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BioMEL: a translational research biobank of melanocytic lesions and melanoma

Por: Helkkula · T. · Christensen · G. · Ingvar · C. · Isaksson · K. · Harbst · K. · Persson · B. · Ingvar · A. · Hafström · A. · Carneiro · A. · Gaspar · V. · Jönsson · G. · Nielsen · K.
Introduction

Diagnosing invasive cutaneous melanoma (CM) can be challenging due to subjectivity in distinguishing equivocal nevi, melanoma in situ and thin CMs. The underlying molecular mechanisms of progression from nevus to melanoma must be better understood. Identifying biomarkers for treatment response, diagnostics and prognostics is crucial. Using biomedical data from biobanks and population-based healthcare data, translational research can improve patient care by implementing evidence-based findings. The BioMEL biobank is a prospective, multicentre, large-scale biomedical database on equivocal nevi and all stages of primary melanoma to metastases. Its purpose is to serve as a translational resource, enabling researchers to uncover objective molecular, genotypic, phenotypic and structural differences in nevi and all stages of melanoma. The main objective is to leverage BioMEL to significantly improve diagnostics, prognostics and therapy outcomes of patients with melanoma.

Methods and analysis

The BioMEL biobank contains biological samples, epidemiological information and medical data from adult patients who receive routine care for melanoma. BioMEL is focused on primary and metastatic melanoma, but equivocal pigmented lesions such as clinically atypical nevi and melanoma in situ are also included. BioMEL data are gathered by questionnaires, blood sampling, tumour imaging, tissue sampling, medical records and histopathological reports.

Ethics and dissemination

The BioMEL biobank project is approved by the national Swedish Ethical Review Authority (Dnr. 2013/101, 2013/339, 2020/00469, 2021/01432 and 2022/02421-02). The datasets generated are not publicly available due to regulations related to the ethical review authority.

Trial registration number

NCT05446155.

Family members' experiences of COVID‐19 visiting restrictions in the intensive care unit—A qualitative study

Abstract

Objective

To describe how family members of critically ill patients experienced the COVID-19 visiting restrictions in Sweden.

Background

In Sweden, the response to COVID-19 was less invasive than in many other countries. However, some visiting restrictions were introduced for intensive care units, with local variations. Although there is a growing body of literature regarding healthcare professionals' and family caregivers' perspectives on visiting restriction policies, there may be inter-country differences, which remain to be elucidated.

Design

This study has a qualitative descriptive design. Focus group interviews with 14 family members of patients treated for severe COVID-19 infection were conducted. The interviews took place via digital meetings during the months after the patients' hospital discharge. Qualitative content analysis was used to interpret the interview transcripts. Reporting of the study followed the COREQ checklist.

Results

Two categories—dealing with uncertainty and being involved at a distance—described family members' experiences of coping with visiting restrictions during the COVID-19 pandemic. These restrictions were found to reduce family members' ability to cope with the situation. Communication via telephone or video calls to maintain contact was appreciated but could not replace the importance of personal contact.

Conclusions

Family members perceived that the visiting restriction routines in place during the COVID-19 pandemic negatively influenced their ability to cope with the situation and to achieve realistic expectations of the patients' needs when they returned home.

Relevance to Clinical Practice

This study suggests that, during the COVID-19 pandemic, the visiting restrictions were experienced negatively by family members and specific family-centred care guidelines need to be developed for use during crises, including the possibility of regular family visits to the ICU.

Patient and Public Contribution

None in the conceptualisation or design of the study.

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the e

Por: Engdahl · J. · Straat · K. · Isaksson · E. · Rooth · E. · Svennberg · E. · Norrving · B. · Euler · M. v. · Hellqvist · K. · Gu · W. · Ström · J. O. · Själander · S. · Eriksson · M. · Asberg · S. · Wester · P.
Introduction

Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.

Methods and analysis

AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.

Ethics and dissemination

Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.

Trial registration number

NCT05134454.

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