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Ayer — Octubre 2nd 2025Tus fuentes RSS

Use of ambulatory pathways in emergency general surgery: a systematic review

Por: Fox · B. · Walters · M. · Pathak · S. · Peckham-Cooper · A. · Blencowe · N. S.
Objectives

Ambulatory care is defined as the provision of medical treatment by healthcare professionals outside an inpatient hospital setting. While well-established in acute medicine, uptake of ambulatory pathways in emergency general surgery (EGS) is variable and optimal design and delivery is unclear in this context. This systematic review sought to (1) appraise current EGS ambulatory pathway literature and (2) ascertain the constituent components across the identified pathways, guiding the development of comprehensive templates for future EGS ambulatory pathways.

Design

Systematic review.

Data sources

PubMed, Embase, Medline and Cochrane Library, from 5 December 2018 to 5 December 2023 inclusive.

Eligibility criteria

All primary observational studies (ie, case–control, cohort studies and randomised controlled trials (RCTs)) were included. Case series and conference abstracts were excluded due to the high likelihood of incomplete data. Studies reporting paediatric or non-surgical populations, or ambulatory surgical care within a primary care setting, were also excluded.

Data extraction and synthesis

General study characteristics (year and journal of publication, country of origin, study design, disease area, number of patients receiving ambulatory management and use of control groups) were recorded. To identify the constituent components of EGS ambulatory pathways, an initial subset of five papers was reviewed, from which four categories were identified (decision-making processes, scoring/classification systems, investigations and care escalation and discharge criteria). An additional fifth component (‘follow-up’) was identified during data extraction. Reporting of the constituent components of ambulatory pathways was also extracted, as well as outcomes including readmission, complications and mortality.

Results

Of 43 included studies, there were 8 RCTs, 31 cohort studies and 4 studies using other methods. Reporting of all aspects of EGS ambulatory pathways was heterogeneous. 24 (56%) papers reported the specialty and grade of clinician acting as senior decision-maker. 17 different scoring/classification systems were used. 32 (74%) papers described using investigations to select ambulatory patients, including blood tests (n=12) and imaging (n=16). Eight studies (19%) specified both care escalation and discharge criteria. Information about follow-up was described in 29 papers, with location (n=29), time points (n=26), personnel (n=16) and the form of the follow-up (n=23) all reported variably. Readmission rates were recorded in 34 studies and ranged from 0% to 13%. Most studies (n=32) reported 30-day readmission, although 48 hours (n=1) and 90 days (n=1) were also used. Mortality was recorded in 24 papers, with 21 reporting a mortality rate of 0 and the remaining 3 reporting rates of

Conclusions

Key components of published EGS ambulatory pathways include decision-making processes, scoring/classification systems, investigations, care escalation and discharge criteria, and follow-up. However, this information is currently inconsistently reported. Future work to identify and agree on guidelines for the ‘core’ components of ambulatory EGS pathways is needed, to facilitate cross-study comparisons, and crucially, provide a ‘gold-standard’ framework for developing future ambulatory pathways.

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Advocates, Academics, Survivors and Clinicians to END Intimate Partner Violence (ASCEND-IPV) initiative: a prospective observational case-control study protocol to identify plasma biomarkers of intimate partner violence (IPV)-caused brain injury (BI)

Por: Harper · M. I. · McKinney · K. · McLennan · C. · Adhikari · S. P. · Ghodsi · M. · Cooper · J. G. · Stukas · S. · Maldonado-Rodroguez · N. · Agbay · A. · Morelli · T. · Nouri Zadeh-Tehrani · S. · Lorenz · B. R. · Rothlander · K. · Smirl · J. D. · Wallace · C. · Symons · G. F. · Brand · J
Introduction

Although as many as 92% of survivors of physical intimate partner violence (IPV) report impacts to the head and/or non-fatal strangulation (NFS) that raise clinical suspicion of brain injury (BI), there are no evidence-based methods to document and characterise BI in this vulnerable population, limited clinical practice guidelines and insufficient understanding about long-term risks for conditions including Alzheimer’s Disease and Related Dementias (ADRD). This leaves most survivors of IPV-caused BI (IPV-BI), overwhelmingly women, without adequate access to medical care and support, safe housing, back-to-school/work accommodations or follow-up care for long-term neurocognitive health. Although traumatic brain injury (TBI) is an established ADRD risk factor, little is known about the attributable risk of ADRD due to IPV-BI, particularly in women.

Methods of analysis

Our overarching objectives are to (1) use plasma biomarkers as novel tools to assist clinicians to improve diagnosis of IPV-BI at the acute, subacute and chronic stages in a manner sensitive to the needs of this vulnerable population and (2) raise awareness of the importance of considering IPV-BI as a potential ADRD risk factor. A prospective observational study funded by the US Department of Defense (HT9425-24-1-0462), Brain Canada (6200) and the Canadian Institutes of Health Research (523320-NWT-CAAA-37499) leverages collaborative research at multiple clinical sites in British Columbia to maximise equity, diversity and inclusion among participants, with a target enrolment of n=600 participants.

