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Experience-based co-design informed development of a toolbox to help optimise primary care support during transition from childrens hospice care: HOPSCOTCH study protocol

Por: Chapman · E. · Mitchell · S. · Fraser · L. K. · Wozencroft · J. · Morris · B. · Peat · G. · Charles · T. · Elverson · J. · Carder · P. · Tallowin · K. · Magnusson · J. · Ziegler · L.
Introduction

The HOPSCOTCH study ‘Helping Optimise Primary Care Support During Transition From Children’s Hospice Care’ aims to develop a toolbox to enable engagement of primary care services in the care of young people with life-limiting conditions (LLC) with a specific focus on the point of transition from children’s hospice services.

Methods and analysis

Individual interviews will be held with young people with LLC, their families and healthcare professionals (HCPs). In alignment with Experience Based Co-Design (EBCD) methodology, extracts of film and audio from young people and family interviews will be combined to professionally produce a ‘catalyst film’ highlighting key points and experiences before, during and after the transition from children’s hospice care. Role-specific workshops will be held with young people with LLC, their families and HCPs working in primary care, children’s hospices and adult hospice services. The catalyst film will be used in feedback workshops to prompt prioritisation of key issues to take forward into toolbox development in a shared young people, family and HCP workshop. A documentary analysis of resources currently used to support transition and communication between care settings will support contextual understanding of the transition process. Young people, parents and professionals have shaped and continue to have influence over the study delivery as advisors alongside a multidisciplinary steering committee.

The study design has been guided by the UK Medical Research Council complex intervention framework. Intervention development draws on the principles of EBCD and is theoretically driven by the Behaviour Change Wheel.

Ethics and dissemination

The study is registered with the UK’s Clinical Study Registry (ISCTRN75964234).

Ethical approval was obtained from Wales 3 ethics board on 2 July 2025 (IRAS ID 334486). This study will include ongoing dissemination and knowledge transfer to key audiences (young people, parents, service providers, commissioners) via publications, national bodies, knowledge exchange events, web-based platforms, social media and clinical/academic forums.

Examining implementation of the first risk stratification-based programme for evaluating penicillin allergy labels in Western Norway hospitals: a study protocol

Por: Alnaes · M. B. · Oppegaard · O. · Kittang · B. R. · Kleppe · L. K. · Storaas · T.
Introduction

Penicillin allergy is a significant barrier to optimal antibiotic stewardship, contributing to increased antimicrobial resistance, higher treatment costs, prolonged hospital stays and elevated mortality rates. However, approximately 90% of penicillin allergy labels are disproven on evaluation. Risk stratification-based penicillin allergy evaluation (PAE) has proven safe and effective outside allergology departments, yet its adoption in routine clinical practice remains limited. This study aims to examine the implementation of a risk stratification-based PAE programme across hospitals in Western Norway.

Methods and analysis

We aim to examine implementation of a risk stratification-based programme for evaluating and de-labelling declared penicillin allergy in Western Norway hospitals in a multicentre study. The study employs a combined stepped wedge- and interrupted time series design. It includes hospitals of varying service levels in both urban and rural settings. Each participating centre receives 12 months of active implementation support, followed by a 6 month postintervention evaluation. The study is guided by the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change. Implementation outcomes assessed include acceptability, fidelity, adoption, penetration, feasibility and sustainability.

Ethics and dissemination

The study was approved by the Regional Ethics Committee of Western Norway (approval number: 199210). All legal and formal research requirements are met. Results will be published open access in peer-reviewed journals and included in the first author’s publicly available PhD. Nationwide implementation of PAE is planned, informed by the study’s findings.

Trial registration number

Current Research Information System (Cristin) in Norway project identification number: 2500736.

Exploring family health, support, self-efficacy and quality of life during the cancer trajectory: a protocol for a longitudinal mixed methods multi-centre cohort study

Por: Tolstrup · L. K. · Hyldig · N. · Moller · S. · Stie · M. · Kjerholt · M. · Jarden · M. · Piil · K. · Coyne · E. · Garcia-Vivar · C. · Voltelen · B. · Munk-Olsen · T. · Dieperink · K. B.
Introduction

A cancer diagnosis not only profoundly impacts individuals but also the very core of their families, reshaping their lives in many ways. However, there is a lack of focus on the well-being and health of the entire family across adult cancer research. This is concerning given that one-third of the Danish population will get a cancer diagnosis before the age of 75, suggesting that many Danes will become caregivers during their lifetime. In addition, identifying vulnerable families is challenging, and the determinant factors for their vulnerability are unknown.

