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Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials

Por: Holzer · K. J. · Bartosiak · K. A. · Calfee · R. P. · Hammill · C. W. · Haroutounian · S. · Kozower · B. D. · Cordner · T. A. · Lenard · E. M. · Freedland · K. E. · Tellor Pennington · B. R. · Wolfe · R. C. · Miller · J. P. · Politi · M. C. · Zhang · Y. · Yingling · M. D. · Baumann
Introduction

Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Methods and analysis

Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.

Ethics and dissemination

The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.

Trial registration numbers

NCT05575128, NCT05685511, NCT05697835, pre-results.

The prevalence of incivility in hospitals and the effects of incivility on patient safety culture and outcomes: A systematic review and meta‐analysis

Abstract

Aim

Workplace incivility is a barrier to safe and high-quality patient care in nursing workplaces and more broadly in tertiary hospitals. The present study aims to systematically review the existing evidence to provide a comprehensive understanding of the prevalence of co-worker incivility experienced and witnessed by nurses and other healthcare professionals, the effects of incivility on patient safety culture (PSC) and patient outcomes, and the factors which mediate the relationship between incivility and patient safety.

Methods

A systematic review with narrative synthesis and meta-analysis was undertaken to synthesize the data from 41 studies.

Data Sources

Databases searched included MEDLINE, PubMed, SCOPUS, CINAHL, PsycInfo, ProQuest, Emcare and Embase. Searches were conducted on 17 August 2021 and repeated on 15 March 2023.

Results

The pooled prevalence of experienced incivility was 25.0%. The pooled prevalence of witnessed incivility was 30.1%. Workplace incivility was negatively associated with the PSC domains of teamwork, reporting patient safety events, organization learning/improvement, management support for safety, leadership, communication openness and communication about error. The composite pooled effect size of incivility on these domains of PSC was OR = 0.590, 95% CI [0.515, 0.676]. Workplace incivility was associated with a range of patient safety outcomes (PSOs) including near misses, adverse events, reduced procedural and diagnostic performance, medical error and mortality. State depletion, profession, psychological responses to incivility, information sharing, help seeking, workload and satisfaction with organizational communication were found to mediate the relationship between incivility and patient safety.

Conclusion

Experienced and witnessed incivility is prevalent in tertiary hospitals and has a deleterious effect on PSC and PSOs. A better understanding of the mechanisms of this relationship will support the development of interventions aimed at reducing both incivility and patient harm.

Implications for the Profession and/or Patient Care Impact

This study quantifies the effect of incivility on PSC and outcomes. It provides support that interventions focusing on incivility are a valuable mechanism for improving patient care. It guides intervention design by highlighting which domains of PSC are most associated with incivility. It explores the profession-specific experiences of workplace incivility.

Reporting Method

This report adheres to PRISMA reporting guidelines.

Patient or Public Contribution

No patient or public contribution. The focus of this study is the nursing and healthcare workforce, therefore, patient or public involvement not required.

Retinoid orphan receptor gamma t (rorγt) promotes inflammatory eosinophilia but is dispensable for innate immune-mediated colitis

by Alvaro Torres-Huerta, Katelyn Ruley-Haase, Theodore Reed, Antonia Boger-May, Derek Rubadeux, Lauren Mayer, Arpitha Mysore Rajashekara, Morgan Hiller, Madeleine Frech, Connor Roncagli, Cameron Pedersen, Mary Catherine Camacho, Lauren Hollmer, Lauren English, Grace Kane, David L. Boone

Inflammatory bowel diseases (IBD) result from uncontrolled inflammation in the intestinal mucosa leading to damage and loss of function. Both innate and adaptive immunity contribute to the inflammation of IBD and innate and adaptive immune cells reciprocally activate each other in a forward feedback loop. In order to better understand innate immune contributions to IBD, we developed a model of spontaneous 100% penetrant, early onset colitis that occurs in the absence of adaptive immunity by crossing villin-TNFAIP3 mice to RAG1-/- mice (TRAG mice). This model is driven by microbes and features increased levels of innate lymphoid cells in the intestinal mucosa. To investigate the role of type 3 innate lymphoid cells (ILC3) in the innate colitis of TRAG mice, we crossed them to retinoid orphan receptor gamma t deficient (Rorγt-/-) mice. Rorγt-/- x TRAG mice exhibited markedly reduced eosinophilia in the colonic mucosa, but colitis persisted in these mice. Colitis in Rorγt-/- x TRAG mice was characterized by increased infiltration of the intestinal mucosa by neutrophils, inflammatory monocytes, macrophages and other innate cells. RNA and cellular profiles of Rorγt-/- x TRAG mice were consistent with a lack of ILC3 and ILC3 derived cytokines, reduced antimicrobial factors, increased activation oof epithelial repair processes and reduced activation of epithelial cell STAT3. The colitis in Rorγt-/- x TRAG mice was ameliorated by antibiotic treatment indicating that microbes contribute to the ILC3-independent colitis of these mice. Together, these gene expression and cell signaling signatures reflect the double-edged sword of ILC3 in the intestine, inducing both proinflammatory and antimicrobial protective responses. Thus, Rorγt promotes eosinophilia but Rorγt and Rorγt-dependent ILC3 are dispensable for the innate colitis in TRAG mice.

Virological, serological and clinical outcomes in chronic hepatitis B virus infection: development and validation of the HEPA-B simulation model

Por: Mohareb · A. M. · Kim · A. Y. · Boyd · A. · Noubary · F. · Kouame · M. G. · Anglaret · X. · Coffie · P. A. · Eholie · S. P. · Freedberg · K. A. · Hyle · E. P.
Objectives

Detailed simulation models are needed to assess strategies for prevention and treatment of hepatitis B virus (HBV) infection, the world’s leading cause of liver disease. We sought to develop and validate a simulation model of chronic HBV that incorporates virological, serological and clinical outcomes.

