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The barriers for primary and secondary use of EHR systems: The clinical point of view. The Maastricht experience Philippe Lambin. Contents. The MAASTRO experience:
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The barriers for primary and secondary use of EHR systems:The clinical point of view The Maastricht experience Philippe Lambin
Contents • The MAASTRO experience: • MAASTRO = An independent Radiotherapy centre receiving cancer patients from 5 different hospitals (interoperability is sorted out!) • The barriers from a clinical point of view
EHR MAASTRO: 240 RT protocols + workflow, made by MD’s, costs 5 minutes extra per patient List of Treatment protocol
In the coming years moren then 500 protocols (see PWC Pharma 2005)
- Survival: National Database (GBA) - Complications: Module EMF, Questionnaire CTC like GP-Patients-Long specialist Predictive model allowing treatment individualization: An holistic approach Prospective gathering of pre-treatment data (+CI) Part of EHR Biological Data • Data-based & Knowledge based models: • Probability • of Survival & • Complications • (+ CI) • for treatment • x, y, z… Real Outcome (Complications, Survival) Treatment administered Clinical Data Image Data Feed-back Loop
Quality of treatment is important! Register ite.g.Two Dimensional Dose Guide radiotherapy with Portal Dose Verification predicted portal dose measured portal dose gamma evaluation = vs Equivalent for drug = Compliance, PK *van Elmpt, Nijsten et al., Med. Phys. 32(9), 2005.
Computer Assisted Theragnostic model Prospective gathering of per, post treatment data (+CI) Prospective gathering of pre-treatment data (+CI) • Data-based & Knowledge based models: • Probability • of Survival & • Complications (+CI) • for treatment • x, y, z… Biological Data • Data-based & Knowledge based models: • Probability • of Survival & • Complications (+ CI) • for treatment • administered Biological Data Clinical Data Treatment administered Clinical Data Image Data Image Data Treatment Data (Description, Quality) Feed-back Loop Real Outcome (Complications, Survival)
Contents • The Maastricht experience • The barriers from a clinical point of view
Solution: Use defaults, create a “win-win” Train-educate MD’s, improve interaction with IT Solution: Involve them upfront in the R&D Barrier? The MD’s EHR = decrease of efficiency (less patient seen in consultation, more work for the MD’s, MD’s can not type...) MD’s are responsible of the individual care!
Barrier? Lack of common ontology -language Especially for multicentric use Solution: Use standard, invest in ontology = high priority An ontology is the representation of the entities, ideas and events, together with their properties and relations. These are structured according to a system of categories. It is more abstract and generic than a data model, which is often grounded in the organisation and business processes of a particular enterprise. The process of creating an ontology for a specific domain is known as ‘ontology engineering’.
Barrier? Conventional clinical research Three problems: a) less than 3% of the patient population included in trials; b) standard clinical trials often exhibit a strong bias in patient selection; c) the costs of R&D and clinical research are increasing. We need a new complementary paradigm: Machine learning clinical research based on the “No objection rules” (e.g. The Netherlands) only when standard treatment (observational study, long. cohort, saftey monitoring.
Partial solution: GRID SOKU: Data mining without moving the data Barrier? Privacy aspects Software for imaging, Coded data, not anonymous!
Barrier? Methodological, need of large numbers + independent validation dataset • Multicentric approach to have: • Large numbers of patients • Independant data set for validation
Barrier? Clinical aspects: Follow-up For Survival: National database(e.g. GBA in The Netherlands) For complications, other diseases...: Standardized scoring system (CTC NCI) (e)Questionnaire to the patients Database of the GP or minimum European EHR
Barrier? Higher requirement for clinical research More data needed: QoL, unusual imaging… Higher quality: check inconsistencies Stricter rules :e.g. GCP certification
Barrier? IT No really: we did it HL7 too limited for Radiotherapy: we need a broader standard
Barrier? Summary MD’s Semantics – Ontology Legal aspects, informed consent Need of multicentric data Access to follow-up data (including national database) Higher requirement for clinical research New paradigm for clinical research
Barrier? Summary of potential solutions: Merge HER for care and research MD’s No objection rule, new concept of clinical research + safety monitoring Common ontology National - European database Minimum EHR GRID- SOKU – improved HL7 Certification, standard for EHR