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Prospective accuracy study on an artificial intelligence-based ultrasound system for gestational age estimation among pregnant women in Ghana, Kenya and South Africa: protocol

Por: Swarray Deen · A. · McDougall · A. R. A. · Chemway · R. · Craik · R. · Jayaratnam · S. · Joseph · N. · Mahar · R. · Koye · D. · Nguyen · L. · Simpson · J. · Gwako · G. · Hadebe · R. L. · Nartey · E. T. · Minckas · N. · Gülmezoglu · A. M. · Vogel · J. P. · Osman · A. · PEARLS Collaborat
Background

Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

Methods and analysis

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11+0 to 13+6 weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14+0 and 27+6 weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11+0 to 13+6 weeks’).

Ethics and dissemination

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

[18F]AlF-FAPI-74 PET/CT for preoperative assessment of the peritoneal cancer index and comparison with MRI-based, surgical and pathological assessment in colorectal cancer patients eligible for CRS-HIPEC: study protocol for a prospective observational pro

Por: van den Bos · M. · Vogel · W. V. · van Duijvenvoorde · M. · Kok · N. F. M. · Aalbers · A. G. J. · Snaebjornsson · P. · Lacle · M. M. · Willemse · J. R. J. · Kool · W. · Hendrikx · J. J. M. A. · de Hingh · I. H. J. T. · van Grevenstein · W. M. U. · Boerma · D. · Milne · A. N. · van
Introduction

Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.

Methods and analysis

TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [18F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.

Ethics and dissemination

This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.

Trial registration number

2024-512301-16-01

Effectiveness of a just-in-time adaptive intervention for improving pain catastrophising in patients with chronic back pain: protocol for a pragmatic randomised controlled trial

Por: Sühs · E. · Atkins · L. A. · Koeppen · L.-S. · Schmigalle · P. · Scholz · C. · Liegl · G. · Pryss · R. · Kraft · R. · Vogel · C. · Idrees · A. R. · Kopf · A. · Reisshauer · A. · Vajkoczy · P. · Prasser · F. · Nolte · S. · Rose · M. · Obbarius · A.
Introduction

Chronic back pain (CBP), defined as back pain persisting for more than 3 months, is highly prevalent and associated with substantial socioeconomic burden and impaired quality of life. Pain catastrophising is an important cognitive-affective factor in the maintenance of CBP and may fluctuate in daily life. Conventional treatment approaches often do not address these momentary dynamics. Just-in-time adaptive interventions (JITAIs) deliver tailored support at opportune moments based on time-varying information and may therefore complement existing treatments for CBP. In this study, ecological momentary assessment (EMA) is used to capture momentary pain-related states and guide the delivery of adaptive microinterventions. To our knowledge, no JITAI specifically targeting pain catastrophising in CBP has yet been evaluated in a randomised controlled trial.

Methods and analysis

This pragmatic, two-arm randomised controlled trial will compare a JITAI with enhanced treatment as usual (TAU+). A total of 100 participants will be recruited to obtain an evaluable sample of 86 participants. Eligible participants are adults with CBP persisting for more than 3 months and an average pain intensity over the previous week of at least 3 on a 0–10 Numerical Rating Scale. Participants in the intervention group will receive app-based, adaptive microinterventions, such as relaxation exercises and physical activities triggered by EMA responses on pain catastrophising and pain intensity. Participants in the TAU+ group complete the same EMA assessments but will not receive adaptive micro-interventions. The primary outcome is reduction in pain catastrophising, assessed with the Pain Catastrophizing Scale. Secondary outcomes include pain intensity, pain interference, pain behaviour, pain quality, physical functioning, anxiety, depression, fatigue, sleep disturbance, social participation, fear-avoidance beliefs, pain-related self-efficacy and treatment satisfaction. Primary and secondary outcomes will be analysed using between-group comparisons according to the intention-to-treat principle. Exploratory analyses will examine proximal, short-term effects of microinterventions using dynamic structural equation modelling. Assessments will be conducted at baseline before randomisation (T0), mid-treatment 2 weeks after intervention start (T1), end of treatment 4 weeks after intervention start (T2) and at 3 months (T3) and 6 months (T4) after end of treatment.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Charité Universitätsmedizin Berlin (approval number: EA4/207/21, 18 October 2021). Results will be submitted for publication in peer-reviewed journals and presented at conferences.

Trial registration number

DRKS00028494.

