Last data update: Sep 16, 2024. (Total: 47680 publications since 2009)
Records 1-15 (of 15 Records) |
Query Trace: O'Hara B [original query] |
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Studying the post-COVID-19 condition: research challenges, strategies, and importance of Core Outcome Set development.
Munblit D , Nicholson TR , Needham DM , Seylanova N , Parr C , Chen J , Kokorina A , Sigfrid L , Buonsenso D , Bhatnagar S , Thiruvengadam R , Parker AM , Preller J , Avdeev S , Klok FA , Tong A , Diaz JV , Groote W , Schiess N , Akrami A , Simpson F , Olliaro P , Apfelbacher C , Rosa RG , Chevinsky JR , Saydah S , Schmitt J , Guekht A , Gorst SL , Genuneit J , Reyes LF , Asmanov A , O'Hara ME , Scott JT , Michelen M , Stavropoulou C , Warner JO , Herridge M , Williamson PR . BMC Med 2022 20 (1) 50 BACKGROUND: A substantial portion of people with COVID-19 subsequently experience lasting symptoms including fatigue, shortness of breath, and neurological complaints such as cognitive dysfunction many months after acute infection. Emerging evidence suggests that this condition, commonly referred to as long COVID but also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or post-COVID-19 condition, could become a significant global health burden. MAIN TEXT: While the number of studies investigating the post-COVID-19 condition is increasing, there is no agreement on how this new disease should be defined and diagnosed in clinical practice and what relevant outcomes to measure. There is an urgent need to optimise and standardise outcome measures for this important patient group both for clinical services and for research and to allow comparing and pooling of data. CONCLUSIONS: A Core Outcome Set for post-COVID-19 condition should be developed in the shortest time frame possible, for improvement in data quality, harmonisation, and comparability between different geographical locations. We call for a global initiative, involving all relevant partners, including, but not limited to, healthcare professionals, researchers, methodologists, patients, and caregivers. We urge coordinated actions aiming to develop a Core Outcome Set (COS) for post-COVID-19 condition in both the adult and paediatric populations. |
Risk Factors Associated With SARS-CoV-2 Seropositivity Among US Health Care Personnel.
Jacob JT , Baker JM , Fridkin SK , Lopman BA , Steinberg JP , Christenson RH , King B , Leekha S , O'Hara LM , Rock P , Schrank GM , Hayden MK , Hota B , Lin MY , Stein BD , Caturegli P , Milstone AM , Rock C , Voskertchian A , Reddy SC , Harris AD . JAMA Netw Open 2021 4 (3) e211283 IMPORTANCE: Risks for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among health care personnel (HCP) are unclear. OBJECTIVE: To evaluate the risk factors associated with SARS-CoV-2 seropositivity among HCP with the a priori hypothesis that community exposure but not health care exposure was associated with seropositivity. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was conducted among volunteer HCP at 4 large health care systems in 3 US states. Sites shared deidentified data sets, including previously collected serology results, questionnaire results on community and workplace exposures at the time of serology, and 3-digit residential zip code prefix of HCP. Site-specific responses were mapped to a common metadata set. Residential weekly coronavirus disease 2019 (COVID-19) cumulative incidence was calculated from state-based COVID-19 case and census data. EXPOSURES: Model variables included demographic (age, race, sex, ethnicity), community (known COVID-19 contact, COVID-19 cumulative incidence by 3-digit zip code prefix), and health care (workplace, job role, COVID-19 patient contact) factors. MAIN OUTCOME AND MEASURES: The main outcome was SARS-CoV-2 seropositivity. Risk factors for seropositivity were estimated using a mixed-effects logistic regression model with a random intercept to account for clustering by site. RESULTS: Among 2 749 HCP, most were younger than 50 years (17 233 [69.6%]), were women (19 361 [78.2%]), were White individuals (15 157 [61.2%]), and reported workplace contact with patients with COVID-19 (12 413 [50.2%]). Many HCP worked in the inpatient setting (8893 [35.9%]) and were nurses (7830 [31.6%]). Cumulative incidence of COVID-19 per 10 000 in the community up to 1 week prior to serology testing ranged from 8.2 to 275.6; 20 072 HCP (81.1%) reported no COVID-19 contact in the community. Seropositivity was 4.4% (95% CI, 4.1%-4.6%; 1080 HCP) overall. In multivariable analysis, community COVID-19 contact and community COVID-19 cumulative incidence were associated with seropositivity (community contact: adjusted odds ratio [aOR], 3.5; 95% CI, 2.9-4.1; community cumulative incidence: aOR, 1.8; 95% CI, 1.3-2.6). No assessed workplace factors were associated with seropositivity, including nurse job role (aOR, 1.1; 95% CI, 0.9-1.3), working in the emergency department (aOR, 1.0; 95% CI, 0.8-1.3), or workplace contact with patients with COVID-19 (aOR, 1.1; 95% CI, 0.9-1.3). CONCLUSIONS AND RELEVANCE: In this cross-sectional study of US HCP in 3 states, community exposures were associated with seropositivity to SARS-CoV-2, but workplace factors, including workplace role, environment, or contact with patients with known COVID-19, were not. These findings provide reassurance that current infection prevention practices in diverse health care settings are effective in preventing transmission of SARS-CoV-2 from patients to HCP. |
