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- Hansson, Emma, 1981, et al.
(author)
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Gothenburg Breast reconstruction (GoBreast) II protocol: a Swedish partially randomised patient preference, superiority trial comparing autologous and implant-based breast reconstruction.
- 2024
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In: BMJ open. - 2044-6055. ; 14:7
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Journal article (peer-reviewed)abstract
- 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.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.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.NCT06195865.
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| 2. |
- Löfstrand, Jonas, 1981, et al.
(author)
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Long-term patient-reported back and shoulder function after delayed breast reconstruction with a latissimus dorsi flap: case-control cohort study.
- 2024
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In: The British journal of surgery. - 1365-2168. ; 111:1
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Journal article (peer-reviewed)abstract
- Sacrifice of the latissimus dorsi (LD) muscle might entail donor site morbidity when used in delayed breast reconstruction. Previous studies are small, have short follow-up, and demonstrate diverging results. The aims of this study were to evaluate long-term patient-reported effects on shoulder and back function following LD flap harvest, and to investigate predictors for a worse outcome.This is a retrospective observational case-control cohort study. Cases were all patients who had undergone an LD flap reconstruction during the years 2007-2017. Controls were patients reconstructed with a deep inferior epigastric perforator (DIEP) flap during the same time period. Participants completed two validated questionnaires; the BREAST-Q reconstruction LD domains and the Western Ontario Shoulder Osteoarthritis Index (WOOS).A total of 135 cases (75 per cent) and 118 controls (60 per cent) responded to the questionnaires. The mean follow-up time was 7 years. Patients reconstructed with a LD flap were significantly less satisfied with their back and shoulder function when compared to the DIEP controls, as measured with BREAST-Q and WOOS. Predictors for a poor patient-reported back and shoulder function included axillary surgery and axillary radiotherapy, especially when combined, as well as higher age at reconstruction.Patients who have undergone LD flap for delayed breast reconstruction had a lower satisfaction with back and shoulder function, when compared to patients who had undergone a DIEP reconstruction. Delayed LD reconstruction should be used with care, especially in patients who have undergone axillary surgery and axillary radiotherapy.
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| 5. |
- Hansson, Emma, 1981, et al.
(author)
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A systematic review of randomised controlled trials in breast reconstruction.
- 2024
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In: Journal of Plastic Surgery and Hand Surgery. - 2000-656X .- 2000-6764. ; 59, s. 53-64
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Journal article (peer-reviewed)abstract
- 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.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.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.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.
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| 6. |
- Paganini, Anna, 1979, et al.
(author)
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Women's decision process when actively choosing to 'go flat' after breast cancer: a constructivist grounded theory study.
- 2024
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In: BMC women's health. - 1472-6874. ; 24:1
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Journal article (peer-reviewed)abstract
- This study aims to describe a conceptual model that could illuminate the decision process women go through when choosing to go flat on one or both sides due to breast cancer.A qualitative design, with constructivist grounded theory was used. Eighteen women were individually interviewed, digitally or by telephone, until saturation was reached. Data were analysed using a constant comparative iterative method in accordance with grounded theory. By examining the text data to identify the decision process for going flat and rejecting reconstructive surgery open coding was obtained. As the study proceeded patterns were explored and categories developed into a core category.The overall decision process for women choosing to go flat on one or both sides emerged in three phases: Phase 1, where the women are forced to "Face the cancer", Phase 2 comprising "Reflections on health and motivation" and Phase 3, described as "Hobson's choice". The fundament of the decision process was found in the core category "Establishing and safeguarding the chosen self".The decision process involved in actively going flat and rejecting reconstructive surgery is founded in the individual woman's motivations, such as view of femininity and apprehensions about the offered reconstructive surgery.
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