Setting the context for a complex dental intervention of role substitution in care homes: Initial process evaluation findings.

OBJECTIVES: SENIOR (uSing rolE-substitutioN In care homes to improve oRal health) is a randomised controlled trial designed to determine whether role substitution could improve oral health for this population. A parallel process evaluation was undertaken to understand context. This paper reports on the first phase of the process evaluation. BACKGROUND: The oral health and quality-of-life of older adults residing in care homes is poorer than those in the community. Oral health care provision is often unavailable and a concern and challenge for managers. The use of Dental Therapists and Dental Nurses rather than dentists could potentially meet these needs. MATERIALS AND METHODS: Semi-structured interviews were conducted with 21 key stakeholders who either worked or had experience of dependent care settings. Questions were theoretically informed by the: Promoting Action on Research Implementation in Health Services (PAHRIS) framework. The focus was on contextual factors that could influence adoption in practice and the pathway-to-impact. Interviews were fully transcribed and analysed thematically. RESULTS: Three themes (receptive context, culture, and leadership) and 11 codes were generated. Data show the complexity of the setting and contextual factors that may work as barriers and facilitators to intervention delivery. Managers are aware of the issues regarding oral health and seek to provide best care, but face many challenges including staff turnover, time pressures, competing needs, access to services, and financial constraints. Dental professionals recognise the need for improvement and view role substitution as a viable alternative to current practice. CONCLUSION: Although role substitution could potentially meet the needs of this population, an in-depth understanding of contextual factors appeared important in understanding intervention delivery and implementation.

Arts and creativity interventions for improving health and wellbeing in older adults: a systematic literature review of economic evaluation studies.

BACKGROUND: As the population ages, older people account for a larger proportion of the health and social care budget. A significant body of evidence suggests that arts and creativity interventions can improve the physical, mental and social wellbeing of older adults, however the value and/or cost-effectiveness of such interventions remains unclear. METHODS: We systematically reviewed the economic evidence relating to such interventions, reporting our findings according to PRISMA guidelines. We searched bibliographic databases (MEDLINE, EMBASE, Econlit and Web of Science and NHSEED), trial registries and grey literature. No language or temporal restrictions were applied. Two screening rounds were conducted independently by health economists experienced in systematic literature review. Methodological quality was assessed, and key information extracted and tabulated to provide an overview of the published literature. A narrative synthesis without meta-analysis was conducted. RESULTS: Only six studies were identified which provided evidence relating to the value or cost-effectiveness of arts and creativity interventions to improve health and wellbeing in older adults. The evidence which was identified was encouraging, with five out of the six studies reporting an acceptable probability of cost-effectiveness or positive return on investment (ranging from £1.20 to over £8 for every £1 of expenditure). However, considerable heterogeneity was observed with respect to study participants, design, and outcomes assessed. Of particular concern were potential biases inherent in social value analyses. CONCLUSIONS: Despite many studies reporting positive health and wellbeing benefits of arts and creativity interventions in this population, we found meagre evidence on their value or cost-effectiveness. Such evidence is costly and time-consuming to generate, but essential if innovative non-pharmacological interventions are to be introduced to minimise the burden of illness in this population and ensure efficient use of public funds. The findings from this review suggests that capturing data on the value and/or cost-effectiveness of such interventions should be prioritised; furthermore, research effort should be directed to developing evaluative methods which move beyond the confines of current health technology assessment frameworks, to capture a broader picture of 'value' more applicable to arts and creativity interventions and public health interventions more generally. PROSPERO REGISTRATION: CRD42021267944 (14/07/2021).

Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2]).

