bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP57 Threats And Opportunities To Digital Health In Primary Care
Authors: Gagnon Marie-Pierre , Rouleau Geneviève , Alami Hassane , Fortin Jean-Paul 
Published: December 2019

IntroductionThe use of digital technologies in healthcare systems (digital health)– such as electronic health records and telehealth – can improve primary care (PC). However, integration of digital health can be constrained/impaired and/or facilitated due to several factors. We propose an integrative framework for classifying the factors that could favour or limit digital health integration in PC in order to guide the identification of strategies that could be helpful for technology promoters, managers, clinicians and researchers.MethodsBased on a systematic review, our framework includes seven categories to classify the main opportunities and threats to digital health integration in PC: technological; individual/interpersonal; professional; organisational/institutional; ethical/legal; sociopolitical; economical. We consulted a panel of researchers, managers, clinicians, and citizens/patients in a scientific meeting regarding the main opportunities and threats to the integration of digital health in PC. We performed a content analysis of the reported factors according to the framework.ResultsTechnological factors such as maturity, interoperability and ease of use were often mentioned as key conditions for digital health integration. Individual and interpersonal factors such as depersonalisation and digital literacy were seen as threats. The impact on workload and shared responsibility were threats at the professional level, whereas silos and change management were noted as organisational threats. Current policies and social trends favored digital health. Threats regarding privacy and confidentiality were mentioned at the legal/ethical level. The possibility to reduce costs and sharing of benefits were noted as opportunities at the economic level.ConclusionsKnowing these multidimensional conditions, perceived as either threats or opportunities depending on the context of each PC setting, is essential to inform decisions, from strategic planning to evaluation. Our integrative framework allows a simple classification of opportunities and threats that can guide the development and implementation of tailored strategies favouring the integration of digital health in PC.
OP63 Clinical Videoconferencing - Critical-realist Review As Evidence?
Authors: Ekeland Anne 
Published: December 2019

IntroductionIt is not clear yet whether new digital health interventions can and should be assessed by using ‘conventional’ health technology assessment (HTA) methodology. In response to the question about how much and which type of evidence is needed for decisions on new digital health interventions, this presentation discusses complimentary evidence as generated through a critical-realist review and a qualitative meta-synthesis. This work follows from earlier work by AG Ekeland, AH Hansen and TS Bergmo.MethodsA realist review addresses complex social interventions investigated in real life settings. The review was conducted with the purpose of generating knowledge on what works, for whom and under which circumstances. The aim was to enable decision-makers to reach a deeper understanding of how the intervention can be made to work most effectively. A critical review goes beyond mere description of identified articles and includes analysis and conceptual innovation. An effective critical review synthesizes material from diverse sources, provides an opportunity to ‘take stock’ and evaluate what is of value related to a previous body of work.ResultsUser patterns of clinical videoconferencing turned out to be dependent on contextual factors like clinical condition, motivation, technological skills, professional and organizational arrangements, trust and the perceived value they add compared with “services as usual”. The pattern of what works, for whom and under which circumstances was heterogeneous and dynamic. The review types helped identify and conceptualize new user categories, and understand the complex patterns of use.ConclusionsThe in-depth accounts of different clinical use resulting from such a review provide decision makers with a highly practical understanding of complex social interventions which is likely to be of use when planning and implementing programs at a national, regional or local level. A critical-realist review of digital services can complement controlled studies and evidence summaries in HTA.
OP83 Iterative Formative Research Informing Primary Care Education Design
Authors: Belcher Josephine , Alzaher Woroud , Naik-Panvelkar Pradnya , Granger Renee 
Published: December 2019

