There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

A cross-sectional mixed methods online survey.

Primary care in England.

120 clinical pharmacists with experience in conducting SMRs in primary care.

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

The co-occurrence of multiple long-term conditions, that is, multimorbidity, is increasing globally and is associated with lower quality of life and increased risk of death. The risk and prevalence of multimorbidity are higher among women compared with men, but currently, evidence focusing on women’s multiple long-term conditions during the perinatal period is limited. Existing evidence needs to be examined to determine the extent to which maternal multimorbidity or women’s multiple health needs related to pregnancy have been addressed, especially for women living in low-income and middle-income countries (LMICs) where this burden of disease is the highest. The objective of this scoping review is to map existing evidence in LMICs on (a) Study designs and data sources, (b) Context-relevant definitions and descriptions, (c) Associated risk and protective factors, (d) Relevant maternal and infant health outcomes and (e) Treatments and interventions used to manage multiple long-term conditions before, during and after pregnancy.

This scoping review will be conducted using Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement extension for scoping reviews. This review will include observational, experimental or quasi-experimental studies, as well as systematic or umbrella reviews, on multimorbidity in women of reproductive age (15–49 years) in prepregnancy, pregnancy or up to 6 weeks after childbirth in LMICs. The studies will focus on definitions, risk and protective factors and management strategies for multiple long-term conditions before, during and after pregnancy. Studies of morbidity in women with a single index condition or conditions that are not related to pregnancy or childbirth will be excluded. A search strategy will be developed using thesaurus (including MeSH) and free-text terms for ‘maternal morbidity’ or ‘multiple long-term conditions’ and associated keywords such as multimorbidity, co-morbidity and unmet health needs related to pregnancy and/or childbirth for women living in LMICs. Electronic (EBSCOhost (CINAHL Ultimate, STM Source, Medline Ultimate), Cochrane Library, Web of Science or Scopus and Google Scholar) and grey literature databases will be searched from database inception. Reference lists and bibliographies of key topic articles will also be searched, and any additional papers that meet the inclusion criteria will be obtained. There will be no limitations on dates or languages. Records will be independently screened, selected and extracted by two researchers. Data will be presented in tables and narrative summaries.

Ethics approval is not required as this scoping review will summarise previously published data. Findings from the review will be disseminated through various platforms, including peer-reviewed journals, conferences and community meetings.

Open Science Framework (https://doi.org/10.17605/OSF.IO/FYCR8).

The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

ISRCTN68786622.

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m² and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

ISRCTN68786622.

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

CRD42024568297.

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

CRD42024568532.

Despite the abundant evidence showing the benefits of muscle-strengthening exercise (MSE), no epidemiological tool is available for assessing MSE among Indonesian university students. This study is the first to adapt the Muscle-Strengthening Exercise Questionnaire (MSEQ) from its original English version into another language, specifically Indonesian, incorporating cultural adaptations and to pilot test it to assess its validity and reliability among university students in Indonesia.

Translation and cultural adaptation, content validity studies, concurrent validity studies and reliability studies were conducted following COnsensus-based Standards for the Selection of Health Status Measurement INstruments guidelines. Content validation, conducted with three experts and nine university students, informed the development of the MSEQ Indonesian version. The concurrent validity study compared the results of measuring MSE frequency, intensity, duration and volume with those of the 7-day diary and relative handgrip strength with 22 respondents for concurrent validity against subjective measurement and 70 respondents for concurrent validity against objective measurement. For the reliability study, 39 respondents were asked to fill the MSEQ Indonesian version twice with a time interval of 7 days.

The study involved 143 participants, including experts and university students from three universities across two different islands in Indonesia.

Single administration MSEQ, consecutive administration MSEQ and 7-day diary recording resulted in 0%, 33.8% and 68.5% dropout rate, respectively. Moderate-to-strong correlations were observed between the results for the weekly frequency, duration, intensity and volume of MSE and those of the 7-day diary and hand grip strength. Test–retest reliabilities were good to excellent for machine weight, holistic and overall MSE but poor for bodyweight MSE. In assessing the target muscle group, the MSEQ Indonesian version showed good test–retest reliability for machine-weight MSE but poor-to-very good test–retest reliability for bodyweight, free weight and holistic MSE.

