Review article

https://doi.org/10.21860/medflum2017_187362

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

Silvio Garattini ; IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
Janus C Jakobsen ; The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Holbæk Hospital, Holbæk, Denmark
Jørn Wetterslev ; The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
Vittorio Bertele’ ; IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
Rita Banzi ; IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
Ana Rath ; Orphanet, Institut National de la Santé et de la Recherche Médicale US14, Paris, France
Edmund A.M. Neugebauer ; Faculty of Health, School of Medicine, Witten/Herdecke University, Campus Cologne, Germany
Martine Laville ; Centre de Recherche en Nutrition Humaine, Rhône-Alpes, Univ de Lyon, Lyon, France
Yvonne Masson ; Centre de Recherche en Nutrition Humaine, Rhône-Alpes, Univ de Lyon, Lyon, France
Virginie Hivert ; Centre de Recherche en Nutrition Humaine, Rhône-Alpes, Univ de Lyon, Lyon, France
Michaela Eikermann ; Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University, Cologne, Germany
Burc Aydin ; Department of Medical Pharmacology, School of Medicine, Dokuz Eylul University, Izmir, Turkey
Sandra Ngwabyt ; Orphanet, Institut National de la Santé et de la Recherche Médicale US14, Paris, France
Cecilia Martinho ; Palliative Care Service, Portuguese Institute of Oncology, Porto, Portugal
Chiara Gerardi ; IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
Cezary A Szmigielski ; Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw, Warsaw, Poland
Jacques Demotes-Maynard ; European Clinical Research Infrastructure Network, Ministry of Higher Education and Research, Paris, France
Christian Gluud orcid.org/0000-0002-8861-0799 ; The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

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.

Keywords

evidence-based clinical practice; evidence-based medicine; meta-analysis; randomised clinical trial; systematic review; trial sequential analysis

Hrčak ID:

187362

URI

https://hrcak.srce.hr/187362

Publication date:

1.12.2017.

Article data in other languages: croatian

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