General Practice and Primary Care - Research Publications

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    An exploratory trial of insulin initiation and titration among patients with type 2 diabetes in the primary care setting with retrospective continuous glucose monitoring as an adjunct: INITIATION study protocol
    Blackberry, ID ; Furler, JS ; Ginnivan, LE ; Derraz, H ; Jenkins, A ; Cohen, N ; Best, JD ; Young, D ; Liew, D ; Ward, G ; Manski-Nankervis, J-A ; O'Neal, DN (BMC, 2014-05-03)
    BACKGROUND: Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes (T2D). The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse (PN) teams supported by a Credentialed Diabetes Educator-Registered Nurse (CDE-RN) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24 weeks. This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring (r-CGM) in comparison with self-monitoring of blood glucose (SMBG) among people with T2D in primary care. METHODS/DESIGN: The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM. A total of 102 insulin naïve T2D patients with a glycated haemoglobin (HbA1c) level of >7.5% in the previous 6 months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne, Australia. All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms, with intensification to a "basal plus" regimen if required. The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne, Australia. DISCUSSION: This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care. Findings from the INITIATION study will inform development of a larger randomized controlled trial. TRIAL REGISTRATION: ACTRN12610000797077.
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    Socioeconomic status and time in glucose target range in people with type 2 diabetes: a baseline analysis of the GP-OSMOTIC study
    Tan, ML ; Manski-Nankervis, J-A ; Thuraisingam, S ; Jenkins, A ; O'Neal, D ; Furler, J (BMC, 2018-07-21)
    BACKGROUND: Optimal glycaemia, reflected by glycated haemoglobin (HbA1c) levels, is key in reducing type 2 diabetes (T2D) complications. However, most people with T2D have suboptimal recall and understanding of HbA1c. Continuous glucose monitoring (CGM) measures glucose levels every 5 to 15-min over days and may be more readily understood. Given that T2D is more common in lower socioeconomic settings, we aim to study relationships between socioeconomic status (SES) and percentage time in glucose target range (TIR) which is a key metric calculated from CGM. METHODS: Analysis of baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) randomised controlled trial (October 2016 - November 2017) of 300 people with T2D from 25 Victorian General Practices. FreeStyle Libre Pro® sensor patch was used for this study. SES was defined by the Index of Relative Socio-economic Disadvantage (IRSD) and educational attainment. Univariable and multivariable mixed-effects linear regression analyses controlling for age, BMI, diet, exercise and study arm were performed. RESULTS: One hundred and sixty-seven (60.1%) participants were male, the mean (SD) participant age was 61.0 (9.7) years, and the mean (SD) duration of CGM use was 12.3 (2.5) days. The 10th IRSD decile (least disadvantaged) was associated with a 15% higher TIR vs. the 1st decile (most disadvantaged) (95% CI 5, 25; p = 0.003) and a 0.6% lower HbA1c (95% CI 0.1, 1; p = 0.03). There was no evidence of an association between educational attainment and TIR/HbA1c. CONCLUSION: Higher SES measured at an area level is associated with better achievement of glycaemic target using complementary measures of HbA1c and TIR in the GP-OSMOTIC cohort. Given that TIR may be more easily used in patient education and self-management support compared to HbA1c values, the social gradient identified in TIR provides an opportunity for clinicians and policy makers to address health inequities in T2D. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry Trial ACTRN12616001372471 , prospective, Date registered 4/10/2016.
