The Biomedical Informatics Section (BIS) is committed to supporting the IRP in the following ways:
- Development of a comprehensive intelligent clinical decision support system through application of knowledge discovery in databases and other advanced techniques.
- Conduct of research in theoretical and applied areas of medical and clinical informatics and study of new methods for acquiring, representing, processing, and managing knowledge and data within the IRP’s clinical and research programs.
- Development of transactional electronic recording and telemetry solutions for implementation in various research environments such as clinical neuroimaging, pharmacology & therapeutics and nicotine psychopharmacology research.
- Development of innovative field-deployable tools to measure exposures to psychosocial stress and addictive substances within geographic contexts in real time.
- Development of a comprehensive automated animal study protocols management, review and approval system to validate the status of various protocols; and management of multi-site necropsy facilities.
- Conduct research in generalization of an automated contingency management for delivery of behavioral interventions and expansion of its scope to encompass other fields and special populations such as people with mental illness, pregnant women, alcohol abusers and adolescents.
- Exploration of development and implementation of an informatics platform for the management, retrieval and communication of neuroimaging archives integrated with IRP’s other research information systems.
Selected Publications
2010
Vahabzadeh, Massoud; Mezghanni, Mustapha; Lin, Jia-Ling; Epstein, David H.; Preston, Kenzie L.
PGIS: Electronic diary data integration with GPS data initial application in substance-abuse patients Presentation
12.10.2010.
@misc{Vahabzadeh2010,
title = {PGIS: Electronic diary data integration with GPS data initial application in substance-abuse patients},
author = {Massoud Vahabzadeh and Mustapha Mezghanni and Jia-Ling Lin and David H. Epstein and Kenzie L. Preston},
url = {http://ieeexplore.ieee.org/document/6042691/},
doi = {10.1109/CBMS.2010.6042691},
year = {2010},
date = {2010-10-12},
abstract = {Quantification of exposure to psychosocial stressors and drug availability might assist in the prevention and treatment of substance-use problems. The core of such interventions lies in combining real-time self-report data (via Ecological Momentary Assessment, EMA) with real-time geolocation data (via GPS logging). Combining these types of data and linking the result with patients' clinical research records has inherent technical challenges. In this paper, we describe how we have addressed those challenges with our Psychosocial Geolocation Integration System (PGIS), which we successfully used in two clinical studies involving polydrug-abusing participants.},
keywords = {},
pubstate = {published},
tppubtype = {presentation}
}
Quantification of exposure to psychosocial stressors and drug availability might assist in the prevention and treatment of substance-use problems. The core of such interventions lies in combining real-time self-report data (via Ecological Momentary Assessment, EMA) with real-time geolocation data (via GPS logging). Combining these types of data and linking the result with patients' clinical research records has inherent technical challenges. In this paper, we describe how we have addressed those challenges with our Psychosocial Geolocation Integration System (PGIS), which we successfully used in two clinical studies involving polydrug-abusing participants.
2009
Preston, Kenzie L; Vahabzadeh, Massoud; Schmittner, John; Lin, Jia-Ling; Gorelick, David A; Epstein, David H
Cocaine craving and use during daily life. Journal Article
In: Psychopharmacology (Berl), vol. 207, no. 2, pp. 291–301, 2009, ISSN: 1432-2072 (Electronic); 0033-3158 (Linking).
