Clinical Research from EHR data

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1 Clinical Research from EHR data Gunnar O Klein professor in Health Informatics at NSEP Norwegian Centre for EHR Research Workshop at HelseIT in Trondheim

2 Purpose of the workshop Together with some very interesting invited experts we will get an update on some recent projects that in various ways provide insights into the future possibilities for research using clinical data in EHRsystems (Electronic Health Record) or EPJ in Norwegian But this is a Workshop and not just a set of presentations We shall discuss the issues and reflect on statements by others Please interrupt with your comments or questions In the end we shall have an extended discussion with the panel and the audience 2

3 The panel Gerard Freriks, Netherlands, former GP and medical scientist, past convenor of the CEN working group that developed the EHR standard. Now working for the EN13606 Association Arnulf Langhammer, Associate Professor, NTNU, The Nord-Trøndelag health study (HUNT) Rong Chen MD, PhD, Sweden, Chief Medical Informatics Officer, Cambio HealthCare Systems & Karolinska Institutet, Stockholm Damon Berry, PhD, Dublin Institute of Technology, Ireland 3

4 Who is Gunnar Klein Professor of Health informatics at NTNU Jan 2012 Have worked with ICT for health since 1975 in different roles, often from Karolinska Institutet Chairman of European standardization of Health Informatics in Europe (CEN/TC 251) Leader and participant of a number of European R&D projects, particularly in Information Security and for communication of EHRs with semantic interoperabilty Physician, mainly in Primary care but 2009 at the Karolinska University hospital Also a background as a Cancer researcher and in Biotech industry in the 1980ies 4

5 We are missing We were going to get a representative from HEMIT the IT provider of the region here on Quality registers If some in the audience knows about that please interfer We are going to get a presentation on the project EHR4CR but given by me since all the leading figures were busy this day and could not come 5

6 Why should we attempt to use data from clinical records? There is so much we do not know in medicine and about health systems effectiveness and efficency A lot has been found in the past using records, even paper records but very inefficiently With electronic records it should be much easier piece of cake Or 6

7 Is the ocean empty? Or is it a gold mine? 7

8 How can we turn EHRs into gold mines? 8

9 There is so much we do not know Evaluations of health outcomes related to various interventions, including medication On real life patient groups in large scale, at all locations With multiple diseases and treatments In all age groups Comparing biomedical laboratory data, genotypic and phenotypic with outcomes and treatments - IRL Generate and test new hypotheses for basic biomedical functions compared with genetics Functional genomics Results for management of quality and planning of health services. Eg. Do we follow guidelines? 9

10 The alternatives: Registries Special health registries on a national or local level that has collected certain data for certain purposes. The general registry of all causes of deaths and the cancer registries are such examples but also the more recent quality registries in relation to certain diseases or procedures. Has generated a lot of useful information despite very limited in information content Cumbersome to get data, often increased work for health professionals and double registrations also in EHRs. A limited and predetermined set of questions that may be asked even if a lot remains to be explored One question of today How can we improve collection of data from EHRs to these registries? 10

11 The alternatives: Questionaires Questionaires to the persons included. This has often been performed in conjunction with the collection of the biological sample but may be repeated over the years. More and more examples from various countries are using web based surveys for easy data collection. The method has several weaknesses in addition to the ethical consequences related to disturbing repeatedly possibly healthy persons with intimate questions on their health. The answers are subjective and may often lack the accuracy of a professional assessment that may be needed to achieve the desired results. 11

12 The alternatives: Examniations Special clinical and laboratory examinations of the study group for the sole purpose of obtaining research data. This is the typical means of conducting clinical trials e.g. for the approval of new medicines Very time consuming and expensive Interfering with the daily lives of the study population Will be necessary for a long time But how do we find the interesting patients if they have a particular health problem ( excl. a general population study) 12

13 Obstacles to EHR based research Splitted EHRs The records over time of one individual may be scattered in several institutions: - geographic location - specialty - legal entity c.f. the division between primary care and specialist health care, in Norway 13

14 Obstacles to EHR based research Various formats and terminologies The data of the EHRs exists in various formats with regard to information structure and terminology used. - partly follows various EHR products - Whereas the exchange of some limited data in the form of electronic messages has some good results, essentially no attention has been given to the task of long term harmonization of EHR structure of terminology in order to create a better infrastructure for clinical research 14

15 Obstacles to EHR based research Lack of structure Often there is very little structure in the EHR systems of today. Typewriters. Many health care organisations and thus systems have focused on the perceived easiness for the physicians to record data, with the use of free text dictation as the solution, more and more often combined with automatic speech recognition software. 15

16 Obstacles to EHR based research Privacy concerns Concerns about protecting the confidentiality of sensitive personal information must also be addressed. Ethical approval and patient consent is necessary. New systems may facilitate the latter using electronic means and the net. 16

17 Obstacles are challenges «Obstacles are those frightful things you see when you take your eyes off the goal» 17

18 The road to better health goes through research and structured EHR systems based on standards Strukturert EPJ Gunnar O Klein professor i helseinformatikk Presentation for Helse Midt-Norge, IKT- strategigruppa 13 september, 2012 A bridge to the future 18

19 Today s agenda Gunnar Klein Introduction to the workshop Gerard Freriks The business case for re-use of EHR data - Experiences in the world of pharma Arnulf Langhammer The requirements for EHR information and some of the problems in routine record information for research Rong Chen Experience from Sweden in using modern archetype methodology for extracting EHR data from large scale regional EHR systems to national quality registers Coffee Break Damon Berry Experiences from Ireland using archetype methodology for clinical research Gunnar Klein The EHR4CR project within the Innovative Medicines Programme General discussion 19

20 Discussion issues What is needed for a gradual move to standardised records with some common structure in Norway? Recommendations to the Norwegian government for the new ehealth strategy? What can be done now for improving the use of EHRs for research? and/or openehr? Ideas for co-operation projects European, National and regional? 20

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