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Ayer — Octubre 2nd 2025Tus fuentes RSS

Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia
Objectives

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

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

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

Results

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.

Conclusions

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.

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Understanding Canadian experiences of suicidality during the COVID-19 pandemic: protocol of a pan-Canadian qualitative study

Por: Baharikhoob · P. · Hollenberg · E. · Cuperfain · A. B. · Rudoler · D. · Nicoll · G. · Blumberger · D. · Bolton · J. · Chartier · G. B. · Crawford · A. · Furqan · Z. · Gajaria · A. · Gratzer · D. · Hatcher · S. · Husain · M. I. · Kurdyak · P. · Lam · J. S. H. · Lavergne · M. R. · Marshall
Introduction

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

Methods and analysis

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

Ethics and dissemination

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

I CAN DO Surgical ACP (Improving Completion, Accuracy and Dissemination of Surgical Advanced Care Planning): a protocol for a multisite, single-blinded, pragmatic randomised controlled trial to improve ACP completion in older adults in the presurgical set

Por: Welton · L. · Colley · A. · Sudore · R. L. · Melton · G. B. · Botsford · C. · Oreper · S. · O'Brien · S. E. · Koopmeiners · J. S. · Gibbs · L. · Carmichael · J. C. · Wick · E. C.
Introduction

Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.

Methods and analysis

This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.

Ethics and dissemination

The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.

Trial registration number

ClinicalTrials.gov ID: NCT06090552.

Protocol number

Advarra Pro 00070994.

University of California, San Francisco IRB iRIS number

23-38948.

Protocol Date: 24 October 2024. Protocol Version: 4.

Constructive Resistance: Essential to Optimise Workplace Quality

Journal of Advanced Nursing, Volume 81, Issue 10, Page 6071-6073, October 2025.

Human papillomavirus, sexually transmitted infections, and antimicrobial resistance in West Africa: Estimating population burden and understanding exposures to accelerate vaccine impact and drive new interventions: The PHASE survey protocol

by Adedapo Olufemi Bashorun, Larry Kotei, Abdoulie F. Jallow, Ousubie Jawla, Emmanuel U. Richard-Ugwuadu, Muhammed Jagana, Lamin Bah, Amadou Tijan Bah, Karamo Conteh, Mamadou S.K. Jallow, Mehrab Karim, Bai Lamin Dondeh, Anne Segonds-Pichon, Gary M. Clifford, Iacopo Baussano, Bruno Pichon, David Jeffries, Ed Clarke

Human papillomavirus (HPV) infection is a primary cause of preventable deaths from cervical cancer, a condition of profound inequality with approximately 90% of deaths occurring in low- and middle-income countries, particularly in sub-Saharan Africa. In May 2018, the WHO Director-General declared a Joint Global Commitment to Cervical Cancer Elimination, highlighting the critical role of HPV vaccines in achieving this goal. However, there is a lack of systemically collected data on HPV prevalence in The Gambia, and impact data from high-income countries may not be reliably extrapolated to West African settings due to geographical variation in HPV types and distinct behavioural, biological, and sociodemographic exposures. The Gambia introduced a two-dose HPV vaccination schedule in 2019, but coverage has been very low, interrupted mainly by the COVID-19 pandemic. This presents a key opportunity to generate vital baseline data on HPV prevalence in the population before potential scale-up of vaccination efforts. The PHASE survey, a multi-stage cluster survey, aims to establish the baseline, population prevalence estimates of high-risk and low-risk, vaccine-type and non-vaccine-type HPV infection in 15- to 49-year-old females in The Gambia by measuring urinary HPV-DNA. The survey will also quantify the effects of various exposures on HPV prevalence, including sexual behaviour, the presence of other sexually-transmitted infections (STIs) - Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), syphilis, as well as blood borne viruses, human immunodeficiency virus (HIV), hepatitis B and hepatitis C; obstetric history, socio-demographic characteristics, and cervical cancer screening and/or treatment. Additionally, the study will provide important antimicrobial resistance (AMR) data for NG and MG in sub-Saharan Africa, a region poorly represented in global surveillance programs. This data is needed to guide regional treatment guidelines and advocate for new solutions, including gonococcal vaccines. The AMR data are expected to immediately influence recommendations regarding the appropriate choice of antibiotics for syndromic STI management in West Africa and hence to address an important driver of AMR in the sub-region. Leveraging on the Medical Research Council Unit The Gambia funded Health Demographic Surveillance system (HDSS) as its sampling frame, the survey will utilize validated diagnostic assays and culturally sensitive data collection methods, to ensure both scientific rigor and local relevance. Tools such as Audio Computer-Assisted Self-Interviewing (ACASI) technology, developed in consultation with local community advisory boards, are included to reduce social desirability bias in reporting sexual behaviour. This approach aims to maximize both the reliability and cultural appropriateness of the findings. This study directly addresses the critical need for baseline epidemiological data on HPV in a West African setting to accelerate vaccine impact and drive new interventions towards cervical cancer elimination. By understanding other factors that influence HPV (like other STIs, sexual behaviour, etc.), the study aims to ensure that, when the vaccine’s impact is measured later, changes in other confounding factors that may impact on HPV prevalence can be accounted for. The study will also establish the population prevalence of the measured STIs and their relationship to common symptoms and other adverse health outcomes related to STIs.

