Background
In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation.
Methods
This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and
ClinicalTrials.gov
(
NCT04381936
).
Findings
Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57%
vs
50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35%
vs
42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001).
Interpretation
In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids.
Funding
UK Research and Innovation (Medical Research Council) and National Institute of Health Research.
Background Accurate implant orientation reduces wear and increases stability in arthroplasty but is a technically demanding skill. Augmented reality (AR) headsets overlay digital information on top of the real world. We have developed an enhanced AR headset capable of tracking bony anatomy in relation to an implant, but it has not yet been assessed for its suitability as a training tool for implant orientation. Questions/purposes (1) In the setting of simulated THA performed by novices, does an AR headset improve the accuracy of acetabular component positioning compared with hands-on training by an expert surgeon? (2) What are trainees' perceptions of the AR headset in terms of realism of the task, acceptability of the technology, and its potential role for surgical training? Methods Twenty-four study participants (medical students in their final year of school, who were applying to surgery residency programs, and who had no prior arthroplasty experience) participated in a randomized simulation trial using an AR headset and a simulated THA. Participants were randomized to two groups completing four once-weekly sessions of baseline assessment, training, and reassessment. One group trained using AR (with live holographic orientation feedback) and the other received one-on-one training from a hip arthroplasty surgeon. Demographics and baseline performance in orienting an acetabular implant to six patient-specific values on the phantom pelvis were collected before training and were comparable. The orientation error in degrees between the planned and achieved orientations was measured and was not different between groups with the numbers available (surgeon group mean error 6 SD 16°6 7°versus AR 14°6 7°; p = 0.22). Participants trained by AR also completed a validated posttraining questionnaire evaluating their experiences. Results During the four training sessions, participants using AR-guidance had smaller mean (6 SD) errors in orientation than those receiving guidance from the surgeon: 1°6 1°versus AR 6°6 4°, p < 0.001. In the fourth session's assessment, participants in both groups had improved (surgeon group mean improvement 6°, 95% CI, 4-8°; p < 0.001 versus AR group 9°, 95% CI 7-10°; p < 0.001). There was no difference between participants in the surgeon-trained and AR-trained group: mean difference 1.2°, 95% CI,-1.8 to 4.2°; p = 0.281. In posttraining evaluation, 11 of 12 participants would use the AR One of the authors (FI) received funding from Orthopaedic Research UK (31434). One of the authors (KL) received funding from the Royal College of Surgeons of England (P67699). Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDAapproval status, of any drug or device prior to clinical use. Each author certifies that his institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research. Al...
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