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PROJECT DIOS

Dose intensity in standardized health
technology assessment in oncology




PROJECT ASSUMPTIONS AND AIMS

Principal aim of the project is to contribute to the development and standardization of health technology assessment (HTA) methodology in the field of clinical oncology. Project is not only of theoretical importance but implies also development of practically acceptable software tools that can help in implementation of the above mentioned principles in clinical practice.

HTA methodology brings a very wide spectrum of problems and scientific challenges, the project however will be focused namely to the field of longitudinal evaluation of anti-tumour therapy and associated assessment of reached results. These aspects are still not adequately addressed even in internationally available standards and there is substantial variability among different oncological specializations. The main aim of the project is to contribute to the evaluation of complications associated with anti-tumour therapy both from prospective and retrospective point of view. Prospectively applicable criteria should improve optimization of supporting therapy and finally thus reduce probability of risk events.

The project will propose set of standard endpoints that should be associated with distinct health care episodes. It means not only categories of reached complex therapeutic response, but also evaluation of dose intensity parameters (e.g. dose reductions, dose delays, relative dose intensity of actual treatment, etc.), complications including toxicity grading and explained consequences for anti-tumour therapy. Planned software tools should bring these standards into clinical practice.

Regarding specific problems of Czech oncology, the project proposal was motivated namely by following facts:

  • there is still no unified set of standard measures for longitudinal monitoring of anti-tumour therapy and running results; although some fields of oncology (e.g. pediatric oncology) already accepted this evaluation according to international protocols, widely applicable standards are not available - this fact embarrasses both retrospective and prospective health technology assessment.
  • nearly all installed hospital information systems have no parametric data entry for running monitoring of anti-tumour therapy, serious adverse event and in most of them, there is no space for computer-assisted planning of therapeutic plans; this situation represents serious drawback in health care quality evaluation and makes prospective optimization of supporting care impossible.
  • numerous Czech clinical institutes and hospitals have recently adopted modern software information systems for orders and preparation of chemotherapy, implemented into clinical practice - these early phases of development seem to be ideal for implementation of standardized evaluation rules.
  • leading Czech clinical teams reveal strong professional attitude towards implementation of therapeutic plans, not only for pharmacotherapy and RT, but also for time-related detailed dosage schemes.

Both theoretical and practical outputs of the project will be prepared in form that allows their presentation and application in international level.





PROJECT AIMS AND OUTCOMES

  1. To prepare documentation that defines endpoints of separated health care episodes in different fields in oncology with special emphasis on often neglected aspect of dose-intensity.
  2. To prepare prospectively applicable standards for therapeutic plans and their longitudinal evaluation, including reasons of plan violation. To include project documentation "Dose - intensity as endpoint in standardized anti-tumour therapy" into official methodology of Health Technology Assessment to be adopted in guidance of Czech Society for Oncology.
  3. To implement routine evaluation of proposed endpoint (including dose intensity) in existing models for HTA. There will be developed an expert SW system that will be able to follow complex parametric monitoring of disease development including longitudinal evaluation of therapeutic plans accomplishment (e.g. parameter of actual total dose intensity, relative dose intensity, reasons for dose delays and dose reductions, etc.).
  4. To ensure pilot service carried out by developed software tools and collection of relevant clinical data in model studies. On the basis of acquired data, to prepare model methodology for other potential users in Czech Republic or other countries.
  5. Powerful scientifically oriented presentation of the results and software tools in clinical conferences and seminars held by Czech Society for Oncology and Czech Ministry of Health. To prepare all outputs with adequate project documentation and to enable their availability for clinical institutions under guarantee of Czech Society for Oncology.




PUBLICATION PLAN

All official outputs of the project will be issued both in Czech and English language (software workspace, project documentation, manuals for users, papers, web presentation).

Project is aimed to bring out project documentation as special edition in book format (published as official, reviewed material, under the auspices of Czech Oncological Society, in collaboration of involved guarantees and AMGEN company). The material will summarize theoretical principles of the project, proposed model solution and practical guidelines for implementation in different types of clinical institutions.

Second key outcome of the project will be devoted to developed software, i.e. user manual and project documentation. Publishing of these issues will make the tool widely available.

As an output of model studies gathering data from different diagnostic groups (see below - phase IV of the project) several scientific papers will be prepared. These titles can not be precisely specified at the moment, but their content will correspond to the project aims: dose intensity as an indispensable component of complex health technology assessment in oncology, model clinical studies. The papers should be targeted to the following potentially acceptable international journals: Neoplasma, Breast Disease, The Journal of Supportive Oncology, Cancer Investigation.

Project outputs will be presented in renown Czech and international conferences /lectures, posters/: Czech national oncology conference /Oncology days in Brno/ 2005, 2006; ECO 2006; Health Technology Assessment International Society Congress 2005.





SELECTED REFERENCES

M. Foote (1998): The Importance of Planned Dose of Chemotherapy on Time: Do We Need to Change Our Clinical Practice?. The Oncologist; 3, 365-368

A. M. Gianni, M. J. Piccart (2000): Optimising chemotherapy dose density and dose intensity: new strategies to improve outcomes in adjuvant therapy for breast cancer. European Journal of Cancer; 36, S1-S3

M. Smith, J. Abrams, E. L. Trimble, R. S. Ungerleider (1996): Dose Intensity of Chemotherapy for Childhood Cancers. The Oncologist; 1, 293-304

J. Chang (2000): Chemotherapy dose reduction and delay in clinical practice: evaluating the risk to patient outcome in adjuvant chemotherapy for breast cancer. European Journal of Cancer; 36, S11-S14

D. K. Armstrong, N. E. Davidson (2001): Dose Intensity for Breast Cancer: Where Do We Go from Here?. Breast Disease; 14, 91-97

W. Hryniuk (2001): Dosage Parameters in Chemotherapy of Breast Cancer. Breast Disease; 14, 21-30

E. Frei III, P. Richardson, D. Avigan, C. Bunnell, C. Wheeeler, A. Elias (1999): Perspective. The interval between courses of high-dose chemotherapy with stem cell rescue: therapeutic hypotheses. Bone Marrow Transplantation; 24, 939-945

T. W. Gillespie (2001): Chemotherapy Dose and Dose Intensity: Analyzing Data to Guide Therapeutic Decisions. vol. 28, no. 2, supplement, 5-10





ACKNOWLEDGEMENTS

Development of data standards and implementation of HTA principles in oncology is supported by Ministry of Health Care of the Czech Republic. Development of DIOS portal and SW tools is supported by AMGEN company through research grant bestowed upon Czech Society for Oncology.



Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk UniversityMasaryk Memorial Cancer Institute Project Dios   Map of the portal   Methodical guidelines   Results and reporting  
Software tools   Project news      

Citation:    D. Klimeš, L. Dušek, J. Fínek, M. Kubásek, J. Koptíková, L. Šnajdrová, P. Brabec, J. Novotný, R. Vyzula, J. Abrahámová, L. Petruželka: Electronic library of chemotherapeutical regimens - web portal solution, 2007. ISBN 978-80-7392-002-9, Brno. [cit. 2018-12-17]. Accessible: http://dios.registry.cz.