Technology Assessment Research Articles

O’Speak Version 1.0: A New Tool to Measure Segmental Pronunciation Features

The rapid enhancement of technology has made it possible to integrate technology and L2 pronunciation assessment. While the investigation of L2 pronunciation was considered vital in English Language Teaching, assessing pronunciation is granted the least attention. This study attempts to discuss the roles and impacts of O’Speak version 1.0 as an automated pronunciation tool and compare it with human ratings while assessing L2 segmental pronunciation features uttered by Indonesian learners of English. This study aims to pilot an android-based pronunciation test, namely, O’Speak, which was developed using Feuerstein’s Mediated Learning Experience principles. Performed under a quasi-experimental research design, this study ran an independent two-sample t-test involving 50 participants. The study showed that there was no statistically significant difference between O’Speak and human ratings in the segmental pronunciation assessment. This indicates that a new tool functions equally with the ability that human rating has. During the study, this study identified some caveats shown by the human rating that leads to its ability to be equal to O’Speak, and these include teaching experience, hallo effect, and rating experience.

The EQ-5D-3L valuation study for Bermuda: using an on-line EQ-VT protocol.

In many countries, methods of economic evaluation and Health Technology Assessment are used to inform healthcare resource allocation decisions. These approaches often require EQ-5D health outcomes measures. This study aimed to create an EQ-5D-3L value set for Bermuda from which EQ-5D-5L Crosswalk values could be obtained. Respondents in Bermuda were recruited locally. A team of Trinidad-based interviewers with prior EQ-5D-3L valuation experience conducted valuation interviews on-line using the EQ-VT protocol. Respondents completed composite time-trade off (cTTO) and discrete choice experiment (DCE) tasks. A hybrid model that included both the cTTO and DCE data was estimated. An EQ-5D-5L crosswalk value set was then created from the EQ-5D-3L index values. Coefficients in the resulting crosswalk model were compared with those of crosswalk and valuation studies from other countries. The valuation tasks were completed by a near-representative sample of 366 adult Bermuda citizens. Half of the respondents reported being in state 11111. The lowest EQ VAS and EQ-5D-3L index values were 20 and -0.120 respectively. The hybrid model produced all logically consistent and statistically significant coefficients that in turn produced index values that were very similar to those obtained in a preliminary model (MAD of 0.027). The on-line EQ-VT valuation study was successfully conducted in Bermuda and the values therein can now be used for economic analysis in Bermuda. The Bermuda values differed considerably from those of the other countries against which they were compared. Challenges were encountered with recruitment for an on-line survey in a small population.

Improving Sustainable Financing for Universal Health Coverage in Bhutan: Exploring Policy Options and Financial Strategies

AbstractDeeply rooted in its developmental philosophy of gross national happiness (GNH), Bhutan's healthcare system strives towards achieving a shared goal of universal health coverage (UHC). Despite being primarily financed by the government, the health system faces a plethora of challenges. To overcome these hurdles and achieve UHC goals, expanding the fiscal space for health and improving operational efficiency are crucial. This article aims to address Bhutan's evolving healthcare landscape and advance the achievement of UHC through two policy options. The first policy option focuses on the dual objective of improving health outcomes and promoting financial sustainability by leveraging health taxes, whereas the second option emphasizes reinforcing a systematic health technology assessment (HTA) in the Bhutanese health system. First, drawing lessons from global experiences, the policy brief recommends leveraging health taxes to reduce societal and healthcare costs and enhance financial sustainability in the health sector. Considering Bhutan's high prevalence of tobacco and alcohol consumption, and taking opportunity from the ongoing Goods and Services Tax (GST) reform, continued advocacy on health taxes is essential, and soft earmarking the health taxes may be considered to finance a broader array of public health programmes, particularly focusing on the promotion of healthy lifestyle, health screening and outreach public health activities. Second, the integration of HTA into policymaking and decision‐making processes is essential for effective resource allocation in UHC. Nurturing and strengthening the existing HTA governance structure under the Ministry of Health (MoH) and establishing a dedicated multidisciplinary HTA Committee will ensure informed decision‐making and resource optimization. HTA evidence should inform the revision of health service standards, clinical guidelines development, procurement decisions and healthcare priorities. These policy options can assist the country in improving financial sustainability, enhancing effective resource allocation and utilization and improving healthcare delivery, aligning with its vision of GNH and ultimately accelerating progress towards achieving UHC.

