Last data update: May 20, 2024. (Total: 46824 publications since 2009)
Records 1-30 (of 33 Records) |
Query Trace: Hsieh H [original query] |
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Climate change, malaria and neglected tropical diseases: a scoping review
Klepac P , Hsieh JL , Ducker CL , Assoum M , Booth M , Byrne I , Dodson S , Martin DL , Turner CMR , van Daalen KR , Abela B , Akamboe J , Alves F , Brooker SJ , Ciceri-Reynolds K , Cole J , Desjardins A , Drakeley C , Ediriweera DS , Ferguson NM , Gabrielli AF , Gahir J , Jain S , John MR , Juma E , Kanayson P , Deribe K , King JD , Kipingu AM , Kiware S , Kolaczinski J , Kulei WJ , Laizer TL , Lal V , Lowe R , Maige JS , Mayer S , McIver L , Mosser JF , Nicholls RS , Nunes-Alves C , Panjwani J , Parameswaran N , Polson K , Radoykova HS , Ramani A , Reimer LJ , Reynolds ZM , Ribeiro I , Robb A , Sanikullah KH , Smith DRM , Shirima GG , Shott JP , Tidman R , Tribe L , Turner J , Vaz Nery S , Velayudhan R , Warusavithana S , Wheeler HS , Yajima A , Abdilleh AR , Hounkpatin B , Wangmo D , Whitty CJM , Campbell-Lendrum D , Hollingsworth TD , Solomon AW , Fall IS . Trans R Soc Trop Med Hyg 2024 To explore the effects of climate change on malaria and 20 neglected tropical diseases (NTDs), and potential effect amelioration through mitigation and adaptation, we searched for papers published from January 2010 to October 2023. We descriptively synthesised extracted data. We analysed numbers of papers meeting our inclusion criteria by country and national disease burden, healthcare access and quality index (HAQI), as well as by climate vulnerability score. From 42 693 retrieved records, 1543 full-text papers were assessed. Of 511 papers meeting the inclusion criteria, 185 studied malaria, 181 dengue and chikungunya and 53 leishmaniasis; other NTDs were relatively understudied. Mitigation was considered in 174 papers (34%) and adaption strategies in 24 (5%). Amplitude and direction of effects of climate change on malaria and NTDs are likely to vary by disease and location, be non-linear and evolve over time. Available analyses do not allow confident prediction of the overall global impact of climate change on these diseases. For dengue and chikungunya and the group of non-vector-borne NTDs, the literature privileged consideration of current low-burden countries with a high HAQI. No leishmaniasis papers considered outcomes in East Africa. Comprehensive, collaborative and standardised modelling efforts are needed to better understand how climate change will directly and indirectly affect malaria and NTDs. |
In silico approaches in organ toxicity hazard assessment: Current status and future needs for predicting heart, kidney and lung toxicities
Bassan A , Alves VM , Amberg A , Anger LT , Beilke L , Bender A , Bernal A , Cronin MTD , Hsieh JH , Johnson C , Kemper R , Mumtaz M , Neilson L , Pavan M , Pointon A , Pletz J , Ruiz P , Russo DP , Sabnis Y , Sandhu R , Schaefer M , Stavitskaya L , Szabo DT , Valentin JP , Woolley D , Zwickl C , Myatt GJ . Comput Toxicol 12/28/2021 20 The kidneys, heart and lungs are vital organ systems evaluated as part of acute or chronic toxicity assessments. New methodologies are being developed to predict these adverse effects based on in vitro and in silico approaches. This paper reviews the current state of the art in predicting these organ toxicities. It outlines the biological basis, processes and endpoints for kidney toxicity, pulmonary toxicity, respiratory irritation and sensitization as well as functional and structural cardiac toxicities. The review also covers current experimental approaches, including off-target panels from secondary pharmacology batteries. Current in silico approaches for prediction of these effects and mechanisms are described as well as obstacles to the use of in silico methods. Ultimately, a commonly accepted protocol for performing such assessment would be a valuable resource to expand the use of such approaches across different regulatory and industrial applications. However, a number of factors impede their widespread deployment including a lack of a comprehensive mechanistic understanding, limited in vitro testing approaches and limited in vivo databases suitable for modeling, a limited understanding of how to incorporate absorption, distribution, metabolism, and excretion (ADME) considerations into the overall process, a lack of in silico models designed to predict a safe dose and an accepted framework for organizing the key characteristics of these organ toxicants. |
Neuroinvasive bacillus cereus infection in immunocompromised hosts: Epidemiologic investigation of 5 patients with acute myeloid leukemia
Little JS , Coughlin C , Hsieh C , Lanza M , Huang WY , Kumar A , Dandawate T , Tucker R , Gable P , Vazquez Deida AA , Moulton-Meissner H , Stevens V , McAllister G , Ewing T , Diaz M , Glowicz J , Winkler ML , Pecora N , Kubiak DW , Pearson JC , Luskin MR , Sherman AC , Woolley AE , Brandeburg C , Bolstorff B , McHale E , Fortes E , Doucette M , Smole S , Bunnell C , Gross A , Platt D , Desai S , Fiumara K , Issa NC , Baden LR , Rhee C , Klompas M , Baker MA . Open Forum Infect Dis 2024 11 (3) ofae048 BACKGROUND: Bacillus cereus is a ubiquitous gram-positive rod-shaped bacterium that can cause sepsis and neuroinvasive disease in patients with acute leukemia or neutropenia. METHODS: A single-center retrospective review was conducted to evaluate patients with acute leukemia, positive blood or cerebrospinal fluid test results for B cereus, and abnormal neuroradiographic findings between January 2018 and October 2022. Infection control practices were observed, environmental samples obtained, a dietary case-control study completed, and whole genome sequencing performed on environmental and clinical Bacillus isolates. RESULTS: Five patients with B cereus neuroinvasive disease were identified. All patients had acute myeloid leukemia (AML), were receiving induction chemotherapy, and were neutropenic. Neurologic involvement included subarachnoid or intraparenchymal hemorrhage or brain abscess. All patients were treated with ciprofloxacin and survived with limited or no neurologic sequelae. B cereus was identified in 7 of 61 environmental samples and 1 of 19 dietary protein samples-these were unrelated to clinical isolates via sequencing. No point source was identified. Ciprofloxacin was added to the empiric antimicrobial regimen for patients with AML and prolonged or recurrent neutropenic fevers; no new cases were identified in the ensuing year. CONCLUSIONS: B cereus is ubiquitous in the hospital environment, at times leading to clusters with unrelated isolates. Fastidious infection control practices addressing a range of possible exposures are warranted, but their efficacy is unknown and they may not be sufficient to prevent all infections. Thus, including B cereus coverage in empiric regimens for patients with AML and persistent neutropenic fever may limit the morbidity of this pathogen. |
Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial
Bayan MH , Smalls T , Boudreau A , Mirza AW , Pasco C , Demko ZO , Rothman RE , Hsieh YH , Eshleman SH , Mostafa HH , Gonzalez-Jimenez N , Chavez PR , Emerson B , Delaney KP , Daugherty D , MacGowan RJ , Manabe YC , Hamill MM . BMC Infect Dis 2023 23 (1) 570 BACKGROUND: Integration of a sensitive point-of-care (POC) HIV viral load (VL) test into screening algorithms may help detect acute HIV infection earlier, identify people with HIV (PWH) who are not virally suppressed, and facilitate earlier referral to antiretroviral therapy (ART), or evaluation for pre-exposure prophylaxis (PrEP). This report describes a randomized clinical trial sponsored by the Centers for Disease Control and Prevention (CDC): "Ending the HIV Epidemic Through Point-of-Care Technologies" (EHPOC). The study's primary aim is to evaluate the use of a POC HIV VL test as part of a testing approach and assess the impact on time to linkage to ART or PrEP. The study will recruit people in Baltimore, Maryland, including patients attending a hospital emergency department, patients attending an infectious disease clinic, and people recruited via community outreach. The secondary aim is to evaluate the performance characteristics of two rapid HIV antibody tests approved by the United States Food and Drug Administration (FDA). METHODS: The study will recruit people 18 years or older who have risk factors for HIV acquisition and are not on PrEP, or PWH who are not taking ART. Participants will be randomly assigned to either the control arm or the intervention arm. Participants randomized to the control arm will only receive the standard-of-care (SOC) HIV screening tests. Intervention arm participants will receive a POC HIV VL test in addition to the SOC HIV diagnostic screening tests. Follow up will consist of an interim phone survey conducted at week-4 and an in-person week-12 visit. Demographic and behavioral information, and oral fluid and blood specimens will be collected at enrollment and at week-12. Survey data will be captured in a Research Electronic Data Capture (REDCap) database. Participants in both arms will be referred for either ART or PrEP based on their HIV test results. DISCUSSION: The EHPOC trial will explore a novel HIV diagnostic technology that can be performed at the POC and provide viral assessment. The study may help inform HIV testing algorithms and contribute to the evidence to support same day ART and PrEP recommendations. TRIAL REGISTRATION: NIH ClinicalTrials.gov NCT04793750. Date: 11 March 2021. |
Determining fitness for use of SEER cause-specific cause of death in analyses of cause-specific survival
Morawski BM , Hsieh MC , Wu M , Sherman R , Mariotto AB , Johnson CJ . J Registry Manag 2022 49 (4) 177-189 BACKGROUND: Net and crude cancer survival statistics can be calculated using cause of death or expected survival from life tables. In some instances, using cause of death information may be advantageous. The Surveillance, Epidemiology, and End Results (SEER) Program cause-specific cause of death variable (North American Association of Central Cancer Registries [NAACCR] item #1914) designates that a patient died of their cancer. We evaluated how miss-ingness in NAACCR item #1914 impacted survival estimates to determine fitness for use in NAACCR Cancer in North America (CiNA) products. METHODS: We used CiNA survival and prevalence data (November 2020 submission) to calculate 60-month cause-specific survival among persons aged 15-99 years at time of diagnosis using NAACCR item #1914. We treated missing/unknown causes of death in 3 ways: excluded from analysis, included as dead from this cancer, or included as censored at time of last follow-up. Autopsy/death-certificate-only cases were excluded from survival analyses. We calculated the proportion of deaths with unknown/missing cause of death by registry and demographic variables. RESULTS: Generally, 60-month cause-specific survival estimates differed by <1% between the 3 approaches when NAACCR item #1914 was missing/unknown for <3% of deaths. When applying a <3% fit-for-use standard to SEER cause-specific cause of death, data from 34 registries were included in cause-specific survival analyses. The proportion of deaths with missing/unknown cause of death varied by primary site, age at diagnosis, race/ethnicity, year of diagnosis, and registry. CONCLUSION: We have identified missingness cut points for NAACCR item #1914, which strike a balance between scientific integrity and registry inclusiveness, to designate data in NAACCR CiNA data products as fit for use in cause-specific survival analyses. |
Remdesivir for the Treatment of Covid-19 - Final Report
Beigel JH , Tomashek KM , Dodd LE , Mehta AK , Zingman BS , Kalil AC , Hohmann E , Chu HY , Luetkemeyer A , Kline S , Lopez de Castilla D , Finberg RW , Dierberg K , Tapson V , Hsieh L , Patterson TF , Paredes R , Sweeney DA , Short WR , Touloumi G , Lye DC , Ohmagari N , Oh MD , Ruiz-Palacios GM , Benfield T , Fätkenheuer G , Kortepeter MG , Atmar RL , Creech CB , Lundgren J , Babiker AG , Pett S , Neaton JD , Burgess TH , Bonnett T , Green M , Makowski M , Osinusi A , Nayak S , Lane HC , ACTT-1 Study Group Members , Uyeki Timothy . N Engl J Med 2020 383 (19) 1813-1826 BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. RESULTS: A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%). CONCLUSIONS: Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.). |
Evaluating the Use of LAST 2-Tiered Nomenclature and Its Impact on Reporting Cervical Lesions in a Population-Based Cancer Registry
Hsieh MC , Van Dyne E , Lefante C , Shapiro JA , Pordell P , Lynch MA , Gomez N , Mumphrey B , Maniscalco L , Jetly-Shridhar R , Saraiya M , Wu XC . J Registry Manag 2019 46 (4) 120-127 BACKGROUND: Since 2012, the Lower Anogenital Squamous Terminology (LAST) Project recommended a 2-tiered nomenclature, low-grade and high-grade squamous intraepithelial lesion (LSIL and HSIL), to replace the 3-tiered cervical intraepithelial neoplasia (CIN) system for HPV-associated lesions. Prior to 2019, preinvasive cervical lesions classified as CIN3, severe dysplasia, carcinoma in situ (CIS), and adenocarcinoma in situ (AIS) were considered reportable to the Louisiana Tumor Registry for a CIN3 project funded by the Centers for Disease Control and Prevention (CDC); but lesions classified exclusively as high-grade/HSIL based on the 2-tiered system were not considered reportable. Due to the terminology changes, we wanted to know whether pre-2019 reportable criteria need to be modified to capture all reportable precancerous cervical cases diagnosed in 2019 forward. OBJECTIVES: To evaluate the utilization of LAST 2-tiered classification, low-grade and high-grade squamous intraepithelial lesion, and p16 immunohistochemistry (IHC) testing on cervical biopsy/surgical specimens, assess the search criteria needed to identify high-grade lesions for the CDC-funded CIN3 project, and assess the impact of underreporting cervical lesions caused by terminology changes. METHODS: An equal number of abnormal/precancerous and normal cervical findings from biopsy pathology reports received in 2015 were randomly selected by an artificial intelligence (AI) search engine developed by Artificial Intelligence in Medicine Inc (AIM) using pre2019 search criteria. Selected pathology reports were reflagged for the reportability by AIM audit software based on 2019 search criteria and manually reviewed for the use of reportable terms including CIN3, severe dysplasia, CIS, AIS, highgrade/HSIL terminology, and CIN2 or CIN2-3 with positive p16 IHC testing. Cohen's kappa statistic was used to assess the agreement between AIM auto-coding and manual review. Positive predictive values (PPV) and sensitivity tests were computed to evaluate the reportable terms. RESULTS: Six out of 9 surveyed laboratories used 2-tiered terminology on cervical biopsy pathology reports and 7 performed p16 IHC tests. Of 1,974 randomly selected reports from 5 laboratories, 987 were flagged as precancer by AI using pre-2019 search criteria. After adding the high-grade/HSIL term into pre-2019 search criteria, precancerous reports increased by 29%. After manual review, 41.6% of these cases were reportable precancerous cervical cases with a PPV of 0.65 (95% CI, 0.62-0.67) and 13.6% had p16 IHC performed. CONCLUSIONS: Both the 2-tiered and 3-tiered nomenclature are needed to ensure complete identification of all reportable high-grade cervical lesions. |
In silico toxicology protocols.
