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1.
Hepatology ; 2024 Mar 27.
Artículo en Inglés | MEDLINE | ID: mdl-38825975

RESUMEN

BACKGROUND AND AIMS: Improving the care of decompensated cirrhosis is a significant clinical challenge. The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA). The secondary aims were to assess model effects on quality-of-care and patient-reported outcomes. APPROACH AND RESULTS: The study design was a 2-year, multicenter, randomized controlled study with 1:1 allocation of a CDM model versus usual care. The study setting involved both tertiary and community care. Participants were randomly allocated following a decompensated cirrhosis admission. The intervention was a multifaceted CDM model coordinated by a liver nurse. A total of 147 participants (intervention=75, control=71) were recruited with a median Model for End-Stage Liver Disease score of 19. For the primary outcome, there was no difference in the overall LREA rate for the intervention group versus the control group (incident rate ratio 0.89; 95% CI: 0.53-1.50, p=0.666) or in actuarial survival (HR=1.14; 95% CI: 0.66-1.96, p=0.646). However, there was a reduced risk of LREA due to encephalopathy in the intervention versus control group (HR=1.87; 95% CI: 1.18-2.96, p=0.007). Significant improvement in quality-of-care measures was seen for the performance of bone density (p<0.001), vitamin D testing (p<0.001), and HCC surveillance adherence (p=0.050). For assessable participants (44/74 intervention, 32/71 controls) significant improvements in patient-reported outcomes at 3 months were seen in self-management ability and quality of life as assessed by visual analog scale (p=0.044). CONCLUSIONS: This CDM intervention did not reduce overall LREA events and may not be effective in decompensated cirrhosis for this end point.

2.
Arterioscler Thromb Vasc Biol ; 44(2): e54-e64, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38095109

RESUMEN

BACKGROUND: Abdominal aortic calcification (AAC), a marker of vascular disease, is associated with disease in other vascular beds including gastrointestinal arteries. We investigated whether AAC is related to rapid weight loss over 5 years and whether rapid weight loss is associated with 9.5-year all-cause mortality in community-dwelling older women. METHODS: Lateral spine images from dual-energy x-ray absorptiometry (1998/1999) were used to assess AAC (24-point AAC scoring method) in 929 older women. Over 5 years, body weight was assessed at 12-month intervals. Rapid weight loss was defined as >5% decrease in body weight within any 12-month interval. Multivariable-adjusted logistic regression was used to assess AAC and rapid weight loss and Cox regression to assess the relationship between rapid weight loss and 9.5-year all-cause mortality. RESULTS: Mean±SD age of women was 75.0±2.6 years. During the initial 5 years, 366 (39%) women presented with rapid weight loss. Compared with women with low AAC (24-point AAC score 0-1), those with moderate (24-point AAC score 2-5: odds ratio, 1.36 [95% CI, 1.00-1.85]) and extensive (24-point AAC score 6+: odds ratio, 1.59 [95% CI, 1.10-2.31]) AAC had higher odds for presenting with rapid weight loss. Results remained similar after further adjustment for dietary factors (alcohol, protein, fat, and carbohydrates), diet quality, blood pressure, and cholesterol measures. The estimates were similar in subgroups of women who met protein intake (n=599) and physical activity (n=735) recommendations (extensive AAC: odds ratios, 1.81 [95% CI, 1.12-2.92] and 1.58 [95% CI, 1.02-2.44], respectively). Rapid weight loss was associated with all-cause mortality over the next 9.5 years (hazard ratio, 1.49 [95% CI, 1.17-1.89]; P=0.001). CONCLUSIONS: AAC extent was associated with greater risk for rapid weight loss over 5 years in older women, a risk for all-cause mortality. Since the association was unchanged after taking nutritional intakes into account, these data support the possibility that vascular disease may play a role in the maintenance of body weight.


Asunto(s)
Enfermedades de la Aorta , Calcificación Vascular , Enfermedades Vasculares , Humanos , Femenino , Anciano , Masculino , Factores de Riesgo , Estudios Longitudinales , Calcificación Vascular/etiología , Envejecimiento , Peso Corporal , Pérdida de Peso , Aorta Abdominal/diagnóstico por imagen , Enfermedades de la Aorta/etiología
3.
BMC Cancer ; 24(1): 813, 2024 Jul 08.
Artículo en Inglés | MEDLINE | ID: mdl-38973009