The Role of Patient-Reported Outcomes to Measure Treatment Satisfaction in Drug Development.

Treatment satisfaction is a person's rating of his or her treatment experience, including processes and outcomes. It is directly related to treatment adherence, which may be predictive of treatment effectiveness in clinical and real-world research. Consequently, patient-reported outcome (PRO) instruments have been developed to incorporate patient experience throughout various stages of drug development and routine care. PRO instruments enable clinicians and researchers to evaluate and compare treatment satisfaction data in different clinical settings. It is important to select fit-for-purpose PRO instruments that have demonstrated adequate levels of reliability, validity, and sensitivity to change to support their use. Some of these instruments are unidimensional while some are multidimensional; some are generic and can be applied across different therapeutic areas, while others have been developed for use in a specific treatment modality or condition. This article describes the role of treatment satisfaction in drug development as well as regulatory and Health Technology Assessment (HTA) decision making and calls for more widespread use of carefully selected treatment satisfaction PRO instruments in early- and late-phase drug development.

Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union: Preparing for the European Union’s Regulation on Health Technology Assessment for Vaccines

ObjectivesThe appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA). MethodsLiterature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines. ResultsWe found that significant variation exists across the EU member states in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU: (1) support the creation of appropriate terminology and measurements for clinical appraisals of vaccines; (2) develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision making and appraisal; and (3) improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals. ConclusionsGiven the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework. The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU.

Health Technology Assessment of Cardiopulmonary Bypass Circuit with and without Phosphorylcholine Coating: A Retrospective Study on Safety and Efficiency in Cardiac Surgery.

Phosphorylcholine has emerged as a potential adjunctive agent in cardiopulmonary bypass (CPB) circuits. Phosphorylcholine serves as a coating for the CPB circuit, potentially enhancing biocompatibility and reducing thrombotic events. However, its impact on specific patient populations and procedural outcomes remains underexplored. In this retrospective study, we analyzed data from 60 patients who underwent cardiac surgery with CPB, comprising 20 cases each of coronary artery bypass grafting (CABG), mitral valve repair, and aortic valve replacement. The patient cohort was divided into two groups-30 patients whose CPB circuits were coated with phosphorylcholine (phosphorylcholine-coated group) and 30 patients who did not receive phosphorylcholine supplementation or circuit coating. Both groups underwent surgery with identical CPB circuit designs. We assessed the absence of adverse events, safety, and efficacy parameters, including blood loss, clotting, and the structural integrity of the CPB circuit. Additionally, we measured changes in mean albumin levels (g/dL), mean platelet counts (×109/L), and antithrombin III (ATIII) levels before and after CPB. The retrospective analysis revealed an absence of adverse events in both groups. In the phosphorylcholine-coated group compared to the non-phosphorylcholine-coated group, there was a notable difference in the delta change in mean albumin levels (0.87 ± 0.1 vs. 1.65 ± 0.2 g/dL, p-value 0.021), mean platelet counts (42.251 ± 0.121 vs. 54.21 ± 0.194 × 109/L, p-value 0.049), and ATIII levels (16.85 ± 0.2 vs. 31.21 ± 0.3 p-value 0.017). There was a notable reduction in the perioperative consumption of human complex units after CPB (3 vs. 12, p-value 0.019). Both groups, phosphorylcholine and non-phosphorylcholine, demonstrated the absence of adverse events and that the systems are safe for iatrogenic complication. Our findings suggest that the use of phosphorylcholine coating on the CPB circuit, in the absence of supplementary phosphorylcholine, in cardiac surgery is associated with favorable changes in mean albumin levels, mean platelet counts, and ATIII levels. Further research is warranted to elucidate the full extent of phosphorylcholine's impact on patient outcomes and CPB circuit performance.

Mixture and Non-mixture Cure Models for Health Technology Assessment: What You Need to Know.

There is increasing interest in the use of cure modelling to inform health technology assessment (HTA) due to the development of new treatments that appear to offer the potential for cure in some patients. However, cure models are often not included in evidence dossiers submitted to HTA agencies, and they are relatively rarely relied upon to inform decision-making. This is likely due to a lack of understanding of how cure models work, what they assume, and how reliable they are. In this tutorial we explain why and when cure models may be useful for HTA, describe the key characteristics of mixture and non-mixture cure models, and demonstrate their use in a range of scenarios, providing Stata code. We highlight key issues that must be taken into account by analysts when fitting these models and by reviewers and decision-makers when interpreting their predictions. In particular, we note that flexible parametric non-mixture cure models have not been used in HTA, but they offer advantages that make them well suited to an HTA context when a cure assumption is valid but follow-up is limited.

