Carl Thomas Anthon1, Anders Granholm2, Anders Perner3, Jon Henrik Laake4, Morten Hylander Møller3. 1. Department of Intensive Care 4131, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, 2100, Copenhagen, Denmark. Electronic address: carl.anthon@gmail.com. 2. Department of Intensive Care 4131, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, 2100, Copenhagen, Denmark. 3. Department of Intensive Care 4131, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, 2100, Copenhagen, Denmark; Centre for Research in Intensive Care (CRIC), Department 7831, Blegdamsvej 9, 2100, Copenhagen, Denmark. 4. Department of Anaesthesiology, National Hospital (Rikshospitalet), Sognsvannsveien 20, 0372, Oslo, Norway.
Abstract
OBJECTIVE: To evaluate the effect of blinding on mortality effect estimates in randomized clinical trials (RCTs) in adult intensive care unit (ICU) patients. STUDY DESIGN AND SETTING: A systematic review and meta-analysis of RCTs reporting mortality effect estimates of ICU interventions in adult ICU patients. We assessed differences in summarized risk ratios with 95% confidence intervals between blinded and unblinded RCTs. P < 0.10 was considered statistically significant (test of interaction). RESULTS: We included 22 ICU interventions assessed in 269 RCTs enrolling a total of 42,007 adult ICU patients in the primary analyses. We observed statistically significant differences between blinded and unblinded RCTs for all-cause mortality at longest follow-up in one of 22 interventions (5%), for in-hospital mortality in one of 12 interventions (8%) but not for in-ICU mortality. Combining all interventions, unblinded trials reported larger summary effect estimates on all-cause mortality at longest follow-up compared to blinded trials (test of interaction, P = 0.09). However, the difference was not statistically significant following adjustment for other risk of bias domains. CONCLUSIONS: We observed no firm evidence that lack of blinding affects estimates of mortality in RCTs of ICU interventions.
OBJECTIVE: To evaluate the effect of blinding on mortality effect estimates in randomized clinical trials (RCTs) in adult intensive care unit (ICU) patients. STUDY DESIGN AND SETTING: A systematic review and meta-analysis of RCTs reporting mortality effect estimates of ICU interventions in adult ICU patients. We assessed differences in summarized risk ratios with 95% confidence intervals between blinded and unblinded RCTs. P < 0.10 was considered statistically significant (test of interaction). RESULTS: We included 22 ICU interventions assessed in 269 RCTs enrolling a total of 42,007 adult ICU patients in the primary analyses. We observed statistically significant differences between blinded and unblinded RCTs for all-cause mortality at longest follow-up in one of 22 interventions (5%), for in-hospital mortality in one of 12 interventions (8%) but not for in-ICU mortality. Combining all interventions, unblinded trials reported larger summary effect estimates on all-cause mortality at longest follow-up compared to blinded trials (test of interaction, P = 0.09). However, the difference was not statistically significant following adjustment for other risk of bias domains. CONCLUSIONS: We observed no firm evidence that lack of blinding affects estimates of mortality in RCTs of ICU interventions.
Authors: Leland Shapiro; Sias Scherger; Carlos Franco-Paredes; Amal A Gharamti; David Fraulino; Andrés F Henao-Martinez Journal: Front Pharmacol Date: 2022-06-23 Impact factor: 5.988
Authors: Mathias Lühr Hansen; Adelina Pellicer; Christian Gluud; Eugene Dempsey; Jonathan Mintzer; Simon Hyttel-Sørensen; Anne Marie Heuchan; Cornelia Hagmann; Ebru Ergenekon; Gabriel Dimitriou; Gerhard Pichler; Gunnar Naulaers; Guoqiang Cheng; Hercilia Guimarães; Jakub Tkaczyk; Karen B Kreutzer; Monica Fumagalli; Olivier Claris; Petra Lemmers; Siv Fredly; Tomasz Szczapa; Topun Austin; Janus Christian Jakobsen; Gorm Greisen Journal: Trials Date: 2019-12-30 Impact factor: 2.279