Incidence and Secondary Transmission of SARS-Cov-2 Infections in Schools
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FDA Oncology Experience in Innovative Adaptive Trial Designs
Innovative Adaptive Trial Designs Rajeshwari Sridhara, Ph.D. Director, Division of Biometrics V Office of Biostatistics, CDER, FDA 9/3/2015 Sridhara - Ovarian cancer workshop 1 Fixed Sample Designs • Patient population, disease assessments, treatment, sample size, hypothesis to be tested, primary outcome measure - all fixed • No change in the design features during the study Adaptive Designs • A study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (interim data) from subjects in the study 9/3/2015 Sridhara - Ovarian cancer workshop 2 Bayesian Designs • In the Bayesian paradigm, the parameter measuring treatment effect is regarded as a random variable • Bayesian inference is based on the posterior distribution (Bayes’ Rule – updated based on observed data) – Outcome adaptive • By definition adaptive design 9/3/2015 Sridhara - Ovarian cancer workshop 3 Adaptive Designs (Frequentist or Bayesian) • Allows for planned design modifications • Modifications based on data accrued in the trial up to the interim time • Unblinded or blinded interim results • Control probability of false positive rate for multiple options • Control operational bias • Assumes independent increments of information 9/3/2015 Sridhara - Ovarian cancer workshop 4 Enrichment Designs – Prognostic or Predictive • Untargeted or All comers design: – post-hoc enrichment, prospective-retrospective designs – Marker evaluation after randomization (example: KRAS in cetuximab -
FORMULAS from EPIDEMIOLOGY KEPT SIMPLE (3E) Chapter 3: Epidemiologic Measures
FORMULAS FROM EPIDEMIOLOGY KEPT SIMPLE (3e) Chapter 3: Epidemiologic Measures Basic epidemiologic measures used to quantify: • frequency of occurrence • the effect of an exposure • the potential impact of an intervention. Epidemiologic Measures Measures of disease Measures of Measures of potential frequency association impact (“Measures of Effect”) Incidence Prevalence Absolute measures of Relative measures of Attributable Fraction Attributable Fraction effect effect in exposed cases in the Population Incidence proportion Incidence rate Risk difference Risk Ratio (Cumulative (incidence density, (Incidence proportion (Incidence Incidence, Incidence hazard rate, person- difference) Proportion Ratio) Risk) time rate) Incidence odds Rate Difference Rate Ratio (Incidence density (Incidence density difference) ratio) Prevalence Odds Ratio Difference Macintosh HD:Users:buddygerstman:Dropbox:eks:formula_sheet.doc Page 1 of 7 3.1 Measures of Disease Frequency No. of onsets Incidence Proportion = No. at risk at beginning of follow-up • Also called risk, average risk, and cumulative incidence. • Can be measured in cohorts (closed populations) only. • Requires follow-up of individuals. No. of onsets Incidence Rate = ∑person-time • Also called incidence density and average hazard. • When disease is rare (incidence proportion < 5%), incidence rate ≈ incidence proportion. • In cohorts (closed populations), it is best to sum individual person-time longitudinally. It can also be estimated as Σperson-time ≈ (average population size) × (duration of follow-up). Actuarial adjustments may be needed when the disease outcome is not rare. • In an open populations, Σperson-time ≈ (average population size) × (duration of follow-up). Examples of incidence rates in open populations include: births Crude birth rate (per m) = × m mid-year population size deaths Crude mortality rate (per m) = × m mid-year population size deaths < 1 year of age Infant mortality rate (per m) = × m live births No. -
The Status of Women in the Charlotte Metropolitan Area, North Carolina
IWPR #R362 January 2013 The Status of Women in the Charlotte Metropolitan Area, North Carolina Women in the Charlotte metropolitan area,i and in North Carolina as a whole, have made much progress during the last few decades. The majority of women work—many in professional jobs—and women are essential to the economic health of their communities. Yet, there are some ways in which women’s status still lags behind men’s, and not all women are prospering equally. This briefing paper provides basic information about the status of women the Charlotte area, focusing on women’s earnings and workforce participation, level of education, poverty, access to child care, and health status. It also provides background demographic information about women in the region. Basic Facts About Women in the Charlotte Area The Charlotte metropolitan statistical area—defined here to include Cabarrus, Gaston, Lincoln, Mecklenburg, Rowan, and Union counties—has a relatively diverse population of women and girls. Thirty-eight percent are from a minority racial or ethnic group, which is a slightly higher share than in the state as a whole (35 percent; Figure 1 and Table 1). The Charlotte area also has a larger share of foreign- born women and girls than in the state overall due to rapid growth in its immigrant population in recent years (Smith and Furuseth 2008). One in ten women and girls in this area is an immigrant, compared with seven percent of women and girls in North Carolina as a whole (Table 1). Figure 1. Distribution of Women and Girls by Race and Ethnicity in the Charlotte Metropolitan Area, All Ages, 2008–2010 3% 0.3% 2% 9% White Black Hispanic 23% Asian Ameican 62% American Indian Other Notes: Racial categories are exclusive: white, not Hispanic; black, not Hispanic; Asian American, not Hispanic; American Indian, not Hispanic; and other, not Hispanic. -
