Introduction Of New Health Technologies Research Articles

Adoption of Diabetes Technology in Denmark: Continuous Glucose Monitor as Time-Machine

ABSTRACT Health technologies to monitor glucose values are an important part of daily diabetes self-care. Based on 12 months of fieldwork in Denmark with 14 people with type 2 diabetes, I explore people’s experience of living with Continuous Glucose Monitoring. This new technology automatically measures glucose levels throughout the day but is not yet common in type 2 diabetes treatment in Denmark. In this article, I capture the social shaping of Continuous Glucose Monitoring, employing the concept of time. I show how adoption of the technology is embedded in a form of biographical time. This refers to people’s use of the technology linked to their stories about themselves. Drawing on a notion of habitus, people’s embodied past experiences and future prospects come to shape its use, I propose. My main claim is that while people with diabetes implement the technology into their lives in unique ways, adapting it to their circumstances and social conditions, practice of Continuous Glucose Monitoring reproduce social structures. This is evinced, I argue, in people’s tinkering with the technology and the frames of reference used to inform it. I introduce the term “tinkering in time”, highlighting the introduction of new health technology within the frame of lived human time.

Public participation: healthcare rationing in the newspaper media

BackgroundIt is impossible to meet all healthcare demands, but an open and fair rationing process may improve the public acceptability of priority setting in healthcare. Decision-making is subject to scrutiny by newspaper media, an important public institution and information source for discussions about rationing. In Norway, healthcare rationing has been subject to public debate both before and after the establishment of “The National System for Managed Introduction of New Health Technologies within the Specialist Health Service” (New Methods) in 2013.AimTo describe and assess the development of the public debate on Norwegian healthcare rationing through three cases in print media.MethodsWe purposively sampled Norwegian newspaper articles between 2012 and 2018 concerning three reimbursement decisions in the Norwegian system. The reimbursement decisions were ipilimumab (Yervoy, n = 45) against metastatic melanoma, nivolumab (Opdivo, n = 23) against non-small cell lung cancer, and nusinersen (Spinraza, n = 68) against spinal muscular atrophy. Cases were analysed separately using the qualitative method of systematic text condensation.ResultsOur analysis highlighted four common themes—money, rationales, patient stories, and process—and a unique theme for each case. Ipilimumab was uniquely themed by rationing rejection, nivolumab by healthcare two-tiering, and Spinraza by patients’ rights. We found wide media deliberation among a multitude of stakeholders in all cases. Perceptions of rationing were found to be chiefly aligned with previous empirical research. We found that the media reported more frequently on opposition to rationing compared to findings from previous studies on Norwegian healthcare decision-making attitudes. We think this was influenced by our selection of cases receiving extraordinary media attention, and from media sources being subject to political communication from special interest groups.ConclusionWe observed that the introduction of New Methods institutionalised Norwegian healthcare rationing and isolated the public debate into conversations between stakeholders and decision makers outside the political sphere. The findings from these three extraordinary debates are not generalisable and should be seen as a stakeholder learning opportunity regarding media coverage and engagement with expensive specialist healthcare decision-making in Norway.

Introduction of new health technologies - is the patient being heard?

Introduction of new health technologies - is the patient being heard?

Digi-HTA: Health technology assessment framework for digital healthcare services

Health technology assessment (HTA) refers to the systematic evaluation of the properties, effects, and/or impacts of health technology. The main purpose of the assessment is to inform decisionmakers in order to better support the introduction of new health technologies. New digital healthcare solutions like mHealth, artificial intelligence (AI), and robotics have brought with them a great potential to further develop healthcare services, but their introduction should follow the same criteria as that of other healthcare methods. They must provide evidence-based benefits and be safe to use, and their impacts on patients and organizations need to be clarified.
 The first objective of this study was to describe the state-of-the-art HTA methods for mHealth, AI, and robotics. The second objective of this study was to evaluate the domains needed in the assessment. The final aim was to develop an HTA framework for digital healthcare services to support the introduction of novel technologies into Finnish healthcare.
 In this study, the state-of-the-art HTA methods were evaluated using a literature review and interviews. It was noted that some good practices already existed, but the overall picture showed that further development is still needed, especially in the AI and robotics fields. With the cooperation of professionals, key aspects and domains that should be taken into account to make fast but comprehensive assessments were identified. Based on this information, we created a new framework which supports the HTA process for digital healthcare services. The framework was named Digi-HTA.

Introduction of a new health technology into a provincial health system: A case study of insulin pump therapy.

