bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP128 Evaluating The NPS MedicineWise Medicines Information Phone Service
Authors: Humphreys Lauren , Packham Nerida , Blogg Suzanne , Gonzaga Nicole , Dickinson Scott , Granger Renee 
Published: January 2019

Introduction:The NPS MedicineWise pharmacist-delivered phone service, Medicines Line, aims to provide evidence-based medicines information to consumers. We evaluated outcomes of the Medicines Line, including common consumer inquiries and resultant decision-making, and explored consumer motivations for seeking medicines information.Methods:The evaluation involved conducting paper-based and telephone surveys of a sample of 200 Medicines Line callers, and semi-structured telephone interviews of a subset of twenty callers. Quantitative data were analyzed using SPSS software. Qualitative data were analyzed using content analysis.Results:Preliminary analysis found that the majority of callers thought the Medicines Line had improved their knowledge (ninety-six percent), confidence (eighty-two percent) and decision-making (eighty-nine percent). The most common reasons for calling the Medicines Line were inquiries about side effects or medicine compatibility. The medicines most commonly asked about were antidepressants (twenty percent), analgesics (thirteen percent) and antibiotics (nine percent). Questions about sertraline accounted for thirty-six percent of antidepressant inquiries. Interview themes regarding motivations for using the service included: trust; efficiency and convenience; specialized drug knowledge; and reporting adverse drug reactions to protect others from medicine-related harm. Medicines Line was perceived to be especially useful as an alternative to family physician or specialist consultations when consumers had a non-urgent inquiry about a medicine, and as a service to provide medicines information in remote communities.Conclusions:These results indicate that pharmacist-delivered medicines information telephone services are an effective and efficient way of handling medicines inquiries. Medicines information telephone services are effective in improving health literacy, by increasing callers’ knowledge and confidence to source evidence-based medicines information and improving their ability to make informed decisions about medicine use. This evaluation identified knowledge gaps in medicine side effects and antidepressant use. Identifying such knowledge gaps may be useful in informing future health professional education programs, community campaigns, and shared decision-making resources.
OP143 Conceptualizing Patients’ Experience With Atrial Fibrillation
Authors: Oehrlein Elisabeth , Perfetto Eleanor , McCall Debbe , Albrecht Jennifer , Slejko Julia , Cooke Catherine , dosReis Susan 
Published: January 2019

Introduction:Conceptual models (CMs) are useful tools for researchers and health technology assessment bodies to understand the interplay among environmental characteristics (e.g., health care system), patient characteristics, health behaviors, and patient outcomes. The objective of this pilot study was to elicit perspectives of patients with atrial fibrillation (AF) and health care providers (HCPs) to develop a patient-centered CM of the AF patient experience in a US-based sample.Methods:We developed two preliminary versions of the Andersen model of healthcare utilization (standard and patient-friendly versions) based on the published literature and the help of a patient advisor. For example, instead of describing “predisposing characteristics,” the patient-friendly CM describes, “what is it about me, or other afib patients that could impact disease or outcomes;” “enabling resources” is swapped for “helpful resources,” and “perceived need” is changed to “what impacts whether I believe I need to be treated”. Five patients from an online patient community and 10 HCPs from the University of Maryland Medical System provided feedback on the preliminary models. Audio recordings of interviews were transcribed verbatim, analyzed, and findings incorporated into a revised CM.Results:Interviewee additions under “what impacts whether I believe I need to be treated” included: absence of symptoms and fear of experiencing an AF episode; under “helpful resources” suggested additions include resources for navigating insurer formulary/benefits. Suggested additional outcomes of interest include anxiety, bruising, and shortness-of-breath. While patients found the patient-friendly version easy to understand, HCPs required explanation of standard-version headers, for example ‘predisposing characteristics’ and ‘enabling resources’, which had been adapted in the patient-friendly version.Conclusions:Soliciting input from stakeholders ensures CMs are pragmatic, reflect the real-world experiences of patients and HCPs, and incorporate variables or other considerations not currently described in published literature. Researchers can utilize CMs to aid in selection of variables for observational studies.
OP160 Enhancing Innovation Through HTA: Experience From South Australia
Authors: Burgess Naomi , Chen Deborah 
Published: January 2019