Health economic impact of early versus delayed treatment of herpes simplex virus encephalitis in the UK

Por: Defres · S. · Navvuga · P. · Moore · S. · Hardwick · H. · Easton · A. · Michael · B. D. · Kneen · R. · Griffiths · M. · ENCEPHUK Study Group · Medina-Lara · A. · Solomon · T. · Barlow · Beeching · Blanchard · Body · Boyd · Cebria-Prejan · Chadwick · Cooke · Crawford · Davies · Davies
Objective

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

Design and setting

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Study participants

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Primary and secondary outcome measures

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

Results

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

Conclusions

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

10 years on from the landmark stroke thrombectomy trials, where are we now? A qualitative study examining professional views on the implementation of endovascular treatment for ischaemic stroke in England

Por: Simmonds · R. L. · Day · J. · James · M. · White · P. · Price · C. I. · Shaw · L. · Ford · G. · Pope · C. J.
Objective

To explore multiprofessional views about system-wide factors influencing (impeding or facilitating) the delivery of stroke mechanical thrombectomy (MT) services and/or improvements to this pathway in England.

Design

A pragmatic exploratory qualitative study using online focus groups and semi-structured interviews with National Health Service (NHS) professionals and those working in a stroke strategic/policy lead role. We thematically analysed the data using the Framework Approach to understand participants’ views on the challenges to improving current and future MT implementation.

Setting

NHS trusts and other key stroke strategic/policy organisations covering 10 geographical regions in England and a national perspective.

Participants

A total of 29 professionals, working in an NHS clinical and managerial position and/or a stroke strategic national/regional clinical/policy lead role, participated in five focus groups and six individual semi-structured interviews between April and June 2024.

Results

We identified five themes relating to MT implementation progress and challenges (1) workforce, (2) clinical care pathways, (3) service/system, (4) cross-cutting theme: communications and (5) cross-cutting theme: culture. Our analysis emphasised the increasing complexity and inter-related factors shaping the emergency stroke pathway for MT provision and a need to acknowledge key people-related, organisational and sociocultural factors during service planning.

Conclusions

Despite the challenges and complexity, professionals were optimistic that further progress would be made with MT delivery in England. However, ongoing improvement strategies are required, which also acknowledge wider cultural factors and system-wide relationships and are not just focused on care pathways and resources.

Development and Psychometric Testing of a Comprehensive Cancer Nurse Self‐Assessment Tool (CaN‐SAT) for Identifying Cancer Nursing Skills

ABSTRACT

Aim

To develop and psychometrically test a comprehensive Cancer Nurse Self-Assessment Tool (CaN-SAT).

