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INTRODUCTION: Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose-response nature of any identified association, to inform future hypertension management. METHODS AND ANALYSIS: The study will use data from 2 of Australia's largest cohort studies; the Australian Longitudinal Study on Women's Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004-2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used. ETHICS AND DISSEMINATION: Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings. TRIAL REGISTRATION NUMBER: NCT05972785.
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Neoplasias da Mama , Hipertensão , Feminino , Humanos , Bloqueadores dos Canais de Cálcio/efeitos adversos , Neoplasias da Mama/induzido quimicamente , Neoplasias da Mama/tratamento farmacológico , Estudos Retrospectivos , Estudos Longitudinais , Mastectomia , Austrália/epidemiologia , Hipertensão/tratamento farmacológico , Estudos Observacionais como Assunto , Metanálise como AssuntoRESUMO
A hospital-wide point prevalence study investigated frailty and pain in patients with a cancer-related admission. Modifiable factors associated with frailty in people with cancer were determined through logistic regression. Forty-eight patients (19%) with cancer-related admissions were 2.65 times more likely to be frail and 2.12 more likely to have moderate pain. Frailty and pain were highly prevalent among cancer-related admissions, reinforcing the need for frailty screening and importance of pain assessment for patients with cancer.
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Fragilidade , Neoplasias , Humanos , Idoso , Fragilidade/diagnóstico , Fragilidade/epidemiologia , Prevalência , Idoso Fragilizado , Hospitalização , Dor/epidemiologia , Avaliação Geriátrica , Neoplasias/complicações , Neoplasias/epidemiologia , Neoplasias/terapiaRESUMO
BACKGROUND: We investigated differences in cumulative incidence of first distant recurrence (DR) following non-metastatic breast cancer over a time period when new adjuvant therapies became available in Australia. METHODS: We conducted a health record linkage study of females with localized (T1-3N0) or regional (T4 or N+) breast cancer in the New South Wales Cancer Registry in 2001 to 2002 and 2006 to 2007. We linked cancer registry records with administrative records from hospitals, dispensed medicines, radiotherapy services, and death registrations to estimate the 9-year cumulative incidence of DR and describe use of adjuvant treatment. RESULTS: The study included 13,170 women (2001-2002 n = 6,338, 2006-2007 n = 6,832). The 9-year cumulative incidence of DR was 3.6% [95% confidence interval (CI), 2.3%-4.9%] lower for 2006-2007 diagnoses (15.0%) than 2001-2002 (18.6%). Differences in the annual hazard of DR between cohorts were largest in year two. DR incidence declined for localized and regional disease. Decline was largest for ages <40 years (absolute difference, 14.4%; 95% CI, 8.3%-20.6%), whereas their use of adjuvant chemotherapy (2001-2002 49%, 2006-2007 75%) and HER2-targeted therapy (2001-2002 0%, 2006-2007 16%) increased. DR did not decline for ages ≥70 years (absolute difference, 0.9%; 95% CI, -3.6%-1.8%) who had low use of adjuvant chemotherapy and HER2-targeted therapy. CONCLUSIONS: This whole-of-population study suggests that DR incidence declined over time. Decline was largest for younger ages, coinciding with changes to adjuvant breast cancer therapy. IMPACT: Study findings support the need for trials addressing questions relevant to older people and cancer registry surveillance of DR to inform cancer control programs.
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Neoplasias da Mama , Feminino , Humanos , Idoso , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/terapia , Neoplasias da Mama/patologia , Incidência , Austrália/epidemiologia , New South Wales/epidemiologia , Quimioterapia Adjuvante , Recidiva Local de Neoplasia/patologiaRESUMO
AIM: To assess population-level characteristics and post-metastasis survival of people with recurrent metastatic breast cancer (rMBC) during a period when new publicly-subsidised adjuvant and metastatic systemic therapies became available. METHODS: Record linkage study of females in NSW Cancer Registry (NSWCR) diagnosed with non-metastatic breast cancer (BC) in 2001-2002 (C1) and 2006-2007 (C2). We identified first rMBC from NSWCR, administrative hospital records, dispensed medicines and radiotherapy services (2001-2016). We used death registrations to estimate cumulative incidence of BC death. RESULTS: The analysis included 2267 women with rMBC (C1:1210, C2:1057). Compared to C1, C2 had access to adjuvant HER2-targeted therapy and were more likely to have received adjuvant chemotherapy (C1:38%, C2:47%) and aromatase inhibitors (C1:52%, C2:73%, of those dispensed endocrine therapy). Five-year probability of BC death was 65% (95%CI:62-68%) in C1 and 63% (95%CI:60-66%) in C2. Regional disease (T4 or N + ) at initial BC diagnosis (C1:62%, C2:68%), and age ≥ 70 years at first metastasis (C1:27%, C2:31%) were more common in C2 and had poorer prognosis. Five-year probability of BC death was lower in C2 than C1 for treatment-defined HER2-positive BC (C1:72% 95%CI:63-79%; C2:52% 95%CI 45-60%) and those dispensed chemotherapy alone (C1:76% 95%CI:69-82, C2:67% 95%CI:59-74%, p = 0.01), but not treatment-defined hormone receptor-positive HER2-negative BC (C1:60% 95%CI 56-63%, C2:64% 95%CI 60-68%). CONCLUSIONS: Despite less favourable prognostic characteristics in C2, BC-related survival following rMBC was similar between the two cohorts; and improved for women with HER2-positive tumours. These findings support the real-world benefits of newer treatments for rMBC.
