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1.  Design and Applications of a Multimodality Image Data Warehouse Framework 
A comprehensive data warehouse framework is needed, which encompasses imaging and non-imaging information in supporting disease management and research. The authors propose such a framework, describe general design principles and system architecture, and illustrate a multimodality neuroimaging data warehouse system implemented for clinical epilepsy research. The data warehouse system is built on top of a picture archiving and communication system (PACS) environment and applies an iterative object-oriented analysis and design (OOAD) approach and recognized data interface and design standards. The implementation is based on a Java CORBA (Common Object Request Broker Architecture) and Web-based architecture that separates the graphical user interface presentation, data warehouse business services, data staging area, and backend source systems into distinct software layers. To illustrate the practicality of the data warehouse system, the authors describe two distinct biomedical applications—namely, clinical diagnostic workup of multimodality neuroimaging cases and research data analysis and decision threshold on seizure foci lateralization. The image data warehouse framework can be modified and generalized for new application domains.
doi:10.1197/jamia.M0988
PMCID: PMC344584  PMID: 11971885
2.  An ICT infrastructure to integrate clinical and molecular data in oncology research 
BMC Bioinformatics  2012;13(Suppl 4):S5.
Background
The ONCO-i2b2 platform is a bioinformatics tool designed to integrate clinical and research data and support translational research in oncology. It is implemented by the University of Pavia and the IRCCS Fondazione Maugeri hospital (FSM), and grounded on the software developed by the Informatics for Integrating Biology and the Bedside (i2b2) research center. I2b2 has delivered an open source suite based on a data warehouse, which is efficiently interrogated to find sets of interesting patients through a query tool interface.
Methods
Onco-i2b2 integrates data coming from multiple sources and allows the users to jointly query them. I2b2 data are then stored in a data warehouse, where facts are hierarchically structured as ontologies. Onco-i2b2 gathers data from the FSM pathology unit (PU) database and from the hospital biobank and merges them with the clinical information from the hospital information system.
Our main effort was to provide a robust integrated research environment, giving a particular emphasis to the integration process and facing different challenges, consecutively listed: biospecimen samples privacy and anonymization; synchronization of the biobank database with the i2b2 data warehouse through a series of Extract, Transform, Load (ETL) operations; development and integration of a Natural Language Processing (NLP) module, to retrieve coded information, such as SNOMED terms and malignant tumors (TNM) classifications, and clinical tests results from unstructured medical records. Furthermore, we have developed an internal SNOMED ontology rested on the NCBO BioPortal web services.
Results
Onco-i2b2 manages data of more than 6,500 patients with breast cancer diagnosis collected between 2001 and 2011 (over 390 of them have at least one biological sample in the cancer biobank), more than 47,000 visits and 96,000 observations over 960 medical concepts.
Conclusions
Onco-i2b2 is a concrete example of how integrated Information and Communication Technology architecture can be implemented to support translational research. The next steps of our project will involve the extension of its capabilities by implementing new plug-in devoted to bioinformatics data analysis as well as a temporal query module.
doi:10.1186/1471-2105-13-S4-S5
PMCID: PMC3303735  PMID: 22536972
3.  Proceedings of the Canadian society of allergy and clinical immunology annual scientific meeting 2015 
Côté, Marie-Ève | Boulay, Marie-Ève | Plante, Sophie | Chakir, Jamila | Boulet, Louis-Philippe | Ahmed, Hanan | Ospina, Maria-Beatriz | Sideri, Kyriaki | Vliagoftis, Harissios | Johnson, Sara F. | Woodgate, Roberta L. | Cros, Guilhem | Teira, Pierre | Cellot, Sonia | Bittencourt, Henrique | Decaluwe, Helene | Vachon, Marie France | Duval, Michel | Haddad, Elie | Kim, Vy H. D. | Pham-Huy, Anne | Grunebaum, Eyal | Oliveria, John-Paul | Phan, Stephanie | Tenn, Mark W. | Tworek, Damian | Smith, Steven G. | Baatjes, Adrian J. | Obminski, Caitlin D. | Munoz, Caroline E. | Scime, Tara X. | Sehmi, Roma | Gauvreau, Gail M. | Salter, Brittany M. | Smith, Steven G. | Obminski, Caitlin D. | Munoz, Caroline E. | Schlatman, Abbey | Scime, Tara X. | Watson, Rick | Sherkat, Roya | Khoshnevisan, Razieh | Sheikhbahaei, Saba | Betschel, Stephen | Warrington, Richard | Schellenberg, Robert | Fein, Michael N. | Pelletier, Jean-Philippe | Kan, Manstein | Labrosse, Roxane | Mak, Raymond | Loh, James | Kanani, Amin | Nowak, Dominik A. | Keith, Paul K. | Pannozzo, Daniel | Lima, Hermenio C. | Pham, Diana | Pham, Hoang | Alvarez, Gonzalo G. | Bencze, Istvan T. | Sharma, Krishna B. | Smith, Mark | Aaron, Shawn | Block, Jennifer | Keays, Tara | Leech, Judith | Schneidermen, David | Cameron, Jodi | Forgie, Jennifer | Ring, Alicia | O’Quinn, John W. | Santucci, Stephanie | Yang, William H. | Gaudet, Ena | Aaron, Shawn | Voisin, Mathew R. | Borici-Mazi, Rozita | Vostretsova, Kateryna | Stark, Donald F. | Yeboah, Elizabeth | Martin-Rhee, Michelle | Gula, Cheryl | Cheng, Clare | Paltser, Geoff | Dery, Alizée | Clarke, Ann | Nadeau, Kari | Harada, Laurie | Weatherall, Kimberley | Greenwood, Celia | Daley, Denise | Asai, Yuka | Ben-Shoshan, Moshe | Ling, Ling | Ospina, Maria B. | Protudjer, Jennifer L. P. | Vetander, Mirja | van Hage, Marianne | Olén, Ola | Wickman, Magnus | Bergström, Anna | Teoh, Timothy | Mill, Christopher | Wong, Tiffany | Baerg, Ingrid | Alexander, Angela | Hildebrand, Kyla J. | Dean, John | Kuzeljevic, Boris | Chan, Edmond S. | Argeny, Jonathan | Gona-Hoepler, Mia | Fucik, Petra | Nachbaur, Edith | Gruber, Saskia | Crameri, Reto | Glaser, Andreas | Szépfalusi, Zsolt | Rhyner, Claudio | Eiwegger, Thomas | Plunkett, Greg | Mire, Brad | Yazicioglu, Mehtap | Can, Ceren | Ciplak, Gokce | Cook, Victoria E. | Portales-Casamar, Elodie | Nashi, Emil P. | Gabrielli, Sofianne | Primeau, Marie-Noel | Lejtenyi, Christine | Netchiporouk, Elena | Dery, Alizee | Shand, Greg | Hoe, Erica | Liem, Joel | Ko, Jason K. | Huang, David J. T. | Mazza, Jorge A. | McHenry, Mary | Otley, Anthony | Watson, Wade | Kraft, John N. | Paina, Mihaela | Darwish Hassan, Ahmed A. | Heroux, Delia | Crawford, Lynn | Gauvreau, Gail | Denburg, Judah | Pedder, Linda | Chad, Zave | Sussman, Gordon | Hébert, Jacques | Frankish, Charles | Olynych, Timothy | Cheema, Amarjit | Del Carpio, Jaime | Harrison, Rachel | Torabi, Bahar | Medoff, Elaine | Mill, Jennifer | Quirt, Jaclyn A. | Wen, Xia | Kim, Jonathan | Herrero, Angel Jimenez | Kim, Harold L. | Grzyb, Magdalena J. | Primeau, Marie-Noël | Azad, Meghan B. | Lu, Zihang | Becker, Allan B. | Subbarao, Padmaja | Mandhane, Piushkumar J. | Turvey, Stuart E. | Sears, Malcolm R. | Boucher-Lafleur, Anne-Marie | Gagné-Ouellet, Valérie | Jacques, Éric | Laprise, Catherine | Chen, Michael | McGovern, Toby | Adner, Mikael | Martin, James G. | Cosic, Nela | Ntanda, Henry | Giesbrecht, Gerald | Kozyrskyj, Anita | Letourneau, Nicole | Dawod, Bassel | Marshall, Jean | De Schryver, Sarah | Halbrich, Michelle | La Vieille, Sebastian | Eisman, Harley | Alizadehfar, Reza | Joseph, Lawrence | Morris, Judy | Feldman, Laura Y. | Thacher, Jesse D. | Kull, Inger | Melén, Erik | Pershagen, Göran | Protudjer, Jennifer L. P. | Hosseini, Ali | Hackett, Tillie L. | Hirota, Jeremy | McNagny, Kelly | Wilson, Susan | Carlsten, Chris | Huq, Saiful | Chooniedass, Rishma | Gerwing, Brenda | Huang, Henry | Lefebvre, Diana | Becker, Allan | Khamis, Mona M. | Awad, Hanan | Allen, Kevin | Adamko, Darryl J. | El-Aneed, Anas | Kim, Young Woong | Gliddon, Daniel R. | Shannon, Casey P. | Singh, Amrit | Hickey, Pascal L. C. | Ellis, Anne K. | Neighbour, Helen | Larche, Mark | Tebbutt, Scott J. | Ladouceur, Erika | Stewart, Miriam | Evans, Josh | Masuda, Jeff | To, Teresa | King, Malcolm | Larouche, Miriam | Liang, Liming | Legere, Stephanie A. | Haidl, Ian D. | Legaré, Jean-Francois | Marshall, Jean S. | Sears, Malcolm | Moraes, Theo J. | Ratjen, Felix | Gustafsson, Per | Lou, Wendy | North, Michelle L. | Lee, Elizabeth | Omana, Vanessa | Thiele, Jenny | Brook, Jeff | Rahman, Tanvir | Lejtenyi, Duncan | Fiter, Ryan | Piccirillo, Ciriaco | Mazer, Bruce | Simons, Elinor | Hildebrand, Kyla | Turvey, Stuart | DeMarco, Mari | Le Cao, Kim-Anh | Gauvreau, Gail M. | Mark FitzGerald, J. | O’Byrne, Paul M. | Stiemsma, Leah T. | Arrieta, Marie-Claire | Cheng, Jasmine | Dimitriu, Pedro A. | Thorson, Lisa | Yurist, Sophie | Lefebvre, Diana L. | Mandhane, Piush | McNagny, Kelly M. | Kollmann, Tobias | Mohn, William W. | Brett Finlay, B. | Tran, Maxwell M. | Lefebvre, Diana L. | Ramasundarahettige, Chinthanie F. | Dai, Wei Hao | Mandhane, Piush J. | Tworek, Damian | O’Byrne, Seamus N. | O’Byrne, Paul M. | Denburg, Judah A. | Walsh, Laura | Soliman, Mena | Steacy, Lisa M. | Adams, Daniel E. | Warner, Linda | Mauro, Mary Ann | Mamonluk, Robby | Yang, ChenXi | Conway, Ed M.
Table of contents
A1 Role of fibrocytes in allergic rhinitis
Marie-Ève Côté, Marie-Ève Boulay, Sophie Plante, Jamila Chakir, Louis-Philippe Boulet
A2 Patterns of aeroallergens sensitization in Northern Alberta
Hanan Ahmed, Maria-Beatriz Ospina, Kyriaki Sideri, Harissios Vliagoftis
A3 Addressing acceptable risk for adolescents with Food-Induced Anaphylaxis (FIA)
Sara F. Johnson, Roberta L. Woodgate
A4 Outcomes of matched related and unrelated bone marrow transplantation after reduced-toxicity conditioning for children suffering from Chronic Granulomatous Disease
Guilhem Cros, Pierre Teira, Sonia Cellot, Henrique Bittencourt, Helene Decaluwe, Marie France Vachon, Michel Duval, Elie Haddad
A5 Outcomes of patients with severe combined immunodeficiency (SCID) prior to and after initiation of newborn screening for SCID in Ontario
Vy H.D. Kim, Anne Pham-Huy, Eyal Grunebaum
A6 Detection of regulatory B cells in the airways of subjects with asthma
John-Paul Oliveria, Stephanie Phan, Mark W. Tenn, Damian Tworek, Steven G. Smith, Adrian J. Baatjes, Caitlin D. Obminski, Caroline E. Munoz, Tara X. Scime, Roma Sehmi, Gail M Gauvreau
A7 Characterization of IgE-expressing B cells in the airways and peripheral blood of allergic asthmatic subjects
John-Paul Oliveria, Stephanie Phan, Mark W. Tenn, Brittany M Salter, Steven G Smith, Caitlin D Obminski, Caroline E Munoz, Abbey Schlatman, Tara X Scime, Rick Watson, Roma Sehmi, Gail M Gauvreau
A8 Pregnancy: could it be a risk factor for primary immunodeficient patients
Roya Sherkat, Razieh Khoshnevisan, Saba Sheikhbahaei
A9 Clinical experience with Octagam: a Canadian retrospective chart review
Stephen Betschel, Richard Warrington, Robert Schellenberg
A10 Kounis syndrome secondary to contrast media with inferior ST elevations and bilateral ischemic stroke
Michael N Fein, Jean-Philippe Pelletier
A11 Honey bee venom immunotherapy ineffective in bumble bee-induced anaphylaxis: case report and review of literature
Manstein Kan, Robert Schellenberg
A12 Delayed immune reconstitution occurring after multiple immune complications of hematological stem cell transplantation for a leaky SCID
Roxane Labrosse, Guilhem Cros, Pierre Teira, Henrique Bittencourt, Helene Decaluwe, Michel Duval, Elie Haddad
A13 Comparison of Three Case Reports of Acquired Angioedema: presentation, management and outcome
Raymond Mak, James Loh, Amin Kanani
A14 Sitagliptin-associated angioedema not related to concurrent use of ARB or ACE inhibitor
Dominik A. Nowak, Paul K. Keith
A15 Sneddon-Wilkinson subcorneal pustular dermatosis associated with an IgA monoclonal gammopathy
Daniel Pannozzo, Dominik A. Nowak, Hermenio C. Lima
A16 Omalizumab can be effective in patients with allergic bronchopulmonary aspergillosis
Diana Pham, Hoang Pham, Gonzalo G. Alvarez, Istvan T. Bencze, Krishna B. Sharma, Mark Smith, Shawn Aaron, Jennifer Block, Tara Keays, Judith Leech, David Schneidermen, Jodi Cameron, Jennifer Forgie, Alicia Ring, John W. O’Quinn, Stephanie Santucci, William H. Yang
A17 Efficacious use of omalizumab in the treatment of cystic fibrosis
Diana Pham, Hoang Pham, Ena Gaudet, Shawn Aaron, Stephanie Santucci, William H. Yang
A18 HAE with normal C1-INH with inconsistent response to C1 esterase inhibitor infusion but reliably responsive to icatibant
Hoang Pham, Stephanie Santucci, William H. Yang
A19 Anaphylaxis reaction to lactase enzyme
Mathew R. Voisin, Rozita Borici-Mazi
A20 Risk of solid tumor malignancies in patients with primary immune deficiency
Kateryna Vostretsova, Donald F. Stark
A21 Is it time to adopt the chromogenic assay for measuring C1 esterase inhibitor function in patients with HAE Type 2?