Estimated HIV Incidence and Prevalence in the United States
Volume 26, Number 1 Estimated HIV Incidence and Prevalence in the United States, 2015–2019 This issue of the HIV Surveillance Supplemental Report is published by the Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, Georgia. Estimates are presented for the incidence and prevalence of HIV infection among adults and adolescents (aged 13 years and older) based on data reported to CDC through December 2020. The HIV Surveillance Supplemental Report is not copyrighted and may be used and reproduced without permission. Citation of the source is, however, appreciated. Suggested citation Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2015–2019. HIV Surveillance Supplemental Report 2021;26(No. 1). http://www.cdc.gov/ hiv/library/reports/hiv-surveillance.html. Published May 2021. Accessed [date]. On the Web: http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html Confidential information, referrals, and educational material on HIV infection CDC-INFO 1-800-232-4636 (in English, en Español) 1-888-232-6348 (TTY) http://wwwn.cdc.gov/dcs/ContactUs/Form Acknowledgments Publication of this report was made possible by the contributions of the state and territorial health departments and the HIV surveillance programs that provided surveillance data to CDC. This report was prepared by the following staff and contractors of the Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC: Laurie Linley, Anna Satcher Johnson, Ruiguang Song, Sherry Hu, Baohua Wu, H. -
Understanding Relative Risk, Odds Ratio, and Related Terms: As Simple As It Can Get Chittaranjan Andrade, MD
Understanding Relative Risk, Odds Ratio, and Related Terms: As Simple as It Can Get Chittaranjan Andrade, MD Each month in his online Introduction column, Dr Andrade Many research papers present findings as odds ratios (ORs) and considers theoretical and relative risks (RRs) as measures of effect size for categorical outcomes. practical ideas in clinical Whereas these and related terms have been well explained in many psychopharmacology articles,1–5 this article presents a version, with examples, that is meant with a view to update the knowledge and skills to be both simple and practical. Readers may note that the explanations of medical practitioners and examples provided apply mostly to randomized controlled trials who treat patients with (RCTs), cohort studies, and case-control studies. Nevertheless, similar psychiatric conditions. principles operate when these concepts are applied in epidemiologic Department of Psychopharmacology, National Institute research. Whereas the terms may be applied slightly differently in of Mental Health and Neurosciences, Bangalore, India different explanatory texts, the general principles are the same. ([email protected]). ABSTRACT Clinical Situation Risk, and related measures of effect size (for Consider a hypothetical RCT in which 76 depressed patients were categorical outcomes) such as relative risks and randomly assigned to receive either venlafaxine (n = 40) or placebo odds ratios, are frequently presented in research (n = 36) for 8 weeks. During the trial, new-onset sexual dysfunction articles. Not all readers know how these statistics was identified in 8 patients treated with venlafaxine and in 3 patients are derived and interpreted, nor are all readers treated with placebo. These results are presented in Table 1. -
Disease Incidence, Prevalence and Disability
Part 3 Disease incidence, prevalence and disability 9. How many people become sick each year? 28 10. Cancer incidence by site and region 29 11. How many people are sick at any given time? 31 12. Prevalence of moderate and severe disability 31 13. Leading causes of years lost due to disability in 2004 36 World Health Organization 9. How many people become sick each such as diarrhoeal disease or malaria, it is common year? for individuals to be infected repeatedly and have several episodes. For such conditions, the number The “incidence” of a condition is the number of new given in the table is the number of disease episodes, cases in a period of time – usually one year (Table 5). rather than the number of individuals affected. For most conditions in this table, the figure given is It is important to remember that the incidence of the number of individuals who developed the illness a disease or condition measures how many people or problem in 2004. However, for some conditions, are affected by it for the first time over a period of Table 5: Incidence (millions) of selected conditions by WHO region, 2004 Eastern The Mediter- South- Western World Africa Americas ranean Europe East Asia Pacific Tuberculosisa 7.8 1.4 0.4 0.6 0.6 2.8 2.1 HIV infectiona 2.8 1.9 0.2 0.1 0.2 0.2 0.1 Diarrhoeal diseaseb 4 620.4 912.9 543.1 424.9 207.1 1 276.5 1 255.9 Pertussisb 18.4 5.2 1.2 1.6 0.7 7.5 2.1 Measlesa 27.1 5.3 0.0e 1.0 0.2 17.4 3.3 Tetanusa 0.3 0.1 0.0 0.1 0.0 0.1 0.0 Meningitisb 0.7 0.3 0.1 0.1 0.0 0.2 0.1 Malariab 241.3 203.9 2.9 8.6 0.0 23.3 2.7 -
