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Effects of Eurycoma longifolia Jack standardised water extract (Physta) on well-being of perimenopausal and postmenopausal women: protocol for a randomised, double-blinded, placebo-controlled, parallel group study

Por: Muniandy · S. · Yahya · H. M. · Shahar · S. · Kamisan Atan · I. · Mahdy · Z. A. · Rajab · N. F. · George · A. · Chinnappan · S. M.
Introduction

Eurycoma longifolia Jack (EL), profoundly recognised as ‘Tongkat Ali’, is a medicinal herb originating from Southeast Asia. It is commonly used in traditional ‘antiageing’ treatments to address decreased energy, mood, libido and hormonal imbalances. While the benefits of EL have been extensively studied among the male population, less attention has been given to its effects on women. Menopause can impact the overall well-being of middle-aged women and incorporation of herbal supplements can aid them in managing the menopausal symptoms.

Methods and analysis

This 12-week randomised double-blind, placebo-controlled, parallel-group study aims to evaluate the efficacy of the standardised water extract of EL known as Physta in increasing the quality of life of perimenopausal and postmenopausal women. The study involves 150 women aged 40–55 years who score more than 61 on the Menopause-Specific Quality of Life (MENQOL) assessment. These participants will be randomised into three groups, receiving Physta at either 50 mg or 100 mg or a placebo. The outcomes measures include mood state, quality of life, fatigue, sleep quality, sexual function and pain score assessed using Profile of Mood State, MENQOL, Chalder Fatigue Scale, Pittsburgh Sleep Quality Index, Female Sexual Function Index and the Brief Pain Inventory questionnaires, respectively. The secondary outcome of the study includes full blood analysis, urine analysis, female reproductive hormone profiling, inflammatory and oxidative stress biomarkers analysis.

Ethics and dissemination

The research protocol of the study was reviewed and approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM/PPI/111/8/JEP-2021-898). The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.

Trial registration number

ACTRN12622001341718.

What is the association between adverse childhood experiences and late-life cognitive decline? Study of Healthy Aging in African Americans (STAR) cohort study

Por: Lor · Y. · George · K. M. · Gilsanz · P. · Meunier · C. C. · Peterson · R. L. · Hayes-Larson · E. · Barnes · L. L. · Mungas · D. · Whitmer · R. A.
Objectives

Adverse childhood experiences (ACEs) are associated with higher risk of chronic disease, but little is known about the association with late life cognitive decline. We examined the longitudinal association between ACEs and late-life cognitive decline in the Study of Healthy Aging in African Americans (STAR).

Design

Linear mixed models with random intercepts and slope examined the association of individual and composite ACEs with cognitive change adjusting for years from baseline (timescale), baseline age, sex, parental education, childhood socioeconomic status and childhood social support. Participants reported whether they had experienced nine types of ACEs. Executive function and verbal episodic memory were measured up to three times over a 3-year period using the Spanish and English Neuropsychological Assessment Scales.

Settings

Kaiser Permanente Northern California members living in the Bay Area.

Participants

STAR is a cohort study of cognitive ageing launched in 2018 that has enrolled 764 black Americans ages ≥50 years (mean age=67.5; SD=8.5).

Results

Twenty-one per cent of participants reported no ACEs, 24% one ACE, 20% two ACEs, 17% three ACEs and 17% four or more ACEs. Compared with no ACEs, two ACEs (β=0.117; 95% CI 0.052 to 0.182), three ACEs (β=0.075; 95% CI 0.007 to 0.143) and four or more ACEs (β=0.089; 95% CI 0.002 to 0.158) were associated with less decline in executive function. There were no significant associations between number of ACEs and baseline or longitudinal verbal episodic memory or between individual ACEs and executive function or verbal episodic memory.

Conclusion

In this cohort of older black Americans, there was no association between ACEs and baseline cognition or cognitive change in verbal episodic memory; however, experiencing ≥ 2 ACEs was associated with less decline in executive function. These results may indicate that participants who survived to age 50+ and experienced ACEs may have cognitive resilience that warrants further investigation.

