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INDIGO randomised controlled digital clinical trial: INvestigating DIgital outcomes and quality of life in cancer survivors - a study protocol

Por: Le Calvez · K. · Gregory · J. J. · Gath · J. · Wheatstone · P. · Ashley · L. · Chinembiri · O. · Cunliffe · A. · Davenport · G. · Jamieson Gilmore · K. · Langel · K. · Miglio · C. · Pakzad-Shahabi · L. · Padmasri · D. · Ruta · D. · Williams · H. · Williams · M.
Introduction

There are estimated to be 3.4 million patients in the UK living after a diagnosis of cancer. We know very little about their quality of life or healthcare usage. Patient-reported outcome measures (PROMs) are tools which help to translate a patient’s quality of life into measurable categories, but how to do this at scale remains underexplored. The study employs a randomised design to assess different engagement strategies for optimising participation, data linkage and questionnaire completion in Northwest London and then nationally, with appropriate research approvals.

Methods and analysis

We have designed and implemented an online, patient-completed, randomised observational trial. We will pilot it in Northwest London before national roll-out, using initially the General Practice (GP) record of a cancer diagnosis and then exploring the use of social media. The primary objective is to explore the feasibility of recruiting participants via self-identification or contact from the primary care research network and obtaining consent to link participants’ PROMs responses to their cancer registry records. Data collection occurs through a secure platform, with participants directly responsible for data entry. There is no formal target sample size because this is a feasibility study, and we want to explore how many patients we can recruit. Analyses will be conducted using descriptive statistics, repeated measures multilevel modelling and machine learning techniques. If a substantial difference in responses between randomisation arms is detected, ineffective strategies will be removed. If no clear difference is observed, recruitment will continue with periodic reviews based on response rates and data completeness.

Ethics and dissemination

The Study Coordination Centre has obtained approval from the London—Surrey Research Ethics Committee and Health Research Authority. We will publish and disseminate the results in local, national and international meetings, in peer-reviewed journals, on social media and on websites.

It has been registered under ‘Investigating Digital Outcomes for Cancer Survivors in the Community’ (NCT06095024).

Trial registration number

NCT06095024: Investigating Digital Outcomes for Cancer Survivors in the Community.

Nutritional supplement containing a nuclear fraction of bovine thymus gland increases the circulating levels of spermidine

by Natalia Surzenko, Ashley Dominique, Taleen Hanania, Melville Osborne, Bassem F. El-Khodor

Polyamines (PAs), including spermidine, spermine and their precursor, putrescine, are ubiquitous molecules that are vital for a variety of physiological processes. Recently, PAs gained research attention because of their roles in promoting longevity and preventing age-related diseases. Circulating and tissue levels of PAs appear to decline with age, while higher intake of PAs in humans is correlated with better health during aging. Many foods, including plants and offal (organ meats), are good sources of dietary PAs, but are consumed much less in regions with prevailing Western diets. Elevating the circulating levels of PAs through dietary supplementation with PA-rich plant extracts or foods, on the other hand, has proven to be challenging, most likely due to their low bioavailability. In this study, we evaluated the effectiveness of nutritional supplements derived from bovine glandular tissues and/or plant material in elevating blood and tissue levels of spermidine, spermine and putrescine in adult rats. We detected appreciable amounts of PAs in the following materials: 1) spermidine-rich supplement (SRS), containing wheat germ, 2) a cytosolic fraction extract of bovine thymus gland (Thymus Cytosolic Fraction – TCF) and 3) a nuclear fraction extract of bovine thymus gland (Thymus Nuclear Fraction – TNF). We showed that all three PA-containing supplements also contain liposomes, with TNF displaying the largest amounts of liposomal PAs, as well as RNAs, among the tested supplements. We demonstrated that oral administration of SRS, TCF and TNF induce rapid changes in blood PA concentrations. Finally, we showed that TNF supplement is superior to SRS and TCF in elevating the levels of spermidine in the blood, liver and heart following a 28-day supplementation period. Considering the importance of PAs in prevention of age-related disease, supplementation with TNF could be a plausible approach towards the maintenance of proper cellular PA homeostasis during aging.

