Gothenburg Breast reconstruction (GoBreast) II protocol: a Swedish partially randomised patient preference, superiority trial comparing autologous and implant-based breast reconstruction.

INTRODUCTION: Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. Randomised controlled trials (RCTs) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The objective of this study is to compare implant-based and autologous breast reconstruction in non-irradiated patients. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. METHODS AND ANALYSIS: The study design partially randomised patient preference trial might be a way to overcome the aforementioned challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose the method. The study is designed as a superiority trial based on the patient-reported questionnaire BREAST-Q and 124 participants will be randomised. In the preference cohort, patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60 months. Embedded qualitative studies and within-trial economic evaluation will be performed. The primary outcome is patient-reported breast-specific quality of life/satisfaction, and the secondary outcomes are complications, factors affecting satisfaction and cost-effectiveness. ETHICS AND DISSEMINATION: The study has been approved by the Swedish Ethical Review Authority (2023-04754-01). Results will be published in peer-reviewed scientific journals and presented at peer-reviewed scientific meetings. TRIAL REGISTRATION NUMBER: NCT06195865.

A systematic review of randomised controlled trials in breast reconstruction.

BACKGROUND: For preference sensitive treatments, such as breast reconstructions, there are barriers to conducting randomised controlled trials (RCTs). The primary aims of this systematic review were to investigate what type of research questions are explored by RCTs in breast reconstruction, where have they been performed and where have they been published, and to thematise the research questions and thus create an overview of the state of the research field. METHODS: Randomised controlled trials investigating any aspect of breast reconstructions were included. The PubMed database was searched with a pre-defined search string. Inclusion and data abstraction was performed in a pre-defined standardised fashion. For the purpose of this study, we defined key issues as comparison of categories of breast reconstruction and comparison of immediate and delayed breast reconstruction, when the thematisation was done. RESULTS: A total of 419 abstracts were retrieved from the search. Of the 419, 310 were excluded as they were not RCTs concerning some aspect of breast reconstruction, which left us with 110 abstracts to be included in the study. The research questions of the included studies could more or less be divided into seven different themes inclusive of 2 key issues: Other issues - comparison of different categories of breast reconstruction, comparison of immediate and delayed breast reconstruction, surgical details within a category of breast reconstruction, surgical details valid for several categories of breast reconstruction, donor site management, anaesthetics, and non-surgical details. Only five studies compared key issues, and they all illustrate the challenges with RCTs in breast reconstruction. CONCLUSIONS: A total of 110 publications based on RCTs in breast reconstruction have been published. Seven themes of research questions could be identified. Only five studies have explored the key issues. Better scientific evidence is needed for the key issues in breast reconstruction, for example by implementing a new study design in the field.

School health professionals' understanding of culture: a scoping review protocol.

INTRODUCTION: Culture is highlighted in previous research as important in encounters where health professionals and children do not share a language or culture. In these encounters, culture is described as mainly related to the child, whereas the health professionals' understanding of their own culture as impacting the encounter tends to be left out. To clarify how culture is understood and conceptualised among professionals, it is of relevance to collate previous research on health professionals' understanding of culture. In the scoping review that this protocol describes, we aim to focus on the context of the school health services, being a context accessible to many children in their everyday life. The aim of the review will be to identify, describe and analyse previous research concerning school health professionals' (ie, school nurses, school social workers, school doctors and school psychologists) understanding of culture. METHODS AND ANALYSIS: This scoping review will be guided by the methodology described by Peters et al and Khalil et al. Searches will be conducted in Scopus, PubMed, Cinahl Plus, SocIndex, Sociological Abstracts, Social Services Abstracts, APA PsycInfo, APA PsycArticles, Web of Science and Applied Social Sciences Index & Abstracts (ASSIA). Any published scientific papers focusing on school health professionals' understanding of culture (conceptualised through a variety of related terms) and school health services conducted within the last 10 years (2013-2023) will be included. Two reviewers will independently screen all titles and abstracts for inclusion. Two reviewers will conduct the screening of full-text documents and the extraction of information. Qualitative content analysis as well as discourse analysis will be employed. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The findings will be disseminated through peer review publication as well as presentation at conferences and to relevant stakeholders.

Comparison of 10 Control hPSC Lines for Drug Screening in an Engineered Heart Tissue Format.

Human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CM) are commercially available, and cardiac differentiation established routine. Systematic evaluation of several control hiPSC-CM is lacking. We investigated 10 different control hiPSC-CM lines and analyzed function and suitability for drug screening. Five commercial and 5 academic hPSC-CM lines were casted in engineered heart tissue (EHT) format. Spontaneous and stimulated EHT contractions were analyzed, and 7 inotropic indicator compounds investigated on 8 cell lines. Baseline contractile force, kinetics, and rate varied widely among the different lines (e.g., relaxation time range: 118-471 ms). In contrast, the qualitative correctness of responses to BayK-8644, nifedipine, EMD-57033, isoprenaline, and digoxin in terms of force and kinetics varied only between 80% and 93%. Large baseline differences between control cell lines support the request for isogenic controls in disease modeling. Variability appears less relevant for drug screening but needs to be considered, arguing for studies with more than one line.