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Purpose: It is assumed that sensory taste perception shapes food choices and impacts dietary intake. However, this has rarely been studied in free living subjects of different age-groups with standardised methods. The present study investigated the association of the ability to rank sweet and fat taste intensities with consumption frequency of sweet and fatty foods in children, adolescents and adults from eight European countries., Methods: In total, 461 children, 421 adolescents and 612 adults from the IDEFICS/I.Family cohort participated in sensory sweet and fat intensity rating tests. Sweet and fatty food consumption frequencies were assessed using a food frequency questionnaire. The association between the ability to rank sweet and fat intensity with sweet and fatty food consumption frequencies was estimated using linear mixed regression models adjusting for weight status, country, sex, age and family affiliation., Results: Across all age groups, the largest proportion of participants had medium sweet and fat taste intensity ranking abilities. The next largest proportion had low sweet and fat taste intensity rating abilities, while the smallest proportion had high intensity rating abilities to sweet and fat taste. A negative association of sweet and fat taste intensity ranking ability with sweet and fatty food consumption frequencies was found for children. In adolescents, the association was positive. In adults, there was no association., Conclusion: It seems that the association of taste intensity ratings with food consumption frequencies during adolescence differs from the associations in children and adults. This could be due to hormonal changes during puberty, growth and maturation. Thus, further research focussing on maturation processes in association with taste perception during adolescence may be required., Competing Interests: Declarations. Conflict of interest: The authors declare that they have no conflict of interest.  Ethics approval and consent to participate : Each study centre obtained ethical approval from the local institutional review board; Belgium: Ethics Committee of the Gent University Hospital, 15/10/2007, ref: No. EC UZG 2007/243 and 19/02/2013, No. B670201316342, Cyprus: Cyprus National Bioethics Committee, 12/07/2007, ref: No. EEBK/EM/2007/16 and 21/Feb/2013, No. EEBK/ETI/2012/33, Estonia: Tallinn Medical Research Ethics Committee (TMREC), 14/06/2007, ref: No. 1093 and 17/January 2013, No. 128, Germany: Ethic Commission of the University of Bremen, 16/01/2007 and 11/12/2012, Hungary: Medical Research Council, 21/Jun/2007, ref: 22-156/2007-1018EKU and 18/12/2012, 4536/2013/EKU, Italy: Ethics Committee of the Local Health Authority (ASL) in Avellino, 19/06/2007, ref: No. 2/CE and 18/Sep/2012, No. 12/12, Spain: Ethics Committee for Clinical Research of Aragon (CEICA), 20/06/2007, ref:No. PI07/13 and 13/Feb/2013, No. PI13/0012, Sweden: Regional Ethics Research Board in Gothenburg, 30/07/2007, ref: No. 264-07 and 10/Jan/2013, No. 927-12. The ISRCTN reference is: ISRCTN62310987. Besides the oral information given, all participants above 12 years gave a written consent and parents gave a written consent on behalf of their children below 12 years in addition to the oral consent of their children., (© 2024. The Author(s).)

Background: Patient and Public Involvement (PPI) is increasingly recognized as an essential aspect of clinical research, particularly for ensuring relevancy and impact of research to those most affected. This study addresses the gap in involving older patients, particularly nursing home residents, in the research process by exploring motivations, expectations, and experiences of nursing home residents in Bremen, Germany, involved in PPI for developing a clinical trial on polypharmacy., Methods: Two Patient Advisory Boards (PABs) were established in nursing homes as part of the INVOLVE-Clin project. A Patient Advocate (PA) facilitated communication between nursing home residents and researchers. A qualitative case study approach was employed, involving semi-structured interviews and group discussions with nursing home residents and researchers. Data was analyzed using structured qualitative content analysis., Results: The study found varied motivations and expectations between nursing home residents and researchers. Nursing home residents valued the social interaction and the opportunity to voice their health concerns, while researchers aimed to incorporate patients' perspectives into study design. The PA was considered crucial in facilitating communication between nursing home residents and researchers. Challenges included the complexity of the study topic and the need for methodological adjustments to suit nursing home residents´ cognitive abilities. Generally, PAB participation was experienced to provide mental stimulation and increased confidence among nursing home residents in discussing their medication management. The PAB's influence led to the decision not to conduct a polypharmacy study., Discussion: The findings underscore the importance of flexible approaches to PPI, particularly when involving older nursing home residents. Methodological adjustments, such as tailoring content and structure of PABs, and the inclusion of additional boards for diverse perspectives, are vital for effective involvement. The study also highlights the need for ongoing innovation in PPI methods to ensure meaningful engagement of older patients in clinical research., Conclusion: This study contributes essential insights into the practical implementation of PPI with nursing home residents, highlighting the need for patient-centric approaches that recognize their unique challenges and contributions. These findings are critical for shaping scientifically robust but also socially relevant and impactful research, especially in an aging society., (© 2024. The Author(s).)

