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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.
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.
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.
Type 2 Diabetes Mellitus: Risk Evaluation and Advice in Undergraduate Students in Ashrafieh, Lebanon
(2016)
Type 2 diabetes mellitus (T2DM) is a chronic lifestyle disease. It has become evident that T2DM occurs even among the younger age groups.1 In Lebanon, T2DM has a major public health impact through high disease prevalence, significant downstream pathophysiologic effects, and enormous financial liabilities.2
Introduction
Atopic dermatitis (AD) is a common inflammatory skin disease. Many patients are initiating a systemic therapy, if the disease is not adequately controlled with topical treatment only. Currently, there is little real-world evidence on the AD-related medical care situation in Germany. This study analyzed patient characteristics, treatment patterns, healthcare resource utilization and costs associated with systemically treated AD for the German healthcare system.
Methods
In this descriptive, retrospective cohort study, aggregated anonymized German health claims data from the InGef research database were used. Within a representative sample of four million insured individuals, patients with AD and systemic drug therapy initiation (SDTI) in the index year 2017 were identified and included into the study cohort. Systemic drug therapy included dupilumab, systemic corticosteroids (SCS) and systemic immunosuppressants (SIS). Patients were observed for one year starting from the date of SDTI in 2017.
Results
9975 patients were included (57.8% female, mean age 39.6 years [SD 25.5]). In the one-year observation period, the most common systemic drug therapy was SCS (> 99.0%). Administrations of dupilumab (0.3%) or dispensations of SIS were rare (cyclosporine: 0.5%, azathioprine: 0.6%, methotrexate: 0.1%). Median treatment duration of SCS, cyclosporine and azathioprine was 27 days, 102 days, and 109 days, respectively. 2.8% of the patients received phototherapy; 41.6% used topical corticosteroids and/or topical calcineurin inhibitor. Average annual costs for medications amounted to € 1237 per patient. Outpatient services were used by 99.6% with associated mean annual costs of € 943; 25.4% had at least one hospitalization (mean annual costs: € 5836). 5.3% of adult patients received sickness benefits with associated mean annual costs of € 5026.
Conclusions
Despite unfavorable risk–benefit profile, this study demonstrated a common treatment with SCS, whereas other systemic drug therapy options were rarely used. Furthermore, the results suggest a substantial economic burden for patients with AD and SDTI.
Background: One of the major challenges in pediatric intensive care is the detection of life-threatening health conditions under acute time constraints and performance pressure. This includes the assessment of pediatric organ dysfunction (OD) that demands extraordinary clinical expertise and the clinician’s ability to derive a decision based on multiple information and data sources. Clinical decision support systems (CDSS) offer a solution to support medical staff in stressful routine work. Simultaneously, detection of OD by using computerized decision support approaches has been scarcely investigated, especially not in pediatrics.
Objectives: The aim of the study is to enhance an existing, interoperable, and rulebased CDSS prototype for tracing the progression of sepsis in critically ill children by augmenting it with the capability to detect SIRS/sepsis-associated hematologic OD, and to determine its diagnostic accuracy.
Methods: We reproduced an interoperable CDSS approach previously introduced by our working group: (1) a knowledge model was designed by following the commonKADS methodology, (2) routine care data was semantically standardized and harmonized using openEHR as clinical information standard, (3) rules were formulated and implemented in a business rule management system. Data from a prospective diagnostic study, including 168 patients, was used to estimate the diagnostic accuracy of the rule-based CDSS using the clinicians’ diagnoses as reference
Objectives: Injury to major white matter pathways during language-area associated glioma surgery often leads to permanent loss of neurological function. The aim was to establish standardized tractography of language pathways as a predictor of language outcome in clinical neurosurgery.
Methods: We prospectively analyzed 50 surgical cases of patients with left perisylvian, diffuse gliomas. Standardized preoperative Diffusion-Tensor-Imaging (DTI)-based tractography of the 5 main language tracts (Arcuate Fasciculus [AF], Frontal Aslant Tract [FAT], Inferior Fronto-Occipital Fasciculus [IFOF], Inferior Longitudinal Fasciculus [ILF], Uncinate Fasciculus [UF]) and spatial analysis of tumor and tracts was performed. Postoperative imaging and the resulting resection map were analyzed for potential surgical injury of tracts. The language status was assessed preoperatively, postoperatively and after 3 months using the Aachen Aphasia Test and Berlin Aphasia Score. Correlation analyses, two-step cluster analysis and binary logistic regression were used to analyze associations of tractography results with language outcome after surgery.
Results: In 14 out of 50 patients (28%), new aphasic symptoms were detected 3 months after surgery. The preoperative infiltration of the AF was associated with functional worsening (cc = 0.314; p = 0.019). Cluster analysis of tract injury profiles revealed two areas particularly related to aphasia: the temporo-parieto-occipital junction (TPO; temporo-parietal AF, middle IFOF, middle ILF) and the temporal stem/peri-insular white matter (middle IFOF, anterior ILF, temporal UF, temporal AF). Injury to these areas (TPO: OR: 23.04; CI: 4.11 – 129.06; temporal stem: OR: 21.96; CI: 2.93 – 164.41) was associated with a higher-risk of persisting aphasia.
Conclusions: Tractography of language pathways can help to determine the individual aphasia risk profile presurgically. The TPO and temporal stem/peri-insular white matter were confirmed as functional nodes particularly sensitive to surgical injuries.
Appropriate data models are essential for the systematic collection, aggregation, and integration of health data and for subsequent analysis. However, recommendations for modeling health data are often not publicly available within specific projects. Therefore, the project Zukunftslabor Gesundheit investigates recommendations for modeling. Expert interviews with five experts were conducted and analyzed using qualitative content analysis. Based on the condensed categories “governance”, “modeling” and “standards”, the project team generated eight hypotheses for recommendations on health data modeling. In addition, relevant framework conditions such as different roles, international cooperation, education/training and political influence were identified. Although emerging from interviewing a small convenience sample of experts, the results help to plan more extensive data collections and to create recommendations for health data modeling.