Design

Modified Delphi to assess content validity and cross-sectional survey to assess reliability and validity.

Methods

Phase 1: An expert group developed the tool structure and item content. Phase 2: Through a modified Delphi, cancer nursing experts rated the importance of each element of practice and assessed the relevance and clarity of each item. Content Validation Indexes (CVI) were calculated, and a CVI of ≥ 0.78 was required for items to be included. Phase 3: Cancer nurses participated in a survey to test internal consistency (using Cronbach's alpha coefficients) and known-group validity (through Mann–Whitney U tests). This study was reported using the Guidelines for Reporting Reliability and Agreement Studies (GRRAS) checklist.

Results

The CaN-SAT underwent two rounds of Delphi with 24 then 15 cancer nursing experts. All elements of practice were rated as important. Only three items achieved a CVI < 0.78 after round one; however, based on open-ended comments, 26 items were revised and one new item added. After round two, all items received a CVI above 0.78. The final tool consisted of 93 items across 15 elements of practice. Cronbach's alpha coefficients were between 0.92 and 0.98 indicating good reliability. Mann–Whitney U tests demonstrated significant differences between clinical nurses and advanced practice nurses across 13 out of 15 elements of practice.

Conclusion

The CaN-SAT is a comprehensive, valid and reliable tool that can be used for cancer nurses to self-assess current skill levels, identify their learning needs and inform decisions about educational opportunities to optimise cancer care provision.

Patient or Public Contribution

The research team included three patient advocates from Cancer Voices NSW, who were actively involved in all aspects of the study and are listed as authors.

What are the Aboriginal worldviews of disability in the Fitzroy Valley? Aboriginal Participatory Action Research to develop strategies for decolonising disability services

Por: Stubbs · T. · Bedford · M. · Bear · E. · Carter · E. · Pickard · A. · Davies · J. · Thomas · S. · Martiniuk · A. L. C. · Elliott · E. J. · Rice · L. J.
Objectives

Aboriginal and Torres Strait Islander people living with disability have unequal access to health and disability support services. The impacts of colonialism and the deficit-based, Western medical model of disability have been identified as barriers to services in remote Aboriginal communities. This study explored different perceptions of disability and identified strategies to help bridge the gap between Aboriginal community members in the Fitzroy Valley and Western health and disability support services.

Design

Aboriginal Participatory Action Research approach with in-depth interviews. Transcripts were analysed using reflexive thematic analysis. Preliminary results were presented to community representatives for contextualisation, validation and to co-design recommendations.

Setting

Fitzroy Valley in the Kimberley region, Western Australia.

Participants

Aboriginal community members with lived experience of disability (n=7) and health and disability support service providers (n=12).

Results

Eight themes were identified: (1) Aboriginal kinship systems are a community strength and support for people living with disability; (2) Aboriginal people from the Fitzroy Valley perceive disability as a social construct; (3) Western medical model of disability differs from Aboriginal perceptions of disability; (4) Aboriginal people from the Fitzroy Valley perceive different types of disabilities in various ways; (5) good awareness of fetal alcohol spectrum disorder in the Fitzroy Valley, but more education is wanted; (6) focus on functional needs and supports for disability; (7) barriers to disability services and (8) decolonise disability services. Community co-designed recommendations focus on centring the Aboriginal worldviews of disability in the Fitzroy Valley.

Conclusions

Decolonising disability services is needed to improve access for Aboriginal and Torres Strait Islander communities. This should involve adapting the current Western medical model of services to enable strengths-based diagnostic and support services that align with Aboriginal and Torres Strait Islander kinship systems, cultures and ways of being. Community leadership must play a central role in this shift.