Myatt GJ , Ahlberg E , Akahori Y , Allen D , Amberg A , Anger LT , Aptula A , Auerbach S , Beilke L , Bellion P , Benigni R , Bercu J , Booth ED , Bower D , Brigo A , Burden N , Cammerer Z , Cronin MTD , Cross KP , Custer L , Dettwiler M , Dobo K , Ford KA , Fortin MC , Gad-McDonald SE , Gellatly N , Gervais V , Glover KP , Glowienke S , Van Gompel J , Gutsell S , Hardy B , Harvey JS , Hillegass J , Honma M , Hsieh JH , Hsu CW , Hughes K , Johnson C , Jolly R , Jones D , Kemper R , Kenyon MO , Kim MT , Kruhlak NL , Kulkarni SA , Kümmerer K , Leavitt P , Majer B , Masten S , Miller S , Moser J , Mumtaz M , Muster W , Neilson L , Oprea TI , Patlewicz G , Paulino A , Lo Piparo E , Powley M , Quigley DP , Reddy MV , Richarz AN , Ruiz P , Schilter B , Serafimova R , Simpson W , Stavitskaya L , Stidl R , Suarez-Rodriguez D , Szabo DT , Teasdale A , Trejo-Martin A , Valentin JP , Vuorinen A , Wall BA , Watts P , White AT , Wichard J , Witt KL , Woolley A , Woolley D , Zwickl C , Hasselgren C . Regul Toxicol Pharmacol 2018 96 1-17 The present publication surveys several applications of in silico (i.e., computational) toxicology approaches across different industries and institutions. It highlights the need to develop standardized protocols when conducting toxicity-related predictions. This contribution articulates the information needed for protocols to support in silico predictions for major toxicological endpoints of concern (e.g., genetic toxicity, carcinogenicity, acute toxicity, reproductive toxicity, developmental toxicity) across several industries and regulatory bodies. Such novel in silico toxicology (IST) protocols, when fully developed and implemented, will ensure in silico toxicological assessments are performed and evaluated in a consistent, reproducible, and well-documented manner across industries and regulatory bodies to support wider uptake and acceptance of the approaches. The development of IST protocols is an initiative developed through a collaboration among an international consortium to reflect the state-of-the-art in in silico toxicology for hazard identification and characterization. A general outline for describing the development of such protocols is included and it is based on in silico predictions and/or available experimental data for a defined series of relevant toxicological effects or mechanisms. The publication presents a novel approach for determining the reliability of in silico predictions alongside experimental data. In addition, we discuss how to determine the level of confidence in the assessment based on the relevance and reliability of the information. |
In silico approaches in organ toxicity hazard assessment: current status and future needs in predicting liver toxicity.
Bassan A , Alves VM , Amberg A , Anger LT , Auerbach S , Beilke L , Bender A , Cronin MTD , Cross KP , Hsieh JH , Greene N , Kemper R , Kim MT , Mumtaz M , Noeske T , Pavan M , Pletz J , Russo DP , Sabnis Y , Schaefer M , Szabo DT , Valentin JP , Wichard J , Williams D , Woolley D , Zwickl C , Myatt GJ . Comput Toxicol 2021 20 Hepatotoxicity is one of the most frequently observed adverse effects resulting from exposure to a xenobiotic. For example, in pharmaceutical research and development it is one of the major reasons for drug withdrawals, clinical failures, and discontinuation of drug candidates. The development of faster and cheaper methods to assess hepatotoxicity that are both more sustainable and more informative is critically needed. The biological mechanisms and processes underpinning hepatotoxicity are summarized and experimental approaches to support the prediction of hepatotoxicity are described, including toxicokinetic considerations. The paper describes the increasingly important role of in silico approaches and highlights challenges to the adoption of these methods including the lack of a commonly agreed upon protocol for performing such an assessment and the need for in silico solutions that take dose into consideration. A proposed framework for the integration of in silico and experimental information is provided along with a case study describing how computational methods have been used to successfully respond to a regulatory question concerning non-genotoxic impurities in chemically synthesized pharmaceuticals. |
Cloud-Based Influenza Surveillance System in Emergency Departments Using Molecular-Based Testing: Advances and Challenges.
Shaw-Saliba K , Hansoti B , Burkom H , Martinez DA , DuVal A , Lee B , Chau P , McBride B , Hsieh YH , Sathananthan V , Persing D , Turnlund M , Shively R , Dugas A , Rothman RE . West J Emerg Med 2022 23 (2) 115-123 INTRODUCTION: Electronic influenza surveillance systems aid in health surveillance and clinical decision-making within the emergency department (ED). While major advances have been made in integrating clinical decision-making tools within the electronic health record (EHR), tools for sharing surveillance data are often piecemeal, with the need for data downloads and manual uploads to shared servers, delaying time from data acquisition to end-user. Real-time surveillance can help both clinicians and public health professionals recognize circulating influenza earlier in the season and provide ongoing situational awareness. METHODS: We created a prototype, cloud-based, real-time reporting system in two large, academically affiliated EDs that streamed continuous data on a web-based dashboard within hours of specimen collection during the influenza season. Data included influenza test results (positive or negative) coupled with test date, test instrument geolocation, and basic patient demographics. The system provided immediate reporting to frontline clinicians and to local, state, and federal health department partners. RESULTS: We describe the process, infrastructure requirements, and challenges of developing and implementing the prototype system. Key process-related requirements for system development included merging data from the molecular test (GeneXpert) with the hospitals' EHRs, securing data, authorizing/authenticating users, and providing permissions for data access refining visualizations for end-users. CONCLUSION: In this case study, we effectively integrated multiple data systems at four distinct hospital EDs, relaying data in near real time to hospital-based staff and local and national public health entities, to provide laboratory-confirmed influenza test results during the 2014-2015 influenza season. Future innovations need to focus on integrating the dashboard within the EHR and clinical decision tools. |
Impact of Relative Dose Intensity of FOLFOX Adjuvant Chemotherapy on Risk of Death Among Stage III Colon Cancer Patients
Zhou M , Thompson TD , Lin HY , Chen VW , Karlitz JJ , Fontham ETH , Theall KP , Zhang L , Hsieh MC , Pollack LA , Wu XC . Clin Colorectal Cancer 2021 21 (2) e62-e75 BACKGROUND: The National Comprehensive Cancer Network (NCCN) guidelines have recommended tailored chemotherapy for stage III high-risk (T4 and/or N2) and low-risk (T1-T3 and N1) colon cancer since 2018. Studies have investigated the effect of relative dose intensity (RDI) of FOLFOX on stage III colon cancer survival, however, none has performed a stratified analysis by risk profiles. This study aims to identify the FOLFOX optimal RDI for high-risk and low-risk stage III colon cancer patients. METHODS: Data on 407 eligible patients, diagnosed with stage III colon cancer in 2011 who received FOLFOX, were collected by 8 population-based cancer registries. Multivariable Cox model and Fine-Gray competing risks model were employed to explore Optimal RDI defined as the lowest RDI administered without significant differences in either overall or cause-specific death. RESULTS: Among the 168 high-risk patients, the optimal RDI cut-off was 70% (HR = 1.59 with 95% CI: 0.69-3.66 in overall mortality; HR = 1.24 with 95% CI: 0.42-3.64 in cause-specific mortality when RDI < 70% vs. RDI ≥ 70%). Among the 239 low-risk patients, none of the evaluated cut-offs were associated with significant differences in risk of death between comparison groups. The lowest assessed RDI was 45%, HR = 0.80; 95% CI: 0.24 to 2.73 for overall mortality and HR = 0.53; 95% CI: 0.06 to 4.95 for cause-specific mortality, when RDI <45% versus RDI ≥45%. CONCLUSIONS: There is no significant harm on the risk of death when reducing RDI by <30% for high-risk patients. For the low-risk patients, we found that RDI as low as 45% did not significantly affect the risk of death. |