Introduction:A statewide health technology assessment (HTA) program was implemented to increase equity of access and support robust assessment of technologies, with a focus on those that are high-cost, high-risk, or have state-wide impact.Methods:Local hospital networks and clinicians refer technologies to the South Australia Policy Advisory Committee on Technology (SAPACT) for assessment. Independently produced, comprehensive HTA reports are developed using internationally recognized evidence and critical appraisal methodologies. Clinical and economic systematic analyses are utilized, with extensive clinical consultation, to develop recommendations for new technologies and their role in models of care. Feasibility of adoption and local implementation are considered, including existing service delivery and appropriate training and credentialing. For approved technologies, SAPACT may also develop audit criteria and seek implementation reports on clinical outcomes.Results:The HTA framework has been successfully adopted across South Australia Health, increasing the incorporation of evidence-based decision making in the use of high-cost and high-risk health technologies. Over 35 evidence evaluations for high-risk and high-cost health technologies have been conducted for a broad range of treatment interventions. SAPACT develops and utilizes HTA decision-making criteria for transparency of Committee considerations. The program recommends adoption or rejection of technologies, or it may request a re-submission due to safety concerns or a lack of proven effectiveness. SAPACT has also granted temporary approval through adoption under clinical evaluation to inform investment decisions. A key component is working with clinicians to define specific treatment criteria and patient selection. SAPACT continues to strengthen relationships with all stakeholders, increase patient input through the development of public summary documents for technologies, and improve monitoring and reporting of clinical outcomes.Conclusions:The HTA program has been very productive and positively received. The success of the program is underpinned by its engagement with clinicians, hospital networks, and consumers. The completion of SAPACT HTA reviews and the publication of the SAPACT decision-making criteria have increased the credibility of decisions, supporting enhancements in patient care and cost efficiency for the state government.
OP170 Regulatory And Health Technology Assessment Considerations In Alzheimer's Disease
Authors: Bouvy Jacoline , Jonsson Pall 
Published: January 2019

Introduction:There has been a move towards the development of disease-modifying agents in Alzheimer's disease (AD) and it is likely that early disease-modifying treatments will initially be offered to people who have positive AD markers and mild cognitive impairment (MCI). Consequently, disease-modifying drugs will have distinctive features as compared to currently licensed symptomatic treatments, which makes the implications of these new agents for regulatory and health technology assessment (HTA) processes unclear.Methods:The ROADMAP (Real-world Outcomes across the AD spectrum for better care: Multi-modal data Access Platform) project provides the foundation for a European data platform for real-world evidence in AD, and established an expert advisory group (EXAG) consisting of regulatory and HTA experts. This presentation will summarize the key lessons from the first year of ROADMAP's EXAG and identifies the next steps that are required to prepare Europe's healthcare systems for a disease-modifying drug.Results:The EXAG identified a need for: (i) establishing the rationale for the selection of priority outcomes in pre-clinical AD and MCI; (ii) establishing accepted outcomes for defining prevention of AD or delayed AD onset; (iii) exploring modern technology that could assist in testing cognition that could easily be used in clinical practice; and (iv) establishing caregiver-relevant outcomes (e.g. quality of life, loss of income, carer time) that are important to capture; and found that not all evidence to support modelling assumptions can be generated through RCTs, making the case for using real-world evidence.Conclusions:Many of the challenges that the EXAG identified can be solved by generating better real-world data in AD. There is a clear need to agree on the outcomes that will facilitate and inform regulatory and HTA decision-making. Once the gaps in the availability of outcomes in AD will be closed, we will be one step closer towards being ready for a disease-modifying drug.
OP171 Does Parallel Regulatory-Health Technology Assessment Reviews Affect Time To Health Technology Assessment Decisions?
Authors: Cai Jesmine , Wang Tina , McAuslane Neil , Liberti Lawrence 
Published: January 2019

Introduction:Timely recommendation by Health Technology Assessment (HTA) agencies for drug reimbursement is critical to ensure patient access to medicines of therapeutic value. In this study, HTA performance was examined in terms of their outcome and timing by looking at how 103 drugs, which gained regulatory approval from 2013 to 2015, were assessed by HTA agencies from 2014 to 2016.Methods:Products must have received regulatory approval from one of the following regulatory agencies: EMA (Europe), Health Canada (Canada) and TGA (Australia). The first HTA recommendations were then collected from PBAC (Australia), CADTH (Canada), HAS (France), IQWiG (Germany), SMC (Scotland) and TLV (Sweden). The HTA decisions were classified as positive, positive with restrictions, negative and multiple.Results:Eighty-four drugs were approved in Europe before Australia and Canada. Of the studied HTA agencies, PBAC had the highest percentage of products recommended within a year from regulatory approval (93 percent). In addition, Australia had the shortest median time between first regulatory submission by any of the three agencies and HTA recommendation (553 days) as compared to Europe (616 days) and Canada (722 days). This can be attributed to the TGA/PBAC parallel process. However, Australia has the highest proportion of products receiving a negative PBAC recommendation (62 percent).Conclusions:The majority of drugs were first submitted for reimbursement in Europe, but the time from regulatory submission to HTA decision was the fastest in Australia. This can be attributed to the TGA/PBAC parallel review process, which showed its benefit in reducing the overall time. A parallel review process is also available in Canada; however, it is not utilized as frequently by companies as in Australia.
OP172 Do Expedited Regulatory Pathways Affect Time To Health Technology Assessment Decision?
Authors: Cai Jesmine , Wang Tina , McAuslane Neil , Liberti Lawrence 
Published: January 2019

