https://www.mdu.se/

BACKGROUND: GPS alarms aim to support users in independent activities. Previous systematic reviews have reported a lack of clear evidence of the effectiveness of GPS alarms for the health and welfare of users and their families and for social care provision. As GPS devices are currently being implemented in social care, it is important to investigate whether the evidence of their clinical effectiveness remains insufficient. Standardized evidence frameworks have been developed to ensure that new technologies are clinically effective and offer economic value. The frameworks for analyzing existing evidence of the clinical effectiveness of GPS devices can be used to identify the risks associated with their implementation and demonstrate key aspects of successful piloting or implementation.

OBJECTIVE: The principal aim of this study is to provide an up-to-date systematic review of evidence based on existing studies of the effects of GPS alarms on health, welfare, and social provision in the care of older adults compared with non-GPS-based standard care. In addition, the study findings were assessed by using the evidence standards framework for digital health technologies (DHTs) established by the National Institute for Health and Care Excellence (NICE) in the United Kingdom.

METHODS: This review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Primary studies published in peer-reviewed journals and gray literature from January 2005 to August 2020 were identified through searches in 13 databases and several sources of gray literature. Included studies had individuals (aged ≥50 years) who were receiving social care for older adults or for persons with dementia; used GPS devices as an intervention; were performed in Canada, the United States, European Union, Singapore, Australia, New Zealand, Hong Kong, South Korea, or Japan; and addressed quantitative outcomes related to health, welfare, and social care. The study findings were analyzed by using the NICE framework requirements for active monitoring DHTs.

RESULTS: Of the screened records, 1.6% (16/986) were included. Following the standards of the NICE framework, practice evidence was identified for the tier 1 categories Relevance to current pathways in health/social care system and Acceptability with users, and minimum evidence was identified for the tier 1 category Credibility with health, social care professionals. However, several evidence categories for tiers 1 and 2 could not be assessed, and no clear evidence demonstrating effectiveness could be identified. Thus, the evidence required for using DHTs to track patient location according to the NICE framework was insufficient.

CONCLUSIONS: Evidence of the beneficial effects of GPS alarms on the health and welfare of older adults and social care provision remains insufficient. This review illustrated the application of the NICE framework in analyses of evidence, demonstrated successful piloting and acceptability with users of GPS devices, and identified implications for future research.

The development of evidence to demonstrate 'value for money' is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the continuum of healthcare represents the most valuable source in technology evaluation. However, in the European Union, the value assessment based on real-world data has become challenging as individuals have recently been given the right to have their personal data erased in the case of consent withdrawal or when the data are regarded as being no longer necessary. This act may limit the usefulness of data in the future as it may introduce information bias. Among healthcare stakeholders, this has become an important topic of discussion because it relates to the importance of data on one side and to the need for personal data protection on the other side, especially when it comes to "personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveals information about his or her health status". At the forefront of these discussions are data protection issues as well as the population's trust in digital services. It seems that the new era has begun, where citizens and patients will have the ability to manage their personal or self-generated data. The European Commission has laid the groundwork for this paradigm shift that will steadily emerge in the coming years. To prepare for this change, we believe attention should be given to data security and other rules of data privacy. It has become increasingly important to ensure that individuals are properly introduced into complex environments with multiple sources of Big Data for clinical and behavioral purposes to provide an optimal balance between societal and individual benefits. In this article, a number of issues are considered and discussed, based upon the authors' experience, with the aim of helping the reader better understand the implications of the use of Big Data and the importance of data protection in the coming years.

BACKGROUND: Severe adverse events after treatment with ivermectin in individuals with high levels of Loa loa microfilariae in the blood preclude onchocerciasis elimination through community-directed treatment with ivermectin (CDTI) in Central Africa. We measured the cost of a community-based pilot using a test-and-not-treat (TaNT) strategy in the Soa health district in Cameroon. METHODS: Based on actual expenditures, we empirically estimated the economic cost of the Soa TaNT campaign, including financial costs and opportunity costs that will likely be borne by control programs and stakeholders in the future. In addition to the empirical analyses, we estimated base-case, less intensive, and more intensive resource use scenarios to explore how costs might differ if TaNT were implemented programmatically. RESULTS: The total costs of US$283 938 divided by total population, people tested, and people treated with 42% coverage were US$4.0, US$9.2, and US$9.5, respectively. In programmatic implementation, these costs (base-case estimates with less and more intensive scenarios) could be US$2.2 ($1.9-$3.6), US$5.2 ($4.5-$8.3), and US$5.4 ($4.6-$8.6), respectively. CONCLUSIONS: TaNT clearly provides a safe strategy for large-scale ivermectin treatment and overcomes a major obstacle to the elimination of onchocerciasis in areas coendemic for Loa loa. Although it is more expensive than standard CDTI, costs vary depending on the setting, the implementation choices made by the institutions involved, and the community participation rate. Research on the required duration of TaNT is needed to improve the affordability assessment, and more experience is needed to understand how to implement TaNT optimally. 