RESUMEN

BACKGROUND: Therapeutic options for early-stage hepatocellular carcinoma (HCC) in individual patients can be limited by tumor and location, liver dysfunction and comorbidities. Many patients with early-stage HCC do not receive curative-intent therapies. Stereotactic ablative body radiotherapy (SABR) has emerged as an effective, non-invasive HCC treatment option, however, randomized evidence for SABR in the first line setting is lacking. METHODS: Trans-Tasman Radiation Oncology Group (TROG) 21.07 SOCRATES-HCC is a phase II, prospective, randomised trial comparing SABR to other current standard of care therapies for patients with a solitary HCC ≤ 8 cm, ineligible for surgical resection or transplantation. The study is divided into 2 cohorts. Cohort 1 will compromise 118 patients with tumors ≤ 3 cm eligible for thermal ablation randomly assigned (1:1 ratio) to thermal ablation or SABR. Cohort 2 will comprise 100 patients with tumors > 3 cm up to 8 cm in size, or tumors ≤ 3 cm ineligible for thermal ablation, randomly assigned (1:1 ratio) to SABR or best other standard of care therapy including transarterial therapies. The primary objective is to determine whether SABR results in superior freedom from local progression (FFLP) at 2 years compared to thermal ablation in cohort 1 and compared to best standard of care therapy in cohort 2. Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses. DISCUSSION: The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC. It is a broad, multicentre collaboration between hepatology, interventional radiology and radiation oncology groups around Australia, coordinated by TROG Cancer Research. TRIAL REGISTRATION: anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.


Asunto(s)
Carcinoma Hepatocelular , Neoplasias Hepáticas , Radiocirugia , Nivel de Atención , Humanos , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/radioterapia , Neoplasias Hepáticas/cirugía , Carcinoma Hepatocelular/terapia , Carcinoma Hepatocelular/patología , Carcinoma Hepatocelular/radioterapia , Carcinoma Hepatocelular/cirugía , Radiocirugia/métodos , Estudios Prospectivos , Masculino , Femenino , Estadificación de Neoplasias , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Anciano , Adulto
4.
J Infect Dis ; 2023 Dec 29.
Artículo en Inglés | MEDLINE | ID: mdl-38157402

RESUMEN

BACKGROUND: The aim of this study was to determine the safety and immunogenicity of trivalent inactivated influenza vaccine (TIV) alone or formulated with Advax™ delta inulin adjuvant in those of older age (> 60 years) or with chronic disease. METHODS: Over four consecutive years from 2008-2011, adult participants with chronic disease or over 60 years were recruited into a randomised controlled study to assess the safety, tolerability and immunogenicity of Advax-adjuvanted versus standard TIV. The per protocol (PP) population with at least one post-baseline measurement of influenza antibodies comprised 1297 participants: 447 in the TIV, and 850 in the Advax-adjuvanted TIV, groups. RESULTS: No safety issues were identified. Variables negatively affecting vaccine responses included obesity and diabetes mellitus. Advax adjuvant had a positive impact on anti-influenza IgM responses and on H3N2 and B strain seropositivity as assessed by hemagglutination inhibition. CONCLUSIONS: Advax-adjuvanted TIV was safe and well tolerated in individuals with chronic disease. There is an ongoing need for research into improved influenza vaccines for high-risk populations. Australia New Zealand Clinical Trial Registry: ACTRN 12608000364370.

5.
Clin Infect Dis ; 76(3): e820-e826, 2023 02 08.
Artículo en Inglés | MEDLINE | ID: mdl-35903021

RESUMEN

BACKGROUND: A link between chronic inflammation and several noncommunicable diseases (NCDs) has been established. Although chronic infection with the human T-cell leukemia virus type 1 (HTLV-1) is the recognized cause of several inflammatory diseases and these are associated with a high number of HTLV-1-infected cells in peripheral blood (proviral load [PVL]), possible interactions between PVL and NCDs have not been studied at a community level. METHODS: Adult Aboriginal residents of 7 remote communities were invited to complete a health survey between 25 August 2014 and 30 June 2018. Blood was drawn for HTLV-1 serology and PVL, and relevant medical conditions were obtained from health records. Associations between HTLV-1 PVL and diabetes, chronic kidney disease (CKD), and coronary artery disease (CAD) were determined using logistic regression, adjusting for available confounders. RESULTS: Among 510 participants (56% of the estimated adult resident population, 922), 197 (38.6%) were HTLV-1-infected. A high HTLV-1 PVL was associated with a 2-fold increase in the odds of diabetes and CKD (diabetes, adjusted odds ratio [aOR], 1.95; 95% confidence interval [CI], 1.06-3.61; P = .033 and CKD: aOR, 2.00; 95% CI, 1.03-3.8; P = .041). A nonsignificant association between high PVL and CAD (aOR, 7.08; 95% CI, 1.00-50.18; P = .05) was found for participants aged <50 years at the time of angiography. CONCLUSIONS: In a community-based study in central Australia, people with HTLV-1 who had high HTLV-1 PVL were more likely to have diabetes and CKD. These findings have potential clinical implications.


