Co-designing a dashboard of predictive analytics and decision support to drive care quality and client outcomes in aged care: a mixed-method study protocol.

INTRODUCTION: There is a clear need for improved care quality and quality monitoring in aged care. Aged care providers collect an abundance of data, yet rarely are these data integrated and transformed in real-time into actionable information to support evidence-based care, nor are they shared with older people and informal caregivers. This protocol describes the co-design and testing of a dashboard in residential aged care facilities (nursing or care homes) and community-based aged care settings (formal care provided at home or in the community). The dashboard will comprise integrated data to provide an 'at-a-glance' overview of aged care clients, indicators to identify clients at risk of fall-related hospitalisations and poor quality of life, and evidence-based decision support to minimise these risks. Longer term plans for dashboard implementation and evaluation are also outlined. METHODS: This mixed-method study will involve (1) co-designing dashboard features with aged care staff, clients, informal caregivers and general practitioners (GPs), (2) integrating aged care data silos and developing risk models, and (3) testing dashboard prototypes with users. The dashboard features will be informed by direct observations of routine work, interviews, focus groups and co-design groups with users, and a community forum. Multivariable discrete time survival models will be used to develop risk indicators, using predictors from linked historical aged care and hospital data. Dashboard prototype testing will comprise interviews, focus groups and walk-through scenarios using a think-aloud approach with staff members, clients and informal caregivers, and a GP workshop. ETHICS AND DISSEMINATION: This study has received ethical approval from the New South Wales (NSW) Population & Health Services Research Ethics Committee and Macquarie University's Human Research Ethics Committee. The research findings will be presented to the aged care provider who will share results with staff members, clients, residents and informal caregivers. Findings will be disseminated as peer-reviewed journal articles, policy briefs and conference presentations.

Healthcare expenditure and its predictors in a cohort of Australians living with sciatica.

PURPOSE: To estimate the healthcare resource utilisation of an Australian cohort of people with sciatica and explore individual-level factors associated with expenditure. METHODS: Healthcare utilisation (services and medication) data from a randomised, double-blind, placebo-controlled trial of pregabalin in patients with sciatica (n = 185) were analysed to estimate healthcare expenditure of participants over 12 months. Associations between key baseline socio-economic, pain and quality of life characteristics and healthcare expenditure were examined using generalised linear imputation models. RESULTS: On average, participants accessed AUD$1,134 of healthcare over the year, predominantly made up of $114 of medication and $914 of health services, which included $418 of physiotherapy services. Participants randomised to receive pregabalin incurred higher expenditure ($1,263 compared to $1,001 for placebo), which was largely driven by pregabalin ($158) and greater health services ($107). Healthcare expenditure was significantly higher for participants prescribed pregabalin, earning greater than $1,700 per week ($88,400 per year) and reporting poorer quality of life (physical and mental). CONCLUSION: Our results suggest inefficiency in the use of healthcare resources due to increased healthcare resource utilisation in people with sciatica treated with pregabalin, compared to placebo. Costs of treating sciatica varied based on individual quality of life and socio-economic characteristics.

Out-of-pocket spending among a cohort of Australians living with gout.

OBJECTIVE: To measure the direct and indirect out-of-pocket (OOP) costs borne by Australians with gout. METHODS: A cross-sectional, Australia-wide, web-based survey was conducted over 12 months between May 2017 and April 2018. Participants were recruited via advertisements in doctors' clinics and healthcare organizations' websites, and social media platforms such as Facebook and Twitter. Survey questions collected information about participants' OOP spending on direct medical and non-medical gout-related healthcare costs. Participant demographics, gout status, healthcare sought, workdays lost to due gout and health-related quality of life were also collected. RESULTS: Seventy-nine patients with gout completed the survey; 70 (89%) were male, and on average were 56 (SD 16) years of age and had gout for 14 (SD 12) years. For this cohort, the median total OOP direct medical cost was AU$200 per year (interquartile range [IQR]: AU$60-AU$570). Sixty (76%) people with gout reported being affected by gout during work; however, only 0.25 (IQR: 0-3) days of work (approximately $60) were lost due to gout in a year. Nine percent (n = 7) of participants experienced cost-related treatment attrition and 33% reported economic hardship (n = 26). Participants who experienced economic hardship or cost-related treatment attrition had higher median total gout-related direct costs than those who did not. CONCLUSION: In Australia, gout has an OOP financial cost and reduces work productivity. The presence of cost-related treatment attrition among people with gout indicates that financial costs may be a significant barrier to seeking treatment for a subset of patients with gout.