Introduction:In an effort to speed the assessment of new medicines while maintaining the quality of the regulatory review, facilitated regulatory pathways (FRPs) have been introduced in many countries. In this study, the effects of FRPs (expedited and conditional reviews) were investigated in terms of their influence on HTA outcomes and timing.Methods:HTA recommendations issued between 2014 and 2016 were collected from CADTH (Canada), HAS (France), IQWIG (Germany), SMC (Scotland) and TLV (Sweden) for 90 internationalized medicines (new active substances approved between 2012 and 2016 by all regulatory agencies in the five jurisdictions). The HTA decisions were then classified into the following categories: positive, positive with restrictions, negative and multiple.Results:Of this cohort of internationalized medicines that received an HTA recommendation, 31 percent in Canada and 28 percent in Europe were approved via a FRP. With the exception of Scotland, expedited medicines were more likely to be appraised within a year from regulatory approval and had a shorter median time between regulatory approval to HTA recommendation than standard medicines. The largest difference was seen in Sweden, where medicines were 66.5 days faster than standard pathways when it underwent the expedited pathways. Compared to standard pathways, there were generally a higher proportion of positive and positive with restrictions recommendations when expedited pathways were used. Germany reported the largest proportional difference (31 percent) between the two pathways.Conclusions:Medicines being designated for an expedited review pathway show a reduced time from regulatory approval to HTA decision. This finding suggests there is an alignment between regulators and HTA agencies on which medicines require expedited HTA pathways; however, from this data it cannot be assessed whether the reduced time from approval to HTA decision is attributed to the company strategy, HTA review time or both. Further investigation is required.
OP174 Development Of A Formal Priority-Setting For The Philippine Government
Authors: Wong John , Reyes Katherine Ann , Ho Beverly Lorraine 
Published: January 2019

Introduction:The lack of institutional mechanisms in the Philippine Health Insurance Corporation (PhilHealth) for rationalizing spending has led to a less than optimal allocation of financial resources. The study's objective is an explicit and systematic priority setting process of selecting new interventions for PhilHealth through identification of relevant literature evidence on the themes under study, then subjecting these to stakeholder and expert consultations.Methods:The qualitative study followed a problem solving approach to policy analysis. Bardach's Eightfold Path, supplemented by a World Health Organization (WHO) guideline on policy analysis, provided the framework. Eightfold path recommends that the analysis proceed by (i) defining the problem, (ii) assembling the evidence, (iii) constructing the alternatives, (iv) selecting the criteria for identifying the best alternative, (v) projecting the outcomes, (vi) confronting the tradeoffs, (vii) making the decision, and (viii) disseminating the results.Results:A six-step priority setting process to facilitate the assessment of new interventions for PhilHealth coverage was developed. The process is governed by seven accountability-based principles and four explicit criteria to evaluate interventions. Additionally, the study provided proof-of-concept for conducting local cost-effectiveness and budget impact analyses as key inputs to a national systematic priority-setting process.Conclusions:This study recommended four criteria and a seven-step process for priority setting to be adopted and an overarching set of principles that will guide the conduct of such activities. The proposed priority-setting process was approved by the PhilHealth. The same process was adopted by the Department of Health in the draft administrative order for health technology assessment. This study stimulated research projects for economic evaluations of health interventions.
PP08 Health Technology Assessment Of Autologous Chondrocyte Implantation
Authors: Mistry Hema , Connock Martin , Royle Pamela , Waugh Norman 
Published: January 2019

Introduction:Microfracture (MF) has been the main intervention in symptomatic articular cartilage knee defects. Autologous chondrocyte implantation (ACI) has looked promising, but was not recommended by the UK National Institute for Health and Care Excellence (NICE) in 2015 due to the short-term follow-up data from trials.Methods:Most long-term data comes from observational studies. We provided new unpublished analyses to NICE based on survival data of these studies, with appropriate caveats. They included: a large ACI study by Nawaz with useful subgroup data by osteoarthritis Kellgren-Lawrence stage and previous repair attempts; a very large MF study by Layton, and a small RCT by Knutsen indicating MF was as ‘good’ as ACI. A Markov model explored the cost-effectiveness of ACI vs. MF. Different scenarios were explored: ACI or MF as a first procedure, followed by ACI or MF in those needing a second repair. A NHS England perspective was adopted. Health outcomes were expressed as quality-adjusted life-years (QALYs).Results:The revised base-case analysis, used a list price of £16,000 (EUR 17,380 in 2013 prices) for cells, used ACI failure data from Nawaz with no previous procedures for ACI, and pooled MF failure data from two studies-Saris and Knutsen. ACI was more expensive but provided more QALYs. The incremental cost-effectiveness ratio comparing ACI then MF with MF then ACI was £8,000 (EUR 8,690) per QALY. Various sensitivity analyses were conducted assuming a threshold of £20,000 (EUR 21,730) per QALY: previous repair attempts reduced success of ACI (£22,000 (EUR 23,900) per QALY); reducing cell costs, ACI improved its cost-effectiveness; and limiting intervention to patients with higher Kellgren-Lawrence score did not appear cost-effectiveness.Conclusions:The final NICE guidance published in October 2017 approved the use of ACI for patients who had no previous knee repairs, for people with minimal osteoarthritic damage to the knee, and for people with articular defects of over 2cm2.
PP15 Incorporating Participatory Design Approaches Into HTA
Authors: Peddie David , Small Serena , Wickham Maeve , Badke Katherin , Woo Stephanie , Hohl Corinne , Balka Ellen 
Published: January 2019

