Examining the quality of news media reporting of complex mental illness in relation to violent crime in Australia.

PURPOSE: News reporting on mental illness can perpetuate stigma. An understanding of the current picture of such reporting is important to identify areas for improvement. This study investigated the quality of Australian news media coverage of complex mental illness in the context of crime and violence over a 2-year period, prior to the release of new media guidelines. METHODS: This research utilised a systematic search of Australian news articles that were published between July 2018 and July 2020 and reported on mental illness in relation to violent crime. Researchers developed a Mental Illness and Crime Reporting Quality Framework to determine quality scores for news articles according to 11 relevant factors in media guidelines. An additional 11 characteristics of articles were extracted for further descriptive analysis. RESULTS: One-hundred and twenty-eight Australian news articles met inclusion criteria. The average quality score was 50 (SD = 13.91) out of a possible maximum score of 100 (range 11-78). Strengths and weaknesses were identified as some criteria were consistently met, and other criteria were met rarely or not at all. There were emerging trends between quality scores and article characteristics, including publication source, though these analyses were not statistically significant. CONCLUSION: The findings indicate that Australian news coverage of complex mental illness and violent crime met half of the criteria of reporting guidelines that minimises risk of perpetuating or reinforcing stigma. This demonstrates significant opportunity to improve the overall quality of media reporting on crime and mental illness. Future research should evaluate the impact of the guidelines on the quality of news reporting after their implementation by utilising a similar methodology, using these findings as a baseline measure.

Providers' Perceptions Versus Practices Inform Pediatric Colorectal Enhanced Recovery After Surgery Implementation.

INTRODUCTION: There are many barriers to the implementation of an enhanced recovery after surgery (ERAS) pathway. The aim of this study was to compare surgeon and anesthesia perceptions with current practices prior to the initiation of an ERAS protocol in pediatric colorectal patients and to use that information to inform ERAS implementation. METHODS: This was a mixed method single institution study of barriers to implementation of an ERAS pathway at a free-standing children's hospital. Anesthesiologists and surgeons at a free-standing children's hospital were surveyed regarding current practices of ERAS components. A retrospective chart review was performed of 5- to 18-y-old patients undergoing colorectal procedures between 2013 and 2017, followed by the initiation of an ERAS pathway, and a prospective chart review for 18 mo postimplementation. RESULTS: The response rate was 100% (n = 7) for surgeons and 60% (n = 9) for anesthesiologists. Preoperative nonopioid analgesics and regional anesthesia were rarely used. Intraoperatively, 54.7% of patients had a fluid balance of <10 cc/kg/h and normothermia was achieved in only 38.7%. Mechanical bowel prep was frequently utilized (48%). Median nil per os time was significantly longer than required at 12 h. Postoperatively, 42.9% of surgeons reported that patients could have clears on postoperative day zero, 28.6% on postoperative day one, and 28.6% after flatus. In reality, 53.3% of patients were started on clears after flatus, with a median time of 2 d. Most surgeons (85.7%) expected patients to get out of bed once awake from anesthesia; however, median time that patients were out of bed was postoperative day one. While most surgeons reported frequent use of acetaminophen and/or ketorolac, only 69.3% received any nonopioid analgesic postoperatively, with only 41.3% receiving two or more nonopioid analgesics. Nonopioid analgesia showed the highest rates of improvement from retrospective to prospective: preoperative use of analgesics increased from 5.3% to 41.2% (P < 0.0001), postoperative use of acetaminophen increased by 27.4% (P = 0.5), Toradol by 45.5% (P = 0.11), and gabapentin by 86.7% (P < 0.0001). Postoperative nausea/vomiting prophylaxis with >1 class of antiemetic increased from 8% to 47.1% (P < 0.001). The length of stay was unchanged (5.7 versus 4.4 d, P = 0.14). CONCLUSIONS: For the successful implementation of an ERAS protocol, perceptions versus reality must be assessed to determine current practices and identify barriers to implementation.

Upper Gastrointestinal Series in the Workup for Pediatric Gastrostomy Placement: Does it Delay Care?

