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

R E Kibbelaar; B E Oortgiesen; A M van der Wal-Oost; K Boslooper; J W Coebergh; N J G M Veeger; P Joosten; H Storm; E N van Roon; M Hoogendoorn

doi:10.1016/j.ejca.2017.09.007

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

Eur J Cancer. 2017 Nov:86:178-185. doi: 10.1016/j.ejca.2017.09.007. Epub 2017 Oct 6.

Authors

R E Kibbelaar¹, B E Oortgiesen², A M van der Wal-Oost³, K Boslooper⁴, J W Coebergh⁵, N J G M Veeger⁶, P Joosten⁷, H Storm⁸, E N van Roon⁹, M Hoogendoorn⁷

Affiliations

¹ Dept. of Pathology, Pathology Friesland, Leeuwarden, The Netherlands. Electronic address: r.kibbelaar@pathologiefriesland.nl.
² Dept. of Clinical Pharmacy and Pharmacology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
³ Dept. of Epidemiology, MCL Academy, Leeuwarden, The Netherlands.
⁴ Dept. of Haematology, University Medical Centre Groningen, Groningen, The Netherlands.
⁵ Dept. of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands.
⁶ Dept. of Epidemiology, MCL Academy, Leeuwarden, The Netherlands; Dept. of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
⁷ Dept. of Haematology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
⁸ Dept. of Clinical Chemistry, CERTE KCL, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
⁹ Dept. of Clinical Pharmacy and Pharmacology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands; Unit of Pharmacotherapy, Epidemiology and Economics, Department of Pharmacy, University of Groningen, Groningen, The Netherlands.

PMID: 28992561
DOI: 10.1016/j.ejca.2017.09.007

Abstract

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.

Keywords: Electronic health record; Evidence-based medicine; Haematology; Oncology; Population-based registry; Randomised clinical trial.

Publication types

Review

MeSH terms

Data Collection
Data Mining / methods*
Electronic Health Records*
Evidence-Based Medicine / methods*
Hematology / methods*
Humans
Medical Oncology / methods*
Medical Record Linkage
Randomized Controlled Trials as Topic / methods*
Registries*