DOCSLIB.ORG

Naloxone Versus Methadone for Treatment of Opioid Use Disorder

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Naloxone Versus Methadone for Treatment of Opioid Use Disorder Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-036102 on 9 September 2020. Downloaded from Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population- based observational study protocol in British Columbia, Canada Micah Piske,1 Trevor Thomson,1 Emanuel Krebs,1 Natt Hongdilokkul,1 Julie Bruneau,2,3 Sander Greenland,4 Paul Gustafson,5 M Ehsan Karim,6,7 Lawrence C McCandless,8,9 Malcolm Maclure,10 Robert W Platt,11,12 Uwe Siebert,13,14,15 M Eugenia Socías,16,17 Judith I Tsui,18 Evan Wood,16,17 Bohdan Nosyk 1,9 To cite: Piske M, Thomson T, ABSTRACT Strengths and limitations of this study Krebs E, et al. Comparative Introduction Despite a recent meta- analysis including 31 effectiveness of buprenorphine- randomised controlled trials comparing methadone and ► British Columbia’s single- payer system represents naloxone versus methadone buprenorphine for the treatment of opioid use disorder, for treatment of opioid use an ideal setting for direct comparisons at the pop- important knowledge gaps remain regarding the long- disorder: a population- ulation level and within key subgroups. term effectiveness of different treatment modalities based observational study ► An intent- to- treat analysis with both instrumental across individuals, including rigorously collected data on protocol in British Columbia, variable and high-dimensional propensity score retention rates and other treatment outcomes. Evidence Canada. BMJ Open matching techniques will emulate trials featuring from real- world data represents a valuable opportunity 2020;10:e036102. doi:10.1136/ flexible dosing regimens. bmjopen-2019-036102 to improve personalised treatment and patient- centred ► A per- protocol analysis, implemented with G- guidelines for vulnerable populations and inform strategies http://bmjopen.bmj.com/ ► Prepublication history and estimation methods, will provide a direct compar- to reduce opioid- related mortality. Our objective is to additional material for this ison of the treatment regimens administered at determine the comparative effectiveness of methadone paper are available online. clinical guideline- recommended doses and other versus buprenorphine/naloxone, both overall and within Toview these files, please visit guideline- recommended clinical practices. the journal online (http:// dx. doi. key populations, in a setting where both medications are ► Potential uncontrolled confounding and other threats org/ 10. 1136/ bmjopen- 2019- simultaneously available in office- based practices and to validity will be assessed via a range of sensitivity 036102). specialised clinics. analyses and bias analysis. Methods and analysis We propose a retrospective Received 29 November 2019 cohort study of all adults living in British Columbia Revised 26 May 2020 on September 26, 2021 by guest. Protected copyright. receiving opioid agonist treatment (OAT) with methadone Accepted 24 July 2020 direct engagement and collaboration with entities that or buprenorphine/naloxone between 1 January 2008 and issue clinical guidelines, such as professional medical 30 September 2018. The study will draw on seven linked societies and public health organisations. population- level administrative databases. The primary outcomes include retention in OAT and all- cause mortality. We will determine the effectiveness of buprenorphine/ INTRODUCTION naloxone vs methadone using intention- to- treat and per- Evidence supporting the use of opioid protocol analyses—the former emulating flexible- dose agonist treatment (OAT) for long- term © Author(s) (or their trials and the latter focusing on the comparison of the treatment of opioid use disorder (OUD) is employer(s)) 2020. Re- use two medication regimens offered at the optimal dose. well established.1 Nonetheless, a consensus permitted under CC BY-NC. No Sensitivity analyses will be used to assess the robustness study report of the National Academies of commercial re- use. See rights of results to heterogeneity in the patient population and and permissions. Published by Sciences, Engineering and Medicine, with threats to internal validity. BMJ. Ethics and dissemination The protocol, cohort creation support from the National Institute on Drug For numbered affiliations see and analysis plan have been approved and classified as a Abuse and the Substance Abuse and Mental end of article. quality improvement initiative exempt from ethical review Health Services Administration, recently Correspondence to (Providence Health Care Research Institute and the Simon highlighted the need for further studies to Dr Bohdan Nosyk; Fraser University Office of Research Ethics). Dissemination determine