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Fetal alcohol spectrum disorder and attention deficit hyperactivity disorder stimulant trial in children: an N-of-1 pilot trial to compare stimulant to placebo (FASST): protocol

Por: Crichton · A. · Harris · K. · McGree · J. M. · Nikles · J. · Anderson · P. J. · Williams · K.
Introduction

Fetal alcohol spectrum disorder (FASD) is a neurodevelopmental disorder caused by alcohol exposure during pregnancy. FASD is associated with neurodevelopmental deviations, and 50%–94% of children with FASD meet the Diagnostic and Statistical Manual of Mental Disorders-fifth edition diagnostic criteria for attention deficit hyperactivity disorder (ADHD). There is a paucity of evidence around medication efficacy for ADHD symptoms in children with FASD. This series of N-of-1 trials aims to provide pilot data on the feasibility of conducting N-of-1 trials in children with FASD and ADHD.

Methods and analysis

A pilot N-of-1 randomised trial design with 20 cycles of stimulant and placebo (four cycles of 2-week duration) for each child will be conducted (n=20) in Melbourne, Australia.

Feasibility and tolerability will be assessed using recruitment and retention rates, protocol adherence, adverse events and parent ratings of side effects. Each child’s treatment effect will be determined by analysing teacher ADHD ratings across stimulant and placebo conditions (Wilcoxon rank). N-of-1 data will be aggregated to provide an estimate of the cohort treatment effect as well as individual-level treatment effects. We will assess the sample size and number of cycles required for a future trial. Potential mediating factors will be explored to identify variables that might be associated with treatment response variability.

Ethics and dissemination

The study was approved by the Hospital and Health Service Human Research Ethics Committee (HREC/74678/MonH-2021-269029), Monash (protocol V6, 25 June 2023).

Individual outcome data will be summarised and provided to participating carers and practitioners to enhance care. Group-level findings will be presented at a local workshop to engage stakeholders. Findings will be presented at national and international conferences and published in peer-reviewed journals. All results will be reported so that they can be used to inform prior information for future trials.

Trial registration number

NCT04968522.

Defining predictors of responsiveness to advanced therapies in Crohns disease and ulcerative colitis: protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine

Por: Wyatt · N. J. · Watson · H. · Anderson · C. A. · Kennedy · N. A. · Raine · T. · Ahmad · T. · Allerton · D. · Bardgett · M. · Clark · E. · Clewes · D. · Cotobal Martin · C. · Doona · M. · Doyle · J. A. · Frith · K. · Hancock · H. C. · Hart · A. L. · Hildreth · V. · Irving · P. M. · Iqbal · S
Introduction

Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic developments in the last 20 years have revolutionised treatment. However, clinical trials and real-world data show primary non-response rates up to 40%. A significant challenge is an inability to predict which treatment will benefit individual patients.

Current understanding of IBD pathogenesis implicates complex interactions between host genetics and the gut microbiome. Most cohorts studying the gut microbiota to date have been underpowered, examined single treatments and produced heterogeneous results. Lack of cross-treatment comparisons and well-powered independent replication cohorts hampers the ability to infer real-world utility of predictive signatures.

IBD-RESPONSE will use multi-omic data to create a predictive tool for treatment response. Future patient benefit may include development of biomarker-based treatment stratification or manipulation of intestinal microbial targets. IBD-RESPONSE and downstream studies have the potential to improve quality of life, reduce patient risk and reduce expenditure on ineffective treatments.

Methods and analysis

This prospective, multicentre, observational study will identify and validate a predictive model for response to advanced IBD therapies, incorporating gut microbiome, metabolome, single-cell transcriptome, human genome, dietary and clinical data. 1325 participants commencing advanced therapies will be recruited from ~40 UK sites. Data will be collected at baseline, week 14 and week 54. The primary outcome is week 14 clinical response. Secondary outcomes include clinical remission, loss of response in week 14 responders, corticosteroid-free response/remission, time to treatment escalation and change in patient-reported outcome measures.

Ethics and dissemination

Ethical approval was obtained from the Wales Research Ethics Committee 5 (ref: 21/WA/0228). Recruitment is ongoing. Following study completion, results will be submitted for publication in peer-reviewed journals and presented at scientific meetings. Publications will be summarised at www.ibd-response.co.uk.

