Approximately 12–20% of those with osteoarthritis (OA) in Australia who undergo total knee replacement (TKR) surgery do not report any clinical improvement. There is a need to develop prediction ...tools for use in general practice that allow early identification of patients likely to undergo TKR and those unlikely to benefit from the surgery. First-line treatment strategies can then be implemented and optimised to delay or prevent the need for TKR. The identification of potential non-responders to TKR may provide the opportunity for new treatment strategies to be developed and help ensure surgery is reserved for those most likely to benefit. This statistical analysis plan (SAP) details the statistical methodology used to develop such prediction tools.
To describe in detail the statistical methods used to develop and validate prediction models for TKR surgery in Australian patients with OA for use in general practice.
This SAP contains a brief justification for the need for prediction models for TKR surgery in general practice. A description of the data sources that will be linked and used to develop the models, and estimated sample sizes is provided. The planned methodologies for candidate predictor selection, model development, measuring model performance and internal model validation are described in detail. Intended table layouts for presentation of model results are provided.
Consistent with best practice guidelines, the statistical methodologies outlined in this SAP have been pre-specified prior to data pre-processing and model development.
Background and objective: General practitioners provide essential primary care to paediatric patients. The aim of this study was to explore associations between prevocational paediatric experiences ...of general practice registrars and their confidence in providing paediatric care in the general practice setting.
Methods: This was a cross-sectional observational study. Paediatric experiences and level of confidence ratings were collected using an online survey emailed to 530 Victorian general practice registrars in 2017; the response rate was 41% (217/530). Analysis used descriptive statistics, cross tabulation and Fishers' exact test.
Results: The most common paediatric training was undertaken in a general hospital emergency department (180/197, 91%). The majority of registrars reported that they felt confident or very confident in managing acute presentations (92% for upper respiratory tract infection, 80% for asthma, 81% for immunisation), but fewer were confident in managing mental health, behavioural or developmental presentations (all <36%).
Discussion: Registrars felt more confident managing acute presentations. However, the predominantly hospital-based prevocational paediatric training offers limited exposure to - and, thus, confidence in - managing behavioural, mental health and developmental issues. Training opportunities to address this identified gap should be explored.
The objective of this study was to develop and internally validate a clinical algorithm for use in general practice that predicts the probability of total knee replacement (TKR) surgery within the ...next five years for patients with osteoarthritis. The purpose of the model is to encourage early uptake of first-line treatment strategies in patients likely to undergo TKR and to provide a cohort for the development and testing of novel interventions that prevent or delay the progression to TKR.
Electronic health records (EHRs) from 201,462 patients with osteoarthritis aged 45 years and over from 483 general practices across Australia were linked with records from the Australian Orthopaedic Association National Joint Replacement Registry and the National Death Index. A Fine and Gray competing risk prediction model was developed using these data to predict the risk of TKR within the next five years.
During a follow-up time of 5 years, 15,979 (7.9%) patients underwent TKR and 13,873 (6.9%) died. Predictors included in the final algorithm were age, previous knee replacement, knee surgery (other than TKR), prescribing of osteoarthritis medication in the 12 months prior, comorbidity count and diagnosis of a mental health condition. Optimism corrected model discrimination was 0.67 (95% CI: 0.66 to 0.67) and model calibration acceptable.
The model has the potential to reduce some of the economic burden associated with TKR in Australia. External validation and further optimisation of the algorithm will be carried out prior to implementation within Australian general practice EHR systems.
Australia and New Zealand have the highest incidence rates of colorectal cancer worldwide. In Australia there is significant unwarranted variation in colorectal cancer screening due to low uptake of ...the immunochemical faecal occult blood test, poor identification of individuals at increased risk of colorectal cancer, and over-referral of individuals at average risk for colonoscopy. Our pre-trial research has developed a novel Colorectal cancer RISk Prediction (CRISP) tool, which could be used to implement precision screening in primary care. This paper describes the protocol for a phase II multi-site individually randomised controlled trial of the CRISP tool in primary care.