Creating an evidence map of the safety profile of spironolactone across all clinical indications to establish whether it may be a safe treatment in female adolescent acne: a protocol for a scoping review

Por: Sexton · F. C. · Attard · M. · OHiggins · L. · Moledina · Z. · Fordham · J. · Ramesh · G. · Law · J. · George · S. · Burden-Teh · E.
Introduction

Spironolactone is a useful and effective acne treatment option for adult female patients. We aim to establish whether spironolactone could be a safe treatment for the management of acne in the female adolescent population as well. The objective of this scoping review is to provide an evidence map of the safety profile of spironolactone in the paediatric population aged 0–17 across all clinical indications.

Methods and analysis

This scoping review will be conducted according to the Joanna Briggs Institute scoping review protocol. Relevant publications will be searched on the MEDLINE, Embase and Web of Science databases from inception until July 2025. The authors of included studies will be contacted using contact details provided in the manuscript to check for any further published or unpublished data on the review question. An initial search will be conducted using keywords to identify relevant articles. After identifying the research strategy, articles will be extracted into a reference management tool, and a two-part study selection process will be systematically applied by two reviewers. The first part consists of screening titles and abstracts to define the eligibility of each article. In the second part, the full texts will be screened and only relevant articles will be kept. All articles related to the safety of spironolactone in children and adolescents across all clinical indications will be included. Data will be extracted using a scoping review management software such as Covidence, collated and charted to summarise all the relevant methods, outcomes and key findings in the articles.

Ethics and dissemination

This scoping review will provide an extensive overview of the available safety evidence for the use of spironolactone in children and teenagers. Since the scoping review methodology consists of reviewing and collecting data from publicly available materials, this study does not require ethics approval. The results will be disseminated in a peer-reviewed publication.

Putting the patient at the centre: a call for research involvement of nurses, midwives and allied health professionals working in genomics

Por: Cowley · L. · Henriques · S. · Roberts · J. · Monje-Garcia · L. · Nolan · J. · Lubasch · K. · Theobald · R. · Greer · R. · Fennell · N. · Clarkson · A. · Clapham · M. · Chilton · S. · Allon · R. · Stopford · C. · Pierce · H. H. · Holliday · D.
Introduction

We report the collaborative views of a group of nurses, midwives and allied health professionals (NMAHPs) in the UK who have a genomics research remit or interest. Our group includes genetic counsellors under this diverse category of healthcare workers.

This group came together as part of the National Institute for Health and Social Care Research (NIHR) Genomics Research National Specialty Group. After responding to a survey to elicit the views of NMAHPs working in genomics, some of the original 45 respondents, along with others who learnt of the project by word of mouth, have worked together to produce this article.

Objective

The paper aims to set out in clear terms the value of NMAHPs to research that supports the patient-centred implementation of genomics in the National Health Service (NHS).

Key argument

We discuss four potential areas where NMAHPs, in particular, can contribute to the research. These are patient perspectives and epistemic justice, psychosocial impacts, the familial nature of genomics and equity. We argue that this group (NMAHPs) represents a potentially underused resource for the NHS as it seeks to ensure that advances in genomics are translated into patient benefit.

Conclusions

We propose that NMAHPs, with our research expertise, are well placed to shape and deliver a research agenda that explores models of patient-centred care in the genomics era. We call for increased funding for NMAHP research roles and funding opportunities to deliver this fundamental work.

Comparative relationships between physical and verbal abuse of children, life course mental well-being and trends in exposure: a multi-study secondary analysis of cross-sectional surveys in England and Wales

Por: Bellis · M. A. · Hughes · K. · Ford · K. · Quigg · Z. · Butler · N. · Wilson · C.
Objectives

To test associations between mental well-being across the life course and exposure to childhood physical and/or verbal abuse.

Design

Secondary analysis of combined data from seven cross-sectional general adult population surveys measuring childhood experience of physical and/or verbal abuse and current mental well-being.

Setting

Households across England and Wales.

Participants

20 687 residents in England and Wales aged 18 years or over.

Measures

Self-reported childhood physical and verbal abuse using questions from an Adverse Childhood Experiences tool. Individual and combined components of adult mental well-being measured using the short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS).