Trial registration number

ISRCTN96296121.

The impact of a climate of perceived organizational support on nurses' well‐being and healthcare‐unit performance: A longitudinal questionnaire study

Abstract

Aim

To investigate the relationship between nurses' climate of perceived organizational support, and their well-being and healthcare-unit performance.

Design

A two-wave cohort questionnaire study among nurses within six hospitals in Sweden.

Methods

Hypotheses were tested using cross-lagged path models on the individual (organizational support, job satisfaction, burnout, intention to stay) and aggregate levels (care-unit organizational support, team effectiveness, patient safety climate and patient safety). Analyses were based on 1.817 nurses in 228 care-units (T1), 1.362 nurses in 213 care-units (T2) and longitudinal samples of 711 nurses and 140 care-units.

Results

Organizational support (T1) positively influenced job satisfaction (T2) and tended to decrease burnout (T2) but did not affect turnover intent. Reversed relationships were also found. No statistically significant prospective effects were found on the aggregate level.

Conclusion

The results indicated a prospective reciprocally reinforcing relationship between organizational support and job satisfaction. Burnout and intention to stay were predictors rather than outcomes of the organizational support climate.

Implications for the Profession and/or Patient Care

A climate where nurses perceive that their organization values their contributions and cares about their well-being is beneficial for their job satisfaction and health, which, according to previous research, may influence nurse retention.

Impact

The study addressed perceived organizational support as a potential predictor of nurses' well-being and healthcare-unit performance. A mutually reinforcing relation was indicated between organizational support and nurses' job satisfaction and health. Job dissatisfaction, burnout symptoms and turnover intentions were prospectively negatively related to the organizational support. Identifying and implementing a variety of practical measures to support perceptions of organizational support may be an effective way for healthcare management to start and sustain the development of a healthier work environment for healthcare professionals.

Reporting Method

STROBE statement for cohort studies.

Patient or Public Contribution

No patient or public contribution.

Role of patient characteristics in adherence to first-line treatment guidelines in breast, lung and prostate cancer: insights from the Nordic healthcare system

Por: Sandström · N. · Leppälä · E. · Jekunen · A. · Johansson · M. · Andersen · H.
Objectives

This study investigates the influence of socioeconomic status, health literacy, and numeracy on treatment decisions and the occurrence of adverse events in patients with breast, lung, and prostate cancer within a Nordic healthcare setting.

Design

A follow-up to a cross-sectional, mixed-methods, single-centre study.

Setting

A Nordic, tertiary cancer clinic.

Participants

A total of 244 participants with breast, lung and prostate cancer were initially identified, of which 138 first-line treatment participants were eligible for this study. First-line treatment participants (n=138) surpassed the expected cases (n=108).

Interventions

Not applicable as this was an observational study.

Primary and secondary outcome measures

The study’s primary endpoint was the rate of guideline adherence. The secondary endpoint involved assessing treatment toxicity in the form of adverse events.

Results

Guideline-adherent treatment was observed in 114 (82.6%) cases. First-line treatment selection appeared uninfluenced by participants’ education, occupation, income or self-reported health literacy. A minority (3.6%) experienced difficulties following treatment instructions, primarily with oral cancer medications.

Conclusions

The findings indicated lesser cancer health disparities regarding guideline adherence and treatment toxicity within the Nordic healthcare framework. A causal connection may not be established; however, the findings contribute to discourse on equitable cancer health provision.

‘We had conversations we wouldn't have had otherwise’—Exploring home‐dwelling people with dementia and family members' experiences of deliberating on ethical issues in a literature‐based intervention

Abstract

Aim

To explore home-dwelling people with dementia and family members' perceptions of the feasibility and acceptability of an intervention using dementia-related literature excerpts to facilitate conversations on ethical issues related to living with dementia.

Background

Ethical issues in dementia care emerge throughout the illness. In the early stages, they may involve decisions about disclosing the illness to the family, shifting roles and responsibilities, and considerations of transitioning to a nursing home. Addressing ethical issues and providing adequate support to home-dwelling people with dementia and their families are often lacking.

Design

An exploratory-descriptive qualitative study.

Methods

We conducted eight interviews with 14 home-dwelling persons with dementia and their family caregivers. Six were dyadic interviews, and two were individual interviews with family caregivers. We analysed the interview data using template analysis. We adhered to the COREQ checklist in reporting this study.