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Neoplasias da Mama , Idoso , Feminino , Humanos , Inibidores da Aromatase/uso terapêutico , Austrália/epidemiologia , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Prognóstico , Receptor ErbB-2 , Metástase NeoplásicaRESUMO
OBJECTIVE: To examine the use of CT, emergency department (ED)-presentation and hospitalisation and in 12 months before and after a diagnosis of cancer. DESIGN: Population-based retrospective cohort study. SETTING: West Australian linked administrative records at individual level. PARTICIPANTS: 104 009 adults newly diagnosed with cancer in 2004-2014. MAIN OUTCOME MEASURES: CT use, ED presentations, hospitalisations. RESULTS: As compared with the rates in the 12th month before diagnosis, the rate of CT scans started to increase from 2 months before diagnosis with an increase in both ED presentations and hospitalisation from 1 month before the diagnosis. These rates peaked in the month of diagnosis for CT scans (477 (95% CI 471 to 482) per 1000 patients), and for hospitalisations (910 (95% CI 902 to 919) per 1000 patients), and the month prior to diagnosis for ED (181 (95% CI 178 to 184) per 1000 patients) then rapidly reduced after diagnosis but remained high for the next 12 months. While the patterns of the health services used were similar between 2004 and 2014, the rate of the health services used during after diagnosis was higher in 2014 versus 2004 except for CT use in patients with lymphohaematopoietic cancer with a significant reduction. CONCLUSION: Our results showed an increase in demand for health services from 2 months before diagnosis of cancer. Increasing use of health services during and post cancer diagnosis may warrant further investigation to identify factors driving this change.
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Hospitalização , Neoplasias , Adulto , Humanos , Estudos Retrospectivos , Austrália , Austrália Ocidental/epidemiologia , Serviço Hospitalar de Emergência , Neoplasias/diagnóstico por imagem , Tomografia Computadorizada por Raios XRESUMO
Infant and Young Child Feeding (IYCF) breastfeeding guidelines of the World Health Organization (WHO) have been promoted in Nepal since the early 1990s. This study investigated whether antenatal and perinatal service delivery in Nepal are associated with early initiation of breastfeeding and age-appropriate feeding practice (exclusive breastfeeding to six months; introduction of complementary foods at six months with continued breastfeeding to two years). Data from the 2016 Nepal Demographic and Health Survey (NDHS) were analysed using multivariable logistic regression. The unit of analysis was an interviewed woman and her last-born child aged 0-23 months. We examined number of antenatal visits, place and type of delivery, infant-mother skin-to-skin contact post-delivery, and breastfeeding observation and counselling by a healthcare provider within two days post-delivery. Of 1938 mother-infant dyads, 1073 (55.4%) commenced breastfeeding within one hour of delivery and 1665 (85.9%) were engaged in age-appropriate feeding. Breastfeeding within one hour of delivery was associated with infants delivered vaginally (aOR: 4.76, 95% CI: 2.96-7.65), infant-mother skin-to-skin contact post-delivery (aOR:2.10, 95% CI: 1.63-2.72) and observation of breastfeeding by a healthcare provider within two days post-delivery (aOR: 1.58, 95% CI: 1.20-2.08). Age-appropriate feeding was lowest amongst mothers with infants aged 4-5 months (40.8%) compared to those with infants aged 0-1 month (aOR: 0.158, 95% CI: 0.083-0.302). Antenatal and perinatal service delivery were not significantly associated with age-appropriate feeding. Further promotion of infant-mother skin-to-skin contact post-delivery (including after caesarean delivery) and observation of early breastfeeding may increase the rate of breastfeeding within one hour of delivery. Promotion of exclusive breastfeeding in antenatal and perinatal services and additional postnatal support should be considered to increase exclusive breastfeeding of infants to six months. These improvements may be achieved through enhanced implementation of the Baby Friendly Hospitals Initiative and effective training and sufficient practice for skilled birth attendants.
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Frailty and pain in hospitalised patients are associated with adverse clinical outcomes. However, there is limited data on the associations between frailty and pain in this group of patients. Understanding the prevalence, distribution and interaction of frailty and pain in hospitals will help to determine the magnitude of this association and assist health care professionals to target interventions and develop resources to improve patient outcomes. This study reports the point prevalence concurrence of frailty and pain in adult patients in an acute hospital. A point prevalence, observational study of frailty and pain was conducted. All adult inpatients (excluding high dependency units) at an acute, private, 860-bed metropolitan hospital were eligible to participate. Frailty was assessed using the self-report modified Reported Edmonton Frail Scale. Current pain and worst pain in the last 24 h were self-reported using the standard 0-10 numeric rating scale. Pain scores were categorised by severity (none, mild, moderate, severe). Demographic and clinical information including admitting services (medical, mental health, rehabilitation, surgical) were collected. The STROBE checklist was followed. Data were collected from 251 participants (54.9% of eligible). The prevalence of frailty was 26.7%, prevalence of current pain was 68.1% and prevalence of pain in the last 24 h was 81.3%. After adjusting for age, sex, admitting service and pain severity, admitting services medical (AOR: 13.5 95% CI 5.7-32.8), mental health (AOR: 6.3, 95% CI 1. 9-20.9) and rehabilitation (AOR: 8.1, 95% CI 2.4-37.1) and moderate pain (AOR: 3.9, 95% CI 1. 6-9.8) were associated with increased frailty. The number of older patients identified in this study who were frail has implications for managing this group in a hospital setting. This indicates a need to focus on developing strategies including frailty assessment on admission, and the development of interventions to meet the care needs of these patients. The findings also highlight the need for increased pain assessment, particularly in those who are frail, for more effective pain management.Trial registration: The study was prospectively registered (ACTRN12620000904976; 14th September 2020).