Do user preferences align with human factors assessment scores of drug-drug interaction alerts?

This study aimed to assess drug-drug interaction alert interfaces and to examine the relationship between compliance with human factors principles and user-preferences of alerts. Three reviewers independently evaluated drug-drug interaction alert interfaces in seven electronic systems using the Instrument-for-Evaluating-Human-Factors-Principles-in-Medication-Related-Decision-Support-Alerts (I-MeDeSA). Fifty-three doctors and pharmacists completed a survey to rate the alert interfaces from best to worst and reported on liked and disliked features. Human factors compliance and user-preferences of alerts were compared. Statistical analysis revealed no significant association between I-MeDeSA scores and user-preferences. However, the strengths and weaknesses of drug-drug interaction alerts from users' perspectives were in-line with the human factors constructs evaluated by the I-MeDeSA. I-MeDeSA in its current form, is unable to identify alerts that are preferred by the users. The design principles assessed by I-MeDeSA appear to be sound, but its arbitrary allocation of points to each human factors construct may not reflect the relative importance that the end-users place on different aspects of alert design.

Does splitting a tablet obtain the accurate dose?: A systematic review protocol.

BACKGROUND: Physical manipulation of the manufactured dose form is a common practice, with almost a quarter of all drugs administered in primary care having their dose altered. Splitting a tablet can be advantageous as it facilitates swallowing, allows for dose flexibility and provides cost reductions. However, there are concerns these physical changes can lead to inaccurate portions resulting in significant variations from the prescribed dose. Thus, the review described in this protocol aims to summarise the literature assessing the effect of tablet splitting on dose accuracy. METHODS: Relevant studies will be identified through electronic searches in databases including EMBASE, MEDLINE, CINAHL, and the Cochrane Library, from the beginning of databases until January 2020. Studies investigating any drug, where the tablet was split, will be potentially eligible. Two reviewers will independently screen studies and extract data using standardised forms. Data extracted will include general study information, characteristics of the study, intervention characteristics and outcomes. Primary outcome is to assess dose accuracy of a split tablet measured by drug content or weight variability. Assessment of risk of bias will be dependent upon study design. If deemed feasible, meta-analysis will be performed. RESULTS: The study described within this protocol will provide a synthesis of current evidence assessing the effect of tablet splitting on dose accuracy. CONCLUSION: The conclusion of our study will provide evidence to judge whether splitting a tablet results in an accurate half dose. ETHICS AND DISSEMINATION: Ethics approval was not required for this study. The results of the systematic review described will be published in a peer-reviewed journal. REGISTRATION DETAILS: PROSPERO CRD42018106252.

The economic burden of guideline-recommended first line care for acute low back pain.

PURPOSE: To report health care costs and the factors associated with such costs in people with acute low back pain receiving guideline-recommended first line care. METHODS: This is a secondary analysis of a trial which found no difference in clinical outcomes. Participants with acute low back pain received reassurance and advice, and either paracetamol (taken regularly or as needed) or placebo for up to 4 weeks and followed up for 12 weeks. Data on health service utilisation were collected by self-report. A health sector perspective was adopted to report all direct costs incurred (in 2015 AUD, 1 AUD = 0.53 Euro). Costs were reported for the entire study cohort and for each group. Various baseline clinical, demographic, work-related and socioeconomic factors were investigated for their association with increased costs using generalised linear models. RESULTS: The mean cost per participant was AUD167.74 (SD = 427.24) for the entire cohort (n = 1365). Most of these costs were incurred in primary care through visits to a general practitioner or physiotherapist. Compared to the placebo group, there was an increase in cost when paracetamol was taken. Multivariate analysis showed that disability, symptom duration and compensation were associated with costs. Receiving compensation was associated with a twofold increase compared to not receiving compensation. CONCLUSIONS: Taking paracetamol as part of first line care for acute low back pain increased the economic burden. Higher disability, longer symptom duration and receiving compensation were independently associated with increased health care costs.