Aims

The principal aim of this study is to investigate family health during cancer treatment. This will be done by gathering information on various parameters such as perceived support, quality of life and self-efficacy in patients with cancer and families across the cancer trajectory. Additionally, the study seeks to pinpoint particularly vulnerable families and investigate contributing factors to their vulnerability.

Methods and analysis

This mixed-methods study follows a sequential explanatory design, combining patient-reported outcomes in a longitudinal, prospective multicentre survey with interviews conducted with a nested sampling of the participants from the survey. A total of 240 patients diagnosed with prostate-, breast-, gastrointestinal- and lymphoma cancer, and designated adult family caregivers will be recruited from six different sites for the survey. Variables such as family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience will be explored. Survey data will be collected at baseline, 3, 6, 12 and 18 months. The interviews (n=12–15) will be conducted twice with patients and caregivers jointly: once during the treatment phase (3 months) and once after completion of treatment (12 months). For the survey part, we estimated a sample size with 90% power and 5% significance to detect a minimal clinically important change in the Family Health Scale. Assuming an SD of 2x22 = 31, based on a cross-sectional SD of 22, 44 patients per group were required; to allow for dropout, 60 per group (240 total) were included. Patient and caregiver characteristics will be summarised descriptively. Longitudinal patient-reported outcomes will be analysed with linear mixed regression, separately for patients and caregivers. Changes will be reported as mean differences with 95% CIs and compared with published minimal clinically important differences or, if unavailable, 0.3xbaseline SD. For the qualitative part, thematic analysis by Braun and Clarke is chosen to extract data, identify patterns and analyse data and themes from the interviews. NVivo will be used for coding interview data.

Ethics and dissemination

The study will be conducted in accordance with the Helsinki Declaration. Measures will be taken to ensure confidentiality, data protection and participant safety throughout the study. The results will be published in peer-reviewed journals and conference presentations.

Trial registration number

ClinicalTrials.gov: NCT06433349. Protocol version 2.0, June 2024.

Inappropriate prescription of antibiotics and analgesics, treatment adequacy and associated factors among surgical patients: an observational study in comprehensive specialised hospitals, northwest Ethiopia

Por: Zeleke · T. K. · Getachew · M. · Tegegne · B. A. · Teshome · A. H. · Yismaw · M. B. · Bazezew · Z. A. · Kemal · L. K. · Abebe · R. B.
Objective

Inappropriate medication use among surgical patients poses significant risks, including antibiotic resistance, complications, mortality, increased healthcare costs and challenges in pain management. This study aimed to assess the extent of inappropriate antibiotic and analgesic prescriptions, treatment adequacy and contributing factors.

Design and setting

A hospital-based cross-sectional study was conducted among patients admitted to surgical wards in three comprehensive specialised hospitals in northwest Ethiopia.

Participants

All eligible adult patients admitted to the surgical wards during the data collection period were included in the study.

Main outcomes measures

The primary outcomes were the appropriateness of antibiotic and analgesic prescriptions. To assess patients’ pain perception and the effectiveness of pain management strategies, the American Pain Society Patient Outcome Questionnaire was used. The Pain Management Index was employed to evaluate the treatment adequacy. The RAND (Research and Development)-modified Delphi method was applied to reach expert consensus on best practices for antibiotic prescribing. Additionally, the national standard treatment guideline was used to benchmark prescribing practices. Binary logistic regression was used to identify factors associated with inappropriate prescriptions of antibiotics and analgesics.