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Fragilidade , Adulto , Humanos , Prevalência , Fragilidade/epidemiologia , Hospitais Privados , Dor/epidemiologia , Manejo da DorRESUMO
INTRODUCTION: In patients with acute ischemic stroke, the location and volume of an irreversible infarct core determine prognosis and treatment. We aimed to determine if automated CT perfusion (CTP) is non-inferior to diffusion-weighted imaging (DWI) or fluid-attenuated inversion recovery (FLAIR) in predicting the acute infarct core. METHODS: In this systematic review and meta-analysis, we searched MEDLINE and EMBASE from 1960 to December 2020. Five outcome measures were examined: volumetric difference, volumetric correlation, sensitivity and specificity at the patient level, Dice coefficient, and sensitivity and specificity at the voxel level. A random-effects meta-analysis was performed for volumetric difference and correlation. RESULTS: From 3,986 studies retrieved, 48 studies met our inclusion criteria with 46 studies on anterior circulation, one study on posterior circulation, and one study on lacunar infarct strokes. In anterior circulation stroke, there were no significant mean volumetric differences between CTP and acute DWI (cerebral blood flow [CBF] 0.52 mL, 95% CI [-0.07, 1.11], I2 0.0%; relative CBF [rCBF] 3.01 mL, 95% CI [-0.46, 6.48], I2 82.6%; relative cerebral blood volume [rCBV] -12.84 mL, 95% CI [-38.56, 12.88], I2 96.2%) and between CTP and delayed DWI or FLAIR (rCBF -1.29 mL, 95% CI [-6.49, 3.92], I2 91.8%; rCBV -5.80 mL, 95% CI [-16.20, 4.60], I2 84.2%). Mean correlation between CTP and acute DWI was 0.90 (95% CI [0.80, 0.95], I2 60.0%) for rCBF and 0.84 (95% CI [0.58, 0.94], I2 93.5%) for rCBV. Mean correlation between CTP and delayed DWI or FLAIR was 0.74 (95% CI [0.57, 0.85], I2 94.6%) for rCBF and 0.90 (95% CI [0.69, 0.97], I2 93.1%) for rCBV. Sensitivity and specificity at the patient level were reported by three studies and Dice coefficient by four studies. Statistical analysis could not be performed for sensitivity and specificity at the voxel level. Limited evidence was available for posterior circulation or lacunar infarct strokes. CONCLUSION: Due to significant heterogeneity and insufficient high-quality studies reporting each outcome, there is insufficient evidence to reliably determine the accuracy of CTP prediction of the infarct core compared to DWI or FLAIR.
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Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral Lacunar , Acidente Vascular Cerebral , Humanos , Tomografia Computadorizada por Raios X/métodos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/terapia , Circulação Cerebrovascular , Perfusão , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/terapia , Imagem de Perfusão/métodosRESUMO
OBJECTIVES: To estimate the long term risk of distant metastases (DM) for women with initial diagnoses of non-metastatic breast cancer; to estimate breast cancer-specific and overall survival for women with DM. DESIGN: Population-based health record linkage study. SETTING, PARTICIPANTS: Women diagnosed with localised or regional primary breast cancer recorded in the NSW Cancer Registry, 2001-2002. MAJOR OUTCOME MEASURES: Time from breast cancer diagnosis to first DM, time from first DM to death from breast cancer. SECONDARY OUTCOME: time to death from any cause. RESULTS: 6338 women were diagnosed with non-metastatic breast cancer (localised, 3885; regional, 2453; median age, 59 years [IQR, 49-69 years]). DM were recorded (to 30 September 2016) for 1432 women (23%; median age, 62 years [IQR, 51-73 years]). The 14-year cumulative DM incidence was 22.2% (95% CI, 21.1-23.2%; localised disease: 14.3% [95% CI, 13.2-15.4%]; regional disease: 34.7% [95% CI, 32.8-36.6%]). Annual hazard of DM was highest during the second year after breast cancer diagnosis (localised disease: 2.8%; 95% CI, 2.3-3.3%; regional disease: 9.1%; 95% CI, 7.8-10.3%); from year five it was about 1% for those with localised disease, from year seven about 2% for women with regional disease at diagnosis. Five years after diagnosis, the 5-year conditional probability of DM was 4.4% (95% CI, 3.7-5.1%) for women with localised and 10.4% (95% CI, 9.1-12.0%) for those with regional disease at diagnosis. Median breast cancer-specific survival from first DM record date was 28 months (95% CI, 25-31 months); the annual hazard of breast cancer death after the first DM record declined from 36% (95% CI, 33-40%) during the first year to 14% (95% CI, 11-18%) during the fourth year since detection. CONCLUSIONS: DM risk declines with time from diagnosis of non-metastatic breast cancer, and the annual risk of dying from breast cancer declines with time from initial DM detection. These findings can be used to inform patients at follow-up about changes in risk over time since diagnosis and for planning health services.
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Neoplasias da Mama , Humanos , Feminino , Pessoa de Meia-Idade , Incidência , Sistema de Registros , Metástase NeoplásicaRESUMO
OBJECTIVE: High use of CT scanning has raised concern due to the potential ionising radiation exposure. This study examined trends of CT during admission to tertiary hospitals and its associations with length of stay (LOS), readmission and mortality. DESIGN: Retrospective observational study from 2003 to 2015. SETTING: West Australian linked administrative records at individual level. PARTICIPANTS: 2 375 787 episodes of tertiary hospital admission in adults aged 18+ years. MAIN OUTCOME MEASURES: LOS, 30-day readmissions and mortality stratified by CT use status (any, multiple (CTs to multiple areas during episode), and repeat (repeated CT to the same area)). METHODS: Multivariable regression models were used to calculate adjusted rate of CT use status. The significance of changes since 2003 in the outcomes (LOS, 30-day readmission and mortality) was compared among patients with specific CT imaging status relative to those without. RESULTS: Between 2003 and 2015, while the rate of CT increased 3.4% annually, the rate of repeat CTs significantly decreased -1.8% annually and multiple CT showed no change. Compared with 2003 while LOS had a greater decrease in those with any CT, 30-day readmissions had a greater increase among those with any CT, while the probability of mortality remained unchanged between the any CT/no CT groups. A similar result was observed in patients with multiple and repeat CT scanning, except for a significant increase in mortality in the recent years in the repeat CT group. CONCLUSION: The observed pattern of increase in CT utilisation is likely to be activity-based funding policy-driven based on the discordance between LOS and readmissions. Meanwhile, the repeat CT reduction aligns with a more selective strategy of use based on clinical severity. Future research should incorporate in-hospital and out-of-hospital CT to better understand overall CT trends and potential shifts between settings over time.
