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An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from 6 working groups, and a recent symposium cosponsored by the ACS, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology, which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (eg, the management of screen positives and screening intervals for screen negatives) of women after screening, the age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections. [PUBLICATION ABSTRACT]

An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from 6 working groups, and a recent symposium cosponsored by the ACS, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology, which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (eg, the management of screen positives and screening intervals for screen negatives) of women after screening, the age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections.

Hypertension is the most common primary diagnosis associated with postpartum readmissions within 42 days of delivery hospitalization. In the United States, nearly half of the cases of eclampsia, a severe form of preeclampsia, develop during the postpartum period, and the postpartum onset of hypertensive disorders of pregnancy, like antepartum hypertension poses long-term health risks to pregnant individuals, including an increased likelihood of developing overall cardiovascular disease, coronary heart disease, heart failure, and chronic hypertension. In this paper, we estimate the trends in the incidence of readmissions for postpartum hypertension within 42 days of delivery discharge in the US, disaggregated by median household income. Using National Readmissions Database, we calculated the readmission rates for postpartum hypertension, both overall and stratified by ZIP Code median household income for each year between 2010 and 2019. We also calculated the percentage change and average annual growth rate (AAGR) in the rate of readmissions for postpartum hypertension between 2010 and 2019 for each income group. We then used a logistic regression model to compare the temporal changes in readmission for postpartum hypertension between the lowest and the highest income quartiles. The estimated incidence of postpartum hypertension readmissions doubled for all the income groups between 2010 and 2019 (0.36% vs. 0.8%). While the incidence of postpartum hypertension cases was higher among the lowest-income quartile, the increase in postpartum hypertension readmissions between 2010 and 2019 was greater in the highest-income quartile. Moreover, the incidence of postpartum hypertension readmissions rose faster in pregnant patients without a history of hypertension compared to those with a history of hypertension (AAGR 8.3% vs. 5.1%). The increasing postpartum hypertension readmission burden suggests rising future health risks among mothers and a growing cost burden to the U.S. healthcare system. The higher rate of increase in postpartum hypertension readmissions among people without a history of hypertension calls for blood pressure checking in the postpartum period for all patients regardless of risk status.

Background While 60% of older adults have hearing loss (HL), the majority have never had their hearing tested. Objective We sought to estimate long-term clinical and economic effects of alternative adult hearing screening schedules in the USA. Design Model-based cost-effectiveness analysis simulating Current Detection (CD) and linkage of persons with HL to hearing healthcare, compared to alternative screening schedules varying by age at first screen (45 to 75 years) and screening frequency (every 1 or 5 years). Simulated persons experience yearly age- and sex-specific probabilities of acquiring HL, and subsequent hearing aid uptake (0.5–8%/year) and discontinuation (13–4%). Quality-adjusted life-years (QALYs) were estimated according to hearing level and treatment status. Costs from a health system perspective include screening ($30–120; 2020 USD), HL diagnosis ($300), and hearing aid devices ($3690 year 1, $910/subsequent year). Data sources were published estimates from NHANES and clinical trials of adult hearing screening. Participants Forty-year-old persons in US primary care across their lifetime. Intervention Alternative screening schedules that increase baseline probabilities of hearing aid uptake (base-case 1.62-fold; range 1.05–2.25-fold). Main Measures Lifetime undiscounted and discounted (3%/year) costs and QALYs and incremental cost-effectiveness ratios (ICERs). Key Results CD resulted in 1.20 average person-years of hearing aid use compared to 1.27–1.68 with the screening schedules. Lifetime total per-person undiscounted costs were $3300 for CD and ranged from $3630 for 5-yearly screening beginning at age 75 to $6490 for yearly screening beginning at age 45. In cost-effectiveness analysis, yearly screening beginning at ages 75, 65, and 55 years had ICERs of $39,100/QALY, $48,900/QALY, and $96,900/QALY, respectively. Results were most sensitive to variations in hearing aid utility benefit and screening effectiveness. Limitation Input uncertainty around screening effectiveness. Conclusions We project that yearly hearing screening beginning at age 55+ is cost-effective by US standards.