Background: Ectrodactyly is a rare congenital limb malformation characterized by a deep median cleft of the hand and/or foot due to the absence of central rays. It could be isolated or depicts a part of diverse syndromic forms. Heterozygous pathogenic variants in the TP63 gene are responsible for at least four rare syndromic human disorders associated with ectrodactyly. Among them, ADULT (Acro-Dermato-Ungual-Lacrimal-Tooth) syndrome is characterized by ectodermal dysplasia, excessive freckling, nail dysplasia, and lacrimal duct obstruction, in addition to ectrodactyly and/or syndactyly. Ophthalmic findings are very common in TP63 -related disorders, consisting mainly of lacrimal duct hypoplasia. Absent meibomian glands have also been well documented in EEC3 (Ectrodactyly Ectodermal dysplasia Cleft lip/palate) syndrome but not in ADULT syndrome., Methods: We report a case of syndromic ectrodactyly consistent with ADULT syndrome, with an additional ophthalmic manifestation of agenesis of meibomian glands. The proband, as well as her elder sister, presented with congenital cone dystrophy.The molecular investigation was performed in the proband using Whole Exome Sequencing. Family segregation of the identified variants was confirmed by Sanger sequencing., Results: Two clinically relevant variants were found in the proband: the novel de novo heterozygous missense c.931A > G (p.Ser311Gly) in the TP63 gene classified as pathogenic, and the homozygous nonsense pathogenic c.1810C > T (p.Arg604Ter) in the CNGB3 gene. The same homozygous CNGB3 variation was also found in the sister, explaining the cone dystrophy in both cases., Conclusions: Whole Exome Sequencing allowed dual molecular diagnoses: de novo TP63 -related syndromic ectrodactyly and familial CNGB3 -related congenital cone dystrophy.

Background: Wolfram syndrome type 1 is a rare neurodegenerative disorder including diabetes insipidus, diabetes mellitus, optic atrophy, and deafness, with variable additional findings. The phenotypic spectrum is very heterogeneous, with non-autoimmune juvenile-onset diabetes and optic atrophy as minimal criteria for the diagnosis. Biallelic mutations in the WFS1 gene are the causative genetic anomaly for the syndrome, with, however, no evident genotype-phenotype correlation. Among the clinical features of the disease, diabetic retinopathy depicts a rarely reported microvascular complication. In this report, we describe the clinical and genetic findings in a 26-year-old patient presenting with Wolfram syndrome and severe diabetic retinopathy., Methods: The mutation screening was performed by polymerase chain reaction followed by Sanger sequencing of the entire coding sequence of the WFS1 gene., Results: A novel homozygous missense variant c.1901A>T (p.Lys634Met) was found in the proband and classified as probably pathogenic according to the American College of Medical Genetics and Genomics., Conclusions: The molecular study of the WFS1 gene is essential for the diagnostic confirmation, to provide appropriate genetic counseling and a mutational screening in the at-risk relatives. The c.1901A>T (p.Lys634 Met) is a novel variant that could be responsible for a severe form of Wolfram syndrome with early and proliferative diabetic retinopathy.