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Readmissão do Paciente , Tomografia Computadorizada por Raios X , Adulto , Austrália , Mortalidade Hospitalar , Humanos , Tempo de Internação , Centros de Atenção Terciária , Austrália Ocidental/epidemiologiaRESUMO
INTRODUCTION: Hospitalised older adults are prone to functional deterioration, which is more evident in frail older patients and can be further exacerbated by pain. Two interventions that have the potential to prevent progression of frailty and improve patient outcomes in hospitalised older adults but have yet to be subject to clinical trials are nurse-led volunteer support and technology-driven assessment of pain. METHODS AND ANALYSIS: This single-centre, prospective, non-blinded, cluster randomised controlled trial will compare the efficacy of nurse-led volunteer support, technology-driven pain assessment and the combination of the two interventions to usual care for hospitalised older adults. Prior to commencing recruitment, the intervention and control conditions will be randomised across four wards. Recruitment will continue for 12 months. Data will be collected on admission, at discharge and at 30 days post discharge, with additional data collected during hospitalisation comprising records of pain assessment and volunteer support activity. The primary outcome of this study will be the change in frailty between both admission and discharge, and admission and 30 days, and secondary outcomes include length of stay, adverse events, discharge destination, quality of life, depression, cognitive function, functional independence, pain scores, pain management intervention (type and frequency) and unplanned 30-day readmissions. Stakeholder evaluation and an economic analysis of the interventions will also be conducted. ETHICS AND DISSEMINATION: Ethical approval has been granted by Human Research Ethics Committees at Ramsay Health Care WA|SA (number: 2057) and Edith Cowan University (number: 2021-02210-SAUNDERS). The findings will be disseminated through conference presentations, peer-reviewed publications and social media. TRIAL REGISTRATION NUMBER: ACTRN12620001173987.
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Fragilidade , Alta do Paciente , Assistência ao Convalescente , Idoso , Humanos , Papel do Profissional de Enfermagem , Dor , Medição da Dor , Estudos Prospectivos , Qualidade de Vida/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Tecnologia , VoluntáriosRESUMO
OBJECTIVES: The top causes of adolescents' mortality in Australia and worldwide are mostly preventable and many stem from psychosocial difficulties. The HEEADSSS screening is a widely accepted screening tool in assessing young people's psychosocial wellbeing. This retrospective audit was done to evaluate the service implementation of an electronic-HEEADSSS (e-HEEADSSS) screening system in a regional hospital's paediatric in-patient setting in Western Australia. The aim is to examine and compare the uptake rate of conventional HEEADSSS screening in 2018 and e-HEEADSSS screening in 2019, and to examine the relevant outcome and disclosure rate by the young person. METHODS: This retrospective audit (pre-post cross sectional study) is reported using the STROBE guideline. It was done over two different time frames: Pre e-HEEADSSS implementation (September-December 2018) and Post e-HEEADSSS implementation (September-December 2019). Inclusion criteria includes: All paediatric inpatients aged 12-16 years old. Exclusion criteria includes: Admission under other disciplines or clinically unstable/unsuitable patients. The uptake rate of conventional-HEEADSSS (2018) in comparison to e-HEEADSSS screening (2019) was examined. Other relevant data was extracted and analysed. RESULTS: The sample size pre-implementation was 26 while post-implementation was 24. The uptake rate increased from 12% (conventional-HEEADSSS) to 54% (e-HEEADSSS), a 450% increment with the e-HEEADSSS system implementation (Fisher Exact Test, p=0.005). More than half of young people who completed their e-HEEADSSS screening had concerns/flags which required management by the clinicians. 86% of patients in the e-HEEADSSS group with concerns/flags were acted appropriately by the treating clinicians prior to discharge. The overall disclosure rate of e-HEEADSSS was 93% with highest disclosure rate for 'Drugs' domain. CONCLUSIONS: There is significant increase in uptake rate with high disclosure rate using e-HEEADSSS screening device when compared to conventional HEEADSSS screening in the paediatric in-patient setting. The e-HEEADSSS is a better screening tool for in-patient setting and should be implemented widely.
