Conectar
Proactive deprescribing is the process of stopping a medicine and comprises four steps: (1) identify a patient for potential stop of a medicine, (2) evaluate a patient for potential stop of a medicine, (3) stop a medicine and (4) monitor after stopping.
The CHARMER (CompreHensive geriAtRician-led MEdication Review) trial is a stepped-wedge design to evaluate the effectiveness and cost-effectiveness of a behaviour change intervention to increase proactive deprescribing in hospitals. The CHARMER intervention comprises a deprescribing action plan, deprescribing briefings, videos of successful deprescribing consultations, deprescribing case studies workshop and a deprescribing performance dashboard. The process evaluation will explore trial processes, CHARMER intervention implementation, CHARMER behavioural mechanisms of action and contextual factors influencing these aspects.
The convergent parallel design process evaluation will follow the UK Medical Research Council guidance. We will interview: staff involved in CHARMER implementation, geriatricians and pharmacists who receive the intervention and research delivery staff involved in patient/carer recruitment and data collection. We will also interview patients/carers and primary care practitioners. Interviews will be supplemented with recordings of implementation activities and completed implementation manuals. Questionnaires will capture the extent to which the four proactive deprescribing steps are enacted by intervention recipients, measure the behavioural mechanisms by which the CHARMER intervention operates and capture the patient experience of proactive deprescribing. Qualitative data will be analysed thematically and then mapped to Normalisation Process Theory to explore implementation and the Theoretical Domains Framework to explore behaviour change. Most quantitative data will be analysed descriptively; however, changes in staff questionnaire responses preintervention and postintervention will be analysed using a Mann-Whitney test. We will triangulate qualitative and quantitative findings to explain intervention effects.
Ethical and governance approvals have been obtained by the Wales 2 Research Ethics Committee and the Health Research Authority, respectively. The dissemination strategy will be underpinned by the evidence-based Guide to Disseminating Research (GuiDiR) targeting healthcare practitioners, policy makers and patient-facing organisations.
Each year over 130 000 patients in the UK are discharged from an intensive care unit (ICU), with many experiencing poor outcomes such as in-hospital mortality, emergency ICU readmission and/or significant morbidity. Despite current national guidance and the availability of follow-up services, post-ICU care remains variable. Critical Care Outreach Teams (CCOTs) are key in supporting this patient group, yet practice differs considerably. Recovery pathways have been successfully employed in other patient populations and are a potential option to standardise post-ICU care. Understanding how care is currently delivered by CCOT throughout the UK is essential to inform future development of an evidence-based recovery pathway for this patient group. Our primary aim is to understand how post-ICU follow-up care is delivered within the wider remit of CCOT workloads.
This is a pragmatic multicentre qualitative study of post-ICU follow-up care. The study will be split into two sub-studies: semi-structured interviews and ethnographic observations. Semi-structured interviews will be conducted with three groups of individuals: multi-professional staff members involved in the care of patients discharged from ICU to the wards, patients discharged from ICU to the wards and their family members. Direct participant observations alongside ad hoc informal discussions will be undertaken with members of the CCOT at participating sites focusing on their workflow to generate an understanding of the CCOT role and how post-ICU support fits within this. An overarching thematic analysis approach will be taken to analyse data from both sub-studies to clearly identify the barriers and facilitators to providing post-ICU support within the CCOT role.
Ethical approval has been obtained through the London—Chelsea Research Ethics Committee (25/PR/0773). We aim to disseminate the findings to local teams, at regional and international conferences, in peer-reviewed journals and through social media.
In the UK, a range of services provide same day, urgent and emergency care (UEC). Urgent medical needs can be addressed through pharmacy services, same day general practice (GP) appointments, phone or online triage services, out-of-hours GP appointments and urgent treatment centres (or equivalents). For emergency medical needs, patients can access emergency departments (EDs) and ambulance services. These services are highly vulnerable to excessive strain due to rising, unpredictable demand and limitations in patient flow across the system. The workforce operates in time-critical situations, often with limited resources, which can lead to staff burnout, low job satisfaction and retention and poor health. The organisation of services and their workforce continues to evolve in response to local and national pressures and varies considerably across the UK, where there are four distinct, publicly funded healthcare systems managed separately in each country. This makes it difficult to describe and compare services within and across regions and understand the impact of workforce organisation on service delivery, staff well-being and patient care. This study aims to develop a comprehensive understanding of the range and types of UK UEC services, the relative experiences of the workforce and the available workforce data.
