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Bipolar disorder affects around 2% of the population and is linked with reduced life expectancy and socioeconomic burden. Depressive episodes are difficult to treat and typically more prevalent, enduring and burdensome than manic episodes. The use of antidepressants alone has limited effect and is associated with significant clinical risk through polarity switch. Current National Institute for Health and Care Excellence guidelines recommend quetiapine, olanzapine (with or without fluoxetine) and lamotrigine; however, these medications have limited efficacy, tolerability and acceptability. The ASCEnD study aims to assess the clinical and cost-effectiveness of aripiprazole plus sertraline compared with quetiapine, offering potential improvements for outcomes in bipolar depression. The study is funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR132773).
ASCEnD is a prospective, two-arm, superiority, individually 1:1 randomised, controlled, pragmatic, parallel group, type A open-label clinical trial of aripiprazole/sertraline medication combination compared with quetiapine for bipolar depression. The study is conducted in the UK National Health Service setting with the aim of recruiting and randomising 270 participants followed-up for 24 weeks. Adults with bipolar disorder self-refer or are recruited through primary and secondary care services. The primary outcome is change in depressive symptoms 12–16 weeks after randomisation. Secondary outcomes include measures of symptom change, treatment satisfaction, tolerability, medication adherence, concomitant medication use, psychosocial functioning, quality of life and cost-effectiveness and informal carer measures of quality of life and costs of caring. The exploratory outcome is change in participant reward and punishment responsiveness. Analysis will follow a prespecified statistical analysis plan. A nested qualitative study is included to examine feasibility and acceptability of the trial design.
A Clinical Trial Authorisation from Medicines and Healthcare products Regulatory Agency, and approval from the Health Research Authority (IRAS 1007468) and North East – Newcastle and North Tyneside 1 Research Ethics Committee (23/NE/0132) were obtained. Results will be disseminated through peer-reviewed publications, conference presentations and lay summaries for participants and patient and public groups.
Increased risks and concerns regarding patient safety in early-phase studies exist because knowledge about the new intervention is still accumulating. This means that narrow eligibility criteria are needed. However, if early-phase studies are narrow in their inclusion, for example, by not including diverse populations, there is a potential risk that new therapies have insufficient relevant efficacy and safety data. Existing research has explored equity, diversity and inclusion (EDI) factors in early-phase pharmaceutical studies, but it has not been possible to find studies that have systematically examined whether EDI factors have been considered in surgical studies reporting innovative procedures. We aim to examine how EDI factors are considered in early-phase surgical studies and surgical innovation reports to explore how this may impact on later-phase evaluation and inclusive intervention implementation.
A scoping review following the JBI (Joanna Briggs Institute) and Arksey and O’Malley’s five-step process is being conducted. We will search Scopus, PubMed and Web of Science for surgical early-phase studies. A two-step screening process for eligibility is being used. Independent double screening will take place for 20% of the papers. Eligible articles will report early evaluation of an innovative surgical/invasive procedure. Excluded will be comparative and later-phase studies and early evaluations of pharmaceutical products even in a surgical setting. Data on article details, patient eligibility and whether protected characteristics are reported and considered will be extracted. Information about EDI considerations reported in the introduction or discussion of the papers will also be extracted. Findings will be discussed with a patient advisory group. A content synthesis approach will be undertaken and descriptive summaries presented.
This study does not require ethical approval being a secondary analysis. The findings will be disseminated through academic journal publications and oral presentations.
To examine practical, ethical, and organisational implications of the use of a key technology deployed in the care of hospitalised people with dementia—visual identifiers—through a comparative analysis with parallel interventions in other spheres of healthcare and social activity.
Discursive paper.
We contrast visual identification systems used for hospitalised patients with dementia with other, ostensibly similar, systems to understand how they differ in key characteristics: what they disclose, to whom and with what intended consequence.
Certain distinctive features of the ways identifier systems are used to improve dementia care appear particularly consequential for their impact. Given how much is expected of such identifiers, they are likely to fail at least a proportion of patients.
We argue that it is important to critically evaluate the interests served by visual identifiers, identifying the dimensions of quality they can enhance and those that may be negatively impacted.