the most appropriate medica- bnosyk@ cfenet. ubc. ca is planned via conferences and publications, and through tion for key population subgroups and the Piske M, et al. BMJ Open 2020;10:e036102. doi:10.1136/bmjopen-2019-036102 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-036102 on 9 September 2020. Downloaded from comparative effectiveness of different medications over in this meta-analysis with respect to participant selec- the long term.2 The report further noted the refining of tion and exclusion criteria, disease severity, study design, treatment protocols for effective use of existing medica- dosing protocols, observation times and how retention is tions as a priority topic. This is due in part to the fact measured limits generalisability, particularly to key popu- that much of the existing evidence from randomised lations excluded from the RCTs. Consequently, there controlled trials (RCTs) has been generated using proto- are several factors which limit conclusions drawn from cols not representative of current clinical practice guide- previous studies in the comparative effectiveness between lines (which themselves are based on limited evidence) buprenorphine and methadone, and challenge their and within restrictive study cohorts over short durations applicability to clinical practice. (eg, ranging from 6 to 52 weeks) that do not account 1. Restricted participant inclusion criteria in previous for the chronic nature of OUD. The lack of consistent, RCTs meta- analysed by Mattick et al4 have resulted in high- quality evidence, therefore, continues to challenge an unrepresentative sample of the population living informed decision- making when determining the best with OUD included in these studies. People with OUD treatment option for individuals with OUD. (PWOUD) have been observed to have a high preva- Numerous RCTs have indicated that buprenorphine lence of comorbid conditions, such as mental health and methadone are effective treatments for OUD.3–5 The disorders, other substance use disorders, respirato- effectiveness of methadone as a therapeutic treatment for ry illness, chronic pain, Hepatitis C virus (HCV) and OUD is the most established among the various forms of HIV/AIDS.10–12 We previously reported a high preva- OAT. 6 Methadone is a synthetic opioid agonist with high lence of mental health disorders (66%), chronic pain μ-opioid receptor binding affinity,7 but has a narrow ther- (53%), substance use disorders (43%) and alcohol use apeutic index, long elimination half-life and potential disorders (20%) in a recent population-based study of for interactions with alcohol and other drugs; proper- PWOUD in British Columbia (BC).13 A majority of the ties which increase its risk of toxicity and other adverse RCTs included in the Cochrane review excluded indi- effects.8 Buprenorphine is a safe and effective alternative viduals with major psychiatric medical conditions, other to methadone treatment,9 working as a partial agonist serious conditions, previous receipt of OAT and those with high affinity at the μ-opioid receptor and an antago- with codependence on other substances, such as stim- nist at the κ-opioid receptor. Compared with methadone, ulants, alcohol, cannabis and sedatives. Additionally, buprenorphine features an improved safety profile with a vast majority of these studies investigated treatment shorter induction; a milder side effect profile; milder with- among heroin users before the era of fentanyl and the drawal symptoms and fewer drug interactions; decreased dramatic rise in synthetic opioid use. Furthermore, risk of overdose due to a partial agonist ‘ceiling effect’ most of the RCTs did not investigate OAT effectiveness and reduced risks of respiratory depression.8 Buprenor- among special populations outlined in the American phine additionally may offer a decreased risk of injection, Society of Addiction Medicine (ASAM) guidelines, http://bmjopen.bmj.com/ and therefore, harms related to diversion when taken in particularly through the exclusion of pregnant wom- the buprenorphine/naloxone formulation. As a result, en and youth. A prior Cochrane review conducted by most settings have allowed more flexible and take-home Minozzi et al14 investigating OAT efficacy in pregnant dosing schedules earlier in the course of treatment.8 women with OUD, reported insufficient evidence to Regarding the comparative effectiveness of OAT regi- draw firm conclusions about the equivalence of the mens, evidence from randomised studies is mixed and treatments for all outcomes including retention. dependent on whether a fixed or flexible dosing schedule 2. Limited observation periods afforded by the RCTs in- 4 was assigned. Retention in buprenorphine was less effec- cluded in the Mattick et al study provided an insuffi- on September 26, 2021 by guest.
