Electronic consultations (eConsults): a proof of concept trial in Australia.

BACKGROUND: Electronic consultations (eConsults) allow general practitioners (GP) to seek the advice of a specialist via secure asynchronous digital communication. AIMS: To report the outcomes of a proof of concept (POC) trial of eConsults for patients with diabetes and endocrine disorders. METHODS: A prospective observational study conducted from November 2020 to May 2021. eConsults were provided by endocrinologists from the Princess Alexandra Hospital, Brisbane. The requests for advice were from GP in Brisbane South. An online questionnaire was completed by the GP and endocrinologist after each eConsult. RESULTS: Forty eConsults were performed over 7 months. The majority were in relation to type 2 diabetes (30%) or thyroid conditions (30%). All eConsult responses were performed within the target of 72 h with 92.5% responses provided within 24 h. The average time taken for the endocrinologist to perform the eConsult was 14.2 ± 4.4 min. The GP rated the value of eConsults as excellent 97% of the time. The eConsult resulted in a new or additional course of action 68% (19/28) of the time and confirmed a course of action 32% (9/28) of the time. The eConsult avoided the need for referral of the patient for a face-to-face specialist review in 55% of the eConsults. CONCLUSION: An eConsult service was able to be delivered by endocrinologists from a tertiary hospital to GP in Brisbane South. With an appropriate funding model, the broader implementation and adoption of eConsults has the potential to address specialist waiting lists and facilitate models of integrated care.

Clinical outcomes of an integrated primary-secondary model of care for individuals with complex type 2 diabetes: a non-inferiority randomised controlled trial.

AIMS/HYPOTHESIS: The aim of the study was to determine if a Beacon model of integrated care utilising general practitioners (GPs) with special interests could achieve similar clinical outcomes to a hospital-based specialist diabetes outpatient clinic. METHODS: This pragmatic non-inferiority multisite randomised controlled trial assigned individuals with complex type 2 diabetes to care delivered by a Beacon clinic or to usual care delivered by a hospital outpatient department, in a 3:1 ratio. Owing to the nature of the study, researchers were only blinded during the allocation process. Eligible participants were aged 18 or over, had been referred by their usual GP to the hospital central referral hub with type 2 diabetes and had been triaged to be seen within 30 or 90 days. The intervention consisted of diabetes management in primary care by GPs with a special interest who had been upskilled in complex diabetes under the supervision of an endocrinologist. The primary outcome was HbA1c at 12 months post-recruitment. The non-inferiority margin was 4.4 mmol/mol (0.4%). Both per-protocol and intention-to-treat analyses are reported. RESULTS: Between 27 November 2012 and 14 July 2015, 352 individuals were recruited and 305 comprised the intention-to-treat sample (71 in usual care group and 234 in the Beacon model group). The Beacon model was non-inferior to usual care for both the per-protocol (difference -0.38 mmol/mol [95% CI -4.72, 3.96]; -0.03% [95% CI -0.43, 0.36]) and the intention-to-treat (difference -1.28 mmol/mol [95% CI -5.96, 3.40]; -0.12% [95% CI -0.55, 0.31]) analyses. Non-inferiority was sustained in a sensitivity analysis at 12 months. There were no statistically or clinically significant differences in the secondary outcomes of BP, lipids or quality of life as measured by the 12 item short-form health survey (SF-12v2) and the diabetes-related quality of life (DQoL-Brief) survey. Safety indicators did not differ between groups. Participant satisfaction on the eight-item client satisfaction questionnaire (CSQ-8) was good in both groups, but scores were significantly higher in the Beacon model group than the usual care group (mean [SD] 28.4 [4.9] vs 25.6 [4.9], respectively, p < 0.001). CONCLUSIONS/INTERPRETATION: In individuals with type 2 diabetes, a model of integrated care delivered in the community by GPs with a special interest can safely achieve clinical outcomes that are not inferior to those achieved with gold-standard hospital-based specialist outpatient clinics. Individuals receiving care in the community had greater satisfaction. Further studies will determine the cost of delivering this model of care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000380897 FUNDING: The study was funded by the Australian National Health and Medical Research Council (GNT1001157).