Introduction:To address local workability, cross-setting variation, and clinician and patient perspectives, health technology assessment (HTA) practitioners and health system decision-makers incorporate varying forms of qualitative evidence into evaluations of novel health technologies. Employing principles and methods from long-established sociotechnical fields such as participatory design (PD) may help HTA teams in the production of formal, rigorous ‘practice-based evidence’.Methods:We draw on a theoretical review of foundational PD literature and experiences using PD for a large-scale health information technology project to summarize principles and strategies for the effective introduction and evaluation of new technologies in healthcare.Results:HTA may benefit from observing some of the core commitments of PD: (i) Ensuring that technologies enhance rather than detract from the quality of working life; (ii) Fostering democratic engagement in the implementation and evaluation of technologies; and (iii) Proceeding via direct partnership with technology users. These are practical commitments stemming from the recognition that technology implementation entails re-configuring existing practices and social arrangements. The experts of this existing milieu are the people on the ground, who may reject or underutilize technologies that they perceive as impractical, ill-adapted to their needs, or having negative consequences on their work. At the same time, PD recognizes that local activities occur within larger systems and that effective technology introduction also requires attention to macro-politics (e.g. governance challenges, competing priorities). PD employs a diversity of methods (e.g. participant observation, focus groups, workshops, interviews) to develop evidence that is holistically informed.Conclusions:Many of the challenges that HTA faces, both in terms of evidence production and translation, have been encountered before in PD. Given that decision-making around health technologies necessarily involves consideration of many forms of qualitative evidence, there is value in producing and evaluating such evidence in carefully designed manner – a challenge to which fields like PD can lend a wealth of experience.
PP16 Turning The Tide On Antibiotic Use With Consumers And Health Professionals
Authors: Wu Jianyun , Taylor Daniel , Dartnell Jonathan , Heaney Aine , Weekes Lynn , Blogg Suzanne , Sterling Kirsten , Carr Anthony 
Published: January 2019

Introduction:Many countries have a national antimicrobial resistance strategy. In Australia, primary care is especially important because this setting encompasses a high proportion of antibiotic use. While antibiotic use decreased during the 1990s, it began to increase again in the mid-2000s. In response to this, in 2009 NPS MedicineWise implemented a series of nationwide educational interventions for consumers, family physicians (general practitioners), and community pharmacies that aimed to reduce excessive antibiotic use.Methods:For consumers a social marketing approach was used, including strategies that leveraged collectivism, nudge theory, celebrity endorsement, and co-creation. Channels included social, print, radio, and other media as well as practice waiting rooms and pharmacies. For health professionals, interventions included face-to-face education, audits, comparative prescribing feedback, case studies, and point-of-care materials. Surveys of consumers and family physicians were conducted periodically to evaluate changes in knowledge and behavior. National Pharmaceutical Benefits Scheme claims data were analyzed using a Bayesian structural time-series model to estimate the cumulative effect of interventions by comparing the observed and expected monthly dispensing volumes if the interventions had not occurred.Results:The consumer survey results indicated that more people were aware of antibiotic resistance (seventy-four percent in 2017 versus seventy percent in 2014), with the minority requesting or expecting antibiotics for upper respiratory tract infections (URTIs) (twenty-two percent in 2017). People underestimated the usual duration of symptoms for URTIs and were more inclined to expect antibiotics beyond that timeframe. Compared with non-participants, family physicians who participated in the program reported more frequent discussions about hand hygiene (ninety percent versus eighty-two percent) and proper use of antibiotics with patients (ninety-five percent versus eighty-eight percent). Between 2009 and 2015 there was an estimated fourteen percent reduction in prescriptions dispensed to concessional patients for antibiotics commonly prescribed for URTIs.Conclusions:Family physicians and consumers have responded positively to national programs. Sustaining and building on these improvements will require continued education and further innovation.