@article{Preston:2009aa,
title = {Cocaine craving and use during daily life.},
author = {Kenzie L Preston and Massoud Vahabzadeh and John Schmittner and Jia-Ling Lin and David A Gorelick and David H Epstein},
url = {https://www.ncbi.nlm.nih.gov/pubmed/19777216},
doi = {10.1007/s00213-009-1655-8},
issn = {1432-2072 (Electronic); 0033-3158 (Linking)},
year = {2009},
date = {2009-12-01},
journal = {Psychopharmacology (Berl)},
volume = {207},
number = {2},
pages = {291--301},
address = {Treatment Section, Clinical Pharmacology and Therapeutics Research Branch, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, MD 21224, USA. kpreston@intra.nida.nih.gov},
abstract = {RATIONALE: Craving is often assumed to cause ongoing drug use and relapse and is a major focus of addiction research. However, its relationship to drug use has not been adequately documented. OBJECTIVES: The aim of this study was to investigate the relationship between craving and drug use in real time and in the daily living environments of drug users. METHODS: In a prospective, longitudinal, cohort design (ecological momentary assessment), 112 cocaine-abusing individuals in methadone maintenance treatment rated their craving and mood at random times (two to five times daily, prompted by electronic diaries) as they went about their everyday activities. They also initiated an electronic diary entry each time they used cocaine. Drug use was monitored by thrice-weekly urine testing. RESULTS: During periods of urine-verified cocaine use, ratings of cocaine craving increased across the day and were higher than during periods of urine-verified abstinence. During the 5 h prior to cocaine use, ratings of craving significantly increased. These patterns were not seen in ratings of heroin craving or mood (e.g., feeling happy or bored). CONCLUSIONS: Cocaine craving is tightly coupled to cocaine use in users' normal environments. Our findings provide previously unavailable support for a relationship that has been seriously questioned in some theoretical accounts. We discuss what steps will be needed to determine whether craving causes use.},
keywords = {},
pubstate = {published},
tppubtype = {article}
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RATIONALE: Craving is often assumed to cause ongoing drug use and relapse and is a major focus of addiction research. However, its relationship to drug use has not been adequately documented. OBJECTIVES: The aim of this study was to investigate the relationship between craving and drug use in real time and in the daily living environments of drug users. METHODS: In a prospective, longitudinal, cohort design (ecological momentary assessment), 112 cocaine-abusing individuals in methadone maintenance treatment rated their craving and mood at random times (two to five times daily, prompted by electronic diaries) as they went about their everyday activities. They also initiated an electronic diary entry each time they used cocaine. Drug use was monitored by thrice-weekly urine testing. RESULTS: During periods of urine-verified cocaine use, ratings of cocaine craving increased across the day and were higher than during periods of urine-verified abstinence. During the 5 h prior to cocaine use, ratings of craving significantly increased. These patterns were not seen in ratings of heroin craving or mood (e.g., feeling happy or bored). CONCLUSIONS: Cocaine craving is tightly coupled to cocaine use in users' normal environments. Our findings provide previously unavailable support for a relationship that has been seriously questioned in some theoretical accounts. We discuss what steps will be needed to determine whether craving causes use.
Vahabzadeh, Massoud; Lin, Jia-Ling; Mezghanni, Mustapha; Epstein, David H; Preston, Kenzie L
In: Drug Alcohol Rev, vol. 28, no. 1, pp. 3–11, 2009, ISSN: 1465-3362 (Electronic); 0959-5236 (Linking), (https://www.ncbi.nlm.nih.gov/pubmed/19320669).
