Assessment of Glycemia Risk Index and Standard Continuous Glucose Monitoring Metrics in a Real-World Setting of Exercise in Adults With Type 1 Diabetes: A Post-Hoc Analysis of the Type 1 Diabetes and Exercise Initiative.

BACKGROUND: Standardized reporting of continuous glucose monitoring (CGM) metrics does not provide extra weighting for very high or very low glucose, despite their distinct clinical significance, and thus may underestimate glycemic risk in people with type 1 diabetes (T1D) during exercise. Glycemia Risk Index (GRI) is a novel composite metric incorporating clinician-validated extra weighting for glycemic extremes, which may provide a novel summary index of glycemia risk around exercise. METHODS: Adults (≥18 years) in the T1D EXercise Initiative study wore CGM and activity trackers for four weeks. For this analysis, exercise days were defined as 24 hours following ≥20 minutes of exercise, with no other exercise in the 24-hour period. Sedentary days were defined as any 24 hours with no recorded exercise within that period or the preceding 24 hours. Linear mixed-effects regression was used to evaluate exercise effects on GRI and CGM metrics within 24 hours postexercise. RESULTS: In 408 adults with T1D with >70% CGM and activity data, GRI on exercise (N = 3790) versus sedentary days (N = 1865) was significantly lower (mean [SD]: 29.9 [24.0] vs 34.0 [26.1], respectively, absolute mean difference -1.70 [-2.73, -0.67], P < .001), a ~5% reduction in glycemic risk. Percent time in range (TIR; 70-180 mg/dL) increased on exercise days (absolute mean difference 2.67 [1.83, 3.50], P < .001), as did time below range (TBR; relative mean difference 1.17 [1.12, 1.22], P < .001), while time above range (TAR) decreased (relative mean difference 0.84 [0.79, 0.88], P < .001). CONCLUSIONS: Glycemia Risk Index improved on exercise versus sedentary days, despite increased TBR, which is weighted most heavily in the GRI calculation, due to a robust reduction in TAR.

Early Discharge to Clinic-Based Therapy of Patients Presenting With Decompensated Heart Failure (EDICT-HF): Study Protocol for a Multi-Centre Randomised Controlled Trial.

BACKGROUND: Acute decompensated heart failure involves a high rate of mortality and complications. Management typically involves a multi-day hospital admission. However, patients often lose part of their function with each successive admission, and are at a high risk for hospital-associated complications such as nosocomial infection. This study aims to determine the safety and efficacy of the management of patients presenting with acute decompensated heart failure to clinic-based therapy vs usual inpatient care using a reproducible management pathway. METHOD: An investigator-initiated, prospective, non-inferiority, 1:1 randomised-controlled trial, stratified by left ventricular ejection fraction including 460 patients with a minimum follow-up of 7 days. This is a multi-centre study to be performed in centres across Victoria, Australia. Participants will be patients with either heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF), admitted for acute decompensation of heart failure. INTERVENTION: Early discharge to an outpatient-based Heart Failure Rapid Access Clinical Review (RACER) in addition to frequent medical/nursing at-home review for patients admitted with decompensated heart failure. RESULTS: The primary endpoint will be a non-inferiority assessment of re-hospitalisation at 30 days. Secondary outcomes include superiority assessment of hospitalisation at 30 days, a composite clinical endpoint of major adverse cardiac and cerebrovascular event (MACCE), hospital re-admission or mortality at 3 months, achievement of guideline-directed medical therapy, patient assessment of symptoms (visual-analogue scale quantified as area under curve and Kansas City Cardiomyopathy Questionnaire-12 [KCCQ-12]), attendance at 3-month outpatient follow-up, number of bed stays/clinics attended, proportion of patients free from congestion, change in serum creatinine level, treatment for electrolyte disturbances, time to transition from intravenous to oral diuretics, and health economics analysis (cost-benefit analysis, cost-utility analysis, incremental cost-effectiveness ratio). CONCLUSIONS: The Early Discharge to Clinic-Based Therapy of Patients Presenting with Decompensated Heart Failure (EDICT-HF) trial will help determine whether earlier discharge to out-of-hospital care is non-inferior to the usual practice of inpatient care, in patients with heart failure admitted to hospital for acute decompensation, as an alternative model of care.

Continuous Glucose Monitoring-Based Composite Metrics: A Review and Assessment of Performance in Recent-Onset and Long-Duration Type 1 Diabetes.

