To clarify the concept of disempowerment in adults with chronic illness.
The Walker and Avant approach to concept analysis was used.
A systematic literature search was performed on 14 February 2024, using the following databases: CINHAL, PubMed, PsycINFO, Sociological Abstracts and ProQuest Dissertations & Theses Global A&I: The Humanities and Social Sciences Collection. Studies examining adults' experience of individual disempowerment stemming from chronic illness were included. Definitions and descriptions of the concept in the included studies were extracted and synthesised into defining attributes, antecedents, and consequences.
Forty-five articles were included. Two defining attributes were identified: (1) diminishing opportunities to take control and (2) clients' dissatisfaction with diminishing control. Antecedents were changes in health status related to chronic illness and expectation mismatch within the client, or between clients and their care partners. The consequence of disempowerment was disengagement in the context of disempowerment.
Disempowerment was found as the state of dissatisfaction with diminishing opportunities to control personal lives, which stems from changes in health status and expectation mismatch and leads to disengagement in the context of disempowerment. Contrary to prior studies, where disempowerment was often considered an outcome of an imbalanced relationship between clients and care partners, the present findings showcased disempowerment as a holistic illness experience, involving changes in health status. The understanding of disempowerment as the dissatisfaction with the situation of diminishing opportunities to take control differentiates this concept from the opposite of empowerment, which is conceptualised as clients' ability to make decisions or manage diseases. Findings further highlight the importance of understanding clients' illness experience comprehensively and providing care in a manner that is matched with clients' abilities, expectations and needs. It is suggested that operationalising the concept based on this understanding is necessary in order to understand correlations between disempowerment, its causes and consequences.
Disempowerment has been applied to describe interruptions in their states of being, perceived role performances, and independence in adults with chronic illness from diverse perspectives in the extant literature, such as the opposite of empowerment, action to take away control over personal lives and a state of diminishing ability to tackle problems. Through clarifying the concept, this article will guide the communication, measurement tool development and response in clinical practice.
No patient or public contribution.
by Job Kasule, Julius L. Tonzel, Natalie Burns, Tyler Hamby, Roger Ying, Grace Mirembe, Immaculate Nakabuye, Hannah Kibuuka, Margaret Yacovone, Betty Mwesigwa, Trevor A. Crowell, for the Multinational Observational Cohort of HIV and other Infections (MOCHI) Study Group
BackgroundPeople with behavioral vulnerability to HIV face barriers to healthcare engagement that may impede uptake of non-pharmaceutical and other interventions to prevent COVID-19. Understanding COVID-19 knowledge, attitudes, and practices in this population can inform disease prevention efforts during future pandemics.
Materials and methodsFrom October 2022 to September 2024, we enrolled participants aged 14–55 years without HIV who endorsed recent sexually transmitted infection, injection drug use, transactional sex, condomless sex, and/or anal sex with male partners. At enrollment, we collected socio-behavioral data, including assessments of COVID-19 knowledge, attitudes, and practices. Robust Poisson regression with purposeful variable selection was used to estimate prevalence ratios with 95% confidence intervals for factors associated with COVID-19 preventive practices.
ResultsAmong 418 participants, 228 (56.9%) were female, the median age was 21 years (interquartile range 19−24), and 362 (84.9%) reported sex work. Knowledge about SARS-CoV-2 transmission routes was high (95.4%) but lower for the consequences of genetic variants (48.5%−69.7%) and possibility for asymptomatic infection or transmission (66.7%−80.8%). Handwashing was practiced by 90.8% of participants in the preceding month, whereas mask-wearing (76.5%), avoiding symptomatic people (73.7%), and any history of COVID-19 vaccination (46.9%) were less prevalent. Males were more likely to report avoiding symptomatic people (adjusted prevalence ratio 1.16 [95% confidence interval 1.03–1.31]) and COVID-19 vaccination (1.30 [1.05–1.60]). Enrollment during the BQ.1/BQ.1.1 Omicron wave was associated with less mask-wearing (0.81 [0.67–0.99]) but more vaccination (1.59 [1.29–1.95]).
