Five-year experience with setup and implementation of an integrated database system for clinical documentation and research

Computer Methods and Programs in Biomedicine

Volumn 114, Issue 2, 2014, Pages 206-217

  Kessel, Kerstin A ^a   Bohn, Christian ^b   Engelmann, Uwe ^b   Oetzel, Dieter ^a   Bougatf, Nina ^a   Bendl, Rolf ^c   Debus, Jürgen ^a   Combs, Stephanie E ^a,d  

^a UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^b CHILI GMBH   (Germany)

^c HEILBRONN UNIVERSITY   (Germany)

^d TECHNICAL UNIVERSITY OF MUNICH   (Germany)

Author keywords

Clinical trials; Data capture; Data management; Documentation system; Electronic analysis; Information systems

Indexed keywords

CLINICAL RESEARCH; DATA ACQUISITION; DATABASE SYSTEMS; HOSPITAL DATA PROCESSING; INFORMATION SYSTEMS; INFORMATION USE; MANAGEMENT INFORMATION SYSTEMS; MEDICAL COMPUTING; ONCOLOGY; PATIENT TREATMENT;

CLINICAL DOCUMENTATION; CLINICAL TRIAL; DATA MANAGEMENT SYSTEM; DOCUMENTATION SYSTEMS; ELECTRONIC ANALYSIS; ELECTRONIC DOCUMENTATION; INTEGRATED DATABASE SYSTEMS; INTERDISCIPLINARY COLLABORATIONS;

INFORMATION MANAGEMENT;

ARTICLE; CLINICAL EVALUATION; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; HUMAN; IMAGE PROCESSING; INTERNET; MEDICAL DOCUMENTATION; MEDICAL INFORMATICS; MEDICAL INFORMATION SYSTEM; MULTICENTER STUDY (TOPIC); ONCOLOGY; COMPUTER ASSISTED RADIOTHERAPY; COMPUTER PROGRAM; COMPUTER SECURITY; DATA BASE; ELECTRONIC MEDICAL RECORD; FACTUAL DATABASE; PROSPECTIVE STUDY; RETROSPECTIVE STUDY; STATISTICS AND NUMERICAL DATA;

CLINICAL TRIALS AS TOPIC; COMPUTER SECURITY; DATABASE MANAGEMENT SYSTEMS; DATABASES, FACTUAL; ELECTRONIC HEALTH RECORDS; HUMANS; INTERNET; MULTICENTER STUDIES AS TOPIC; PROSPECTIVE STUDIES; RADIOTHERAPY PLANNING, COMPUTER-ASSISTED; RETROSPECTIVE STUDIES; SOFTWARE;

EID: 84896545887     PISSN: 01692607     EISSN: 18727565     Source Type: Journal    
DOI: 10.1016/j.cmpb.2014.02.002     Document Type: Article

References (52)