BACKGROUND: Depression is a common psychiatric disorder and a leading cause of disability worldwide. Conventional monoaminergic antidepressants have limited efficacy and take weeks to exert a therapeutic effect. Single infusions of subanaesthetic doses of ketamine exhibit rapid antidepressant action but effects are transient and relapse is common. One potential strategy for increasing ketamine's antidepressant efficacy and/or prolonging its therapeutic benefit may be serial infusions. There is limited evidence on the efficacy and safety of repeated ketamine infusions against an active comparator. METHODS: This protocol describes an ongoing pragmatic, randomised, controlled, parallel-group, patient- and rater-blind, superiority trial. Eligible adult inpatients with a confirmed DSM-5 diagnosis of a major depressive episode (unipolar or bipolar) are randomly allocated in a 1:1 ratio to a course of up to eight infusions of ketamine or midazolam twice-weekly over four weeks. The primary objective is to assess the efficacy of serial adjunctive ketamine infusions versus active comparator midazolam by measuring Montgomery-Åsberg Depression Rating Scale score difference between arms from before the first infusion to 24 h after the final infusion, supplemented by a 95% confidence interval. To facilitate generalisability of results, the trial takes place under "real world" conditions with both groups continuing to receive regular inpatient care including treatment-as-usual pharmacotherapy, nursing care, and psychological and other therapies during the randomised treatment phase and regular outpatient care thereafter. Participants are monitored for relapse during a 24-week follow-up after the end of the randomised phase. Secondary objectives of the trial are to assess: response and remission rates at the end of randomised phase; relapse status during the 24-week follow-up after the end of the randomised phase; the safety and tolerability of repeated ketamine infusions regarding psychotomimetic and other psychiatric side effects, cognitive side effects, as well as withdrawal symptoms, haemodynamic stability, neurological, urological, and other physical side effects; and quality of life and cost-effectiveness. DISCUSSION: There is an unmet clinical need for rapidly-acting novel antidepressants. This trial will provide efficacy, safety and health economic data on serial ketamine infusions and thus help inform clinical practice on the potential role of this treatment in the management of depression. TRIAL REGISTRATION: EudraCT 2019-003109-92. Registered 2 October 2019. CLINICALTRIALS: gov NCT04939649. Registered 25 June 2021.

The relationship between region of residence, socio-demographic factors, and healthcare utilization among Saudi citizens: insights from the 2013 Saudi Health Interview Survey.

Background: There is a dearth of research on the nature and extent of variation in patterns of health service use in Saudi Arabia. This is an important gap in knowledge, given ongoing efforts to improve service provision and delivery. This study examined the relationship between the region of residence and socio-demographic factors and patterns of health service use in Saudi Arabia. Methods: Data were taken from the 2013 Saudi Health Interview Survey (SHIS), a national multistage survey of individuals aged 15 years and above in Saudi Arabia. Data included measures of service use, respondent health, socio-demographic characteristics, and region or area of residence. Descriptive statistics, Chi-square tests, and multivariable logistic regression analyses were used to describe the data and examine the likelihood of a respondent visiting a doctor or healthcare professional in the preceding 12 months. In addition, the analyses examined the role of health and socio-demographic characteristics within selected regions. Results: The increased likelihood of using health services in terms of visiting a doctor or healthcare professional was related to poor health status, being female, married, having a low income, and residing in particular regions. Respondents aged <65 and who lived furthest from service providers were less likely to visit a doctor or other health professionals (p < 0.01). Residents who lived in Riyadh, Al Medina, Baha, or Aseer demonstrated a higher likelihood of service utilization compared to respondents residing in other regions (p < 0.05). In sub-group analyses, there was variation between regions with respect to socio-demographic status and distance to service. Conclusion: Region of residence and income level, in particular, may help to explain the likelihood of primary care use in Saudi Arabia and the distinct patterns of service use in relation to regional and socio-demographic characteristics. The relationship between regional variation in service utilization and the socio-demographic characteristics of respondents may reflect differences with respect to population need, enabling, and predisposing factors as represented in Anderson's Behavioral Model (ABM) of health service use. The findings from this study underscore the importance of considering region or area of residence when seeking to understand the utilization of health services, particularly primary care services.

Technologies for the diagnosis of angle closure glaucoma (ACE): protocol of a prospective, multicentre, cross-sectional diagnostic study.