The Advocates, Academics, Survivors and Clinicians to END Intimate Partner Violence Biomarkers study, which is predicated on pre-specified research questions, represents one of the most significant community-based studies on plasma biomarkers affected by an IPV-BI incident. Of particular significance is the fact our study uses robust biomarker approaches being applied in the TBI and ADRD fields to determine how the biomarker profile after IPV-BI compares to typical TBI and the early stage of neurodegenerative disorders.

Ethics and dissemination

This study was approved by the University of British Columbia Clinical Research Ethics Board (H24-01990, H22-02241 and H16-02792) and the Island Health Research Ethics Board (H22-03510). Upon publication of primary papers, de-identified data and biospecimens will be made widely available, including the US Federal Interagency Traumatic Brain Injury Research (FITBIR) federated database. Our data and integrated knowledge translation activities with persons with lived experience of IPV-BI and those working in the healthcare sector will be synthesised into co-designed and implemented knowledge tools to improve outcomes for survivors of IPV-BI.

A Scoping Review of Instruments Used to Measure Resilience in Samples of Nurses

ABSTRACT

Aim

To identify and critically appraise instruments that have been used to measure nurse resilience.

Design

A scoping review.

Data Sources

Comprehensive literature searches were conducted using four electronic databases CINAHL Ultimate, MEDLINE, PsycINFO and Emcare from the year 2012 to December 2024.

Methods

The titles, then abstracts, of retrieved articles were screened by the authors against inclusion and exclusion criteria, then full-text screening was performed using Rayyan. Data about the study characteristics and the instruments used to measure nurse resilience were extracted. Copies of the instruments used to measure resilience were obtained and appraised.

Results

Of the n = 4694 publications identified in the initial search n = 386 were included in the scoping review. Studies originated in n = 45 countries, the majority were conducted in China (n = 119) and the United States of America (n = 53). Across the n = 386 included studies, n = 15 instruments to measure resilience were identified and critically appraised. The scores for the instruments critically appraised ranged from 0 to 6 out of a total possible score of 11. Synthesis of results examined instrument development, instrument features and application of instruments.

Conclusion

Critical appraisal of the instruments used to measure nurse resilience revealed significant deficiencies. None of the instruments included all of the key attributes and factors that influence nurse resilience. There was a predominant focus on individual factors and little consideration of the influence of nursing work environments. Due to the shortcomings of the existing instruments, there are currently substantial limitations in our understanding of nurse resilience and how to measure it.

Implications for the Profession

A profession-specific comprehensive measure of nurse resilience needs to be developed to better capture the attributes of nurse resilience.

Impact

This review highlights the limitations of instruments applied to measure nurse resilience.

Reporting Method

The JBI scoping review framework.

Patient or Public Contribution

No patient or public contribution.

Research Publication Performance of the Australian and New Zealand Nursing and Midwifery Professoriate

ABSTRACT

Aim

To analyse research publication performance of Australian and New Zealand professors and associate professors of nursing and midwifery, and compare with 2016 data.

Methods

A search of university websites was conducted to identify all nursing and midwifery professoriate in Australia and New Zealand. Each individual was then searched in the Scopus database to identify individual total citations, h-index, number of publications, first author Field Weighted Citation Impact (FWCI) and overall FWCI. Comparisons with 2016 data were also undertaken.

Results

A total of 304 academics were included, comprising 270 from Australia and 34 from New Zealand, and 169 full professors and 135 associate professors. Overall, total publications and citations had increased. Maximum h-index had increased; however, median only changed slightly.

Conclusion

The study provides contemporary data that can support cases for academic promotion along with other benchmarking activities.

Impact

Findings reflect the current research publication performance of the Australian and New Zealand professoriate and provide invaluable data for academic benchmarking in those countries and also in many others.

Patient or Public Contribution

No patient or public contribution.

Clinical decision-making and care pathways for people with multiple long-term conditions admitted to hospital: a scoping review

Por: Howe · N. L. · Blackburn · E.-R. · Sheppard · A. · Pretorius · S. · Suklan · J. · Bellass · S. · Cooper · R. · Gallier · S. · Sapey · E. · Sayer · A. A. P. · Witham · M.
Objectives

People living with multiple long-term conditions (MLTC) admitted to hospital have worse outcomes and report lower satisfaction with care. Understanding how people living with MLTC admitted to the hospital are cared for is a key step in redesigning systems to better meet their needs. This scoping review aimed to identify existing evidence regarding clinical decision-making and care pathways for people with MLTC admitted to the hospital. In addition, we described research methods used to investigate hospital care for people living with MLTC.

Design

A scoping review methodological framework formed the basis of this review. We took a narrative approach to describe our study findings.