This mixed-methods study includes two components, integrated through an explanatory sequential design. Study 1 will use data on NHS service availability and direct enquiry to map UEC services and populate a structured database, which will facilitate the generation of a UEC typology of the range and types of services and regional variation across the UK. Multiple case studies will be conducted in a subset of services using qualitative interviews (n=136–220) with service leaders (n=3–5), workforce (n=10–12), and patients or carers (n=4–5), as well as document analysis where relevant, in each service of interest (n=8–10). Study 2 will create a metadata catalogue of workforce data and produce descriptive summaries of key metrics (eg, staffing levels and skill mix). The study will be supported by our Community Inclusion and Engagement (CIE) panel and Patient and Public Advisory Group (PPAG) to ensure relevance, inclusivity and impact.
This study received ethical approval from Yorkshire and The Humber - Sheffield Research Ethics Committee (04/08/2025, IRAS ID: 357276, REC Reference: 25/YH/0125) and HRA and Health and Care Research Wales approval (12/08/2025). Data collection poses minimal risk, informed consent will be obtained, and participants may withdraw at any time. Dissemination will follow knowledge mobilisation principles to maximise impact. We will build on our existing networks and work with our CIE panel and PPAG to tailor study outputs to different audiences. The outputs will improve understanding of the variation in how UEC services and workforces are organised across the UK, as well as the type and format of available workforce data, and provide benchmarks for future research.
Research Registry (REF: researchregistry11555; https://www.researchregistry.com/register-now/%23home/registrationdetails/68d402672341e502cd0ce888/)
Androgen deprivation therapy (ADT) improves survival in advanced prostate cancer but may lead to debilitating side effects, including sarcopenic obesity and a 10–45% increased risk of other comorbidities. Guidelines recommend exercise and nutrition interventions during ADT, but access to these services is often limited, and referral pathways are unclear. This study aims to evaluate the feasibility and preliminary efficacy of an online, home-based, multi-faceted, exercise, nutrition and education programme (ProHealth) for men with prostate cancer treated with ADT. ProHealth was co-designed with consumers and healthcare professionals to include (i) education on prostate cancer and treatment-related side effects and (ii) multimedia behaviour change resources to support individualised nutrition and exercise behaviour change.
This 12-week randomised controlled trial (target n=50) will include men treated with ADT for >3 months or who have completed ADT in the last 24 months, are overweight or obese and are not under the care of a dietitian or exercise professional. Participants will be randomised (1:1) to the ProHealth intervention or usual care. The intervention group will receive four consultations with an Accredited Practising Dietitian to promote a high protein and energy reduced diet, and five consultations with an Accredited Exercise Physiologist to follow a home-based progressive resistance training and aerobic exercise programme. The primary outcomes are feasibility (recruitment rate, retention, data completeness, reach, safety, consultation attendance and adherence, and usage of the ProHealth web platform), acceptability and satisfaction of the ProHealth intervention. Exploratory secondary outcomes will be assessed at baseline and 12 weeks and include changes in body weight and composition (total and appendicular fat-free mass, fat mass), quality of life (Functional Assessment of Cancer Therapy (FACT)—General, FACT-Prostate, FACT-Fatigue), physical function (30-second sit-to-stand), dietary intake (3-day food diary) and physical activity (7-day accelerometer). Linear regression models will estimate differences between the intervention and usual care group. Qualitative interviews on participant satisfaction will be transcribed verbatim for thematic analysis.
This study is approved by Deakin University Human Research Ethics Committee (DUHREC2024-038) and registered on Australian and New Zealand Clinical Trials Registry (ACTRN12624000874516). Findings will be disseminated through peer-reviewed journals, scientific meetings and other public forums.
ACTRN12624000874516.
To explore staff and patient perception of the newly co-developed wearable monitoring system (WMS), including acceptability of use in clinical practice.
Pragmatic qualitative descriptive study.
Semi-structured interviews were conducted with 12 patient participants and eight staff members between June 2023 and August 2024, and were analysed thematically.
