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Background: For patients who are node positive at presentation and are found to have a complete nodal tumour response (ypN0) post-neoadjuvant chemotherapy (NACT), we do not yet know whether local axillary therapy can be modified based on the response to NACT. ATNEC addresses whether axillary treatment can be de-escalated, post-surgery, in T1-3N1M0 breast cancer patients who have no residual nodal disease post-NACT. Methods: Design: ATNEC is a phase III, randomized (1:1), multi-centre trial, with embedded economic evaluation. Patients with proven axillary node metastases on needle biopsy receive NACT followed by sentinel node biopsy (SNB). If the sentinel nodes have converted to ypN0, ATNEC randomizes patients to axillary treatment (nodal radiotherapy [ART] or axillary nodal clearance [ANC]) vs. no further axillary treatment. Stratification: Institution, type of surgery (breast conserving surgery vs mastectomy), receptor status (triple negative vs HER2 positive vs ER positive and/or PR positive and HER2 negative). Inclusion criteria: • Age ≥ 18 • Male or female • T1-3N1M0 breast cancer at diagnosis (pre-NACT) • FNA or core biopsy confirmed axillary nodal metastases at presentation • ER and HER2 status evaluated on primary tumour • Received standard NACT as per local guidelines • Imaging of the axilla to assess response to NACT • Dual tracer SNB post-NACT and at least 3 nodes removed (sentinel nodes and marked node). o If a single tracer is used, the patient is eligible if the involved node is marked pre-NACT and at least 3 nodes removed (including the marked node) o If axillary node sampling is performed following failed localization of sentinel nodes, patient is eligible if at least 3 nodes removed (including the marked node). o If node is not marked, or marked node is not removed, patient is eligible if the histology report shows evidence of down-staging with complete pathological response in at least one node of the 3 removed nodes. • No evidence of nodal metastases post-NACT (ypN0) Exclusion criteria: • Bilateral invasive breast cancer • SNB prior to NACT • Previous ipsilateral axillary nodal surgery • Previous cancer within last 5 years or concomitant malignancy Aims: To assess whether omitting further axillary treatment (ART or ANC) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy - who post NACT have no residual nodal disease on SNB (ypN0) - is non-inferior to axillary treatment in terms of disease-free survival, and whether lymphoedema is reduced at 5 years. Statistical methods: All analyses will be carried out on an intention-to-treat basis to preserve randomization, avoid bias from exclusions and preserve statistical power. Radiotherapy Quality Assurance: ATNEC has in-built radiotherapy QA coordinated by National Radiotherapy Trials QA (RTTQA) group. The RTQA monitors trial protocol compliance ensuring clinical outcomes reflect differences in randomization schedules rather than departures from the protocol. ATNEC is the only trial in the UK that offers QA for IMC radiotherapy. Screening Data: ATNEC collects screening data to monitor acceptance rates and reasons why patients decline the trial to identify ways to improve recruitment. Screening data until 30-Jun-22 shows that 69% of eligible patients were approached (244/354) and, of those approached, 45% were consented (109/244). For the 81 patients who declined, the most common reasons were; preference for axillary treatment (31%), preference for no axillary treatment (10%), no reason documented (23%) and ineligibility (21%). ClinicalTrials.gov: NCT04109079 Target accrual: 1900 Target sites: 100 Trial Status: Recruiting. As of 30-Jun-22: 52 sites open, 158 patients enrolled, 54 randomised. ATNEC is open to new sites and international collaboration. Citation Format: Amit Goyal, Sophie Nicholls, Andrea Marshall, Natalie Hammonds, Duncan Wheatley, Beatrix Elsberger, Janice Rose, Helen-Teresa Edwards, Roeum Butt, Abeer Shaaban, Shama Puri, Samreen Ahmed, Tara Homer, Luke Vale, Julie Bruce, Sophie J. Gasson, Helen Higgins, Janet A. Dunn. ATNEC: A multicentre, randomized trial investigating whether axillary treatment can be avoided in T1-3N1M0 breast cancer patients with no residual cancer in the axillary lymph nodes after neoadjuvant chemotherapy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-09-02.

