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The aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes.
In-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs.
Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians.
An MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module.
Quantitative comparative social scientists have long worried about the performance of multilevel models when the number of upper-level units is small. Adding to these concerns, an influential Monte Carlo study by Stegmueller (2013) suggests that standard maximum-likelihood (ML) methods yield biased point estimates and severely anti-conservative inference with few upper-level units. In this article, the authors seek to rectify this negative assessment. First, they show that ML estimators of coefficients are unbiased in linear multilevel models. The apparent bias in coefficient estimates found by Stegmueller can be attributed to Monte Carlo Error and a flaw in the design of his simulation study. Secondly, they demonstrate how inferential problems can be overcome by using restricted ML estimators for variance parameters and a t-distribution with appropriate degrees of freedom for statistical inference. Thus, accurate multilevel analysis is possible within the framework that most practitioners are familiar with, even if there are only a few upper-level units.
An important part of the patients are affected with Mental Disorder associate with the cognitive alterations and its exercises an influence in the patient's daily routine.
This field study, a descriptive diagnostic encompassing the case and had as objective to evaluate the cognitive aspects: motor aptitude and attention.
The sample was the intentional kind, composed of female patients with diagnosis of Mental Disorder (major depressive disorder and bipolar disorder) according to DSM IV, in depressive condition, from 22 to 55 years old, interned in a psychiatric hospital.
For the evaluation of the motor aptitude it was used the Motor Aptitude Rank for the Elderly (Escala Motora para a Terceira Idade - EMTI - Pink Grandson, 2002) adapted that evaluates the general and specific motor aptitude: Specific Motricity, Global Motricity, Balance, Corporal Design, Space Organization, Shedule Organization. It was used the TMT (Trail Making Test - parts A and B - neuropsychological battery Halstead-Reitan) to evaluate the attention (Reitan, 1958).
The data had been organized and analyzed through descriptive statistics and correlation analysis.
General Motor Aptitude (GMA) was classified as Normal Low; Global Motricity, Balance, Corporal Design, Space Organization and Schedule Organization had low output; the worse execution in the TMT indicating attention deficit disorder; the increasing of the time in the execution of the TMT proportional to the increase of the age; a negative value of the correlation of the GMA and the attention, a bigger slowness in the execution of the TMT tests shows minors values of GMA.
Trends in utilization of Emergency Medical Services (EMS) systems can be used to extrapolate future use of an EMS system, which will be valuable for the budgeting and planning of finances and resources. The best model for incorporation of seasonal and regional fluctuations in utilization to predict future utilization is unknown.
Authors aimed to trend patterns of utilization in a regional EMS system to identify the needs of a growing population and to allow for a better understanding of how the EMS system is used on a basis of call volume and frequency of EMS transportation. The authors then used a best-fitting prediction model approach to show how the studied EMS system will be used in future years.
Systems data were retrospectively extracted by using the electronic medical records of the studied EMS system and its computer-assisted dispatch (CAD) database from 2010 through 2017. All EMS dispatches entering the system’s 9-1-1 public service access point were captured. Annual utilization data were available from 2010 through 2017, while quarterly data were available only from 2013 through 2017. The 9-1-1 utilization per capita, Advanced Life Support (ALS) utilization per capita, and ALS cancel rates were calculated and trended over the study period. The methods of prediction were assessed through a best-fitting model approach, which statistically suggested that Additive Winter’s approach (SAS) was the best fit to determine future utilization and ALS cancel rates.
Total 9-1-1 call volume per capita increased by 32.46% between 2010 and 2017, with an average quarterly increase of 0.78% between 2013 and 2017. Total ALS call volume per capita increased by 1.93% between 2010 and 2017. Percent ALS cancellations (cancelled en route to scene) increased by eight percent between 2010 and 2017, with an average quarterly increase of 0.42% (2013–2017). Predictions to end of 2019 using Additive Winter’s approach demonstrated increasing trends in 9-1-1 call volume per capita (R2 = 0.47), increasing trends of ALS utilization per capita (R2 = 0.71), and increasing percent ALS cancellation (R2 = 0.93). Each prediction showed increasing future trends with a 95% confidence interval.
The authors demonstrate paramount per capita increases of 9-1-1 call volume in the studied ALS system. There are concomitant increases of ALS cancellations prior to arrival, which suggests a potential burden on this regional ALS response system.