Three themes were identified, building on previous qualitative work around the use of WMS on hospital wards. The first theme—centralised continuous monitoring enhances care—explores how WMS provides staff with a means to provide safe, efficient care with the ability to see the vital signs away from the patient. Patients reported feeling safer, knowing they were being monitored when staff were not at the bedside. The second theme—human connection at the bedside—considers how both patients and staff emphasised that the system should not replace nurse/patient interactions and face-to-face care, even though it provided patients with a stronger sense of independence. The final theme—system usability and integration into care—focuses on use of the system in clinical practice and implications for the future.
Wearable monitoring systems have the potential to support nurses to provide safer, more efficient care, whilst providing reassurance to patients. However, centralised monitoring should not replace face-to-face clinical contact, and careful consideration should be given to who would benefit most from the technology.
This study extends existing knowledge of the impact of WMS from being a tool to enhance patient safety to an intervention to improve nurse efficiency and patient experience, within the context of a high-demand surgical ward.
Patients and members of the public were involved in study design and data collection. Their contributions included participating in advisory groups, ensuring the research addressed patient-relevant priorities.
Non-communicable diseases, particularly cardiovascular diseases (CVDs), have become major contributors to morbidity and mortality in sub-Saharan Africa (SSA) and are projected to surpass infectious diseases as the leading cause of death among adults by 2030. Although CVDs have traditionally been associated with older age and obesity, adverse cardiovascular phenotypes are increasingly being observed in younger and leaner individuals in SSA. This pattern suggests that pathways to CVD risk in SSA may differ from those described in high-income countries. Early-life infectious exposures, undernutrition and socio-demographic conditions common in many SSA settings have been proposed as potential risk factors. Still, empirical evidence linking these exposures to cardiovascular risk in early adulthood remains limited due to a scarcity of long-running birth cohorts in the region.
This protocol describes a new round of data collection nested within the Entebbe Mother and Baby Study (EMaBS), a population-based Ugandan birth cohort established originally as a clinical trial (ISRCTN32849447) between 2003 and 2006 with prospective follow-up from pregnancy through adolescence. All participants currently under follow-up will be invited to participate at approximately 21 years of age. Primary outcomes are physiological determinants of CVD measured in early adulthood, including blood pressure, blood lipid levels, body mass index, body composition and markers of glucose metabolism. Secondary outcomes include behavioural CVD risk factors (diet, physical inactivity, alcohol use and tobacco use) and qualitative measures of CVD knowledge and risk perception. Key exposures of interest include prospectively collected early-life and childhood infectious exposures (malaria and helminth infections), markers of growth and undernutrition, micronutrient status, inflammatory markers, socio-demographic factors and selected genetic variants. Quantitative analyses will use multivariable regression and causal modelling approaches and will be complemented by qualitative interviews and focus group discussions.
The study protocol has been reviewed and approved by the Uganda Virus Research Institute Research and Ethics Committee (UVRI REC Ref: GC/127/35), the Uganda National Council for Science and Technology (UNCST Ref: MV625), and the London School of Hygiene & Tropical Medicine Research Ethics Committee (LSHTM Ethics Ref: 8811). Written informed consent will be obtained from all participants before study activities. Study findings will be shared and discussed with participants and community stakeholders through established engagement platforms. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations, and data will be made available to other researchers via established data-sharing platforms. We will engage policymakers at the district, national and international levels to facilitate the translation of findings into policy-relevant outputs.
While almost half of older adults admitted to hospital are prescribed potentially inappropriate medicines, less than 1% have a medicine proactively deprescribed during admission in the UK. The CompreHensive geriAtRician-led MEdication Review (CHARMER) intervention is designed to address geriatricians’ and pharmacists’ barriers and enablers to deprescribing. The CHARMER definitive trial will evaluate effectiveness, cost-effectiveness and safety.