@article{Vahabzadeh:2009aa,
title = {Automation in an addiction treatment research clinic: computerised contingency management, ecological momentary assessment and a protocol workflow system.},
author = {Massoud Vahabzadeh and Jia-Ling Lin and Mustapha Mezghanni and David H Epstein and Kenzie L Preston},
doi = {10.1111/j.1465-3362.2008.00007.x},
issn = {1465-3362 (Electronic); 0959-5236 (Linking)},
year = {2009},
date = {2009-01-01},
journal = {Drug Alcohol Rev},
volume = {28},
number = {1},
pages = {3--11},
address = {Biomedical Informatics Section, Administrative Management Branch, Intramural Research Program, National Institute on Drug Abuse, NIH/DHHS, Baltimore, Maryland 21224, USA. massoudv@nih.gov},
abstract = {INTRODUCTION AND AIMS: A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients' treatment needs and to accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with the provision of seamless methods for exporting, mining and querying the data. DESIGN AND METHODS: We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialised applications: the Automated Contingency Management (ACM) system for the delivery of behavioural interventions, the transactional electronic diary (TED) system for the management of behavioural assessments and the Protocol Workflow System (PWS) for computerised workflow automation and guidance of each participant's daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorised staff. RESULTS: ACM and the TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80 patient capacity, having an annual average of 18,000 patient visits and 7300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarise participant safety data for research oversight. DISCUSSION AND CONCLUSIONS: When developed in consultation with end users, automation in treatment research clinics can enable more efficient operations, better communication among staff and expansions in research methods.},
note = {https://www.ncbi.nlm.nih.gov/pubmed/19320669},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
INTRODUCTION AND AIMS: A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients' treatment needs and to accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with the provision of seamless methods for exporting, mining and querying the data. DESIGN AND METHODS: We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialised applications: the Automated Contingency Management (ACM) system for the delivery of behavioural interventions, the transactional electronic diary (TED) system for the management of behavioural assessments and the Protocol Workflow System (PWS) for computerised workflow automation and guidance of each participant's daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorised staff. RESULTS: ACM and the TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80 patient capacity, having an annual average of 18,000 patient visits and 7300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarise participant safety data for research oversight. DISCUSSION AND CONCLUSIONS: When developed in consultation with end users, automation in treatment research clinics can enable more efficient operations, better communication among staff and expansions in research methods.
Epstein, David H; Willner-Reid, Jessica; Vahabzadeh, Massoud; Mezghanni, Mustapha; Lin, Jia-Ling; Preston, Kenzie L
Real-time electronic diary reports of cue exposure and mood in the hours before cocaine and heroin craving and use. Journal Article
In: Arch Gen Psychiatry, vol. 66, no. 1, pp. 88–94, 2009, ISSN: 1538-3636 (Electronic); 0003-990X (Linking).
@article{Epstein:2009aa,
title = {Real-time electronic diary reports of cue exposure and mood in the hours before cocaine and heroin craving and use.},
author = {David H Epstein and Jessica Willner-Reid and Massoud Vahabzadeh and Mustapha Mezghanni and Jia-Ling Lin and Kenzie L Preston},
url = {https://www.ncbi.nlm.nih.gov/pubmed/19124692},
doi = {10.1001/archgenpsychiatry.2008.509},
issn = {1538-3636 (Electronic); 0003-990X (Linking)},
year = {2009},
date = {2009-01-01},
journal = {Arch Gen Psychiatry},
volume = {66},
number = {1},
pages = {88--94},
address = {National Institute on Drug Abuse Intramural Research Program, Treatment Section, Clinical Pharmacology and Therapeutics Branch, Baltimore, MD 21224, USA. depstein@intra.nida.nih.gov},
abstract = {CONTEXT: In ecological momentary assessment (EMA), participants electronically report their activities and moods in their daily environments in real time, enabling a truly prospective approach to the study of acute precipitants of behavioral events. Ecological momentary assessment has greatly enhanced the study of tobacco addiction, but its use has rarely been attempted in individuals with cocaine or heroin addiction. OBJECTIVE: To prospectively monitor the acute daily life precipitants of craving for and use of cocaine and heroin. DESIGN: Cohort study. PARTICIPANTS: A volunteer sample of 114 cocaine- and heroin-abusing outpatients who were being treated with methadone provided EMA data on handheld electronic devices for 14 918 person-days (mean, 130.9; range, 6-189 days per participant). Of these outpatients, a total of 102 (63 men, 39 women) provided acute precraving and/or preuse data and were thus included in the present analyses. MAIN OUTCOME MEASURES: Changes in reports of mood and exposure to 12 putative drug-use triggers at random intervals during the 5 hours preceding each self-reported episode of drug craving or use, analyzed via repeated-measures logistic regression (generalized linear mixed models). RESULTS: During the 5 hours