DiscussionWe observed variable COVID-19 knowledge and attitudes among Ugandan adolescents and adults with little impact on COVID-19 preventive practices. Efforts to address suboptimal uptake of disease preventive practices during this and future disease outbreaks will require more than just improving knowledge.
by Ralph Kwakye, Grace Boakye, Bright Yaw Vigbedor, Albert Aniagyei, Bernard Owusu Asimeng, Boniface Yeboah Antwi, David Neglo, Salifu Nanga
Zeolite X was synthesized from kaolin and then modified using (Azadirachta indica) neem together with silver nitrate solution by ion exchange. X-ray diffraction confirmed a highly crystalline FAU framework characterised by a low angle reflection, which showed that silver incorporation did not alter the zeolite structure. Scanning Electron Microscopy (SEM) revealed a well-defined polyhedral crystal for zeolite X, whiles the Ag-zeolite X exhibited increased surface heterogeneity and agglomeration. Fourier Transform Infrared (FT-IR) and Raman Spectroscopy further confirmed framework retention, with band broadening attributed to the partial substitution of Na⁺ by Ag+ within the zeolite lattice. The antimicrobial activity of zeolite X, Ag-zeolite X, were evaluated against Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Enterococcus faecalis, Candida albicans, Aspergillus niger strains by Minimum Inhibition Concentration (MIC) and Minimum Bacterial/fungal Concentration (MBC/MFC) Assays. The antioxidant properties were evaluated using 2,2-Diphenyl-1-picrylhydrazyl (DPPH) and 2,2’-Azino-bis (3-ethylbenzothialine-6-sulfonic acid (ABTS) radical scavenging assays. The unmodified zeolite X showed weak activity (MIC, MBC, MFC > 1 mg/mL, R > 4) whilst the Ag-zeolite X showed strong antimicrobial activity (MIC = 0.5–1.0 mg/mL, MBC, MFC = 0.5–2 mg/mL, R ≤ 4) across all tested strains. Antioxidant activity assessed using DPPH and ABTS radical scavenging assays showed significantly enhanced antioxidant performance for Ag-zeolite X compared to unmodified zeolite X, particularly in the ABTS assay. These findings demonstrate that neem-assisted silver modification enhances the bioactivity of kaolin-derived zeolite X while preserving its crystalline framework, supporting its potential application in biomedical, food packaging, and water treatment systems.To (1) examine the attitudes of community-dwelling adults towards death and their ability to cope with death, as well as (2) understand the influence of advance care planning on community-dwelling adults' death attitudes and coping with death.
A sequential explanatory mixed-methods study was conducted in Singapore.
In Phase I, a case–control study was conducted to examine the differences in death attitudes and coping with death ability between community-dwelling adults who have completed advance care planning and those who have not. A univariate general linear model was used to compute the mean difference in death attitudes and coping with death scores. In Phase II, a descriptive qualitative study was conducted to provide an in-depth understanding of the influence of advance care planning among community-dwelling adults. Thematic analysis was used for qualitative analysis. Mixed-methods analysis was conducted to integrate the quantitative and qualitative data.
In Phase I, 80 community-dwelling adults who had completed advance care planning and 81 community-dwelling adults who did not have advance care planning were included. Adults who had completed advance care planning had significantly higher coping with death scores (t = 4.14, p < 0.01). In Phase II, a purposive sample of 24 adults who had completed advance care planning was selected for individual semi-structured interviews. From the thematic analysis, three themes were developed: (1) Advance care planning enables coping with death, (2) overcoming fear of death with advance care planning and (3) confronting death with advance care planning.
Advance care planning may influence death attitudes and coping with death. Further work on longitudinal designs and among individuals from different age groups should be used to gain further in-depth understanding of the impacts of advance care planning.
Strategies to enhance one's coping abilities with death and death attitudes should be developed to stimulate the uptake of advance care planning.
This paper was reported according to the Good Reporting of A Mixed Methods Study framework.
Community-dwelling adults participated in the survey and interviews.
by Taylor E. Gin, Charlotte O. Moore, Trey Tomlinson, Grace Wilson, Amiah Gray, Cameron Sutherland, Kamilyah Miller, Krista Li, Michael Canfield, Brian Herrin, Erin Lashnits, Benjamin Callahan
BackgroundCtenocephalides felis is a common ectoparasite of dogs and cats and can transmit a variety of pathogens including Bartonella and Rickettsia species. These bacteria, along with the known endosymbiont Wolbachia, are well-documented members of the C. felis microbiome, but species-level information is limited. Additionally, little is known about the variation in the C. felis microbiome in fleas from different sources and when different sequencing methods are applied to the same samples.