A stepped-wedge cluster randomised controlled trial will be conducted in 20 hospitals in England, with four hospitals in reserve. All hospitals will collect baseline data. Every 3 months, five hospitals will be randomised to receive the intervention. The intervention, implemented by a local project manager, comprises a hospital action plan to set deprescribing as an organisational goal; workshops for pharmacists and geriatricians to change beliefs about deprescribing; weekly briefings between geriatricians and pharmacists to discuss opportunities for deprescribing; benchmarking reports to compare deprescribing performance across participating hospitals. With an average of 200 patients admitted and discharged during each step, the study will have 89.5% power at 5% significance level and intra-class correlation coefficient of 0.05 to detect a 3% difference in 90-day re-admission rate from 16.7% versus 13.7%. Anonymised routinely collected data, including readmissions, will be obtained for all patients admitted during the study period. Enhanced data collection periods of 1 month during control and intervention periods will be used to recruit patients and data for secondary outcomes and process evaluation.
A stepped-wedge design enabled a smaller number of hospitals and patients to be included than a traditional cluster-randomised design. The complexity of intervention implementation necessitated a project manager in addition to the principal investigator responsible for trial conduct. Using routinely collected data for the primary outcome measure should ensure that the trial has sufficient power on completion. Planned enhanced data collection for short periods of time improves trial efficiency.
The debate about whether health visiting, a specialist community public health nursing role, is at the level of advanced practice nurse has gone on for more than a decade. There is little empirical evidence that the role matches the traditional role of an advanced practice nurse, although many of the attributes of advanced practice nursing such as prescribing rights, managing complex cases, caseloads with undifferentiated need and advanced assessment and decision-making are certainly present.
The current study aimed to develop, refine and test the Health Visiting Advanced Practice Scale to assess the scope of advanced practice of UK health visitors.
A cross-sectional and methodological scale validation design, following classical test theory.
The design consisted of three phases; the first involved scale development including item generation, phase two assessed the content validity index, and the third phase involved a cross-sectional survey to establish construct validity, content validity, and internal consistency reliability, and conduct exploratory and confirmatory factor analysis.
The initial 44-item scale underwent iterative exploratory and confirmatory factor analyses, leading to a refined 5-factor structure with 29 items covering domains such as family-centred care, leadership, prescribing, diagnostic reasoning, and professional practice. This final version demonstrated strong reliability and construct validity in the EFA but mixed fit indices in the CFA, supporting both internal consistency and validity of the scale.
The final scale offers a rigorously validated tool for assessing advanced practice among UK health visitors, capturing core domains such as family-centred care, leadership, prescribing, and diagnostic reasoning. By bridging theoretical frameworks with real-world practice, it fills a critical gap in evaluating and supporting the professional scope of this public health nursing specialty.
These findings provide valid and reliable insights for measuring and improving health visitors' advanced practice and developing future professional policies.
No patient or public contribution.
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies.
Hypertension is the leading risk factor for death globally. Undiagnosed hypertension is common, but the incidence in hospitalised patients is unclear. There are calls for universal facility-based screening for hypertension among all attending patients. The hospital inpatient setting, where blood pressure (BP) is measured routinely and repeatedly, presents an ideal opportunity. However, international hypertension guidelines do not include inpatient BP thresholds for diagnostic or treatment purposes. We investigated the performance of current UK community BP thresholds for diagnosing hypertension in the hospital setting.
Investigate the diagnostic performance of the current UK ambulatory BP diagnostic thresholds for systolic and diastolic hypertension in the hospital setting against the reference test of community-based ambulatory BP monitoring (ABPM).
A prospective diagnostic accuracy study.
Hospital inpatients admitted to three UK centres were approached. Follow-up ABPM was delivered in the community.
Eligible patients were aged between 18 and 80 years, with no prior diagnosis of, or prescription for hypertension, and whose mean cumulative daytime BP was 120 mm Hg to 179 mm Hg systolic and ≤109 mm Hg diastolic from the 24th hour of their hospital admission.
Participants received 24-hour ABPM 4–26 weeks post-discharge, as the reference test for hypertension, with UK diagnostic thresholds of an average daytime BP of ≥135 mm Hg systolic and ≥85 mm Hg diastolic applied. Participants found to be severely hypertensive at the ABPM fitting appointment were also considered reference-test positive but did not proceed with ABPM.
The diagnostic performance of a mean daytime in-hospital BP of ≥135 mm Hg systolic or ≥85 mm Hg diastolic (index test) for the prediction of hypertension diagnosed on ABPM (reference test) was assessed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as primary outcome measures. Additionally, we explored the accuracy of a range of alternative in-hospital systolic and diastolic BP thresholds against the same reference test.