A study on the formative usability testing for modular powered wheelchair

The increasing prevalence of mobility impairments underscores the urgent need for accessible and affordable mobility aids. To overcome the mobility limitations of people with disabilities, there is an increasing need for the development of lightweight and portable powered wheelchairs that can be easily loaded. This study aimed to perform an early health technology assessment and a formative usability evaluation on a modular (detachable) powered wheelchair. It aimed to gauge device satisfaction among users, pinpoint areas for improvement, and detect any unforeseen errors to inform future development. Engaging 16 participants, including powered wheelchair users, healthcare professionals, and caregivers, the research evaluated the wheelchair’s functionality in various scenarios, emphasizing safety, effectiveness, and convenience. Statistical analyses of task performance and satisfaction surveys highlighted that, while powered wheelchair users successfully completed tasks focusing on driving and power control, healthcare professionals and caregivers encountered difficulties with the wheelchair’s assembly and disassembly. Despite general positivity, the surveys indicated mixed satisfaction levels regarding safety, validity, and convenience, with specific issues related to frame durability, seat comfort, and control mechanisms. These findings suggest that refining the wheelchair’s design and addressing user concerns could significantly enhance satisfaction and mobility services. Future efforts will include a thorough review of an advanced prototype and further satisfaction assessments.

Are Medical Device Characteristics Included in HTA Methods Guidelines and Reports? A Brief Review.

It is well accepted that medical devices (MDs) and procedures have several unique characteristics compared with pharmaceuticals, such as learning curve (LC), incremental innovation (II), dynamic pricing (DP), and organizational impact (OI). The objective of this study was to determine the extent to which these MD characteristics are routinely assessed by health technology assessment (HTA) agencies and incorporated in their guidelines and reports. Three approaches were taken. First, a review of the most recent HTA methods guidelines from 14 selected HTA agencies and 5 HTA networks was undertaken. Next, HTA reports from these agencies were reviewed for inclusion of MD-specific characteristics for 16 selected MDs. Finally, a narrative literature review on this topic was conducted. A total of 13 of the included HTA organizations, and some HTA networks (2/5), have published either general or MD-specific method guidelines, whilst several addressed MD-specific characteristics. NICE included all four MD characteristics in their guidelines, but this did not equate to their inclusion in published HTA evaluations. European Network HTA (EUnetHTA) described the inclusion of LC (within patient safety) and OI within their guidance. The results highlight a lack of consistency. For the narrative review, 10/149 articles identified were reviewed. Most provided recommendations on challenges faced by HTAs, proposed steps to address uncertainties around MD characteristics and reported a lack of methodological guidance for evaluating MDs. A lack of inclusion of MD characteristics in HTA is a complex interplay of several important factors. For these characteristics to become a formal part of HTA of MDs in the future, clear guidance and frameworks are required to enable manufacturers to develop appropriate evidence, and HTA practitioners to assess their impact more broadly.

Uncertainty in Long-Term Relative Effectiveness of Medicines in Health Technology Assessment

ObjectivesUncertainty regarding the long-term relative effectiveness is an important factor in health technology assessment (HTA) of medicines. This study investigated how different HTA bodies address this uncertainty in their assessments. MethodsA total of 49 HTA reports from 6 national HTA bodies, assessing 9 medicines for spinal muscular atrophy, cystic fibrosis, and hypercholesterolemia, were included. In these reports, 81 relative effectiveness assessments and 45 cost-effectiveness assessments were performed on an indication level. We collected information on included trials, assessment outcomes, uncertainty regarding the long-term effectiveness, proposed managed entry agreements, and reassessments. ResultsUncertainty regarding the long-term effectiveness was an important consideration in almost all cost-effectiveness assessments (91%) and three-quarters of relative effectiveness assessments (74%), despite differences in methodologies among HTA bodies. There were considerable differences in the amount and type of long-term effectiveness data included by HTA bodies due to timing and inclusion criteria. In total 23 managed entry agreements were proposed of which 14 were linked to uncertainty regarding the long-term effectiveness. In addition, 13 reassessments were performed of which 4 led to an increase in patient access because of more available long-term effectiveness data. ConclusionsUncertainty regarding the long-term effectiveness is an important challenge for HTA bodies. There are large differences in the acceptance of evidence among HTA bodies, which leads to heterogeneity in the inclusion of available long-term effectiveness data for decision making. In cases with large uncertainty regarding the long-term effectiveness, outcome-based agreements and reassessments are used by HTA bodies, but differently between HTA bodies and indications.