Asunto(s)
Diabetes Mellitus , Infecciones por HTLV-I , Virus Linfotrópico T Tipo 1 Humano , Leucemia de Células T , Insuficiencia Renal Crónica , Adulto , Humanos , Provirus , Infecciones por HTLV-I/complicaciones , Infecciones por HTLV-I/epidemiología , Estudios Transversales , Australia/epidemiología , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/complicaciones , Carga Viral , Encuestas y Cuestionarios , Leucemia de Células T/complicaciones
6.
Int J Colorectal Dis ; 38(1): 201, 2023 Jul 25.
Artículo en Inglés | MEDLINE | ID: mdl-37490150

RESUMEN

PURPOSE: There is increasing demand for colorectal cancer (CRC) surveillance, but healthcare capacity is limited. The burden on colonoscopy resources could be reduced by personalizing surveillance frequency using the fecal immunochemical test (FIT). This study will determine the safety, cost-effectiveness, and patient acceptance of using FIT to extend surveillance colonoscopy intervals for individuals at elevated risk of CRC. METHODS: This multicenter, prospective, randomized controlled trial will invite participants who are scheduled for surveillance colonoscopy (due to a personal history of adenomas or a family history of CRC) and who have returned a low fecal hemoglobin (< 2 µg Hb/g feces; F-Hb) using a two-sample FIT (OC Sensor, Eiken Chemical Company) in the prior 3 years. A total of 1344 individuals will be randomized to either surveillance colonoscopy as scheduled or delayed by 1 or 2 years for individuals originally recommended a 3- or 5-year surveillance interval, respectively. The primary endpoint is incidence of advanced neoplasia (advanced adenoma and/or CRC). Secondary endpoints include cost-effectiveness and consumer acceptability of extending surveillance intervals, determined using surveys and discrete choice experiments. CONCLUSION: This study will establish the safety, cost-effectiveness, and acceptability of utilizing a low FIT Hb result to extend colonoscopy surveillance intervals in a cohort at elevated risk for CRC. This personalized approach to CRC surveillance will lead to a reduction in unnecessary colonoscopies, increases in healthcare savings, and a better patient experience.  TRIAL REGISTRATION: Registration was approved on December 9, 2019 with the Australian New Zealand Clinical Trials Registry ANZCTR 12619001743156.


Asunto(s)
Colonoscopía , Neoplasias Colorrectales , Humanos , Australia , Estudios Prospectivos , Heces , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto
7.
BMC Geriatr ; 23(1): 111, 2023 02 24.
Artículo en Inglés | MEDLINE | ID: mdl-36829128

RESUMEN

BACKGROUND: Opioid use is common among adults 65 years and older, while long-term use of opioids remains controversial and poses risks of drug dependence and other adverse events. The acute disease caused by the SARS-CoV-2 (COVID-19) pandemic has created new challenges and barriers to healthcare access, particularly for long-term care residents. Australia had a relatively low incidence and deaths due to COVID-19 during the first year of the pandemic compared to most OECD countries. In this context, we examined opioid prescribing rates and their dosage in residential aged care facilities (RACFs) before (2019) and during the COVID-19 pandemic (2020) from March to December in Australia. METHODS: We conducted a retrospective cohort using general practice electronic health records. This includes 17,304 RACF residents aged 65 years and over from 361 general practices in New South Wales and Victoria. Number of opioid prescriptions and percentage of opioids over 50 mg/day of oral morphine equivalent (OME) were described. Multivariate generalized estimating equations were applied to estimate odds ratios [aORs (95% confidence intervals)] for 1) opioids prescribed per consultation and 2) prescription opioids over 50 mg/day OME. RESULTS: In 2020 among 11,154 residents, 22.8% of 90,897 total prescriptions were opioids, and of the opioids, 11.3% were over 50 mg/day OME. In 2019 among 10,506 residents, 18.8% of 71,829 total prescriptions were opioids, of which 10.3% were over 50 mg/day OME. Year [2020 vs. 2019: aOR (95% CI):1.50 (1.44, 1.56); 1.29 (1.15, 1.46)] and regionality [rural/regional vs. metropolitan: 1.37 (1.26, 1.49); 1.40 (1.14, 1.71)] were associated with higher odds of prescription opioids and OME > 50 mg/day, respectively. Similar results were found when limited to the same residents (n = 7,340) recorded in both years. CONCLUSIONS: Higher prescription rates of opioids were observed during the COVID-19 pandemic in 2020 than in 2019 in Australian RACFs. The higher odds of prescription opioids and higher dosing in rural/regional than metropolitan areas indicate a widening of the gap in the quality of pain management during the pandemic. Our findings contribute to the limited data that indicate increased opioid prescriptions in long-term care facilities, likely to continue while COVID-19 pandemic restrictions remain.


Asunto(s)
COVID-19 , Medicina General , Anciano , Humanos , Analgésicos Opioides/efectos adversos , Pandemias , Estudios Retrospectivos , Pautas de la Práctica en Medicina , Prescripciones de Medicamentos , SARS-CoV-2 , Victoria
8.
Aging Clin Exp Res ; 35(11): 2363-2397, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37682491

RESUMEN

The increasing access to health data worldwide is driving a resurgence in machine learning research, including data-hungry deep learning algorithms. More computationally efficient algorithms now offer unique opportunities to enhance diagnosis, risk stratification, and individualised approaches to patient management. Such opportunities are particularly relevant for the management of older patients, a group that is characterised by complex multimorbidity patterns and significant interindividual variability in homeostatic capacity, organ function, and response to treatment. Clinical tools that utilise machine learning algorithms to determine the optimal choice of treatment are slowly gaining the necessary approval from governing bodies and being implemented into healthcare, with significant implications for virtually all medical disciplines during the next phase of digital medicine. Beyond obtaining regulatory approval, a crucial element in implementing these tools is the trust and support of the people that use them. In this context, an increased understanding by clinicians of artificial intelligence and machine learning algorithms provides an appreciation of the possible benefits, risks, and uncertainties, and improves the chances for successful adoption. This review provides a broad taxonomy of machine learning algorithms, followed by a more detailed description of each algorithm class, their purpose and capabilities, and examples of their applications, particularly in geriatric medicine. Additional focus is given on the clinical implications and challenges involved in relying on devices with reduced interpretability and the progress made in counteracting the latter via the development of explainable machine learning.