Urea treatment in fluid restriction-refractory hyponatraemia.

OBJECTIVE: Hyponatraemia in hospitalized patients is common and associated with increased mortality. International guidelines give conflicting advice regarding the role of urea in the treatment of SIADH. We hypothesized that urea is a safe, effective treatment for fluid restriction-refractory hyponatraemia. DESIGN: Review of urea for the treatment of hyponatraemia in patients admitted to a tertiary hospital during 2016-2017. Primary end-point: proportion of patients achieving a serum sodium ≥130 mmol/L at 72 hours. PATIENTS: Urea was used on 78 occasions in 69 patients. The median age was 67 (IQR 52-76), 41% were female. Seventy (89.7%) had hyponatraemia due to SIADH-CNS pathology (64.3%) was the most common cause. The duration was acute in 32 (41%), chronic in 35 (44.9%) and unknown in the rest. RESULTS: The median nadir serum sodium was 122 mmol/L (IQR 118-126). Fluid restriction was first-line treatment in 65.4%. Urea was used first line in 21.8% and second line in 78.2%. Fifty treatment episodes (64.1%) resulted in serum sodium ≥130 mmol/L at 72 hours. In 56 patients who received other prior treatment, the mean sodium change at 72 hours (6.9 ± 4.8 mmol/L) was greater than with the preceding treatments (-1.0 ± 4.7 mmol/L; P < 0.001). Seventeen patients (22.7%) had side effects (principally distaste), none were severe. No patients developed hypernatraemia, overcorrection (>10 mmol/L in 24 hours or >18 mmol/L in 48 hours), or died. CONCLUSIONS: Urea is safe and effective in fluid restriction-refractory hyponatraemia. We recommend urea with a starting dose of ≥30 g/d, in patients with SIADH and moderate to profound hyponatraemia who are unable to undergo, or have failed fluid restriction.

Glucagon-like peptide-1 receptor agonists for antipsychotic-associated cardio-metabolic risk factors: A systematic review and individual participant data meta-analysis.

AIMS: To evaluate if glucagon-like peptide-1 receptor agonists (GLP-1RAs) reduce antipsychotic-associated body weight gain in patients with schizophrenia, when compared to controls. MATERIALS AND METHODS: We systematically searched PubMed/EMBASE/PsycINFO/Cochrane using the search terms '(antipsychotic and GLP-1RA)'. Individual participant data from studies randomizing patients to GLP-1RA or control were meta-analysed. The primary outcome was difference in body weight between GLP-1RA and control; secondary outcomes included cardio-metabolic variables and adverse drug reactions (ADRs). Multiple linear regression was conducted including sex, age, psychosis severity, metabolic variable, ADRs, and GLP-1RA agent. RESULTS: Three studies (exenatide once-weekly = 2; liraglutide once-daily = 1) provided participant-level data (n = 164, age = 40.0 ± 11.1 years, body weight = 105.8 ± 20.8 kg). After 16.2 ± 4.0 weeks of treatment, body weight loss was 3.71 kg (95% CI = 2.44-4.99 kg) greater for GLP-1RA versus control (p < 0.001), number-needed-to-treat ≥5% body weight loss = 3.8 (95% CI = 2.6-7.2). Waist circumference, body mass index, HbA1c, fasting glucose and visceral adiposity were each significantly lower with GLP-1RA. Sex, age, psychosis severity, nausea, any ADR, and GLP-1RA agent did not significantly impact outcomes. Body weight loss with GLP-1RAs was greater for clozapine/olanzapine-treated patients (n = 141) than other antipsychotics (n = 27) (4.70 kg, 95% CI = 3.13-6.27 vs. 1.5 kg, 95% CI = -1.47-4.47) (p < 0.001). Nausea was more common with GLP-1RAs than control (53.6% vs. 27.5%, p = 0.002, number-needed-to-harm = 3.8). CONCLUSION: GLP-1RAs are effective and tolerable for antipsychotic-associated body weight gain, particularly clozapine/olanzapine-treated patients. With few included patients, further studies are required before making routine use recommendations for GLP-1RAs.

