Last data update: May 20, 2024. (Total: 46824 publications since 2009)
Records 1-16 (of 16 Records) |
Query Trace: Kim HJ [original query] |
---|
Evaluating demographic representation in clinical trials: Use of the adaptive coronavirus disease 2019 treatment trial (ACTT) as a test case
Ortega-Villa AM , Hynes NA , Levine CB , Yang K , Wiley Z , Jilg N , Wang J , Whitaker JA , Colombo CJ , Nayak SU , Kim HJ , Iovine NM , Ince D , Cohen SH , Langer AJ , Wortham JM , Atmar RL , El Sahly HM , Jain MK , Mehta AK , Wolfe CR , Gomez CA , Beresnev T , Mularski RA , Paules CI , Kalil AC , Branche AR , Luetkemeyer A , Zingman BS , Voell J , Whitaker M , Harkins MS , Davey RT Jr , Grossberg R , George SL , Tapson V , Short WR , Ghazaryan V , Benson CA , Dodd LE , Sweeney DA , Tomashek KM . Open Forum Infect Dis 2023 10 (6) ofad290 BACKGROUND: Clinical trials initiated during emerging infectious disease outbreaks must quickly enroll participants to identify treatments to reduce morbidity and mortality. This may be at odds with enrolling a representative study population, especially when the population affected is undefined. METHODS: We evaluated the utility of the Centers for Disease Control and Prevention's COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), the COVID-19 Case Surveillance System (CCSS), and 2020 United States (US) Census data to determine demographic representation in the 4 stages of the Adaptive COVID-19 Treatment Trial (ACTT). We compared the cumulative proportion of participants by sex, race, ethnicity, and age enrolled at US ACTT sites, with respective 95% confidence intervals, to the reference data in forest plots. RESULTS: US ACTT sites enrolled 3509 adults hospitalized with COVID-19. When compared with COVID-NET, ACTT enrolled a similar or higher proportion of Hispanic/Latino and White participants depending on the stage, and a similar proportion of African American participants in all stages. In contrast, ACTT enrolled a higher proportion of these groups when compared with US Census and CCSS. The proportion of participants aged ≥65 years was either similar or lower than COVID-NET and higher than CCSS and the US Census. The proportion of females enrolled in ACTT was lower than the proportion of females in the reference datasets. CONCLUSIONS: Although surveillance data of hospitalized cases may not be available early in an outbreak, they are a better comparator than US Census data and surveillance of all cases, which may not reflect the population affected and at higher risk of severe disease. |
Concurrent outbreaks of circulating vaccine-derived poliovirus types 1 and 2 affecting the Republic of the Philippines and Malaysia, 2019-2021.
Snider CJ , Boualam L , Tallis G , Takashima Y , Abeyasinghe R , Lo YR , Grabovac V , Avagyan T , Aslam SK , Eltayeb AO , Aung KD , Wang X , Shrestha A , Ante-Orozco C , Silva MWT , Lapastora-Sucaldito N , Apostol LNG , Jikal MBH , Miraj W , Lodhi F , Kim HJ , Rusli N , Thorley BR , Kaye MB , Nishimura Y , Arita M , Sani JAM , Rundi C , Feldon K . Vaccine 2022 41 Suppl 1 A58-A69 Concurrent outbreaks of circulating vaccine-derived poliovirus serotypes 1 and 2 (cVDPV1, cVDPV2) were confirmed in the Republic of the Philippines in September 2019 and were subsequently confirmed in Malaysia by early 2020. There is continuous population subgroup movement in specific geographies between the two countries. Outbreak response efforts focused on sequential supplemental immunization activities with monovalent Sabin strain oral poliovirus vaccine type 2 (mOPV2) and bivalent oral poliovirus vaccines (bOPV, containing Sabin strain types 1 and 3) as well as activities to enhance poliovirus surveillance sensitivity to detect virus circulation. A total of six cVDPV1 cases, 13 cVDPV2 cases, and one immunodeficiency-associated vaccine-derived poliovirus type 2 case were detected, and there were 35 cVDPV1 and 31 cVDPV2 isolates from environmental surveillance sewage collection sites. No further cVDPV1 or cVDPV2 have been detected in either country since March 2020. Response efforts in both countries encountered challenges, particularly those caused by the global COVID-19 pandemic. Important lessons were identified and could be useful for other countries that experience outbreaks of concurrent cVDPV serotypes. |
