Reproducibility 1 Reproducibility in Clinical Psychology Christopher J
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Reproducibility, Replicability, and Generalization in the Social, Behavioral, and Economic Sciences
REPRODUCIBILITY, REPLICABILITY, AND GENERALIZATION IN THE SOCIAL, BEHAVIORAL, AND ECONOMIC SCIENCES Report of the Subcommittee on Replicability in Science of the SBE Advisory Committee to the National Science Foundation 13 May 2015 Presentation at SBE AC Spring Meeting by K. Bollen. Report of the Subcommittee on Replicability in Science Advisory Committee to the NSF SBE Directorate Subcommittee Members: Kenneth Bollen (University of North Carolina at Chapel Hill, Cochair) John T. Cacioppo (University of Chicago, Cochair) Robert M. Kaplan (Agency for Healthcare Research and Quality) Jon A. Krosnick (Stanford University) James L. Olds (George Mason University) Staff Assistance Heather Dean (National Science Foundation) TOPICS I. Background II. Subcommittee Report III. Definitions IV. Recommendations V. Final Comments Background • Spring, 2013 o NSF SBE Advisory Committee establishes subcommittee on how SBE can promote robust research practices • Summer & Fall 2013 o Subcommittee proposal for workshop on “Robust Research in the Social, Behavioral, and Economic Sciences.” • February 20-21, 2014 o Workshop convened o Participants drawn from variety of universities, funding agencies, scientific associations, and journals o Cover broad range of issues from extent and cause of problems to possible solutions o Details are in the appendix of the circulated report • Post-workshop period o Document & digest workshop content o Discuss and propose recommendations o Complete report Subcommittee Report • DEFINITIONS o No consensus in science on the meanings -
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. -
Incidence and Secondary Transmission of SARS-Cov-2 Infections in Schools
Prepublication Release Incidence and Secondary Transmission of SARS-CoV-2 Infections in Schools Kanecia O. Zimmerman, MD; Ibukunoluwa C. Akinboyo, MD; M. Alan Brookhart, PhD; Angelique E. Boutzoukas, MD; Kathleen McGann, MD; Michael J. Smith, MD, MSCE; Gabriela Maradiaga Panayotti, MD; Sarah C. Armstrong, MD; Helen Bristow, MPH; Donna Parker, MPH; Sabrina Zadrozny, PhD; David J. Weber, MD, MPH; Daniel K. Benjamin, Jr., MD, PhD; for The ABC Science Collaborative DOI: 10.1542/peds.2020-048090 Journal: Pediatrics Article Type: Regular Article Citation: Zimmerman KO, Akinboyo IC, Brookhart A, et al. Incidence and secondary transmission of SARS-CoV-2 infections in schools. Pediatrics. 2021; doi: 10.1542/peds.2020- 048090 This is a prepublication version of an article that has undergone peer review and been accepted for publication but is not the final version of record. This paper may be cited using the DOI and date of access. This paper may contain information that has errors in facts, figures, and statements, and will be corrected in the final published version. The journal is providing an early version of this article to expedite access to this information. The American Academy of Pediatrics, the editors, and authors are not responsible for inaccurate information and data described in this version. Downloaded from©2021 www.aappublications.org/news American Academy by of guest Pediatrics on September 27, 2021 Prepublication Release Incidence and Secondary Transmission of SARS-CoV-2 Infections in Schools Kanecia O. Zimmerman, MD1,2,3; Ibukunoluwa C. Akinboyo, MD1,2; M. Alan Brookhart, PhD4; Angelique E. Boutzoukas, MD1,2; Kathleen McGann, MD2; Michael J. -
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. -
Becoming Autistic: How Do Late Diagnosed Autistic People
Becoming Autistic: How do Late Diagnosed Autistic People Assigned Female at Birth Understand, Discuss and Create their Gender Identity through the Discourses of Autism? Emily Violet Maddox Submitted in accordance with the requirements for the degree of Master of Philosophy The University of Leeds School of Sociology and Social Policy September 2019 1 Table of Contents ACKNOWLEDGEMENTS ................................................................................................................................... 5 ABSTRACT ....................................................................................................................................................... 6 ABBREVIATIONS ............................................................................................................................................. 7 CHAPTER ONE ................................................................................................................................................. 8 INTRODUCTION .............................................................................................................................................. 8 1.1 RESEARCH OBJECTIVES ........................................................................................................................................ 8 1.2 TERMINOLOGY ................................................................................................................................................ 14 1.3 OUTLINE OF CHAPTERS .................................................................................................................................... -
