.30 kg; 95% CI, -1.08 to 0.48) or third- (-0.26 kg; 95% CI, -1.08 to 0.55) trimester GWG. First-trimester GWG rate also related to 3-year postpartum weight change in overweight (2.28 kg; 95% CI, 0.95-3.61) and obese (2.47 kg; 95% CI, 0.98-3.97) women. Greater total and first-trimester GWG rate were associated with larger WC and higher SBP but not insulin resistance. CONCLUSION: In this observational cohort, first-trimester weight gain was more strongly associated with maternal weight retention as well as higher WC and blood pressure than second- or third-trimester gain. Interventions targeting GWG beginning very early in pregnancy may benefit long-term maternal health.
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Adiposidade , Pressão Sanguínea , Hipertensão/etiologia , Sobrepeso/etiologia , Trimestres da Gravidez/fisiologia , Aumento de Peso/fisiologia , Adolescente , Adulto , Peso Corporal , Feminino , Seguimentos , Humanos , Resistência à Insulina , Modelos Estatísticos , Obesidade/etiologia , Gravidez , Estudos Prospectivos , Fatores de Risco , Circunferência da Cintura , Adulto JovemRESUMO
OBJECTIVE: To report detailed, pooled multicenter experiences and outcomes after in vitro fertilization (IVF) treatment among patients undergoing uterus transplantation (UTx) in the US. DESIGN: Cohort study. SETTING: Hospital. PATIENTS: Patients undergoing UTxsfrom the three longest-running UTx clinical trials in the US. INTERVENTION: In vitro fertilization treatment among patients undergoing UTx. MAIN OUTCOME MEASURES: Reproductive outcomes pretransplant and posttransplant ovarian stimulation. RESULTS: Thirty-one uterus transplant recipients were included in this cohort (mean [±SD] age at transplant was 31 ± 4.7 years). Before transplant, recipients completed a mean of two oocyte retrievals (range 1-4), banking a mean of eight untested embryos (range 3-24) or six euploid embryos (range 2-10). Posttransplant retrieval cycles were required in 19% (n = 6/31) of recipients, for a total of 16 cycles (range 2-4 cycles per recipient). All posttransplant retrievals were performed vaginally without complications. Preimplantation genetic testing was used by 74% (n = 23/31) of subjects. Seventy-two autologous single embryo transfers (ETs) occurred in 23 patients who completed at least one ET. Two ETs followed a fresh IVF treatment cycle, and the remainder (n = 70) were frozen ETs. Endometrial preparation was more commonly performed with programmed protocols (n = 61) (exogenous administration of estrogen and progesterone) compared with natural cycle protocols (n = 9). The overall live birth rate (LBR) for this cohort was 35% (n = 25/72) per ET. Among those patients (n = 21) who had an ET leading to a live birth, a mean of 2.2 ETs were performed. The overall LBR after the first ET was 57% (n = 13/23) and rose to 74% (n = 17/23) after a second ET. There was no difference in rate of preeclampsia, live birth, neonatal birth, or placental weights among programmed vs. natural cycle frozen ETs. There were no differences in the LBR between living or deceased donor uteri (37% vs. 32%). CONCLUSIONS: Posttransplant ovarian stimulation was required in 26% (n = 6/23) of recipients undergoing at least one ET, despite high rates of preimplantation genetic testing and pretransplant embryo cryopreservation. Posttransplant retrievals were performed transvaginally, without complications. Future reporting of IVF treatment experiences will be essential to optimizing reproductive outcomes after a uterus transplant. CLINICAL TRIAL REGISTRATION NUMBERS: NCT02656550 (Baylor University Medical Center); NCT03307356 (University of Pennsylvania); and NCT02573415 (Cleveland Clinic).
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Fertilização in vitro , Infertilidade Feminina , Útero , Humanos , Feminino , Adulto , Fertilização in vitro/métodos , Gravidez , Estados Unidos/epidemiologia , Útero/transplante , Infertilidade Feminina/terapia , Infertilidade Feminina/diagnóstico , Resultado do Tratamento , Taxa de Gravidez , Nascido Vivo , Indução da Ovulação/métodos , Indução da Ovulação/tendências , Fertilidade , Transplante de Órgãos/efeitos adversos , Transplante de Órgãos/métodos , Transplante de Órgãos/tendências , Transferência de Embrião Único/efeitos adversosRESUMO
There have been over 769 million cases of COVID-19, and up to 50% of infected individuals are asymptomatic. The purpose of this study aimed to assess the use of a clinical-grade physiological wearable monitoring system, ANNE One, to develop an artificial intelligence algorithm for (1) cough detection and (2) early detection of COVID-19, through the retrospective analysis of prospectively collected physiological data from longitudinal wear of ANNE sensors in a multicenter single arm study of subjects at high risk for COVID-19 due to occupational or home exposures. The study employed a two-fold approach: cough detection algorithm development and COVID-19 detection algorithm development. For cough detection, healthy individuals wore an ANNE One chest sensor during scripted activity. The final performance of the algorithm achieved an F-1 score of 83.3% in twenty-seven healthy subjects during biomarker validation. In the COVID-19 detection algorithm, individuals at high-risk for developing COVID-19 because of recent exposures received ANNE One sensors and completed daily symptom surveys. An algorithm analyzing vital parameters (heart rate, respiratory rate, cough count, etc.) for early COVID-19 detection was developed. The COVID-19 detection algorithm exhibited a sensitivity of 0.47 and specificity of 0.72 for detecting COVID-19 in 325 individuals with recent exposures. Participants demonstrated high adherence (≥ 4 days of wear per week). ANNE One shows promise for detection of COVID-19. Inclusion of respiratory biomarkers (e.g., cough count) enhanced the algorithm's predictive ability. These findings highlight the potential value of wearable devices in early disease detection and monitoring.