IntroductionNPS MedicineWise delivers nationwide educational programs for Australian general practitioners and community pharmacists. Extensive searching and synthesis of published and grey literature is undertaken to inform program design and development. However, this formative research process is lengthy, labour intensive and attempts to pre-emptively answer questions that could arise during design and development, prompting a process re-evaluation.MethodsA more targeted and iterative process was piloted entailing: (i) rapid collation (two weeks maximum) of basic contextual information into a pre-scoping briefing document including high-level statistics on medicines or test usage, key guidelines identification and collation of findings from relevant government and stakeholder reports, (ii) an internal advisory group reviewing the pre-scoping brief and identifying the highest priority research questions that must be answered to inform the design and development of the educational program, (iii) iterative work to answer the highest priority research questions with findings provided to the advisory group fortnightly, involving ad hoc search methods and snowballing techniques to identify pertinent literature quickly, (iv) iterative feedback from the advisory group as to whether the resulting work is adequate and development or whether further information is required, and reprioritisation of the work plan if necessary, and (v) completion of the formative research process within four or five iterations. The new approach was evaluated via surveys of the internal advisory group and staff involved in design and development. Administrative data on staffing and costs using the new approach were also compared with previous data.ResultsThis approach was trialled for three different educational programs. The resulting reports are more targeted, answer specific advisory group questions and take half the time to produce.ConclusionsThis approach can rapidly provide appropriate information to inform program design. The iterative approach has allowed greater responsiveness to changing advisory group priorities and process improvements.
OP85 Persistence Leads To Ongoing Decreases In Primary Care Antibiotic Use
Authors: Dartnell Jonathan , Sterling Kirsten , Heaney Aine , Blogg Suzanne 
Published: December 2019

IntroductionAustralia has had high rates of antibiotic use in primary care. Consumer and health professional knowledge and practices in the community vary. In 2012, NPS MedicineWise implemented a five-year national educational program for consumers, general practitioners (GPs) and pharmacies to reduce antibiotic use in Australia.MethodsFor consumers, a social marketing approach was used focusing on the winter months. Strategies leveraged collectivism, nudge theory, celebrity endorsement and co-creation and used multiple communication channels. For health professionals, interventions were most intense in 2012 with additional activities implemented each year including face-to-face educational visiting, audits, comparative prescribing feedback, case studies and point-of-care materials. Surveys were conducted periodically to evaluate changes in knowledge and awareness. Pharmaceutical Benefits Scheme (PBS) claims data were analyzed. Organization for Economic Co-operation and Development data was used to compare Australian antibiotic per capita consumption to other countries. Time series analyses were used to estimate the cumulative program effect comparing observed and expected monthly dispensing volumes of antibiotics commonly prescribed for upper respiratory tract infections (URTIs), had interventions not occurred.ResultsBetween 2012 and 2017, GP antibiotic PBS prescriptions reduced by 18.4 percent. Antibiotic defined daily doses per 1000 inhabitants reduced from 23.7 in 2012 to 18.4 in 2016, similar to Norway (18.6 in 2016) and the UK (18.7). Time series modelling estimated 24.8 percent fewer GP antibiotic URTI prescriptions by 2017 versus no program. Consumer survey results indicated increased awareness of antibiotic resistance (50 percent in 2011, 74 percent in 2017) and the minority expect/request antibiotics for URTIs (22 percent in 2017).ConclusionsA five-year national educational program with multiple and repeated interventions for health professionals and consumers has resulted in ongoing reductions in antibiotic use in primary care.
OP129 Healthcare Utilization After Bariatric Surgery
Authors: Kelles Silvana Marcia Bruschi , Soares dos Santos Augusto Cesar , Horta Maria da Glória Cruvinel , Fernandes Mariana Ribeiro , Rodrigues Luíza de Oliveira , Avelar Sandra de Oliveira Sapori , Carvalho Lélia Maria de Almeida , Campos Nelson Otavio Beltrao , Scherrer Luciano Rios , Biscione Fernando Martin 
Published: December 2019

