Evidence map›Paper›PMID 26721599›Full record

ArticleInternational journal of epidemiology2016

Using observational data to emulate a randomized trial of dynamic treatment-switching strategies: an application to antiretroviral therapy.

Lauren E Cain, Michael S Saag, Maya Petersen, Margaret T May, Suzanne M Ingle, Roger Logan, James M Robins, Sophie Abgrall, Bryan E Shepherd, Steven G Deeks and 46 more

Open access · bronzeAbstract read
In one paragraph

Article in International journal of epidemiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Simulating Data From Marginal Structural Models for a Survival Time Outcome.Biometrical journal. Biometrische Zeitschrift · 2024
    Article
  14. Review
  15. Article
  16. Early Mortality After the First Dose of COVID-19 Vaccination: A Target Trial Emulation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Observational
  17. Article
  18. Review
  19. Treatment Outcomes After Offering Same-Day Initiation of Human Immunodeficiency Virus Treatment-How to Interpret Discrepancies Between Different Studies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

56 authors at 20 institutions in 10 countries.

Lauren E CainDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Michael S SaagDepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Maya PetersenDivisions of Biostatistics and Epidemiology, University of California, Berkeley, School of Public Health, Berkeley, CA, USA.
Margaret T MaySchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Suzanne M IngleSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Roger LoganDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
James M RobinsDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Sophie AbgrallSorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), F75013, Paris, France.
Bryan E ShepherdDepartment of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Steven G DeeksPositive Health Program, San Francisco General Hospital, San Francisco, CA, USA.
M John GillDivision of Infectious Diseases, University of Calgary, Calgary, AB, Canada.
Giota TouloumiDepartment of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece.
Georgia VourliDepartment of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece.
François DabisINSERM U897, Centre Inserm Epidémiologie et Biostatistique, Université de Bordeaux, and Bordeaux University Hospital, Department of Internal Medicine, Bordeaux, France.
Marie-Anne VandenhendeINSERM U897, Centre Inserm Epidémiologie et Biostatistique, Université de Bordeaux, and Bordeaux University Hospital, Department of Internal Medicine, Bordeaux, France.
Peter ReissStichting HIV Monitoring, Amsterdam, Netherlands.
Ard van SighemStichting HIV Monitoring, Amsterdam, Netherlands.
Hasina SamjiEpidemiology and Population Health Program, BC Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada.
Robert S HoggEpidemiology and Population Health Program, BC Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada.
Jan Rybniker1st Department of Internal Medicine, University of Cologne, D-50937 Cologne, Germany.
Caroline A SabinUniversity College London, London, UK.
Sophie JoseUniversity College London, London, UK.
Julia Del AmoNational Centre of Epidemiology, Instituto de Salud Carlos III, Madrid, Spain.
Santiago MorenoRamón y Cajal Hospital, IRYCIS, Madrid, Spain.
Benigno RodríguezDivision of Infectious Disease, Case Western Reserve University, Cleveland, OH, USA.
Alessandro Cozzi-LepriDepartment of Infection and Population Health; Division of Population Health, University College London, London, UK.
Stephen L BoswellFenway Health, Boston, MA, USA.
Christoph StephanHIV Center, Department of Infectious Diseases, University Hospital, Frankfurt, Germany.
Santiago Pérez-HoyosVall d'Hebron Research Institute, Barcelona, Spain.
Inma JarrinNational Centre of Epidemiology, Instituto de Salud Carlos III, Madrid, Spain.
Jodie L GuestRollins School of Public Health at Emory University, Atlanta, GA, USA.
Antonella D'Arminio MonforteClinic of Infectious Diseases and Tropical Medicine, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.
Andrea AntinoriIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.
Richard MooreSchool of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Colin Nj CampbellConsorcio de Investigación Biomédica de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
Jordi CasabonaConsorcio de Investigación Biomédica de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
Laurence MeyerUniversité Paris Sud, INSERM CESP U1018, and AP-HP, Hôpital de Bicêtre, Service de Santé Publique, le Kremlin Bicêtre, France.
Rémonie SengUniversité Paris Sud, INSERM CESP U1018, and AP-HP, Hôpital de Bicêtre, Service de Santé Publique, le Kremlin Bicêtre, France.
Andrew N PhillipsUniversity College London, London, UK.
Heiner C BucherBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
Matthias EggerCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Michael J MugaveroUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Richard HaubrichUniversity of California San Diego, CA, USA (Currently Gilead Sciences, Foster City, CA, USA).
Elvin H GengDivision of HIV/AIDS, Department of Medicine, University of California, San Francisco, CA, USA.
Ashley OlsonMedical Research Council Clinical Trials Unit, University College London, London, UK.
Joseph J EronDivision of Infectious Diseases, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Sonia NapravnikDivision of Infectious Diseases, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Mari M KitahataDepartment of Medicine, University of Washington, Seattle, WA, USA.
Stephen E Van RompaeyDepartment of Medicine, University of Washington, Seattle, WA, USA.
Ramón TeiraUnit of Infectious Diseases, Hospital Sierrallana, Torrelavega, Spain.
Amy C JusticeYale School of Medicine, New Haven, CT, USA.
Janet P TateYale School of Medicine, New Haven, CT, USA.
Dominique CostagliolaSorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), F75013, Paris, France.
Jonathan Ac SterneSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Miguel A HernánDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Antiretroviral Therapy Cohort Collaboration, the Centers for AIDS Research Network of Integrated Clinical Systems, and the HIV-CAUSAL Collaboration
University College London · GBHarvard University · USInserm · FRUniversity of Bristol · GBInstituto de Salud Carlos III · ESSorbonne Université · FRUniversity of Alabama at Birmingham · USUniversity of North Carolina at Chapel Hill · USUniversity of Washington · USAIDS Vancouver · CACase Western Reserve University · USCentre de recherche en Epidémiologie et Santé des Populations · FRFenway Health · USGoethe University Frankfurt · DEGovernment of Catalonia · ESHospital Sierrallana · ESInstituto Ramón y Cajal de Investigación Sanitaria · ESIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani · ITJohns Hopkins University · USOspedale San Paolo · IT