Exploring sub-optimal use of an electronic risk assessment tool for venous thromboembolism.

International guidelines and consensus groups recommend using a risk assessment tool (RAT) to assess Venous Thromboembolism (VTE) risk prior to the prescription of prophylaxis. We set out to examine how an electronic RAT was being used (i.e. if by the right clinician, at the right time, for the right purpose) and to identify factors influencing utilization of the RAT. A sample of 112 risk assessments was audited and 12 prescribers were interviewed. The RAT was used as intended in only 40 (35.7%) cases (i.e. completed by a doctor within 24 h of admission, prior to the prescription of prophylaxis). We identified several reasons for sub-optimal use of the RAT, including beliefs about the need for a RAT, poor awareness of the tool, and poor RAT design. If a user-centred approach had been adopted, it is likely that a RAT would not have been implemented or that problematic design issues would have been identified.

PRECISE--pregabalin in addition to usual care: statistical analysis plan.

BACKGROUND: Sciatica is a severe, disabling condition that lacks high quality evidence for effective treatment strategies. This a priori statistical analysis plan describes the methodology of analysis for the PRECISE study. METHODS/DESIGN: PRECISE is a prospectively registered, double blind, randomised placebo controlled trial of pregabalin compared to placebo, in addition to usual care in patients with sciatica. The aim of this study is to determine the efficacy and cost-effectiveness of pregabalin in reducing leg pain intensity (primary outcome). Secondary outcomes include disability (key secondary), back pain intensity, quality of life, participants' perceived global effect, work absenteeism and health utilisation. Information about medication usage and tolerability are also collected. Outcomes are collected over one year (weeks 2, 4, 8, 12, 26 and 52). Double data entry will be conducted for primary and key secondary outcomes. Other outcomes will be checked using a risk-based approach. Analyses will be consistent with the intention-to-treat principle. Statistical tests will be two-tailed with a p value <0.05 considered significant. Group allocation will remain masked until analyses and interpretation are finalised. Repeated-measure linear mixed models will assess the effect of treatment (pregabalin versus placebo) on primary and secondary outcomes at all time points. Fixed effects will include group allocation, visit as a categorical variable and the interaction between group and visit. Covariates will include baseline leg pain and symptom duration, with an interaction term between baseline leg pain and visit. Pairwise differences between groups will be tested at weeks 8 and 52. The number of serious adverse events and adverse events will be reported, and the proportion of patients per group who have at least one event will be compared using Fisher's exact test. An economic evaluation will be conducted if there is a treatment effect on the primary outcome at week 8. A subgroup analysis will assess whether presenting features of neuropathic pain at baseline modify the treatment effect of leg pain at week 8. DISCUSSION: This statistical analysis plan provides detailed methodology for the analysis of the PRECISE study, which aims to deliver much needed evidence about effective and affordable management of sciatica. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN12613000530729. Registered 13 May 2013).

Cost-effectiveness analysis of a hospital electronic medication management system.

