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Hepatopancreaticobiliary Resection Arginine Immunomodulation (PRIMe) trial: protocol for a randomised phase II trial of the impact of perioperative immunomodulation on immune function following resection for hepatopancreaticobiliary malignancy

Por: Behman · R. · Auer · R. C. · Bubis · L. · Xu · G. · Coburn · N. G. · Martel · G. · Hallet · J. · Balaa · F. · Law · C. · Bertens · K. A. · Abou Khalil · J. · Karanicolas · P. J.
Introduction

Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found to potentially improve short-term and cancer outcomes. This study seeks to measure the impact of perioperative immunomodulation on biomarkers of the immune response and perioperative outcomes following hepatopancreaticobiliary surgery.

Methods and analysis

This is a 1:1:1 randomised, controlled and blinded superiority trial of 45 patients. Baseline and perioperative variables were collected to evaluate immune function, clinical outcomes and feasibility outcomes. The primary outcome is a reduction in natural killer cell killing as measured on postoperative day 1 compared with baseline between the control and experimental cohorts.

Ethics and dissemination

This trial has been approved by the research ethics boards at participating sites and Health Canada (parent control number: 223646). Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov (identifier: NCT04549662). Any modifications to the protocol will be communicated via publications and ClinicalTrials.gov.

Trial registration number

ClinicalTrials.gov identifier: NCT04549662.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S.
Introduction

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

Methods and analysis

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

Ethics and dissemination

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

Trial registration number

ACTRN12622000584730.

Perinatal healthcare for women at risk of childrens social care involvement: a qualitative survey of professionals in England

Por: Grant · C. · Bicknell-Morel · T. · Lever Taylor · B. · Powell · C. · Blackburn · R. M. · Lacey · R. · Woodman · J.
Background

Women with complex health needs are more at risk of having children’s social care involvement with their newborns than other mothers. Around the time of pregnancy, there are opportunities for health services to support women with these needs and mitigate the risk of mother–baby separation. Yet little is known about healthcare professionals’ experiences of providing this support.

Methods

We administered an online survey to perinatal healthcare professionals across England (n=70 responders), including midwives, obstetricians, perinatal psychologists/psychiatrists and health visitors. We asked about their experiences of providing care for pregnant women with chronic physical conditions, mental health needs, intellectual/developmental disabilities and substance use disorders, who might be at risk of children’s social care involvement. We conducted a framework analysis.

Results

We constructed five themes from participant data. These include (1) inaccessible healthcare for women with complex needs, (2) the challenges and importance of restoring trust, (3) services focusing on individuals, not families, (4) the necessity and caution around multidisciplinary support and (5) underfunded services inhibiting good practice.

Conclusions

Women who are at risk of children’s social care involvement will likely experience perinatal healthcare inequities. Our findings suggest that current perinatal healthcare provision for this population is inadequate and national guidelines need updated to inform support.

Protective and risk factors of mental health of working age adults with adventitious total bilateral blindness and low vision: A scoping review protocol

by Nneoma Dike, Lucia D’Ambruoso, Heather May Morgan, Zoë Skea, Emma-Louise Tarburn

Vision loss has been associated with mental health problems such as depression, anxiety, and post-traumatic stress disorder, which significantly impact lives of working age adults with adventitious total bilateral blindness and low vision. It is imperative, therefore, to prioritize the mental health in this population by exploring and understanding the factors that impact on their mental health. Hence, the objective of this scoping review is to identify and chart existing literature on the protective and risk factors of mental health of working age adults with adventitious total bilateral blindness and low vision. We developed this scoping review protocol in line with the Joanna Briggs Institute guidance. This scoping review will include publications in English language with no date restrictions exploring the protective and risk factors of mental health of our study population. A three-step search strategy will be employed. Searches will be carried out in the following databases: Medline, Embase, PsycInfo, PsycArticles, CINAHL and Web of Science. Search for grey literature will be conducted in Google, Google Scholar and Websites dedicated to information on visual impairment. Collated results will be imported into Endnote Basic (Clarivate) for deduplication. Two reviewers will independently conduct double screening of all the titles and abstracts in Rayyan- a web application, and full texts in Endnote while three other reviewers will conduct screening of a subset of for example 10% of titles and abstracts and full texts. Furthermore, two reviewers will independently conduct double data extraction while three other reviewers will revise, cross check, and correct any extraction errors. Extracted data will be presented in tabular formats and summarized descriptively in line with the research objectives. This scoping review will generate evidence on factors impacting the mental health of the working age adults with adventitious total bilateral blindness and low vision as well as critically highlight gaps in the literature. The findings will inform and critically underpin future empirical research which will explore the lived experiences of working age people with adventitious total bilateral blindness. Additionally, evidence from this review will inform the development of interventions in the promotion of mental health as well as assisting rehabilitation specialists and workers, public health practitioners and other relevant stakeholders in addressing the mental health needs of working age adults with adventitious total bilateral blindness and low vision.