Data sources

A search of Medline, Embase and PsycInfo electronic databases in July 2024 captured relevant literature published from 1996 to 2024.

Eligibility criteria

Studies that explored care pathways and clinical decision-making for people living with MLTC or co-morbidities, studies conducted fully or primarily in secondary or tertiary care published in English Language and with full text available.

Data extraction and synthesis

Titles and abstracts were independently screened by two authors. Extracted data included country of origin, aims, study design, any use of an analytical framework or design, type of analyses performed, setting, participant group, number of participants included, health condition(s) studied and main findings. Included studies were categorised as either: studies reviewing existing literature, studies reviewing guidance, studies utilising qualitative methods or ‘other’.

Results

A total of 521 articles were screened, 17 of which met the inclusion criteria. We identified a range of investigative methods. Eight studies used qualitative methods (interviews or focus groups), four were guideline reviews, four were literature reviews and one was classified as ‘other’. Often, researchers choose to combine methods, gathering evidence both empirically and from reviews of existing evidence or guidelines. However, none of the empirical qualitative studies directly or solely investigated clinical decision-making when treating people living with MLTC in acute care and the emergency department. Studies identified complexities in care for people living with MLTC, and some authors attempted to make their own recommendations or draft their own guidance to counter these.

Conclusions

This scoping review highlights the limitations of the current evidence base, which, while diverse in methods, provides sparse insights into clinical decision-making and care pathways for people living with MLTC admitted to hospital. Further research is recommended, including reviews of guidelines and gathering insights from both healthcare professionals and people living with MLTC.

Understanding trauma-impaired executive function and its impacts on homeless adults in the UK: a realist evaluative synthesis protocol

Por: Cooper · C. · Lhussier · M.
Introduction

Approximately 90% of people with experience of homelessness report adverse childhood experiences, having far-reaching consequences across the life course. Trauma-informed approaches have burgeoned in the last decade; however, biological understandings, including neurological perspectives of the impact of trauma, are typically overlooked. At present, there is little evidence exploring the impacts of executive function (EF) deficits in adulthood as a result of childhood trauma from a lived experience perspective, with none specifically exploring the role these deficits might play in homelessness.

Methods and analysis

The proposed research takes a realist evaluative synthesis approach combining evidence from the extant literature with qualitative data from professionals involved in the delivery of services to support people with experience of homelessness (n=15–20) and people with experience of homelessness who have previously engaged with services (n=15–20).

A combination of keywords (Adverse childhood experiences, executive function, social functioning and complex needs) and their synonyms will be used to search databases MEDLINE, PubMed, SCOPUS, Web of Science and CINAHL. Data analysis will follow a realist logic, developing and refining programme theories. An iterative and cyclical approach to data analysis and evidence synthesis will be taken until the aims of the research have been met.

Ethics and dissemination

Findings from this study will contribute to new understandings of the pathways into and out of homelessness through the lens of EF. Findings will contribute to the development of a trauma-informed care toolkit for service providers. Findings will be disseminated via coproductive workshops, conferences and peer-reviewed publications.

This study has received ethical approval from the ethics committee at Northumbria University.

Routine testing for group B streptococcus in pregnancy: protocol for a UK cluster randomised trial (GBS3)

Por: Daniels · J. · Walker · K. · Bradshaw · L. · Dorling · J. · Ojha · S. · Gray · J. · Thornton · J. · Plumb · J. · Petrou · S. · Madan · J. · Achana · F. · Ayers · S. · Constantinou · G. · Mitchell · E. J. · Downe · S. · Grace · N. · Plachcinski · R. · Cooper · T. · Moore · S. · Jones · A.-M.
Introduction

It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy.

Methods and analysis

Cluster randomised trial.

Sites and participants

320 000 women from up to 80 hospital maternity units.

Strategies

Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design.

Outcomes

The primary outcome is all-cause early (

Ethics and dissemination

The trial received a favourable opinion from Derby Research Ethics Committee on 16 September 2019 (19/EM/0253). The allocated testing strategy will be adopted as standard clinical practice by the site. Women in the routine testing sites will give verbal consent for the test. The trial will use routinely collected data retrieved from National Health Service databases, supplemented with limited participant-level collection of process outcomes. Individual written consent will not be sought. The trial results, and parallel economic, qualitative, implementation and methodological results, will be published in the journal Health Technology Assessment.

Trial registration number

ISRCTN49639731.

Hospital at home digital twin for the management of patients with frailty: a scoping review protocol

Por: Yahya · F. · Cooper · M. · Kassem · M. · Nazar · H.
Introduction

Patients with frailty are at risk of adverse outcomes such as mortality, falls, deconditioning and hospital readmissions. With an increasingly ageing population and a greater likelihood of frailty, there is a significant need to ensure that patients are managed in the right place and at the right time. There has been a focus on offering hospital-level care at home as a way to meet this need, incorporating strategies to integrate care and use digital solutions. Digital twin (DT) technology is one advancement, offering a virtual replica of an object/environment, which has the potential to make use of real-time data personalised for an individual patient and/or setting to inform and support patient management decisions. We are yet to realise the full potential of this new way of integrated working and technological advancements. This scoping review aims to ascertain the current evidence for the components of the DT architecture to enable the monitoring and management of patients with frailty living at home.