Background: Ectodermal dysplasias (EDs) are a large and complex group of disorders affecting the ectoderm-derived organs; the clinical and genetic heterogeneity of these conditions renders an accurate diagnosis more challenging. The aim of this study is to demonstrate the clinical utility of a targeted resequencing panel through enhancing the molecular and clinical diagnosis of EDs. Given the recent developments in gene and protein-based therapies for X-linked hypohidrotic ectodermal dysplasia, there is a re-emerging interest in identifying the genetic basis of EDs and the respective phenotypic presentations, in an aim to facilitate potential treatments for affected families., Methods: We assessed seventeen individuals, from three unrelated families, who presented with diverse phenotypes suggestive of ED. An extensive multidisciplinary clinical evaluation was performed followed by a targeted exome resequencing panel (including genes that are known to cause EDs). MiSeq TM data software was used, variants with Qscore >30 were accepted., Results: Three different previously reported hemizygous EDA mutations were found in the families. However, a complete genotype-phenotype correlation could not be established, neither in our patients nor in the previously reported patients., Conclusions: Targeted exome resequencing can provide a rapid and accurate diagnosis of EDs, while further contributing to the existing ED genetic data. Moreover, the identification of the disease-causing mutation in an affected family is crucial for proper genetic counseling and the establishment of a genotype-phenotype correlation which will subsequently provide the affected individuals with a more suitable treatment plan.

We aimed to describe differences in taste sensitivity in children according to age across 7- to 11-year-old children from eight European countries. We further compared taste sensitivity between boys vs. girls and under-/normal weight vs. overweight/obese children. Within the European multicentre IDEFICS (Identification and prevention of dietary and lifestyle-induced health effects in children and infants) study, 1938 school children participated in sweet, bitter, salty and umami detection threshold tests between 2007 and 2010, using the paired comparison staircase method. The lowest concentration at which the child was able to detect a difference to water was determined as taste detection threshold as a proxy of taste sensitivity. Mean taste thresholds were calculated stratified for sex, age groups, weight groups and country. BMI was calculated using measured height and weight; socio-demographic information was collected using questionnaires. Ordinal logistic regressions were conducted to investigate the association between sex, weight status (as categorical exposure variable) and age (as continuous exposure variable) and the taste sensitivity for the four taste modalities (as outcome), separately. Older children were more taste sensitive for sweet and salty and less taste sensitive for umami and bitter than younger children. Girls were more sensitive to sweet taste than boys. Overweight or obese children were less sensitive to sweet and salty taste compared to normal weight children This was the first study comparing taste sensitivity by measuring taste thresholds in children across different European countries. We conclude that taste thresholds are associated with weight status, children become more sensitive to sweet and salty tastes with increasing age, and girls might be more sensitive to sweet than boys., (Copyright © 2022. Published by Elsevier Ltd.)

Gaucher disease (GD) is a rare metabolic disorder due to pathogenic variants in the GBA gene. We report the first case of the rare p.Arg87Trp pathogenic variant (formerly known as R48W) of the GBA gene in the Tunisian population. A female Arab patient was assessed at the age of 26 due to abdominal distension, bone pain, and headache since she was 25. Physical examination revealed splenomegaly, rib deformation, lumbar scoliosis, and upper limb tremor. Bone marrow was infiltrated by Gaucher cells. The patient was homozygous for the rare p.Arg87Trp variant which is known to be associated with a mild phenotype. This report highlights the necessity of screening the Tunisian population for this rare variant., Competing Interests: None., (© 2022 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.)

Dyskeratosis congenital (DC) is the first genetic syndrome described among telomeropathies. Its classical phenotype is characterized by the mucocutaneous triad of reticulated pigmentation of skin lace, nail dystrophy and oral leukoplakia. The clinical presentation, however, is heterogeneous and serious clinical complications include bone marrow failure, hematological and solid tumors. It may also involve immunodeficiencies, dental, pulmonary and liver disorders, and other minor complication. Dyskeratosis congenita shows marked genetic heterogeneity, as at least 14 genes are responsible for the shortening of telomeres characteristic of this disease. This review discusses clinical characteristics, molecular genetics, disease evolution, available therapeutic options and differential diagnosis of dyskeratosis congenita to provide an interdisciplinary and personalized medical assessment that includes family genetic counseling.