Taenia solium cysticercosis and taeniasis in urban settings: Epidemiological evidence from a health-center based study among people with epilepsy in Dar es Salaam, Tanzania
Schmidt V , O'Hara MC , Ngowi B , Herbinger KH , Noh J , Wilkins PP , Richter V , Kositz C , Matuja W , Winkler AS . PLoS Negl Trop Dis 2019 13 (12) e0007751 In Africa, urbanization is happening faster than ever before which results in new implications for transmission of infectious diseases. For the zoonotic parasite Taenia solium, a major cause of acquired epilepsy in endemic countries, the prevalence in urban settings is unknown. The present study investigated epidemiological, neurological, and radiological characteristics of T. solium cysticercosis and taeniasis (TSCT) in people with epilepsy (PWE) living in Dar es Salaam, Tanzania, one of the fastest growing cities worldwide. A total of 302 PWE were recruited from six health centers in the Kinondoni district of Dar es Salaam. Serological testing for T. solium cysticercosis-antigen (Ag) and -antibodies (Abs) and for T. solium taeniasis-Abs was performed in all PWE. In addition, clinical and radiological examinations that included cranial computed tomography (CT) were performed. With questionnaires, demographic data from study populations were collected, and factors associated with TSCT were assessed. Follow-up examinations were conducted in PWE with TSCT. T. solium cysticercosis-Ag was detected in three (0.99%; 95% CI: 0-2.11%), -Abs in eight (2.65%; 95% CI: 0.84-4.46%), and taeniasis-Abs in five (1.66%; 95% CI: 0.22-3.09%) of 302 PWE. Six PWE (1.99%; 95% CI: 0.41-3.56%) were diagnosed with neurocysticercosis (NCC). This study demonstrates the presence of TSCT in Dar es Salaam, however, NCC was only associated with a few cases of epilepsy. The small fraction of PWE with cysticercosis- and taeniasis-Abs may suggest that active transmission of T. solium plays only a minor role in Dar es Salaam. A sufficiently powered risk analysis was hampered by the small number of PWE with TSCT; therefore, further studies are required to determine the exact routes of infection and risk behavior of affected individuals. |
Sample size estimates for cluster-randomized trials in hospital infection control and antimicrobial stewardship
Blanco N , Harris AD , Magder LS , Jernigan JA , Reddy SC , O'Hagan J , Hatfield KM , Pineles L , Perencevich E , O'Hara LM . JAMA Netw Open 2019 2 (10) e1912644 Importance: An important step in designing, executing, and evaluating cluster-randomized trials (CRTs) is understanding the correlation and thus nonindependence that exists among individuals in a cluster. In hospital epidemiology, there is a shortage of CRTs that have published their intraclass correlation coefficient or coefficient of variation (CV), making prospective sample size calculations difficult for investigators. Objectives: To estimate the number of hospitals needed to power parallel CRTs of interventions to reduce health care-associated infection outcomes and to demonstrate how different parameters such as CV and expected effect size are associated with the sample size estimates in practice. Design, Setting, and Participants: This longitudinal cohort study estimated parameters for sample size calculations using national rates developed by the Centers for Disease Control and Prevention for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia, central-line-associated bloodstream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), and Clostridium difficile infections (CDI) from 2016. For MRSA and vancomycin-resistant enterococci (VRE) acquisition, outcomes were estimated using data from 2012 from the Benefits of Universal Glove and Gown study. Data were collected from June 2017 through September 2018 and analyzed from September 2018 through January 2019. Main Outcomes and Measures: Calculated number of clusters needed for adequate power to detect an intervention effect using a 2-group parallel CRT. Results: To study an intervention with a 30% decrease in daily rates, 73 total clusters were needed (37 in the intervention group and 36 in the control group) for MRSA bacteremia, 82 for CAUTI, 60 for CLABSI, and 31 for CDI. If a 10% decrease in rates was expected, 768 clusters were needed for MRSA bacteremia, 875 for CAUTI, 631 for CLABSI, and 329 for CDI. For MRSA or VRE acquisition, 50 or 40 total clusters, respectively, were required to observe a 30% decrease, whereas 540 or 426 clusters, respectively, were required to detect a 10% decrease. Conclusions and Relevance: This study suggests that large sample sizes are needed to appropriately power parallel CRTs targeting infection prevention outcomes. Sample sizes are most associated with expected effect size and CV of hospital rates. |
Greater Cognitive Deficits with Sleep-Disordered Breathing among Individuals with Genetic Susceptibility to Alzheimer's Disease: The Multi-Ethnic Study of Atherosclerosis.