Background Using the World Health Organization’s ‘Guide to Tailoring Immunization Programmes’ (TIP), a three-step program was developed by health services in partnership with a marginalised community in New South Wales, Australia. The aim was to improve immunisation rates of 1-year-old children. For Step 1, nurses identified and monitored local children overdue for immunisation from a national register, and sent parents or family doctors reminders by mail or telephone. For Step 2, parents were offered appointments at a local health centre; and for Step 3, they were offered home visits. Methods An economic costing study was undertaken to examine the program’s resource use. Costs were collected between 1 June 2020 and 31 May 2021. Case records were obtained for 139 children. Results A total of 56 children became up to date after receiving TIP services; most after receiving Step 1 services (n = 37). Total annual costs (A$) for the program were $34 250 or $246 per case; or $612 per case becoming up to date. At $44 per case and $98 per case becoming up to date, Step 1B: personalised reminders, was the lowest costing step. Sensitivity analysis showed a possible 8% program savings through employment of nurses with a lower salary and use of video conference meetings. Conclusion This study provides information to the local health provider on the cost of TIP alongside their community-based programs. It also identified ways in which TIP could be made more cost-effective. Decision-makers can use this information to consider whether the investment in TIP is recommended.

Background: For patients who are node positive to start at presentation and are found to have a complete nodal tumour response (ypN0) post neoadjuvant chemotherapy (NACT), we do not yet know whether local axillary therapy can be modified based on the response to NACT. ATNEC randomised trial specifically address axillary management following NACT in patients with proven axillary node metastases. Methods: Design: ATNEC is a phase III, randomised (1:1), multi-centre trial, with embedded economic evaluation. Patients with proven axillary node metastases on needle biopsy receive NACT followed by sentinel node biopsy (SNB). If the sentinel nodes have converted to benign (ypN0), ATNEC randomly assigns patients to axillary treatment (nodal radiotherapy or axillary nodal clearance) vs. no axillary treatment (without further surgery). Aims: To assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy - who after NACT have no residual nodal disease on SNB - is non-inferior to axillary treatment in terms of disease free survival, and reduces the risk of lymphoedema at 5 years. Stratification: Institution, type of surgery (breast conserving surgery [BCS] vs mastectomy), receptor status (triple negative vs HER2 positive vs ER status positive and/or PR status positive and HER2 negative). Inclusion criteria:. • Age ≥ 18. • Male or female. • T1-3N1M0 breast cancer at diagnosis (pre-NACT). • FNA or core biopsy confirmed axillary nodal metastases at presentation. • ER and HER2 status evaluated on primary tumour. • Received standard NACT as per local guidelines. • Imaging assessment of the axilla at completion of NACT. • Dual tracer SNB after NACT and at least 3 nodes removed (sentinel nodes and marked node). o If a single tracer is used, the patient is eligible if the involved node is marked before NACT and at least 3 nodes removed (including the marked node). o If axillary node sampling is performed following failed localisation of sentinel nodes, patient is eligible if at least 3 nodes removed (including the marked node). o If node is not marked, or marked node is not removed, patient is eligible if the histology report shows evidence of down-staging with complete pathological response in at least one node and at least 3 nodes removed. • No evidence of nodal metastases post NACT (ypN0). Exclusion criteria:. • Bilateral invasive breast cancer. • SNB prior to NACT. • Previous ipsilateral axillary nodal surgery. • Previous cancer within last 5 years or concomitant malignancy. Radiotherapy Quality Assurance: ATNEC has in-built radiotherapy QA programme that is coordinated by National Radiotherapy Trials QA (RTTQA) group. Target accrual: 1900 Number of sites: 100 Trial Status: Recruiting. Trial is open to new sites. Disclaimer: This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (Reference - HTA NIHR128311). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Citation Format: Amit Goyal, Sophie Cramp, Andrea Marshall, Duncan Wheatley, Natalie Hammonds, Shama Puri, Tara Homer, Luke Vale, Roeum Butt, Romaana Mir, Janice Rose, Helen Teresa Edwards, Samreen Ahmed, Abeer Shaaban, Beatrix Elsberger, Julie Bruce, Sophie Gasson, Valerie Speirs, Jacqui Shaw, Helen Higgins, Janet Dunn. ATNEC: A multi-centre, randomised trial investigating whether axillary treatment can be avoided in T1-3N1M0 breast cancer patients with no residual cancer in the lymph glands after neoadjuvant chemotherapy (clinicaltrials.gov: nct04109079) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-04-01.

