Conectar
by Claire L. Chan, Saskia Eddy, Jennie Hejdenberg, Ben Morgan, Heather M. Morgan, Gillian Lancaster, Clare Robinson, Sandra M. Eldridge
BackgroundThe National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications.
MethodsThe study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document.
DiscussionThis work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications.
Protocol RegistrationOpen Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG.
To assess the impact of a National Enhanced Service (NES) incentive for weight management that financially rewarded practices for each eligible patient referred to a weight management programme.
Interrupted time-series analysis to examine the rate of weight management referral and weight management advice.
Primary healthcare records from January 2018 to December 2024 in the Oxford Clinical Informatics Digital Hub, covering 8.3 million patients in 1198 primary care clinics around England.
NES payments to practices for weight management were introduced in April 2021.
The rate of referral increased from 1 referral per 1000 patients per month before the incentive to around 4 referrals per 1000 patients per month afterwards. There was no evidence that the increase differed by age, gender, ethnic group or socioeconomic status. The occurrence of weight management advice was unchanged by the introduction of the NES and was at least three times more common than referral to weight management services.
The NES was associated with a fourfold increase in referrals to weight management services. However, clinicians are much more likely to offer advice rather than a referral to a weight management programme. There is a clear opportunity to improve outcomes for patients by encouraging greater use of referrals to effective weight management services in place of advice.
Osteogenesis imperfecta (OI) is the most common inherited cause of bone fragility (approximately 1 in 16 000). People with OI suffer bone fragility causing fractures, pain and deformity; sarcopenia causing fatigue and poor endurance; aortic root dilatation and hearing loss. No drug currently has market authorisation to treat OI in Europe. Current standard-of-care is multidisciplinary, with pharmacological interventions—primarily bisphosphonates—directed at increasing bone mass; however, such interventions are of equivocal efficacy. The structural damage that can accumulate as a result of repeated fractures over time may not be reversible. The lack of a treatment with clearly defined efficacy in terms of reducing fracture frequency or the sarcopenia, that is increasingly recognised in this condition, leads to the consideration of alternatives based on what is known about the molecular pathophysiology of the condition. For reasons that are currently unclear, transforming growth factor beta (TGFβ) pathway signalling is increased in OI, and both studies in mouse models and more recently also in humans suggest that reducing TGFβ pathway signalling could be of benefit in OI. This demonstrator project tests the hypothesis that losartan, an antihypertensive agent known to reduce circulating TGFβ, will reduce bone turnover and bone loss and have a positive effect on muscle function and quality of life in adults and older adolescents with OI.
This is a phase 2/pilot, open-label, dose-escalating study. This study aims to identify the effective dose for losartan in this population to inform the design of a pivotal phase III study. The study aims to recruit 30 adolescents and adults aged 16 years and above with OI across secondary care study sites in the UK and Italy. Participants will be recruited from the patient populations attending for treatment of OI at the participating hospital sites or referred by clinicians at the Participant Identification Centres (PIC sites). Participants will be randomised to one of three ‘final doses’—25, 50 or 75 mg losartan once daily. All participants will start on 25 mg once daily. Those assigned to higher ‘final doses’ will increase in 25 mg once daily increments on day 8 and day 15 following safety assessments. The primary outcome measures are to establish the effective dose of losartan in OI patients, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX) over the 24-week period of the study.
Secondary outcome measures are to determine the changes in proxy efficacy outcomes for bone (turnover, mass, architecture and strength) using blood tests, high-resolution peripheral quantitative CT (HRpQCT), dual-energy X-ray absorptiometry (DXA) and muscle (strength) using the ‘Timed Up and Go’ test. In addition, the changes in quality of life, including pain and fatigue, will be evaluated by using a disease-specific tool (OI-QOL) and a validated generic tool (EQ-5D-5L-VAS).
In the UK, the study protocol and amendments have been approved by the London Bridge Research Ethics Committee (REC reference: 23/LO/015) and by the Medicines and Healthcare products Regulatory Agency (MHRA). In Italy, the study protocol and amendments have been approved by the Italian and European ethics and regulatory authorities (Clinical Trials Information System European Union (CTIS EU) portal according to EU Regulation 536/2014). Final version of study protocol: Version 3.2, 05.03.2025. Final results will be disseminated in peer-reviewed journals through local OI, orthopaedic and other relevant clinical networks and at national and international meetings. Sheffield Children’s National Health Service Foundation Trust (UK) and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli (Italy) are the joint study sponsors.
ISRCTN (ISRCTN13317811).
