Evaluating clinical decision support software (CDSS): challenges for robust evidence generation.

OBJECTIVES: Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia. METHODS: Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches. RESULTS: Our results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety. CONCLUSION: Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.

Challenges in the Evaluation of Emerging Highly Specialised Technologies: Is There a Role for Living HTA?

There is currently deep uncertainty about the clinical benefits and cost effectiveness of highly specialised technologies (HSTs), like gene and cell therapies. These treatments are novel, typically have high upfront costs, the patient populations are small and heterogenous, there is minimal information on their long-term safety and effectiveness, and data are limited and often of poor quality. With the increasing number of these technologies and their high cost burden on governments and health care providers, policy makers are currently walking a decision tightrope. On the one hand, an unfavourable funding decision could potentially limit patient access to life-saving treatments, while on the other, a favourable decision could result in unsustainable budget impacts and perhaps poorer patient health outcomes. Health technology assessment (HTA) is meant to determine the value of a health technology in order to promote an equitable, efficient, and high-quality health system. However, standard HTA processes have failed to mitigate the deep uncertainties associated with these technologies. In this paper, we propose a Living HTA framework to address these challenges. This framework includes a one-off process for making explicit the societal values associated with HSTs. These would inform the decision-making approach, data collection and the development of disease-specific reference models to be used by industry sponsors as the basis for their submissions for public funding. Coverage with an evidence development mechanism is also proposed by which data can be collected in real time to update the reference model on a rolling basis, thereby allowing re-assessment of the clinical and cost effectiveness of individual HSTs. The HTA would be 'live' until the results indicate there is sufficient certainty for the funding decision to be confirmed, the price changed or the funding removed.

Establishing a clinical ethics support service: lessons from the first 18 months of a new Australian service - a case study.

BACKGROUND: Although the importance of clinical ethics in contemporary clinical environments is established, development of formal clinical ethics services in the Australia health system has, to date, been ad hoc. This study was designed to systematically follow and reflect upon the first 18 months of activity by a newly established service, to examine key barriers and facilitators to establishing a new service in an Australian hospital setting. METHODS: HOW THE STUDY WAS PERFORMED AND STATISTICAL TESTS USED: A qualitative case study approach was utilised. The study gathered and analysed data using observations of service committee meetings, document analysis of agendas and minutes, and semi-structured interviews with committee members to generate semantic themes. By interpreting the thematic findings in reference to national capacity building resources, this study also aimed to provide practice-based reflections for other health agencies. RESULTS: THE MAIN FINDINGS: An overarching theme identified in the data was a strong commitment to supporting clinicians facing difficult patient care decisions and navigating difficult discussions with patients and families. Another key theme was the role of the new clinical ethics support service in providing clinicians with a pathway to raise system-wide issues with the organisation Executive. While there was strong clinical engagement, consumer and community participation remained a challenge, as did unresolved governance issues and a need for clearer policy relationship between the service and the organisation. Considering these themes in relation to the national capacity building resources, the study identifies three areas likely to require ongoing development and negotiation. These are: the role of the clinical ethics support service as a link between the workforce and the Executive; the incorporation of consumers and patients; and ethical reasoning. To improve the effectiveness of the service, it is necessary to increase clarity on the service's role at the governance and policy level, as well as develop strategies for engaging consumers, patients and families. Finally, the capacity of the service to reflect on complex cases may be enhanced through explicit discussions of various different ethical frameworks and ways of deliberating.

Is the quality of evidence in health technology assessment deteriorating over time? A case study on cancer drugs in Australia.

OBJECTIVE: This study aimed to assess whether there have been changes in the quality of clinical evidence submitted for government subsidy decisions on cancer medicines over the past 15 years. METHODS: We reviewed public summary documents (PSDs) reporting on subsidy decisions made by the Pharmaceutical Benefits Advisory Committee (PBAC) from July 2005 to July 2020. Information was extracted on the study design, directness of comparison, sample size, and risk of bias (RoB). Changes in the quality of evidence were assessed using regression analysis. RESULTS: Overall, 214 PSDs were included in the analysis. Thirty-seven percent lacked direct comparative evidence. Thirteen percent presented observational or single-arm studies as the basis for decisions. Among PSDs presenting indirect comparisons, 78 percent reported transitivity issues. Nearly half (41 percent) of PSDs reporting on medicines supported by head-to-head studies noted there was a moderate/high/unclear RoB. PSDs reporting concerns with RoB increased by a third over the past 7 years, even after adjusting for disease rarity and trial data maturity (OR 1.30, 95% CI: 0.99, 1.70). No time trends were observed regarding the directness of clinical evidence, study design, transitivity issues, or sample size during any of the analyzed periods. CONCLUSION: Our findings indicate that the clinical evidence supplied to inform funding decisions for cancer medicines is often of poor quality and has been deteriorating over time. This is concerning as it introduces greater uncertainty in decision making. This is particularly important as the evidence supplied to the PBAC is often the same as that supplied to other global decision-making bodies.

