scholarly journals Virtual Data Repository Stimulates Data Sharing in a Consortium

2021 ◽  
Vol 13 (3) ◽  
Author(s):  
Suzanne Siminski Siminski ◽  
Soyeon Kim ◽  
Adel Ahmed ◽  
Jake Currie ◽  
Alex Benns ◽  
...  
Keyword(s):  
Substance Use ◽  
Drug Users ◽  
Data Transfer ◽  
Data Repository ◽  
Common Data Elements ◽  
Substantial Impact ◽  
Wide Range ◽  
Data Elements ◽  
Immunodeficiency Syndrome ◽  
Virtual Data

Abstract Research data may have substantial impact beyond the original study objectives. The Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) facilitates the combination of data and access to specimens from nine NIDA-funded cohorts in a virtual data repository (VDR). Unique challenges were addressed to create the VDR. An initial set of common data elements was agreed upon, selected based on their importance for a wide range of research proposals. Data were mapped to a common set of values. Bioethics consultations resulted in the development of various controls and procedures to protect against inadvertent disclosure of personally identifiable information. Standard operating procedures govern the evaluation of proposed concepts, and specimen and data use agreements ensure proper data handling and storage. Data from eight cohorts have been loaded into a relational database with tables capturing substance use, available specimens, and other participant data. A total of 6,177 participants were seen at a study visit within the past six months and are considered under active follow-up for C3PNO cohort participation as of the third data transfer, which occurred in January 2020. A total of 70,391 biospecimens of various types are available for these participants to test approved scientific hypotheses. Sociodemographic and clinical data accompany these samples. The VDR is a web-based interactive, searchable database available in the public domain, accessed at www.c3pno.org. The VDR are available to inform both consortium and external investigators interested in submitting concept sheets to address novel scientific questions to address high priority research on HIV/AIDS in the context of substance use. Keywords: common data elements, data repository Abbreviations: National Institute on Drug Abuse (NIDA), Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO), human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), injecting drug users (IDU), virtual data repository (VDR) Correspondence: [email protected]*

Abstract 17059: Re-Use of Clinical Trial Data From the NHLBI Data Repository (BioLINCC) for Patient-Level Meta-Analyses of Cardiovascular Outcomes: Challenges and Opportunities

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Helena Sviglin ◽  
Gauri Dandi ◽  
Eileen Navarro Almario ◽  
Tejas Patel ◽  
Colin O Wu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Meta Analysis ◽  
Cardiovascular Outcomes ◽  
Data Repository ◽  
Common Data Elements ◽  
Patient Level Data ◽  
Patient Level ◽  
Level Data ◽  
Data Elements ◽  
Meta Analyses

Introduction: An objective of the Meta-AnalyTical Interagency Group (MATIG) is to conduct patient-level meta-analyses of cardiovascular outcomes using data from publicly available repositories. We describe challenges with data re-use from a seminal trial, provide a systematic approach to identify and curate data elements for hypothesis generation, and establish stackable trials to support these analyses. Methods: We used data from the ACCORD trial to assess risk factors and their gender specific differences for the event of hospitalization or death due to heart failure (hdHF), in patients with type 2 diabetes*. We identified the data elements needed to answer the research questions, reviewed the trial protocol to verify definitions, extracted patient-level data, performed quality assessment and statistical analysis. The results showed a gender difference in the effect of intensive vs. standard glucose-lowering therapy on hdHF. To validate the findings, we sought additional trials in BioLINCC to develop a compendium for meta-analysis, and repeated these steps for each trial. Results: Challenges for reusing the ACCORD trial included access to complete patient-level data and metadata. The compendium, developed to evaluate the stackability** of data across trials, identified differences in trial designs, patient populations, study interventions, and data elements that may impact the feasibility and interpretation of meta-analysis. An example of compendium components is shown in Table 1. Conclusion: High-quality metadata facilitate re-use of trial repository data. This compendium standardizes common data elements for gender, racial and age-group specific outcome assessment in major clinical trials. It provides the framework to assess the fitness of trials for patient-level meta-analyses. Efforts are underway by MATIG to expand the compendium to include risk factors and major cardiovascular outcomes across multiple large trials for meta-analysis.

scholarly journals Clinical Audit of Gabapentin use in a Mental Health Hospital in Qatar

2018 ◽  
Author(s):  
Nervana Elbakary ◽  
Hazem Hashem
Keyword(s):  
Substance Use ◽  
Substance Use Disorder ◽  
Drug Users ◽  
Off Label ◽  
Wide Range ◽  
Potential Abuse ◽  
History Of ◽  
Almost All ◽  
To Receive ◽  
Mental Health Hospital