preceding cocaine use or heroin craving, most of the 12 putative triggers showed linear increases. Cocaine use was most robustly associated with increases in participants reporting that they "saw [the] drug" (P < .001), were "tempted to use out of the blue" (P < .001), "wanted to see what would happen if I used" (P < .001), and were in a good mood (P < .001). Heroin craving was most robustly associated with increases in reports of feeling sad (P < .001) or angry (P = .01). Cocaine craving and heroin use showed few reliable associations with any of the putative triggers assessed. CONCLUSIONS: These findings confirm that polydrug-abusing individuals can provide behavioral data in their daily environments using handheld electronic devices and that those data can reveal orderly patterns, including prospectively detectable harbingers of craving and use, which may differ across drugs.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
CONTEXT: In ecological momentary assessment (EMA), participants electronically report their activities and moods in their daily environments in real time, enabling a truly prospective approach to the study of acute precipitants of behavioral events. Ecological momentary assessment has greatly enhanced the study of tobacco addiction, but its use has rarely been attempted in individuals with cocaine or heroin addiction. OBJECTIVE: To prospectively monitor the acute daily life precipitants of craving for and use of cocaine and heroin. DESIGN: Cohort study. PARTICIPANTS: A volunteer sample of 114 cocaine- and heroin-abusing outpatients who were being treated with methadone provided EMA data on handheld electronic devices for 14 918 person-days (mean, 130.9; range, 6-189 days per participant). Of these outpatients, a total of 102 (63 men, 39 women) provided acute precraving and/or preuse data and were thus included in the present analyses. MAIN OUTCOME MEASURES: Changes in reports of mood and exposure to 12 putative drug-use triggers at random intervals during the 5 hours preceding each self-reported episode of drug craving or use, analyzed via repeated-measures logistic regression (generalized linear mixed models). RESULTS: During the 5 hours preceding cocaine use or heroin craving, most of the 12 putative triggers showed linear increases. Cocaine use was most robustly associated with increases in participants reporting that they "saw [the] drug" (P < .001), were "tempted to use out of the blue" (P < .001), "wanted to see what would happen if I used" (P < .001), and were in a good mood (P < .001). Heroin craving was most robustly associated with increases in reports of feeling sad (P < .001) or angry (P = .01). Cocaine craving and heroin use showed few reliable associations with any of the putative triggers assessed. CONCLUSIONS: These findings confirm that polydrug-abusing individuals can provide behavioral data in their daily environments using handheld electronic devices and that those data can reveal orderly patterns, including prospectively detectable harbingers of craving and use, which may differ across drugs.
2008
Ghitza, Udi E; Epstein, David H; Schmittner, John; Vahabzadeh, Massoud; Lin, Jia-Ling; Preston, Kenzie L
Effect of reinforcement probability and prize size on cocaine and heroin abstinence in prize-based contingency management. Journal Article
In: J Appl Behav Anal, vol. 41, no. 4, pp. 539–549, 2008, ISSN: 0021-8855 (Print); 0021-8855 (Linking).
@article{Ghitza:2008aa,
title = {Effect of reinforcement probability and prize size on cocaine and heroin abstinence in prize-based contingency management.},
author = {Udi E Ghitza and David H Epstein and John Schmittner and Massoud Vahabzadeh and Jia-Ling Lin and Kenzie L Preston},
url = {https://www.ncbi.nlm.nih.gov/pubmed/19192858},
issn = {0021-8855 (Print); 0021-8855 (Linking)},
year = {2008},
date = {2008-01-01},
journal = {J Appl Behav Anal},
volume = {41},
number = {4},
pages = {539--549},
address = {National Institute on Drug Abuse, Clinical Pharmacology and Therapeutics Research Branch/Treatment Section, 251 Bayview Boulevard, Suite 200, Baltimore, Maryland 21224, USA. ghitzau@nida.nih.gov},
abstract = {Although treatment outcome in prize-based contingency management has been shown to depend on reinforcement schedule, the optimal schedule is still unknown. Therefore, we conducted a retrospective analysis of data from a randomized clinical trial (Ghitza et al., 2007) to determine the effects of the probability of winning a prize (low vs. high) and the size of the prize won (small, large, or jumbo) on likelihood of abstinence until the next urine-collection day for heroin and cocaine users (N=116) in methadone maintenance. Higher probability of winning, but not the size of individual prizes, was associated with a greater percentage of cocaine-negative, but not opiate-negative, urines.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Although treatment outcome in prize-based contingency management has been shown to depend on reinforcement schedule, the optimal schedule is still unknown. Therefore, we conducted a retrospective analysis of data from a randomized clinical trial (Ghitza et al., 2007) to determine the effects of the probability of winning a prize (low vs. high) and the size of the prize won (small, large, or jumbo) on likelihood of abstinence until the next urine-collection day for heroin and cocaine users (N=116) in methadone maintenance. Higher probability of winning, but not the size of individual prizes, was associated with a greater percentage of cocaine-negative, but not opiate-negative, urines.
