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Development of a lifelong core outcome set for oesophageal atresia {+/-} tracheoesophageal fistula: the OCELOT study

Por: Thursfield · R. · Gorst · S. · Teunisson · N. · Lansdale · N. · Faulkner · J. · Krishnan · U. · Kovesi · T. · Slater · G. · Cullis · P. · Bray · L. · Donne · A. · Teague · W. · Losty · P. D. · Carr · S. · Gray · V. · Gutierrez-Gammino · L. · Nah · S. A. · Hall · N. J.
Background

Despite anatomical correction, people born with oesophageal atresia±tracheoesophageal fistula (OA-TOF) experience lifelong morbidity. Core outcome sets (COSs) are recognised as a means of improving research quality and, as a consequence, improving patient outcomes; one was not available for this population.

Objective

The scope of the study was to develop a COS for people born with OA-TOF that would be applicable regardless of age or geographic location.

Study design

Patient input was paramount to this study. For long-list generation, in addition to the systematic review (SR), patients and representatives were invited to participate in focus groups, interviews or complete activity packs to ascertain outcomes that matter most to them. International consensus was then sought using a two-step Delphi survey followed by an online consensus meeting.

Results

Eight outcomes were identified through patient events that had not been picked up from SR. 175 people completed the Delphi survey from 26 countries and health care professionals from 13 different disciplines. 24 outcomes met predefined criteria for inclusion and following discussion and voting in the consensus meeting, and 14/24 outcomes were agreed for inclusion in the COS.

Conclusion

14 outcomes have been agreed on to form the COS. 12 of these outcomes are relevant to people of all ages, 1 to paediatric population and 1 to adult cohorts. The COS is, therefore, truly applicable lifelong, which was the scope of the project. This COS will help reduce research heterogeneity, enabling better quality research outcomes and more comparable data.

Psychological Outcomes of Family Members Related to a Loved One's Resuscitation in the Emergency Department: A Cross‐Sectional Study

ABSTRACT

Aims

This study aimed to assess the psychological outcomes of family members of patients who were resuscitated in the Emergency Department (ED) and analyse factors associated with these outcomes.

Design

This study utilised a cross-sectional design

Methods

Data were collected using a self-reported questionnaire sent to family members of patients who had undergone resuscitation in the ED from February 2024 to January 2025. Instruments for data collection included The Impact of Event Scale-Revised (IES-R), the short version of The Depression, Anxiety and Stress Scale–21 items (DASS-21), the Multicultural Quality of Life Index (MQLI) and questions related to demographic variables and the resuscitation event.

Results

A total of 106 family members completed the questionnaire. Of this, 64.2% (n = 68) reported witnessing the resuscitation attempt, and 35.8% (n = 38) did not witness the event. Family members who witnessed the resuscitation displayed more symptoms of post-traumatic stress disorder (PTSD), measured by the IES-R, compared to those who did not witness the event. A statistically significant negative correlation was found between the IES-R and the MQLI scores, indicating that higher PTSD symptoms correlate with lower quality of life (QoL) ratings.

Conclusion

The findings of this study indicated that witnessing the resuscitation of a loved one in the ED is associated with increased PTSD symptoms.

Implications for Health Professionals and Patient Care

Patients' and family members' cultural and religious needs should be acknowledged by the health care providers. Study findings indicate that family members prefer to be with the patient during the patient's resuscitation. However, without adequate support from hospital staff, this experience may cause adverse psychological effects. Strategies to support family members during and after resuscitation should be developed and integrated into the management of in-hospital resuscitation.

Reporting Method

This study followed the STROBE guidelines.

Patient or Public Contribution

No patient or public contribution.

Evaluating the delivery of trauma and orthopaedic education in UK medical schools: a national cross-sectional survey protocol (TENDON study)

Por: Nazar · N. · OHanlon · C. · Kolhe · S. · Bellamy · M. · Barberon · M. · Khajuria · A. · Low · W. X. · Geetala · R. · Chahal · K. · Banaszkiewicz · P. · McCaskie · A. · McDonnell · S.
Introduction

Musculoskeletal (MSK) conditions account for up to one-third of general practice consultations and over one-fifth of emergency department attendances in the UK. Postpandemic, the elective orthopaedic surgery backlog remains one of the most substantial across surgical specialties. Despite this burden, undergraduate exposure to trauma and orthopaedics (T&O) remains limited and inconsistent. Most UK medical students receive only 2–3 weeks of T&O teaching, with up to 40% of foundation doctors feeling underprepared to manage MSK conditions. The Evaluation of Trauma and Orthopaedic Teaching in Medical Schools Nationally (TENDON Study) aims to evaluate the current state of undergraduate T&O education in UK medical schools from both student and educator perspectives.

