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.
National data about mortality in people with ID provides a basis for public health interventions. Linked data using GP records to identify people with ID could provide comprehensive population-based monitoring in England, unbiased by the circumstances of illnesses or death; to date information governance constraints have prevented this. However, GPs in England currently identify only around 0.5% of the population as having ID, suggesting that individuals with mild, non-syndromic ID are largely missed. Notably common causes of death suggest control of cardiovascular risk factors, epilepsy and dysphagia, management of thrombotic risks and colorectal screening are important areas for health promotion initiatives.
BackgroundWe aimed to systematically review the evidence on adverse mental health outcomes in breast cancer survivors (≥1 year) compared with women with no history of cancer.MethodsStudies were identified by searching MEDLINE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature, and the Social Sciences Citation Index, and through backward citation tracking. Two researchers selected the studies, extracted data, and assessed the risk of bias.ResultsSixty studies were included. Of 38 studies of depression, 33 observed more depression in breast cancer survivors; this was statistically significant in 19 studies overall, including six of seven where depression was ascertained clinically, three of four studies of antidepressants, and 13 of 31 that quantified depressive symptoms. Of 21 studies of anxiety, 17 observed more anxiety in breast cancer survivors, statistically significant in 11 studies overall, including two of four with clinical/prescription-based outcomes, and in eight of 17 of anxiety symptoms. Breast cancer survivors also had statistically significantly increased symptoms/frequency of neurocognitive dysfunction (18 of 24 studies), sexual dysfunctions (5 of 6 studies), sleep disturbance (5 of 5 studies), stress-related disorders/PTSD (2 of 3 studies), suicide (2 of 2 studies), somatisation (2 of 2 studies), and bipolar and obsessive-compulsive disorders (1 of 1 study each). Studies were heterogeneous in terms of participants’ characteristics, time since diagnosis, ascertainment of outcomes, and measures reported. Approximately one-half of the studies were at high risk of selection bias and confounding by socio-economic status.ConclusionsThere is compelling evidence of an increased risk of anxiety, depression and suicide, and neurocognitive and sexual dysfunctions in breast cancer survivors compared with women with no prior cancer. This information can be used to support evidence-based prevention and management strategies. Further population-based and longitudinal research would help to better characterize these associations.
A prospective validation study was conducted in 171 consenting patients from oncology and palliative care outpatient clinics to validate the Distress Thermometer (DT) against the Hospital Anxiety and Depression Scale (HADS), General Health Questionnaire-12 (GHQ-12) and Brief Symptom Inventory-18 (BSI-18) at baseline, four weeks and eight weeks. Receiver Operating Characteristic analysis was used to examine the sensitivity and specificity of the DT scores against the clinically significant cut-off scores of the criterion measures reporting 95% confidence intervals. Standardised response means were used to compare DT scores with criterion measures over time. For a cut-off of 4 vs 5, sensitivity against HADS was 79%, specificity 81%; against GHQ-12, sensitivity was 63%, specificity 83%; and against BSI-18, sensitivity was 88%, specificity 74%. At both four and eight weeks, DT scores tended to change significantly in the same direction as the criterion measures. Ninety-five percent of patients found completing the DT acceptable. The DT is valid and acceptable for use as a rapid screening instrument for patients in the UK with cancer. Our results indicate that it can be used to monitor change in psychological distress over time, but further work is needed to confirm this.
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