Methods

This scoping review will follow the Joanna Briggs Institute methodology for scoping reviews and will be reported following the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews guidelines. The following electronic databases will be searched: Medline, Embase, CINAHL, Cochrane CENTRAL, Web of Science and Scopus. Relevant websites will be searched for grey literature or case reports to capture the required information, as well as any documents provided by stakeholders. Primary studies, published in the English language from 2019 to the present day, which report on the monitoring or management of patients with long-term conditions and frailty within their home environment, will be included. Screening will be conducted by at least two independent reviewers against eligibility criteria, and a piloted data extraction form will be used to align with the research questions. Qualitative content analysis will be used. Data will be presented in tabular form, as well as descriptive and illustrative formats, to address the objectives of this review.

Ethics and dissemination

This scoping review does not require ethical approval. The findings of this review will be disseminated through peer-reviewed journals and conferences and will support the development of a conceptual model of a hospital-at-home DT for the management of patients with frailty.

Comparison of complications and recovery after laparoscopic and abdominal hysterectomy for benign disease: the LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial

Por: Antoun · L. · Woolley · R. · Middleton · L. · Smith · P. · Saridogan · E. · Cooper · K. · McKinnon · W. · Bevan · S. · Ziomek · K. · Sairally · Z. · Jones · L. · Fullard · J. · Morgan · M. · Clark · T. J.
Objective

To compare recovery after laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH).

Design

A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial.

Setting

10 NHS (National Health Service) hospitals within the UK.

Participants

Women undergoing hysterectomy for a benign gynaecological condition.

Interventions

Consenting women of 18–55 years were randomised to LH or AH using a secure internet facility by a surgeon with self-declared expertise. Major complications were recorded by clinicians, and recovery was assessed by regular text messaging and postal questionnaires.

Primary and secondary outcome measures

Major surgical complications (Clavien-Dindo≥level 3) up to six completed weeks postsurgery, time to resumption of normal activities measured by the Patient-Reported Outcomes Measurement Information System Physical Function tool and quality of recovery at 24 hours (Quality of Recovery 15 score; 0–150).

Results

75 women were randomised before early curtailment of the trial; 32/39 (82%) and 30/36 (83%) women underwent LH and AH, respectively. Major complications occurred in 2/32 (6%) LH versus 4/30 (13%) AH groups. No difference in time to resumption of usual activities was found (median [IQR, n] 7.5 weeks (3.6–8.2, 25) LH vs 7.5 weeks (5.5–10.6, 26) AH groups or quality of recovery (mean [SD, n] 81.1 (13.4, 27) vs 72.3 (17.6, 22), respectively; adjusted mean difference 7.2, 95% CI –3.2 to 17.6).

Conclusions

No differences were found in complications or recovery between LH and AH. However, early cessation of the trial due to recruitment challenges limits clinical inferences. It is important that larger comparative trials are conducted now that LH, including robotics, is becoming adopted as standard practice.

Trial registration number

ISRCTN14566195, IRAS ID 287988.

Burnout, Mental Health, and Workplace Characteristics: Contributors and Protective Factors Associated With Suicidal Ideation in High‐Risk Nurses

ABSTRACT

Background

A call for action has been issued nationwide to prevent suicide among nurses. An increased understanding of contributing and protective factors associated with suicidal ideation in nurses is needed to implement preventive measures. Factors needing exploration include nurses' burnout, mental well-being, physical health, and workplace characteristics.

Aims

This study aimed to determine factors associated with suicidal ideation in 501 moderate-to-high-risk nurses, including their mental health, level of burnout, health-related personal beliefs, healthy lifestyle behaviors, and workplace characteristics.

Methods

A descriptive, cross-sectional correlational study was conducted on baseline survey data that was completed before the nurses were randomized to one of two interventions as part of their participation in a randomized controlled trial investigating the efficacy of a combined mental health screening program and cognitive-behavioral skills building intervention versus a screening program alone. Nurses were recruited from across the United States via email. Only nurses identified with moderate-to-high-risk adverse mental health outcomes, including suicidal ideation, were included. The survey used valid and reliable measures to assess burnout, anxiety, depression, suicidal ideation, post-traumatic stress, healthy lifestyle behaviors, health-related personal beliefs, resilience, job satisfaction, self-perceived mattering to the workplace, and intent to leave. Bivariate tests were performed.

Results

Burnout, anxiety, depression, and post-traumatic stress were individually correlated with increased odds of suicidal ideation, as were nurses working 12-h shifts and those who reported an intent to leave their jobs. Protective factors against suicidal ideation included resilience, positive health-related personal beliefs, healthy lifestyle behaviors, job satisfaction, and workplace mattering.