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    What are the patient factors that impact on decisions to progress to total knee replacement? A qualitative study involving patients with knee osteoarthritis
    O'Brien, P ; Bunzli, S ; Ayton, D ; Dowsey, MM ; Gunn, J ; Manski-Nankervis, J-A (BMJ PUBLISHING GROUP, 2019-09)
    OBJECTIVES: General practitioners (GPs) are often the first health professionals to assess patients with osteoarthritis (OA). Despite clinical guideline recommendations for non-surgical intervention as first-line therapies, the most frequent referral from a GP for a person with knee OA is to an orthopaedic surgeon. The aim of our study was to explore patient factors that impact on the decision to progress to total knee replacement (TKR), including the experience of patients in general practice, their perceptions of their condition, and their access and use of community-based allied health interventions. DESIGN: Qualitative investigation using semi-structured interviews. The Candidacy framework was selected as a lens to examine the factors driving healthcare access. Data were analysed using a thematic analysis approach. Codes identified in the data were mapped to the seven Candidacy domains. Themes corresponding to each domain were described. SETTING: A public hospital in Melbourne, Australia. PARTICIPANTS: 27 patients with knee OA who were on a waiting list to undergo TKR. RESULTS: Ten themes described factors influencing access and use of non-surgical interventions and decision-making for undergoing TKR: (1) History of knee problems, change in symptoms; (2) Physical and psychosocial functioning (Identification of Candidacy); (3) GP and social networks as information sources, access to care (Navigation); (4) Referral pathways (Permeability of services); (5) Communication of impact (Appearances at health services); (6) GP-Surgeon as the predominant referral pathway (Adjudications); (7) Physical activity as painful; (8) Beliefs about effectiveness of non-surgical interventions (Offers and resistance); (9) Familiarity with local system; and (10) Availability (Operating conditions and local production of Candidacy). CONCLUSIONS: Using the Candidacy framework to analyse patients' experiences when deciding to progress to TKR highlighted missed opportunities in general practice to orient patients to first try non-surgical interventions. Patients with knee OA also require improved support to navigate allied health services.
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    Prescribing of diabetes medications to people with type 2 diabetes and chronic kidney disease: a national cross-sectional study
    Manski-Nankervis, J-A ; Thuraisingam, S ; Sluggett, JK ; Kilov, G ; Furler, J ; O'Neal, D ; Jenkins, A (BMC, 2019-02-18)
    BACKGROUND: Previous studies in general practice and hospital settings have identified that prescribing of non-insulin diabetes medications may be sub-optimal in people with type 2 diabetes (T2D) and renal impairment. Since these publications, a number of new medications have become available for the management of T2D. Study aims were to, in a cohort of Australians with T2D and renal impairment attending general practice, (1) investigate whether the prescribing of non-insulin diabetes medications is consistent with dosing adjustments recommended within current Australian Diabetes Society (ADS) guidelines; and (2) identify patient socio-demographic and clinical factors associated with at least one prescription of a non-insulin diabetes medication inconsistent with current ADS guidelines for medication doses. METHODS: Cross-sectional study using data from the MedicineInsight general practice database managed by NPS MedicineWise. Patients with T2D who were aged 18 years and over, with an average eGFR< 60 ml/min/1.73m2 and at least one prescription of a non-insulin diabetes medication between 1st January 2015 and 30th June 2017 were included. Descriptive statistics were used to summarise patient characteristics and medication use. Marginal logistic regression models were used to estimate associations between sociodemographic and clinical factors and prescribing of ≥1non-insulin diabetes medicine not consistent with ADS guidelines. RESULTS: The majority of the 3505 patients included (90.4%) had an average eGFR of 30-59 ml/min/1.73m2. In terms of absolute numbers, metformin was the medication most frequently prescribed at a dose not consistent with current ADS guidelines for dosing in renal impairment (n = 1601 patients), followed by DPP4 inhibitors (n = 611) and sulphonylureas (n = 278). The drug classes with the highest proportion of prescriptions with dosage not consistent with ADS guidelines were SGLT2 inhibitors (83%), followed by biguanides (58%) and DPP4 inhibitors (46%). Higher HbA1c, longer known diabetes duration and diagnosis of retinopathy were associated with receiving ≥1prescription with a dosage not consistent with guidelines. CONCLUSIONS: Prescribing of non-insulin diabetes medications at doses inconsistent with current ADS guideline recommendations for dosing adjustments for people with renal impairment was common. Further research is needed to understand how general practitioners access, interpret and apply the ADS guidelines and the impact this may have on patient outcomes.