The changing role of substances: trends, characteristics of individuals and prior healthcare utilization among individuals with accidental substance-related toxicity deaths in Ontario Canada

by Shaleesa Ledlie, Alice Holton, Pamela Leece, Bisola Hamzat, Joanna Yang, Gillian Kolla, Nikki Bozinoff, Rob Boyd, Mike Franklyn, Ashley Smoke, Paul Newcombe, Tara Gomes

Objective

To investigate trends and the circumstances surrounding fatal substance-related toxicities directly attributed to alcohol, stimulants, benzodiazepines or opioids and combinations of substances in Ontario, Canada.

Methods

We conducted a population-based cross-sectional study of all accidental substance-related toxicity deaths in Ontario, Canada from January 1, 2018 to June 30, 2022. We reported monthly rates of substance-related toxicity deaths and investigated the combination of substances most commonly involved in deaths. Demographic characteristics, location of incident, and prior healthcare encounters for non-fatal toxicities and substance use disorders were examined.

Results

Overall, 10,022 accidental substance-related toxicity deaths occurred, with the annual number of deaths nearly doubling between the first and last 12 months of the study period (N = 1,570–2,702). Opioids were directly involved in the majority of deaths (84.1%; N = 8,431), followed by stimulants (60.9%; N = 6,108), alcohol (13.4%; N = 1,346) and benzodiazepines (7.8%; N = 782). In total, 56.9% (N = 5,698) of deaths involved combinations of substances. Approximately one-fifth of individuals were treated in a hospital setting for a substance-related toxicity in the past year, with the majority being opioid-related (17.4%; N = 1,748). Finally, 60.9% (N = 6,098) of people had a substance use disorder diagnosis at time of death.

Conclusions

Our study shows not only the enormous loss of life from substance-related toxicities but also the growing importance of combinations of substances in these deaths. A large proportion of people had previously interacted within an hospital setting for prior substance-related toxicity events or related to a substance use disorder, representing important missed intervention points in providing appropriate care.

Lymphoedema Development Following a Cancer Diagnosis: An Anonymised Data Linkage Study in Wales, United Kingdom

ABSTRACT

This observational cohort study explored lymphoedema development following a cancer diagnosis and whether demographic factors impacted the time to lymphoedema development. We identified cases through the Secure Anonymised Information Linkage (SAIL) Databank. We used cancer diagnostic codes to identify a cohort of six broad cancer ‘types’. We independently used lymphoedema diagnostic codes to identify a cohort who developed lymphoedema. We linked these two cohorts to develop a single cohort of cases and describe the number of cases who went on to develop lymphoedema after a cancer diagnosis, and the time to lymphoedema diagnosis. We used Cox regression models to calculate hazard ratios and produced survival curves to explore whether pre-defined factors (gender, age, deprivation, cancer type) had any impact on time to lymphoedema development. We identified 7538 cases of lymphoedema development after a cancer diagnosis, relating to 7279 people. There was considerable variation in the time to diagnosis, with a mean and standard deviation of 483.3 (701.8) days. Cancer type was the single most important factor in explaining time to lymphoedema diagnosis. Time to lymphoedema was shortest in breast cancer. A large number of breast cancer cases have undergone surgery, and this may account for the earlier development of lymphoedema. Consideration should be made of risk factors for lymphoedema development in order to allow for more targeted treatment plans that could improve health-related quality of life for patients.