Innovative pressure sensing with amorphous silicon nanostructures: Exploring applications in sports training supervision

This study introduces an innovative approach to pressure sensing in sports training using amorphous silicon nanostructure-based sensors. These sensors demonstrated high sensitivity (0.75 Ω/kPa) and a broad pressure detection range (1–100 kPa), making them ideal for capturing the nuances of athletic movements. Their compact size (5 mm×5 mm) and superior durability (over 5000 cycles with minimal performance variation) allowed for seamless integration into athletic shoes and attire. The sensors effectively captured pressure patterns in running, such as heel strikes peaking at 300 kPa, and cycling, revealing a 200 kPa increase in the perineal region during posture shifts. Comparative analysis highlighted the advantages of amorphous silicon nanostructure sensors over existing technologies, including higher sensitivity, wider pressure range, smaller size, and better durability. The integration of these sensors provided invaluable data for optimizing training regimes and preventing injuries. The study also delved into the physical and chemical characterization of the nanostructures, confirming their uniform size distribution, surface morphology, and amorphous nature, which contributed to their exceptional sensing performance. The findings underscore the immense potential of amorphous silicon nanostructure sensors in revolutionizing athletic performance analysis and injury prevention, offering a significant upgrade over current technologies in terms of accuracy, adaptability, and user-friendliness. This research paves the way for more sophisticated, precise, and athlete-centric pressure sensing solutions, transforming the landscape of sports technology and biomechanical assessment.

Health technology assessment implementation in WHO South-East Asia Region: a realist review protocol.

A robust Health Technology Assessment (HTA) framework is crucial to address the rising burden of healthcare costs and to inform decision-making to promote high-quality health systems. This research aims to describe the HTA methods and mechanisms for the successful implementation of HTA in the WHO South-East Asia region, and contextualize the synthesized evidence relevant to Indian settings. Realist review involves developing a program theory by conducting a systematic search strategy, screening, study selection, data extraction, and data synthesis. A systematic search for literature will be conducted on PubMed (NCBI), EMBASE (Elsevier), Scopus (Elsevier), Web of Science (Clarivate), and ProQuest Central for identifying the methods used for HTA of health technology interventions. Stakeholder consultations will be conducted to develop a program theory following the Context-Mechanism-Outcome configurations (CMOcs) framework. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. The proposed realist review will be reported as per the Realist and MEta-narrative Evidence Syntheses: Evolving Standards [RAMESES II] guidelines. To our knowledge, there has been no comprehensive review conducted to understand the mechanisms of HTA methods in the WHO South-East Asia region. The findings from the realist review will help us understand the mechanisms through which the HTA could work in WHO South-East Asian countries. We will then contextualize the findings obtained from evidence to Indian settings, based on program theory development through stakeholder consultation. A framework will be developed that can be used by policymakers/HTA experts in India for effective implementation of the same.

Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy

BackgroundThe European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At “midterms” of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward.MethodsDuring the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation’s implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session.ResultsOverall “readiness” for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process.ConclusionsAt “midterms” of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA’s Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.

Key Issues of Economic Evaluations for Health Technology Assessment in China: A Nationwide Expert Survey

ObjectivesHealth technology assessment (HTA) is increasingly crucial in medicine price negotiations in China, yet previous appraisals revealed national discrepancies on key economic evaluation issues: willingness-to-pay threshold, pricing models for multi-indication medicines, and comparator selection principles. This study aimed to collect expert opinions on these issues for future HTA evaluations. MethodsA nationwide anonymous web-based survey encompassing experts across academia, HTA, consultancy/contract research organization/industry, service provider, and payer. In 2023, a generic invitation containing a web link to the questionnaire was disseminated via WeChat using convenience and snowball sampling. Agreement rates for questionnaire views were analyzed using descriptive statistics. The relationship between participants’ responses and demographics was examined using appropriate logistic models. ResultsA total of 303 responses were received from experts in 34 cities. Key expert views include a suggested base willingness-to-pay threshold ranging from 0.5 to 1.5 times gross domestic product (52.1% agreement); elevated thresholds for childhood diseases, rare diseases, end-of-life diseases, and first-in-class medicines (>78.0% agreement); a single pricing model for multi-indication medicines (60.4% agreement); consideration of multiple medicines as comparators (79.9% agreement); and avoiding the use of centrally procured medicines as comparators for medicines with a time to market of less than 3 years (71.0% agreement). Participants who are service provider had lower odds of selecting higher thresholds (odds ratio 0.26; P < .01) than responders from consultancy/contract research organization/industry. ConclusionsExpert views indicate the need for substantial changes in China’s current HTA methods, highlighting the need for increased investment in HTA processes and expertise cultivation.