Impact of health system governance on healthcare quality in low-income and middle-income countries: a scoping review

Por: George · J. · Jack · S. · Gauld · R. · Colbourn · T. · Stokes · T.
Introduction

Improving healthcare quality in low-/middle-income countries (LMICs) is a critical step in the pathway to Universal Health Coverage and health-related sustainable development goals. This study aimed to map the available evidence on the impacts of health system governance interventions on the quality of healthcare services in LMICs.

Methods

We conducted a scoping review of the literature. The search strategy used a combination of keywords and phrases relevant to health system governance, quality of healthcare and LMICs. Studies published in English until August 2023, with no start date limitation, were searched on PubMed, Cochrane Library, CINAHL, Web of Science, Scopus, Google Scholar and ProQuest. Additional publications were identified by snowballing. The effects reported by the studies on processes of care and quality impacts were reviewed.

Results

The findings from 201 primary studies were grouped under (1) leadership, (2) system design, (3) accountability and transparency, (4) financing, (5) private sector partnerships, (6) information and monitoring; (7) participation and engagement and (8) regulation.

Conclusions

We identified a stronger evidence base linking improved quality of care with health financing, private sector partnerships and community participation and engagement strategies. The evidence related to leadership, system design, information and monitoring, and accountability and transparency is limited.

Planning for healthcare services during the COVID-19 pandemic in the Southeast of England: a system dynamics modelling approach

Por: George · A. · Lacey · P. · Badrinath · P. · Gray · A. · Turner · P. · Harwood · C. · Gregson · M.
Objectives

To develop, test, validate and implement a system dynamics model to simulate the pandemic progress and the impact of various interventions on viral spread, healthcare utilisation and demand in secondary care.

Design

We adopted the system dynamics model incorporating susceptible, exposed, infection and recovery framework to simulate the progress of the pandemic and how the interventions for the COVID-19 response influence the outcomes with a focus on secondary care.

Setting

This study was carried out covering all the local health systems in Southeast of England with a catchment population of six million with a specific focus on Kent and Medway system.

Participants

Six local health systems in Southeast of England using Kent and Medway as a case study.

Interventions

Short to medium ‘what if’ scenarios incorporating human behaviour, non-pharmaceutical interventions and medical interventions were tested using the model with regular and continuous feedback of the model results to the local health system leaders for monitoring, planning and rapid response as needed.

Main outcome measures

Daily output from the model which included number infected in the population, hospital admissions needing COVID-19 care, occupied general beds, continuous positive airway pressure beds, intensive care beds, hospital discharge pathways and deaths.

Results

We successfully implemented a regional series of models based on the local population needs which were used in healthcare planning as part of the pandemic response.

Conclusions

In this study, we have demonstrated the utility of system dynamics modelling incorporating local intelligence and collaborative working during the pandemic to respond rapidly and take decisions to protect the population. This led to strengthened cooperation among partners and ensured that the local population healthcare needs were met.

Thirty-day hospital readmission predictors in older patients receiving hospital-at-home: a 3-year retrospective study in France

Por: de Stampa · M. · Georges · A. · Grino · M. · Cerase · V. · Baudouin · E. · Vedel · I.
Objective

This study described older patients receiving hospitalisation-at-home (HaH) services and identified factors associated with 30-day hospital readmission.

Design

3-year retrospective study in 2017–2019 in France.

Participants

75 108 patients aged 75 years and older who were discharged from hospital medical wards (internal medicine and geriatric units) and admitted to HaH.

Primary outcome measure

30-day hospital readmission.