Safety of antimicrobials during pregnancy: A systematic review of antimicrobials considered for treatment and postexposure prophylaxis of plague
Yu PA , Tran EL , Parker CM , Kim HJ , Yee EL , Smith PW , Russell Z , Nelson CA , Broussard CS , Yu YC , Meaney-Delman D . Clin Infect Dis 2020 70 S37-s50 BACKGROUND: The safety profile of antimicrobials used during pregnancy is one important consideration in the decision on how to treat and provide postexposure prophylaxis (PEP) for plague during pregnancy. METHODS: We searched 5 scientific literature databases for primary sources on the safety of 9 antimicrobials considered for plague during pregnancy (amikacin, gentamicin, plazomicin, streptomycin, tobramycin, chloramphenicol, doxycycline, sulfadiazine, and trimethoprim-sulfamethoxazole [TMP-SMX]) and abstracted data on maternal, pregnancy, and fetal/neonatal outcomes. RESULTS: Of 13 052 articles identified, 66 studies (case-control, case series, cohort, and randomized studies) and 96 case reports were included, totaling 27 751 prenatal exposures to amikacin (n = 9), gentamicin (n = 345), plazomicin (n = 0), streptomycin (n = 285), tobramycin (n = 43), chloramphenicol (n = 246), doxycycline (n = 2351), sulfadiazine (n = 870), and TMP-SMX (n = 23 602). Hearing or vestibular deficits were reported in 18/121 (15%) children and 17/109 (16%) pregnant women following prenatal streptomycin exposure. First trimester chloramphenicol exposure was associated with an elevated risk of an undescended testis (odds ratio [OR] 5.9, 95% confidence interval [CI] 1.2-28.7). Doxycycline was associated with cardiovascular malformations (OR 2.4, 95% CI 1.2-4.7) in 1 study and spontaneous abortion (OR 2.8, 95% CI 1.9-4.1) in a separate study. First trimester exposure to TMP-SMX was associated with increased risk of neural tube defects (pooled OR 2.5, 95% CI 1.4-4.3), spontaneous abortion (OR 3.5, 95% CI 2.3-5.6), preterm birth (OR 1.5, 95% CI 1.1-2.1), and small for gestational age (OR 1.6, 95% CI 1.2-2.2). No other statistically significant associations were reported. CONCLUSIONS: For most antimicrobials reviewed, adverse maternal/fetal/neonatal outcomes were not observed consistently. Prenatal exposure to streptomycin and TMP-SMX was associated with select birth defects in some studies. Based on limited data, chloramphenicol and doxycycline may be associated with adverse pregnancy or neonatal outcomes; however, more data are needed to confirm these associations. Antimicrobials should be used for treatment and PEP of plague during pregnancy; the choice of antimicrobials may be influenced by these data as well as information about the risks of plague during pregnancy. |
The joinpoint-jump and joinpoint-comparability ratio model for trend analysis with applications to coding changes in health statistics
Chen HS , Zeichner S , Anderson RN , Espey DK , Kim HJ , Feuer EJ . J Off Stat 2020 36 (1) 49-62 Analysis of trends in health data collected over time can be affected by instantaneous changes in coding that cause sudden increases/decreases, or "jumps," in data. Despite these sudden changes, the underlying continuous trends can present valuable information related to the changing risk profile of the population, the introduction of screening, new diagnostic technologies, or other causes. The joinpoint model is a well-established methodology for modeling trends over time using connected linear segments, usually on a logarithmic scale. Joinpoint models that ignore data jumps due to coding changes may produce biased estimates of trends. In this article, we introduce methods to incorporate a sudden discontinuous jump in an otherwise continuous joinpoint model. The size of the jump is either estimated directly (the Joinpoint-Jump model) or estimated using supplementary data (the Joinpoint-Comparability Ratio model). Examples using ICD-9/ICD-10 cause of death coding changes, and coding changes in the staging of cancer illustrate the use of these models. |
Seroepidemiology of Hepatitis Viruses and Hepatitis B Genotypes of Female Marriage Immigrants in Korea.