INTRODUCTION: Upper gastrointestinal (UGI) series is often part of the workup prior to the placement of gastrostomy tubes in children. Prior studies have suggested UGI to be limited in utility and an extra financial burden. The goal of this study was to investigate the utility and cost of UGI studies. METHODS: A retrospective, case control study of patients aged < 18 y receiving gastrostomy tubes at a free-standing children's hospital between 2012 and 2017. Total costs were obtained from the Pediatric Health Information System. RESULTS: Six hundred eighty five patients underwent gastrostomy placement during the study period. UGI was obtained in 90.8% of patients; 23.6% of studies were abnormal. The most common abnormal findings were reflux (13.8%) and abnormal anatomy (5.8%). The median time to obtain a UGI was 0.82 d (interquartile range 0.22-1.05). Obtaining a UGI was associated with delayed care in 104 patients (15.2%). If a delay was encountered, median time was 2.47 d (interquartile range 1.86-2.99). Ladd's procedures were performed in 12 patients (1.7%) found to have malrotation on UGI. None of the 63 patients who did not undergo UGI required a Ladd's procedure. Patients that had a UGI did not experience an increase in overall length of stay (14.3 versus 15.6 d, excluding intensive care unit patients), operative time (34 versus 39 min), or a change in rate of operative complications (11.5% versus 14.3%). In addition, UGI did not have a significant impact on total adjusted costs ($49,844 versus $83,438 without UGI, P = 0.12) but did slightly increase total adjusted costs per day ($2212 versus $1999 without UGI, P = 0.01). CONCLUSIONS: UGI prior to gastrostomy placement in children rarely identified abnormal findings that changed the operative plan, was associated with delayed care in 15% of patients, and was associated with slightly increased costs per day. Further analyses to identify subsets of children that may benefit from routine UGI are warranted.

Media reporting on alcohol and other drugs in Australia and the Mindframe guidelines: Baseline data.

INTRODUCTION: The aim of this study was to generate a baseline database of print media reporting on alcohol and other drug (AOD) issues prior to the release of the Mindframe guidelines in March 2019. Specifically, to: (i) describe the content associated with media entries that focus on AOD use in Australian news media; (ii) determine how the media entries compare to several domains associated with recently developed Mindframe guidelines for publicly reporting on AOD; and (iii) identify content factors associated with different scores. METHODS: Media entries between July 2016 and June 2017 were searched for key AOD-related terms using the Australian and New Zealand Newsstream database. Two coding schemes were developed to rate a stratified sample of 50% of the media entries against the Mindframe guidelines. Associations between content and total comparison scores were determined using linear regression models. RESULTS: Detailed coding of the 2007 articles identified as relevant for the current study indicated that a majority (67%) were focused on one of three substances: alcohol, cannabis or methamphetamine. Most of the entries were either law enforcement (22%) or criminal justice related (19%). Entries that focused on methamphetamine scored significantly lower than entries on alcohol when compared to the Mindframe guidelines, similarly entries focused on crime/justice-related topics scored significantly lower than entries focused on positive outcomes. DISCUSSION AND CONCLUSIONS: A disproportionate number of print media entries, particularly those related methamphetamine use, focused on crime or justice-related topics, potentially further contributing to stigma, and emphasising the legal consequences of AOD use.

Multicenter Assessment of Cryoanalgesia Use in Minimally Invasive Repair of Pectus Excavatum: A 20-center Retrospective Cohort Study.

OBJECTIVE: To assess the clinical implications of cryoanalgesia for pain management in children undergoing minimally invasive repair of pectus excavatum (MIRPE). BACKGROUND: MIRPE entails significant pain management challenges, often requiring high postoperative opioid use. Cryoanalgesia, which blocks pain signals by temporarily ablating intercostal nerves, has been recently utilized as an analgesic adjunct. We hypothesized that the use of cryoanalgesia during MIRPE would decrease postoperative opioid use and length of stay (LOS). MATERIALS AND METHODS: A multicenter retrospective cohort study of 20 US children's hospitals was conducted of children (age below 18 years) undergoing MIRPE from January 1, 2014, to August 1, 2019. Differences in total postoperative, inpatient, oral morphine equivalents per kilogram, and 30-day LOS between patients who received cryoanalgesia versus those who did not were assessed using bivariate and multivariable analysis. P value <0.05 is considered significant. RESULTS: Of 898 patients, 136 (15%) received cryoanalgesia. Groups were similar by age, sex, body mass index, comorbidities, and Haller index. Receipt of cryoanalgesia was associated with lower oral morphine equivalents per kilogram (risk ratio=0.43, 95% confidence interval: 0.33-0.57) and a shorter LOS (risk ratio=0.66, 95% confidence interval: 0.50-0.87). Complications were similar between groups (29.8% vs 22.1, P =0.07), including a similar rate of emergency department visit, readmission, and/or reoperation. CONCLUSIONS: Use of cryoanalgesia during MIRPE appears to be effective in lowering postoperative opioid requirements and LOS without increasing complication rates. With the exception of preoperative gabapentin, other adjuncts appear to increase and/or be ineffective at reducing opioid utilization. Cryoanalgesia should be considered for patients undergoing this surgery.