Linking Action to Evidence

There is an urgent need for policies and implementation of evidence-based interventions to address mental health issues in nurses to ultimately prevent suicide. Burnout should be considered as a possible precursor to serious adverse mental health problems and not just an operational retention issue. Leaders need to invest in resources to enhance nurses' mental health, fix system problems that are at the root cause of burnout, routinely recognize employees for their excellent work, and communicate that they matter. Leaders should listen carefully to their nurses, prioritize their ideas for impactful change, and appreciate those who contribute to improving culture and caring practices.

Linear and Area Coverage With Closed Incision Negative Pressure Therapy Management: International Multidisciplinary Consensus Recommendations

ABSTRACT

Closed incision negative pressure therapy (ciNPT) with foam dressings has received broad recognition for its ability to support incision healing for a variety of surgical procedures. Over time, these dressings have evolved to include linear and ‘area’ shapes to better conform to different incision types and surface geometries. To address new studies on these configurations and provide guidance for dressing selection, an international, multidisciplinary panel of experts was convened. The panel reviewed recent publications on ciNPT with reticulated open cell foam (ROCF) dressings, shared their cases and experiences and engaged in roundtable discussions on benefits, drawbacks and technical challenges. Topics were ranked by importance and refined into potential consensus statements. These were shared for anonymous feedback, requiring 80% agreement for consensus. This manuscript establishes 12 consensus statements regarding risk factors supporting the use of ciNPT, conditions supporting preference of linear or area ciNPT dressings and tips for practical application of ciNPT with ROCF dressings. While this consensus panel expands on previous publications to aid clinicians' decision-making, further research is needed to refine recommendations and identify the strengths and limitations of ciNPT. Continued multidisciplinary collaboration will ensure ciNPT remains vital for improving surgical outcomes and patient care.

Randomised controlled trial with parallel process evaluation and health economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with amyotrophic lateral sclerosis: study protocol

Por: Peace · A. · White · D. A. · Hackney · G. · Bradburn · M. · Norman · P. · White · S. · Al-Chalabi · A. · Baird · W. · Beever · D. · Cade · J. · Coates · E. · Cooper · C. · Ezaydi · N. · Halliday · V. · Maguire · C. · Shaw · P. J. · Stavroulakis · H. · Waterhouse · S. · Young · T. A. · McDerm
Introduction

Amyotrophic lateral sclerosis (ALS) is a devastating illness that leads to muscle weakness and death usually within around 3 years of diagnosis. People with ALS (pwALS) often lose weight due to raised energy requirements and symptoms of the disease presenting significant challenges to taking adequate oral diet, with those who lose more weight being at a greater chance of earlier death. There is also some evidence to suggest that a higher calorie diet may benefit the disease course in pwALS, but further research is needed.

Methods and analysis

Two armed, parallel group, superiority, open labelled, randomised controlled trial, with internal pilot, to assess the effectiveness of an early high calorie diet on functional outcomes in ALS, comprising two treatment arms: (1) standard care, (2) standard care with additional active management using the OptiCALS complex intervention to achieve a high calorie diet (initially randomised 1:1, then 1:2 following a protocol amendment). Using a food first approach, pwALS will be encouraged and supported to follow a diet that meets an individualised calorie target from food before prescribing oral nutritional supplements. 259 pwALS will be recruited from up to 20 ALS centres across the United Kingdom and Ireland and followed up for a period of 12 months. Primary outcome is functional change measured over 12 months, using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. Secondary end points include measures of functional health, quality of life, calorie intake and weight, as well as time to gastrostomy and survival. A health economic analysis and process evaluation will also be undertaken. Participant recruitment is expected to complete in September 2025, and participant follow-up is expected to complete in September 2026. The results of this study are expected in March 2027.

Ethics and dissemination

The trial was approved by Greater Manchester—North West Research Ethics Committee, reference 20/NW/0334 on 8 September 2020. We will publish the study findings in peer-reviewed academic journals and present at local, national and international conferences where possible.

Trial registration number

ISRCTN30588041.

Mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: MissionEB protocol for a randomised, double-blinded, placebo-controlled, two-centre, crossover trial with an internal phase I dose de-escalation ph

Por: Bageta · M. L. · Lopez-Balboa · P. · Dimairo · M. · Glover · R. · Hutchence · K. · Papaioannou · D. · Cooper · C. · Biggs · K. · Tappenden · P. · Ennis · K. · Ogboli · M. · Lovgren · M.-L. · Poudel · P. · Nadeem · M. · McGrath · J. A. · Julious · S. A. · Petrof · G. · Martinez · A. E.
Introduction

Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genetic mucocutaneous fragility disorder characterised by chronic blistering, slow wound healing and increased risk of squamous cell carcinoma. Current management options are very limited.

Methods

This is a randomised (1:1), placebo-controlled, double-blinded crossover (A/B) trial with an internal phase I dose de-escalation (4+5 design) in the first 3 months and a 12-month continued treatment follow-on open-label study if 3-month outcome data from the crossover trial indicate safe and beneficial effects. RDEB is a rare condition, so we expect to recruit a maximum of 36 participants based on feasibility and not formal power considerations. Participants aged>6 months and x106 cells/kg intravenous infusion of umbilical cord-derived mesenchymal stem cells or placebo at the start of each crossover period (day 0) and 14 days later. The dose will be de-escalated to 1–1.5x106 cells/kg depending on observed toxicity. For the main crossover trial, the primary outcome is the change in disease severity as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index at 3 months from day 0 infusion. Secondary outcomes measured at 3 and 6 months from day 0 infusion include changes in general clinical appearance of skin disease, pain and itch, and quality of life. Adverse events and serious adverse events will be monitored throughout the trial.

Ethics and dissemination

North East—York Research Ethics Committee approved the protocol (ref: 21/NE/0016) on 16 March 2021. Findings will be published in peer-reviewed scientific journals, presented at relevant national and international conferences, and an open-access final report submitted to the funder.

Trial registration number

ISRCTN14409785. Protocol V. 8.0, 14 November 2022.

Patient Bridge Role: a new approach for patient and public involvement in healthcare research programmes

Por: Summers · B. · Farmer · L. · Cooper · S. · von Wagner · C. · Friedrich · B. · Abel · G. A. · Spencer · A. · Cockcroft · E.
Background

Patient and public involvement (PPI) in research involves an active collaboration between patients/members of the public and researchers in equal partnership. PPI in health research ensures the research benefits those most impacted by the research and is a well-established necessity of high-quality research. PPI for large programmes of work involving multiple studies frequently relies on a single PPI group that oversees the entire programme. We believe that this ‘traditional’ approach can negatively contribute to the power imbalance between researchers and PPI members, since PPI members have a very wide remit and are unable to embed themselves fully in all aspects of the research.

Aim

The study aimed to evaluate a novel PPI approach, the ‘Patient Bridge Role’, designed to promote a more equal distribution of power between public collaborators and researchers in a large research programme. The Patient Bridge Role involves assigning specific public collaborators to each work package, facilitating deeper engagement and communication.

Main argument

The Patient Bridge Role addresses the limitations of traditional PPI. This approach requires clear role definitions and collaborative development of guidelines to ensure effective communication and shared decision-making. Despite initial challenges related to role clarity and boundaries, the Patient Bridge Roles successfully promoted a more balanced partnership between researchers and public collaborators.

Conclusions

Active partnerships between public collaborators and researchers are critical to creating more relevant and higher quality research. Yet, there are many practical and conceptual barriers to this. The Patient Bridge Role offers a promising strategy for enhancing PPI in large research programmes.

Effectiveness of a community-based rehabilitation programme following hip fracture: results from the Fracture in the Elderly Multidisciplinary Rehabilitation phase III (FEMuR III) randomised controlled trial

Por: Williams · N. · Busse · M. · Cooper · R. · Dodd · S. · Dorkenoo · S. · Doungsong · K. · Edwards · R. T. · Green · J. · Hardwick · B. · Lemmey · A. · Logan · P. · Morrison · V. · Ralph · P. · Sackley · C. · Smith · B. E. · Smith · T. · Spencer · L. H.
Objective

To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design

Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting

Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants

Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions

Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures

Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results

In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions

The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number

ISRCTN28376407.

Bridging the gap: A systematic review of intraoperative electrocochleography during cochlear implantation and preservation of residual hearing

by Jaimee Cooper, Jeenu Mittal, Max Zalta, Nicholas DiStefano, Delany L. Klassen, Keelin McKenna, Dimitri A. Godur, Andrea Monterrubio, Moeed Moosa, Rahul Mittal, Adrien A. Eshraghi

Cochlear implantation is a surgical intervention to provide auditory rehabilitation to individuals with severe to profound hearing loss. Intraoperative electrocochleography (ECochG) has emerged as a promising tool for monitoring cochlear health during cochlear implant (CI) surgery. This systematic review aims to synthesize current evidence regarding the effectiveness of intraoperative ECochG in predicting postoperative residual hearing levels in CI recipients. A comprehensive literature search was conducted across major databases including PubMed, Embase, Web of Science, and SCOPUS. The protocol for this systematic review was registered in the PROSPERO database (registration number: CRD42023476617). The key outcomes assessed were the correlation between intraoperative ECochG patterns and postoperative residual hearing levels, as well as the influence of surgical techniques and electrode design on ECochG responses and hearing preservation. The Risk of Bias analysis was conducted using the Joanna Briggs Institute Critical Appraisal Tool. The review included a total of eighteen studies that met the inclusion and exclusion criteria. A significant correlation was reported between specific intraoperative ECochG response patterns and the preservation of residual hearing post-surgery. Studies highlighted that robust ECochG responses typically indicated a higher likelihood of postoperative hearing preservation. The review also identified factors influencing ECochG responses, including electrode design and insertion techniques. Several studies reported improved preservation of residual hearing with modifications in surgical approaches guided by ECochG feedback. Intraoperative ECochG monitoring emerges as a crucial tool in predicting and potentially enhancing postoperative residual hearing outcomes in implanted individuals. The review underscores the value of ECochG in guiding surgical technique adjustments, thereby maximizing hearing preservation. However, the heterogeneity in study designs and ECochG protocols suggests a need for standardization in this field. Future research should focus on large-scale, multicenter trials to establish definitive guidelines for integrating ECochG in CI surgeries, with an emphasis on long-term hearing outcomes.

