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    Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial
    Dearnaley, D ; Syndikus, I ; Mossop, H ; Khoo, V ; Birtle, A ; Bloomfield, D ; Graham, J ; Kirkbride, P ; Logue, J ; Malik, Z ; Money-Kyrle, J ; O'Sullivan, JM ; Panades, M ; Parker, C ; Patterson, H ; Scrase, C ; Staffurth, J ; Stockdale, A ; Tremlett, J ; Bidmead, M ; Mayles, H ; Naismith, O ; South, C ; Gao, A ; Cruickshank, C ; Hassan, S ; Pugh, J ; Griffin, C ; Hall, E (ELSEVIER SCIENCE INC, 2016-08-01)
    BACKGROUND: Prostate cancer might have high radiation-fraction sensitivity that would give a therapeutic advantage to hypofractionated treatment. We present a pre-planned analysis of the efficacy and side-effects of a randomised trial comparing conventional and hypofractionated radiotherapy after 5 years follow-up. METHODS: CHHiP is a randomised, phase 3, non-inferiority trial that recruited men with localised prostate cancer (pT1b-T3aN0M0). Patients were randomly assigned (1:1:1) to conventional (74 Gy delivered in 37 fractions over 7·4 weeks) or one of two hypofractionated schedules (60 Gy in 20 fractions over 4 weeks or 57 Gy in 19 fractions over 3·8 weeks) all delivered with intensity-modulated techniques. Most patients were given radiotherapy with 3-6 months of neoadjuvant and concurrent androgen suppression. Randomisation was by computer-generated random permuted blocks, stratified by National Comprehensive Cancer Network (NCCN) risk group and radiotherapy treatment centre, and treatment allocation was not masked. The primary endpoint was time to biochemical or clinical failure; the critical hazard ratio (HR) for non-inferiority was 1·208. Analysis was by intention to treat. Long-term follow-up continues. The CHHiP trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN97182923. FINDINGS: Between Oct 18, 2002, and June 17, 2011, 3216 men were enrolled from 71 centres and randomly assigned (74 Gy group, 1065 patients; 60 Gy group, 1074 patients; 57 Gy group, 1077 patients). Median follow-up was 62·4 months (IQR 53·9-77·0). The proportion of patients who were biochemical or clinical failure free at 5 years was 88·3% (95% CI 86·0-90·2) in the 74 Gy group, 90·6% (88·5-92·3) in the 60 Gy group, and 85·9% (83·4-88·0) in the 57 Gy group. 60 Gy was non-inferior to 74 Gy (HR 0·84 [90% CI 0·68-1·03], pNI=0·0018) but non-inferiority could not be claimed for 57 Gy compared with 74 Gy (HR 1·20 [0·99-1·46], pNI=0·48). Long-term side-effects were similar in the hypofractionated groups compared with the conventional group. There were no significant differences in either the proportion or cumulative incidence of side-effects 5 years after treatment using three clinician-reported as well as patient-reported outcome measures. The estimated cumulative 5 year incidence of Radiation Therapy Oncology Group (RTOG) grade 2 or worse bowel and bladder adverse events was 13·7% (111 events) and 9·1% (66 events) in the 74 Gy group, 11·9% (105 events) and 11·7% (88 events) in the 60 Gy group, 11·3% (95 events) and 6·6% (57 events) in the 57 Gy group, respectively. No treatment-related deaths were reported. INTERPRETATION: Hypofractionated radiotherapy using 60 Gy in 20 fractions is non-inferior to conventional fractionation using 74 Gy in 37 fractions and is recommended as a new standard of care for external-beam radiotherapy of localised prostate cancer. FUNDING: Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network.