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

OBJECTIVE: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions. DESIGN AND SETTING: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities. PARTICIPANTS: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine. INTERVENTION: Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months. COMPARATOR: Usual care (Residential Medication Management Review) provided by accredited pharmacists. OUTCOMES: Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life. RESULTS: 248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength. CONCLUSIONS: The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.

Modelling the Future Clinical and Economic Burden of Antimicrobial Resistance: The Feasibility and Value of Models to Inform Policy.

Due to the increasing threat to public health and the economy, governments internationally are interested in models to estimate the future clinical and economic burden of antimicrobial resistance (AMR) and to evaluate the cost-effectiveness of interventions to prevent or control resistance and to inform resource-allocation decision making. A widely cited UK report estimated that 10 million additional deaths will occur globally per annum due to AMR by 2050; however, the utility and accuracy of this prediction has been challenged. The precision of models predicting the future economic burden of AMR is dependent upon the accuracy of predicting future resistance rates. This paper reviews the feasibility and value of modelling to inform policy and resource allocation to manage and curb AMR. Here we describe methods used to estimate future resistance in published burden-of-disease models; the sources of uncertainty are highlighted, which could potentially mislead policy decision-making. While broad assumptions can be made regarding some predictable factors contributing to future resistance rates, the unexpected emergence, establishment and spread of new resistance genes introduces substantial uncertainty into estimates of future economic burden, and in models evaluating the effectiveness of interventions or policies to address AMR. Existing reporting standards for best practice in modelling should be adapted to guide the reporting of AMR economic models, to ensure model transparency and validation for interpretation by policymakers.

Evidence-based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved.

BACKGROUND: The Medical Services Advisory Committee (MSAC) is responsible for the assessment of medical imaging tests proposed for public funding. A number of factors related to the clinical or cost effectiveness of an imaging service may impact on the funding decision. OBJECTIVE: To determine what evidentiary and economic factors impact most on MSAC recommendations for the funding of imaging tests. METHODS: Information was extracted on health technology assessments (HTAs) of medical imaging tests published on the MSAC website, with a funding decision between 2006 to July 2021. Imaging tests with diagnostic, staging or screening indications were eligible. Data were extracted in test-indication pairs and included data on evidence quality, quantity, consistency of findings, cost-effectiveness and financial impact. Multivariate logistic regression analysis was performed with adjustments for clustered data. RESULTS: Overall, 42 imaging test applications to MSAC were included, representing 91 clinical indications. Most were diagnostic tests. The most common evidentiary concerns reported by MSAC were limited evidence (36%), low quality evidence (26%), and applicability of the data (22%). The reference standard for diagnostic accuracy was imperfect or not appropriate in 25% of the indications. In regression analyses, uncertainty about cost-effectiveness of an imaging service predicted most negative funding decisions. CONCLUSIONS: The single biggest contributor to a negative funding decision by MSAC was uncertainty about the cost-effectiveness of the imaging service. This was likely driven by uncertainty regarding the impact on patient health. HTAs that are able to demonstrate the clinical utility of a new imaging service are more likely to publicly funded.

Inappropriate antibiotic prescribing: understanding clinicians’ perceptions to enable changes in prescribing practices.

