Immunogenicity and safety of Fluzone intradermal and high-dose influenza vaccines in older adults ≥65 years of age: A randomized,controlled, phase II trial

We conducted a randomized, controlled, multicenter, phase II study to evaluate the immunogenicity and safety of an investigational intradermal (ID) trivalent influenza vaccine (TIV) and a high-dose (HD) intramuscular (IM) TIV in older adults (≥65 years of age). Older adult subjects were immunized with ID vaccine containing either 15 μg hemagglutinin (HA)/strain (n = 636) or 21 μg HA/strain (n = 634), with HD IM vaccine containing 60 μg HA/strain (n = 320), or with standard-dose (SD) IM vaccine (Fluzone^®; 15 μg HA/strain; n = 319). For comparison, younger adults (18–49 years of age) were immunized with SD IM vaccine. In older adults, post-vaccination geometric mean titers induced by the ID vaccines were superior to those induced by the SD IM vaccine for the A/H1N1 and A/H3N2 strains and non-inferior for the B strain. Seroconversion rates induced by the ID vaccines were superior to those induced by the SD IM vaccine in older adults for the A/H1N1 and B strains and non-inferior for the A/H3N2 strain. Results did not differ significantly for the two ID vaccine dosages. Post-vaccination geometric mean titers, seroconversion rates, and most seroprotection rates were significantly higher in HD vaccine recipients than in older adult recipients of the SD IM or ID vaccines and, for most measures, were comparable to those of younger adult SD IM vaccine recipients. Injection-site reactions, but not systemic reactions or unsolicited adverse events, were more common with the ID vaccines than with the IM vaccines. No treatment-related serious adverse events were reported. This study demonstrated that: (1) the ID and HD vaccines were well-tolerated and more immunogenic than the SD IM vaccine in older adults; (2) the HD vaccine was more immunogenic than the ID vaccines in older adults; and (3) the HD vaccine in older adults and the SD IM vaccine in younger adults elicited comparable antibody responses (ClinicalTrials.gov identifier no.: NCT00551031).     

Lifelong learning in community healthcare: Testing competence after learning activities in a blended learning space

Aims and Objectives

This study reports from a municipality in Norway that implemented a competence enhancement programme for all its institutional nursing staff during the COVID-19 pandemic to fill identified competence gaps.

Background

Many Norwegian municipalities are experiencing a demand for expanded community healthcare services due to an increase in elderly patients and patients with extensive and complex needs. At the same time, most municipalities are striving to recruit and keep competent health personnel. New ways of organising and increasing the competence of the workforce may help ensure that the healthcare delivered corresponds to patients' changing needs.

Design and Methods

Nursing staff were encouraged to complete targeted competence enhancing activities with the aim of enhancing their competence in identified areas. The learning activities were blended and consisted of e-learning courses, lectures, supervision, vocational training and meetings with a superior. Competence was measured before and after the competence enhancing activities (n = 96). The STROBE checklist was applied.

Results

The results provide insight into the competence development of registered nurses and assistant nurses in institutional community health services. They show that the implementation of a workplace-based blended learning programme improved competence significantly, especially for assistant nurses.

Conclusions

Offering workplace-based competence enhancing activities seems to be a sustainable way of facilitating lifelong learning among nursing staff. Facilitation of learning activities in a blended learning space may enhance accessibility and increase the potential for participation. A combination of reorganisation of roles and simultaneous competence enhancing activities can ensure that both managers and nursing staff prioritise filling competence gaps.     

Deforestation reduces fruit and vegetable consumption in rural Tanzania

Strategies to improve food and nutrition security continue to promote increasing food via agricultural intensification. Little (if any) consideration is given to the role of natural landscapes such as forests in meeting nutrition goals, despite a growing body of literature that shows that having access to these landscapes can improve people’s diets, particularly in rural areas of low- and middle-income countries. In this study, we tested whether deforestation over a 5-y period (2008–2013) affected people’s dietary quality in rural Tanzania using a modeling approach that combined two-way fixed-effects regression analysis with covariate balancing generalized propensity score (CBGPS) weighting which allowed for causal inferences to be made. We found that, over the 5 y, deforestation caused a reduction in household fruit and vegetable consumption and thus vitamin A adequacy of diets. The average household member experienced a reduction in fruit and vegetable consumption of 14 g⋅d⁻¹, which represented a substantial proportion (11%) of average daily intake. Conversely, we found that forest fragmentation over the survey period led to an increase in consumption of these foods and dietary vitamin A adequacy. This study finds a causal link between deforestation and people’s dietary quality, and the results have important implications for policy makers given that forests are largely overlooked in strategies to improve nutrition, but offer potential “win–wins” in terms of meeting nutrition goals as well as conservation and environmental goals.