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. -
The Persistence of Fad Interventions in the Face of Negative Scientific Evidence: Facilitated Communication for Autism As a Case Example
Evidence-Based Communication Assessment and Intervention ISSN: 1748-9539 (Print) 1748-9547 (Online) Journal homepage: http://www.tandfonline.com/loi/tebc20 The persistence of fad interventions in the face of negative scientific evidence: Facilitated communication for autism as a case example Scott O. Lilienfeld, Julia Marshall, James T. Todd & Howard C. Shane To cite this article: Scott O. Lilienfeld, Julia Marshall, James T. Todd & Howard C. Shane (2014) The persistence of fad interventions in the face of negative scientific evidence: Facilitated communication for autism as a case example, Evidence-Based Communication Assessment and Intervention, 8:2, 62-101, DOI: 10.1080/17489539.2014.976332 To link to this article: http://dx.doi.org/10.1080/17489539.2014.976332 Published online: 02 Feb 2015. Submit your article to this journal Article views: 5252 View related articles View Crossmark data Citing articles: 1 View citing articles Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=tebc20 Download by: [University of Lethbridge] Date: 05 October 2015, At: 05:52 Evidence-Based Communication Assessment and Intervention, 2014 Vol. 8, No. 2, 62–101, http://dx.doi.org/10.1080/17489539.2014.976332 EBP Advancement Corner The persistence of fad interventions in the face of negative scientific evidence: Facilitated communication for autism as a case example Scott O. Lilienfeld1, Julia Marshall1, James T. Todd2 & Howard C. Shane3 1Department of Psychology, Emory University, Atlanta, GA, USA, 2Department of Psychology, Eastern Michigan University, Ypsilanti, MI, USA, 3Boston Children’s Hospital, Boston, MA, USA ................................................................................................................................................. Abstract Communication disorder and mental health professionals may assume that once novel clinical techniques have been refuted by research, they will be promptly abandoned. -
Rhythm and Timing in Autism: Learning to Dance
REVIEW ARTICLE published: 19 April 2013 INTEGRATIVE NEUROSCIENCE doi: 10.3389/fnint.2013.00027 Rhythm and timing in autism: learning to dance Pat Amos* Training and Private Consultation, Ardmore, PA, USA Edited by: In recent years, a significant body of research has focused on challenges to neural Anne M. Donnellan, University of connectivity as a key to understanding autism. In contrast to attempts to identify a Wisconsin-Madison, University of single static, primarily brain-based deficit, children and adults diagnosed with autism are San Diego, USA increasingly perceived as out of sync with their internal and external environments in Reviewed by: Elizabeth B. Torres, Rutgers dynamic ways that must also involve operations of the peripheral nervous systems. The University, USA noisiness that seems to occur in both directions of neural flow may help explain challenges Trevor McDonald, Education to movement and sensing, and ultimately to entrainment with circadian rhythms and social Associates Inc., USA interactions across the autism spectrum, profound differences in the rhythm and timing of *Correspondence: movement have been tracked to infancy. Difficulties with self-synchrony inhibit praxis, and Pat Amos, 635 Ardmore Avenue, Ardmore, PA 19003-1831, USA. can disrupt the “dance of relationship” through which caregiver and child build meaning. e-mail: [email protected] Different sensory aspects of a situation may fail to match up; ultimately, intentions and actions themselves may be uncoupled. This uncoupling may help explain the expressions of alienation from the actions of one’s body which recur in the autobiographical autism literature. Multi-modal/cross-modal coordination of different types of sensory information into coherent events may be difficult to achieve because amodal properties (e.g., rhythm and tempo) that help unite perceptions are unreliable. -
Disability in an Age of Environmental Risk by Sarah Gibbons a Thesis