An evaluation of 6-month versus continuous isoniazid preventive therapy for M. tuberculosis in adults living with HIV/AIDS in Malawi
Hsieh YL , Jahn A , Menzies NA , Yaesoubi R , Salomon JA , Girma B , Gunde L , Eaton JW , Auld A , Odo M , Kiyiika CN , Kalua T , Chiwandira B , Mpunga JU , Mbendra K , Corbett L , Hosseinipour MC , Cohen T , Kunkel A . J Acquir Immune Defic Syndr 2020 85 (5) 643-650 BACKGROUND: To assist the Malawi Ministry of Health to evaluate two competing strategies for scale-up of isoniazid preventive therapy (IPT) among HIV-positive adults receiving ART. SETTING: Malawi. METHODS: We used a multi-district, compartmental model of the Malawi TB/HIV epidemic to compare the anticipated health impacts of 6-month versus continuous IPT programs over a 12-year horizon, while respecting a US$10.8 million constraint on drug costs in the first three years. RESULTS: The 6-month IPT program could be implemented nationwide while the continuous IPT alternative could be introduced in 14 (out of 27) districts. By the end of year 12, the continuous IPT strategy was predicted to avert more TB cases than the 6-month alternative, although not statistically significantly (2368 additional cases averted; 95%PI, -1459, 5023). The 6-month strategy required fewer person-years of IPT to avert a case of TB or death than the continuous strategy. For both programs, the mean reductions in TB incidence among PLHIV by year 12 were expected to be <10%, and the cumulative numbers of IPT-related hepatotoxicity to exceed the number of all-cause deaths averted in the first three years. CONCLUSION: With the given budgetary constraint, nationwide implementation of 6-month IPT would be more efficient and yield comparable health benefits than implementing continuous IPT program in fewer districts. The anticipated health effects associated with both IPT strategies suggested a combination of different TB intervention strategies would likely be required to yield greater impact on TB control in settings like Malawi, where ART coverage is relatively high. |
Enzyme-linked immunosorbent assays using virus-like particles containing mutations of conserved residues on envelope protein can distinguish three flavivirus infections
Tsai WY , Driesse K , Tsai JJ , Hsieh SC , Sznajder Granat R , Jenkins O , Chang GJ , Wang WK . Emerg Microbes Infect 2020 9 (1) 1722-1732 The recent outbreaks of Zika virus (ZIKV) in flavivirus-endemic regions highlight the need for sensitive and specific serological tests. Previously we and others reported key fusion loop (FL) residues and/or BC loop (BCL) residues on dengue virus (DENV) envelope protein recognized by flavivirus cross-reactive human monoclonal antibodies and polyclonal sera. To improve ZIKV serodiagnosis, we employed wild type (WT) and FL or FL/BCL mutant virus-like particles (VLP) of ZIKV, DENV1 and West Nile virus (WNV) in enzyme linked immunosorbent assays (ELISA), and tested convalescent-phase serum or plasma samples from reverse-transcription PCR-confirmed cases with different ZIKV, DENV and WNV infections. For IgG ELISA, ZIKV WT-VLP had a sensitivity of 100% and specificity of 52.9%, which was improved to 83.3% by FL/BCL mutant VLP and 92.2% by the ratio of relative optical density of mutant to WT VLP. Similarly, DENV1 and WNV WT-VLP had a sensitivity/specificity of 100%/70.0% and 100%/56.3%, respectively; the specificity was improved to 93.3% and 83.0% by FL mutant VLP. For IgM ELISA, ZIKV, DENV1 and WNV WT-VLP had a specificity of 96.4%, 92.3% and 91.4%, respectively, for primary infection; the specificity was improved to 93.7-99.3% by FL or FL/BCL mutant VLP. An algorithm based on a combination of mutant and WT-VLP IgG ELISA is proposed to discriminate primary ZIKV, DENV and WNV infections as well as secondary DENV and ZIKV infection with previous DENV infections; this could be a powerful tool to better understand the seroprevalence and pathogenesis of ZIKV in regions where multiple flaviviruses co-circulate. |
High prevalence of hepatitis C infection among adult patients at four urban emergency departments - Birmingham, Oakland, Baltimore, and Boston, 2015-2017
Galbraith JW , Anderson ES , Hsieh YH , Franco RA , Donnelly JP , Rodgers JB , Schechter-Perkins EM , Thompson WW , Nelson NP , Rothman RE , White DAE . MMWR Morb Mortal Wkly Rep 2020 69 (19) 569-574 Identifying persons with hepatitis C virus (HCV) infection has become an urgent public health challenge because of increasing HCV-related morbidity and mortality, low rates of awareness among infected persons, and the advent of curative therapies (1). Since 2012, CDC has recommended testing of all persons born during 1945-1965 (baby boomers) for identification of chronic HCV infection (1); urban emergency departments (EDs) are well positioned venues for detecting HCV infection among these persons. The United States has witnessed an unprecedented opioid overdose epidemic since 2013 that derives primarily from commonly injected illicit opioids (e.g., heroin and fentanyl) (2). This injection drug use behavior has led to an increase in HCV infections among persons who inject drugs and heightened concern about increases in human immunodeficiency virus (HIV) and HCV infection within communities disproportionately affected by the opioid crisis (3,4). However, targeted strategies for identifying HCV infection among persons who inject drugs is challenging (5,6). During 2015-2016, EDs at the University of Alabama at Birmingham; Highland Hospital, Oakland, California; Johns Hopkins Hospital, Baltimore, Maryland; and Boston University Medical Center, Massachusetts, adopted opt-out (i.e., patients can implicitly accept or explicitly decline testing), universal hepatitis C screening for all adult patients. ED staff members offered HCV antibody (anti-HCV) screening to patients who were unaware of their status.* During similar observation periods at each site, ED staff members tested 14,252 patients and identified an overall 9.2% prevalence of positive results for anti-HCV among the adult patient population. Among the 1945-1965 birth cohort, prevalence of positive results for anti-HCV (13.9%) was significantly higher among non-Hispanic blacks (blacks) (16.0%) than among non-Hispanic whites (whites) (12.2%) (p<0.001). Among persons born after 1965, overall prevalence of positive results for anti-HCV was 6.7% and was significantly higher among whites (15.3%) than among blacks (3.2%) (p<0.001). These findings highlight age-associated differences in racial/ethnic prevalences and the potential for ED venues and opt-out, universal testing strategies to improve HCV infection awareness and surveillance for hard-to-reach populations. This opt-out, universal testing approach is supported by new recommendations for hepatitis C screening at least once in a lifetime for all adults aged >/=18 years, except in settings where the prevalence of positive results for HCV infection is <0.1% (7). |
Breast and colorectal cancer recurrence and progression captured by five U.S. population-based registries: Findings from National Program of Cancer Registries patient-centered outcome research