Forming secure attachment relationships provides children with the best possible start to life. Children from families with high psychosocial vulnerability and complex mental health needs (eg, caregivers with lived experience of trauma, experiencing mental illness or substance abuse, current or past domestic violence, and/or current or a history of child protection issues) are at the greatest risk of experiencing attachment disturbances. Nurturing Connections is a new early intervention service launched by the New South Wales State Ministry of Health targeting both caregiver adversity and the caregiver-child attachment relationships in families with high psychosocial vulnerability and complex mental health needs. This paper outlines the evaluation protocol of the Nurturing Connections Programme.
A mixed-methods design will be used to undertake an implementation and outcomes evaluation. The study will draw on both qualitative and quantitative data, including routinely collected service data, surveys, participant observations, and semi-structured interview and yarning circle data. Appropriate descriptive and inferential techniques will be used to analyse quantitative data while thematic analysis will be drawn on to analyse qualitative data.
This research was approved by the South Eastern Sydney Local Health District Research Ethics Committee (2024/ETH01715). The Mid North Coast Local Health District also received ethics approval from the Aboriginal Health and Medical Research Council of New South Wales (2380/25). Evaluation findings will be shared via published manuscripts, conference presentations, as well as a final report to funding bodies.
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.
Despite extensive research on doctoral education, reliable tools to measure how writers' development relates to participation in social interventions such as writing groups are lacking. To address this, we conducted a study to create and evaluate a measurement tool for assessing the impact of writing group interventions on writers' development.
This methodology paper reports on the design, content validity, and evaluation of a new survey tool: the Doctoral and Academic Writing in Nursing, Midwifery, and Allied Health Professional writing questionnaire (DAWNMAHP).
We created a pool of 39 items based on empirical articles from SCOPUS, ERIC, BEI, ZETOC, CINAHL, EBHOST, and PsycINFO, our experience, and stakeholder consultations. After a content validity assessment by writing experts, we revised the pool to 44 items in five domains. Finally, we tested it on doctoral writing workshop attendees using factor analysis, Pearson correlations, and Cronbach's Alpha evaluation.
Thirty-six participants completed the DAWNMAHP survey tool: 22 doctoral students, seven early-career researchers, and seven participants on a designated pre-doctoral pathway. Cronbach's Alpha evaluation demonstrated good reliability (α > 0.70) for all five factors. This sample was deemed moderately sufficient (KMO = 0.579), and the items were loaded onto the five factors with all items' factor loadings > 0.5 through principal component analysis.
DAWNMAHP is a novel, reliable tool that measures the impact of writing group interventions on an individual writer's development concerning time management, the writing process, identity, social domains, and relational agency.
Conducting pre- and post-writing group intervention tests and recruiting larger sample sizes is essential to further developing DAWNMAHP. It is a rigorous tool for researching the benefits of writing group interventions. Furthermore, DAWNMAHP is an effective assessment and measurement tool, making a novel contribution to research into doctoral education.
No patient or public involvement was necessary at the validation stage of the DAWNMAHP tool.
To co-identify adaptations with key stakeholders needed to optimise elements of a video-based intervention (i.e., PREEMIE PROGRESS [PP]), which trains parents in evidence-based family management skills to care for their very preterm infant in the neonatal intensive care unit (NICU).
Descriptive qualitative study oriented with a pragmatic philosophy, informed by the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework and the framework for reporting adaptations and modifications-expanded (FRAME).
Semistructured interviews to identify potential adaptations with key stakeholders: family management researchers (n = 5), clinicians (n = 9), technology experts (n = 5) and parents of preterm infants (n = 17). Weekly design team meetings to select and implement high-priority adaptations necessary for the next research phase. Monthly NICU parent partnership meetings to review adaptations and make recommendations for potential adaptations with conflicting data.
Stakeholders (N = 36) suggested 98 potential adaptations: 32 (33.0%) were completed, 8 (8.2%) were abandoned, 5 (5.2%) have work that is ongoing and 52 (53.6%) were tabled for future research phases. Content adaptations (70, 71.4%) were the most frequently suggested adaptation type. Potential adaptations mostly addressed RE-AIM dimensions of effectiveness (43, 43.9%), and implementation (46, 46.9%) and were directed at the parent (i.e., intervention recipient) level (79, 81.4%).
Use of the RE-AIM framework ensured we systematically identified needed adaptations with key stakeholders across a range of dimensions that would improve PP for parents now and in future phases of this research.
Co-identifying potential adaptations with key stakeholders, paired with FRAME documentation, can help nurses prioritise adaptations most appropriate for each phase of implementation.
Our paper highlights for nurse clinicians and researchers how FRAME documentation of potential adaptations can support stakeholder engagement and a systematic approach to incorporating adaptations throughout all phases of the research process, thereby shortening the evidence to practice gap.
COREQ guidelines for qualitative reporting.