Incidence Density Sampling for Nested Case-Control Study Designs
Paper AS09 Incidence Density Sampling for Nested Case-Control Study Designs Quratul Ann, IQVIA, London, United Kingdom Rachel Tham, IQVIA, London, United Kingdom ABSTRACT The nested case-control design is commonly used in safety studies, as it is an efficient approach to an epidemiological investigation. When the design is implemented appropriately, it can yield unbiased estimates of relative risk; and in exchange for a small loss in precision, considerable improved efficiency and reduction in costs can be achieved. There are several ways of sampling controls to cases in a nested case-control design. The most sophisticated way is via incidence density sampling. Incidence density sampling matches cases to controls based on the dynamic risk set at the time of case occurrence, where the probability of control selection is proportional to the total person-time at risk. Incidence density sampling alleviates the rare disease assumption; however, it is rarely used due to its computational complexity. This paper presents a novel and simple Statistical Analysis System (SAS) program for incidence density sampling, which could minimise bias and introduce a more appropriate way of optimising the matching of controls to cases. INTRODUCTION Retrospective studies gather available previous exposure information for a clearly defined source population and the outcome event is determined for all members of the cohort4. Retrospective studies facilitate an efficient approach to draw inferences and determine the association between exposure and disease prevalence particularly for rare outcomes and with long-term disease conditions. Real-world data (RWD) are a valuable source of information for investigating health-related outcomes in human populations. -
North Carolina/Virginia Boundary Update
How did North Carolina get its shape? • NC Boundary Commission recommends that we start work on the NC-VA boundary How did North Carolina get its shape? • North Carolina/Virginia boundary – Charter of 1665 by King Charles “All that province, territory, or tract of land, scituate [situate], lying or being within our dominions of America aforesaid; extending north and eastward, as far as the north end of Currituck River, or inlet, upon a strait [straight] westerly line to Wyonoak Creek, which lies within or about the degrees of thirty-six and thirty minutes, northern latitude; and so west in a direct line as far as the South Seas [Pacific Ocean].” I like the part about North Carolina extending to the Pacific Ocean. Unfortunately, Tennessee eventually becomes a state and gets in the way, but that is another story. How did North Carolina get its shape? • North Carolina/Virginia boundary – Charter of 1665 by King Charles “All that province, territory, or tract of land, scituate [situate], lying or being within our dominions of America aforesaid; extending north and eastward, as far as the north end of Currituck River, or inlet, upon a strait [straight] westerly line to Wyonoak Creek, which lies within or about the degrees of thirty-six and thirty minutes, northern latitude; and so west in a direct line as far as the South Seas [Pacific Ocean].” I like the part about North Carolina extending to the Pacific Ocean. Unfortunately, Tennessee eventually becomes a state and gets in the way, but that is another story. How did North Carolina get its -
Incidence, Risk, and Case Fatality of First Ever Stroke in the Elderly Population
J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp.74.3.317 on 1 March 2003. Downloaded from 317 PAPER Incidence, risk, and case fatality of first ever stroke in the elderly population. The Rotterdam Study M Hollander, P J Koudstaal, M L Bots, D E Grobbee, A Hofman,MMBBreteler ............................................................................................................................. J Neurol Neurosurg Psychiatry 2003;74:317–321 See end of article for authors’ affiliations ....................... Objective: To estimate the incidence, survival, and lifetime risk of stroke in the elderly population. Methods: The authors conducted a study in 7721 participants from the population based Rotterdam Correspondence to: Dr M M.B. Breteler, Study who were free from stroke at baseline (1990–1993) and were followed up for stroke until Department of 1 January 1999. Age and sex specific incidence, case fatality rates, and lifetime risks of stroke were Epidemiology and calculated. Biostatistics, Erasmus Results: Mean follow up was 6.0 years and 432 strokes occurred. The incidence rate of stroke per Medical Centre Rotterdam, 1000 person years increased with age and ranged from 1.7 (95% CI 0.4 to 6.6) in men aged 55 to PO Box 1738, 3000 DR Rotterdam, Netherlands; 59 years to 69.8 (95% CI 22.5 to 216.6) in men aged 95 years or over. Corresponding figures for [email protected] women were 1.2 (95% CI 0.3 to 4.7) and 33.1 (95% CI 17.8 to 61.6). Men and women had similar absolute lifetime risks of stroke (21% for those aged 55 years). The survival after stroke did not differ Received 17 April 2002 Accepted in revised form according to sex. -