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    Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial
    Wilkins, A ; Mossop, H ; Syndikus, I ; Khoo, V ; Bloomfield, D ; Parker, C ; Logue, J ; Scrase, C ; Patterson, H ; Birtle, A ; Staffurth, J ; Malik, Z ; Panades, M ; Eswar, C ; Graham, J ; Russell, M ; Kirkbride, P ; O'Sullivan, JM ; Gao, A ; Cruickshank, C ; Griffin, C ; Dearnaley, D ; Hall, E (ELSEVIER SCIENCE INC, 2015-12-01)
    BACKGROUND: Patient-reported outcomes (PROs) might detect more toxic effects of radiotherapy than do clinician-reported outcomes. We did a quality of life (QoL) substudy to assess PROs up to 24 months after conventionally fractionated or hypofractionated radiotherapy in the Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer (CHHiP) trial. METHODS: The CHHiP trial is a randomised, non-inferiority phase 3 trial done in 71 centres, of which 57 UK hospitals took part in the QoL substudy. Men with localised prostate cancer who were undergoing radiotherapy were eligible for trial entry if they had histologically confirmed T1b-T3aN0M0 prostate cancer, an estimated risk of seminal vesicle involvement less than 30%, prostate-specific antigen concentration less than 30 ng/mL, and a WHO performance status of 0 or 1. Participants were randomly assigned (1:1:1) to receive a standard fractionation schedule of 74 Gy in 37 fractions or one of two hypofractionated schedules: 60 Gy in 20 fractions or 57 Gy in 19 fractions. Randomisation was done with computer-generated permuted block sizes of six and nine, stratified by centre and National Comprehensive Cancer Network (NCCN) risk group. Treatment allocation was not masked. UCLA Prostate Cancer Index (UCLA-PCI), including Short Form (SF)-36 and Functional Assessment of Cancer Therapy-Prostate (FACT-P), or Expanded Prostate Cancer Index Composite (EPIC) and SF-12 quality-of-life questionnaires were completed at baseline, pre-radiotherapy, 10 weeks post-radiotherapy, and 6, 12, 18, and 24 months post-radiotherapy. The CHHiP trial completed accrual on June 16, 2011, and the QoL substudy was closed to further recruitment on Nov 1, 2009. Analysis was on an intention-to-treat basis. The primary endpoint of the QoL substudy was overall bowel bother and comparisons between fractionation groups were done at 24 months post-radiotherapy. The CHHiP trial is registered with ISRCTN registry, number ISRCTN97182923. FINDINGS: 2100 participants in the CHHiP trial consented to be included in the QoL substudy: 696 assigned to the 74 Gy schedule, 698 assigned to the 60 Gy schedule, and 706 assigned to the 57 Gy schedule. Of these individuals, 1659 (79%) provided data pre-radiotherapy and 1444 (69%) provided data at 24 months after radiotherapy. Median follow-up was 50·0 months (IQR 38·4-64·2) on April 9, 2014, which was the most recent follow-up measurement of all data collected before the QoL data were analysed in September, 2014. Comparison of 74 Gy in 37 fractions, 60 Gy in 20 fractions, and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 (66%), 266 (65%), and 282 (65%) men; very small bother in 92 (22%), 91 (22%), and 93 (21%) men; small bother in 26 (6%), 28 (7%), and 38 (9%) men; moderate bother in 19 (5%), 23 (6%), and 21 (5%) men, and severe bother in four (<1%), three (<1%) and three (<1%) men respectively (74 Gy vs 60 Gy, ptrend=0.64, 74 Gy vs 57 Gy, ptrend=0·59). We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months. INTERPRETATION: The incidence of patient-reported bowel symptoms was low and similar between patients in the 74 Gy control group and the hypofractionated groups up to 24 months after radiotherapy. If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments, these findings will add to the growing evidence for moderately hypofractionated radiotherapy schedules becoming the standard treatment for localised prostate cancer. FUNDING: Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network.
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    Validation of administrative hospital data for identifying incident pancreatic and periampullary cancer cases: a population-based study using linked cancer registry and administrative hospital data in New South Wales, Australia
    Creighton, N ; Walton, R ; Roder, D ; Aranda, S ; Currow, D (BMJ PUBLISHING GROUP, 2016-01-01)
    OBJECTIVES: Informing cancer service delivery with timely and accurate data is essential to cancer control activities and health system monitoring. This study aimed to assess the validity of ascertaining incident cases and resection use for pancreatic and periampullary cancers from linked administrative hospital data, compared with data from a cancer registry (the 'gold standard'). DESIGN, SETTING AND PARTICIPANTS: Analysis of linked statutory population-based cancer registry data and administrative hospital data for adults (aged ≥18 years) with a pancreatic or periampullary cancer case diagnosed during 2005-2009 or a hospital admission for these cancers between 2005 and 2013 in New South Wales, Australia. METHODS: The sensitivity and positive predictive value (PPV) of pancreatic and periampullary cancer case ascertainment from hospital admission data were calculated for the 2005-2009 period through comparison with registry data. We examined the effect of the look-back period to distinguish incident cancer cases from prevalent cancer cases from hospital admission data using 2009 and 2013 as index years. RESULTS: Sensitivity of case ascertainment from the hospital data was 87.5% (4322/4939), with higher sensitivity when the cancer was resected (97.9%, 715/730) and for pancreatic cancers (88.6%, 3733/4211). Sensitivity was lower in regional (83.3%) and remote (85.7%) areas, particularly in areas with interstate outflow of patients for treatment, and for cases notified to the registry by death certificate only (9.6%). The PPV for the identification of incident cases was 82.0% (4322/5272). A 2-year look-back period distinguished the majority (98%) of incident cases from prevalent cases in linked hospital data. CONCLUSIONS: Pancreatic and periampullary cancer cases and resection use can be ascertained from linked hospital admission data with sufficient validity for informing aspects of health service delivery and system-level monitoring. Limited tumour clinical information and variation in case ascertainment across population subgroups are limitations of hospital-derived cancer incidence data when compared with population cancer registries.