The research team was supported by members of the NICU's Parent Partnership Council (PPC), whose mission is to promote family-centred care improvement projects and research within the NICU. This committee is comprised of nursing, physician, allied health leadership and parents of infants previously hospitalised in the NICU. The NICU PPC met monthly to review conflicting data on potential adaptations and provide recommendations on adaptation decisions.
Maternal respiratory syncytial virus (RSV) vaccination has been introduced to protect infants from severe respiratory infections. However, its uptake and impact on perinatal outcomes are unknown in the UK.
To evaluate uptake of RSV vaccine during pregnancy in a UK population.
This cross-sectional study was conducted at a tertiary maternity hospital in London. The participants included pregnant women who delivered between 1 September and 17 December 2024 (n=1157). For the analysis of vaccine uptake, the cohort included women eligible for vaccination who delivered beyond 28 weeks’ gestation and were at 36 weeks or less on 1 September 2024 (n=911). The main outcome measures were RSV vaccine uptake and its association with sociodemographic factors, perinatal outcomes including preterm birth (PTB), hypertensive disorders of pregnancy and stillbirth.
Of 911 eligible women, 19% (n=173) received the RSV vaccine during pregnancy. Uptake increased significantly from 4% in September to 32% in December (p
RSV vaccine uptake shows significant increases over time, with disparities in uptake by ethnicity and socioeconomic status. Further research is needed to increase vaccination rates, particularly in disadvantaged groups, and evaluate perinatal outcomes.
To explore oncology nursing advance care planning practices and understand how to better support nurses in conducting advance care planning with patients and their families.
Qualitative interpretive descriptive methodology.
Semi-structured, individual telephone or Zoom interviews with 19 oncology nurses in a Western province of Canada between May and August 2022. Interviews were audio-recorded, transcribed, de-identified, and analysed using inductive, thematic, and constant comparative techniques.
Oncology nurses highlighted several factors affecting their ability to engage in advance care planning, including (1) uncertainties related to the nursing role in advance care planning, such as how and when a nurse ought to engage; (2) the educational, experiential, and training environment; and (3) structural barriers, such as a lack of time, space, and privacy; models of care that inhibit nurses from developing longitudinal relationships with their patients; and team dynamics that affect advance care planning interdisciplinary collaboration.
To create environments that support oncology nurses to conduct advance care planning, the findings suggest uncertainties be addressed through a clear and cohesive organisational approach to advance care planning and ongoing, integrated educational opportunities. Further, service delivery models may need to be restructured such that nurses have dedicated time and space for nurse-led advance care planning and opportunities to develop trusting relationships with both patients and their interdisciplinary colleagues.
Oncology nurses recognised the value of advance care planning in supporting patient-centred care and shared decision making, yet they reported limited engagement in advance care planning in their practice. To support oncology nurses in conducting advance care planning, healthcare leaders may address (1) advance care planning-related uncertainties and (2) structural barriers that prevent nurses from engaging in advance care planning with patients and their families. Findings may guide modifications to care models, enhancing support for oncology nurses in conducting advance care planning.
We selected and adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ) as the most applicable guideline.
No patient or public contribution.
The aim of this study was to develop a conceptual understanding of the role of caring for older adults with combined vision and hearing impairment (DSI).
Dual sensory impairment (DSI) impacts both listening and speechreading communication, function and social participation, meaning that older adults often require support and care to ‘age in place’ successfully. Family carers play a key role in supporting older adults with DSI to maintain social and physical health.
This qualitative study uses Charmaz's constructivist grounded theory (GT) methodology. Data were collected between 2017 and 2019 and analysed using constructivist GT methods. Lengthy interviews with eight family carers of older adults living with DSI explored personal histories of DSI, relationships with families, social networks and health care professionals.
This study demonstrates that caring in this context is predominantly social and ‘invisible’. To reduce the social effort of their family member with DSI and to maintain their own self-identity, family carers adopted a ‘conscious caring’ approach. This is conceptualised as an approach to caring that supports family carers to access resources embedded in their social networks by bridging the gap between the dyad and their broader, more diverse social networks.
This study identifies that a reduction in both close and broader social networks limits personal, social and psychosocial resources and impacts the capacity of the dyad to renegotiate their roles, create and maintain their individual and shared social networks and successfully transition to living with DSI.
There is a gap in the literature regarding the impact of sensory impairments on complex communication, health and social care needs of older adults and the role that family carers play. Registered nurses require complex communication skills to support older persons with DSI during health and social care interactions. A better understanding of DSI itself, as well as understanding the key role family carers play in integrating care for their family member, is crucial to delivering person-centred care.