Load more

Recommended publications
  • (STROBE) Statement: Guidelines for Reporting Observational Studies
    Policy and practice The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies* Erik von Elm,a Douglas G Altman,b Matthias Egger,a,c Stuart J Pocock,d Peter C Gøtzsche e & Jan P Vandenbroucke f for the STROBE Initiative Abstract Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study’s generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control and cross-sectional studies. We convened a two-day workshop, in September 2004, with methodologists, researchers and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
    [Show full text]
  • Dictionary Epidemiology
    A Dictionary ofof Epidemiology Fifth Edition Edited for the International Epidemiological Association by Miquel Porta Professor of Preventive Medicine & Public Health, School of Medicine, Universitat Autònoma de Barcelona; Senior Scientist, Institut Municipal d’Investigació Mèdica, Barcelona, Spain; Adjunct Professor of Epidemiology, School of Public Health, University of North Carolina at Chapel Hill Associate Editors Sander Greenland John M. Last 1 2008 PPorta_FM.inddorta_FM.indd iiiiii 44/16/08/16/08 111:51:201:51:20 PPMM 1 Oxford University Press, Inc., publishes works that further Oxford University’s objective excellence in research, schollarship, and education Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi Shanghai Taipei Toronto With offi ces in Argentina Austria Brazil Chile Czech Republic France Greece Guatemala Hungary Italy Japan Poland Portugal Singapore South Korea Switzerland Thailand Turkey Ukraine Vietnam Copyright © 1983, 1988, 1995, 2001, 2008 International Epidemiological Association, Inc. Published by Oxford University Press, Inc. 198 Madison Avenue, New York, New York 10016 www.oup-usa.org All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of Oxford University Press. This edition was prepared with support from Esteve Foundation (Barcelona, Catalonia, Spain) (http://www.esteve.org) Library of Congress Cataloging-in-Publication Data A dictionary of epidemiology / edited for the International Epidemiological Association by Miquel Porta; associate editors, John M. Last . [et al.].—5th ed. p. cm. Includes bibliographical references and index.
    [Show full text]
  • Statistics As a Condemned Building: a Demolition and Reconstruction Plan
    EPIDEMIOLOGY SEMINAR / WINTER 2019 THE DEPARTMENT OF EPIDEMIOLOGY, BIOSTATISTICS AND OCCUPATIONAL HEALTH, - SEMINAR SERIES IS A SELF-APPROVED GROUP LEARNING ACTIVITY (SECTION 1) AS DEFINED BY THE MAINTENANCE OF CERTIFICATION PROGRAM OF THE ROYAL COLLEGE OF PHYSICIANS AND SURGEONS OF CANADA Sander Greenland Emeritus Professor Epidemiology and Statistics University of California, Los Angeles Statistics as a Condemned Building: A Demolition and Reconstruction Plan MONDAY, 18 FEBRUARY 2019 / 4:00PM 5:00PM McIntyre Medical Building 3655 promenade Sir William Osler – Meakins Rm 521 ALL ARE WELCOME ABSTRACT: OBJECTIVES BIO: As part of the vast debate about how 1. To stop dichotomania Sander Greenland is Emeritus to reform statistics, I will argue that (unnecessary chopping of quan- Professor of Epidemiology and Sta- probability-centered statistics should tities into dichotomies); tistics at the University of California, be replaced by an integra- Los Angeles, specializing in the lim- 2. To stop nullism (unwarranted tion of cognitive science, caus- itations and misuse of statistical bias toward "null hypotheses" of al modeling, data descrip- methods, especially in observational no association or no effect); tion, and information transmis- studies. He has published over 400 sion, with probability entering as 3. To replace terms and concepts articles and book chapters in epide- one of the mathemati- like "statistical significance" and miology, statistics, and medicine, cal tools for delineating the pri- "confidence interval" with com- and given over 250 invited lectures, mary elements. Ironically, giv- patibility statements about hy- seminars and courses en the decades of treating it as potheses and models. worldwide in epidemiologic and scapegoat for all the ills of statistics, statistical methodology.
