Predictors of recovering ambulation after hip fracture inpatient rehabilitation

Abstract Background Despite progress in surgery and care, hip fracture (HF) remains a catastrophic event, burdened with high risk of mortality and disability. This study aims at identifying predictors of recovering ambulation after intensive inpatient rehabilitation within the Tuscany Region HF rehabilitation pathway. Methods All HF patients referred from acute care to the two Massa-Carrara Rehabilitation facilities January 2015–June 2017 were enrolled. Comorbidity Total Score (CIRS) defined high- or low-care setting referral. Recovery of ambulation, with or without aid, (assessed by SAHFE) was the primary outcome. Personal data, comorbidity, cognitive (MMSe) and pre-fracture function (mRANKIN) were recorded on admission. Outcomes included hospital readmission, length of stay (LOS) and home discharge. Urinary catheter, bedsores, disability (modified Barthel Index-mBI), communication disability (CDS), trunk control (TCT), pain (NRS), and ambulation were recorded (admission-discharge). Results Of 352 patients enrolled (age 83.9 ± 7.1; 80% women), 1 died and 6 were readmitted to acute-care hospital; 97% patients referred to high-care, and 64% referred to low-care, presented moderate-high comorbidity on admission. Median LOS was 22 days; 95% patients were discharged back home; daily functional gain (mBIscore/LOS) was 1.3 ± 0.7. Patients who recovered ambulation on discharge were 84%. Older age, higher comorbidity, bladder catheter, impaired trunk control, worse cognitive and functional status on admission, and pre-fracture disability were associated to poor outcome, but only higher comorbidity and impaired communication on admission predicted failure to recover ambulation on discharge. Conclusion In HF patients entitled to intensive inpatient rehabilitation, moderate-high comorbidity and impaired communication are frequent findings and predict rehabilitation failure

Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

BackgroundTocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.MethodsA multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.ResultsIn the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P=0.52) and 22.4% (97.5% CI: 17.2-28.3, P<0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.ConclusionsTocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)

Correction to: Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial (Journal of Translational Medicine, (2020), 18, 1, (405), 10.1186/s12967-020-02573-9)

Following publication of the original article [1] the authors identified that the collaborators of the TOCIVID-19 investigators, Italy were only available in the supplementary file. The original article has been updated so that the collaborators are correctly acknowledged. For clarity, all collaborators are listed in this correction article

Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

BackgroundTocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.MethodsA multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.ResultsIn the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P=0.52) and 22.4% (97.5% CI: 17.2-28.3, P<0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.ConclusionsTocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)