Acceptability and feasibility of acceptance and commitment therapy for improving outcomes in hematopoietic stem cell transplant

by Rhonda M. Merwin, Patrick J. Smith, J.A. Riley, Jordan Infield, Christine O’Connell, Dorothy Mayo, Ashley A. Moskovich, Lauren Hill, Hilary Winthrop, Amy Bush, Ernaya Johnson, Francesca Scheiber, Anthony D. Sung

Introduction: Allogeneic hematopoietic stem cell transplant (HCT) has the potential to cure patients with hematologic malignancies, but treatment-related morbidity and mortality is high. Transplant outcomes are optimized by patients maintaining physical activity. The aim of the current study was to examine whether a brief Acceptance and Commitment Therapy (ACT) intervention is acceptable to HCT patients and caregivers and helps patients engage in healthy behavior despite physical and emotional discomfort. Methods: Patients ≥ 18 years of age who were undergoing allogenic HCT for any cancer or non-cancer illness and their caregivers were invited to complete six ACT sessions between transplant day − 30 and day + 90. Multiple small cohorts of n = 3 dyads were enrolled, and the protocol content was iterated after each cohort to reflect the experiences and breadth of concerns of individuals undergoing HCT. Acceptability was indexed by session completion rates and acceptability surveys. Pre-post 6-minute walk distance was collected as an index of physical function as part of standard care. Results: Sixteen HCT dyads enrolled in the study; 12 continued to treatment. Most participants completed all assigned sessions. Participants perceived ACT to be helpful and 70% (5 of 7) of the patients with pre-post 6-minute walk test data showed improvement. Conclusion: ACT is an acceptable and potentially useful intervention for individuals undergoing HCT. Additional controlled studies are warranted.

Contemporary Factors Influencing Professional Identity in Acute Care Nurses: An Integrative Review

ABSTRACT

Aim

To explore the current state of the science on influencing factors of acute care nursing professional identity.

Design

Integrative review.

Methods

Data were collected and screened using Covidence systematic review software, adhering to pre-defined inclusion criteria. The Critical Appraisal Skills Programme checklist was used for critical appraisal, and content analysis was applied to analyse the data.

Data Sources

CINAHL, PsycINFO and PubMed were utilised to search literature published between 2018 and 2023.

Results

A total of 18 articles were included. Five themes were identified: (1) internal influences; (2) external influences; (3) externalisation of role; (4) early versus seasoned career experiences and (5) barriers to professional identity formation.

Conclusion

This review found evidence of multiple influencing factors, predominantly external, shaping acute care nurse professional identity. Research on the long-term impacts on practice, management, policy and education remains limited.

Implications

Enablers to forming professional identity foster empowerment, confidence, belonging and job satisfaction. Barriers to formation lead to hesitation, performance impediments, stress and exhaustion. Development of nurse professional identity may be instrumental in tackling acute care workforce challenges.

Impact

Review findings on professional identity formation can guide initiatives for enhancing healthy work environments and workforce retention. This exploration has international contemporary relevance for the nursing profession with suggestions for future research.

Impact Statement

Existing literature underscores the significance of professional identity in nursing, yet the mechanisms underlying its integration and maintenance in the contemporary acute care workforce remain unclear. In the context of overwhelming workloads that adversely affect nurse mental health and retention, coupled with the escalating nursing shortage as we emerge from the pandemic, this examination of professional identity formation holds contemporary relevance for the evolving acute care landscape, offering implications for future research. The insights gleaned from this review may guide organisational leaders in developing new strategies addressing acute care nurse management, policy, education and retention.

Reporting Method

Reporting adheres to the EQUATOR network, ENTREQ guidelines.

Patient or Public Contribution

None.

Exploring Post‐Fall Management Interventions in Long‐Term Care Facilities and Hospitals for Older Adults: A Scoping Review

ABSTRACT

Background

The population is rapidly growing, significantly impacting healthcare settings such as hospitals and long-term care. Falls are a major concern, being a leading cause of hospitalisations and injuries especially among adults aged 60 and above. Despite extensive research on falls prevention and risk factors, there is limited study on effective post-fall management strategies, making it crucial to review and develop interventions to improve care and safety for older adults in healthcare settings.

Aim

To explore the interventions implemented for post-fall management for residents and patients within healthcare settings, including hospitals and long-term care facilities.

Design

A scoping literature review.

Methods

We used the Joanna Briggs Institute guidance and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for scoping reviews (PRISMA-ScR). Eligible articles included hospital and long-term care post-fall management interventions. Data were manually extracted by two independent reviewers using the AACTT (Actor, Action, Context, Target and Time) Framework to detail intervention characteristics and guide the data charting process, allowing for thematic analysis and narrative synthesis of key findings.

