Highlights
- •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.
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
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References
- Evidence based medicine: what it is and what it isn't.BMJ. 1996 Jan 13; 312: 71-72
- The randomized registry trial–the next disruptive technology in clinical research?.N Engl J Med. 2013 Oct 24; 369: 1579-1581
- Are ongoing trials on hematologic malignancies still excluding older subjects?.Haematologica. 2013 Jul; 98: 997-1000
- Bridging the inferential gap: the electronic health record and clinical evidence.Health Aff (Millwood). 2007 Mar-Apr; 26: w181-w191
- Information technology and the inferential gap.Health Aff (Millwood). 2007 Mar-Apr; 26: w192-w194
- EUROCOURSE lessons learned from and for population-based cancer registries in europe and their programme owners: improving performance by research programming for public health and clinical evaluation.Eur J Cancer. 2015 Jun; 51: 997-1017
- The effect of distant metastases sites on survival in de novo stage-IV breast cancer: a SEER database analysis.Tumour Biol. 2017 Jun; 39https://doi.org/10.1177/1010428317705082
- Gallbladder carcinoma in the United States: a population based clinical outcomes study involving 22,343 patients from the surveillance, epidemiology, and end result database (1973-2013).HPB Surg. 2017; 2017: 1532835
- Uses of cancer registries for public health and clinical research in europe: results of the european network of cancer registries survey among 161 population-based cancer registries during 2010-2012.Eur J Cancer. 2015 Jun; 51: 1039-1049
- Survival for haematological malignancies in europe between 1997 and 2008 by region and age: results of EUROCARE-5, a population-based study.Lancet Oncol. 2014 Aug; 15: 931-942
- The heterogeneity of changes in incidence and survival among lymphoid malignancies in a 30-year French population-based registry.Leuk Lymphoma. 2015 Apr; 56: 1050-1057
- Patterns of care and outcomes for stage IIIB non-small cell lung cancer in the TNM-7 era: results from The Netherlands cancer registry.Lung Cancer. 2017 Aug; 110: 14-18
- Modest decline in late mortality following hodgkin's disease in the southeastern Netherlands since 1972.Ann Hematol. 1998 May; 76: 205-209
- Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients.Haematologica. 2015 Jan; 100: 107-113
- Outcome of a risk-related therapeutic strategy used prospectively in a population-based study of hodgkin's lymphoma in adolescents.Br J Cancer. 2007 Jul 2; 97: 29-36
- Survival of 86,690 patients with thyroid cancer: a population-based study in 29 european countries from EUROCARE-5.Eur J Cancer. 2017 May; 77: 140-152
- Towards optimal clinical and epidemiological registration of haematological malignancies: guidelines for recording progressions, transformations and multiple diagnoses.Eur J Cancer. 2015 Jun; 51: 1109-1122
- Survival differences between patients with hodgkin lymphoma treated inside and outside clinical trials. A study based on the EORTC-Netherlands cancer registry linked data with 20 years of follow-up.Br J Haematol. 2017 Jan; 176: 65-75
- A web-based study concept designed to progress clinical research for 'orphan' disease areas in haematological oncology in the elderly: the SHIELD programme.Crit Rev Oncol Hematol. 2007 Jan; 61: 79-83
- EUROCOURSE recipe for cancer surveillance by visible population-based cancer RegisTrees in europe: from roots to fruits.Eur J Cancer. 2015 Jun; 51: 1050-1063
- A practical guide for using registry data to inform decisions about the cost effectiveness of new cancer drugs: lessons learned from the PHAROS registry.Pharmacoeconomics. 2015 Jun; 33: 551-560
- Health-related quality of life and persistent symptoms in relation to (R-)CHOP14, (R-)CHOP21, and other therapies among patients with diffuse large B-cell lymphoma: results of the population-based PHAROS-registry.Ann Hematol. 2014 Oct; 93: 1705-1715
- Observational data for comparative effectiveness research: an emulation of randomised trials of statins and primary prevention of coronary heart disease.Stat Methods Med Res. 2013 Feb; 22: 70-96
- Treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone is beneficial but toxic in very elderly patients with diffuse large B-cell lymphoma: a population-based cohort study on treatment, toxicity and outcome.Leuk Lymphoma. 2014 Mar; 55: 526-532
- Comorbidity is an independent prognostic factor in patients with advanced-stage diffuse large B-cell lymphoma treated with R-CHOP: a population-based cohort study.Br J Haematol. 2014 May; 165: 489-496
- No outcome disparities in patients with diffuse large B-cell lymphoma and a low socioeconomic status.Cancer Epidemiol. 2017 Jun; 48: 110-116
- The role of initial clinical presentation, comorbidity and treatment in multiple myeloma patients on survival: a detailed population-based cohort study.Eur J Clin Pharmacol. 2017 Jun; 73: 771-778
- Restoration of renal function in patients with newly diagnosed multiple myeloma is not associated with improved survival: a population-based study.Leuk Lymphoma. 2017 Sep; 58: 1-9
- Electronic health records to facilitate clinical research.Clin Res Cardiol. 2017 Jan; 106: 1-9
- Using existing data to address important clinical questions in critical care.Crit Care Med. 2013 Mar; 41: 886-896
- Fusing randomized trials with big data: the key to self-learning health care systems?.JAMA. 2015 Aug 25; 314: 767-768
- Use of electronic medical records in oncology outcomes research.Clin Outcomes Res. 2010; 2: 1-14
- Randomized trial comparing a web-mediated follow-up with routine surveillance in lung cancer patients.J Natl Cancer Inst. 2017 Sep 1; 109https://doi.org/10.1093/jnci/djx029
Article info
Publication history
Published online: October 06, 2017
Accepted:
September 4,
2017
Received in revised form:
September 1,
2017
Received:
July 31,
2017
Identification
Copyright
© 2017 Elsevier Ltd. All rights reserved.