Background and ObjectivesChronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce the burden of headache disability. We tested the effectiveness of a group educational and supportive self-management program for people living with chronic headaches.MethodsThis was a pragmatic randomized controlled trial. Participants were aged 18 years or older with chronic migraine or chronic tension–type headache, with or without medication overuse headache. We primarily recruited from general practices. Participants were assigned to either a 2-day group education and self-management program, a one-to-one nurse interview, and telephone support or to usual care plus relaxation material. The primary outcome was headache related-quality of life using the Headache Impact Test (HIT)-6 at 12 months. The primary analysis used intention-to-treat principles for participants with migraine and both baseline and 12-month HIT-6 data.ResultsBetween April 2017 and March 2019, we randomized 736 participants. Because only 9 participants just had tension-type headache, our main analyses were on the 727 participants with migraine. Of them, 376 were allocated to the self-management intervention and 351 to usual care. Data from 586 (81%) participants were analyzed for primary outcome. There was no between-group difference in HIT-6 (adjusted mean difference = −0.3, 95% CI −1.23 to 0.67) or headache days (0.9, 95% CI −0.29 to 2.05) at 12 months. The Chronic Headache Education and Self-management Study intervention generated incremental adjusted costs of £268 (95% CI, £176–£377) (USD383 [95% CI USD252–USD539]) and incremental adjusted quality-adjusted life years (QALYs) of 0.031 (95% CI −0.005 to 0.063). The incremental cost-effectiveness ratio was £8,617 (USD12,322) per QALY gained.DiscussionThese findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management program for people living with chronic migraine or chronic tension–type headache with episodic migraine.Trial Registration InformationRegistered on the International Standard Randomized Controlled Trial Number registry,ISRCTN7970810016th December 2015doi.org/10.1186/ISRCTN79708100. The first enrollment was April 24, 2017.Classification of EvidenceThis study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life in people with chronic migraine.

TPS615 Background: Neoadjuvant chemotherapy (NACT) results in eradication of cancer in the axillary nodes in 40-70% of patients. This raises questions about the benefit of further axillary treatment in patients with no evidence of residual nodal disease (ypN0) post NACT. Methods: Design: ATNEC is a phase 3, randomized (1:1), multi-center UK trial, with embedded economic evaluation. Patients with proven axillary node metastases on needle biopsy receive NACT followed by sentinel node biopsy (SNB). If the sentinel nodes have converted to benign (ypN0), ATNEC randomly assigns patients to axillary treatment (nodal radiotherapy [ART] or axillary nodal clearance [ALND]) vs no further axillary treatment. Stratification: Institution, type of surgery (breast conserving surgery vs mastectomy), receptor status (triple negative vs HER2 positive vs ER positive and/or PR positive and HER2 negative).Inclusion criteria: Age ≥ 18; Male or female; T1-3N1M0 breast cancer at diagnosis (pre-NACT); FNA or core biopsy confirmed axillary nodal metastases at presentation; ER and HER2 status evaluated on primary tumor; Received standard NACT as per local guidelines; Imaging of the axilla to assess response to NACT;Dual tracer SNB post-NACT and at least 3 nodes removed (sentinel nodes and marked node): If a single tracer is used, the patient is eligible if the involved node is marked pre-NACT and at least 3 nodes removed (including the marked node), If axillary node sampling is performed following failed localization of sentinel nodes, patient is eligible if at least 3 nodes removed (including the marked node), If node is not marked, or marked node is not removed, patient is eligible if the histology report shows evidence of down-staging with complete pathological response in at least one node and at least 3 nodes removed; No evidence of nodal metastases post NACT (ypN0). Exclusion criteria: Bilateral invasive breast cancer; SNB prior to NACT; Previous ipsilateral axillary nodal surgery; Previous cancer within last 5 years or concomitant malignancy. Aims: To assess whether omitting further axillary treatment (ALND & ART) for patients with early-stage breast cancer and axillary nodal metastases on needle biopsy - who after NACT have no residual nodal disease on SNB (ypN0) - is non-inferior to axillary treatment in terms of disease-free survival, and reduces lymphoedema at 5 years. Statistical methods: All analyses will be carried out on an intention-to-treat basis to preserve randomization, avoid bias from exclusions and preserve statistical power. Radiotherapy Quality Assurance: Study has in-built radiotherapy QA program that will be coordinated by National Radiotherapy Trials QA (RTTQA) group. Target accrual: 1,900 Status: Recruiting. As of 11-Feb-2022, 39 sites open, 87 patients enrolled, 31 randomized. Clinical trial information: NCT04109079.