Asunto(s)
Inteligencia Artificial , Geriatría , Humanos , Anciano , Algoritmos , Aprendizaje Automático
9.
J ECT ; 39(2): 106-110, 2023 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-36318226

RESUMEN

OBJECTIVE: The aims of this study were to compare threshold and suprathreshold ictal electroencephalograms (EEGs) in right unilateral (RUL) ultrabrief (UB) electroconvulsive therapy (ECT) and to identify the differences between these EEGs. METHODS: This study is a retrospective review of 125 pairs EEGs from titration and subsequent sessions across a 2-year period. All EEGs were independently rated for by 2 assessors using a scale based on qualities of an EEG used to guide ECT treatment dose adequacy, for example, midictal amplitude, regularity, interhemispheric coherence, seizure end point, and postictal suppression. The scores of threshold and suprathreshold EEGs were compared within and between groups based on 2 ECT types, that is, RUL UB ECT and RUL brief pulse (BP) ECT. RESULTS: Paired t tests showed a statistically significant difference in between threshold and suprathreshold EEG scores in RUL UB ECT. There were no statistically significant differences between corresponding scores for RUL UB ECT and RUL BP ECT threshold and suprathreshold EEGs. CONCLUSIONS: There is a significant difference between the quality of threshold and suprathreshold EEGs in RUL UB ECT when measured with an EEG rating scale. Visual rating of ictal EEGs is as reliable in discriminating between threshold and suprathreshold seizure in RUL UB ECT as it is in RUL BP ECT.


Asunto(s)
Terapia Electroconvulsiva , Humanos , Resultado del Tratamiento , Electroencefalografía , Convulsiones , Estudios Retrospectivos
10.
JAMA ; 330(13): 1255-1265, 2023 10 03.
Artículo en Inglés | MEDLINE | ID: mdl-37787793

RESUMEN

Importance: The effect of continuous positive airway pressure (CPAP) on secondary cardiovascular disease prevention is highly debated. Objective: To assess the effect of CPAP treatment for obstructive sleep apnea (OSA) on the risk of adverse cardiovascular events in randomized clinical trials. Data Sources: PubMed (MEDLINE), EMBASE, Current Controlled Trials: metaRegister of Controlled Trials, ISRCTN Registry, European Union clinical trials database, CENTRAL (Cochrane Central Register of Controlled Trials), and ClinicalTrials.gov databases were systematically searched through June 22, 2023. Study Selection: For qualitative and individual participant data (IPD) meta-analysis, randomized clinical trials addressing the therapeutic effect of CPAP on cardiovascular outcomes and mortality in adults with cardiovascular disease and OSA were included. Data Extraction and Synthesis: Two reviewers independently screened records, evaluated potentially eligible primary studies in full text, extracted data, and cross-checked errors. IPD were requested from authors of the selected studies (SAVE [NCT00738179], ISAACC [NCT01335087], and RICCADSA [NCT00519597]). Main Outcomes and Measures: One-stage and 2-stage IPD meta-analyses were completed to estimate the effect of CPAP treatment on risk of recurrent major adverse cardiac and cerebrovascular events (MACCEs) using mixed-effect Cox regression models. Additionally, an on-treatment analysis with marginal structural Cox models using inverse probability of treatment weighting was fitted to assess the effect of good adherence to CPAP (≥4 hours per day). Results: A total of 4186 individual participants were evaluated (82.1% men; mean [SD] body mass index, 28.9 [4.5]; mean [SD] age, 61.2 [8.7] years; mean [SD] apnea-hypopnea index, 31.2 [17] events per hour; 71% with hypertension; 50.1% receiving CPAP [mean {SD} adherence, 3.1 {2.4} hours per day]; 49.9% not receiving CPAP [usual care], mean [SD] follow-up, 3.25 [1.8] years). The main outcome was defined as the first MACCE, which was similar for the CPAP and no CPAP groups (hazard ratio, 1.01 [95% CI, 0.87-1.17]). However, an on-treatment analysis by marginal structural model revealed a reduced risk of MACCEs associated with good adherence to CPAP (hazard ratio, 0.69 [95% CI, 0.52-0.92]). Conclusions and Relevance: Adherence to CPAP was associated with a reduced MACCE recurrence risk, suggesting that treatment adherence is a key factor in secondary cardiovascular prevention in patients with OSA.