2007
Vahabzadeh, Massoud; Lin, Jia-Ling; Mezghanni, Mustapha; Contoreggi, Carlo; Leff, Michelle
A clinical recruiting management system for complex multi-site clinical trials using qualification decision support systems. Journal Article
In: AMIA Annu Symp Proc, pp. 1141, 2007, ISSN: 1942-597X (Electronic); 1559-4076 (Linking).
@article{Vahabzadeh:2007aa,
title = {A clinical recruiting management system for complex multi-site clinical trials using qualification decision support systems.},
author = {Massoud Vahabzadeh and Jia-Ling Lin and Mustapha Mezghanni and Carlo Contoreggi and Michelle Leff},
url = {https://www.ncbi.nlm.nih.gov/pubmed/18694237},
issn = {1942-597X (Electronic); 1559-4076 (Linking)},
year = {2007},
date = {2007-10-11},
journal = {AMIA Annu Symp Proc},
pages = {1141},
address = {DHHS, NIH, National Institute of Drug Abuse, Intramural Research Program, USA.},
abstract = {A clinical recruiting management system with qualification decision support systems was developed to increase the efficiency of screening and evaluation of participants during a recruiting process whereby recruiting for various protocols are conducted at multiple sites by different groups with process interdependencies. This system is seamlessly integrated into our enterprise-scale Human Research Information System (HuRIS), encompassing research participants' electronic health records (EHR), with real-time access to the clinical trial data.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
A clinical recruiting management system with qualification decision support systems was developed to increase the efficiency of screening and evaluation of participants during a recruiting process whereby recruiting for various protocols are conducted at multiple sites by different groups with process interdependencies. This system is seamlessly integrated into our enterprise-scale Human Research Information System (HuRIS), encompassing research participants' electronic health records (EHR), with real-time access to the clinical trial data.
Ghitza, Udi E; Epstein, David H; Schmittner, John; Vahabzadeh, Massoud; Lin, Jia-Ling; Preston, Kenzie L
Randomized trial of prize-based reinforcement density for simultaneous abstinence from cocaine and heroin. Journal Article
In: J Consult Clin Psychol, vol. 75, no. 5, pp. 765–774, 2007, ISSN: 0022-006X (Print); 0022-006X (Linking).