In 2017 the World Health Organization’s Tailoring Immunization Programmes guide (TIP) was used to identify pockets of low immunization coverage in Australia. The regional centre of Maitland had high numbers and rates of children who were overdue for scheduled vaccinations (2016, n = 344, 37.7%). Families were not opposed to immunization but had conflicting priorities or experienced service access barriers. A tailored strategy was developed including friendly, personalised reminders, outreach appointments and home visiting for those families most in need. Research translation was not quick and easy. A process evaluation identified areas where more support was needed to advance the strategy. Coverage rates have increased from 62.3% (2016) to 86.2% (2020). The number of overdue children has decreased even during COVID-19 restrictions when health services expected families would avoid primary care services. The TIP approach is valuable for improving childhood immunization coverage and is being utilised in other communities with low coverage.

The World Health Organization’s Tailoring Immunization Programmes approach was used to develop a new strategy to increase child vaccination coverage in a disadvantaged community in New South Wales, Australia, including reminders, outreach and home visiting. After 18 months, the strategy hasn’t been fully implemented. A process evaluation was conducted to identify barriers and facilitators for research translation. Participants included child health nurses, Population Health staff, managers and general practitioners. The Capability–Opportunity–Motivation model of behaviour change (COM-B) was used to develop questions. Twenty-four participants took part in three focus groups and four interviews. Five themes emerged: (i) designing and adopting new ways of working is time-consuming and requires new skills, new ways of thinking and changes in service delivery; (ii) genuine engagement and interaction across fields and institutions helps build capacity and strengthen motivation; (iii) implementation of a new strategy requires clarity; who’s doing what, when and how?; (iv) it is important not to lose sight of research findings related to the needs of disadvantaged families; and (v) trust in the process and perseverance are fundamental. There was strong motivation and opportunity for change, but a need to enhance service capability. Areas requiring support and resources were identified.

Objective To evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements “QRI actions” to address these as recruitment proceeds. Study Design and Setting A mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) qualitative case studies, including documentary analysis and interviews with RCT investigators. Results Five UK-based publicly funded RCTs were included in the evaluation. All recruited to target. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI actions in RCTs 1, 3, 4, and 5. Randomization rates significantly improved after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action. Conclusion There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.

Objectives To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. Study Design and Setting Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties. Results One in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was “best for them”. Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation. Conclusions The methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation., Highlights • Practices commonly used to describe randomisation in RCT recruitment could confuse patients. • Patients found it difficult to comprehend gambling-related metaphors of randomisation. • Computer-agency descriptions led to patients believing they would receive the best treatment.

Oestrus detection in Holstein cows is difficult. Hormones to induce oestrus or for fixed-time artificial insemination are now commonly prescribed to facilitate, or remove the need for, detection of oestrus. The acceptability of pharmaceutical intervention to overcome short fallings in management is discussed, including from the wider perspective of global food security. Public perception and the veterinary profession's engagement with the public over potentially controversial issues are raised.

In Australia, the Scientists-in-Schools program partners professional scientists with teachers from K-12 schools to improve early engagement and educational outcomes in the sciences and mathematics. An overview of the developing syllabus of a K-6 course resulting from the pairing of a senior AI researcher with teachers from a K-6 (primary) school is presented. Now entering its third year, the course introduces the basic concepts, vocabulary and history of science generally and AI specifically in a manner that emphasises student engagement and provides a challenging but age appropriate syllabus. Reflecting on the course at this time provides an action research basis for ongoing maturation of the syllabus, and the paper is presented in that light.