This study examined correlations between continuous glucose monitoring (CGM)-based composite metrics and standard glucose metrics within CGM data sets from individuals with recent-onset and long-duration type 1 diabetes. First, a literature review and critique of published CGM-based composite metrics was undertaken. Second, composite metric results were calculated for the two CGM data sets and correlations with six standard glucose metrics were examined. Fourteen composite metrics met selection criteria; these metrics focused on overall glycemia (n = 8), glycemic variability (n = 4), and hypoglycemia (n = 2), respectively. Results for the two diabetes cohorts were similar. All eight metrics focusing on overall glycemia strongly correlated with glucose time in range; none strongly correlated with time below range. The eight overall glycemia-focused and two hypoglycemia-focused composite metrics were all sensitive to automated insulin delivery therapeutic intervention. Until a composite metric can adequately capture both achieved target glycemia and hypoglycemia burden, the current two-dimensional CGM assessment approach may offer greatest clinical utility.

Penicillin Allergy Delabeling Program: an exploratory economic evaluation in the Australian context.

BACKGROUND: Internationally, clinical and economic advantages of low-risk penicillin delabelling have been explored, supporting changes to healthcare delivery systems where penicillin delabelling is embedded into inpatient usual care. AIMS: To determine if economic advantages of low-risk inpatient penicillin delabelling, described in the international literature, are realised in the Australian context. METHODS: This explorative economic evaluation had prospective patient data collection between January and August 2019, across two Australian health services. Part 1: determine the cost per effectively delabelled patient for Penicillin Allergy Delabeling Program inpatients (PADP cohort) compared with Outpatient Antibiotic Allergy Testing Service outpatients (OAATS cohort). Part 2: a cost analysis to compare hospital costs for inpatients with low-risk penicillin allergy who did (PADP cohort) and did not (usual care cohort) undergo PADP delabelling. RESULTS: Part 1: the PADP (n = 350) and OAATS (n = 27 patients, n = 36 individual visits) cohorts were comparable. In PADP, costs/proportion delabelled was $20.10/0.98, equating to $20.51 per effectively delabelled patient; in OAATS, it was $181.24/0.50, equating to $362. Compared with OAATS, PADP was associated with savings of $341.97 per effectively delabelled patient, indicating the outpatient testing was the dominated strategy, being more costly and less effective. Part 2: the PADP (n = 218) and usual care (n = 32) cohorts were comparable. Significantly favouring the delabelled PADP cohort, the mean difference per patient was -4.41 days (95% confidence interval: -7.64, -1.18) and -$9467.72 (95% confidence interval: -$15 419.98, -$3515.46). CONCLUSIONS: Consistent with international literature, delabelling low-risk penicillin allergies in the inpatient setting had economic advantages in the Australian context. Fully powered economic evaluations are urgently required to consolidate these findings.

An Assessment of Clinical Continuous Glucose Monitoring Targets for Older and High-Risk People Living with Type 1 Diabetes.

Aim: To assess relationships between continuous glucose monitoring (CGM) time in range (TIR), 70-180 mg/dL, time below range (TBR), <70 mg/dL, time above range (TAR), >180 mg/dL, and glucose coefficient of variation (CV) in relation to currently recommended clinical CGM targets for older people, which recommend reduced TIR and TBR targets relative to the general type 1 diabetes population. Methods: We conducted a post hoc analysis using the JDRF Australia Adult Hybrid Closed Loop trial database examining correlations in 120 adults with type 1 diabetes of 3 weeks masked CGM (Guardian Sensor 3; Medtronic) metrics (n = 61 on multiple daily injections, 59 on non-CGM augmented pumps) using manual insulin dosing at baseline and at 26-weeks, with 50% randomized to automated insulin dosing (AID). Results: Correlations between baseline TIR and TAR were strong (r = -0.966; P < 0.0001), weak for TBR (r = 0.363; P < 0.0001), and glucose CV (r = 0.037; P = 0.687) while moderate between CV and TBR (r = 0.726; P < 0.0001). Associations were similar for participants aged >60 years (n = 15) versus younger subjects. Correlations of changes in (Δ) TIR with ΔTAR over 26 weeks were strong (r = -0.945; P < 0.001) and correlations for ΔTBR were weak (r = 0.025; P = 0.802). ΔCV did not significantly correlate with ΔTAR (r = -0.064; P = 0.526) but did with ΔTBR (r = 0.770; P = <0.001). Conclusions: Changes in TIR are not associated with changes in TBR. Thus, we recommend that for older AID users whilst TBR targets should be prioritized to reduce hypoglycemia-related risk, TBR should be addressed independently of TIR. Clinical Trial Registratrion number: (ACTRN12617000520336).