This trial aims to test whether a standardised consultation using the CRISP tool in general practice (the CRISP intervention) increases risk-appropriate colorectal cancer screening compared to control participants who receive standardised information on cancer prevention. Patients between 50 and 74 years old, attending an appointment with their general practitioner for any reason, will be invited into the trial. A total of 732 participants will be randomised to intervention or control arms using a computer-generated allocation sequence stratified by general practice. The primary outcome (risk-appropriate screening at 12 months) will be measured using baseline data for colorectal cancer risk and objective health service data to measure screening behaviour. Secondary outcomes will include participant cancer risk perception, anxiety, cancer worry, screening intentions and health service utilisation measured at 1, 6 and 12 months post randomisation.
This trial tests a systematic approach to implementing risk-stratified colorectal cancer screening in primary care, based on an individual's absolute risk, using a state-of-the-art risk assessment tool. Trial results will be reported in 2020.
Australian and New Zealand Clinical Trial Registry, ACTRN12616001573448p . Registered on 14 November 2016.
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.
To describe in detail the data management process and statistical methods that will be used to analyse the trial data.
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.
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.
Australian New Zealand Clinical Trials Registry, ACTRN12616001372471 . Registered on 3 August 2016.
Objective: To report patient responses to the General Practice Assessment Questionnaire (GPAQ) as a measure of satisfaction with health care received from Australian general practitioners.
Design, ...setting and participants: A clustered cross‐sectional study involving general practice patients from 30 randomly selected general practices in Victoria. Between January and December 2005, a screening survey, including a postal version of the GPAQ, was mailed to 17 780 eligible patients.
Main outcome measure: Scores on the six GPAQ items.
Results: We analysed data from 7130 patients who completed the screening survey and fulfilled our eligibility criteria. Levels of patient satisfaction with general practice care were generally high: mean GPAQ scores ranged from 68.6 (95% CI, 66.1–71.0) for satisfaction with access to the practice to 84.0 (95% CI, 82.2–85.4) for satisfaction with communication. Intracluster correlations for the GPAQ items ranged from 0.016 for overall satisfaction with the practice to 0.163 for satisfaction with access to the practice. Compared with national benchmarks in the United Kingdom, the GPs and practices participating in our study were rated higher on all six GPAQ items. Multivariable mixed effects linear regression showed that patients who were older, rated their health more highly, visited their GP more frequently and saw the same GP each time tended to express greater satisfaction with their care.
Conclusion: Generally patients reported high levels of satisfaction with GP care. Greater satisfaction with care was associated with older patients, good health, more frequent contact with the GP, and seeing the one GP consistently.
The Effect of Flexible Low Glycemic Index Dietary Advice Versus Measured Carbohydrate Exchange Diets on Glycemic Control in
Children With Type 1 Diabetes
Heather R. Gilbertson , GDD 1 ,
Jennie C. ...Brand-Miller , PHD 4 ,
Anne W. Thorburn , PHD 5 ,
Sharon Evans , MND 1 ,
Patty Chondros , MSC 2 and
George A. Werther , MD 3
1 Department of Nutrition and Food Services, the
2 Department of Clinical Epidemiology and Biostatistics, and the
3 Department of Endocrinology and Diabetes, Royal Children’s Hospital, Melbourne
4 Human Nutrition Unit, Department of Biochemistry, University of Sydney
5 Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Melbourne, Australia
Abstract
OBJECTIVE —To determine the long-term effect of low glycemic index dietary advice on metabolic control and quality of life in children
with type 1 diabetes.
RESEARCH DESIGN AND METHODS —Children with type 1 diabetes ( n = 104) were recruited to a prospective, stratified, randomized, parallel study to examine the effects of a measured carbohydrate
exchange (CHOx) diet versus a more flexible low–glycemic index (GI) dietary regimen on HbA 1c levels, incidence of hypo- and hyperglycemia, insulin dose, dietary intake, and measures of quality of life over 12 months.
