International journal of surgery protocols
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Neoadjuvant systemic therapy (NST) has several potential advantages in the treatment of breast cancer. However, there is currently considerable variation in NST use across the UK. The NeST study is a national, prospective, multicentre cohort study that will investigate current patterns of care with respect to NST in the UK. ⋯ Research ethics approval is not required for this study, as per the online Health Research Authority decision tool. The information obtained will provide valuable insights to help patients make informed decisions about their treatment. These data should establish current practice in the UK concerning NST, inform future service delivery as well as identifying further research questions.This protocol will be disseminated through the Mammary Fold Academic Research Collaborative (MFAC), the Reconstructive Surgery Trials Network and the Association of Breast Surgery. Participating units will have access to their own data and collective results will be presented at relevant conferences and published in appropriate peer-reviewed journals, as well as being made accessible to relevant patient groups.
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New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. The IDEAL Framework and Recommendations lay out a pathway to achieve this and offer general guidance on how studies at each stage should be reported. However, researchers require some assistance in translating theory into practice. We will develop a set of reporting guidelines for each IDEAL stage where deemed necessary through Delphi consensus methodology. ⋯ For each IDEAL stage requiring a new set of reporting guidelines, we will use the following process. We will search for the relevant reporting guidelines already in existence and use principles developed by the IDEAL Collaboration to compile the initial long list of potential checklist items. In each round, the participants will rate the importance of reporting each element on a nine-point Likert scale as proposed by the GRADE group. Sequential rounds and questionnaire administration and completion will take place until a final set of items is produced. There will then be a final consensus meeting of a working group to condense and refine the final recommendations for the reporting guidelines.
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Wide local excision and adjuvant radiotherapy is the standard of care for early breast cancer. For large tumours, however, mastectomy is frequently recommended as conventional breast-conserving techniques often result in poor cosmetic outcomes. Therapeutic mammaplasty (TM) may extend the boundaries of breast-conserving surgery by combining breast reduction and mastopexy techniques with tumour excision, preserving a natural breast shape and avoiding the need for mastectomy. The prevalence of this operative option among surgeons in the UK and its success rate are unknown. The TeaM study is a multicentre prospective study that aims to investigate the practice and outcomes of TM. ⋯ Research ethics approval is not required for this study. This has been confirmed by the on-line Health Research Authority decision tool. This study will provide novel information regarding the practice and outcomes of TM in the UK. This will inform decision-making for patients and surgeons and inform future research. Dissemination of the study protocol will be via the Mammary Fold Academic and Research Collaborative, the Reconstructive Surgery Trials Network and the professional associations, the Association of Breast Surgery and British Association of Plastic, Reconstructive and Aesthetic Surgeons. Results will be presented at relevant surgical conferences and published in peer-reviewed journals.