Visual identifiers for people with dementia can contribute to the ‘taskification’ of nursing care, implying that achieving person-centred care is a matter of following defined protocols rather than an emergent, relational, time-consuming process. Staff may end up prioritising risk avoidance and hospital routines (tasks that are measurable and auditable) rather than embracing the unpredictability of developing relationships with patients.
Visual identifiers are a part of well-established strategies to improve hospital care for those with cognitive impairment. While these identifiers aim to prompt healthcare professionals to deliver individually tailored care, research suggests that they are unable to consistently ensure the desirable quality of care. Understanding influences on how they are deployed can help reshape the expectations placed on such low-tech interventions and inform more reflective use.
Patients and public were not directly involved in the development of this discursive paper.
A lack of murine models that mimic impaired wound healing in people with type 2 diabetes has hindered research. The commonly used leptin-receptor knockout model (db/db) fails to accurately reflect the pathophysiology of human disease. This study aimed: (i) to investigate whether our novel murine model of diabetes, whilst less hyperglycaemic and obese than db/dbs, effectively demonstrated impaired wound healing, and (ii) to identify the most robust methods for quantifying wound closure. C57BL/6J mice were high-fat diet fed for a total of 11 weeks and injected with three doses of streptozotocin (65 mg/kg body weight) at week 5 with chow-fed mice as controls. All mice received four excisional wounds and were euthanised at day-4 or day-10 post-wounding (n = 8/group/timepoint). Wound healing was evaluated by digital planimetry, histology, Micro-CT, and tensiometry. Histological analysis was the most sensitive method for identifying impaired wound healing. Our high-fat diet/low-dose streptozotocin model had significantly higher non-fasting blood glucose (25.7 ± 5.4 mmol/L vs. 8.7 ± 0.8 mmol/L) and lower wound quality scores (day-4 post-wounding: 2.6 ± 1.9 vs. 4.4 ± 0.8) than healthy controls (both p < 0.05). At day-10 post-wounding, a linear trend in wound healing was observed between healthy controls, our novel model and the db/db model, indicating that our diabetic murine model may be clinically relevant for studying diabetes-related wound healing.
Most patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return to work and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The Work And Vocational advicE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA.
A mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study.
Primary care.
The study included participant follow-up by fortnightly Short Message Service text and 6-week questionnaire. Stop/go criteria focus on recruitment and intervention engagement. The semistructured interviews explored participants’ experiences of recruitment and receipt and engagement with the intervention.
19 participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with ≥50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a vocational support worker. Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable.
This study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement.
To explore the views and perspectives of British South Asian (BSA) women and Positive Health Programme (PHP) facilitators on the usefulness and experiences of the PHP intervention for managing postnatal depression (PND) in primary care settings.
Qualitative study with semi-structured interviews to explore perceptions of acceptability and implementation. A patient and public involvement group provided their insights and feedback on study topic guides, analysis and outcomes.
We sampled trial participants from the PHP intervention database to ensure variation in geographic setting, age, socioeconomic status and ethnicity. PHP facilitators involved in the trial were also invited to participate in an interview.
Interviews with study participants were conducted at participants’ homes, and community centres, or via phone. Interviews with PHP facilitators were conducted via phone or online. Interview recordings were transcribed verbatim and analysed using thematic analysis and subsequently the Theoretical Framework of Acceptability (TFA) was applied. Recruitment took place between February 2017 and March 2020.
Thirty interviews were conducted—19 trial participants and 11 PHP facilitators. The PHP intervention was viewed positively, with appreciation of its therapeutic content and components such as childcare and refreshments that facilitated engagement. Participants reported improved confidence and well-being and supported their needs. Participants understood the intervention’s purpose. Both intervention participants and facilitators noted strengthened self-efficacy.
Some participants experienced difficulties balancing childcare and attendance, implying a need for logistical assistance. Stigma about mental health in the BSA community was viewed as persistent, recommending future programmes efforts on strategies to reduce stigma and develop supportive environment.
