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)

Data-based & Knowledge

based models:Probability

of Survival &Complications

(+ CI)for treatment

x, y, z…

Treatment administered

Biological Data

Clinical Data

Image Data

Real Outcome (Complications,

Survival)

Prospective gathering of pre-treatment data (+CI)

Feed-back Loop

Predictive model allowing treatment individualization:

An holistic approach - Survival: National Database (GBA)

- Complications: Module EMF, Questionnaire CTC like GP-Patients-Long specialist

Part of EHR

3 W. van Elmpt et al., WIP

3

3 W. van Elmpt et al., WIP

3measured portal dose

predicted portal dose

vs

Quality of treatment is important! Register ite.g.Two Dimensional Dose Guide radiotherapy with Portal Dose

Verification

=

gamma evaluation

*van Elmpt, Nijsten et al., Med. Phys. 32(9), 2005.

Equivalent for drug = Compliance, PK

Data-based & Knowledge

based models:Probability

of Survival &Complications

(+CI)for treatment

x, y, z…

Treatment administered

Biological Data

Clinical Data

Image Data

Biological Data

Clinical Data

Image Data

Treatment Data

(Description, Quality)

Prospective gathering of per, post treatment data (+CI)

Data-based & Knowledge

based models:Probability

of Survival &Complications (+

CI)for treatmentadministered

Feed-back Loop

Prospective gathering of pre-treatment data (+CI)

Real Outcome (Complications,

Survival)

Computer Assisted Theragnostic model

Contents

• The Maastricht experience

• The barriers from a clinical point of view

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!

Solution: Use defaults, create a “win-win”

Train-educate MD’s, improve interaction with IT

Solution: Involve them upfront in the R&D

Barrier? Lack of common ontology -language

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’.

Especially for multicentric use

Solution: Use standard, invest in ontology = high priority

Barrier? Conventional clinical research

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.

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.

Barrier? Privacy aspects

Partial solution: GRIDSOKU: Data mining without moving the dataSoftware for imaging, Coded data, not anonymous!

Barrier? Methodological, need of large numbers + independent

validation dataset

Multicentric approach to have:

1.Large numbers of patients

2. 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

Thank you for your attention

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

researchMD’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