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IntroductionBreast cancer is the most common cancer among women worldwide. While increasing numbers of women are living beyond breast cancer, treatment-related body image concerns are common and associated with adverse consequences. Nonetheless, rigorously evaluated and effective body image interventions are lacking among this group. Accepting your Body after Cancer (ABC) has indicated promise in relation to inperson delivery. However, online delivery may increase accessibility and facilitate sustainability of the intervention. Therefore, we aim to establish the feasibility of conducting a fully powered randomised controlled trial to evaluate online delivery of ABC.Methods and analysis120 women who have received treatment for breast cancer and are experiencing body image concerns will be randomised equally to either the ABC or standard care control group. All participants in both conditions will receive a body image booklet for people who have had cancer. ABC participants will also take part in a weekly seven-session, group-based cognitive behavioural therapy intervention, delivered online by a psychologist and cancer support specialist. Outcome measures will be completed at baseline and 9 weeks, 20 weeks and 32 weeks post baseline. Quantitative data on recruitment, retention, ABC attendance and questionnaire completion rates will be analysed using descriptive statistics. Qualitative data will also be collected to better understand the feasibility and acceptability of the research process and intervention, with data analysed using ‘codebook’ thematic analysis.Ethics and disseminationThe study has received ethical approval from the Newcastle North Tyneside Research Ethics Committee (ref: 24/NE/0092). The findings will be disseminated to academic and health professionals via a peer-reviewed publication and presentations at relevant conferences. Results will also be disseminated to participants, national cancer organisations and the general public via accessible reports, online presentations and different communication channels.Trial registration numberClinicalTrials.gov NCT06412341; ISRCTN ISRCTN88199566; IRAS 327507; REC reference 24/NE/0092; funder reference NIHR205415.

BackgroundCompared with conventional top down costing, micro-costing may provide a more accurate method of resource-use assessment in economic analyses of surgical interventions, but little is known about its current use. The aim of this study was to systematically-review the use of micro-costing in surgery.MethodsComprehensive searches identified complete papers, published in English reporting micro-costing of surgical interventions up to and including 22nd June 2018. Studies were critically appraised using a modified version of the Consensus on Health Economic Criteria (CHEC) Checklist. Study demographics and details of resources identified; methods for measuring and valuing identified resources and any cost-drivers identified in each study were summarised.ResultsA total of 85 papers were identified. Included studies were mainly observational comparative studies (n = 42, 49.4%) with few conducted in the context of a randomised trial (n = 5, 5.9%). The majority of studies were single-centre (n = 66, 77.6%) and almost half (n = 40, 47.1%) collected data retrospectively. Only half (n = 46, 54.1%) self-identified as being ‘micro-costing’ studies. Rationale for the use of micro-costing was most commonly to compare procedures/techniques/processes but over a third were conducted specifically to accurately assess costs and/or identify cost-drivers. The most commonly included resources were personnel costs (n = 76, 89.4%); materials/disposables (n = 76, 89.4%) and operating-room costs (n = 62,72.9%). No single resource was included in all studies. Most studies (n = 72, 84.7%) identified key cost-drivers for their interventions.ConclusionsThere is lack of consistency regarding the current use of micro-costing in surgery. Standardising terminology and focusing on identifying and accurately costing key cost-drivers may improve the quality and value of micro-costing in future studies.Trial registrationPROSPERO registration CRD42018099604.

Background Consistent outcome assessment in surgical research, from early phase studies (during introduction and refinement of new procedures) to late phase studies (to establish comparative effectiveness) needs improvement to ensure efficient and safe surgical care. This study explored the potential continuity of outcome domain assessment throughout the evaluation lifecycle of surgical interventions. Methods Core outcome sets (COS) for late phase studies of surgical interventions were identified through COMET database searches. Core outcomes/outcome domains were extracted and mapped to core domains of a COS developed specifically for evaluating surgical innovation (COHESIVE COS). Outcomes/domains were categorised as “definite match” (clear similarity), “possible match” (potential similarity) and “no match” (no similarity) COHESIVE domain based on similarity in wording or meaning. Results A total of 54 COS studies were included, yielding 573 core outcomes/domains. Most late phase core outcomes/domains ( N  = 519, 91%) showed clear or possible similarity. All late phase COS studies recommended measurement of COHESIVE domains ‘Intended benefits’ and ‘Expected and unexpected disadvantages’. Some late phase outcomes/domains also showed similarity with early phase COHESIVE domains, including ‘Problems with the device working’, ‘Patients’ experience’ and ‘Operators’/surgeons’ experience’. A minority of late phase outcomes/domains showed no similarity with COHESIVE domains ( n  = 54, 9%). Conclusion High similarity between outcome domains recommended in early and late phase evaluations of surgical interventions demonstrates continuity of outcome domain assessment throughout the surgical innovation lifecycle is possible. Harmonising outcome measurement throughout the research pathway can streamline evaluation, enhancing access to beneficial treatment and improving early detection of harms.

IntroductionThe introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently inconsistently defined, measured and reported. This study aims to develop a core data set that can be applied in all studies describing or measuring the learning curve in novel invasive procedures.MethodsA core data set will be developed using methods adapted from the Core Outcome Measures in Effectiveness Trials initiative. The study will involve three phases: (1) Identification of a comprehensive list of data items through (a) an umbrella review of existing systematic reviews on the learning curve in surgery and (b) qualitative interviews with key stakeholders. (2) Key stakeholders (eg, clinical innovators, clinicians, patients, methodologists, statisticians, journal editors and governance representatives) will complete a Delphi survey to score the importance of each data item, generating a shortened list. (3) Consensus meeting(s) with stakeholders to discuss and agree on the final core data set.Ethics and disseminationThe study is approved by an Institutional Ethics Committee at the University of Bristol (ref: 111362). Participants will complete written informed consent to participate. Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, patient engagement events, use of social media platforms, workshops and other events.

IntroductionNeoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow the translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. The development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved.Methods and analysisA COS for reporting locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development guidelines. Reporting guidance will be developed concurrently.The project will have three phases: (1) generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items. (2) At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome. (3) A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance.Ethics and disseminationEthical approval for the consensus process will be obtained from the Queen’s University Belfast Faculty Ethics Committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely.RegistrationThe study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854).

IntroductionMammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as ‘overdiagnosed’ cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.MethodsSMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment.Ethics and disseminationEthical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer.Trial registration numberISRCTN12240119.

A systematic review undertaken to map the current landscape of locoregional de-escalation trials to inform future research. Online databases and trial registries were searched to identify ongoing, recently completed or published studies de-escalating surgery or radiotherapy in patients with early breast cancer. 97 trials evaluated de-escalation of surgery or radiotherapy in up to 94,866 participants. Surgery studies more commonly evaluated treatment omission/reduction after neoadjuvant systemic therapy (NST) and de-escalation of nodal treatment. Radiotherapy studies were more frequently biomarker stratified. Patients were rarely involved in study design. Research questions focused on response-adjusted treatment after NST and omission/reduction of locoregional therapy in patients with low- or intermediate-risk disease. Significant duplication was identified with multiple studies addressing similar questions. This systematic review demonstrates that the current de-escalation portfolio is inefficient, lacks patient focus and needs improvement. An internationally collaborative approach using innovative study designs and patient partnership will be essential to address this.

Background In 2020, 1.4 and 2.3 million new cases of prostate cancer and breast cancer respectively were diagnosed globally. In the UK, prostate cancer is the most common male cancer, while breast cancer is the most common female cancer. Engaging in physical activity (PA) is a key component of treatment. However, rates of PA are low in these clinical populations. This paper describes the protocol of CRANK-P and CRANK-B , two pilot randomised controlled trials, involving an e-cycling intervention aimed at increasing PA in individuals with prostate cancer or breast cancer respectively. Methods These two trials are single-centre, stratified, parallel-group, two-arm randomised waitlist-controlled pilot trials in which forty individuals with prostate cancer ( CRANK-P ) and forty individuals with breast cancer ( CRANK-B ) will be randomly assigned, in a 1:1 allocation ratio, to an e-cycling intervention or waitlist control. The intervention consists of e-bike training with a certified cycle instructor, followed by the provision of an e-bike for 12 weeks. Following the intervention period, participants in the e-bike condition will be directed to community-based initiatives through which they can access an e-bike. Data will be collected at baseline (T0), immediately post intervention (T1) and at 3-month follow-up (T2). In addition, in the intervention group, data will be collected during the intervention and follow-up periods. Quantitative and qualitative methods will be used. The primary objectives are to determine effective recruitment strategies, establish recruitment and consent rates, adherence and retention in the study, and determine the feasibility and acceptability of the study procedures and intervention. The potential impact of the intervention on clinical, physiological and behavioural outcomes will be assessed to examine intervention promise. Data analyses will be descriptive. Discussion The findings from these trials will provide information on trial feasibility and highlight the potential of e-cycling as a strategy to positively impact the health and behaviour of individuals with prostate cancer and breast cancer. If appropriate, this information can be used to design and deliver a fully powered definitive trial. Trial registration CRANK-B: [ISRCTN39112034]. CRANK-P [ISRCTN42852156]. Registered [08/04/2022] https://www.isrctn.com .

IntroductionPatients with node-positive breast cancer having primary surgery currently undergo axillary node clearance (ANC) to reduce the risk of breast cancer recurrence. Evidence that this highly morbid procedure improves survival is lacking, but approximately 30% of patients will develop lifelong complications which significantly impact their quality of life.Targeted axillary dissection (TAD) may be a safe, less morbid alternative to ANC and will be evaluated in the upcoming Targeted Axillary Dissection versus axillary node clearance in patients with POsitive axillary Lymph nodes in Early breast cancer (TADPOLE) randomised controlled trial.TAD is not currently routine practice in patients having primary surgery, so it is vital that the procedure is performed in an agreed upon, standardised way within the trial and procedure fidelity monitored to ensure the results are generalisable and will be accepted by the surgical community. Robust surgical quality assurance (SQA) is essential. Here we describe the first phase of the TADPOLE SQA, a consensus process with the breast surgical community to agree upon how (1) surgery should be performed and standardised; (2) procedure fidelity will be monitored and (3) requirements for surgeon credentialling within the trial.Methods and analysisThe consensus process will have three phases:Generation of a long list of possible components of TAD from a scoping review and expert opinion. Identified items will be categorised and formatted into Delphi consensus questionnaire items.At least two rounds of an online Delphi survey in which at least 100 breast cancer surgeons will rate the importance of mandating/prohibiting, standardising and/or monitoring each component.A consensus meeting with surgeons to discuss, agree upon and ratify the approach to SQA within TADPOLE.Ethics and disseminationEthical approval has been obtained from the University of Bristol Faculty of Health Sciences Ethics Committee. Educational materials including videos and webinars will be developed and shared with surgeons participating in TADPOLE. Results will be presented at national/international meetings and published in peer-reviewed journals.

IntroductionRigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation.Methods and analysisA COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases:1. Generation of a list of relevant outcome domains and reporting items identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items.2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome.3. A consensus meeting with key stakeholders will discuss and agree the final content of the reporting guidance and COS(s).Ethics and disseminationEthical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events.