Our study demonstrated the acceptable validity and reliability of the Indonesian version of the MSEQ for assessing MSE among university students in Indonesia, not only by comparing each dimension of MSE with subjective measures but also by comparing MSE volume with objective measures. To enhance the generalisability of these findings, future studies should assess the MSEQ Indonesian version in diverse adult populations by considering dropout rates found by our study, ensuring its broader applicability and sample size adequacy.

Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.

Observational study using general practice electronic health record data linked to specialist claims data.

272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.

Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).

The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.

Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).

Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.

The study evaluated healthcare professionals’ adherence to guidelines on quality neonatal resuscitation practices in Ghana.

This study employed an observational design. A validated observational checklist for neonatal resuscitation was used to assess the adherence to quality neonatal resuscitation guidelines among healthcare professionals.

The study was conducted among healthcare professionals in six healthcare facilities, consisting of five government-owned healthcare facilities and a private non-profit health facility across the northern, middle and coastal belts of Ghana.

The study participants were 75 healthcare professionals across the six sampled healthcare facilities.

Outcome measures of interest are: initial preparation prior to resuscitation; stimulation and airway maintenance; positive pressure ventilation; coordinated positive pressure ventilation with chest compression and postresuscitation infection prevention and control measures.

The results revealed that 53% of the healthcare professionals demonstrated good (scored 80%–100%) adherence to guidelines on quality neonatal resuscitation practices; the remaining scored moderate 36% (scored 50%–79%) and 11% (scored 0%–49%) poor adherence. Binary logistic regression analysis revealed that increased staffing levels and a bachelor’s degree or higher were positively associated with the performance of positive pressure ventilation (adjusted OR (aOR) 19.3 (95% CI 2.430799, 152.8657), p=0.005) and (aOR 9.9 (95% CI 1.070278, 92.38303), p=0.043), respectively. Furthermore, professional nurses and medical practitioners were more likely to adhere to coordinated positive pressure ventilation with chest compressions than auxiliary nursing staff (aOR 13.2 (95% CI 1.917858, 92.61999), p=0.009) and (aOR 15.7 (95% CI 1.227859, 200.1105), p=0.034).

The results showed that 53% of healthcare professionals demonstrated good adherence for neonatal resuscitation practices. Addressing the identified gaps and inequalities in neonatal resuscitation practice will improve healthcare professionals’ knowledge and skills in neonatal resuscitation, which ultimately helps to reduce neonatal deaths among babies in Ghana.

To examine the impact of the COVID-19 pandemic on the substitution of surgical procedures in benign gynaecology in the Netherlands.

Quantitative longitudinal study evaluating the effects of the COVID-19 pandemic.

Nationwide healthcare delivery was analysed across six benign gynaecological pathways from 2016 to 2022 using Vektis and Dutch Hospital Data (DHD), accessed via Statistics Netherlands (Centraal Bureau voor de Statistiek).

The study focused on six benign gynaecological pathways classified using Dutch Diagnosis Treatment Combinations (DTCs): heavy menstrual blood loss (G11), uterine fibroids (G15), endometriosis (G17), prolapse (G25), infertility treatment (F11) and first trimester pregnancy complications (Z12). All patients receiving care within these pathways between 1 January 2016 and 31 December 2022 were included. Exclusions applied to all patients under 18 years old and, only within the menstrual disorder pathway, patients over 51 years old to exclude most postmenopausal blood loss cases where no alternative treatment applies.

Cohorts from the initial pandemic year (2020) were compared with four prepandemic cohorts (2016–2019) and late-pandemic (2021) and postpandemic (2022) cohorts.

The primary outcome was the trend in the total number of patients in surgical and non-surgical procedure groups across cohort periods. Secondary outcomes included trends within individual pathways.