Cost Analysis of Adjuvant Whole-Brain Radiotherapy Treatment Versus No Whole-Brain Radiotherapy After Stereotactic Radiosurgery and/or Surgery Among Adults with One to Three Melanoma Brain Metastases: Results from a Randomized Trial.

PURPOSE: We aimed to compare Australian health system costs at 12 months for adjuvant whole-brain radiotherapy (WBRT) treatment after stereotactic radiosurgery (SRS) and/or surgery versus observation among adults with one to three melanoma brain metastases. We hypothesized that treatment with adjuvant WBRT and subsequent healthcare would be more expensive than SRS/surgery alone. METHODS: The analysis was conducted alongside a multicentre, randomized phase III trial. A bespoke cost questionnaire was used to measure healthcare use, including hospitalizations, specialist and primary care visits, imaging, and medicines over 12 months. Mean per-patient costs were calculated based on the quantity of resources used and unit costs, reported in Australian dollars ($AU), year 2018 values. Skewness of cost data was determined using normality tests and censor-adjusted costs reported using the Kaplan-Meier sample average method. The analysis of difference in mean costs at each 2-month time point and at 12 months was performed and checked using Kruskal-Wallis, generalized linear models with gamma distribution and log link, modified Park test, ordinary least squares, and non-parametric bootstrapping. RESULTS: In total, 89 patients with similar characteristics at baseline were included in the cost analysis (n = 43 WBRT; n = 46 observation). Hospitalization cost was the main cost, ranging from 63 to 89% of total healthcare costs. The unadjusted 12-monthly cost for WBRT was $AU71,138 ± standard deviation 41,475 and for observation $AU69,848 ± 33,233; p = 0.7426. The censor-adjusted 12-monthly cost for WBRT was $AU90,277 ± 36,274 and $AU82,080 ± 34,411 for observation. There was no significant difference in 2-monthly costs between groups (p > 0.30 for all models). CONCLUSIONS: Most costs were related to inpatient hospitalizations associated with disease recurrence. Adding WBRT after local SRS/surgery for patients with one to three melanoma brain metastases did not significantly increase health system costs during the first 12 months. TRIAL REGISTRATION: ACTRN12607000512426, prospectively registered 14 September 2007.

Journey to a new era: An innovative academic-practice partnership.

Successful academic-clinical partnerships are mutually beneficial for academic nursing and clinical organizations, supporting the long-term success of nursing programs while simultaneously improving patient outcomes. Advocated by the American Association of Colleges of Nursing in their 2016 report, Advancing Healthcare Transformation: New Era for Academic Nursing, this position paper provides six actions for transforming academic nursing. However, developing sustainable academic-practice models has proven challenging despite this roadmap, as research has not substantiated their benefits. This article describes an innovative academic-practice model that transitioned advanced practice registered nurses practicing at Le Bonheur Children's Hospital to full-time faculty, with a continued primary clinical practice role, in the College of Nursing at the University of Tennessee Health Science Center. We present the origin, development, and implementation of this academic-practice partnership model, offering recommendations for its replication by other universities and clinical agencies on this journey. Creating a sustainable model requires a shared vision, buy-in at all levels, frequent and transparent communication, planning that considers the individual policies of the partnering agencies, and persistence despite leadership changes. Two years into the partnership and remaining intact despite critical leadership changes within the clinical agency, the next phase of the relationship will permit us to document the model's impact on academic and clinical outcomes.

Ultrasound is safe and highly specific for confirmation of proper gastrostomy tube replacement in pediatric patients.