Results

Using excerpts from dementia-related literature was a feasible and acceptable way of initiating discussions on ethical issues among home-dwelling persons with dementia and family caregivers. However, engaging the families of newly diagnosed individuals was challenging due to emotional distress. The intervention provided peer support, including identifying with others and sharing experiences. Moreover, participating couples found intimacy and relational attunement through shared reflections.

Conclusion

Based on the findings, it appears that the participants in this study felt that using excerpts from dementia-related literature to deliberate on ethical issues was feasible and acceptable. Deliberating on ethical issues with peers and family caregivers offers valuable social support and opportunities for strengthening relationships.

Implications for patient care

This study makes an important contribution by providing valuable insights into how ethical issues related to living with dementia can be addressed using related literature and suggests how the intervention can be integrated into existing care initiatives for home-dwelling people with dementia and their families.

Reporting method

We have adhered to relevant EQUATOR guidelines with the COREQ reporting method.

Patient or public contribution

A healthcare professional working as a so-called dementia coordinator (a title used in the Danish context) was involved in the conduct of this study by being responsible for the recruitment of home-dwelling people with dementia and their family members. Moreover, she had joint responsibility for facilitating the intervention along with the first author.

Self‐determination in older patients: Experiences from nurse‐dominated ambulance services

Abstract

Aim

To describe ambulance clinicians' experiences of self-determination in older patients.

Design

The study had an inductive and explorative design, guided from a life-world perspective.

Methods

Thirty-two Swedish ambulance clinicians were interviewed in six focus groups in November 2019. The data were analysed with content analysis, developing manifest categories and latent themes.

Findings

The ambulance clinicians assessed the older patients' exercise of self-determination by engaging in conversation and by being visually alert, to eventually gain an overall picture of their decision-making capacity. This assessment was used as a platform when informing older patients of their rights, thus promoting their participation in care. Having limited time and narrow guidelines counteracted ambulance clinicians' ambitions to support older patients' general desire to avoid hospitalization, which resulted in an urge to displace their responsibility to external decision-makers.

Conclusion

Expectations that older patients with impaired decision-making ability will give homogeneous responses mean an increased risk of ageist attitudes with a simplified view of patient autonomy. Such attitudes risk the withholding of information about options that healthcare professionals do not wish older patients to choose. When decision-making is difficult, requests for expanded guidelines may paradoxically risk alienation from the professional nursing role.

Implications and Impact

The findings show ambulance clinicians' unwillingness to shoulder their professional responsibility when encountering older patients with impaired decision-making ability. In assuming that all older patients reason in the same way, ambulance clinicians tend to adopt a simplistic and somewhat ageist approach when it comes to patient autonomy. This points to deficiencies in ethical competence, which is why increased ethics support is deemed suitable to promote and develop ethical competence. Such support can increase the ability to act as autonomous professionals in accordance with professional ethical codes.

Reporting Method

This study adhered to COREQ guidelines.

Patient and Public Contribution

None.

Nurses' use of an advisory decision support system in ambulance services: A qualitative study

Abstract

Aim

To illuminate from the perspective of nurses in ambulance services the experiences of using a web-based advisory decision support system to assess care needs and refer patients.

Design

Inductive and descriptive approaches.

Method

Thirteen semi-structured interviews were conducted in the spring of 2020. The data were analysed through the reflexive thematic analysis.

Results

The Swedish web-based advisory decision support system (ADSS) was found to strengthen nurses' feelings of security when they assess patients' care needs, promote their competence and professional pride, and help them manage stress. However, the system also generated difficulties for nurses to adjust to the dynamic ambulance team and revealed a discrepancy between their professional roles and responsibilities to refer patients and provide self-care advice. The nurses thought that the support system facilitated their increased participation and helped them understand patients and significant others by offering transparency in assessment and decision making. Thus, the support system provides nurses with an opportunity to strengthen patients' independence through information and education. However, in the care relationship, nurses worked to overcome patients' expectations.

Conclusion

Nurses using the ADSS increased their security while performing assessments and referrals and found new opportunities to provide information and promote understanding of their decisions. However, nursing care values can be threatened when new support systems are introduced, especially as ambulance services become increasingly protocol-driven.