351 participants were enrolled and 206 completed the study protocol. The average age of the 206 participants was 53 years, 55% were male, and 91 (44%) had daytime community hypertension on ABPM reference testing. Of 107 participants with raised in-hospital daytime BP, 59 (55%) had daytime community hypertension. When assessing the performance of the index test for detecting daytime community hypertension, sensitivity was 65% (59/91, 54% to 75%) and specificity was 58% (67/115, 49% to 67%). The PPV was 55% (59/107, 45% to 65%) and NPV was 68% (67/99, 58% to 77%), respectively. A further 45/206 participants (23%) had night-time community hypertension when assessed using European diagnostic thresholds for nocturnal hypertension (120 mm Hg systolic or 70 mm Hg diastolic), while 25/107 of those with raised in-hospital daytime BP (23%) had night-time community hypertension. When assessing the performance of the index test for detecting either day or night-time community hypertension, sensitivity was 62% (84/135, 53% to 70%) and specificity was 68% (48/71, 55% to 78%). The PPV was 79% (84/107, 70% to 86%) and NPV was 48% (48/99, 38% to 59%).
Undiagnosed hypertension is common in hospitalised patients, particularly those with raised in-hospital BP. While in-hospital BP alone is an imperfect predictor and should not be used as a stand-alone diagnostic test, this could serve as a trigger for further assessment of BP in the community after discharge.
The study protocol was registered with the ISCTRN Registry (ISRCTN80586284).
Women who use drugs in Tanzania face a disproportionately high burden of HIV and mental health disorders. Despite the availability of pre-exposure prophylaxis (PrEP), uptake remains low, highlighting the need for integrated, scalable interventions that address co-occurring substance use and mental health challenges. Motivational interviewing (MI) and cognitive-behavioural approaches, such as the Common Elements Treatment Approach (CETA), show promise for enhancing HIV prevention outcomes in this population. This study presents the protocol for a pilot feasibility trial assessing the acceptability, feasibility and preliminary efficacy of MI for PrEP (MI-PrEP) and a combined CETA and MI-PrEP intervention (CETA + MI-PrEP) to improve PrEP engagement among women who use drugs in Tanzania.
This individually randomised, parallel-group pilot trial will be conducted in Dar es Salaam, Tanzania, guided by the situated Information, Motivation and Behavioral Skills model. Eligible participants are adult women who use heroin, report recent drug-related or sex-related HIV risk behaviours, are HIV-negative and exhibit symptoms of depression, anxiety or post-traumatic stress disorder. Participants are randomised to one of three arms: MI-PrEP, CETA + MI-PrEP or enhanced treatment as usual. Interventions are delivered face-to-face by trained counsellors. Feasibility and acceptability will be assessed using recruitment and retention data, surveys and qualitative interviews. Preliminary effects will be measured for PrEP initiation, symptoms of common mental disorders and substance use.
Ethical approval has been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4830). Results will be disseminated through ClinicalTrials.gov, peer-reviewed publications, conferences, presentations and research briefings to community stakeholders.
ClinicalTrials.gov ID: NCT06835751. Initially registered 14 February 2025,
Chronic dyspnoea is a prevalent symptom, and primary care is ideally placed to identify and manage it. However, chronic dyspnoea is under-reported by patients and can be a diagnostic dilemma for practitioners. A fully automated system of patient screening, coupled with a clinical decision support system (CDSS) that uses a validated and evidence-based dyspnoea algorithm, may improve detection, diagnosis and management of the condition. There is currently no CDSS validated for chronic dyspnoea diagnosis and management in primary care in Australia. The objectives of this study are to assess the clinical impact of a CDSS for chronic dyspnoea in primary care. We hypothesise that the use of the CDSS will lead to a clinically significant improvement in patient-reported dyspnoea scores, reduced time to diagnosis and healthcare costs at 12 months compared with standard care.