Treatment of clozapine-associated obesity and diabetes with exenatide in adults with schizophrenia: A randomized controlled trial (CODEX).

Clozapine causes obesity and type 2 diabetes (T2DM). Glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide) can counter clozapine-associated GLP-1 dysregulation in animals, and may be beneficial in people on clozapine. This randomized, controlled, open-label, pilot trial evaluated weekly exenatide for weight loss among clozapine-treated obese adults with schizophrenia, with or without T2DM. A total of 28 outpatients were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had T2DM. Six people on exenatide achieved >5% weight loss vs one receiving usual care (P = .029). Compared with usual care, participants on exenatide had greater mean weight loss (-5.29 vs -1.12 kg; P = .015) and body mass index reduction (-1.78 vs -0.39 kg/m2 ; P = .019), and reduced fasting glucose (-0.34 vs 0.39 mmol/L; P = .036) and glycated haemoglobin levels (-0.21% vs 0.03%; P = .004). There were no significant differences in other metabolic syndrome components. Exenatide may be a promising therapeutic agent for glycaemic control and weight loss in clozapine-treated people with obesity, and could assist in reducing clozapine-associated cardio-metabolic morbidity and mortality.

Underappreciation of non-alcoholic fatty liver disease by primary care clinicians: limited awareness of surrogate markers of fibrosis.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a common cause of incidental liver test abnormalities. General practitioners (GP) have a key role in identifying people with NAFLD at risk of significant liver disease. Recent specialist guidelines emphasise the use of fibrosis algorithms or serum biomarkers rather than routine liver tests, to assess advanced fibrosis. AIM: To evaluate primary care clinicians' current approach to diagnosis, management and referral of NAFLD. METHODS: A cross-sectional survey of primary care clinicians was undertaken through a structured questionnaire about NAFLD. A convenience sample of general practice clinics and general practice conferences in Metropolitan Brisbane and regional south east Queensland was selected. RESULTS: A total of 108 primary care clinicians completed the survey (participation rate 100%). Fifty-one percent of respondents considered the prevalence of NAFLD in the general population to be ≤10%. Twenty-four percent of respondents felt that liver enzymes were sufficiently sensitive to detect underlying NAFLD. Most respondents were unsure whether the Fibrosis 4 score (62.7% unsure) or Enhanced Liver Fibrosis score (63.7% unsure) could help to identify advanced fibrosis or cirrhosis. Although 47% of respondents said they would refer a patient to a Gastroenterologist/Hepatologist if they suspect the patient has NAFLD, 44.1% do not make any referrals. Of concern, 70.6% of clinicians said they were unlikely to refer a patient to Hepatology unless liver function tests are abnormal. CONCLUSION: Our findings demonstrate that many primary care clinicians underestimate the prevalence of NAFLD and under-recognise the clinical spectrum of NAFLD and how this is assessed.

User Experience of an Innovative Mobile Health Program to Assist in Insulin Dose Adjustment: Outcomes of a Proof-Of-Concept Trial.