Linking Reimbursement to Patient Benefits for Advanced Therapy Medicinal Products and Other High-Cost Innovations: Policy Recommendations for Outcomes-Based Agreements in Europe

ObjectivesHealth technology assessment (HTA) of advanced therapy medicinal products (ATMPs), such as high-cost and one-time cell and gene therapies, is particularly challenging. Outcomes-based agreements (OBAs) are a potential solution to mitigate the risks while providing access to patients but are not widely used across Europe. This study aimed to develop policy recommendations to support the acceptability and implementation of OBAs in Europe. MethodsA policy sandbox approach was used to engage with stakeholders and explore how HTA organizations can support reimbursement decisions regarding OBAs for ATMPs. A panel of 38 experts from across the European region was convened in 2 workshops, representing payers, HTA organizations, patients, registries, and an industry trade body. ResultsPolicy recommendations were developed to support the appropriate consideration of OBAs for reimbursing highly uncertain technologies, such as ATMPs. If a positive HTA recommendation cannot be made at the proposed price, then a simple price discount reflecting the uncertainty is preferred over complex solutions such as OBAs. If an OBA is pursued, it should be designed collaboratively with all stakeholders to understand data collection feasibility and minimize burden to patients and providers. Payers are encouraged to approach OBAs as a tool for informed decision making, including a readiness to make negative reimbursement decisions based on unfavorable evidence. ConclusionsThe study presents a policy framework for using OBAs in reimbursement decisions. OBAs must be carefully designed, focusing on appropriateness and the burden of implementation. The relevant authorities should be committed to making decisions in light of the resulting evidence.

Informing the United States Medicare Drug Price Negotiation for Apixaban and Rivaroxaban: Methodological Considerations for Value Assessments Many Years After Launch

ObjectivesTo demonstrate how health technology assessment methods can be used to support Medicare’s price negotiations for apixaban and rivaroxaban. MethodsFollowing the statutory outline of evidence that will be considered by Medicare, we conducted a systematic literature review, network meta-analyses, and decision analyses to evaluate the health outcomes and costs associated with apixaban and rivaroxaban compared with warfarin and dabigatran for patients with nonvalvular atrial fibrillation. Our methods inform discussions about the therapeutic impact of apixaban and rivaroxaban and suggest price premiums above their therapeutic alternatives over a range of cost-effectiveness thresholds. ResultsNetwork meta-analyses found apixaban resulted in a lower risk of major bleeding compared with warfarin and dabigatran and a lower risk of stroke/systemic embolism compared with warfarin but not compared with dabigatran. Rivaroxaban resulted in a lower risk of stroke/systemic embolism versus warfarin but not dabigatran, and there was no difference in major bleeding. Decision-analytic modeling of apixaban suggested annual price premiums up to $4350 above the price of warfarin and up to $530 above the price for dabigatran at cost-effectiveness thresholds up to $200 000 per equal value of life-years gained. Analyses of rivaroxaban showed an annual price premium of up to $3920 above warfarin and no premium above that paid for dabigatran. ConclusionsAlthough health technology assessment is typically performed near the time of regulatory approval, with modifications, we produced comparative clinical and relative cost-effectiveness findings to help guide negotiations on a “fair” price for drugs on the market for over a decade.

Health-Economic Evaluation of Psychological Interventions for Anxiety Prevention: A Systematic Review.

