On the Necessity of Systematically Planning Clinical Tumor Documentation

Abstract

Tumor documentation is an important task for both clinical research and patient care. Documentation systems for these purposes have to be planned systematically and should be goal oriented. We applied the method of a so-called ‘standardized documentation protocol’ for systematically planning two documentation systems in oncology: one for the tumor center Heidelberg/Mannheim and the other for a nationwide project in the field of documentation and therapy planning in pediatric oncology. The method proved to be helpful in both cases even though the resulting documentation protocols are completely different and although they served different objectives. Therefore, the aim of the paper is to motivate and help medical informatics professionals to systematically plan other documentation systems using this method.

Keywords

Tumor Documentation - Electronic Patient Record - Tumor Center - Systematic Planning - Clinical Research

• References

• 1 Wirtschafter DD, Scalise M, Henke C, Gams RA. Do Information Systems Improve the Quality of Clinical Research? Results of a Randomized Trial in a Cooperative Multi-institutional Cancer Group. Comp Biomed Res 1981; 14: 78-90.
• 2 Kent DL, Shortliffe EH, Carlson RW, Bischoff MB, Jacobs CD. Improvement in Data Collection Through Physician Use of a Computer-Based Chemotherapy Treatment Consultant. J Clin Oncol 1985; 3: 1409-17.
• 3 Shortliffe EH, Hubbart SM. Information systems in oncology. In: De Vita VT, Hellman S, and Rosenberg S. Cancer: Principles and Practise of Oncology. Philadelphia: 1989: 2403-12.
• 4 Kaatsch P, Haaf G, Michaelis J. Childhood malignancies in Germany – Methods and Results of a Nationwide Registry. Europ J Cancer 1995; 31A: 993-9.
• 5 Leiner F, Haux R. Systematic planning of clinical documentations. Method Inform Med 1996; 35: 25-34.
• 6 Wiedemann T, Knaup P, Bachert A, Creutzig U, Haux R, Schilling F. Computer-aided Documentation and Therapy Planning in Pediatric Oncology. In: Cesnik B, McCray AT, and Scherrer J-R. MedInfo 98, Proceedings of the Ninth World Congress on Medical Informatics. Amsterdam: IOS Press; 1998: 1306-9.
• 7 Leiner F. Systematic planning of clinical documentations. University of Heidelberg, Medical Faculty; 1994. PhD Thesis (in German).
• 8 Kaatsch P, Kaletsch U, Spix C, Michaelis J. Jahresbericht/Annual Report 1998. German Childhood Cancer Registry. Institute for Medical Statistics and Documentation; 1999. (bilingual).
• 9 Sauter S, Kaatsch P, Creutzig U, Michaelis J. Definition of a Common Data Set for Clinical Trials in Pediatric Oncology. Klin Pädiat 1994; 206: 302-12 (in German).
• 10 Enterline JP, Lenhard R, Blum B. A clinical information system for oncology. New York: Springer; 1989
• 11 Hickam DH, Shortliffe EH, Bischoff MB, Scott AC, Jacobs CD. The Treatment Advice of a Computer-Based Cancer Chemo-therapy Protocol Advisor. Ann Intern Med 1985; 103: 928-36.
• 12 Musen MA, Tu SW, Das AK, Shahar Y. EON: A Component-Based Approach to Automation of Protocol-Directed Therapy. J Am Med Inform Assoc 1996; 3: 367-88.
• 13 Altmann U, Katz FR, Haeberlin V, Willems C, Dudeck J. GTDS – An Oncology Workstation. In: Prokosch HU, and Dudeck J. Hospital Information Systems – design and development characteristics, impact and future architecture. Amsterdam: Elsevier; 1995: 117-28.
• 14 Novopachennyi I, Ogurol Y, Wischnewsky M, Zhao J. Knowledge-based systems in oncology. The example of ONCO-CONS. KI 1997 3/97: 47-51 (in German).
• 15 Müller R, Thews O, Rohrbach C, Sergl M, Pommerening K. A Graph-Grammar Approach to Represent Causal, Temporal and Other Contexts in an Oncological Patient Record. Method Inform Med 1996; 35: 127-41.
• 16 Müller R, Sergl M, Nauerth U, Schoppe D, Pommerening K, Dittrich HM. THEMPO: A knowledge-based system for therapy planning in pediatric oncology. Comput Biol Med 1997; 27: 177-200.
• 17 Knaup P, Wiedemann T, Bachert A, Creutzig U, Haux R, Schäfer M, Schilling F. Experiences of Using a Computer-Aided Therapy Planning for Pediatric Oncology in Clinical Routine. In: Puppe F. XPS-99: Knowledge-Based Systems. Berlin: Springer; 1999: 210-7.
• 18 Hartung S. A documentation protocol for systematically planning a documentation system for pediatric oncology. University of Heidelberg/Technical School Heilbronn, Graduate Program Medical Informatics; 1997. Master’s thesis (in German).
• 19 Ellsässer K-H, Köhler CO, Wagner G. KRAZTUR a generator for medical documentation and information systems. Method Inform Med 1981; 20: 191-5.
• 20 Dudeck J, Wächter W, Altmann U, Katz FR. The definition of a new uniform basic data set for hospital cancer registries in Germany. In: Proceedings of MIE 93. Reichert A, Sadan BA, Bengtsson S, Bryant J, and Piccolo U. London: Freund; 1993: 489-92.
• 21 Leven FJ, Haux R. Twenty five years of medical informatics education at Heidelberg/ Heilbronn: discussion of a specialized curriculum for medical informatics. Int J Med Inform 1998; 50: 31-42.
• 22 Pocock SJ. Clinical Trials – A Practical Approach. Chichester: John Wiley; 1990
• 23 CPMP/ICH/135/95. Committee for Proprietary Medicinal Products of the European Commission (CPMP) and International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Note for Guidance on Good Clinical Practice: Consolidated Guideline. 1996
• 24 Schäfer H, Berger J, Biebler K-E. et al. Recommendations for study protocols for clinical studies. Informatik, Biometrie und Epidemiologie in Medizin und Biologie 1999; 30: 141-54 (in German).
• 25 Rondel RK, Varley SA, Webb CF. Clinical Data Management. Chichester: John Wiley; 2000