Methods

We developed a novel Monte Carlo simulation model (the HEPA-B Model) detailing the natural history of chronic HBV. We parameterised the model with epidemiological data from the Western Pacific and sub-Saharan Africa. We simulated the evolution of HBV DNA, ‘e’ antigen (HBeAg) and surface antigen (HBsAg). We projected incidence of HBeAg loss, HBsAg loss, cirrhosis, hepatocellular carcinoma (HCC) and death over 10-year and lifetime horizons. We stratified outcomes by five HBV DNA categories at the time of HBeAg loss, ranging from HBV DNA106 copies/mL. We tested goodness of fit using intraclass coefficients (ICC).

Results

Model-projected incidence of HBeAg loss was 5.18% per year over lifetime (ICC, 0.969 (95% CI: 0.728 to 0.990)). For people in HBeAg-negative phases of infection, model-projected HBsAg loss ranged from 0.78% to 3.34% per year depending on HBV DNA level (ICC, 0.889 (95% CI: 0.542 to 0.959)). Model-projected incidence of cirrhosis was 0.29–2.09% per year (ICC, 0.965 (95% CI: 0.942 to 0.979)) and HCC incidence was 0.06–1.65% per year (ICC, 0.977 (95% CI: 0.962 to 0.986)). Over a lifetime simulation of HBV disease, mortality rates were higher for people with older age, higher HBV DNA level and liver-related complications, consistent with observational studies.

Conclusions

We simulated HBV DNA-stratified clinical outcomes with the novel HEPA-B Model and validated them to observational data. This model can be used to examine strategies of HBV prevention and management.

Wearables for early detection of atrial fibrillation and timely referral for Indigenous people >=55 years: mixed-methods protocol

Por: Henson · C. · Rambaldini · B. · Freedman · B. · Carlson · B. · Parter · C. · Christie · V. · Skinner · J. · Meharg · D. · Kirwan · M. · Ward · K. · Speier · S. N. K. · Gwynne · K.
Introduction

Digital health technologies have the potential to provide cost-effective care to remote and underserved populations. To realise this potential, research must involve people not traditionally included. No research focuses on the acceptability and feasibility of older Indigenous people using wearables for early atrial fibrillation (AF) detection. This protocol compares digital augmentation against standard practice to detect AF, evaluate heart health self-efficacy and health literacy changes and identify barriers in collaboration with Aboriginal Community Controlled Health Organisations. It will establish a framework for implementing culturally safe and acceptable wearable programmes for detecting and managing AF in Indigenous adults ≥55 years and older.

Methods

This mixed-methods research will use the Rambaldini model of collective impact, a user-centred, co-design methodology and yarning circles, a recognised Indigenous research methodology to assess the cultural safety, acceptability, feasibility and efficacy of incorporating wearables into standard care for early AF detection.

Analysis

Qualitative data will be analysed to create composite descriptions of participants' experiences and perspectives related to comfort, cultural safety, convenience, confidence, family reactions and concerns. Quantitative device data will be extracted and analysed via Statistical Product and Service Solutions (SPSS).

Conclusion

Prioritising perspectives of older Indigenous adults on using wearables for detecting and monitoring cardiovascular disease will ensure that the findings are effective, relevant and acceptable to those impacted.

Ethics and dissemination

Findings will be published in open-source peer-reviewed journals, shared at professional conferences, described in lay terms and made available to the public. The AHMRC HREC Reference Number approved 1135/15.

Designing intervention prototypes to improve infant and young child nutrition in Peru: a participatory design study protocol

Por: Rousham · E. · Pareja · R. G. · Creed-Kanashiro · H. M. · Bartolini · R. · Pradeilles · R. · Ortega-Roman · D. · Holdsworth · M. · Griffiths · P. · Verdezoto · N.
Introduction

Nutrition during the complementary feeding period (6–23 months) is critical to ensure optimal growth and reduce the risk of diet-related disease across the life course. Strategies to reduce multiple forms of malnutrition (stunting, overweight/obesity and anaemia) in infants and young children (IYC) are a key priority in low-income and middle-income countries, including Peru. This study aims to co-design and develop prototypes for interventions to address the multiple forms of malnutrition in IYC in urban Peru, using a participatory design approach.

Methods and analysis

The study will be based within peri-urban communities in two areas of Peru (Lima and Huánuco city). Following the identification of key nutritional challenges for IYC aged 6–23 months through formative research (phase I), we will conduct a series of workshops bringing together healthcare professionals from government health centres and caregivers of IYC aged 6–23 months. Workshops (on idea generation; creating future scenarios; storyboarding and early implementation and feedback) will take place in parallel in the two study areas. Through these workshops, we will engage with community participants to explore, experiment, co-design and iteratively validate new design ideas to address the challenges around IYC complementary feeding from phase I. Workshop outputs and transcripts will be analysed qualitatively using affinity diagramming and thematic analyses. The intervention prototypes will be evaluated qualitatively and piloted with the participating communities.

Ethics and dissemination

Ethical approval for this study was obtained from the Ethical Review Committee of the Instituto de Investigación Nutricional (IIN) Peru (388-2019/CIEI-IIN), Loughborough University (C19-87) and confirmed by Cardiff University. Findings of the participatory design process will be disseminated through a deliberative workshop in Lima, Peru with national and regional government stakeholders, as well as participants and researchers involved in the design process. Further dissemination will take place through policy briefs, conferences and academic publications.

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