Clearance of anogenital and oropharyngeal HPV infections is attributed primarily to a successful adaptive immune response. To date, little attention has been paid to the potential role of stochastic cell dynamics in the time it takes to clear an HPV infection. In this study, we combine mechanistic mathematical models at the cellular level with epidemiological data at the population level to disentangle the respective roles of immune capacity and cell dynamics in the clearing mechanism. Our results suggest that chance-in form of the stochastic dynamics of basal stem cells-plays a critical role in the elimination of HPV-infected cell clones. In particular, we find that in immunocompetent adolescents with cervical HPV infections, the immune response may contribute less than 20% to virus clearance-the rest is taken care of by the stochastic proliferation dynamics in the basal layer. In HIV-negative individuals, the contribution of the immune response may be negligible.

Background Abortion may be medically indicated to avert death or permanent harm of the pregnant person. However, some US states now prevent access to abortion for these patients. To evaluate the population for whom this may cause harm, we aimed to estimate the prevalence of severe chronic conditions and pregnancy complications for which induced abortion is indicated, the odds of pregnancy for patients with severe chronic conditions, and compare pregnancy outcomes including induced abortion for pregnancies where such indications are present with pregnancies where they are not. Methods In a retrospective observational study using the Virginia All-Payer Claims Database (2018–2019), we identified 1,502,965 female patients aged 14–55 with ≥ 6 months insurance coverage. Medical codes identified severe chronic conditions and pregnancy complications. Pregnancy outcomes were classified using an established algorithm. Results Among reproductive-aged people, 2.9% had severe chronic conditions that could threaten life with pregnancy. Among 101,582 people who experienced pregnancy, 5.6% had life-threatening complications before their third trimester. Severe chronic conditions were associated with reduced risk of pregnancy (OR: 0.44 [95% CI: 0.41–0.46]), but sickle cell disease patients had increased odds of pregnancy (OR: 2.42 [95% CI: 2.10–2.78]). Compared to pregnancies with neither early complications or severe conditions present, pregnancies involving severe chronic conditions had fewer live births (68.2% vs. 75.3%), more spontaneous abortions (16.9% vs. 12.2%), and more induced abortions (3.7% vs. 2.2%), while pregnancies with early complications also had fewer live births (61.7%) and more spontaneous abortions (25.2%; p  < 0.01 for all comparisons). Abortion ratios (induced abortions per 1000 live births) in these data were 5–6 times lower than in Center for Disease Control abortion surveillance data for Virginia 2018–2019, indicating under-ascertainment of induced abortion. Conclusions In a state with some abortion restrictions and some protections, thousands of patients experience severe chronic conditions or pregnancy complications for which induced abortion is indicated.

BackgroundHuman papillomavirus (HPV)–6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18–related cervical intraepithelial neoplasia (CIN) 1–3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1–3/AIS associated with nonvaccine oncogenic HPV types was evaluated MethodsWe enrolled 17,622 women aged 16–26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotying was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of ⩾6 months’ duration and CIN1–3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types ResultsVaccination reduced the incidence of HPV-31/45 infection by 40.3% (95% confidence interval [CI], 13.9% to 59.0%) and of CIN1–3/AIS by 43.6% (95% CI, 12.9% to 64.1%), respectively. The reduction in HPV-31/33/45/52/58 infection and CIN1–3/AIS was 25.0% (95% CI, 5.0% to 40.9%) and 29.2% (95% CI, 8.3% to 45.5%), respectively. Efficacy for CIN2–3/AIS associated with the 10 nonvaccine HPV types was 32.5% (95% CI, 6.0% to 51.9%). Reductions were most notable for HPV-31 ConclusionsHPV-6/11/16/18 vaccine reduced the risk of CIN2–3/AIS associated with nonvaccine types responsible for ∼20% of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18–related disease, because women may have >1 CIN lesion, each associated with a different HPV type Trial registrationClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482

