OBJECTIVE: Estimates of minimally important differences (MID) can assist interpretation of data collected using patient-reported outcomes (PRO), but variability exists in the emphasis placed on MIDs in health technology assessment (HTA) guidelines. This study aimed to identify to what extent information on the MID of a commonly used PRO, the EQ-5D, is required and utilised by selected HTA agencies.
METHODS: Technology appraisal (TA) documents from HTA agencies in England, France, Germany, and the US between 2019 and 2021 were reviewed to identify documents which discussed MID of EQ-5D data as a clinical outcome assessment (COA) endpoint.
RESULTS: Of 151 TAs utilising EQ-5D as a COA endpoint, 58 (38%) discussed MID of EQ-5D data. Discussion of MID was most frequent in Germany, in 75% (n = 12/16) of Gemeinsamer Bundesausschuss (G-BA) and 44% (n = 34/78) of Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, (IQWiG) TAs. MID was predominantly applied to the EQ-VAS (n = 50), most frequently using a threshold of > 7 or > 10 points (n = 13). G-BA and IQWiG frequently criticised MID analyses, particularly the sources of MID thresholds for the EQ-VAS, as they were perceived as being unsuitable for assessing the validity of MID.
CONCLUSIONS: MID of the EQ-5D was not frequently discussed outside of Germany, and this did not appear to negatively impact decision-making of these HTA agencies. While MID thresholds were often applied to EQ-VAS data in German TAs, analyses were frequently rejected in benefit assessments due to concerns with their validity. Companies should pre-specify analyses of continuous data in statistical analysis plans to be considered for treatment benefit assessment in Germany.

BACKGROUND: With the purpose of supporting scientific professionals and helping them to better integrate the expertise of users in their work, a users\' and relatives\' panel (URP) was set up at the National Institute for Excellence in Health and Social Services in Quebec (INESSS), Canada for the social services and mental health directorate. URPs are advisory structures that mobilise the experiential knowledge of people affected by various issues.
OBJECTIVE: The objective of this study is to assess from a diverse stakeholders\' perceptions: (1) the experience of developing and implementing the URP within the context of an Agencies for Health Technology Assessment and Assessment of Social Services (AHTAASS), (2) the contribution of such a URP, (3) the challenges encountered and (4) the perspectives of improvement for the following years.
METHODS: We conducted a qualitative descriptive evaluation study. Nineteen interviews were conducted: six with URP members and 13 with staff representatives. The documents related to the creation of the panel, the URP minutes summarising the discussions and the reports published during that period were collected and analysed. Following a preliminary round of data analysis, a debriefing meeting was conducted with a few participants to validate the results.
RESULTS: The panel was set up as part of the INESSS\' desire to better integrate experiential knowledge into its recommendations. Twelve projects were presented to the panel on various themes. The URP enabled health professionals to consider dimensions they had not identified, to better integrate the experiential data collected from users into their work and to develop recommendations that made more sense to users. Panel members and INESSS professionals learned to work together, moving the working methods from consultation to collaboration and even coconstruction. Based on the panel\'s significant contribution, the INESSS decided to maintain it and to strengthen its place in its system to better integrate the experiential knowledge of users into its work.
CONCLUSIONS: This research illustrates how AHTAASS can set up a URP composed exclusively of users, and how it can contribute and be evaluated. It shows that URPs are structures that value the sharing of experiential knowledge of its members, humanise decision-making and give meaning to the work done by scientific professionals.
UNASSIGNED: One patient-researcher has contributed to the preparation and writing of this manuscript.

In the pursuit of universal health coverage, countries are invariably confronted with questions about which services to pay with public funds, to whom, and at what cost. Such priority-setting processes have major ramifications for the costs and benefits of care delivered. These processes are not just technical, but also highly political and organizational in nature and expressions of social values. This special issue focuses on building institutions for priority setting in health. These institutions serve a public purpose and are primarily concerned with conducting or using health technology assessment (HTA) to inform resource allocation decisions. We first define the concept of institutions for priority setting in health and the methodological considerations of assessing and evaluating these institutions. Next, we present key common themes and summarize key messages across the articles, including lessons learned and future challenges in building these institutions.

