Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. © 2019 GlaxoSmithKline Biologicals SA

Introduction: Residual pump blood from the cardiopulmonary bypass (CPB) circuit is often collected into an infusion bag (IB) and re-transfused. An alternative is to chase the residual blood into the circulation through the arterial cannula with Ringer's acetate. Our aim was to assess possible differences in hemostatic blood quality between these two techniques. Methods: Forty adult patients undergoing elective coronary artery bypass graft surgery with CPB were randomized to receive the residual pump blood by either an IB or through the Ringer's chase (RC) technique. Platelet activation and function (impedance aggregometry), coagulation and hemolysis variables were assessed in the re-transfused blood and in the patients before, during and after surgery. Results are presented as median (25-75 quartiles). Results: Total hemoglobin and platelet levels in the re-transfused blood were comparable with the two methods, as were soluble platelet activation markers P-selectin and soluble glycoprotein VI (GPVI). Platelet aggregation (U) in the IB blood was significantly lower compared to the RC blood, with the agonists adenosine diphosphate (ADP) 24 (10-32) vs 46 (33-65), p<0.01, thrombin receptor activating peptide (TRAP) 50 (29-73) vs 69 (51-92), p=0.04 and collagen 24 (17-28) vs 34 (26-59), p<0.01. The IB blood had higher amounts of free hemoglobin (mg/L) (1086 (891-1717) vs 591(517-646), p<0.01) and D-dimer 0.60 (0.33-0.98) vs 0.3 (0.3-0.48), p<0.01. Other coagulation variables showed no difference between the groups. Conclusions: The handling of blood after CPB increases hemolysis, impairs platelet function and activates coagulation and fibrinolysis. The RC technique preserved the blood better than the commonly used IB technique.

Purpose Research indicates that health-oriented applications on mobile units such as smartphones and PDAs, so called mHealth applications, can be useful to support older persons with cognitive impairment and their informal caregivers1. However, several studies suggest that a prerequisite for older persons to start using computer-based technology is that it offers individual customization according to personal preference 2,3,4. In the ongoing Horizon 2020 project SMART4MD (Support, Monitoring And Reminder Technology for older persons with Mild Dementia), an health-oriented model app has been developed through a user-centered process involving stakeholders in six European countries and with an emphasis on customization to allow for the various needs of older persons with cognitive impairment and their informal caregivers. The aim of this study is to gain insights about the specific needs of the target group and success factors related to the user-centered design process. Method Within the frames of the SMART4MD project, an initial Feasibility study was conducted in two countries (Spain and Sweden) simultaneously, in which in total nineteen persons with cognitive impairment aged 66-93, and their respective informal caregivers, performed a taskbased usability test of the SMART4MD model app individually in a clinical setting, followed by a four-week testing of the app in their home environment. Finally, a usability evaluation was done through individual structured interviews. Results & Discussion The result indicates that less exposure to similar technology affects both ability and self-esteem when confronted with the model app, and that evaluating usability with the target group using standard forms within usability testing requires pre-cautions. © 2018 International Society for Gerontechnology.

Background: The voices of those who have grown up in a family with maternal intellectual or developmental disability (IDD) are valuable for gaining an understanding of their situation, which is essential in order to be able to support these families and avoid potentially detrimental situations. Aim: The study aim was to describe the experience of having grown up in a family where the mother has an IDD, with a focus on everyday life and perceived health consequences in adult life. Method: A qualitative method with retrospective narrative interviews and narrative content analysis was chosen. In-depth interviews were performed with four women who had experiences of a childhood with maternal IDD. Findings: Four themes emerged: Living under adverse circumstances; Dealing with one’s everyday life situation; Receiving insufficient support and wishing for more; and The echo from childhood into adult life. The findings revealed a distressing childhood, characterized by neglect, abuse, anxiety, and overburdening responsibilities, and also endeavors to keep the family situation a secret, while at the same time wanting the adult world to react. Discussion: The findings can hopefully stimulate occupational therapists and other professionals to more effectively identify the situation of these children and provide support to prevent adverse future health conditions and poor well-being. © 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Aim: The aim of this study was to investigate child health-care coordinators’ experiences of being a facilitator for the implementation of a new national child health-care programme in the form of a web-based national guide. Methods: The study was based on eight remote, online focus groups, using Skype for Business. A qualitative content analysis was performed. Results: The analysis generated three categories: adapt to a local context, transition challenges and led by strong incentives. There were eight subcategories. In the latent analysis, the theme ‘Being a facilitator: a complex role’ was formed to express the child health-care coordinators’ experiences. Conclusions: Facilitating a national guideline or decision support in a local context is a complex task that requires an advocating and mediating role. For successful implementation, guidelines and decision support, such as a web-based guide and the new child health-care programme, must match professional consensus and needs and be seen as relevant by all. Participation in the development and a strong bottom-up approach was important, making the web-based guide and the programme relevant to whom it is intended to serve, and for successful implementation. The study contributes valuable knowledge when planning to implement a national web-based decision support and policy programme in a local health-care context. © 2018, © Author(s) 2018.