COVID-Care - a safe and successful digital self-assessment tool for outpatients with proven and suspected coronavirus-2019.

INTRODUCTION: The coronavirus-2019 (COVID-19) pandemic and restrictions placed on movement to prevent its transmission have led to a surge in demand for remote medical care. We investigated whether COVID-Care, a patient-reported, telehealth, symptom monitoring system, was successful at delivering safe monitoring and care for these patients leading to decreased hospital presentations. METHODS: We performed a single centre, prospective, interventional cohort study with symptomatic outpatients who presented for COVID-19 screening at Austin Health, Australia. Participants were invited to take part in the COVID-Care programme, entering common COVID-19 symptoms on a purpose-built, online survey monitored by infectious diseases physicians, and matched with clinical data including date of symptom onset, hospital admission, and screening clinic presentations. RESULTS: 42,158 COVID-19 swabs were performed in 31,626 patients from March to October 2020, with 414 positive cases. 20,768 people used the COVID-Care survey at least once. COVID-Care users were significantly younger than non-users. Of the 414 positive cases, 254 (61.3%) used COVID-Care, with 160 (38.6%) non-users. Excluding presentations on the same day or prior to the COVID-19 swab, of the positive cases there were 56 hospital presentations. 4.3% (11) of COVID-Care users and 28.1% (45) non-users were admitted to hospital or the emergency department (p < 0.001), with 3.9% (10) versus 22.5% (36) requiring inpatient admission (p < 0.001). There were no deaths in COVID-Care users versus 2 deaths in non-users. CONCLUSION: COVID-Care, a digitally integrated, outpatient, symptom tracking and telemedical service for patients with COVID-19, was safe and successful at reducing hospital and emergency department admissions, suggesting a strong role for telemedicine for future healthcare delivery in this logistically challenging setting.

Recovery of quality of life is associated with lower mortality 5-year post-fracture: the Australian arm of the International Costs and Utilities Related to Osteoporotic Fractures Study (AusICUROS).

Little is known about factors that lead to excess mortality post-fracture. This study demonstrated that 5-year mortality is lower in older adults who recovered to their pre-fracture health-related quality of life (HRQoL) at 12-months compared to those who did not recover. Our results highlight the importance of post-fracture interventions known to improve HRQoL. INTRODUCTION: Fragility fractures lead to increased mortality and decreased health-related quality of life (HRQoL) in older adults, although whether an association exists between these outcomes remains uncertain. The aim of this study was to determine whether recovery of HRQoL 12-month post-fracture is associated with lower 5-year mortality. METHODS: This data linkage study included 524 adults (mean age: 70.2 years; 79.2% women) with fragility fracture (150 hip, 261 distal forearm, 61 vertebral, 52 humerus) from the Australian arm of the International Costs and Utilities Related to Osteoporotic fractures Study (AusICUROS). HRQoL was measured using the EQ-5D-3L and all-cause mortality post-fracture was ascertained from the Australian National Death Index (NDI). Cox proportional hazards models were used to assess the association between HRQoL recovery (vs. non-recovery) and all-cause mortality within 5 years. RESULTS: Overall, 279 participants (53.2%) recovered to their pre-fracture HRQoL at 12-month follow-up. There were 70 deaths (13.4%) during the 5-year post-fracture. Mortality rate was the highest in hip fracture participants (24.7%), followed by vertebral (16.4%), humeral (13.5%), and distal forearm fracture participants (6.1%). After adjustment for age, pre-fracture HRQoL, and fracture site, mortality risk was lower in participants who recovered to their pre-fracture HRQoL at 12-months compared to those who did not recover (HR = 0.56, 95% CI: 0.33-0.96, p = 0.034). CONCLUSION: This study provides evidence that HRQoL recovery post-fracture is associated with improved 5-year survival in older adults. The extent to whether current interventions known to improve HRQoL post-fracture could prevent some of these deaths is unknown.

Triaging the Terminally Ill-Development of the Responding to Urgency of Need in Palliative Care (RUN-PC) Triage Tool.