IntroductionBariatric surgery has become one of the fastest growing operative procedures due to its sustained results and the increasing prevalence of obesity worldwide. Despite this fact, bariatric surgery carries the usual risks and threats of surgical interventions and therefore its benefits might be undermined by its mid and long-term complications.MethodsThis retrospective study included obese patients requiring bariatric surgery from January 2004 to December 2017 provided by a private healthcare organization in Belo Horizonte, Brazil. Data regarding healthcare utilization were extracted from an administrative database (software Oracle Business Intelligence). Continuous variables were expressed as mean and standard deviation. Log-Rank test was used to adjust the survival curve (software STATA 13.1, Stata Corp, USA). This historical cohort resulted in no interventions, neither during the instituted treatment nor after the observed outcome. Privacy of subjects and the confidentiality of their personal information were handled in accordance with the ethical principles of the Declaration of Helsinki.ResultsIn total, 16,786 patients were included in the study (mean age 37.2 ± 10.2 years; female 79.2 percent; mean body mass index 42.4 ± 5.5 kg/m2). Patients were followed for up to seven years before and after surgery (total of 78,113 patients/year). For this group, the hospitalization rate was 0.099 / patients-year before versus 0.151 / patients-year after the bariatric surgery (p < 0.001). There were 224 deaths (1.33 percent) identified during the follow-up period, 0.4 percent in the first 30 postoperative days. The average costs for hospitalization were USD 3,339.36 and USD 4,305.04 for open and laparoscopic surgery, respectively.ConclusionsBariatric surgery has been an increasingly popular choice in the management of obesity. In our sample, it did not reduce the overall mid-term healthcare utilization rate.
OP131 Rapid Review For Policy: Interchangeability Of Biological Medicines
Authors: Rego Daniela , Farinasso Cecilia , Silva Roberta Borges , Gomes Dalila Fernandes , de Aguiar Aurelina Aguiar , Leão Luciana Simões Camara , Sachetti Camile Giaretta , Gonçalves Lenilson Pereira , Leite Betânia 
Published: December 2019

IntroductionDue to the high judicialization rates which pressure the financing of biologic medicines by the Brazilian Unified Health System (Sistema Único de Saúde - SUS), it has been decided to formulate the National Policy for Biologic Medicines. After identification of problems and prioritization, interchangeability based only on economic criteria was the main problem to be confronted. The primary objective of this study was to identify political options to approach the problem of interchangeability in systematic reviews.MethodsWe conducted a rapid evidence synthesis for policy based on an adaptation of the SUPPORT tools, and searched in six literature databases. The selection of studies was performed in a systematic, transparent and independent manner. The International Network of Agencies in Health Technology Assessment (INAHTA) members were consulted to learn how this practice occurs worldwide.ResultsWe included seven systematic reviews and one policy brief, whose options to approach the problem were: production of robust scientific evidence on interchangeability; implementation of a pharmacovigilance system; appreciation of the clinical efficacy in the practice of interchangeability; and educational strategies for healthcare professionals in Brazil. Nine countries responded to our query.ConclusionsEvidence-informed policy has a central role for the Brazilian Ministry of Health. The present rapid evidence synthesis for policy will subsidize decision making regarding the interchangeability of biologic medicines within the Brazilian Unified Health System.
OP132 What Future For Drugs After An Early Dialogue Procedure?
Authors: Fernandez Judith , Thomassin Camille , Grande Mathilde , Bélorgey Chantal , Thuillez Christian , d'Andon Anne 
Published: December 2019

IntroductionThe French health technology assessment (HTA) body, Haute Autorité de la Santé (HAS), started to provide early advice on evidence generation plans to pharmaceutical manufacturers in 2010. It became an official mission in 2016. Requests are eligible when the product has a new mechanism of action, if there is an unmet or partially met medical need in the claimed indication and when the pivotal study has not yet started. This analysis aims to provide a first overview of clinical developments for which pharmaceutical companies sought an early dialogue with HAS.MethodsFor each product that went through an early dialogue procedure with HAS, information regarding the clinical development was collected on pharmaceuticals companies’ pipelines, clinicaltrials.gov, the website of the European Medicine Agency (EMA) and HAS's internal database.ResultsBy the end of 2018, HAS has performed 84 early dialogues of which 53 were conducted in collaboration with the EMA and/or others European HTA bodies. They were mainly focused on phase III trials. Following early dialogue, the clinical study for which the company sought advice was not yet implemented in 25 cases. When the clinical trial was effectively launched, results were negative in 10 cases, positive in 11 cases and the study was still ongoing for 29 products. In nine cases, the clinical development was officially withdrawn or suspended before the initiation of the trial. Overall, only eight medicinal products were appraised by HAS, they all obtained a clinical added value score.ConclusionsThe success rate of clinical development for products that underwent an early dialogue procedure tends to be higher than data from literature, although it is likely to decrease in follow-up analysis. This could be partially explained by HAS's eligibility criteria that restrict early dialogues to promising products and by the scientific recommendations provided to pharmaceuticals companies.
OP142 Reviewing Methods For Early Assessment
Authors: Stome Linn Nathalie , Moger Tron , Kidholm Kristian , Kvaerner Kari 
Published: December 2019