BACKGROUND: Gastrostomy tube (GT) dislodgement is a common cause of Pediatric Emergency Department (PED) visits. Postoperative patients and those who require stoma dilation are more likely to have complications during emergent replacement. Although incorrect replacement can cause significant morbidity overall, the occurrence is infrequent. Contrast injection of the GT is considered the standard for confirming proper placement. Case reports in both pediatric and adult patients suggest that ultrasound can be used to confirm proper replacement. The objective of the present study was to assess the utility of ultrasound to confirm GT placement in pediatric patients most at risk for complications from incorrect replacement. METHODS: This is a non-randomized cohort pilot trial to determine the sensitivity and specificity of ultrasound to confirm proper replacement of a GT in a Pediatric Emergency Department. RESULTS: We enrolled 55 pediatric subjects, of which 50 had ultrasound imaging after GT replacement in the PED prior to contrast injection. Ultrasound was found to have 96% sensitivity and 100% specificity for confirming GT placement. CONCLUSIONS: Ultrasound is a safe and reliable confirmatory study to confirm GT placement in pediatric patients, especially those at highest risk of complications from incorrect placement. LEVEL OF EVIDENCE: II.

A practical guide on the use of imiquimod cream to treat lentigo maligna.

Lentigo maligna (LM) is a common in situ melanoma subtype arising on chronically sun-damaged skin and mostly affects the head and neck region. Localisation in cosmetically sensitive areas, difficulty to obtain wide resection margins and advanced patient age/comorbidities have encouraged investigation of less invasive therapeutic strategies than surgery in managing complex cases of LM. Radiotherapy and imiquimod have emerged as alternative treatment options in this context. The treatment of LM with imiquimod cream can be challenging due to the nature of the disease including its often large size, variegated appearance, involvement of adnexal structures, poorly defined peripheral edge and frequent localisation close to sensitive structures such as the eyes and lips, and elderly patients with multiple comorbidities. Prolonged and unpredictable inflammatory reaction and side effects and compliance with a patient-delivered therapy can also be challenging. In the literature to date, studies evaluating the use of imiquimod to treat LM have utilised varying methodologies and provided short follow-up and these limitations have impaired the development of clear guidelines for dosage and management of side effects. Based on our multidisciplinary experience and review of the literature, we propose practical clinical strategies for the use of imiquimod for treating LM, detailing optimal administration procedures in various clinical scenarios and long-term management, with the aim of facilitating optimal patient outcomes.

Phase I/II trial of concurrent extracranial palliative radiation therapy with Dabrafenib and Trametinib in metastatic BRAF V600E/K mutation-positive cutaneous Melanoma.

BACKGROUND: Concurrent treatment with BRAF inhibitors and palliative radiation therapy (RT) could be associated with increased toxicity, especially skin toxicity. Current Eastern Cooperative Oncology Group (ECOG) consensus guideline recommend ceasing BRAF inhibitors during RT. There is a lack of data regarding concurrent RT with combined BRAF and MEK inhibitors. This single-arm phase I/II trial was designed to assess the safety and tolerability of palliative RT with concurrent Dabrafenib and Trametinib in patients with BRAF-mutant metastatic melanoma. MATERIALS AND METHODS: Patients received Dabrafenib and Trametinib before and during palliative RT to soft tissue, nodal or bony metastases. The RT dose was escalated stepwise during the study period. Toxicity data including clinical photographs of the irradiated area was collected for up to 12 months following completion of RT. RESULTS: Between June 2016 to October 2019, ten patients were enrolled before the study was stopped early due to low accrual rate. Six patients were treated at level 1 (20 Gy in 5 fractions, any location) and 4 patients at level 2a (30 Gy in 10 fractions with no abdominal viscera exposed). All alive patients completed one year of post-RT follow-up. Of the 82 adverse events (AEs) documented, the majority (90%) were grade 1 and 2. Eight grade 3 events (10%) occurred in five patients, only one was treatment-related (grade 3 fever due to Dabrafenib and Trametinib). No patients experienced grade 3 or 4 RT related toxicities, including skin toxicities. One serious AE was documented in relation to a grade 3 fever due to Dabrafenib and Trametinib requiring hospitalisation. CONCLUSIONS: The lack of grade 3 and 4 RT-related toxicities in our study suggests that Dabrafenib and Trametinib may be continued concurrently during fractionated non-visceral palliative RT to extracranial sites.

A survey of surgical management of the sentinel node positive melanoma patient in the post-MSLT2 era.