Thompson TD , Pollack LA , Johnson CJ , Wu XC , Rees JR , Hsieh MC , Rycroft R , Culp M , Wilson R , Wu M , Zhang K , Benard V . Cancer Epidemiol 2020 64 101653 OBJECTIVES: Cancer recurrence is a meaningful patient outcome that is not captured in population-based cancer surveillance. This project supported National Program of Cancer Registries central cancer registries in five U.S. states to determine the disease course of all breast and colorectal cancer cases. The aims were to assess the feasibility of capturing disease-free (DF) status and subsequent cancer outcomes and to explore analytic approaches for future studies. METHODS: Data were obtained on 11,769 breast and 6033 colorectal cancer cancers diagnosed in 2011. Registry-trained abstractors reviewed medical records from multiple sources for up to 60 months to determine documented DF status, recurrence, progression and residual disease. We described the occurrence of these patient-centered outcomes along with analytic considerations when determining time-to-event outcomes and recurrence-free survival. RESULTS: Disease-free status was determined on all but 3.8 % of cancer cases. Among 14,458 cases that became DF, 6.1 % of breast and 13.0 % of colorectal cancer cases had a documented recurrence. Recurrence-free survival varied by stage; for stage II-III cancers at 48 months, 83.2 % of female breast and 69.2 % of colorectal cancer patients were alive without recurrence. The ability to distinguish between progression and residual disease among never disease-free patients limited our ability to examine progression as an outcome. CONCLUSIONS: This study demonstrated that population-based registries given intense support and resources can capture recurrence and offer a generalizable picture of cancer outcomes. Further work on refining definitions, sampling strategies, and novel approaches to capture recurrence could advance the ability of a national cancer surveillance system to contribute to patient-centered outcomes research. |
Overview of Centers for Disease Control and Prevention's Case Investigation of Cervical Cancer Study
Benard VB , Greek A , Jackson JE , Senkomago V , Hsieh MC , Crosbie A , Alverson G , Stroup AM , Richardson LC , Thomas CC . J Womens Health (Larchmt) 2019 28 (7) 890-896 Background: Despite advances in cervical cancer screening, a significant number of women in the United States have not received adequate screening. Studies have suggested that approximately half of the women who developed cervical cancer were not adequately screened. The Centers for Disease Control and Prevention (CDC) Case Investigation of Cervical Cancer (CICC) Study took a unique approach to reconstruct the time before a woman's cervical cancer diagnosis and understand the facilitators and barriers to screening and care. This article provides an overview of the study. Methods: This study included all cervical cancer survivors diagnosed with invasive cervical cancer aged 21 years and older in three U.S. states from 2014-2016. The study design consisted of three different data collection methods, including comprehensive registry data, a mailed survey, and medical chart abstraction. This overview compares the characteristics of cervical cancer survivors in the three states by study participation and eligibility status. Results: Registries identified 2,748 women diagnosed with invasive cervical cancer. Of these, 1,730 participants were eligible for participation, 28% (n = 481) enrolled in the study and 23% (n = 400) consented to the medical chart abstraction. Conclusion: The CICC Study is unique in that it addresses, with medical record verification, the medical history of woman 5 years before their cervical cancer diagnosis as well as provides information from the woman on her health care behaviors. This study provides data on a general population of cervical cancer survivors in three states that could be used to guide interventions to increase cervical cancer screening. |
Racial/ethnic differences in the utilization of chemotherapy among stage I-III breast cancer patients, stratified by subtype: Findings from ten National Program of Cancer Registries states
Zhang L , King J , Wu XC , Hsieh MC , Chen VW , Yu Q , Fontham E , Loch M , Pollack LA , Ferguson T . Cancer Epidemiol 2018 58 1-7 BACKGROUND: The study aimed to examine racial/ethnic differences in chemotherapy utilization by breast cancer subtype. METHODS: Data on female non-Hispanic white (NHW), non-Hispanic black (NHB), and Hispanic stage I-III breast cancer patients diagnosed in 2011 were obtained from a project to enhance population-based National Program of Cancer Registry data for Comparative Effectiveness Research. Hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) were used to classify subtypes: HR+/HER2-; HR+/HER2+; HR-/HER2-; and HR-/HER2 + . We used multivariable logistic regression models to examine the association of race/ethnicity with three outcomes: chemotherapy (yes, no), neo-adjuvant chemotherapy (yes, no), and delayed chemotherapy (yes, no). Covariates included patient demographics, tumor characteristics, Charlson Comorbidity Index, other cancer treatment, and participating states/areas. RESULTS: The study included 25,535 patients (72.1% NHW, 13.7% NHB, and 14.2% Hispanics). NHB with HR+/HER2- (adjusted odds ratio [aOR] 1.22, 95% CI 1.04-1.42) and Hispanics with HR-/HER2- (aOR 1.62, 95% CI 1.15-2.28) were more likely to receive chemotherapy than their NHW counterparts. Both NHB and Hispanics were more likely to receive delayed chemotherapy than NHW, and the pattern was consistent across each subtype. No racial/ethnic differences were found in the receipt of neo-adjuvant chemotherapy. CONCLUSIONS: Compared to NHW with the same subtype, NHB with HR+/HER2- and Hispanics with HR-/HER2- have higher odds of using chemotherapy; however, they are more likely to receive delayed chemotherapy, regardless of subtype. Whether the increased chemotherapy use among NHB with HR+/HER2- indicates overtreatment needs further investigation. Interventions to improve the timely chemotherapy among NHB and Hispanics are warranted. |
Young adults' access to insurance through parents: Relationship to receipt of reproductive health services and chlamydia testing, 2007-2014
Loosier PS , Hsieh H , Cramer R , Tao G . J Adolesc Health 2018 63 (5) 575-581 PURPOSE: Adolescents' concerns about confidential service receipt have been linked to avoidance of sexual and reproductive healthcare. Healthcare system changes allowing young adults to remain on a parent's health insurance plan up to age 26 may have extended these concerns to young adults. This study examines: (1) The association between the relationship of young women to primary health plan policy holder (parent or self) on receipt of reproductive health services and chlamydia screening. (2) Changes, over time, in the proportion of young women who are parentally- versus self-insured. METHODS: Cross-sectional analysis of commercially insured young women (18-25) enrolled >/=330 days in health plans included in the Truven Health MarketScan commercial claims and encounters database (2007-2014). RESULTS: Between 2010 and 2014, the proportion of parentally-insured young women increased significantly across all age groups (AOR=4.32, CI=4.29, 4.33). Compared to self-insured young women, parentally-insured young women were less likely to receive a reproductive health service (AOR=.66, CI=.66, .67) and sexually active parentally-insured young women were less likely to receive chlamydia testing (AOR=.75, CI=.75, .76) using their parent's insurance. CONCLUSIONS: Young women who are insured through a parent are less likely to receive reproductive health services or chlamydia testing using their parent's insurance, which could suggest that concerns about confidential receipt of health services may result in missed care. Various policies, including those related to explanation of benefits sent to a plan policy holder outlining services received, may affect the receipt of confidential healthcare by young adults. |
Multi-site evaluation of the LN34 pan-lyssavirus real-time RT-PCR assay for post-mortem rabies diagnostics.