Implications for Profession and/or Patient Care

These findings have implications for nurses' work environments and help them maintain consistency in making medical assessments and in providing equivalent self-care advice when referring patients to the different levels of care. The findings will also impact researchers and policymakers who formulate decision support systems.

Reporting Method

Consolidated criteria for reporting qualitative research (COREQ).

Patient or Public Contribution

None.

Contemporary national outcomes of hyperbaric oxygen therapy in necrotizing soft tissue infections

by William Toppen, Nam Yong Cho, Sohail Sareh, Anders Kjellberg, Anthony Medak, Peyman Benharash, Peter Lindholm

Background

The role of hyperbaric oxygen therapy (HBOT) in necrotizing soft tissue infections (NSTI) is mainly based on small retrospective studies. A previous study using the 1998–2009 National Inpatient Sample (NIS) found HBOT to be associated with decreased mortality in NSTI. Given the argument of advancements in critical care, we aimed to investigate the continued role of HBOT in NSTI.

Methods

The 2012–2020 National Inpatient Sample (NIS) was queried for NSTI admissions who received surgery. 60,481 patients between 2012–2020 were included, 600 ( Results

Age, gender, and comorbidities were similar between the two groups. On bivariate comparison, the HBOT group had lower mortality rate ( Conclusions

After correction for differences, HBOT was associated with decreased mortality, amputations, and non-home discharges in NSTI with the tradeoff of increase to costs and length of stay.

Cohort profile: The Health, Food, Purchases and Lifestyle (SMIL) cohort - a Danish open cohort

Por: Sorensen · K. K. · Andersen · M. P. · Moller · F. T. · Eves · C. · Junker · T. G. · Zareini · B. · Torp-Pedersen · C.
Purpose

The Health, Food, Purchases and Lifestyle (SMIL) cohort is a prospective open Danish cohort that collects electronic consumer purchase data, which can be linked to Danish nationwide administrative health and social registries. This paper provides an overview of the cohort’s baseline characteristics and marginal differences in the monetary percentage spent on food groups by sex, age and hour of the day.

Participants

As of 31 December 2022, the cohort included 11 214 users of a smartphone-based receipt collection application who consented to share their unique identification number for linkage to registries in Denmark. In 2022, the composition of the cohort was as follows: 62% were men while 24% were aged 45–55. The cohort had a median of 63 (IQR 26–116) unique shopping trips. The cohort included participants with a range of health statuses. Notably, 21% of participants had a history of cardiovascular disease and 8% had diabetes before donating receipts.

Findings to date

The feasibility of translating consumer purchase data to operationalisable food groups and merging with registers has been demonstrated. We further demonstrated differences in marginal distributions which revealed disparities in the amount of money spent on various food groups by sex and age, as well as systematic variations by the hour of the day. For example, men under 30 spent 8.2% of their total reported expenditure on sugary drinks, while women under 30 spent 6.5%, men over 30 spent 4.3% and women over 30 spent 3.9%.

Future plans

The SMIL cohort is characterised by its dynamic, continuously updated database, offering an opportunity to explore the relationship between diet and disease without the limitations of self-reported data. Currently encompassing data from 2018 to 2022, data collection is set to continue. We expect data collection to continue for many years and we are taking several initiatives to increase the cohort.

What Matters to Aboriginal and Torres Strait Islander Youth (WM2Y): a study protocol to develop a national youth well-being measure

Por: Garvey · G. · Howard · K. · Garvey · D. · Dickson · M. · Howell · M. · Butler · T. L. · Cadet-James · Y. · Cunningham · J. · Bainbridge · R. · McGorry · P. · Williamson · A. · Anderson · K. M.
Introduction

Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.

To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).

Methods and analysis

This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.

Ethics and dissemination

Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.

Low-value MRI of the knee in Norway: a register-based study to identify the proportion of potentially low-value MRIs and estimate the related costs

Por: Hofmann · B. · Havik · V. · Andersen · E. R. · Brandsaeter · I. O. · Kjelle · E.
Objectives

The objective of this study is to investigate the proportion of potentially low-value knee MRI in Norway and to provide an estimate of the related costs.

Design

Register study based on conditional data extraction and analysis of data from Control and Reimbursement of Healthcare Claims registry in Norway.

Setting

MRI in public specialist healthcare with universal health coverage (Norway).

Participants

48 212 MRIs for 41 456 unique patients and 45 946 reimbursement claims.

