Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology

Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aim...

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Bibliographic Details
Published in:	European journal of cancer (1990) Vol. 86; pp. 178 - 185
Main Authors:	Kibbelaar, R.E., Oortgiesen, B.E., van der Wal-Oost, A.M., Boslooper, K., Coebergh, J.W., Veeger, N.J.G.M., Joosten, P., Storm, H., van Roon, E.N., Hoogendoorn, M.
Format:	Journal Article
Language:	English
Published:	England Elsevier Ltd 01-11-2017 Elsevier Science Ltd
Subjects:	Best practice Case studies Clinical trials Data Collection Data Mining - methods Data processing Decision making Electronic health record Electronic Health Records Electronic medical records Evidence-based medicine Evidence-Based Medicine - methods Haematology Hematology - methods Humans Medical Oncology - methods Medical Record Linkage Medical research Oncology Population-based registry Population-based studies Randomised clinical trial Randomization Randomized Controlled Trials as Topic - methods Registries Oncology Haematology Electronic health record Population-based registry Randomised clinical trial Evidence-based medicine
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Summary:	Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. •The limitations of randomised clinical trials to evidence-based medicine are reviewed.•Complementary strategies based on exploiting population-based registries and electronic health records are discussed.•A novel approach combining population-based registry and electronic health record features is proposed.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1
ISSN:	0959-8049 1879-0852
DOI:	10.1016/j.ejca.2017.09.007