Asunto(s)
Enfermedades Cardiovasculares , Presión de las Vías Aéreas Positiva Contínua , Cooperación del Paciente , Apnea Obstructiva del Sueño , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/prevención & control , Presión de las Vías Aéreas Positiva Contínua/efectos adversos , Hipertensión/complicaciones , Modelos de Riesgos Proporcionales , Apnea Obstructiva del Sueño/complicaciones , Apnea Obstructiva del Sueño/terapia , Riesgo , Anciano , Prevención Secundaria/métodos
11.
Int J Mol Sci ; 24(8)2023 Apr 11.
Artículo en Inglés | MEDLINE | ID: mdl-37108236

RESUMEN

The biomarker development field within molecular medicine remains limited by the methods that are available for building predictive models. We developed an efficient method for conservatively estimating confidence intervals for the cross validation-derived prediction errors of biomarker models. This new method was investigated for its ability to improve the capacity of our previously developed method, StaVarSel, for selecting stable biomarkers. Compared with the standard cross validation method, StaVarSel markedly improved the estimated generalisable predictive capacity of serum miRNA biomarkers for the detection of disease states that are at increased risk of progressing to oesophageal adenocarcinoma. The incorporation of our new method for conservatively estimating confidence intervals into StaVarSel resulted in the selection of less complex models with increased stability and improved or similar predictive capacities. The methods developed in this study have the potential to improve progress from biomarker discovery to biomarker driven translational research.


Asunto(s)
Esófago de Barrett , Neoplasias Esofágicas , MicroARNs , Humanos , Esófago de Barrett/diagnóstico , Esófago de Barrett/genética , Esófago de Barrett/patología , MicroARNs/genética , Medicina Molecular , Neoplasias Esofágicas/diagnóstico , Neoplasias Esofágicas/genética , Neoplasias Esofágicas/patología , Biomarcadores
12.
Arch Orthop Trauma Surg ; 143(3): 1341-1351, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-35028706

RESUMEN

INTRODUCTION: Identification of intra-articular involvement in proximal humeral fractures is important for operative decision making. The aim of this study was to identify the risk factors associated with intra-articular involvement in proximal humeral fractures. MATERIALS AND METHODS: One hundred consecutive three-dimensional computed tomography reconstructions of proximal humeral fractures were identified. The fracture lines were then accurately transcribed onto a two-dimensional superior view of the humeral head and each fracture was assessed for intra-articular involvement. Statistical analyses were undertaken to identify risk factors for intra-articular involvement and extent of involvement. Furthermore, for each risk factor, common fracture patterns were identified and compared to anatomical landmarks. RESULTS: Overall, 58% of the fractures involved the articular surface. High-energy mechanism, female gender, age ≥ 65, and posterior dislocation were risk factors for intra-articular involvement. Low-energy mechanism, female gender, age ≥ 65, varus angulation, and posterior dislocation were risk factors for increased extension of the fracture onto the articular surface. CONCLUSION: Intra-articular involvement in proximal humeral fractures is influenced by demographics and fracture characteristics (mechanism of injury, angulation, and dislocation). Patients with identified risk factors should be appropriately evaluated for intra-articular fractures during preoperative planning to assist in operative decision making. LEVEL OF EVIDENCE: Basic science; anatomy study.


Asunto(s)
Fracturas del Húmero , Fracturas Intraarticulares , Luxaciones Articulares , Fracturas del Hombro , Humanos , Femenino , Tomografía Computarizada por Rayos X/métodos , Fracturas del Hombro/cirugía , Cabeza Humeral , Luxaciones Articulares/etiología , Fijación Interna de Fracturas/métodos
13.
Rheumatology (Oxford) ; 61(4): 1328-1340, 2022 04 11.
Artículo en Inglés | MEDLINE | ID: mdl-34664615

RESUMEN

OBJECTIVE: To determine the placebo response rate in PsA randomized clinical trials (RCTs), its contributing factors and impact on the effect size of active treatments. METHODS: We searched multiple databases, from inception to 20 December 2020, for placebo-controlled RCTs in PsA. We used a random-effects meta-analysis to pool the response rates for the ACR20 criteria in the placebo arm, determined the risk difference for treatment vs placebo, and used meta-regression to determine the factors associated with placebo response rates. The risk of bias was assessed in duplicate. The study protocol was registered with PROSPERO: CRD42021226000. RESULTS: We included 42 RCTs (5050 patients receiving placebo) published between 2000 and 2020. The risk of bias was low in 28 trials, high in four, and with some concerns in 10. The pooled placebo response rate was 20.3% (95% CI: 18.6%, 22.1%; predicted intervals, 11.7-29.0%), with significant between-trial heterogeneity (I2 = 56.8%, P < 0.005). The pooled risk difference for treatment vs placebo was 27% (95% CI: 24%, 31%). In the multivariable meta-regression, there was a 15% (95% CI: 2.9%, 29.8%) increase in the odds of achieving the placebo response for each 5-year increment in publication year (P = 0.016). In addition, the active treatment risk difference decreased for every 5-year increment in publication year (ß = -0.053, 95% CI: -0.099, -0.007; P = 0.024) but was not associated with the placebo response. CONCLUSION: Despite increasing over time, the placebo response for ACR20 in PsA RCTs was not associated with the active treatment effect size.


Asunto(s)
Artritis Psoriásica , Artritis Psoriásica/tratamiento farmacológico , Humanos , Efecto Placebo
14.
BMC Cancer ; 22(1): 1353, 2022 Dec 24.
Artículo en Inglés | MEDLINE | ID: mdl-36566189

RESUMEN

BACKGROUND: Women living with metastatic breast cancer (MBC) are at risk of significantly impaired quality of life (QOL), symptom burden, distress and fear of progression, and unmet needs, yet they face barriers to accessing evidence-based psychosocial treatments. Our group therefore developed Finding My Way-Advanced (FMW-A), a web-based self-guided psychosocial program for women with MBC. This study aims to assess its efficacy in improving mental and other QOL domains, distress, fear of progression, unmet needs, and health service utilisation. METHODS: The multi-site randomised controlled trial (RCT) will enrol 370 Australian participants. Eligible participants are adult (18 years +) women diagnosed with MBC, with a life expectancy of 6 months or more, with sufficient English-language literacy to provide informed consent. Participants will be identified, screened and referred from one of 10 Australian sites, or via self-referral in response to advertisements. Participants complete four online questionnaires: prior to accessing their program ('baseline'), 6 weeks later ('post-intervention'), then 3 months and 6 months post-intervention. Consenting participants will be randomised to either FMW-A (intervention), or Breast Cancer Network Australia's (BCNA) online/app resource My Journey (minimal intervention attention-control). This is a single-blind study, with randomisation computer-generated and stratified by site. FMW-A is a 6-module program addressing some of the most common issues experienced by women with MBC, with BCNA control resources integrated within the 'resources' section. All modules are immediately accessible, with an additional booster module released 10 weeks later. The primary outcome is mental QOL; statistical criteria for superiority is defined as a 4-point difference between groups at post-treatment. Secondary outcomes include other QOL domains, distress, fear of progression, health service use, intervention adherence, and user satisfaction. DISCUSSION: This will be the first adequately powered RCT of a self-directed online intervention for women with MBC. If efficacious, FMW-A will help address two national key priorities for management of MBC - enhancing QOL and reducing symptom burden. FMW-A has the potential to address unmet needs and overcome access barriers for this overlooked population, while reducing health system burden. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 29/10/2021. Trial ID ACTRN12621001482853p.  https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382714&isReview=true.


Asunto(s)
Neoplasias de la Mama , Intervención basada en la Internet , Adulto , Femenino , Humanos , Intervención Psicosocial , Australia , Neoplasias de la Mama/terapia , Calidad de Vida/psicología , Ensayos Clínicos Controlados Aleatorios como Asunto
15.
Clin Transplant ; 36(7): e14682, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35441375

RESUMEN

The prognostic role of cardiac dysfunction in cirrhotic patients is increasingly recognized. We studied its impact on morbidity and mortality before and after liver transplantation (LT) including development of post-transplant cardiovascular disease (CVD). In this retrospective study, cirrhotic patients who underwent LT assessment from January 2010 to December 2020 were reviewed. Demographics, cardiac investigations and clinical courses were analyzed to identify the prevalence of cardiac dysfunction and its role in LT outcomes. Survival analysis was performed using Cox proportional hazard regression modelling, with LT as a time-varying covariate and as an interaction variable with cardiac dysfunction. Three hundred and eight patients (70% male) were studied. The median (interquartile range) age at LT assessment was 56 (12) years. Cardiac dysfunction was found in 178 (58%) patients (diastolic, 169; systolic, 26; both, 17) and was significantly associated with hepatorenal syndrome/acute kidney injury and peri- and post-transplant morbidity (adjusted odds ratio [aOR] 1.94, 95% CI 1.06-3.52, P < .001; aOR 2.01, 95% CI 1.06-3.82, P = .033; aOR 1.9, 95% CI 1.01-3.65, P = .023, respectively). Cardiac dysfunction was not associated with mortality before (adjusted hazard ratio [aHR] 1.01, 95% CI .99-1.01) or after LT (aHR .74, 95% CI .4-1.05. Post-transplant CVD (61% cardiac failure) occurred in 36 patients, and there was no significant association with cardiac dysfunction (P = .11). Cardiac dysfunction was common in LT candidates and was significantly associated with morbidity before and after LT. Studies on the role of advanced echocardiographic parameters to improve diagnosis of cardiac dysfunction and optimize LT outcomes are needed.


