Evidence map›Paper›PMID 27282427›Full record

ArticleDrug safety2016

Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale.

Beth Rachlis, Rakhi Karwa, Celia Chema, Sonak Pastakia, Sten Olsson, Kara Wools-Kaloustian, Beatrice Jakait, Mercy Maina, Marcel Yotebieng, Nagalingeswaran Kumarasamy and 5 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 25% 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

1 citing paper in PubMed, 11 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 8 countries.

Beth RachlisOntario HIV Treatment Network, Toronto, ON, Canada.
Rakhi KarwaCollege of Pharmacy, Purdue University, West Lafayette, IN, USA.
Celia ChemaAcademic Model Providing Access to Healthcare, Eldoret, Kenya.
Sonak PastakiaCollege of Pharmacy, Purdue University, West Lafayette, IN, USA.
Sten OlssonUppsala Monitoring Centre, Uppsala, Sweden.
Kara Wools-KaloustianAcademic Model Providing Access to Healthcare, Eldoret, Kenya.
Beatrice JakaitAcademic Model Providing Access to Healthcare, Eldoret, Kenya.
Mercy MainaAcademic Model Providing Access to Healthcare, Eldoret, Kenya.
Marcel YotebiengCollege of Public Health, Ohio State University, Columbus, OH, USA.
Nagalingeswaran KumarasamyYRGCARE Medical Centre, Chennai Antiviral Research and Treatment Clinical Research Site (CART CRS), Voluntary Health Services, Chennai, India.
Aimee FreemanBloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Nathalie de RekeneireUniversity of Bordeaux, INSERM ISPED U1219, Bordeaux, France.
Stephany N DudaDepartment of Medical Informatics, School of Medicine, Vanderbilt University, Nashville, TN, USA.
Mary-Ann DaviesCentre for Infectious Disease Epidemiology and Research, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Paula BraitsteinAcademic Model Providing Access to Healthcare, Eldoret, Kenya. pbraitstein@gmail.com.
AMPATH · KEInserm · FRJohns Hopkins University · USMoi University · KEOntario HIV Treatment Network · CAPurdue University West Lafayette · USUniversity of Cape Town · ZAUniversity of Kinshasa · CDUppsala Monitoring Centre · SEVanderbilt University · USYR Gaitonde Centre for AIDS Research and Education · IN

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
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 STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Virology CoreP30AI027767 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI OLAF KUTSCH · 1988 to 2026
$84.1M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Studies of Ocular Complications of AIDS - Coordinating CenterU10EY008057 · NEI · JOHNS HOPKINS UNIVERSITY · PI VAN NATTA, MARK L · 1988 to 2012
$78.0M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
CIHRIntramural NIH HHS Z01 CP010176NCATS NIH HHS KL2 TR000421NCATS NIH HHS KL2 TR002317NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000083NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR000454NCI NIH HHS N02 CP055504NCI NIH HHS R01 CA165937NCRR NIH HHS M01 RR000052NCRR NIH HHS UL1 RR024131NEI NIH HHS K23 EY013707NEI NIH HHS U10 EY008052NEI NIH HHS U10 EY008057NEI NIH HHS U10 EY008067NIAAA NIH HHS R01 AA016893NIAAA NIH HHS U01 AA013566NIAAA NIH HHS U01 AA020790NIAAA NIH HHS U24 AA020794NIAID NIH HHS K01 AI093197NIAID NIH HHS K24 AI065298NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI027767NIAID NIH HHS P30 AI036219NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI094189NIAID NIH HHS P30 AI110527NIAID NIH HHS R24 AI067039NIAID NIH HHS U01 AI031834NIAID NIH HHS U01 AI034989NIAID NIH HHS U01 AI034993NIAID NIH HHS U01 AI034994NIAID NIH HHS U01 AI035004NIAID NIH HHS U01 AI035039NIAID NIH HHS U01 AI035040NIAID NIH HHS U01 AI035041NIAID NIH HHS U01 AI035042NIAID NIH HHS U01 AI037613NIAID NIH HHS U01 AI037984NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI042590NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069434NIAID NIH HHS U01 AI069907NIAID NIH HHS U01 AI069911NIAID NIH HHS U01 AI069918NIAID NIH HHS U01 AI069919NIAID NIH HHS U01 AI069923NIAID NIH HHS U01 AI069924NIAID NIH HHS U01 AI103390NIAID NIH HHS U01 AI103397NIAID NIH HHS U01 AI103401NIAID NIH HHS U01 AI103408NIAID NIH HHS UM1 AI035043NIAID NIH HHS UM1 AI068634NICHD NIH HHS U01 HD032632NIDA NIH HHS F31 DA037788NIDA NIH HHS K24 DA000432NIDA NIH HHS R01 DA004334NIDA NIH HHS R01 DA011602NIDA NIH HHS R01 DA012568NIDA NIH HHS U01 DA036935NIMHD NIH HHS G12 MD007583NIMHD NIH HHS U54 MD007587NIMH NIH HHS P30 MH062246PEPFAR
6 · The paper itself

Abstract

introductionTargeted spontaneous reporting (TSR) is a pharmacovigilance method that can enhance reporting of adverse drug reactions related to antiretroviral therapy (ART). Minimal data exist on the needs or capacity of facilities to conduct TSR.

objectivesUsing data from the International epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium, the present study had two objectives: (1) to develop a list of facility characteristics that could constitute key assets in the conduct of TSR; (2) to use this list as a starting point to describe the existing capacity of IeDEA-participating facilities to conduct pharmacovigilance through TSR.

methodsWe generated our facility characteristics list using an iterative approach, through a review of relevant World Health Organization (WHO) and Uppsala Monitoring Centre documents focused on pharmacovigilance activities related to HIV and ART and consultation with expert stakeholders. IeDEA facility data were drawn from a 2009/2010 IeDEA site assessment that included reported characteristics of adult and pediatric HIV care programs, including outreach, staffing, laboratory capacity, adverse event monitoring, and non-HIV care.

resultsA total of 137 facilities were included: East Africa (43); Asia-Pacific (28); West Africa (21); Southern Africa (19); Central Africa (12); Caribbean, Central, and South America (7); and North America (7). Key facility characteristics were grouped as follows: outcome ascertainment and follow-up; laboratory monitoring; documentation-sources and management of data; and human resources. Facility characteristics ranged by facility and region. The majority of facilities reported that patients were assigned a unique identification number (n = 114; 83.2 %) and most sites recorded adverse drug reactions (n = 101; 73.7 %), while 82 facilities (59.9 %) reported having an electronic database on site.

conclusionWe found minimal information is available about facility characteristics that may contribute to pharmacovigilance activities. Our findings, therefore, are a first step that can potentially assist implementers and facility staff to identify opportunities and leverage their existing capacities to incorporate TSR into their routine clinical programs.

Indexed as

PharmacovigilanceAdverse Drug Reaction Reporting SystemsAnti-Retroviral AgentsDatabases, PharmaceuticalDrug-Related Side Effects and Adverse ReactionsHumansInternational CooperationAnti-Retroviral Agents

Identifiers

PMID27282427
PMCPMC5018020
OpenAlexW2413974287

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.