Aim: To determine whether having periodontitis is associated with cognitive decline among older adults. Material and Methods: A prospective population study of older adults, Swedish National Study on Ageing and Care, (SNAC) provided repeated registrations of cognitive functions. Cognitive decline was defined as ≥3-points deterioration from a predetermined level at baseline, using the Mini-Mental State Examination (MMSE). Between 2001 and 2003, 715 individuals had a medical as well as a clinical and radiographic dental examination. The individuals were re-examined after 6 years. Periodontitis was defined as ≥4 mm bone loss at ≥30% of tooth sites. Social variables were captured from questionnaires. Results: The multivariate logistic regression analysis demonstrated a statistically significant association between prevalence of periodontitis and cognitive decline after adjustments of confounding factors of importance. Conclusions: A history of periodontitis may be of importance for cognitive functions among older adults. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Background:

Several models suggest how the qualities of a product or service influence user satisfaction. Models, such as the Customer Satisfaction Index (CSI), Technology Acceptance Model (TAM), and Delone and McLean Information Systems Success (D&M IS), demonstrate those relations and have been used in the context of health information systems.

Objective:

We want to investigate which qualities foster greater satisfaction among patient and professional users. In addition, we are interested in knowing to what extent improvement in those qualities can explain user satisfaction and if this makes user satisfaction a proxy indicator of those qualities.

Methods:

The Unified eValuation using ONtology (UVON) method was utilised to construct an ontology of the required qualities for seven e-health applications being developed in the FI-STAR project, a European Union (EU) project in e-health. The e-health applications were deployed across seven EU countries. The ontology included and unified the required qualities of those systems together with the aspects suggested by the Model for ASsessment of Telemedicine applications (MAST) evaluation framework. Two similar questionnaires, for 87 patient users and 31 health professional users, were elicited from the ontology. In the questionnaires, user was asked if the system has improved the specified qualities and if the user was satisfied with the system. The results were analysed using Kendall correlation coefficients matrices, incorporating the quality and satisfaction aspects. For the next step, two Partial Least Squares Structural Equation Modelling (PLS-SEM) path models were developed using the quality and satisfaction measure variables and the latent construct variables that were suggested by the UVON method.

Results:

Most of the quality aspects grouped by the UVON method are highly correlated. Strong correlations in each group suggest that the grouped qualities can be measures which reflect a latent quality construct. The PLS-SEM path analysis for the patients reveals that the effectiveness, safety, and efficiency of treatment provided by the system are the most influential qualities in achieving and predicting user satisfaction. For the professional users, effectiveness and affordability are the most influential. The parameters of the PLS-SEM that are calculated allow for the measurement of a user satisfaction index similar to CSI for similar health information systems.

Conclusions:

For both patients and professionals, the effectiveness of systems highly contributes to their satisfaction. Patients care about improvements in safety and efficiency, while professionals care about improvements in the affordability of treatments with health information systems. User satisfaction is reflected more in the users' evaluation of system output and fulfilment of expectations, but slightly less in how far the system is from ideal. Investigating satisfaction scores can be a simple, fast way to infer if the system has improved the abovementioned qualities in treatment and care.

Objective: This study aims to evaluate the potential association between periodontitis, the number of teeth and cognitive functions in a cohort of older adults in Sweden. Material and methods: In total, 775 individuals from 60 to 99 years of age were selected for the study. A clinical and radiographic examination was performed. The number of teeth and prevalence of periodontal pockets and bone loss was calculated and categorised. Cognitive functions were assessed using the Mini-Mental State Examination (MMSE) and clock test. The education level was obtained from a questionnaire. Data were analysed using chi-square tests and multivariate logistic regression. Results: Age and gender were associated with the prevalence of bone loss. Age and education were associated with lower number of teeth. Gender was also associated with the presence of pockets. The multivariate logistic regression analysis demonstrated a statistically significant association between prevalence of bone loss, the number of teeth and the outcome on MMSE test. This association remained even after adjustment for age, education and gender. Tooth loss was also associated with lower outcome on clock test. Presence of periodontal pockets ≥ 5 mm was not associated with cognitive test outcome. Conclusions: A history of periodontitis and tooth loss may be of importance for cognitive functions among older adults. Clinical relevance: Diseases with and inflammatory profile may have an impact on cognitive decline. © 2017 Springer-Verlag GmbH Germany, part of Springer Nature

Background: Many studies reported effectiveness of mhealth interventions targeting middle aged and older adults to improve healthcare delivery process, efficacy and management of chronic diseases. However, the knowledge about their cost-effectiveness is important to implement mhealth interventions at large scale for proper allocation of scarce resources. This systematic review will summarize the results from identified studies for the cost effectiveness of mhealth interventions aimed for middle aged and older adults.

Method: mhealth interventions aimed to improve healthcare delivery process, efficacy and delivering training will be included in this systematic review. A comprehensive electronic search strategy will be used to identify health economic evaluations, published since 2007, and indexed in Pubmed, Scopus and CINAHL. The search strategy will include terms (and synonyms) for the following mhealth devices: mobile phone, smartphone, mhealth. Middle aged and older adults will be used to identify all mhealth interventions introduced to middle aged and older adults. Terms such as economic evaluation, cost effectiveness, cost utility etc will be used to identify economic evaluations of all mhealth interventions.

Discussion: This systematic review will report evidence on cost effectiveness of mhealth interventions targeting middle aged and older adults.