INTRODUCTION: Angle-closure is responsible for half of all glaucoma blindness globally. Patients with suspected glaucoma require assessment of the drainage angle by an experienced clinician. The goal of this study is to evaluate the diagnostic performance and cost-effectiveness of two non-contact tests, anterior segment OCT (Optical Coherence Tomography) (AS-OCT) and limbal anterior chamber depth for patients referred to hospital with suspected angle closure compared with gonioscopy by ophthalmologist. METHODS AND ANALYSIS: Study design: prospective, multicentre, cross-sectional diagnostic accuracy study. INCLUSION CRITERIA: adults referred from community optometry to hospital with suspected angle closure. PRIMARY OUTCOME: Sensitivity and specificity. SECONDARY OUTCOMES: Positive/negative likelihood ratios, concordance, cost-effectiveness, proportion of patients requiring subsequent clinical assessment by ophthalmologist. SAMPLE SIZE: 600 individuals who have been referred with suspected angle closure from primary care (community optometry). We will have a 95% probability of detecting the true sensitivity of either test to within ±3.5% based on a sensitivity of 90%. The study would also have a 95% probability of detecting the true specificity of either test to within ±5%, assuming a specificity of 75%. ETHICS AND DISSEMINATION: Ethical Review Board approval was obtained. REC reference: 22/LO/0885. Our findings will be disseminated to those involved in eye care services. We will have a knowledge exchange event at the end of the study, published via the Health Technology Assessment web page and in specialist journals. The results will be presented at professional conferences and directly to patients via patient group meetings and the Glaucoma UK charity. TRIAL REGISTRATION NUMBER: ISRCTN15115867.

UK Valuation of EQ-5D-5L, a Generic Measure of Health-Related Quality of Life: A Study Protocol.

OBJECTIVES: A high-quality and widely accepted UK EQ-5D-5L value set is urgently required to enable the latest version of EQ-5D scored using recent UK public preferences to inform policy including health technology assessments submitted to the National Institute for Health and Care Excellence. This article outlines the study protocol for the generation of a new EQ-5D-5L UK value set. METHODS: Twelve hundred interviews will be undertaken using the composite time trade-off elicitation technique for 102 health states (86 from the international EQ-5D-5L valuation protocol, plus 16 with best predictive performance in an extended design used in the Native American EQ-5D-5L valuation). The sample will be UK adults (age ≥18 years) proportionately representative across England, Wales, Scotland, and Northern Ireland, representative for age, sex, ethnicity, and socioeconomic group, with inclusion of participants with/without health problems. Participants will choose to be interviewed via videoconference (by Zoom) or in-person in a central venue. Data quality will be rigorously assessed. RESULTS: The value set will be generated using tobit random effects and heteroscedastic tobit models (with censoring at -1) using all data, excluding time trade-off values highlighted by participants as ones they would reconsider and data from interviewers failing protocol compliance. Quality and acceptance will be achieved by public involvement, regular Steering Group meetings, independent assessment of data quality at 4 time points, and final endorsement of data and analyses. CONCLUSION: This study will produce a UK value set for the EQ-5D-5L for use in prospective and retrospective data sets containing EQ-5D-5L data.

Compliance with oral hygiene and dietary advice for the prevention of post-radiotherapy dental disease among head and neck cancer patients - a qualitative study.