The International Network of Agencies for Health Technology Assessment (INAHTA) spans the globe as a network of 50 publicly-funded health technology assessment (HTA) agencies supporting health system decision making for 1.4 billion people in thirty countries. Agency members are non-profit HTA organizations that are part of, or directly support, regional or national governments. Recently, INAHTA surveyed its members to gather perspectives from agency leadership on the most important issues in HTA today. This paper describes the top 10 challenges identified by INAHTA members. Addressing these challenges requires a call for action from INAHTA member agencies and the many other actors involved in the HTA ecosystem. In opening this call for action, INAHTA will lead the way; however, a comprehensive undertaking from all players is needed to effectively address these challenges and to continue to evolve HTA in its role as a strong and effective contributor to health systems.
We investigate the aggregate and distributional effects of banking spreads in an economy with informality. We build a heterogeneous agents model with incomplete markets, credit frictions, and a rich occupational choice setting, in which informality is an option for both employers and workers. The main finding is that reductions in spreads for formal firms increase wages, output, and welfare but have a deleterious impact on unemployment and inequality. Dropping spreads for informal firms lead to reduction in inequality indicators at the expense of consumption and welfare. By calibrating the model for Brazil, we also find that a hypothetical extinction of the informal sector can be harmful for poor agents, but combined with a spread reduction, it can generate strong positive effects on output and welfare.
Australia has a two-tier public funding system, and many genetic tests are funded by different states and territories prior to being considered for public funding by the Federal government. In this context, health technology assessments (HTAs) of genetic tests for heritable conditions are problematic. We aimed to discuss the possible impacts on HTA methodology of a shift from regional to federal funding for genetic testing for heritable conditions.
Several HTA reports and economic models on genetic tests considered by the Medical Services Advisory Committee (MSAC) were reviewed and compared to ‘real world’ clinical practice.
Every HTA of germline testing performed for the MSAC have so far compared genetic testing versus no genetic testing. However, testing for BRCA1/2 for patients with breast cancer currently occurs in Familial Cancer Centres, and testing for germline mutations for familial hypercholesterolaemia currently occurs through specialist lipid clinics. In both settings, the index patient and family members are given multidisciplinary support, including genetic counselling. The HTA comparison therefore did not reflect what the true clinical and cost-effectiveness impact of federal funding would be. Federal funding means that tests may be ordered by a broader range of specialists or general practitioners. The evidence identified was predominantly sourced from specialised centres, where knowledge regarding how to interpret the tests is high. The clinical utility of these tests largely depended on how clinicians understood and conveyed the results.
The benefit of testing may have been overestimated due to the comparator and setting used (i.e. specialised and centralized care, associated with high clinical utility). Any HTA of genetic testing for heritable conditions, which could result in a shift in the delivery of testing or care for the patient, should consider the applicability of the evidence identified. Further, it should assess the subsequent impact this may have on the effectiveness and cost-effectiveness of the test and the quality of care provided for patients and their family.
Mobile health (mHealth) applications (app) are being integrated into healthcare by patients and practitioners in Australia. However, there are currently no policies or frameworks available that can be used to conduct a health technology assessment (HTA) on mHealth apps for reimbursement purposes. The aim of the study was to determine what policy changes and assessment criteria are needed to facilitate the development of a system that evaluates mobile medical apps for regulatory and reimbursement purposes in Australia.
To obtain the information to determine what policy changes are needed and create an evidence-based framework that can evaluate mHealth apps for reimbursement decision-making, four studies were conducted. This research included (i) a policy analysis on international mHealth app regulation; (ii) a case study on American and Australian app regulation; (iii) a methodological systematic review on the suitability of current mHealth evaluation frameworks for reimbursement purposes; and (iv) the identification of HTA pathways and impediments to app reimbursement through stakeholder interviews. An evaluation framework for apps was created by combining and synthesizing the results.
Software changes, connectivity, and cybersecurity need to be considered when evaluating mHealth apps for reimbursement purposes. Additionally, the potential dangers of apps providing misinformation, and poor software reliability in current regulation must be considered. Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement in Australia. They expressed caution around the lack of clarity regarding who is responsible for app quality as well as concerns about the digital literacy of medical practitioners and their patients.