Background: Although children's intake of fruit and vegetables has seen a recent rise, almost half of adolescents do not eat even one piece of fruit or vegetables per day. One way to address this problem is through interventions that provide fruit and vegetables directly to children in kindergartens and schools. For such interventions to meet their intended goals, what is important to consider in addition to impact is implementation. Our objective is to systematically review qualitative results reporting on the determinants (barriers and facilitators) to implementation of interventions that entail direct provision of fruit and vegetables in kindergarten and school settings and conduct a framework analysis of those results using the Consolidated Framework for Implementation Research (CFIR)., Methods: A systematic search was designed and run in November 2019 for: MEDLINE (Ovid), Embase (Ovid), PsychINFO (Ovid), ERIC (Ovid), Cochrane Library Reviews and Cochrane Library Trials. A keyword search of the journal Implementation Science was completed. Screening of titles and abstracts (n = 5427) and full texts (n = 227), led to 14 included articles. Coding and analysis were done using the framework method and CFIR., Results: The following CFIR constructs were found relevant: 1) intervention characteristics domain: 'design quality and packaging', 'adaptability' 'cost'; 2) outer setting: 'cosmopolitanism', 'external policy and incentives' 'patients' needs and resources'; 3) inner setting: 'implementation climate', 'readiness for implementation' and 'structural characteristics'; 4) characteristics of individuals: 'individual stage of change', 'knowledge and beliefs about the intervention' 5) process: 'engaging', 'executing' and 'reflecting and evaluating'. The review stresses the dual role of parents as both supporting the implementation and targets of the intervention, which could have implications for the design and implementation of future fruit and vegetables interventions. Positive child perceptions of the value of the intervention and perceived behavior change due to the intervention were reported as relevant facilitators to implementation across several studies, and should be taken into consideration in future design efforts., Conclusions: CFIR offers a systematic way to identify and organize barriers and facilitators to implementation of interventions in the kindergarten and school setting. Revisions are encouraged to allow adequate space for perceptions of various implementation actors and the target group., Prospero Registration: CRD42020167697., (© 2022. The Author(s).)

Background: Beckwith-Wiedemann syndrome (BWS) is a rare overgrowth syndrome characterized by congenital malformations and predisposition to embryonic tumors. Loss of methylation of imprinting center 2 (IC2) is the most frequent alteration and rarely associated with tumors compared to paternal uniparental disomy of chromosome 11 (UPD(11)pat) and gain of methylation of imprinting center 1., Methods: Our study aimed to describe the clinical, histopathological and genetic characteristics of two patients and establish genotype-phenotype correlations. The clinical diagnosis was based on the criteria defined by the international expert consensus of BWS. Molecular study of 11p15.5 methylation status was assessed using methylation-specific-multiplex ligation probe amplification (MS-MLPA)., Results: Patients were aged 12 months and 3 months and fulfilled the clinical score of BWS. MS-MLPA showed molecular alterations consisting of loss of methylation in IC2 (IC2-LOM) at the maternal allele for one patient and a mosaic UPD(11)pat for the second patient in whom follow-up at 6months revealed adrenocortical carcinoma (ACC) with low grade of malignancy. Molecular subtypes guide the follow-up and tumor surveillance, our major concern., Conclusion: We have to take into account the psychological impact of a possible tumor whatever the underlying mechanism is. Nevertheless, the tumor risk remains high for UPD(11)pat. Our study extended the phenotype of BWS with absence of macrosomia in Tunisian patients, contrasting with literature, and added a supplementary case of ACC in the tumor spectrum of BWS patients with UPD(11)pat., (© 2021 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals LLC.)