BACKGROUND: Many patients with diabetes require insulin therapy to achieve optimal glycemic control. Initiation and titration of insulin often require an insulin dose adjustment (IDA) program, involving frequent exchange of blood glucose levels (BGLs) and insulin prescription advice between the patient and healthcare team. This process is time consuming with logistical barriers. OBJECTIVE: To develop an innovative mobile health (m-Health) mobile-based IDA program (mIDA) and evaluate the user adherence and experience through a proof-of-concept trial. METHODS: In the program, an m-Health system was designed to be integrated within a clinical IDA service, comprising a Bluetooth-enabled glucose meter, smartphone application, and clinician portal. Insulin-requiring patients with type-2 diabetes mellitus and stable BGL were recruited to use the m-Health system to record and exchange BGL entries, insulin dosages, and clinical messages for 2 weeks. The user experience was evaluated by a Likert scale questionnaire. RESULTS: Nine participants, aged 58 ± 14 years (mean ± SD), completed the trial with average daily records of 3.1 BGL entries and 1.2 insulin dosage entries. The participants recognized the potential value of the clinical messages. They felt confident about managing their diabetes and were positive regarding ease of use and family support of the system, but disagreed that there were no technical issues. Finally, they were satisfied with the program and would continue to use it if possible. CONCLUSIONS: The m-Health system for IDA showed promising levels of adherence, usability, perception of usefulness, and satisfaction. Further research is required to assess the feasibility and cost-effectiveness of using this system in outpatient settings.

Establishing a new model of integrated primary and secondary care based around general practice: a case study of lessons learned and challenges.

This case study describes the development and implementation of an innovative integrated primary-secondary model of care for people with complex diabetes. The aim of the paper is to present the experiences of clinicians and researchers involved in implementing the 'Beacon' model by providing a discussion of the contextual factors, including lessons learned, challenges and solutions. Beacon-type models of community care for people with chronic disease are well placed to deliver on Australia's health care reform agenda, and this commentary provides rich contextual information relevant to the translation of such models into policy and practice.

Predictors for secondary therapy after surgical resection of nonfunctioning pituitary adenomas.

OBJECTIVE: Factors determining recurrence of nonfunctioning pituitary adenomas (NFAs) that require further therapy are unclear as are postoperative follow-up imaging guidelines. We aimed to identify predictors for secondary therapy after surgical resection of NFAs and use this knowledge to inform postoperative management. DESIGN AND PATIENTS: A single-centre retrospective study of surgically resected NFAs in 108 patients followed for up to 15 years. Serial tumour images were analysed for size, location and growth rate (GR) and tissue analysed for hormone cell type and proliferation indices with secondary treatment as outcome measure. RESULTS: Twenty-four of 66 (36%) patients harbouring a postoperative remnant required secondary treatment, all occurring within 10 years. No secondary treatment was required in any of 42 patients with complete tumour resection. Age, gender, remnant volume and tumour histology were not different between patients requiring and not requiring secondary therapy. Remnant GRs in those requiring secondary therapy were more than 10-fold higher (P<.01). Tumours with a GR ≥80 mm3 /y (Hazard Ratio[HR]: 8.1, Confidence Interval [CI]: 2.4-27.3,P<.01) and those located in the suprasellar region (HR: 6.1, CI: 1.1-32, P=.03) had a higher risk for secondary therapy. Tumour GR in the first three postoperative years correlated significantly (r2 =.6, P<.01) with GR during the period of follow-up. CONCLUSION: In surgically resected NFAs further treatment is dependent on the presence of residual tumour, growth rate and location but not tumour histology. Postoperative growth rate of NFAs in the first 3 years of imaging can be used to tailor long-term follow-up to optimize use of health resources.

Prospective evaluation of a week one overnight metyrapone test with subsequent dynamic assessments of hypothalamic-pituitary-adrenal axis function after pituitary surgery.