A Point Prevalence Study of Need and Provision of Palliative Care in Adult and Medical Surgical Inpatients

ABSTRACT

Aim

To gain an understanding of palliative care need and provision in adult medical and surgical inpatients.

Design

An observational point prevalence study was conducted across four study sites in Western Australia.

Methods

All data were collected directly from patient medical records by Registered Nurses. Potential palliative care need was assessed using disease-specific indicators for the 12 conditions outlined in the Gold Standards Framework Proactive Indicator Guidance.

Results

A total of 865 medical and surgical inpatients met study inclusion criteria. Across the four study sites, 38% (n = 331) of adult inpatients reviewed could have potentially benefitted from palliative care. Of the n = 331 patients assessed as having indicators for palliative care, there was evidence that 27% (n = 90) were currently receiving some form of palliative care, while 3% (n = 9) had been referred for specialist palliative care. For the majority of patients (70%, n = 232) there was no evidence of them receiving any form of palliative care or awaiting specialist palliative care.

Conclusion

This study identified high levels of potential palliative care need among adult medical and surgical inpatients. The majority of the patients identified as having indicators for palliative care were not receiving any form of palliative care.

Implications for the Profession and/or Patient Care

The high prevalence of palliative care need found in this study highlights that recognising and addressing palliative care is essential for high-quality care for medical and surgical inpatients. To address the high level of need identified all nurses require basic palliative care training to provide optimal patient care.

Impact

Knowledge about the level of palliative care need and provision of palliative care in public hospitals was limited. This study identified a high prevalence of potential palliative care need in medical and surgical inpatients. The majority of patients with indicators for palliative care were not receiving any form of palliative care. This research demonstrates that palliative care needs should be considered by all registered nurses and other health professionals caring for medical and surgical inpatients.

Reporting Method

The study is reported using the STROBE guidelines.

Patient or Public Contribution

No patient or public contribution.

QbTest for ADHD assessment and medication management: a mixed-methods systematic review of impact on clinical outcomes and patient, carer and clinician experiences

Por: Tomlinson · E. · Owen-Smith · A. · Benavente · M. · Cooper · C. · Jones · H. E. · Ward · M. · Walker · J. G. · Wang · H. · Lopez Manzano · C. · Hank · D. · Welton · N. J. · Leeflang · M. · Whiting · P.
Objectives

To explore patient, carer and clinician experiences of the QbTest and its impact on patient outcomes for attention deficit hyperactivity disorder (ADHD) diagnosis and medication management.

Design

Mixed-methods systematic review.

Data sources

MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and WHO ICTRP (from inception to September 2024).

Study selection

Primary studies, of any design, that evaluated any version of the QbTest (QbMini

Data extraction and synthesis

Two reviewers independently screened titles and abstracts and assessed potentially relevant reports for inclusion. One reviewer conducted data extraction and risk of bias (RoB) assessment, checked by a second reviewer. Mixed-methods synthesis followed the convergent-integrated approach.

Results

We identified 10 eligible studies (9 QbTest; 1 QbCheck), including 1 randomised controlled trial (RCT), 2 feasibility RCTs, 5 before-and-after studies, 1 mixed-methods study and 1 diagnostic study. Most studies enrolled children in the UK and included surveys or interviews with patients, carers or clinicians. The RCT and before-and-after studies were judged at high/serious RoB. Six survey components and two qualitative interview components were judged at some concerns of RoB. We identified one ongoing study of the QbMT and no studies for QbMini. We organised themes emerging from the qualitative synthesis into two broad conceptual categories: views around the helpfulness of the QbTest (contribution to ADHD diagnosis, treatment decision-making, communication with caregivers) and barriers to QbTest implementation (practical barriers and acceptability of the test to patients and caregivers). Findings suggested that the addition of the QbTest may reduce time to diagnosis, improve clinician confidence in the diagnostic decision, increase the proportion of patients with a diagnostic decision and reduce cost and number of clinic appointments. The QbTest appeared to be generally well received by clinicians, patients and carers. However, barriers to test implementation were reported. Clinicians cited staffing, room requirements and issues with technology, and patients highlighted the test length and repetitive nature. Little data exist on the use of the QbTest for medication management.