Since stakeholder trust in the current HTA process for medical devices in Australia is high, the process was adapted to create an evaluation framework for mHealth apps. The adaptations included making provisions for cybersecurity, software updates, and compatibility issues. Provisions to address concerns around practitioner responsibility and misinformation were incorporated into the framework.
Australians 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.
A 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.
All 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.
None 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.
The aim of this study is to determine whether the approach used in Australia to regulate mobile medical applications (MMA) is consistent with international standards and is suitable to address the unique challenges of these technologies.
The policies of members of the International Medical Device Regulator's Forum (IMDRF) were analyzed, to determine whether these regulatory bodies address IMDRF recommendations for the clinical evaluation of software as a medical device (SaMD). Case-studies of varying types of regulated MMAs in Australia and the United States were also reviewed to determine how well the guidance in the IMDRF's SaMD: Clinical Evaluation (2017) document was operationalized.
All included jurisdictions evaluated the effectiveness of MMAs and addressed the majority of the key sub-categories recommended in the IMDRF guidance document. However, safety principles concerning information security (cybersecurity) and potential dangers of misinformation (risk-classification) were generally not addressed in either the case-studies or in the policy documents of international regulatory bodies. Australia's approach was consistent with MMA regulation conducted internationally. None of the approaches used by global regulatory bodies adequately addressed the risk of misinformation from apps and the potential for adverse clinical consequences.
The risks posed by MMAs are mainly through the information they provide and how this is used in clinical decision-making. Policy in Australia and elsewhere should be adjusted to follow the IMDRF risk-classification criteria to address potential harms from misinformation. Australian regulatory information should also be updated so the harm posed by cybersecurity and connectivity can be comprehensively evaluated.
Research participants are entitled to many rights that may easily come into conflict. The most important ones are that researchers respect their autonomy as persons and act on the principles of beneficence, nonmaleficence, and justice. Since 2014, research subjects from numerous states in the United States of America also have a legal “right to try” that allows them, under certain circumstances, to receive experimental (i.e., preliminarily tested) interventions, including medical devices, before official approval from the United States Food and Drug Administration. In the context of experimental interventions, such as deep brain stimulation (DBS) for Alzheimer’s disease, this article argues that research participants ought never to have a legal “right to try” without a corresponding “right to be sure.” The latter refers to external epistemic justification construed in terms of reliance on reliable evidence. This article demonstrates that the mere complexity of intervention ensembles, as in the case of DBS for Alzheimer’s disease which serves as a paradigm example, illustrate how unanswered and/or unasked open questions give rise to a “combinatorial explosion” of uncertainties that require epistemic responses that no single research team alone is likely able to provide. From this assessment, several epistemic asymmetrical relations between researchers and participants are developed. By elucidating these epistemic asymmetries, this article unravels the reasons why open science, transparent exhaustive data reporting, preregistration, and continued constant critical appraisal via pre- and postpublication peer review are not scientific virtues of moral excellence but rather ordinary obligations of the scientific work routine required to increase reliability and strength of evidence.
We study randomness beyond
-randomness and its Martin-Löf type variant, which was introduced in  and further studied in . Here we focus on a class strictly between
that is given by the infinite time Turing machines (ITTMs) introduced by Hamkins and Kidder. The main results show that the randomness notions associated with this class have several desirable properties, which resemble those of classical random notions such as Martin-Löf randomness and randomness notions defined via effective descriptive set theory such as
-randomness. For instance, mutual randoms do not share information and a version of van Lambalgen’s theorem holds.
Towards these results, we prove the following analogue to a theorem of Sacks. If a real is infinite time Turing computable relative to all reals in some given set of reals with positive Lebesgue measure, then it is already infinite time Turing computable. As a technical tool towards this result, we prove facts of independent interest about random forcing over increasing unions of admissible sets, which allow efficient proofs of some classical results about hyperarithmetic sets.
Cystic fibrosis (CF) is the most common autosomal recessive disorder in Caucasians, occurring in one out of every 2,500–2,800 births worldwide, and is associated with a high burden of disease. In Australia, prenatal testing for CF is indicated for pregnant couples identified as carriers or when a fetus is found to have an ‘echogenic bowel’ (FEB). We aimed to determine the effectiveness of prenatal CF testing and to assess ethical dimensions. A key challenge in assessing a prenatal test is selecting appropriate endpoints to indicate clinical effectiveness.
A systematic review was conducted and a linked evidence approach was used to answer the effectiveness question. The literature on ethical considerations relating to prenatal testing was also reviewed.