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OBJECTIVES: While CT scanning plays a significant role in healthcare, its increasing use has raised concerns about inappropriate use. This study investigated factors driving the changing use of CT among people admitted to tertiary hospitals in Western Australia (WA). DESIGN AND SETTING: A repeated cross-sectional study of CT use in WA in 2003-2005 and 2013-2015 using linked administrative heath data at the individual patient level. PARTICIPANTS: A total of 2 375 787 tertiary hospital admissions of people aged 18 years or older. MAIN OUTCOME MEASURE: Rate of CT scanning per 1000 hospital admissions. METHODS: A multivariable decomposition model was used to quantify the contribution of changes in patient characteristics and changes in the probability of having a CT over the study period. RESULTS: The rate of CT scanning increased by 112 CT scans per 1000 admissions over the study period. Changes in the distribution of the observed patient characteristics were accounted for 62.7% of the growth in CT use. However, among unplanned admissions, changes in the distribution of patient characteristics only explained 17% of the growth in CT use, the remainder being explained by changes in the probability of having a CT scan. While the relative probability of having a CT scan generally increased over time across most observed characteristics, it reduced in young adults (-2.8%), people living in the rural/remote areas (-0.8%) and people transferred from secondary hospitals (-0.8%). CONCLUSIONS: Our study highlights potential improvements in practice towards reducing medical radiation exposure in certain high risk population. Since changes in the relative probability of having a CT scan (representing changes in scope) rather than changes in the distribution of the patient characteristics (representing changes in need) explained a major proportion of the growth in CT use, this warrants more in-depth investigations in clinical practices to better inform health policies promoting appropriate use of diagnostic imaging tests.
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Exposição à Radiação , Tomografia Computadorizada por Raios X , Estudos Transversais , Humanos , Centros de Atenção Terciária , Austrália Ocidental/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane Review. OBJECTIVES: To assess the effects of all commercially available botulinum toxin type A products for the treatment of any type of facial wrinkles. SEARCH METHODS: We searched the following databases up to May 2020: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs). SELECTION CRITERIA: We included RCTs with over 50 participants, comparing BontA versus placebo, other types of BontA, or fillers (hyaluronic acid), for treating facial wrinkles in adults. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Primary outcomes were participant assessment of success and major adverse events (AEs) (eyelid ptosis, eyelid sensory disorder, strabismus). Secondary outcomes included physician assessment of success; proportion of participants with at least one AE and duration of treatment effect. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 65 RCTs, involving 14,919 randomised participants. Most participants were female, aged 18 to 65 years. All participants were outpatients (private office or day clinic). Study duration was between one week and one year. No studies were assessed as low risk of bias in all domains; the overall risk of bias was unclear for most studies. The most common comparator was placebo (36 studies). An active control was used in 19 studies. There were eight dose-ranging studies of onabotulinumtoxinA, and a small number of studies compared against fillers. Treatment was given in one cycle (54 studies), two cycles (three studies), or three or more cycles (eight studies). The treated regions were glabella (43 studies), crow's feet (seven studies), forehead (two studies), perioral (two studies), full face (one study), or more than two regions (nine studies). Most studies analysed moderate to severe wrinkles; mean duration of treatment was 20 weeks. The following results summarise the main comparisons, based on studies of one treatment cycle for the glabella. AEs were collected over the duration of these studies (over four to 24 weeks). Compared to placebo, onabotulinumtoxinA-20 U probably has a higher success rate when assessed by participants (risk ratio (RR) 19.45, 95% confidence interval (CI) 8.60 to 43.99; 575 participants; 4 studies; moderate-certainty evidence) or physicians (RR 17.10, 95% CI 10.07 to 29.05; 1339 participants; 7 studies; moderate-certainty evidence) at week four. Major AEs are probably higher with onabotulinumtoxinA-20 U (Peto OR 3.62, 95% CI 1.50 to 8.74; 1390 participants; 8 studies; moderate-certainty evidence), but there may be no difference in any AEs (RR 1.14, 95% CI 0.89 to 1.45; 1388 participants; 8 studies; low-certainty evidence). Compared to placebo, abobotulinumtoxinA-50 U has a higher participant-assessed success rate at week four (RR 21.22, 95% CI 7.40 to 60.56; 915 participants; 6 studies; high-certainty evidence); and probably has a higher physician-assessed success rate (RR 14.93, 95% CI 8.09 to 27.55; 1059 participants; 7 studies; moderate-certainty evidence). There are probably more major AEs with abobotulinumtoxinA-50 U (Peto OR 3.36, 95% CI 0.88 to 12.87; 1294 participants; 7 studies; moderate-certainty evidence). Any AE may be more common with abobotulinumtoxinA-50 U (RR 1.25, 95% CI 1.05 to 1.49; 1471 participants; 8 studies; low-certainty evidence). Compared to placebo, incobotulinumtoxinA-20 U probably has a higher participant-assessed success rate at week four (RR 66.57, 95% CI 13.50 to 328.28; 547 participants; 2 studies; moderate-certainty evidence), and physician-assessed success rate (RR 134.62, 95% CI 19.05 to 951.45; 547 participants; 2 studies; moderate-certainty evidence). Major AEs were not observed (547 participants; 2 studies; moderate-certainty evidence). There may be no difference between groups in any AEs (RR 1.17, 95% CI 0.90 to 1.53; 547 participants; 2 studies; low-certainty evidence). AbobotulinumtoxinA-50 U is no different to onabotulinumtoxinA-20 U in participant-assessed success rate (RR 1.00, 95% CI 0.92 to 1.08, 388 participants, 1 study, high-certainty evidence) and physician-assessed success rate (RR 1.01, 95% CI 0.95 to 1.06; 388 participants; 1 study; high-certainty evidence) at week four. Major AEs are probably more likely in the abobotulinumtoxinA-50 U group than the onabotulinumtoxinA-20 U group (Peto OR 2.65, 95% CI 0.77 to 9.09; 433 participants; 1 study; moderate-certainty evidence). There is probably no difference in any AE (RR 1.02, 95% CI 0.67 to 1.54; 492 participants; 2 studies; moderate-certainty evidence). IncobotulinumtoxinA-24 U may be no different to onabotulinumtoxinA-24 U in physician-assessed success rate at week four (RR 1.01, 95% CI 0.96 to 1.05; 381 participants; 1 study; low-certainty evidence) (participant assessment was not measured). One participant reported ptosis with onabotulinumtoxinA, but we are uncertain of the risk of AEs (Peto OR 0.02, 95% CI 0.00 to 1.77; 381 participants; 1 study; very low-certainty evidence). Compared to placebo, daxibotulinumtoxinA-40 U probably has a higher participant-assessed success rate (RR 21.10, 95% CI 11.31 to 39.34; 683 participants; 2 studies; moderate-certainty evidence) and physician-assessed success rate (RR 23.40, 95% CI 12.56 to 43.61; 683 participants; 2 studies; moderate-certainty evidence) at week four. Major AEs were not observed (716 participants; 2 studies; moderate-certainty evidence). There may be an increase in any AE with daxibotulinumtoxinA compared to placebo (RR 2.23, 95% CI 1.46 to 3.40; 716 participants; 2 studies; moderate-certainty evidence). Major AEs reported were mainly ptosis; BontA is also known to carry a risk of strabismus or eyelid sensory disorders. AUTHORS' CONCLUSIONS: BontA treatment reduces wrinkles within four weeks of treatment, but probably increases risk of ptosis. We found several heterogeneous studies (different types or doses of BontA, number of cycles, and different facial regions) hindering meta-analyses. The certainty of the evidence for effectiveness outcomes was high, low or moderate; for AEs, very low to moderate. Future RCTs should compare the most common BontA (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, daxibotulinumtoxinA, prabotulinumtoxinA) and evaluate long-term outcomes. There is a lack of evidence about the effects of multiple cycles of BontA, frequency of major AEs, duration of effect, efficacy of recently-approved BontA and comparisons with other treatments.
