Ways of integrating eating into everyday lives - a qualitative study in Germany.

BACKGROUND: Food-related behaviour is a very complex topic. A common way to reduce complex issues to their essential content is to create a typology. In Germany, with regard to food-related behaviour, the creation of a typology has often been carried out by commercial research institutes, but also by (international) scientific institutes. The former have mostly used quantitative methods, the latter usually have a specific content focus. Within this study, we want to investigate how people integrate eating into their everyday lives while engaging with themselves and the environment, thereby living out personality development and related socialisation. METHODS: 37 qualitative interviews were conducted and evaluated by means of content-structuring qualitative analysis and type-forming qualitative content analysis. Interviewees were recruited via recruitment calls using different channels, such as newspapers or university e-mail lists. Participants over the age of seventeen were eligible to take part in the study. Both the individual action processes and the interpretation processes regarding food-related behaviour were taken into account. The final sample consisted of 20 male and 18 female participants with an age range from 18 to 83. RESULTS: The result were seven eating action types, namely: Eating as a way of life, The Relaxed, Eating as self-determination, Eating as a necessary Evil, The Adaptive, The Overstrained and The Controlled. CONCLUSIONS: We contribute to the study of food-related behaviour with the chosen qualitative method of type-building and by looking at how people integrate eating into their everyday lives. This contributes to a broader understanding of this phenomenon and complements the findings of existing commercial and academic food-related typing-building activities. Specifically, through identifying "The Overstrained" as a novel eating action type, this study adds to the literature in the field and may be a useful baseline for future research.

Neonatal blood pressure by birth weight, gestational age, and postnatal age: a systematic review.

BACKGROUND: Blood pressure is a vital hemodynamic marker during the neonatal period. However, normative values are often derived from small observational studies. Understanding the normative range would help to identify ideal thresholds for intervention to treat hypotension or hypertension. Therefore, the aim of this study was to assess observed blood pressure values in neonates who have not received any blood-pressure modifying treatments from birth to three months postnatal age and whether these vary according to birth weight, gestational age and postnatal age. METHODS: This was a systematic review. A literature search was conducted in MEDLINE, PubMed, Embase, Cochrane Library, and CINAHL from 1946 to 2017 on blood pressure in neonates from birth to 3 months of age (PROSPERO ID CRD42018092886). Unpublished data were included where appropriate. RESULTS: Of 3,587 non-duplicate publications identified, 30 were included (one unpublished study). Twelve studies contained data grouped by birth weight, while 23 contained data grouped by gestational age. Study and clinical heterogeneity precluded meta-analyses thus results are presented by subgroup. A consistent blood pressure rise was associated with increasing birth weight, gestational age, and postnatal age. In addition, blood pressure seemed to rise more rapidly in the most preterm and low birth weight neonates. CONCLUSION: Despite blood pressure increasing with birth weight, gestational age, and postnatal age, there was marked blood pressure variability observed throughout. To better define hypotension and hypertension, future studies should develop consistent approaches for factors related to blood pressure variability, including the method and timing of measurement as well as statistical control of relevant patient characteristics.

Factors influencing the use of natural health products, in particular for concentration and cognition in Germany.

BACKGROUND: Natural health products (NHP) are an important part of the healthcare system. They are mainly non-prescription and sold over the counter, which requires active decision making by the consumer. Within the framework of the Complementary and Alternative Healthcare Model, this study aims to identify factors that influence NHP usage, in particular related to concentration and cognition (CC), a topic that concerns all ages and social classes within the population. METHODS: Data were collected by means of a representative online survey (n = 1,707) in Germany in April 2022. Three user groups were defined: NHPCC users, who used NHP for CC (12 month prevalence); nCC-NHP users, who used NHP but not for CC indications (12 month prevalence); and past NHP users, who have used NHP but not within the previous 12 months. Independent influencing variables were categorized into predisposing, enabling, need, and health service use factors. Data were analyzed with descriptive statistics, inferential statistics, and binary logistic regression models to compare NHPCC users to nCC-NHP users (model 1) and to past NHP users (model 2). RESULTS: A higher share of NHPCC and nCC-NHP users compared to past NHP users were women, self-medicated with NHP, and used information about NHP provided by health professionals or on product. Their openness-to-change value orientation was more pronounced than of past users. Compared to nCC-NHP and past NHP users, the probability of being an NHPCC user increased if an individual had more difficulties in daily attention and memory performance, made use of health professionals and literature to seek information about NHP, and used NHP for health support and illness prevention. Additionally, a female gender, NHP self-medication, and having higher values of self-transcendence were significant indicators for NHPCC usage compared to past NHP usage. CONCLUSION: NHP manufacturers, health professionals, and policymakers should be aware of the factors that lead to NHP consumption decisions and consider them in the development and optimization of healthcare strategies as well as in the marketing and communication strategies of companies producing NHP, in particular for CC. The current study can contribute to characterizing the target groups and to defining the aims and communication channels of such campaigns.