Results

The mean age of patients was 83.4 years (SD 5.7), 52.3% were male and 88.4% lived in a private household. Patients were primarily discharged from the internal medicine unit (85.3%). The top four areas of care in the HaH were palliative care, complex dressing, intravenous therapy and complex nursing care. Overall, 23.5% of patients died during their HaH stay and 27.8% were readmitted to the hospital at 30 days. In the multivariate model, male (OR 1.19, 95% CI 1.16 to 1.23), supportive cancer HaH care (OR 1.78, 95% CI 1.51 to 2.11) and very high intensity care during the previous in-person hospitalisation (OR 1.45, 95% CI 1.34 to 1.57) increased the risk of hospital readmission at 30 days. Older age (OR 0.97, 95% CI 0.97 to 0.98), living in a nursing home (OR 0.51, 95% CI 0.48 to 0.54), postsurgery HaH care (OR 0.49, 95% CI 0.41 to 0.58) and having been previously hospitalised in a geriatric unit (OR 0.81, 95% CI 0.77 to 0.85) decreased the risk of hospital readmission at 30 days.

Conclusions

HaH provides complex care to very old patients, which is associated with high mortality. Several factors are associated with rehospitalisation within 30 days that could be avoided with better integration of different services with higher geriatric skills.

Trial registration number

CNIL:2228861.

Crawling toward obsolescence: The extended lifespan of amylase for pancreatitis

by Naga Sasidhar Kanaparthy, Andrew J. Loza, Ronald George Hauser

The correlation between hyperamylasemia and acute pancreatitis was discovered in 1929, yet another test, lipase, was shown to provide better diagnostic performance in the late 1980s and early 1990s. Subsequent studies demonstrated co-ordering amylase with lipase did not provide additional benefit, only added cost. We sought to investigate the impact of studies advocating for the obsolescence of amylase on its clinical demand. We reviewed 1.3 million reportable results for amylase over 14 years (2009–2022). The trend in utilization of amylase over this period declined by 66% along a linear trajectory (R2 = 0.97). Despite demand for amylase decreasing by an average of 17,003 tests per year, the last year of the study (2022) recorded over 100,000 results for amylase. By interpolating the decline of amylase until the utilization reached zero, we calculated amylase orders will continue for 6 more years until 2028. Tests for creatinine and lipase changed

Adverse drug events associated with nortriptyline compared with paroxetine and alternative medications in an older adult population: a retrospective cohort study in Southern California

Por: George · M. M. · Deamer · R. L. · Do · D.
Objective

Investigate risk for falls, fractures and syncope in older adult patients treated with nortriptyline compared with paroxetine and alternative medications.

Design

Retrospective cohort study.

Setting

The electronic medical record and prescription drug database of a large integrated healthcare system in Southern California.

Participants

Ambulatory patients, age ≥65 years diagnosed with depression, anxiety disorder or peripheral neuropathy, dispensed one or more of ten study medications between 1 January 2008 and 31 December 2018.

Main outcome measures

HR for falls, fractures and syncope with exposure to study medications adjusted for patient demographic variables and comorbidities.

Results

Among 195 207 subjects, 19 305 falls, 15 088 fractures and 11 313 episodes of syncope were observed during the study period. Compared with the reference medication, nortriptyline, the adjusted HRs (aHRs) for falls were statistically significantly greater for: paroxetine (aHR 1.48, 95% CI 1.39 to 1.57), amitriptyline (1.20, 95% CI 1.08 to 1.33), venlafaxine (1.44, 95% CI 1.34 to 1.56), duloxetine (1.25, 95% CI 1.12 to 1.40), fluoxetine (1.51, 95% CI 1.44 to 1.59), sertraline (1.53, 95% CI 1.44 to 1.62), citalopram (1.61, 95% CI 1.52 to 1.71) and escitalopram (1.37, 95% CI 1.21 to 1.54), but not gabapentin (0.95, 95% CI 0.89 to 1.02). For fractures, compared with nortriptyline, aHRs were significantly greater for: paroxetine, venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, escitalopram and gabapentin, with aHRs ranging from 1.30 for gabapentin to 1.82 for escitalopram; risk was statistically similar for amitriptyline. For syncope, the aHRs were significantly greater for: paroxetine, venlafaxine, fluoxetine, sertraline and citalopram, with aHRs ranging from 1.19 for fluoxetine and paroxetine up to 1.30 for citalopram and sertraline; risk was similar for amitriptyline, duloxetine, escitalopram and gabapentin.