Kwon JC , Chang HY , Kwon OY , Park JH , Oh IS , Kim HJ , Lee JH , Roh HJ , Lee HW . Yonsei Med J 2018 59 (9) 1072-1078 PURPOSE: The Korean society has moved rapidly toward becoming a multicultural society. This study aimed to estimate the seroprevalence of hepatitis viruses and investigate hepatitis B virus (HBV) genotypic diversity in female marriage immigrants. MATERIALS AND METHODS: Screening program was conducted at support centers for multicultural families in 21 administrative districts in Korea between July 2011 and January 2017. A total of 963 female marriage immigrants were included in this study. Blood samples were tested for hepatitis viral markers and HBV genotype. RESULTS: Subjects' median age was 33 years (20-40 years), and they originated from nine countries including Vietnam (n=422, 43.8%), China (n=311, 32.3%), the Philippines (n=85, 8.8%), Cambodia (n=58, 6.0%), and Japan (n=39, 4.0%). About 30% (n=288) of subjects required hepatitis A vaccination. HBsAg positive rate was 5.4% (n=52). Positive HBsAg results were the highest in subjects from Southeast Asia (6.6%, n=38). Anti-HBs positive rate was 60.4% (n=582). About 34% (n=329) of subjects who were negative for anti-HBs and HBsAg required HBV vaccinations. Genotypes B and C were found in 54.6% (n=12) and 45.4% (n=10) of the 22 subjects with HBV, in whom genotypes were tested. Eight (0.8%) subjects were positive for anti-HCV. Positive anti-HCV results were the highest in subjects from Central Asia (7.9%, n=3). CONCLUSION: Testing for hepatitis viral marker (hepatitis A virus IgG and HBsAg/anti-HBs) is needed for female marriage immigrants. Especially, HBV genotype B is different from genotype C of Koreans. Therefore, interest and attention to vaccination programs for female marriage immigrants are necessary for both clinicians and public health institutes. |
Safety and improved clinical outcomes in patients treated with new equine-derived heptavalent botulinum antitoxin
Yu PA , Lin NH , Mahon BE , Sobel J , Yu Y , Mody RK , Gu W , Clements J , Kim HJ , Rao AK . Clin Infect Dis 2017 66 S57-s64 Background: Botulism is a rare, life-threatening paralytic illness. Equine-derived heptavalent botulinum antitoxin (HBAT), the only currently available treatment for noninfant botulism in the United States, was licensed in 2013. No reports have systematically examined safety and clinical benefit of HBAT among botulism patients. Methods: From March 2010 through March 2013, we collected data prospectively and through medical record reviews of patients with confirmed or suspected botulism who were treated with HBAT under an expanded-access Investigational New Drug program. Results: Among 249 HBAT-treated patients, 1 (<1%) child experienced an HBAT-related serious adverse event (hemodynamic instability characterized by bradycardia, tachycardia, and asystole); 22 (9%) patients experienced 38 nonserious adverse events reported by physicians to be HBAT related. Twelve (5%) deaths occurred; all were determined to be likely unrelated to HBAT. Among 104 (42%) patients with confirmed botulism, those treated early (</=2 days) spent fewer days in the hospital (median, 15 vs 25 days; P < .01) and intensive care (10 vs 17 days; P = .04) than those treated later. Improvements in any botulism sign/symptom were detected a median of 2.4 days and in muscle strength a median of 4.8 days after HBAT. Conclusions: HBAT was safe and provided clinical benefit in treated patients. HBAT administration within 2 days of symptom onset was associated with shorter hospital and intensive care stays. These results highlight the importance of maintaining clinical suspicion for botulism among patients presenting with paralytic illness to facilitate early HBAT treatment before laboratory confirmation might be available. Clinical consultation and, if indicated, HBAT release, are available to clinicians 24/7 through their state health department in conjunction with CDC. |
Estimating the future burden of multidrug-resistant and extensively drug-resistant tuberculosis in India, the Philippines, Russia, and South Africa: a mathematical modelling study