This study demonstrates the possibility of PHP intervention being integrated into routine care by providing culturally tailored support for BSA women with PND, primarily through family engagement and facilitator support. Future research on scalability, alongside community engagement efforts, will strengthen its acceptability and broader applicability.
by Georgia Black, Reena Besa, Daniel Blumberger, Heather Brooks, Graham Collingridge, John Georgiou, Evelyn K. Lambe, Clement Ma, Bernadette Mdawar, Tarek K. Rajji, Sanjeev Sockalingam, Cara Sullivan, Quincy Vaz, Zhengbang Yao, Branka Agic
IntroductionIntegrated knowledge translation (iKT) is a collaborative research approach that emphasizes the meaningful and active participation of knowledge users throughout the research process. Evidence suggests that integrated knowledge translation has the potential to increase the relevance, applicability, and use of research findings. This approach has been increasingly utilized in health research in recent years. However, the extent to which it has been applied in preclinical research and its effectiveness are unknown. To address this gap, we will conduct a scoping review to map the current use, potential benefits, and challenges of iKT in preclinical research.
MethodsGuided by a modified Arksey and O’Malley’s scoping review framework, we will systematically search reference lists and key research databases including Medline, Embase, PsycINFO, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, and Web of Science. Peer-reviewed articles written or translated in English that focus on iKT or approaches that align with iKT within the context of preclinical research will be included. This review will be conducted as part of the Improving Neuroplasticity through Spaced Prefrontal intermittent-Theta-Beta-Stimulation REfinement in Depression (INSPiRE-D) project, which features preclinical research from mouse models to human work (Grant number CAMH File No.22-060). The project’s multidisciplinary team and knowledge user advisory committee will be consulted at key points throughout the scoping review process. A person with lived experience co-chairs the project advisory committee, co-authored this manuscript, and will be routinely included in the decision-making process of the scoping review.
Many amputees experience phantom limb pain (PLP). Pharmacological management is the mainstay of treatment, but effectiveness is limited, and it is associated with significant side effects. Sensory discrimination training (SDT) is a non-pharmacological treatment for PLP. Previously, SDT required a clinician, or carer, to administer it, creating a barrier to real world use. In this trial, an automated SDT device (SP1X, 2pd Ltd, Middlesbrough, United Kingdom) for the self-management of PLP will be investigated for efficacy.
The Phantom Relief is a decentralised, randomised, placebo-controlled, mixed-methods, superiority trial. Participants will take part from their own homes, using an electronic data capture tool to complete all trial documentation. Eligible, consenting individuals with PLP (intensity rated as ≥4 on a 0–10 scale; n=100) will be randomised to receive the SP1X device (intervention group) or a placebo device SP1X7 (placebo group). The first and second treatment sessions will be observed via video call to provide set-up guidance and any additional advice needed. The primary outcome measure will be the McGill Pain Questionnaire revised (SF-MPQ-2). Outcome measures will be collected at baseline, 3 weeks (immediately post intervention) and 3 months follow-up. Statistical analysis will be carried out by a blinded statistician (analysis of covariance model conditioning on the baseline and stratification factors). Semi-structured interviews will be carried out with a sub-sample (n=10–15) of intervention group participants. Participants will be provided with their allocated device for home use. Online video calls will be used to instruct participants on how to set up and use the device by the research assistant (RA). The RA will observe the first and second treatment sessions and provide any additional advice needed. Participants in both groups will be asked to use the device for 60 min/day for at least 15 days of the 21-day treatment period and to record device use in a study diary.
Approval has been obtained from Teesside University School of Health and Life Sciences Research and Ethics Committee, the North of Scotland Research Ethics Service, Health Research Authority, and a letter of no objection was obtained from the Medicines and Healthcare products Regulatory Authority. The results will be disseminated through peer-reviewed articles, conference presentations and a doctoral thesis.
To understand why patients with chronic kidney disease (CKD) may not be treated according to international guidelines for myocardial infarction (MI).
Multicentre qualitative interview study. Interviews were analysed using reflexive thematic analysis approach as outlined by Braun and Clarke to generate themes associated with MI treatment decision-making for, and by, patients with CKD.
Four National Health Service hospital centres in the UK (February 2022 to July 2024).
A purposive sample of 46 participants (patients and clinicians). Clinicians (n=32) were senior doctors-in-training or consultants in cardiology, nephrology, acute or emergency care or cardiac surgery. Patient participants (n=14) had CKD, defined as an estimated glomerular filtration rate 2, or receipt of kidney replacement therapy (KRT).