Conclusions

Compared with therapeutic alternatives, nortriptyline was found to represent a lower risk for falls, fractures and syncope, versus comparator medications, except for a few instances that had equivalent risk. The risk for these adverse events from paroxetine was comparable to the alternative medications.

Profiles of vulnerability for suicide and self-harm in UK prisoners: Neurodisability, mood disturbance, substance use, and bullying

by Hope Kent, Bella Magner-Parsons, George Leckie, Tuna Dulgar, Anggita Lusiandari, Lee Hogarth, Huw Williams, Amanda Kirby

Screening for vulnerability factors associated with historic suicidality and self-harm on entry to prison is critical to help prisons understand how to allocate extremely limited mental health resources. It has been established that having previous suicide attempts increases odds of future suicidality and self-harm in prison. We utilised administrative screening data from 665 adult male prisoners on entry to a category B prison in Wales, UK, collected using the Do-IT Profiler. This sample represents 16% of all prisoners who entered that prison during a 26-month period. 12% of prisoners reported a history of attempted suicide, 11% reported historic self-harm, and 8% reported a history of both. Historic traumatic brain injury and substance use problems were associated with a 3.3- and 1.9- times increased odds of a historic suicide attempt, respectively, but no significant increased risk of historic self-harm (95% CI: 1.51–6.60 and 1.02–3.50). However, those who were bullied at school had 2.7 times increased odds of reporting a history of self-harm (95% CI: 1.63–6.09). The most salient risk factors associated with both historic suicide and self-harm were higher levels of functional neurodisability (odds ratio 0.6 for a 1 standard deviation change in score, 95% CI: 0.35–0.75), and mood disturbance (odds ratio 2.1 for a 1 standard deviation change in score, 95% CI: 1.26–3.56). Therefore, it could be beneficial for prisons to screen for broader profiles of needs, to better understand how to provide appropriate services to prisoners vulnerable to suicide and self-harm. Multidisciplinary care pathways for prisoner mental health interventions are important, to account for complex multimorbidity. Adaptations may be needed for mental health interventions to be appropriate for, for example, a prisoner with a brain injury. Understanding this broad profile of vulnerability could also contribute to more compassionate responses to suicide and self-harm from prison staff.

Effects of service dogs on children with ASD’s symptoms and parents’ well-being: On the importance of considering those effects with a more systemic perspective

by Nicolas Dollion, Margot Poirier, Florian Auffret, Nathe François, Pierrich Plusquellec, Marine Grandgeorge, Handi’Chiens , Fondation Mira

The integration of a service dog can have numerous benefits for children with Autism Spectrum Disorder (ASD). However, although integration takes place within a family, little is known about the dynamics of these benefits on the family microsystem. Thus, the aim of our study was to propose a more systemic perspective, not only by investigating the benefits of SD integration, but also by exploring the relationships between improvements in children with ASD, parents’ well-being, parenting strategies and the quality of the child-dog relationship. Twenty parent-child with ASD dyads were followed before, as well as 3 and 6 months after service dog integration. At each stage, parents completed an online survey which included: the Autism Behavior Inventory (ABI-S), the State-Trait Anxiety Inventory (STAI-Y), the Parenting Stress Index Short Version (PSI-SF), the Monash Dog Owner Relationship Scale (MDORS) and the Parenting Styles and Dimensions Questionnaire (PSDQ). First, repeated measure one-way ANOVAs revealed that both children’s ASD symptoms and parents’ anxiety decreased significantly after service dog integration. Additionally, Spearman correlations revealed that the more ASD symptoms decreased, the more parent’s anxiety and parenting stress also decreased. Second, the quality of the child-dog relationship appeared to contribute to those benefits on both children’s ASD symptoms and parents’ well-being. Interestingly, parenting strategies seemed to adapt according to these benefits and to the quality of the child-dog relationship. Through a more systemic perspective, this study highlighted that the integration of a service dog involved reciprocal and dynamic effects for children with ASD and their parents, and shed new light on the processes that may underlie the effects of a service dog for children with ASD.