Decisions on the introduction of new non-drug health technologies into healthcare are challenging. This article describes the introduction of insulin pump therapy for type 1 diabetes in Alberta, using an Access with Evidence Development (AED) approach. The organization and implementation of the AED, its current status, and lessons learned are described.

Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers' Perspectives on Testing, Training and Quality Assurance.

Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues.

Development, implementation and evaluation of an evidence-based program for introduction of new health technologies and clinical practices in a local healthcare setting.

BackgroundThis paper reports the process of establishing a transparent, accountable, evidence-based program for introduction of new technologies and clinical practices (TCPs) in a large Australian healthcare network. Many countries have robust evidence-based processes for assessment of new TCPs at national level. However many decisions are made by local health services where the resources and expertise to undertake health technology assessment (HTA) are limited and a lack of structure, process and transparency has been reported.MethodsAn evidence-based model for process change was used to establish the program. Evidence from research and local data, experience of health service staff and consumer perspectives were incorporated at each of four steps: identifying the need for change, developing a proposal, implementation and evaluation. Checklists assessing characteristics of success, factors for sustainability and barriers and enablers were applied and implementation strategies were based on these findings. Quantitative and qualitative methods were used for process and outcome evaluation. An action research approach underpinned ongoing refinement to systems, processes and resources.ResultsA Best Practice Guide developed from the literature and stakeholder consultation identified seven program components: Governance, Decision-Making, Application Process, Monitoring and Reporting, Resources, Administration, and Evaluation and Quality Improvement. The aims of transparency and accountability were achieved. The processes are explicit, decisions published, outcomes recorded and activities reported. The aim of ascertaining rigorous evidence-based information for decision-making was not achieved in all cases. Applicants proposing new TCPs provided the evidence from research literature and local data however the information was often incorrect or inadequate, overestimating benefits and underestimating costs. Due to these limitations the initial application process was replaced by an Expression of Interest from applicants followed by a rigorous HTA by independent in-house experts.ConclusionThe program is generalisable to most health care organisations. With one exception, the components would be achievable with minimal additional resources; the lack of skills and resources required for HTA will limit effective application in many settings. A toolkit containing details of the processes and sample materials is provided to facilitate replication or local adaptation by those wishing to establish a similar program.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-015-1178-4) contains supplementary material, which is available to authorized users.

The impact of head and neck cancer service guidance on surgical workload

In 1995 the Calman–Hine report provided a policy framework for commissioning high-quality cancer services in England and Wales. 1 A comprehensive NHS cancer plan followed in 2000. 2 Both documents recommended that cancer care should be centralised around site-specific multidisciplinary teams. These reforms aimed to improve outcomes and reduce inequalities in NHS cancer care through service reconfiguration rather than the introduction of new health technologies. A body of evidence that high-workload 3 or specialist 4,5 teams had better outcomes than their low-workload or generalist peers supported the recommendations. In contrast, some studies produced inconclusive results 6 and not all health services adopted this site-specific approach. 7

Puzzling about problems: the ambiguous search for an evidence-based strategy for handling influx of health technology

This paper focuses on problem frame differences among actors (members of an advisory body, senior administrators and clinical unit managers) who are concerned with the introduction of new health technology at the regional level in Sweden. It explores issues related to problem framing, puzzling, powering, participation and the various rationales articulated in the ambiguous search for an evidence-based strategy to handle the influx of new technologies. The Health Technology Advisory Committee (HTAC) was established in one Swedish county council in 2004 with the intention of controlling both the introduction of health technology and supporting policy decision and clinical practice by promoting the use of best evidence. The HTAC followed a scientific rationality dominated by one problem frame, although the problematic situation, as it was framed by all the actor groups, was highly complex and not solely a matter of evidence. This paper illustrates how problem frame differences shape the puzzling of a policy problem and how the different distinguishable policy styles are dependent on who is participating and who is not participating in the puzzling.

Revolution then evolution: The advance of health economic evaluation in Australia

All governments face immense challenges in providing affordable healthcare for their citizens, and the diffusion of novel health technologies is a key driver of growth in expenditure for many. Although important methodological and process variations exist around the world, health economic evaluation is increasingly seen as an important tool to support decision-making around the introduction of new health technologies, interventions and programmes in countries of varying stages of economic development. In Australia, the assessment of the comparative cost-effectiveness of new medicines proposed for subsidy under the country's national drug subsidy programme, the Pharmaceutical Benefits Scheme, was introduced in the late 1980s and became mandatory in 1993, making Australia the first country to introduce such a requirement nationally. Since then the use of health economic evaluation has expanded and been applied to support decision-making across a broader range of health technologies, as well as to programmes in public health.