OBJECTIVES: To elicit head and neck cancer (HANC) patients' views about their oral health and to identify potential issues regarding compliance with clinical oral hygiene and dietary advice for the prevention of post-radiotherapy dental disease. METHODS: A purposive sample of twelve HANC patients between 6- and 12-months post-radiotherapy were recruited to undergo a semi-structured interview with a qualitative researcher. A pre-piloted topic guide was used to frame each interview. Qualitative data were analysed via thematic analysis. RESULTS: Data were categorised into four main themes - 'How HANC patients perceive oral health', 'Cancer diagnosis and cancer care pathway', 'Impact of oncology treatment (radiotherapy, surgery, and chemotherapy)', and 'Post-oncology treatment recovery', with 14 subthemes. Oral health was viewed as an important component of HANC patients' overall physical and mental health post-treatment. Patients' non-compliance with adequate oral hygiene practice was related to oral mucositis, a "burning" sensation associated with high fluoride toothpaste, forgotten or inconsistent clinical advice, and an inadequate supply of preventive oral hygiene products. The potentially highly cariogenic nature of prescribed nutritional supplements for patients at risk of malnutrition did not tend to be communicated to patients in advance of their prescription. CONCLUSIONS: Adequate oral health is essential for the overall physical and mental well-being of post-treatment HANC patients. Non-compliance with preventive clinical advice increases the risk of post-treatment oral health deterioration and was related to miscommunication, inadequate supplies of oral hygiene products, and treatment-related oral discomfort. CLINICAL SIGNIFICANCE: Post-treatment HANC patients are at increased risk of dental disease. Educational and behavioural techniques should be employed to enhance patients' compliance with clinical oral hygiene and dietary advice for the prevention of post-radiotherapy dental disease. Patients should be informed about the potentially highly cariogenic nature of nutritional supplements, and these patients should undergo frequent dental recall. Clinical advice regarding oral hygiene and dietary practices needs to be given consistently to HANC patients by different specialists of the HANC multidisciplinary team.

Financial toxicity among cancer patients, survivors and their families in the United Kingdom: a scoping review.

BACKGROUND: The aim of this scoping review was to identify key research gaps and priorities in order to advance policy and practice for people living with cancer in the UK. METHODS: The review adhered to PRISMA guidelines for scoping review. We searched MEDLINE, EMBASE, Scopus, Web of Science and Google Scholar on 16 July 2022. There were no restrictions in terms of study design and publication time; gray literature was included. The key words, 'financial' or 'economic', were combined with each of the following words 'hardship/stress/burden/distress/strain/toxicity/catastrophe/consequence/impact.' RESULTS: 29/629 studies/reports published during 1982-2022 were eligible to be included in the review. No study conducted a comprehensive inquiry and reported all aspects of financial toxicity (FT) or used a validated measure of FT. The most three commonly reported outcomes related to financial hardship were financial well-being (24/29), benefit/welfare (17/29) and mental health status (16/29). CONCLUSIONS: It is evident that FT is experienced by UK cancer patients/survivors and that the issue is under-researched. There is an urgent need for further research including rigorous studies which contribute to a comprehensive understanding about the nature and extent of FT, disparities in experience, the impacts of FT on outcomes and potential solutions to alleviate FT and related problems.

Trends in pathology diagnoses during 10 years of a colorectal cancer screening programme.

AIMS: We report pathology findings from the first 10 years of the faecal-occult blood-based Northern Ireland Bowel Cancer Screening Programme, presenting summary data and trends in pathology diagnoses and clinicopathological features of screen-detected cancers. METHODS AND RESULTS: Data were analysed from a comprehensive polyp-level pathology database representing all endoscopy specimens from programme inception in 2010 until 2021. A total of 9800 individuals underwent 13 472 endoscopy procedures, yielding 25 967 pathology specimens and 32 119 diagnoses. Index specimen diagnoses (4.1%) and index colonoscopies (10.4%) yielded a diagnosis of colorectal cancer, representing 1045 cancers from 1020 individuals (25 with synchronous cancers). A further 13 index cancers were identified via computed tomography colonography; 65.3% of cancer diagnoses were in males; 41.7% were stage I, 23.1% stage II, 25.8% stage III and 1.8% stage IV (7.6% unstaged). Of 233 pT1 cancers diagnosed within local excision specimens, 79 (33.9%) had completion surgery. Ten-year trends showed a steady decline in the proportion of index colonoscopies that yielded a diagnosis of cancer (14.7% in year 1; 4.8% in year 11) or advanced colorectal polyp. There was a strong upward trend in diagnoses of sessile serrated lesions, which overtook hyperplastic polyps in proportions of total index diagnoses by the end of the study time-frame (8.7% compared to 8.5%). CONCLUSIONS: Over the first 10 years of a population colorectal cancer screening programme, 'real world' pathology data demonstrate success in the form of reduced diagnoses of cancer and advanced colorectal polyp with passage of successive screening rounds. Interesting trends with respect to serrated polyp diagnoses are also evident, probably related to pathologist and endoscopist behaviour.