Despite expressing strong views regarding their health priorities, patients reported minimal involvement in treatment decision-making. Decision-making by clinicians was driven by the desire to avoid causing harm to patients by ‘active’ treatment initiation. In general, despite the concept of evidence-based medicine being widely accepted, there remained scepticism of guidelines or epidemiological data, especially in the light of personal adverse experiences or anecdotes. Clinicians described how, in the absence of collaborative decision-making and a clinical safety-net for managing treatment complications, they tended to make conservative treatment decisions for patients with CKD.
Interventions to foster teamworking between specialists and ensure adequately resourced specialist clinical service safety-nets may improve access to treatments for MI for people with CKD. Intervention development and evaluation should follow to determine if outcomes for people with CKD and MI can be improved.
To determine the barriers, facilitators and effectiveness of using an intergenerational café to enable intergenerational learning.
Implementation science using the ‘Consolidated Framework for Implementation Research’ framework.
Ethical approval for this research was granted by the University of Limerick. Online intergenerational cafés were held with older people and student nurses. Original data were collected through surveys and facilitator reflections. Participants were invited post-café to participate in the study. Student nurses (n = 50) and older people (n = 49) participated in an anonymous online survey, and facilitators (n = 7) took part in a peer focus group on planning and co-ordinating the cafés. Post hoc ‘CFIR’ analysis comprised secondary data analysis through mapping descriptive statistics and thematically analysed data to codebooks derived from CFIR domains and constructs.
Barriers and facilitators to café implementation were identified. Organisational factors are important for effective implementation. More students felt that the purpose, topics and running of the café were clear and organised. In contrast, more older people wanted additional time in the discussion groups. Technical difficulties (e.g., computer, logging on) were identified by some as a barrier to participation. Overall, having a clear purpose and topics along with an online approach facilitated implementation. All participants supported the café innovation as a way of increasing intergenerational learning. Facilitators worked effectively as a team to ensure the smooth running of the cafés. The analysis helped determine the effectiveness of the intervention.
These cafés facilitated mutual learning and understanding and were well received by participants.
Intergenerational cafés can support intergenerational learning.
Intergenerational cafés facilitated intergenerational learning.
SRQR/EQUATOR.
There was no patient/public contribution.
To evaluate the associations between depressive symptoms, HIV vulnerability factors and oral pre-exposure prophylaxis (PrEP) use and adherence among adolescent girls and young women (AGYW) in Kenya.
Cross-sectional observational study.
Research site in Kisumu, Kenya.
300 AGYW aged 19–24 years (median age 21 years, IQR 20–22), attending follow-up visits in a randomised controlled trial of the efficacy of a single-dose HPV vaccine.
Participants responded to questionnaires assessing their depressive symptoms (Patient Health Questionnaire-9), HIV vulnerability and PrEP use and adherence.
Moderate to severe depressive symptoms were reported by 14.3% (95% CI 10.5% to 18.8%). Factors associated with increased prevalence of depressive symptoms included medium HIV risk perception (adjusted prevalence ratio (aPR) 2.25; 95% CI 1.20 to 4.26) and engaging in transactional sex (aPR 2.51; 95% CI 1.15 to 5.48). The rate of oral PrEP use was 19.3% (n=58, 95% CI 15.0% to 24.0%), with 43.0% reporting adherence (≥5 doses in the past week). Depressive symptoms were not significantly associated with PrEP use (aPR 0.94; 95% CI 0.52 to 1.70).
The high prevalence of depressive symptoms among AGYW highlights the importance of integrating mental health screening into HIV prevention services, particularly for individuals with higher HIV risk perception and those engaging in transactional sex.
To assess the preliminary effectiveness and cost-effectiveness of a culturally tailored, music-based broadcast intervention delivered through schools and community radio to improve referral adherence among schoolchildren to inform the need for a definitive trial.
Pilot randomised interventional study.
18 schools across Unguja and Pemba islands, Zanzibar.
Schoolchildren (6–18 years old) who failed vision screening and were referred for care recruited from January to February 2024. The registered sample size reflects the full cohort, including children and adults. This manuscript reports on the child cohort only, as per the predefined analysis plan.
Group 1 received 3 months of school-based broadcasts of culturally tailored 3–6 min songs (played three times daily on 2 days per week), followed by 3 months of community radio broadcasts of additional songs (3–6 min, aired three times daily); Group 2 received the community broadcasts during the same period as Group 1.