This multicenter, randomized trial compared the effects of clomiphene citrate plus placebo, metformin plus placebo, and combination therapy in infertile women with the polycystic ovary syndrome. The rate of live birth was significantly higher with clomiphene than with metformin; there was no significant difference between the rates with combination therapy and with clomiphene alone. Multiple birth was a complication associated with clomiphene but was infrequent. These data support the use of clomiphene over metformin for the treatment of infertility in women with the polycystic ovary syndrome. In infertile women with the polycystic ovary syndrome, the rate of live birth was significantly higher with clomiphene than with metformin. The polycystic ovary syndrome affects 7 to 8% of women 1 and may be the most common cause of female infertility. 2 Anovulation, 2 early pregnancy loss, 3 and later pregnancy complications 4 have all been implicated in the low fecundity of women with this disorder. Obesity is also common in such women, 5 and this condition alone appears to have an adverse effect on reproduction. 6 , 7 The cause of the polycystic ovary syndrome is poorly understood, and both the diagnosis and treatment of the disorder are controversial. 5 , 8 , 9 Women with this syndrome have hyperandrogenism, 10 morphologic changes in the ovary (polycystic), 10 inappropriate gonadotropin secretion (elevated . . .

BackgroundWe evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment MethodsPhase 3 efficacy studies enrolled 17,622 women aged 16–26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6–12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received ⩾1 dose and returned for follow-up were included ResultsVaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1–3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59–related CIN1–3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58–related CIN2 or worse was observed, the estimated reduction was not statistically significant ConclusionsThese cross-protection results complement the vaccine’s prophylactic efficacy against disease associated with HPV-6, -11, -16, and -18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings Trial registrationClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482

Background Multi-sensory behavioral interventions for preterm infants have the potential to accelerate feeding, growth, and optimize developmental trajectories and increase parents’ interactive engagement with their infants. However, few neonatal intensive care units (NICUs) provide evidence-based standardized early behavioral interventions as routine care. Lack of implementation is a major gap between research and clinical practice. H-HOPE, is a standardized behavioral intervention with an infant- directed component (Massage+) and a parent-directed component (four participatory guidance sessions that focus on preterm infants’ behaviors and appropriate responses). H-HOPE has well documented efficacy. The purpose of this implementation study is to establish H-HOPE as the standard of care in 5 NICUs. Methods The study employs a Type 3 Hybrid design to simultaneously examine the implementation process and effectiveness in five NICUs. To stagger implementation across the clinical sites, we use an incomplete stepped wedge design. The five participating NICUs were purposively selected to represent different acuity levels, number of beds, locations and populations served. Our implementation strategy integrates our experience conducting H-HOPE and a well-established implementation model, the Consolidated Framework for Implementation Research (CFIR). The CFIR identifies influences (facilitators and barriers) that affect successful implementation within five domains: intervention characteristics, outer setting (the hospital and external events and stakeholders), inner setting (NICU), implementers’ individual characteristics, and the implementation process. NICUs will use the CFIR process, which includes three phases: Planning and Engaging, Executing, and Reflecting and Evaluating. Because sustaining is a critical goal of implementation, we modify the CFIR implementation process by adding a final phase of Sustaining. Discussion This study builds on the CFIR, adding Sustaining H-HOPE to observe what happens when sites begin to maintain implementation without outside support, and extends its use to the NICU acute care setting. Our mixed methods analysis systematically identifies key facilitators and barriers of implementation success and effectiveness across the five domains of the CFIR. Long term benefits have not yet been studied but may include substantial health and developmental outcomes for infants, more optimal parent-child relationships, reduced stress and costs for families, and substantial indirect societal benefits including reduced health care and special education costs. Trial registration ClinicalTrials.gov registration number NCT04555590 , Registered on 8/19/2020.