ObjectiveThis study aimed to characterize the flea microbiome using both short-read (V3/V4) and long-read (full-length) 16S rRNA gene sequencing, determine whether long-read sequencing improves species-level identification especially in known pathogenic genera, and evaluate differences in microbial composition between fleas collected from cats, dogs, and environmental traps.
MethodsFleas were collected from cats, dogs, and traps in flea-infested homes in Florida, pooled by source, and sequenced using short- (V3/V4) and long-read (full-length) 16S rRNA gene sequencing. Microbial prevalence and abundance were compared across sequencing approaches. Community composition was evaluated for differences between sources and houses. Candidate members of the flea microbiome were identified based on a combination of prevalence, abundance, and statistical signatures of potential contaminant origin. For Rickettsia and Bartonella, species-level taxonomic assignments were refined using a phylogenetic approach.
ResultsWolbachia, Rickettsia, and Bartonella were the most prevalent and abundant taxa. Spiroplasma was identified as a fourth core member of the flea microbiome. Long-read sequencing enabled better, but not perfect, species-level classification of Bartonella and Rickettsia compared to short-read sequencing. Important relationships between specific ASVs and flea sources were identified, for example fleas from cats harbored higher abundances of B. clarridgeiae and B. henselae than fleas from traps.
Identify and describe patient engagement interventions used to improve medication management in older adults during transitions of care.
A mixed-methods systematic review.
A comprehensive search of all study designs was conducted. Studies were categorised using the ladder of patient and family engagement, a framework that positions engagement from low (passive) to high (active partnership) patient engagement.
Six databases were searched from inception to April 2024.
The search yielded 29 reports, with 25 classified as studies. Most interventions (n = 19, 76%) were low-level interventions that comprised informing patients in a passive manner. Interventions that facilitated high-level engagement (n = 6, 24%) where patients were integrated in the decision-making process were associated with consistently improved patient and healthcare long-term outcomes.
While low and high-level engagement interventions were associated with significantly decreased hospital readmission rates, high-level interventions consistently demonstrated positive patient outcomes. Interventions supporting older adults beyond discharge achieved meaningful and lasting patient and healthcare outcomes for older adults.
Findings provide clinical reference for designing engagement interventions, highlighting long-term benefits of partnership-based approaches and continuity beyond discharge.
Engagement in medication management during transitions of care varied significantly. High-level engagement was consistently linked to improved patient and healthcare outcomes but was often resource intensive. This review identifies the need to design balanced interventions that align with the preferences of older adults and real-world contextual healthcare settings.
PRISMA guidelines.
No patient or public contribution.
PROSPERO (registration number CRD42024557385).
This systematic review and meta-analysis evaluated the efficacy of infrared (IR) devices versus the traditional palpation technique for first-attempt success of peripheral intravenous catheter (PIVC) insertion in adults.
Systematic review and meta-analysis of randomised controlled trials (RCTs).
A comprehensive search of PubMed, Embase, Cochrane Library, Scopus and CINAHL was conducted on 28 May 2024 and included articles in English or French published from 1st January 2000 onwards.
Eligible studies included RCTs comparing IR devices with the traditional palpation method for PIVC insertion in adults. The primary outcome was first-attempt success. Secondary outcomes included overall success, number of attempts, cannulation time and patient pain. The risk of bias was assessed using the RoB2 tool, and a random-effects model was applied for meta-analysis.
Five RCTs were included, involving 690 patients and 704 catheters, including 289 PIVCs in patients with Difficult Intravascular Access (DIVA) criteria. First attempt insertion success was similar when using infrared devices (139/331, 42%) and traditional palpation (143/373, 38%) with Risk Ratio (RR) 1.08 (95% CI, 0.69 to 1.70). No significant statistical differences were noted in secondary outcomes: overall insertion success, number of attempts, time to cannulate and patient pain. Clinical and statistical heterogeneity were substantial (primary analysis I 2 = 83%).
Current evidence does not support the systematic use of infrared devices to improve PIVC insertion success, reduce the number of attempts or alleviate patient pain compared with traditional palpation in adults. Further high-quality studies with suitable sample sizes and varied populations are needed to better establish the potential place of infrared devices.
This study highlights the limited benefit of IR devices in routine clinical practice and underscores the need for further research into their use in specialised settings.
No Patient or Public Involvement. This study did not include patient or public involvement in its design, conduct or reporting.
This study explores the lived experiences of critical care nurses who are also mothers, focusing on their challenges with breastfeeding and pumping at work.