Gigante CM , Dettinger L , Powell JW , Seiders M , Condori REC , Griesser R , Okogi K , Carlos M , Pesko K , Breckenridge M , Simon EMM , Chu Myjv , Davis AD , Brunt SJ , Orciari L , Yager P , Carson WC , Hartloge C , Saliki JT , Sanchez S , Deldari M , Hsieh K , Wadhwa A , Wilkins K , Peredo VY , Rabideau P , Gruhn N , Cadet R , Isloor S , Nath SS , Joseph T , Gao J , Wallace R , Reynolds M , Olson VA , Li Y . PLoS One 2018 13 (5) e0197074 Rabies is a fatal zoonotic disease that requires fast, accurate diagnosis to prevent disease in an exposed individual. The current gold standard for post-mortem diagnosis of human and animal rabies is the direct fluorescent antibody (DFA) test. While the DFA test has proven sensitive and reliable, it requires high quality antibody conjugates, a skilled technician, a fluorescence microscope and diagnostic specimen of sufficient quality. The LN34 pan-lyssavirus real-time RT-PCR assay represents a strong candidate for rabies post-mortem diagnostics due to its ability to detect RNA across the diverse Lyssavirus genus, its high sensitivity, its potential for use with deteriorated tissues, and its simple, easy to implement design. Here, we present data from a multi-site evaluation of the LN34 assay in 14 laboratories. A total of 2,978 samples (1,049 DFA positive) from Africa, the Americas, Asia, Europe, and the Middle East were tested. The LN34 assay exhibited low variability in repeatability and reproducibility studies and was capable of detecting viral RNA in fresh, frozen, archived, deteriorated and formalin-fixed brain tissue. The LN34 assay displayed high diagnostic specificity (99.68%) and sensitivity (99.90%) when compared to the DFA test, and no DFA positive samples were negative by the LN34 assay. The LN34 assay produced definitive findings for 80 samples that were inconclusive or untestable by DFA; 29 were positive. Five samples were inconclusive by the LN34 assay, and only one sample was inconclusive by both tests. Furthermore, use of the LN34 assay led to the identification of one false negative and 11 false positive DFA results. Together, these results demonstrate the reliability and robustness of the LN34 assay and support a role for the LN34 assay in improving rabies diagnostics and surveillance. |
Application of MALDI-TOF MS Systems in the Rapid Identification of Campylobacter spp. of Public Health Importance.
Hsieh YH , Wang YF , Moura H , Miranda N , Simpson S , Gowrishankar R , Barr J , Kerdahi K , Sulaiman IM . J AOAC Int 2017 101 (3) 761-768 Campylobacteriosis is an infectious gastrointestinal disease caused by Campylobacter spp.In most cases, it is either underdiagnosed or underreported due to poor diagnostics and limited databases. Several DNA-based molecular diagnostic techniques, including 16S ribosomal RNA (rRNA) sequence typing, have been widely used in the species identification of Campylobacter. Nevertheless, these assays are time-consuming and require a high quality of bacterial DNA. Matrix-assisted laser desorption ionization (MALDI) time-of-flight (TOF) MS is an emerging diagnostic technology that can provide the rapid identification of microorganisms by using their intact cells without extraction or purification. In this study, we analyzed 24 American Type Culture Collection reference isolates of 16 Campylobacter spp. and five unknown clinical bacterial isolates for rapid identification utilizing two commercially available MADI-TOF MS platforms, namely the bioMérieux VITEK® MS and Bruker Biotyper systems. In addition, 16S rRNA sequencing was performed to confirm the species-level identification of the unknown clinical isolates. Both MALDI-TOF MS systems identified the isolates of C. jejuni, C. coli, C. lari, and C. fetus. The results of this study suggest that the MALDI-TOF MS technique can be used in the identification of Campylobacter spp. of public health importance. |
The Impact of the American College of Obstetricians and Gynecologists Guideline Changes in Pap Tests on Annual Chlamydia Test Rates
Hsieh HL , Huppert J , Patel CG , Tao G . J Adolesc Health 2017 61 (4) 440-445 PURPOSE: To assess impact of the 2009 American College of Obstetricians and Gynecologists (ACOG) Pap guideline changes on chlamydia testing rates among sexually active young women. METHODS: The study included sexually active women aged 15-25 years enrolled in commercial health plans from 2005 to 2014. We identified sexually active women by diagnosis, procedure, and drug codes in inpatient, outpatient, and drug claims databases. We identified Pap tests and chlamydia tests among sexually active adolescents (15-20 years) and young adults (21-25 years) over time. Using piecewise regression models, we compared the change in chlamydia testing rates before and after 2009 ACOG guidelines. RESULTS: From 2005 to 2014, chlamydia testing rates in sexually active women increased from 23% to 37% among adolescents and from 24% to 43% among young adults. Although the overall increase in chlamydia testing was positive, the annual rate of change in chlamydia testing (slope) decreased significantly after the 2009 ACOG guideline change from 1.9% before to 1.0% after for adolescents (p < .05) and from 2.5% to 1.7% for young adults (p < .05). CONCLUSIONS: Although chlamydia test rates are increasing among sexually active women aged 15-25 years from 2005 to 2014, the slower growth in chlamydia testing rate after 2009 may relate to the change in the Pap testing guidelines. Our finding that more than half of sexually active women aged 15-25 years did not have chlamydia testing and that the rate of increased chlamydia testing slowed after 2009 suggests that interventions to improve chlamydia testing apart from combining with Pap testing are still needed. |
Capture and coding of industry and occupation measures: Findings from eight National Program of Cancer Registries states
Freeman MB , Pollack LA , Rees JR , Johnson CJ , Rycroft RK , Rousseau DL , Hsieh MC . Am J Ind Med 2017 60 (8) 689-695 BACKGROUND: Although data on industry and occupation (I&O) are important for understanding cancer risks, obtaining standardized data is challenging. This study describes the capture of specific I&O text and the ability of a web-based tool to translate text into standardized codes. METHODS: Data on 62 525 cancers cases received from eight National Program of Cancer Registries (NPCR) states were submitted to a web-based coding tool developed by the National Institute for Occupational Safety and Health for translation into standardized I&O codes. We determined the percentage of sufficiently analyzable codes generated by the tool. RESULTS: Using the web-based coding tool on data obtained from chart abstraction, the NPCR cancer registries achieved between 48% and 75% autocoding, but only 12-57% sufficiently analyzable codes. CONCLUSIONS: The ability to explore associations between work-related exposures and cancer is limited by current capture and coding of I&O data. Increased training of providers and registrars, as well as software enhancements, will improve the utility of I&O data. |
Outbreak of non-tuberculous mycobacteria skin or soft tissue infections associated with handling fish - New York City, 2013-2014