Surgical mapping with advanced 3D-reconstruction in minimally invasive liver surgery (SMART-MILS): protocol for a prospective randomised controlled trial

Por: Laurenz · N. · Bilge · A. · DeTemple · D. · van der Veen · J. · Tessmer · P. · Wiemann · B. A. · Oldhafer · F. · von Websky · M. · Vogel · T. · Vondran · F. W. · Beetz · O.
Introduction

Liver resection is a technically demanding procedure due to the complex and highly variable anatomy of the liver. Conventional preoperative planning relies on two-dimensional imaging, which requires mental reconstruction of three-dimensional anatomical relationships and may increase cognitive workload and intraoperative decision-making time. Patient-specific three-dimensional (3D) liver mapping has been shown to improve anatomical understanding and planning accuracy; however its impact on intraoperative efficiency has not been adequately investigated.

Methods and analysis

This is a prospective, randomised, controlled, open-label superiority trial with a 1:1 allocation ratio, stratified by planned resection type (extent of resection according to highest applicable Iwate difficulty score). Adult patients (≥18 years) scheduled for elective minimally invasive liver resection at the University Hospital RWTH Aachen will be enrolled. The control arm will receive standard preoperative planning using conventional two-dimensional CT and/or MRI. The intervention arm will receive additional patient-specific 3D liver mapping generated using CE-approved software (MeVis Liver Suite), available preoperatively and intraoperatively. The primary endpoint will be the operative time (minutes from the first cutaneous incision to the final suture). Secondary endpoints will include intraoperative blood loss, rate of R0 resection in oncological cases, length of stay in the hospital and intensive care unit, surgeon task load, surgeons’ salivary cortisol levels and cost-effectiveness. A total of 126 patients (63 per arm) will be enrolled to achieve 120 evaluable datasets.

Ethics and dissemination

Ethics approval has been obtained from the Ethics Committee of the Medical Faculty, University Hospital RWTH Aachen (Ref. No. 26–050). Written informed consent will be obtained from all patients and participating surgeons. Results will be disseminated through peer-reviewed publications and scientific conferences, independent of study outcomes.

Trial registration number

DRKS00039587.

Anxiety, depression and post-traumatic stress disorder in displaced and non-displaced individuals after armed conflict: cross-sectional survey evidence from Kasai, Democratic Republic of Congo

Por: Stoop · N. · van der Windt · P. · Weber · S. · Ventevogel · P.
Objectives

The study aims to estimate the prevalence of anxiety, depression and post-traumatic stress disorder (PTSD) in the Greater Kasai region of the Democratic Republic of the Congo (DRC) and to examine how demographic and socio-economic factors, such as displacement status and livelihood conditions, are associated with these mental health outcomes.

Design

A cross-sectional two-stage multi-cluster sampling survey.

Setting

In 2016–2019, a violent conflict in the Greater Kasai region of the DRC led to widespread atrocities and massive displacement. The population not only has to cope with the aftermath of interpersonal violence, loss of loved ones and displacement but also faces severe food shortages and livelihood crises.

Participants

Data were collected in 2022 from 4069 randomly selected heads of households (displaced and non-displaced) within 126 randomly selected localities in 27 health zones in the Greater Kasai. The study collected data from households with different displacement experiences: internally displaced people (IDPs), returned IDPs, repatriated refugees and members of the host community (those without a displacement history).

Primary and secondary outcome measures

The primary outcomes are mental health disorders. Anxiety, depression and PTSD were measured with the Generalised Anxiety Disorder-7, the Patient Health Questionnaire-9 and the Primary Care PTSD Screen for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.

Results

The prevalence of anxiety, depression and PTSD was 8.3%, 18.3% and 37.8%, respectively. Anxiety affected 10% of non-displaced respondents, with a similar prevalence among IDPs (9%) and returned IDPs (8%), compared with a substantially lower prevalence among repatriated refugees (4%). About 17% of non-displaced respondents have symptoms of depression; this number is considerably higher for IDPs (22%) and returned IDPs (22%) but lower for repatriated refugees (11%). Around 40% of the non-displaced individuals, IDPs and repatriated refugees are characterised by PTSD, while this share is lower for returned IDPs (31%). Overall, a one unit increase in food insecurity (on a 0–7 scale) is associated with higher levels of anxiety (0.33 on a 0–21 scale, p

Conclusions

Food insecurity is associated with poor mental health in Greater Kasai. Further research needs to explore how to develop synergistic interventions to improve both mental health and livelihoods in conflict-affected populations.

Determinants and strategies for implementing guideline-adherent physiotherapy: a scoping review

Por: Reiter · N. L. · Rosen · D. · Erhart · M. · Vogel · B.
Objectives

Clinical practice guidelines support evidence-based care and aim to reduce unwarranted variation in healthcare. Despite evidence that guideline-adherent physiotherapy is associated with reduced healthcare utilisation, adherence among physiotherapists remains inconsistent. This scoping review aimed to synthesise evidence on determinants of guideline adherence and implementation strategies in physiotherapy and to identify research gaps relevant to guideline implementation.