Usage of Natural Health Products (NHPs) for respiratory diseases: user characteristics and NHP-Consumption behavior during the Covid-19 pandemic in Germany.

BACKGROUND: Respiratory diseases (RD) can challenge healthcare systems around the globe. Natural health products (NHPs) are popular complementary and alternative medicine options for health issues concerning non-fatal RD. Little is known about the characteristics of the users of RD-NHPs and about their NHP consumption behavior during the Covid-19 pandemic in Germany. METHODS: A representative online survey was conducted in Germany in 2022. 1707 participants were classified based on having used NHPs for RD within the previous 12 months, having used NHPs but not for RD within the previous 12 months and not having used NHPs. Data were analyzed using descriptive and inferential statistical methods as well as a multinomial logistic regression model. RESULTS: Users of RD-NHPs within the previous 12 months were more likely to be employed and to consult pharmacists more often for non-fatal health issues than individuals who did not take RD-NHPs. RD-NHP users were more likely to suffer from a Covid-19 infection and to have children living in the same household than other NHP users. Compared to non-NHP users, RD-NHP users were more likely to be female, highly educated and have stronger openness-to-change value orientations. Vaccination-related behavior was no indicator of RD-NHP usage. Most RD-NHP users took NHPs in self-medication. Few reported informing their practitioner about their self-medication. Drugstores were the most visited supply source for NHPs during the pandemic, followed by pharmacies. Common information sources regarding NHPs were the products themselves and pharmacists. CONCLUSION: This study emphasized the important role of NHPs as a popular prevention and treatment option for RD. RD-NHPs were more likely used by individuals who were employed, who suffered from a RD and who consult pharmacists for non-fatal health issues. The importance of product information and pharmacies as information sources should be considered to make communication strategies about safe self-medication options with RD-NHPs more effective, which could help to reduce the burden of health facilities regarding non-fatal RD. To improve and develop future pandemic-control strategies, health professionals and policy makers should consider NHP usage behavior and provide critical information about chances and risks of self-medicated NHP consumption.

Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches.

BACKGROUND: For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification. METHODS: To address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies-including human insulin, insulin analogs, and porcine insulin-by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods. RESULTS: We demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs-insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content. CONCLUSIONS: Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.

Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases.

The literature thoroughly describes the challenges of pediatric drug development for rare diseases. This includes (1) generating interest from sponsors, (2) small numbers of children affected by a particular disease, (3) difficulties with study design, (4) lack of definitive outcome measures and assessment tools, (5) the need for additional safeguards for children as a vulnerable population, and (6) logistical hurdles to completing trials, especially with the need for longer term follow-up to establish safety and efficacy. There has also been an increasing awareness of the need to engage patients and their families in drug development processes and to address inequities in access to pediatric clinical trials. The year 2020 ushered in yet another challenge-the COVID-19 pandemic. The pediatric drug development ecosystem continues to evolve to meet these challenges. This article will focus on several key factors including recent regulatory approaches and public health policies to facilitate pediatric rare disease drug development, emerging trends in product development (biologics, molecularly targeted therapies), innovations in trial design/endpoints and data collection, and current efforts to increase patient engagement and promote equity. Finally, lessons learned from COVID-19 about building adaptable pediatric rare disease drug development processes will be discussed.

Determining the Distinguishing Features of Different Eating Action Types in Germany Using a Mixed-Method Approach.