Funding

Unsolicited R24 for the CFAR-Network of Integrated Clinical Sciences, CNICSR24AI067039 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Michael S. Saag · 2006 to 2026
$99.4M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 1988 to 2026
$93.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Alcohol and Multisubstance Use in the Veterans Aging Cohort StudyU01AA020790 · NIAAA · YALE UNIVERSITY · PI JUSTICE, AMY CAROLINE · 2011 to 2020
$7.7M
Sex Disparities in Overall Response to ART Among HIV Infected IndividualsU24AA020794 · NIAAA · YALE UNIVERSITY · PI JUSTICE, AMY CAROLINE · 2011 to 2020
$5.5M
Translational Research on Alcohol, Immunodeficiency, and Aging In COMpAAASU24AA022001 · NIAAA · YALE UNIVERSITY · PI BRANDT, CYNTHIA A. · 2012 to 2020
$3.2M
Pooling HIV Cohorts to Inform Clinical DecisionR01AI073127 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HERNAN, MIGUEL · 2007 to 2010
$1.5M
Department of Health NF-SI-0611-10168Medical Research Council G0000199Medical Research Council G0100221Medical Research Council G0600337Medical Research Council G0700820Medical Research Council G0900274Medical Research Council MR/J002380/1Medical Research Council MR/M004236/1NIAAA NIH HHS U01 AA020790NIAAA NIH HHS U24 AA020794NIAAA NIH HHS U24 AA022001NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI073127NIAID NIH HHS R24 AI067039
6 · The paper itself

Abstract

Background: When a clinical treatment fails or shows suboptimal results, the question of when to switch to another treatment arises. Treatment switching strategies are often dynamic because the time of switching depends on the evolution of an individual's time-varying covariates. Dynamic strategies can be directly compared in randomized trials. For example, HIV-infected individuals receiving antiretroviral therapy could be randomized to switching therapy within 90 days of HIV-1 RNA crossing above a threshold of either 400 copies/ml (tight-control strategy) or 1000 copies/ml (loose-control strategy). Methods: We review an approach to emulate a randomized trial of dynamic switching strategies using observational data from the Antiretroviral Therapy Cohort Collaboration, the Centers for AIDS Research Network of Integrated Clinical Systems and the HIV-CAUSAL Collaboration. We estimated the comparative effect of tight-control vs. loose-control strategies on death and AIDS or death via inverse-probability weighting. Results: Of 43 803 individuals who initiated an eligible antiretroviral therapy regimen in 2002 or later, 2001 met the baseline inclusion criteria for the mortality analysis and 1641 for the AIDS or death analysis. There were 21 deaths and 33 AIDS or death events in the tight-control group, and 28 deaths and 41 AIDS or death events in the loose-control group. Compared with tight control, the adjusted hazard ratios (95% confidence interval) for loose control were 1.10 (0.73, 1.66) for death, and 1.04 (0.86, 1.27) for AIDS or death. Conclusions: Although our effective sample sizes were small and our estimates imprecise, the described methodological approach can serve as an example for future analyses.

Indexed as

Randomized Controlled Trials as TopicAdultAnti-HIV AgentsCD4 Lymphocyte CountFemaleHIV-1HIV InfectionsHumansMaleMiddle AgedObservational Studies as TopicSurvival AnalysisUnited KingdomViral LoadAnti-HIV Agentsantiretroviral therapydynamic strategiesHIVinverse-probability weightingmortalityobservational studies

Identifiers

PMID26721599
PMCPMC5841611
OpenAlexW2284501626

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.