Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them

Silvio Garattini, Janus C. Jakobsen, Jørn Wetterslev, Vittorio Bertele', Rita Banzi, Ana Rath, Edmund A M Neugebauer, Martine Laville, Yvonne Masson, Virginie Hivert, Michaela Eikermann, Burc Aydin, Sandra Ngwabyt, Cecilia Martinho, Chiara Gerardi, Cezary A. Szmigielski, Jacques Demotes-Mainard, Christian Gluud

Research output: Contribution to journalArticle

Abstract

Using the best quality of clinical research evidence is essential for choosing the right treatment for patients. How to identify the best research evidence is, however, difficult. In this narrative review we summarise these threats and describe how to minimise them. Pertinent literature was considered through literature searches combined with personal files. Treatments should generally not be chosen based only on evidence from observational studies or single randomised clinical trials. Systematic reviews with meta-analysis of all identifiable randomised clinical trials with Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment represent the highest level of evidence. Even though systematic reviews are trust worthier than other types of evidence, all levels of the evidence hierarchy are under threats from systematic errors (bias); design errors (abuse of surrogate outcomes, composite outcomes, etc.); and random errors (play of chance). Clinical research infrastructures may help in providing larger and better conducted trials. Trial Sequential Analysis may help in deciding when there is sufficient evidence in meta-analyses. If threats to the validity of clinical research are carefully considered and minimised, research results will be more valid and this will benefit patients and heath care systems.

Original languageEnglish
Pages (from-to)13-21
JournalEuropean Journal of Internal Medicine
Volume32
DOIs
Publication statusPublished - Mar 15 2016

Keywords

  • Evidence-based clinical practice
  • Evidence-based medicine
  • Meta-analysis
  • Randomised clinical trial
  • Systematic review
  • Trial Sequential Analysis

ASJC Scopus subject areas

  • Internal Medicine

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    Garattini, S., Jakobsen, J. C., Wetterslev, J., Bertele', V., Banzi, R., Rath, A., Neugebauer, E. A. M., Laville, M., Masson, Y., Hivert, V., Eikermann, M., Aydin, B., Ngwabyt, S., Martinho, C., Gerardi, C., Szmigielski, C. A., Demotes-Mainard, J., & Gluud, C. (2016). Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them. European Journal of Internal Medicine, 32, 13-21. https://doi.org/10.1016/j.ejim.2016.03.020