Expression of concern

Abstract

Following the publication online on June 27, 2014, of the Article “Effect of early versus late or no tracheostomy on mortality of critically ill patients receiving mechanical ventilation: a systematic review and meta-analysis” by Siempos and colleagues, The Lancet Respiratory Medicine received a letter from Dr Gusmao-Flores and Dr Barreto (Hospital Universitário Professor Edgard Santos, UFBA, Salvador, Bahia, Brazil) that highlighted some possible data discrepancies related to intensive-care unit (ICU) mortality for one trial (Zheng and colleagues) included in the paper. These concerns were put to the authors and after investigation by the authors and discussion between the editors and Dr Siempos, the authors have indicated “While extracting data on ICU mortality from two trials (Zheng et al and Terragni et al), we made an incorrect assumption; we assumed that patients who were not discharged from the ICU, died in the ICU. These extracted data appeared in figure 2, lines 6 and 8 of our paper. We have made every effort subsequently to acquire the correct data on ICU mortality for both trials, but have been unable to obtain data for ICU mortality. The original paper reported that all-cause mortality in the ICU was significantly lower in patients assigned to the early versus the late or no tracheostomy group (OR 0·72, 95% CI 0·53–0·98; p=0·04). If one repeats the analysis by using the earliest timepoint for mortality provided in the trials by Zheng and colleagues (10 days) and Terragni and colleagues (28 days) as an approximation for ICU mortality, one calculates a pooled odds ratio of 0·76 (95% CI 0·55–1·05) using a random-effects model, and 0·83 (95% CI 0·69—0·99) using a fixed effect model. In our original paper, we used a random effects model. We (the authors) cannot be sure that our finding regarding ICU mortality is not misleading.” The editors therefore wish to alert our readers that the ICU mortality findings are incorrect. A panel of experts has been convened to discuss the findings, and we will inform readers as soon as we have the thoughts of this group. RETRACTED: Effect of early versus late or no tracheostomy on mortality of critically ill patients receiving mechanical ventilation: a systematic review and meta-analysisThe synthesised evidence suggests that early tracheostomy is associated with lower mortality in the intensive-care unit than late or no tracheostomy; a finding that might question the present practice of delaying tracheostomy beyond the first week after translaryngeal intubation in mechanically ventilated patients. However, the scarcity of a beneficial effect on long-term mortality and the potential complications associated with tracheostomy need careful consideration; thus, further studies focusing on long-term outcomes are warranted. Full-Text PDF Retraction and republication—Effect of early versus late or no tracheostomy on mortality of critically ill patients receiving mechanical ventilation: a systematic review and meta-analysisOn June 27, 2014, The Lancet Respiratory Medicine published online a systematic review and meta-analysis of early versus late tracheostomy.1 Following publication, our attention was drawn to some possible data discrepancies affecting the findings for intensive-care-unit mortality and we issued an expression of concern highlighting the details on Oct 14, 2014.2 The editors have discussed the corrections that are necessary in the paper, and the findings of a panel that we convened, and decided that because of the extent of the changes necessary, the previous version of the Article should be retracted and a corrected version republished after re-review. Full-Text PDF Effect of early versus late or no tracheostomy on mortality and pneumonia of critically ill patients receiving mechanical ventilation: a systematic review and meta-analysisThe synthesised evidence suggests that early tracheostomy is not associated with lower mortality in the intensive-care unit than late or no tracheostomy. However, early, compared with late or no, tracheostomy might be associated with a lower incidence of pneumonia; a finding that could question the present practice of delaying tracheostomy beyond the first week after translaryngeal intubation in mechanically ventilated patients. Nevertheless, the scarcity of a beneficial effect on long-term mortality and the potential complications associated with tracheostomy need careful consideration; thus, further studies focusing on long-term outcomes are warranted. Full-Text PDF