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Background
The business of clinical research has changed in the past two decades, shifting from industrialised Western countries to so-called emerging markets such as Eastern Europe, Latin America and Africa. An appraisal of the trends could identify associated factors that may have implications for the local populations and their endemic diseases.
Objectives
To identify potential reasons why emerging countries have become attractive places for international sponsors to conduct their clinical trials.
Methods
Using ClinicalTrials.gov, the Pan African Clinical Trials Registry, the National Health Research Database and the Nigeria Clinical Trials Registry, trend data on clinical research development were determined for two emerging African markets, Nigeria and South Africa (SA), from 2010 to 2018. Also, health data on the two countries from the fact sheets of health statistics of the World Health Organization were compared, as well as regulatory and ethical conditions. Available data were analysed using descriptive statistics and trend analysis.
Results
The impact of globalisation is evident from the upward trend in clinical trials in SA before 2010, and the clear downward trend thereafter. One reason for this change could be the alignment of SA’s regulatory and ethical frameworks with the Western world. In contrast,
the upward trend is only just beginning in Nigeria, with the introduction of ethical/regulatory frameworks, and supportive institutions making the business of clinical research more attractive on an international level. Although the number of international and local sponsors increased in Nigeria from 2010 to 2018, only the latter increased in SA, with the former decreasing over the same period. Overall, there is a mismatch between country-specific diseases and the drugs being tested, to the extent that leprosy, which is endemic in Nigeria, and tuberculosis in SA were not in the list of top 10 study areas in either country.
Conclusions
The globalisation trend is evident in the clinical trials business, but cannot be generalised to all emerging countries. Timing and intensity vary from country to country relative to factors that advance the existing profit-orientated business models of the sponsors. Furthermore, various diseases have been localised, which entails a diversely increasing need for research.
Objectives:
The aim was to identify theoretically expected as well as actually reported benefits from drug development and the importance of individual patient benefits compared to the collective benefits to society in general.
Background:
Ethical guidelines require that clinical research involving humans offer the potential for benefit. A number of characteristics can be applied to define research benefit. Often benefit is categorized as being either direct or indirect. Indirect benefits can involve collective benefits for society rather than any benefits to the trial patient or subject. The purpose of this review was to examine which potential individual and societal benefits were mentioned as being expected in publications from government experts and which were mentioned in publications describing completed drug development trial results.
Methods:
Literature on research benefit was first identified by searching the PubMed database using several combinations of the key words benefit and clinical research. The search was limited to articles published in English. A Google search with the same combinations of key words but without any language limitation was then performed. Additionally, the reference lists of promising articles were screened for further thematically related articles. Finally, a narrative review was performed of relevant English- and German-language articles published between 1996 and 2016 to identify which of several potential benefits were either theoretically expected or which were mentioned in publications on clinical drug development trial results.
Results:
The principal benefits from drug development discussed included 2 main types of benefit, namely individual benefits for the patients and collective benefits for society. Twenty-one of an overall total of 26 articles discussing theoretically expected benefits focused on individual patient benefits, whereas 17 out of 26 articles mentioned collective benefits to society. In these publications, the most commonly mentioned theoretically expected individual patient benefit was the chance to receive up-to-date care (38.1%). A general increase in knowledge about health care, treatments, or drugs (70.6%) was the most commonly mentioned theoretically expected benefit for society. In contrast, all 13 publications reporting actual benefits of clinical drug development trials focused on personal benefits and only 1 of these publications also mentioned a societal benefit. The most commonly mentioned individual benefit was an increased quality of life (53.9%), whereas the only mentioned collective benefit to society was a general gain of knowledge (100.0%).
Conclusions:
Both theoretically expected and actually reported benefits in the majority of the included publications emphasized the importance of individual patient benefits from drug development rather than the collective benefits to society in general. The authors of these publications emphasized the right of each individual patient or subject to look for and expect some personal benefit from participating in a clinical trial rather than considering societal benefit as a top priority. From an ethical point of view, the benefits each individual patient receives from his or her participation in a clinical trial might also be seen as a societal benefit, especially when the drug or device tested, if approved for marketing, would eventually be made available for other similar patients from the country in which the clinical trial was conducted.