Sharma A , Hill A , Kurbatova E , van der Walt M , Kvasnovsky C , Tupasi TE , Caoili JC , Gler MT , Volchenkov GV , Kazennyy BY , Demikhova OV , Bayona J , Contreras C , Yagui M , Leimane V , Cho SN , Kim HJ , Kliiman K , Akksilp S , Jou R , Ershova J , Dalton T , Cegielski P . Lancet Infect Dis 2017 17 (7) 707-715 BACKGROUND: Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis are emerging worldwide. The Green Light Committee initiative supported programmatic management of drug-resistant tuberculosis in 90 countries. We used estimates from the Preserving Effective TB Treatment Study to predict MDR and XDR tuberculosis trends in four countries with a high burden of MDR tuberculosis: India, the Philippines, Russia, and South Africa. METHODS: We calibrated a compartmental model to data from drug resistance surveys and WHO tuberculosis reports to forecast estimates of incident MDR and XDR tuberculosis and the percentage of incident MDR and XDR tuberculosis caused by acquired drug resistance, assuming no fitness cost of resistance from 2000 to 2040 in India, the Philippines, Russia, and South Africa. FINDINGS: The model forecasted the percentage of MDR tuberculosis among incident cases of tuberculosis to increase, reaching 12.4% (95% prediction interval 9.4-16.2) in India, 8.9% (4.5-11.7) in the Philippines, 32.5% (27.0-35.8) in Russia, and 5.7% (3.0-7.6) in South Africa in 2040. It also predicted the percentage of XDR tuberculosis among incident MDR tuberculosis to increase, reaching 8.9% (95% prediction interval 5.1-12.9) in India, 9.0% (4.0-14.7) in the Philippines, 9.0% (4.8-14.2) in Russia, and 8.5% (2.5-14.7) in South Africa in 2040. Acquired drug resistance would cause less than 30% of incident MDR tuberculosis during 2000-40. Acquired drug resistance caused 80% of incident XDR tuberculosis in 2000, but this estimate would decrease to less than 50% by 2040. INTERPRETATION: MDR and XDR tuberculosis were forecast to increase in all four countries despite improvements in acquired drug resistance shown by the Green Light Committee-supported programmatic management of drug-resistant tuberculosis. Additional control efforts beyond improving acquired drug resistance rates are needed to stop the spread of MDR and XDR tuberculosis in countries with a high burden of MDR tuberculosis. FUNDING: US Agency for International Development and US Centers for Disease Control and Prevention, Division of Tuberculosis Elimination. |
Multidrug-resistant tuberculosis treatment outcomes in relation to treatment, initial and acquired second-line drug resistance
Cegielski JP , Kurbatova E , van der Walt M , Brand J , Ershova J , Tupasi T , Campos Caoili J , Dalton T , Contreras C , Yagui M , Bayona J , Kvasnovsky C , Leimane V , Kuksa L , Chen MP , Via LE , Hwang SH , Wolfgang M , Volchenkov GV , Somova T , Smith SE , Akksilp S , Wattanaamornkiet W , Kim HJ , Kim CK , Kazennyy BY , Khorosheva T , Kliiman K , Viiklepp P , Jou R , Huang AS , Vasilyeva IA , Demikhova OV . Clin Infect Dis 2015 62 (4) 418-430 BACKGROUND: Resistance to second-line drugs (SLD) develops during treatment of multidrug-resistant (MDR) tuberculosis (TB), but the impact on treatment outcome has not been determined. OBJECTIVES: To determine the relationship with treatment outcomes of (1) initial versus acquired drug resistance and (2) treatment regimens. METHODS: MDR-TB patients starting SLD treatment were enrolled in a prospective cohort study. Sputum cultures were analyzed at a central reference laboratory. We compared subjects with successful and poor treatment outcomes in terms of (1) initial and acquired resistance to fluoroquinolones and second-line injectables (SLI), and (2) treatment regimens. RESULTS: Of 1,244 MDR-TB patients, 973 (78.2%) had known outcomes and 232 (18.6%) were lost to follow-up. Among those with known outcomes, treatment succeeded in 85.8% with plain MDR-TB, 69.7% with initial resistance to either a fluoroquinolone or SLI, 37.5% with acquired resistance to a fluoroquinolone or SLI, 29.3% with initial XDR-TB, and 13.0% with acquired XDR-TB (P<0.0001 for trend). In contrast, among those with known outcomes, treatment success increased stepwise from 41.6% to 92.3% as the number of proven effective drugs increased from ≤1 to ≥5 (P<0.0001 for trend); while acquired drug resistance decreased from 12%-16% range, depending on the drug, down to 0%-2% (P<0.0001 for trend). In multivariable analysis, the adjusted odds of treatment success decreased 0.62-fold (CL 0.56,0.69) for each increment in drug resistance and increased 2.1-fold (1.40,3.18) for each additional effective drug, controlling for differences between programs and patients. Specific treatment, patient and program variables were also associated with treatment outcome. CONCLUSION: Increasing drug resistance was associated in a logical stepwise manner with poor treatment outcomes. Acquired resistance was worse than initial resistance to the same drugs. Increasing numbers of effective drugs, specific drugs, and specific program characteristics were associated with better outcomes and less acquired resistance. |