Although evidence supports the effectiveness of psychological interventions for prevention of anxiety, little is known about their cost-effectiveness. The aim of this study was to conduct a systematic review of health-economic evaluations of psychological interventions for anxiety prevention. PubMed, PsycInfo, Web of Science, Embase, Cochrane Central Register of Controlled Trials, EconLit, National Health Service (NHS) Economic Evaluations Database, NHS Health Technology Assessment, and OpenGrey databases were searched electronically on December 23, 2022. Included studies focused on economic evaluations based on randomized controlled trials of psychological interventions to prevent anxiety. Study data were extracted, and the quality of the selected studies was assessed by using the Consensus on Health Economic Criteria and the Cochrane risk-of-bias tool. All included studies (N=5) had economic evaluations that were considered to be of good quality. In two studies, the interventions showed favorable cost-effectiveness compared with usual care groups. In one study, the intervention was not cost-effective. Findings from another study cast doubt on the cost-effectiveness of the intervention, and the cost-effectiveness of the intervention in the remaining study could not be established. Although the findings suggest some preliminary evidence of cost-effectiveness of psychological interventions for preventing anxiety, they were limited by the small number of included studies. Additional research on the cost-effectiveness of psychological interventions for anxiety in different countries and populations is required.

Devices for remote continuous monitoring of people with Parkinson's disease: a systematic review and cost-effectiveness analysis.

Parkinson's disease is a brain condition causing a progressive loss of co ordination and movement problems. Around 145,500 people have Parkinson's disease in the United Kingdom. Levodopa is the most prescribed treatment for managing motor symptoms in the early stages. Patients should be monitored by a specialist every 6-12 months for disease progression and treatment of adverse effects. Wearable devices may provide a novel approach to management by directly monitoring patients for bradykinesia, dyskinesia, tremor and other symptoms. They are intended to be used alongside clinical judgement. To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson's disease: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor and STAT-ON. We performed systematic reviews of all evidence on the five devices, outcomes included: diagnostic accuracy, impact on decision-making, clinical outcomes, patient and clinician opinions and economic outcomes. We searched MEDLINE and 12 other databases/trial registries to February 2022. Risk of bias was assessed. Narrative synthesis was used to summarise all identified evidence, as the evidence was insufficient for meta-analysis. One included trial provided individual-level data, which was re-analysed. A de novo decision-analytic model was developed to estimate the cost-effectiveness of Personal KinetiGraph and Kinesia 360 compared to standard of care in the UK NHS over a 5-year time horizon. The base-case analysis considered two alternative monitoring strategies: one-time use and routine use of the device. Fifty-seven studies of Personal KinetiGraph, 15 of STAT-ON, 3 of Kinesia 360, 1 of KinesiaU and 1 of PDMonitor were included. There was some evidence to suggest that Personal KinetiGraph can accurately measure bradykinesia and dyskinesia, leading to treatment modification in some patients, and a possible improvement in clinical outcomes when measured using the Unified Parkinson's Disease Rating Scale. The evidence for STAT-ON suggested it may be of value for diagnosing symptoms, but there is currently no evidence on its clinical impact. The evidence for Kinesia 360, KinesiaU and PDMonitor is insufficient to draw any conclusions on their value in clinical practice. The base-case results for Personal KinetiGraph compared to standard of care for one-time and routine use resulted in incremental cost-effectiveness ratios of £67,856 and £57,877 per quality-adjusted life-year gained, respectively, with a beneficial impact of the Personal KinetiGraph on Unified Parkinson's Disease Rating Scale domains III and IV. The incremental cost-effectiveness ratio results for Kinesia 360 compared to standard of care for one-time and routine use were £38,828 and £67,203 per quality-adjusted life-year gained, respectively. The evidence was limited in extent and often low quality. For all devices, except Personal KinetiGraph, there was little to no evidence on the clinical impact of the technology. Personal KinetiGraph could reasonably be used in practice to monitor patient symptoms and modify treatment where required. There is too little evidence on STAT-ON, Kinesia 360, KinesiaU or PDMonitor to be confident that they are clinically useful. The cost-effectiveness of remote monitoring appears to be largely unfavourable with incremental cost-effectiveness ratios in excess of £30,000 per quality-adjusted life-year across a range of alternative assumptions. The main driver of cost-effectiveness was the durability of improvements in patient symptoms. This study is registered as PROSPERO CRD42022308597. This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135437) and is published in full in Health Technology Assessment; Vol. 28, No. 30. See the NIHR Funding and Awards website for further award information.