Community service learning is the integration of experiential learning and community service into coursework such that community needs are met and students gain both professional skills and a sense of civic responsibility. A critical component is student reflection. This paper provides an example of the application of community service learning within an undergraduate health unit at the Queensland University of Technology. Based on survey data from 36 program participants, it demonstrates the impact of CSL on student outcomes. Results show that students benefited by developing autonomy through real world experiences, through increased self‐assurance and achievement of personal growth, through gaining new insights into the operations of community service organisations and through moving towards becoming responsible citizens. Students expect their CSL experience to have long‐lasting impact on their lives, with two‐thirds of participants noting that they would like to continue volunteering as part of their f...

The purpose of this paper is to review the sociodemographic, clinical, and psychological characteristics suggested as being predictors of difficulty with smoking cessation in patients with coronary artery disease. These characteristics include age, gender, socioeconomic status, social support, intensity of smoking, severity of coronary artery disease, anxiety, depression, hostility/anger/aggression, and health locus of control. In addition, nicotine addiction is discussed as a factor which may further compound this problem. Consideration of these factors in relation to the patient with coronary artery disease may assist in the delivery of an optimal and individualized intervention program to facilitate sustained smoking cessation. A brief overview of intervention strategies is provided.

Evaluation of health promotion interventions is essential in order to collect evidence about the efficacy of a program, identify ways to improve practice, justify the use of resources, and identify unexpected outcomes. This paper clarifies the role of evaluation as a crucial component of health promotion interventions. Moreover, it summarises the key elements of the most widely used planning/evaluation frameworks necessary for constructive evaluations of health promotion interventions and incorporates them into a single approach. It provides a methodical framework for the provision of evaluation guidance to health promotion practitioners and discusses the importance of including evaluation when planning any health promotion intervention. The focus of this paper is on the essential elements of the evaluation of health promotion programs.

To evaluate the use of stereotactic directional vacuum-assisted biopsy (SDVAB) in diagnosing and managing papillary lesions of the breast.The authors retrospectively reviewed the mammographic and histopathologic findings of 26 cases in which papillary lesions were diagnosed at SDVAB. In all cases, subsequent surgical excision (n = 20) or long-term imaging follow-up (n = 6) was performed and correlated with findings at SDVAB.SDVAB of 26 lesions yielded tissue that was classified as benign in 12, atypical in six, and malignant in eight. Of the 12 lesions that were diagnosed as histologically benign at SDVAB, six were surgically excised. Of these six lesions, five yielded benign correlative results. The sixth lesion was thought to be discordant with the imaging findings, and was surgically excised and determined to be malignant. Of the six benign lesions that were not surgically sampled for biopsy, five decreased in size and one was not seen at radiographic follow-up. Of the six lesions diagnosed as atypical at SDVAB that were surgically excised, one was benign and five were atypical. None proved to be malignant. Of the eight lesions diagnosed as malignant at SDVAB, surgical excision demonstrated ductal carcinoma in situ in all eight; two also had foci of invasive carcinoma.Benign and malignant papillary lesions of the breast can be reliably diagnosed at SDVAB when the SDVAB results correlate with the imaging findings. However, the extent of malignant papillary disease may be underestimated at SDVAB; in our study, invasive carcinoma was later discovered in 25% of patients with this diagnosis.

This paper discusses a health promotion intervention that sets out to develop local capacity to address chronic disease risk factors in a remote Australian community. Community focus groups, and researcher and community discussions, aimed to determine the community's health concerns and build a partnership for community action. The journey from conception to reality was difficult for a number of reasons that are described here. Despite these difficulties, a range of outcomes included the establishment of an organisational structure that involved a local health promotion committee as the principal decision-maker, the establishment of a grants scheme to support locally determined initiatives and the formal incorporation of a community Health Promotion Committee (HPC) that ensured the sustainability of activities beyond the funded project period. The HPC is still coordinating health promotion activities. The promotion of community ownership of health promotion activities is a complicated process, given that time, resources, expertise and community involvement require a much longer-term commitment than that currently imposed by many funding bodies.