Methods and analysis

This national, prospective, cross-sectional survey will be conducted between 25 July and 27 October 2025. A dual-instrument electronic survey was developed through Qualtrics, informed by the British Orthopaedic Association (BOA) Undergraduate Curriculum and UK Medical Licensing Assessment content map. Participants will include medical students (Years 1–6), foundation doctors and orthopaedic educators recruited through British Orthopaedic Medical Students Association and BOA networks, and designated school representatives. Survey domains include curriculum coverage, teaching methods, clinical exposure and self-reported competence. Quantitative data will be analysed using descriptive and inferential statistics; qualitative data will undergo thematic analysis. Reporting will follow the Checklist for Reporting Of Survey Studies framework, with relevant elements drawn from the Checklist for Reporting Results of Internet E-Surveys checklist.

Ethics and dissemination

Ethical approval was obtained from the Human Biology Research Ethics Committee, University of Cambridge. Findings will be disseminated via peer-reviewed publication, conference presentations and summary reports to curriculum leads and relevant educational bodies.

Visualisation of hypertension: A non-randomised pilot study to explore the feasibility of a Community Pharmacy-based intervention to support medication adherence (Hi-BP)

by Sarah L. Brown, Barry J. McDonnell, David McRae, Paul Angel, Imtiaz Khan, Rhiannon Phillips, Britt Hallingberg, Delyth H. James

Using visualisation to conceptualise a chronic condition can encourage accurate illness beliefs and support treatment adherence. Hi-BP is a digital visual intervention to support adherence to antihypertensive medication, co-produced with patients. The aim of this study was to investigate the feasibility and acceptability of Hi-BP and explore the preliminary direction of effects on illness and treatment beliefs, medication adherence and blood pressure (BP). A two-phased mixed-methods non-randomised feasibility study was conducted from April 2021 to March 2022 in eight community pharmacies across one Health Board in South-East Wales, UK. Hi-BP was delivered as a single researcher-led consultation to 69 patients in Phase 1 and by pharmacists to three patients in Phase 2. Feasibility was determined using predefined criteria, with acceptability explored qualitatively using semi-structured interviews. Quantitative outcome measures (illness perceptions, medication beliefs, medication-adherence, prescription dispensing and collection data, BP) were recorded at baseline and immediately post-intervention.Follow-up outcome measures were collected at two-weeks (medication-adherence) and three-months (all baseline measures). Hi-BP met feasibility criteria for pharmacist recruitment in both phases, and patient recruitment in Phase 1, but not Phase 2. Hi-BP was acceptable to the sub-sample of 15 patient participants interviewed in Phase 1; insufficient data were available to determine patient acceptability at Phase 2. Hi-BP was acceptable to pharmacists in Phase 1 and partially acceptable at Phase 2, due to competing demands on time for intervention delivery. All outcome measures were considered feasible for use, though a ceiling effect was noted for medication adherence. A potentially positive directional effect was found for illness perceptions (X2(2)=10.83,n=54,p=0.004), medication beliefs (BMQ-Necessity (X2(2)=11.71,n=54,p=0.003) and BP (Systolic BP Z=-3.91,n=51,p=2(2)= 2.4,n=45,p=0.299). In the Community Pharmacy setting, Hi-BP was well-accepted and has the potential for significant reductions in BP; however, further research is needed to explore pharmacist capacity to support implementation.

Optimising time-limited trials in acute respiratory failure: a multicentre focused ethnography protocol

Por: Kruser · J. M. · Wiegmann · D. A. · Nadig · N. R. · Secunda · K. E. · Hanlon · B. M. · Moy · J. X. · Ahmad · A. · Campbell · E. G. · Donnelly · H. K. · Martinez · F. J. · Polley · M. · Orhan · C. · Korth · E. · Stalter · L. N. · Rowe · T. J. · Wu · A. L. · Viglianti · E. M. · Eisinger · E
Introduction

The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

Methods and analysis

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

Ethics and dissemination

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

Trial registration number

NCT06042621.

Participants experiences with the Delphi method: an online evaluation of a three-round Delphi across German-speaking countries

Por: Niederberger · M. · Dieudonne · J. · Schifano · J. · Vogt · S.
Objectives

This study evaluates how participants experienced and assessed a three-round Delphi study on the terminology of developmental language disorders in childhood. It compares participants who completed all rounds (completers) with those who withdrew early (dropouts) and aims to derive methodological quality criteria for future Delphi studies.