Outcome measures

Proportion of MRIs of the knee that (1) did not have a relevant tentative diagnosis prior to the knee MRI, (2) did not have a relevant alternative image of the knee before the MRI or (3) did not have a relevant code from the specialist care within 6 months after the MRI, and those that had combinations of 1, 2 and 3. Estimated costs for those that had combinations of 1, 2 and 3.

Results

Very few patients (6.4%) had a relevant diagnosis code or prior imaging examination when having the MRI and only 14.6% got a knee-related diagnosis code from the specialist care within 6 months after the MRI. 21.8% of the patients had knee X-ray, CT or ultrasound within 6 months before the MRI. Between 58% and 85% of patients having knee MRIs in Norway have no relevant examinations or diagnoses six months prior to or after the MRI examination. These examinations are unlikely to benefit patients and they correspond to between 24 108 and 35 416 MRIs at a cost of 6.7–9.8 million per year.

Conclusion

A substantial proportion of MRIs of the knee in Norway have no relevant examinations or diagnoses before or after the MRI and are potentially of low value. Reducing low-value MRIs could free resources for high-value imaging, reduce waiting times, improve the quality of care and increase patient safety and professional integrity.

Effects of COVID-19 contagion in cohabitants and family members on mental health and academic self-efficacy among university students in Sweden: a prospective longitudinal study

Por: Andersson · C. · Berman · A. H. · Lindfors · P. · Bendtsen · M.
Objective

This study used causal inference to estimate the longitudinal effects of contagion in cohabitants and family members on university students’ mental health and academic self-efficacy during the COVID-19 pandemic.

Design

A prospective longitudinal study including a baseline online measurement in May 2020, and online follow-ups after 5 months and 10 months. Participants were recruited through open-access online advertising.

Setting

Public universities and university colleges in Sweden.

Participants

The analytical sample included 2796 students.

Outcome measures

Contagion in cohabitants and in family members was assessed at baseline and at the 5-month follow-up. Mental health and academic self-efficacy were assessed at the 5-month and 10-month follow-ups.

Results

Mild symptoms reported in cohabitants at baseline resulted in negative mental health effects at follow-up 5 months later, and mild baseline symptoms in family members resulted in negative effects on academic self-efficacy at follow-ups both 5 and 10 months later.

Conclusions

Notwithstanding the lack of precision in estimated effects, the findings emphasise the importance of social relationships and the challenges of providing students with sufficient support in times of crisis.

Experiences of patients with advanced COPD affiliated to a cross‐sectorial outgoing lung team: A qualitative study

Abstract

Aim

To explore experiences of patients affiliated to a cross-sectorial outgoing lung team.

Background

The outgoing lung team consisted of respiratory nurses from the hospital and community nurses. The lung team offered 24/7 help to patients with advanced chronic obstructive pulmonary disease (COPD) through visits and/or treatment in the patients' home. Affiliation to the lung team reduced both hospitalizations and length of hospital stay due to acute exacerbation of COPD. However, based on questionnaires on health-related quality of life, no significant differences were found between patients affiliated to the lung team and patients receiving usual care.

Design

A qualitative interview study.

Methods

In total, 16 patients, aged 61–88 years were interviewed between February 2019 and July 2021. They had been affiliated to the outgoing lung team for 1–3 years. Semi-structured interviews were conducted in the patients' home and audio-recorded after informed consent was obtained. The interviews were transcribed verbatim and analysed, inspired by systematic text condensation by Malterud.

Findings

Four themes emerged from the analysis: (1) feeling safe, (2) improvements in living with COPD, (3) avoiding hospitalization and (4) satisfied with staying at home.

Conclusion

Affiliation to the cross-sectorial outgoing lung team gave the patients peace of mind and improved their ability to live with advanced COPD. The patients preferred contacting the lung team because they could stay at home and receive treatment, and thus avoid hospitalization.

Impact

The findings from this study support that municipalities should consider implementing an outgoing lung team, as it has the potential to bring several benefits, including improving patient self-management.

Reporting Method

The manuscript adhered to Consolidated criteria for reporting qualitative research (COREQ) guideline.