UNASSIGNED: The rapid growth of digital health tools, including digital applications, wearables, sensors, diagnostics, digital therapeutics (DTx), and prescription DTx, offers new ways to treat patients and close gaps in care. Payers need transparent, credible, and efficient processes to differentiate products for potential reimbursement from the larger universe of digital health products.
UNASSIGNED: To identify areas of agreement, disagreement, and rationale for payers to determine which digital health products should be evaluated for formulary consideration and to develop generalizable criteria for health care decision-makers developing policies and approaches for digital health products.
UNASSIGNED: Experts from the Academy of Managed Care Pharmacy DTx Advisory Group Payer Evaluation subcommittee rated whether a pharmacy and therapeutics committee, health technology assessment group, or an innovation center within a health plan or pharmacy benefit manager should consider 14 hypothetical products for potential formulary coverage. Using a 4-step modified Delphi approach, experts rated whether it was appropriate for a payer to evaluate each product on a scale of 1 (strongly disagree) to 9 (strongly agree). Quantitative agreement was assessed using terciles of responses, medians, and the distribution of appropriateness scores. The corresponding discussions are summarized to identify generalizable criteria for payers to consider as they develop approaches to determine which digital health products to evaluate.
UNASSIGNED: Among the 14 hypothetical products, 4 achieved quantitative agreement that payers should evaluate the product. 5 products had quantitative disagreement, and the remaining were indeterminant. Payers were most likely to review a product if it (1) was reviewed by the US Food and Drug Administration, (2) required a prescription, (3) was intended to be paid for using premium dollars, (4) treated rather than diagnosed or monitored a clinical condition, (5) had a low clinical opportunity cost, and (6) could address population health metrics.
UNASSIGNED: The rapid availability of digital health and DTx options can be daunting for health care decision-makers when determining which products to evaluate. These generalizable criteria can help payers develop a more efficient process.

UNASSIGNED: Diabetic foot ulcers and venous leg ulcers may not always heal in a timely manner despite proper wound care. Treatments that improve the healing rate of these ulcers would improve clinical outcomes for patients and may result in downstream cost savings for the health care system. We conducted a health technology assessment of sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding sucrose octasulfate-impregnated dressings, and patient preferences and values.
UNASSIGNED: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane risk-of-bias tool for randomized trials (RoB 2) and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and analyzed the budget impact of publicly funding sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers in Ontario. We did not conduct a primary economic evaluation because there is existing evidence to approximate the cost-effectiveness of sucrose octasulfate-impregnated dressings in Ontario. We leveraged 4 previous health technology assessments to explore the perspectives and experiences of patients with diabetic foot ulcers and venous leg ulcers, as well as the perspectives and experiences of their care partners.
UNASSIGNED: We included 3 randomized controlled trials and 2 subsequent publications of these randomized controlled trials in the clinical evidence review. Compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings result in faster wound closure in patients with difficult-to-heal noninfected neuroischemic diabetic foot ulcers (GRADE: Moderate) and reduce ulcer size and improve health-related quality of life in the domains of pain/discomfort and anxiety/depression for patients with difficult-to-heal noninfected venous leg ulcers (GRADE: Moderate). The use of sucrose octasulfate-impregnated dressings with noninfected wounds is considered safe (GRADE: Moderate).The economic evidence showed that, compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings are highly likely to be cost-effective for both difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers and would lead to cost savings due to faster and increased complete wound healing. The annual budget impact of publicly funding sucrose octasulfate-impregnated dressings in Ontario over the next 5 years would range from cost savings of $0.93 million in year 1 to $0.62 million in year 5 for adults with difficult-to-heal noninfected diabetic foot ulcers, and cost savings of $0.8 million in year 1 to $0.53 million in year 5 for adults with difficult-to-heal noninfected venous leg ulcers. Overall, we estimate that publicly funding sucrose octasulfate-impregnated dressings in Ontario for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers would lead to total cost savings of $3.91 million and $3.38 million, respectively, over the next 5 years.Patients with diabetic foot ulcers and venous leg ulcers discussed the effects of living with these wounds, as well as their treatment journey. They spoke about the burden of their condition and its negative impact on their daily lives, including mobility, employment, social activities, and mental health. Patients also spoke about the variety of treatment options available and the financial barriers to accessing these treatments.
UNASSIGNED: Sucrose octasulfate-impregnated dressings are safe and improve the healing of difficult-to-heal noninfected neuroischemic diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers compared with dressings that do not contain sucrose octasulfate. We estimate that publicly funding sucrose octasulfate-impregnated dressings in Ontario would result in cost savings for both difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers. Evidence from patient engagement suggests that people with diabetic foot ulcers or venous leg ulcers face negative impacts on their quality of life, especially related to mobility. Patients spoke about their challenges, including long and difficult care journeys, as well as trying different treatment options to heal their ulcers and avoid amputation. It is not clear if the participants had direct experience with sucrose octasulfate-impregnated dressings, so we could not draw specific conclusions about these dressings from the preferences and values evidence.