Spondylometaphyseal dysplasia Algerian type (MIM no.: 184253) is an uncommon autosomal dominant skeletal dysplasia caused by heterozygous mutations in the COL2A1 gene (MIM no.: 120140). In this case based review, we reported a 5-year-old boy with short stature, severe dorsolumbar scoliosis, lumbar hyperlordosis, short trunk, and severe genu valgum . Radiological examination showed platyspondyly, irregular metaphyseal radiolucencies intermingled with radiodensities, and corner fractures. The patient has a c.3275G > A; p.Gly1092Asp mutation in exon 47 of the COL2A1 gene and a variant of unknown significance in c.1366-13C > A in intron 21. This latter sequence variant could partially or completely disrupt the natural splice acceptor site of intron 21/exon 22 in the COL2A1 gene leading to a potential modification of the phenotypic severity., Competing Interests: Conflict of Interest None declared., (Thieme. All rights reserved.)

Background: Karyomegalic interstitial nephritis (KIN) is a rare disease entity first described by Burry in 1974. The term KIN was introduced by Mihatsch et al. in 1979. KIN is characterized by chronic tubulointerstitial nephritis associated with enlarged tubular epithelial cell nuclei, which leads to a progressive decline of renal function. The prevalence of this disease is less than 1% of all biopsies, and its pathogenesis is unclear. KIN results from mutations in FAN1 (FANCD2/FANCI-Associated Nuclease 1), a gene involved in the DNA damage response pathway, particularly in the kidney. In this study, we report two Tunisian consanguineous families with KIN caused by mutations in the FAN1 gene., Methods: Direct sequencing of the coding regions and flanking intronic sequences of the FAN1 gene was performed in three affected members. Three prediction programs (Polyphen-2 software, SIFT, and MutationTaster) were used to predict the functional effect of the detected variations., Results: Two causative frameshift variants in the FAN1 gene were identified in each family: The previously described frameshift mutation c.2616delA (p.Asp873ThrfsTer17) and a novel mutation c.2603delT (p.Leu868ArgfsTer22) classified as "pathogenic" according to the American College of Medical Genetics and Genomics (ACMG) guidelines., Conclusion: To our best knowledge, this is the first Tunisian study involving familial cases of KIN with mutations in the FAN1 gene. We hypothesize that these findings can expand the mutational spectrum of KIN and provide valuable information on the genetic cause of KIN.

Plant foods, rich in fibre, can offer textures that children find difficult to orally manipulate, resulting in low preferences but are important for a healthy diet and prevention of overweight in children. Our aim was to investigate preferences for food texture, intake of fibre-associated foods and the relation to BMI. Three hundred thirty European children (9-12 years, 54% female) indicated their texture preferences using the Child-Food-Texture-Preference- Questionnaire (CFTPQ), and their parents responded on fibre-associated food consumption and anthropometric information. BMI was significantly lower for children with higher intake of wholegrain alternatives of common foods; in addition to being significantly influenced by country and the wearing of a dental brace. Overall BMI-for-age-percentiles (BMI_pct) were negatively associated with the consumption of wholegrain cereals, white pasta and wholemeal products and positively associated with the intake of legumes and white biscuits. In males, BMI_pct were negatively associated with wholegrain products and dried fruits, and in females, positively with legume consumption. A few country-related associations were found for BMI_pct and wholegrain biscuits, seeds and nuts and refined products. No overall correlation was found between BMI_pct and the texture preference of soft/hard foods by CFTPQ, except in Austria. We conclude that this study revealed evidence of a connection between fibre-associated foods and children's BMI at a cross-cultural level and that sex is an important determinant of fibre-associated food intake and the development of overweight in childhood., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Hörmann-Wallner, Krause, Alfaro, Jilani, Laureati, Almli, Sandell, Sandvik, Zeinstra and Methven.)