Challenges with pediatric antiretroviral therapy administration: Qualitative perspectives from caregivers and HIV providers in Kenya

by Michala Sliefert, May Maloba, Catherine Wexler, Frederick Were, Yvonne Mbithi, George Mugendi, Edward Maliski, Zachary Nicolay, Gregory Thomas, Shadrack Kale, Nicodemus Maosa, Sarah Finocchario-Kessler

Background

Current formulations of pediatric antiretroviral therapy (ART) for children with HIV present significant barriers to adherence, leading to drug resistance, ART ineffectiveness, and preventable child morbidity and mortality. Understanding these challenges and how they contribute to suboptimal adherence is an important step in improving outcomes. This qualitative study describes how regimen-related challenges create barriers to adherence and impact families.

Methods

We conducted key informant interviews (KIIs) with 30 healthcare providers and 9 focus group discussions (FGDs) with a total of 72 caregivers, across three public hospitals in Siaya and Mombasa Kenya. The KIIs and FGDs were audio recorded, translated, and transcribed verbatim. The transcripts were hand coded based on emergent and a-priori themes.

Results

Caregivers discussed major regimen-related challenges to adherence included poor palatability of current formulations, complex preparation, and administration (including measuring, crushing, dissolving, mixing), complex drug storage, and frequent refill appointments and how these regimen-related challenges contributed to individual and intrapersonal barriers to adherence. Caregivers discussed how poor taste led to child anxiety, refusal of medications, and the need for caregivers to use bribes or threats during administration. Complex preparation led to concerns and challenges about maintaining privacy and confidentiality, especially during times of travel. Providers corroborated this patient experience and described how these challenges with administration led to poor infant outcomes, including high viral load and preventable morbidity. Providers discussed how the frequency of refills could range from every 2 weeks to every 3 months, depending on the patient. Caregivers discussed how these refill frequencies interrupted work and school schedules, risked unwanted disclosure to peers, required use of financial resources for travel, and ultimately were a challenge to adherence.

Conclusion

These findings highlight the need for improved formulations for pediatric ART to ease the daily burden on caregivers and children to increase adherence, improve child health, and overall quality of life of families.

Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study

Por: Long · E. · Paediatric Research In Emergency Departments International Collaborative (PREDICT) · Borland · M. L. · George · S. · Jani · S. · Tan · E. · Neutze · J. · Phillips · N. · Kochar · A. · Craig · S. · Lithgow · A. · Rao · A. · Dalziel · S. · Oakley · E. · Hearps · S. · Singh
Introduction

Sepsis affects 25.2 million children per year globally and causes 3.4 million deaths, with an annual cost of hospitalisation in the USA of US$7.3 billion. Despite being common, severe and expensive, therapies and outcomes from sepsis have not substantially changed in decades. Variable case definitions, lack of a reference standard for diagnosis and broad spectrum of disease hamper efforts to evaluate therapies that may improve sepsis outcomes. This landscape analysis of community-acquired childhood sepsis in Australia and New Zealand will characterise the burden of disease, including incidence, severity, outcomes and cost. Sepsis diagnostic criteria and risk stratification tools will be prospectively evaluated. Sepsis therapies, quality of care, parental awareness and understanding of sepsis and parent-reported outcome measures will be described. Understanding these aspects of sepsis care is fundamental for the design and conduct of interventional trials to improve childhood sepsis outcomes.

Methods and analysis

This prospective observational study will include children up to 18 years of age presenting to 12 emergency departments with suspected sepsis within the Paediatric Research in Emergency Departments International Collaborative network in Australia and New Zealand. Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, clinician assessment of severity of disease, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length-of-stay, mortality censored at hospital discharge or 30 days from enrolment (whichever comes first) and parent-reported outcomes 90 days from enrolment. We will use these data to determine sepsis epidemiology based on existing and novel diagnostic criteria. We will also validate existing and novel sepsis risk stratification criteria, characterise antimicrobial stewardship, guideline adherence, cost and report parental awareness and understanding of sepsis and parent-reported outcome measures.