Using interpretive phenomenology, grounded in Martin Heidegger's work, semi-structured interviews were conducted with critical care nurses (N = 54) who were also breastfeeding mothers in the United States in 2024. Data were transcribed verbatim and analysed using Patricia Benner's interpretation of the hermeneutic circle in nursing data analysis to identify the essence of lived experiences in breastfeeding as a critical care nurse mother.
Four main themes emerged during the analysis. They are as follows: (1) The Impact of Workplace Environment on Breastfeeding Nurse Mothers and Their Children, (2) The Role of Organisational Support and Resources in Retaining Breastfeeding Nurse Mothers in Critical Care, (3) Team Dynamics and Career Implications of Breastfeeding for Nurse Mothers in Critical Care and (4) Organisational and Systemic Approaches to Supporting Breastfeeding Nurse Mothers in Critical Care.
The findings highlight critical gaps in workplace policies and support systems for breastfeeding nurses. Addressing these inequities through the provision of adequate lactation facilities, flexible pumping schedules and a supportive workplace culture is essential to reducing stress and enabling nurse mothers to continue breastfeeding successfully. This study underscores the need for systemic reforms to support breastfeeding in the nursing profession.
This study did not include patient or public involvement in its design, conduct or reporting.
To examine the American Cancer Society's HPV vaccination guidelines through a nursing policy analysis framework, assessing justice and equity outcomes in cancer prevention policy implementation.
Human papillomavirus vaccination remains critical for cancer prevention, yet persistent health disparities undermine equity goals despite evidence-based policy recommendations. Limited research has systematically applied nursing conceptual frameworks to analyse vaccination policy through an explicit equity lens.
Policy Analysis Using the Russell and Fawcett Conceptual Model for Nursing and Health Policy, Focusing on Level 4 Outcomes Addressing Justice, Social Changes and Market Interventions.
Systematic analysis of policy sources (public, organisational, professional), components (personnel, services, expenditures) and outcomes across quality, cost and access dimensions. Data sources included primary policy documents, implementation reports and peer-reviewed literature from 2015 to 2024. Thematic analysis examined policy effectiveness through distributive and procedural justice lenses.
Critical policy fragmentation creates systematic equity barriers, with only five jurisdictions (Virginia, District of Columbia, Rhode Island, Puerto Rico, Hawaii) achieving > 70% vaccination coverage through school-entry mandates and 46 states and territories demonstrating substantially lower rates. Rural adolescents experience 15%–20% lower vaccination rates, while Black adolescents show 10 percentage points lower coverage than white adolescents despite federal Vaccines for Children (VFC) program investment of $4.2 billion annually. Provider training gaps and cultural competency limitations disproportionately affect communities of colour. Healthcare system transformation remains concentrated in well-resourced organisations, creating two-tiered implementation that reinforces existing disparities.
Achieving cancer prevention equity requires coordinated interventions across multiple policy levels, enhanced provider training emphasising cultural competency, community-based service expansion and equity-focused resource allocation. Federal leadership establishing minimum vaccination requirements linked to education funding, respecting state constitutional authority, sustainable funding models and nursing leadership represent essential actions for advancing health equity.
Demonstrates nursing frameworks' utility for rigorous health policy analysis while providing evidence-based recommendations for strengthening vaccination policy to achieve cancer prevention equity across diverse populations.
This study did not include patient or public involvement in its design, conduct or reporting.
To characterise nurses' perspectives on factors that influence their ability to provide patient-centered nursing care for autistic patients in a large urban hospital setting.
Qualitative exploratory study.
We conducted semi-structured interviews via Zoom with nurses from a large urban hospital serving primarily adult patients. We analysed interviews using codebook/template analysis. Two researchers coded each interview and resolved discrepancies through discussion.
Twelve nurses (3 males) with 2–20 years of professional experience across research, management, and patient care roles were interviewed. Three primary themes were generated: (1) barriers to patient-centered care, including lack of formal autism education, factors related to the hospital setting, and specific nurse characteristics, such as inflexible adherence to care routines; (2) facilitators of patient-centered care, including experiential autism knowledge, caregiver involvement, and specific nurse characteristics, such as showing respect for all patients; and (3) missed opportunities for patient-centered care, including underuse of behavioural care teams, inadequate time for planning and preparation, and reliance upon restraints and security personnel for behaviour management.