Digital media (DM) influences children's food choice. We aim to investigate associations between DM use and taste preferences (TP) for sweet, fatty, bitter, and salty in European children and adolescents. Individuals aged 6-17 years (N = 7094) providing cross-sectional data for DM use: television (TV), computer/game console (PC), smartphone and internet, were included. Children (6 to <12 years) and adolescents (≥12 years) completed a Food and Beverage Preference Questionnaire; scores were calculated for sweet, fatty, salty and bitter preference and categorized (high vs. low). Logistic regression was used to calculate odds ratios as association measures between DM exposure and TP. On average, individuals used media for 2.4 h/day (SD = 1.7). Increasing exposures to DM were associated positively with sweet, fatty and salty TP, while inversely with bitter preference. In female adolescents, DM exposure for >2 h/day was associated with sweet (OR = 1.27, 95% CI = 1.02-1.57) and fatty preference (OR = 1.37; 95% CI = 1.10-1.70). Internet exposure was inversely associated with bitter preference, notably in male adolescents (OR = 0.65, 95% CI = 0.50-0.84), but positively associated with salty preference (OR = 1.29, 95% CI = 1.02-1.64). DM exposure was associated with sweet, fatty, salty and bitter TP in children and adolescents, serving as the basis for future longitudinal studies to shed light on the underlying mechanism by which DM exposure may determine eating habits.

Non-Immune Hydrops Fetalis (NIHF) is an intrauterine condition characterized by excessive fluid accumulation in at least two fetal compartments in the absence of maternal circulating red cell antibodies. It is associated with a poor prognosis and a wide etiological spectrum. Among the metabolic causes, Mucopolysaccharidosis type VII depicts the most frequent type of lysosomal storage disorders in the cause of NIHF. Nonetheless, it remains an ultra-rare disorder, as less than 150 cases have been reported in the literature. This rarity seems to be related to misdiagnosis since the underlying etiology remains unelusive in most cases of NIHF. In this report, we describe the first Tunisian case of Mucopolysaccharidosis type VII caused by a homozygous mutation in the GUSB gene confirmed by a Next-Generation Sequencing gene panel in a patient with recurrent NIHF., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Food neophobia influences food choice in school-aged children. However, little is known about how children with different degrees of food neophobia perceive food and to what extent different sensory attributes drive their liking. This paper explores liking and sensory perception of fibre-rich biscuits in school-aged children ( n = 509, age 9-12 years) with different degrees of food neophobia and from five different European countries (Finland, Italy, Spain, Sweden and United Kingdom). Children tasted and rated their liking of eight commercial biscuits and performed a Check-All-That-Apply task to describe the samples and further completed a Food Neophobia Scale. Children with a higher degree of neophobia displayed a lower liking for all tasted biscuits ( p < 0.001). Cross-cultural differences in liking also appeared ( p < 0.001). A negative correlation was found between degree of neophobia and the number of CATA-terms used to describe the samples ( r = -0.116, p = 0.009). Penalty analysis showed that degree of food neophobia also affected drivers of biscuit liking, where particularly appearance terms were drivers of disliking for neophobic children. Cross-cultural differences in drivers of liking and disliking were particularly salient for texture attributes. Further research should explore if optimizing appearance attributes could be a way to increase liking of fibre-rich foods in neophobic children.

Introduction: Patient involvement in health research is an integral part of health care in many countries. It promotes the relevance and quality of research and increases the meaningfulness of research results. Meanwhile, the value of patient involvement has also been recognised in Germany. The lack of a common understanding of patient involvement and appropriate methods make implementation difficult. In Germany, patients are still rarely involved in the planning and conduct of health research. Vulnerable patient groups such as the elderly and the very old are considered particularly challenging for researchers in active patient involvement due to their special needs, which is why they are often neglected. Especially nursing home residents suffer from a variety of health impairments which are accompanied by a high number of prescription drugs and adverse events and can therefore make patient involvement more difficult. The present project aims to test the method of patient advisory boards for the involvement of nursing home residents. Using the design of a clinical trial to optimise medication for nursing home residents as a case study, we will assess the feasibility of the method for this target group. We will also install a patient advocate as moderator of the advisory board. The study plan is described in the present study protocol., Methods: Two patient advisory boards with nursing home residents will be established. With a patient advocate acting as moderator, the essential elements of a clinical trial to optimise medication will be discussed and passed on to the study planning team via the patient advocate. The overall topic of the clinical trial is the optimisation of medication in cardiovascular disease. The nursing home residents are informed about the contents and ideas of the study to be planned and the interests of the researchers, respectively, and will discuss the proposals of the study planning team. Nursing home residents', the patient advocate's and the researchers' expectations and experiences will be examined in individual interviews., Discussion: The study will provide a potentially suitable method to involve nursing home residents in the research process. The jointly developed study design will be incorporated into a new project proposal. The results will be used to inform the development of a German handbook on active public and patient involvement., (Copyright © 2020. Published by Elsevier GmbH.)