The BREATHE study is an open-label, cluster-randomised controlled trial of standard of care compared with a CDSS. General practices (n=40) in metropolitan, regional/rural and rural/remote settings will be recruited and randomised equally to pre-screening for chronic dyspnoea and usual standard-of-care management or pre-screening and CDSS-guided management. The CDSS includes an algorithm derived from a robust data and clinical knowledge model and incorporates evidence-based recommendations for the assessment and management of chronic dyspnoea. It is integrated into general practice medical software systems, fitting in the workflow of general practitioners (GPs). Eligible patients will be ≥18 years old and will have previously consented to receive SMS communication from their practice. In-scope patients will receive an automated text message prior to their GP appointment and will be screened for chronic dyspnoea (≥4 weeks). Patients identified with chronic dyspnoea will be invited to participate in the BREATHE study and followed up for 12 months. The primary outcome is improvement in the Dyspnoea-12 (D-12) score from baseline to 12 months, measured by the Dyspnoea-12 (D-12) questionnaire. Secondary outcomes include disease-specific questionnaires to assess changes in clinical outcomes, time to final diagnosis, quality of life, healthcare utilisation and costs incurred to patients.
The trial is registered at ANZCTR (ACTRN12624001451594). ANZCTR is a primary registry that meets the requirements of the ICMJE and is listed on the ICTRP Registry Network.
The study protocol has been approved by the University of New South Wales Human Research Ethics Committee (HREC) (iRECS6645) and complies with the National Health and Medical Research Council ethical guidelines. Participating practices and each GP will provide written, informed consent. All patients being screened will provide electronic informed consent. Results of the study will be disseminated through various forums, including peer-reviewed publications and presentation at national and international conferences. Following the study, participating practices will be provided with a summary of the findings of the study, together with a full copy of any publications and a plain language statement for participants, which will be made available in the practice reception area.
For people whose stroke risk would be reduced by taking a long-term oral anticoagulant (OAC), it is important to implement effective strategies to support medication initiation, adherence and persistence. To do this, a better understanding of the factors associated with implementation of interventions to optimise OAC management is needed.
This scoping review aimed to summarise the evidence-based characteristics associated with implementing interventions designed to optimise long-term OAC adherence.
Primary research (published post-2000) evaluating any intervention designed to optimise implementation of long-term OAC for stroke prevention by way of change in OAC services, staff or patient behaviour.
Five databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo, Cochrane Library) were searched from 1 January 2000 to 4 August 2023 using a combination of terms relating to population, intervention and study design.
Titles/abstracts were screened by at least one reviewer. Data from each full text were abstracted (with 20% double-checked for accuracy) and its implementation content reviewed, guided by the Expert Recommendations for Implementing Change strategies.
216 studies were included, with varying descriptive reporting of implementation strategies, and only 61 (28%) self-identifying as an implementation study. The median number of implementation strategies used was three, with recently published studies (2015 onwards), those including patients receiving either direct OACs (DOACs) or vitamin K antagonists (VKAs) and those including multiple intervention targets (service, staff or patients) associated with using more implementation strategies. ‘Train and educate stakeholders’ strategies were the most commonly used, and ‘Adapt and tailor to the context’ strategies were the least used by included studies. Conversely, self-defined implementation studies were less likely to use ‘Train and educate stakeholders’ strategies, although they were positively associated with use of ‘Adapt and tailor to the context’. ‘Use evaluative & iterative’ strategies were used more frequently in studies where patients used either VKAs or DOACs, or were published more recently.
Studies need to self-define as implementation studies, improve implementation strategy reporting and be transparently registered, alongside conducting process evaluations or more richly describing implementation processes. Future research could explore why some implementation strategies are used more than others and whether aligning strategy clusters with intervention targets results in clinically significant differences in patient care.
The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.
This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ
The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.
This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.
This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.
A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.
Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.