Design

Scoping review.

Data sources

MEDLINE (PubMed), EMBASE, the Cochrane Library, PEDro and CINAHL were searched from database inception to July 2023 and updated in July 2025. Grey literature sources, including Grey Literature Report, OpenGrey and Web of Science Conference Proceedings, were also searched. Reference lists of included studies were screened.

Eligibility criteria

Studies were eligible if they examined determinants of guideline adherence and/or implementation strategies in physiotherapy. Studies involving physiotherapists across all clinical fields and settings were included. Only studies published in English or German were considered.

Data extraction and synthesis

Determinants were analysed using qualitative content analysis and mapped to the Consolidated Framework for Implementation Research (CFIR). Implementation strategies were summarised using Proctor’s reporting recommendations.

Results

Fifty-eight studies were included: 29 examined determinants, 25 implementation strategies and four both. Determinants were identified across all CFIR domains, with most relating to the Inner Setting and Characteristics of Individuals. Implementation strategies primarily targeted individual-level change, such as education, reminders and feedback, whereas few addressed system-level factors, including organisational leadership or reimbursement structures.

Conclusion

Guideline implementation in physiotherapy is shaped by determinants across individual, organisational and system levels, yet current strategies predominantly focus on individual clinicians. This individual-level focus may contribute to the responsibilisation of clinicians for care quality, while organisational and system-level strategies that have shown promise in other fields remain underutilised in physiotherapy. Future implementation initiatives should adopt broader, system-oriented approaches to enhance long-term implementation success.

Study registration

Open Science Framework (https://osf.io/g5cpt/).

Relatives' Experiences of Circulatory Death Following Out‐of‐Hospital Cardiac Arrest and Their Hypothetical Perspectives on Organ Donation: A Qualitative Study

ABSTRACT

Aims

To explore relatives' experiences of the circulatory death of a family member following out-of-hospital cardiac arrest and to explore their hypothetical perspectives on being asked to decide about organ donation in this situation. This study forms part of a broader initiative undertaken to assess the prerequisites for implementing uncontrolled donation after circulatory death in Sweden with a focus on ethical issues.

Design

A qualitative design, using semi-structured interviews with open-ended questions.

Methods

Data were collected in Sweden between March 2024 and September 2024 and analysed using reflexive thematic analysis with an inductive, descriptive approach. Included were 13 bereaved relatives, four men and nine women.

Findings

The analysis generated three themes: ‘Fluctuating between hope and despair’, which describes relatives' experiences of their family member's sudden cardiac arrest; ‘Exposed to vulnerability’, concerning their experiences of death and their perspectives on reasoning about the deceased person's wishes regarding donation; and ‘Balancing a major life change’, which involves experiences of facilitators and barriers to dealing with the loss.

Conclusions

Awareness of the deceased family member's wishes regarding organ donation facilitates relatives' ability to support the deceased's known or presumed wishes. Compassionate and communicatively competent healthcare professionals influence relatives' capacity to reason about the deceased's wishes and cope with their experience of loss. Ensuring sufficient time for goodbyes and providing follow-up may facilitate emotional processing and should be considered when implementing uncontrolled donation after circulatory death.

Implication for the Profession

Policies and clinical practice should ensure that relatives are adequately informed and supported in reasoning on their family members' wishes regarding organ donation. To achieve this, nurses and other healthcare professionals require training in compassionate and empathetic communication strategies. Such training is essential both for guiding relatives through reasoning about their family preferences and for providing emotional support during the grieving process.

Impact

What is already known? ○

Organ donation after sudden death in out-of-hospital cardiac arrest is a complex process that raises ethical issues concerning both the timing and the content of conversation with the deceased's relatives, as well as the relatives' capacity to reason about the deceased's wishes in the context of sudden death.

Knowing the wishes of the deceased person, personal beliefs, and receiving clear, direct, and honest information from nurses and other healthcare professionals prepares relatives to reason about the deceased's known or presumed wishes regarding organ donation.

What were the main findings? ○

The quality of nurses' and healthcare professionals' communicative competence and their behaviours influence relatives' ability to reason and reflect on organ donation.

Factors that facilitate family members' experiences of donation following out-of-hospital cardiac arrest and death include awareness of the deceased's wishes regarding organ donation, being able to see with their own eyes that their family member is dead, and having sufficient time to say farewell.

Follow-up from health care services could have an impact on relatives' experiences and their processing of loss.

Where and on whom will the research have an impact? ○

This research has an impact on organ donation services, pre-hospital emergency care, and emergency department operations. It can assist nurses and physicians in planning ethical and family-centred care in cases of out-of-hospital sudden death and uncontrolled donation after circulatory death.

Reporting Method

COREQ-checklist.

Patient or Public Contributions

No patient or public involvement in design, conduct or reporting.