BACKGROUND: The evidence-based management of melanoma patients with a positive sentinel lymph node biopsy (SLNB) has undergone a dramatic shift following publication of practice-changing surgical trials demonstrating no melanoma-specific survival advantage for completion lymph node dissection (CLND) in this scenario. We aimed to survey how surgeons' clinical practice had shifted in response to new evidence from these trials, and at a time when there was starting to become available systemic adjuvant treatments for AJCC Stage III melanoma patients. METHODS: A web-based survey consisting of practice-based questions and hypothetical clinical scenarios about current melanoma practice with regard to positive sentinel node biopsy was developed and sent to the surgical members of a Melanoma and Skin Cancer (MASC) Trials group in December 2018. Responses were analysed using descriptive statistics. RESULTS: There were 212 invitations sent and 65 respondents (31%). Respondents were from 17 countries, 94% of whom practice in specialist melanoma centres or at referral centres. Of these 97% were familiar with the MSLT2 and DeCOG-SLT clinical trials. At survey, 5% of respondents reported routinely recommending CLND and 55% recommend CLND in selected cases. Respondents were most likely to recommend CLND when multiple SLNs were positive. Important factors for surgical decision-making mentioned included size of SLN deposit, number of positive SLNs and likely compliance with the recommended surveillance regimen. CONCLUSION: In line with rapid adoption of published evidence, surgical management of Stage III melanoma has altered significantly, with few surgeons within the cohort now performing routine CLNDs after positive SLNB.

Outcomes Associated With Early vs Late Initiation of Exclusive Enteral Feeding Regimens Following Laparoscopic Gastrostomy Tube Placement in the Pediatric Patient.

OBJECTIVES: Despite frequent placement of pediatric laparoscopic gastrostomy tubes (GTs), no rigorous evaluation of initial feeding and advancement regimens exists. Therefore, the aim of this study was to determine whether early enteral feeding after GT placement is associated with increased symptoms, procedural complications, or length of stay (LOS). METHODS: In this retrospective cohort study, the records of all patients at a tertiary care pediatric hospital who had gastrostomy placement were reviewed. Only patients fed exclusively via gastrostomy were included. Feeding was monitored starting with the first postoperative feed and subsequently in 24-hour increments. Adverse events were recorded based on clinical documentation. RESULTS: A total of 480 patients met inclusion criteria. Patients who started feeds between 24 and 36 hours had a shorter LOS compared with those who started at 36-48 hours (P = .0072) or >48 hours (P < .0001). Patients requiring ≥60 hours to reach goal feeds had significantly longer LOS than the other groups. There was no difference in the distribution of the LOS based on percentage of goal feeds initiated. Patients who required ≥60 hours to attain goal feeds had the most feeding complications. CONCLUSIONS: More aggressive feeding advancement and earlier initiation of feeds were associated with decreased LOS without an associated increase in adverse clinical events.

i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol.

INTRODUCTION: There is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue. METHODS AND ANALYSIS: Thirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning. ETHICS AND DISSEMINATION: This study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients. TRIAL REGISTRATION NUMBER: ACTRN12619000952145; Pre-results.

The uptake of evidence-informed guidelines for reporting suicide into media codes of practice and policies in Australia.

ISSUE ADDRESSED: Despite different models and frameworks for effective suicide prevention, a universal intervention that is consistently highlighted is the need for responsible and safe media reporting of suicide. This is based on evidence of an association between media reporting of suicide and subsequent suicidal behaviour. This study examines the extent to which media-led policies and codes of practice in Australia have integrated and aligned with evidence-informed recommendations about reporting suicide. METHODS: An online search of Australian media agency websites was used to identify codes of practice or similar guidance for news reporting. Content analysis was conducted on all identified documents, assessing alignment with 16 key recommendations from the Mindframe media guidelines for reporting on suicide. RESULTS: A total of 17 documents across 12 media agencies were identified. Ten of the 12 agencies provided specific advice about the reporting of suicide, with all agencies that issue codes of practice or editorial policies including between two and 10 recommendations aligned with the Mindframe guidelines. CONCLUSIONS: While the results of this study are positive, significant variation between media agencies shows that there are opportunities to enhance adoption and implementation of evidence-informed guidance for media professionals in Australia. SO WHAT?: With over 3000 people dying by suicide and over 60 000 people attempting suicide each year in Australia, the prevention of suicide remains a key public health priority requiring a multi-sector and health-in-all-policies approach. This study reveals that there is a strong platform for ongoing collaboration with the Australian media to ensure safe and sensitive coverage of suicide.

Adjuvant Whole-Brain Radiation Therapy Compared With Observation After Local Treatment of Melanoma Brain Metastases: A Multicenter, Randomized Phase III Trial.

