ImportanceThere are limited efficacious treatments for Alzheimer disease.ObjectiveTo assess efficacy and adverse events of donanemab, an antibody designed to clear brain amyloid plaque.Design, Setting, and ParticipantsMulticenter (277 medical research centers/hospitals in 8 countries), randomized, double-blind, placebo-controlled, 18-month phase 3 trial that enrolled 1736 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology based on positron emission tomography imaging from June 2020 to November 2021 (last patient visit for primary outcome in April 2023).InterventionsParticipants were randomized in a 1:1 ratio to receive donanemab (n = 860) or placebo (n = 876) intravenously every 4 weeks for 72 weeks. Participants in the donanemab group were switched to receive placebo in a blinded manner if dose completion criteria were met.Main Outcomes and MeasuresThe primary outcome was change in integrated Alzheimer Disease Rating Scale (iADRS) score from baseline to 76 weeks (range, 0-144; lower scores indicate greater impairment). There were 24 gated outcomes (primary, secondary, and exploratory), including the secondary outcome of change in the sum of boxes of the Clinical Dementia Rating Scale (CDR-SB) score (range, 0-18; higher scores indicate greater impairment). Statistical testing allocated α of .04 to testing low/medium tau population outcomes, with the remainder (.01) for combined population outcomes.ResultsAmong 1736 randomized participants (mean age, 73.0 years; 996 [57.4%] women; 1182 [68.1%] with low/medium tau pathology and 552 [31.8%] with high tau pathology), 1320 (76%) completed the trial. Of the 24 gated outcomes, 23 were statistically significant. The least-squares mean (LSM) change in iADRS score at 76 weeks was −6.02 (95% CI, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25 [95% CI, 1.88-4.62]; P < .001) in the low/medium tau population and −10.2 (95% CI, −11.22 to −9.16) with donanemab and −13.1 (95% CI, −14.10 to −12.13) with placebo (difference, 2.92 [95% CI, 1.51-4.33]; P < .001) in the combined population. LSM change in CDR-SB score at 76 weeks was 1.20 (95% CI, 1.00-1.41) with donanemab and 1.88 (95% CI, 1.68-2.08) with placebo (difference, −0.67 [95% CI, −0.95 to −0.40]; P < .001) in the low/medium tau population and 1.72 (95% CI, 1.53-1.91) with donanemab and 2.42 (95% CI, 2.24-2.60) with placebo (difference, −0.7 [95% CI, −0.95 to −0.45]; P < .001) in the combined population. Amyloid-related imaging abnormalities of edema or effusion occurred in 205 participants (24.0%; 52 symptomatic) in the donanemab group and 18 (2.1%; 0 symptomatic during study) in the placebo group and infusion-related reactions occurred in 74 participants (8.7%) with donanemab and 4 (0.5%) with placebo. Three deaths in the donanemab group and 1 in the placebo group were considered treatment related.Conclusions and RelevanceAmong participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab significantly slowed clinical progression at 76 weeks in those with low/medium tau and in the combined low/medium and high tau pathology population.Trial RegistrationClinicalTrials.gov Identifier: NCT04437511
IntroductionDomestic violence (DV) is a major cause of morbidity worldwide. The ED is a location recommended for opportunistic screening. However, screening within EDs remains irregular.ObjectiveTo examine intrinsic and extrinsic barriers to routine screening in Australian EDs, while describing actions taken after identification of DV.MethodsEmergency clinicians at nine public hospitals participated in an anonymous online survey. Factor analysis was performed to identify principal components around attitudes and beliefs towards screening.ResultsIn total, 496 emergency clinicians participated. Universal screening was uncommon; less than 2% of respondents reported screening all adults or all women. Although willing, nearly half (45%) reported not knowing how to screen. High patient load and no single rooms were ‘very or severely limiting’ for 88% of respondents, respectively, while 24/7 social work and interpreter services, and online/written DV protocols were top enablers. Factor analysis identified four distinct intrinsic belief components: (1) screening is not futile and could be done in ED, (2) screening will not cause harm, (3) there is a duty to screen and (4) I am willing to screen.ConclusionThis study describes a culture of Queensland ED clinicians that believe DV screening in ED is important and interventions are effective. Most ED clinicians are willing to screen. In this setting, availability of social work and interpreter services are important mitigating resources. Clinician education focusing on duty to screen, coupled with a built-in screening tool, and e-links to a local management protocol may improve the uptake of screening and subsequently increase detection.
INTRODUCTIONDomestic and family violence is a public health problem of epidemic proportions and a significant issue facing the Australian community. It knows no boundaries, is indiscriminate to geographical location, social class, age, religious or cultural background. AIMThis study aimed to analyse the processes currently used to identify and respond to domestic and family violence in a large tertiary hospital in Australia, and to classify the benefits and weaknesses of these existing systems. METHODSA qualitative method used semistructured, face-to-face and telephone interviews with key informants in 16 key areas across the hospital. Thematic analysis of the interviews was used to define the key issues and areas of interest identified by participants. RESULTSThere was a dearth of existing guidelines or pathways of care for patients experiencing domestic violence. Several strengths and weaknesses were identified in relation to the protocols and systems used by the hospital, including limited training for staff and a lack of standardisation of processes, workplace instructions and clinical guidelines. With the exception of maternity services, no clinical service area used a guideline or work instruction. Most interviewees highlighted the need for the safety and protection of staff and victims as a priority. DISCUSSIONDomestic and family violence is an enormous burden on the health system. However, many staff have little or no guidance on dealing with it or are unaware of existing protocols or guidelines for detection or response. Participants recommended further education and training for staff, consistent guidelines, specialist liaison and more educational and information resources for staff and patients. Further investigation and discussions with patients affected by violence is warranted to provide robust recommendations for policy change.
What is known on the subject?• Mental health clients experience higher estimated rates of domestic violence, yet mental health services are less likely to screen for domestic violence. What the paper adds to existing knowledge?• This paper qualitatively explores the perspectives and experiences of mental health practitioners in inpatient and community teams in a publicly funded hospital and health service (i.e. public mental health service).• Mental health practitioners described a lack of domestic violence training, as well as a lack of knowledge of domestic violence and support mechanisms for victims, when domestic violence is disclosed by clients.• The paper highlights the unique difficulties and barriers experienced by clinicians in screening for domestic violence while also dealing with clients suffering a mental health crisis. What are the implications for practice?• The paper sheds more light on the issue of domestic violence in mental health in terms of screening, and identifies avenues for improvement in mental health services; particularly the need for staff training and education.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.