Food-related behavior is a very complex topic, as it affects the most diverse areas of life. Accordingly, wide varieties of disciplines have already dealt with the topic to understand it better. The result is that there is neither a uniform nutrition knowledge nor a uniform nutrition behavior. In order to reduce the complexity of a field of study, there is the methodical means of type-building. Both commercial and academic studies have already formed nutrition types, either by means of standardized questionnaires or with a specific content focus. However, since both individual and social aspects influence food-related behavior, we investigate how people integrate eating into their everyday life against the background of (competing) individual and social demands by focusing on the individual point of view, for which a mixed methods approach is used. Based on 42 semi-structured, problem-centered interviews conducted in Germany in 2017, we built qualitative food-related types in a first step, which are analyzed in this article using a quantitative content analysis and cross-over analysis to identify the particular distinguishing feature(s) of each type and test them for significance. The results show the prominent characteristics for each type and indicate furthermore that subjectivization, self-determination, the body as an instrument of power, adaptation to the environment and being overstrained with the own behavior are particularly prominent when it comes to eating. Moreover, we clearly identified The Overstrained and The Relaxed as independent eating action types, which we could not find anywhere else. The study shows that interventions, especially for The Overstrained and The Controlled, are necessary to achieve a relaxed approach to eating in everyday life. At the same time, systematic approaches should be used to intervene in cases of overstraining or controlled behavior.

The culture of research communication in neonatal intensive care units: key stakeholder perspectives.

OBJECTIVE: To assess the perspectives of neonatologists, neonatal nurses, and parents on research-related education and communication practices in the neonatal intensive care unit (NICU). STUDY DESIGN: Questionnaire circulated through interest groups and administered using the internet. RESULTS: 323 respondents responded to the survey. 52 were neonatologists, 188 were neonatal nurses, and 83 were parents of NICU graduates. Analysis was descriptive. Differences were noted between stakeholder groups with respect to whether current medications meet the needs of sick neonates, research as central to the mission of the NICU, availability of appropriate education/training for all members of the research team, and adequacy of information provided to parents before, during, and after a research study is completed. CONCLUSION: Engagement of nurses and parents at all stages of NICU research is currently suboptimal; relevant good practices, including education, should be shared among neonatal units.

Antenatal and perinatal factors influencing neonatal blood pressure: a systematic review.

OBJECTIVE: A comprehensive understanding of the factors contributing to perinatal blood pressure is vital to ensure optimal postnatal hemodynamic support. The objective of this study was to review existing literature on maternal and perinatal factors influencing blood pressure in neonates up to 3 months corrected age. METHODS: A systematic search of published literature in OVID Medline, OVID Embase and the COCHRANE library identified publications relating to maternal factors affecting blood pressure of neonates up to corrected age of 3 months. Summary data were extracted and compared (PROSPERO CRD42018092886). RESULTS: Of the 3683 non-duplicate publications identified, 44 were eligible for inclusion in this review. Topics elicited were sociodemographic factors, maternal health status, medications, smoking during pregnancy, and cord management at birth. Limited data were available for each factor. Results regarding the impact of these factors on neonatal blood pressure were inconsistent across studies. CONCLUSIONS: There is insufficient evidence to draw definitive conclusions regarding the impact of various maternal and perinatal factors on neonatal blood pressure. Future investigations of neonatal cardiovascular therapies should account for these factors in their study design. Similarly, studies on maternal diseases and perinatal interventions should include neonatal blood pressure as part of their primary or secondary analyses.

Protein for Community-Dwelling Older People: Aspects That Influence the Perception of Commercially Available Protein Drinks.

In an aging population, support for independent living is increasingly critical for older generations. Currently, sarcopenia is a major cause of frailty, which increases the risk of decreased mobility, falls, morbidity, and mortality and leads to dependence on third parties. Sarcopenia is preventable by consumption of adequate protein. However, many older people do not meet the recommended daily allowance of protein, thereby supporting dependence rather than independent living. Current literature indicates that a protein drink could be an appropriate product for older peoples' protein consumption. We were interested in autonomous persons whose nutritional decisions were still self-determined and thus could preventively influence their personal health. This study evaluated three commercially available protein drinks in three focus groups (n = 25) to gain insight into which aspects influence the perception of commercial protein drinks on community-dwelling older people (age, 76.8 ± 4.9). Findings from the focus groups revealed only aspects, which influenced the perception of commercial protein drinks negatively. Most importantly, the drinks did not comply with relevant aspects when buying (healthy) foods, which where naturalness, freshness, locally grown ingredients, and trust. Furthermore, the target group did not see a need for additional protein consumption. Thus, we identify important aspects to be considered for the development of a target-group-specific protein drink as well as more suitable communication to prevent distrust in order to support independent living for community-dwelling older people.

Method of Blood Pressure Measurement in Neonates and Infants: A Systematic Review and Analysis.