The case for individualised public health interventions: Smoking prevalence and inequalities in Northern Ireland 1985-2015.

BACKGROUND: While smoking prevalence in high income countries has declined over time, socioeconomic inequalities in smoking have widened. This study is one of the few studies to examine the longitudinal pattern of income-related smoking inequalities and only the second using concentration indices in its analysis. METHOD: Income-related smoking inequalities were measured using concentration indices using the Northern Ireland Continuous Household Survey data. Smoking inequalities were compared quantitatively and visually across three periods: 1985-1995, 1997-2005 and 2007-2015. Joinpoint analysis was used to measure the overall time trend of smoking inequalities. Subgroup analysis was used to examine the nature of change in smoking inequalities across population sub-groups. FINDINGS: Throughout 1985-2015, smoking was more concentrated among the poor (standard concentration index of-0·131, p < 0·001). While prevalence declined sharply across population, income-related inequalities increased sharply in general and within subgroups. Income-related smoking inequalities were significantly larger among high educated group and those who were employed. No structural break was observed with respect to the adoption of any specific policy measures over the period. CONCLUSION: Current approaches to tobacco control may be ill-suited to addressing smoking inequalities and may indeed be counterproductive. More tailored approaches that address the specific needs of population sub-groups or more draconian approaches such as extensions to prohibition may be required to reduce prevalence further while avoiding a widening of inequalities.

Caretakers' stated willingness to pay for children's spectacles in cross river state, Nigeria and its implication for a cross-subsidisation scheme: a cross-sectional study.

BACKGROUND: Understanding caretakers' willingness to pay (WTP) for their children's spectacles is essential to improving the sustainability of refractive error services and spectacle provision. Therefore, we investigated the willingness of caretakers to pay for their children's spectacles in a multi-centre study to develop a spectacle cross-subsidisation scheme in the Cross River State (CRS), Nigeria. METHODS: We administered the questionnaire to all caretakers whose children were referred from school vision screenings to four eye centres for full refraction assessment and dispensing of corrective spectacles from 9 August to 31 October 2019. We collected information on socio-demography, children's refractive error types, and spectacle prescription and then asked the caretakers about their WTP for the spectacles using a structured questionnaire and bidding format (in the local currency, Naira, ₦). RESULTS: A total of 137 respondents (response rate = 100%) from four centres were interviewed: with greater proportion of women (n = 92, 67.1%), aged between 41 and 50 years (n = 59, 43.1%), government employees (n = 64, 46.7%) and had acquired college or university education (n = 77, 56.2%). Of the 137 spectacles dispensed to their children, 74 (54.0%) had myopia or myopic astigmatism (equal to or greater than 0.50D). The mean stated WTP for the sample population was ₦3,560 (US$ 8.9) (SD ± ₦1,913.4). Men (p = 0.039), those with higher education (p < 0.001), higher monthly incomes (p = 0.042), and government employees (p = 0.001) were more willing to pay ₦3,600 (US$9.0) or more. CONCLUSION: Combining our previous findings from marketing analysis, these findings provided a basis to plan for a children's spectacles cross-subsidisation scheme in CRS. Further research will be needed to determine the acceptability of the scheme and the actual WTP.

Tunable, Textile-Based Joint Impedance Module for Soft Robotic Applications.

The design of soft actuators is often focused on achieving target trajectories or delivering specific forces and torques, rather than controlling the impedance of the actuator. This article outlines a new soft, tunable pneumatic impedance module based on an antagonistic actuator setup of textile-based pneumatic actuators intended to deliver bidirectional torques about a joint. Through mechanical programming of the actuators (select tuning of geometric parameters), the baseline torque to angle relationship of the module can be tuned. A high bandwidth fluidic controller that can rapidly modulate the pressure at up to 8 Hz in each antagonistic actuator was also developed to enable tunable impedance modulation. This high bandwidth was achieved through the characterization and modeling of the proportional valves used, derivation of a fluidic model, and derivation of control equations. The resulting impedance module was capable of modulating its stiffness from 0 to 100 Nm/rad, at velocities up to 120°/s and emulating asymmetric and nonlinear stiffness profiles, typical in wearable robotic applications.