Objective The aim of this study was to identify perceived barriers to appropriate antibiotic prescribing across different healthcare settings. Methods A cross-sectional survey of clinicians in Australian hospitals and primary care was undertaken between June and October 2019. The perceived barriers to appropriate antibiotic prescribing were considered as dependent variables, whereas age, sex, clinical experience, healthcare setting and the use of guidelines were considered independent variables. We used multivariate logistic regression to identify factors predictive of inappropriate antibiotic prescribing. Content analysis of free-text responses provided additional insights into the impediments to appropriate prescribing. Results In all, 180 clinicians completed the survey. Overall, diagnostic uncertainty and limited access to guidelines and prescribing information were significant barriers to appropriate antibiotic prescribing. Factors associated with these barriers were clinical experience, care setting (hospitals vs primary care) and the use of guidelines. Experienced clinicians (>11 years) were less likely to consider that limited access to information negatively affected prescribing practices (experience 11-20 years, odds ratio (OR) 0.66, 95% confidence interval (CI) 0.31-0.84; experience >20 years, OR 0.51, 95% CI 0.24-0.91). Conversely, general practitioners considered diagnostic uncertainty (OR 1.31, 95% CI 1.09-1.63) and patient expectations (OR 1.41, 95% CI 1.12-1.84) were more likely to be perceived barriers to appropriate prescribing. The use of guidelines and clinical experience may counteract this. Conclusion Years of experience, use of guidelines and type of setting were predictors of clinicians' perceptions regarding antibiotic prescribing. Our data highlight the importance of individual and setting characteristics in understanding variations in prescribing practices and designing targeted interventions for appropriate antibiotic prescribing. What is known about the topic? Inappropriate antibiotic prescribing is a significant health issue in Australia. Drivers of inappropriate prescribing are known, but how individual and setting characteristics contribute to variations in prescribing behaviour has not been fully understood. What does this paper add? Diagnostic uncertainty and limited access to prescribing information, including guidelines, formulary restrictions and antibiotic resistance patterns, can limit appropriate antibiotic prescribing. Clinicians' years of experience, the healthcare settings and clinician use of guidelines are important predictors of antibiotic prescribing behaviour. What are the implications for practitioners? The findings of this study can inform the design of tailored interventions to promote rational antibiotic prescribing practices in general practice and hospital settings.

South Australian Medicines Evaluation Panel in review: providing evidence-based guidance on the use of high-cost medicines in the South Australian public health system.

Objective The South Australian Medicines Evaluation Panel (SAMEP) was established in 2011 to make evidence-based recommendations on the funding of high-cost medicines in South Australian public hospitals via a high-cost medicines formulary. SAMEP represents one component of South Australia's process for state-based health technology assessment (HTA). The aim of this study was to describe the experience of SAMEP in the context of Australia's complex governance model for hospital-based care. Methods A retrospective review was conducted of the SAMEP process and outcomes of medicine evaluations. Decision summaries and meeting minutes were reviewed and reflected upon by the authors to explore the views of the SAMEP membership regarding the function of the committee and state-based HTA more broadly. Results SAMEP has reviewed 29 applications, with 14 (48%) listed on the high-cost medicines formulary. Three applications have been the subject of outcome review and confirm expectations of patient benefit. Conclusion Retrospective review of the committee experience suggests that state-based HTA as operationalised by SAMEP is feasible, provides greater equity of access to high-cost medicines in the South Australian public hospital system and allows for access with evidence development. What is known about the topic? State-based hospital funders often need to make decisions on the provision of high-cost medicines for which there is no national guidance or subsidy. Little published information exists about state-based approaches to medicines evaluation and reimbursement within public hospitals in Australia. What does this paper add? The South Australian experience demonstrates a method for states and territories to tackle the challenges of providing evidence-based access to high-cost medicines in Australian public hospitals. What are the implications for practitioners? This paper provides information for other jurisdictions considering state-based approaches to medicines evaluation and contributes to the broader literature about state-based HTA in Australia.

Factors That Impact the Adoption of Clinical Decision Support Systems (CDSS) for Antibiotic Management.

