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.
Child and adolescent trauma exposure is prevalent, with trauma exposure-related symptoms, including posttraumatic stress, depressive, and anxiety symptoms often causing substantial impairment. This article updates the evidence base on psychosocial treatments for child and adolescent trauma exposure completed for this journal by Silverman et al. (2008). For this review, we focus on 37 studies conducted during the seven years since the last review. Treatments are grouped by overall treatment family (e.g., cognitive behavioral therapy), treatment modality (e.g., individual vs. group), and treatment participants (e.g., child only vs. child and parent). All studies were evaluated for methodological rigor according to Journal of Clinical Child & Adolescent Psychology evidence-based treatment evaluation criteria (Southam-Gerow & Prinstein, 2014), with cumulative designations for level of support for each treatment family. Individual CBT with parent involvement, individual CBT, and group CBT were deemed well-established; group CBT with parent involvement and eye movement desensitization and reprocessing (EMDR) were deemed probably efficacious; individual integrated therapy for complex trauma and group mind–body skills were deemed possibly efficacious; individual client-centered play therapy, individual mind–body skills, and individual psychoanalysis were deemed experimental; and group creative expressive + CBT was deemed questionable efficacy. Advances in the evidence base, with comparisons to the state of the science at the time of the Silverman et al. (2008) review, are discussed. Finally, we present dissemination and implementation challenges and areas for future research.
Background.This paper reports on: (1) an evaluation of a common elements treatment approach (CETA) developed for comorbid presentations of depression, anxiety, traumatic stress, and/or externalizing symptoms among children in three Somali refugee camps on the Ethiopian/Somali border, and (2) an evaluation of implementation factors from the perspective of staff, lay providers, and families who engaged in the intervention.Methods.This project was conducted in three refugee camps and utilized locally validated mental health instruments for internalizing, externalizing, and posttraumatic stress (PTS) symptoms. Participants were recruited from either a validity study or from referrals from social workers within International Rescue Committee Programs. Lay providers delivered CETA to youth (CETA-Youth) and families, and symptoms were re-assessed post-treatment. Providers and families responded to a semi-structured interview to assess implementation factors.Results.Children who participated in the CETA-Youth open trial reported significant decreases in symptoms of internalizing (d = 1.37), externalizing (d = 0.85), and posttraumatic stress (d = 1.71), and improvements in well-being (d = 0.75). Caregivers also reported significant decreases in child symptoms. Qualitative results were positive toward the acceptability and appropriateness of treatment, and its feasibility.Conclusions.This project is the first to examine a common elements approach (CETA: defined as flexible delivery of elements, order, and dosing) with children and caregivers in a low-resource setting with delivery by lay providers. CETA-Youth may offer an effective treatment that is easier to implement and scale-up versus multiple focal interventions. A fullscale randomized clinical trial is warranted.
BackgroundWorkplace-based clinical supervision as an implementation strategy to support evidence-based treatment (EBT) in public mental health has received limited research attention. A commonly provided infrastructure support, it may offer a relatively cost-neutral implementation strategy for organizations. However, research has not objectively examined workplace-based supervision of EBT and specifically how it might differ from EBT supervision provided in efficacy and effectiveness trials.MethodsData come from a descriptive study of supervision in the context of a state-funded EBT implementation effort. Verbal interactions from audio recordings of 438 supervision sessions between 28 supervisors and 70 clinicians from 17 public mental health organizations (in 23 offices) were objectively coded for presence and intensity coverage of 29 supervision strategies (16 content and 13 technique items), duration, and temporal focus. Random effects mixed models estimated proportion of variance in content and techniques attributable to the supervisor and clinician levels.ResultsInterrater reliability among coders was excellent. EBT cases averaged 12.4 min of supervision per session. Intensity of coverage for EBT content varied, with some discussed frequently at medium or high intensity (exposure) and others infrequently discussed or discussed only at low intensity (behavior management; assigning/reviewing client homework). Other than fidelity assessment, supervision techniques common in treatment trials (e.g., reviewing actual practice, behavioral rehearsal) were used rarely or primarily at low intensity. In general, EBT content clustered more at the clinician level; different techniques clustered at either the clinician or supervisor level.ConclusionsWorkplace-based clinical supervision may be a feasible implementation strategy for supporting EBT implementation, yet it differs from supervision in treatment trials. Time allotted per case is limited, compressing time for EBT coverage. Techniques that involve observation of clinician skills are rarely used. Workplace-based supervision content appears to be tailored to individual clinicians and driven to some degree by the individual supervisor. Our findings point to areas for intervention to enhance the potential of workplace-based supervision for implementation effectiveness.Trial registrationNCT01800266, Clinical Trials, Retrospectively Registered (for this descriptive study; registration prior to any intervention [part of phase II RCT, this manuscript is only phase I descriptive results])Electronic supplementary materialThe online version of this article (10.1186/s13012-017-0708-3) contains supplementary material, which is available to authorized users.
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