OBJECTIVE: To determine whether an overnight metyrapone test (OMT) within the first week postpituitary surgery can definitively assess the hypothalamic-pituitary-adrenal (HPA) axis, compared with subsequent dynamic tests and glucocorticoid requirement at 6 months. DESIGN: Prospective study measuring morning cortisol levels on days 3 and 4 post-operatively, OMT day 5-7 and week 6, week 6 250 µg short Synacthen test (SST) and week 7 insulin tolerance test (ITT). PATIENTS AND MEASUREMENTS: Forty participants who underwent pituitary surgery at a single centre (Cushing's disease excluded) were followed for at least 6 months. 46% had pre-operative adrenal insufficiency. PRIMARY OUTCOME: week 1 OMT compared to glucocorticoid requirement at 6 months. SECONDARY OUTCOMES: the performance of ITT as a "definitive" test and all tests compared to glucocorticoid requirement at 6 months. RESULTS: Week 1 OMT showed concordance with ITT at week 7 of 78% and glucocorticoid requirement at 6 months of 81% respectively which was not significantly different from post-operative morning cortisol levels; 37% of participants with an abnormal OMT on day 6 had a normal OMT at week 6. All HPA axis tests showed similar concordance with glucocorticoid requirement at 6 months of 80%-85%. CONCLUSIONS: Overnight metyrapone test within the first week after pituitary surgery was no better than an early morning cortisol level at predicting glucocorticoid requirement at 6 months. OMT at week 6 demonstrated recovery of HPA axis in a substantial proportion of participants who failed earlier assessments; thus, definitive testing should be delayed until 6 weeks post-operatively.

Optical coherence tomography predicts 4-year incident diabetic neuropathy.

PURPOSE: To examine the capability of optical coherence tomography-derived retinal thickness measures in detecting 4-year incident diabetic peripheral neuropathy (DPN). METHODS: 145 eyes of 145 participants with diabetes but no DPN at baseline were examined for incident DPN. HbA1c levels, nephropathy, neuropathy (DPN), cardiovascular measures, and various retinal thickness measures were examined at baseline and after 4 years. Incidence of DPN was defined as newly developed DPN at follow-up. Baseline factors were assessed by univariate and a step-wise multiple logistic regression, and the predictors were examined for diagnostic capabilities. RESULTS: Of the 145 participants without DPN at baseline, 51 had developed DPN when examined after 4 years (35% incidence). Of the ophthalmic variables, the mean (S.D.) of the overall thickness in the parafovea at baseline was 315 (18) µm in the no DPN group and 306 (18) µm in the 'incidence' group, and the differences were significant, p = 0.005. The superior hemisphere parafovea (mean (S.D.): 318 (17) µm vs 310 (20) µm, p = 0.02) and inferior hemisphere parafovea (313 (19) µm vs 302 (18) µm, p = 0.002) were different in the incident DPN group compared with the no DPN group. When adjusted for age, retinal thickness in the parafovea (AUC = 0.65, p = 0.003, 86% sensitivity and 44% specificity at 321 µm criterion), and body mass index or BMI (AUC = 0.65, p = 0.003, 49% sensitivity and 83% specificity at 29.3 kg m-2 criterion) at baseline were significant predictors for 4-year incident DPN. CONCLUSIONS: A lower retinal thickness at the parafovea and a higher BMI can predict 4-year incident neuropathy in patients with diabetes, with acceptable diagnostic accuracies. This OCT-derived measure may serve as a potential ophthalmic marker in the screening of patients at risk of developing DPN.

Longitudinal evaluation of the natural history of conservatively managed nonfunctioning pituitary adenomas.