Yacisin K , Hsieh JL , Weiss D , Ackelsberg J , Lee E , Jones L , Leung YL , Li L , Yung J , Slavinski S , Hanson H , Ridpath A , Kornblum J , Lin Y , Robbe-Austerman S , Rakeman J , Siemetzki-Kapoor U , Stuber T , Greene SK . Epidemiol Infect 2017 145 (11) 1-11 Mycobacterium marinum, a bacterium found in freshwater and saltwater, can infect persons with direct exposure to fish or aquariums. During December 2013, the New York City Department of Health and Mental Hygiene learned of four suspected or confirmed M. marinum skin or soft tissue infections (SSTIs) among persons who purchased whole fish from Chinese markets. Ninety-eight case-patients with non-tuberculous mycobacteria (NTM) SSTIs were identified with onset June 2013-March 2014. Of these, 77 (79%) were female. The median age was 62 years (range 30-91). Whole genome sequencing of clinical isolates revealed two main clusters and marked genetic diversity. Environmental samples from distributors yielded NTM though not M. marinum. We compared 56 case-patients with 185 control subjects who shopped in Chinese markets, frequency-matched by age group and sex. Risk factors for infection included skin injury to the finger or hand (odds ratio [OR]: 15.5; 95% confidence interval [CI]: 6.9-37.3), hand injury while preparing fish or seafood (OR 8.3; 95% CI 3.8-19.1), and purchasing tilapia (OR 3.6; 95% CI 1.1-13.9) or whiting (OR 2.7; 95% CI 1.1-6.6). A definitive environmental outbreak source was not identified. |
KRAS testing and first-line treatment among patients diagnosed with metastatic colorectal cancer using population data from ten National Program of Cancer Registries in the United States
Rico A , Pollack LA , Thompson TD , Hsieh MC , Wu XC , Karlitz JJ , West DW , Rainey JM , Chen VW . J Cancer Res Ther (Manch) 2016 5 (2) 7-13 BACKGROUND: In 2011, the National Comprehensive Cancer Network (NCCN) recommended KRAS testing for metastatic colorectal cancer (mCRC) patients. Our study assessed KRAS testing prevalence and its association with socio-demographic and clinical factors and examined first-line treatment. METHODS: Ten state population-based registries supported by Centers for Disease Control and Prevention's (CDC) National Program of Cancer Registries (NPCR) collected detailed cancer information on mCRC cases diagnosed in 2011, including KRAS biomarker testing and first-line treatment from ten central cancer registries. Data were analyzed with Chi-square tests and multivariate logistic regression. RESULTS: Of the 3,608 mCRC cases, 27% (n = 992) had a documented KRAS test. Increased age at diagnosis (p < 0.0001), racial/ethnic minorities (p = 0.0155), public insurance (p = 0.0018), and lower census tract education (p = 0.0023) were associated with less KRAS testing. Significant geographic variation in KRAS testing (p < 0.0001) ranged from 46% in New Hampshire to 18% in California. After adjusting for all covariates, age and residence at diagnosis (both p < 0.0001) remained predictors of KRAS testing. Non-Hispanic Blacks had less KRAS testing than non-Hispanic Whites (OR = 0.77, 95% CI = 0.61-0.97). Among those tested and found to have normal (wild-type) KRAS, 7% received anti-EGFR treatment; none received such treatment among those with KRAS mutated gene. CONCLUSIONS: Despite NCCN guideline recommendations, 73% of mCRC cases diagnosed in 2011 had no documented KRAS test. Disparities in KRAS testing existed based on age, race, and residence at diagnosis. IMPACT: These findings show the capacity of monitoring KRAS testing in the US using cancer registry data and suggest the need to understand the low uptake of KRAS testing, and associated treatment choices during the first year since diagnosis. |
The effect of comorbidity on the use of adjuvant chemotherapy and type of regimen for curatively resected stage III colon cancer patients
Hsieh MC , Thompson T , Wu XC , Styles T , O'Flarity MB , Morris CR , Chen VW . Cancer Med 2016 5 (5) 871-80 Postsurgical chemotherapy is guideline-recommended therapy for stage III colon cancer patients. Factors associated with patients not receiving adjuvant chemotherapy were identified in numerous studies; comorbidity was recognized as an important factor besides patient's age. We assessed the association between comorbidity and the use of adjuvant chemotherapy and type of chemotherapy regimen. Stage III colon cancer patients who underwent surgical resection were obtained from ten Centers for Disease Control and Prevention (CDC)-NPCR Specialized Registries which participated in the Comparative Effectiveness Research (CER) project. Comorbidity was classified into no comorbidity recorded, Charlson, non-Charlson comorbidities, number, and severity of Charlson comorbidity. Pearson chi-square test and multivariable logistic regression were employed. Of 3180 resected stage III colon cancer patients, 64% received adjuvant chemotherapy. After adjusting for patient's demographic and tumor characteristics, there were no significant differences in receipt of chemotherapy between Charlson and non-Charlson comorbidity. However, patients who had two or more Charlson comorbidities or had moderate to severe disease were significantly less likely to have chemotherapy (ORs 0.69 [95% CI, 0.51-0.92] and 0.62 [95% CI, 0.42-0.91], respectively) when compared with those with non-Charlson comorbidity. In addition, those with moderate or severe comorbidities were more likely to receive single chemotherapy agent (P < 0.0001). Capecitabine and FOLFOX were the most common single- and multi-agent regimens regardless of type of comorbidity grouping. Both the number and severity of comorbidity were significantly associated with receipt of guideline-recommended chemotherapy and type of agent in stage III resected colon cancer patients. Better personalized care based on individual patient's condition ought to be recognized. |
Epidemiologic Investigation of a Cluster of Neuroinvasive Bacillus cereus Infections in 5 Patients With Acute Myelogenous Leukemia.
Rhee C , Klompas M , Tamburini FB , Fremin BJ , Chea N , Epstein L , Halpin AL , Guh A , Gallen R , Coulliette A , Gee J , Hsieh C , Desjardins CA , Pedamullu CS , DeAngelo DJ , Manzo VE , Folkerth RD , Milner DA Jr , Pecora N , Osborne M , Chalifoux-Judge D , Bhatt AS , Yokoe DS . Open Forum Infect Dis 2015 2 (3) ofv096 BACKGROUND: Five neuroinvasive Bacillus cereus infections (4 fatal) occurred in hospitalized patients with acute myelogenous leukemia (AML) during a 9-month period, prompting an investigation by infection control and public health officials. METHODS: Medical records of case-patients were reviewed and a matched case-control study was performed. Infection control practices were observed. Multiple environmental, food, and medication samples common to AML patients were cultured. Multilocus sequence typing was performed for case and environmental B cereus isolates. RESULTS: All 5 case-patients received chemotherapy and had early-onset neutropenic fevers that resolved with empiric antibiotics. Fever recurred at a median of 17 days (range, 9-20) with headaches and abrupt neurological deterioration. Case-patients had B cereus identified in central nervous system (CNS) samples by (1) polymerase chain reaction or culture or (2) bacilli seen on CNS pathology stains with high-grade B cereus bacteremia. Two case-patients also had colonic ulcers with abundant bacilli on autopsy. No infection control breaches were observed. On case-control analysis, bananas were the only significant exposure shared by all 5 case-patients (odds ratio, 9.3; P = .04). Five environmental or food isolates tested positive for B cereus, including a homogenized banana peel isolate and the shelf of a kitchen cart where bananas were stored. Multilocus sequence typing confirmed that all case and environmental strains were genetically distinct. Multilocus sequence typing-based phylogenetic analysis revealed that the organisms clustered in 2 separate clades. CONCLUSIONS: The investigation of this neuroinvasive B cereus cluster did not identify a single point source but was suggestive of a possible dietary exposure. Our experience underscores the potential virulence of B cereus in immunocompromised hosts. |
Epidemiology and molecular characteristics of norovirus GII.4 Sydney outbreaks in Taiwan, January 2012-December 2013.