Ethics and dissemination

Ethics approval was received from the Royal Children’s Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/69948/RCHM-2021). This included incorporated informed consent for follow-up. The findings will be disseminated in a peer-reviewed journal and at academic conferences.

Trial registration number

ACTRN12621000920897; Pre-results.

Coping profiles and their association with vicarious post‐traumatic growth among nurses during the three waves of the COVID‐19 pandemic

Abstract

Aims

This study aimed to examine (a) changes in coping strategies and vicarious post-traumatic growth (VPTG) across three timepoints of the COVID-19 pandemic among nurses; (b) discrete groups of nurses with unique coping profiles and (c) the association of these coping profiles with VPTG across the timepoints.

Background

Although literature abounds with the negative mental health consequences of the pandemic among healthcare professionals, much less is known about the positive consequences on nurses, the coping strategies that they use, and how these change over time.

Design

This was a cross-sectional web-based survey at three timepoints during the pandemic.

Methods

A sample of 429 nurses completed online the Post-Traumatic Growth Inventory (PTGI) and the Brief Coping Orientation to Problems Experienced Inventory (COPE) to measure vicarious post-traumatic growth (VPTG) and coping strategies, respectively. The STROBE checklist was used to report the present study.

Results

Significantly higher VPTG scores were observed during the third timepoint. Different coping strategies were employed across the three timepoints. Nurses responded to the pandemic either with an active, an avoidant or a passive coping profile. Significantly higher VPTG levels were reported by the nurses of the active profile compared to those of the passive profile, whereas the difference between active and avoidant profiles was not significant.

Conclusions

Notwithstanding the preponderance of the nurses with the active coping profile in achieving high VPTG, the avoidant copers had more gains (VPTG) than the passive copers, suggesting that doing something to cope with the stressor—let it be trying to avoid it—was better than doing nothing.

Relevance to Clinical Practice

The identification of distinct coping profiles among nurses and their association with VPTG is of particular use to policymakers and practitioners in developing tailored prevention and intervention efforts to help the nurses effectively manage the demands of the pandemic.

Patient or Public Contribution

No patient or public contribution since the study was exclusively conducted by the authors.

Interventions in adult patients with multimorbidity in low-income and middle-income countries: protocol for a mixed-methods systematic review

Por: George · T. · Manski-Nankervis · J.-A. · Klaic · M. · Kang · G. · Sudarsanam · T. D.
Introduction

Multimorbidity, the coexistence of two or more chronic conditions in the same individual, is a major public health problem in low-income and middle-income countries (LMICs). The use of single-disease guidelines contributes to polypharmacy, fragmented care and increased treatment burden. Health systems in LMICs are very different from those in high-income countries, and adapting interventions from one to the other may not be feasible. This review aims to systematically present the current evidence for interventions for multimorbidity in the LMIC setting.

Methods and analysis

In this mixed-methods systematic review, we will include all studies of interventions for the care of adults (>18 years of age) with multimorbidity (defined as the presence of two or more chronic illnesses in an individual) in any healthcare organisation (primary, secondary or tertiary care) in an LMIC (as defined by the World Bank), published between 2000 and March 2023. All primary study designs will be included. Studies reported in languages other than English and those describing interventions classified as ‘financial’ or ‘governance arrangement’ according to the Cochrane Effective Practice and Organisation of Care classification will be excluded. MEDLINE, PubMed, Cochrane Library, TRIP, SCOPUS and the 3ie databases will be searched. The titles will be screened by one author, and two authors will independently screen all included abstracts and full texts. A third author will resolve conflicts at every stage. Studies will be reviewed for quality of evidence using appropriate tools. Epidemiological, intervention and outcome data will be extracted and summarised. Outcomes of interest for LMICs defined by the Global Alliance for Chronic Diseases research group will be analysed. Subgroup analysis according to study types and study settings will be done.

Ethics and dissemination

No ethics approval is required for this systematic review. Results will be disseminated through publication in an open-access journal and presentation at conferences.

PROSPERO registration number

CRD42023391897.

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