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Toxinas Botulínicas Tipo A/uso terapêutico , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Viés , Toxinas Botulínicas Tipo A/efeitos adversos , Preenchedores Dérmicos/uso terapêutico , Face , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: There are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers' health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers' health-related quality of life (HRQOL) after care recipients' hospital discharge. METHODS AND ANALYSIS: A multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient's discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30-45 min telephone support sessions over 6 months. The primary outcome is caregivers' HRQOL measured using the Assessment of Quality of Life-eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements. ETHICS AND DISSEMINATION: Participants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: ACTRN12620000060943.
Assuntos
Cuidadores , Alta do Paciente , Idoso , Humanos , Austrália , Hospitais , Estudos Multicêntricos como Assunto , Qualidade de Vida , Queensland , Ensaios Clínicos Controlados Aleatórios como Assunto , Austrália OcidentalRESUMO
BACKGROUND: Sepsis is a major cause of mortality and morbidity in neonates. With the improvement in health care standards, the incidence of neonatal Early Onset Sepsis (EOS) has reduced significantly. A recent Web-based EOS-calculator has been introduced with the aim to reduce the use of IV antibiotics in neonates. The role of the EOS-calculator has yet to be ascertained in this regional Special Care Nursery (SCN) in Western Australia. This study aims at examining the local incidence of culture proven EOS and the role of the EOS calculator. METHOD: It is a retrospective study examining all newborns ≥35 weeks gestation throughout 2019 (Jan-Dec 2019) who received IV-antibiotics. The local incidence of culture-proven EOS was established and applied onto the EOS calculator. The recommended management by the EOS-calculator was cross-examined with the local EOS guideline. Overall proportion of reduction in IV antibiotics use was formulated. Other relevant laboratory data extracted was analysed with Pearson's correlation test with the EOS scores. RESULTS: Total included sample was n = 252 with an annual birth of 1880s indicating 13.4% of all neonates born throughout year 2019 was treated with IV antibiotics. The local incidence of culture-proven EOS was 0.5/1000. By applying the EOS-calculator, a significant reduction of IV antibiotics usage from 13.4% to 3.9% (z value 10.4, p < 0.0001) could be achieved in this cohort. Sixty three percent of neonates who received IV antibiotics in this cohort were classified as 'clinically well' based on the EOS-calculator. CONCLUSION: The EOS-calculator could reduce the use of IV antibiotics in the neonatal population significantly in this regional SCN (from 13.4% to 3.9%). Judicial use of IV antibiotics is imperative as part of the holistic care for the neonates. Implementation of the EOS-calculator must be done strategically considering the local incidence of EOS and other health care policies.