OBJECTIVES: To determine the recommended blood pressure (BP) measurement methods in neonates after systematically analyzing the literature regarding proper BP cuff size and measurement location and method. STUDY DESIGN: A literature search was conducted in MEDLINE, PubMed, Embase, Cochrane Library, and CINAHL from 1946 to 2017 on BP in neonates <3 months of age (PROSPERO ID CRD42018092886). Study data were extracted and analyzed with separate analysis of Bland-Altman studies comparing measurement methods. RESULTS: Of 3587 nonduplicate publications identified, 34 were appropriate for inclusion in the analysis. Four studies evaluating BP cuff size support a recommendation for a cuff width to arm circumference ratio of approximately 0.5. Studies investigating measurement location identified the upper arm as the most accurate and least variable location for oscillometric BP measurement. Analysis of studies using Bland-Altman methods for comparison of intra-arterial to oscillometric BP measurement show that the 2 methods correlate best for mean arterial pressure, whereas systolic BP by the oscillometric method tends to overestimate intra-arterial systolic BP. Compared with intra-arterial methods, systolic BP, diastolic BP, and mean arterial pressure by oscillometric methods are less accurate and precise, especially in neonates with a mean arterial pressure <30 mm Hg. CONCLUSIONS: Proper BP measurement is critical in neonates with naturally lower BP and attention to BP cuff size, location, and method of measurement are essential. With decreasing use of intra-arterial catheters for long-term BP monitoring in neonates, further studies are urgently needed to validate and develop oscillometric methodology with enhanced accuracy.

The importance of herbal medicine use in the German health-care system: prevalence, usage pattern, and influencing factors.

BACKGROUND: Prevalence rates for herbal medicine (HM) have been increasing worldwide. However, little is known about prevalence, user characteristics, usage pattern and factors influencing HM usage for the general German population. METHODS: A nationwide online survey on HM usage was conducted in Germany. The 2906 participants were categorised into three groups: the ones who used HM in the last 12 months, the ones who did not use HM in the last 12 months but in their lifetime, and the ones who did not use HM until now. Data were analysed by descriptive statistics, Chi Square tests and binary hierarchical logistic regression analyses. RESULTS: Prevalence rates of HM were found to be very high for the general German population. Self-medication appeared as a common praxis, when at the same time HM users responded that they do not inform their physician about it, rate their knowledge about HM as somewhat poor, and use the internet as the most frequent source of information. The HM user in the last 12 months was found to include people that were more likely female, highly educated, privately insured, employed, and engaged in a more health-oriented lifestyle. While certain sociodemographic- and health-related variables influence HM usage vs. non-usage, they explain variance only to a limited extent. For distinguishing the user in the last 12 months vs. the less recent user who did not use HM in the last 12 months, ratings on different reasons for HM usage were found to perform better as predictors than sociodemographic- and health-related variables. CONCLUSIONS: This study demonstrated that HM usage plays an essential role in the German health-care system. Furthermore, the HM usage pattern may be potentially harmful for patients, as it included self-medication, little knowledge on interaction- and side-effects of HM, and a lack of communication with physicians about the usage. Moreover, prediction of HM usage in the previous year is impacted by variables beyond conventional sociodemographic- and health-related ones. In view of the high prevalence rates of HM in Germany, medical as well as health service providers should be aware of these issues.

The virtual doctor: An interactive clinical-decision-support system based on deep learning for non-invasive prediction of diabetes.

Artificial intelligence (AI) will pave the way to a new era in medicine. However, currently available AI systems do not interact with a patient, e.g., for anamnesis, and thus are only used by the physicians for predictions in diagnosis or prognosis. However, these systems are widely used, e.g., in diabetes or cancer prediction. In the current study, we developed an AI that is able to interact with a patient (virtual doctor) by using a speech recognition and speech synthesis system and thus can autonomously interact with the patient, which is particularly important for, e.g., rural areas, where the availability of primary medical care is strongly limited by low population densities. As a proof-of-concept, the system is able to predict type 2 diabetes mellitus (T2DM) based on non-invasive sensors and deep neural networks. Moreover, the system provides an easy-to-interpret probability estimation for T2DM for a given patient. Besides the development of the AI, we further analyzed the acceptance of young people for AI in healthcare to estimate the impact of such a system in the future.

Development of a neonatal adverse event severity scale through a Delphi consensus approach.

BACKGROUND: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. METHODS: A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. RESULTS: Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. DISCUSSION: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.

What motivates new, established and long-term users of herbal medicine: is there more than push and pull?