Johnson DA , Lane J , Wang R , Reid M , Djonlagic I , Fitzpatrick AL , Rapp SR , Charles LE , O'Hara R , Saxena R , Redline S . Ann Am Thorac Soc 2017 14 (11) 1697-1705 RATIONALE: There are conflicting findings regarding the link between sleep apnea and cognitive dysfunction. OBJECTIVE: Investigate associations between indicators of sleep-disordered breathing (SDB) and cognitive function in the Multi-Ethnic Study of Atherosclerosis and assess effect modification by the apolipoprotein epsilon-4 (APOE-epsilon4) allele. METHODS: A diverse population (N=1,752) underwent Type 2 in-home polysomnography, which included measurement of % sleep time <90% oxyhemoglobin saturation (%Sat<90%) and apnea-hypopnea index (AHI). Epworth Sleepiness Scale score (ESS) and sleep apnea syndrome (SAS; AHI > 5 and ESS> 10) were also analyzed. Cognitive outcomes included the Cognitive Abilities Screening Instrument (CASI); Digit Symbol Coding Test (DSC); and Digit Span Tests (DST) Forward and Backward. RESULTS: Participants were 45.4% male, age 68.1(standard deviation: 9.1) years with a median AHI=9.0 and mean ESS=6.0. Approximately, 9.7% had SAS and 26.8% had at least one copy of the APOepsilon4 allele. In adjusted analyses, a one standard deviation increase in %Sat<90% and ESS score were associated with a poorer attention and memory assessed by the DST Forward score (beta=-0.12 (standard error: 0.06) and beta=-0.13 (0.06), respectively; P<0.05). SAS and higher ESS scores were also associated with poorer attention and processing speed as measured by the DSC, beta=-0.69 (0.35) and beta=-1.42 (0.35), respectively (P<0.05). The presence of APOE-epsilon4 allele modified the associations of %Sat<90% with DST forward and of ESS with DSCT, Pinteraction<0.05. CONCLUSIONS: Overnight hypoxemia and sleepiness were associated with cognition. The average effect estimates were small, similar to effects estimated for several other individual dementia risk factors. Associations were strongest in APOE-epsilon4 risk allele carriers. Our results: 1) suggest that SDB be considered among a group of modifiable dementia risk factors; and 2) highlight the potential vulnerability of APOE-epsilon4 risk allele carriers with SDB. |
Development of Medical Countermeasures to Middle East Respiratory Syndrome Coronavirus
Uyeki TM , Erlandson KJ , Korch G , O'Hara M , Wathen M , Hu-Primmer J , Hojvat S , Stemmy EJ , Donabedian A . Emerg Infect Dis 2016 22 (7) Preclinical development of and research on potential Middle East respiratory syndrome coronavirus (MERS-CoV) medical countermeasures remain preliminary; advancements are needed before most countermeasures are ready to be tested in human clinical trials. Research priorities include standardization of animal models and virus stocks for studying disease pathogenesis and efficacy of medical countermeasures; development of MERS-CoV diagnostics; improved access to nonhuman primates to support preclinical research; studies to better understand and control MERS-CoV disease, including vaccination studies in camels; and development of a standardized clinical trial protocol. Partnering with clinical trial networks in affected countries to evaluate safety and efficacy of investigational therapeutics will strengthen efforts to identify successful medical countermeasures. |
Breast cancer screening of underserved women in the USA: results from the National Breast and Cervical Cancer Early Detection Program, 1998-2012
Howard DH , Tangka FK , Royalty J , Dalzell LP , Miller J , O'Hara B , Joseph K , Kenney K , Guy G , Hall IJ . Cancer Causes Control 2015 26 (5) 657-68 OBJECTIVE: To describe the number and proportion of eligible women receiving mammograms funded by the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). METHODS: Low-income, uninsured, and underinsured women aged 40-64 are eligible for mammography screening through the NBCCEDP. We used data from the NBCCEDP, the Current Population Survey, and Medical Expenditure Panel Survey to describe the number and proportion of women screened by the NBCCEDP and overall. RESULTS: In 2011 and 2012, the NBCCEDP screened 549,043 women aged 40-64, an estimated 10.6 % (90 % confidence interval [CI] 10.4-10.9 %) of the eligible population. We estimate that 30.6 % (90 % CI 26.4-34.8 %) of eligible women aged 40-64 were screened outside the NBCCEDP, and 58.8 % (90 % CI 54.6-63.0 %) were not screened. The