Evidence map›Paper›PMID 35027974›Full record

Observational studyJournal of medicine and life

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

Open access · diamondAbstract readObservational Study
In one paragraph

Observational study in Journal of medicine and life. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke.International journal of stroke : official journal of the International Stroke Society · 2025
    Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 4 countries.

Johannes VesterDepartment of Biometry and Clinical Research, idv Data Analysis and Study Planning, Krailling, Germany.
Natan BornsteinDepartment of Neurology, Shaare Zedek Medical Center, Tel Aviv, Israel.
Wolf-Dieter HeissDepartment of Neurology, Max Planck Institute for Metabolism Research, Koln, Germany.
Milan VoskoDepartment of Neurology, Kepler University Hospital, Linz, Austria.
Herbert MoesslerComamo Life Sciences, Zell am Moos, Austria.
Marion JechDepartment of Research and Development, Ever Neuro Pharma, Unterach, Austria.
Stefan WinterDepartment of Research and Development, Ever Neuro Pharma, Unterach, Austria.
Michael BraininDepartment of Clinical Neurosciences and Preventive Medicine, Danube University Krems, Krems, Austria.
EVER Neuro Pharma (Austria) · ATUniversität für Weiterbildung Krems · ATKepler Universitätsklinikum · ATMax Planck Institute for Metabolism Research · DEPTV Group (Germany) · DEShaare Zedek Medical Center · ILTauern Hospital Zell am See · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 practice. 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 centralized 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.

Indexed as

Brain IschemiaStrokeHumansReproducibility of ResultsResearch Designcerebrolysinhigh-quality comparative effectivenessobservational trial

Identifiers

PMID35027974
PMCPMC8742899
OpenAlexW4205683069

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.