Design

The evaluation is based on a Delphi study conducted in 2021/2022 across five German-speaking countries. After the final round, n=179 experts (40% response rate) completed a standardised survey assessing their expertise, motivation, reasons for discontinuation, time commitment and perceptions of questionnaire and feedback design. Responses from completers (n=156) and dropouts (n=23) were analysed descriptively.

Results

Most participants had no prior experience with Delphi methods but rated the study positively and considered the topic highly relevant. Completers reported their subjective time commitment to be lower and rated the handling of the questionnaire more positively than dropouts. Feedback was used by nearly half of all experts and was more actively considered by completers. Lack of time was the most common reason for discontinuation.

Conclusion

The findings confirm the feasibility and acceptance of the Delphi method in interdisciplinary health research. In addition to established methodological principles, topic relevance, clear communication and time commitment emerged as key areas for expert motivation and engagement.

A Scoping Review on Long‐Term Care Workers' Perceptions of Robot‐Assisted Care for Older Adults in Long‐Term Care Facilities

ABSTRACT

Aims

To synthesise the current research on long-term care workers' perceptions (i.e., attitudes, concerns, and expected functions) of robot-assisted care and their perceived effects of different types of robot-assisted care for older adults in long-term care facilities.

Design

Scoping review.

Data Sources

A search was conducted in July 2024 using five databases. Articles published between 2010 and 2024 on the perceptions and/or perceived effects of robot-assisted care for older adults among frontline long-term care workers in long-term care facilities were identified. Additionally, the reference lists of the included articles were manually searched.

Methods

A five-step framework that guided the development of research questions, screening of studies, and synthesis and presentation of data was adopted. Two authors independently screened and analysed the identified articles. Conflicts were resolved through joint-discussions.

Results

Forty-one articles were included in the review. Data were narratively synthesised into three categories: expected function of care robots, perceived effects of robot-assisted care, and attitudes and concerns regarding robot-assisted care. Subcategories were identified and presented in tabular form.

Conclusion

This review shows the physical, psychological, social, and practical benefits and limitations of different types of robot-assisted care. It also contributes to understanding long-term care workers' attitudes, concerns, and expectations regarding the function of robot-assisted care.

Implications for the Profession and/or Patient Care

Having a priori discussion with long-term care workers about their expectations regarding using robot-assisted care is needed. Improvements in the design and in the digital literacy of the workers are also necessary.

Impact

This review provides an overview of the perceptions and perceived effects of different types of robot-assisted care among care workers in long-term care facilities. The findings provide practical implications and highlight areas in need of further studies.

Reporting Method

Scoping Review (PRISMA-ScR) checklist.

Patient or Public Contribution

No Patient or Public Contribution.

Exploring Students' Perceptions and Experiences of Raising Concerns During Pre‐Registration Training in England: A Systematic Review

ABSTRACT

Aim

To explore the perceptions and experiences of students raising concerns during pre-registration health and/or social care training in England.

Design

Systematic review.

Data Sources

MEDLINE, CINAHL, ERIC, PsycINFO and Education Research Complete were systematically searched for studies published between September 2015 and August 2024. Grey literature searches were conducted using Google Scholar and ETHOS British Library. Reference lists from included studies were hand searched.

Methods

Joanna Briggs Institute methodological guidance for the conduct of systematic review informed conduct and the convergent integrated approach. Mixed methods appraisal tool was used for quality appraisal.

Findings

Eleven studies were included. Synthesis of findings generated three themes: (1) conflicting needs of self and others, (2) navigating the professional workspace and, (3) ‘choice to voice’.

Conclusion

Speaking up and raising concerns as a pre-registration student is a complex, multi-faceted and non-linear social phenomenon. Experiences and perceptions are impacted by the novice student position alongside individual, interpersonal and organisational factors. Open cultures within teams and organisations, leadership, support and feedback may enable students overcome barriers to raising concerns.

Impact

Raising concerns may reduce avoidable harm. Pre-registration students offer a ‘fresh pair of eyes’; however, they face barriers related to their student position. Synthesis of speaking-up experiences and perceptions of students in English settings can inform the design of learning environments which equip pre-registration students with the knowledge and skills required to cultivate safety behaviours. These skills contribute positively to safety culture and support learning and improvement in complex systems such as health and social care.

Reporting Method

The review followed PRISMA reporting guidelines.

Patient or Public Contribution

The conceptualisation of this project was informed by engagement events with higher education staff, students and Freedom to Speak Up Guardians.