An exploratory study of maternal diabetes and offspring use of dental services-Northern Ireland national cohort study.

INTRODUCTION: A small number of literature has posited a link between prenatal exposure to gestational diabetes mellitus and an increased risk of developmental defects in the enamel of offspring. However, the evidence remains inconclusive. AIMS: This study examined the relationship between the diabetes status of mothers and the use of dental services by offspring to that pregnancy. MATERIAL AND METHODS: Anonymised data from a cohort of mothers who carried a child to term in Northern Ireland between 2012 and 2017 and service use by the child were taken from administrative databases from March 2015 to September 2021. Descriptive statistics, differences in means and regression analyses were used to examine the relationship between service use and maternal diabetes status, controlling for covariates. RESULTS: In multivariate analyses that controlled inter alia for age and deprivation, diabetes status was negatively related to restoration, extraction, prevention, and total service use. In the analysis of the COVID period, pre-COVID prevention was negatively related to extractions, restorations, prevention and services in general. CONCLUSION: The relationship between maternal diabetic status and aspects of offspring use of dental services was contrary to that suggested in previous studies and warrants more detailed investigation using this valuable data resource.

An umbrella review of the effectiveness of fiscal and pricing policies on food and non-alcoholic beverages to improve health.

Poor quality diets represent major risk factors for the global burden of disease. Modeling studies indicate a potential for diet-related fiscal and pricing policies (FPs) to improve health. There is real-world evidence (RWE) that such policies can change behavior; however, the evidence regarding health is less clear. We conducted an umbrella review of the effectiveness of FPs on food and non-alcoholic beverages in influencing health or intermediate outcomes like consumption. We considered FPs applied to an entire population within a jurisdiction and included four systematic reviews in our final sample. Quality appraisal, an examination of excluded reviews, and a literature review of recent primary studies assessed the robustness of our results. Taxes and, to some extent, subsidies are effective in changing consumption of taxed/subsidized items; however, substitution is likely to occur. There is a lack of RWE supporting the effectiveness of FPs in improving health but this does not mean that they are ineffective. FPs may be important for improving health but their design is critical. Poorly designed FPs may fail to improve health and could reduce support for such policies or be used to support their repeal. More high-quality RWE on the impact of FPs on health is needed.

Estimating the health impacts of sugar-sweetened beverage tax for informing policy decisions about the obesity burden in Vietnam.

BACKGROUND: Taxation on sugar-sweetened beverages (SSBs) has been adopted in more than 40 countries but remained under discussion in Vietnam. This study aimed to estimate the health impacts of different SSBs tax plans currently under discussion to provide an evidence base to inform decision-making about a SSBs tax policy in Vietnam. METHOD & FINDINGS: Five tax scenarios were modelled, representing three levels of price increase: 5%, 11% and 19-20%. Scenarios of the highest price increase were assessed across three different tax designs: ad valorem, volume-based specific tax & sugar-based specific tax. We modelled SSBs consumption in each tax scenario; how this reduction in consumption translates to a reduction in total energy intake and how this relationship in turn translates to an average change in body weight and obesity status among adults by applying the calorie-to weight conversion factor. Changes in type 2 diabetes burden were then calculated based on the change in average BMI of the modelled cohort. A Monte Carlo simulation approach was applied on the conversion factor of weight change and diabetes risk reduction for the sensitivity analysis. We found that the taxation that involved a 5% price increase gave relatively small impacts while increasing SSBs' price up to 20% appeared to impact substantially on overweight and obesity rates (reduction of 12.7% and 12.4% respectively) saving 27 million USD for direct medical cost. The greatest reduction was observed for overweight and obesity class I. The decline in overweight and obesity rates was slightly higher for women than men. CONCLUSION: This study supports the SSB tax policy in pursuit of public health benefits, especially where the tax increase involves around a 20% price increase. The health benefit and revenue gains were evident across all three tax designs with the specific tax based on sugar density achieving greatest effects.

Cost-Effectiveness of Fractional Exhaled Nitric Oxide Suppression Testing as an Adherence Screening Tool Among Patients With Difficult-to-Control Asthma.

BACKGROUND: Approximately 50% of adults on long-term asthma medication are nonadherent. Current methods to detect nonadherence have had limited effect. Fractional exhaled nitric oxide suppression testing (FeNOSuppT) has demonstrated clinical effectiveness as an adherence screening tool to detect poor adherence to inhaled corticosteroids in difficult-to-control asthma prior to initiation of expensive biologic therapy. OBJECTIVE: Estimate the cost effectiveness and budget impact of FeNOSuppT as a screen prior to the initiation of biologic therapy among U.S. adults with difficult-to-control asthma and high fractional exhaled nitric oxide (≥45 ppb). METHODS: A decision tree simulated the progression of a cohort of patients over a 1-year time horizon into 1 of 3 states ([1] discharged from or [2] remain in specialist care; or [3] progress to biologics). Two strategies, with and without FeNOSuppT, were examined and the incremental net monetary benefit estimated using a discount rate of 3% and a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY). Sensitivity analysis and a budget impact analysis were also undertaken. RESULTS: In the baseline scenario, FeNOSuppT prior to the initiation of biologic therapy was associated with lower costs ($4,435/patient) and fewer QALYs (0.0023 QALY/patient) compared with no FeNOSuppT over 1 year and was considered cost effective (incremental net monetary benefit = $4,207). The FeNOSuppT was consistently found to be cost effective across a range of scenarios and in deterministic and probabilistic sensitivity analyses. Assuming differential levels of FeNOSuppT uptake (20%-100%), this was associated with budget savings ranging from USD $5 million to $27 million. CONCLUSIONS: The FeNOSuppT is likely to be cost effective as a protocol-driven, objective, biomarker-based tool for identifying nonadherence in difficult-to-control asthma. This cost effectiveness is driven by cost savings from patients not progressing to expensive biologic therapy.

Budget impact analysis of a home-based colorectal cancer screening programme in Malaysia.

OBJECTIVES: The 2020-2022 research project 'Colorectal Cancer Screening Intervention for Malaysia' (CRC-SIM) evaluated the implementation of a home-based CRC screening pilot in Segamat District. This budget impact analysis (BIA) assessed the expected changes in health expenditure of the Malaysian Ministry of Health budget in the scenario where the pilot programme was implemented nationwide vs current opportunistic screening. DESIGN: Budget impact analysis. Assumptions and costs in the opportunistic and novel CRC screening scenarios were derived from a previous evaluation of opportunistic CRC screening in community health clinics across Malaysia and the CRC-SIM research project, respectively. SETTING: National level (with supplement analysis for district level). The BIA was conducted from the viewpoint of the federal government and estimated the annual financial impact over a period of 5 years. RESULTS: The total annual cost of the current practice of opportunistic screening was RM1 584 321 (~I$1 099 460) of which 80% (RM1 274 690 or ~I$884 587) was expended on the provision of opportunistic CRC to adults who availed of the service. Regarding the implementation of national CRC screening programme, the net budget impact in the first year was estimated to be RM107 631 959 (~I$74 692 546) and to reach RM148 485 812 (~I$103 043 589) in the fifth year based on an assumed increased uptake of 5% annually. The costs were calculated to be sensitive to the probability of adults who were contactable, eligible and agreeable to participating in the programme. CONCLUSIONS: Results from the BIA provided direct and explicit estimates of the budget changes to when implementing a population-based national CRC screening programme to aid decision making by health services planners and commissioners in Malaysia about whether such programme is affordable within given their budget constraint. The study also illustrates the use and value of the BIA approach in low-income and middle-income countries and resource-constrained settings.