Results

Exposure to either childhood physical abuse or verbal abuse was associated independently with a similar significant increase in likelihood of low adult mental well-being, with exposure to both abuse types compounding increases (adjusted ORs 1.52, 1.64, 2.15 respectively, reference category: neither abuse type). Individual components of mental well-being showed similar associations, with adjusted prevalence of never or rarely having felt close to people in the last 2 weeks rising from 7.7% (neither abuse type) to 9.9% (physical abuse), 13.6% (verbal abuse) and 18.2% (both types of abuse). Within sample trends showed a significant drop in the prevalence of child physical abuse from around 20% in those born from 1950 to 1979 to 10% in those born in 2000 or after. However, verbal abuse rose from 11.9% in those born before 1950 to nearly 20% in those born in 2000 or after.

Conclusion

Exposure to childhood physical or verbal abuse have similar associations with lower mental well-being during adulthood. Interventions to reduce child abuse, including physical chastisement, should consider both physical and verbal abuse and their individual and combined consequences to life course health. The potential role of childhood verbal abuse in escalating levels of poor mental health among younger age groups needs greater consideration.

Pancreatic, nutritional and clinical outcomes in children 0-5 years with cystic fibrosis during the first 2 years of CFTR modulator therapy (PaNC): a multicentre prospective observational study protocol

Por: Miles · C. · Katz · T. · Grunert · J. · Ford · K. · Hall · C. · Hawthorn · C. · See · D. W. · McMahon · M. · Vass · H. · Watkins · S. · Zanardo · G. · Brookes · I. · Handley · S. · Woodward · T. · Wademan · J. · Cameron · B. · King · S. · Nixon · G. M. · Davidson · Z.
Background

Cystic fibrosis (CF) is a genetic condition of impaired membrane electrolyte transport and is characterised by defects in the production and function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Ground-breaking CFTR modulator therapy has resulted in a notable shift in the clinical presentation and progressive nature of CF, across both pulmonary and extrapulmonary systems. Access to CFTR modulator therapies in people with CF is occurring in a staged, descending age process, with clinical trials focusing primarily on safety and efficacy. There is a lack of robust, real-world longitudinal data on CFTR modulator therapy in infants and young children where extrapulmonary outcomes such as growth, micronutrient status and pancreatic function are the key focus.

Methods and analysis

Pancreatic, nutritional and clinical outcomes in children 0–5 years with CF during the first 2 years of CFTR modulator therapy (PaNC) is a prospective cohort study involving all eight tertiary paediatric CF centres in Australia. Infants and children 4 months to 5 years of age who are eligible for elexacaftor/tezacaftor/ivacaftor (ETI) or ivacaftor (IVA) meet the inclusion criteria for PaNC, with a total eligible cohort of 303 children at the commencement of recruitment. The primary outcomes are change in weight-for-length/body mass index z score and change in serum micronutrient status, at 6–12 monthly intervals, during the first 2 years of treatment with ETI or IVA. Secondary outcomes include change in exocrine pancreatic function, measured by faecal elastase-1, change in the use and dose of pancreatic enzyme replacement therapy, nutritional and gastrointestinal therapies and change in sweat chloride levels. Linear mixed modelling will be used to analyse primary and secondary endpoints. This protocol is reported in accordance with ‘The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement’ reporting guidelines.

Ethics and dissemination

Overarching governance and ethics approval has been granted by Monash Health Human Research Ethics Committee, in addition to all eight sites receiving site-specific authorisation approvals prior to the commencement of recruitment. Opportunities for CF consumers to be involved in targeted dissemination plans will be initiated via CF Australia at the completion of the study period. Additionally, a summary of non-identifiable results will be provided to CF consumers and CF healthcare providers via scientific and lay conferences and via peer-reviewed journals.

Trial registration number

ACTRN12624001185550; Pre-results.