First use of a serogroup B meningococcal vaccine in the US in response to a university outbreak
McNamara LA , Shumate AM , Johnsen P , MacNeil JR , Patel M , Bhavsar T , Cohn AC , Dinitz-Sklar J , Duffy J , Finnie J , Garon D , Hary R , Hu F , Kamiya H , Kim HJ , Kolligian J Jr , Neglia J , Oakley J , Wagner J , Wagner K , Wang X , Yu Y , Montana B , Tan C , Izzo R , Clark TA . Pediatrics 2015 135 (5) 798-804 BACKGROUND: In 2013-2014, an outbreak of serogroup B meningococcal disease occurred among persons linked to a New Jersey university (University A). In the absence of a licensed serogroup B meningococcal (MenB) vaccine in the United States, the Food and Drug Administration authorized use of an investigational MenB vaccine to control the outbreak. An investigation of the outbreak and response was undertaken to determine the population at risk and assess vaccination coverage. METHODS: The epidemiologic investigation relied on compilation and review of case and population data, laboratory typing of meningococcal isolates, and unstructured interviews with university staff. Vaccination coverage data were collected during the vaccination campaign held under an expanded-access Investigational New Drug protocol. RESULTS: Between March 25, 2013, and March 10, 2014, 9 cases of serogroup B meningococcal disease occurred in persons linked to University A. Laboratory typing results were identical for all 8 isolates available. Through May 14, 2014, 89.1% coverage with the 2-dose vaccination series was achieved in the target population. From the initiation of MenB vaccination through February 1, 2015, no additional cases of serogroup B meningococcal disease occurred in University A students. However, the ninth case occurred in March 2014 in an unvaccinated close contact of University A students. CONCLUSIONS: No serogroup B meningococcal disease cases occurred in persons who received 1 or more doses of 4CMenB vaccine, suggesting 4CMenB may have protected vaccinated individuals from disease. However, the ninth case demonstrates that carriage of serogroup B Neisseria meningitidis among vaccinated persons was not eliminated. |
Sputum culture conversion as a prognostic marker for end-of-treatment outcome in patients with multidrug-resistant tuberculosis: a secondary analysis of data from two observational cohort studies
Kurbatova EV , Cegielski JP , Lienhardt C , Akksilp R , Bayona J , Becerra MC , Caoili J , Contreras C , Dalton T , Danilovits M , Demikhova OV , Ershova J , Gammino VM , Gelmanova I , Heilig CM , Jou R , Kazennyy B , Keshavjee S , Kim HJ , Kliiman K , Kvasnovsky C , Leimane V , Mitnick CD , Quelapio I , Riekstina V , Smith SE , Tupasi T , van der Walt M , Vasilyeva IA , Via LE , Viiklepp P , Volchenkov G , Walker AT , Wolfgang M , Yagui M , Zignol M . Lancet Respir Med 2015 3 (3) 201-9 BACKGROUND: Sputum culture conversion is often used as an early microbiological endpoint in phase 2 clinical trials of tuberculosis treatment on the basis of its assumed predictive value for end-of-treatment outcome, particularly in patients with drug-susceptible tuberculosis. We aimed to assess the validity of sputum culture conversion on solid media at varying timepoints, and the time to conversion, as prognostic markers for end-of-treatment outcome in patients with multidrug-resistant (MDR) tuberculosis. METHODS: We analysed data from two large cohort studies of patients with MDR tuberculosis. We defined sputum culture conversion as two or more consecutive negative cultures from sputum samples obtained at least 30 days apart. To estimate the association of 2 month and 6 month conversion with successful treatment outcome, we calculated odds ratios (ORs) and 95% CIs with random-effects multivariable logistic regression. We calculated predictive values with bivariate random-effects generalised linear mixed modelling. FINDINGS: We assessed data for 1712 patients who had treatment success, treatment failure, or who died. Among patients with treatment success, median time to sputum culture conversion was significantly shorter than in those who had poor outcomes (2 months [IQR 1-3] vs 7 months [3 to ≥24]; log-rank p<0.0001). Furthermore, conversion status at 6 months (adjusted OR 14.07 [95% CI 10.05-19.71]) was significantly associated with treatment success compared with failure or death. Sputum culture conversion status at 2 months was significantly associated with treatment success only in patients who were HIV negative (adjusted OR 4.12 [95% CI 2.25-7.54]) or who had unknown HIV infection (3.59 [1.96-6.58]), but not in those who were HIV positive (0.38 [0.12-1.18]). Thus, the overall association of sputum culture conversion with a successful outcome was substantially greater at 6 months than at 2 months. 