General Practice and Primary Care - Research Publications
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ItemDeveloping and internally validating a prediction model for total knee replacement surgery in patients with osteoarthritis.(Elsevier BV, 2022-09)OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSION: 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.
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ItemTowards a health promoting university: descriptive findings on health, wellbeing and academic performance amongst university students in Australia(BMC, 2022-12-27)BACKGROUND: Universities are increasingly recognised as institutions where health and wellbeing can be promoted to maximise academic outcomes, career transitions, and lifelong positive health behaviours. There is concern about the mental health of university students and other factors which affect academic outcomes particularly for subgroups such as international students. There are few cohort studies of the breadth of issues that can impact on mental health and academic outcomes for both local and international students. We conducted a baseline prevalence survey of students at a large Australian university covering health, academic, and social determinants of wellbeing. The purpose was to inform the university's new student health and wellbeing framework with a view to follow-up to determine predictors of mental ill-health and academic outcomes in the subsequent year. In this paper we present the baseline prevalence data and report on selected mental health and health care access issues for local and international students. METHODS: The entire university population as of April 2019 of over 56,375 students aged 18 or above were invited to complete the online survey. Questions explored eight domains: demographic characteristics, general health and wellbeing, mental health, risk taking behaviours, psychosocial stressors, learning and academic factors, social and cultural environment, and awareness of and access to health and wellbeing services. Records of academic results were also accessed and matched with survey data for a large subset of students providing consent. RESULTS: Fourteen thousand eight hundred eighty (26.4%) students commenced our survey and were representative of the entire student population on demographic characteristics. Three quarters were aged between 18 to 25 years and one third were international students. Eighty-five percent consented to access of their academic records. Similar proportions of local and international students experienced symptoms of a depression or anxiety disorder, however international students were less aware of and less likely to access available health services both inside and external to the university. We also reported on the prevalence of: general lifestyle factors (diet, exercise, amount of daily sleep); risk-taking behaviours (including alcohol, tobacco and other drug use; unprotected sexual activity); psychosocial stressors (financial, intimate partner violence, discrimination, academic stressors, acculturative stress); subjects failed; resilience; social supports; social media use; and health services accessed online. CONCLUSIONS: This rigorous and comprehensive examination of the health status of local and international students in an Australian university student population establishes the prevalence of mental health issues and other psychosocial determinants of health and wellbeing, along with academic performance. This study will inform a university-wide student wellbeing framework to guide health and wellbeing promotion and is a baseline for a 12-month follow-up of the cohort in 2020 during the COVID-19 pandemic.
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ItemThe SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care(BMC, 2022-09-27)BACKGROUND: Polygenic risk scores (PRSs) can predict the risk of colorectal cancer (CRC) and target screening more precisely than current guidelines using age and family history alone. Primary care, as a far-reaching point of healthcare and routine provider of cancer screening and risk information, may be an ideal location for their widespread implementation. METHODS: This trial aims to determine whether the SCRIPT intervention results in more risk-appropriate CRC screening after 12 months in individuals attending general practice, compared with standard cancer risk reduction information. The SCRIPT intervention consists of a CRC PRS, tailored risk-specific screening recommendations and a risk report for participants and their GP, delivered in general practice. Patients aged between 45 and 70 inclusive, attending their GP, will be approached for participation. For those over 50, only those overdue for CRC screening will be eligible to participate. Two hundred and seventy-four participants will be randomised to the intervention or control arms, stratified by general practice, using a computer-generated allocation sequence. The primary outcome is risk-appropriate CRC screening after 12 months. For those in the intervention arm, risk-appropriate screening is defined using PRS-derived risk; for those in the control arm, it is defined using family history and national screening guidelines. Timing, type and results of the previous screening are considered in both arms. Objective health service data will capture screening behaviour. Secondary outcomes include cancer-specific worry, risk perception, predictors of CRC screening behaviour, screening intentions and health service use at 1, 6 and 12 months post-intervention delivery. DISCUSSION: This trial aims to determine whether a PRS-derived personalised CRC risk estimate delivered in primary care increases risk-appropriate CRC screening. A future population risk-stratified CRC screening programme could incorporate risk assessment within primary care while encouraging adherence to targeted screening recommendations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000092897p. Registered on 1 February 2021.