    [Show full text]
  • Dictionary of Epidemiology, 5Th Edition
    A Dictionary of Epidemiology This page intentionally left blank A Dictionary ofof Epidemiology Fifth Edition Edited for the International Epidemiological Association by Miquel Porta Professor of Preventive Medicine & Public Health School of Medicine, Universitat Autònoma de Barcelona Senior Scientist, Institut Municipal d’Investigació Mèdica Barcelona, Spain Adjunct Professor of Epidemiology, School of Public Health University of North Carolina at Chapel Hill Associate Editors Sander Greenland John M. Last 1 2008 1 Oxford University Press, Inc., publishes works that further Oxford University’s objective excellence in research, scholarship, and education Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi Shanghai Taipei Toronto With offi ces in Argentina Austria Brazil Chile Czech Republic France Greece Guatemala Hungary Italy Japan Poland Portugal Singapore South Korea Switzerland Thailand Turkey Ukraine Vietnam Copyright © 1983, 1988, 1995, 2001, 2008 International Epidemiological Association, Inc. Published by Oxford University Press, Inc. 198 Madison Avenue, New York, New York 10016 www.oup-usa.org All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of Oxford University Press. This edition was prepared with support from Esteve Foundation (Barcelona, Catalonia, Spain) (http://www.esteve.org) Library of Congress Cataloging-in-Publication Data A dictionary of epidemiology / edited for the International Epidemiological Association by Miquel Porta; associate editors, John M. Last . [et al.].—5th ed. p. cm. Includes bibliographical references and index. ISBN 978–0-19–531449–6 ISBN 978–0-19–531450–2 (pbk.) 1.
    [Show full text]
  • Statistical Tests, P Values, Confidence Intervals, and Power
    Eur J Epidemiol (2016) 31:337–350 DOI 10.1007/s10654-016-0149-3 ESSAY Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations 1 2 3 4 Sander Greenland • Stephen J. Senn • Kenneth J. Rothman • John B. Carlin • 5 6 7 Charles Poole • Steven N. Goodman • Douglas G. Altman Received: 9 April 2016 / Accepted: 9 April 2016 / Published online: 21 May 2016 Ó The Author(s) 2016. This article is published with open access at Springerlink.com Abstract Misinterpretation and abuse of statistical tests, literature. In light of this problem, we provide definitions confidence intervals, and statistical power have been and a discussion of basic statistics that are more general decried for decades, yet remain rampant. A key problem is and critical than typically found in traditional introductory that there are no interpretations of these concepts that are at expositions. Our goal is to provide a resource for instruc- once simple, intuitive, correct, and foolproof. Instead, tors, researchers, and consumers of statistics whose correct use and interpretation of these statistics requires an knowledge of statistical theory and technique may be attention to detail which seems to tax the patience of limited but who wish to avoid and spot misinterpretations. working scientists. This high cognitive demand has led to We emphasize how violation of often unstated analysis an epidemic of shortcut definitions and interpretations that protocols (such as selecting analyses for presentation based are simply wrong, sometimes disastrously so—and yet on the P values they produce) can lead to small P values these misinterpretations dominate much of the scientific even if the declared test hypothesis is correct, and can lead to large P values even if that hypothesis is incorrect.
