C-REGS 2-Design and methodology of a high-quality comparative effectiveness observational trial

Johannes Vester, Natan Bornstein, Wolf Dieter Heiss, Milan Vosko, Herbert Moessler, Marion Jech, Stefan Winter*, Michael Brainin

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

The main aim of this study is to systematically record Cerebrolysin treatment modalities and concomitant medication, according to local standards, in patients with moderate to severe neurological deficits after acute ischemic stroke and to assess the impact of these parameters on therapy outcome during early rehabilitation (day 21) and on day 90. An open observational treatment design based on the principles of high-quality comparative effectiveness research (HQCER) has been chosen to capture the therapies as applied in real-world clinical prac-tice. HQCER opens a new horizon for strengthening the validity of the results from observational trials, thereby enhancing the associated level of evidence. Rigorous pre-specification of analytical procedures and tight risk-based central-ized monitoring were additional measures to improve the impact of the observational approach. The value for real-world studies has become obvious, and such studies based on comparative effectiveness designs supplement the classical study designs by enabling the inclusion of larger proband numbers and more statistical reliability for practical use.

Original languageEnglish
Pages (from-to)700-709
Number of pages10
JournalJournal of medicine and life
Volume2021
Issue number5
DOIs
StatePublished - 1 Jan 2021
Externally publishedYes

Funding

FundersFunder number
Ever Neuro Pharma

    Keywords

    • cerebrolysin
    • high-quality comparative effectiveness
    • observationatrial

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