Assuntos
Sepse Neonatal , Sepse , Antibacterianos/uso terapêutico , Humanos , Recém-Nascido , Sepse Neonatal/tratamento farmacológico , Sepse Neonatal/epidemiologia , Estudos Retrospectivos , Medição de Risco , Sepse/tratamento farmacológicoRESUMO
BACKGROUND: Retrospective analyses suggest that capecitabine may carry superior activity in hormone receptor-positive relative to hormone receptor-negative metastatic breast cancer. This review examined the veracity of that finding and explored whether this differential activity extends to early breast cancer. OBJECTIVES: To assess effects of chemotherapy regimens containing capecitabine compared with regimens not containing capecitabine for women with hormone receptor-positive versus hormone receptor-negative breast cancer across the three major treatment scenarios: neoadjuvant, adjuvant, metastatic. SEARCH METHODS: On 4 June 2019, we searched the Cochrane Breast Cancer Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5) in the Cochrane Library; MEDLINE; Embase; the World Health Organization International Clinical Trials Registry Platform; and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials looking at chemotherapy regimens containing capecitabine alone or in combination with other agents versus a control or similar regimen without capecitabine for treatment of breast cancer at any stage. The primary outcome measure for metastatic and adjuvant trials was overall survival (OS), and for neoadjuvant studies pathological complete response (pCR). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. Hazard ratios (HRs) were derived for time-to-event outcomes, and odds ratios (ORs) for dichotomous outcomes, and meta-analysis was performed using a fixed-effect model. MAIN RESULTS: We included 26 studies with outcome data by hormone receptor: 12 metastatic studies (n = 4325), 6 neoadjuvant trials (n = 3152), and 8 adjuvant studies (n = 13,457). Capecitabine treatment was added in several different ways across studies. These could be classified as capecitabine alone compared to another treatment, capecitabine substituted for part of the control chemotherapy, and capecitabine added to control chemotherapy. In the metastatic setting, the effect of capecitabine was heterogenous between hormone receptor-positive and -negative tumours. For OS, no difference between capecitabine-containing and non-capecitabine-containing regimens was observed for all participants taken together (HR 1.01, 95% confidence interval (CI) 0.98 to 1.05; 12 studies, 4325 participants; high-certainty evidence), for those with hormone receptor-positive disease (HR 0.93, 95% CI 0.84 to 1.04; 7 studies, 1834 participants; high-certainty evidence), and for those with hormone receptor-negative disease (HR 1.00, 95% CI 0.88 to 1.13; 8 studies, 1577 participants; high-certainty evidence). For progression-free survival (PFS), a small improvement was seen for all people (HR 0.89, 95% CI 0.82 to 0.96; 12 studies, 4325 participants; moderate-certainty evidence). This was largely accounted for by a moderate improvement in PFS for inclusion of capecitabine in hormone receptor-positive cancers (HR 0.82, 95% CI 0.73 to 0.91; 7 studies, 1594 participants; moderate-certainty evidence) compared to no difference in PFS for hormone receptor-negative cancers (HR 0.96, 95% CI 0.83 to 1.10; 7 studies, 1122 participants; moderate-certainty evidence). Quality of life was assessed in five studies; in general there did not seem to be differences in global health scores between the two treatment groups at around two years' follow-up. Neoadjuvant studies were highly variable in design, having been undertaken to test various experimental regimens using pathological complete response (pCR) as a surrogate for disease-free survival (DFS) and OS. Across all patients, capecitabine-containing regimens resulted in little difference in pCR in comparison to non-capecitabine-containing regimens (odds ratio (OR) 1.12, 95% CI 0.94 to 1.33; 6 studies, 3152 participants; high-certainty evidence). By subtype, no difference in pCR was observed for either hormone receptor-positive (OR 1.22, 95% CI 0.76 to 1.95; 4 studies, 964 participants; moderate-certainty evidence) or hormone receptor-negative tumours (OR 1.28, 95% CI 0.61 to 2.66; 4 studies, 646 participants; moderate-certainty evidence). Four studies with 2460 people reported longer-term outcomes: these investigators detected no difference in either DFS (HR 1.02, 95% CI 0.86 to 1.21; high-certainty evidence) or OS (HR 0.97, 95% CI 0.77 to 1.23; high-certainty evidence). In the adjuvant setting, a modest improvement in OS was observed across all participants (HR 0.89, 95% CI 0.81 to 0.98; 8 studies, 13,547 participants; moderate-certainty evidence), and no difference in OS was seen in hormone receptor-positive cancers (HR 0.86, 95% CI 0.68 to 1.09; 3 studies, 3683 participants), whereas OS improved in hormone receptor-negative cancers (HR 0.72, 95% CI 0.59 to 0.89; 5 studies, 3432 participants). No difference in DFS or relapse-free survival (RFS) was observed across all participants (HR 0.93, 95% CI 0.86 to 1.01; 8 studies, 13,457 participants; moderate-certainty evidence). As was observed for OS, no difference in DFS/RFS was seen in hormone receptor-positive cancers (HR 1.03, 95% CI 0.91 to 1.17; 5 studies, 5604 participants; moderate-certainty evidence), and improvements in DFS/RFS with inclusion of capecitabine were observed for hormone receptor-negative cancers (HR 0.74, 95% CI 0.64 to 0.86; 7 studies, 3307 participants; moderate-certainty evidence). Adverse effects were reported across all three scenarios. When grade 3 or 4 febrile neutropenia was considered, no difference was seen for capecitabine compared to non-capecitabine regimens in neoadjuvant studies (OR 1.31, 95% CI 0.97 to 1.77; 4 studies, 2890 participants; moderate-certainty evidence), and a marked reduction was seen for capecitabine in adjuvant studies (OR 0.55, 95% CI 0.47 to 0.64; 5 studies, 8086 participants; moderate-certainty evidence). There was an increase in diarrhoea and hand-foot syndrome in neoadjuvant (diarrhoea: OR 1.95, 95% CI 1.32 to 2.89; 3 studies, 2686 participants; hand-foot syndrome: OR 6.77, 95% CI 4.89 to 9.38; 5 studies, 3021 participants; both moderate-certainty evidence) and adjuvant trials (diarrhoea: OR 2.46, 95% CI 2.01 to 3.01; hand-foot syndrome: OR 13.60, 95% CI 10.65 to 17.37; 8 studies, 11,207 participants; moderate-certainty evidence for both outcomes). AUTHORS' CONCLUSIONS: In summary, a moderate PFS benefit by including capecitabine was seen only in hormone receptor-positive cancers in metastatic studies. No benefit of capecitabine for pCR was noted overall or in hormone receptor subgroups when included in neoadjuvant therapy. In contrast, the addition of capecitabine in the adjuvant setting led to improved outcomes for OS and DFS in hormone receptor-negative cancer. Future studies should stratify by hormone receptor and triple-negative breast cancer (TNBC) status to clarify the differential effects of capecitabine in these subgroups across all treatment scenarios, to optimally guide capecitabine inclusion.