1. Huang H.K. PACS and Imaging Informatics 2010, John Wiley & Sons, Hoboken, New Jersey.
2. Maitland M.L., Schilsky R.L. Clinical trials in the era of personalized oncology. CA Cancer J. Clin. 2011, 61:365-381.
3. Elsner C.H., Egbring M., Kottkamp H., Berger T., Zoller S., Hindricks G. Open source or commercial products for electronic data capture in clinical trials? A scorecard comparison. Comput. Cardiol. 2003, 30:371-373.
4. Integrating the Healthcare Enterprise, (IHE), (accessed 06.09.13) (n.d.). http://www.ihe.net/.
5. Reboussin D., Espeland M.A. The science of web-based clinical trial management. Clin. Trials 2005, 2:1-2.
6. Combs S.E., Jäkel O., Haberer T., Debus J. Particle therapy at the Heidelberg Ion Therapy Center (HIT) - integrated research-driven university-hospital-based radiation oncology service in Heidelberg, Germany. Radiother. Oncol. 2010, 95:41-44.
7. Welsh J.S. Basics of particle therapy. Am. J. Clin. Oncol. 2008, 31:493-495.
8. Law M.Y.Y., Liu B., Chan L.W. Informatics in radiology: DICOM-RT-based electronic patient record information system for radiation therapy. Radiographics 2009, 29:961-972.
9. Mandal A., Asthana A.K., Aggarwal L.M. Development of an electronic radiation oncology patient information management system. J. Cancer Res. Ther. 2008, 4:178-185.
10. Prokosch H.U., Ganslandt T. Perspectives for medical informatics. Reusing the electronic medical record for clinical research. Methods Inf. Med. 2009, 48:38-44.
11. Lu Z., Su J. Clinical data management: current status, challenges, and future directions from industry perspectives. Open Access J. Clin. Trials 2010, 2:93-105.
12. Eisenstein E.L., Collins R., Cracknell B.S., Podesta O., Reid E.D., Sandercock P., et al. Sensible approaches for reducing clinical trial costs. Clin. Trials 2008, 5:75-84.
13. Ene-Iordache B., Carminati S., Antiga L., Rubis N., Ruggenenti P., Remuzzi G., et al. Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial. J. Am. Med. Inform. Assoc. 2009, 16:404-408.
14. Ebert M.A., Blight J., Price S., Haworth A., Hamilton C., Cornes D., et al. Multicentre analysis of treatment planning information: technical requirements, possible applications and a proposal. Australas. Radiol. 2004, 48:347-352.
15. Steil V., Röhner F., Schneider F., Wenz F., Lohr F., Weisser G. Current requirements for image management in radiotherapy. Strahlenther. Onkol. 2012, 188:499-506.
16. Elger B.S., Iavindrasana J., Lo Iacono L., Müller H., Roduit N., Summers P., et al. Strategies for health data exchange for secondary, cross-institutional clinical research. Comput. Methods Programs Biomed. 2010, 99:230-251.
17. Hernandez J.A., Acuna C.J., de Castro M.V., Marcos E., Lopez M., Malpica N. Web-PACS for multicenter clinical trials. IEEE Trans. Inform. Technol. Biomed. 2007, 11:87-93.
18. Pavlovic I., Kern T., Miklavcic D. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemp. Clin. Trials 2009, 30:300-316.
19. El Emam K., Jonker E., Sampson M., Krleza-Jerić K., Neisa A. The use of electronic data capture tools in clinical trials: web-survey of 259 Canadian trials. J. Med. Internet Res. 2009, 11:e8.
20. Ratib O., Swiernik M., McCoy J.M. From PACS to integrated EMR. Comput. Med. Imaging Graph. 2003, 27:207-215.
21. Kessel K.A., Bougatf N., Bohn C., Habermehl D., Oetzel D., Bendl R., et al. Connection of European particle therapy centers and generation of a common particle database system within the European ULICE-framework. Radiat. Oncol. 2012, 7:115.
22. Edwards R.L., Edwards S.L., Bryner J., Cunningham K., Rogers A., Slattery M.L. A computer-assisted data collection system for use in a multicenter study of American Indians and Alaska Natives: SCAPES. Comput. Methods Programs Biomed. 2008, 90:38-55.
23. Pavlovic I., Miklavcic D. Web-based electronic data collection system to support electrochemotherapy clinical trial. IEEE Trans. Inform. Technol. Biomed. 2007, 11:222-230.
24. Syed-Mohamad S.-M. Development and implementation of a web-based system to study children with malnutrition. Comput. Methods Programs Biomed. 2008, 93:83-92.
25. Maass M.C.M., Asikainen P.P., Mäenpää T.T., Wanne O.O., Suominen T.T. Usefulness of a Regional Health Care Information System in primary care: a case study. Comput. Methods Programs Biomed. 2008, 91:175-181.
26. Angelow A., Schmidt M., Weitmann K., Schwedler S., Vogt H., Havemann C., et al. Methods and implementation of a central biosample and data management in a three-centre clinical study. Comput. Methods Programs Biomed. 2008, 91:82-90.
27. Buchsbaum R., Kaufmann P., Barsdorf A.I., Arbing R., Montes J., Thompson J.L.P. Web-based data management for a phase II clinical trial in ALS. Amyotroph. Lateral Scler. 2009, 10:374-377.
28. Heinemann F., Roehner F., Schmucker M., Bruggmoser G., Henne K., Grosu A.-L., et al. Department and patient management in radiotherapy. The Freiburg model. Strahlenther. Onkol. 2009, 185:143-154.