CONTEXT: The optimal management of nonfunctioning pituitary adenomas presenting without symptomatic mass effect remains uncertain. The objective of this study was to elucidate the natural history of nonfunctioning pituitary adenomas managed conservatively. DESIGN: Volumetric evaluation of tumour growth in serial pituitary MRI scans by a single observer and retrospective review of changes in pituitary function. PATIENTS: Patients with nonfunctioning pituitary adenomas who underwent at least 2 serial pituitary MRI scans over ≥6 months between 2003 and 2013 prior to any intervention. MEASUREMENTS: Primary end-point was a ≥20% increase in volume or surgery. Secondary end-points were rate of pituitary dysfunction and pituitary apoplexy. RESULTS: Fifty nonfunctioning pituitary adenomas (23 macroadenomas and 27 microadenomas, mean age 49, range 17-85 years) were identified. Mean follow-up was 36 months (range 6-79). An increase in volume occurred in macroadenomas (P < 0·01) but not in microadenomas (P = 0·44). A ≥20% increase in volume occurred in nine of 23 macroadenomas compared with two of 27 microadenomas (P < 0·05). Five macroadenomas (one with new visual field defect) and one microadenoma proceeded to surgery (P = 0·08). Hormone deficiency was present in four of 24 macroadenomas vs 0 of 27 microadenomas (P < 0·05) at baseline, while new hormone deficiency developed in only two macroadenomas during follow-up. Pituitary apoplexy occurred in one microadenoma. A growth rate of >10 mm3 /month assessed at approximately 2 years of follow-up among the macroadenoma group was highly predictive (sensitivity and specificity of 90%) of a ≥20% increase in volume or surgery. CONCLUSIONS: Nonfunctioning pituitary macroadenomas have a greater tendency to grow and require surgical intervention while microadenomas rarely progress.

Making sense of change: patients' views of diabetes and GP-led integrated diabetes care.

BACKGROUND: Health system reform is directed towards better management of diabetes. However, change can be difficult, and patients' perspectives are a key aspect of implementing change. OBJECTIVE: This study investigated patients' perceptions and experiences of type 2 diabetes (T2DM), self-care and engagement with GP-led integrated diabetes care. DESIGN: Qualitative interviews were conducted with purposively selected patients with T2DM following their initial medical appointment in the new model of care. Normalization process theory was used to orientate the thematic analysis, to explain the work of implementing change. SETTING: Two specialist GP-based complex diabetes services in primary care in Brisbane, Australia. PARTICIPANTS: Intervention group patients (n = 30) in a randomized controlled trial to evaluate a model of GP-led integrated care for complex T2DM. MAIN OUTCOME MEASURES: Participants' experiences and perceptions of diabetes management and a GP-led model of care. RESULTS: Three themes were identified: sensibility of change, 'diabetic life' and diabetes care alliance. The imperative of change made sense, but some participants experienced dissonance between this rational view and their lived reality. Diabetes invaded life, revealing incongruities between participants' values and living with diabetes. They appreciated a flexible and personalized approach to care. DISCUSSION: Participants responded to advice in ways that seemed rational within the complexities of their life context. Their diabetes partnerships with health professionals coupled providers' biomedical expertise with patients' contextual expertise. CONCLUSIONS: Learning to manage relationships with various health professionals adds to patients' diabetes-related work. Providers need to adopt a flexible, interactive approach and foster trust, to enable better diabetes care.

Retinal thickness profile of individuals with diabetes.

PURPOSE: To examine the retinal thickness profiles of individuals with and without diabetic retinopathy (DR). METHODS: Full retinal thickness in the central zone, overall and hemisphere thicknesses of the parafovea and perifovea, ganglion cell complex (GCC) thickness and retinal nerve fibre layer (RNFL) thickness were assessed in 185 individuals using spectral domain optical coherence tomography (88 individuals with diabetes but no DR, 55 with DR, and 42 non-diabetic controls). The DR group comprised of 60% of participants with very mild non-proliferative diabetic retinopathy (NPDR) (representing microaneurysms only) and 40% with mild NPDR (hard exudates, cotton-wool spots, and/or mild retinal haemorrhages). Regression analysis was performed to determine the factors associated with retinal tissue thickness, taking into account, age, sex, presence of DR, duration of diabetes, HbA1c levels and type of diabetes. RESULTS: The mean (S.D.) of the overall parafoveal thickness was 306 (16) in the DR group and 314 (14) in the control group (p = 0.02). The mean (S.D.) of the superior hemisphere parafoveal thickness was 309 (16) in the DR group and 318 (14) in the control group (p = 0.02). The mean (S.D.) of the inferior hemisphere parafoveal thickness was 303 (17) in the DR group and 311 (15) in the control group (p = 0.02). There were no significant differences in retinal thickness between groups in the central zone (p = 0.27) or perifovea (p > 0.41). Neither the overall nor the hemisphere RNFL (p > 0.75) and GCC thickness (p > 0.37) were significantly different between the groups. Regression analysis revealed that parafoveal thickness in diabetic individuals was reduced in association with presence of DR (B = -5.9 µm, p = 0.02) and with advancing age (B = -4.5 µm, p = 0.004, for every 10 year increase in age) when adjusted for sex, duration of diabetes, HbA1c levels and type of diabetes. CONCLUSION: The inner macula is thinner in the presence of clinical signs of diabetic retinopathy and is compounded by advancing age. The influence of any macular oedema or that by cotton-wool spots could not be ruled out and may still confound these results.