    [Show full text]
  • What Is the Evidence for Interactions Between Filaggrin Null Mutations and Environmental Exposures in the Aetiology of Atopic Dermatitis? - a Systematic Review
    MS HELENA BLAKEWAY (Orcid ID : 0000-0003-4000-8923) PROFESSOR CARSTEN FLOHR (Orcid ID : 0000-0003-4884-6286) DR RICHARD BERESFORD WELLER (Orcid ID : 0000-0003-2550-9586) PROFESSOR ALAN IRVINE (Orcid ID : 0000-0002-9048-2044) Article type : Original Article Corresponding author maid id :- [email protected] WHAT IS THE EVIDENCE FOR INTERACTIONS BETWEEN FILAGGRIN NULL MUTATIONS AND ENVIRONMENTAL EXPOSURES IN THE AETIOLOGY OF ATOPIC DERMATITIS? - A SYSTEMATIC REVIEW H. Blakeway,1 V. Van-de-Velde,2 V. B. Allen,3 G. Kravvas,2 L. Palla,4 M. J. Page,5 C. Flohr,6 R. B. Weller,7 A. D. Irvine,8,9,10 T. McPherson,11 A. Roberts,12 H. C. Williams,13 N. Reynolds,14,15 S. J. Brown,16,17 L. Paternoster18 and S. M. Langan19,20 (on behalf of UK-TREND Eczema Network) 1 Faculty of Health Sciences, University of Bristol, Bristol Medical School, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, United Kingdom 2Department of Dermatology, Department of Dermatology, Lauriston Building, Lauriston Place, Edinburgh, EH3 9HA, United Kingdom 3Department of Infection, St. Thomas' Hospital, Westminster Bridge Rd, Lambeth, London SE1 7EH, United Kingdom 4Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom This article has been accepted for publication and undergone full peer review but has not been throughAccepted Article the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/BJD.18778 This article
    [Show full text]
  • The ASA's Statement on P-Values: Context, Process, and Purpose
    The American Statistician ISSN: 0003-1305 (Print) 1537-2731 (Online) Journal homepage: http://amstat.tandfonline.com/loi/utas20 The ASA's Statement on p-Values: Context, Process, and Purpose Ronald L. Wasserstein & Nicole A. Lazar To cite this article: Ronald L. Wasserstein & Nicole A. Lazar (2016) The ASA's Statement on p-Values: Context, Process, and Purpose, The American Statistician, 70:2, 129-133, DOI: 10.1080/00031305.2016.1154108 To link to this article: http://dx.doi.org/10.1080/00031305.2016.1154108 View supplementary material Accepted author version posted online: 07 Mar 2016. Published online: 09 Jun 2016. Submit your article to this journal Article views: 204716 View Crossmark data Citing articles: 310 View citing articles Full Terms & Conditions of access and use can be found at http://amstat.tandfonline.com/action/journalInformation?journalCode=utas20 Download by: [University of Connecticut] Date: 29 August 2017, At: 22:40 THE AMERICAN STATISTICIAN , VOL. , NO. , – http://dx.doi.org/./.. EDITORIAL The ASA’s Statement on p-Values: Context, Process, and Purpose In February 2014, George Cobb, Professor Emeritus of Math- 2014) and a statement on risk-limiting post-election audits ematics and Statistics at Mount Holyoke College, posed these (American Statistical Association 2010). However, these were questionstoanASAdiscussionforum: truly policy-related statements. The VAM statement addressed a key educational policy issue, acknowledging the complexity of Q:Whydosomanycollegesandgradschoolsteachp = 0.05? A: Because that’s still what the scientific community and journal the issues involved, citing limitations of VAMs as effective per- editors use. formance models, and urging that they be developed and inter- Q:Whydosomanypeoplestillusep = 0.05? preted with the involvement of statisticians.