Standards of care for CFTR variant-specific therapy (including modulators) for people with cystic fibrosis.

Cystic fibrosis (CF) has entered the era of variant-specific therapy, tailored to the genetic variants in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. CFTR modulators, the first variant-specific therapy available, have transformed the management of CF. The latest standards of care from the European CF Society (2018) did not include guidance on variant-specific therapy, as CFTR modulators were becoming established as a novel therapy. We have produced interim standards to guide healthcare professionals in the provision of variant-specific therapy for people with CF. Here we provide evidence-based guidance covering the spectrum of care, established using evidence from systematic reviews and expert opinion. Statements were reviewed by key stakeholders using Delphi methodology, with agreement (≥80%) achieved for all statements after one round of consultation. Issues around accessibility are discussed and there is clear consensus that all eligible people with CF should have access to variant-specific therapy.

An umbrella review of the acceptability of fiscal and pricing policies to reduce diet-related noncommunicable disease.

CONTEXT: Poor diet has been implicated in a range of noncommunicable diseases. Fiscal and pricing policies (FPs) may offer a means by which consumption of food and non-alcoholic beverages with links to such diseases can be influenced to improve public health. OBJECTIVE: To examine the acceptability of FPs to reduce diet-related noncommunicable disease, based on systematic review evidence. DATA SOURCES: MEDLINE, EMBASE, PsychInfo, SCI, SSCI, Web of Science, Scopus, EconLit, the Cochrane Library, Epistemonikos, and the Campbell Collaboration Library were searched for relevant studies published between January 1, 1990 and June 2021. DATA EXTRACTION: The studies included systematic reviews of diet-related FPs and: used real-world evidence; examined real or perceived barriers/facilitators; targeted the price of food or non-alcoholic beverages; and applied to entire populations within a jurisdiction. A total of 9996 unique relevant records were identified, which were augmented by a search of bibliographies and recommendations from an external expert advisory panel. Following screening, 4 systematic reviews remained. DATA ANALYSIS: Quality appraisal was conducted using the AMSTAR 2 tool. A narrative synthesis was undertaken, with outcomes grouped according to the WHO-INTEGRATE criteria. The findings indicated a paucity of high-quality systematic review evidence and limited public support for the use of FPs to change dietary habits. This lack of support was related to a number of factors that included: their perceived potential to be regressive; a lack of transparency, ie, there was mistrust around the use of revenues raised; a paucity of evidence around health benefits; the deliberate choice of rates that were lower than those considered necessary to affect diet; and concerns about the potential of such FPs to harm economic outcomes such as employment. CONCLUSION: The findings underscore the need for high-quality systematic review evidence on this topic, and the importance of responding to public concerns and putting in place mechanisms to address these when implementing FPs. This study was funded by Safefood [02A-2020]. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42021274454.

Restoring arm function with a soft robotic wearable for individuals with amyotrophic lateral sclerosis.

Despite promising results in the rehabilitation field, it remains unclear whether upper limb robotic wearables, e.g., for people with physical impairments resulting from neurodegenerative disease, can be made portable and suitable for everyday use. We present a lightweight, fully portable, textile-based, soft inflatable wearable robot for shoulder elevation assistance that provides dynamic active support to the upper limbs. The technology is mechanically transparent when unpowered, can quantitatively assess free movement of the user, and adds only 150 grams of weight to each upper limb. In 10 individuals with amyotrophic lateral sclerosis (ALS) with different degrees of neuromuscular impairment, we demonstrated immediate improvement in the active range of motion and compensation for continuing physical deterioration in two individuals with ALS over 6 months. Along with improvements in movement, we show that this robotic wearable can improve functional activity without any training, restoring performance of basic activities of daily living. In addition, a reduction in shoulder muscle activity and perceived muscular exertion, coupled with increased endurance for holding objects, highlight the potential of this device to mitigate the impact of muscular fatigue for patients with ALS. These results represent a further step toward everyday use of assistive, soft, robotic wearables for the upper limbs.