Disablement, Diversity, Deviation: Disability in an Age of Environmental Risk by Sarah Gibbons A thesis presented to the University of Waterloo in fulfillment of the thesis requirement for the degree of Doctor of Philosophy in English Waterloo, Ontario, Canada, 2016 © Sarah Gibbons 2016 I hereby declare that I am the sole author of this thesis. This is a true copy of the thesis, including any required final revisions, as accepted by my examiners. I understand that my thesis may be made electronically available to the public. ii Abstract This dissertation brings disability studies and postcolonial studies into dialogue with discourse surrounding risk in the environmental humanities. The central question that it investigates is how critics can reframe and reinterpret existing threat registers to accept and celebrate disability and embodied difference without passively accepting the social policies that produce disabling conditions. It examines the literary and rhetorical strategies of contemporary cultural works that one, promote a disability politics that aims for greater recognition of how our environmental surroundings affect human health and ability, but also two, put forward a disability politics that objects to devaluing disabled bodies by stigmatizing them as unnatural. Some of the major works under discussion in this dissertation include Marie Clements’s Burning Vision (2003), Indra Sinha’s Animal’s People (2007), Gerardine Wurzburg’s Wretches & Jabberers (2010) and Corinne Duyvis’s On the Edge of Gone (2016). The first section of this dissertation focuses on disability, illness, industry, and environmental health to consider how critics can discuss disability and environmental health in conjunction without returning to a medical model in which the term ‘disability’ often designates how closely bodies visibly conform or deviate from definitions of the normal body. -
Certification Accredited Schools List
= Academic Clinical Research Programs Which Currently Meet Waiver Requirements for the Academy of Clinical Research Professional (Updated October 15, 2015) This list includes academic clinical research programs which, as of the above date, have been evaluated and found to meet the current waiver requirements established by the Academy of Clinical Research Professionals (Academy) Board of Trustees. Programs that meet the waiver requirements allow a candidate to waive 1,500 hours of hands-on experience performing the Essential Duties of the program to which the candidate has made application. This list is not to be considered exhaustive and is not designed to represent all the academic offerings available. Appearance on this list is not to be construed as an endorsement of its content or format by the Academy or a guarantee that a candidate will be eligible for certification. All individuals interested in enrolling in a program of study should evaluate any program on the basis of his or her personal needs. (* - programs marked with an asterisk MAY be accepted but acceptance will be dependent on the complete listing of courses completed) Individuals seeking additional information about each program should contact the institution directly. Academic Institution Program Name ( Click Title for Web Navigation) Academy of Applied Pharmaceutical Sciences Clinical Research Diploma Program American University of Health Sciences Master of Science in Clinical Research Anoka-Ramsey Community College Clinical Research Professional - Certificate Graduate -
Placebo-Controlled Trials of New Drugs: Ethical Considerations
Reviews/Commentaries/Position Statements COMMENTARY Placebo-Controlled Trials of New Drugs: Ethical Considerations DAVID ORENTLICHER, MD, JD als, placebo controls are not appropriate when patients’ health would be placed at significant risk (8–10). A placebo- controlled study for a new hair- uch controversy exists regarding sufficiently more effective than placebo to thickening agent could be justified; a the ethics of placebo-controlled justify its use. Finally, not all established placebo-controlled study for patients M trials in which an experimental therapies have been shown to be superior with moderate or severe hypertension therapy will compete with an already es- to placebo. If newer drugs are compared would not be acceptable (11). Similarly, if tablished treatment (or treatments). In with the unproven existing therapies, an illness causes problems when it goes such cases, argue critics, patients in the then patients may continue to receive untreated for a long period of time, a 52- control arm of the study should receive an drugs that are harmful without being week study with a placebo control is accepted therapy rather than a placebo. helpful. much more difficult to justify than a By using an active and effective drug, the Moreover, say proponents of placebo 6-week study (12). control patients would not be placed at controls, patients can be protected from When David S.H. Bell (13) explains risk for deterioration of their disease, and harm by “escape” criteria, which call for why placebo controls are unacceptable the study would generate more meaning- withdrawal from the trial if the patient for new drugs to treat type 2 diabetes, he ful results for physicians.