Data Sources

Medline, CINAHL, PsychINFO and Scopus were searched from inception until 30th September 2024.

Results

Eighteen articles were included. Over half the studies (55.5%) focused on post-fall interventions in LTCFs, testing assessment tools (50%), structured protocols (27.7%), huddles (11.1%) or multifactorial approaches (11.1%), with varied effectiveness. While assessment tools and huddles showed mixed results, structured protocols showed encouraging results with reduced unnecessary hospital transfers and hospitalisations.

Conclusion

This scoping review identified a variety of interventions used after falls in healthcare settings. However, there is inconclusive evidence about the effectiveness of interventions to reduce hospitalisation and injuries. This review identified areas for research that may help to inform post-fall management, including the need for further research into various interventions (e.g., standardised toolkit) to enhance care immediately following a fall.

Patient or Public Contribution

No Patient or Public Contribution.

Implementation of an external female urinary catheter strategy on prevention of skin breakdown in acute care: A quality improvement study

Abstract

Aim(s)

To evaluate the incidence of skin-related complications attributable to incontinence-associated dermatitis (IAD) using an external female urinary catheter device strategy for urinary incontinent (UI) patients in acute care.

Design

Multicenter quality improvement study.

Methods

Randomized allocation of two commercially available external female urinary catheter devices was used in hospitalized UI female patients. Daily nursing skin assessments were documented in the electronic health record before, during and after external catheter device application. Methods and results were reported following SQUIRE guidelines.

Results

Three hundred and eighty-one patients from 57 inpatient care units were included in the analysis. Both catheter devices were associated with an overall low risk (5 %) of new or worsening skin breakdown.

Conclusion

The overall benefit of external catheters is most persuasive for skin integrity, rather than infection prevention.

Impact

Significant negative outcomes are associated with UI patients. External female urinary catheters are a non-invasive alternative strategy to reduce exposure of regional skin to urine contamination and IAD-related skin complications. Use of external female urinary catheters in hospitalized UI female patients offers low risk (5%) of new or worsening overall skin breakdown.

Patient Contribution

Hospitalized UI female patients were screened for external catheter device eligibility by the bedside nurse. The quality improvement review committee waved consent because the intervention was considered standard care.

Association between nurses’ personal, professional and work characteristics, and engagement in hospital‐based clinical research

Abstract

Purpose

The purpose of this study was to assess the associations between demographic, professional and other personal nurse characteristics, social support factors and comfort in conducting research with nurses' level of active participation in clinical research.

Design

A prospective, cross-sectional, correlational design was used.

Methods

Clinical nurses working in a multihospital healthcare system were recruited by email to complete an anonymous survey that used multiple valid and reliable scales to assess demographic and professional work characteristics, curiosity, grit, locus of control, perceived social support (for research activities), comfort in conducting research, and level of being research-active. Univariate and multivariable analyses were completed.

Results

Of 310 participants, 274 (88.4%) were female and mean (SD) age was 42.9 (13.1) years. After condensing 11 levels of research activity to four categories, 179 (57.7%) were not research-active, and 91 (29.4%), 26 (8.3%) and 14 (4.5%) were engaged at low, moderate, and high levels, respectively. Of 78 factors, 69 (88.5%) were associated with being research-active in univariate analyses. In multivariable analysis that adjusted for age, personal experience as a patient, years as a nurse and hours in direct patient care, professionalism characteristics, higher curiosity, internal locus of control, grit perseverance, support of a nurse scientist and nurse friends, and comfort in conducting research remained associated with higher levels of being research-active (all p < 0.01).

Conclusion

Research-active nurses were more likely to be engaged professionally in hospital-based activities beyond their work roles and displayed higher levels of positive psychological characteristics and mentorship that supported research capacity.

Clinical Relevance

Research-active nurses were more likely to have internal factors and external resources that promoted higher levels of being research-active. A strong professional governance model may enhance clinical nurses research activities.

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