Estrogen and selective estrogen receptor modulators (SERMs) for the treatment of acromegaly: a meta-analysis of published observational studies.

Estrogen and selective estrogen receptor modulator (SERM) treatments for acromegaly have received limited attention since the development of newer pharmacologic therapies. There has been ongoing research evidence suggesting their utility in the biochemical control of acromegaly. Therefore, the aim of this meta-analysis was to synthesise current evidence with a view to determining to what extent and in which acromegalic patient subsets do estrogen and SERMs reduce IGF-1 levels. A literature search was conducted (finished December 2012), which included all studies pertaining to estrogen or SERM treatment and IGF-1. Seven patient subsets were identified from six published observational studies, and were pooled using meta-analytic methods. Overall, the pooled mean loss in IGF-1 was -29.09 nmol/L (95 % CI -37.23 to -20.95). A sensitivity analysis indicated that women receiving estrogen had a substantially greater reduction in IGF-1 levels compared with women receiving SERMs, with a weighted mean loss in IGF-1 of -38.12 nmol/L (95 % CI -46.78 to -29.45) compared with -22.91 nmol/L (95 % CI -32.73 to -13.09). There was a trend that did not reach statistical significance for men receiving SERM treatment at -11.41 nmol/L (95 % CI -30.14 to 7.31). It was concluded that estrogen and SERMs are a low cost and effective treatment to achieve control of IGF-1 levels in acromegalic women either as concomitant treatment for refractory disease, or where access to conventional therapy is restricted. Their use in men requires further study.

Design of a randomized, non-inferiority trial to evaluate the reliability of videoconferencing for remote consultation of diabetes.

BACKGROUND: An estimated 366 million people are living with diabetes worldwide and it is predicted that its prevalence will increase to 552 million by 2030. Management of this disease and its complications is a challenge for many countries. Optimal glycaemic control is necessary to minimize complications, but less than 70% of diabetic patients achieve target levels of blood glucose, partly due to poor access to qualified health care providers. Telemedicine has the potential to improve access to health care, especially for rural and remote residents. Video teleconsultation, a real-time (or synchronous) mode of telemedicine, is gaining more popularity around the world through recent improvements in digital telecommunications. If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management, then it is important to demonstrate that this can be achieved without loss of clinical fidelity. This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes. METHODS/DESIGN: A total of 160 people with diabetes will be randomised into either a Telemedicine or a Reference group. Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference. The primary outcome measure will be a change in the patient's medication. Secondary outcome measures will be findings in physical examination, detecting complications, and patient satisfaction. A difference of less than 20% in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care (face-to-face). DISCUSSION: Despite rapid growth in application of telemedicine in a variety of medical specialties, little is known about the reliability of videoconferencing for remote consultation of people with diabetes. Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12612000315819.

Optimal image sample size for corneal nerve morphometry.