Releasing time to deliver care: a mixed methods evaluation of the implementation of enhanced midwifery continuity of carer

Por: Gillibrand · S. · Parkyn · K. · Hall · C. · Kletter · M. · Harkness · E. · Munford · L. A. · Wilson · P. · Dumville · J.
Objectives

The enhanced midwifery continuity of carer (eMCoC) pilot programme provided additional resource (funding) to midwifery teams operating in the 10% most deprived areas in England. The eMCoC programme aims to provide additional support to those at greatest risk of poor maternal health outcomes. We conducted a rapid formative evaluation aiming to explore the implementation of the pilot programme to (1) generate timely insights to inform ongoing service delivery; (2) generate a logical framework of the eMCoC service and; (3) inform the design of a longer-term summative evaluation.

Design

Rapid evaluation using mixed-methods.

Setting

We explored implementation of the eMCoC service in 58 funded local midwifery teams across 23 Local Maternity and Neonatal Systems (LMNS). We undertook qualitative data collection in 10 case study sites across England, focusing on the implementation in 17 teams.

Participants

We purposively sampled 34 service users who received care from enhanced teams, and 38 staff working in enhanced teams. Inclusion criteria for the service user interviews included women who had received care from enhanced teams during our evaluation period and were more than 28 weeks pregnant. Exclusion criteria included women who had not received care from our target teams. We undertook descriptive analysis using the Maternity Services Dataset to compare the characteristics of service users in enhanced teams with service users receiving other midwifery service models.

Results

Many of the 58 teams funded were unable to implement eMCoC during the evaluation period because of institutional and organisational barriers. The barriers identified here are indicative of the barriers associated with implementing midwifery continuity of carer. Largely, the eMCoC service successfully targeted women living in the most deprived areas and a focus on reaching women living in these areas was valued by enhanced teams. Equally, enhanced teams strived to broaden the targeted characteristics (i.e. more broadly than on the basis of deprivation) to include a wider and more diverse set of social risk factors and vulnerabilities, based on local needs and priorities. Service users reported being well supported by the enhanced teams, including receiving relational and well-being support and personalised one-to-one public health education, information and support. Service users emphasised that enhanced teams went ‘above and beyond in their care’.

Conclusions

Funding for eMCoC has been well received by both staff and service users. The implementation of the enhanced roles was perceived to have supported delivery of team-based care, facilitating successful release of midwifery capacity and the delivery of additional public health activities. Supporting a team-focused ethos seems an important feature of eMCoC services. This was consistent across sites and from both staff and service user perspectives. There appears to be many routes (i.e. different service delivery types) to delivering enhanced care, and the multiplicity of service delivery types found in this evaluation suggests no tightly prescribed way of meeting eMCoC’s objectives. The flexibility of the initial funding specification guidance from NHS England has been a key driver of local ownership and permitted eMCoC services to be organically built ‘from the ground up’. Our conclusions point to the value of autonomy afforded to local areas to use eMCoC funding as they deem necessary to best suit the needs of their staff and specific service user groups. Attention should be placed on the barriers to implementation and sustainability issues which can be addressed, namely: delays in releasing funding from LMNS and Integrated Care Boards to providers, and protecting maternity support worker and midwifery time to their allocated teams.

Culturally and Linguistically Diverse Informal Carer Experiences of Older Adult Care Transitions From Hospital to Home: A Scoping Review

ABSTRACT

Aim

To review the evidence on the experiences and perceptions of culturally and linguistically diverse informal carers supporting older adults during transitions from hospital to home, including their interactions with transitional care interventions.

Design

Scoping review guided by Arksey and O'Malley's framework.

Data Sources

We searched CINAHL, MEDLINE, Embase, Emcare, AMED, PsycINFO, Global Health, Social Work Abstracts, JBI EBP, Scopus, Web of Science Core Collection, ProQuest and Informit for studies published between January 2010 and November 2024.