by Andrea Lopez-Soto, Esmeralda Ramírez, Duyen H. Vo, Aigerim Alpysbekova, Seo Woo Lee, Maria Duque, Lawrence Watkins, Cory L. Cobb, Beyhan Ertanir, Alejandra Garcia Isaza, Evelyn Gualdron, Sumeyra Sahbaz, Collette Steed, Neel Devan Youts, Shriya Senapathi, Seth J. Schwartz, Pablo Montero-Zamora
There is a limited understanding of how different subgroups of Latin American immigrant parents experience cultural stressors, as well as its impact on family dynamics, health behaviors, and mental health. The present study aimed to (1) identify latent cultural stress profiles among Latin American immigrant parents in the U.S. and (2) examine differences among these profiles concerning family intimacy, democratic parenting style, family conflict, hazardous alcohol use, and depressive and anxiety symptoms. Participants consisted of a sample of 1,351 parents (61.9% female; M age = 39.83, 62% first-generation; North America [61%], Central America and the Caribbean [21%], and South America [19%]) of children aged 8–16. We used latent profile analysis to identify subgroups of cultural stress, defined by perceived discrimination (PDS) and negative context of reception (NCR). Multinomial logistic regression was conducted to examine key correlates of profile membership. Five latent profiles were identified (1) Low PDS/NCR (22.2%), (2) Low PDS/Elevated NCR (14.8%), (3) Moderate PDS/NCR (18.7%), (4) Elevated PDS/NCR (33.5%), and (5) Highest PDS/NCR (10.8%). Compared with Profile 1 (Low PDS/NCR), parents in Profiles 2–5 generally reported lower family intimacy (RRR = 0.93–0.97). Parents in Profile 5 (Highest PDS/NCR) reported more family conflict (RRR = 1.13), hazardous alcohol use (RRR = 1.20), depressive symptoms (RRR = 1.31), and anxiety symptoms (RRR = 1.29), with markedly elevated depressive (RRR = 22.94) and anxiety symptomatology (RRR = 17.48) compared with Profile 1. Our findings suggest the presence of vulnerable subgroups due to cultural stress among Latin American parents in the United States. A better understanding of cultural stress patterns may improve current and future interventions tailored for Latin American families, addressing health disparities within this population.Inequities in health status exist in New Zealand across the rural–urban spectrum. In parallel, rural–urban differences in health service utilisation vary by service type. Despite the New Zealand public health system being based on principles of universal access, equity and fairness, levels of health expenditure on rural and urban populations are not well understood. The purpose of the study is to undertake a rural–urban analysis of public health system expenditure, based on individual-level service utilisation and national pricing of health service events.
Individual-level service utilisation and pricing will be collated from national collection databases for all eligible users of publicly funded services. The analysis will include calendar years 2017–2024. Descriptive analysis and a two-part generalised linear regression model will be used to identify if rural–urban differences in expenditure exist, and what the association of rurality is with expenditure (if any). The model will also be used to identify geographic regions with expenditure levels that vary from those predicted using regression model weights. As the specific statistical approach will be determined by data attributes, this protocol outlines the intended approach to construct the analytical model.
Ethics approval was obtained from the University of Otago Human Research Ethics Committee (HD23/052). Māori consultation has been undertaken with the Ngāi Tahu Research Consultation Committee and will continue throughout the research process.
The aim of this work was to understand carer involvement in transitions of care from hospital to home in relation to medicines management. Specifically, via a realist review, to describe how carers provide support, to what extent do they support patients and under what circumstances are carers able to provide support towards patient care in relation to medicines management.
A realist review was conducted in line with a published protocol and as registered via PROSPERO (CRD42021262827). An initial programme theory (PT) was developed before searches of three databases, PubMed, CINHAL and EMBASE, were conducted in accordance with eligibility criteria. Data were extracted from eligible studies and synthesised into realist causal explanations in the form of Context-Mechanism-Outcome-Configurations (CMOCs) and the PT was refined. Throughout the review, a patient and PPIE group (n≥5) was involved, meeting five times, to inform the research focus and develop CMOCs and the PT by providing feedback and ensuring they capture the carer experience.
Following title and abstract screening of 4835 papers, the final number of included articles was 208. The evidence synthesis identified 31 CMOCs which were categorised into three themes: (1) continuum of support; (2) understanding the carers’ priorities, role and responsibilities through shared decision-making (SDM) and (3) access to appropriate materials, resources and support information. These themes were formed into an updated PT with accompanying narrative that explained the transition from hospital to home involving carers in medicines management and identified possible areas for future intervention development.
This review provides insights and recommendations on how carers can be better supported when managing medicines when patients are discharged from hospital. Carers need a continuum of support throughout and following the transition. Healthcare professionals can support this by understanding the carer’s priorities, role and responsibilities through SDM during the hospital stay. Consequently, carers can then be offered access to appropriate materials, resources and support information which allows them to provide better care relating to medicines in the long term.
Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.
The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.
We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.
The study findings will provide the evidence base to inform future colorectal diagnostic services.
The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.
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.
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