PURPOSE: Arbitrary numbers of corneal confocal microscopy images have been used for analysis of corneal subbasal nerve parameters under the implicit assumption that these are a representative sample of the central corneal nerve plexus. The purpose of this study is to present a technique for quantifying the number of random central corneal images required to achieve an acceptable level of accuracy in the measurement of corneal nerve fiber length and branch density. METHODS: Every possible combination of 2 to 16 images (where 16 was deemed the true mean) of the central corneal subbasal nerve plexus, not overlapping by more than 20%, were assessed for nerve fiber length and branch density in 20 subjects with type 2 diabetes and varying degrees of functional nerve deficit. Mean ratios were calculated to allow comparisons between and within subjects. RESULTS: In assessing nerve branch density, eight randomly chosen images not overlapping by more than 20% produced an average that was within 30% of the true mean 95% of the time. A similar sampling strategy of five images was 13% within the true mean 80% of the time for corneal nerve fiber length. CONCLUSIONS: The "sample combination analysis" presented here can be used to determine the sample size required for a desired level of accuracy of quantification of corneal subbasal nerve parameters. This technique may have applications in other biological sampling studies.

Standardising practices improves clinical diabetic foot management: the Queensland Diabetic Foot Innovation Project, 2006-09.

OBJECTIVE: The aim of this paper is to report the clinical practice changes resulting from strategies to standardise diabetic foot clinical management in three diverse ambulatory service sites in Queensland, Australia. METHODS: Multifaceted strategies were implemented in 2008, including: multidisciplinary teams, clinical pathways, clinical training, clinical indicators, and telehealth support. Prior to the intervention, none of the aforementioned strategies were used, except one site had a basic multidisciplinary team. A retrospective audit of consecutive patient records from July 2006 to June 2007 determined baseline clinical activity (n=101). A clinical pathway teleform was implemented as a clinical activity analyser in 2008 (n=327) and followed up in 2009 (n=406). Pre- and post-implementation data were analysed using Chi-square tests with a significance level set at P<0.05. RESULTS: There was an improvement in surveillance of the high risk population of 34% in 2008 and 19% in 2009, and treating according to risk of 15% in 2009 (P<0.05). The documentation of all best-practice clinical activities performed improved 13-66% (P<0.03). CONCLUSION: These findings support the use of multifaceted strategies to standardise practice and improve diabetic foot complications management in diverse ambulatory services.

Digital interventions to improve safety and quality of inpatient diabetes management: A systematic review.

IMPORTANCE: Diabetes is common amongst hospitalised patients and contributes to increased length of stay and poorer outcomes. Digital transformation, particularly the implementation of electronic medical records (EMRs), is rapidly occurring across the healthcare sector and provides an opportunity to improve the safety and quality of inpatient diabetes care. Alongside this revolution has been a considerable and ongoing evolution of digital interventions to optimise care of inpatients with diabetes including optimisation of EMRs, digital clinical decision support systems (CDSS) and solutions utilising data visibility to allow targeted patient review. OBJECTIVE: To systematically appraise the recent literature to determine which digitally-enabled interventions including EMR, CDSS and data visibility solutions improve the safety and quality of non-critical care inpatient diabetes management. METHODS: Pubmed, Embase and Cochrane databases were searched for suitable articles. Selected articles underwent quality assessment and analysis with results grouped by intervention type. RESULTS: 1202 articles were identified with 42 meeting inclusion criteria. Four key interventions were identified; computerised physician order entry (n = 4), clinician decision support systems (n = 21), EMR driven active case finding (data visibility solutions) and targeted patient review (n = 10) and multicomponent system interventions (n = 7). Studies reported on glucometric outcomes, evidence-based medication ordering including medication errors, and patient and user outcomes. An improvement in glucometric measures particularly mean blood glucose and proportion of target range blood glucose levels and rates of evidence-based insulin prescribing were consistently demonstrated. CONCLUSION: Digitally-enabled interventions utilised to improve quality and safety of inpatient diabetes care were heterogenous in design. The majority of studies across all intervention types reported positive effects for evidence-based prescribing and glucometric outcomes. There was less evidence for digital interventions reducing diabetes medication administration errors or impacting patient outcomes (length of stay).