CONTEXT: Evidence-based resource allocation is receiving increasing attention as we strive for equity, transparency, and cost-effectiveness across health care. In the context of finite resources, which of our patients with terminal illness should be prioritized for urgent palliative care? OBJECTIVES: To develop the scoring system for the novel Responding to Urgency of Need in Palliative Care triage tool. METHODS: Online international discrete choice experiment involving palliative care clinicians to establish the relative importance of seven key attributes of palliative care triage identified during an earlier qualitative study. RESULTS: Participants (n = 772) were mainly female (79.9%) with a decade of clinical experience. All attributes contributed significantly (all P-values < 0.001) and independently to clinician assessment of urgency. This study found physical suffering (coefficient 3.45; 95% confidence interval: 3.24 to 3.66) was the most important determinant of urgency, followed by imminent dying (coefficient 1.56; 1.43 to 1.69), psychological suffering (coefficient 1.49; 1.37 to 1.60), caregiver distress (coefficient 1.47; 1.35 to 1.59), discrepancy between care needs and care arrangements (coefficient 1.14; 1.02 to 1.26), mismatch between current and desired site of care (coefficient 0.94; 0.85 to 1.03), and unmet communication needs (coefficient 0.84; 0.76 to 0.92). CONCLUSION: Palliative care triage, which is complex and contextual, has been made more transparent through this discrete choice experiment. The Responding to Urgency of Need in Palliative Care triage tool provides an important step toward evidence-based assessment of priority for palliative care. Further research is underway to determine the validity of the tool in clinical practice and its impact on patient and caregiver outcomes.

Economic impact of keratoconus using a health expenditure questionnaire: A patient perspective.

IMPORTANCE: This is the first study to estimate the lifetime costs associated with keratoconus based on a questionnaire completed by patients and highlights the significant economic burden of the disease. As keratoconus affects individuals from a young age, the study highlights keratoconus as a public health concern. BACKGROUND: Keratoconus is a disorder characterized by corneal steepening and thinning, leading to reduced visual acuity. To date, there have been no studies evaluating the economic costs of keratoconus from a patient's perspective. DESIGN: A randomized cross-sectional study undertaken in Australia where keratoconus subjects were recruited from public and private ophthalmology and optometry clinics. PARTICIPANTS: A total of 100 participants completed the questionnaire: median age was 31 years and 57% were males. METHODS: A keratoconus health expenditure questionnaire was designed to assess direct and indirect expenditures for each individual. MAIN OUTCOME MEASURES: Total direct and indirect costs associated with the condition were calculated along with the estimated lifetime per capita costs. RESULTS: The total cost related to direct and indirect care was estimated to be AUD 3365. By applying our cost data to keratoconus prevalence data for the Australian population, the total cost is estimated to be approximately AUD 44.7 million per year in Australia. CONCLUSIONS AND RELEVANCE: Our results show that the costs associated with the diagnosis and management of keratoconus represent a significant cost to patients. An understanding of this is important not only to individuals and their families, but also health care providers, health insurers and the wider health system.

Responding to urgency of need: Initial qualitative stage in the development of a triage tool for use in palliative care services.

BACKGROUND: Palliative care services face the challenge of a workload increasing in volume and diversity. An evidence-based triage method to assess urgency of palliative care needs is required to ensure equitable, efficient and transparent allocation of specialist resources when managing waiting lists. AIM: As the initial stage of a mixed-method sequential design, this study aimed to explore palliative care providers' practices and attitudes towards triaging palliative care needs and their views regarding the implementation of a standardised approach. DESIGN: A qualitative study was conducted involving focus groups and interviews. Transcripts were subjected to deductive thematic analysis. SETTING/PARTICIPANTS: A total of 20 palliative care providers were purposively sampled to ensure representation across disciplines (primary, specialist; medicine, nursing and allied health), service types (inpatient, hospital liaison and community) and locations (metropolitan and rural). RESULTS: A series of markers of urgency were identified, including physical and psychological suffering, caregiver distress, discrepancy between care needs and care arrangements, mismatch between current site of care and desired site of death when in terminal phase and complex communication needs. Performance status and phase of disease were reported to be less informative when considered in isolation. Interpersonal and system-based barriers to the implementation of a palliative care triage tool were highlighted. CONCLUSION: The process of triage in the palliative care setting is complex but can be conceptualised using a limited number of domains. Further research is required to establish the relative value clinicians attribute to these domains and thus inform the development of an acceptable and useful evidence-based palliative care triage tool.