OBJECTIVE: To conduct a cost-effectiveness analysis of a hospital electronic medication management system (eMMS). METHODS: We compared costs and benefits of paper-based prescribing with a commercial eMMS (CSC MedChart) on one cardiology ward in a major 326-bed teaching hospital, assuming a 15-year time horizon and a health system perspective. The eMMS implementation and operating costs were obtained from the study site. We used data on eMMS effectiveness in reducing potential adverse drug events (ADEs), and potential ADEs intercepted, based on review of 1 202 patient charts before (n = 801) and after (n = 401) eMMS. These were combined with published estimates of actual ADEs and their costs. RESULTS: The rate of potential ADEs following eMMS fell from 0.17 per admission to 0.05; a reduction of 71%. The annualized eMMS implementation, maintenance, and operating costs for the cardiology ward were A$61 741 (US$55 296). The estimated reduction in ADEs post eMMS was approximately 80 actual ADEs per year. The reduced costs associated with these ADEs were more than sufficient to offset the costs of the eMMS. Estimated savings resulting from eMMS implementation were A$63-66 (US$56-59) per admission (A$97 740-$102 000 per annum for this ward). Sensitivity analyses demonstrated results were robust when both eMMS effectiveness and costs of actual ADEs were varied substantially. CONCLUSION: The eMMS within this setting was more effective and less expensive than paper-based prescribing. Comparison with the few previous full economic evaluations available suggests a marked improvement in the cost-effectiveness of eMMS, largely driven by increased effectiveness of contemporary eMMs in reducing medication errors.

What are incident reports telling us? A comparative study at two Australian hospitals of medication errors identified at audit, detected by staff and reported to an incident system.

OBJECTIVES: To (i) compare medication errors identified at audit and observation with medication incident reports; (ii) identify differences between two hospitals in incident report frequency and medication error rates; (iii) identify prescribing error detection rates by staff. DESIGN: Audit of 3291 patient records at two hospitals to identify prescribing errors and evidence of their detection by staff. Medication administration errors were identified from a direct observational study of 180 nurses administering 7451 medications. Severity of errors was classified. Those likely to lead to patient harm were categorized as 'clinically important'. SETTING: Two major academic teaching hospitals in Sydney, Australia. MAIN OUTCOME MEASURES: Rates of medication errors identified from audit and from direct observation were compared with reported medication incident reports. RESULTS: A total of 12 567 prescribing errors were identified at audit. Of these 1.2/1000 errors (95% CI: 0.6-1.8) had incident reports. Clinically important prescribing errors (n = 539) were detected by staff at a rate of 218.9/1000 (95% CI: 184.0-253.8), but only 13.0/1000 (95% CI: 3.4-22.5) were reported. 78.1% (n = 421) of clinically important prescribing errors were not detected. A total of 2043 drug administrations (27.4%; 95% CI: 26.4-28.4%) contained ≥ 1 errors; none had an incident report. Hospital A had a higher frequency of incident reports than Hospital B, but a lower rate of errors at audit. CONCLUSIONS: Prescribing errors with the potential to cause harm frequently go undetected. Reported incidents do not reflect the profile of medication errors which occur in hospitals or the underlying rates. This demonstrates the inaccuracy of using incident frequency to compare patient risk or quality performance within or across hospitals. New approaches including data mining of electronic clinical information systems are required to support more effective medication error detection and mitigation.

Multidisciplinary diabetes team care: the experiences of young adults with Type 1 diabetes.

BACKGROUND: This research examined whether young adults with Type 1 diabetes engage with the multidisciplinary consultation process and if not, then why. METHODS: We designed a web-based self-reported survey, available online from February to May 2011, for Australian adults 18-35 years with Type 1 diabetes. Respondents were asked about which clinicians they consulted to assist with self-management. To expand on the results of the survey, we interviewed 33 respondents. SURVEY: Respondents (n = 150) consulted with the following clinicians: endocrinologist and diabetes educators: 23.3%; endocrinologist only: 18.0%; endocrinologist, diabetes educators and dieticians: 14.6%; endocrinologist, diabetes educators, dietician and general practitioners (GP): 11.3%; endocrinologist and GP: 10.6%; GP only: 4.6%; all clinicians recommended to assist with self-management: 1.3%; 2.7% did not consult any clinician. Interview: Participants (n = 33) reported eight key disincentives to consultation with multidisciplinary clinicians. These were time constraints; provision of conflicting advice; inaccessibility of health services; variation in service standards; cost constraints; failure of clinicians to refer to other clinicians; lack of opportunity to build a therapeutic relationship; and failure of clinicians to engage in shared decision making. CONCLUSION: Our results indicate that high attrition rates of young adults with Type 1 diabetes from recommended diabetes health services is linked to the failure of those services to meet the needs and preferences of their patients. The identified needs and preferences included joint consultation with multi-disciplinary team clinicians; flexible access to advice by email or telephone consultation; and shared decision making. Patient engagement in health-service re-design has implications for improved health-service delivery and enhanced treatment outcomes.