Litigios por derecho a la salud en tres países de América Latina: revisión sistemática de la literatura

Identify and evaluate studies that analyzed characteristics of right-to-health litigation in Brazil, Colombia, and Costa Rica. Studies were evaluated that analyzed characteristics of right-to-health litigation identified through a search of PubMed, LILACS, Cochrane Library, and Scirus (April 2012). Two reviewers evaluated the studies. Variables collected were, among others, grounds for litigation, proportion of lawsuits for benefits covered by the health system, and lawsuits on high-cost technologies. Thirty studies were identified (Brazil 19, Colombia 10, and Costa Rica 1). Judgments were frequently in favor of plaintiffs: Colombia (75%-87%), Costa Rica (89.7%), and Brazil (70%-100%). In Colombia, lawsuits were filed for benefits included in the Compulsory Health Plan (range: 41%-69.9%). In Brazil there was considerable variation in the amount of lawsuits between the Exceptional Circumstance Drug Dispensing Program (13%-31%) and basic medicines in the Unified Health System (approximately 50%). Lawsuits on drugs varied as a percentage of all lawsuits (Colombia 11.9%-35.6%, Costa Rica 30.2%, and Brazil 49.6%). A study in Brazil found a statistically significant difference when comparing lawsuits on exceptional drugs versus all other drugs, by social class; and in another study, according to lawsuits from municipalities with better socioeconomic indicators. A concentration of lawsuits on drug prescribing by a limited group of physicians was reported. Prescribing was not always supported by scientific evidence. Another study found that in half of the cases, the cost of legal proceedings was higher than the cost of the services being claimed. There are similarities in the grounds, nature, and impact of litigation in the context of the countries studied. The studies included show weaknesses of health systems to ensure access to different services as well as in the introduction of new health technologies.

Systematic review for new health technology assessment

We used a systematic review to evaluate the safety and effectiveness of a new health technology in Korea. The results of the systematic review are being used by the Health Insurance Review and Assessment Service when the Ministry of Health and Welfare introduces new medical technology. The purpose of this study is to introduce this systematic review, which is the main methodology for evaluating the safety and effectiveness of new medical technology, and to share our experience of performing a systematic review to guide the reader in performing a systematic literature review accurately and easily. This paper presents the process of new health technology evaluation using a systematic review. A systematic review involves collecting current available evidence of health technology systematically. According to the evaluation process, in the first meeting of sub-committee, we develop a systematic review protocol including PICO and criteria for inclusion/exclusion. In the second meeting of sub-committee, we search comprehensively for appropriate literature according to the clinical question and to select in a clear and reproducible method. We also assess study quality, considering the internal validity and external validity of the selected literature, and make a table of extracted data. In the third meeting of sub-committee, we extract general information, study characteristics information, and study outcome information, and synthesize the outcomes. In the forth meeting of sub-committee, we finalize the conclusions based on synthesizing the studies. After the subcommittees' assessments, the results are presented to the Committee for New Health Technology. Finally, we report this result to the Ministry of Health and Welfare. The systematic review is useful for helping policymakers make decisions about the introduction of new health technology based on evidence. It enables people to minimize confusion due to weak evidence for health technology. In case of domestically developed technology and technology for rare disease, it is difficult assess health technology due to a lack of evidence, so assessing raw data (charts, results of clinical trials) is needed in addition to a systematic review. Furthermore, the government should support clinical studies to develop evidence on new health technologies with potential benefit, and the introduction of a conditional coverage decision in the new health technology assessment system is necessary to deal with uncertainty.

Funding the Unfundable

As tensions between payers, responsible for ensuring prudent and principled use of scarce resources, and both providers and patients, who legitimately want access to technologies from which they could benefit, continue to mount, interest in approaches to managing the uncertainty surrounding the introduction of new health technologies has heightened. The purpose of this project was to compile an inventory of various types of 'access with evidence development' (AED) schemes, examining characteristics of the technologies to which they have been applied, the uncertainty they sought to address, the terms of arrangements of each scheme, and the policy outcomes. It also aimed to identify issues related to such schemes, including advantages and disadvantages from the perspectives of various stakeholder groups. A comprehensive search, review and appraisal of peer-reviewed and 'grey' literature were performed, followed by a facilitated workshop of academics and decision makers with expertise in AED schemes. Information was extracted and compiled in tabular form to identify patterns or trends. To enhance the validity of interpretations made, member checking was performed. Although the concept of AED is not new, evaluative data are sparse. Despite varying opinions on the 'right' answers to some of the questions raised, there appears to be consensus on a 'way forward'--development of methodological guidelines. All stakeholders seemed to share the view that AEDs offer the potential to facilitate patient access to promising new technologies and encourage innovation while ensuring effective use of scarce healthcare resources. There is no agreement on what constitutes 'sufficient evidence', and it depends on the specific uncertainty in question. There is agreement on the need for 'best practice' guidelines around the implementation and evaluation of AED schemes. This is the first attempt at a comprehensive analysis of methods that have been used to address uncertainty concerning a new drug or other technology. The analysis reveals that, although various approaches have been experimented with, many of them have not achieved the ostensible goal of the approach. This article outlines challenges related to AED schemes and issues that remain unresolved.