Elizabeth Yeboah, Paul K. Keith
A22 Emergency department visits for anaphylaxis and allergic reactions
Michelle Martin-Rhee, Cheryl Gula, Clare Cheng, Geoff Paltser
A23 START: Susceptibility To food Allergies in a Registry of Twins
Alizée Dery, Ann Clarke, Kari Nadeau, Laurie Harada, Kimberley Weatherall, Celia Greenwood, Denise Daley, Yuka Asai, Moshe Ben-Shoshan
A24 Qualifying the diagnostic approach employed by allergists when managing patients with self-diagnosed non-celiac gluten sensitivity (NCGS)
Lee Horgan, Teresa Pun
A25 Retrospective analysis on the agreement between skin prick test and serum food specific IgE antibody in adults with suspected food allergy
Ling Ling, Maria B. Ospina, Kyriaki Sideri, Harissios Vliagoftis
A26 Staple food hypersensitivity from infancy to adolescence: a report from the BAMSE cohort
Jennifer L.P. Protudjer, Mirja Vetander, Marianne van Hage, Ola Olén, Magnus Wickman, Anna Bergström
A27 Evaluating the impact of supervised epinephrine autoinjector administration during food challenges on perceived parent confidence
Timothy Teoh, Christopher Mill, Tiffany Wong, Ingrid Baerg, Angela Alexander, Kyla J. Hildebrand, John Dean, Boris Kuzeljevic, Edmond S. Chan
A28 Local immunoglobulin production to Aspergillus fumigatus cystic fibrosis
Jonathan Argeny, Mia Gona-Hoepler, Petra Fucik, Edith Nachbaur, Saskia Gruber, Reto Crameri, Andreas Glaser, Zsolt Szépfalusi, Claudio Rhyner, Thomas Eiwegger
A29 Extract consumption with skin prick test (SPT) devices
Greg. Plunkett, Brad Mire
A30 Evaluation of our cases with nonsteroidal anti-inflammatory drug reactions
Mehtap Yazicioglu, Ceren Can, Gokce Ciplak
A31 Reasons for referral and final diagnoses in a tertiary care pediatric allergy clinic
Victoria E. Cook, Kyla J. Hildebrand, Elodie Portales-Casamar, Christopher Mill, Edmond S. Chan
A32 Internist referral practices for inpatients with self-reported penicillin allergies at a tertiary care teaching hospital
Michael N Fein, Emil P Nashi
A33 Assessing the risk of reactions in children with a negative oral challenge after a subsequent use of amoxicillin
Sofianne Gabrielli, Christopher Mill, Marie-Noel Primeau, Christine Lejtenyi, Elena Netchiporouk, Alizee Dery, Greg Shand, Moshe Ben-Shoshan
A34 Validity of self-reported penicillin allergies
Erica Hoe, Joel Liem
A35 Effectiveness of allergy-test directed elimination diets in eosinophilic esophagitis
Jason K. Ko, David J.T. Huang, Jorge A. Mazza
A36 Allergy testing and dietary management in pediatric eosinophilic esophagitis (EoE): A retrospective review of a tertiary Canadian centre’s experience
Mary McHenry, Anthony Otley,Wade Watson
A37 Visualizing the impact of atopic and allergic skin disease
Dominik A. Nowak, John N. Kraft
A38 Cystic fibrosis with and without nasal polyposis in pediatric patients: a cross-sectional comparative study
Mihaela Paina, Ahmed A. Darwish Hassan, Delia Heroux, Lynn Crawford, Gail Gauvreau, Judah Denburg, Linda Pedder, Paul K. Keith
A39 Evaluation of macrolide antibiotic hypersensitivity: the role of oral challenges in children
Bahar Torabi, Marie-Noel Primeau, Christine Lejtenyi, Elaine Medoff, Jennifer Mill, Moshe Ben-Shoshan
A40 Venom allergy testing: is a graded approach necessary?
Jaclyn A. Quirt, Xia Wen, Jonathan Kim, Angel Jimenez Herrero, Harold L. Kim
A41 The role of oral challenges in evaluating cephalosporin hypersensitivity reactions in children
Magdalena J. Grzyb, Marie-Noël Primeau, Christine Lejtenyi, Elaine Medoff, Jennifer Mill, Moshe Ben-Shoshan
A42 Breastfeeding and infant wheeze, atopy and atopic dermatitis: findings from the Canadian Healthy Infant Longitudinal Development Study
Meghan B. Azad, Zihang Lu, Allan B. Becker, Padmaja Subbarao, Piushkumar J. Mandhane, Stuart E. Turvey, Malcolm R. Sears, the CHILD Study Investigators
A43 IL33 DNA methylation in bronchial epithelial cells is associated to asthma
Anne-Marie Boucher-Lafleur, Valérie Gagné-Ouellet, Éric Jacques, Sophie Plante, Jamila Chakir, Catherine Laprise
A44 NRF2 mediates the antioxidant response to organic dust-induced oxidative stress in bronchial epithelial cells
Michael Chen, Toby McGovern, Mikael Adner, James G. Martin
A45 The effects of perinatal distress, immune biomarkers and mother-infant interaction quality on childhood atopic dermatitis (rash) at 18 months
Nela Cosic, Henry Ntanda, Gerald Giesbrecht, Anita Kozyrskyj, Nicole Letourneau
A46 Examining the immunological mechanisms associated with cow’s milk allergy
Bassel Dawod, Jean Marshall
A47 Tryptase levels in children presenting with anaphylaxis to the Montréal Children’s Hospital
Sarah De Schryver, Michelle Halbrich, Ann Clarke, Sebastian La Vieille, Harley Eisman, Reza Alizadehfar, Lawrence Joseph, Judy Morris, Moshe Ben-Shoshan
A48 Secondhand tobacco smoke exposure in infancy and the development of food hypersensitivity from childhood to adolescence
Laura Y. Feldman, Jesse D. Thacher, Inger Kull, Erik Melén, Göran Pershagen, Magnus Wickman, Jennifer L. P. Protudjer, Anna Bergström
A49 Combined exposure to diesel exhaust and allergen enhances allergic inflammation in the bronchial submucosa of atopic subjects
Ali Hosseini, Tillie L. Hackett, Jeremy Hirota, Kelly McNagny, Susan Wilson, Chris Carlsten
A50 Comparison of skin-prick test measurements by an automated system against the manual method
Saiful Huq, Rishma Chooniedass, Brenda Gerwing, Henry Huang, Diana Lefebvre, Allan Becker
A51 The accurate identification and quantification of urinary biomarkers of asthma and COPD through the use of novel DIL- LC-MS/MS methods
Mona M. Khamis, Hanan Awad, Kevin Allen, Darryl J. Adamko, Anas El-Aneed
A52 Systemic immune pathways associated with the mechanism of Cat-Synthetic Peptide Immuno-Regulatory Epitopes, a novel immunotherapy, in whole blood of cat-allergic people
Young Woong Kim, Daniel R. Gliddon, Casey P. Shannon, Amrit Singh, Pascal L. C. Hickey, Anne K. Ellis, Helen Neighbour, Mark Larche, Scott J. Tebbutt
A53 Reducing the health disparities: online support for children with asthma and allergies from low-income families
Erika Ladouceur, Miriam Stewart, Josh Evans, Jeff Masuda, Nicole Letourneau, Teresa To, Malcolm King
A54 Epigenetic association of PSORS1C1 and asthma in the Saguenay-Lac-Saint-Jean asthma study
Miriam Larouche, Liming Liang, Catherine Laprise
A55 IL-33 induces cytokine and chemokine production in human mast cells
Stephanie A. Legere, Ian D. Haidl, Jean-Francois Legaré, Jean S. Marshall
A56 Reference ranges for lung clearance index from infancy to adolescence for Canadian population
Zihang Lu, Malcolm Sears, Theo J. Moraes, Felix Ratjen, Per Gustafsson, Wendy Lou, Padmaja Subbarao
A57 Kingston Allergy Birth Cohort: cohort profile and mother/child characteristics to age 2
Michelle L. North, Elizabeth Lee, Vanessa Omana, Jenny Thiele, Jeff Brook, Anne K. Ellis
A58 Cow’s milk protein specific IgE, IgA and IgG4 as a predictor of outcome in oral immunotherapy
Tanvir Rahman, Duncan Lejtenyi, Sarah De Schryver, Ryan Fiter, Ciriaco Piccirillo, Moshe Ben-Shoshan, Bruce Mazer
A59 Age of peanut introduction and development of reactions and sensitization to peanut
Elinor Simons, Allan B. Becker, Rishma Chooniedass, Kyla Hildebrand, Edmond S. Chan, Stuart Turvey, Padmaja Subbarao, Malcolm Sears
A60 Multi-omic blood biomarker signatures of the late phase asthmatic response
Amrit Singh, Casey P. Shannon, Young Woong Kim, Mari DeMarco, Kim-Anh Le Cao, Gail M. Gauvreau, J. Mark FitzGerald, Louis-Philippe Boulet, Paul M. O’Byrne, Scott J. Tebbutt
A61 Early life gut microbial alterations in children diagnosed with asthma by three years of age
Leah T. Stiemsma, Marie-Claire Arrieta, Jasmine Cheng, Pedro A. Dimitriu, Lisa Thorson, Sophie Yurist, Boris Kuzeljevic, Diana L. Lefebvre, Padmaja Subbarao, Piush Mandhane, Allan Becker, Malcolm R. Sears, Kelly M. McNagny, Tobias Kollmann, the CHILD Study Investigators, William W. Mohn, B. Brett Finlay, Stuart E. Turvey
A62 The relationship between food sensitization and atopic dermatitis at age 1 year in a Canadian birth cohort
Maxwell M. Tran, Diana L. Lefebvre, Chinthanie F. Ramasundarahettige, Allan B. Becker, Wei Hao Dai, Padmaja Subbarao, Piush J. Mandhane, Stuart E. Turvey, Malcolm R. Sears
A63 Allergen inhalation enhances Toll-like receptor-induced thymic stromal lymphopoietin receptor expression by hematopoietic progenitor cells in mild asthmatics
Damian Tworek, Delia Heroux, Seamus N. O’Byrne, Paul M. O’Byrne, Judah A. Denburg
A64 The Allergic Rhinitis Clinical Investigator Collaborative – replicated eosinophilia on repeated cumulative allergen challenges in nasal lavage samples
Laura Walsh, Mena Soliman, Jenny Thiele, Lisa M. Steacy, Daniel E. Adams, Anne K. Ellis
A65 The CHILD Study: optimizing subject retention in pediatric longitudinal cohort research
Linda Warner, Mary Ann Mauro, Robby Mamonluk, Stuart E. Turvey
A66 Differential expression of C3a and C5a in allergic asthma
ChenXi Yang, Amrit Singh, Casey P. Shannon, Young Woong Kim, Ed M. Conway, Scott J. Tebbutt
doi:10.1186/s13223-016-0118-0
PMCID: PMC5009563
4.  Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety 
Long working hours and sleep deprivation have been a facet of physician training in the US since the advent of the modern residency system. However, the scientific evidence linking fatigue with deficits in human performance, accidents and errors in industries from aeronautics to medicine, nuclear power, and transportation has mounted over the last 40 years. This evidence has also spawned regulations to help ensure public safety across safety-sensitive industries, with the notable exception of medicine.
In late 2007, at the behest of the US Congress, the Institute of Medicine embarked on a year-long examination of the scientific evidence linking resident physician sleep deprivation with clinical performance deficits and medical errors. The Institute of Medicine’s report, entitled “Resident duty hours: Enhancing sleep, supervision and safety”, published in January 2009, recommended new limits on resident physician work hours and workload, increased supervision, a heightened focus on resident physician safety, training in structured handovers and quality improvement, more rigorous external oversight of work hours and other aspects of residency training, and the identification of expanded funding sources necessary to implement the recommended reforms successfully and protect the public and resident physicians themselves from preventable harm.
Given that resident physicians comprise almost a quarter of all physicians who work in hospitals, and that taxpayers, through Medicare and Medicaid, fund graduate medical education, the public has a deep investment in physician training. Patients expect to receive safe, high-quality care in the nation’s teaching hospitals. Because it is their safety that is at issue, their voices should be central in policy decisions affecting patient safety. It is likewise important to integrate the perspectives of resident physicians, policy makers, and other constituencies in designing new policies. However, since its release, discussion of the Institute of Medicine report has been largely confined to the medical education community, led by the Accreditation Council for Graduate Medical Education (ACGME).