Methods

Two reviewers independently screened studies and extracted data. Analysis followed the Patterns, Advances, Gaps, Evidence for Practice and Research recommendations framework.

Results

Seventeen studies involving 1275 carers were included. Carer experiences were summarised into four themes: (1) cultural and communication barriers; (2) role ambiguity and practical challenges; (3) limited involvement in discharge planning and (4) barriers to accessing support and services. Perceptions of transitional care interventions were mixed. While some interventions improved carer preparedness and reduced stress, most lacked cultural tailoring and did not address carers' psychosocial and communication needs.

Conclusion

Culturally and linguistically diverse informal carers face challenges navigating transitional care. While involving them in care planning improves outcomes, implementation remains inconsistent. Emotional support and culturally tailored services are insufficient.

Implications for the Profession and/or Patient Care

There is a need for culturally and linguistically tailored transitional care programmes that prioritise carer education and communication support. Key areas for improvement include: (1) health literacy and system navigation; (2) involvement in care planning; (3) communication with providers; (4) psychosocial and emotional support and (5) culturally appropriate services. Future research should explore the unique emotional and psychosocial needs of these carers to inform targeted support strategies.

Reporting Method

This review follows the PRISMA guideline for reporting.

Patient or Public Contribution

No patient or public contribution.

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol

Por: Howe · B. D. · Macdonald · S. P. J. · Arendts · G. · Bellomo · R. · Burcham · J. · Delaney · A. · Egerton-Warburton · D. · Fatovich · D. · Fraser · J. F. · Higgins · A. · Jones · P. · Keijzers · G. · Milford · E. · Udy · A. A. · Williams · P. · Young · P. · Peake · S. L.
Introduction

International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.

Methods and analysis

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.

Ethics and dissemination

The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.

Trial registration number

NCT04569942

Effects of interventional public health laws and regulations intended to reduce gambling-related harms: a realist review study protocol

Por: Fisher · M. · Piper · T. · Mavi · S. · Nambiar · J. · Sharma · P. K. · Kirby · J. · Melendez-Torres · G. J. · Montgomery · P. · Fewell · G. · Chandan · J. S. · Bedford · K.
Introduction

Gambling is now widely acknowledged to be a major public health (PH) issue. The Office for Health Improvement and Disparities conservatively estimated that gambling harm is associated with an annual cost of £1.05–£1.77 billion in England alone. Marionneau et al have categorised gambling harms into seven themes: (1) financial, (2) relationship/conflict, (3) emotional and psychological (mental health), (4) health decrements (physical health), (5) employment/education, (6) cultural and (7) criminal activity. In this understanding, gambling harms are not restricted to individual experiences: they also impact families, the wider community and society, and hence they require a whole systems, PH approach, anchored in population-level interventions to reduce harms. We aim to identify the effects of interventional PH laws and regulations on the harms associated with gambling.

Methods and analysis

We limit our focus to interventional PH laws and regulations within a comprehensive search of scientific and legal databases, grey literature and books. Following Population, Intervention, Comparator, Outcome, Study, Timing inclusion criteria, evidence will be screened and appraised in Covidence by two reviewers (MF and TP). Included evidence will be analysed and synthesised using a narrative synthesis approach. Methodological quality will be appraised using the relevant risk of bias tool. Randomised controlled trials will be assessed using the Cochrane risk of bias tool (RoB2), Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) will be used for other non-randomised studies. Qualitative studies will be appraised using the EPPI reviewer software for systematic reviewing.

Ethics and dissemination

The review protocol is registered with PROSPERO (International prospective register of systematic reviews) at the National Institute for Health Research and the Centre for Reviews and Dissemination (CRD) at the University of York (CRD42024574502). We aim to define a theory of change and produce a context-mechanism-outcome framework with relevant experts using the findings. We plan to disseminate the findings through peer-reviewed publications, meetings with relevant experts and international conference presentations.