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    Knowledge of the signs and symptoms and risk factors of lung cancer in Australia: mixed methods study
    Crane, M ; Scott, N ; O'Hara, BJ ; Aranda, S ; Lafontaine, M ; Stacey, I ; Varlow, M ; Currow, D (BMC, 2016-06-13)
    BACKGROUND: Lung cancer is the leading cause of cancer death in Australia. There is potential that health promotion about the risks and warning signs of lung cancer could be used to reduce delays in symptom presentation when symptoms are first detected. This study investigated knowledge, attitudes and beliefs which might impact help-seeking behaviour and could provide insight into possible public health interventions in New South Wales (NSW). METHODS: A convergent mixed method study design was used wherein data from 16 qualitative focus groups of residents (40+ years), purposefully recruited and stratified by smoking status, age and geography (metropolitan/regional), were compared with a CATI administered population-wide telephone survey (n = 1,000) using the Cancer Research UK cancer awareness measure (LungCAM). Qualitative findings were analysed thematically using NVIVO. Logistic regression analysis was used to investigate predictors of symptom knowledge in STATA. Findings were integrated using triangulation techniques. RESULTS: Across focus groups, haemoptysis was the only symptom creating a sense of medical urgency. Life experiences evoked a 'wait and see' attitude to any health deterioration. Perceived risk was low amongst those at risk with current smokers preferring to deny their risk while former smokers were generally unaware of any ongoing risk. The quantitative sample consisted of females (62 %), 40-65 years (53 %), low SES (53 %), former (46 %) and current smokers (14 %). In quantitative findings, haemoptysis and dyspnoea were the most recognised symptoms across the sample population. Age (<65 years), sex (female) and high socio-economic status contributed to a higher recognition of symptoms. Smoking was recognised as a cause of lung cancer, yet ever-smokers were less likely to recognise the risk of lung cancer due to second-hand smoke (OR 0.7 95 % CI 0.5-0.9). CONCLUSION: While there was some recognition of risk factors and symptoms indicative of lung cancer, there was disparity across the sample population. The qualitative findings also suggest that knowledge may not lead to earlier presentation; a lack of urgency about symptoms considered trivial, and smoking-related barriers such as stigma may also contribute to time delays in presentation. Public health interventions may be required to increase awareness of risk and emphasise the importance of seeking medical attention for ongoing symptoms.
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    Moving on: Transition experiences of young adults with chronic pain
    Higginson, A ; Forgeron, P ; Harrison, D ; Finley, GA ; Dick, BD (TAYLOR & FRANCIS LTD, 2019-01-01)
    Purpose: The purpose of this study was to explore the transition experience of young adults with chronic pain in Canada from the pediatric health care setting to the adult health care setting. Materials and Methods: A qualitative descriptive approach using semistructured interviews was used to capture the transition experiences of young people with chronic pain who have recently transferred from the pediatric setting to the adult health care setting. Participants were recruited from west, central, and the east coast of Canada to situate the findings within the context of Canada. Interviews were transcribed and analyzed using qualitative inductive content analysis. Results: Nine participants were interviewed, three from each part of Canada (west, central, and east). Five common categories were determined to describe the transition experience of young adults with chronic pain which include (1) independence (I can do it, maybe?), (2) pain trajectory (stress and pain along for the ride), (3) social support networks (need a shoulder to lean on), (4) parental support (obviously they are there), and (5) collaborative systems (the bridge). Conclusion: Young people with chronic pain experience unique challenges when faced with transitioning to the adult health care setting. Supporting the young person and his or her family in preparation and readiness and collaboration between the pediatric and adult health care settings are essential to ensure a smooth transition and avoid negative transition outcomes. Further research is needed to determine the best ways to prepare young people for transition and the care activities required in both pediatric and adult health care settings to improve pain-related outcomes posttransition.