BACKGROUND: The COVID-19 pandemic has highlighted the importance of evidence-informed priority setting and situational analysis in pandemic preparedness and response. Health Technology Assessment (HTA) has been identified as an essential tool for evidence-informed decision-making in healthcare. However, the potential role of HTA in pandemic preparedness and response in Africa has yet to be explored. The objective of this scoping review is to ascertain the current understanding of the possible role of HTA in Africa to support future pandemic preparedness and response.
METHODS: We will conduct a scoping review of literature published between 2010 and 2024. Electronic databases like Embase, PubMed, Scopus, Web of Science, and Google Scholar will be utilized to perform the search. We will also search grey literature sources such as websites of relevant organizations and government agencies. The search will only include studies that were conducted in the English language. Two reviewers will evaluate the titles and abstracts of the publications independently to determine their eligibility using Covidence. Full-text articles will be reviewed for eligibility and data extraction. The data will be extracted using a standardized form. The extracted data will include information on the study design, objectives, methods, findings, and conclusions. The thematic analysis approach will guide the data analysis. Themes and sub-themes will be identified and reported. The review will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines.
CONCLUSIONS: This scoping review will identify the existing knowledge on the potential role of HTA in Africa to support future pandemic preparedness and response. The findings will aid in identifying deficiencies in knowledge and provide valuable insights for future study. Additionally, they will inform policy-makers and other stakeholders about the potential contribution of the Health Technology Assessment (HTA) in enhancing Africa\'s readiness and response to pandemics.

UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Diagnostic test accuracy cohort study, stratified by time since starting treatment.
UNASSIGNED: Six United Kingdom Hospital Eye Service macular clinics (Belfast, Liverpool, Moorfields, James Paget, Southampton, Gloucester).
UNASSIGNED: Patients with at least one study eye being monitored by hospital follow-up.
UNASSIGNED: Detection of active neovascular age-related macular degeneration by an ophthalmologist at hospital follow-up.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Pre-specified sample size not met; participants\' difficulties using the devices; electronic tests not always available.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This trial is registered as ISRCTN79058224.
UNASSIGNED: 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.
Treatment for neovascular age-related macular degeneration, the most common cause of sight loss in those over 50 years, involves regular eye injections and frequent follow-up appointments. This is inconvenient for patients and causes capacity issues in the hospital eye service. Finding tests that could be undertaken at home that could detect if a further injection and hospital appointment was required or not would increase capacity to see those at highest risk of sight loss and also reduce the burden on patients and their carers. We investigated three different visual function tests, one paper-based and two applications on an iPod TouchTM tablet (Apple, Cupertino, CA, USA). We wanted to see if they could detect an increase in disease activity that would require treatment, compared to the decision by a retinal specialist at a traditional hospital eye outpatient visit based on clinical examination and retinal imaging. To encourage those without a smartphone or home internet to participate, we provided both an iPod Touch and Mobile Wireless-Fidelity device with a mobile contract. None of the tests performed well enough to safely monitor patients at home. Those who were willing to participate tended to be younger, had previous experience of using smartphones, sending e-mail and internet access and were more well-off than those who chose not to participate. Some participants also experienced difficulties with the devices provided and successfully uploading the data which were not related to the extent of previous information technology experience. There were also significant technical challenges for the research team. The study helpline was used heavily, considerably more than we anticipated. These tests are not ready to be used in this context. Future studies involving mobile health technology need to carefully consider how to reach those unlikely to participate and provide sufficient technical support to support long-term follow-up.