    [Show full text]
  • How to Embrace Variation and Accept Uncertainty in Linguistic and Psycholinguistic Data Analysis
    Linguistics 2021; aop Shravan Vasishth* and Andrew Gelman How to embrace variation and accept uncertainty in linguistic and psycholinguistic data analysis https://doi.org/..., Received ...; accepted ...5 Abstract: The use of statistical inference in linguistics and related areas like psychology typically involves a binary decision: either reject or accept some null hypothesis using statistical significance testing. When statistical power is low, this frequentist data-analytic approach breaks down: null results are uninformative, and effect size estimates associated with significant results are overestimated. Using an example from psycholinguistics, 10 several alternative approaches are demonstrated for reporting inconsistencies between the data and a theoretical prediction. The key here is to focus on committing to a falsifiable prediction, on quantifying uncertainty statistically, and learning to accept the fact that—in almost all practical data analysis situations—we can only draw uncertain conclusions from data, regardless of whether we manage to obtain statistical significance 15 or not. A focus on uncertainty quantification is likely to lead to fewer excessively bold claims that, on closer investigation, may turn out to be not supported by the data. Keywords: experimental linguistics;statistical data analysis; statistical inference; un- certainty quantification 1 Introduction 20 Statistical tools are widely employed in linguistics and in related areas like psychology to quantify empirical evidence from planned experiments and corpus
    [Show full text]
  • Epidemiology, Risk and Causation Conceptual and Methodological Issues in Public Health Science Alex Broadbent Background
    Epidemiology, risk and causation Conceptual and methodological issues in public health science Alex Broadbent Background In 2007 the PHG Foundation began funding the author of this report, Dr Alex Broadbent, to conduct research into the conceptual and methodological issues arising in connection with epidemiology. These issues include the nature of causation, methods for causal inference, the nature and communication of risk, the proper use of statistical significance testing, and the social determinants of health. The project produced a number of academic articles and included a series of workshops held at Cambridge in 2010, contributions for which form the basis of a special section of the journal Preventive Medicine (2011) Volume 53, issues 4-5. A book on the philosophy of epidemiology is now under contract with Palgrave Macmillan. Acknowledgements The author is especially grateful to Ron Zimmern for suggesting a philosophical project on epidemiology, for continual interest and encouragement, and for his support in funding decisions. Thanks are also due to: the steering committee for the workshops – Philip Dawid, Stephen John, Tim Lewens, Sridhar Venkatapuram and Ron Zimmern; the Department of History and Philosophy of Science at Cambridge for administrative and academic support and for providing venues for the workshops; the Brocher Foundation in Geneva for supporting some of this research; and a number of individuals at the PHG Foundation including Jane Lane, Carol Lyon, Hilary Burton and Caroline Wright for various academic discussions and administrative support. This report is available from www.phgfoundation.org Published by PHG Foundation 2 Worts Causeway Cambridge CB1 8RN UK Tel: +44 (0)1223 740200 Fax: +44 (0)1223 740892 November 2011 © 2011 PHG Foundation ISBN 978-1-907198-09-0 The PHG Foundation is the working name of the Foundation for Genomics and Population Health, a charitable organisation (registered in England and Wales, charity no.
    [Show full text]
  • To Aid Scientific Inference, Emphasize Unconditional Descriptions Of
    Page 1 To Aid Scientific Inference, Emphasize Unconditional Descriptions of Statistics Sander Greenland* Department of Epidemiology and Department of Statistics, University of California, Los Angeles, CA, U.S.A. [email protected] Zad Rafi Department of Population Health, NYU Langone Medical Center, New York, NY, U.S.A. 27 February 2021 *Corresponding Author Suggested Running Head: Emphasize Unconditional Descriptions Conflict of Interest Disclosure: The authors declare no conflicts of interest. Page 2 Abstract: All scientific interpretations of statistical outputs depend on background (auxiliary) assumptions that are rarely delineated or checked in full detail. These include not only the usual modeling assumptions, but also deeper assumptions about the data-generating mechanism that are implicit in conventional statistical interpretations yet are unrealistic in most health, medical and social research. We provide arguments and methods for reinterpreting statistics such as P- values and interval estimates in unconditional terms, which describe compatibility of observations with an entire set of analysis assumptions, rather than just a narrow target hypothesis. Such reinterpretations help avoid overconfident inferences whenever there is uncertainty about the assumptions used to derive and compute the statistical results. These include assumptions about absence of systematic errors, protocol violations, and data corruption. Unconditional descriptions introduce assumption uncertainty directly into statistical interpretations of results, rather than leaving that uncertainty to caveats about conditional interpretations or limited sensitivity analyses. By interpreting statistical outputs in unconditional terms, researchers can avoid making overconfident statements for statistical outputs when there are uncertainties about assumptions, and instead emphasize the compatibility of the results with a range of plausible explanations. We thus view unconditional description as a vital component of good statistical training and presentation.