To begin gathering these perspectives and developing a plan to implement safer work hours for resident physicians, a conference entitled “Enhancing sleep, supervision and safety: What will it take to implement the Institute of Medicine recommendations?” was held at Harvard Medical School on June 17–18, 2010. This White Paper is a product of a diverse group of 26 representative stakeholders bringing relevant new information and innovative practices to bear on a critical patient safety problem. Given that our conference included experts from across disciplines with diverse perspectives and interests, not every recommendation was endorsed by each invited conference participant. However, every recommendation made here was endorsed by the majority of the group, and many were endorsed unanimously. Conference members participated in the process, reviewed the final product, and provided input before publication. Participants provided their individual perspectives, which do not necessarily represent the formal views of any organization.
In September 2010 the ACGME issued new rules to go into effect on July 1, 2011. Unfortunately, they stop considerably short of the Institute of Medicine’s recommendations and those endorsed by this conference. In particular, the ACGME only applied the limitation of 16 hours to first-year resident physicans. Thus, it is clear that policymakers, hospital administrators, and residency program directors who wish to implement safer health care systems must go far beyond what the ACGME will require. We hope this White Paper will serve as a guide and provide encouragement for that effort.
Resident physician workload and supervision
By the end of training, a resident physician should be able to practice independently. Yet much of resident physicians’ time is dominated by tasks with little educational value. The caseload can be so great that inadequate reflective time is left for learning based on clinical experiences. In addition, supervision is often vaguely defined and discontinuous. Medical malpractice data indicate that resident physicians are frequently named in lawsuits, most often for lack of supervision. The recommendations are: The ACGME should adjust resident physicians workload requirements to optimize educational value. Resident physicians as well as faculty should be involved in work redesign that eliminates nonessential and noneducational activity from resident physician dutiesMechanisms should be developed for identifying in real time when a resident physician’s workload is excessive, and processes developed to activate additional providersTeamwork should be actively encouraged in delivery of patient care. Historically, much of medical training has focused on individual knowledge, skills, and responsibility. As health care delivery has become more complex, it will be essential to train resident and attending physicians in effective teamwork that emphasizes collective responsibility for patient care and recognizes the signs, both individual and systemic, of a schedule and working conditions that are too demanding to be safeHospitals should embrace the opportunities that resident physician training redesign offers. Hospitals should recognize and act on the potential benefits of work redesign, eg, increased efficiency, reduced costs, improved quality of care, and resident physician and attending job satisfactionAttending physicians should supervise all hospital admissions. Resident physicians should directly discuss all admissions with attending physicians. Attending physicians should be both cognizant of and have input into the care patients are to receive upon admission to the hospitalInhouse supervision should be required for all critical care services, including emergency rooms, intensive care units, and trauma services. Resident physicians should not be left unsupervised to care for critically ill patients. In settings in which the acuity is high, physicians who have completed residency should provide direct supervision for resident physicians. Supervising physicians should always be physically in the hospital for supervision of resident physicians who care for critically ill patientsThe ACGME should explicitly define “good” supervision by specialty and by year of training. Explicit requirements for intensity and level of training for supervision of specific clinical scenarios should be providedCenters for Medicare and Medicaid Services (CMS) should use graduate medical education funding to provide incentives to programs with proven, effective levels of supervision. Although this action would require federal legislation, reimbursement rules would help to ensure that hospitals pay attention to the importance of good supervision and require it from their training programs
Resident physician work hours
Although the IOM “Sleep, supervision and safety” report provides a comprehensive review and discussion of all aspects of graduate medical education training, the report’s focal point is its recommendations regarding the hours that resident physicians are currently required to work. A considerable body of scientific evidence, much of it cited by the Institute of Medicine report, describes deteriorating performance in fatigued humans, as well as specific studies on resident physician fatigue and preventable medical errors.
The question before this conference was what work redesign and cultural changes are needed to reform work hours as recommended by the Institute of Medicine’s evidence-based report? Extensive scientific data demonstrate that shifts exceeding 12–16 hours without sleep are unsafe. Several principles should be followed in efforts to reduce consecutive hours below this level and achieve safer work schedules. The recommendations are: Limit resident physician work hours to 12–16 hour maximum shiftsA minimum of 10 hours off duty should be scheduled between shiftsResident physician input into work redesign should be actively solicitedSchedules should be designed that adhere to principles of sleep and circadian science; this includes careful consideration of the effects of multiple consecutive night shifts, and provision of adequate time off after night work, as specified in the IOM reportResident physicians should not be scheduled up to the maximum permissible limits; emergencies frequently occur that require resident physicians to stay longer than their scheduled shifts, and this should be anticipated in scheduling resident physicians’ work shiftsHospitals should anticipate the need for iterative improvement as new schedules are initiated; be prepared to learn from the initial phase-in, and change the plan as neededAs resident physician work hours are redesigned, attending physicians should also be considered; a potential consequence of resident physician work hour reduction and increased supervisory requirements may be an increase in work for attending physicians; this should be carefully monitored, and adjustments to attending physician work schedules made as needed to prevent unsafe work hours or working conditions for this group“Home call” should be brought under the overall limits of working hours; work load and hours should be monitored in each residency program to ensure that resident physicians and fellows on home call are getting sufficient sleepMedicare funding for graduate medical education in each hospital should be linked with adherence to the Institute of Medicine limits on resident physician work hours
Moonlighting by resident physicians
The Institute of Medicine report recommended including external as well as internal moonlighting in working hour limits. The recommendation is: All moonlighting work hours should be included in the ACGME working hour limits and actively monitored. Hospitals should formalize a moonlighting policy and establish systems for actively monitoring resident physician moonlighting
Safety of resident physicians
The “Sleep, supervision and safety” report also addresses fatigue-related harm done to resident physicians themselves. The report focuses on two main sources of physical injury to resident physicians impaired by fatigue, ie, needle-stick exposure to blood-borne pathogens and motor vehicle crashes. Providing safe transportation home for resident physicians is a logistical and financial challenge for hospitals. Educating physicians at all levels on the dangers of fatigue is clearly required to change driving behavior so that safe hospital-funded transport home is used effectively. Fatigue-related injury prevention (including not driving while drowsy) should be taught in medical school and during residency, and reinforced with attending physicians; hospitals and residency programs must be informed that resident physicians’ ability to judge their own level of impairment is impaired when they are sleep deprived; hence, leaving decisions about the capacity to drive to impaired resident physicians is not recommendedHospitals should provide transportation to all resident physicians who report feeling too tired to drive safely; in addition, although consecutive work should not exceed 16 hours, hospitals should provide transportation for all resident physicians who, because of unforeseen reasons or emergencies, work for longer than consecutive 24 hours; transportation under these circumstances should be automatically provided to house staff, and should not rely on self-identification or request
Training in effective handovers and quality improvement
Handover practice for resident physicians, attendings, and other health care providers has long been identified as a weak link in patient safety throughout health care settings. Policies to improve handovers of care must be tailored to fit the appropriate clinical scenario, recognizing that information overload can also be a problem. At the heart of improving handovers is the organizational effort to improve quality, an effort in which resident physicians have typically been insufficiently engaged. The recommendations are: Hospitals should train attending and resident physicians in effective handovers of careHospitals should create uniform processes for handovers that are tailored to meet each clinical setting; all handovers should be done verbally and face-to-face, but should also utilize written toolsWhen possible, hospitals should integrate hand-over tools into their electronic medical records (EMR) systems; these systems should be standardized to the extent possible across residency programs in a hospital, but may be tailored to the needs of specific programs and services; federal government should help subsidize adoption of electronic medical records by hospitals to improve signoutWhen feasible, handovers should be a team effort including nurses, patients, and familiesHospitals should include residents in their quality improvement and patient safety efforts; the ACGME should specify in their core competency requirements that resident physicians work on quality improvement projects; likewise, the Joint Commission should require that resident physicians be included in quality improvement and patient safety programs at teaching hospitals; hospital administrators and residency program directors should create opportunities for resident physicians to become involved in ongoing quality improvement projects and root cause analysis teams; feedback on successful quality improvement interventions should be shared with resident physicians and broadly disseminatedQuality improvement/patient safety concepts should be integral to the medical school curriculum; medical school deans should elevate the topics of patient safety, quality improvement, and teamwork; these concepts should be integrated throughout the medical school curriculum and reinforced throughout residency; mastery of these concepts by medical students should be tested on the United States Medical Licensing Examination (USMLE) stepsFederal government should support involvement of resident physicians in quality improvement efforts; initiatives to improve quality by including resident physicians in quality improvement projects should be financially supported by the Department of Health and Human Services
Monitoring and oversight of the ACGME
While the ACGME is a key stakeholder in residency training, external voices are essential to ensure that public interests are heard in the development and monitoring of standards. Consequently, the Institute of Medicine report recommended external oversight and monitoring through the Joint Commission and Centers for Medicare and Medicaid Services (CMS). The recommendations are: Make comprehensive fatigue management a Joint Commission National Patient Safety Goal; fatigue is a safety concern not only for resident physicians, but also for nurses, attending physicians, and other health care workers; the Joint Commission should seek to ensure that all health care workers, not just resident physicians, are working as safely as possibleFederal government, including the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, should encourage development of comprehensive fatigue management programs which all health systems would eventually be required to implementMake ACGME compliance with working hours a “ condition of participation” for reimbursement of direct and indirect graduate medical education costs; financial incentives will greatly increase the adoption of and compliance with ACGME standards
Future financial support for implementation
The Institute of Medicine’s report estimates that $1.7 billion (in 2008 dollars) would be needed to implement its recommendations. Twenty-five percent of that amount ($376 million) will be required just to bring hospitals into compliance with the existing 2003 ACGME rules. Downstream savings to the health care system could potentially result from safer care, but these benefits typically do not accrue to hospitals and residency programs, who have been asked historically to bear the burden of residency reform costs. The recommendations are: The Institute of Medicine should convene a panel of stakeholders, including private and public funders of health care and graduate medical education, to lay down the concrete steps necessary to identify and allocate the resources needed to implement the recommendations contained in the IOM “Resident duty hours: Enhancing sleep, supervision and safety” report. Conference participants suggested several approaches to engage public and private support for this initiativeEfforts to find additional funding to implement the Institute of Medicine recommendations should focus more broadly on patient safety and health care delivery reform; policy efforts focused narrowly upon resident physician work hours are less likely to succeed than broad patient safety initiatives that include residency redesign as a key componentHospitals should view the Institute of Medicine recommendations as an opportunity to begin resident physician work redesign projects as the core of a business model that embraces safety and ultimately saves resourcesBoth the Secretary of Health and Human Services and the Director of the Centers for Medicare and Medicaid Services should take the Institute of Medicine recommendations into consideration when promulgating rules for innovation grantsThe National Health Care Workforce Commission should consider the Institute of Medicine recommendations when analyzing the nation’s physician workforce needs
Recommendations for future research
Conference participants concurred that convening the stakeholders and agreeing on a research agenda was key. Some observed that some sectors within the medical education community have been reluctant to act on the data. Several logical funders for future research were identified. But above all agencies, Centers for Medicare and Medicaid Services is the only stakeholder that funds graduate medical education upstream and will reap savings downstream if preventable medical errors are reduced as a result of reform of resident physician work hours.
doi:10.2147/NSS.S19649
PMCID: PMC3630963  PMID: 23616719
resident; hospital; working hours; safety
5.  IT Infrastructure Components for Biobanking 
Applied Clinical Informatics  2010;1(4):419-429.
Objective
Within translational research projects in the recent years large biobanks have been established, mostly supported by homegrown, proprietary software solutions. No general requirements for biobanking IT infrastructures have been published yet. This paper presents an exemplary biobanking IT architecture, a requirements specification for a biorepository management tool and exemplary illustrations of three major types of requirements.
Methods
We have pursued a comprehensive literature review for biobanking IT solutions and established an interdisciplinary expert panel for creating the requirements specification. The exemplary illustrations were derived from a requirements analysis within two university hospitals.
Results
The requirements specification comprises a catalog with more than 130 detailed requirements grouped into 3 major categories and 20 subcategories. Special attention is given to multitenancy capabilities in order to support the project-specific definition of varying research and bio-banking contexts, the definition of workflows to track sample processing, sample transportation and sample storage and the automated integration of preanalytic handling and storage robots.
Conclusion
IT support for biobanking projects can be based on a federated architectural framework comprising primary data sources for clinical annotations, a pseudonymization service, a clinical data warehouse with a flexible and user-friendly query interface and a biorepository management system. Flexibility and scalability of all such components are vital since large medical facilities such as university hospitals will have to support biobanking for varying monocentric and multicentric research scenarios and multiple medical clients.
doi:10.4338/ACI-2010-05-RA-0034
PMCID: PMC3633318  PMID: 23616851
Requirement specification; biobanking; translational research information technology infrastructure
6.  Ethnobotanical study of medicinal plants in the environs of Tara-gedam and Amba remnant forests of Libo Kemkem District, northwest Ethiopia 
Background
Remnant forests found in areas that have long been converted to agricultural landscapes are refuges of wild useful plants; and societies inhabiting them are custodians of rich indigenous botanical knowledge. This study was undertaken to document the medicinal plants used by the people living in and around Tara-gedam and Amba remnant forests, northwestern Ethiopia, together with the associated ethnomedicinal knowledge.
Methods
Data were collected from 105 informants through semi-structured interviews, guided field walk, market survey; and analyzed using standard ethnobotanical analytical tools including ranking and comparison.