IntroductionThe project DigiHelse aims to support the municipality health in Norway by offering a digital communication platform to users of the home care service nationally. In a concept stage of innovation, an early assessment of the potential socioeconomic value of the project was carried out by means of stakeholder insight and scenario drafting. As the assessment showed favorable potential in providing decision support and reducing risk, the project received funding to move into the pilot phase. The objective of this study is to reassess the effect of stakeholder insight and scenario drafting by validating the results using empirical data from the first pilot of DigiHelse.MethodsThrough collecting empirical data on resource consumption and inquiries to the service from four intervention districts and one control district in Oslo, the socioeconomic value of DigiHelse was reassessed. In addition to survey and register data collected before and after the pilot, behavioral data was introduced as a new data source.ResultsThe effect of early assessment by means of stakeholder insight and scenario drafting was successfully studied adding empirical data from the projects first pilot. The real-time data on user behavior registered in the DigiHelse server contributed to verify the assumptions from the first assessment of the project. Although the results from the analysis were less optimistic than the first assessment, the study revealed important improvement measures necessary to improve the innovation process.ConclusionsThe usefulness of early assessment is questioned, due to lack of precision of estimates caused by scarce available data. The present study presents a first step in evaluating the precision of employing stakeholder insight and scenario drafting as additional information in early assessment of innovation. The studied approach to early assessment showed potential in enhancing decision support and reducing risk from a concept stage of innovation.
OP143 Assessment Of mHealth Apps: Is Current Regulation Policy Adequate?
Authors: Moshi Magdalena , Parsons Jacqueline , Tooher Rebecca , Merlin Tracy 
Published: December 2019

IntroductionAustralians are adjusting to mobile health (mHealth) applications (apps) being used in clinical care. The nature of apps presents unique challenges (e.g. rapid lifecycle) to mHealth regulation. The risks they pose are mainly through the information they provide and how it is used in clinical decision-making. This study explores the international regulation of mHealth apps. It assesses whether the approach used in Australia to regulate apps is consistent with international standards and suitable to address the unique challenges presented by the technology.MethodsA policy analysis was conducted of all nine member jurisdictions of the International Medical Device Regulator's Forum (IMDRF), to determine if their regulatory agencies addressed the IMDRF recommendations relevant to the clinical evaluation of mHealth apps. Case-studies (submission to regulatory agencies) were also selected on varying types of regulated apps (standalone, active implantable, etc.) and assessed relative to the principles in the IMDRF's software as a medical device (SaMD): Clinical evaluation (2017) guidance document.ResultsAll included jurisdictions evaluated the effectiveness of mHealth apps, assessing the majority of the key sub-categories recommended by SaMD: Clinical evaluation. The submissions and jurisdictional regulatory bodies did not address the IMDRF safety principles in terms of the apps’ information security (cybersecurity). Furthermore, by failing to use the method recommended by the IMDRF (risk-classification), none of the submissions or jurisdictions recognized the potential dangers of misinformation on patient safety.ConclusionsNone of the approaches used by global regulatory bodies adequately address the unique challenges posed by apps. Australia's approach is consistent with app regulatory procedures used internationally. We recommend that mHealth apps are evaluated for cybersecurity and are also classified using the IMDRF risk-categories so as to fully protect the public.
OP151 Cost-Utility Of Gender-Neutral HPV Vaccination In Ireland
Authors: Teljeur Conor , Murchu Eamon O , Harrington Patricia , Ryan Mairin 
Published: December 2019