Bakground: Gabapentin was approved by FDA for the treatment of epilepsy, and as an analgesic for post-herpetic neuralgia (PHN). Gabapentin has been prescribed off-label for a wide range of disorders. Off-label use of gabapentin has been estimated to range from 83 to 95% of all its use. In the last few years, gabapentin has been becoming dispensed extensively for appropriate and inappropriate uses; meanwhile, drug-monitoring agencies have warned for potential abuse liabilities associated with gabapentin. The principal population at risk for addiction consists of patients with history of substance use disorders (SUD), mostly pregabalin and opioids. Purpose: To audit the appropriate use of gabapentin among a cohort of drug users, followed by subgroup analysis to determine the likelihood of drug abuse, misuse and/or diversion. Results: A total of 76 patients were included in the study. 99% of candidates used Gabapentin for off label indications, 30% for managing of behavioral symptoms related to dementia (BPSD). 27%, of the cohort used the medication had a confirmed history of substance-use disorder (SUD). One patient found to receive an inappropriate dose with regard to Creatine clearance Crcl. Conclusion: The data analysis has revealed that almost all gabapentin use in this setting was for off-label indications. Without placing limitations on the prescribing of this medication, it is expected that misuse of it by patients will continue to upsurge. This study highlights the need to standardize a hospital protocol for Gabapentin use within this facility, especially among patients with a history of substance- use disorder.

A Generic Data Harmonization Process for Cross-linked Research and Network Interaction

2015 ◽  
Vol 54 (05) ◽  
pp. 455-460 ◽  
Author(s):  
M. Ganzinger ◽  
T. Muley ◽  
M. Thomas ◽  
P. Knaup ◽  
D. Firnkorn
Keyword(s):  
Lung Cancer ◽  
Research Networks ◽  
Data Set ◽  
Common Data Elements ◽  
Cancer Data ◽  
Data Harmonization ◽  
Wide Range ◽  
Harmonization Process ◽  
Cancer Phenotype ◽  
Data Elements

Summary Objective: Joint data analysis is a key requirement in medical research networks. Data are available in heterogeneous formats at each network partner and their harmonization is often rather complex. The objective of our paper is to provide a generic approach for the harmonization process in research networks. We applied the process when harmonizing data from three sites for the Lung Cancer Phenotype Database within the German Center for Lung Research. Methods: We developed a spreadsheet-based solution as tool to support the harmonization process for lung cancer data and a data integration procedure based on Talend Open Studio. Results: The harmonization process consists of eight steps describing a systematic approach for defining and reviewing source data elements and standardizing common data elements. The steps for defining common data elements and harmonizing them with local data definitions are repeated until consensus is reached. Application of this process for building the phenotype database led to a common basic data set on lung cancer with 285 structured parameters. The Lung Cancer Phenotype Database was realized as an i2b2 research data warehouse. Conclusion: Data harmonization is a challenging task requiring informatics skills as well as domain knowledge. Our approach facilitates data harmonization by providing guidance through a uniform process that can be applied in a wide range of projects.

Common data elements for substance use disorders in electronic health records: the NIDA Clinical Trials Network experience

Addiction ◽  
2012 ◽  
Vol 108 (1) ◽  
pp. 3-8 ◽  
Author(s):  
Udi E. Ghitza ◽  
Robert E. Gore-Langton ◽  
Robert Lindblad ◽  
David Shide ◽  
Geetha Subramaniam ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Substance Use ◽  
Electronic Health Records ◽  
Substance Use Disorders ◽  
Common Data Elements ◽  
Health Records ◽  
Electronic Health ◽  
Data Elements

Cultural Accommodation of Internet-Based Interventions for Substance Use and Related Disorders: A Proposed Comprehensive Framework (Preprint)

2019 ◽  
Author(s):  
Keren Gueta ◽  
Yossi Harel-Fisch ◽  
Sophie D. Walsh
Keyword(s):  
Substance Use ◽  
Ecological Validity ◽  
Limited Attention ◽  
Diverse Range ◽  
Four Dimensions ◽  
Service Engagement ◽  
Wide Range ◽  
Cultural Accommodation ◽  
Abuse Treatment ◽  
Comprehensive Framework

BACKGROUND Despite the low utilization rates of substance use and related disorders services, and the ability of internet-based interventions for substance use and related disorders (IBIS) to address challenges related to service engagement, limited attention has been placed on the processes for the accommodation of these interventions to diverse cultural settings. OBJECTIVE The purpose of this study was to develop a conceptual framework for the cultural accommodation of IBIS across populations, settings, and countries. METHODS A pilot study of cultural accommodation of an existing internet intervention for alcohol use (Down Your Drink (DYD)), focus groups and daily online surveys of prospective consumers (N=24) and interviews with experts (N=7) in the substance abuse treatment field were conducted. RESULTS Thematic analysis revealed a wide range of themes identified as needing to be addressed in the process of DYD accommodation. It also emphasized that accommodation needs to incorporate both technical and contents themes, shaped by both the general Israeli cultural as well as by the specific Israeli drinking subculture. A combined mixed emic–etic theoretical approach incorporating the pilot findings together with a scoping literature review was employed to develop a framework for cultural accommodation of IBIS. A comprehensive framework for cultural accommodation of IBIS is introduced consisting of five chronological stages of IBIS accommodation and four dimensions of accommodation. CONCLUSIONS The proposed framework can serve as a guide for the cultural accommodation of existing IBIS across a diverse range of cultural and geographical settings thus augmenting the ecological validity of IBIS and reducing health disparities worldwide.