Longitudinal symptom profile of palliative care patients receiving a nurse-led end-of-life (PEACH) programme to support preference to die at home

Por: Agar · M. · Xuan · W. · Lee · J. · Barclay · G. · Oloffs · A. · Jobburn · K. · Harlum · J. · Maurya · N. · Chow · J. S. F.
Objectives

Tailored models of home-based palliative care aimed to support death at home, should also ensure optimal symptom control. This study aimed to explore symptom occurrence and distress over time in Palliative Extended And Care at Home (PEACH) model of care recipients.

Design

This was a prospective cohort study.

Setting and participants

Participants were consecutive recipients of the PEACH rapid response nurse-led model of care in metropolitan Sydney (December 2013–January 2017) who were in the last weeks of life with a terminal or deteriorating phase of illness and had a preference to be cared or die at home.

Outcome measures

Deidentified data including sociodemographic and clinical characteristics, and symptom distress scores (Symptom Assessment Score) were collected at each clinical visit. Descriptive statistics and forward selection logistic regression analysis were used to explore influence of symptom distress levels on mode of separation ((1) died at home while still receiving a PEACH package, (2) admitted to a hospital or an inpatient palliative care unit or (3) discharged from the package (alive and no longer requiring PEACH)) across four symptom distress level categories.

Results

1754 consecutive clients received a PEACH package (mean age 70 years, 55% male). 75.7% (n=1327) had a home death, 13.5% (n=237) were admitted and 10.8% (n=190) were still alive and residing at home when the package ceased. Mean symptom distress scores improved from baseline to final scores in the three groups (p

Conclusion

Tailored home-based palliative care models to meet preference to die at home, achieve this while maintaining symptom control. A focus on particular symptoms may further optimise these models of care.

Validation of oxygen saturations measured in the community by emergency medical services as a marker of clinical deterioration in patients with confirmed COVID-19: a retrospective cohort study

Por: Inada-Kim · M. · Chmiel · F. P. · Boniface · M. · Burns · D. · Pocock · H. · Black · J. · Deakin · C.
Objectives

To evaluate oxygen saturation and vital signs measured in the community by emergency medical services (EMS) as clinical markers of COVID-19-positive patient deterioration.

Design

A retrospective data analysis.

Setting

Patients were conveyed by EMS to two hospitals in Hampshire, UK, between 1 March 2020 and 31 July 2020.

Participants

A total of 1080 patients aged ≥18 years with a COVID-19 diagnosis were conveyed by EMS to the hospital.

Primary and secondary outcome measures

The primary study outcome was admission to the intensive care unit (ICU) within 30 days of conveyance, with a secondary outcome representing mortality within 30 days of conveyance. Receiver operating characteristic (ROC) analysis was performed to evaluate, in a retrospective fashion, the efficacy of different variables in predicting patient outcomes.

Results

Vital signs measured by EMS staff at the first point of contact in the community correlated with patient 30-day ICU admission and mortality. Oxygen saturation was comparably predictive of 30-day ICU admission (area under ROC (AUROC) 0.753; 95% CI 0.668 to 0.826) to the National Early Warning Score 2 (AUROC 0.731; 95% CI 0.655 to 0.800), followed by temperature (AUROC 0.720; 95% CI 0.640 to 0.793) and respiration rate (AUROC 0.672; 95% CI 0.586 to 0.756).

Conclusions

Initial oxygen saturation measurements (on air) for confirmed COVID-19 patients conveyed by EMS correlated with short-term patient outcomes, demonstrating an AUROC of 0.753 (95% CI 0.668 to 0.826) in predicting 30-day ICU admission. We found that the threshold of 93% oxygen saturation is prognostic of adverse events and of value for clinician decision-making with sensitivity (74.2% CI 0.642 to 0.840) and specificity (70.6% CI 0.678 to 0.734).