Rationale, Aims, and Objectives: While different imaging and treatment options are available in acute coronary syndrome (ACS) care, there is a lack of data regarding their use across Europe. We examined the diagnostic and treatment strategies in patients with known or suspected ACS as reported by physicians and identified variations in responses across European countries and geographical areas. Method: A web-based clinician survey focusing on ACS imaging and revascularization treatments was circulated through email distribution lists and websites of European professional societies in the field of cardiology. We collected information on respondents' clinical setting and specialty. Reported percentages of patients receiving imaging or treatment modalities and percentages of clinicians reporting to use modalities in a range of clinical scenarios were analyzed. Statistical comparisons were performed. Results: In total, 69 responses were received (Sweden [n = 20], United Kingdom [n = 16], Northern/Western Europe [n = 17], Southern Europe [n = 9], and Central Europe [n = 7]). Considerable variations between geographical areas were seen in terms of reported diagnostic modalities and treatment strategies. For example, when presented with the scenario of a theoretical 45-year-old smoking female with a suspected ACS, 56% of UK clinicians reported to use coronary computed tomography angiography, compared to only 10% of Swedish clinicians (P =.002). Large variations were observed regarding the reported use of fractional flow reserve by physicians for non-culprit lesions during invasive management of myocardial infarction patients (44% in Sweden, 31% in the United Kingdom, and 30% in Northern/Western Europe vs non-use in Central and Southern Europe). Conclusions: In this survey, respondents reported different diagnostic and treatment strategies in ACS care. These variations seem to have geographic components. Larger studies or real world data are needed to verify these observations and investigate their causes. More research is needed to compare the quality and efficiency of ACS care across countries and explore pathways for improvement. 

Importance Two 2018 randomized controlled trials (DAWN and DEFUSE 3) demonstrated the clinical benefit of mechanical thrombectomy (MT) more than 6 hours after onset in acute ischemic stroke (AIS). Health-economic evidence is needed to determine whether the short-term health benefits of late MT translate to a cost-effective option during a lifetime in the United States. Objective To compare the cost-effectiveness of 2 strategies (MT added to standard medical care [SMC] vs SMC alone) for various subgroups of patients with AIS receiving care more than 6 hours after symptom onset. Design, Setting, and Participants This economic evaluation study used the results of the DAWN and DEFUSE 3 trials to populate a cost-effectiveness model from a US health care perspective combining a decision tree and Markov trace. The DAWN and DEFUSE 3 trials enrolled 206 international patients from 2014 to 2017 and 182 US patients from 2016 to 2017, respectively. Patients were followed until 3 months after stroke. The clinical outcome at 3 months was available for 29 subgroups of patients with AIS and anterior circulation large vessel occlusions. Data analysis was conducted from July 2018 to October 2019. Exposures MT with SMC in the extended treatment window vs SMC alone. Main Outcomes and Measures Expected costs and quality-adjusted life-years (QALYs) during lifetime were estimated. Deterministic results (incremental costs and effectiveness, incremental cost-effectiveness ratios, and net monetary benefit) were presented, and probabilistic analyses were performed for the total populations and 27 patient subgroups. Results In the DAWN study, the MT group had a mean (SD) age of 69.4 (14.1) years and 42 of 107 (39.3%) were men, and the control group had a mean (SD) age of 70.7 (13.2) years and 51 of 99 (51.5%) were men. In the DEFUSE 3 study, the MT group had a median (interquartile range) age of 70 (59-79) years, and 46 of 92 (50.0%) were men, and the control group had a median (interquartile range) age of 71 (59-80) years, and 44 of 90 (48.9%) were men. For the total trial population, incremental cost-effectiveness ratios were $662/QALY and $13877/QALY based on the DAWN and DEFUSE 3 trials, respectively. MT with SMC beyond 6 hours had a probability greater than 99.9% of being cost-effective vs SMC alone at a willingness-to-pay threshold of $100 000/QALY. Subgroup analyses showed a wide range of probabilities for MT with SMC to be cost-effective at a willingness-to-pay threshold of $50000/QALY, with the greatest uncertainty observed for patients with a National Institute of Health Stroke Scale score of at least 16 and for those aged 80 years or older. Conclusions and Relevance The results of this study suggest that late MT added to SMC is cost-effective in all subgroups evaluated in the DAWN and DEFUSE 3 trials, with most results being robust in probabilistic sensitivity analyses. Future MT evidence-gathering could focus on older patients and those with National Institute of Health Stroke Scale scores of 16 and greater.