Results
A total of 163 medicinal plant species in 145 genera and 67 families were recorded among which Zehneria scabra drew the highest community consensus. Seventy-one percent of the medicinal plants were those used for treating human ailments only, 21% for both human and livestock and 8% for livestock only. Asteraceae, with 14 species, had the highest number of medicinal plant species. The medicinal plants mainly (79.1%) belong to the shrub and herb categories and most of them were sourced from the wild habitats. Leaves and fresh plant materials were more frequently used for medicine preparation than other parts. Protected government and church forests as well as tree propagation in nurseries followed by planting them and local practices constitute the major forest conservation efforts that indirectly protect the medicinal plants in the area. Elders and healers knew more about the medicinal plants, their distribution, the local ethnomedicinal practices and knowledge transfer patterns. Though important for the local healthcare system and with potentials for modern drug discovery, both the plants and the knowledge pool are under threat.
Conclusion
The diversity of medicinal plants and the associated indigenous knowledge of Tara-gedam and its environs are of a considerable value to the local community and beyond. There is, therefore, a need for conservation of the vegetation and the medicinal plants along with preservation of the wealth of the indigenous knowledge.
doi:10.1186/1746-4269-11-4
PMCID: PMC4417315  PMID: 25572933
Ethiopia; Ethnobotany; Indigenous botanical knowledge; Medicinal plants; Tara-gedam
7.  Pseudonymization of patient identifiers for translational research 
Background
The usage of patient data for research poses risks concerning the patients’ privacy and informational self-determination. Next-generation-sequencing technologies and various other methods gain data from biospecimen, both for translational research and personalized medicine. If these biospecimen are anonymized, individual research results from genomic research, which should be offered to patients in a clinically relevant timeframe, cannot be associated back to the individual. This raises an ethical concern and challenges the legitimacy of anonymized patient samples. In this paper we present a new approach which supports both data privacy and the possibility to give feedback to patients about their individual research results.
Methods
We examined previously published privacy concepts regarding a streamlined de-pseudonymization process and a patient-based pseudonym as applicable to research with genomic data and warehousing approaches. All concepts identified in the literature review were compared to each other and analyzed for their applicability to translational research projects. We evaluated how these concepts cope with challenges implicated by personalized medicine. Therefore, both person-centricity issues and a separation of pseudonymization and de-pseudonymization stood out as a central theme in our examination. This motivated us to enhance an existing pseudonymization method regarding a separation of duties.
Results
The existing concepts rely on external trusted third parties, making de-pseudonymization a multistage process involving additional interpersonal communication, which might cause critical delays in patient care. Therefore we propose an enhanced method with an asymmetric encryption scheme separating the duties of pseudonymization and de-pseudonymization. The pseudonymization service provider is unable to conclude the patient identifier from the pseudonym, but assigns this ability to an authorized third party (ombudsman) instead. To solve person-centricity issues, a collision-resistant function is incorporated into the method. These two facts combined enable us to address essential challenges in translational research. A productive software prototype was implemented to prove the functionality of the suggested translational, data privacy-preserving method. Eventually, we performed a threat analysis to evaluate potential hazards connected with this pseudonymization method.
Conclusions
The proposed method offers sustainable organizational simplification regarding an ethically indicated, but secure and controlled process of de-pseudonymizing patients. A pseudonym is patient-centered to allow correlating separate datasets from one patient. Therefore, this method bridges the gap between bench and bedside in translational research while preserving patient privacy. Assigned ombudsmen are able to de-pseudonymize a patient, if an individual research result is clinically relevant.
doi:10.1186/1472-6947-13-75
PMCID: PMC3733629  PMID: 23883409
Pseudonymization; Pseudonymisation; Pseudonym; Anonyms and pseudonyms; Translational research; Biobanking; Data privacy; Individual research results; Record linkage; Re-identification; De-pseudonymization; De-pseudonymisation
8.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
9.  Computers in imaging and health care: Now and in the future 
Journal of Digital Imaging  2000;13(4):145-156.
Early picture archiving and communication systems (PACS) were characterized by the use of very expensive hardware devices, cumbersome display stations, duplication of database content, lack of interfaces to other clinical information systems, and immaturity in their understanding of the folder manager concepts and workflow reengineering. They were implemented historically at large academic medical centers by biomedical engineers and imaging informaticists. PACS were nonstandard, home-grown projects with mixed clinical acceptance. However, they clearly showed the great potential for PACS and filmless medical imaging. Filmless radiology is a reality today. The advent of efficient softcopy display of images provides a means for dealing with the ever-increasing number of studies and number of images per study. Computer power has increased, and archival storage cost has decreased to the extent that the economics of PACS is justifiable with respect to film. Network bandwidths have increased to allow large studies of many megabytes to arrive at display stations within seconds of examination completion. PACS vendors have recognized the need for efficient workflow and have built systems with intelligence in the mangement of patient data. Close integration with the hospital information system (HIS)-radiology information system (RIS) is critical for system functionality. Successful implementation of PACS requires integration or interoperation with hospital and radiology information systems. Besides the economic advantages, secure rapid access to all clinical information on patients, including imaging studies, anytime and anywhere, enhances the quality of patient care, although it is difficult to quantify. Medical image management systems are maturing, providing access outside of the radiology department to images and clinical information throughout the hospital or the enterprise via the Internet. Small and medium-sized community hospitals, private practices, and outpatient centers in rural areas will begin realizing the benefits of PACS already realized by the large tertiary care academic medical centers and research institutions. Hand-held devices and the Worldwide Web are going to change the way people communicate and do business. The impact on health care will be huge, including radiology. Computer-aided diagnosis, decision support tools, virtual imaging, and guidance systems will transform our practice as value-added applications utilizing the technologies pushed by PACS development efforts. Outcomes data and the electronic medical record (EMR) will drive our interactions with referring physicians and we expect the radiologist to become the informaticist, a new version of the medical management consultant.
doi:10.1007/BF03168389
PMCID: PMC3453069  PMID: 11110253
picture archiving and communication systems (PACS); image storage and retrieval; folder manager; workflow manager; radiology information systems; computers; digital radiology
10.  The Visit-Data Warehouse: Enabling Novel Secondary Use of Health Information Exchange Data 
eGEMs  2014;2(1):1099.
Introduction/Objectives:
Health Information Exchange (HIE) efforts face challenges with data quality and performance, and this becomes especially problematic when data is leveraged for uses beyond primary clinical use. We describe a secondary data infrastructure focusing on patient-encounter, nonclinical data that was built on top of a functioning HIE platform to support novel secondary data uses and prevent potentially negative impacts these uses might have otherwise had on HIE system performance.
Background:
HIE efforts have generally formed for the primary clinical use of individual clinical providers searching for data on individual patients under their care, but many secondary uses have been proposed and are being piloted to support care management, quality improvement, and public health.
Description of the HIE and Base Infrastructure:
This infrastructure review describes a module built into the Healthix HIE. Healthix, based in the New York metropolitan region, comprises 107 participating organizations with 29,946 acute-care beds in 383 facilities, and includes more than 9.2 million unique patients. The primary infrastructure is based on the InterSystems proprietary Caché data model distributed across servers in multiple locations, and uses a master patient index to link individual patients’ records across multiple sites. We built a parallel platform, the “visit data warehouse,” of patient encounter data (demographics, date, time, and type of visit) using a relational database model to allow accessibility using standard database tools and flexibility for developing secondary data use cases. These four secondary use cases include the following: (1) tracking encounter-based metrics in a newly established geriatric emergency department (ED), (2) creating a dashboard to provide a visual display as well as a tabular output of near-real-time de-identified encounter data from the data warehouse, (3) tracking frequent ED users as part of a regional-approach to case management intervention, and (4) improving an existing quality improvement program that analyzes patients with return visits to EDs within 72 hours of discharge.
Results/Lessons Learned:
Setting up a separate, near-real-time, encounters-based relational database to complement an HIE built on a hierarchical database is feasible, and may be necessary to support many secondary uses of HIE data. As of November 2014, the visit-data warehouse (VDW) built by Healthix is undergoing technical validation testing and updates on an hourly basis. We had to address data integrity issues with both nonstandard and missing HL7 messages because of varied HL7 implementation across the HIE. Also, given our HIEs federated structure, some sites expressed concerns regarding data centralization for the VDW. An established and stable HIE governance structure was critical in overcoming this initial reluctance.
Conclusions:
As secondary use of HIE data becomes more prevalent, it may be increasingly necessary to build separate infrastructure to support secondary use without compromising performance. More research is needed to determine optimal ways of building such infrastructure and validating its use for secondary purposes.
doi:10.13063/2327-9214.1099
PMCID: PMC4371519  PMID: 25848595
informatics; health information technology; quality; health information exchange
11.  The development of an RDoC-based treatment program for adolescent depression: “Training for Awareness, Resilience, and Action” (TARA) 
Major depressive disorder (MDD) is one of the current leading causes of disability worldwide. Adolescence is a vulnerable period for the onset of depression, with MDD affecting 8–20% of all youth. Traditional treatment methods have not been sufficiently effective to slow the increasing prevalence of adolescent depression. We therefore propose a new model for the treatment of adolescent depression – Training for Awareness, Resilience, and Action (TARA) – that is based on current understanding of developmental and depression neurobiology. The TARA model is aligned with the Research Domain Criteria (RDoC) of the National Institute of Mental Health. In this article, we first address the relevance of RDoC to adolescent depression. Second, we identify the major RDoC domains of function involved in adolescent depression and organize them in a way that gives priority to domains thought to be driving the psychopathology. Third, we select therapeutic training strategies for TARA based on current scientific evidence of efficacy for the prioritized domains of function in a manner that maximizes time, resources, and feasibility. The TARA model takes into consideration the developmental limitation in top-down cognitive control in adolescence and promotes bottom-up strategies such as vagal afference to decrease limbic hyperactivation and its secondary effects. The program has been informed by mindfulness-based therapy and yoga, as well as modern psychotherapeutic techniques. The treatment program is semi-manualized, progressive, and applied in a module-based approach designed for a group setting that is to be conducted one session per week for 12 weeks. We hope that this work may form the basis for a novel and more effective treatment strategy for adolescent depression, as well as broaden the discussion on how to address this challenge.
doi:10.3389/fnhum.2014.00630
PMCID: PMC4137278  PMID: 25191250
adolescent depression; RDoC; treatment development; emotion regulation; attention training; yoga-based movement; mindfulness
12.  The Project Data Sphere Initiative: Accelerating Cancer Research by Sharing Data 
The Oncologist  2015;20(5):464-e20.
By providing access to large, late-phase, cancer-trial data sets, the Project Data Sphere initiative has the potential to transform cancer research by optimizing research efficiency and accelerating progress toward meaningful improvements in cancer care. This type of platform provides opportunities for unique research projects that can examine relatively neglected areas and that can construct models necessitating large amounts of detailed data.
Background.
In this paper, we provide background and context regarding the potential for a new data-sharing platform, the Project Data Sphere (PDS) initiative, funded by financial and in-kind contributions from the CEO Roundtable on Cancer, to transform cancer research and improve patient outcomes. Given the relatively modest decline in cancer death rates over the past several years, a new research paradigm is needed to accelerate therapeutic approaches for oncologic diseases. Phase III clinical trials generate large volumes of potentially usable information, often on hundreds of patients, including patients treated with standard of care therapies (i.e., controls). Both nationally and internationally, a variety of stakeholders have pursued data-sharing efforts to make individual patient-level clinical trial data available to the scientific research community.
Potential Benefits and Risks of Data Sharing.
For researchers, shared data have the potential to foster a more collaborative environment, to answer research questions in a shorter time frame than traditional randomized control trials, to reduce duplication of effort, and to improve efficiency. For industry participants, use of trial data to answer additional clinical questions could increase research and development efficiency and guide future projects through validation of surrogate end points, development of prognostic or predictive models, selection of patients for phase II trials, stratification in phase III studies, and identification of patient subgroups for development of novel therapies. Data transparency also helps promote a public image of collaboration and altruism among industry participants. For patient participants, data sharing maximizes their contribution to public health and increases access to information that may be used to develop better treatments. Concerns about data-sharing efforts include protection of patient privacy and confidentiality. To alleviate these concerns, data sets are deidentified to maintain anonymity. To address industry concerns about protection of intellectual property and competitiveness, we illustrate several models for data sharing with varying levels of access to the data and varying relationships between trial sponsors and data access sponsors.
The Project Data Sphere Initiative.
PDS is an independent initiative of the CEO Roundtable on Cancer Life Sciences Consortium, built to voluntarily share, integrate, and analyze comparator arms of historical cancer clinical trial data sets to advance future cancer research. The aim is to provide a neutral, broad-access platform for industry and academia to share raw, deidentified data from late-phase oncology clinical trials using comparator-arm data sets. These data are likely to be hypothesis generating or hypothesis confirming but, notably, do not take the place of performing a well-designed trial to address a specific hypothesis. Prospective providers of data to PDS complete and sign a data sharing agreement that includes a description of the data they propose to upload, and then they follow easy instructions on the website for uploading their deidentified data. The SAS Institute has also collaborated with the initiative to provide intrinsic analytic tools accessible within the website itself.
As of October 2014, the PDS website has available data from 14 cancer clinical trials covering 9,000 subjects, with hopes to further expand the database to include more than 25,000 subject accruals within the next year. PDS differentiates itself from other data-sharing initiatives by its degree of openness, requiring submission of only a brief application with background information of the individual requesting access and agreement to terms of use. Data from several different sponsors may be pooled to develop a comprehensive cohort for analysis. In order to protect patient privacy, data providers in the U.S. are responsible for deidentifying data according to standards set forth by the Privacy Rule of the U.S. Health Insurance Portability and Accountability Act of 1996.
Using Data Sharing to Improve Outcomes in Cancer: The “Prostate Cancer Challenge.”
Control-arm data of several studies among patients with metastatic castration-resistant prostate cancer (mCRPC) are currently available through PDS. These data sets have multiple potential uses. The “Prostate Cancer Challenge” will ask the cancer research community to use clinical trial data deposited in the PDS website to address key research questions regarding mCRPC.