Pulsed Laser Links Simulation for Small Satellite Clock Model Estimation

The expansion of satellite constellation applications brings attention to the need for responsive, reliable satellite communication. For preflight technology assessment of missions, a simulation of two spacecraft in low Earth orbit has been created to estimate clock synchronization and precision orbit determination based on measured instrumentation performance. A novel MATLAB-based numerical simulator was developed to model spacecraft-to-spacecraft laser time-transfer and estimate the offset between the spacecraft clocks over time. This simulation includes timing errors associated with laser pulse detection, as well as non-Gaussian clock drift models. Two on-board clocks are modeled: a cesium-based chip-scale atomic clock and a rubidium-based miniature atomic clock. The positions and velocities of the spacecraft at a reference epoch and the constant coefficients of a polynomial clock model are estimated. Results compare the estimated clock model of a mission operation that only uses GPS measurements and one that uses both GPS and laser pulse time-of-flight measurements between spacecraft referenced to their on-board clocks. Including lasing measurements reduces the root-mean-square clock model error to approximately 80% of the RMS of the cases with only GPS measurements. This simulation tool can be used to optimize the lasing operations schedule based on mission timing performance objectives.

Home-monitoring for neovascular age-related macular degeneration in older adults within the UK: the MONARCH diagnostic accuracy study.

Most neovascular age-related macular degeneration treatments involve long-term follow-up of disease activity. Home monitoring would reduce the burden on patients and those they depend on for transport, and release clinic appointments for other patients. The study aimed to evaluate three home-monitoring tests for patients to use to detect active neovascular age-related macular degeneration compared with diagnosing active neovascular age-related macular degeneration by hospital follow-up. There were five objectives: Estimate the accuracy of three home-monitoring tests to detect active neovascular age-related macular degeneration. Determine the acceptability of home monitoring to patients and carers and adherence to home monitoring. Explore whether inequalities exist in recruitment, participants' ability to self-test and their adherence to weekly testing during follow-up. Provide pilot data about the accuracy of home monitoring to detect conversion to neovascular age-related macular degeneration in fellow eyes of patients with unilateral neovascular age-related macular degeneration. Describe challenges experienced when implementing home-monitoring tests. Diagnostic test accuracy cohort study, stratified by time since starting treatment. Six United Kingdom Hospital Eye Service macular clinics (Belfast, Liverpool, Moorfields, James Paget, Southampton, Gloucester). Patients with at least one study eye being monitored by hospital follow-up. Detection of active neovascular age-related macular degeneration by an ophthalmologist at hospital follow-up. KeepSight Journal: paper-based near-vision tests presented as word puzzles. MyVisionTrack®: electronic test, viewed on a tablet device. MultiBit: electronic test, viewed on a tablet device. Participants provided test scores weekly. Raw scores between hospital follow-ups were summarised as averages. Two hundred and ninety-seven patients (mean age 74.9 years) took part. At least one hospital follow-up was available for 317 study eyes, including 9 second eyes that became eligible during follow-up, in 261 participants (1549 complete visits). Median testing frequency was three times/month. Estimated areas under receiver operating curves were < 0.6 for all index tests, and only KeepSight Journal summary score was significantly associated with the lesion activity (odds ratio = 3.48, 95% confidence interval 1.09 to 11.13, p = 0.036). Older age and worse deprivation for home address were associated with lower participation (χ2 = 50.5 and 24.3, respectively, p < 0.001) but not ability or adherence to self-testing. Areas under receiver operating curves appeared higher for conversion of fellow eyes to neovascular age-related macular degeneration (0.85 for KeepSight Journal) but were estimated with less precision. Almost half of participants called a study helpline, most often due to inability to test electronically. Pre-specified sample size not met; participants' difficulties using the devices; electronic tests not always available. No index test provided adequate test accuracy to identify lesion diagnosed as active in follow-up clinics. If used to detect conversion, patients would still need to be monitored at hospital. Associations of older age and worse deprivation with study participation highlight the potential for inequities with such interventions. Provision of reliable electronic testing was challenging. Future studies evaluating similar technologies should consider: Independent monitoring with clear stopping rules based on test performance. Deployment of apps on patients' own devices since providing devices did not reduce inequalities in participation and complicated home testing. Alternative methods to summarise multiple scores over the period preceding a follow-up. This trial is registered as ISRCTN79058224. This award was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/97/02) and is published in full in Health Technology Assessment; Vol. 28, No. 32. See the NIHR Funding and Awards website for further award information.