Faith-based organisations and their role in supporting vaccine confidence and uptake: a scoping review protocol

Por: Song · M. Y. · Blake-Hepburn · D. · Fadel · S. · Allin · S. · Ataullahjan · A. · Di Ruggiero · E.
Introduction

Faith-based organisations (FBOs) and religious actors increase vaccine confidence and uptake among ethnoracially minoritised communities in low-income and middle-income countries. During the COVID-19 pandemic and the subsequent vaccine rollout, global organisations such as the WHO and UNICEF called for faith-based collaborations with public health agencies (PHAs). As PHA-FBO partnerships emerge to support vaccine uptake, the scoping review aims to: (1) outline intervention typologies and implementation frameworks guiding interventions; (2) describe the roles of PHAs and FBOs in the design, implementation and evaluation of strategies and (3) synthesise outcomes and evaluations of PHA-FBO vaccine uptake initiatives for ethnoracially minoritised communities.

Methods and analysis

We will perform six library database searches in PROQUEST-Public Health, OVID MEDLINE, Cochrane Library, CINAHL, SCOPUS- all, PROQUEST - Policy File index; three theses repositories, four website searches, five niche journals and 11 document repositories for public health. These databases will be searched for literature that describe partnerships for vaccine confidence and uptake for ethnoracially minoritised populations, involving at least one PHA and one FBO, published in English from January 2011 to October 2023. Two reviewers will pilot-test 20 articles to refine and finalise the inclusion/exclusion criteria and data extraction template. Four reviewers will independently screen and extract the included full-text articles. An implementation science process framework outlining the design, implementation and evaluation of the interventions will be used to capture the array of partnerships and effectiveness of PHA-FBO vaccine uptake initiatives.

Ethics and dissemination

This multiphase Canadian Institutes of Health Research (CIHR) project received ethics approval from the University of Toronto. Findings will be translated into a series of written materials for dissemination to CIHR, and collaborating knowledge users (ie, regional and provincial PHAs), and panel presentations at conferences to inform the development of a best-practices framework for increasing vaccine confidence and uptake.

Influence of scanbody design and intraoral scanner on the trueness of complete arch implant digital impressions: An <i>in vitro</i> study

by Priscila Ceolin Meneghetti, Junying Li, Paulo Sérgio Borella, Gustavo Mendonça, Luiz Henrique Burnett Jr

This study aimed to compare the accuracy of full-arch digital implant impressions using seven different scanbodies and four intraoral scanners. A 3D-printed maxillary model with six implants and their respective multi-unit abutments was used for this study. Seven scanbodies (SB1, SB2, SB3, SB4, SB5, SB6, and SB7) and four intraoral scanners (Primescan®, Omnican®, Trios 3®, and Trios 4®) were assessed. Each combination group was scanned ten times and a dental lab scanner (D2000, 3Shape) was used as a reference. All scans were exported as STL files, imported into Convince software (3Shape) for alignment, and later into Blender software, where their 3D positions were analyzed using a Python script. The 3D deviation, angular deviation, and linear distance between implants #3 and #14 were also measured. Accuracy was measured in terms of “trueness” (scanbody 3D deviation between intraoral scan and desktop scan). Kruskal-Wallis followed by the Bonferroni correction was used to analyze the data (⍺ = .05). The study found statistically significant differences in digital impression accuracy among the scanners and scanbodies (p

Acceptability of aspirin for cancer preventive therapy: a survey and qualitative study exploring the views of the UK general population

Por: Lloyd · K. E. · Hall · L. H. · Ziegler · L. · Foy · R. · Green · S. M. C. · MacKenzie · M. · Taylor · D. G. · Smith · S. G. · Aspirin for Cancer Prevention AsCaP Steering Committee · Cuzick · Balkwill · Bishop · Burn · Chan · Crooks · Hawkey · Langley · McKenzie · Nedjai · Patrign
Objectives

Aspirin could be offered for colorectal cancer prevention for the UK general population. To ensure the views of the general population are considered in future guidance, we explored public perceptions of aspirin for preventive therapy.

Design

We conducted an online survey to investigate aspirin use, and awareness of aspirin for cancer prevention among the UK general population. We conducted semistructured interviews with a subsample of survey respondents to explore participants’ acceptability towards aspirin for cancer preventive therapy. We analysed the interview data using reflexive thematic analysis and mapped the themes onto the Theoretical Domains Framework, and the Necessity and Concerns Framework.

Setting

Online survey and remote interviews.