IntroductionA number of economic evaluations of gender-neutral human papillomavirus (HPV) vaccination have been published, generally finding that the cost-effectiveness is sensitive to the uptake rate in girls. In Ireland there is a girls-only program in place, but the initial high uptake rate (>85 percent) was substantially impacted by high profile negative publicity concerning perceived vaccine safety issues. Efforts to address perceived safety concerns have recently yielded a partial recovery in uptake rates. The aim of this study was to estimate the cost-utility of extending the program to include boys and explore the impact of fluctuating uptake rates.MethodsA previously published cost-utility model used in the United States of America and Norway was adapted to the Irish setting and populated with Irish epidemiological and cost data. Comparators included no vaccination, and girls-only and gender-neutral vaccination, both with either a 4-valent or 9-valent vaccine. Vaccination is at age 12 years and oropharyngeal and penile cancers were excluded in the base case analysis. Additional analyses were used to incorporate fluctuating uptake rates into the model.ResultsA 9-valent girls-only program dominated the existing girls-only 4-valent program. The incremental cost-effectiveness ratio (ICER) for a gender-neutral 9-valent program was EUR 50,823/quality-adjusted life year (QALY). Gender-neutral vaccination would be cost-effective at a willingness-to-pay threshold of EUR 45,000/QALY when the uptake rate is below 78 percent. The ICER decreased to between EUR 41,000 and EUR 42,000/QALY when the uptake rate was allowed to fluctuate across six to 12 yearly cycles.ConclusionsThe cost-effectiveness of gender-neutral HPV vaccination is highly sensitive to the assumed uptake rate in girls. Large fluctuations in HPV vaccine uptake rates have been observed in a number of countries in the last decade. Incorporating fluctuating uptake rates in the model shows that a gender-neutral program may be more cost-effective than when a stable uptake is assumed.
OP163 Health Technology Assessment Participation And Prioritization In Core Outcome Set Development
Authors: Clearfield Elizabeth , Naber Jennifer Al , Tunis Sean , Messner Donna 
Published: December 2019

IntroductionA core outcome set (COS) is a minimum standardized set of agreed-upon outcomes for clinical trials of a specific condition. COS development can improve research by aligning stakeholder priorities for the outcomes most important in decision-making across the life-cycle of a product. It is important to include health technology assessment (HTA) representatives in COS development to ensure that outcomes useful to HTA are consistently included in clinical trials. Here we describe the role of HTA representatives in two COS projects: coreHEM, for gene therapy for hemophilia, a genetic blood clotting disease; and coreNASH, for nonalcoholic steatohepatitis (NASH), a progressive form of fatty liver disease that can lead to cirrhosis. We will describe the voting patterns of HTA representatives and consider aspects of their role in shaping the final COS.MethodsFor each multi-stakeholder COS, a modified Delphi process was utilized (three online surveys plus an in-person consensus meeting). Candidate outcome lists were compiled via a literature review complemented by participant interviews. Voters condensed and prioritized the lists by rating each outcome on a scale of 1-9 (not important-essential). Votes on each outcome were stratified by stakeholder group; HTA votes were compared with those of other stakeholders.ResultsHTA representatives made up 12.2 percent and 13.5 percent of the voters in coreHEM and coreNASH, respectively. They tended to give the highest votes to mortality outcomes, outcomes measuring the severity of disease, and outcomes related to a patient's quality of life, general well-being and general health perspective. HTA votes helped certain outcomes meet the inclusion criteria in the final voting rounds; without HTA voters, the “mental health status” outcome in coreHEM and the “hepatic-related mortality” and “liver transplantation” outcomes in coreNASH would have been eliminated.ConclusionsHTA participation in COS projects provides HTA representatives an opportunity to help shape COS in clinical research for better decision-making.