General themes that could be explored by the cancer community are described in this article: prognostic models evaluating the influence of pretreatment factors on survival and patient-reported outcomes; comparative effectiveness research evaluating the efficacy of standard of care therapies, as illustrated in our companion article comparing mitoxantrone plus prednisone with prednisone alone; effects of practice variation in dose, frequency, and duration of therapy; level of patient adherence to elements of trial protocols to inform the design of future clinical trials; and age of subjects, regional differences in health care, and other confounding factors that might affect outcomes.
Potential Limitations and Methodological Challenges.
The number of data sets available and the lack of experimental-arm data limit the potential scope of research using the current PDS. The number of trials is expected to grow exponentially over the next year and may include multiple cancer settings, such as breast, colorectal, lung, hematologic malignancy, and bone marrow transplantation. Other potential limitations include the retrospective nature of the data analyses performed using PDS and its generalizability, given that clinical trials are often conducted among younger, healthier, and less racially diverse patient populations. Methodological challenges exist when combining individual patient data from multiple clinical trials; however, advancements in statistical methods for secondary database analysis offer many tools for reanalyzing data arising from disparate trials, such as propensity score matching. Despite these concerns, few if any comparable data sets include this level of detail across multiple clinical trials and populations.
Conclusion.
Access to large, late-phase, cancer-trial data sets has the potential to transform cancer research by optimizing research efficiency and accelerating progress toward meaningful improvements in cancer care. This type of platform provides opportunities for unique research projects that can examine relatively neglected areas and that can construct models necessitating large amounts of detailed data. The full potential of PDS will be realized only when multiple tumor types and larger numbers of data sets are available through the website.
doi:10.1634/theoncologist.2014-0431
PMCID: PMC4425388  PMID: 25876994
Project Data Sphere; Data sharing; Prostate cancer; Comparative effectiveness research
13.  Hospital information systems: experience at the fully digitized Seoul National University Bundang Hospital 
Journal of Thoracic Disease  2016;8(Suppl 8):S637-S641.
The different levels of health information technology (IT) adoption and its integration into hospital workflow can affect the maximization of the benefits of using of health IT. We aimed at sharing our experiences and the journey to the successful adoption of health IT over 13 years at a tertiary university hospital in South Korea. The integrated system of comprehensive applications for direct care, support care, and smart care has been implemented with the latest IT and a rich user information platform, achieving the fully digitized hospital. The users experience design methodology, barcode and radio-frequency identification (RFID) technologies, smartphone and mobile technologies, and data analytics were integrated into hospital workflow. Applications for user-centered electronic medical record (EMR) and clinical decision support (CDS), closed loop medication administration (CLMA), mobile EMR and dashboard system for care coordination, clinical data warehouse (CDW) system, and patient engagement solutions were designed and developed to improve quality of care, work efficiency, and patient safety. We believe that comprehensive electronic health record systems and patient-centered smart hospital applications will go a long way in ensuring seamless patient care and experience.
doi:10.21037/jtd.2016.08.44
PMCID: PMC5009069  PMID: 27651940
Hospital information system (HIS); electronic health records (EHR); health information technology (health IT); patient safety; patient engagement
14.  Using Health Information Technology and Data to Improve Chronic Disease Outcomes in Federally Qualified Health Centers in Maryland 
Federally Qualified Health Centers provide health care services to underserved communities and vulnerable populations. In Maryland, the burden of chronic disease is high among Federally Qualified Health Center patients. Electronic health records (EHRs) are becoming more widely used, and effective use of EHR data may improve chronic disease outcomes. This article describes the process of developing a data aggregation and analytics platform to support health centers in using population health data based on standardized clinical quality measures. This data warehouse, capable of aggregating EHR data across multiple health centers, provides opportunities for benchmarking and elicits a discussion of quality improvement, including identifying and sharing clinical best practices. Phase 1 of the project involved the strategic engagement of health center leadership and staff to get buy-in and to assess readiness. Phase 2 established the technological infrastructure and processes to support data warehouse implementation and began the process of information sharing and collaboration among 4 early adopters. Phase 3 will expand the project to additional health centers and continue quality improvement efforts. The health information technology marketplace is rapidly changing, and staying current will be a priority so that the data warehouse remains a useful quality improvement tool that continues to meet the demands of Maryland health centers. Ongoing efforts will also focus on ways to further add value to the system, such as incorporating new metrics to better inform health center decision making and allocation of resources. The data warehouse can inform and transform the quality of health care delivered to Maryland’s most vulnerable populations, and future research should focus on the ability of health centers to translate this potential into actual improvements.
doi:10.5888/pcd13.160445
PMCID: PMC5201151  PMID: 28033091
15.  Open science resources for the discovery and analysis of Tara Oceans data 
Scientific Data  2015;2:150023.
The Tara Oceans expedition (2009–2013) sampled contrasting ecosystems of the world oceans, collecting environmental data and plankton, from viruses to metazoans, for later analysis using modern sequencing and state-of-the-art imaging technologies. It surveyed 210 ecosystems in 20 biogeographic provinces, collecting over 35,000 samples of seawater and plankton. The interpretation of such an extensive collection of samples in their ecological context requires means to explore, assess and access raw and validated data sets. To address this challenge, the Tara Oceans Consortium offers open science resources, including the use of open access archives for nucleotides (ENA) and for environmental, biogeochemical, taxonomic and morphological data (PANGAEA), and the development of on line discovery tools and collaborative annotation tools for sequences and images. Here, we present an overview of Tara Oceans Data, and we provide detailed registries (data sets) of all campaigns (from port-to-port), stations and sampling events.
doi:10.1038/sdata.2015.23
PMCID: PMC4443879  PMID: 26029378
16.  OPTIMAS-DW: A comprehensive transcriptomics, metabolomics, ionomics, proteomics and phenomics data resource for maize 
BMC Plant Biology  2012;12:245.
Background
Maize is a major crop plant, grown for human and animal nutrition, as well as a renewable resource for bioenergy. When looking at the problems of limited fossil fuels, the growth of the world’s population or the world’s climate change, it is important to find ways to increase the yield and biomass of maize and to study how it reacts to specific abiotic and biotic stress situations. Within the OPTIMAS systems biology project maize plants were grown under a large set of controlled stress conditions, phenotypically characterised and plant material was harvested to analyse the effect of specific environmental conditions or developmental stages. Transcriptomic, metabolomic, ionomic and proteomic parameters were measured from the same plant material allowing the comparison of results across different omics domains. A data warehouse was developed to store experimental data as well as analysis results of the performed experiments.
Description
The OPTIMAS Data Warehouse (OPTIMAS-DW) is a comprehensive data collection for maize and integrates data from different data domains such as transcriptomics, metabolomics, ionomics, proteomics and phenomics. Within the OPTIMAS project, a 44K oligo chip was designed and annotated to describe the functions of the selected unigenes. Several treatment- and plant growth stage experiments were performed and measured data were filled into data templates and imported into the data warehouse by a Java based import tool. A web interface allows users to browse through all stored experiment data in OPTIMAS-DW including all data domains. Furthermore, the user can filter the data to extract information of particular interest. All data can be exported into different file formats for further data analysis and visualisation. The data analysis integrates data from different data domains and enables the user to find answers to different systems biology questions. Finally, maize specific pathway information is provided.
Conclusions
With OPTIMAS-DW a data warehouse for maize was established, which is able to handle different data domains, comprises several analysis results that will support researchers within their work and supports systems biological research in particular. The system is available at http://www.optimas-bioenergy.org/optimas_dw.
doi:10.1186/1471-2229-12-245
PMCID: PMC3577462  PMID: 23272737
Maize; Zea mays; Database; WGCNA; Biomass; Yield; Data integration; Transcriptomics; Metabolomics; Phenomics
17.  Toward a Fully De-identified Biomedical Information Warehouse 
The Information Warehouse at the Ohio State University Medical Center is a comprehensive repository of business, clinical, and research data from various source systems. Data collected here is a valuable resource that facilitates both translational research and personalized healthcare. The use of such data in research is governed by federal privacy regulations with oversight by the Institutional Review Board. In 2006, the Information Warehouse was recognized by the OSU IRB as an “Honest Broker” of clinical data, providing investigators with de-identified or limited datasets under stipulations contained in a signed data use agreement. In order to streamline this process even further, the Information Warehouse is developing a de-identified data warehouse that is suitable for direct user access through a controlled query tool that is aimed to support both research and education activities. In this paper we report our findings on performance evaluation of different de-identification schemes that may be used to ensure regulatory compliance while also facilitating practical database updating and querying. We also discuss how date-shifting in the de-identification process can impact other data elements such as diagnosis and procedure codes and consider a possible solution to those problems.
PMCID: PMC2815386  PMID: 20351882
18.  Development of a Clinical Data Warehouse for Hospital Infection Control 
Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse.
doi:10.1197/jamia.M1299
PMCID: PMC212782  PMID: 12807807
19.  A generic solution for web-based management of pseudonymized data 
Background
Collaborative collection and sharing of data have become a core element of biomedical research. Typical applications are multi-site registries which collect sensitive person-related data prospectively, often together with biospecimens. To secure these sensitive data, national and international data protection laws and regulations demand the separation of identifying data from biomedical data and to introduce pseudonyms. Neither the formulation in laws and regulations nor existing pseudonymization concepts, however, are precise enough to directly provide an implementation guideline. We therefore describe core requirements as well as implementation options for registries and study databases with sensitive biomedical data.
Methods
We first analyze existing concepts and compile a set of fundamental requirements for pseudonymized data management. Then we derive a system architecture that fulfills these requirements. Next, we provide a comprehensive overview and a comparison of different technical options for an implementation. Finally, we develop a generic software solution for managing pseudonymized data and show its feasibility by describing how we have used it to realize two research networks.
Results
We have found that pseudonymization models are highly heterogeneous, already on a conceptual level. We have compiled a set of requirements from different pseudonymization schemes. We propose an architecture and present an overview of technical options. Based on a selection of technical elements, we suggest a generic solution. It supports the multi-site collection and management of biomedical data. Security measures are multi-tier pseudonymity and physical separation of data over independent backend servers. Integrated views are provided by a web-based user interface. Our approach has been successfully used to implement a national and an international rare disease network.
Conclusions
We were able to identify a set of core requirements out of several pseudonymization models. Considering various implementation options, we realized a generic solution which was implemented and deployed in research networks. Still, further conceptual work on pseudonymity is needed. Specifically, it remains unclear how exactly data is to be separated into distributed subsets. Moreover, a thorough risk and threat analysis is needed.
Electronic supplementary material
The online version of this article (doi:10.1186/s12911-015-0222-y) contains supplementary material, which is available to authorized users.
doi:10.1186/s12911-015-0222-y
PMCID: PMC4665916  PMID: 26621059
Electronic data capture; Security; Privacy; Confidentiality; Pseudonymization; Web-based application; Seamless integration; Mashup; Cross-domain communication
20.  Optimum Methadone Compliance Testing 
Executive Summary
Objective
The objective of this analysis was to determine the diagnostic utility of oral fluid testing collected with the Intercept oral fluid collection device.
Clinical Need: Target Population and Condition
Opioids (opiates or narcotics) are a class of drugs derived from the opium poppy plant that typically relieve pain and produce a euphoric feeling. Methadone is a long-acting synthetic opioid used to treat opioid dependence and chronic pain. It prevents symptoms of opioid withdrawal, reduces opioid cravings and blocks the euphoric effects of short-acting opioids such as heroin and morphine. Opioid dependence is associated with harms including an increased risk of exposure to Human Immunodeficiency Virus and Hepatitis C as well as other health, social and psychological crises. The goal of methadone treatment is harm reduction. Treatment with methadone for opioid dependence is often a long-term therapy. The Ontario College of Physicians and Surgeons estimates that there are currently 250 physicians qualified to prescribe methadone, and 15,500 people in methadone maintenance programs across Ontario.
Drug testing is a clinical tool whose purpose is to provide objective meaningful information, which will reinforce positive behavioral changes in patients and guide further treatment needs. Such information includes knowledge of whether the patient is taking their methadone as prescribed and reducing or abstaining from using opioid and other drugs of abuse use. The results of drug testing can be used with behavior modification techniques (contingency management techniques) where positive reinforcements such as increased methadone take-home privileges, sustained employment or parole are granted for drug screens negative for opioid use, and negative reinforcement including loss of these privileges for drug screens positive for opioid used.
Body fluids including blood, oral fluid, often referred to as saliva, and urine may contain metabolites and the parent drug of both methadone and drugs of abuse and provide a means for drug testing. Compared with blood which has a widow of detection of several hours, urine has a wider window of detection, approximately 1 to 3 days, and is therefore considered more useful than blood for drug testing. Because of this, and the fact that obtaining a urine specimen is relatively easy, urine drug screening is considered the criterion measure (gold standard) for methadone maintenance monitoring. However, 2 main concerns exist with urine specimens: the possibility of sample tampering by the patient and the necessity for observed urine collection. Urine specimens may be tampered with in 3 ways: dilution, adulteration (contamination) with chemicals, and substitution (patient submits another persons urine specimen). To circumvent sample tampering the supervised collection of urine specimens is a common and recommended practice. However, it has been suggested that this practice may have negative effects including humiliation experienced by patient and staff, and may discourage patients from staying in treatment. Supervised urine specimen collection may also present an operational problem as staff must be available to provide same-sex supervision. Oral fluid testing has been proposed as a replacement for urine because it can be collected easily under direct supervision without infringement of privacy and reduces the likelihood of sample tampering. Generally, the results of oral fluid drug testing are similar to urine drug testing but there are some differences, such as lower concentrations of substances in oral fluid than urine, and some drugs remain detectable for longer periods of time in urine than oral fluid.