Participants

We recruited 400 UK respondents aged 50–70 years through a market research company to the survey. We purposefully sampled, recruited and interviewed 20 survey respondents.

Results

In the survey, 19.0% (76/400) of respondents were aware that aspirin can be used to prevent cancer. Among those who had previously taken aspirin, 1.9% (4/216) had taken it for cancer prevention. The interviews generated three themes: (1) perceived necessity of aspirin; (2) concerns about side effects; and (3) preferred information sources. Participants with a personal or family history of cancer were more likely to perceive aspirin as necessary for cancer prevention. Concerns about taking aspirin at higher doses and its side effects, such as gastrointestinal bleeding, were common. Many described wanting guidance and advice on aspirin to be communicated from sources perceived as trustworthy, such as healthcare professionals.

Conclusions

Among the general population, those with a personal or family history of cancer may be more receptive towards taking aspirin for preventive therapy. Future policies and campaigns recommending aspirin may be of particular interest to these groups. Multiple considerations about the benefits and risks of aspirin highlight the need to support informed decisions on the medication.

Cultural, sociopolitical, environmental and built assets supporting health and well-being in Torres Strait Island communities: protocol for a scoping review

Por: Webb · T. · Meldrum · K. · Kilburn · M. · Wallace · V. · Russell · S. · Quigley · R. · Strivens · E.
Introduction

Risks to an individual’s health should be considered alongside the environmental, sociocultural and sociopolitical context(s) in which they live. Environmental mapping is an approach to identifying enablers and barriers to health within a community. The Indigenous Indicator Classification System (IICS) framework has been used to map the environment in Australian Indigenous communities. The IICS is a four-level nested hierarchical framework with subject groups including culture, sociopolitical and built at the top of the hierarchy and indicators at the bottom. The objective of this scoping review is to map the cultural, sociopolitical, environmental and built assets that support health and well-being that exist in each Torres Strait Island community.

Methods and analysis

This review will be conducted according the Joanna Briggs Institute (JBI) method for scoping reviews. It will include sources that identify cultural, sociopolitical, environmental and built assets that support health and well-being that exist in each Torres Strait Island community. Databases to be searched include: Informit; Scopus; Web of Science; HealthInfoNet, BioOne Complete and Green File. Sources of unpublished and grey literature will be located using Google and Google Scholar. Searches will be limited to the English language and literature published since January 2018 to ensure that the assets mapped reflect current conditions on each island. Data that answers the research question will be extracted from sources and recorded in an adaptation of the IICS. Quantitative analysis of the data will include summing each asset for individual islands and their associated clusters. Data will be presented graphically, diagrammatically, or in tabular form depending on what approach best conveys its meaning.

Ethics and dissemination

The Far North Queensland Human Research Ethics Committee (reference HREC/2022/QCH/88 155-1624) has approved this study. Dissemination of the review’s findings will be led by Torres Strait Islander members of the research team through conferences and peer-reviewed publications.

Comparing estimates of psychological distress using 7-day and 30-day recall periods: Does it make a difference?

by Miranda R. Chilver, Richard A. Burns, Ferdi Botha, Peter Butterworth

Self-report measures are widely used in mental health research and may use different recall periods depending on the purpose of the assessment. A range of studies aiming to monitor changes in mental health over the course of the COVID-19 pandemic opted to shorten recall periods to increase sensitivity to change over time compared to standard, longer recall periods. However, many of these studies lack pre-pandemic data using the same recall period and may rely on pre-existing data using standard recall periods as a reference point for assessing the impact of the pandemic on mental health. The aim of this study was to assess whether comparing scores on the same questionnaire with a different recall period is valid. A nationally representative sample of 327 participants in Australia completed a 7-day and 30-day version of the six-item Kessler Psychological Distress Scale (K6) and a single-item measure of psychological distress (TTPN item) developed for the Taking the Pulse of the Nation survey. Linear mixed models and mixed logistic regression models were used to assess whether altering the recall period systematically changed response patterns within subjects. No substantive recall period effects were found for the K6 or the TTPN, although there was a trend towards higher K6 scores when asked about the past 30 days compared to the past 7 days (b = 1.00, 95% CI: -0.18, 2.17). This may have been driven by the “feeling nervous” item which was rated higher using the 30-day compared to the 7-day recall period. Neither the K6 nor the TTPN item were significantly affected by the recall period when reduced to a binary variable of likely severe mental illness. The results indicate that altering the recall period of psychological distress measures does not substantively alter the score distribution in the general population of Australian adults.