Patient or Public Contribution

Patients were interviewed. Additionally, no patient or public contributed to the design or conduction of the study, analysis, or interpretation of the data.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Development of radiographic knee osteoarthritis and the associations to radiographic changes and baseline variables in individuals with knee pain: a 2-year longitudinal study

Por: Törnblom · M. · Bremander · A. · Aili · K. · Andersson · M. L. E. · Nilsdotter · A. · Haglund · E.
Objectives

The aim was to study the development of radiographic knee osteoarthritis (RKOA) in individuals with knee pain over 2 years, and the associations between radiographic changes and baseline variables.

Design

Longitudinal cohort study.

Participants and setting

This study is part of the Halland Osteoarthritis cohort. The included 178 individuals, aged 30–67, had knee pain, without cruciate ligament injury or radiographic findings and 67% were women. The presence of RKOA was defined as Ahlbäck score of ≥1 in ≥1 knee. (Ahlbäck grade 1: joint space narrowing in the tibiofemoral joint

Results

In all, 13.8% (n=24) developed RKOA in 2 years whereof all had clinical KOA at baseline, as defined by NICE. Deterioration to RKOA was significantly associated with higher BMI, OR 1.119 (95% CI 1.024 to 1.223; p=0.013), and VFA, 1.008 (95% CI 1.000 to 1.016; p=0.049), worse knee pain intensity, 1.238 (95% CI 1.028 to 1.490; p=0.024), worse scores for KOOS Pain, 0.964 (95% CI 0.937 to 0.992; p=0.013) and KOOS Symptoms, 0.967 (95% CI 0.939 to 0.996; p=0.027), KOOS Activities of daily living 0.965 (95% CI 0.935 to 0.996; p=0.026) and KOOS Quality of Life 0.973 (95% CI 0.947 to 0.999; p=0.044), at baseline.

Conclusions

One out of seven individuals with clinical KOA developed RKOA in only 2 years. Baseline variables associated with RKOA after 2 years may possibly be detected early by using the NICE guideline, assessment of obesity and self-reported data of symptoms to support first-line treatment: education, exercise and weight control.

Trial registration number

ClinicalTrials.gov (NCT04928170)

'DANMM thats good!: evaluating the feasibility and acceptability of the Deadly Aboriginal and Torres Strait Islander Nursing and Midwifery Mentoring (DANMM) Programme across rural, regional and metropolitan NSW-a collaborative study protocol

Por: Biles · B. · Christian · B. · Marshall · C. · McMillan · F. · Sara · G. · Anderson · J. · Davies · N. · Fealy · S. · Biles · J.
Introduction

This paper will describe the research protocol for the Deadly Aboriginal and Torres Strait Islander Nursing and Midwifery Mentoring (DANMM) Project, which will determine the feasibility and acceptability of a cultural mentoring programme designed for Aboriginal and Torres Strait Islander nurses and midwives across five diverse local health districts in New South Wales, Australia. Government and health agencies highlight the importance of culturally appropriate and safe environments for Aboriginal people. Specifically, New South Wales Health prioritises workforce strategies that support Aboriginal people to enter and stay in the health workforce. However, retaining Aboriginal nurses and midwives remains challenging. The DANMM Project aligns with these local and state-wide health plans and strategies, addressing critical issues of workforce cultural safety and retention.

Methods and analysis

A mixed-methods study design will be employed to assess feasibility, acceptability and preliminary efficacy of the DANMM Programme across five publicly funded local health districts in New South Wales, Australia. Adhering to cultural safety, a project cultural governance group will be formed. Quantitative outcome measures include the use of questionnaires (Nursing Workplace Satisfaction Questionnaire, Ganngaleh nga Yagaleh Cultural Safety assessment tool). Resource implications will be measured using the Organisational Commitment and Health Professional Program Readiness Assessment Compass. These will be triangulated with individual and group yarning circles to provide a holistic evaluation of the programme.

Ethics and dissemination

The study has ethics approval: Aboriginal Health and Medical Research Council (#2054/23); New South Wales Health Human Research Committees (Greater Western Human Research Committee #2022/ETH01971, Murrumbidgee—site-specific approval, Sydney Local Health District—site-specific approval, Western Sydney Local Health District—site-specific approval and Mid North Coast—site-specific approval); and Charles Sturt University Human Research Committee (#2054/23). Findings will be disseminated through peer-reviewed articles, conferences and through roundtable discussions with key stakeholders.

Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerou

Por: Hartman · T. J. · Christie · J. · Wilson · A. · Ziegler · T. R. · Methe · B. · Flanders · W. D. · Rolls · B. J. · Loye Eberhart · B. · Li · J. V. · Huneault · H. · Cousineau · B. · Perez · M. R. · O'Keefe · S. J. D.
Introduction

Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).

Methods/design

This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1–3 and one meal/day in months 4–6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1–2 pounds per week.

Ethics and dissemination

The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).

Trial registration number

NCT04780477.

Effectiveness of an adaptive, multifaceted intervention to enhance care for patients with complex multimorbidity in general practice: protocol for a pragmatic cluster randomised controlled trial (the MM600 trial)

Por: Holm · A. · Lyhnebeck · A. B. · Rozing · M. · Buhl · S. F. · Willadsen · T. G. · Prior · A. · Christiansen · A.-K. L. · Kristensen · J. · Andersen · J. S. · Waldorff · F. B. · Siersma · V. · Brodersen · J. B. · Reventlow · S. · The MM600 project team · Prior · Stockmarr · Guassora
Introduction

Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.

Methods and analysis

In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.

Ethics and dissemination

The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.

Trial registration number

NCT05676541.

Healthcare professionals' digital health competence profiles and associated factors: A cross‐sectional study

Abstract

Aims

To identify healthcare professionals' digital health competence profiles and explore associated factors to digital health competence in healthcare settings.

Design

A cross-sectional study.

Methods

Data were collected from 817 healthcare professionals from nine organizations with an electronic questionnaire by using Digital Health Competence instrument (42 items) and Aspects Associated with Digital Health instrument (15 items) between 1st March and 31st July 2022. K-means clustering was used to describe digital health competence profiles. Binary logistic regression analysis was used to explore associated factors.

Results

Analysis revealed three digital health competence profiles: A – high competence (n = 336), B – intermediate competence (n = 352) and C – low competence (n = 129). Between the profiles, digital health competence showed significant differences (p < .001). Recent graduation year, working in outpatient environments and leader or specialist position were associated with higher digital health competence. Organizational practices and the influence from colleagues improved competence in human-centred remote counselling, digital solutions as part of work, competence in utilizing and evaluating digital solutions and ethical competence. Support from management improved digital solutions as part of work and ethical competence.

Conclusion

Nursing and allied health professionals working in other than outpatient environments should be specifically acknowledged when digital health competence development initiatives are designed and targeted. The positive influence from colleagues could be harnessed by enhancing their involvement in digital health competence development methods such as orientation, mentoring or coaching. Additionally, managers should take a stronger role in supporting different areas of digital health competence.

Impact

This was the first study that explored healthcare professionals' digital health competence profiles and associated factors. The detection of healthcare professionals' digital health competence profiles guides the development of digital health education according to different needs in healthcare environments.

Reporting Method

The study has adhered to STROBE guidelines.

Patient or Public Contribution

No patient or public contribution.

Renegotiating identity. A Nordic study of adolescent's experiences of living with a parent having heart disease

Abstract

Aim

To explore adolescents' experiences of having a parent with heart disease.

Design

This qualitative study was performed with semi-structured individual interviews.

Methods

Interviews were conducted with 33 adolescents between 13 and 19 years old, who either had a mother or father with one of these diagnoses: ischemic heart disease, arrhythmia, heart failure, cardiac arrest or heart valve disease. The parent had been ill for at least 6 months and up to 5 years. The study was carried out in Denmark, Norway and Sweden between 2019 and 2022. The analysis was inspired by Reflexive Methodology.

Results

Three central themes emerged: Response to parental heart disease; Growing up ahead of time; and Strategies in a changed life situation. For the adolescents, heart disease was experienced as an acute and lethal disease that put their parents' lives in danger. New routines and roles not only changed everyday life within the family but they also enhanced maturity and appreciation of life. To maintain a balance in life, the adolescents pursued normality and sought a safe space to have a normal youthful life.

Conclusion

In a period known to be significant for development, life with parental heart disease appeared as a biographical disruption because adolescents renegotiated their identity to manage their new life situation.

Impact

It is important to help younger family members adapt to parental heart disease by informing them about possible reactions and supporting them in how to adapt to their new life by seeking breaks and normality.

Patient or Public Contribution

No patient or public involvement.

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