@article{Ghitza:2007aa,
title = {Randomized trial of prize-based reinforcement density for simultaneous abstinence from cocaine and heroin.},
author = {Udi E Ghitza and David H Epstein and John Schmittner and Massoud Vahabzadeh and Jia-Ling Lin and Kenzie L Preston},
url = {https://www.ncbi.nlm.nih.gov/pubmed/17907858},
doi = {10.1037/0022-006X.75.5.765},
issn = {0022-006X (Print); 0022-006X (Linking)},
year = {2007},
date = {2007-10-01},
journal = {J Consult Clin Psychol},
volume = {75},
number = {5},
pages = {765--774},
address = {Treatment Section, Clinical Pharmacology and Therapeutics Branch, Intramural Research Program (IRP), National Institute on Drug Abuse (NIDA), National Institute of Health (NIH), MD, USA. ghitzau@intra.nida.nih.gov},
abstract = {To examine the effect of reinforcer density in prize-based abstinence reinforcement, heroin/cocaine users (N = 116) in methadone maintenance (100 mg/day) were randomly assigned to a noncontingent control group (NonC) or to 1 of 3 groups that earned prize draws for abstinence: manual drawing with standard prize density (MS) or computerized drawing with standard (CS) or high (CH) density. Probabilities (prizes/draw) were standard (50%) and high (78%); prize density was double blind. Mean prize values were CH, $286; CS, $167; MS, $139; and NonC, $171. Outcomes were % opioid/cocaine-negative urines during the 12-week intervention and then 8 weeks postintervention as well as diagnosis of dependence up to 6 months poststudy. CH had significantly more negative specimens than did NonC during intervention and had more than all groups during postintervention treatment: Mean % negative (95% confidence interval) during postintervention treatment adjusted for baseline drug use and dropout were CH, 55% (14%-90%); CS, 7% (1%-27%); MS, 4% (1%-12%); and NonC, 3% (1%-10%). Current cocaine dependence diagnoses after treatment were significantly lower in contingent compared with noncontingent groups. Computerized drawing with higher-density prizes enhanced reduction of cocaine use; abstinence reinforcement had long-term therapeutic benefits.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
To examine the effect of reinforcer density in prize-based abstinence reinforcement, heroin/cocaine users (N = 116) in methadone maintenance (100 mg/day) were randomly assigned to a noncontingent control group (NonC) or to 1 of 3 groups that earned prize draws for abstinence: manual drawing with standard prize density (MS) or computerized drawing with standard (CS) or high (CH) density. Probabilities (prizes/draw) were standard (50%) and high (78%); prize density was double blind. Mean prize values were CH, $286; CS, $167; MS, $139; and NonC, $171. Outcomes were % opioid/cocaine-negative urines during the 12-week intervention and then 8 weeks postintervention as well as diagnosis of dependence up to 6 months poststudy. CH had significantly more negative specimens than did NonC during intervention and had more than all groups during postintervention treatment: Mean % negative (95% confidence interval) during postintervention treatment adjusted for baseline drug use and dropout were CH, 55% (14%-90%); CS, 7% (1%-27%); MS, 4% (1%-12%); and NonC, 3% (1%-10%). Current cocaine dependence diagnoses after treatment were significantly lower in contingent compared with noncontingent groups. Computerized drawing with higher-density prizes enhanced reduction of cocaine use; abstinence reinforcement had long-term therapeutic benefits.
2005
Vahabzadeh, Massoud; Lin, Jia-Ling; Mezghanni, Mustapha; Gupman, Anne E.; Schmittner, John; and Kenzie L. Preston,
An Adaptable Assessment Generation System for Clinical Trials Complementing Human Research Information System Presentation
01.06.2005.
@misc{Vahabzadeh2005,
title = {An Adaptable Assessment Generation System for Clinical Trials Complementing Human Research Information System},
author = {Massoud Vahabzadeh and Jia-Ling Lin and Mustapha Mezghanni and Anne E. Gupman and John Schmittner and and Kenzie L. Preston},
url = {http://ieeexplore.ieee.org/document/1467689/},
doi = {10.1109/CBMS.2005.23},
year = {2005},
date = {2005-06-01},
abstract = {Abstract:
Computerized testing methods have long been used for presenting clinical questionnaires and are regarded as an efficient and accurate data collection mechanism in human research settings. In order to adapt to the constant addition of new research protocols and incorporate the new data collection forms and questionnaires into our computerized medical information environment, it is necessary to have a solution that requires no modifications to the source code for creating new questionnaires and renders the results in a Web browser-based format that can be seamlessly integrated into our patient records system. In this paper we describe our test and questionnaire system (TQS) that addresses our requirements and provides full-page browser-based assessments. In addition to managing the new questionnaires, TQS seamlessly communicates and incorporates the clinician-generated assessments built on and for a handheld electronic diary system and provides a powerful and user-friendly data extraction mechanism that allows full or selective data export for further analysis. This solution not only employs both a generic building tool and a flexible data model, but also renders the required questionnaires in a Web browser-based environment making it possible for the collected data to become an integral part of our browser-based human research information system. Since its implementation 4 years ago, this system has been used to generate approximately 300 questionnaires at our site and is designed to provide the necessary adaptability and flexibility required for all of the current and potentially a very high percentage of future protocols.},
keywords = {},
pubstate = {published},
tppubtype = {presentation}
}
Abstract:
Computerized testing methods have long been used for presenting clinical questionnaires and are regarded as an efficient and accurate data collection mechanism in human research settings. In order to adapt to the constant addition of new research protocols and incorporate the new data collection forms and questionnaires into our computerized medical information environment, it is necessary to have a solution that requires no modifications to the source code for creating new questionnaires and renders the results in a Web browser-based format that can be seamlessly integrated into our patient records system. In this paper we describe our test and questionnaire system (TQS) that addresses our requirements and provides full-page browser-based assessments. In addition to managing the new questionnaires, TQS seamlessly communicates and incorporates the clinician-generated assessments built on and for a handheld electronic diary system and provides a powerful and user-friendly data extraction mechanism that allows full or selective data export for further analysis. This solution not only employs both a generic building tool and a flexible data model, but also renders the required questionnaires in a Web browser-based environment making it possible for the collected data to become an integral part of our browser-based human research information system. Since its implementation 4 years ago, this system has been used to generate approximately 300 questionnaires at our site and is designed to provide the necessary adaptability and flexibility required for all of the current and potentially a very high percentage of future protocols.
Computerized testing methods have long been used for presenting clinical questionnaires and are regarded as an efficient and accurate data collection mechanism in human research settings. In order to adapt to the constant addition of new research protocols and incorporate the new data collection forms and questionnaires into our computerized medical information environment, it is necessary to have a solution that requires no modifications to the source code for creating new questionnaires and renders the results in a Web browser-based format that can be seamlessly integrated into our patient records system. In this paper we describe our test and questionnaire system (TQS) that addresses our requirements and provides full-page browser-based assessments. In addition to managing the new questionnaires, TQS seamlessly communicates and incorporates the clinician-generated assessments built on and for a handheld electronic diary system and provides a powerful and user-friendly data extraction mechanism that allows full or selective data export for further analysis. This solution not only employs both a generic building tool and a flexible data model, but also renders the required questionnaires in a Web browser-based environment making it possible for the collected data to become an integral part of our browser-based human research information system. Since its implementation 4 years ago, this system has been used to generate approximately 300 questionnaires at our site and is designed to provide the necessary adaptability and flexibility required for all of the current and potentially a very high percentage of future protocols.
Lin, Jia-Ling; Vahabzadeh, Massoud; Mezghanni, Mustapha; Epstein, David H; Preston, Kenzie L
DHHS/National Institutes Health, National Institutes on Drug Abuse, Intramural Research Program, USA., 01.02.2005, ISSN: 1942-597X (Electronic); 1559-4076 (Linking).
