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

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• 作者：Silvio Garattini^a ; ^{silvio.garattini@marionegri.it" class="auth_mail" title="E-mail the corresponding author} ; Janus C. Jakobsen^b ; ^c ; ^{jcj@ctu.dk" class="auth_mail" title="E-mail the corresponding author} ; Jø ; rn Wetterslev^b ; ^{wetterslev@ctu.dk" class="auth_mail" title="E-mail the corresponding author} ; Vittorio Bertelé ; ^a ; ^{vittorio.bertele@marionegri.it" class="auth_mail" title="E-mail the corresponding author} ; Rita Banzi^a ; ^{rita.banzi@marionegri.it" class="auth_mail" title="E-mail the corresponding author} ; Ana Rath^d ; ^{ana.rath@inserm.fr" class="auth_mail" title="E-mail the corresponding author} ; Edmund A.M. Neugebauer^e ; ^{Edmund.Neugebauer@uni-wh.de" class="auth_mail" title="E-mail the corresponding author} ; Martine Laville^f ; ^{martine.laville@chu-lyon.fr" class="auth_mail" title="E-mail the corresponding author} ; Yvonne Masson^f ; ^{yvonne.masson@clermont.inra.fr" class="auth_mail" title="E-mail the corresponding author} ; Virginie Hivert^f ; ^{virginie.hivert@inserm.fr" class="auth_mail" title="E-mail the corresponding author} ; Michaela Eikermann^g ; ^{michaela.eikermann@uni-wh.de" class="auth_mail" title="E-mail the corresponding author} ; Burc Aydin^h ; ^{burcaydin@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Sandra Ngwabyt^d ; ^{sandra-nadia.ngwabyt-bikeye@inserm.fr" class="auth_mail" title="E-mail the corresponding author} ; Cecilia Martinhoⁱ ; ^{cvm@aibili.pt" class="auth_mail" title="E-mail the corresponding author} ; Chiara Gerardi^a ; ^{chiara.gerardi@marionegri.it" class="auth_mail" title="E-mail the corresponding author} ; Cezary A. Szmigielski^j ; ^{cezary.szmigielski@wum.edu.pl" class="auth_mail" title="E-mail the corresponding author} ; Jacques Demotes-Mainard^k ; ^{jacques.demotes@ecrin.org" class="auth_mail" title="E-mail the corresponding author} ; Christian Gluud^b ; ^{cgluud@ctu.dk" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Evidence-based medicine ; Evidence-based clinical practice ; Systematic review ; Randomised clinical trial ; Meta-analysis ; Trial Sequential Analysis
• 刊名：European Journal of Internal Medicine
• 出版年：2016
• 出版时间：July 2016
• 年：2016
• 卷：32
• 期：Complete
• 页码：13-21
• 全文大小：628 K

文摘

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.