UNASSIGNED: The CaRi-Heart® device estimates risk of 8-year cardiac death, using a prognostic model, which includes perivascular fat attenuation index, atherosclerotic plaque burden and clinical risk factors.
UNASSIGNED: To provide an Early Value Assessment of the potential of CaRi-Heart Risk to be an effective and cost-effective adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected coronary artery disease, undergoing computed tomography coronary angiography. This assessment includes conceptual modelling which explores the structure and evidence about parameters required for model development, but not development of a full executable cost-effectiveness model.
UNASSIGNED: Twenty-four databases, including MEDLINE, MEDLINE In-Process and EMBASE, were searched from inception to October 2022.
UNASSIGNED: Review methods followed published guidelines. Study quality was assessed using Prediction model Risk Of Bias ASsessment Tool. Results were summarised by research question: prognostic performance; prevalence of risk categories; clinical effects; costs of CaRi-Heart. Exploratory searches were conducted to inform conceptual cost-effectiveness modelling.
UNASSIGNED: The only included study indicated that CaRi-Heart Risk may be predictive of 8 years cardiac death. The hazard ratio, per unit increase in CaRi-Heart Risk, adjusted for smoking, hypercholesterolaemia, hypertension, diabetes mellitus, Duke index, presence of high-risk plaque features and epicardial adipose tissue volume, was 1.04 (95% confidence interval 1.03 to 1.06) in the model validation cohort. Based on Prediction model Risk Of Bias ASsessment Tool, this study was rated as having high risk of bias and high concerns regarding its applicability to the decision problem specified for this Early Value Assessment. We did not identify any studies that reported information about the clinical effects or costs of using CaRi-Heart to assess cardiac risk. Exploratory searches, conducted to inform the conceptual cost-effectiveness modelling, indicated that there is a deficiency with respect to evidence about the effects of changing existing treatments or introducing new treatments, based on assessment of cardiac risk (by any method), or on measures of vascular inflammation (e.g. fat attenuation index). A de novo conceptual decision-analytic model that could be used to inform an early assessment of the cost effectiveness of CaRi-Heart is described. A combination of a short-term diagnostic model component and a long-term model component that evaluates the downstream consequences is anticipated to capture the diagnosis and the progression of coronary artery disease.
UNASSIGNED: The rapid review methods and pragmatic additional searches used to inform this Early Value Assessment mean that, although areas of potential uncertainty have been described, we cannot definitively state where there are evidence gaps.
UNASSIGNED: The evidence about the clinical utility of CaRi-Heart Risk is underdeveloped and has considerable limitations, both in terms of risk of bias and applicability to United Kingdom clinical practice. There is some evidence that CaRi-Heart Risk may be predictive of 8-year risk of cardiac death, for patients undergoing computed tomography coronary angiography for suspected coronary artery disease. However, whether and to what extent CaRi-Heart represents an improvement relative to current standard of care remains uncertain. The evaluation of the CaRi-Heart device is ongoing and currently available data are insufficient to fully inform the cost-effectiveness modelling.
UNASSIGNED: A large (n = 15,000) ongoing study, NCT05169333, the Oxford risk factors and non-invasive imaging study, with an estimated completion date of February 2030, may address some of the uncertainties identified in this Early Value Assessment.
UNASSIGNED: This study is registered as PROSPERO CRD42022366496.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135672) and is published in full in Health Technology Assessment; Vol. 28, No. 31. See the NIHR Funding and Awards website for further award information.
Coronary artery disease affects around 2.3 million people in the United Kingdom. It is caused by a build-up of fatty plaques on the walls of the blood vessels that supply the heart muscle. This can reduce the flow of blood to the heart and result in people experiencing chest pain (angina), especially when they exercise. Over time, the fatty plaques can grow and block more or all of the artery and blood clots can also form, causing blockage. A heart attack happens when the supply of blood to the heart muscle is blocked. People who have episodes of chest pain, whose doctors think that they may have coronary artery disease, can have a type of imaging (computed tomography coronary angiography) which shows whether there is any narrowing of their coronary arteries. When offering treatment, specialist heart doctors are likely to consider a person’s symptoms and other risk factors (such as family history of heart disease, diabetes and smoking history), as well as how much narrowing of the arteries has happened. CaRi-Heart® is a computer programme that uses information about inflammation in a person’s coronary arteries, together with recognised risk factors, such as age, sex, smoking, high cholesterol levels, high blood pressure and diabetes, to estimate an individual’s risk of dying from a heart attack in the next 8 years. There is evidence that CaRi-Heart® is better at estimating this risk than using information recognised risk factors alone. However, there is a lack of information about how treatment could change as a result of using CaRi-Heart® and whether any changes would improve outcomes for patients. There is also a lack of information about how much CaRi-Heart® would cost the National Health Service.