Wu FT , Chen HC , Yen C , Wu CY , Katayama K , Park Y , Hall AJ , Vinje J , Huang JC , Wu HS . J Med Virol 2015 87 (9) 1462-70 In 2012, a new norovirus GII.4 variant (GII.4 Sydney) emerged and caused the majority of the acute gastroenteritis outbreaks in Australia, Asia, Europe, and North America. We examined the epidemiologic and molecular virologic characteristics of reported acute gastroenteritis outbreaks determined to be caused by norovirus in Taiwan from January 2012 to December 2013. A total of 253 (45.7%) of 552 reported acute gastroenteritis outbreaks tested positive for norovirus, of which 165 (65.5%) were typed as GII.4 Sydney. GII.4 Sydney outbreaks were reported from all geographic areas of Taiwan and occurred most frequently in schools (35.8%) and long-term care facilities (24.2%). Person-to-person transmission was identified in 116 (70.3%) of the outbreaks. Phylogenetic analyses of full-length ORF2 of eight specimens indicated that GII.4 Sydney strains detected in Taiwan were closely related to strains detected globally. Continued outbreak surveillance and strain typing are needed to provide information on epidemiologic and virologic trends of novel norovirus strains. |
Clinical and prognostic factors for renal parenchymal, pelvis, and ureter cancers in SEER registries: Collaborative Stage Data Collection System, version 2
Altekruse SF , Dickie L , Wu XC , Hsieh MC , Wu M , Lee R , Delacroix S Jr . Cancer 2014 120 Suppl 23 3826-35 BACKGROUND: The American Joint Committee on Cancer's (AJCC) 7th edition cancer staging manual reflects recent changes in cancer care practices. This report assesses changes from the AJCC 6th to the AJCC 7th edition stage distributions and the quality of site-specific factors (SSFs). METHODS: Incidence data for renal parenchyma and pelvis and ureter cancers from 18 Surveillance, Epidemiology, and End Results (SEER) registries were examined, including staging trends during 2004-2010, stage distribution changes between the AJCC 6th and 7th editions, and SSF completeness for cases diagnosed in 2010. RESULTS: From 2004 to 2010, the percentage of stage I renal parenchyma cancers increased from 50% to 58%, whereas stage IV and unknown stage cases decreased (18% to 15%, and 10% to 6%, respectively). During this period, the percentage of stage 0a renal pelvis and ureter cancers increased from 21% to 25%, and stage IV and unknown stage tumors decreased (20% to 18%, and 7% to 5%, respectively). Stage distributions under the AJCC 6th and 7th editions were about the same. For renal parenchymal cancers, 71%-90% of cases had known values for 6 required SSFs. For renal pelvis and ureter cancers, 74% of cases were coded as known for SSF1 (WHO/ISUP grade) and 47% as known for SSF2 (depth of renal parenchymal invasion). SSF values were known for larger proportions of cases with reported resections. CONCLUSIONS: Stage distributions between the AJCC 6th and 7th editions were similar. SSFs were known for more than two-thirds of cases, providing more detail in the SEER database relevant to prognosis. |
Molecular epidemiology of human G2P[4] rotaviruses in Taiwan, 2004-2011.
Wu FT , Banyai K , Jiang B , Wu CY , Chen HC , Feher E , Huang YC , Hsiung CA , Huang JC , Wu HS . Infect Genet Evol 2014 28 530-6 In 2006, two rotavirus vaccines (Rotarix and RotaTeq) became available on the private market in Taiwan. Although vaccine coverage is currently low, molecular surveillance of rotavirus strains can provide pertinent information for evaluation of the potential impact of vaccine introduction and infection control. During January 2008-December 2011, children aged <5years hospitalized with acute gastroenteritis were enrolled from sentinel surveillance hospitals in three geographic areas of Taiwan. Fecal specimens collected from enrolled patients were tested for rotavirus by enzyme immunoassay and reverse transcriptase-polymerase chain reaction. For genotyping, gene specific primer sets were used to amplify and sequence the genes encoding the neutralization antigens, VP7 and VP4. The resulting sequences were then subjected to phylogenetic analysis. In brief, a total of 4052 fecal specimens were tested and 742 (18%) samples were positive for rotavirus. The annual range of rotavirus positive specimens varied between 16% and 20.7%. Of all specimens, genotype G1P[8] (63.3%) was the predominant strain, followed by G2P[4] (12.5%), G3P[8] (11.7%), and G9P[8] (5.1%). Uncommon strains were also detected in low percentages. We observed that the rotavirus positivity rate steadily decreased from 21% to 16% during 2008-2010, then slightly increased to 20% in 2011, when an increase in the number of G2P[4] cases was observed. Sequence and phylogenetic analysis was carried out to help understand any potential changes of G2P[4] rotaviruses over time. A number of G2P[4] strains collected between 2004 and 2011 were analyzed in detail and our analyses showed marked genetic and antigenic variability in the VP7 and VP4 genes. The Taiwanese strains could be classified into two major G2 VP7 lineages (IV and V) and two major P[4] VP4 lineages (IV and V) and several minor sublineages within lineage IV. Lineage V within both G2 and P[4] represented newly recognized genetic variants of the respective genotypes. The distribution of individual combinations of the G2 and P[4] (sub)lineages showed some temporal variations. This study provides further evidence for the great genetic diversity among G2P[4] strains and helps understand the epidemiological trends of these strains among children in Taiwan. |
Monitoring seasonal influenza A evolution: rapid 2009 pandemic H1N1 surveillance with an reverse transcription-polymerase chain reaction/electro-spray ionization mass spectrometry assay
Jeng K , Massire C , Zembower TR , Deyde VM , Gubareva LV , Hsieh YH , Rothman RE , Sampath R , Penugonda S , Metzgar D , Blyn LB , Hardick J , Gaydos CA . J Clin Virol 2012 54 (4) 332-6 BACKGROUND: The emergence of the pandemic H1N1 influenza strain in 2009 reinforced the need for improved influenza surveillance efforts. A previously described influenza typing assay that utilizes RT-PCR coupled to electro-spray ionization mass spectrometry (ESI-MS) played an early role in the discovery of the pandemic H1N1 influenza strain, and has potential application for monitoring viral genetic diversity in ongoing influenza surveillance efforts. OBJECTIVES: To determine the analytical sensitivity of RT-PCR/ESI-MS influenza typing assay for identifying the pandemic H1N1 strain and describe its ability to assess viral genetic diversity. STUDY DESIGN: Two sets of pandemic H1N1 samples, 190 collected between April and June of 2009, and 69 collected between October 2009 and January 2010, were processed by the RT-PCR/ESI-MS influenza typing assay, and the spectral results were compared to reference laboratory results and historical sequencing data from the Nucleotide Database of the National Center for Biotechnology Information (NCBI). RESULTS: Strain typing concordance with reference standard testing was 100% in both sample sets, and the assay demonstrated a significant increase in influenza genetic diversity, from 10.5% non-wildtype genotypes in early samples to 69.9% in late samples (P<0.001). An NCBI search demonstrated a similar increase, from 13.4% to 45.2% (P<0.001). CONCLUSIONS: This comparison of early versus late influenza samples analyzed by RT-PCR/ESI-MS demonstrates the influenza typing assay's ability as a universal influenza detection platform to provide high-fidelity pH1N1 strain identification over time, despite increasing genetic diversity in the circulating virus. The genotyping data can also be leveraged for high-throughput influenza surveillance. |
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