proportion of eligible women screened by the NBCCEDP varied across states, with an estimated range of 3.2 % (90 % CI 2.9-3.5 %) to 52.8 % (90 % CI 36.1-69.6 %) and a median of 13.7 % (90 % CI 11.0-16.4 %). The estimated proportion of eligible women aged 40-64 who received mammograms through the NBCCEDP was relatively constant over time, 11.1 % (90 % CI 10.2-11.9 %) in 1998-1999 and 10.6 % (90 % CI 10.4-11.9 %) in 2011-2012 (p = 0.23), even as the number of women screened increased from 343,692 to 549,043. CONCLUSIONS: Although the NBCCEDP provided screening services to over a half million low-income uninsured women for mammography, it served a small percentage of those eligible. The majority of low-income, uninsured women were not screened. |
Data sources for identifying low-income, uninsured populations: application to public health - National Breast and Cervical Cancer Early Detection Program
Dalzell LP , Tangka FK , Powers DS , O'Hara BJ , Holmes W , Joseph K , Royalty J . Cancer Causes Control 2015 26 (5) 699-709 OBJECTIVE: To provide information on the sources of data for estimating low-income, uninsured populations. To recommend uses of these data sources. To demonstrate the application of these data sources in the public health field, using the National Breast and Cervical Cancer Early Detection Program as an example. METHODS: We describe U.S. Census Bureau data sources for identifying low-income, uninsured populations using two population surveys: the Annual Social and Economic Supplement to the Current Population Survey (CPS ASEC) and the American Community Survey (ACS), and using one model-based estimation program, the Small Area Health Insurance Estimates (SAHIE). We provide recommendations for use of these data sources, and we use CPS ASEC and SAHIE to estimate the percent of U.S. women eligible for the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). RESULTS: CPS ASEC, ACS, and SAHIE are produced by the U.S. Census Bureau, and they are reliable sources for estimates of the low-income, uninsured populations in the USA. Key characteristics of these three data sources were presented to highlight the strengths of each to meet the needs of various programs at national and local levels. Recommendations are made on the use of the data sources. Based on these three data sources, estimates of NBCCEDP eligibility showed substantial variation over time at the national and state levels, and across states and counties. CONCLUSIONS: Publicly funded programs that are directed toward low-income, uninsured individuals require information on their eligible populations to make decisions about program policy and resource allocation, and to monitor and evaluate the effectiveness of the programs. The U.S. Census Bureau produces three data sources (CPS ASEC, ACS, and SAHIE) for these estimates. The percent of U.S. women eligible for NBCCEDP varies over time and across states and counties. The data sources for these estimates are changing in order to measure key dimensions of the Affordable Care Act (ACA) and can provide helpful information for assessing the legislation's impact. |
Cervical cancer screening of underserved women in the United States: results from the National Breast and Cervical Cancer Early Detection Program, 1997-2012
Tangka FK , Howard DH , Royalty J , Dalzell LP , Miller J , O'Hara BJ , Sabatino SA , Joseph K , Kenney K , Guy GP Jr , Hall IJ . Cancer Causes Control 2015 26 (5) 671-86 OBJECTIVE: The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) provides breast and cervical cancer screens to low-income, uninsured, and underinsured women. We describe the number and proportion of women eligible for cervical cancer screening services and the proportion of eligible women screened over the period 1997-2012. METHODS: Low-income, uninsured, and underinsured women aged 18-64 years who have not had a hysterectomy are eligible for cervical cancer screening through the NBCCEDP. We estimated the number of low-income, uninsured women using data from the US Census Bureau. We adjusted our estimates for hysterectomy status using the National Health Interview Survey and the Behavioral Risk Factor Surveillance System. We used data from the NBCCEDP to describe the number of women receiving NBCCEDP-funded screening and calculated the proportion of eligible women who received screening through the NBCCEDP at the national level (by age group, race/ethnicity) and at the state level by age group. We used the Medical Expenditure Panel Survey to estimate the proportion of NBCCEDP-eligible women who were screened outside the NBCCEDP and the proportion that are not screened. RESULTS: We estimate that in 2010-2012, 705,970 women aged 18-64 years, 6.5 % (705,970 of 9.8 million) of the eligible population, received NBCCEDP-funded Pap tests. We estimate that 60.2 % of eligible women aged 18-64 years were screened outside the NBCCEDP and 33.3 % were not screened. The NBCCEDP provided 623,603 screens to women aged 40-64 years, an estimated 16.5 % of the eligible population, and 83,660 screens to women aged 18-39 years, representing an estimated 1.2 % of the eligible population. The estimated proportions of eligible women screened in each state ranged from 1.5 to 32.7 % and 5 % to 73.2 % among the 18-64 and 40-64 years age groups, respectively. Changes in the proportion of eligible women screened over the study period were nonsignificant. CONCLUSIONS: Although the program provided cervical screening to over 700,000 women between 2010 and 2012, it served a small percent of those eligible. The proportion of women screened varied substantially across age groups, racial/ethnic groups, and states. Many low-income, uninsured women are not being screened. |
Cryptosporidium huwi n. sp. (Apicomplexa: Eimeriidae) from the guppy (Poecilia reticulata).
Ryan U , Paparini A , Tong K , Yang R , Gibson-Kueh S , O'Hara A , Lymbery A , Xiao L . Exp Parasitol 2015 150 31-5 The morphological, biological, and molecular characteristics of Cryptosporidium piscine genotype 1 from the guppy (Poecilia reticulata) are described, and the species name Cryptosporidium huwi n. sp. is proposed to reflect its genetic and biological differences from gastric and intestinal Cryptosporidium species. Oocysts of C.huwi n. sp. over-lap in size with Cryptosporidium molnari, measuring approximately 4.4-4.9 microm (mean 4.6) by 4.0-4.8 microm (mean 4.4 microm) with a length to width ratio of 1.04 (0.92-1.35) (n = 50). Similar to C.molnari, C.huwi n. sp. was identified in the stomach only and clusters of oogonial and sporogonial stages were identified deep within the epithelium. However, phylogenetic analysis of 18S rRNA sequences indicated that C. huwi n. sp. exhibited 8.5-9.2% and 3.5% genetic distance from C.molnari isolates and piscine genotype 7 respectively. At the actin locus, the genetic distance between C.huwi n. sp. and C.molnari was 16.6%. The genetic distance between C.huwi n. sp. and other Cryptosporidium species at the 18S locus was 13.2%-17% and at the actin locus was 18.9%-26.3%. Therefore C. huwi n. sp. is genetically distinct from previously described Cryptosporidium species. |
Postpartum anxiety and comorbid depression in a population-based sample of women
Farr SL , Dietz PM , O'Hara MW , Burley K , Ko JY . J Womens Health (Larchmt) 2013 23 (2) 120-8 BACKGROUND: Population-based estimates of prevalence of anxiety and comorbid depression are lacking. Therefore, we estimated the prevalence and risk factors for postpartum anxiety and comorbid depressive symptoms in a population-based sample of women. METHODS: Using multinomial logistic regression, we examined the prevalence and risk factors for postpartum anxiety and depressive symptoms using 2009-2010 data from the Illinois and Maryland Pregnancy Risk Assessment Monitoring System, a population-based survey of mothers who gave birth to live infants. Survey participants are asked validated screening questions on anxiety and depressive symptoms. RESULTS: Among 4451 postpartum women, 18.0% reported postpartum anxiety symptoms, of whom 35% reported postpartum depressive symptoms (6.3% overall). In the multivariable model, higher numbers of stressors during pregnancy (adjusted odds ratio [aOR] range: 1.3-9.7) and delivering an infant at ≤27 weeks gestation (aOR range: 2.0-5.7) were associated with postpartum anxiety and postpartum depressive symptoms, experienced individually or together. Smoking throughout pregnancy was associated with postpartum anxiety symptoms only (aOR=2.3) and comorbid anxiety and depressive symptoms (aOR=2.9). CONCLUSIONS: Given the possible adverse effects of postpartum anxiety and comorbid depression on maternal health and infant development, clinicians should be aware of the substantial prevalence, comorbidity, and risk factors for both conditions and facilitate identification, referral, and/or treatment. |
