A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events
Por:
Faillie, JL, Ferrer, P, Gouverneur, A, Driot, D, Berkemeyer, S, Vidal, X, Martinez-Zapata, MJ, Huerta, C, Castells, X, Rottenkolber, M, Schmiedl, S, Sabate, M, Ballarin, E, Ibanez, L
Publicada:
1 jun 2017
Resumen:
Objectives: The objective of the study was to develop and validate an adequate tool to evaluate the risk of bias of randomized controlled trials, observational studies, and systematic reviews assessing drug adverse events.
Study Design and Setting: We developed a structured risk of bias checklist applicable to randomized trials, cohort, case control and nested case-control studies, and systematic reviews focusing on drug safety. Face and content validity was judged by three experienced reviewers. Interrater and intrarater reliability were determined using 20 randomly selected studies, assessed by three other independent reviewers including one performing a 3-week retest.
Results: The developed checklist examines eight domains-study design and objectives, selection bias, attrition, adverse events information bias, other information bias, statistical methods to control confounding, other statistical methods, and conflicts of interest. The total number of questions varied from 10 to 32 depending on the study design. Interrater and intrarater agreements were fair with Kendall's W of 0.70 and 0.74, respectively. Median time to complete the checklist was 8.5 minutes.
Conclusion: The developed checklist showed face and content validity and acceptable reliability to assess the risk of bias for studies analyzing drug adverse events. Hence, it might be considered as a novel useful tool for systematic reviews and meta-analyses focusing on drug safety. (C) 2017 Elsevier Inc. All rights reserved.
Filiaciones:
Faillie, JL:
Univ Montpellier, Lab Biostat Epidemiol & Publ Hlth EA2415, Fac Med, Inst Univ Rech Clin, 641 Ave Doyen Gaston Giraud, F-34093 Montpellier, France
CHU Montpellier Univ Hosp, Dept Med Pharmacol & Toxicol, 371 Ave Doyen Gaston Giraud, F-34295 Montpellier, France
Ferrer, P:
Autonomous Univ Barcelona, Catalan Inst Pharmacol Fdn FICF, Dept Pharmacol Therapeut & Toxicol, Clin Pharmacol Unit,Vall dHebron Univ Hosp, Pg Vall dHebron 119-129, E-08035 Barcelona, Spain
Gouverneur, A:
Univ Bordeaux, INSERM, UMR 1219, CHU Bordeaux,Pole Sante Publ,Serv Informat Med, 146 Rue Leo Saignat, F-33076 Bordeaux, France
Driot, D:
Univ Toulouse, Dept Clin & Med Pharmacol, CHU Toulouse Univ Hosp, 37 Allees Jules Guesde, F-31000 Toulouse, France
Berkemeyer, S:
Hsch Gesundheit, Dept Community Hlth, Gesundheitscampus 6-8, D-44801 Bochum, Germany
Vidal, X:
Autonomous Univ Barcelona, Catalan Inst Pharmacol Fdn FICF, Dept Pharmacol Therapeut & Toxicol, Clin Pharmacol Unit,Vall dHebron Univ Hosp, Pg Vall dHebron 119-129, E-08035 Barcelona, Spain
Martinez-Zapata, MJ:
CIBER Epidemiol & Salud Publ CIBERESP, Inst Biomed Res IIB St Pau, Iberoamer Cochrane Ctr, St Antoni Maria Claret 167, Barcelona 08025, Spain
Huerta, C:
Spanish Agcy Med Prod & Med Devices AEMPS, Med Human Use Dept, Pharmacoepidemiol & Pharmacovigilance Div, Calle Campezo 1, E-28022 Madrid, Spain
Castells, X:
Univ Girona, Dept Med Sci, TransLab Res Grp, Girona, Spain
Rottenkolber, M:
Klinikum Univ, Med Klin & Poliklin 4, Diabet Res Grp, Pettenkoferstr 8A, D-81377 Munich, Germany
Schmiedl, S:
Witten Herdecke Univ, Fac Hlth, Sch Med, Dept Clin Pharmacol, Alfred Herrhausen Str 50, D-58448 Witten, Germany
HELIOS Clin Wuppertal, Philipp Klee Institute Clin Pharmacol, Heusnerstr 40, D-42283 Wuppertal, Germany
Sabate, M:
Autonomous Univ Barcelona, Catalan Inst Pharmacol Fdn FICF, Dept Pharmacol Therapeut & Toxicol, Clin Pharmacol Unit,Vall dHebron Univ Hosp, Pg Vall dHebron 119-129, E-08035 Barcelona, Spain
Ballarin, E:
Autonomous Univ Barcelona, Catalan Inst Pharmacol Fdn FICF, Dept Pharmacol Therapeut & Toxicol, Clin Pharmacol Unit,Vall dHebron Univ Hosp, Pg Vall dHebron 119-129, E-08035 Barcelona, Spain
Ibanez, L:
Autonomous Univ Barcelona, Catalan Inst Pharmacol Fdn FICF, Dept Pharmacol Therapeut & Toxicol, Clin Pharmacol Unit,Vall dHebron Univ Hosp, Pg Vall dHebron 119-129, E-08035 Barcelona, Spain
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