The primary outcome was change in referral adherence assessed at two time points: 3 months after school broadcast and 3 months after community broadcast, expressed in difference-in-difference estimates and effect sizes. Secondary outcomes included reporting of adverse events and contamination, and cost-effectiveness calculated as cost per child reached and cost per referred child accessed care in study groups and combined intervention.
374 children were referred to eye care services, including 246 in Group 1 and 128 in Group 2. Referral adherence was 69.8% in Group 1 and 42.9% in Group 2 (p=0.0006). The school broadcast phase yielded an effect size of 0.26 and a cost of US$4.65 per referred child accessing services. The community broadcast produced an effect size of 0.21, with a cost of US$0.29 per person reached. The combined intervention reached individuals at a cost of US$0.37 per person. No adverse event and contamination was reported.
A combined school and community broadcast intervention improved referral adherence in this pilot trial, with evidence of cost-effectiveness. These findings support the conduct of a fully powered definitive trial.
Digital inclusion (which includes skills, accessibility and connectivity to the internet and digital devices) is a ‘super social determinant of health’ because it affects many aspects of life that influence health. Older people are especially vulnerable to digital exclusion. Existing digital inclusion interventions are commonly offered opportunistically to people who come into contact with services, or in specific locations. The lack of systematic identification of need unintentionally excludes older people who may be most in need of support, and that support is not addressing their needs.
This multi-method project includes six workstreams: (1) A survey of people aged 65+ to ask about digital use and engagement. Survey data will be used to develop a model that predicts digital exclusion from data available in primary care records. (2) Testing, via a further survey, the external validity of the model to identify those who are digitally excluded. (3) Interviews with community service providers to identify, understand and define the components of existing digital inclusion services for older people. Concurrently, a rapid review of the literature will identify evidence for interventions aimed at supporting digitally excluded adults aged 65+. (4) Interviews with people aged 65+ representing a range of digital use will explore factors from the COM-B model that influence digital behaviours—their capability (C), opportunity (O) and motivation (M) relating to digital engagement. Analysis outputs will identify the intersectional nature of barriers or facilitators to digital inclusion. (5) Co-production workshops with older people and community service providers will identify key components of interventions that are required to address digital exclusion. Components will be mapped against existing interventions, and the ‘best fit’ intervention(s) refined. An implementation plan will be developed in parallel. (6) Feasibility testing of the refined intervention(s) to assess acceptability and obtain feedback on content and delivery mechanisms.
This study was approved by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee on 23 October 2023 (ref. 23/YH/0234). Findings will be disseminated in academic journals and shared at webinars, seminars, conferences and events arranged by organisations operating across the digital inclusion and older people fields.
To explore how primary care practitioners, including nurses, provide dietary diabetes management to migrants.
The scoping review followed, a refined and structured methodological framework and adhered to the Joanna Briggs Institute Scoping Review guidelines.
Searches were conducted across CINAHL, PubMed, and Scopus databases to identify studies published between 2000 and 2024 that focus on dietary diabetes care for migrants in Primary Health Care settings. Data were synthesised using thematic analysis.
The search identified 377 studies, with 30 meeting the inclusion criteria. Analysis revealed four themes: (1) cultural influences on diabetes management, (2) culturally tailored dietary interventions, (3) communication challenges and (4) access and availability of diabetes care.
Culturally competent primary care practices are crucial for effective diabetes dietary management for migrants, as they can enhance patient engagement, adherence, and overall health outcomes. Primary care nurses are uniquely positioned to address the barriers experienced by migrant populations through tailored care delivery.
The findings provide actionable guidance for nurses to implement targeted and culturally responsive approaches in delivering dietary diabetes management, aiming to improve patient adherence and health outcomes among migrants.
This review identified significant literature gaps in how primary care nurses provide culturally responsive dietary guidance for migrant patients with diabetes. The four themes identified have emphasised the need for culturally preserving care to enhance patient engagement and adherence to clinical guidance. The findings will directly impact nursing practice, education, and clinical guidelines globally, enabling nurses to deliver more effective and culturally responsive diabetes care that improves diabetes-related disparities among migrants globally.
The review adhered to PRISMA-Sc guidelines.
No patient or public contribution. This review received no funding from public, commercial or not-for-profit sectors.
FreshRSS 