Assuntos
Antimetabólitos Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Capecitabina/uso terapêutico , Antimetabólitos Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Viés , Neoplasias da Mama/química , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Capecitabina/efeitos adversos , Quimioterapia Adjuvante , Intervalo Livre de Doença , Feminino , Humanos , Terapia Neoadjuvante , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias de Mama Triplo Negativas/tratamento farmacológicoRESUMO
OBJECTIVES: The study objective was to assess whether moderate-to-vigorous intensity physical activity (MVPA) change in cancer survivors (nâ¯=â¯68, mean ageâ¯=â¯64â¯years) was maintained 12-weeks following the Wearable Activity Technology and Action Planning (WATAAP) intervention. Secondary aims were to assess the effects of the intervention on blood pressure (BP) and body mass index (BMI), and to explore group differences between baseline and 24-weeks. DESIGN: Randomized controlled trial. METHODS: MVPA and sedentary behaviour were assessed using an accelerometer at baseline, the end of the intervention (12-weeks), and at 24-weeks. Generalised linear mixed models with random effects were used to examine between-group and within-group changes in MVPA, sedentary behaviour, BP and BMI. RESULTS: MVPA was significantly higher in the intervention group compared with the control group at 24-weeks following adjustment for known confounders (141.4â¯min/wk. (95% CIâ¯=â¯9.1 to 273.8), pâ¯=â¯0.036). At 24-weeks participants in the intervention group had maintained their increased levels of MVPA (change from 12-weeksâ¯=â¯8.8â¯min/wk.; 95% CIâ¯=â¯-43 to 61; pâ¯=â¯0.74). The reduction in MVPA in the control group over the first 12-weeks was also maintained at 24-weeks (5.4â¯min/wk.; 95% CIâ¯=â¯-3.6 to 4.6; pâ¯=â¯0.80). Secondary outcomes did not differ between groups at 24-weeks. CONCLUSIONS: Our results suggest distance-based interventions using wearable technology produce increases in MVPA that endure at least 12-weeks after the intervention is completed.
Assuntos
Pressão Sanguínea/fisiologia , Índice de Massa Corporal , Sobreviventes de Câncer , Exercício Físico/fisiologia , Comportamento Sedentário , Dispositivos Eletrônicos Vestíveis , Actigrafia/instrumentação , Idoso , Intervalos de Confiança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores Socioeconômicos , Fatores de Tempo , Austrália OcidentalRESUMO
OBJECTIVE: To retrospectively assess a cohort of mothers for characteristics of injuries that they have suffered as a result of family and domestic violence (FDV) and which have required admission to a hospital during both the intrapartum and postpartum periods. DESIGN AND SETTING: Retrospective, whole-population linked data study of FDV in Western Australia using the Western Australia birth registry from 1990 to 2009 and Hospital Morbidity Data System records from 1970 to 2013. MAIN OUTCOME MEASURES: Number of hospitalisations, and mode, location and type of injuries recorded, with particular focus on the head and neck area. RESULTS: There were 11 546 hospitalisations for mothers due to FDV. 8193 hospitalisations recorded an injury code to the head and/or neck region. The upper and middle thirds of the face and scalp were areas most likely to receive superficial injuries (58.7% or 4158 admissions), followed by the mouth and oral cavity (9.7% or 687 admissions). Fracture to the mandible accounted for 479 (4.2%) admissions and was almost equal to the sum of the next three most common facial fractures (nasal, maxillary and orbital floor). Mothers more likely to be hospitalised due to a head injury from FDV included those with more than one child (OR=1.17, 95% CI 1.03 to 1.30) and those with infants (<1 year old) (OR=1.40, 95% CI 1.04 to 1.90) and young children (<7 years old) (OR=1.15, 95% CI 1.01 to 1.30). CONCLUSIONS: FDV is a serious and ongoing problem and front-line clinicians are in need of evidence-based guidelines to recognise and assist victims of FDV. Mothers with children in their care are a particularly vulnerable group.
Assuntos
Violência Doméstica , Mães , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Estudos Retrospectivos , Web Semântica , Austrália Ocidental/epidemiologiaRESUMO
OBJECTIVE: To study effectiveness and safety of cuffed versus uncuffed endotracheal tubes (ETTs) in small infants in the intensive care unit (ICU). DESIGN: Pilot RCT. SETTING: Neonatal and paediatric ICUs of children's hospital in Western Australia. PARTICIPANTS: Seventy-six infants ≥35 weeks gestation and infants <3 months of age, ≥3 kg. INTERVENTIONS: Patients randomly assigned to Microcuff cuffed or Portex uncuffed ETT. MAIN OUTCOMES MEASURES: Primary outcome was achievement of optimal ETT leak in target range (10%-20%). Secondary outcomes included: reintubations, ventilatory parameters, ventilatory complications, postextubation complications and long-term follow-up. RESULTS: Success rate (achievement of mean leak in the range 10%-20%) was 13/42 (30.9%) in the cuffed ETT group and 6/34 (17.6%) in uncuffed ETT group (OR=2.09; 95% CI (0.71 to 6.08); p=0.28). Mean percentage time within target leak range in cuffed ETT group 28% (IQR: 9-42) versus 15% (IQR: 0-28) in uncuffed ETT group (p=0.01). There were less reintubations to optimise size in cuffed ETT group 0/40 versus 10/36 (p<0.001). No differences were found in gaseous exchange, ventilator parameters or postextubation complications. There were fewer episodes of atelectasis in cuffed ETT group 0/42 versus 4/34 (p=0.03). No patient had been diagnosed with subglottic stenosis at long-term follow-up. CONCLUSIONS: There was no difference in the primary outcome, though percentage time spent in optimal leak range was significantly higher in cuffed ETT group. Cuffed ETTs reduced reintubations to optimise ETT size and episodes of atelectasis. Cuffed ETTs may be a feasible alternative to uncuffed ETTs in this group of patients. TRIAL REGISTRATION NUMBER: ACTRN12615000081516.