Nurses identified several areas where consistent implementation of existing processes could improve care. A key finding was the need to explore more patient-centered alternatives to the use of restraints and security personnel in response to aggressive or self-injurious behaviour. Overall, our results support the need for competency training to facilitate increased nursing comfort and ability to provide patient-centered care for autistic patients.
This work suggests nurses gain much of their autism-related knowledge through patient care experiences. Despite providing the majority of hands-on care, nurses receive little to no formal training about caring for the growing autistic population.
This work has identified targeted areas to improve education and processes in caring for autistic patients.
No patient or public contribution.
Examine the meaning of ‘successful feeding’ for parents of infants at risk for feeding difficulties and how this meaning evolved from 1 to 24 months post-term age.
Secondary analysis of responses to an open-ended question from a U.S. longitudinal mixed methods study.
At 1-, 6-, 12-, 18-, and 24-months post-term, parents completed surveys which included the question: What is ‘successful feeding’ to you? Using conventional content analysis, 864 responses from parents of 254 infants were coded into the following categories: Child Behaviour, Positive Response, Intake, and Time. Themes characterizing each category were identified.
Child Behaviour, Positive Response, and Intake were common at all time points. Responses related to Time (e.g., eating in a timely manner) were least frequent at 1, 6, and 12 months and were no longer mentioned thereafter. Demonstrating feeding skill/ability and satiety were common themes at all time points. Adequate quantity of food and no adverse response (e.g., emesis, choking) were common themes at 1 month; both decreased thereafter. The perception that the child was engaged in eating and eating nutritionally adequate food increased as children aged.
Parents' perspectives of successful feeding focused on indicators of their child's development and emotional and physical well-being. As their children aged, ate increasingly complex foods, and developed physiologic stability, the meaning of success focused less on the amount of intake and avoidance of an adverse response and more on child well-being.
Nurses and feeding specialists can incorporate parents' views of success as they provide feeding support.
Children having a positive behavioural and affective response to eating, and adequate intake provide evidence to parents of their success in achieving feeding goals. Understanding issues of importance to parents is an essential component of family-centered care of children with feeding difficulties.
No Patient or Public Contribution.
The authors have adhered to the Standards for reporting qualitative research.
Peripheral intravenous catheters (PIVCs) serve as crucial devices for essential care administration in emergency departments (ED). In Australia, to standardise clinical practice, the national PIVC Clinical Care Standard was introduced in 2021, however adherence to the Standard has not been adequately explored. Therefore, this study aims to investigate ED clinicians' adherence to the Standard via prospective audit.
This cross-sectional observational study of PIVCs was conducted in three Australian EDs between 2022 and 2023. Data were collected in alignment with the quality indicators in the PIVC Clinical Care Standard. Research nurses collected the data from bedside observation and chart audit, with data analysed descriptively.
Out of 1568 episodes of PIVC care recorded, there were notable shortcomings. ED nurses and doctors provided minimal patient partnership during insertion episodes: PIVC self-care education (n = 4, 1.4%), discussion of potential risks/benefits (n = 8, 2.9%), and reporting of concerns (n = 16, 5.8%). Insertions primarily occurred at the antecubital fossa (n = 225, 81.2%), with a common issue being inadequate time for antiseptic solution to air dry (n = 156, 56.3%). Ongoing needs assessment was unable to be assessed due to documentation limitations, which were generally incomplete. Idle catheters (inserted but not used) were prevalent (n = 115, 41.8%), and only a quarter of inpatient ward admissions (n = 75, 27.3%) had clear indications for PIVC use.
These findings highlight the suboptimal ED PIVC practices that require attention and improvement. Innovative interventions and technology are necessary to address some of these suboptimal practices due to their complexity and persistent challenges, despite previous efforts by clinicians and researchers.
The findings underscore the need for well-resourced efforts to ensure adherence to evidence-based practices in dynamic clinical settings.
The study is reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement.
None.
Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.
This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.
Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.
Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B
Among the emergency services, firefighters have the highest percentage of mortality (45%) due to sudden cardiac death, with the majority related to underlying cardiovascular disease. This necessitates that firefighters stay in good physical condition and maintain adequate cardiovascular fitness to cope with these stressors and perform their duties with minimal health risks. Therefore, this study aims to determine the association between metabolic syndrome and physical fitness in firefighters.
