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BACKGROUND: The magnitude and scope of Clostridium difficile infection in the United States continue to evolve. METHODS: In 2011, we performed active population- and laboratory-based surveillance across 10 geographic areas in the United States to identify cases of C. difficile infection (stool specimens positive for C. difficile on either toxin or molecular assay in residents ≥ 1 year of age). Cases were classified as community-associated or health care-associated. In a sample of cases of C. difficile infection, specimens were cultured and isolates underwent molecular typing. We used regression models to calculate estimates of national incidence and total number of infections, first recurrences, and deaths within 30 days after the diagnosis of C. difficile infection. RESULTS: A total of 15,461 cases of C. difficile infection were identified in the 10 geographic areas; 65.8% were health care-associated, but only 24.2% had onset during hospitalization. After adjustment for predictors of disease incidence, the estimated number of incident C. difficile infections in the United States was 453,000 (95% confidence interval [CI], 397,100 to 508,500). The incidence was estimated to be higher among females (rate ratio, 1.26; 95% CI, 1.25 to 1.27), whites (rate ratio, 1.72; 95% CI, 1.56 to 2.0), and persons 65 years of age or older (rate ratio, 8.65; 95% CI, 8.16 to 9.31). The estimated number of first recurrences of C. difficile infection was 83,000 (95% CI, 57,000 to 108,900), and the estimated number of deaths was 29,300 (95% CI, 16,500 to 42,100). The North American pulsed-field gel electrophoresis type 1 (NAP1) strain was more prevalent among health care-associated infections than among community-associated infections (30.7% vs. 18.8%, P<0.001). CONCLUSIONS: C. difficile was responsible for almost half a million infections and was associated with approximately 29,000 deaths in 2011. (Funded by the Centers for Disease Control and Prevention.).
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Clostridioides difficile , Infecciones por Clostridium/epidemiología , Adolescente , Adulto , Distribución por Edad , Anciano , Técnicas de Tipificación Bacteriana , Niño , Preescolar , Clostridioides difficile/genética , Clostridioides difficile/aislamiento & purificación , Infecciones por Clostridium/mortalidad , Infecciones por Clostridium/transmisión , Infección Hospitalaria/epidemiología , Electroforesis en Gel de Campo Pulsado , Femenino , Humanos , Incidencia , Lactante , Masculino , Persona de Mediana Edad , Vigilancia de la Población , Recurrencia , Distribución por Sexo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: A bridging study was performed to compare the safety, dose delivery, and acceptability of a prefilled plastic and user-filled paper applicator to assess whether a low-cost, user-filled, paper applicator could serve as a delivery option for tenofovir (TFV) 1% vaginal microbicide gel. METHODS: The study used a randomized crossover design with 25 healthy women randomized to begin with the prefilled or user-filled applicator. Within each study arm, participants delivered two 4.0-mL doses of TFV 1% gel vaginally for 7 days, with one dose delivered at the clinic each morning and a second dose delivered at home each evening. To assess the primary objective, applicator safety, colposcopy examinations were performed at 2 time points in each study arm. RESULTS: There were no colposcopic findings or adverse events attributable to either applicator. One case of vulvovaginal candidiasis was considered possibly related to gel use. On average, the user-filled applicator delivered 96% of the target dose, with 85% of doses falling within ± 10% of the average dose volume. Participants found both applicators comparable for ease of use, insertion, and dispensing gel, with 60% of participants preferring the user-filled applicator. CONCLUSIONS: This study suggests that both applicators are safe, and most women delivered TFV with the user-filled applicator as directed. Participants found both applicators acceptable, with a slight majority preferring the user-filled applicator. Incorporating a low-cost, user-filled, paper applicator to deliver TFV could help reduce costs and improve access to TFV 1% gel, especially in resource-limited settings heavily impacted by HIV.
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Adenina/análogos & derivados , Fármacos Anti-VIH/efectos adversos , Sistemas de Liberación de Medicamentos/efectos adversos , Infecciones por VIH/prevención & control , Organofosfonatos/efectos adversos , Cremas, Espumas y Geles Vaginales/efectos adversos , Adenina/administración & dosificación , Adenina/efectos adversos , Administración Intravaginal , Adolescente , Adulto , Fármacos Anti-VIH/administración & dosificación , Estudios Cruzados , Sistemas de Liberación de Medicamentos/instrumentación , Sistemas de Liberación de Medicamentos/métodos , Femenino , Humanos , Persona de Mediana Edad , Organofosfonatos/administración & dosificación , Papel , Aceptación de la Atención de Salud , Plásticos , Tenofovir , Resultado del Tratamiento , Cremas, Espumas y Geles Vaginales/administración & dosificación , Adulto JovenRESUMEN
Emerging adults are increasingly cohabiting, but few studies have considered the role of social context in the formation of their views of cohabitation. Drawing on 40 semi-structured interviews with dating couples, we explored the role of romantic partners, family, and peers on evaluations of cohabitation. In couples where each member had a differing view about cohabitation, one romantic partner's desire to not cohabit trumped their partner's more ambivalent feelings about cohabitation. The influence of family in the formation of cohabitation views was evident through a variety of mechanisms, including parental advice, social modeling, religious values, and economic control. Peers also played a key role, with couples using the vicarious trials of their peer networks to judge how cohabitation would affect their own relationship. By using a couple perspective, assessing reports from both members of each couple, this study showcases how beliefs about cohabitation are formed within an intimate dyad.
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Small bowel obstructions (SBO) are a commonly encountered diagnosis within emergency departments. Typically, these patients have evident risk factors including, but not limited to, prior abdominal surgery, personal or family history of gastrointestinal disorders, femoral and inguinal hernias, or neoplasm. In this case, we describe an SBO in a female, professional athlete whose swift, severe symptom onset, rapid resolution with conservative treatment, lack of identifiable risk factors, and prompt return to high level competition without recurrence are certainly unique. A female professional basketball player in her mid-20's with no past medical history presented with a seven-hour history of worsening abdominal pain beginning in the epigastric region and migrating to the right lower quadrant. Physical exam did not reveal abdominal distension, tympany to percussion, or high-pitched bowel sounds. Initial differential diagnosis included appendicitis, ruptured ectopic pregnancy, and other genitourinary pathology. Computed tomography with contrast revealed distended loops of small bowel with wall thickening, enhancement, and decompressed loops of bowel distally, consistent with an SBO. Symptoms resolved after 24 hours with conservative treatment, including decompression with a nasogastric tube. The athlete returned to full participation five days after initial presentation without recurrence of symptoms. Outpatient gastroenterology workup was negative for predisposing conditions. This presentation is rare in the absence of bowel pathology, family history, or prior abdominal surgery. Perhaps, her profession as an athlete, with frequent air travel and extensive exercise, may have contributed to this unique presentation. This case report should serve as a reminder to all providers that SBOs can occur in young, active patients devoid of risk factors. Even in the absence of typical signs on physical examination, providers should use imaging as adjuncts based on their clinical gestalt and utilize conservative management, when appropriate, to maximize chances of recovery with minimal morbidity.
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BACKGROUND: Targeted research on applicator safety has not been conducted as part of microbicide clinical trials and was considered necessary for ensuring safe and effective product use. Colposcopy, regarded as a standard method for assessing the safety of vaginal products, including microbicides, was used in this study to assess the external genitalia, vaginal epithelium and cervical epithelium after a single applicator use. OBJECTIVES: The objectives of this study were to assess and compare the effects of three vaginal applicators on symptoms and signs of irritation of the external genitalia, vagina and cervix as seen by colposcopy after applicator use. METHODS: Twenty women used three different vaginal applicators over three separate clinic visits 7-14 days apart and underwent a colposcopic examination before and after each applicator use. In total, the safety of each applicator was assessed over 20 product uses. RESULTS: No severe colposcopic finding was reported. Four minor colposcopic findings (petechiae) were considered possibly related to product use. No difference was found between applicators. CONCLUSIONS: This study provides reassuring data on the safety of the three applicator products from the perspective of causing vaginal trauma or irritation. Epithelial changes that could be more important for risk of disease transmission were not observed.
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Antiinfecciosos/administración & dosificación , Diseño de Equipo/efectos adversos , Administración Intravaginal , Adolescente , Adulto , Cuello del Útero/lesiones , Colposcopía , República Dominicana , Femenino , Humanos , Persona de Mediana Edad , Vagina/lesionesRESUMEN
Background. Approximately 4 million Americans receive nursing home (NH) care annually. Nursing home residents commonly have risk factors for Clostridium difficile infection (CDI), including advanced age and antibiotic exposures. We estimated national incidence of NH-onset (NHO) CDI and patient outcomes. Methods. We identified NHO-CDI cases from population-based surveillance of 10 geographic areas in the United States. Cases were defined by C difficile-positive stool collected in an NH (or from NH residents in outpatient settings or ≤3 days after hospital admission) without a positive stool in the prior 8 weeks. Medical records were reviewed on a sample of cases. Incidence was estimated using regression models accounting for age and laboratory testing method; sampling weights were applied to estimate hospitalizations, recurrences, and deaths. Results. A total of 3503 NHO-CDI cases were identified. Among 262 sampled cases, median age was 82 years, 76% received antibiotics in the 12 weeks prior to the C difficile-positive specimen, and 57% were discharged from a hospital in the month before specimen collection. After adjusting for age and testing method, the 2012 national estimate for NHO-CDI incidence was 112 800 cases (95% confidence interval [CI], 93 400-131 800); 31 400 (28%) were hospitalized within 7 days after a positive specimen (95% CI, 25 500-37 300), 20 900 (19%) recurred within 14-60 days (95% CI, 14 600-27 100), and 8700 (8%) died within 30 days (95% CI, 6600-10 700). Conclusions. Nursing home onset CDI is associated with substantial morbidity and mortality. Strategies focused on infection prevention in NHs and appropriate antibiotic use in both NHs and acute care settings may decrease the burden of NHO CDI.
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Cohabitation is an integral part of family research; however, little work examines cohabitation among teenagers or links between cohabitation and teenage childbearing. Drawing on the National Survey of Family Growth (2006-10), we examine family formation activities (i.e., cohabitation, marriage, and childbearing) of 3,945 15-19 year old women from the mid 1990s through 2010. One-third (34%) of teenagers cohabit, marry, or have a child. Teenage cohabitation and marriage are both positively associated with higher odds of having a child. The vast majority of single pregnant teenagers do not form a union before the birth of their child; only 22% cohabit and 5% marry. Yet most single pregnant teenagers eventually cohabit, 59% did so by the child's third birthday and about 9% marry. Cohabitation is an important part of the landscape of the adolescent years, and many teenage mothers described as "single mothers" are actually in cohabiting relationships.
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Multipurpose prevention technologies (MPTs) designed to simultaneously prevent pregnancy and HIV could provide urgently needed tools to address unmet sexual and reproductive health needs of women worldwide. Late-stage clinical trials will be complex given the need to demonstrate efficacy for HIV and contraceptive indications simultaneously from a single product. Currently, HIV and pregnancy prevention trials have distinctive design features that will need to be reconciled in MPT trials. This article identifies several ethical issues uniquely associated with this research that will benefit from future deliberation and guidance to ensure that this globally important research can proceed efficiently and expeditiously.
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Ensayos Clínicos como Asunto/ética , Anticoncepción/ética , Infecciones por VIH/prevención & control , Prevención Primaria/ética , Antiinfecciosos/uso terapéutico , Antirretrovirales/uso terapéutico , Femenino , Humanos , Masculino , Embarazo , Prevención Primaria/normasRESUMEN
OBJECTIVE: Little is known about the epidemiology of Clostridium difficile infection (CDI) among children, particularly children ≤3 years of age in whom colonization is common but pathogenicity uncertain. We sought to describe pediatric CDI incidence, clinical presentation, and outcomes across age groups. METHODS: Data from an active population- and laboratory-based CDI surveillance in 10 US geographic areas during 2010-2011 were used to identify cases (ie, residents with C difficile-positive stool without a positive test in the previous 8 weeks). Community-associated (CA) cases had stool collected as outpatients or ≤3 days after hospital admission and no overnight health care facility stay in the previous 12 weeks. A convenience sample of CA cases were interviewed. Demographic, exposure, and clinical data for cases aged 1 to 17 years were compared across 4 age groups: 1 year, 2 to 3 years, 4 to 9 years, and 10 to 17 years. RESULTS: Of 944 pediatric CDI cases identified, 71% were CA. CDI incidence per 100,000 children was highest among 1-year-old (66.3) and white (23.9) cases. The proportion of cases with documented diarrhea (72%) or severe disease (8%) was similar across age groups; no cases died. Among the 84 cases interviewed who reported diarrhea on the day of stool collection, 73% received antibiotics during the previous 12 weeks. CONCLUSIONS: Similar disease severity across age groups suggests an etiologic role for C difficile in the high rates of CDI observed in younger children. Prevention efforts to reduce unnecessary antimicrobial use among young children in outpatient settings should be prioritized.
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Clostridioides difficile , Infecciones por Clostridium/epidemiología , Preescolar , Femenino , Humanos , Incidencia , Lactante , Masculino , Estados Unidos/epidemiologíaRESUMEN
An ongoing question remains for family researchers: Why does a positive association between cohabitation and marital dissolution exist when one of the primary reasons to cohabit is to test relationship compatibility? Drawing on recently collected data from the 2006 - 2008 National Survey of Family Growth, the authors examined whether premarital cohabitation experiences were associated with marital instability among a recent contemporary (married since 1996) marriage cohort of men (N = 1,483) and women (N = 2,003). They found that a dichotomous indicator of premarital cohabitation was in fact not associated with marital instability among women and men. Furthermore, among cohabitors, marital commitment prior to cohabitation (engagement or definite plans for marriage) was tied to lower hazards of marital instability among women, but not men. This research contributes to our understanding of cohabitation, marital instability, and broader family change.
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OBJECTIVES: The objectives of this study were to prioritize applicator design attributes among women in the Dominican Republic and South Africa, and to determine how preferences differed based on sociodemographic variables. GOAL: The goal was to identify acceptable microbicide applicator designs in 2 low-resource settings. STUDY DESIGN: We surveyed 895 women, randomly sampled from clinics in the Dominican Republic (n = 449) and South Africa (n = 446), with questions on sociodemographics, applicator attribute preferences, and price/design tradeoffs. RESULTS: Single-use design was the most valued attribute, and reusable design and low price were the least valued attributes in both populations. Preference for single-use design was associated with concern about reusable applicators spreading germs, secondary or higher education, older age, having children, and perception of moderate to high HIV risk. CONCLUSIONS: Acceptability factors related to microbicide delivery mechanisms should continue to be evaluated among potential microbicide users to directly inform product development and introduction of microbicides.
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Antiinfecciosos/administración & dosificación , Sistemas de Liberación de Medicamentos/instrumentación , Enfermedades de Transmisión Sexual/epidemiología , Enfermedades de Transmisión Sexual/prevención & control , Administración Intravaginal , Adulto , República Dominicana/epidemiología , Femenino , Infecciones por VIH/epidemiología , Infecciones por VIH/etiología , Infecciones por VIH/prevención & control , Humanos , Satisfacción del Paciente , Enfermedades de Transmisión Sexual/etiología , Factores Socioeconómicos , Sudáfrica/epidemiología , Encuestas y Cuestionarios , Salud de la MujerRESUMEN
With more than 60 potential microbicides being assessed in preclinical or clinical trials, most attention has been centered on products intended for topical application, with much less research conducted on the applicators that will be used to deliver the microbicides. However, applicator design relates to safety, efficacy, and acceptability. As the foundation for a more systematic approach to evaluating and possibly improving designs for topical microbicide applicators, we conducted a literature review and a series of interviews with microbicide developers, trial investigators, and trial sponsors. Our findings indicate that issues concerning applicator safety, reuse, and cost warrant further investigation.