Understanding the needs and preferences for cancer care among First Nations people: An integrative review

Abstract

Aim

This systematic review aimed to identify the needs and preferences for cancer care services among Australian First Nations people.

Design

Integrative review.

Data Sources

An integrative review was conducted. A wide range of search terms were used to increase the sensitivity and specificity of the searches in electronic databases. Methodological quality assessment, data extraction, was conducted independently by two reviewers, and a narrative synthesis was conducted.

Results

Forty-two studies were included. A total of 2965 Australian First Nations adults, both men and women of various ages across the lifespan, were represented; no First Nations children affected by cancer were represented in the studies. Three themes emerged which included: (1) discrimination, racism and trauma, resulting from colonization, directly impacted First National people's cancer care experience; (2) cultural ways of knowing, being and doing are fundamental to how First Nations people engage with cancer care services; and (3) First Nations people need culturally safe person-centred cancer care services that address practical needs.

Conclusion

Most participants represented in this review experienced discrimination, racism and trauma, resulting from colonization, which directly negatively impacted Aboriginal peoples' cancer care experience. While the Optimal Cancer Pathway (OCP) was launched in Australia several years ago, people with cancer may continue to experience distressing unmet care needs.

Patient or Public Contribution

Our team includes both First Nations people, non-First Nations researchers and healthcare professionals with expertise in cancer care. The researchers employed decolonizing restorative approaches to ensure voice, respect, accountability and reciprocity in this review work.

Implications for Nursing Practice

Members of the multidisciplinary team including nurses and policymakers should reflect on these findings, ensure that they have up-to-date cultural safety training and stand together with Indigenous and non-Indigenous cancer leaders to take proactive steps to stamp out and dismantle oppression in health, and safely implement the OCP.

Evaluation of variation in special educational needs provision and its impact on health and education using administrative records for England: umbrella protocol for a mixed-methods research programme

Por: Zylbersztejn · A. · Lewis · K. · Nguyen · V. · Matthews · J. · Winterburn · I. · Karwatowska · L. · Barnes · S. · Lilliman · M. · Saxton · J. · Stone · A. · Boddy · K. · Downs · J. · Logan · S. · Rahi · J. · Black-Hawkins · K. · Dearden · L. · Ford · T. · Harron · K. · De Stavola · B. · Gilb
Introduction

One-third of children in England have special educational needs (SEN) provision recorded during their school career. The proportion of children with SEN provision varies between schools and demographic groups, which may reflect variation in need, inequitable provision and/or systemic factors. There is scant evidence on whether SEN provision improves health and education outcomes.

Methods

The Health Outcomes of young People in Education (HOPE) research programme uses administrative data from the Education and Child Health Insights from Linked Data—ECHILD—which contains data from all state schools, and contacts with National Health Service hospitals in England, to explore variation in SEN provision and its impact on health and education outcomes. This umbrella protocol sets out analyses across four work packages (WP). WP1 defined a range of ‘health phenotypes’, that is health conditions expected to need SEN provision in primary school. Next, we describe health and education outcomes (WP1) and individual, school-level and area-level factors affecting variation in SEN provision across different phenotypes (WP2). WP3 assesses the impact of SEN provision on health and education outcomes for specific health phenotypes using a range of causal inference methods to account for confounding factors and possible selection bias. In WP4 we review local policies and synthesise findings from surveys, interviews and focus groups of service users and providers to understand factors associated with variation in and experiences of identification, assessment and provision for SEN. Triangulation of findings on outcomes, variation and impact of SEN provision for different health phenotypes in ECHILD, with experiences of SEN provision will inform interpretation of findings for policy, practice and families and methods for future evaluation.

Ethics and dissemination

Research ethics committees have approved the use of the ECHILD database and, separately, the survey, interviews and focus groups of young people, parents and service providers. These stakeholders will contribute to the design, interpretation and communication of findings.

The development of Midwifery Unit Standards for Europe

The WHO Global Strategy for Women's, Children's and Adolescents’ Health 2016-2030 emphasises the importance of maternity services in preventing illness and promoting optimal clinical outcomes (Every Woman Every Child, 2015). Midwifery has been recognised as having huge potential for transformation; worldwide, over 50 health outcomes could be improved by expanding provision and access to quality midwifery care (Renfrew, et al., 2014). Midwifery care is also associated with efficient use of resources (Renfrew, et al., 2014).
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