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ItemEconomic evaluation of a Decision Support Tool to guide intensity of mental health care in general practice: the Link-me pragmatic randomised controlled trial(BMC, 2022-09-16)BACKGROUND: This paper reports on the cost-effectiveness evaluation of Link-me - a digitally supported, systematic approach to triaging care for depression and anxiety in primary care that uses a patient-completed Decision Support Tool (DST). METHODS: The economic evaluation was conducted alongside a parallel, stratified individually randomised controlled trial (RCT) comparing prognosis-matched care to usual care at six- and 12-month follow-up. Twenty-three general practices in three Australian Primary Health Networks recruited 1,671 adults (aged 18 - 75 years), predicted by the DST to have minimal/mild or severe depressive or anxiety symptoms in three months. The minimal/mild prognostic group was referred to low intensity services. Participants screened in the severe prognostic group were offered high intensity care navigation, a model of care coordination. The outcome measures included in this evaluation were health sector costs (including development and delivery of the DST, care navigation and other healthcare services used) and societal costs (health sector costs plus lost productivity), psychological distress [Kessler Psychological Distress Scale (K10)] and quality adjusted life years (QALYs) derived from the EuroQol 5-dimension quality of life questionnaire with Australian general population preference weights applied. Costs were valued in 2018-19 Australian dollars (A$). RESULTS: Across all participants, the health sector incremental cost-effectiveness ratio (ICER) of Link-me per point decrease in K10 at six months was estimated at $1,082 (95% CI $391 to $6,204) increasing to $2,371 (95% CI $191 to Dominated) at 12 months. From a societal perspective, the ICER was estimated at $1,257/K10 point decrease (95% CI Dominant to Dominated) at six months, decreasing to $1,217 (95% CI Dominant to Dominated) at 12 months. No significant differences in QALYs were detected between trial arms and the intervention was dominated (less effective, more costly) based on the cost/QALY ICER. CONCLUSIONS: The Link-me approach to stepped mental health care would not be considered cost-effective utilising a cost/QALY outcome metric commonly adopted by health technology assessment agencies. Rather, Link-me showed a trend toward cost-effectiveness by providing improvement in mental health symptoms, measured by the K10, at an additional cost. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ANZCTRN 12617001333303.
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ItemEconomic evaluation of the Target-D platform to match depression management to severity prognosis in primary care: A within-trial cost-utility analysis(PUBLIC LIBRARY SCIENCE, 2022)BACKGROUND: Target-D, a new person-centred e-health platform matching depression care to symptom severity prognosis (minimal/mild, moderate or severe) has demonstrated greater improvement in depressive symptoms than usual care plus attention control. The aim of this study was to evaluate the cost-effectiveness of Target-D compared to usual care from a health sector and partial societal perspective across 3-month and 12-month follow-up. METHODS AND FINDINGS: A cost-utility analysis was conducted alongside the Target-D randomised controlled trial; which involved 1,868 participants attending 14 general practices in metropolitan Melbourne, Australia. Data on costs were collected using a resource use questionnaire administered concurrently with all other outcome measures at baseline, 3-month and 12-month follow-up. Intervention costs were assessed using financial records compiled during the trial. All costs were expressed in Australian dollars (A$) for the 2018-19 financial year. QALY outcomes were derived using the Assessment of Quality of Life-8D (AQoL-8D) questionnaire. On a per person basis, the Target-D intervention cost between $14 (minimal/mild prognostic group) and $676 (severe group). Health sector and societal costs were not significantly different between trial arms at both 3 and 12 months. Relative to a A$50,000 per QALY willingness-to-pay threshold, the probability of Target-D being cost-effective under a health sector perspective was 81% at 3 months and 96% at 12 months. From a societal perspective, the probability of cost-effectiveness was 30% at 3 months and 80% at 12 months. CONCLUSIONS: Target-D is likely to represent good value for money for health care decision makers. Further evaluation of QALY outcomes should accompany any routine roll-out to assess comparability of results to those observed in the trial. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000537459).