This study addresses a growing social gerontological issue and identifies the role that family carers play in integrating health and social care for their family member with DSI. Better professional recognition of DSI and increased visibility of the challenges of living with DSI could help address barriers to effective communication between service providers, formal care support staff and those with DSI. Integrating family carers into care teams is critical to improving health and social care experiences for both caregiver and care receiver.
This study did not include patient or public involvement in its design, conduct, or reporting.
Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).
A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.
The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.
ClinicalTrials.gov Identifier: NCT06308029.
The aim of this study was to determine the effect of real-time videos with smart glasses on the performance of cardiopulmonary resuscitation performed by nursing students. In this randomized controlled pilot study, the students were randomly assigned to the smart glass group (n = 12) or control group (n = 8). Each student's cardiopulmonary resuscitation performance was evaluated by determining sequential steps in the American Heart Association algorithm they applied and the accuracy and time of each step. A higher number of participants correctly checked response breathing, requested a defibrillator, activated the emergency response team, and provided appropriate chest compressions and breaths in the smart glass group than the control group. There were significant differences between groups. Furthermore, more participants significantly corrected chest compression rate and depth and hand location, used a defibrillator, and sustained cardiopulmonary resuscitation until the emergency response team arrived in the smart glass group than in the control group. Additionally, a significantly shorter time was observed in the smart glass group than in the control group in all variables except time to activate the emergency response team (P For nurse leaders to excel in leadership roles in the clinical world of informatics, a comprehensive understanding of nursing informatics as translated within the broader scope of health informatics including clinical informatics and business intelligence is necessary. The translation of nursing informatics in the comprehensive scope of health informatics is not consistently taught in graduate nursing leadership curricula. Collaboratively, from an interprofessional education stance, a graduate nurse informatics course was re-visioned using translational pedagogy: the idea of teaching related concepts by translating each and vice versa. Specifically, we translated nursing informatics amid health informatics concepts including business intelligence. Leadership students in the re-visioned course experienced the ability to visualize, conceptualize, and understand how work in information systems impacts broader aspects of clinical and business decision-making. Looking at nursing informatics through the lens of health informatics will develop students' ability to visualize, conceptualize, and understand how work in information systems has an impact on the broader aspects of clinical decision-making and support. Further, this paradigm shift will enhance students' ability to utilize information systems in leadership decision-making as future knowledge workers. No abstract available Background
Women veterans have a high prevalence of traditional and nontraditional risks for cardiovascular disease (CVD) including obesity and posttraumatic stress disorder. Experts from the U.S. Department of Veterans Affairs have called for actions to improve the cardiovascular health of this population. One approach is to assess women veterans’ barriers to care-seeking for CVD prevention, to inform future intervention research.
Objective
The objective of this study was to describe women veterans’ barriers to care-seeking for CVD prevention, guided by the theory of care-seeking behavior and concept awareness.
Methods
Using a cross-sectional, descriptive design, a national sample of 245 women veterans participated in an online survey about barriers to care-seeking. Participants provided narrative responses to open-ended items, endorsements to closed-ended items, and rankings of their top five barriers. Researchers conducted poststratification weighting of numerical data to reflect the women veteran population.
Results
Narrative responses described unaffordable and inaccessible services, feeling harassed or not respected in healthcare settings, and lack of awareness of risks for CVD. Frequently endorsed barriers were unaffordable and inaccessible services. Frequently ranked barriers were feeling not respected in healthcare settings and clinicians not recommending CVD prevention.
Discussion
Findings support concepts in theory of care-seeking behavior and concept awareness. Understanding women veterans’ barriers to care-seeking for CVD prevention can inform clinicians and researchers as they address these barriers. Background
A gap in research about the trajectories of function among men and women aging with functional limitations because of multiple sclerosis (MS) hinders ability to plan for future needs.
Objectives
Using a biopsychosocial model, we characterize how men and women with MS report changes over time in their function and test how person-level differences in age, diagnosis duration, and sex influence perceived function.
Methods
A longitudinal study with multiple waves of surveys was used to collect data on participant perceptions of function, as well as demographic and contextual variables. Self-reported functional limitation was measured over a decade. The study participants were community residing with physician-diagnosed MS.
Results
The people with MS had a diagnosis duration of about 13 years and were around 51 years of age, on average, at the start of the study. They were primarily women and non-Hispanic White. We analyzed the data using mixed-effects models. Subject-specific, functional limitation trajectories were described best with a quadratic growth model. Relative to men, women reported lower functional limitation and greater between-person variation and rates of acceleration in functional limitation scores.
Discussion
Results suggest function progressed through two pathways for over a decade, particularly closer to diagnoses. Variability in trajectories between individuals based on sex and years since diagnosis of disease indicates that men and women with MS may experience perceptions of their function with age differently. This has implications for clinician advice to men and women with MS. 
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