Objectives
Quality of care largely depends on successful teamwork, which in turn needs effective communication between health professionals. To communicate successfully in a team, health professionals need to strive for the same goals. However, it has been left largely unaddressed which goals professionals consider to be important. In this study, we aim to identify these goals and analyse whether differences between (1) personal and organisational goals, (2) different professions and (3) hierarchical levels exist in neonatal intensive care units (NICUs).
Design
Goals were identified based on a literature review and a workshop with health professionals and tested in a pilot study. Subsequently, in the main study, a cross-sectional employee survey was undertaken.
Setting and participants
1489 nurses and 537 physicians from 66 German NICUs completed the
questionnaire regarding personal and organisational goal importance between May and July 2013. Answers were given based on a 7-point Likert scale varying between none and exceptionally high importance.
Results
Results show that the goals can be subdivided into three main goal dimensions: patients, parents and staff. Furthermore, our results reveal significant differences between different professions and different hierarchical level: physicians rated patient goals with a
mean (95% CI) importance of 6.37 (3.32 to 6.43), which is significantly higher than nurses with a mean (95% CI) importance of 6.15 (6.12 to 6.19) (p<0.01). Otherwise, nurses classified parental goals as more important (p<0.01). Furthermore, professionals in leading positions rate patient goals significantly higher than professionals that are not in leading positions (6.36 (3.28 to 6.44) vs 6.19 (6.15 to 6.22), p<0.01).
Conclusions
Different employee goals need to be considered in decision-making
processes to enhance employee motivation and the effectiveness of teamwork.
Wearable sensors in healthcare and sensor-enhanced health information systems: all our tomorrows?
(2012)
Wearable sensor systems which allow for remote or self-monitoring of health-related parameters are regarded as one means to alleviate the consequences of demographic change. This paper aims to summarize current research in wearable sensors as well as in sensor-enhanced health information systems. Wearable sensor technologies are already advanced in terms of their technical capabilities and are frequently used for cardio-vascular monitoring. Epidemiologic predictions suggest that neuro-psychiatric diseases will have a growing impact on our health systems and thus should be addressed more intensively. Two current project examples demonstrate the benefit of wearable sensor technologies: long-term, objective measurement under daily-life, unsupervised conditions. Finally, up-to-date approaches for the implementation of sensor-enhanced health information systems are outlined. Wearable sensors are an integral part of future pervasive, ubiquitous and person-centered health
care delivery. Future challenges include their integration into sensor-enhanced health information systems and sound evaluation studies involving measures of workload reduction and costs.
Background: Depletion of ovarian hormone in postmenopausal women has been associated with changes in the locomotor apparatus that may compromise walking function including muscle atrophy/weakness, weight gain, and bone demineralization. Therefore, handgrip strength (HGS), bone mineral density (BMD) and body composition [percentage body fat mass (%BFM), fat mass (FM), Fat-free mass (FFM) and body mass index (BMI)], may significantly vary and predict WB in postmenopausal women. Consequently, the study sought to 1. Explore body composition, BMD and muscle strength differences between premenopausal and postmenopausal women and 2. Explore how these variables [I.e., body composition, BMD and muscle strength] relate to WB in postmenopausal women.
Method: Fifty-one pre-menopausal (35.74 + 1.52) and 50 postmenopausal (53.32 + 2.28) women were selected by convenience sampling and studied. Six explanatory variables (HGS, BMD, %BFM, FFM, BMI and FM) were explored to predict WB in postmenopausal women: Data collected were analyzed using multiple linear regression, ANCOVA, independent t-test and Pearson correlation coefficient at p < 0.05.