Question Is mechanical thrombectomy in the extended treatment window cost-effective across patient subgroups in the United States? Findings This economic evaluation study found that mechanical thrombectomy provides good value for money in all the defined subgroups the 2 randomized clinical trials evaluated. Sensitivity analyses revealed a wide range of probabilities for late mechanical thrombectomy to be cost-effective at the willingness-to-pay threshold of $50 000 per quality-adjusted life-year. Meaning The results of this study suggest that attention should be placed on increasing access to mechanical thrombectomy rather than on developing subgroup-specific guidelines unless workforce and budget constraints require prioritization.

This economic evaluation study compares the cost-effectiveness of 2 strategies (mechanical thrombectomy with standard medical care vs standard medical care alone) for various subgroups of patients with acute ischemic stroke who were receiving care more than 6 hours after symptom onset.

Background Nocturnal digital surveillance technologies are being widely implemented as interventions for remotely monitoring elderly populations, and often replace person-based surveillance. Such interventions are often placed in care institutions or in the home, and monitored by qualified personnel or relatives, enabling more rapid and/or frequent assessment of the individual's need for assistance than through on-location visits. This systematic review summarized the effects of these surveillance technologies on health, welfare and social care provision outcomes in populations >= 50 years, compared to standard care. Method Primary studies published 2005-2020 that assessed these technologies were identified in 11 databases of peer-reviewed literature and numerous grey literature sources. Initial screening, full-text screening, and citation searching steps yielded the studies included in the review. The Risk of Bias and ROBINS-I tools were used for quality assessment of the included studies. Result Five studies out of 744 identified records met inclusion criteria. Health-related outcomes (e.g. accidents, 2 studies) and social care outcomes (e.g. staff burden, 4 studies) did not differ between interventions and standard care. Quality of life and affect showed improvement (1 study each), as did economic outcomes (1 study). The quality of studies was low however, with all studies possessing a high to critical risk of bias. Conclusions We found little evidence for the benefit of nocturnal digital surveillance interventions as compared to standard care in several key outcomes. Higher quality intervention studies should be prioritized in future research to provide more reliable evidence.

Background: Considering the multiple treatments approved for multiple sclerosis (MS) by the Food and Drug Administration (FDA) and European Medicines Agency (EMA), determining a treatment strategy for patients with clinically isolated syndrome (CIS) and relapsing-remitting MS (RRMS) can be challenging. To date, an overview of the needs and preferences of patients at each treatment decision-making moment is lacking. Therefore, the aim of this systematic review is to examine the existing literature about the needs and preferences of patients with CIS and RRMS when making treatment decisions. Methods: A systematic search was done using Embase, Medline, PsychINFO, Web of Science and Google Scholar. Eligibility criteria included whether the article described a study of adults with CIS/RRMS and reported patient needs or preferences regarding first-line disease modifying treatment (DMT) decisions. Publications were categorized by treatment decision: initiation of first DMT (D1), DMT adherence/discontinuation (D2a/D2b), and switch to a second DMT (D3). A separate category was created for stated preference studies such as discrete choice experiment methods to examine the relative importance of different treatment attributes. Publications were compared to identify key factors. Results: The search yielded 2789 articles after removal of duplicates and 434 full-text publications were reviewed for eligibility. Twenty-four articles fulfilled all criteria: n = 5 (D1), n = 12 (D2a), n = 13 (D2b), and n = 3 (D3); six articles studied more than one treatment decision. The need for social support is important during D1. The most commonly reported reasons for adherence/discontinuation/switch included forgetfulness, side-effects, and injection-related reasons. Eight articles described preference studies; the most important DMT attributes were efficacy, mode and frequency of administration, and side-effect profile. Conclusions: Understanding the needs and preferences of CIS/RRMS patients regarding DMT attributes and non-treatment related attributes are important to improve treatment decision-making and reduce non-adherence. Studies are needed to understand patient preferences upon treatment initiation. Furthermore, preference studies should include attributes based on the patient perspective.