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ItemProtocol for a cluster randomized control trial of the impact of the Breaking the Man Code workshops on adolescent boys' intentions to seek help(BMC, 2022-02-03)BACKGROUND: Males in Australia and many other countries account for three-quarters of all deaths by suicide. School-based programs to support young men's wellbeing have become increasingly common in recent years and show much promise to tackle the issue of male suicide by fostering protective factors and mitigating harmful factors. However, only a few of these programs have been evaluated. This trial seeks to address the lack of knowledge about the potential for school-based gender-transformative programs to have a positive impact on boys. Breaking the Man Code workshops, delivered by Tomorrow Man in Australia, challenge and transform harmful masculinities with young men with a view to ultimately reducing their suicide risk. The trial aims to examine whether adolescent boys who participate in the Breaking the Man Code workshop demonstrate an increase in their likelihood of seeking help for personal or emotional problems compared to boys waiting to take part in the workshop. METHODS: A stratified cluster randomized controlled superiority trial with two parallel groups will be conducted. Schools will be randomly allocated 1:1, stratified by location of the schools (rural or urban), state (Victoria, NSW, or WA), and mode of workshop delivery (face-to-face or online), to the intervention group and waitlist control group. DISCUSSION: The Breaking the Man Code workshops show great promise as a school-based prevention intervention. The trial will fill a gap in knowledge that is critically needed to inform future interventions with boys and men. Some methodological challenges have been identified related to the COVID-19 pandemic in Australia, such as delays in ethics approvals and the need for Tomorrow Man to introduce an online delivery option for the workshop. The trial protocol has been designed to mitigate these challenges. The findings from the trial will be used to improve the workshops and will assist others who are designing and implementing suicide prevention interventions for boys and men. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12620001134910 ). Registered on 30 October 2020.
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ItemThe SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program(BMC, 2022-01-12)BACKGROUND: Increasing participation in the Australian National Bowel Cancer Screening Program (NBCSP) is the most efficient and cost-effective way of reducing mortality associated with colorectal cancer by detecting and treating early-stage disease. Currently, only 44% of Australians aged 50-74 years complete the NBCSP. This efficacy trial aims to test whether this SMS intervention is an effective method for increasing participation in the NBCSP. Furthermore, a process evaluation will explore the barriers and facilitators to sending the SMS from general practice. METHODS: We will recruit 20 general practices in the western region of Victoria, Australia to participate in a cluster randomised controlled trial. General practices will be randomly allocated with a 1:1 ratio to either a control or intervention group. Established general practice software will be used to identify patients aged 50 to 60 years old who are due to receive a NBCSP kit in the next month. The SMS intervention includes GP endorsement and links to narrative messages about the benefits of and instructions on how to complete the NBCSP kit. It will be sent from intervention general practices to eligible patients prior to receiving the NBCSP kit. We require 1400 eligible patients to provide 80% power with a two-sided 5% significance level to detect a 10% increase in CRC screening participation in the intervention group compared to the control group. Our primary outcome is the difference in the proportion of eligible patients who completed a faecal occult blood test (FOBT) between the intervention and control group for up to 12 months after the SMS was sent, as recorded in their electronic medical record (EMR). A process evaluation using interview data collected from general practice staff (GP, practice managers, nurses) and patients will explore the feasibility and acceptability of sending and receiving a SMS to prompt completing a NBCSP kit. DISCUSSION: This efficacy trial will provide initial trial evidence of the utility of an SMS narrative intervention to increase participation in the NBCSP. The results will inform decisions about the need for and design of a larger, multi-state trial of this SMS intervention to determine its cost-effectiveness and future implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001020976 . Registered on 17 October 2020.