Conclusions

The available evidence suggests the QbTest may be a useful addition to ADHD assessment in children and young people. Further well-designed RCTs with qualitative substudies are required to assess the impact of the QbTest on patient outcomes, user experience and cost, particularly for medication management and in adults, where evidence is scarce. Such RCTs should include economic analyses, direct comparisons to other continuous performance tests with motion trackers and subgroup analyses including age, sex, ethnicity and comorbidities.

PROSPERO registration number

CRD42023482963.

Characterising the volume and variation of multiple urgent suspected cancer referrals in England, April 2013-March 2018: a national cohort study

Por: Roberts · K. · Cooper · N. · Webster · L. · Sharpless · B. · Round · T. · Gildea · C. · Nicholson · B. D.
Objectives

To establish a methodology to categorise urgent suspected cancer (USC) referrals in England and use these categories to understand individual patient referral patterns by demographic characteristics, financial year and referral pathway.

Design

Cross-sectional population-based cohort study.

Setting

From Cancer Waiting Times data, linked to demographic information held by the National Disease Registration Service, referral-level data on all USC referrals in England between 1 April 2013 and 31 March 2018.

Participants

After restricting records to those with an English postcode at referral and with complete demographic information, 9 524 435 referrals were identified for 7 542 592 patients.

Primary and secondary outcome measures

USC referrals were categorised into first and subsequent USC referrals, based primarily on intervals between referral dates. Our primary outcome was to describe the distribution of referral categories by financial year, suspected cancer referral type and four demographic variables. Our secondary aim was to understand which suspected cancer referral types were found in combination within the first 4 months.

Results

During the study period, 7.5 million people had an USC referral, with one in five having more than one referral, with 9.5 million referrals in total. Referrals were categorised as first (91.1%) and subsequent (8.9%) USC referrals. The relative increase in the number of referrals across the study period was largest (78.2%) for subsequent USC referrals.

Subsequent referrals were most common in the gynaecological (10%), lung (10%) and haematological cancer pathways (12%).

Suspected lower gastrointestinal referrals were most frequently included in a pair of USC referrals; it was one of the five most common pairings for 14 out of 16 referral type pathways, contributing to 30% of upper gastrointestinal USC referral pairings.

Conclusion

Multiple USC referrals increased in the study period, particularly within a year of the first referral. Common referral pairings suggest opportunities for pathway reorganisation where common non-specific symptoms result in multiple USC referrals.

Patient and healthcare professionals perception of weekly prophylactic catheter washout in adults living with long-term catheters: qualitative study of the CATHETER II trial

Por: Tripathee · S. · Abdel-Fattah · M. · Johnson · D. · Constable · L. · Cotton · S. · Cooper · D. · MacLennan · G. · Evans · S. · Young · A. · Dimitropoulos · K. · Hashim · H. · Kilonzo · M. · Larcombe · J. H. · Little · P. · Murchie · P. · Myint · P. K. · NDow · J. · Paterson · C. · Powell
Objectives

To explore trial participants’ experience of long-term catheters (LTC), the acceptability of washout policies, their experience of the CATHETER II trial (a randomised controlled trial comparing the clinical effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters) and their satisfaction with the outcomes. The objectives of the healthcare professionals (HCPs) focus group and interview were to explore their attitudes towards weekly prophylactic catheter washout, views on the provision of training and participants’ ability to enact washout behaviours.

Methodology

A longitudinal qualitative study embedded within the CATHETER II randomised controlled trial, which included semi-structured interviews and focus groups with participants from multiple trial sites. Data were analysed using the Theoretical Framework of Acceptability and Theoretical Domains Framework. This UK community-based study included 50 (24 female, 26 male) CATHETER II trial participants, aged between 23 and 100 years, with LTC and able to self-manage the washout and study documentation either independently or with the help of a carer. Seven HCPs (five female, two male) also participated.

Results

The participants had positive attitudes towards weekly prophylactic saline or acidic catheter washouts and other trial elements, such as washout training, catheter calendar and monthly phone calls. Participants and HCPs found the ‘ask’ of the CATHETER II trial and the weekly self-administered prophylactic washout policies to be feasible. The participants reported that the catheter washout training provided during the trial enhanced their self-efficacy, skills and self-reported capability to carry out the washouts. Participants reported having positive outcomes from the weekly washout. These included reduced blockage, pain or infection, reduced need for HCP support and greater psychological reassurance. HCPs attested to the participants’ understanding of and adherence to the weekly washouts and other elements of the trial.

Conclusions

This study shows acceptability, feasibility and self-reported fidelity of the CATHETER II trial on a behavioural level. Self-management for prophylactic catheter washouts is both feasible and, following training, achievable without any need for additional support.

Trial registration number

ISRCTN17116445.

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