RESULTS —At 12 months, children in the low-GI group had significantly better HbA 1c levels than those in the CHOx group (8.05 ± 0.95 vs. 8.61 ± 1.37%, P = 0.05). Rates of excessive hyperglycemia (>15 episodes per month) were significantly lower in the low-GI group (35 vs. 66%,
P = 0.006). There were no differences in insulin dose, hypoglycemic episodes, or dietary composition. The low-GI dietary regimen
was associated with better quality of life for both children and parents.
CONCLUSIONS —Flexible dietary instruction based on the food pyramid with an emphasis of low-GI foods improves HbA 1c levels without increasing the risk of hypoglycemia and enhances the quality of life in children with diabetes.
BMR, basal metabolic rate
CHOx, carbohydrate exchange
GI, glycemic index
NMES, nonmilk extrinsic sugars
RCH, Royal Children’s Hospital
Footnotes
Address correspondence and reprint requests to Heather R. Gilbertson, Department of Nutrition and Food Services, Women’s and
Children’s Health Care Network, Royal Children’s Hospital, Melbourne, Parkville, VIC, Australia 3052. E-mail: gilberth{at}cryptic.rch.unimelb.edu.au .
Received for publication 19 October 2000 and accepted in revised form 26 March 2001.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
Intimate partner abuse (IPA) is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, ...hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs) in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours.
weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years) seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation and outcomes.
The weave trial responds to an urgent need for more evidence on what can be achieved in primary care with regard to responding to women who experience IPA. It will provide important knowledge about the effectiveness of a brief method of screening, professional IPA training program and brief counselling for women.
ACTRN12608000032358.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from ...risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing.
clinicians' detection of risk-taking and emotional distress, young people's intention to change and reduction of risk taking.
pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol.
PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff's self-perceived competency in young people's care and clinicians' detection and response to risk taking behaviours and emotional distress in 14-24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking behaviour and emotional distress three and 12 months post consultation.
The PARTY trial is the first to examine the effectiveness and efficiency of a psychosocial risk screening and counselling intervention for young people attending primary care. It will provide important data on health risk profiles of young people attending general practice and on the effects of the intervention on engagement with primary care and health outcomes over 12 months.
ISRCTN16059206.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Cluster sample study designs are cost effective, however cluster samples violate the simple random sample assumption of independence of observations. Failure to account for the intra-cluster ...correlation of observations when sampling through clusters may lead to an under-powered study. Researchers therefore need estimates of intra-cluster correlation for a range of outcomes to calculate sample size. We report intra-cluster correlation coefficients observed within a large-scale cross-sectional study of general practice in Australia, where the general practitioner (GP) was the primary sampling unit and the patient encounter was the unit of inference.
Each year the Bettering the Evaluation and Care of Health (BEACH) study recruits a random sample of approximately 1,000 GPs across Australia. Each GP completes details of 100 consecutive patient encounters. Intra-cluster correlation coefficients were estimated for patient demographics, morbidity managed and treatments received. Intra-cluster correlation coefficients were estimated for descriptive outcomes and for associations between outcomes and predictors and were compared across two independent samples of GPs drawn three years apart.
Between April 1999 and March 2000, a random sample of 1,047 Australian general practitioners recorded details of 104,700 patient encounters. Intra-cluster correlation coefficients for patient demographics ranged from 0.055 for patient sex to 0.451 for language spoken at home. Intra-cluster correlations for morbidity variables ranged from 0.005 for the management of eye problems to 0.059 for management of psychological problems. Intra-cluster correlation for the association between two variables was smaller than the descriptive intra-cluster correlation of each variable. When compared with the April 2002 to March 2003 sample (1,008 GPs) the estimated intra-cluster correlation coefficients were found to be consistent across samples.
The demonstrated precision and reliability of the estimated intra-cluster correlations indicate that these coefficients will be useful for calculating sample sizes in future general practice surveys that use the GP as the primary sampling unit.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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