2 month conversion had low sensitivity (27.3% [95% confidence limit 16.6-41.4]) and high specificity (89.8% [82.3-94.4]) for prediction of treatment success. Conversely, 6 month sputum culture conversion status had high sensitivity (91.8% [85.9-95.4]), but moderate specificity (57.8% [42.5-71.6]). The maximum combined sensitivity and specificity for sputum culture conversion was reached between month 6 and month 10 of treatment. INTERPRETATION: Time to sputum culture conversion, conversion status at 6 months, and conversion status at 2 months in patients without known HIV infection can be considered as proxy markers of end-of-treatment outcome in patients with MDR tuberculosis, although the overall association with treatment success is substantially stronger for 6 month than for 2 month conversion status. Investigators should consider these results regarding the validity of sputum culture conversion at various timepoints as an early predictor of treatment efficacy when designing phase 2 studies before investing substantial resources in large, long-term, phase 3 trials of new treatments for MDR tuberculosis. FUNDING: US Agency for International Development, US Centers for Disease Control and Prevention, Division of Intramural Research of the US National Institute of Allergy and Infectious Diseases, Korea Centers for Disease Control and Prevention. |
Prevalence of and risk factors for resistance to second-line drugs in people with multidrug-resistant tuberculosis in eight countries: a prospective cohort study
Dalton T , Cegielski P , Akksilp S , Asencios L , Caoili JC , Cho SN , Erokhin VV , Ershova J , Gler MT , Kazennyy BY , Kim HJ , Kliiman K , Kurbatova E , Kvasnovsky C , Leimane V , van der Walt M , Via LE , Volchenkov GV , Yagui MA , Kang H . Lancet 2012 380 (9851) 1406-17 BACKGROUND: The prevalence of extensively drug-resistant (XDR) tuberculosis is increasing due to the expanded use of second-line drugs in people with multidrug-resistant (MDR) disease. We prospectively assessed resistance to second-line antituberculosis drugs in eight countries. METHODS: From Jan 1, 2005, to Dec 31, 2008, we enrolled consecutive adults with locally confirmed pulmonary MDR tuberculosis at the start of second-line treatment in Estonia, Latvia, Peru, Philippines, Russia, South Africa, South Korea, and Thailand. Drug-susceptibility testing for study purposes was done centrally at the Centers for Disease Control and Prevention for 11 first-line and second-line drugs. We compared the results with clinical and epidemiological data to identify risk factors for resistance to second-line drugs and XDR tuberculosis. FINDINGS: Among 1278 patients, 43.7% showed resistance to at least one second-line drug, 20.0% to at least one second-line injectable drug, and 12.9% to at least one fluoroquinolone. 6.7% of patients had XDR tuberculosis (range across study sites 0.8-15.2%). Previous treatment with second-line drugs was consistently the strongest risk factor for resistance to these drugs, which increased the risk of XDR tuberculosis by more than four times. Fluoroquinolone resistance and XDR tuberculosis were more frequent in women than in men. Unemployment, alcohol abuse, and smoking were associated with resistance to second-line injectable drugs across countries. Other risk factors differed between drugs and countries. INTERPRETATION: Previous treatment with second-line drugs is a strong, consistent risk factor for resistance to these drugs, including XDR tuberculosis. Representative drug-susceptibility results could guide in-country policies for laboratory capacity and diagnostic strategies. FUNDING: US Agency for International Development, Centers for Disease Control and Prevention, National Institutes of Health/National Institute of Allergy and Infectious Diseases, and Korean Ministry of Health and Welfare. |
Asthma prevalence among US elderly by age groups: age still matters