Results

The prevalence of inappropriate antibiotics use was 67.5% and 42.2% of patients received inappropriate analgesic prescriptions. Moreover, 51.6% of patients experienced inadequate pain management. Significant factors associated with inappropriate antibiotic prescription included the presence of comorbidities (adjsuted OR (AOR) 3.34, 95% CI 1.88 to 5.92), lack of laboratory tests (AOR 0.26, 95% CI 0.16 to 0.43, higher number of medications (AOR 2.71, 95% CI 1.62 to 4.52) and contaminated wound class (AOR 3.13, 95% CI 1.58 to 6.20). For inappropriate analgesic prescription, pain due to disease (AOR 8.69, 95% CI 1.73 to 4.62), mixed causes of pain (AOR 7.20, 95% CI 1.43 to 6.31), head and facial pain (AOR 0.14, 95% CI 0.05 to 0.39) and an increased number of medications (AOR 2.75, 95% CI 1.72 to 4.41) were significant factors.

Conclusion

The majority of the patients admitted to surgical wards were found to receive inappropriate antibiotic and analgesic medications. Prescribers should pay attention to patients with comorbid diseases, receiving multiple medications. Additionally, routine laboratory tests are essential for guiding antibiotic therapy and improving patient outcomes in surgical wards.

Nordic randomised trial on laparoscopic versus vaginal cerclage (NORACT): trial protocol for an international, multicentre, randomised controlled trial

Por: Hansen · L. K. · Krogh · L. Q. · Lantto · A. · Uldbjerg · N. · Jensen · P. T. · Shennan · A. · Hald · K. · Heikinheimo · O. · Jacobsson · B. · Hjartardottir · H. · Karypidis · H. · Glavind · J.
Introduction

Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.

Methods and analysis

The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth

Ethics and dissemination

The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.

Trial registration number

NCT06122506.

Effect on healthcare professionals self-efficacy of a 45-min versus 3-hour educational intervention on communication and play in paediatric clinical practice in Denmark: a randomised controlled trial study protocol

Por: Thestrup · J. · Sorensen · J. L. · Bidstrup · P. E. · Rosthoj · S. · Hybschmann · J. · Esbjorn · B. H. · Dybdal · D. · Barslund · K. · Topperzer · M. K. · Frandsen · T. L. · Gjaerde · L. K.
Introduction

Communication is a professional competence that all paediatric healthcare professionals must learn and maintain to provide age and developmentally appropriate care. Child-centred communication encourages direct communication with children and adolescents, incorporating the use of play as a communicative strategy. Still, many paediatric healthcare professionals receive little or no formal training in communication and play. A critical barrier to communication training is the limited possibilities for healthcare professionals to take time from their clinical duties. Moreover, few randomised controlled trials have evaluated educational programmes on communication and play for paediatric healthcare professionals, and existing programmes vary significantly in design and duration. This study aims to compare the effects of a 45-min and a 3-hour educational intervention for healthcare professionals on age-appropriate communication and the use of play in clinical paediatric practice.

Methods and analysis

We will describe a single-centre, randomised, controlled, two-arm, non-inferiority trial. We will recruit 150 healthcare professionals with different professional backgrounds who will be randomised to one of two arms: a 45-min or 3-hour educational intervention on communication and play in paediatric clinical practice. The primary outcome will be their self-efficacy in patient-centredness at 12-week post-intervention, while secondary outcomes will be self-efficacy immediately after the intervention, motivation to engage in the educational activity, cognitive load, self-evaluated knowledge, satisfaction and the impact on individual practice and training needs. Data will be collected through questionnaires at baseline, immediately after the intervention, and 12 weeks post-intervention and will be analysed using linear mixed models with random effects to account for clustering and within-subject correlation.

Ethics and dissemination

The Danish Data Protection Agency approved the study (P-2020–1144), which will be conducted in accordance with the Declaration of Helsinki. Findings will be published in a peer-reviewed open-access scientific journal and presented at international conferences.

Trial registration number

NCT06859632 (ClinicalTrials.gov).

Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer surv

Por: De Groef · A. · Dams · L. · Moseley · G. L. · Heathcote · L. C. · Wiles · L. K. · Catley · M. · Vogelzang · A. · Hibbert · P. · Morlion · B. · Van Overbeke · M. · Tack · E. · Van Dijck · S. · Devoogdt · N. · Gursen · C. · De Paepe · A. L. · Mertens · M. · van Olmen · J. · Willem · L. · Tja
Introduction

Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).

Methods and analysis

A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.

Trial registration number

ClinicalTrials.gov Identifier: NCT06308029.

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