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Improving the interface for information transfer in acute stroke care: a mixed-methods process evaluation of the emergency use case within the CAEHR project

Por: Wendel · J. · Hofmann · A.-L. · Scriba · S. · Bavendiek · U. · Ertl · M. · Hametner · C. · Klinger · A. · Krefting · D. · Mehdi · M. · Volkmann · J. · Zech · C. · Haeusler · K. G. · Heuschmann · P. · Reese · J.-P.
Objective

Prehospital notification by emergency medical services (EMS) can activate hospital resources before the patient arrives, which has been shown to improve in-hospital care for stroke patients. Optimising prehospital and handover processes in stroke care requires considering end-user perspectives to enhance acceptance and effectiveness of the developed solutions. The aim of this study was to identify current barriers in the preclinical-clinical phase of stroke care.

Design and setting

Within the investigator-initiated CAEHR project (CArdiovascular diseases—Enhancing Healthcare through cross-sectoral Routine data integration), an interface for transferring data from the electronic prenotification system to the hospital information system is implemented. A mixed-methods approach with semi-structured interviews as well as a cross-sectional online survey was used to gather feedback from healthcare professionals at a single stroke centre in Germany as well as from the participating EMS personnel. Data collection for the interviews was conducted between January and August 2023 and for the online survey between May and September 2023.

Participants

Interviews were conducted with 10 healthcare professionals, including seven from the neurological clinic and three from EMS. Additionally, 39 EMS employees took part in a cross-sectional online survey.

Results

Challenges identified were educational and training aspects affecting preclinical processes and patient handover procedures, along with the opportunity for establishing more uniform protocols. Participants emphasised the importance of detailed patient information. Electronic prenotification was seen as an important step regarding structured information transmission, reducing the risk of information loss in stroke care.

Conclusion

The study highlights the importance of addressing organisational processes in addition to technical interfaces for implementing effective stroke care processes.

Trial registration number

German Clinical Trials Register, DRKS00029103.

Evaluating the health and well-being effects of increasing biodiversity within multiple small parks in Edinburgh, UK: a protocol for a mixed-methods, longitudinal, pre-post natural experiment

Por: Malden · S. · McDougall · C. W. · Ward Thompson · C. · Wendelboe-Nelson · C. · Ross-Perez · A. · Clemens · T. · Mason · S. · Villegas-Diaz · R. · Hoadley · A. · Hunter · A. · Jepson · R. · Williams · A. J.
Introduction

Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.

Methods and analysis

This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.

Ethics and dissemination

This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.

The OPTION trial: outpatient induction of labour - study protocol for a prospective, non-inferiority, multicentre randomised controlled trial

Por: Sengpiel · V. · Sangskär · H. · Wennerholm · U.-B. · Elden · H. · Gemzell-Danielsson · K. · Graner · S. · Wallström · T. · Hesselman · S. · Domellöf · M. · Jonsson · M. · Brismar Wendel · S. · Herbst · A. · Kopp-Kallner · H. · Carlsson · Y.
Introduction

Sweden, as many other high-income countries, has adopted guidelines to offer induction of labour at 41+0 gestational weeks to decrease the risk for perinatal death. As more than 20% of the pregnant population reach this gestational age, and along with other contributing factors, induction rates have increased up to 30% in many countries. Both women and care providers have raised the question if outpatient induction could be a convenient, safe and economic alternative, reducing the burden on inpatient care in maternity hospitals. Before introducing outpatient induction into clinical routine, studies need to assure safety for the child and woman as well as efficacy of the method.

Method and analysis

A register-based randomised controlled multicentre non-inferiority trial to study if outpatient induction in low-risk inductions is (1) as safe for the child (perinatal composite of mortality and morbidity) and (2) as effective (proportion of vaginal deliveries) as inpatient induction at the hospital. Secondary outcomes are further health outcomes, experiences of pregnant women, partners and care providers, health economics and future pregnancy outcome. Participating women with a singleton pregnancy and unripe cervix between 37+0 and 41+6 gestational weeks planned for low-risk induction will undergo induction of labour with either a balloon catheter or oral misoprostol according to clinical practice at the study site and the woman’s informed choice. Randomisation will allocate women to either outpatient (home or patient hotel) or inpatient induction (standard care). Women undergoing outpatient induction can remain at home for up to 2 days, with an assessment after 24 hours including cardiotocography. Once active labour ensues, all women will receive standard care in the hospital.

The assessment of non-inferiority will involve a two-sided 95% CI and 80% power, requiring randomisation of 8891 women to ensure a probability of at least 0.80 that the upper limit of a two-sided 95.7% CI for a difference in the primary safety outcome is below the non-inferiority margin of 1.5%. 31 of the 45 delivery units in Sweden are currently recruiting. Data will be collected from the electronic case report form and Swedish healthcare registers. Questionnaire and qualitative interview-based studies will be performed to explore experiences of pregnant women, partners and care providers. Additionally, a health economic evaluation will be performed.

Ethics and dissemination

The Swedish Ethical Review Authority approved the study (3 June 2020; 2020-02675 with amendments 2021-03045, 2022-00865-02, 2023-01252-02, 2024-00560-02, 2024-2024-04597-02). The Swedish Medical Products Agency approved the study for the medication arm (25 August 2020, EudraCT number: 2020-000233-41; 5.1-2020-60240 with amendments 5.1-2022-73500, 5.1-2023-630). Due to changed regulation, in 2023, the study medication arm was transferred and approved by the European Medicines Agency (23 October 2023, EU CT Number: 2023-507164-39-00; CTIS 5.1.2-2023-099775 with amendments 5.1.2-2024-081916, 5.1.2-2025-036291). The Swedish Medical Products Agency approved the study for the medical device arm (6 April 2021, CIV-ID: CIV-20-09-034712; 5.1-2021-14812 with amendments 5.1-2022-14252, 5.1-2023-596, 5.1-2024-8886, 5.1-2024-55554). The medical device arm was transferred to Regulation (EU) 2017/745 (23 December 2024, 5.1-2025-24242 and amendment 5.1-2025-6050). The study will involve more than 80% of all delivery units in Sweden, which will allow for a smooth implementation of any new routine after the study’s conclusion. Results will be published in relevant scientific journals, presented at national and international conferences, and communicated to participants and relevant institutions through the Outpatient Induction study homepage (www.optionstudien.se), the webinars of the Swedish Network for National Clinical Studies in Obstetrics and Gynecology (www.snaks.se) as well as social and public media.

Trial registration number

EudraCT No: 2020-000233-41, after transfer to the European Medicines Agency EU CT Number: 2023-507164-39-00; CIV-ID 20-09-034712.

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