29. Meyer J., Ostrzinski S., Fredrich D., Havemann C., Krafczyk J., Hoffmann W. Efficient data management in a large-scale epidemiology research project. Comput. Methods Programs Biomed. 2012, 107:425-435.
30. Pozamantir A., Lee H., Chapman J., Prohovnik I. Web-based multi-center data management system for clinical neuroscience research. J. Med. Syst. 2010, 34:25-33.
31. Durkalski V., Wenle Zhao, Dillon C., Kim J. A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression. Clin. Trials 2010, 7:174-182.
32. Yamamoto K., Yamanaka K., Hatano E., Sumi E., Ishii T., Taura K., et al. An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records. Clin. Trials 2012, 0:1-10.
33. Modahl M. Tablets Set to Change Medical Practice 2011, 1-10. QuantiaMD.
34. Kiser K. 25 ways to use your smartphone. Physicians share their favorite uses and apps. Minn. Med. 2011, 94:22-29.
35. Costa C., Oliveira J.L., Silva A., Ribeiro V.G., Ribeiro J. Design, development, exploitation and assessment of a Cardiology Web PACS. Comput. Methods Programs Biomed. 2009, 93:273-282.
36. Lu Z. Electronic data-capturing technology for clinical trials: experience with a global postmarketing study. IEEE Eng. Med. Biol. Mag. 2010, 29:95-102.
37. Anderson N.R., Lee E.S., Brockenbrough J.S., Minie M.E., Fuller S., Brinkley J.F., et al. Issues in biomedical research data management and analysis: needs and barriers. J. Am. Med. Inform. Assoc. 2007, 14:478-488.
38. Kessel K.A., Habermehl D., Bohn C., Jäger A., Floca R.O., Zhang L., et al. Database supported electronic retrospective analyses in radiation oncology: establishing a workflow using the example of pancreatic cancer. Strahlenther. Onkol. 2012, 188:1119-1124.
39. Weisser G., Engelmann U., Ruggiero S., Runa A., Schröter A., Baur S., et al. Teleradiology applications with DICOM-e-mail. Eur. Radiol. 2007, 17:1331-1340.
40. Pommerening K., Reng M., Debold P., Semler S.C. Pseudonymisierung in der medizinischen Forschung - das generische TMF-Datenschutzkonzept. GMS Med. Inform. Biom. Epidemiol. 2005, 1. Doc17.
41. Kristianson K.J., Ljunggren H., Gustafsson L.L. Data extraction from a semi-structured electronic medical record system for outpatients: a model to facilitate the access and use of data for quality control and research. Health Inform. J. 2009, 15:305-319.
42. Combs S.E., Habermehl D., Kessel K.A., Bergmann F., Werner J., Brecht I.C., et al. Intensity modulated radiotherapy as neoadjuvant chemoradiation for the treatment of patients with locally advanced pancreatic cancer: outcome analysis and comparison with a 3D-treated patient cohort. Strahlenther. Onkol. 2013, 189:738-744.
43. Kessel K.A., Habermehl D., Jäger A., Floca R.O., Zhang L., Bendl R., et al. Development and validation of automatic tools for interactive recurrence analysis in radiation therapy: optimization of treatment algorithms for locally advanced pancreatic cancer. Radiat. Oncol. 2013, 8:138.
44. Habermehl D., Kessel K.A., Welzel T., Hof H., Abdollahi A., Bergmann F., et al. Neoadjuvant chemoradiation with gemcitabine for locally advanced pancreatic cancer. Radiat. Oncol. 2012, 7:28.
45. Combs S.E., Schall N., Kessel K.A., Rieber J., Bischof M., Behnisch W., et al. Outcome after radiation therapy in pediatric and adult patients with rhabdomyosarcoma treated with modern radiation therapy. Proc. DEGRO 2013.
46. Kessel K.A., Jäger A., Floca R.O., Habermehl D., Bendl R., Debus J., et al. Image guided and adaptive radiotherapy (IGRT and ART) for locally advanced pancreatic cancer - considerations for dose adaption to changes in GTV volume and organ motion. Proc. DEGRO 2013.
47. Habermehl D., Brecht I.C., Bergmann F., Welzel T., Rieken S., Werner J., et al. Chemoradiation in patients with isolated recurrent pancreatic cancer - therapeutical efficacy and probability of re-resection. Radiat. Oncol. 2013, 8:27.
48. Combs S.E., Welzel T., Habermehl D., Rieken S., Dittmar J.-O., Kessel K.A., et al. Prospective evaluation of early treatment outcome in patients with meningiomas treated with particle therapy based on target volume definition with MRI and 68Ga-DOTATOC-PET. Acta Oncol. 2013, 52:514-520.
49. Combs S.E., Kessel K.A., Herfarth K., Jensen A., Oertel S., Blattmann C., et al. Treatment of pediatric patients and young adults with particle therapy at the Heidelberg Ion Therapy Center (HIT): establishment of workflow and initial clinical data. Radiat. Oncol. 2012, 7:170.
50. Hauswald H., Rieken S., Ecker S., Kessel K.A., Herfarth K., Debus J., et al. First experiences in treatment of low-grade glioma grade I and II with proton therapy. Radiat. Oncol. 2012, 7:189.
51. Combs S.E., Kessel K.A., Habermehl D., Haberer T., Jäkel O., Debus J. Proton and carbon ion radiotherapy for primary brain tumors and tumors of the skull base. Acta Oncol. 2013, 52:1504-1509.
52. Teixeira L., Ferreira C., Santos B.S. User-centered requirements engineering in health information systems: a study in the hemophilia field. Comput. Methods Programs Biomed. 2012, 106:160-174.