    [Show full text]
  • Phd Newsletter
    Epidemiology and Translational Science PhD Program News UCSF / Department of Epidemiology and Biostatistics /Issue 3 Fall 2015 ear Friends and Colleagues: Welcome New PhD Students for 2015-16 ! Please join me in welcoming our new D Epidemiology and Translational Science PhD students. This is an exceptional group of students n Ekland Abdiwahab, MPH –coming into the PhD program after previous train- ing at Yale, Berkeley, Minnesota, and UCSF’s own Education: University of California, Davis (BS, Microbiology); Training in Clinical Research program-- and I look University of Minnesota School of Public Health forward to watching their trajectories unfold here (MPH, Community Health Promotion, Health Disparities at UCSF. They will join a fantastic group of students Interdisciplinary Concentration) currently in the program. Our students received My academic and research interests include health many official recognitions of excellence this year equity, breast cancer disparities, social determi- (see page 2 of this newsletter), but I am especially impressed by their behind-the-scenes efforts to nants of health, and methods in social epidemiology. build the PhD program, enrich the university, and Coordinating a breast cancer outreach and edu- help one another, all while doing great population cation program for African American women in health research. Sacramento and conducting breast cancer related We also welcome back our fearless leader, Depart- fieldwork in Ghana have given me insight into the disproportionate bur- ment Chair Dr. Bob Hiatt, who returned this spring den of breast cancer in low-income, minority populations. In the doctoral after a sabbatical in London. Although I am sure Bob’s sabbatical provided him an extremely valuable program I would like to investigate environmental risk factors for breast intellectual renewal and opportunity to check out cancer; specifically, how neighborhood characteristics influence breast London’s post-punk music scene, it is nonethe- cancer risk and outcomes.
    [Show full text]
  • Inferential Statistics As Descriptive Statistics: There Is No Replication Crisis If We Don’T Expect Replication
    The American Statistician ISSN: 0003-1305 (Print) 1537-2731 (Online) Journal homepage: https://www.tandfonline.com/loi/utas20 Inferential Statistics as Descriptive Statistics: There Is No Replication Crisis if We Don’t Expect Replication Valentin Amrhein, David Trafimow & Sander Greenland To cite this article: Valentin Amrhein, David Trafimow & Sander Greenland (2019) Inferential Statistics as Descriptive Statistics: There Is No Replication Crisis if We Don’t Expect Replication, The American Statistician, 73:sup1, 262-270, DOI: 10.1080/00031305.2018.1543137 To link to this article: https://doi.org/10.1080/00031305.2018.1543137 © 2019 The Author(s). Published online: 20 Mar 2019. Submit your article to this journal View Crossmark data Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=utas20 THE AMERICAN STATISTICIAN 2019, VOL. 73, NO. S1, 262–270: Statistical Inference in the 21st Century https://doi.org/10.1080/00031305.2019.1543137 Inferential Statistics as Descriptive Statistics: There Is No Replication Crisis if We Don’t Expect Replication Valentin Amrheina, David Trafimowb,c, and Sander Greenlandc aZoological Institute, University of Basel, Basel, Switzerland; bDepartment of Psychology, New Mexico State University, Las Cruces, NM; cDepartment of Epidemiology and Department of Statistics, University of California, Los Angeles, CA Abstract ARTICLE HISTORY Statistical inference often fails to replicate. One reason is that many results may be selected for drawing Received March 2018 inference because some threshold of a statistic like the P-value was crossed, leading to biased reported Revised October 2018 effect sizes. Nonetheless, considerable non-replication is to be expected even without selective reporting, and generalizations from single studies are rarely if ever warranted.
    [Show full text]