Bias due to censoring of deaths when calculating extra length of stay for patients acquiring a hospital infection

Rahman, Shahina; Cube, Maja von; Schumacher, Martin; Wolkewitz, Martin

doi:10.1186/s12874-018-0500-3

Cited by 6 publications

(6 citation statements)

References 14 publications

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“…Time-to-discharge was presented with the use of the Kaplan-Meier approach. We assigned the 'worst outcome' for individuals who died before day 28 and therefore these patients were managed as those with the longest hospital stay (more than 28 days) 22 . Non-inferiority was assessed for the secondary outcome of time to hospital discharge.…”

Section: Discussionmentioning

confidence: 99%

Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial

Karampitsakos

Papaioannou

Tsiri

et al. 2022

Preprint

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Background: Tocilizumab and baricitinib have proven efficacy in COVID-19. There were no randomized-controlled trials comparing these compounds in patients with COVID-19. Materials/Patients and Methods: In this open label, randomized controlled trial, we assigned 251 patients with COVID-19 and PaO2/FiO2<200 to receive either tocilizumab (n=126) or baricitinib (n=125) plus standard of care. To determine whether baricitinib was non-inferior to tocilizumab, we assessed if the upper boundary of the two-sided 95% confidence interval of the hazard ratio did not exceed 1.50. The primary outcome was mechanical ventilation or death by day 28. Secondary outcomes included time to hospital discharge by day 28 and change in WHO progression scale at day 10. Results: Baricitinib was non-inferior to tocilizumab for the primary composite outcome of mechanical ventilation or death by day 28 (HR 0.83, 95% CI: 0.56 to 1.21, p=0.001 for non-inferiority). Baricitinib was non-inferior to tocilizumab for the time to hospital discharge within 28 days (discharged alive- tocilizumab: 52.4% vs baricitinib: 58.4%; HR 0.85, (95% CI: 0.61 to 1.18), p<0.001 for non-inferiority). There was no significant difference between baricitinib and tocilizumab arm in the change in WHO scale at day 10 [0.0 (95% CI: 0.0 to 0.0) vs 0.0 (95% CI: 0.0 to 1.0), p=0.83]. Conclusion: Baricitinib was non-inferior to tocilizumab with regards to the composite outcome of mechanical ventilation or death by day 28 and the time to discharge by day 28 in patients with severe COVID-19. Cost-effectiveness should be taken into account to avoid a dramatic upswing in health system budgets.

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Section: Discussionmentioning

confidence: 99%

Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial

Karampitsakos

Papaioannou

Tsiri

et al. 2022

Preprint

View full text Add to dashboard Cite

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“…Time-todischarge secondary outcome was compared between the two groups with the use of the Kaplan-Meier approach and cumulative incidence curves were compared between the two groups. We assigned the 'worst outcome' for individuals who died before day 28 and thus these patients were right-censored at the longest hospital stay [24]. Mann Whitney or t-test were used for the investigation of differences in ΔPaO 2 /FiO 2 and ΔWHO scale between the two groups based on the absence or presence of normality.…”

Section: Discussionmentioning

confidence: 99%

Tocilizumab in Hospitalized Patients with Severe COVID-19: An Open Label, Prospective Study

Karampitsakos

Malakounidou

Papaioannou

et al. 2021

Preprint

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Background: Data on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched.Methods: In this open label, prospective study, we evaluated clinical outcomes in consecutive patients with COVID-19 and PaO2/FiO2<200 receiving tocilizumab plus usual care versus usual care alone. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO2/FiO2 at day 5 and change in WHO progression scale at day 10.Findings: Overall, 114 patients were included in the analysis (tocilizumab plus usual care: 56, usual care: 58). Allocation to usual care was associated with significant increase in 28-day mortality compared to tocilizumab plus usual care [Cox proportional-hazards model: HR: 3.34, (95%CI: 1.21 to 9.30), (p=0.02)]. There was not a statistically significant difference with regards to hospital discharge over the 28-day period for patients receiving tocilizumab compared to usual care [11.0 days (95%CI: 9.0 to 16.0) vs 14.0 days (95%CI: 10.0 to 24.0), HR: 1.32 (95%CI: 0.84 to 2.08), p=0.21]. ΔPaO2/FiO2 at day 5 was significantly higher in the tocilizumab group compared to the usual care group [42.0 (95%CI: 23.0 to 84.7) vs 15.8 (95%CI: -19.4 to 50.3), p=0.03]. ΔWHO scale at day 10 was significantly lower in the tocilizumab group compared to the usual care group (-0.5±2.1 vs 0.6±2.6, p=0.005). Conclusion: This is the first study administrating tocilizumab in patients with COVID-19 based on PaO2/FiO2. Tocilizumab improved survival and other clinical outcomes in hospitalized patients with COVID-19 and PaO2/FiO2<200 irrespective of systemic inflammatory markers levels.

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“…We used a multistate model to estimate the change in LOS as an effect of the intermediate state (HO E. coli/Klebsiella spp. bacteremia; Figure 1) [22,23]. In brief, the multistate model accounts for the time-dependent exposure (occurrence of HO E. coli/Klebsiella spp.…”

Section: Discussionmentioning

confidence: 99%

Excess Length of Acute Inpatient Stay Attributable to Acquisition of Hospital-Onset Gram-Negative Bloodstream Infection with and without Antibiotic Resistance: A Multistate Model Analysis

et al. 2020

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Excess length of stay (LOS) is an important outcome when assessing the burden of nosocomial infection, but it can be subject to survival bias. We aimed to estimate the change in LOS attributable to hospital-onset (HO) Escherichia coli/Klebsiella spp. bacteremia using multistate models to circumvent survival bias. We analyzed a cohort of all patients with HO E. coli/Klebsiella spp. bacteremia and matched uninfected control patients within the U.S. Veterans Health Administration System in 2003–2013. A multistate model was used to estimate the change in LOS as an effect of the intermediate state (HO-bacteremia). We stratified analyses by susceptibilities to fluoroquinolones (fluoroquinolone susceptible (FQ-S)/fluoroquinolone resistant (FQ-R)) and extended-spectrum cephalosporins (ESC susceptible (ESC-S)/ESC resistant (ESC-R)). Among the 5964 patients with HO bacteremia analyzed, 957 (16.9%) and 1638 (28.9%) patients had organisms resistant to FQ and ESC, respectively. Any HO E.coli/Klebsiella bacteremia was associated with excess LOS, and both FQ-R and ESC-R were associated with a longer LOS than susceptible strains, but the additional burdens attributable to resistance were small compared to HO bacteremia itself (FQ-S: 12.13 days vs. FQ-R: 12.94 days, difference: 0.81 days (95% CI: 0.56–1.05), p < 0.001 and ESC-S: 11.57 days vs. ESC-R: 16.56 days, difference: 4.99 days (95% CI: 4.75–5.24), p < 0.001). Accurate measurements of excess attributable LOS associated with resistance can help support the business case for infection control interventions.

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Bias due to censoring of deaths when calculating extra length of stay for patients acquiring a hospital infection

Cited by 6 publications

References 14 publications

Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial

Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial

Tocilizumab in Hospitalized Patients with Severe COVID-19: An Open Label, Prospective Study

Excess Length of Acute Inpatient Stay Attributable to Acquisition of Hospital-Onset Gram-Negative Bloodstream Infection with and without Antibiotic Resistance: A Multistate Model Analysis

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