UNASSIGNED: 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.
UNASSIGNED: To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson\'s disease: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor and STAT-ON.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This study is registered as PROSPERO CRD42022308597.
UNASSIGNED: 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.
Parkinson’s disease is a brain condition causing loss of co-ordination and movement problems. Levodopa is the most prescribed treatment for early disease. Patients should be seen by a specialist every 6–12 months to assess their treatment needs. Wearable devices (like smart watches) may aid management by directly monitoring patients for disease symptoms including tremor and slowness of movement (bradykinesia), or side effects of treatment like involuntary movement (dyskinesia). This assessment considered the clinical and economic value of five wearable devices: Personal KinetiGraph, STAT-ON, Kinesia 360, KinesiaU and PDMonitor. We searched medical databases to find all studies of the five devices. We assessed the quality of these studies and reviewed their results. We found 77 studies of the devices. 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 symptoms. The evidence for STAT-ON suggested it may be of value for diagnosing symptoms, but there is currently no evidence on its clinical value. There was insufficient evidence for Kinesia 360, KinesiaU and PDMonitor to draw any conclusions. An economic analysis was conducted to investigate whether using any of these technologies is economically viable. The economic analysis found that the quality-of-life benefits generated by remote monitoring devices were small relative to the additional costs of implementing them in the NHS. As such, none of the remote monitoring devices were good value for money when compared with the current standard of care.

UNASSIGNED: Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.
UNASSIGNED: To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children.
UNASSIGNED: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years.
UNASSIGNED: Twelve secondary and four primary care centres.
UNASSIGNED: Healthy infants (at least 37 weeks\' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery.
UNASSIGNED: Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation.
UNASSIGNED: Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness.
UNASSIGNED: One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; p = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires.
UNASSIGNED: Two emollient types were used which could have had different effects. The median time for starting emollients was 11 days after birth. Some contamination occurred in the control group (< 20%). Participating families were unblinded and reported on some outcomes.
UNASSIGNED: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children. Emollient use was associated with a higher risk of skin infections and a possible increase in food allergy. Emollient use is unlikely to be considered cost-effective in this context.
UNASSIGNED: To pool similar studies in an individual patient data meta-analysis.
UNASSIGNED: This trial is registered as ISRCTN21528841.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/67/12) and is published in full in Health Technology Assessment; Vol. 28, No. 29. See the NIHR Funding and Awards website for further award information.
Eczema is a troublesome itchy skin condition affecting 1 in 5 children and 1 in 10 UK adults. There is no cure and affected children are more likely to develop food allergies. We wanted to see if we could prevent eczema by protecting the skin of babies at higher risk of developing eczema (with an immediate relative with eczema, asthma or hay fever) with moisturisers used to treat dry skin. Previous research suggested that protecting the skin barrier might also prevent food allergy. One thousand three hundred and ninety-four families took part in a study; half of them were asked to apply moisturiser every day to their newborn baby for the first year and half to look after their baby’s skin in the normal way. At the age of 2 years, we did not see any difference in how common eczema was between the two groups: 23% had eczema in the moisturiser group and 25% in the normal care group. It did not matter how we defined eczema – whether examined by a researcher or parent report. We did not find any differences in related conditions like asthma or hay fever either. We found that children using moisturisers had seen their doctor slightly more often for mild skin infections. There was a hint that food allergy might have been increased in the moisturiser group, but there was not enough data to be sure. We followed up the children to age 5 years, but we still did not find any benefits from using moisturisers in early life. Since this study, other similar research has been done using newer types of moisturisers, but their results are the same. This study shows that using daily moisturisers on healthy babies with a high risk of eczema does not prevent eczema. It is one less thing for busy families to worry about.