No studies were identified on the direct effectiveness of prenatal CF testing or downstream consequences. Linked evidence showed good diagnostic performance with a test failure rate of 4.5 percent. Termination of pregnancy occurred in the majority of cases where two mutations were identified in a fetus of carrier parents (155/163; 95 percent), indicating testing impacts clinical management. In FEB cases with CF, termination occurred in around sixty-five percent of pregnancies. Both terminating a pregnancy and having a child with CF were associated with poor short term parental psychological outcomes. Evidence indicates prenatal testing leads to a decreased number of CF-affected births. However, ethical analyses indicated that ‘informed decisions’ should have been the primary outcome of interest.
Proper counselling prior to testing ensures that the aim of prenatal testing is informing reproductive choices in a non-directive way, rather than decreasing the number of CF-affected births (which is ethically problematic). These results suggest that for health technology assessments undertaken on contentious topics, ethical analysis should be undertaken first so appropriate endpoints are selected for the subsequent systematic review of clinical evidence and for the economic model.
To identify and appraise existing evaluation frameworks for mobile medical applications (MMA) and determine their suitability for use in health technology assessment (HTA) of these technologies.
Systematic searches were conducted of seven bibliographic databases to identify literature published between 2008 and 2016 on MMA evaluation frameworks. Frameworks were eligible if they were used to evaluate at least one of the HTA domains of effectiveness, safety, and/or cost and cost-effectiveness of an MMA. After inclusion, the frameworks were reviewed to determine the number and extent to which other elements of an HTA were addressed by the framework.
A total of forty-five frameworks were identified that assessed MMAs. All frameworks assessed whether the app was effective. Of the thirty-four frameworks that examined safety, only seven overtly evaluated potential harms from the MMA (e.g., the impact of inaccurate information). Only one framework explicitly considered a comparator. Technology specific domains were sporadically addressed.
None of the evaluation frameworks could be used, unaltered, to guide the HTA of MMAs. To use these frameworks in HTA they would need to identify relevant comparators, improve assessments of harms and consider the ongoing effect of software updates on the safety and effectiveness of MMAs. Attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics. Implications: Existing MMA evaluation frameworks are not suitable for use in HTA. Further research is needed before an MMA evaluation framework can be developed that will adequately inform policy makers.
Managed Entry Agreements (MEAs) enable payers to subsidize access to new medicines while addressing uncertainties. Uncertainties may relate to the criteria for decision-making articulated in decision-making frameworks. The study's aim was to determine if there was any association between the type of MEA and criteria considered during decision-making.
All medicines with MEAs listed on the Australian national subsidy scheme between 2012-2016 were identified. Data were extracted on the types of MEA and information related to the criteria considered in decision-making for each medicine and its associated indication (i.e. a medicine-indication pair [MIP]). The criteria considered in decision-making included the comparator (therapy to which it was compared), type of economic analysis, accepted value, budget impact, financial cost of supply, cost of therapy per patient, access control (such as restrictions or prior authorization), and clinical need. Associations between types of MEA and the criteria were assessed using Chi Squared test.
There were 87 MIPs, of which 56 had only financial MEAs and 31 had performance-based MEAs. Coverage with evidence development MEAs had very high incremental cost-effectiveness ratio (ICER)/quality adjusted life year (QALY) (74 percent > AUD 50,000 [USD 37,822]). Financial MEAs where performance measures were linked to reimbursement had lower ICER/QALY (13 percent > AUD 50,000 [USD 37,822]) but greater budget impact (33% > AUD 80million [USD 60.5million]) compared to simple financial MEAs. A statistically significant association (Cramer's V = 0.5, p < 0.001) was only found between performance-based MEAs and the cost of unsubsidized therapy per patient.
The main influence on the choice of performance based MEA was the provision of access to clinically important medicines with a high treatment cost for patients.
Objectives: Australia relies on managed entry agreements (MEAs) for many medicines added to the national Pharmaceutical Benefits Scheme (PBS). Previous studies of Australian MEAs examined public domain documents and were not able to provide a comprehensive assessment of the types and operation of MEAs. This study used government documents approved for release to examine the implementation and administration of MEAs implemented January 2012 to May 2016.
Methods: We accessed documents for medicines with MEAs on the PBS between January 2012 and May 2016. Data were extracted on Anatomical Therapeutic Classification (ATC), type of MEA (financial, financial with outcomes, outcomes, and subcategories within each group), implementation and administration methods, source of MEA recommendation, and type of economic analysis.
Results: Of all medication indication pairs (MIPs) recommended for listing, one-third had MEAs implemented. Our study of eighty-seven MIPs had 170 MEAs in place. The Government's expert health technology assessment (HTA) committee recommended MEAs for 90 percent of the eighty-seven MIPs. A total of 81 percent of MEAs were simple financial agreements: the majority either discounts (32 percent) or reimbursement caps (43 percent). Outcome-based MEAs were least common (5 percent). Ninety-two percent of MEAs were implemented and operated through legal agreements. Approximately half of the MIPs were listed on the basis of accepted claims of cost-minimization. Forty-nine percent of medicines were in ATC L group.
Conclusion: Advice from HTA evaluations strongly influences the implementation of ways to manage uncertainties while providing access to medicines. The government relied primarily on simple financial agreements for the managed entry of medicines for which there were perceived risks.
All Dr. Katz's students admired how quickly he expressed a point, often through tidy lists. In honor of that style, I want to focus these remarks about Michael Katz and activism on four dimensions: (1) his understanding of the activist/academic tension; (2) how he advised his graduate students to wrestle with it; (3) how he engaged nonhistorians; and (4) how his work's prognosis of the prospects for social change transformed markedly in the last five years of his career.
The suitability of a single mid-season targeted selective treatment (TST) for gastrointestinal nematodes control, based on flexible average daily weight gain (ADWG) thresholds, was investigated in 23 groups of first grazing season calves. In each group, animals were weighed three times: before turnout, at mid-season and at housing. Just after the first weighing, each group was divided in two homogenous sub-groups in terms of age, breed and weight, and randomly allocated to one of two sub-groups intented for two different mid-season anthelmintic treatment strategies: (1) a treatment of all calves composing the sub-group (whole-group treatment (WT)) or (2) a targeted selective weight gain-based treatment (TST) of the animals showing an individual pre-treatment ADWG inferior to the mean pre-treatment ADWG of the corresponding WT sub-group. Anthelmintic treatment (levamisole 7.5 mg/kg BW) was performed 3 to 4 months after turnout. At housing, two parasitological parameters (the anti-Ostertagia ostertagi antibody level-Ostertagia optical density ratio (ODR) and the pepsinogen level) and a clinical parameter (the breech soiling score) were assessed at individual level in each group. Then, the high exposed groups to gastrointestinal nematode (GIN) were defined as groups for which untreated animals exhibited a mean Ostertagia ODR ⩾0.7 and among these groups, the ones characterized by high abomasal damage due to Ostertagia for which untreated animals exhibited a mean pepsinogen level ⩾2.5 U Tyr were also identified. Among TST sub-groups, the treatment ADWG thresholds varied from 338 to 941 g/day and the percentage of treated animals from 28% to 75%. Pre- and post-treatment ADWG as well as parasitological and clinical parameters measured at housing were similar between TST and WT sub-groups including the 17 high exposed groups to GIN. Within these 17 groups, the treatment allowed to significantly improve post-treatment ADWG compared with untreated animals. In the six high exposed groups showing mean pepsinogen level ⩾2.5 U Tyr, the average effect of treatment on post-treatment ADWG was the highest and estimated up to 14 kg after a grazing duration of 4 months. In contrast, in six other groups showing mean Ostertagia ODR<0.7 in untreated animals, no effect of treatment was seen suggesting an absence of production losses related to a low level of GIN infection. This study highlighted the suitability of a convenient mid-season TST strategy for first grazing season calves, based on the use of flexible thresholds of ADWG, allowing similar growth compared with a whole-group treatment while keeping a GIN population in refugia.
During the Epoch of Reionization (EoR), feedback effects reduce the efficiency of star formation process in small halos or even fully quench it. The galaxy luminosity function (LF) may then turn over at the faint-end. We analyze the number counts of z > 5 galaxies observed in the fields of four Frontier Fields (FFs) clusters and obtain constraints on the LF faint-end: for the turn-over magnitude at z ∼ 6, MUVT ≳-13.3; for the circular velocity threshold of quenching star formation process, vc* ≲ 47 km s−1. We have not yet found significant evidence of the presence of feedback effects suppressing the star formation in small galaxies.