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Observational Study
. 2021 Sep-Oct;14(5):700-709.
doi: 10.25122/jml-2021-0362.

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

Johannes Vester  1 , Natan Bornstein  2 , Wolf-Dieter Heiss  3 , Milan Vosko  4 , Herbert Moessler  5 , Marion Jech  6 , Stefan Winter  6 , Michael Brainin  7
Affiliations
Observational Study

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

Johannes Vester et al. J Med Life. 2021 Sep-Oct.

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.

Keywords: cerebrolysin; high-quality comparative effectiveness; observational trial.

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References

    1. Dreyer NA, Tunis SR, Berger M, Ollendorf D, Mattox P, Gliklich R. Why observational studies should be among the tools used in comparative effectiveness research. Health Affairs. 2010;29(10):1–8. - PubMed
    1. Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE Guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64:401–406. - PubMed
    1. Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, Montori V, Akl EA, Djulbegovic B, Falck-Ytter Y, Norris Sl, Williams JW, Atkins D, Meerpohl J, Schünemann HJ. GRADE Guidelines: 4. Rating the quality of evidence - study limitations (risk of bias) J Clin Epidemiol. 2011;64:407–415. - PubMed
    1. Dreyer NA, Schneeweiss S, McNeil BJ, Berger M, Walker AM, Ollendorf DA, Gliklich R. GRACE principles: recognizing high-quality observational studies of comparative effectiveness. Am J Manag Care. 2010;16(6):467–71. - PubMed
    1. Dreyer NA, Velentgas P, Westrich K, Dubois R. The GRACE checklist for rating the quality of observational studies of comparative effectiveness: a tale of hope and caution. JMCP. 2014;20(3):301–308d. - PMC - PubMed

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