The Technology Being Reviewed
The Intercept Oral Specimen Collection Device (Ora-Sure Technologies, Bethlehem, PA) consists of an absorbent pad mounted on a plastic stick. The pad is coated with common salts. The absorbent pad is inserted into the mouth and placed between the cheek and gums for 3 minutes on average. The pad absorbs the oral fluid. After 3 minutes (range 2min-5 min) the collection device is removed from the mouth and the absorbent pad is placed in a small vial which contains 0.8mL of pH-balanced preservative, for transportation to a laboratory for analysis. It is recommended that the person undergoing oral fluid drug testing have nothing to eat or drink for a 10- minute period before the oral fluid specimen is collected. This will remove opportunity for adulteration. Likewise, it is recommended that the person be observed for the duration of the collection period to prevent adulteration of the specimen. An average of 0.4 mL of saliva can be collected. The specimen may be stored at 4C to 37C and tested within 21 days of collection (or within 6 weeks if frozen).
The oral fluid specimen must be analyzed in a laboratory setting. There is no point-of-care (POC) oral fluid test kit for drugs of abuse (other than for alcohol). In the laboratory the oral fluid is extracted from the vial after centrifugation and a screening test is completed to eliminate negative specimens. Similar to urinalysis, oral fluid specimens are analyzed first by enzyme immunoassay with positive specimens sent for confirmatory testing. Comparable cut-off values to urinalysis by enzyme immunoassay have been developed for oral fluids
Review Strategy
 
Research Question
What is the diagnostic utility of the Intercept oral specimen device?
Inclusion criteria:
Studies evaluating paired urine and oral fluid specimens from the same individual with the Intercept oral fluid collection device.
The population studied includes drug users.
Exclusion criteria:
Studies testing for marijuana (THC) only.
Outcomes:
Sensitivity and Specificity of oral fluid testing compared to urinalysis for methadone (methadone metabolite), opiates, cocaine, benzodiazepines, and alcohol.
Quality of the Body of Evidence
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A description of the GRADE system is reported in Appendix 1.
Summary of Findings
A total of 854 potential citations were retrieved. After reviewing titles and abstracts, 2 met the inclusion and exclusion criteria. Two other relevant studies were found after corresponding with the author of the 2 studies retrieved from the literature search. Therefore a total of 4 published studies are included in this analysis. All 4 studies carried out by the same investigator meet the definition of Medical Advisory Secretariat level III (not a-randomized controlled trial with contemporaneous controls) study design. In each of the studies, paired urine and oral fluid specimens where obtained from drug users. Urine collection was not observed in the studies however, laboratory tests for pH and creatinine were used to determine the reliability of the specimen. Urine specimens thought to be diluted and unreliable were removed from the evaluation. Urinalysis was used as the criterion measurement for which to determine the sensitivity and specificity of oral fluid testing by the Intercept oral fluid device for opiates, benzodiazepines, cocaine and marijuana. Alcohol was not tested in any of the 4 studies. From these 4 studies, the following conclusions were drawn:
The evidence indicates that oral fluid testing with the Intercept oral fluid device has better specificity than sensitivity for opiates, benzodiazepines, cocaine and marijuana.
The sensitivity of oral fluids testing with the Intercept oral fluid device seems to be from best to worst: cocaine > benzodiazepines >opiates> marijuana.
The sensitivity and specificity for opiates of the Intercept oral fluid device ranges from 75 to 90% and 97- 100% respectively.
The consequences of opiate false-negatives by oral fluid testing with the Intercept oral fluid device need to be weighed against the disadvantages of urine testing, including invasion of privacy issues and adulteration and substitution of the urine specimen.
The window of detection is narrower for oral fluid drug testing than urinalysis and because of this oral fluid testing may best be applied in situations where there is suspected frequent drug use. When drug use is thought to be less frequent or remote, urinalysis may offer a wider (24-48 hours more than oral fluids) window of detection.
The narrow window of detection for oral fluid testing may mean more frequent testing is needed compared to urinalysis. This may increase the expense for drug testing in general.
POC oral fluid testing is not yet available and may limit the practical utility of this drug testing methodology. POC urinalysis by immunoassay is available.
The possible applications of oral fluid testing may include:
Because of its narrow window of detection compared to urinalysis oral fluid testing may best be used during periods of suspected frequent or recent drug use (within 24 hours of drug testing). This is not to say that oral fluid testing is superior to urinalysis during these time periods.
In situations where an observed urine specimen is difficult to obtain. This may include persons with “shy bladder syndrome” or with other urinary conditions limiting their ability to provide an observed urine specimen.
When the health of the patient would make urine testing unreliable (e,g., renal disease)
As an alternative drug testing method when urine specimen tampering practices are suspected to be affecting the reliability of the urinalysis test.
Possible limiting Factors to Diffusion of Oral Fluid Technology
No oral fluid POC test equivalent to onsite urine dips or POC analyzer reducing immediacy of results for patient care.
Currently, physicians get reimbursed directly for POC urinalysis. Oral fluid must be analyzed in a lab setting removing physician reimbursement, which is a source of program funding for many methadone clinics.
Small amount of oral fluid specimen obtained; repeat testing on same sample will be difficult.
Reliability of positive oral fluid methadone (parent drug) results may decrease because of possible contamination of oral cavity after ingestion of dose. Therefore high methadone levels may not be indicative of compliance with treatment. Oral fluid does not as yet test for methadone metabolite.
There currently is no licensed provincial laboratory that analyses oral fluid specimens.
Abbreviations
2-ethylidene- 1,5-dimethyl-3,3-diphenylpyrrolidine
enzyme immunoassay
Enzyme Linked Immunosorbent Assay (ELISA),
Enzyme Multiplied Immunoassay Test (EMIT)
Gas chromatography
gas chromatography/mass spectrometry
High-performance liquid chromatography
Limit of Detection
Mass spectrometry
Methadone Maintenance Treatment
Oral fluid testing
Phencyclidine
Point of Care Testing
tetrahydrocannabinol
11-nor-delta-9-tetrhydrocannabinol-9-carboxylic acid
urine drug testing
PMCID: PMC3379523  PMID: 23074492
21.  Implementation of an Audio Computer-Assisted Self-Interview (ACASI) System in a General Medicine Clinic 
Applied Clinical Informatics  2015;6(1):148-162.
Summary
Background
Routine implementation of instruments to capture patient-reported outcomes could guide clinical practice and facilitate health services research. Audio interviews facilitate self-interviews across literacy levels.
Objectives
To evaluate time burden for patients, and factors associated with response times for an audio computer-assisted self interview (ACASI) system integrated into the clinical workflow.
Methods
We developed an ACASI system, integrated with a research data warehouse. Instruments for symptom burden, self-reported health, depression screening, tobacco use, and patient satisfaction were administered through touch-screen monitors in the general medicine clinic at the Cook County Health & Hospitals System during April 8, 2011-July 27, 2012. We performed a cross-sectional study to evaluate the mean time burden per item and for each module of instruments; we evaluated factors associated with longer response latency.
Results
Among 1,670 interviews, the mean per-question response time was 18.4 [SD, 6.1] seconds. By multivariable analysis, age was most strongly associated with prolonged response time and increased per decade compared to < 50 years as follows (additional seconds per question; 95% CI): 50–59 years (1.4; 0.7 to 2.1 seconds); 60–69 (3.4; 2.6 to 4.1); 70–79 (5.1; 4.0 to 6.1); and 80–89 (5.5; 4.1 to 7.0). Response times also were longer for Spanish language (3.9; 2.9 to 4.9); no home computer use (3.3; 2.8 to 3.9); and, low mental self-reported health (0.6; 0.0 to 1.1). However, most interviews were completed within 10 minutes.
Conclusions
An ACASI software system can be included in a patient visit and adds minimal time burden. The burden was greatest for older patients, interviews in Spanish, and for those with less computer exposure. A patient’s self-reported health had minimal impact on response times.
doi:10.4338/ACI-2014-09-RA-0073
PMCID: PMC4377567  PMID: 25848420
Computers; software; quality of life; symptoms; patient-centered outcome research
22.  Asan Medical Information System for Healthcare Quality Improvement 
Healthcare Informatics Research  2010;16(3):191-197.
Objectives
This purpose of this paper is to introduce the status of the Asan Medical Center (AMC) medical information system with respect to healthcare quality improvement.
Methods
Asan Medical Information System (AMIS) is projected to become a completely electronic and digital information hospital. AMIS has played a role in improving the health care quality based on the following measures: safety, effectiveness, patient-centeredness, timeliness, efficiency, privacy, and security.
Results
AMIS consisted of several distinctive systems: order communication system, electronic medical record, picture archiving communication system, clinical research information system, data warehouse, enterprise resource planning, IT service management system, and disaster recovery system. The most distinctive features of AMIS were the high alert-medication recognition & management system, the integrated and severity stratified alert system, the integrated patient monitoring system, the perioperative diabetic care monitoring and support system, and the clinical indicator management system.
Conclusions
AMIS provides IT services for AMC, 7 affiliated hospitals and over 5,000 partners clinics, and was developed to improve healthcare services. The current challenge of AMIS is standard and interoperability. A global health IT strategy is needed to get through the current challenges and to provide new services as needed.
doi:10.4258/hir.2010.16.3.191
PMCID: PMC3089858  PMID: 21818439
Hospital Information Systems; Quality of Health Care; Clinical Decision Support Systems; Electronic Medical Record
23.  Proceedings of the 8th Annual Conference on the Science of Dissemination and Implementation 
Chambers, David | Simpson, Lisa | Hill-Briggs, Felicia | Neta, Gila | Vinson, Cynthia | Chambers, David | Beidas, Rinad | Marcus, Steven | Aarons, Gregory | Hoagwood, Kimberly | Schoenwald, Sonja | Evans, Arthur | Hurford, Matthew | Rubin, Ronnie | Hadley, Trevor | Barg, Frances | Walsh, Lucia | Adams, Danielle | Mandell, David | Martin, Lindsey | Mignogna, Joseph | Mott, Juliette | Hundt, Natalie | Kauth, Michael | Kunik, Mark | Naik, Aanand | Cully, Jeffrey | McGuire, Alan | White, Dominique | Bartholomew, Tom | McGrew, John | Luther, Lauren | Rollins, Angie | Salyers, Michelle | Cooper, Brittany | Funaiole, Angie | Richards, Julie | Lee, Amy | Lapham, Gwen | Caldeiro, Ryan | Lozano, Paula | Gildred, Tory | Achtmeyer, Carol | Ludman, Evette | Addis, Megan | Marx, Larry | Bradley, Katharine | VanDeinse, Tonya | Wilson, Amy Blank | Stacey, Burgin | Powell, Byron | Bunger, Alicia | Cuddeback, Gary | Barnett, Miya | Stadnick, Nicole | Brookman-Frazee, Lauren | Lau, Anna | Dorsey, Shannon | Pullmann, Michael | Mitchell, Shannon | Schwartz, Robert | Kirk, Arethusa | Dusek, Kristi | Oros, Marla | Hosler, Colleen | Gryczynski, Jan | Barbosa, Carolina | Dunlap, Laura | Lounsbury, David | O’Grady, Kevin | Brown, Barry | Damschroder, Laura | Waltz, Thomas | Powell, Byron | Ritchie, Mona | Waltz, Thomas | Atkins, David | Imel, Zac E. | Xiao, Bo | Can, Doğan | Georgiou, Panayiotis | Narayanan, Shrikanth | Berkel, Cady | Gallo, Carlos | Sandler, Irwin | Brown, C. Hendricks | Wolchik, Sharlene | Mauricio, Anne Marie | Gallo, Carlos | Brown, C. Hendricks | Mehrotra, Sanjay | Chandurkar, Dharmendra | Bora, Siddhartha | Das, Arup | Tripathi, Anand | Saggurti, Niranjan | Raj, Anita | Hughes, Eric | Jacobs, Brian | Kirkendall, Eric | Loeb, Danielle | Trinkley, Katy | Yang, Michael | Sprowell, Andrew | Nease, Donald | Lyon, Aaron | Lewis, Cara | Boyd, Meredith | Melvin, Abigail | Nicodimos, Semret | Liu, Freda | Jungbluth, Nathanial | Lyon, Aaron | Lewis, Cara | Boyd, Meredith | Melvin, Abigail | Nicodimos, Semret | Liu, Freda | Jungbluth, Nathanial | Flynn, Allen | Landis-Lewis, Zach | Sales, Anne | Baloh, Jure | Ward, Marcia | Zhu, Xi | Bennett, Ian | Unutzer, Jurgen | Mao, Johnny | Proctor, Enola | Vredevoogd, Mindy | Chan, Ya-Fen | Williams, Nathaniel | Green, Phillip | Bernstein, Steven | Rosner, June-Marie | DeWitt, Michelle | Tetrault, Jeanette | Dziura, James | Hsiao, Allen | Sussman, Scott | O’Connor, Patrick | Toll, Benjamin | Jones, Michael | Gassaway, Julie | Tobin, Jonathan | Zatzick, Douglas | Bradbury, Angela R. | Patrick-Miller, Linda | Egleston, Brian | Olopade, Olufunmilayo I. | Hall, Michael J. | Daly, Mary B. | Fleisher, Linda | Grana, Generosa | Ganschow, Pamela | Fetzer, Dominique | Brandt, Amanda | Farengo-Clark, Dana | Forman, Andrea | Gaber, Rikki S. | Gulden, Cassandra | Horte, Janice | Long, Jessica | Chambers, Rachelle Lorenz | Lucas, Terra | Madaan, Shreshtha | Mattie, Kristin | McKenna, Danielle | Montgomery, Susan | Nielsen, Sarah | Powers, Jacquelyn | Rainey, Kim | Rybak, Christina | Savage, Michelle | Seelaus, Christina | Stoll, Jessica | Stopfer, Jill | Yao, Shirley | Domchek, Susan | Hahn, Erin | Munoz-Plaza, Corrine | Wang, Jianjin | Delgadillo, Jazmine Garcia | Mittman, Brian | Gould, Michael | Liang, Shuting (Lily) | Kegler, Michelle C. | Cotter, Megan | Phillips, Emily | Hermstad, April | Morton, Rentonia | Beasley, Derrick | Martinez, Jeremy | Riehman, Kara | Gustafson, David | Marsch, Lisa | Mares, Louise | Quanbeck, Andrew | McTavish, Fiona | McDowell, Helene | Brown, Randall | Thomas, Chantelle | Glass, Joseph | Isham, Joseph | Shah, Dhavan | Liebschutz, Jane | Lasser, Karen | Watkins, Katherine | Ober, Allison | Hunter, Sarah | Lamp, Karen | Ewing, Brett | Iwelunmor, Juliet | Gyamfi, Joyce | Blackstone, Sarah | Quakyi, Nana Kofi | Plange-Rhule, Jacob | Ogedegbe, Gbenga | Kumar, Pritika | Van Devanter, Nancy | Nguyen, Nam | Nguyen, Linh | Nguyen, Trang | Phuong, Nguyet | Shelley, Donna | Rudge, Sian | Langlois, Etienne | Tricco, Andrea | Ball, Sherry | Lambert-Kerzner, Anne | Sulc, Christine | Simmons, Carol | Shell-Boyd, Jeneen | Oestreich, Taryn | O’Connor, Ashley | Neely, Emily | McCreight, Marina | Labebue, Amy | DiFiore, Doreen | Brostow, Diana | Ho, P. Michael | Aron, David | Harvey, Jillian | McHugh, Megan | Scanlon, Dennis | Lee, Rebecca | Soltero, Erica | Parker, Nathan | McNeill, Lorna | Ledoux, Tracey | McIsaac, Jessie-Lee | MacLeod, Kate | Ata, Nicole | Jarvis, Sherry | Kirk, Sara | Purtle, Jonathan | Dodson, Elizabeth | Brownson, Ross | Mittman, Brian | Curran, Geoffrey | Curran, Geoffrey | Pyne, Jeffrey | Aarons, Gregory | Ehrhart, Mark | Torres, Elisa | Miech, Edward | Miech, Edward | Stevens, Kathleen | Hamilton, Alison | Cohen, Deborah | Padgett, Deborah | Morshed, Alexandra | Patel, Rupa | Prusaczyk, Beth | Aron, David C. | Gupta, Divya | Ball, Sherry | Hand, Rosa | Abram, Jenica | Wolfram, Taylor | Hastings, Molly | Moreland-Russell, Sarah | Tabak, Rachel | Ramsey, Alex | Baumann, Ana | Kryzer, Emily | Montgomery, Katherine | Lewis, Ericka | Padek, Margaret | Powell, Byron | Brownson, Ross | Mamaril, Cezar Brian | Mays, Glen | Branham, Keith | Timsina, Lava | Mays, Glen | Hogg, Rachel | Fagan, Abigail | Shapiro, Valerie | Brown, Eric | Haggerty, Kevin | Hawkins, David | Oesterle, Sabrina | Hawkins, David | Catalano, Richard | McKay, Virginia | Dolcini, M. Margaret | Hoffer, Lee | Moin, Tannaz | Li, Jinnan | Duru, O. Kenrik | Ettner, Susan | Turk, Norman | Chan, Charles | Keckhafer, Abigail | Luchs, Robert | Ho, Sam | Mangione, Carol | Selby, Peter | Zawertailo, Laurie | Minian, Nadia | Balliunas, Dolly | Dragonetti, Rosa | Hussain, Sarwar | Lecce, Julia | Chinman, Matthew | Acosta, Joie | Ebener, Patricia | Malone, Patrick S. | Slaughter, Mary | Freedman, Darcy | Flocke, Susan | Lee, Eunlye | Matlack, Kristen | Trapl, Erika | Ohri-Vachaspati, Punam | Taggart, Morgan | Borawski, Elaine | Parrish, Amanda | Harris, Jeffrey | Kohn, Marlana | Hammerback, Kristen | McMillan, Becca | Hannon, Peggy | Swindle, Taren | Curran, Geoffrey | Whiteside-Mansell, Leanne | Ward, Wendy | Holt, Cheryl | Santos, Sheri Lou | Tagai, Erin | Scheirer, Mary Ann | Carter, Roxanne | Bowie, Janice | Haider, Muhiuddin | Slade, Jimmie | Wang, Min Qi | Masica, Andrew | Ogola, Gerald | Berryman, Candice | Richter, Kathleen | Shelton, Rachel | Jandorf, Lina | Erwin, Deborah | Truong, Khoa | Javier, Joyce R. | Coffey, Dean | Schrager, Sheree M. | Palinkas, Lawrence | Miranda, Jeanne | Johnson, Veda | Hutcherson, Valerie | Ellis, Ruth | Kharmats, Anna | Marshall-King, Sandra | LaPradd, Monica | Fonseca-Becker, Fannie | Kepka, Deanna | Bodson, Julia | Warner, Echo | Fowler, Brynn | Shenkman, Elizabeth | Hogan, William | Odedina, Folakami | De Leon, Jessica | Hooper, Monica | Carrasquillo, Olveen | Reams, Renee | Hurt, Myra | Smith, Steven | Szapocznik, Jose | Nelson, David | Mandal, Prabir | Teufel, James
Implementation Science : IS  2016;11(Suppl 2):100.
Table of contents
A1 Introduction to the 8th Annual Conference on the Science of Dissemination and Implementation: Optimizing Personal and Population Health
David Chambers, Lisa Simpson
D1 Discussion forum: Population health D&I research
Felicia Hill-Briggs
D2 Discussion forum: Global health D&I research
Gila Neta, Cynthia Vinson
D3 Discussion forum: Precision medicine and D&I research
David Chambers
S1 Predictors of community therapists’ use of therapy techniques in a large public mental health system
Rinad Beidas, Steven Marcus, Gregory Aarons, Kimberly Hoagwood, Sonja Schoenwald, Arthur Evans, Matthew Hurford, Ronnie Rubin, Trevor Hadley, Frances Barg, Lucia Walsh, Danielle Adams, David Mandell
S2 Implementing brief cognitive behavioral therapy (CBT) in primary care: Clinicians' experiences from the field
Lindsey Martin, Joseph Mignogna, Juliette Mott, Natalie Hundt, Michael Kauth, Mark Kunik, Aanand Naik, Jeffrey Cully
S3 Clinician competence: Natural variation, factors affecting, and effect on patient outcomes
Alan McGuire, Dominique White, Tom Bartholomew, John McGrew, Lauren Luther, Angie Rollins, Michelle Salyers
S4 Exploring the multifaceted nature of sustainability in community-based prevention: A mixed-method approach
Brittany Cooper, Angie Funaiole
S5 Theory informed behavioral health integration in primary care: Mixed methods evaluation of the implementation of routine depression and alcohol screening and assessment
Julie Richards, Amy Lee, Gwen Lapham, Ryan Caldeiro, Paula Lozano, Tory Gildred, Carol Achtmeyer, Evette Ludman, Megan Addis, Larry Marx, Katharine Bradley
S6 Enhancing the evidence for specialty mental health probation through a hybrid efficacy and implementation study
Tonya VanDeinse, Amy Blank Wilson, Burgin Stacey, Byron Powell, Alicia Bunger, Gary Cuddeback
S7 Personalizing evidence-based child mental health care within a fiscally mandated policy reform
Miya Barnett, Nicole Stadnick, Lauren Brookman-Frazee, Anna Lau
S8 Leveraging an existing resource for technical assistance: Community-based supervisors in public mental health
Shannon Dorsey, Michael Pullmann
S9 SBIRT implementation for adolescents in urban federally qualified health centers: Implementation outcomes
Shannon Mitchell, Robert Schwartz, Arethusa Kirk, Kristi Dusek, Marla Oros, Colleen Hosler, Jan Gryczynski, Carolina Barbosa, Laura Dunlap, David Lounsbury, Kevin O'Grady, Barry Brown
S10 PANEL: Tailoring Implementation Strategies to Context - Expert recommendations for tailoring strategies to context
Laura Damschroder, Thomas Waltz, Byron Powell
S11 PANEL: Tailoring Implementation Strategies to Context - Extreme facilitation: Helping challenged healthcare settings implement complex programs
Mona Ritchie
S12 PANEL: Tailoring Implementation Strategies to Context - Using menu-based choice tasks to obtain expert recommendations for implementing three high-priority practices in the VA
Thomas Waltz
S13 PANEL: The Use of Technology to Improve Efficient Monitoring of Implementation of Evidence-based Programs - Siri, rate my therapist: Using technology to automate fidelity ratings of motivational interviewing
David Atkins, Zac E. Imel, Bo Xiao, Doğan Can, Panayiotis Georgiou, Shrikanth Narayanan
S14 PANEL: The Use of Technology to Improve Efficient Monitoring of Implementation of Evidence-based Programs - Identifying indicators of implementation quality for computer-based ratings
Cady Berkel, Carlos Gallo, Irwin Sandler, C. Hendricks Brown, Sharlene Wolchik, Anne Marie Mauricio
S15 PANEL: The Use of Technology to Improve Efficient Monitoring of Implementation of Evidence-based Programs - Improving implementation of behavioral interventions by monitoring emotion in spoken speech
Carlos Gallo, C. Hendricks Brown, Sanjay Mehrotra
S16 Scorecards and dashboards to assure data quality of health management information system (HMIS) using R
Dharmendra Chandurkar, Siddhartha Bora, Arup Das, Anand Tripathi, Niranjan Saggurti, Anita Raj
S17 A big data approach for discovering and implementing patient safety insights
Eric Hughes, Brian Jacobs, Eric Kirkendall
S18 Improving the efficacy of a depression registry for use in a collaborative care model
Danielle Loeb, Katy Trinkley, Michael Yang, Andrew Sprowell, Donald Nease
S19 Measurement feedback systems as a strategy to support implementation of measurement-based care in behavioral health
Aaron Lyon, Cara Lewis, Meredith Boyd, Abigail Melvin, Semret Nicodimos, Freda Liu, Nathanial Jungbluth
S20 PANEL: Implementation Science and Learning Health Systems: Intersections and Commonalities - Common loop assay: Methods of supporting learning collaboratives
Allen Flynn
S21 PANEL: Implementation Science and Learning Health Systems: Intersections and Commonalities - Innovating audit and feedback using message tailoring models for learning health systems
Zach Landis-Lewis
S22 PANEL: Implementation Science and Learning Health Systems: Intersections and Commonalities - Implementation science and learning health systems: Connecting the dots
Anne Sales
S23 Facilitation activities of Critical Access Hospitals during TeamSTEPPS implementation
Jure Baloh, Marcia Ward, Xi Zhu
S24 Organizational and social context of federally qualified health centers and variation in maternal depression outcomes
Ian Bennett, Jurgen Unutzer, Johnny Mao, Enola Proctor, Mindy Vredevoogd, Ya-Fen Chan, Nathaniel Williams, Phillip Green
S25 Decision support to enhance treatment of hospitalized smokers: A randomized trial
Steven Bernstein, June-Marie Rosner, Michelle DeWitt, Jeanette Tetrault, James Dziura, Allen Hsiao, Scott Sussman, Patrick O’Connor, Benjamin Toll
S26 PANEL: Developing Sustainable Strategies for the Implementation of Patient-Centered Care across Diverse US Healthcare Systems - A patient-centered approach to successful community transition after catastrophic injury
Michael Jones, Julie Gassaway
S27 PANEL: Developing Sustainable Strategies for the Implementation of Patient-Centered Care across Diverse US Healthcare Systems - Conducting PCOR to integrate mental health and cancer screening services in primary care
Jonathan Tobin
S28 PANEL: Developing Sustainable Strategies for the Implementation of Patient-Centered Care across Diverse US Healthcare Systems - A comparative effectiveness trial of optimal patient-centered care for US trauma care systems
Douglas Zatzick
S29 Preferences for in-person communication among patients in a multi-center randomized study of in-person versus telephone communication of genetic test results for cancer susceptibility
Angela R Bradbury, Linda Patrick-Miller, Brian Egleston, Olufunmilayo I Olopade, Michael J Hall, Mary B Daly, Linda Fleisher, Generosa Grana, Pamela Ganschow, Dominique Fetzer, Amanda Brandt, Dana Farengo-Clark, Andrea Forman, Rikki S Gaber, Cassandra Gulden, Janice Horte, Jessica Long, Rachelle Lorenz Chambers, Terra Lucas, Shreshtha Madaan, Kristin Mattie, Danielle McKenna, Susan Montgomery, Sarah Nielsen, Jacquelyn Powers, Kim Rainey, Christina Rybak, Michelle Savage, Christina Seelaus, Jessica Stoll, Jill Stopfer, Shirley Yao and Susan Domchek
S30 Working towards de-implementation: A mixed methods study in breast cancer surveillance care
Erin Hahn, Corrine Munoz-Plaza, Jianjin Wang, Jazmine Garcia Delgadillo, Brian Mittman Michael Gould
S31Integrating evidence-based practices for increasing cancer screenings in safety-net primary care systems: A multiple case study using the consolidated framework for implementation research
Shuting (Lily) Liang, Michelle C. Kegler, Megan Cotter, Emily Phillips, April Hermstad, Rentonia Morton, Derrick Beasley, Jeremy Martinez, Kara Riehman
S32 Observations from implementing an mHealth intervention in an FQHC
David Gustafson, Lisa Marsch, Louise Mares, Andrew Quanbeck, Fiona McTavish, Helene McDowell, Randall Brown, Chantelle Thomas, Joseph Glass, Joseph Isham, Dhavan Shah
S33 A multicomponent intervention to improve primary care provider adherence to chronic opioid therapy guidelines and reduce opioid misuse: A cluster randomized controlled trial protocol
Jane Liebschutz, Karen Lasser
S34 Implementing collaborative care for substance use disorders in primary care: Preliminary findings from the summit study
Katherine Watkins, Allison Ober, Sarah Hunter, Karen Lamp, Brett Ewing
S35 Sustaining a task-shifting strategy for blood pressure control in Ghana: A stakeholder analysis
Juliet Iwelunmor, Joyce Gyamfi, Sarah Blackstone, Nana Kofi Quakyi, Jacob Plange-Rhule, Gbenga Ogedegbe
S36 Contextual adaptation of the consolidated framework for implementation research (CFIR) in a tobacco cessation study in Vietnam
Pritika Kumar, Nancy Van Devanter, Nam Nguyen, Linh Nguyen, Trang Nguyen, Nguyet Phuong, Donna Shelley
S37 Evidence check: A knowledge brokering approach to systematic reviews for policy
Sian Rudge
S38 Using Evidence Synthesis to Strengthen Complex Health Systems in Low- and Middle-Income Countries
Etienne Langlois
S39 Does it matter: timeliness or accuracy of results? The choice of rapid reviews or systematic reviews to inform decision-making
Andrea Tricco
S40 Evaluation of the veterans choice program using lean six sigma at a VA medical center to identify benefits and overcome obstacles
Sherry Ball, Anne Lambert-Kerzner, Christine Sulc, Carol Simmons, Jeneen Shell-Boyd, Taryn Oestreich, Ashley O'Connor, Emily Neely, Marina McCreight, Amy Labebue, Doreen DiFiore, Diana Brostow, P. Michael Ho, David Aron