scholarly journals TBI surveillance using the common data elements for traumatic brain injury: a population study

2013 ◽  
Vol 6 (1) ◽  
Author(s):  
Latha Ganti Stead ◽  
◽  
Aakash N Bodhit ◽  
Pratik Shashikant Patel ◽  
Yasamin Daneshvar ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Population Study ◽  
Common Data Elements ◽  
The Common ◽  
Data Elements

Effects of Atovaquone on the Ultrastructural Morphology of Pneumocystis Carinii

1997 ◽  
Vol 3 (S2) ◽  
pp. 81-82
Author(s):  
M.P. Goheen ◽  
M.S. Bartlett ◽  
M.M. Shaw ◽  
S.R. Meshnick ◽  
J.W. Smith
Keyword(s):  
Adverse Reactions ◽  
Pneumocystis Carinii ◽  
Spinner Flask ◽  
Short Term ◽  
Human Embryonic Lung ◽  
Transmission Electron ◽  
Significant Incidence ◽  
Wide Range ◽  
Acquired Immunodeficiency ◽  
Immunodeficiency Syndrome

Pneumocystis carinii pneumonia (PCP) occurs at some time in most patients with acquired immunodeficiency syndrome (AIDS). Trimethoprim/sulfamethoxazole or pentamidine isothionate are the traditional modes of therapy for treatment and prophylaxis of PCP. Unfortunately these drugs are associated with a significant incidence of adverse side effects particularly in patients with AIDS. Toxicity and a growing concern that P. carinii strains are becoming resistant to these compounds is providing the impetus for the search for additional drugs to combat P. carinii. Atovaquone, developed as an antimalarial agent, has activity against a wide range of other organisms, including Toxoplasma sp. and P. carinii, with a lower incidence of adverse reactions during clinical trials. Atovaquone inhibits mitochondrial respiration in P. falciparum and P. carinii. In this study transmission electron microscopy (TEM) was used to observe the effects of atovaquone on P. carinii organisms in short term spinner flask culture.Spinner flask cultures of human embryonic lung cells were inoculated with P. carinii from infected rat lung.

Substance Use and Peers During Adolescence and the Transition to Adulthood

2014 ◽  
Author(s):  
Megan E. Patrick ◽  
John E. Schulenberg ◽  
Jennifer Maggs ◽  
Julie Maslowsky
Keyword(s):  
Substance Use ◽  
Peer Relationships ◽  
Social Relationships ◽  
Transition To Adulthood ◽  
Peer Relations ◽  
Peer Groups ◽  
Social Contexts ◽  
Cigarette Use ◽  
Developmental Transitions ◽  
Wide Range

This chapter summarizes recent literature concerning the connection between peers and substance use (i.e., alcohol use, cigarette use, and illicit drug use) during adolescence and the transition to adulthood. The broad category of peers consists of a wide range of social relationships including best friends, peer groups, and crowds; important aspects include peer activities, relationships, and influence. Young people both select their friends (e.g., based on shared interests) and are influenced, or socialized, by their selected peers. When examining the dynamic periods of life that cover the transitions into, through, and out of adolescence and into the post-high school years, selection and socialization are especially important, given that many transitions involve changes in social contexts and peer relationships. The authors take a developmental perspective by focusing on the developmental transitions that occur during adolescence and the transition to adulthood and how they influence peer relations and substance use.

scholarly journals Effects of lowered serotonin transmission on cocaine-induced striatal dopamine response: PET [11C]raclopride study in humans

2011 ◽  
Vol 199 (5) ◽  
pp. 391-397 ◽  
Author(s):  
Sylvia M. L. Cox ◽  
Chawki Benkelfat ◽  
Alain Dagher ◽  
J. Scott Delaney ◽  
France Durand ◽  
...  
Keyword(s):  
Substance Use ◽  
Substance Use Disorders ◽  
Striatal Dopamine ◽  
Emission Tomography ◽  
Acute Tryptophan Depletion ◽  
Tryptophan Depletion ◽  
Comorbid Conditions ◽  
Drug Craving ◽  
Positron Emission ◽  
Wide Range

BackgroundLow serotonin transmission is thought to increase susceptibility to a wide range of substance use disorders and impulsive traits.AimsTo investigate the effects of lowered serotonin on cocaine-induced (1.0 mg/kg cocaine, self-administered intranasally) dopamine responses and drug craving.MethodIn non-dependent cocaine users, serotonin transmission was reduced using the acute tryptophan depletion method. Striatal dopamine responses were measured using positron emission tomography with [11C]raclopride.ResultsAcute tryptophan depletion increased drug craving and striatal dopamine responses to cocaine. These acute tryptophan depletion-induced increases did not occur in the absence of cocaine.ConclusionsThe results suggest that low serotonin transmission can increase dopaminergic and appetitive responses to cocaine. These findings might identify a mechanism by which individuals with low serotonin are at elevated risk for both substance use disorders and comorbid conditions.

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