The study evaluated individual and setting-specific factors that moderate clinicians' perception regarding use of clinical decision support systems (CDSS) for antibiotic management. A cross-sectional online survey examined clinicians' perceptions about CDSS implementation for antibiotic management in Australia. Multivariable logistic regression determined the association between drivers of CDSS adoption and different moderators. Clinical experience, CDSS use and care setting were important predictors of clinicians' perception concerning CDSS adoption. Compared to nonusers, CDSS users were less likely to lack confidence in CDSS (OR = 0.63, 95%, CI = 0.32, 0.94) and consider it a threat to professional autonomy (OR = 0.47, 95%, CI = 0.08, 0.83). Conversely, there was higher likelihood in experienced clinicians (>20 years) to distrust CDSS (OR = 1.58, 95%, CI = 1.08, 2.23) due to fear of comprising their clinical judgement (OR = 1.68, 95%, CI = 1.27, 2.85). In primary care, clinicians were more likely to perceive time constraints (OR = 1.96, 95%, CI = 1.04, 3.70) and patient preference (OR = 1.84, 95%, CI = 1.19, 2.78) as barriers to CDSS adoption for antibiotic prescribing. Our findings provide differentiated understanding of the CDSS implementation landscape by identifying different individual, organisational and system-level factors that influence system adoption. The individual and setting characteristics can help understand the variability in CDSS adoption for antibiotic management in different clinicians.

The representation of public values in health technology assessment to inform funding decisions: the case of Australia's national funding bodies.

Over the past few years, there has been an increasing recognition of the value of public involvement in health technology assessment (HTA) to ensure the legitimacy and fairness of public funding decisions [Street J, Stafinski T, Lopes E, Menon D. Defining the role of the public in Health Technology Assessment (HTA) and HTA-informed decision-making processes. Int J Technol Assess Health Care. 2020;36:87-95]. However, important challenges remain, in particular, how to reorient HTA to reflect public priorities. In a recent international survey of thirty HTA agencies conducted by the International Network of Agencies for HTA (INAHTA), public engagement in HTA was listed as one of the "Top 10" challenges for HTA agencies [O'Rourke B, Werko SS, Merlin T, Huang LY, Schuller T. The "Top 10" challenges for health technology assessment: INAHTA viewpoint. Int J Technol Assess. 2020;36:1-4].Historically, Australia has been at the forefront of the application of HTA for assessing the effectiveness and cost-effectiveness of new health technologies to inform public funding decisions. However, current HTA processes in Australia lack meaningful public inputs. Using Australia as an example, we describe this important limitation and discuss the potential impact of this gap on the health system and future directions.

Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

INTRODUCTION: In healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs. METHOD AND ANALYSIS: This protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O'Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted. ETHICS AND DISSEMINATION: This scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.

Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective.

BACKGROUND: The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs. OBJECTIVES: To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation. METHODS: Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed. RESULTS: Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments. CONCLUSIONS: Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.

The rationale and design of public involvement in health-funding decision making: focus groups with the Canadian public.

BACKGROUND: Worldwide, governments employ health technology assessment (HTA) in healthcare funding decision making. Requests to include public perspectives in this are increasing, with the idea being that the public can identify social values to guide policy development, increasing the transparency and accountability of government decision making. OBJECTIVE: To understand the perspectives of the Canadian public on the rationale and design of public involvement in HTA. DESIGN: A demographically representative sample of residents of a Canadian province was selected to take part in two sets of two focus groups (sixteen people for the first set and twenty for the second set). RESULTS: Participants were suspicious of the interests driving various stakeholders involved in HTA. They saw the public as uniquely impartial though also lacking knowledge about health technologies. Participants were also suspicious of personal biases and commended mechanisms to reduce their impact. Participants suggested various involvement methods, such as focus groups, citizens' juries and surveys, noting advantages and disadvantages belonging to each and commending a combination. DISCUSSION AND CONCLUSIONS: We identified a lack of public understanding of how decisions are made and distrust concerning whose interests and values are being considered. Public involvement was seen as a way of providing information to the public and ascertaining their views and values. Participants suggested that public involvement should employ a mixed-methods strategy to support informed debate and participation of a large number of people.

Evidence Synthesis International (ESI): Position Statement.

This paper is the initial Position Statement of Evidence Synthesis International, a new partnership of organizations that produce, support and use evidence synthesis around the world. The paper (i) argues for the importance of synthesis as a research exercise to clarify what is known from research evidence to inform policy, practice and personal decision making; (ii) discusses core issues for research synthesis such as the role of research evidence in decision making, the role of perspectives, participation and democracy in research and synthesis as a core component of evidence ecosystems; (iii) argues for 9 core principles for ESI on the nature and role of research synthesis; and (iv) lists the 5 main goals of ESI as a coordinating partnership for promoting and enabling the production and use of research synthesis.