The analysis identified a significant reduction in benign gynaecological care during 2020, with an 18.3% (p

The COVID-19 pandemic significantly disrupted both surgical and non-surgical procedures within benign gynaecological pathways. Reduced care uptake during the pandemic waves was not recovered but instead forgone. The reduction in surgical procedures did not correspond with increased use of non-surgical alternatives. Future research should prioritise evaluating the long-term impacts of this disruption on patients and society.

Cervical cancer remains a significant global health concern and is the fourth most prevalent cancer among women. In South Africa, it is the leading cause of cancer-related deaths in women aged 15–44 years. The disease is typically preceded by persistent high-risk HPV infection, leading to cervical intraepithelial neoplasia and eventually cancer. Currently, in South Africa, management primarily involves excision, particularly through large loop excision of the transformation zone, which has associated risks and limitations. Thermal ablation is an alternative cost-effective treatment method, providing a straightforward approach to treatment, particularly advantageous in environments characterised by limited resources. The study aims to assess the efficacy, safety and patient experience of thermal ablation, providing valuable data for potential integration into South Africa’s cervical cancer prevention policies.

Randomised controlled trial in which 420 women living with HIV aged 30–60 years will be recruited from the Colposcopy Clinic at Tygerberg Hospital and will be followed up for a period of two years. The primary study endpoint is a test of cure that will be assessed by HPV genotyping, cervical cytology and histology at six month intervals. Other endpoints include the occurrence of adverse events.

The study protocol has been approved by the Health Research Ethics Committee of Stellenbosch University (Ethics Reference No: M20/11/035) and by the Western Cape Department of Health and Wellness via the National Health Research Database (WC_202109_016). All study procedures comply with the Declaration of Helsinki, South African Good Clinical Practice Guidelines and the Medical Research Council’s ethical guidelines. Trial results will be disseminated through peer-reviewed journals, national and international conference presentations and professional associations. A lay summary will be shared with the Community Advisory Board to guide community-level dissemination.

Pan African Clinical Trial Registry: PACTR202504820339039.

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.

To evaluate how insurance influences the risk of a dementia diagnosis among a large, diverse cohort of US civilian adults with traumatic brain injury (TBI) over a 22-year period.

This is a retrospective cohort study involving individuals diagnosed with TBI.

The study used the Merative MarketScan Research Database, specifically drawing from the Commercial Claims and Encounters, Medicare Supplemental and Medicaid databases, from 2000 to 2022 in the USA. These databases provide comprehensive insights into healthcare services received by enrollees, including inpatient and outpatient services, outpatient prescription claims, clinical utilisation records and healthcare expenditures.

267 473 adults aged 55 and older who were diagnosed with a TBI between 1 January 2000 and 31 December 2022. Individuals with unknown TBI severity and dementia claims 2 years preceding TBI were excluded. TBI and dementia diagnoses were identified using International Classification of Disease 9th and 10th editions codes from inpatient and outpatient admission records.

None.

We compared the incidence of all-cause dementia across different insurance types to assess potential disparities in diagnosis following TBI. Cox proportional hazards models, with age as the time scale, were used to study the association between insurance type and dementia diagnosis following a TBI. Models were adjusted for key demographic variables, medical comorbidities and psychiatric conditions to account for potential confounding.

Of the 267 473 individuals with TBI, 12.7% were diagnosed with dementia over a mean follow-up period of 40 months (SD of 42 months). Dementia incidence differed significantly by insurance type, with 18.2% for Medicaid recipients, 17.3% for Medicare beneficiaries and only 2.3% among individuals with commercial insurance. The adjusted HR for dementia was notably higher among individuals enrolled on Medicaid (HR 2.9, 95% CI: 2.8 to 3.1) and Medicare (HR 2.1, 95% CI: 2.0 to 2.2), when compared with those with commercial insurance.

Individuals with TBI covered by Medicaid and Medicare are significantly more likely to be diagnosed with dementia, with a 2.9-fold and 2.1-fold increase risk, respectively, compared with those with commercial insurance. Addressing insurance-related disparities in dementia diagnosis is crucial for building a more equitable healthcare system. It is essential that individuals with TBI cases, regardless of their insurance type, have access to comprehensive care and preventive interventions to achieve the best possible long-term outcomes.