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    Moving on: A survey of Canadian nurses' self-reported transition practices for young people with chronic pain
    Higginson, A ; Forgeron, P ; Dick, B ; Harrison, D (TAYLOR & FRANCIS LTD, 2018-01-01)
    BACKGROUND: Practices to support the transition of a young person from the pediatric to the adult health care setting have been examined for many chronic illness populations. However, specific transition practices to support young people with chronic pain have not been examined. AIM: The aim of this study was to describe the current nursing practices used in the pediatric and the adult health care to support transition of young people with chronic pain in Canada. METHODS: An online survey of pediatric and adult chronic pain nurses' self-reported transition practices was conducted. RESULTS: Twenty-two nurses completed the survey, 10 (45.5%) from the pediatric chronic pain setting and 12 (54.4%) from the adult chronic pain setting. Of the pediatric nurses surveyed none reported using a psychometrically valid tool to assess a young person's readiness of general transition skills; however, one reported using a tool to assess understanding of chronic pain. Most health care facilities in which these pediatric nurses worked offered a general transition clinic, but only one of these facilities also had a chronic pain transition clinic. Nurses in both settings perceived that young people experience increased levels of distress during transition yet most did not report using formal transition practices in their care. CONCLUSION: Nursing practices and clinic resources to support the transition of young people with chronic pain may not meet the needs of this population. Practices may benefit from the use of psychometrically validated tools to assess general transition preparedness. Research is needed to adapt tools and determine best transition practices for the chronic pain population.
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    Protocol for a feasibility exploratory multicentre study of factors influencing trauma patients' outcomes of traffic crashes in Saudi Arabia.
    Alharbi, R ; Miller, C ; Lewis, V (BMJ, 2019-10-07)
    INTRODUCTION: Road traffic injury is a leading cause of death for people of all ages. The burden of road traffic injuries is well established in developed countries. However, there has been limited investigation of the incidence and burden of road traffic injury in low/middle-income countries. With a proportionally high number of road users, there is a need to explore the factors in prehospital and hospital care in Saudi Arabia (SA) that are associated with mortality for adult trauma patients following road traffic crashes (RTCs). This paper outlines the method for the planned research. METHODS AND ANALYSIS: A feasibility exploratory multicentre study will be conducted at three purposefully selected hospitals with different trauma care resources in differing geographic locations of SA. The study sample will include all adult trauma patients who are involved in RTCs in SA and have been admitted to a study site in a 3-month period from May to July 2019. Data regarding the characteristics of the crashes and prehospital health care factors will be extracted from hospital databases where it is available. Information will be collected from patients or carers and hospital records in the two sites that do not have a registry. Patient status at 30 days post-injury, particularly mortality, will be assessed through hospital records. The relative contribution of a range of factors to predicting mortality will be explored using logistic regression analysis. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Board Committee at King Saud Medical City (H-01-R-053), the General Department of Research and Studies at the Ministry of Health in SA (1440-1249939) and (1440-1398648), and the La Trobe University Human Research Ethics Committee (HEC19095). The results will be reported in a thesis and in peer-reviewed journal articles and conference presentations.
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    Utilizing lymphatic cell markers to visualize human lymphatic abnormalities
    Lokmic, Z (WILEY-V C H VERLAG GMBH, 2018-08-01)
    In vivo visualization of the human lymphatic system is limited by the mode of delivery of tracing agents, depth of field and size of the area examined, and specificity of the cell markers used to distinguish lymphatic endothelium from the blood vessels and the surrounding tissues. These limitations are particularly problematic when imaging human lymphatic abnormalities. First, limited understanding of the lymphatic disease aetiology exists with respect to genetic causes and phenotypic presentations. Second, the ability of a tracer to reach the entire lymphatic network within the diseased tissue is suboptimal. Third, what is known about the expression of lymphatic endothelial cell (LEC) markers, such as podoplanin, lymphatic vessel endothelial hyaluronan receptor, Drosophila melanogaster homeobox gene prospero-1 and vascular endothelial growth factor receptor-3 in rodent lymphatic vessels and healthy human LECs may not necessarily apply in human lymphatic disease settings. The aim of this review is to highlight challenges in visualizing lymphatic vessels in human lymphatic abnormalities with respect to distribution patterns of the cellular markers currently employed to visualize abnormal human lymphatic vessels in experimental settings. Allowing for these limitations within new diagnostic visualization technologies is likely to improve our ability to image human lymphatic diseases.