Understanding Canadian Health Technology Assessment through a systems lens.

OBJECTIVE: Governments around the world face challenges in maintaining sustainable, high-quality healthcare systems. Health Technology Assessment (HTA) is widely used as a method to assist in funding decisions. However, the scope and influence of HTA is still limited. We examined how policymakers can improve the usefulness of HTA. METHODS: We used Systems Thinking as a theoretical framework to examine HTA as a system. We purposely sampled stakeholders involved in Canadian HTA at a national or provincial level. We conducted 22 semi-structured interviews in September-December 2016. Data were analysed using NVivo10 and findings are presented as a concept map with explanatory text. FINDINGS: The HTA system is influenced by stakeholder interactions. Such interactions are, in turn, affected by stakeholders' worldviews and environmental factors. Stakeholders' worldviews includes individual's or groups' values and affect the exchange of information, and interpretation of events. External factors, such as changes to government structures, also affect the system. CONCLUSION: Most stakeholder groups are supportive of the system. However, participants identified a need for change, though the exact changes being recommended differed. Some interactions were praised (formal, inclusive collaborations to provide government with policy guidance on both broad and technology-specific matters), while other interactions were criticised (two-party alliances formed around purposes other than the common good, and lacklustre patient and industry engagement on the part of provincial government).

Development of a health technology assessment module for evaluating mobile medical applications.

OBJECTIVE: The aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes. METHODS: In-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs. RESULTS: Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians. CONCLUSION: An MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module.

Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.

INTRODUCTION: Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicine-induced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia. METHODS AND ANALYSIS: The reducing medicine-induced deterioration and adverse reactions trial is a multicentre, open-label randomised controlled trial. Participants will be recruited from 39 facilities in South Australia and Tasmania. Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties. The intervention group will receive a pharmacist assessment which occurs every 8 weeks. The pharmacists will liaise with the participants' general practitioners when medicine-induced deterioration is evident or adverse events are considered serious. The primary outcome is a reduction in medicine-induced deterioration from baseline to 6 and 12 months, as measured by change in frailty index. The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use. The statistical analysis will use mixed-models adjusted for baseline to account for repeated outcome measures. A health economic evaluation will be conducted following trial completion using data collected during the trial. ETHICS AND DISSEMINATION: Ethics approvals have been obtained from the Human Research Ethics Committee of University of South Australia (ID:0000036440) and University of Tasmania (ID:H0017022). A copy of the final report will be provided to the Australian Government Department of Health. TRIAL REGISTRATION NUMBER: Australian and New Zealand Trials Registry ACTRN12618000766213.

Estimating the utilisation of unregistered antimicrobials in Australia.

OBJECTIVE: To identify and estimate the usage of unregistered antimicrobial drugs in Australian clinical practice. METHODS: A descriptive pharmaco-epidemiological study, utilising three data sources: analysis of Special Access Scheme (SAS) applications for unregistered antimicrobials included in clinical guidelines over a five year period, analysis of antimicrobials dispensed from South Australian public hospital pharmacy departments over a two year period and analysis of National Antimicrobial Utilisation Surveillance Program (NAUSP) data for reported inpatient usage of unregistered antimicrobials in Australian hospitals over the last 5 years. RESULTS: 59 unregistered antimicrobials were identified using the mixed methods. 18,362 Special Access Scheme applications were submitted between May 2012 and April 2017 to access the 20 unregistered antimicrobials identified in the Therapeutic Guidelines® (eTG complete); 51.4% were determined by the prescriber to be for life-threatening indications. Annual applications more than doubled over the five years. 34 unregistered antimicrobials were dispensed from South Australian public hospitals between July 2015 and June 2017. On average, 1.1% of total antimicrobial usage (Defined Daily Doses) per month was accessed via the SAS, of which 87.7% were for outpatients or discharged patients. 34 unregistered antimicrobials for systemic use identified in the NAUSP database were used in Australian hospitals between 2013 and 2018. CONCLUSION: The use of unregistered antimicrobials in Australian clinical practice is not uncommon. With increasing antimicrobial resistance, there will be a continued reliance on older less-used antimicrobial agents and an increasing need for novel drugs, therefore regulatory pathways need to facilitate security of supply and assurance of medicine quality and safety.