Transition of care from hospital is a period when the risks of medication errors and adverse events are high, with 50% of adults discharged having at least one medication-related problem. Pharmacist-led medication reviews can reduce medication errors and unplanned readmission when completed promptly post-discharge; however, they are underutilised. A Transition of Care Stewardship pharmacist has been proposed to facilitate and coordinate a patient’s discharge process and facilitate a timely post-discharge medication review. Access to pharmacist medication review in rural and regional areas can be limited. This protocol describes a randomised controlled trial (RCT) to determine whether a virtual Transition of Care Stewardship pharmacist reduces medication-related harm in rural and regional Australia.

Multicentre RCT involving patients at high risk of medication-related harm discharged from regional and rural hospitals to a domiciliary residence. Eligible patients must be aged≥18 years, admitted under a medical specialty, be discharged to a domiciliary setting, have a regular general practitioner (GP) or be willing to visit a GP or an Aboriginal Medical Service after discharge for medical follow-up, have a Medicare card and be at high risk of readmission. High risk of readmission is defined as either a previous admission to the hospital or Emergency Department (ED) presentation in the past 6 months AND≥three regular medications OR on at least ONE high-risk medication. A total of 922 participants will be recruited into the study. Enrolled participants will be randomised to the intervention or control (usual care). The intervention will include a virtual Transition Of Care Stewardship pharmacist to ensure that patients receive discharge medication reconciliation, medication counselling, medication list and communicate directly with primary care providers to facilitate a timely post-discharge medication review. Usual care will include informing the patient’s clinical inpatient treating team that the patient is at high risk of medication misadventure and may benefit from a post-discharge Home Medicines Review (a GP-referred pharmacist medication review funded by the Australian Government).

Data analysis will be performed on a modified intent-to-treat basis. The primary outcome assessed is a composite of a first unplanned medication-related hospitalisation or ED presentation within 30 days of hospital discharge. Comparisons between the intervention and usual care groups for the primary outcome will be made using a mixed-effects logistic regression model, adjusting for site-level clustering as a random effect.

This study is approved to be conducted at the Western New South Wales Local Health District via the Research Ethics and Governance Information System (approval number: 2023/ETH00978). To ensure the needs of Aboriginal and Torres Strait Islander patients are appropriately addressed, ethics for this study were submitted and approved by the Aboriginal Health and Medical Research Council (approval number: 2148/23). Manuscripts resulting from this trial will be submitted to peer-reviewed journals. Results may also be disseminated at scientific conferences and meetings with key stakeholders.

ACTRN12623000727640.

Molar incisor hypomineralisation (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. The secondary objective is to assess whether dentin hypersensitivity and the severity of MIH lesions are associated with alterations in orofacial functions.

Assessments will be performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive analyses will characterise the sample. The Shapiro-Wilk test will assess normality. For normally distributed data, analysis of variance and Tukey’s post hoc test will be used. For non-normal data, the Mann-Whitney U test will be applied. The 2 test will analyse categorical variables and compare NOT-S domains between groups. Potential confounders (eg, age, sex, socioeconomic status) will be controlled through stratification or as covariates. Logistic and Poisson regressions will model associations for categorical and count-based outcomes, respectively. Statistical significance will be set at p

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 83969924.2.0000.5511; approval date: 22 November 2024). Participants will agree to take part in the study by signing an informed consent form. The findings will be published in a peer-reviewed journal. The collected data will be available on request.

NCT06692257.

In Brazil, previous research has highlighted that clinical teachers have little interest in teaching palliative care to undergraduate medical students and there is a need to obtain greater understanding of the reasons for this disinterest.

Our objective was to explore the challenges experienced by Brazilian clinical teachers responsible for palliative care in undergraduate medical education.

A qualitative exploratory study using semistructured interviews and analysed by thematic analysis. A total of six teachers responsible for teaching palliative care to medical students in the state of São Paulo, Brazil, were recruited. Interviews were conducted via video conferencing.