Olive (Olea europaea L.) leaves and tea (Camellia sinensis) are rich sources of bioactive compounds, especially polyphenols. Our previous studies have evidenced the potential use of Saccharomyces cerevisiae as a natural delivery system for these antioxidants and a means to improve their bioaccessibility in the human gut. In the present work, the antiproliferative effect of green tea (GT), black tea (BT) and olive leaves (OL) infusions and suspensions of S. cerevisiae were evaluated, for the first time, in human colon cancer cells (Caco-2) after biosorption and in vitro gastrointestinal digestion. The bioaccessible fractions (BF) were not overtly cytotoxic, not affecting cell viability. ROS and mitochondrial membrane potential changes (Δψm) values were reduced compared with control cells. Moreover, all the BF after biosorption induced a significant (p < 0.05) increase in cell proportions in S-phase. The arrest of the cell cycle was reversible without induction of apoptosis, suggesting that the biosorbed phenolics in both infusions and suspensions act as cytostatic agents., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Usually, patients participating in clinical trials have a passive role as test persons. This creates a risk that patients' needs and interests are not reflected in clinical research. The aim of the present paper is to give an introduction to patient involvement in clinical research. It is based on an exploratory literature research and our own experiences with patient involvement. By actively involving patients in the design, conduct and translation of clinical trials, research and healthcare can be better tailored to meet the patients' needs. Patient involvement has the potential to enhance the quality and relevance of research, support patient empowerment and contribute to the democratisation of research processes. There are different methods to involve patients in research, which are often differentiated as consultation, cooperation and user-led research. Methods, time of involvement and persons to be involved should be chosen to fit the aims of the involvement. While cultural, practical and personal barriers could hinder patient involvement, there are several strategies that enable effective involvement: defining the aims of the involvement, clarifying motivation and expectations as well as roles and the form of cooperation, offering training, planning sufficient resources, involving patients from the start and communicating the benefits of involvement., (Copyright © 2020. Published by Elsevier GmbH.)

Background: Patient and public involvement (PPI) has become an essential part of the design, conduct, and dissemination of research. While researchers who employed PPI mainly report on the positive aspects, in practice PPI is still an exception in clinical trials in Germany. There are specific challenges in the process of involvement that can jeopardize the conduct of involvement. The aim of our study was to analyze the experience of patients and researchers with PPI in a clinical trial in Germany, so we could learn more about potential challenges and how they could be addressed., Methods: We established a patient board for a randomized controlled trial on urinary tract infections, where patients and researchers regularly met to discuss relevant aspects of the trial. Minutes were taken for each meeting and the moderator also noted her observations in a postscript. After four meetings, we conducted two focus groups, one each with the patients and researchers. We analyzed and categorized the minutes, postscripts, and focus group transcripts using thematic qualitative text analysis., Results: Patients and researchers felt comfortable with the composition of the patient board and its' atmosphere. In terms of challenges, patients and researchers needed time to get familiar with PPI. Both parties saw a need for training in PPI but differed in their views on the relevant topics. Patients wished to learn more about their role and tasks within the board at the onset of the PPI. They also preferred to meet more frequently and get more intensely involved in the trial. In contrast, researchers perceived that they were already highly involved. They further felt that the involvement was of benefit to them, the trial and future research. Patients described benefits for themselves, but also wondered if their involvement had had an impact on the trial., Conclusions: To facilitate effective PPI, resources, adequate structures, and training are needed. Patients and researchers need to agree on their respective roles, training needs, and the mode of cooperation right at the beginning. The parties involved should continuously reflect on the actual benefits of PPI, describe them explicitly and make them transparent for all., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s). 2019.)