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    How do general practitioners access guidelines and utilise electronic medical records to make clinical decisions on antibiotic use? Results from an Australian qualitative study
    Biezen, R ; Roberts, C ; Buising, K ; Thursky, K ; Boyle, D ; Lau, P ; Clark, M ; Manski-Nankervis, J-A (BMJ PUBLISHING GROUP, 2019-08)
    OBJECTIVE: This study aimed to explore how general practitioners (GPs) access and use both guidelines and electronic medical records (EMRs) to assist in clinical decision-making when prescribing antibiotics in Australia. DESIGN: This is an exploratory qualitative study with thematic analysis interpreted using the Theory of Planned Behaviour (TPB) framework. SETTING: This study was conducted in general practice in Victoria, Australia. PARTICIPANTS: Twenty-six GPs from five general practices were recruited to participate in five focus groups between February and April 2018. RESULTS: GPs expressed that current EMR systems do not provide clinical decision support to assist with antibiotic prescribing. Access and use of guidelines were variable. GPs who had more clinical experience were less likely to access guidelines than younger and less experienced GPs. Guideline use and guideline-concordant prescribing was facilitated if there was a practice culture encouraging evidence-based practice. However, a lack of access to guidelines and perceived patients' expectation and demand for antibiotics were barriers to guideline-concordant prescribing. Furthermore, guidelines that were easy to access and navigate, free, embedded within EMRs and fit into the clinical workflow were seen as likely to enhance guideline use. CONCLUSIONS: Current barriers to the use of antibiotic guidelines include GPs' experience, patient factors, practice culture, and ease of access and cost of guidelines. To reduce inappropriate antibiotic prescribing and to promote more rational use of antibiotic in the community, guidelines should be made available, accessible and easy to use, with minimal cost to practicing GPs. Integration of evidence-based antibiotic guidelines within the EMR in the form of a clinical decision support tool could optimise guideline use and increase guideline-concordant prescribing.
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    Gathering data for decisions: best practice use of primary care electronic records for research
    Canaway, R ; Boyle, DIR ; Manski-Nankervis, J-AE ; Bell, J ; Hocking, JS ; Clarke, K ; Clark, M ; Gunn, JM ; Emery, JD (WILEY, 2019-03-31)
    In Australia, there is limited use of primary health care data for research and for data linkage between health care settings. This puts Australia behind many developed countries. In addition, without use of primary health care data for research, knowledge about patients' journeys through the health care system is limited. There is growing momentum to establish "big data" repositories of primary care clinical data to enable data linkage, primary care and population health research, and quality assurance activities. However, little research has been conducted on the general public's and practitioners' concerns about secondary use of electronic health records in Australia. International studies have identified barriers to use of general practice patient records for research. These include legal, technical, ethical, social and resource-related issues. Examples include concerns about privacy protection, data security, data custodians and the motives for collecting data, as well as a lack of incentives for general practitioners to share data. Addressing barriers may help define good practices for appropriate use of health data for research. Any model for general practice data sharing for research should be underpinned by transparency and a strong legal, ethical, governance and data security framework. Mechanisms to collect electronic medical records in ethical, secure and privacy-controlled ways are available. Before the potential benefits of health-related data research can be realised, Australians should be well informed of the risks and benefits so that the necessary social licence can be generated to support such endeavours.
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    Update on the General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) trial: statistical analysis plan for a multi-centre randomised controlled trial
    Thuraisingam, S ; Chondros, P ; Catchpool, M ; Dalziel, K ; Manski-Nankervis, J-A ; Speight, J ; Holmes-Truscott, E ; Audehm, R ; Chiang, J ; Blackberry, I ; O'Neal, D ; Khunti, K ; Best, J ; Furler, J (BMC, 2019-01-30)
    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.