Oraka E , Kim HJ , King ME , Callahan DB . J Asthma 2012 49 (6) 593-599 OBJECTIVE: For over three decades, the greatest burden of asthma deaths has occurred among persons aged 65 years and older. This study analyzed the association between increasing age and asthma prevalence among age groups within the US elderly population. METHODS: We analyzed aggregated data on 54,485 civilian, noninstitutionalized US adults aged 65 years and older from the 2001-2010 National Health Interview Survey (NHIS). We estimated the prevalence of current asthma, lifetime asthma, and chronic obstructive pulmonary disease (COPD) among US elderly by 5-year age groups and age stages ("young elderly" aged 65-84 years and "oldest old" aged ≥85 years). We calculated adjusted odds ratios (AOR) and 95% confidence intervals (CI) to identify asthma prevalence patterns among elderly populations. RESULTS: From 2001 to 2010, the estimated average annual prevalence of current asthma among US elderly was 7.0%. Estimates of lifetime asthma, COPD, and co-occurring current asthma and COPD were 9.9%, 9.7%, and 3.0%, respectively. Prevalence of asthma decreased with advancing age while prevalence of COPD increased with advancing age. When controlling for study variables and significant interactions (p = .05) with COPD, the odds of reporting current asthma decreased with advancing age: 0.87 (95% CI, 0.76-1.01) for 70- to 74-year-olds; 0.76 (95% CI, 0.66-0.87) for 75- to 79-year-olds; 0.62 (95% CI, 0.51-0.75) for 80- to 84-year-olds; and 0.45 (95% CI, 0.36-0.55) for ≥85-year-olds, as compared to 65- to 69-year-olds. CONCLUSIONS: Asthma continues to affect a substantial proportion of the US elderly population. Increased diagnosis of COPD may overshadow correct diagnosis and treatment in populations with advancing age. Treatment guidelines should focus on preventable risk behaviors to increase the quality of life within this population. |
Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm09 under Emergency Use Authorization, October 2009 - June 2010
Yu Y , Garg S , Yu PA , Kim HJ , Patel A , Merlin T , Redd S , Uyeki TM . Clin Infect Dis 2012 55 (1) 8-15 BACKGROUND: In response to the influenza A(H1N1)pdm09 [pH1N1] pandemic, peramivir, an investigational intravenous neuraminidase inhibitor, was made available for treatment of hospitalized patients with pH1N1 in the U.S. under Emergency Use Authorization (EUA). The Centers for Disease Control and Prevention (CDC) implemented a program to manage peramivir distribution to requesting clinicians under EUA. We describe results of CDC's peramivir program and three related surveys. METHODS: We analyzed data on peramivir requests made by clinicians to CDC through an electronic request system. Three surveys were administered to enhance clinician compliance with adverse event reporting, to conduct product accountability, and to collect data on peramivir-treated patients. Descriptive analyses were performed and two-source capture-recapture analysis, based upon the three surveys, was used to estimate the number of patients who received peramivir through the EUA. RESULTS: During October 23, 2009 to June 23, 2010, CDC received 1,371 clinician requests for peramivir and delivered 2,129 five-day adult treatment course equivalents of peramivir to 563 hospitals. Based on survey responses, at least 1,274 patients (median age 43 years, range 0-92 years, 49% male) received one or more doses of peramivir (median duration 6 days). Capture-recapture analysis yielded estimates for the potential total number of peramivir recipients ranging from 1,185 (95% CI: 1,076-1,293) to 1,490 (95% CI: 1,321-1,659). CONCLUSIONS: Approximately 1,274 hospitalized patients received peramivir through EUA program during the pH1N1 pandemic. Further analyses are needed to assess the clinical effectiveness of peramivir treatment of hospitalized patients with pH1N1. |
Predicting US- and state-level cancer counts for the current calendar year: Part II: evaluation of spatiotemporal projection methods for incidence
Zhu L , Pickle LW , Ghosh K , Naishadham D , Portier K , Chen HS , Kim HJ , Zou Z , Cucinelli J , Kohler B , Edwards BK , King J , Feuer EJ , Jemal A . Cancer 2012 118 (4) 1100-9 BACKGROUND: The current study was undertaken to evaluate the spatiotemporal projection models applied by the American Cancer Society to predict the number of new cancer cases. METHODS: Adaptations of a model that has been used since 2007 were evaluated. Modeling is conducted in 3 steps. In step I, ecologic predictors of spatiotemporal variation are used to estimate age-specific incidence counts for every county in the country, providing an estimate even in those areas that are missing data for specific years. Step II adjusts the step I estimates for reporting delays. In step III, the delay-adjusted predictions are projected 4 years ahead to the current calendar year. Adaptations of the original model include updating covariates and evaluating alternative projection methods. Residual analysis and evaluation of 5 temporal projection methods were conducted. RESULTS: The differences between the spatiotemporal model-estimated case counts and the observed case counts for 2007 were < 1%. After delays in reporting of cases were considered, the difference was 2.5% for women and 3.3% for men. Residual analysis indicated no significant pattern that suggested the need for additional covariates. The vector autoregressive model was identified as the best temporal projection method. CONCLUSIONS: The current spatiotemporal prediction model is adequate to provide reasonable estimates of case counts. To project the estimated case counts ahead 4 years, the vector autoregressive model is recommended to be the best temporal projection method for producing estimates closest to the observed case counts. (Cancer 2012;. (c) 2012 American Cancer Society.) |
Analysis of antibody responses to Mycobacterium leprae phenolic glycolipid-I, lipoarabinomannan and recombinant proteins to define disease-subtype specific antigenic profiles in leprosy
Spencer JS , Kim HJ , Wheat WH , Chatterjee D , Balagon MV , Cellona RV , Tan EV , Gelber R , Saunderson P , Duthie MS , Reece ST , Burman W , Belknap R , Mac Kenzie WR , Geluk A , Oskam L , Dockrell HM , Brennan PJ . Clin Vaccine Immunol 2010 18 (2) 260-7 A simple serodiagnostic test based on the Mycobacterium leprae-specific phenolic glycolipid, PGL-I, for individuals with leprosy is nearly universally positive in leprosy patients with high bacillary loads, but cannot be used as a stand-alone diagnostic test for the entire spectrum of the disease process. For patients with early infection with no detectable acid fast bacilli in lesions or with low or no antibody titer to PGL-I as in those at the tuberculoid end of the disease spectrum, this diagnostic approach has limited usefulness. To identify additional M. leprae antigens that might enhance the serological detection of these individuals, we have examined the reactivity patterns of patient sera to PGL-I, lipoarabinomannan (LAM) and six recombinant M. leprae proteins (ML1877, ML0841, ML2028, ML2038, ML0380 and ML0050) by Western blot and ELISA. Overall, the responses to ML2028 (Ag85B) and ML2038 (bacterioferritin) were consistently high in both multibacillary and paucibacillary groups and weak or absent in endemic controls, while responses to other antigens showed considerable variability, from strongly positive to completely negative. This analysis has given a clearer understanding of some of the differences in the antibody responses, between individuals at opposite ends of the disease spectrum, as well as illustrating the heterogeneity of antibody responses towards protein, carbohydrate, and glycolipid antigens within a clinical group. Correlating these response patterns with a particular disease state would allow for a more critical assessment of the form of disease within the leprosy spectrum and could lead to better patient management. |
Roles and contributions of pharmacists in regulatory affairs at the Centers for Disease Control and Prevention for public health emergency preparedness and response
Bhavsar TR , Kim HJ , Yu Y . J Am Pharm Assoc (2003) 2010 50 (2) 165-8 OBJECTIVE: To provide a general description of the roles and contributions of three pharmacists from the Regulatory Affairs program (RA) at the Centers for Disease Control and Prevention (CDC) who are involved in emergency preparedness and response activities, including the 2009 pandemic influenza A (H1N1) public health emergency. SETTING: Atlanta, GA. PRACTICE DESCRIPTION: RA consists of a staff of nine members, three of whom are pharmacists. The mission of RA is to support CDC's preparedness and emergency response activities and to ensure regulatory compliance for critical medical countermeasures against potential threats from natural, chemical, biological, radiological, or nuclear events.CONCLUSION: RA was well involved in the response to the H1N1 outbreak through numerous activities, such as submitting multiple Emergency Use Authorization (EUA) requests to the Food and Drug Administration, including those for medical countermeasures to be deployed from the Strategic National Stockpile, and developing the CDC EUA website (www.cdc.gov/h1n1flu/eua). RA will continue to support current and future preparedness and emergency response activities by ensuring that the appropriate regulatory mechanisms are in place for the deployment of critical medical countermeasures from the Strategic National Stockpile against threats to public health. |
- Page last reviewed:Feb 1, 2024
- Page last updated:May 20, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure