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Measuring and Analyzing Length of Stay in Critical Care Trials.

ABSTRACT: BACKGROUND:In randomized clinical trials among critically ill patients, it is uncertain how choices regarding the measurement and analysis of nonmortal outcomes measured in terms of duration, such as intensive care unit (ICU) length of stay (LOS), affect studies' conclusions. OBJECTIVES:Assess the definitions and analytic methods used for ICU LOS analyses in published randomized clinical trials. RESEARCH DESIGN:This is a systematic review and statistical simulation study. RESULTS:Among the 80 of 150 trials providing sufficient information regarding the chosen definition of ICU LOS, 3 different start times (ICU admission, trial enrollment/randomization, receipt of intervention) and 2 end times (discharge readiness, actual discharge) were used. In roughly three quarters of these studies, ICU LOS was compared using approaches that did not explicitly account for death, either by ignoring it entirely or stratifying the analyses by survival status. The remaining studies used time-to-event (discharge) models censoring at death or applied a fixed LOS value to patients who died. In statistical simulations, we showed that each analytic approach tested a different question regarding ICU LOS, and that approaches that do not explicitly account for death often produce misleading or ambiguous conclusions when treatments produce small effects on mortality, even if those are not detected as significant in the trial. CONCLUSIONS:There is considerable variability in how ICU LOS is measured and analyzed which impairs the ability to compare results across trials and can produce spurious conclusions. Analyses of duration-based outcomes such as LOS should jointly assess the impact of the intervention on mortality to yield correct interpretations.

SUBMITTER: Harhay MO

PROVIDER: S-EPMC6635104 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Measuring and Analyzing Length of Stay in Critical Care Trials.

Harhay Michael O MO Ratcliffe Sarah J SJ Small Dylan S DS Suttner Leah H LH Crowther Michael J MJ Halpern Scott D SD

Medical care 20190901 9

<h4>Background</h4>In randomized clinical trials among critically ill patients, it is uncertain how choices regarding the measurement and analysis of nonmortal outcomes measured in terms of duration, such as intensive care unit (ICU) length of stay (LOS), affect studies' conclusions.<h4>Objectives</h4>Assess the definitions and analytic methods used for ICU LOS analyses in published randomized clinical trials.<h4>Research design</h4>This is a systematic review and statistical simulation study.<h ...[more]

PMID: 30664613

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Project description:IntroductionEffective planning of elective surgical procedures requiring postoperative intensive care is important in preventing cancellations and empty intensive care unit (ICU) beds. To improve planning, we constructed, validated and tested three models designed to predict length of stay (LOS) in the ICU in individual patients.MethodsRetrospective data were collected from 518 consecutive patients who underwent oesophagectomy with reconstruction for carcinoma between January 1997 and April 2005. Three multivariable linear regression models for LOS, namely preoperative, postoperative and intra-ICU, were constructed using these data. Internal validation was assessed using bootstrap sampling in order to obtain validated estimates of the explained variance (r2). To determine the potential gain of the best performing model in day-to-day clinical practice, prospective data from a second cohort of 65 consecutive patients undergoing oesophagectomy between May 2005 and April 2006 were used in the model, and the predictive performance of the model was compared with prediction based on mean LOS.ResultsThe intra-ICU model had an r2 of 45% after internal validation. Important prognostic variables for LOS included greater patient age, comorbidity, type of surgical approach, intraoperative respiratory minute volume and complications occurring within 72 hours in the ICU. The potential gain of the best model in day-to-day clinical practice was determined relative to mean LOS. Use of the model reduced the deficit number (underestimation) of ICU days by 65 and increased the excess number (overestimation) of ICU days by 23 for the cohort of 65 patients. A conservative analysis conducted in the second, prospective cohort of patients revealed that 7% more oesophagectomies could have been accommodated, and 15% of cancelled procedures could have been prevented.ConclusionPatient characteristics can be used to create models that will help in predicting LOS in the ICU. This will result in more efficient use of ICU beds and fewer cancellations.

Project description:Background Mini-sternotomy for isolated aortic valve replacement aims to reduce operative trauma hastening recovery and improving the cosmetic outcome of cardiac surgery. The short-term clinical benefits from the mini-sternotomy are presumed to arise because the incision is less extensive and the lower half of the chest cage remains intact. The basic conduct of virtually all other aspects of the aortic valve replacement procedure remains the same. Therefore, similar long-term outcomes are to be expected. Objectives To conduct a meta-analysis of the only available randomised controlled trials (RCT) in the published English literature. Data sources Electronic search for relevant publications in MEDLINE, EMBASE and CENTRAL databases were performed. Four studies met the criteria. Study eligibility criteria RCT comparing minimally invasive (inverted C or L (J)-shaped) hemi-sternotomy versus conventional sternotomy for adults undergoing isolated aortic valve replacement using standard cardiopulmonary bypass technique. Methods Outcome measures were the length of positive pressure ventilation, blood loss, intensive care unit (ICU) and hospital stay. Results The length of ICU stay was significantly shorter by 0.57 days in favour of the mini-sternotomy group (CI -0.95 to -0.2; p=0.003). There was no advantage in terms of duration of ventilation (CI -3.48 to 0.36; p=0.11). However, there was some evidence to suggest a reduction in blood loss and the length of stay in hospital in the mini-sternotomy group. This did not prove to be statistically significant (154.17 ml reduction (CI -324.51 to 16.17; p=0.08) and 2.03 days less (CI -4.12 to 0.05; p=0.06), respectively). Limitations This study includes a relatively small number of subjects (n=220) and outcome variables. The risk of bias was not assessed during this meta-analysis. Conclusion Mini-sternotomy for isolated aortic valve replacement significantly reduces the length of stay in the cardiac ICU. Other short-term benefits may include a reduction in blood loss or the length of hospital stay.

Project description:Background: The coronavirus 2019 (COVID-19) disease, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus led to a global pandemic. HCQ and FPV were used early in the pandemic as a treatment modality for COVID-19. Various studies evaluated the HCQ and FPV effectiveness, based on the mortality endpoint and showed conflicting results. We hypothesize that analyzing the difference in the LOS as a significant endpoint would be of a major interest, especially for healthcare providers, to prevent a lengthy hospitalization and disease progression. Methods: This is a retrospective observational study, conducted via a medical chart review of COVD-19 patients who were admitted between April 2020 and March 2021 with a moderate to severe illness. The LOS endpoint was tested using the paired Wilcoxon signed-rank (WSR) model. Prior to using the WSR model, the balance between the HCQ and FPV groups, the propensity score matching, the LOS distribution, and the normality assumptions were tested. Two sensitivity statistical analyses were conducted to confirm the results (stratified log-rank test and U Welch test after transforming the LOS by the squared root values). Results: A total of 200 patients were included for the analysis: 83 patients in the HCQ group and 117 patients in the FPV group. Thirty-seven patients were matched in each group. The LOS data was positively skewed and violated the normality (Shapiro-Wilk p < 0.001) and had an unequal variance (Levene's test, p = 0.019). The WSR test showed no statistical significance in the LOS endpoint, with a median of -0.75 days (95% confidence interval: -4.0 to 2.5, p = 0.629), in favor of the HCQ group (four days), in comparison to seven days of the FPV group. The WSR findings were further confirmed with the stratified log rank test (p = 740) and the U Welch test (p = 391). Conclusions: The study concluded that the HCQ and FPV treatments have a comparable effectiveness in terms of the LOS in the moderate to severe COVID-19 patients. This study highlights the importance of analyzing the LOS as a relevant endpoint, in order to prevent the costs of a lengthy hospitalization and disease progression. The current study also emphasizes the importance of applying the appropriate statistical testing when dealing with two-sample paired data and analyzing non-parametric data such as the LOS.

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Measuring and Analyzing Length of Stay in Critical Care Trials.

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Measuring and Analyzing Length of Stay in Critical Care Trials.

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