Health technology assessment in Ireland.

Ireland's health system is primarily funded from general taxation and is publicly provided, although private health care retains a considerable role. It is a unique structure, a mixture of universal health service free at the point of consumption and a fee-based private system where individuals subscribe to private health insurance that covers some of their medical expenses. The recent history of the Irish health services saw consolidation of existing services and an expansion into new areas to adapt to changing practices and needs. There has also been a drive to extract maximum efficiency so as to maintain the volume and quality of patient services at a time of very tight financial constraints. Introduction of new health technologies continued to accelerate. New technologies tended to spread rapidly before systematic appraisal of their costs and benefits. When the state is involved in funding the public hospital system, acceptance of new technology is a matter for discussion between agencies and the Department of Health and Children. Decisions about spending annual "development funding" have generally not been based on careful assessment of proposals for new technology. In 1995, a healthcare reform put new Public Health Departments in Health Boards in a prime position in Ireland's health services organization. These departments now emphasize evidence-based medicine. While Ireland does not have a national health technology assessment (HTA) program, there are plans to form an advisory group on HTA in 1998. HTA is seen as a significant element of future health policy in Ireland.

When and how to assess fast-changing technologies: a comparative study of medical applications of four generic technologies.

OBJECTIVES. To try to identify the optimal time at which to start assessing new and fast-evolving health technologies. To provide insight into factors influencing the timing of assessments and the choice of methods for assessing new and fast-changing technologies. HOW THE RESEARCH WAS CONDUCTED. A series of literature reviews were undertaken covering the general principles involved in the timing of health technology assessments (HTAs). Additionally, the reported assessments of laparoscopic cholecystectomy, chorionic villus sampling (CVS), teleradiology, teledermatology, genetic screening for predisposition to breast cancer, and gene therapy for cystic fibrosis were reviewed to try to identify the factors that influenced the timing of these assessments. Key individuals in each field were also interviewed. The selected technologies allowed comparison between those that were new and evolving and those that were relatively well-established. A bibliometric study of publication trends was also undertaken to see whether these trends would suggest points in the development of a technology that could be used as indicators that assessment should be started. RESEARCH FINDINGS. TIMING. The precise point at which assessment should start was not identified but the bibliometric study suggested that extending this approach might give useful results. For all health technologies, more regular reporting of outcomes and side-effects should be encouraged during the period after initial assessment and, where the technology is fast-changing, reassessment should take place from time to time. The precise intervals were not identified and the problem remains of deciding when a technology has changed enough to warrant reassessment. FACTORS INFLUENCING TIMING. Published reports of assessments did not generally specify the reasons for their timing, but a number of factors appear to have influenced the timing of those assessments, directly or indirectly. Product champions and opinion leaders pioneer the introduction of new technologies into clinical practice, and their reports may lead to the rapid diffusion of such technologies before they have been adequately evaluated, as was the case with laparoscopic cholecystectomy; this diffusion may limit the methods of evaluation that can then be used. It is therefore important to assess new health technologies before diffusion takes place. The extent to which regulatory control is imposed on the introduction of new health technologies can also influence the timing of assessments. Such controls might have helped to restrict the diffusion of laparoscopic cholecystectomy, making a large and widely generalisable randomised controlled trial (RCT) feasible. The source and availability of funding for studies may influence the nature and timing of trials. Many telemedicine evaluations were funded by commercial telecommunications organisations and were thus restricted in their timing (and biased towards the technological aspects of the applications) by the availability of funds. Media coverage undoubtedly has an influence although this influence is not always predictable; it may generate 'favourable' publicity about new health technologies, which can lead to immediate demands for the new technique, as was the case with laparosocpic cholecystectomy with its apparent benefits. Thus assessments should be made before media coverage exerts popular pressure on purchasers to adopt the technology and dissuades patients from participating in RCTs (because of fear they may be randomised to the standard treatment as occurred in a US trial of CVS). Innovators should also be cautious in the claims that they make to the media.(ABSTRACT TRUNCATED)