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Increasingly in Ireland, there are specific criteria attached to reimbursement approval for new medicines. Health technology assessment (HTA) identifies where uncertainty is greatest in relation to clinical and cost-effectiveness evidence and budget impact estimates; our health technology management (HTM) approach uses these outputs from HTA to design protocols to manage these uncertainties in the post-reimbursement phase.
Methods
A bespoke managed access protocol (MAP) is developed for each medicine reimbursed under this approach, informed by uncertainties highlighted in the HTA, directions from the decision-maker, and relevant particulars arising from commercial negotiations. Individual patient reimbursement applications are submitted via an online application system linked directly to the national pharmacy claims system. Pharmacists review the applications and approve reimbursement support where the patient meets the reimbursement criteria. The process is adaptive, allowing expansion of the criteria to include previously excluded patient cohorts, and the addition of new indications. It can also work across differing reimbursement arrangements (hospital/primary care).
Results
The MAP for liraglutide for weight management confines reimbursement to patients with a body mass index greater than or equal to 35 kg/m², prediabetes, and high risk for cardiovascular disease. Phase I reimbursement support lasts for six months; patients not attaining greater than or equal to five percent weight loss are deemed non-responders as per the HTA, and reimbursement support is discontinued. The MAP for dupilumab confined reimbursement support to adults with refractory moderate-to-severe atopic dermatitis, where cost-effectiveness was plausible in the HTA. The MAP for calcitonin-gene-related-peptides monoclonal antibodies confines reimbursement support to patients with chronic migraine, refractory to at least three prophylactic treatments, where cost-effectiveness was plausible in the HTA.
Conclusions
Across these MAPs, over 3,000 patients accessed novel treatments for chronic illnesses in September 2023. HTM provides an effective mechanism to facilitate access to high-cost medicines for targeted patient groups, while providing increased oversight and budgetary certainty. Key to acceptance is utilization of HTA outputs to implement evidence-based HTM measures targeting specific uncertainties as highlighted in the HTA report.
Early studies of common mental disorders (CMDs) during the COVID-19 pandemic mainly report increases; however, more recent findings have been mixed. Also, studies assessing the effects of restriction measures on CMDs show varied results. The aim of this meta-analysis was to assess changes in levels of CMDs from pre-/early to during the pandemic and the effects of restriction policies in the European population.
Methods
We searched for studies assessing both pre-pandemic and peri-pandemic self-reported emotional distress and symptoms of depression or anxiety among nationally/regionally representative samples in Europe and collected microdata from those studies. Estimates of corona containment index were related to changes in CMDs using random-effects meta-regression.
Results
Our search strategy resulted in findings from 15 datasets drawn from 8 European countries being included in the meta-analysis. There was no evidence of change in the prevalence of emotional distress, anxiety, or depression from before to during the pandemic; but from early pandemic periods to later periods, there were significant decreases in emotional distress and anxiety. Increased school restrictions and social distancing were associated with small increases in self-reported emotional distress.
Conclusions
Despite initial concerns of increased emotional distress and mental illness due to the COVID-19 pandemic, the results from this meta-analysis indicate that there was a decrease in emotional distress and no change in anxiety or depression in the general population in Europe. Overall, our findings support the importance of strong governance when implementing periodic and robust restriction measures to combat the spread of COVID-19.
Offspring exposed to prenatal maternal depression (PMD) are vulnerable to depression across their lifespan. The underlying cause(s) for this elevated intergenerational risk is most likely complex. However, depression is underpinned by a dysfunctional frontal-limbic network, associated with core information processing biases (e.g. attending more to sad stimuli). Aberrations in this network might mediate transmission of this vulnerability in infants exposed to PMD. In this study, we aimed to explore the association between foetal exposure to PMD and frontal-limbic network function in infancy, hypothesising that, in response to emotional sounds, infants exposed to PMD would exhibit atypical activity in these regions, relative to those not exposed to PMD.
Method
We employed a novel functional magnetic resonance imaging sequence to compare brain function, whilst listening to emotional sounds, in 78 full-term infants (3–6 months of age) born to mothers with and without a diagnosis of PMD.
Results
After exclusion of 19 datasets due to infants waking up, or moving excessively, we report between-group brain activity differences, between 29 infants exposed to PMD and 29 infants not exposed to PMD, occurring in temporal, striatal, amygdala/parahippocampal and frontal regions (p < 0.005). The offspring exposed to PMD exhibited a relative increase in activation to sad sounds and reduced (or unchanged) activation to happy sounds in frontal-limbic clusters.
Conclusions
Findings of a differential response to positive and negative valanced sounds by 3–6 months of age may have significant implications for our understanding of neural mechanisms that underpin the increased risk for later-life depression in this population.
Wisdom is a personality trait comprising seven components: self-reflection, pro-social behaviors, emotional regulation, acceptance of diverse perspectives, decisiveness, social advising, and spirituality. Wisdom, a potentially modifiable trait, is strongly associated with well-being. We have published a validated 28-item San Diego Wisdom Scale, the SD-WISE-28. Brief scales are necessary for use in large population-based studies and in clinical practice. The present study aimed to create an abbreviated 7-item version of the SD-WISE.
Method:
Participants included 2093 people, aged 20-82 years, recruited and surveyed through the online crowdsourcing platform Amazon Mechanical Turk. The participants’ mean age was 46 years, with 55% women. Participants completed the SD-WISE-28 as well as validation scales for various positive and negative constructs. Psychometric analyses (factor analysis and item response theory) were used to select one item from each of the seven SD-WISE-28 subscales.
Results:
We selected a combination of items that produced acceptable unidimensional model fit and good reliability (ω = 0.74). Item statistics suggested that all seven items were strong indicators of wisdom, although the association was weakest for spirituality. Analyses indicated that the 28-item and 7-item SD-WISE are both very highly correlated (r = 0.92) and produce a nearly identical pattern of correlations with demographic and validity variables.
Conclusion:
The SD-WISE-7, and its derived Jeste-Thomas Wisdom Index (JTWI) score, balances reliability and brevity for research applications.
The novel coronavirus (SARS-CoV-2) has produced a considerable public health burden but the impact that contracting the disease has on mental health is unclear. In this observational population-based cohort study, we examined longitudinal changes in psychological distress associated with testing positive for coronavirus disease 2019 (COVID-19).
Methods
Participants (N = 8002; observations = 139 035) were drawn from 23 waves of the Understanding America Study, a nationally representative probability-based online panel of American adults followed-up every 2 weeks from 1 April 2020 to 15 February 2021. Psychological distress was assessed using the standardized total score on the Patient Health Questionnaire-4.
Results
Over the course of the study, 576 participants reported testing positive for COVID-19. Using regression analysis including individual and time-fixed effects we found that psychological distress increased by 0.29 standard deviations (p < 0.001) during the 2-week period when participants first tested positive for COVID-19. Distress levels remained significantly elevated (d = 0.16, p < 0.01) for a further 2 weeks, before returning to baseline levels. Coronavirus symptom severity explained changes in distress attributable to COVID-19, whereby distress was more pronounced among those whose symptoms were more severe and were slower to subside.
Conclusions
This study indicates that testing positive for COVID-19 is associated with an initial increase in psychological distress that diminishes quickly as symptoms subside. Although COVID-19 may not produce lasting psychological distress among the majority of the general population it remains possible that a minority may suffer longer-term mental health consequences.
The Maldives Heritage Survey was established to document cultural heritage vulnerable to human and environmental threats in the Maldives. An open-access online database is being produced to inform academic studies, support heritage-management plans and create a permanent archive of digital heritage resources.
A Canadian health authority implemented a multisectoral intervention designed to control severe acute respiratory coronavirus virus 2 (SARS-CoV-2) transmission during long-term care facility (LTCF) outbreaks. The primary objective was to evaluate the effectiveness of the intervention 14 days after implementation.
A series of outbreak measures classified into 4 categories: case and contact management, proactive case detection, rigorous infection control practices and resource prioritization and stewardship.
Methods:
A mixed-effects segmented Poisson regression model was fitted to the incidence rate of coronavirus disease 2019 (COVID-19), calculated every 2 days, within each facility and case type (staff vs residents). For each facility, the outbreak time period was segmented into an early outbreak period (within 14 days of the intervention) and postintervention period (beyond 14 days following the intervention). Model outputs quantified COVID-19 incidence trend and rate changes between these 2 periods. A secondary model was constructed to identify effect modification by case type.
Results:
The significant upward trend in COVID-19 incidence rate during the early outbreak period (rate ratio [RR], 1.07; 95% confidence interval [CI], 1.03–1.11; P < .001) reversed during the postintervention period (RR, 0.73; 95% CI, 0.67–0.80; P < .001). The average trend did not differ by case type during the early outbreak period (P > .05) or the postintervention period (P > .05). However, staff had a 70% larger decrease in the average rate of COVID-19 during the postintervention period than residents (RR, 0.30; 95% CI, 0.10–0.88; P < .05).
Conclusions:
Our study provides evidence for the effectiveness of this intervention to reduce the transmission of COVID-19 in LTCFs. This intervention can be adapted and utilized by other jurisdictions to protect the vulnerable individuals in LTCFs.
The COVID-19 pandemic has had a range of negative social and economic effects that may contribute to a rise in mental health problems. In this observational population-based study, we examined longitudinal changes in the prevalence of mental health problems from before to during the COVID-19 crisis and identified subgroups that are psychologically vulnerable during the pandemic.
Methods
Participants (N = 14 393; observations = 48 486) were adults drawn from wave 9 (2017–2019) of the nationally representative United Kingdom Household Longitudinal Study (UKHLS) and followed-up across three waves of assessment in April, May, and June 2020. Mental health problems were assessed using the 12-item General Health Questionnaire (GHQ-12).
Results
The population prevalence of mental health problems (GHQ-12 score ⩾3) increased by 13.5 percentage points from 24.3% in 2017–2019 to 37.8% in April 2020 and remained elevated in May (34.7%) and June (31.9%) 2020. All sociodemographic groups examined showed statistically significant increases in mental health problems in April 2020. The increase was largest among those aged 18–34 years (18.6 percentage points, 95% CI 14.3–22.9%), followed by females and high-income and education groups. Levels of mental health problems subsequently declined between April and June 2020 but remained significantly above pre-COVID-19 levels. Additional analyses showed that the rise in mental health problems observed throughout the COVID-19 pandemic was unlikely to be due to seasonality or year-to-year variation.
Conclusions
This study suggests that a pronounced and prolonged deterioration in mental health occurred as the COVID-19 pandemic emerged in the UK between April and June 2020.
Increasingly, products are designed for global markets, yet studies of design practices primarily investigate designers from high-income countries. Specifically, the use of prototypes during design is likely affected by the background of the designer and the environment in which they are designing. To broaden our understanding of the extent to which prototyping best practices are used beyond Western designers, in this study, we conducted interviews with novice designers from Ghana, a middle-income country (MIC), to examine how Ghanaian novice designers (upper-level undergraduate students) used prototypes throughout their design courses. We compared the reported use of prototypes to best practice behaviors and analyzed the types of prototypes used. We found evidence that these Ghanaian novice designers used some critical prototyping best practice behaviors, while other behaviors were underutilized, specifically during the front-end phases of design and for the purpose of engaging with stakeholders. Additionally, virtual models dominated their prototyping choices. We discuss likely reasons for these trends based on participants’ design experiences and design contexts.
Social disadvantage consistently predicts both self-reported distress and clinically diagnosed disorders such as depression. Yet, many individuals who are exposed to disadvantage do not report high levels of distress. This study extends our recent work showing that high cognitive ability may protect against the negative health consequences of exposure to disadvantaged backgrounds. We test whether this ‘buffer effect’ exists across clinically relevant indices of mental health in a population-representative sample.
Methods
In total, 27 985 participants were drawn from the UK Household Longitudinal Study (Understanding Society). Clinical diagnoses of depression and clinically relevant measures of psychological distress [i.e. Short Form-12 (SF-12) Mental Component, General Health Questionnaire (GHQ)] and trait neuroticism were assessed. Cognitive ability was derived from performance on word recall, verbal fluency and numerical ability tasks. Early-life disadvantage was gauged using family background measures assessing parental education and occupation at age 14.
Results
Background disadvantage predicted increased levels of reported psychological distress and neuroticism. These associations were moderated by cognitive ability. Across all available mental health measures, the negative association between early-life disadvantage and poor adult mental health was strongest at low (−1 s.d.) cognitive ability and was no longer evident at high (+1 s.d.) levels of cognitive ability.
Conclusions
The results provide support for a cognitive buffering hypothesis linking high cognitive ability to a decrease in the magnitude of the social gradient in mental health. Those disadvantaged by both low socioeconomic status and low cognitive ability may benefit from targeted prevention and treatment programmes aiming to reduce socioeconomic disparities in mental health.