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    Associations between multimorbidity, all-cause mortality and glycaemia in people with type 2 diabetes: A systematic review
    Chiang, JI ; Jani, BD ; Mair, FS ; Nicholl, BI ; Furler, J ; O'Neal, D ; Jenkins, A ; Condron, P ; Manski-Nankervis, J-A ; Tu, W-J (Public Library of Science (PLoS), 2018-12-26)
    Introduction: Type 2 diabetes (T2D) is a major health priority worldwide and the majority of people with diabetes live with multimorbidity (MM) (the co-occurrence of ≥2 chronic conditions). The aim of this systematic review was to explore the association between MM and all-cause mortality and glycaemic outcomes in people with T2D. Methods: The search strategy centred on: T2D, MM, comorbidity, mortality and glycaemia. Databases searched: MEDLINE, EMBASE, CINAHL Complete, The Cochrane Library, and SCOPUS. Restrictions included: English language, quantitative empirical studies. Two reviewers independently carried out: abstract and full text screening, data extraction, and quality appraisal. Disagreements adjudicated by a third reviewer. Results: Of the 4882 papers identified; 41 met inclusion criteria. The outcome was all-cause mortality in 16 studies, glycaemia in 24 studies and both outcomes in one study. There were 28 longitudinal cohort studies and 13 cross-sectional studies, with the number of participants ranging from 96–892,223. Included studies were conducted in high or upper-middle-income countries. Fifteen of 17 studies showed a statistically significant association between increasing MM and higher mortality. Ten of 14 studies showed no significant associations between MM and HbA1c. Four of 14 studies found higher levels of MM associated with higher HbA1c. Increasing MM was significantly associated with hypoglycaemia in 9/10 studies. There was no significant association between MM and fasting glucose (one study). No studies explored effects on glycaemic variability. Conclusions: This review demonstrates that MM in T2D is associated with higher mortality and hypoglycaemia, whilst evidence regarding the association with other measures of glycaemic control is mixed. The current single disease focused approach to management of T2D seems inappropriate. Our findings highlight the need for clinical guidelines to support a holistic approach to the complex care needs of those with T2D and MM, accounting for the various conditions that people with T2D may be living with.
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    GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice
    Furler, J ; O'Neal, DN ; Speight, J ; Blackberry, I ; Manski-Nankervis, J-A ; Thuraisingam, S ; de La Rue, K ; Ginnivan, L ; Browne, JL ; Holmes-Truscott, E ; Khunti, K ; Dalziel, K ; Chiang, J ; Audehm, R ; Kennedy, M ; Clark, M ; Jenkins, AJ ; Liew, D ; Clarke, P ; Best, J (BMJ PUBLISHING GROUP, 2018-09)
    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.
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    Impact of multimorbidity count on all-cause mortality and glycaemic outcomes in people with type 2 diabetes: a systematic review protocol
    Chiang, JI ; Furler, J ; Mair, FS ; Jani, B ; Nicholl, BI ; Jenkins, A ; Condron, P ; O'Neal, D ; Manski-Nankervis, J-A (BMJ GROUP, 2018)
    Introduction : Type 2 diabetes (T2D) is a leading health priority worldwide. Multimorbidity (MM) is a term describing the co-occurrence of two or more chronic diseases or conditions. The majority of people living with T2D have MM. The relationship between MM and mortality and glycaemia in people with T2D is not clear. Methods and analysis: Medline, Embase, Cumulative Index of Nursing and Allied Health Complete, The Cochrane Library, and SCOPUS will be searched with a prespecified search strategy. The searches will be limited to quantitative empirical studies in English with no restriction on publication date. One reviewer will perform title screening and two review authors will independently screen the abstract and full texts using Covidence software, with disagreements adjudicated by a third reviewer. Data will be extracted using a using a Population, Exposure, Comparator and Outcomes framework. Two reviewers will independently extract data and undertake the risk of bias (quality) assessment. Disagreements will be resolved by consensus. A narrative synthesis of the results will be conducted and meta-analysis considered if appropriate. Quality appraisal will be undertaken using the Newcastle-Ottawa quality assessment scale and the quality of the cumulative evidence of the included studies will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach. This protocol was prepared in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines to ensure the quality of our review. Ethics and dissemination: This review will synthesise the existing evidence about the impact of MM on mortality and glycaemic outcomes in people living with T2D and increase our understanding of this subject and will inform future practice and policy. Findings will be disseminated via conference presentations, social media and peer-reviewed publication.