The challenge of achieving food and nutrition security for the worlds’ growing population while also minimizing and reversing damage to the natural environment is unprecedented. The dominant narrative on how to achieve food and nutrition security continues to be centered on intensifying agricultural production to produce more food (1–3). While agricultural intensification is undoubtedly a key reason we have kept pace with food demands and ended hunger for millions of people over the past decades, it has led to a preoccupation with dietary energy (calories), and thus the production of staple grains which provide the majority of calories globally (4, 5). The focus on staple foods has resulted in dietary quality and diversity being overlooked, despite the fact that far more people suffer from micronutrient deficiency than undernourishment (6–8). Likewise, agricultural intensification is a leading driver of environmental degradation (9–11). There has been much research in recent years examining the impact of different diets on land use (12–15), but less attention has been given to the reverse of this relationship: How do landscapes affect diets? A growing body of literature has examined this relationship with a focus on the linkages between forests and diets in low- and middle-income countries. This relatively new field of research has important implications for strategies to achieve food and nutrition security worldwide, particularly for rural areas in low- and middle-income countries where there are strong connections between livelihoods and landscapes, and undernourishment is most prevalent.Forests provide critical ecosystem services that benefit human populations in several ways, such as the provision of food and fiber, and climate and water regulation (16), with an estimated 1.5 billion forest-proximate people worldwide (i.e., living within 5 km of a forest) (17). Forests can improve people’s diets via four key pathways (18, 19). The most direct way is via the provision of wild forest foods, which most often include fruits, vegetables, mushrooms, and animal products (i.e., bushmeat and insects), all of which tend to be high in essential micronutrients (20–22). The second pathway is via income generation from the sale of forest foods and other nontimber forest products (NTFPs), which can improve livelihoods and facilitate the purchase of nutritious foods from markets (23, 24). The third pathway is via the flow of ecosystem services from forests into surrounding agricultural landscapes (e.g., forests can contribute to soil formation and nutrient cycling, and increase pollination) which can increase and/or diversify production (25). The final pathway is the provision of fuelwood for cooking, which is a key (but often overlooked) pathway that can improve nutrition by facilitating the preparation of a range of foods, particularly those with long cooking times (26, 27).The majority of studies have found a positive relationship between living near (having access to) forests and several measures of diet, nutrition, and food security outcomes. Most studies use metrics of diet quality such as dietary diversity scores or consumption of certain nutritious food groups. Very few studies have examined more detailed measures of dietary quality such as energy and nutrient intakes (28–30), and only one study has examined these in relation to forest cover using multivariate regression (31). Moreover, the majority of studies examine the relationship between forests and diet quality at a single point in time. Two studies have examined the relationship between diets and previous forest loss (32, 33), but no studies, to date, have used longitudinal data to understand concurrent changes in forests and diets over time. In this sense, most studies have only been able to identify associations between forests and diets as opposed to causal relationships. Furthermore, only one study, to date, has examined how the spatial arrangement of forests (as opposed to just forest amount) can affect people’s diets (34), finding that forest configuration may be as important as forest amount for dietary quality.This study aimed to advance the current knowledge on the forest–diet relationship in three main ways:

• 1)By using panel data and a rigorous estimation method which combines covariate balancing generalized propensity score (CBGPS) weighting with two-way fixed-effects regression, we were able to test the causal impact of forest changes on diets, which no studies, to our knowledge, have done. We were also able to explore the causal mechanisms by which forest cover change is hypothesized to affect people’s diets (the direct consumption pathway, the income pathway, and the ecosystem services pathway).
• 2)Most existing studies rely on measures such as dietary diversity scores and consumption of nutritious food groups as proxies for overall diet quality. In addition to these, we also quantified household energy and nutrient adequacy levels in order to gain a better understanding of how forests can affect people’s diets.
• 3)We considered not just forest amount but also the spatial arrangement of forests in relation to diet quality, which only one study has done, to date (34). Thus, this study aimed to extend this research to examine whether changes in forest configuration [in terms of fragmentation (35)] were related to people’s dietary quality.

     

Prevalence, prognostic significance, and treatment of atrial fibrillation in congestive heart failure with particular reference to the DIAMOND-CHF study

Atrial fibrillation is a growing health problem and the most common cardiac arrhythmia, affecting 5% of persons above the age of 65 years. The number of hospital discharges for atrial fibrillation has more than doubled in the past decade. It occurs very often in patients with congestive heart failure and the prevalence increases with the severity of the disease. These two conditions seem to be linked together, and congestive heart failure may either be the cause or the consequence of atrial fibrillation. The prognosis of atrial fibrillation is controversial, but studies indicate that atrial fibrillation is a risk factor in congestive heart failure patients. In the last 10-15 years, significant advances in the treatment of heart failure have improved survival, whereas effective management of atrial fibrillation in heart failure patients still awaits similar progress. Empirically, two strategies have evolved for treatment of atrial fibrillation: 1) rhythm control, which means conversion to sinus rhythm and maintenance of sinus rhythm; and 2) rate control, which means reduction of heart rate to an acceptable frequency. It is unknown whether one of these strategies is better than the other. In this review the authors discuss the prevalence, impact, and treatment of atrial fibrillation in heart failure patients.     