BACKGROUND: The use of herbal medicine (HM) has become an essential form of treatment and it is more and more common around the world. Little is known about the reasons that drive people to initially use HM or to maintain their behaviour, and whether the so-called "push and pull factors" known in the context of decision making for complementary and alternative medicine, also play a role for HM use. Here, our goal was to provide answers to these open questions and to analyse the reasons that motivate new, established and long-term HM consumers in detail. METHODS: Thirteen reasons for HM usage, which were previously identified within a qualitative approach, were analysed quantitatively in a nationwide online survey in Germany. Data of 2,192 German HM users from the general population were grouped into new, established and long-term users. We performed a factor analysis in order to identify factors underlying the set of reasons. RESULTS: We discovered a reliable factor associated with longstanding family traditions and cultural importance of HM in Germany. This finding shows that the reasons for HM use require a three-factor structure going beyond the well-known push and pull factors that explain the use of complementary and alternative medicine. In using the identified factors for further calculations, we were able to reveal important group differences and test how the factor scores perform as predictors for the new, established and long-term choice of HM. Our results showed that a high score on the push factor is associated more with initial HM usage, while long-term HM usage is impacted more by high scores on the pull and traditional factors. CONCLUSIONS: Our exploratory survey and analysis of the reasons that underlie HM usage aimed at providing a better understanding of the decision for this treatment form. The findings of our work deliver insights for medical practitioners and health-care providers, including the role of family traditions for HM usage and the finding that new HM users are driven to use this treatment form in part because of negative aspects they associate with conventional medicine.

Why people use herbal medicine: insights from a focus-group study in Germany.

BACKGROUND: The use of herbal medicine, as one element of complementary and alternative medicine, is increasing worldwide. Little is known about the reasons for and factors associated with its use. This study derives insights for the use of herbal medicine in Germany regarding the usage aims, role played by the type of illness, reasons for preferred usage and sources of information. METHODS: Using a qualitative methodological approach, six focus groups (n = 46) were conducted. Two groups with young, middle-aged and elderly participants, respectively. After audiotaping and verbatim transcription, the data were analysed with a qualitative content analysis. RESULTS: We found that treating illnesses was the most frequently discussed aim for using herbal medicine over all age groups. Preventing illnesses and promoting health were less frequently mentioned overall, but were important for elderly people. Discussions on herbal medicine were associated with either mild/moderate diseases or using herbal medicine as a starting treatment before applying conventional medicine. In this context, participants emphasized the limits of herbal medicine for severe illnesses. Dissatisfaction with conventional treatment, past good experiences, positive aspects associated with herbal medicine, as well as family traditions were the most commonly-mentioned reasons why herbal medicine was preferred as treatment. Concerning information sources, independent reading and family traditions were found to be equally or even more important than consulting medicinal experts. CONCLUSIONS: Although herbal medicine is used mostly for treating mild to moderate illnesses and participants were aware of its limits, the combination of self-medication, non-expert consultation and missing risk awareness of herbal medicine is potentially harmful. This is particularly relevant for elderly users as, even though they appeared to be more aware of health-related issues, they generally use more medicine compared to younger ones. In light of our finding that dissatisfaction with conventional medicine was the most important reason for a preferred use of herbal medicine, government bodies, doctors, and pharmaceutical companies need to be aware of this problem and should aim to establish a certain level of awareness among users concerning this issue.

Nanobody-Displaying Flagellar Nanotubes.

In this work we addressed the problem how to fabricate self-assembling tubular nanostructures displaying target recognition functionalities. Bacterial flagellar filaments, composed of thousands of flagellin subunits, were used as scaffolds to display single-domain antibodies (nanobodies) on their surface. As a representative example, an anti-GFP nanobody was successfully inserted into the middle part of flagellin replacing the hypervariable surface-exposed D3 domain. A novel procedure was developed to select appropriate linkers required for functional internal insertion. Linkers of various lengths and conformational properties were chosen from a linker database and they were randomly attached to both ends of an anti-GFP nanobody to facilitate insertion. Functional fusion constructs capable of forming filaments on the surface of flagellin-deficient host cells were selected by magnetic microparticles covered by target GFP molecules and appropriate linkers were identified. TEM studies revealed that short filaments of 2-900 nm were formed on the cell surface. ITC and fluorescent measurements demonstrated that the fusion protein exhibited high binding affinity towards GFP. Our approach allows the development of functionalized flagellar nanotubes against a variety of important target molecules offering potential applications in biosensorics and bio-nanotechnology.

Biosimilars: State of Clinical and Regulatory Science.

On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace.