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1.
PLoS One ; 19(6): e0306374, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38935771

RESUMO

[This corrects the article DOI: 10.1371/journal.pone.0281703.].

2.
Aust J Gen Pract ; 53(6): 379-386, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38840376

RESUMO

BACKGROUND: Adolescence is a stage of significant transition as children develop into young adults. Optimal sleep is crucial during this period to ensure physical, emotional and mental wellbeing. However, it is well recognised that insufficient quality and quantity of sleep is common among adolescents worldwide. OBJECTIVE: This article aims to provide general practitioners with an overview of the key issues encountered in adolescent patients relating to sleep and summarises approaches to assessment and evidence-based management of sleep problems in this population. DISCUSSION: This review highlights the physiological changes that affect sleep during adolescence and how other factors, including unhealthy sleep behaviours, influence these. It discusses the importance of healthy sleep and the consequences of sleep disturbance in adolescents. Management strategies are outlined, focusing on the key common issues that affect sleep in the teenage years, and guidance on when to consider co-management with specialist care is provided.


Assuntos
Sono , Humanos , Adolescente , Sono/fisiologia , Transtornos do Sono-Vigília/terapia , Transtornos do Sono-Vigília/fisiopatologia
3.
Aust J Gen Pract ; 53(6): 371-378, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38840375

RESUMO

BACKGROUND: Healthy sleep is vital for optimal child development, yet over 30% of Australian parents report having children with disrupted sleep affecting all family members. These sleep difficulties might co-exist with sleep breathing disorders, contributing to morbidity and reduced quality of life. OBJECTIVE: This article aims to provide general practitioners (GPs) with an evidence-based, biopsychosocial approach to managing common sleep problems in infants and preschool-aged children. DISCUSSION: Strategies and techniques are outlined to aid GPs in promoting healthy sleep during infancy, educating parents on typical sleep patterns and supporting families in managing problematic sleep patterns in toddlers. Emphasis is placed on a tailored approach to developing a healthy sleep environment to meet the child's needs and parental values. Valuable resources and indications for specialist consultation are included.


Assuntos
Transtornos do Sono-Vigília , Humanos , Lactente , Pré-Escolar , Austrália , Transtornos do Sono-Vigília/terapia , Transtornos do Sono-Vigília/fisiopatologia , Pais/psicologia , Sono/fisiologia , Qualidade de Vida/psicologia
4.
PLoS One ; 18(2): e0281703, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36763688

RESUMO

Interest in the technique of low temperature environmental nanoindentation has gained momentum in recent years. Low temperature indentation apparatuses can, for instance, be used for systematic measurements of the mechanical properties of ice in the laboratory, in order to accurately determine the inputs for the constitutive equations describing the rheologic behaviour of natural ice (i.e., the Glen flow law). These properties are essential to predict the movement of glaciers and ice sheets over time as a response to a changing climate. Herein, we introduce a new experimental setup and protocol for electron microscope loading and in situ nanoindentation of water ice. Preliminary testing on pure water ice yield elastic modulus and hardness measurements of 4.1 GPa and 176 MPa, respectively, which fall within the range of previously published values. Our approach demonstrates the potential of low temperature, in situ, instrumented nanoindentation of ice under controlled conditions in the SEM, opening the possibility for investigating individual structural elements and systematic studies across species and concentration of impurities to refine to constitutive equations for natural ice.


Assuntos
Elétrons , Água , Temperatura , Módulo de Elasticidade , Dureza
5.
Aust Crit Care ; 36(4): 492-498, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36210281

RESUMO

INTRODUCTION: While paediatric critical illness mortality rates in Australia are declining, the growing cohort of paediatric intensive care unit (PICU) survivors means an increasing number of children facing substantial health challenges after their discharge from intensive care. General practitioners (GPs) play a key role in provision of comprehensive health care to children and families and are ideally positioned to provide developmental surveillance and support the care of both the child and family following critical illness. METHODS: An anonymous, cross-sectional survey of 60 GPs, reached via private invitation (19% response) or via social media weblink, was conducted where the GPs were asked about their current confidence and knowledge in managing children post PICU. This included awareness of short- and long-term problems, of paediatric intensive care syndrome in paediatrics (PICS-p), and of educational materials. Lastly, a parent-completed screening questionnaire and shared-care pathway were proposed to GPs for their feedback on perceived benefit and willingness to participate. Data were analysed using frequency distributions and chi-square statistics. RESULTS: Ninety-three percent of GPs had some level of confidence in caring for a child post PICU admission and low confidence in their knowledge of potential short- and long-term complications. Eighty percent of GPs had not heard of PICS-p, and 93% were unaware of educational materials available on this topic. Ninety-five percent of GPs perceived that the proposed patient-screening tool and shared-care pathways would be beneficial, and 70% predicted that they would definitely use educational materials if accessible through GP central repositories. CONCLUSION: To reduce ongoing health problems for children recovering from critical illness, the family GP plays a pivotal role in providing community-level developmental care, particularly in Australia. Increasing GP confidence and knowledge through education is essential, and using a parent-completed screening questionnaire and shared-care pathway to improve care may be beneficial. GPs must also be involved in the implementation stages of future shared-care models.


Assuntos
Clínicos Gerais , Criança , Humanos , Estudos Transversais , Estado Terminal , Austrália , Pacientes
6.
BMJ Open ; 12(7): e060714, 2022 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-35840297

RESUMO

INTRODUCTION: In Australia, while paediatric intensive care unit (PICU) mortality has dropped to 2.2%, one in three survivors experience long-term neurodevelopmental impairment, limiting their life-course opportunities. Unlike other high-risk paediatric populations, standardised routine neurodevelopmental follow-up of PICU survivors is rare, and there is limited knowledge regarding the best methods. The present study intends to pilot a combined multidisciplinary, online screening platform and general practitioner (GP) shared care neurodevelopmental follow-up model to determine feasibility of a larger, future study. We will also assess the difference between neurodevelopmental vulnerability and parental stress in two intervention groups and the impact of child, parent, sociodemographic and illness/treatment risk factors on child and parent outcomes. METHODS AND ANALYSIS: Single-centre randomised effectiveness-implementation (hybrid-2 design) pilot trial for parents of children aged ≥2 months and <4 years discharged from PICU after critical illness or injury. One intervention group will receive 6 months of collaborative shared care follow-up with GPs (supported by online outcome monitoring), and the other will be offered self-directed screening and education about post-intensive care syndrome and child development. Participants will be followed up at 1, 3 and 6 months post-PICU discharge. The primary outcome is feasibility. Secondary outcomes include neurodevelopmental vulnerability and parental stress. An implementation evaluation will analyse barriers to and facilitators of the intervention. ETHICS AND DISSEMINATION: The study is expected to lead to a full trial, which will provide much-needed guidance about the clinical effectiveness and implementation of follow-up models of care for children after critical illness or injury. The Children's Health Queensland Human Research Ethics Committee approved this study. Dissemination of the outcomes of the study is expected via publication in a peer-reviewed journal, presentation at relevant conferences, and via social media, podcast presentations and open-access medical education resources. REGISTRATION DETAILS: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as 'Pilot testing of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children' (the DAISY Pilot Study). TRIAL REGISTRATION NUMBER: ACTRN12621000799853.


Assuntos
Estado Terminal , Unidades de Terapia Intensiva Pediátrica , Austrália , Pré-Escolar , Estado Terminal/terapia , Humanos , Pais , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Nat Commun ; 13(1): 1102, 2022 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-35232964

RESUMO

Interstitials, e.g., C, N, and O, are attractive alloying elements as small atoms on interstitial sites create strong lattice distortions and hence substantially strengthen metals. However, brittle ceramics such as oxides and carbides usually form, instead of solid solutions, when the interstitial content exceeds a critical yet low value (e.g., 2 at.%). Here we introduce a class of massive interstitial solid solution (MISS) alloys by using a highly distorted substitutional host lattice, which enables solution of massive amounts of interstitials as an additional principal element class, without forming ceramic phases. For a TiNbZr-O-C-N MISS model system, the content of interstitial O reaches 12 at.%, with no oxides formed. The alloy reveals an ultrahigh compressive yield strength of 4.2 GPa, approaching the theoretical limit, and large deformability (65% strain) at ambient temperature, without localized shear deformation. The MISS concept thus offers a new avenue in the development of metallic materials with excellent mechanical properties.

8.
Med J Aust ; 216(5): 255-263, 2022 Mar 21.
Artigo em Inglês | MEDLINE | ID: mdl-34689329

RESUMO

INTRODUCTION: The epidemiology and clinical manifestations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are different in children and adolescents compared with adults. Although coronavirus disease 2019 (COVID-19) appears to be less common in children, with milder disease overall, severe complications may occur, including paediatric inflammatory multisystem syndrome (PIMS-TS). Recognising the distinct needs of this population, the National COVID-19 Clinical Evidence Taskforce formed a Paediatric and Adolescent Care Panel to provide living guidelines for Australian clinicians to manage children and adolescents with COVID-19 and COVID-19 complications. Living guidelines mean that these evidence-based recommendations are updated in near real time to give reliable, contemporaneous advice to Australian clinicians providing paediatric care. MAIN RECOMMENDATIONS: To date, the Taskforce has made 20 specific recommendations for children and adolescents, including definitions of disease severity, recommendations for therapy, respiratory support, and venous thromboembolism prophylaxis for COVID-19 and for the management of PIMS-TS. CHANGES IN MANAGEMENT AS A RESULT OF THE GUIDELINES: The Taskforce currently recommends corticosteroids as first line treatment for acute COVID-19 in children and adolescents who require oxygen. Tocilizumab could be considered, and remdesivir should not be administered routinely in this population. Non-invasive ventilation or high flow nasal cannulae should be considered in children and adolescents with hypoxaemia or respiratory distress unresponsive to low flow oxygen if appropriate infection control measures can be used. Children and adolescents with PIMS-TS should be managed by a multidisciplinary team. Intravenous immunoglobulin and corticosteroids, with concomitant aspirin and thromboprophylaxis, should be considered for the treatment of PIMS-TS. The latest updates and full recommendations are available at www.covid19evidence.net.au.


Assuntos
COVID-19/complicações , COVID-19/terapia , Adolescente , Fatores Etários , Austrália , COVID-19/diagnóstico , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido
9.
JMIR Form Res ; 5(12): e27956, 2021 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-34870611

RESUMO

BACKGROUND: The rising incidence of chronic diseases is a growing concern, especially in Singapore, which is one of the high-income countries with the highest prevalence of diabetes. Interventions that promote healthy lifestyle behavior changes have been proven to be effective in reducing the progression of prediabetes to diabetes, but their in-person delivery may not be feasible on a large scale. Novel technologies such as conversational agents are a potential alternative for delivering behavioral interventions that promote healthy lifestyle behavior changes to the public. OBJECTIVE: The aim of this study is to assess the feasibility and acceptability of using a conversational agent promoting healthy lifestyle behavior changes in the general population in Singapore. METHODS: We performed a web-based, single-arm feasibility study. The participants were recruited through Facebook over 4 weeks. The Facebook Messenger conversational agent was used to deliver the intervention. The conversations focused on diet, exercise, sleep, and stress and aimed to promote healthy lifestyle behavior changes and improve the participants' knowledge of diabetes. Messages were sent to the participants four times a week (once for each of the 4 topics of focus) for 4 weeks. We assessed the feasibility of recruitment, defined as at least 75% (150/200) of our target sample of 200 participants in 4 weeks, as well as retention, defined as 33% (66/200) of the recruited sample completing the study. We also assessed the participants' satisfaction with, and usability of, the conversational agent. In addition, we performed baseline and follow-up assessments of quality of life, diabetes knowledge and risk perception, diet, exercise, sleep, and stress. RESULTS: We recruited 37.5% (75/200) of the target sample size in 1 month. Of the 75 eligible participants, 60 (80%) provided digital informed consent and completed baseline assessments. Of these 60 participants, 56 (93%) followed the study through till completion. Retention was high at 93% (56/60), along with engagement, denoted by 50% (30/60) of the participants communicating with the conversational agent at each interaction. Acceptability, usability, and satisfaction were generally high. Preliminary efficacy of the intervention showed no definitive improvements in health-related behavior. CONCLUSIONS: The delivery of a conversational agent for healthy lifestyle behavior change through Facebook Messenger was feasible and acceptable. We were unable to recruit our planned sample solely using the free options in Facebook. However, participant retention and conversational agent engagement rates were high. Our findings provide important insights to inform the design of a future randomized controlled trial.

10.
JMIR Form Res ; 5(11): e30435, 2021 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-34762053

RESUMO

BACKGROUND: The incidence of chronic diseases such as type 2 diabetes is increasing in countries worldwide, including Singapore. Health professional-delivered healthy lifestyle interventions have been shown to prevent type 2 diabetes. However, ongoing personalized guidance from health professionals is not feasible or affordable at the population level. Novel digital interventions delivered using mobile technology, such as conversational agents, are a potential alternative for the delivery of healthy lifestyle change behavioral interventions to the public. OBJECTIVE: We explored perceptions and experiences of Singaporeans on healthy living, diabetes, and mobile health (mHealth) interventions (apps and conversational agents). This study was conducted to help inform the design and development of a conversational agent focusing on healthy lifestyle changes. METHODS: This qualitative study was conducted in August and September 2019. A total of 20 participants were recruited from relevant healthy living Facebook pages and groups. Semistructured interviews were conducted in person or over the telephone using an interview guide. Interviews were transcribed and analyzed in parallel by 2 researchers using Burnard's method, a structured approach for thematic content analysis. RESULTS: The collected data were organized into 4 main themes: use of conversational agents, ubiquity of smartphone apps, understanding of diabetes, and barriers and facilitators to a healthy living in Singapore. Most participants used health-related mobile apps as well as conversational agents unrelated to health care. They provided diverse suggestions for future conversational agent-delivered interventions. Participants also highlighted several knowledge gaps in relation to diabetes and healthy living. Regarding barriers to healthy living, participants mentioned frequent dining out, high stress levels, lack of work-life balance, and lack of free time to engage in physical activity. In contrast, discipline, preplanning, and sticking to a routine were important for enabling a healthy lifestyle. CONCLUSIONS: Participants in this study commonly used mHealth interventions and provided important insights into their knowledge gaps and needs in relation to changes in healthy lifestyle behaviors. Future digital interventions such as conversational agents focusing on healthy lifestyle and diabetes prevention should aim to address the barriers highlighted in our study and motivate individuals to adopt healthy lifestyle behavior.

11.
Sci Rep ; 11(1): 18708, 2021 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-34548531

RESUMO

People with diabetes are at risk of chronic complications and novel biomarkers, such as Advanced glycation end-products (AGEs) may help stratify this risk. We assessed whether plasma low-molecular weight AGEs, also known as LMW-fluorophores (LMW-F), are associated with risk factors, predict complications, and are altered by fenofibrate in adults with type 2 diabetes. Plasma LMW-F were quantified at baseline, after six weeks fenofibrate, and one year post-randomisation to fenofibrate or placebo. LMW-F associations with existing and new composite vascular complications were determined, and effects of fenofibrate assessed. LMW-F correlated positively with age, glycated haemoglobin (HbA1c), pulse pressure, kidney dysfunction and inflammation; and negatively with urate, body mass index, oxidative stress and leptin, albeit weakly (r = 0.04-0.16, all p < 0.01). Independent determinants of LMW-F included smoking, diastolic blood pressure, prior cardiovascular disease or microvascular complications, Caucasian ethnicity, kidney function, HbA1c and diabetes duration (all p ≤ 0.01). Baseline LMW-F tertiles correlated with on-trial macrovascular and microvascular complications (trend p < 0.001) on univariate analyses only. Six weeks of fenofibrate increased LMW-F levels by 21% (p < 0.001). In conclusion, LMW-F levels correlate with many risk factors and chronic diabetes complications, and are increased with fenofibrate. LMW-F tertiles predict complications, but not independently of traditional risk factors.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Fenofibrato/uso terapêutico , Corantes Fluorescentes/química , Hipolipemiantes/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Peso Molecular
12.
Cureus ; 13(4): e14504, 2021 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-34007757

RESUMO

Introduction Fine needle aspiration cytology (FNAC) forms part of the routine workup for suspicious thyroid nodules. Whilst cytological analysis is less precise than histological assessment, it is quick and easy to perform and may avoid the need for invasive and potentially risky surgery. Methods This retrospective study spanned a 10-year period comparing preoperative FNAC with postoperative histology results to establish the accuracy of diagnosis and malignancy rates within our population. These results were then compared to the published figures in the literature. Results The histological reports of 659 consecutive cases of thyroid surgery between 2006 and 2015 were retrieved from our hospital database. Among the 471 patients (71.5%) who underwent preoperative FNAC, the postoperative histology was reported as benign in 352 (74.7%) and malignant in 119 cases (25.3%). Papillary thyroid cancer (PTC) was the commonest histological diagnosis. Thy1 grade was reported in 165 (30%) cases, with 19.4% having a final histological diagnosis of malignancy. In the Thy2 group, 85.3% of patients had a benign final histological diagnosis, while 14.7% had malignancy (false-negative results). Malignancy was found in 89% of Thy4 and 100% of Thy5 group patients.  Conclusions Rates of malignancy varied considerably from those in the published literature. Each centre should be able to quote a local malignancy rate during patient counselling. It is also prudent for all units performing thyroid diagnostics to investigate the factors that might lead to inaccuracies in reporting.

13.
Aust J Prim Health ; 2021 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-33731251

RESUMO

Integrating healthcare into education settings represents a promising model to address complex health problems in disadvantaged communities through improving access to health and social services. One such example of an effective school-based health hub is the Our Mia Mia (OMM) Wellbeing Hub, located in a primary school in Nowra and servicing a community experiencing significant socioeconomic disadvantage. The efficacy of OMM rests on its success in facilitating access to services by removing the barriers of cost and transport and establishing connection to community. The OMM fosters collaborations between health professionals and educators to coordinate holistic treatment and implement appropriate student supports in a timely manner. The support of key individuals and groups, in addition to the flexibility of the model, has allowed the hub to pivot and adapt to meet the changing needs of its community, particularly as challenges pertaining to bureaucracy, financial sustainability and community mistrust have presented themselves. Future directions for the OMM hub, and the possibility of adapting and translating school-based healthcare delivery models in other disadvantaged communities, is discussed.

14.
Lancet Diabetes Endocrinol ; 8(1): 17-26, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31862147

RESUMO

BACKGROUND: Continuous glucose monitoring, either real-time (personal) or retrospective (professional mode), can identify day-to-day glucose profiles to guide management decisions for people with type 2 diabetes. We aimed to examine the effects of professional-mode flash glucose monitoring, done at 3-month intervals, in adults with type 2 diabetes in general practice. METHODS: We did a pragmatic, two-arm, open label, 12-month, individually randomised controlled trial (GP-OSMOTIC) in 25 general practices in Victoria, Australia. Eligible participants were adults aged 18-80 years, with type 2 diabetes diagnosed for at least 1 year and HbA1c at least 5·5 mmol/mol (0·5%) above their target in the past month despite being prescribed at least two non-insulin glucose-lowering drugs, insulin, or both (with therapy stable for at least 4 months). We randomly assigned participants (1:1) to either use of a professional-mode flash glucose monitoring system or usual clinical care (control). All participants wore the flash glucose monitoring sensor at baseline, and electronic randomisation (using permuted block sizes of four and six, and stratified by clinic) was done after the sensor was attached. Masking of participants and treating clinicians to group allocation was not possible, but the study statistician was masked to allocation when analysing the data. At baseline, and 3, 6, 9, and 12 months, participants in the flash glucose monitoring group wore the professional-mode flash glucose monitoring sensor for 5-14 days before their general practice visit. The sensor recorded interstitial glucose concentrations every 15 min, but the glucose data were not available to the participant until their general practice visit, where the sensor output would be uploaded to a computer by the health professional and discussed. Control group participants wore the sensor at baseline and at 12 months for data analysis only, and had usual care visits every 3 months. The primary outcome was the between-group difference in mean HbA1c at 12 months. Secondary outcomes were the between-group differences in: mean percentage time in target glucose range (4-10 mmol/L), based on ambulatory glucose profile data at 12 months; mean diabetes-specific distress (assessed with the Problem Areas In Diabetes [PAID] scale) at 12 months; and mean HbA1c at 6 months. Analysis was done by intention to treat. This trial is registered at the Australian and New Zealand Clinical Trials Registry, ACTRN12616001372471. FINDINGS: Between Oct 4, 2016, and Nov 17, 2017, we randomly assigned 299 adults: 149 to flash glucose monitoring and 150 to usual care. At 6 months, HbA1c was lower in the flash glucose monitoring group than in the usual care group (difference -0·5%, 95% CI -0·8% to -0·3%; p=0·0001). However, at 12 months (primary outcome), there was no significant between-group difference in estimated mean HbA1c (8·2% [95% CI 8·0 to 8·4] for flash glucose monitoring vs 8·5% [8·3 to 8·7] for usual care; between-group difference -0·3%, 95% CI -0·5 to 0·01; [66 mmol/mol, 95% CI 64 to 68 vs 69 mmol/mol, 67 to 72; between-group difference -3·0, 95% CI -5·0 to 0·1]; p=0·059). Mean percentage time spent in target glucose range at 12 months was 7·9% (95% CI 2·3 to 13·5) higher in the flash glucose monitoring group than in the usual care group (p=0·0060). Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference -0·7, 95% CI -3·3 to 1·9; p=0·61). No episodes of severe hypoglycaemia or treatment-related deaths were reported. One participant died during the study from causes unrelated to the intervention (following complications post-myocardial infarction with multiple comorbidities). INTERPRETATION: Professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice did not improve the primary outcome of HbA1c at 12 months or diabetes-specific distress compared with usual care, but did improve time in target glucose range at 12 months and HbA1c at 6 months. Our findings suggest that professional-mode flash glucose monitoring can be implemented in a pragmatic primary care environment. Although there was no change in HbA1c at 12 months, the improved time in target range might reflect the potential of the technology to support personalised clinical care by providing insights into glycaemic profiles for some people with type 2 diabetes. FUNDING: National Health and Medical Research Council of Australia, Sanofi Australia, and Abbott Diabetes Care.


Assuntos
Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/prevenção & controle , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica , Resultado do Tratamento
16.
Trials ; 20(1): 93, 2019 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-30700324

RESUMO

BACKGROUND: General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermittent retrospective continuous glucose monitoring (r-CGM) to usual care in patients with type 2 diabetes attending general practice. The study protocol was published in the British Medical Journal Open and described the principal features of the statistical methods that will be used to analyse the trial data. This paper provides greater detail on the statistical analysis plan, including background and justification for the statistical methods chosen, in accordance with SPIRIT guidelines. OBJECTIVE: To describe in detail the data management process and statistical methods that will be used to analyse the trial data. METHODS: An overview of the trial design and primary and secondary research questions are provided. Sample size assumptions and calculations are explained, and randomisation and data management processes are described in detail. The planned statistical analyses for primary and secondary outcomes and sub-group analyses are specified along with the intended table layouts for presentation of the results. CONCLUSION: In accordance with best practice, all analyses outlined in the document are based on the aims of the study and have been pre-specified prior to the completion of data collection and outcome analyses. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001372471 . Registered on 3 August 2016.


Assuntos
Automonitorização da Glicemia/métodos , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/diagnóstico , Medicina Geral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Austrália , Biomarcadores/sangue , Automonitorização da Glicemia/estatística & dados numéricos , Interpretação Estatística de Dados , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/terapia , Feminino , Medicina Geral/estatística & dados numéricos , Hemoglobinas Glicadas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Valor Preditivo dos Testes , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
17.
Artigo em Inglês | MEDLINE | ID: mdl-30131956

RESUMO

In order to accommodate the forthcoming wealth of health and disease related information, from genome to body sensors to population and the environment, the approach to disease description and definition demands re-examination. Traditional classification methods remain trapped by history; to provide the descriptive features that are required for a comprehensive description of disease, systems science, which realizes dynamic processes, adaptive response, and asynchronous communication channels, must be applied (Wolkenhauer et al., 2013). When Disease is viewed beyond the thresholds of lines and threshold boundaries, disease definition is not only the result of reductionist, mechanistic categories which reluctantly face re-composition. Disease is process and synergy as the characteristics of Systems Biology and Systems Medicine are included. To capture the wealth of information and contribute meaningfully to medical practice and biology research, Disease classification goes beyond a single spatial biologic level or static time assignment to include the interface of Disease process and organism response (Bechtel, 2017a; Green et al., 2017).

18.
PLoS One ; 13(8): e0200832, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30089149

RESUMO

OBJECTIVE: Gestational Diabetes Mellitus (GDM) increases the risk of type 2 diabetes. A register can be used to follow-up high risk women for early intervention to prevent progression to type 2 diabetes. We evaluate the performance of the world's first national gestational diabetes register. RESEARCH DESIGN AND METHODS: Observational study that used data linkage to merge: (1) pathology data from the Australian states of Victoria (VIC) and South Australia (SA); (2) birth records from the Consultative Council on Obstetric and Paediatric Mortality and Morbidity (CCOPMM, VIC) and the South Australian Perinatal Statistics Collection (SAPSC, SA); (3) GDM and type 2 diabetes register data from the National Gestational Diabetes Register (NGDR). All pregnancies registered on CCOPMM and SAPSC for 2012 and 2013 were included-other data back to 2008 were used to support the analyses. Rates of screening for GDM, rates of registration on the NGDR, and rates of follow-up laboratory screening for type 2 diabetes are reported. RESULTS: Estimated GDM screening rates were 86% in SA and 97% in VIC. Rates of registration on the NGDR ranged from 73% in SA (2013) to 91% in VIC (2013). During the study period rates of screening at six weeks postpartum ranged from 43% in SA (2012) to 58% in VIC (2013). There was little evidence of recall letters resulting in screening 12 months follow-up. CONCLUSIONS: GDM Screening and NGDR registration was effective in Australia. Recall by mail-out to young mothers and their GP's for type 2 diabetes follow-up testing proved ineffective.