Coping with rejection as a sperm donor: A qualitative study of the personal impact of rejection and new health information

by Lina Thirup, Anne-Bine Skytte, Ulrik Schiøler Kesmodel, Ida Vogel, Guido Pennings, Allan Pacey, Stina Lou

Purpose

The demand for sperm donation is increasing, yet only a small percentage of applicants are accepted, and little attention has been given to those who are rejected. The application process may reveal new medical or genetic information with potential personal and emotional consequences. The aim of this study was to explore how men experience rejection as sperm donors, including how they cope with the rejection and integrate potential new information into their lives.

Methods

We conducted qualitative, in-depth interviews with 19 men rejected as sperm donors. Data was analyzed using thematic analysis.

Results

Some men received new medical information that raised significant concerns, particularly regarding their health, fertility, and family. However, for most it was not the reason for rejection that affected them most, but the rejection itself. They had begun to identify as donors, and being turned down felt like a blow to their sense of self. Over time, participants used different coping strategies: information seeking, actionable reasoning, positive reframing, normalizing, and postponing. Although the experience was personally and emotionally challenging for many, it ultimately did not have a lasting negative impact on their lives.

Conclusions

Sperm donation is not only a medical act but also tied to social identity, with rejection having personal and emotional consequences. For men whose rejection is based on new medical information that causes significant concerns, sperm banks should support rejected donors and help them exit the process positively. Further research is warranted to find out how this can be done.

Experiences of Emergency Triage Nurses and Evidence of Bias in the Assessment of People Experiencing Homelessness

ABSTRACT

Aim

To describe how the potential presence of cognitive biases in emergency nurses may influence the triage process in people experiencing homelessness compared to those who were not.

Design

Qualitative descriptive design using observations and interviews.

Methods

Twelve emergency department nurses participated in interviews after being observed for over 128 triage patient interactions. Qualitative content analysis was used for observation data and thematic analysis was used for interview data. Findings were compared to identify differences and similarities between the observed presence of bias and nurses' described experiences.

Results

Observation findings included two themes: (1) Emergency medical services (EMS) presentation: Words matter and (2) Nurse response: Taking action. Interview findings identified four themes: (1) Objective interpretation, (2) Subjective interpretation, (3) Resulting disparities, and (4) Busy environment. Differences included nurses' observed actions of often disregarding people experiencing homelessness compared to perceptions of remaining impartial. Similarities included the presence of bias in observation and interviews and reflected how personal labels and assumptions can influence nurse response.

Conclusion

Findings provide evidence about how cognitive biases can influence the type of nurse response when triaging people experiencing homelessness and suggest an opportunity for future research to investigate strategies to mitigate bias during triage.

Implications

Emergency nurses may require additional bias awareness education specific to vulnerable populations.

Impact

Evidence from this research added knowledge about how bias in emergency nurses may influence nurse response when triaging people experiencing homelessness.

Reporting Method

COREG.

Patient Contribution

Patient contribution included presence and behaviour within the observed nurse/patient interactions, providing data for the descriptive statistics. Patients were not actively involved in data collection or analysis in a participatory sense.

From an Informatics Lens: Dashboards for Hospital Nurse Managers Influencing Unit Patient Outcomes

imageDashboards display hospital quality and patient safety measures aimed to improve patient outcomes. Although literature establishes dashboards aid quality and performance improvement initiatives, research is limited from the frontline nurse manager's perspective. This study characterizes factors influencing hospital nurse managers' use of dashboards for unit-level quality and performance improvement with suggestions for dashboard design. Using a descriptive qualitative design, semistructured interviews were conducted with 11 hospital nurse managers from a health system in the Midwestern United States. Thematic analysis was used to describe four perceived factors influencing dashboard use: external, data, technology features, and personal. External factors included regulatory standards, professional standards of care, organizational expectations, and organizational resources. Data factors included dashboard data quality and usefulness. Technology features included preference for simple, interactive, and customizable visual displays. Personal factors included inherent nurse manager qualities and knowledge. Guidelines for dashboard design involve display of required relevant quality measures that are accurate, timely, useful, and usable. Future research should involve hospital nurse managers in user-centered design to ensure dashboards are favorable for use. Further, opportunities exist for nurse manager informatics training and education on dashboard use in preparation for their role and responsibilities in unit-level quality and performance improvement.

Dimensions in women's experience of the perinatal period

A positive experience of the perinatal period is significant for women in midwifery care. The literature on women's experiences of the care in this period is extensive. However, a clear overview of the dimensions important for women's experiences is lacking. Consequently, care providers and researchers may ignore aspects significant to women's experience. In this short communication, we present a framework identifying the dimensions relevant for women's experiences of the perinatal period.
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