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ItemAssessing the suitability of general practice electronic health records for clinical prediction model development: a data quality assessment(BMC, 2021-10-30)BACKGROUND: The use of general practice electronic health records (EHRs) for research purposes is in its infancy in Australia. Given these data were collected for clinical purposes, questions remain around data quality and whether these data are suitable for use in prediction model development. In this study we assess the quality of data recorded in 201,462 patient EHRs from 483 Australian general practices to determine its usefulness in the development of a clinical prediction model for total knee replacement (TKR) surgery in patients with osteoarthritis (OA). METHODS: Variables to be used in model development were assessed for completeness and plausibility. Accuracy for the outcome and competing risk were assessed through record level linkage with two gold standard national registries, Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and National Death Index (NDI). The validity of the EHR data was tested using participant characteristics from the 2014-15 Australian National Health Survey (NHS). RESULTS: There were substantial missing data for body mass index and weight gain between early adulthood and middle age. TKR and death were recorded with good accuracy, however, year of TKR, year of death and side of TKR were poorly recorded. Patient characteristics recorded in the EHR were comparable to participant characteristics from the NHS, except for OA medication and metastatic solid tumour. CONCLUSIONS: In this study, data relating to the outcome, competing risk and two predictors were unfit for prediction model development. This study highlights the need for more accurate and complete recording of patient data within EHRs if these data are to be used to develop clinical prediction models. Data linkage with other gold standard data sets/registries may in the meantime help overcome some of the current data quality challenges in general practice EHRs when developing prediction models.
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ItemThe CORE study-An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized-controlled trial(WILEY, 2021-12)BACKGROUND: Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. OBJECTIVE: The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery-orientation of services led to greater psychosocial recovery outcomes for service users. DESIGN: A stepped wedge cluster randomized-controlled trial was conducted. SETTING AND PARTICIPANTS: Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. MAIN OUTCOME MEASURES: The 24-item Revised Recovery Assessment Scale (RAS-R) measured individual psychosocial recovery. RESULTS: A total of 841 observations were completed with 287 service users. The intention-to-treat analysis found RAS-R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS-R score was -1.70 (95% confidence interval: -3.81 to 0.40; p = .11). DISCUSSION: This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. CONCLUSIONS: More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. PATIENT AND PUBLIC INVOLVEMENT: The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived-experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.
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ItemAn RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial(BMC, 2021-07-15)BACKGROUND: Australian guidelines recommend that all people aged 50-70 years old actively consider taking daily low-dose aspirin (100-300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). Despite the change of national CRC prevention guidelines, there has been no active implementation of the guidelines into clinical practice. We aim to test the efficacy of a health consultation and decision aid, using a novel expected frequency tree (EFT) to present the benefits and harms of low dose aspirin prior to a general practice consultation with patients aged 50-70 years, on informed decision-making and uptake of aspirin. METHODS: Approximately five to seven general practices in Victoria, Australia, will be recruited to participate. Patients 50-70 years old, attending an appointment with their general practitioner (GP) for any reason, will be invited to participate in the trial. Two hundred fifty-eight eligible participants will be randomly allocated 1:1 to intervention or active control arms using a computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery (face-to-face or teletrial). There are two co-primary outcomes: informed decision-making at 1-month post randomisation, measured by the Multi-dimensional Measure of Informed Choice (MMIC), and self-reported daily use of aspirin at 6 months. Secondary outcomes include decisional conflict at 1-month and other behavioural changes to reduce CRC risk at both time points. DISCUSSION: This trial will test the efficacy of novel methods for implementing national guidelines to support informed decision-making about taking aspirin in 50-70-year-olds to reduce the risk of CRC and other chronic diseases. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020.