Result: Postmenopausal women had higher BMI(t = + 1.72; p = 0.04), %BFM(t = + 2.77; p = .003), FM(t = + 1.77; p = 0.04) and lower HGS(t = − 3.05; p = 0.001),compared to the premenopausal women. The predicted main effect of age on HGS was not significant, F(1, 197) = 0.03, p = 0.06, likewise the interaction between age and %BFM, F(1, 197) = 0.02, p = 0.89; unlike the predicted main effect of %BFM, F(1, 197) = 10.34, p = .002, on HGS. HGS was the highest predictor of WB (t = 2.203; β=0.3046) in postmenopausal women and combined with T-score right big toe (Tscorert) to produce R2 = 0.11;F (2, 47)=4.11;p = 0.02 as the best fit for the predictive model. The variance (R2) change was significant from HGS model (R2 = 0.09;p = 0.03) to HGS + Tscorert model (R2 = 0.11;p = 0.02). The regression model equation was therefore given as: WB =5.4805 + 0.1578(HGS) + (− 1.3532) Tscorert.
Conclusion: There are differences in body composition suggesting re-compartmentalization of the body, which may adversely impact the (HGS) muscle strength in postmenopausal women. Muscle strength and BMD areassociated with WB, although, only contribute to a marginal amount of the variance for WB. Therefore, other factors in addition to musculoskeletal health are necessary to mitigate fall risk in postmenopausal women.
This study investigates the influence of traumatic events on the mental health of North Korean refugee women by examining the prevalence and severity of posttraumatic stress disorder (PTSD), depression, and anxiety in comparison with their male counterparts (women = 496; men = 131). Our results suggest that women are at greater risk of developing mental health problems than men. In particular, symptoms of PTSD and anxiety were higher among women who experienced forced repatriation to North Korea, which is operationalized as a constellation of gendered traumatic incidents such as sexual abuse, rape, witnessing infanticides, and forced abortion. The policy implications of our results and suggestions for future studies are discussed.
The use of vibrational sum-frequency spectroscopy (VSFS) to study transferred graphene, produced by chemical vapour deposition, is presented. The VSF spectrum shows a clear CeH stretching mode at ~2924 cm⁻¹, which is attributed to residue of the polymer used for the transfer. This makes VSFS a powerful tool to identify adsorbates and contaminants affecting the properties of graphene.
We report velocity-dependent internal energy distributions of nitric oxide molecules, NO, scattered off graphene supported on gold to further explore the dynamics of the collision process between NO radicals and graphene. These experiments were performed by directing a molecular beam of NO onto graphene in a surface-velocity map imaging setup, which allowed us to record internal energy distributions of the NO radicals as a function of their velocity. We do not observe bond formation but (1) major contributions from direct inelastic scattering and (2) a smaller trapping–desorption component where some physisorbed NO molecules have residence times on the order of microseconds. This is in agreement with our classical molecular dynamics simulations which also observe a small proportion of two- and multi-bounce collisions events but likewise a small proportion of NO radicals trapped at the surface for the entire length of the molecular dynamics simulations (a few picoseconds). Despite a collision energy of 0.31 eV, which would be sufficient to populate NO(v = 1), we do not detect vibrationally excited nitric oxide.
Worldwide, seagrass meadows are under threat. Consequently, there is a strong need for seagrass restoration to guarantee the provision of related ecosystem services such as nutrient cycling, carbon sequestration and habitat provision. Seagrass often grows in vast meadows in which the presence of seagrass itself leads to a reduction of hydrodynamic energy. By modifying the environment, seagrass thus serves as foundation species and ecosystem engineer improving habitat quality for itself and other species as well as positively affecting its own fitness. On the downside, this positive feedback mechanism can render natural recovery of vanished and destroyed seagrass meadows impossible. An innovative approach to promote positive feedback mechanisms in seagrass restoration is to create an artificial seagrass (ASG) that mimics the facilitation function of natural seagrass. ASG could provide a window of opportunity with respect to suitable hydrodynamic and light conditions as well as sediment stabilization to allow natural seagrass to re-establish. Here, we give an overview of challenges and open questions for the application of ASG to promote seagrass restoration based on experimental studies and restoration trials and we propose a general approach for the design of an ASG produced from biodegradable materials. Considering positive feedback mechanisms is crucial to support restoration attempts. ASG provides promising benefits when habitat conditions are too harsh for seagrass meadows to re-establish themselves.
For the introduction of technical nursing care innovations, a usability assessment survey is conducted by nursing staff. The questionnaire is used before and after the introduction of technical products. This poster contribution shows the latest comparison of pre- and post-surveys on selected products.