Optimal sampling of antipsychotic medicines: a pharmacometric approach for clinical practice.

AIM: To determine optimal sampling strategies to allow the calculation of clinical pharmacokinetic parameters for selected antipsychotic medicines using a pharmacometric approach. METHODS: This study utilized previous population pharmacokinetic parameters of the antipsychotic medicines aripiprazole, clozapine, olanzapine, perphenazine, quetiapine, risperidone (including 9-OH risperidone) and ziprasidone. d-optimality was utilized to identify time points which accurately predicted the pharmacokinetic parameters (and expected error) of each drug at steady-state. A standard two stage population approach (STS) with MAP-Bayesian estimation was used to compare area under the concentration-time curves (AUC) generated from sparse optimal time points and rich extensive data. Monte Carlo Simulation (MCS) was used to simulate 1000 patients with population variability in pharmacokinetic parameters. Forward stepwise regression analysis was used to determine the most predictive time points of the AUC for each drug at steady-state. RESULTS: Three optimal sampling times were identified for each antipsychotic medicine. For aripiprazole, clozapine, olanzapine, perphenazine, risperidone, 9-OH risperidone, quetiapine and ziprasidone the CV% of the apparent clearance using optimal sampling strategies were 19.5, 8.6, 9.5, 13.5, 12.9, 10.0, 16.0 and 10.7, respectively. Using the MCS and linear regression approach to predict AUC, the recommended sampling windows were 16.5-17.5 h, 10-11 h, 23-24 h, 19-20 h, 16.5-17.5 h, 22.5-23.5 h, 5-6 h and 5.5-6.5 h, respectively. CONCLUSION: This analysis provides important sampling information for future population pharmacokinetic studies and clinical studies investigating the pharmacokinetics of antipsychotic medicines.

Ethics & evidence in medical debates: the case of recombinant activated factor VII.

We cannot just point to the facts to solve a medical debate. The use of evidence is itself a matter of values. What the evidence tells us to do tends to depend on what we see as important.

The economic evaluation of personalised oncology medicines: ethical challenges.

Insights into the molecular drivers of cancer are providing opportunities for the development of new targeted treatments and more personalised approaches to cancer management. Drugs targeting mutant epidermal growth factor receptors, such as erlotinib and gefitinib, may provide more effective, safer and better tolerated treatment options compared with chemotherapy among appropriately selected patients with advanced non-small cell lung cancer (NSCLC). First-line access to these newer treatments remains unfunded after several considerations by the Pharmaceutical Benefits Advisory Committee and their assessment that these are not cost-effective treatments. We suggest that there may be evidentiary and ethical challenges associated with the assessment of the cost-effectiveness of personalised oncology medicines in Australia, and that a new approach is needed to determine the value and cost-effectiveness of personalised medicine.

PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial.

BACKGROUND: Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. METHODS/DESIGN: PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant's optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. DISCUSSION: This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life. The impact of this research may allow the future development of a cost-effective conservative treatment strategy for patients with sciatica. TRIAL REGISTRATION: ClinicalTrial.gov, ACTRN 12613000530729.

What's in a name? Brand name confusion and generic medicines.

We need an urgent review of medicines labelling in Australia and New Zealand.

Saving money on the PBS: ranibizumab or bevacizumab for neovascular macular degeneration?

The cost differential between these two drugs is no longer defensible.