FACTORS ASSOCIATED WITH MET AND UNMET REHABILITATION NEEDS AFTER STROKE: A MULTICENTRE COHORT STUDY IN DENMARK AND NORWAY

ObjectivesTo examine patient-reported needs for care and rehabilitation in a cohort following different subacute pathways of rehabilitation, and to explore factors underpinning met and unmet needs.DesignObservational multicentre cohort study.Patients and methodsA total of 318 Norwegian and 155 Danish patients with first-ever stroke were included. Participants answered questions from the Norwegian Stroke Registry about perceived met, unmet or lack of need for help and training during the first 3 months post stroke. The term “training” in this context was used for all rehabilitative therapy offered by physiotherapists, occupational or speech therapists. The term “help” was used for care and support in daily activities provided by nurses or health assistants.ResultsNeed for training: 15% reported unmet need, 52% reported met need, and 33% reported no need. Need for help: 10% reported unmet need, 58% reported met, and 31% reported no need. Participants from both Norway and Denmark had similar patterns of unmet/met need for help or training. Unmet need for training was associated with lower functioning, (odds ratio (OR) = 0.32, p < 0.05) and more anxiety (OR = 0.36, p < 0.05). Patients reporting unmet needs for help more often lived alone (OR = 0.40, p < 0.05) and were more often depressed (OR = 0.31, p < 0.05).ConclusionSimilar levels of met and unmet needs for training and help at 3 months after stroke were reported despite differences in the organization of the rehabilitation services. Functioning and psychological factors were associated with unmet rehabilitation needs.LAY ABSTRACTThe aim of this study was to examine patient-reported needs for care and rehabilitation among selected patients with stroke in Norway and Denmark. A total of 318 Norwegian and 155 Danish patients with first-ever stroke were included. Participants answered the following 2 questions from the Norwegian Stroke Registry: Have you received enough help after the stroke? Have you received as much training as you wanted after the stroke? The term “training” in this context was used for all rehabilitative therapy offered by physio-, occupational or speech therapists. The term «help» was used for care and support in daily activities provided by nurses or health assistants. Levels of anxiety and depression were investigated. With regard to training needs, 15% of all participants reported unmet needs, 52% reported that their needs had been met, and 33% reported that they had no need for training. Regarding the need for help, 10%, 58% and 31% reported unmet needs, that needs had been met, and that they had no need for care, respectively. Participants in the 2 countries had similar patterns of unmet/met needs for help or training. Unmet need for training was associated with low function and anxiety. Patients reporting an unmet need for help more often lived alone and were more often depressed. There was no difference in met or unmet needs between Norwegian and Danish participants.Different rehabilitative follow-up after stroke did not affect levels of met and unmet rehabilitation needs. Health services should pay special attention to patients at risk, including those who are anxious or depressed, live alone or have functional deficits after stroke.Key words: stroke, rehabilitation, unmet needs, rehabilitation pathways

Stroke is a major cause of death, with an increasing number of patients affected worldwide (1). Stroke survivors often have varying degrees of physical, psychosocial and cognitive disabilities, which may substantially affect their functional ability in daily and working life (2). Treatment offered by specialized stroke units (3), inpatient multidisciplinary rehabilitation teams (4) and community-based rehabilitation services adapted to patients’ home environment (5) are key elements to successful rehabilitation. At all intervention levels, the identification of patients’ individual needs is crucial for the optimization of rehabilitation outcomes. The definition of a need is, however, not unambiguous (6). A pragmatic approach is to adopt the most commonly used definition of healthcare needs and define rehabilitation needs as the needs that can be fulfilled by rehabilitation interventions and services (7). From the patient’s perspective, a need represents the perception of a situation in which help or support is desired. If adequate help is not offered, the provision of services does not fit the needs, gaps occur and needs become unmet (8).A perceived need for therapy, comprehensive care, pscyhological support or information are examples of commonly reported unmet needs post-stroke (9).Unmet rehabilitation needs may persist for years after stroke (10). According to a UK study, they are more often reported by people with disabilities, those belonging to ethnic minorities, and those living in the most deprived areas (10). According to a recent systematic review of 19 studies, mostly cross-sectional in design, 74% of stroke survivors experienced at least one unmet need. The studies revealed heterogeneous levels of unmet needs, ranging between 5% and 40% for care and between 2% and 36% for therapy (9). In most studies, unmet needs were assessed by using different multi-item questionnaires, such as the Longer-term Unmet Need after Stroke (11) and the Greater Manchester Stroke Assessment Tool (12), or by the self-report of long-term needs after stroke (10).In a Swedish registry study evaluating perceived unmet or partly met rehabilitation needs with a single question, 21.5% of patients reported unmet needs one year after stroke. Important underpinning factors were older age, dependency on others, pain and depressive/ affective symptoms (13).Rehabilitation practices are formulated and enacted in a cultural and historical context aligned to the development of healthcare services (14). Specialized stroke rehabilitation is integrated in the public healthcare systems in Nordic countries (15), but, whereas the Norwegian study region mainly emphasizes inpatient rehabilitation, the Danish region has developed an additional and more specialized, community-based rehabilitation programme (16). Although some studies have reported different rehabilitation pathways in the early subacute phase of stroke (17), no previous studies have, to our knowledge, compared unmet needs post stroke in participants with different subacute rehabilitation pathways.The primary aim of this study was to examine patient-reported needs for healthcare and rehabilitation services in a cohort with different rehabilitation pathways recruited from 2 Nordic country-regions. Secondary aims were to assess to what extent these needs were met or unmet 3 months post stroke and to explore factors associated with met and unmet needs.     

Relationship between saliva and plasma rufinamide concentrations in patients with epilepsy

The assay of saliva samples provides a valuable alternative to the use of blood samples for therapeutic drug monitoring (TDM), at least for certain categories of patients. To determine the feasibility of using saliva sampling for the TDM of rufinamide, we compared rufinamide concentrations in paired samples of saliva and plasma collected from 26 patients with epilepsy at steady state. Within-patient relationships between plasma rufinamide concentrations and dose, and the influence of comedication were also investigated. Assay results in the two tested fluids showed a good correlation (r² = .78, P < .0001), but concentrations in saliva were moderately lower than those in plasma (mean saliva to plasma ratio = 0.7 ± 0.2). In eight patients evaluated at three different dose levels, plasma rufinamide concentrations increased linearly with increasing dose. Patients receiving valproic acid comedication had higher dose-normalized plasma rufinamide levels than patients comedicated with drugs devoid of strong enzyme-inducing or enzyme-inhibiting activity. Overall, these findings indicate that use of saliva represents a feasible option for the application of TDM in patients treated with rufinamide. Because rufinamide concentrations are lower in saliva than in plasma, a correction factor is needed if measurements made in saliva are used as a surrogate for plasma concentrations.     

A national study on conditional survival,excess mortality and second cancer after high dose therapy with autologous stem cell transplantation for non‐Hodgkin lymphoma

This national population‐based study aimed to investigate conditional survival and standardized mortality ratios (SMR) after high‐dose therapy with autologous stem‐cell transplantation (HDT‐ASCT) for non‐Hodgkin lymphoma (NHL), and to analyse cause of death, relapses and second malignancies. All patients ≥18 years treated with HDT‐ASCT for NHL in Norway between 1987 and 2008 were included (n = 578). Information from the Cause of Death Registry and Cancer Registry of Norway were linked with clinical data. The 5‐, 10‐ and 20‐year overall survival was 61% (95% confidence interval [CI] 56–64%), 52% (95%CI 48–56%) and 45% (95%CI 40–50%), respectively. The 5‐year survival conditional on having survived 2, 5 and 10 years after HDT‐ASCT was 81%, 86% and 93%. SMRs were 12·3 (95%CI 11·0–13·9), 4·9 (95%CI 4·1–5·9), 2·4 (95%CI 1·8–3·2) and 1·0 (95%CI 0·6–1·8) for the entire cohort and for patients having survived 2, 5 and 10 years after HDT‐ASCT respectively. Of the 281 deaths observed, 77% were relapse‐related. Treatment‐related mortality was 3·6%. The 10‐year cumulative incidence of second malignancies was 7·9% and standardized incidence ratio was 2·0 (95%CI 1·5–2·6). NHL patients treated with HDT‐ASCT were at increased risk of second cancer and premature death. The mortality was still elevated at 5 years, but after 10 years mortality equalled that of the general population.     

Testing the right target and right drug at the right stage

Alzheimer's disease (AD) is the only leading cause of death for which no disease-modifying therapy is currently available. Recent disappointing trial results at the dementia stage of AD have raised multiple questions about our current approaches to the development of disease-modifying agents. Converging evidence suggests that the pathophysiological process of AD begins many years before the onset of dementia. So why do we keep testing drugs aimed at the initial stages of the disease process in patients at the end-stage of the illness?