Asunto(s)
Cardiopatías , Trasplante de Hígado , Femenino , Cardiopatías/etiología , Cardiopatías/cirugía , Humanos , Cirrosis Hepática/diagnóstico , Trasplante de Hígado/efectos adversos , Masculino , Morbilidad , Estudios Retrospectivos
16.
Eur J Nutr ; 61(6): 2929-2938, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35307760

RESUMEN

PURPOSE: Higher total fruit and vegetable (FV) intakes have been associated with lower perceived stress. The relationship between specific types of FV and perceived stress remains uncertain. The aims of this cross-sectional study were to explore the relationship between consumption of specific types of FV with perceived stress in a population-based cohort of men and women aged ≥ 25 years from the Australian Diabetes, Obesity and Lifestyle (AusDiab) Study. METHODS: Dietary intake was assessed using a validated Food Frequency Questionnaire (n = 8,640). Perceived stress was evaluated using a validated Perceived Stress Questionnaire, with values ranging 0-1 (lowest to highest). High perceived stress cut-offs of ≥0.34 for men and ≥0.39 for women were obtained from the highest quartile of the perceived stress score for each sex. Multivariable-adjusted logistic regression was performed to investigate the associations. RESULTS: The mean age of participants (50.1% females) was 47.8 (SD 15) years. Persons in the highest, versus lowest, quartiles of apples and pears, orange and other citrus, and banana intakes had a significantly lower odds (24-31%) of having high perceived stress. Similarly, persons with higher intakes of cruciferous, yellow/orange/red, and legume vegetables had significantly lower odds (25-27%) of having high perceived stress. CONCLUSION: In Australian adults, a higher consumption of apples and pears, oranges and other citrus, and bananas, as well as cruciferous, yellow/orange/red, and legume vegetables were associated with lower odds of having high perceived stress. The recommendations of "eating a rainbow" of colours may assist in preventing and/or reducing perceived stress.


Asunto(s)
Frutas , Verduras , Australia/epidemiología , Estudios Transversales , Dieta , Femenino , Humanos , Masculino , Estrés Psicológico
17.
J Gastroenterol Hepatol ; 37(7): 1263-1274, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35315547

RESUMEN

BACKGROUND AND AIM: Rates of antimicrobial-resistant Helicobacter pylori infection are rising globally; however, geospatial location and its interaction with risk factors for infection have not been closely examined. METHODS: Gastric biopsy specimens were collected to detect H. pylori infection at multiple centers in Adelaide, South Australia, between 1998 and 2017. The geospatial distribution of antibiotic-resistant H. pylori in the Greater Adelaide region was plotted using choropleth maps. Moran's I was used to assess geospatial correlation, and multivariate linear regression (MLR) was used to examine associations between migration status, socioeconomic status, age, gender, and rates of H. pylori positivity and antibiotic resistance. Geographically weighted regression (GWR) was used to determine the extent to which the associations varied according to geospatial location. RESULTS: Of 20 108 biopsies across 136 postcodes within the Greater Adelaide region, 1901 (9.45%) were H. pylori positive. Of these, 797 (41.9%) displayed clarithromycin, tetracycline, metronidazole, or amoxicillin resistance. In MLR, migration status was associated with the rate of H. pylori positivity (ß = 3.85% per 10% increase in a postcode's migrant population; P < 0.001). H. pylori positivity and resistance to any antibiotic were geospatially clustered (Moran's I = 0.571 and 0.280, respectively; P < 0.001 for both). In GWR, there was significant geospatial variation in the strength of the migrant association for both H. pylori positivity and antibiotic resistance. CONCLUSION: Our study demonstrates the heterogeneous geospatial distribution of H. pylori positivity and antibiotic resistance, as well as its interaction with migrant status. Geographic location and migrant status are important factors to consider for H. pylori eradication therapy.


Asunto(s)
Infecciones por Helicobacter , Helicobacter pylori , Amoxicilina/uso terapéutico , Antibacterianos/farmacología , Antibacterianos/uso terapéutico , Claritromicina , Farmacorresistencia Bacteriana , Infecciones por Helicobacter/tratamiento farmacológico , Infecciones por Helicobacter/epidemiología , Humanos , Metronidazol , Pruebas de Sensibilidad Microbiana , Australia del Sur/epidemiología
18.
BMC Pregnancy Childbirth ; 22(1): 316, 2022 Apr 13.
Artículo en Inglés | MEDLINE | ID: mdl-35418020

RESUMEN

BACKGROUND: Induction of labour (IOL) is a common obstetric intervention. When planning IOL, especially in women at risk for complications at delivery, the aim should be for delivery to occur when senior staff are available to optimise safe care. METHODS: A change in timing of IOL protocol at our institution was introduced in November 2018 aiming to increase births occurring "in-hours" defined as 08:00 to 20:00 h. This retrospective cohort study compares the odds of "in-hours" birth before and after the intervention and the association on birth outcomes. The study compared outcomes during the new IOL pathway period to a historical birth cohort from January to December 2017. Inclusion criteria were nulliparous women undergoing planned IOL at term with a cephalic singleton pregnancy. Logistic regression was used to compare odds of in-hours birth for the 2 periods with adjustment for maternal age at delivery, gestation, more than 2 cervical ripening agents required, undergoing IOL for post-dates pregnancy, mode of birth, whether or not IOL proceeded according to planned protocol and missing values using multiple imputation. RESULTS: The rate of deliveries occurring in-hours were higher following the intervention; n = 118/285 (45.6%) pre-intervention versus n = 251/470 (53.4%) post-intervention; adjusted OR = 1.47, 95% CI = 1.07-2.01, p = 0.02). The percentage of caesarean sections (CS) occurring in-hours was significantly lower in the pre-intervention group n = 71/153 (28.3%) compared with the post intervention group = 35/132(46.4%) (p < 0.001)). The rate of CS was higher in the pre intervention n = 132/285(46.3%) compared with the post intervention group n = 153/470 (32.4%)). CONCLUSIONS: The change in induction procedures was associated with a significantly higher rate of births occurring in-hours and a lower rate of overall of CS. This policy change led to a better pattern of timing of birth for nulliparous women undergoing IOL.