Effects of a drinking motives and readiness to change tailored digital alcohol intervention among online help-seekers: protocol for a randomised controlled trial

Por: Crawford · J. · Collier · E. · Ulfsdotter Gunnarsson · K. · Shorter · G. · McCambridge · J. · Lundgren · O. · Bendtsen · M.
Introduction

Alcohol consumption that damages health remains highly prevalent in Sweden despite macrolevel intervention measures such as availability, restrictions and taxation. As understanding of behaviour change develops, there may be an opportunity to enhance individual level interventions by targeting personal dimensions of behaviour, such as underlying motives for drinking alcohol and readiness to change behaviour. This protocol describes a randomised controlled trial aimed at estimating the effectiveness of an intervention tailored to motives and readiness to change.

Methods and analysis

A three-arm, parallel groups, randomised controlled trial will be used to estimate the effects of a motives and readiness to change tailored intervention. We will use a Bayesian sequential design to decide when to stop recruitment, with target criteria for benefit, harm and futility. Recruitment will be completed via web adverts and social media. Inclusion criteria are being aged 18 or older, having access to a mobile phone and being classified as a risky drinker. Participants allocated to the two intervention groups will receive either a personalised digital intervention or an intervention with enhanced tailoring for motives and readiness to change. The personalised intervention consists of weekly screening, personalised feedback and tools for planning behaviour. The enhanced tailored version will follow the same logic but will contain materials tailored for individuals’ drinking motives and readiness to change. The control group will be redirected to two national websites with information about alcohol and health. Outcome measures are weekly alcohol consumption and monthly heavy drinking episodes, which will be contrasted with regression models and estimated using Bayesian inference.

Ethics and dissemination

Ethical approval was obtained from the Swedish Ethical Review Authority on 16 April 2024, (Dnr 2024-01630-01). The results of the study will be disseminated in academic journals and research conferences.

Trial registration number

The trial was preregistered in the ISRCTN Registry on 12 June 2024 (ISRCTN87600318).

Use of an electronic medication management application to support Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC): a study protocol for a parallel cluster randomised controlled trial

Por: Page · A. T. · Mangin · D. · Almutairi · H. · Chen · E. Y. H. · Lee · K. · Ailabouni · N. · Johnson · J. · Potter · K. · Mavaddat · N. · Clifford · R. M. · Lobo · E. · Baldassar · L. · Seubert · L. · Petrie · D. · Wang · K. · Hosking · S. · Tasker · J. · Etherton-Beer · C.
Introduction

Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.

Methods and analysis

The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.

Ethics and dissemination

Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.

Trial registration number

ACTRN12624001409561.

Consumer perspectives on implementing falls prevention and management in rehabilitation hospitals: protocol for a qualitative study

Por: McKercher · J. P. · Peiris · C. L. · Peterson · S. · Thwaites · C. · Hill · A.-M. · Clifford · A. M. · Morris · M. E.
Introduction

High-quality clinical practice guidelines and hospital standards on falls prevention and management now exist, yet their implementation into clinical practice is variable. Insights from consumers could help to guide the development of a process to improve the implementation of falls prevention and management, particularly in rehabilitation hospitals where fall rates are high.

Methods and analysis

A qualitative descriptive study will incorporate semistructured interviews and focus groups to explore the perspectives of hospital consumers on how hospital falls prevention evidence can best be implemented into rehabilitation practice. Thematic analysis of the data will be conducted in NVivo using a six-phase thematic coding process guided by Braun and Clarke. Evaluation and synthesis of the data will also follow the Consolidated Criteria for Reporting Qualitative Research checklist. Consideration of the results from the interviews and focus groups will provide insights into the views of people with lived experience of hospitalisation and falls. Thematic analysis will be supported by direct quotes for each key theme and will highlight how the themes relate to the study aims and the rehabilitation context.

Ethics and dissemination

The study was approved by La Trobe University Human Research Ethics Committee (HEC24526). The study will be published in a peer-reviewed journal, and findings will be presented at conferences, workshops and online events.

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