@misc{Lin2005,
title = {A high-level specification for adaptive ecological momentary assessment: real-time assessment of drug craving, use and abstinence.},
author = {Jia-Ling Lin and Massoud Vahabzadeh and Mustapha Mezghanni and David H Epstein and Kenzie L Preston},
url = {https://www.ncbi.nlm.nih.gov/pubmed/16779081},
issn = {1942-597X (Electronic); 1559-4076 (Linking)},
year = {2005},
date = {2005-02-01},
journal = {AMIA Annu Symp Proc},
pages = {455--459},
address = {DHHS/National Institutes Health, National Institutes on Drug Abuse, Intramural Research Program, USA.},
abstract = {In psychological research, efforts to capture day-to-day human experience traditionally relied on pen-and-paper diaries and questionnaires. Some current studies, however, incorporate handheld computers, which provide researchers with many options and advantages in addition to providing more reliable data. One advantage of using handheld computers is the programmability of the electronic diary, which, compared to old-fashioned paper diaries, affords the researchers with a wealth of possibilities. An important possibility is to construct a built-in mechanism in the computer-administered questionnaires that would allow transparent branching, in which question presentation is contingent on participants' answers to previous questions. The major hurdle in implementing such an approach is the limitations of the platform used for such assessments: inexpensive "low-end" handheld devices. We propose a high-level specification which enables non-programming researchers to "branch" their questionnaires without modifications to the source code in a highly user-friendly fashion, with backtracking capability and very modest hardware requirements. A finite state automaton approach was implemented, we believe for the first time, to create an auto-trigger mechanism for the real-time evaluation of the conditions. This solution provides our investigators with the capacity to administer efficient assessments that are dynamically customized to reflect participants' behaviors without the need for any post-production programming.},
keywords = {},
pubstate = {published},
tppubtype = {presentation}
}
In psychological research, efforts to capture day-to-day human experience traditionally relied on pen-and-paper diaries and questionnaires. Some current studies, however, incorporate handheld computers, which provide researchers with many options and advantages in addition to providing more reliable data. One advantage of using handheld computers is the programmability of the electronic diary, which, compared to old-fashioned paper diaries, affords the researchers with a wealth of possibilities. An important possibility is to construct a built-in mechanism in the computer-administered questionnaires that would allow transparent branching, in which question presentation is contingent on participants' answers to previous questions. The major hurdle in implementing such an approach is the limitations of the platform used for such assessments: inexpensive "low-end" handheld devices. We propose a high-level specification which enables non-programming researchers to "branch" their questionnaires without modifications to the source code in a highly user-friendly fashion, with backtracking capability and very modest hardware requirements. A finite state automaton approach was implemented, we believe for the first time, to create an auto-trigger mechanism for the real-time evaluation of the conditions. This solution provides our investigators with the capacity to administer efficient assessments that are dynamically customized to reflect participants' behaviors without the need for any post-production programming.
2004
Vahabzadeh, Massoud; Lin, Jia-Ling; Gupman, Anne; Schmittner, John; Preston, Kenzie
Automating variations in clinical research protocols workflow Presentation
25.06.2004.
@misc{Vahabzadeh2004,
title = {Automating variations in clinical research protocols workflow},
author = {Massoud Vahabzadeh and Jia-Ling Lin and Anne Gupman and John Schmittner and Kenzie Preston},
url = {http://ieeexplore.ieee.org/document/1311723/},
doi = {10.1109/CBMS.2004.1311723},
year = {2004},
date = {2004-06-25},
abstract = {Clinical research protocols follow rigorous methodologies requiring painstaking precision in every step of the process. A variety of factors determine the required steps an individual participant will take throughout the protocol timeline. Such steps could easily become more complicated and complex in a research setting aimed at new discoveries, which require various degrees of flexibility depending on the specific conditions at various points of the study. In this paper we describe our protocol workflow system (PWS), which is designed to accommodate all of the current and potential future protocols while simultaneously providing the capability for workflow adjustments during various phases of ongoing studies. Furthermore, it is robust enough to organize and handle participants who are enrolled concurrently in multiple protocols. This automated system not only collects information at an outpatient research center, but also automates the workflow and data collection points throughout the clinic.},
keywords = {},
pubstate = {published},
tppubtype = {presentation}
}
Clinical research protocols follow rigorous methodologies requiring painstaking precision in every step of the process. A variety of factors determine the required steps an individual participant will take throughout the protocol timeline. Such steps could easily become more complicated and complex in a research setting aimed at new discoveries, which require various degrees of flexibility depending on the specific conditions at various points of the study. In this paper we describe our protocol workflow system (PWS), which is designed to accommodate all of the current and potential future protocols while simultaneously providing the capability for workflow adjustments during various phases of ongoing studies. Furthermore, it is robust enough to organize and handle participants who are enrolled concurrently in multiple protocols. This automated system not only collects information at an outpatient research center, but also automates the workflow and data collection points throughout the clinic.