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    Behavioural assessment unit improves outcomes for patients with complex psychosocial needs
    Braitberg, G ; Gerdtz, M ; Harding, S ; Pincus, S ; Thompson, M ; Knott, J (WILEY, 2018-06-01)
    OBJECTIVE: We aimed to assess the impact of a new model of care for patients presenting to the ED with acute behavioural disturbance. METHODS: This pre-/post-intervention study involved creating a dedicated, highly resourced six bed unit, the behavioural assessment unit (BAU). Co-located with the ED at the Royal Melbourne Hospital, the unit was designed to fast-track the admission of patients affected by intoxication, mental illness or psychosocial crisis and provide front-loaded interventions. RESULTS: In 12 months from 1 April 2016, 2379 patients were admitted to the BAU. They were compared with a similar cohort of 3047 patients from the entire 2015 ED population. The BAU resulted in a decreased wait to be seen (40 min [interquartile range (IQR): 17-86] vs 68 min [IQR: 24-130], P < 0.001), a decreased wait for a mental health review (117 min [IQR: 49-224] vs 139 min [IQR: 57-262], P = 0.001) and a decreased ED length of stay (180 min [IQR: 101-237] vs 328 min [IQR: 227-534], P < 0.001). Patients admitted to the BAU were less likely to have a security code (349 (14.7%) vs 538 (17.7%), P = 0.003) and less likely to have mechanical restraint (156 episodes (6.6%) vs 275 (9.0%), P < 0.001) or therapeutic sedation (156 episodes (6.6%) vs 250 (8.2%), P < 0.001). CONCLUSION: A unit specifically designed to improve the care of patients requiring prolonged ED care due to mental illness and/or intoxication reduces the time spent in the ED and the use of some restrictive interventions. We recommend this model of care to EDs that care for this complex and challenging group of patients.
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    Hospital in the Home nurses' recognition and response to clinical deterioration.
    Gray, E ; Currey, J ; Considine, J (Wiley, 2018-05)
    AIMS AND OBJECTIVES: To obtain an understanding of how Hospital in the Home (HITH) nurses recognise and respond to clinical deterioration in patients receiving care at home or in their usual place of residence. BACKGROUND: Recognising and responding to clinical deterioration is an international safety priority and a key nursing responsibility. Despite an increase in care delivery in home environments, how HITH nurses recognise and respond to clinical deterioration is not yet fully understood. DESIGN: A prospective, descriptive exploratory design was used. A survey containing questions related to participant characteristics and 10 patient scenarios was used to collect data from 47 nurses employed in the HITH units of three major health services in Melbourne, Australia. The 10 scenarios reflected typical HITH patients and included medical history and clinical assessment findings (respiratory rate, oxygen saturation, heart rate, blood pressure, temperature, conscious state and pain score). RESULTS: The three major findings from this study were that: (i) nurse and patient characteristics influenced HITH nurses' assessment decisions; (ii) the cues used by HITH nurses to recognise clinical deterioration varied according to the clinical context; and (iii) although HITH nurses work in an autonomous role, they engage in collaborative practice when responding to clinical deterioration. CONCLUSION: Hospital in the Home nurses play a fundamental role in patient assessment, and the context in which they recognise and respond to deterioration is markedly different to that of hospital nurses. RELEVANCE TO CLINICAL PRACTICE: The assessment, measurement and interpretation of clinical data are a nursing responsibility that is crucial to early recognition and response to clinical deterioration. The capacity of HITH services to care for increasing numbers of patients in their home environment, and to promptly recognise and respond to clinical deterioration should it occur, is fundamental to safety within the healthcare system. Hospital in the Home nurses are integral to a sustainable healthcare system that is responsive to dynamic changes in public health policies, and meets the healthcare needs of the community.