Youth Med.Info: a case study in co-design of mental health medicines-information resources for children, young people and their parents/guardians

Por: Hynes-Ryan · C. · Kelleher · I. · Kathryn · S. · Beaudelot · C. · Carolan · A. · Columb · D. · Donnelly · S. · Gamage · N. · Hill · N. · Migone · M. · McWilliams · S. · Morning · J. · ODonoghue · B. · Solan · I. · Strawbridge · J. · Hayden · J. C. · Keating · D.
Objectives

To address the lack of accurate and accessible mental health medicines-information resources for children, young people and their parents/guardians using design thinking to co-design free-to-use, video resources tailored to this audience.

Design

A multiphase qualitative case study using the Double Diamond model of Design Thinking: Discover, Define, Develop and Deliver. This included iterative prototyping, thematic analysis and public and patient involvement throughout.

Setting

Dublin, Ireland with online distribution of the final resources internationally through a free, open-access platform.

Participants

A multidisciplinary co-design team including two specialist mental health pharmacists, two academic pharmacists, five consultant psychiatrists, a psychiatric nurse, a youth content specialist, three youth activists and a parent representative.

Results

26 co-designed, medicines-information videos were created, including versions for children (voiced by children), parents/guardians and young people. Videos feature storytelling formats with Bitmoji characters. Feedback from youth and parent collaborators guided design and content. Since launch, www.youthmed.info has had over 25 000 website views and more than 30 000 video views, with engagement from over 91 countries. The resources are also linked on national and international clinical and charity platforms.

Conclusions

Youth Med.Info addresses a gap in accessible, accurate mental health medicines-information by placing users – children, young people, parents/guardians and clinicians—at the centre of its design.

Development and evaluation of the first fertility preservation patient decision aid to support boys and young men with cancer: The Cancer, Fertility and Me for Boys and Young Men research protocol.

Por: Jones · G. L. · Musson · D. S. · ODonnell · N. · Lewis · A. · Williamson · M. · Yeomanson · D. · Pacey · A. · Lane · S. · Folan · A.-M. · Gough · B. · Phillips · B. · Porteous · C. · Anderson · R. · Mitchell · R. T.
Introduction

Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.

Methods and analysis

The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.

Ethics and dissemination

This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.

Use of nicotine replacement therapy to create a smoke-free home: study protocol for a pilot randomised controlled trial of a smoke-free home intervention in Scotland

Por: ODonnell · R. · Howell · R. · Henderson · T. · Sinclair · L. · Mather · K. · McMeekin · N. · Semple · S.
Introduction

The harmful health effects of children’s exposure to secondhand smoke (SHS) are well established. Most SHS exposure now occurs in the home, in low-income households. Previous research suggests that using nicotine replacement therapy (NRT) in the home can help with temporary smoking abstinence and could reduce smoking indoors. This pilot randomised controlled trial tests the feasibility of providing parents, carers and relatives with posted-to-home nicotine replacement therapy alongside fortnightly telephone support to reduce children’s exposure to SHS.

Methods and analysis

100 participants are being recruited through existing National Health Service (NHS) Lanarkshire initiatives and social media. Parents/carers who are at least 18 years old, smoke in the home and care for one or more children aged 0–16 years are eligible to take part. Participants are randomised to either the intervention (Group A) or control (Group B) arm. Group A receives NRT posted to their home for 12 weeks free of charge, alongside fortnightly telephone calls and materials to support them in reducing children’s exposure to SHS. Group B is signposted to the Scottish Government’s ‘Take it Right Outside’ website which provides interactive advice on creating a smoke-free home. To quantify the child’s exposure to SHS, participants instal an air quality monitor to measure fine particulate matter (PM2.5) concentrations in their living room for 7 days at baseline and 12-week follow-up and/or collect and post saliva samples from their youngest child (age 5 or over) for cotinine analysis. Qualitative interviews explore intervention experience, NRT use and adherence and changes to home-smoking behaviours/smoking-related expenditure. Descriptive data analyses will be performed to address the feasibility of recruitment, randomisation, retention and adherence, data collection and intervention delivery. Analysis will also include pre/post changes (paired t-test) in both child’s salivary cotinine and PM2.5 levels to provide preliminary data on intervention effectiveness and difference between the intervention and control arms of the study. Health economics and resource use data will be collected and assessed for completeness, to test the process of data collection and estimate mean cost of both study arms.

Ethics and dissemination

NHS ethical approval has been obtained by the West of Scotland Research Ethics Service (15 December 2023, ref 23/WS/0153; 13 December 2024, ref AM01). The findings will be disseminated to participants, funders, NHS Lanarkshire and other health services, and in peer-reviewed journals and academic conferences. Findings will inform new approaches that are timely and important, providing valuable evidence to help reduce children’s exposure to SHS in the home in Scotland and elsewhere.

Trail registration number

ISRCTN79307718.

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