EPI Case Study 1 Incidence, Prevalence, and Disease
EPIDEMIOLOGY CASE STUDY 1: Incidence, Prevalence, and Disease Surveillance; Historical Trends in the Epidemiology of M. tuberculosis STUDENT VERSION 1.0 EPI Case Study 1: Incidence, Prevalence, and Disease Surveillance; Historical Trends in the Epidemiology of M. tuberculosis Estimated Time to Complete Exercise: 30 minutes LEARNING OBJECTIVES At the completion of this Case Study, participants should be able to: ¾ Explain why denominators are necessary when comparing changes in morbidity and mortality over time ¾ Distinguish between incidence rates and prevalence ratios ¾ Calculate and interpret cause-specific morbidity and mortality rates ¾ Describe how changes in mortality or morbidity could be due to an artifact rather than a real change ASPH EPIDEMIOLOGY COMPETENCIES ADDRESSED C. 3. Describe a public health problem in terms of magnitude, person, place, and time C. 6. Apply the basic terminology and definitions of epidemiology C. 7. Calculate basic epidemiology measures C. 9. Draw appropriate inference from epidemiologic data C. 10. Evaluate the strengths and limitations of epidemiologic reports ASPH INTERDISCIPLINARY/CROSS-CUTTING COMPETENCIES ADDRESSED F.1. [Communication and Informatics] Describe how the public health information infrastructure is used to collect, process, maintain, and disseminate data J.1. [Professionalism] Discuss sentinel events in the history and development of the public health profession and their relevance for practice in the field L.2. [Systems Thinking] Identify unintended consequences produced by changes made to a public health system This material was developed by the staff at the Global Tuberculosis Institute (GTBI), one of four Regional Training and Medical Consultation Centers funded by the Centers for Disease Control and Prevention. It is published for learning purposes only. -
Alabama V. North Carolina
No. 132, Original In the Supreme Court of the United States STATE OF ALABAMA, ET AL., PLAINTIFFS v. STATE OF NORTH CAROLINA ON EXCEPTIONS TO THE PRELIMINARY AND SECOND REPORTS OF THE SPECIAL MASTER BRIEF FOR THE UNITED STATES AS AMICUS CURIAE ELENA KAGAN Solicitor General Counsel of Record JOHN C. CRUDEN Acting Assistant Attorney General EDWIN S. KNEEDLER Deputy Solicitor General TOBY J. HEYTENS Assistant to the Solicitor General CHARLES FINDLAY BARCLAY T. SAMFORD Attorneys Department of Justice Washington, D.C. 20530-0001 (202) 514-2217 QUESTIONS PRESENTED The United States will address the following ques- tions: 1. Whether sovereign immunity principles require the dismissal of the Southeast Low-Level Radioactive Waste Management Commission (Commission) as a plaintiff in this original action brought jointly by the Commission and four States against the State of North Carolina. 2. Whether the Southeast Low-Level Radioactive Waste Management Compact (Compact) authorizes the Com- mission to impose monetary sanctions against North Carolina in response to North Carolina’s alleged breach of its obligations under the Compact. (I) TABLE OF CONTENTS Page Interest of the United States............................ 1 Statement............................................ 2 Summary of Argument................................. 7 Argument: I. The Court should deny North Carolina’s motion to dismiss the Commission based on North Carolina’s sovereign immunity ............................... 9 A. A non-State party may participate in a suit that is properly instituted under this Court’s original jurisdiction so long as it does not bring new claims against a defendant State............ 10 B. The Commission is not seeking to “bring new claims” against North Carolina................. 16 C. -
ALABAMA V. NORTH CAROLINA
(Slip Opinion) OCTOBER TERM, 2009 1 Syllabus NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337. SUPREME COURT OF THE UNITED STATES Syllabus ALABAMA ET AL. v. NORTH CAROLINA ON EXCEPTIONS TO THE PRELIMINARY AND SECOND REPORTS OF THE SPECIAL MASTER No. 132, Orig. Argued January 11, 2010—Decided June 1, 2010 In 1986, Congress granted its consent to the Southeast Interstate Low- Level Radioactive Waste Management Compact (Compact), which was entered into by Alabama, Florida, Georgia, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia. The Compact is administered by a Commission, which was required, inter alia, to “identif[y] a host State for the development of a [new] regional- disposal facility,” and to “seek to ensure that such facility is licensed and ready to operate . no . later than 1991.” Art. 4(E)(6), 99 Stat. 1875. The Commission designated North Carolina as a host State in 1986, thereby obligating North Carolina to take “appropriate steps to ensure that an application for a license to construct and op- erate a [low-level radioactive waste storage facility] is filed with and issued by the appropriate authority.” Art. 5(C), id., at 1877. In 1988, North Carolina asked the Commission for assistance with the costs of licensing and building a facility.