PURPOSE: The brain is a common site of metastasis for patients with high-risk melanoma. Although surgery or stereotactic radiosurgery are highly effective local treatments for a small number of metastases, there is a high risk of developing additional brain metastases. The role of adjuvant whole-brain radiotherapy (WBRT) in reducing new metastases is controversial, with a lack of high-level evidence specifically for melanoma. METHODS: In this randomized phase III trial, patients who had local treatment of one to three melanoma brain metastases were randomly assigned to WBRT or observation. The primary end point was distant intracranial failure within 12 months, and secondary end points included time to intracranial failure, survival, and time to deterioration in performance status. RESULTS: Between April 2009 and September 2017, 215 patients were randomly assigned from 24 centers. Median follow-up was 48.1 months (range, 39.6 to 68 months). Forty-two percent of patients in the WBRT group and 50.5% of those in the observation developed distant intracranial failure within 12 months (odds ratio, 0.71; 95% CI, 0.41 to 1.23; P = .22) and the rates over the entire follow-up period were 52.0% and 57.9%, respectively (odds ratio, 0.79; 95% CI, 0.45 to 1.36; P = .39). Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03). At 12 months, 41.5% of patients in the WBRT group and 51.4% of patients in the observation group had died (P = .28), with no difference in the rate of neurologic death. Median time to deterioration in performance status was 3.8 months after WBRT and 4.4 months with observation (P = .32). WBRT was associated with more grade 1 to 2 acute toxicity. CONCLUSION: After local treatment of one to three melanoma brain metastases, adjuvant WBRT does not provide clinical benefit in terms of distant intracranial control, survival, or preservation of performance status.

Exercise Behaviors and Fatigue in Patients Receiving Immunotherapy for Advanced Melanoma: A Cross-Sectional Survey via Social Media.

Objective: Treatment with immunotherapy has positively changed the long-term outlook of many patients with advanced melanoma; however, fatigue is a common and debilitating side effect. Evidence indicates exercise can improve treatment-related fatigue for patients receiving chemotherapy and radiotherapy. However, currently little is known about exercise behaviors and preferences of patients receiving immunotherapy. This project aimed to describe self-reported levels of fatigue related to immunotherapy; patient perspectives of exercise behaviors; and barriers and facilitators to engagement in exercise for patients receiving, or recently completed immunotherapy for unresectable stage III and stage IV melanoma. Method: A cross-sectional purpose-built survey was distributed to members of the Melanoma Patients Australia closed Facebook group via an online survey platform. The survey remained active for 1 month, with 3 posts during this time inviting members to participate. Results: A total of 55 responses were collected. Just over half the participants (n = 31; 56%) described exercising while receiving immunotherapy, with walking as the most common activity (n = 24; 77%). Participants described a range of physical and emotional benefits of exercise, the most predominant being fatigue reduction. Barriers to exercise also included fatigue and competing physical demands at home or work. Patient understanding of what constitutes exercise appeared to differ from clinical classifications. Conclusions: Results from this study indicate that patients are engaging in exercise while receiving immunotherapy, with the intent of mediating treatment-related fatigue. Identification of preferred exercise activities and barriers will assist in developing tailored exercise interventions for this cohort.

Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan.

BACKGROUND: The WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metastases with surgery and/or stereotactic irradiation. The primary trial endpoint was to determine the effect of adding WBRT to local treatment on distant intracranial control, and the secondary endpoints were neurocognitive function, quality of life (QoL), performance status, overall survival, death from intracranial causes, death from melanoma and cost-effectiveness. OBJECTIVE: The objective of this update is to outline and publish the pre-determined statistical analysis plan (SAP) before the database lock and the start of analysis. METHODS: The SAP describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues and the specific statistical procedures for analysing efficacy and safety outcomes. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses regarding the clinical and QoL outcomes. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid analysis bias arising from knowledge of the data. RESULTS: The resulting SAP is consistent with best practice and will allow open and transparent reporting. CONCLUSION: We have developed a SAP for the WBRTMel trial which will be followed to ensure high-quality standards of internal validity to minimise analysis bias. TRIAL REGISTRATION: ANZ Clinical Trials Registry, ACTRN12607000512426 . Registered on 9 October 2007. ClinicalTrials.gov, NCT01503827 . Registered on 4 January 2012. Trial group reference numbers ANZMTG 01.07, TROG 08.05.