The authors will search the following electronic databases: PubMed/Medline, SCOPUS and Web of Science, with no limitations to publication year. For data extraction, the two principal reviewers will use a general data extraction form to retrieve the key characteristics of each study. The Rayyan intelligent systematic review tool will be used to screen and select studies for inclusion. Thereafter, information from the included studies will be captured on the researcher-generated data extraction form. The Joanna Briggs Institute (JBI) Critical Appraisal Tools for quantitative studies will be used to conduct the methodological assessment of each study included. Data will be analysed using Review Manager 5.3 to determine the exposure effects and MedCalc statistical software Ltd and will be used to determine the pooled correlation effects. The results will be presented using figures, graphs and tables.
Details for this systematic review protocol can be accessed on PROSPERO (CRD42024535088). The authors will disseminate this protocol and the findings of the systematic review and meta-analysis in peer-reviewed journals and in national and international conferences. In addition, this review will add significantly to the body of knowledge in the scientific community worldwide and assist academics in exploring research gaps on this topic.
CRD42024535088.
Heart failure clinics (HFCs) are associated with increased survival rates, lower hospitalisation and improved quality of life. This study investigated factors influencing patient access to multidisciplinary outpatient HFCs from the perspective of patients and cardiologists.
This was a qualitative study. A trained researcher conducted semistructured face-to-face interviews with patients and online interviews with cardiologists. Interviews, conducted between March and October 2023, were audio-recorded. Transcripts were cleaned (deidentification, translation verification) and analysed by two trained researchers independently using systematic text condensation in NVivo v12. Codes were derived from the transcripts and grouped and organised into themes. Two authors independently coded data, reconciling disagreements with the senior author, followed by respondent validation. Member checking ensued.
Outpatient multidisciplinary HFCs in Qatar.
A purposive sample of patients diagnosed with heart failure who had attended at least one HFC appointment at Qatar’s Heart Hospital were approached in person or via phone, and cardiologists with the authority to make referrals to these clinics via the electronic medical record system were emailed; interviews ensued until theme saturation was achieved.
26 individuals (14 patients and 12 cardiologists) participated in the interviews. Four major themes were identified: health system organisation (subthemes: benefits, HFC triage criteria, need/capacity), HFC referral processes (subthemes: electronic record system, patient communication and education), care continuity and communication (subthemes: patient navigators, clinician preferences) and access challenges (subthemes: transportation, costs).
Resources are needed to expand HFC capacity and coverage, leverage electronic medical record tools as well as telehealth, educate physicians and patients on referral guidelines and processes and engage primary care to ultimately improve patient outcomes.
Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.
A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.
Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.
COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)
CRD42024562735.
Acute intracerebral haemorrhage (ICH) is devastating with a 1 month mortality rate of ~40%. Cerebral oedema can complicate acute ICH and is associated with poor outcome. In patients with large ICH, the accompanying swelling increases mass effect and causes brain herniation. Mannitol, an osmotic diuretic, is used to treat cerebral oedema after traumatic brain injury, but its safety and efficacy in ICH is unclear. We aim to assess the feasibility of a phase II randomised, controlled trial of mannitol in patients with ICH with, or at risk of, cerebral oedema to inform a definitive trial.
The mannitol for cerebral oedema after acute intracerebral haemorrhage trial (MACE-ICH) aims to include 45 ICH participants from 10 UK sites with estimated largest diameter of haematoma volume >2 cm, presenting within 72 hours of onset with, or at risk of, cerebral oedema (limited Glasgow Coma Scale (GCS)8) with or without mass effect. Participants will be randomised (1:1:1) to 1 g/kg 10% single-dose intravenous mannitol, 1 g/kg 10% mannitol followed by a second dose at 24 hours, or standard care alone. Outcome assessors will be masked to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, participants receiving allocated treatment, recruitment rate, treatment adherence and follow-up. Secondary outcomes include serum electrolytes and osmolality at days 1–2; change in ICH and oedema volume at day 5; number of participants who developed urinary tract infection, GCS and National Institutes of Health Stroke Scale at day 5±2; length of hospital stay, discharge destination and death up to day 28; death and death or dependency by day 180 and disability (Barthel Index), quality of life (EuroQol, 5-D) and cognition (telephone mini-mental state examination) at day 180.
MACE-ICH received ethics approval from the East Midlands-Leicester Central research ethics committee (22/EM/0242). The trial is funded by a National Institute for Health and Care Research RfPB grant (203080). The results will be published in an academic journal and disseminated through academic conferences and patient support groups. Reporting will be in line with Consolidated Standards of Reporting Trials recommendations.
ISRCTN15383301; EUDRACT 2022-000283-22.