John H Holmes1, Thomas E Elliott2, Jeffrey S Brown3, Marsha A Raebel4, Arthur Davidson5, Andrew F Nelson6, Annie Chung1, Pierre La Chance7, John F Steiner8. 1. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA. 2. University of Minnesota Medical School, HealthPartners Institute for Education and Research, Duluth, Minnesota, USA. 3. Harvard Medical School Department of Population Medicine, Boston, Massachusetts, USA. 4. Kaiser Permanente Colorado Institute for Health Research, Denver, Colorado, USA. 5. Denver Health and Hospital Authority, Denver, Colorado, USA. 6. HealthPartners Institute for Education and Research, Minneapolis, Minnesota, USA. 7. Research Informatics, Center for Health Research, Kaiser Permanente, Portland, Oregon, USA. 8. Kaiser Permanente Colorado, Denver, Colorado, USA.
Abstract
OBJECTIVE: To review the published, peer-reviewed literature on clinical research data warehouse governance in distributed research networks (DRNs). MATERIALS AND METHODS: Medline, PubMed, EMBASE, CINAHL, and INSPEC were searched for relevant documents published through July 31, 2013 using a systematic approach. Only documents relating to DRNs in the USA were included. Documents were analyzed using a classification framework consisting of 10 facets to identify themes. RESULTS: 6641 documents were retrieved. After screening for duplicates and relevance, 38 were included in the final review. A peer-reviewed literature on data warehouse governance is emerging, but is still sparse. Peer-reviewed publications on UK research network governance were more prevalent, although not reviewed for this analysis. All 10 classification facets were used, with some documents falling into two or more classifications. No document addressed costs associated with governance. DISCUSSION: Even though DRNs are emerging as vehicles for research and public health surveillance, understanding of DRN data governance policies and procedures is limited. This is expected to change as more DRN projects disseminate their governance approaches as publicly available toolkits and peer-reviewed publications. CONCLUSIONS: While peer-reviewed, US-based DRN data warehouse governance publications have increased, DRN developers and administrators are encouraged to publish information about these programs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
OBJECTIVE: To review the published, peer-reviewed literature on clinical research data warehouse governance in distributed research networks (DRNs). MATERIALS AND METHODS: Medline, PubMed, EMBASE, CINAHL, and INSPEC were searched for relevant documents published through July 31, 2013 using a systematic approach. Only documents relating to DRNs in the USA were included. Documents were analyzed using a classification framework consisting of 10 facets to identify themes. RESULTS: 6641 documents were retrieved. After screening for duplicates and relevance, 38 were included in the final review. A peer-reviewed literature on data warehouse governance is emerging, but is still sparse. Peer-reviewed publications on UK research network governance were more prevalent, although not reviewed for this analysis. All 10 classification facets were used, with some documents falling into two or more classifications. No document addressed costs associated with governance. DISCUSSION: Even though DRNs are emerging as vehicles for research and public health surveillance, understanding of DRN data governance policies and procedures is limited. This is expected to change as more DRN projects disseminate their governance approaches as publicly available toolkits and peer-reviewed publications. CONCLUSIONS: While peer-reviewed, US-based DRN data warehouse governance publications have increased, DRN developers and administrators are encouraged to publish information about these programs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Keywords:
Clinical research; Data governance; Data privacy; Data warehouse; Research networks
Authors: R Platt; R Davis; J Finkelstein; A S Go; J H Gurwitz; D Roblin; S Soumerai; D Ross-Degnan; S Andrade; M J Goodman; B Martinson; M A Raebel; D Smith; M Ulcickas-Yood; K A Chan Journal: Pharmacoepidemiol Drug Saf Date: 2001 Aug-Sep Impact factor: 2.890
Authors: Andrew J McMurry; Clint A Gilbert; Ben Y Reis; Henry C Chueh; Isaac S Kohane; Kenneth D Mandl Journal: J Am Med Inform Assoc Date: 2007-04-25 Impact factor: 4.497
Authors: Edward H Wagner; Sarah M Greene; Gene Hart; Terry S Field; Suzanne Fletcher; Ann M Geiger; Lisa J Herrinton; Mark C Hornbrook; Christine C Johnson; Judy Mouchawar; Sharon J Rolnick; Victor J Stevens; Stephen H Taplin; Dennis Tolsma; Thomas M Vogt Journal: J Natl Cancer Inst Monogr Date: 2005
Authors: James Baggs; Julianne Gee; Edwin Lewis; Gabrielle Fowler; Patti Benson; Tracy Lieu; Allison Naleway; Nicola P Klein; Roger Baxter; Edward Belongia; Jason Glanz; Simon J Hambidge; Steven J Jacobsen; Lisa Jackson; Jim Nordin; Eric Weintraub Journal: Pediatrics Date: 2011-04-18 Impact factor: 7.124
Authors: Kari L Walker; Olga Kirillova; Suzanne E Gillespie; David Hsiao; Valentyna Pishchalenko; Akshatha Kalsanka Pai; Jon E Puro; Robert Plumley; Rustam Kudyakov; Weiming Hu; Art Allisany; MaryAnn McBurnie; Stephen E Kurtz; Brian L Hazlehurst Journal: J Am Med Inform Assoc Date: 2014-07-03 Impact factor: 4.497
Authors: Rui Duan; Mary Regina Boland; Zixuan Liu; Yue Liu; Howard H Chang; Hua Xu; Haitao Chu; Christopher H Schmid; Christopher B Forrest; John H Holmes; Martijn J Schuemie; Jesse A Berlin; Jason H Moore; Yong Chen Journal: J Am Med Inform Assoc Date: 2020-03-01 Impact factor: 4.497
Authors: Boyd M Knosp; Catherine K Craven; David A Dorr; Elmer V Bernstam; Thomas R Campion Journal: J Am Med Inform Assoc Date: 2022-03-15 Impact factor: 7.942
Authors: Daniella Meeker; Xiaoqian Jiang; Michael E Matheny; Claudiu Farcas; Michel D'Arcy; Laura Pearlman; Lavanya Nookala; Michele E Day; Katherine K Kim; Hyeoneui Kim; Aziz Boxwala; Robert El-Kareh; Grace M Kuo; Frederic S Resnic; Carl Kesselman; Lucila Ohno-Machado Journal: J Am Med Inform Assoc Date: 2015-07-03 Impact factor: 4.497