Asunto(s)
Cesárea , Trabajo de Parto Inducido , Maduración Cervical , Femenino , Humanos , Trabajo de Parto Inducido/métodos , Edad Materna , Embarazo , Estudios Retrospectivos
19.
Intern Med J ; 52(8): 1347-1353, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-33979037

RESUMEN

BACKGROUND: Chronic hepatitis B (CHB) infection remains a significant public health issue for Indigenous Australians, in particular for remote communities. AIM: To evaluate the spectrum of hepatitis B virus (HBV) care provided to a remote Aboriginal community. Measures studied included screening, seroprevalence, vaccination rates and efficacy, and HCC risk and surveillance adherence. METHODS: A retrospective audit of HBV care received by all permanent residents currently attending a remote Aboriginal Health service. This study was endorsed by both the local Aboriginal Health service and the Aboriginal Health Council of South Australia. RESULTS: A total of 208 patients attended the clinic, of whom 52% (109) were screened for HBV. Of these, 12% (13) had CHB and 20% (22) had evidence of past infection. Similarly, of the 208 attending patients, complete vaccination was documented in 48% (99). Of the 33 patients with post-vaccination serology, 24% (8) had subtherapeutic (<10 IU/mL) levels of HBsAb. Subtherapeutic HBsAb was independently associated with higher Charlson Comorbidity scores (odds ratio = 17.1; 95% confidence interval 1.2-243.3; P = 0.036). Definitive breakthrough infection was identified in 6% (2) patients. One HBsAg positive patient was identified as needing HCC surveillance, but had not undertaken HCC surveillance. CONCLUSION: Opportunities to improve the quality of CHB care through increased HBV vaccination, screening and adherence to HCC surveillance were identified. High rates of subtherapeutic vaccine responses and documented breakthrough infection raises concerns about the effectiveness of current CHB vaccines in this population.


Asunto(s)
Carcinoma Hepatocelular , Servicios de Salud del Indígena , Hepatitis B Crónica , Hepatitis B , Neoplasias Hepáticas , Australia/epidemiología , Anticuerpos contra la Hepatitis B , Antígenos de Superficie de la Hepatitis B , Vacunas contra Hepatitis B/uso terapéutico , Virus de la Hepatitis B , Hepatitis B Crónica/diagnóstico , Hepatitis B Crónica/epidemiología , Hepatitis B Crónica/prevención & control , Humanos , Nativos de Hawái y Otras Islas del Pacífico , Estudios Retrospectivos , Estudios Seroepidemiológicos
20.
Intern Med J ; 52(6): 1048-1056, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-33342052

RESUMEN

BACKGROUND: Severe community-acquired pneumonia (SCAP) has high mortality and morbidity. AIMS: To describe the epidemiology and microbiology of SCAP in Central Australia. METHODS: A retrospective epidemiological study describing the characteristics, incidence rates (IR) and microbiological aetiology of SCAP in Central Australia. Adult patients admitted to Alice Springs Hospital Intensive Care Unit (ICU) between 2011 and 2014 that fitted the Infectious Diseases Society of America and American Thoracic Society definition of SCAP were included. Medical records were reviewed and compared between indigenous and non-indigenous patients. Primary outcomes were incidence rate and microbiological aetiology of SCAP. Secondary outcomes were 30-day mortality, and ICU and hospital length of stay (LoS). RESULTS: A total of 185 patents were included (156 indigenous; 29 non-indigenous). The overall SCAP IR per 1000 person-years was 3.24 (3.75 indigenous; 1.87 non-indigenous) with an IR difference of 2.71 after adjustment (P < 0.001). Those aged ≥50 years had an IR 74.8% higher than those younger. Male IR was 50% higher than females. There was a significant difference between indigenous and non-indigenous groups for age (48 vs 64 years), but not for 30-day mortality (7.7% vs 10.3%), ICU LoS (4.8 vs 4.6 days) and hospital LoS (10.9 vs 15.1 days) respectively. Likely causative pathogen(s) were identified in 117 patients; Streptococcus pneumoniae was the most common pathogen (28.2%), followed by Haemophilus influenzae (19.7%), Influenza A/B (16.2%) and Staphylococcus aureus (14.5%). CONCLUSION: A high incidence of SCAP was observed in Central Australia, disproportionately affecting the indigenous population. Prevention strategies are imperative, as well as early identification of SCAP and appropriate empiric antibiotic regimens.


Asunto(s)
Infecciones Comunitarias Adquiridas , Neumonía , Adulto , Antibacterianos/uso terapéutico , Infecciones Comunitarias Adquiridas/epidemiología , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Neumonía/tratamiento farmacológico , Neumonía/epidemiología , Estudios Retrospectivos
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