S41 The influence of local context on multi-stakeholder alliance quality improvement activities: A multiple case study
Jillian Harvey, Megan McHugh, Dennis Scanlon
S42 Increasing physical activity in early care and education: Sustainability via active garden education (SAGE)
Rebecca Lee, Erica Soltero, Nathan Parker, Lorna McNeill, Tracey Ledoux
S43 Marking a decade of policy implementation: The successes and continuing challenges of a provincial school food and nutrition policy in Canada
Jessie-Lee McIsaac, Kate MacLeod, Nicole Ata, Sherry Jarvis, Sara Kirk
S44 Use of research evidence among state legislators who prioritize mental health and substance abuse issues
Jonathan Purtle, Elizabeth Dodson, Ross Brownson
S45 PANEL: Effectiveness-Implementation Hybrid Designs: Clarifications, Refinements, and Additional Guidance Based on a Systematic Review and Reports from the Field - Hybrid type 1 designs
Brian Mittman, Geoffrey Curran
S46 PANEL: Effectiveness-Implementation Hybrid Designs: Clarifications, Refinements, and Additional Guidance Based on a Systematic Review and Reports from the Field - Hybrid type 2 designs
Geoffrey Curran
S47 PANEL: Effectiveness-Implementation Hybrid Designs: Clarifications, Refinements, and Additional Guidance Based on a Systematic Review and Reports from the Field - Hybrid type 3 designs
Jeffrey Pyne
S48 Linking team level implementation leadership and implementation climate to individual level attitudes, behaviors, and implementation outcomes
Gregory Aarons, Mark Ehrhart, Elisa Torres
S49 Pinpointing the specific elements of local context that matter most to implementation outcomes: Findings from qualitative comparative analysis in the RE-inspire study of VA acute stroke care
Edward Miech
S50 The GO score: A new context-sensitive instrument to measure group organization level for providing and improving care
Edward Miech
S51 A research network approach for boosting implementation and improvement
Kathleen Stevens, I.S.R.N. Steering Council
S52 PANEL: Qualitative methods in D&I Research: Value, rigor and challenge - The value of qualitative methods in implementation research
Alison Hamilton
S53 PANEL: Qualitative methods in D&I Research: Value, rigor and challenge - Learning evaluation: The role of qualitative methods in dissemination and implementation research
Deborah Cohen
S54 PANEL: Qualitative methods in D&I Research: Value, rigor and challenge - Qualitative methods in D&I research
Deborah Padgett
S55 PANEL: Maps & models: The promise of network science for clinical D&I - Hospital network of sharing patients with acute and chronic diseases in California
Alexandra Morshed
S56 PANEL: Maps & models: The promise of network science for clinical D&I - The use of social network analysis to identify dissemination targets and enhance D&I research study recruitment for pre-exposure prophylaxis for HIV (PrEP) among men who have sex with men
Rupa Patel
S57 PANEL: Maps & models: The promise of network science for clinical D&I - Network and organizational factors related to the adoption of patient navigation services among rural breast cancer care providers
Beth Prusaczyk
S58 A theory of de-implementation based on the theory of healthcare professionals’ behavior and intention (THPBI) and the becker model of unlearning
David C. Aron, Divya Gupta, Sherry Ball
S59 Observation of registered dietitian nutritionist-patient encounters by dietetic interns highlights low awareness and implementation of evidence-based nutrition practice guidelines
Rosa Hand, Jenica Abram, Taylor Wolfram
S60 Program sustainability action planning: Building capacity for program sustainability using the program sustainability assessment tool
Molly Hastings, Sarah Moreland-Russell
S61 A review of D&I study designs in published study protocols
Rachel Tabak, Alex Ramsey, Ana Baumann, Emily Kryzer, Katherine Montgomery, Ericka Lewis, Margaret Padek, Byron Powell, Ross Brownson
S62 PANEL: Geographic variation in the implementation of public health services: Economic, organizational, and network determinants - Model simulation techniques to estimate the cost of implementing foundational public health services
Cezar Brian Mamaril, Glen Mays, Keith Branham, Lava Timsina
S63 PANEL: Geographic variation in the implementation of public health services: Economic, organizational, and network determinants - Inter-organizational network effects on the implementation of public health services
Glen Mays, Rachel Hogg
S64 PANEL: Building capacity for implementation and dissemination of the communities that care prevention system at scale to promote evidence-based practices in behavioral health - Implementation fidelity, coalition functioning, and community prevention system transformation using communities that care
Abigail Fagan, Valerie Shapiro, Eric Brown
S65 PANEL: Building capacity for implementation and dissemination of the communities that care prevention system at scale to promote evidence-based practices in behavioral health - Expanding capacity for implementation of communities that care at scale using a web-based, video-assisted training system
Kevin Haggerty, David Hawkins
S66 PANEL: Building capacity for implementation and dissemination of the communities that care prevention system at scale to promote evidence-based practices in behavioral health - Effects of communities that care on reducing youth behavioral health problems
Sabrina Oesterle, David Hawkins, Richard Catalano
S68 When interventions end: the dynamics of intervention de-adoption and replacement
Virginia McKay, M. Margaret Dolcini, Lee Hoffer
S69 Results from next-d: can a disease specific health plan reduce incident diabetes development among a national sample of working-age adults with pre-diabetes?
Tannaz Moin, Jinnan Li, O. Kenrik Duru, Susan Ettner, Norman Turk, Charles Chan, Abigail Keckhafer, Robert Luchs, Sam Ho, Carol Mangione
S70 Implementing smoking cessation interventions in primary care settings (STOP): using the interactive systems framework
Peter Selby, Laurie Zawertailo, Nadia Minian, Dolly Balliunas, Rosa Dragonetti, Sarwar Hussain, Julia Lecce
S71 Testing the Getting To Outcomes implementation support intervention in prevention-oriented, community-based settings
Matthew Chinman, Joie Acosta, Patricia Ebener, Patrick S Malone, Mary Slaughter
S72 Examining the reach of a multi-component farmers’ market implementation approach among low-income consumers in an urban context
Darcy Freedman, Susan Flocke, Eunlye Lee, Kristen Matlack, Erika Trapl, Punam Ohri-Vachaspati, Morgan Taggart, Elaine Borawski
S73 Increasing implementation of evidence-based health promotion practices at large workplaces: The CEOs Challenge
Amanda Parrish, Jeffrey Harris, Marlana Kohn, Kristen Hammerback, Becca McMillan, Peggy Hannon
S74 A qualitative assessment of barriers to nutrition promotion and obesity prevention in childcare
Taren Swindle, Geoffrey Curran, Leanne Whiteside-Mansell, Wendy Ward
S75 Documenting institutionalization of a health communication intervention in African American churches
Cheryl Holt, Sheri Lou Santos, Erin Tagai, Mary Ann Scheirer, Roxanne Carter, Janice Bowie, Muhiuddin Haider, Jimmie Slade, Min Qi Wang
S76 Reduction in hospital utilization by underserved patients through use of a community-medical home
Andrew Masica, Gerald Ogola, Candice Berryman, Kathleen Richter
S77 Sustainability of evidence-based lay health advisor programs in African American communities: A mixed methods investigation of the National Witness Project
Rachel Shelton, Lina Jandorf, Deborah Erwin
S78 Predicting the long-term uninsured population and analyzing their gaps in physical access to healthcare in South Carolina
Khoa Truong
S79 Using an evidence-based parenting intervention in churches to prevent behavioral problems among Filipino youth: A randomized pilot study
Joyce R. Javier, Dean Coffey, Sheree M. Schrager, Lawrence Palinkas, Jeanne Miranda
S80 Sustainability of elementary school-based health centers in three health-disparate southern communities
Veda Johnson, Valerie Hutcherson, Ruth Ellis
S81 Childhood obesity prevention partnership in Louisville: creative opportunities to engage families in a multifaceted approach to obesity prevention
Anna Kharmats, Sandra Marshall-King, Monica LaPradd, Fannie Fonseca-Becker
S82 Improvements in cervical cancer prevention found after implementation of evidence-based Latina prevention care management program
Deanna Kepka, Julia Bodson, Echo Warner, Brynn Fowler
S83 The OneFlorida data trust: Achieving health equity through research & training capacity building
Elizabeth Shenkman, William Hogan, Folakami Odedina, Jessica De Leon, Monica Hooper, Olveen Carrasquillo, Renee Reams, Myra Hurt, Steven Smith, Jose Szapocznik, David Nelson, Prabir Mandal
S84 Disseminating and sustaining medical-legal partnerships: Shared value and social return on investment
James Teufel
doi:10.1186/s13012-016-0452-0
PMCID: PMC4977475  PMID: 27490260
24.  Implementation of the CDC translational informatics platform - from genetic variants to the national Swedish Rheumatology Quality Register 
Background
Sequencing of the human genome and the subsequent analyses have produced immense volumes of data. The technological advances have opened new windows into genomics beyond the DNA sequence. In parallel, clinical practice generate large amounts of data. This represents an underused data source that has much greater potential in translational research than is currently realized. This research aims at implementing a translational medicine informatics platform to integrate clinical data (disease diagnosis, diseases activity and treatment) of Rheumatoid Arthritis (RA) patients from Karolinska University Hospital and their research database (biobanks, genotype variants and serology) at the Center for Molecular Medicine, Karolinska Institutet.
Methods
Requirements engineering methods were utilized to identify user requirements. Unified Modeling Language and data modeling methods were used to model the universe of discourse and data sources. Oracle11g were used as the database management system, and the clinical development center (CDC) was used as the application interface. Patient data were anonymized, and we employed authorization and security methods to protect the system.
Results
We developed a user requirement matrix, which provided a framework for evaluating three translation informatics systems. The implementation of the CDC successfully integrated biological research database (15172 DNA, serum and synovial samples, 1436 cell samples and 65 SNPs per patient) and clinical database (5652 clinical visit) for the cohort of 379 patients presents three profiles. Basic functionalities provided by the translational medicine platform are research data management, development of bioinformatics workflow and analysis, sub-cohort selection, and re-use of clinical data in research settings. Finally, the system allowed researchers to extract subsets of attributes from cohorts according to specific biological, clinical, or statistical features.
Conclusions
Research and clinical database integration is a real challenge and a road-block in translational research. Through this research we addressed the challenges and demonstrated the usefulness of CDC. We adhered to ethical regulations pertaining to patient data, and we determined that the existing software solutions cannot meet the translational research needs at hand. We used RA as a test case since we have ample data on active and longitudinal cohort.
doi:10.1186/1479-5876-11-85
PMCID: PMC3623742  PMID: 23548156
Swedish Rheumatology Quality Register (SRQ); Translational medicine platform; Secondary use of clinical data; Patient de-identification
25.  Data Warehouse Governance Programs in Healthcare Settings: A Literature Review and a Call to Action 
EGEMS  2013;1(1):1010.
Purpose:
Given the extensive data stored in healthcare data warehouses, data warehouse governance policies are needed to ensure data integrity and privacy. This review examines the current state of the data warehouse governance literature as it applies to healthcare data warehouses, identifies knowledge gaps, provides recommendations, and suggests approaches for further research.
Methods:
A comprehensive literature search using five data bases, journal article title-search, and citation searches was conducted between 1997 and 2012. Data warehouse governance documents from two healthcare systems in the USA were also reviewed. A modified version of nine components from the Data Governance Institute Framework for data warehouse governance guided the qualitative analysis.
Results:
Fifteen articles were retrieved. Only three were related to healthcare settings, each of which addressed only one of the nine framework components. Of the remaining 12 articles, 10 addressed between one and seven framework components and the remainder addressed none. Each of the two data warehouse governance plans obtained from healthcare systems in the USA addressed a subset of the framework components, and between them they covered all nine.
Conclusions:
While published data warehouse governance policies are rare, the 15 articles and two healthcare organizational documents reviewed in this study may provide guidance to creating such policies. Additional research is needed in this area to ensure that data warehouse governance polices are feasible and effective. The gap between the development of data warehouses in healthcare settings and formal governance policies is substantial, as evidenced by the sparse literature in this domain.
doi:10.13063/2327-9214.1010
PMCID: PMC4371514  PMID: 25848561
Governance; Health Information Technology; SPAN

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