Assuntos
Diabetes Gestacional/epidemiologia , Programas de Rastreamento/métodos , Sistema de Registros/estatística & dados numéricos , Adulto , Diabetes Mellitus Tipo 2/prevenção & controle , Programas de Triagem Diagnóstica , Feminino , Seguimentos , Humanos , Gravidez , Registros , Fatores de Risco , Austrália do Sul , Vitória
19.
BMJ Open ; 8(7): e021435, 2018 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-30018097

RESUMO

INTRODUCTION: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP). METHODS AND ANALYSIS: General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking 'does intermittent r-CGM in adults with T2D in primary care improve HbA1c?' PRIMARY OUTCOME: Absolute difference in mean HbA1c at 12 months follow-up between intervention and control arms. SECONDARY OUTCOMES: (a) r-CGM per cent time in target (4-10 mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes). ELIGIBILITY: Aged 18-80 years, T2D for ≥1 year, a (past month) HbA1c>5.5 mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four months). Our general glycaemic target is 53 mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64 mmol/mol (8%)).Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1 hour education by a specialist diabetes nurse.The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5 mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition). ETHICS AND DISSEMINATION: University of Melbourne Human Ethics Sub-Committee (ID 1647151.1). Dissemination will be in peer-reviewed journals, conferences and a plain-language summary for participants. TRIAL REGISTRATION NUMBER: >ACTRN12616001372471; Pre-results.


Assuntos
Automonitorização da Glicemia , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/sangue , Medicina Geral , Hemoglobinas Glicadas/metabolismo , Hipoglicemia/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto , Idoso , Feminino , Humanos , Hipoglicemia/prevenção & controle , Masculino , Pessoa de Meia-Idade , Formulação de Políticas , Estudos Retrospectivos , Adulto Jovem
20.
Medicines (Basel) ; 5(2)2018 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-29899241

RESUMO

Background: The effect of synchronous chemotherapy in squamous cell carcinoma of the head and neck (SCCHN) has been modelled as additional Biologically Effective Dose (BED) or as a prolonged tumour cell turnover time during accelerated repopulation. Such models may not accurately predict the local control seen when hypofractionated accelerated radiotherapy is used with synchronous chemotherapy. Methods: For the purposes of this study three isoeffect relationships were assumed: Firstly, from the RTOG 0129 trial, synchronous cisplatin chemotherapy with 70 Gy in 35 fractions over 46 days results in equivalent local control to synchronous cisplatin chemotherapy with 36 Gy in 18# followed by 36 Gy in 24# (2# per day) over a total of 39 days. Secondly, in line with primary local control outcomes from the PET-Neck study, synchronous cisplatin chemotherapy with 70 Gy in 35# over 46 days results in equivalent local control to synchronous cisplatin chemotherapy delivered with 65 Gy in 30# over 39 days. Thirdly, from meta-analysis data, 70 Gy in 35# over 46 days with synchronous cisplatin results in equivalent local control to 84 Gy in 70# over 46 days delivered without synchronous chemotherapy. Using the linear quadratic equation the above isoeffect relationships were expressed algebraically to determine values of α, α/β, and k for SCCHN when treated with synchronous cisplatin using standard parameters for the radiotherapy alone schedule (α = 0.3 Gy−1, α/β = 10 Gy, and k = 0.42 Gy10day−1). Results: The values derived for α/β, α and k were 2 Gy, 0.20 and 0.21 Gy−1, and 0.65 and 0.71 Gy2day−1. Conclusions: Within the limitations of the assumptions made, this model suggests that accelerated repopulation may remain a significant factor when synchronous chemotherapy is delivered with radiotherapy in SCCHN. The finding of a low α/β for SCCHN treated with cisplatin suggests a greater tumour susceptibility to increasing dose per fraction and underlines the importance of the completion of randomized trials examining the role of hypofractionated acceleration in SCCHN.

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