gms | German Medical Science

Klasse statt Masse – wider die wertlose Wissenschaft: 18. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

09.03. - 11.03.2017, Hamburg

Routinely collected health data (RCD) for randomized controlled trials (RCT)

Meeting Abstract

Suche in Medline nach

  • corresponding author presenting/speaker Lars G. Hemkens - Basel Institute for Clinical Epidemiology and Biostatistics (ceb), Basel, Schweiz
  • author presenting/speaker Rustam Salman - University of Edinburgh, Edinburgh, Schottland

Klasse statt Masse – wider die wertlose Wissenschaft. 18. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Hamburg, 09.-11.03.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. Doc17ebmW1

doi: 10.3205/17ebm092, urn:nbn:de:0183-17ebm0924

Veröffentlicht: 23. Februar 2017

© 2017 Hemkens et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Objectives: To discuss promises, opportunities and real world challenges of using routinely collected health data when conducting randomized trials.

To spread the understanding of the potential of this evidence and ignite collaborative research activities.

Relevance: Routinely collected health data (RCD) such as administrative claims data from health insurers, disease or patient registries, or hospital databases can be used for more than observational data analyses. Their true value for evidence based health care may be their potential to generate more and more useful randomized trials (RCTs). They may, for example, facilitate large-scale pragmatic trials where outcomes are measured in large patient populations [1]. They may also allow to screen large populations for recruitment purposes to realize small trials in patients with rare conditions [2]. All this may even be possible at costs that are substantially lower [3].

Speakers: Lars G Hemkens, Rustam Al-Shahi Salman, further stakeholders

Methods: This interactive workshop invites researchers, decision-makers, regulators and other interested stakeholders. We will present and discuss empirical research on the validity and reliability of RCD in general and specifically for recruiting patients to RCTs or measuring outcomes in RCTs. Real world case examples from the UK, Switzerland and other countries will be shown and discussed and we aim to interactively outline promises, opportunities and challenges of this way of evidence generation.

We will collect contact information of interested participants to form an interest group aiming to establish a network of interested researchers to foster future activities on using RCD for RCTs.


References

1.
Ford I, Murray H, Packard CJ, Shepherd J, Macfarlane PW, Cobbe SM; West of Scotland Coronary Prevention Study Group. Long-term follow-up of the West of Scotland Coronary Prevention Study. N Engl J Med. 2007 Oct 11;357(15):1477-86.
2.
Tan MH, Thomas M, MacEachern MP. Using registries to recruit subjects for clinical trials. Contemp Clin Trials. 2015 Mar;41:31-8.
3.
Li G, Sajobi TT, Menon BK, Korngut L, Lowerison M, James M, Wilton SB, Williamson T, Gill S, Drogos LL, Smith EE, Vohra S, Hill MD, Thabane L; 2016 Symposium on Registry-Based Randomized Controlled Trials in Calgary. Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research? J Clin Epidemiol. 2016 Aug 20. pii: S0895-4356(16)30350-X.