Sexual risk behavior among HIV-uninfected men who have sex with men (MSM) participating in a tenofovir pre-exposure prophylaxis (PrEP) randomized trial in the United States
Liu AY , Vittinghoff E , Chillag K , Mayer K , Thompson M , Grohskopf L , Colfax G , Pathak S , Gvetadze R , O'Hara B , Collins B , Ackers M , Paxton L , Buchbinder SP . J Acquir Immune Defic Syndr 2013 64 (1) 87-94 OBJECTIVE: To evaluate for changes in sexual behaviors associated with daily pill-use among MSM participating in a PrEP trial. DESIGN: Randomized, double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to receive tenofovir disoproxil fumarate or placebo at enrollment or after a 9-month delay and followed for 24 months. METHODS: 400 HIV-negative MSM reporting anal sex with a man in the past 12 months and meeting other eligibility criteria enrolled in San Francisco, Atlanta, and Boston. Sexual risk was assessed at baseline and quarterly visits using Audio Computer-Assisted Self-Interview. The association of pill-taking with sexual behavior was evaluated using logistic and negative-binomial regression for repeated measures. RESULTS: Overall indices of behavioral risk declined or remained stable during follow-up. Mean numbers of partners and proportion reporting unprotected anal sex (UAS) declined during follow-up (p<0.05), and mean UAS episodes remained stable. During the initial 9 months, changes in risk practices were similar in the group that began pills immediately vs. those in the delayed arm. These indices of risk did not differ significantly after initiation of pill-use in the delayed arm or continuation of study medication in the immediate arm. Use of poppers, amphetamines, and sexual performance-enhancing drugs were independently associated with one or more indices of sexual risk. CONCLUSIONS: There was no evidence of risk compensation among HIV-uninfected MSM in this clinical trial. Monitoring for risk compensation should continue now that PrEP has been shown to be efficacious in MSM and other populations and will be provided in open-label trials and other contexts. |
Randomized trial of clinical safety of daily oral tenofovir disoproxil fumarate (TDF) among HIV-uninfected men who have sex with men (MSM) in the United States
Grohskopf LA , Chillag KL , Gvetadze R , Liu AY , Thompson M , Mayer KH , Collins BM , Pathak SR , O'Hara B , Ackers ML , Rose CE , Grant RM , Paxton LA , Buchbinder SP . J Acquir Immune Defic Syndr 2013 64 (1) 79-86 OBJECTIVES: To evaluate the clinical safety of daily tenofovir disoproxil fumarate (TDF) among HIV-negative MSM. DESIGN: Randomized, double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to immediate or delayed study drug (TDF [300mg orally/day] or placebo). METHODS: 400 healthy HIV-uninfected MSM reporting anal sex with another man within the previous 12 months enrolled in Atlanta, Boston, and San Francisco. HIV serostatus, clinical and laboratory adverse events, adherence (pill count, Medical Event Monitoring System, [MEMS] and self-report), sexual and other sociobehavioral data were assessed at 3-month intervals for 24 months. Primary outcomes were clinical safety, assessed by incidence of adverse events and laboratory abnormalities. RESULTS: Study drug was initiated by 373 (93%) participants (186 TDF, 187 placebo), of whom 325 (87%) completed the final study visit. Of 2,428 adverse events reported among 334 (90%) participants, 2,366 (97%) were mild or moderate in severity.Frequencies of commonly reported adverse events did not differ significantly between TDF and placebo arms. In multivariable analyses, back pain was more likely among TDF recipients (p=0.04); these reports were not associated with documented fractures or other objective findings. There were no Grade ≥3 creatinine elevations; Grade 1 and 2 creatinine increases were not associated with TDF receipt. Estimated percent of study drug doses taken was 92% by pill count and 77% by MEMS. Seven seroconversions occurred; 4 on placebo and 3 among delayed arm participants not yet on study drug. CONCLUSION: Daily oral TDF was well tolerated, with reasonable adherence. No significant renal concerns were identified. |
Meeting the cervical cancer screening needs of underserved women: the National Breast and Cervical Cancer Early Detection Program, 2004-2006.