Four themes were identified from the data: (1) conflicting ideals on clinical care, (2) teaching in palliative care: from the possible to the ideal, (3) missed teaching opportunities in palliative care and (4) challenges of palliative care in the health system. The main challenge of teaching palliative care was the lack of understanding of the concept and importance of palliative care within the healthcare system.

Challenges in teaching palliative care in Brazil include limited understanding of its importance, conflicting clinical care perspectives and emotional discomfort. Targeted strategies are recommended to prepare clinical teachers, integrate palliative care into curricula and address systemic barriers in similar low and middle income contexts.

Effective management of type 2 diabetes mellitus (T2DM) consists of lifestyle modification and therapy optimisation. While glycaemic monitoring can be used as a tool to guide these changes, this can be challenging with self-monitoring of blood glucose (SMBG). The FreeStyle Libre 3 (FSL3) is a real-time continuous glucose monitoring (CGM) system designed to replace SMBG. The evidence for the benefit of CGM in people with T2DM on non-intensive insulin regimens is limited. This study aims primarily to assess the glycaemic impact of FSL3 in people with suboptimally controlled T2DM treated with basal-only insulin regimens plus sodium-glucose cotransporter-2 (SGLT-2) inhibitor and/or glucagon-like peptide (GLP)-1 agonist.

This is an open-label, multicentre, parallel design, randomised (2:1) controlled trial. Recruitment has been offered across 24 clinical centres in the UK and nationally through self-referral. Adults with T2DM treated with basal-only insulin regimens plus SGLT-2 inhibitor and/or GLP-1 agonist and with screening HbA1c from ≥59 mmol/mol to ≤97 mmol/mol are included. Eligible participants will be randomised to either FSL3 (intervention) for 32 weeks or continuation of SMBG (control). The study is split into two phases, each of 16 weeks duration: phase 1 consisting of self-management with basal-insulin self-titration and phase 2 where additional therapies may be initiated. Control group participants may subsequently enter an optional extension phase to receive FSL3. The primary endpoint is the difference between treatment groups in mean change from baseline in HbA1c at 16 weeks. Secondary outcomes include HbA1c at 32 weeks, CGM-based metrics, therapy changes, physical activity levels and psychosocial measures. An economic evaluation for costs and patient outcomes will be undertaken.

The study was approved by the Health Research Authority, Health and Care Research Wales and the West Midlands-Edgbaston Research Ethics Committee (reference: 23/WM/0092). Study results will be disseminated in peer-reviewed journals.

NCT05944432.

Identifier assigned by the sponsor: ADC-UK-PMS-22057.

Revision D. Dated, 13 December 2024.

Identifying individuals at risk of suicide remains an ongoing challenge. Previous research investigating risk factors for suicidal thoughts and behaviours (STB) has been informative for assessing suicide risk. However, the complex biological, psychological and sociocultural factors underlying STB have not been comprehensively captured to date, which has limited our understanding of how these factors interact to influence STB. Moreover, acute care settings, such as emergency departments (EDs), are often first points of contact for individuals with STB, highlighting a need for more research in these settings.

We aim to (1) characterize a cohort seeking care for STB and their clinical trajectories; (2) situate the cohort by comparing its characteristics and outcomes to other groups seeking emergency care; (3) explore their experiences of seeking care; and (4) examine blood-based biomarkers modulating risk for STB. Using a multimethod, prospective cohort design, we will follow up to 500 people aged 16 or older presenting to the ED with STB at a psychiatric hospital over 1 year. Analyses will involve descriptive statistics and latent profile analysis to characterize the cohort, hypothesis tests and regression models to situate the cohort, qualitative analysis based on a realist research framework to understand experiences, and within-participant comparisons of proteins, mRNA and epigenetic DNA modifications to examine biomarkers of contrasting states of STB.

This study was approved by the hospital’s Research Ethics Board with safeguards in place to ensure the well-being of participants and research team. An integrated knowledge translation approach will be used for dissemination, wherein patient and family advisors are engaged throughout each study phase. Findings will enhance our understanding of the multifactorial nature of suicide risk, inform strategies for prevention and provide important insights into characteristics, experiences and outcomes of individuals with STB, who are under-represented in mental health research.