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COVID-19 , Dispositivos Eletrônicos Vestíveis , Humanos , Algoritmos , Inteligência Artificial , Tosse/diagnóstico , COVID-19/diagnóstico , Teste para COVID-19 , Reação em Cadeia da Polimerase , Estudos RetrospectivosRESUMO
OBJECTIVE: To describe the incidence and management of vaginal stricture after uterus transplantation (UTx) in the US, to propose a grading system to classify stricture severity, and to identify risk factors for stricture formation. DESIGN: Prospective cohort study. SETTING: University Hospital. PATIENTS: Recipients undergoing UTx from 2016-2023 at Baylor University Medical Center in Dallas, Cleveland Clinic, the University of Pennsylvania, and the University of Alabama at Birmingham were monitored postoperatively with regular pelvic examinations. Stricture was defined as vaginal narrowing of <3 cm in patients with graft survival of at least 7 days. INTERVENTION: Demographic and surgery characteristics. MAIN OUTCOME MEASURES: Stricture development and severity (grade 1 for diameter 2-<3 cm, grade 2 for 1-<2 cm, or grade 3 for <1 cm). RESULTS: Of the 45 UTx from 2016-2023 (16 deceased donors and 29 living donors), 3 were excluded from the analysis because of graft loss within 7 days. Of the 42 remaining recipients, 39 (92.9%) had Mayer-Rokitansky-Küster-Hauser syndrome and 3 (7.1%) had a prior hysterectomy. Twenty-eight (66.7%) UTx recipients developed postoperative vaginal strictures with a median time to stricture of 33 days (interquartile range 19-53 days). Most strictures were of moderate severity, with 4 (14.3%) strictures categorized as grade 1, 19 (67.9%) as grade 2, and 5 (17.9%) as grade 3. History of Mayer-Rokitansky-Küster-Hauser syndrome and preoperative recipient vaginal length were significant risk factors for stricture, after adjustment for donor and recipient age and body mass index, anastomosis technique, total ischemia time, center, and year. Patients with longer preoperative vaginal length had a lower risk of stricture (hazard ratio 0.45, 0.29-0.70). The severity grading of the stricture was associated with the effectiveness of a nonoperative treatment approach (grade 1 vs. grade 3). No patients with grade 3 strictures improved with self-dilation alone; all required surgical repair and/or dilation under anesthesia. Conversely, for grade 1 or 2 strictures, self-dilation alone was successful in 47.8% (11/23), and no grade 1 strictures required surgical repair. CONCLUSIONS: Vaginal stricture is a common postoperative complication after UTx, affecting >65% of recipients. Short preoperative vaginal length and history of müllerian agenesis in the recipient are significant risk factors. Vaginal self-dilation was effective for some mild to moderate strictures, although dilation under anesthesia or surgical repair was required in most cases. CLINICAL TRIAL REGISTRATION NUMBERS: Dallas UtErus Transplant Study (DUETS) at Baylor University Medical Center (NCT02656550), Uterine transplantation for the treatment of uterine factor infertility at the Cleveland Clinic (NCT02573415), The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial (UNTIL) (NCT03307356).
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Anastomose Cirúrgica , Útero , Vagina , Feminino , Humanos , Útero/cirurgia , Adulto , Vagina/cirurgia , Vagina/patologia , Constrição Patológica , Estudos Prospectivos , Fatores de Risco , Anastomose Cirúrgica/efeitos adversos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/terapia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/cirurgia , Resultado do Tratamento , Adulto Jovem , Transtornos 46, XX do Desenvolvimento Sexual/cirurgia , Transtornos 46, XX do Desenvolvimento Sexual/diagnóstico , Índice de Gravidade de Doença , Transplante de Órgãos/efeitos adversos , Transplante de Órgãos/métodos , Pessoa de Meia-Idade , Incidência , Doadores de Tecidos , Sobrevivência de Enxerto , Anormalidades Congênitas , Ductos Paramesonéfricos/anormalidadesRESUMO
OBJECTIVE(S): To evaluate the association between neighborhood disadvantage and ovarian reserve stratified by body mass index (BMI). DESIGN: Cross-sectional cohort study. SETTING: Single academic medical center. PATIENT(S): A total of 193 healthy reproductive-age women with regular menstrual cycles in the St. Louis, Missouri metropolitan area. INTERVENTION(S): Residence in a disadvantaged neighborhood. MAIN OUTCOME MEASURE(S): Ovarian reserve as assessed by ovarian antral follicle count (AFC) and serum anti-Müllerian hormone (AMH) concentration. RESULT(S): Women (n = 193) ranged from 20 to 44 years. The majority had overweight or obesity (59%, n = 117) with mean BMI of 28±7 kg/m2. Forty-eight women lived in the most disadvantaged neighborhood quartile, of which 75% had overweight or obesity, compared with 54% of the 145 women living in the 3 less disadvantaged neighborhood quartiles. When controlling for age, race, and smoking status, women with overweight or obesity living in the most disadvantaged neighborhoods had significantly lower AMH compared with those living in the less disadvantaged neighborhoods. Antral follicle count did not differ among women with overweight or obesity by neighborhood of residence. Neighborhood disadvantage was not associated with ovarian reserve by AFC or AMH in women with normal weight or underweight status. CONCLUSION(S): Living in a socioeconomically deprived area is associated with lower markers of ovarian reserve among women with an elevated BMI.