Tangka FK , O'Hara B , Gardner JG , Turner J , Royalty J , Shaw K , Sabatino S , Hall IJ , Coates RJ . Cancer Causes Control 2010 21 (7) 1081-90 OBJECTIVE: To examine the extent to which the only national organized screening program in the US, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), has helped to meet the cervical cancer screening needs of underserved women. METHODS: Low-income, uninsured women 18-64 years of age are eligible for free cervical cancer screening services through NBCCEDP. We used data from the US Census Bureau to estimate the number of eligible women, based on insurance status and income. The estimates were adjusted for hysterectomy status using the National Health Interview Survey and the Behavioral Risk Factor Surveillance System. We used administrative data from NBCCEDP to obtain the number of women receiving NBCCEDP-funded Papanicolaou (Pap) tests. We then calculated the percentage of NBCCEDP-eligible women who received free cervical cancer screening through NBCCEDP. We also used the NHIS to calculate the percentage of NBCCEDP-eligible women screened nationally and the percentage unscreened. RESULTS: In 2004-2006, nearly 9% (775,312 of 8.9 million) of NBCCEDP-eligible women, received NBCCEDP-funded Pap test. Rates varied substantially by age groups, race, and ethnicity. NBCCEDP-eligible women 40-64 years of age had a higher screening rate (22.6%) than eligible women 18-39 years of age (2.3%). Non-Hispanic women had a higher screening rate (9.3%) than Hispanic women (7.3%). Among non-Hispanics, the screening rate was highest among American Indian and Alaska Native (AIAN) women (36.1%) and lowest among women of different race combinations (4.6%), The percentage of eligible women screened in each state ranged from 2.0 to 38.4%. CONCLUSIONS: Although NBCCEDP provided cervical cancer screening services to 775,312 low-income, uninsured women, this number represented a small percentage of those eligible. In 2005, more than 34% of NBCCEDP-eligible women (3.1 million women) did not receive recommended Pap tests from either NBCCEDP or other sources. |
Evolution of the Global Tobacco Surveillance System (GTSS) 1998-2008
Warren CW , Lee J , Lea V , Goding A , O'Hara B , Carlberg M , Asma S , McKenna M . Glob Health Promot 2009 16 4-37 Tobacco use is one of the leading preventable causes of morbidity and mortality worldwide. Given that country-specific international data on tobacco use were limited or nonexistent, in 1998, the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Canadian Public Health Association (CPHA) initiated the Global Tobacco Surveillance System (GTSS) to assist countries in establishing tobacco control surveillance and monitoring programs. GTSS includes collection of data through three school-based surveys: the Global Youth Tobacco Survey (GYTS) for youth; the Global School Personnel Survey (GSPS), and the Global Health Professions Student Survey (GHPSS) for adults; and one household survey: the Global Adult Tobacco Survey (GATS) for adults. The GTSS provides a globally implemented and consistent framework for conducting surveillance including standard sampling procedures, core questionnaire items, training in field procedures and analysis of data consistent across all GTSS countries. The GTSS also enhances the role of the nongovernmental sector by supporting participation of civil society agencies in surveillance, monitoring, and policy and program development. The synergy between countries passing tobacco control laws, regulations or decrees, ratifying and complying with the WHO Framework Convention on Tobacco Control, and conducting GTSS surveys offers a unique opportunity to develop, implement, and evaluate comprehensive tobacco control policy that can be helpful to each country document the development, growth, and collaboration in sustaining the GTSS. The report highlights countries' involvement in tobacco control measures and the establishment of comprehensive tobacco control programs worldwide. This report can assist countries in prioritizing and developing tobacco control programs, including surveillance, evaluation, and policy development. |
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