Improving quality and patient safety in surgical care through standardisation and harmonisation of perioperative care (SAFEST project): A research protocol for a mixed methods study.

INTRODUCTION: Adverse events in health care affect 8% to 12% of patients admitted to hospitals in the European Union (EU), with surgical adverse events being the most common types reported. AIM: SAFEST project aims to enhance perioperative care quality and patient safety by establishing and implementing widely supported evidence-based perioperative patient safety practices to reduce surgical adverse events. METHODS: We will conduct a mixed-methods hybrid type III implementation study supporting the development and adoption of evidence-based practices through a Quality Improvement Learning Collaborative (QILC) in co-creation with stakeholders. The project will be conducted in 10 hospitals and related healthcare facilities of 5 European countries. We will assess the level of adherence to the standardised practices, as well as surgical complications incidence, patient-reported outcomes, contextual factors influencing the implementation of the patient safety practices, and sustainability. The project will consist of six components: 1) Development of patient safety standardised practices in perioperative care; 2) Guided self-evaluation of the standardised practices; 3) Identification of priorities and actions plans; 4) Implementation of a QILC strategy; 5) Evaluation of the strategy effectiveness; 6) Patient empowerment for patient safety. Sustainability of the project will be ensured by systematic assessment of sustainability factors and business plans. Towards the end of the project, a call for participation will be launched to allow other hospitals to conduct the self-evaluation of the standardized practices. DISCUSSION: The SAFEST project will promote patient safety standardized practices in the continuum of care for adult patients undergoing surgery. This project will result in a broad implementation of evidence-based practices for perioperative care, spanning from the care provided before hospital admission to post-operative recovery at home or outpatient facilities. Different implementation challenges will be faced in the application of the evidence-based practices, which will be mitigated by developing context-specific implementation strategies. Results will be disseminated in peer-reviewed publications and will be available in an online platform.

Health-Related Quality of Life, Stress, Caregiving Burden and Special Needs of Parents Caring for a Short-Statured Child-Review and Recommendations for Future Research.

Children with short stature can experience a range of burdens due to their chronic condition. However, little is known about parents' experiences dealing with their child's short stature and the potential caregiving burdens and concerns they may face. We aim to review the literature on health-related quality of life (HRQOL), caregiving burden, and special needs among parents caring for a child with isolated growth hormone deficiency (IGHD) or idiopathic short stature (ISS). Using pre-defined inclusion and exclusion criteria, we systematically searched for literature using PubMed and Web of Science from its inception to December 2022. We identified 15 articles assessing HRQOL, special needs, or caregiving burdens in parents of IGHD/ISS children. The main problems included concerns about the future, organizational issues, side effects from growth hormone treatment, and social stigmatization. Furthermore, two studies assessed parents' special needs to cope with caregiving stress, mainly the dialogue between them and their families or parent support groups. This review outlines parental burdens, needs, and resources when caring for an IGHD/ISS child. Furthermore, it provides information about previously used measures appraising parents' special needs and underlines the need for disease-specific measurements.

Health-related quality of life and patient-reported outcome measurements in patients with cystinosis.

Nephropathic cystinosis is a rare autosomal recessive lysosomal storage disorder. With the availability of treatment and renal replacement therapy, nephropathic cystinosis has evolved from an early fatal disease to a chronic, progressive disorder with potentially high impairment. We aim to review the literature on the health-related quality of life and identify appropriate patient-reported outcome measurements to assess the health-related quality of life of patients with cystinosis. For this review, we conducted a literature search in PubMed and Web of Science in September 2021. Inclusion and exclusion criteria for the selection of articles were defined a priori. We identified 668 unique articles through the search and screened them based on title and abstract. The full texts of 27 articles were assessed. Finally, we included five articles (published between 2009 and 2020) describing the health-related quality of life in patients with cystinosis. All studies, apart from one, were conducted in the United States, and no condition-specific measurement was used. Patients with cystinosis reported a lower health-related quality of life (for certain dimensions) than healthy subjects. Few published studies address the health-related quality of life of patients with cystinosis. Such data must be collected standardized and follow the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. To gain a comprehensive understanding of the impact of this disorder on health-related quality of life, it is necessary to use generic and condition-specific instruments to measure this, preferably in large samples from longitudinal studies. A cystinosis-specific instrument for measuring health-related quality of life has yet to be developed.

[Measures for optimal access to psychosocial care of children with rare diseases and their families]. / Maßnahmen für einen optimalen Zugang von Kindern mit seltenen Erkrankungen und ihrer Familien zur psychosozialen Versorgung.

BACKGROUND: The diagnosis and treatment of rare diseases in childhood can affect the quality of life and mental health of the entire family. The psychosocial challenges are significant for those affected and are often compounded by a lack of appropriate support services. RESEARCH QUESTION: This article aims to summarize the barriers of current pathways to psychosocial care and identify potential solutions for a care strategy adapted to the needs of families. MATERIALS AND METHODS: In three focus group sessions with 14 professionals from the field of rare pediatric diseases, the results of a previous qualitative study on barriers in current pathways to psychosocial care were presented. In the focus groups, the experts discussed possible solutions. RESULTS AND DISCUSSION: Despite an increased need for psychosocial support services, it is difficult for children with rare diseases and their families to access these. To facilitate access, interventions should address multiple levels. On the one hand, care should be increasingly adapted to the needs of families. At the same time, long-term and reliable care structures need to be established to ensure sustainable care. Structural interdisciplinary collaboration should be promoted, while the training of health professionals should also be more strongly geared to rare diseases.

[Quality of Life and Experienced Distress of Patients Suspected of having a Rare (Chronic) Health Condition - Initial Findings from the ZSE-DUO Study]. / Lebensqualität und erlebte Belastungen von Patient*innen mit Verdacht auf eine Seltene Erkrankung ­ erste Erkenntnisse aus der ZSE-DUO Studie.

OBJECTIVE: Patients suspected of having a rare (chronic) health condition have often gone a long way within the healthcare system. To date, little is known about the health-related quality of life of this group of patients. The study aims to describe the health-related quality of life and the perceived distress of patients suspected of having a rare (chronic) health condition and compare the results with standard values of the German population. METHODS: Eighty patients suspected of having a rare (chronic) health condition were recruited in the nationwide intervention study "ZSE-DUO" and reported their health-related quality of life and perceived distress using the SF-8 and the Distress-Thermometer. RESULTS: The patients rated all eight dimensions of quality of life as well as the physical and mental component scores of the SF-8 significantly lower than the general population. On average, the perceived distress was rated significantly higher. More than 90% of the sample indicated distress in the clinical range. Exhaustion, pain, limited mobility as well as worries and fears were mentioned most frequently as concrete problems, with percentages ranging from 73% to 90% of the total sample. DISCUSSION: In comparison to German reference data, patients suspected of having a rare (chronic) health condition report a massive impairment of their quality of life and a high burden, which is especially characterized by physical and emotional problems. The lack of a diagnosis could explain the high proportion of emotional problems, as it can create a form of legitimation of one's own disease experience. CONCLUSION: The present results underline the need for research on the psychosocial impact of the possible presence of a rare (chronic) health condition. The high distress and the impact on the physical and psychological quality of life domains also highlight the need for care in this patient group.

Effects of different moisture contents on the structural and functional properties of cellulose with cell wall components in different citrus fibres.

This research used a multi-method approach to analyse the influence of different moisture levels (low, medium and high) on the structural and functional properties of cellulose with cell wall materials such as pectin, lignin, and hemicellulose present in citrus fibres. The influence of the drying and purification processes and the source of the citrus fibres on these interactions were also considered. A fluidized bed dryer results in a higher aggregation of cellulose fibres, which limits their interactions with water, pectin, lignin, and hemicellulose. Citrus fibre suspension produce by a alcohol washing in combination with a centrifugal drying process showed higher storage modulus (G'), loss modulus (G'') and water retention capacity. The compositions of the citrus fibres and the type of hydrogen bonding (analysed by FTIR) play a key role in generating stable rheological and thermal properties as well as controlling the moisture sorption behaviour of the citrus fibres.

Knowledge, attitudes, behaviors, and serological status related to Chagas disease among Latin American migrants in Germany: A cross-sectional study in six German cities.

Background: Little is known about knowledge, attitudes and behaviors concerning Chagas disease (CD) among Latin American migrants in Germany to inform public health decision making. Methods: A cross-sectional, questionnaire-based study was conducted between March 2014 and October 2019 among Latin American migrants in six cities in Germany to obtain information on migration history, socioeconomic and insurance status, knowledge about CD, potential risk factors for Trypanosoma cruzi infection, and willingness to donate blood or organs. Results: 168 participants completed the questionnaire. The four countries with the highest proportion of participants contributing to the study population were Colombia, Mexico, Peru and Ecuador. Before migrating to Europe, the majority of the study population resided in an urban setting in houses made of stone or concrete, had higher academic education and was integrated into the German healthcare and healthcare insurance system. The majority of all study participants were also willing to donate blood and organs and a quarter of them had donated blood previously. However, many participants lacked basic knowledge about symptoms and modes of transmission of Chagas disease. One out of 56 serologic tests (1.8%) performed was positive. The seropositive female participant born in Argentina had a negative PCR test and no signs of cardiac or other organ involvement. Conclusions: The study population does not reflect the population structure at risk for T. cruzi infection in endemic countries. Most participants had a low risk profile for infection with T. cruzi. Although the sample size was small and sampling was not representative of all persons at risk in Germany, the seroprevalence found was similar to studies previously conducted in Europe. As no systematic screening for T. cruzi in Latin American blood and organ donors as well as in women of child-bearing age of Latin American origin is implemented in Germany, a risk of occasional transmission of T. cruzi remains.

Health-Related Quality of Life of Children and Adolescents With Congenital Hyperinsulinism - A Scoping Review.

Introduction: Despite improvements in diagnosis and therapeutic advances in treatment, congenital hyperinsulinism (CHI) remains a severe disease with high patient impairment. We aimed to review the literature on Health-related Quality of Life in children and adolescents with congenital hyperinsulinism and summarize the findings. Materials and Methods: For this scoping review, a literature search was conducted in PubMed and Web of Science in May 2021. Inclusion and exclusion criteria for the selection of articles were defined a priori. Results: Two hundred and forty-five (245) articles were identified through the search and screened on the basis of title and abstract. The full texts of forty articles were then assessed. Finally, four articles (published 2012-2020) describing Health-related Quality of Life in children and adolescents with congenital hyperinsulinism were included. The study designs were heterogeneous and included cross-sectional observational studies (n=2), clinical trials (n =1), and case reports (n=1) with different sample sizes. Three studies were conducted in European countries and one in Japan. The results for Health-related Quality of Life revealed inconsistencies. Conclusion: There are only a few studies looking at Health-related Quality of Life in children and adolescents with congenital hyperinsulinism. To gain a comprehensive understanding of the impact of congenital hyperinsulinism on Health-related Quality of Life in children and adolescents, it is necessary to use both generic and condition-specific instruments to measure Health-related Quality of Life of young patients in larger samples, to collect longitudinal data, and to consider qualitative research approaches.

Rare pediatric diseases and pathways to psychosocial care: a qualitative interview study with professional experts working with affected families in Germany.

BACKGROUND: Rare diseases occur in early childhood and have a major impact on the quality of life of the affected children and their families. Their need for psychosocial support is considerable, but psychosocial care in Germany is still far from being part of routine care. We interviewed experts to explore how they describe the current pathways to psychosocial care, potential barriers and problems, and possibilities for improvements. RESULTS: We conducted telephone interviews with 49 experts working in somatic medicine, psychosocial medicine, patient organizations, child and youth welfare, and the educational sector. Interviews were transcribed and analyzed using focused interview analysis. Results document ways of access and facilities used by families to receive psychosocial care. The barriers described by the experts can be summarized on three levels: the family-organizational level, the family-psycho-emotional level, and finally, the structural system level. Accordingly, suggestions for improvement were directed at these levels. CONCLUSION: Based on the experts' perspectives, there is ample room for improvement to facilitate the pathways to psychosocial care for children with rare diseases and their families. Unfortunately, there seems to be a long way to go before psychosocial care will be routinely provided. However, awareness of the issue among different professional groups is high, and numerous suggestions for improvement were made, including continuous expansion of services to all family members, strengthening of low-threshold services, simplifying application procedures, and more cooperation between different funding agencies as well as between different care providers.

The empty nest, depressive symptoms and loneliness of older parents: Prospective findings from the German Ageing Survey.

OBJECTIVES: The aim of this study was to analyse the longitudinal association between the transition to an empty nest and depressive symptoms and loneliness, respectively. METHOD: Longitudinal data was used from the German Ageing Survey, a representative sample of community-dwelling adults aged 40 and over. The indication of children living outside the respondent's household was defined as an empty nest. A 6-item version of the validated De Jong Gierveld Loneliness scale was used to assess perceived loneliness. The 15 item version of the Center for Epidemiological Studies Depression Scale was used to measure depressive symptoms. Fixed-effects regression analyses adjusted for time-varying socio-demographic and health-related variables were applied. RESULTS: The unadjusted regression yielded that transitioning to an empty nest led to decreased loneliness in men (b =  -0.05; p < 0.05) and increased depressive symptoms in women (b =  0.48; p =  0.05). However, when controlling for potential confounders, the transition was no longer associated with a change in loneliness or depressive symptom scores. CONCLUSION: The empty nest is an expected phase of the family life cycle that most parents will experience. In this longitudinal study, this phase of the family life cycle was shown not to be associated with parents' psychosocial health in terms of loneliness and depressive symptoms. Our study suggests that the consequences of an empty nest have been overestimated in the past. Future longitudinal studies with panel regression models in different cultural settings are needed to confirm our findings.

Exploring the use of web searches for risk communication during COVID-19 in Germany.

Risk communication during pandemics is an element of utmost importance. Understanding the level of public attention-a prerequisite for effective communication-implicates expensive and time-consuming surveys. We hypothesise that the relative search volume from Google Trends could be used as an indicator of public attention of a disease and its prevention measures. The search terms 'RKI' (Robert Koch Institute, national public health authority in Germany), 'corona' and 'protective mask' in German language were shortlisted. Cross-correlations between these terms and the reported cases from 15 February to 27 April were conducted for each German federal state. The findings were contrasted against a timeline of official communications concerning COVID-19. The highest correlations of the term 'RKI' with reported COVID-19 cases were found between lags of - 2 and - 12 days, meaning web searches were already performed from 2 to 12 days before case numbers increased. A similar pattern was seen for the term 'corona'. Cross-correlations indicated that most searches on 'protective mask' were performed from 6 to 12 days after the peak of cases. The results for the term 'protective mask' indicate a degree of confusion in the population. This is supported by conflicting recommendations to wear face masks during the first wave. The relative search volumes could be a useful tool to provide timely and location-specific information on public attention for risk communication.

Investigating the utility of Google trends for Zika and Chikungunya surveillance in Venezuela.

INTRODUCTION: Chikungunya and Zika Virus are vector-borne diseases responsible for a substantial disease burden in the Americas. Between 2013 and 2016, no cases of Chikungunya or Zika Virus were reported by the Venezuelan Ministry of Health. However, peaks of undiagnosed fever cases have been observed during the same period. In the context of scarce data, alternative surveillance methods are needed. Assuming that unusual peaks of acute fever cases correspond to the incidences of both diseases, this study aims to evaluate the use of Google Trends as an indicator of the epidemic behavior of Chikungunya and Zika. METHODS: Time-series cross-correlations of acute fever cases reported by the Venezuelan Ministry of Health and data on Google search queries related to Chikungunya and Zika were calculated. RESULTS: A temporal distinction has been made so that acute febrile cases occurring between 25th of June 2014 and 23rd of April 2015 were attributed to the Chikungunya virus, while cases occurring between 30th of April 2015 and 29th of April 2016 were ascribed to the Zika virus. The highest cross-correlations for each disease were shown at a lag of 0 (r = 0.784) for Chikungunya and at + 1 (r = 0.754) for Zika. CONCLUSION: The strong positive correlation between Google search queries and official data on acute febrile cases suggests that this resource can be used as an indicator of endemic urban arboviruses activity. In the Venezuelan context, Internet search queries might help to overcome some of the gaps that exist in the national surveillance system.

The association of multimorbidity, loneliness, social exclusion and network size: findings from the population-based German Ageing Survey.

BACKGROUND: The aim of this study was to examine the association between multimorbidity and (i) loneliness, (ii) social exclusion and (iii) network size, respectively. METHODS: Cross-sectional data from a German representative sample of community-dwelling adults aged 40 and over was used (N = 7604). Multimorbidity was indicated with the presence of two or more diseases. Self-rated loneliness was assessed with a short form of the validated De Jong Gierveld Loneliness Scale and social exclusion was measured with a validated scale developed by Bude and Lantermann. Counts of important people in regular contact represented the network size of respondents. RESULTS: Multimorbidity was present in 68% of the sample. While controlling for potential confounders, multiple linear regression analysis yielded that multimorbidity was associated with increased loneliness (b = 0.08; p < 0.001) and increased social exclusion (b = 0.10; p < 0.01). Multimorbidity was also associated with an increased network size (b = 0.27; p < 0.001). CONCLUSION: While there was an association between multimorbidity and increased social exclusion as well as increased loneliness, regressions also revealed an association between multimorbidity and an increased network size. Although the association between multimorbidity and our outcome measures is weak, its complex nature should be investigated further using a longitudinal approach.

Combined in vitro fertilization and culture (IVF/IVC) in mouse for reprotoxicity assessment of xenobiotic exposure.

Litter size and other conventional measures in rodents are common end-points in the assessment of xenobiotics for reprotoxic effects. However, since litter size may be normal despite reduced semen quality, we established and tested a mouse in vitro fertilization/in vitro culture (IVF/IVC) system to assess other aspects of reprotoxicity of xenobiotic exposure. Two pesticides, vinclozolin (V) and chlormequat (C), were added to feed in low (40 and 900 ppm, respectively) and high (300 and 2700 ppm, respectively) doses and compared to control (nil pesticide). Exposed males were used for natural mating to evaluate litter size and then used for IVF/IVC and sperm evaluation. The IVF/IVC system detected significant adverse effect of high dose of vinclozolin on blastocyst formation, which was not detected by conventional measures such as litter size or sperm motility and viability. We conclude that assessment based on IVF/IVC measures may complement litter size and other conventional end-points.

The longitudinal association of multimorbidity on loneliness and network size: Findings from a population-based study.

OBJECTIVE: The aim of this study was to investigate the association between the onset of multimorbidity with loneliness and social network size longitudinally. METHODS: Longitudinal data was used from the German Ageing Survey, a representative sample of adults aged 40 and over, residing in private households. The presence of two or more illnesses indicated multimorbidity. A 6-item version of the validated De Jong Gierveld Loneliness scale was used to assess perceived loneliness. The network size of respondents was represented by counts of important people in regular contact. Fixed-effects regressions adjusted for time-varying socio-demographic, life style, and health-related variables were used. RESULTS: The regression analysis yielded, when controlling for possible confounders, that the onset of multimorbidity led to increased loneliness (ß = .06, p < .001). However, the results revealed as well that the onset of multimorbidity was associated with an increased network size (ß = .29, p < .001). CONCLUSION: Results demonstrate a complex relationship of the variables examined. Efforts to target multimorbidity, eg, to postpone or prevent it, could be helpful to decrease loneliness.

Sleep and Pain: A Systematic Review of Studies of Mediation.

OBJECTIVES: A relationship between sleep and pain is well established. A better understanding of the mechanisms that link sleep and pain intensity is urgently needed to optimize pain management interventions. The objective of this systematic review was to identify, synthesize, and critically appraise studies that have investigated putative mediators on the path between sleep and pain intensity. METHODS: A systematic search of 5 electronic bibliographic databases (EMBASE, MEDLINE, CINAHL, PsycINFO, and the Cochrane Central Register of Controlled Trials) was conducted. Eligible studies had to apply a formal test of mediation to variables on the path between a sleep variable and pain intensity or vice versa. All searches, data extraction and quality assessment were conducted by at least 2 independent reviewers. RESULTS: The search yielded 2839 unique articles, 9 of which were eligible. Of 13 mediation analyses, 11 investigated pathways from a sleep variable to pain intensity. Putative mediators included affect/mood, depression and/or anxiety, attention to pain, pain helplessness, stress, fatigue, and physical activity. Two analyses investigated pathways from pain intensity to a sleep variable, examining the potentially mediating role of depressive symptoms and mood. Although evidence supported a mediating role for psychological and physiological aspects of emotional experiences and attentional processes, methodological limitations were common, including use of cross-sectional data and minimal adjustment for potential confounders. DISCUSSION: A growing body of research is applying mediation analysis to elucidate mechanistic pathways between sleep and pain intensity. Currently sparse evidence would be illuminated by more intensively collected longitudinal data and improvements in analysis.

Molecular cloning and characterization of porcine Na⁺/K⁺-ATPase isoform α4.

Na+/K+-ATPase is responsible for maintaining electrochemical gradients of Na+ and K+, which is essential for a variety of cellular functions including neuronal activity. The α-subunit of the Na+/K+-ATPase is composed of four different polypeptides (α1-α4) encoded by different genes. Na,K-ATPase α4, encoded by the ATP1A4 gene, is expressed in testis and in male germ cells of humans, rats and mice. The α4 polypeptide has an important role in sperm motility, and is essential for male fertility. Here we present the RT-PCR cloning and characterization of the porcine ATP1A4 cDNA coding for Na⁺/K⁺-ATPase polypeptide α4. The Na⁺/K⁺-ATPase polypeptide α4, consisting of 1030 amino acids, displays a high homology with its human counterpart (86%). Phylogenetic analysis demonstrated that porcine Na⁺/K⁺-ATPase polypeptide α4 is closely related to other mammalian counterparts. In addition, the genomic structure of the porcine ATP1A4 gene was determined, and the intron-exon organization was found to be similar to that of the human ATP1A4 gene. The promoter sequence for the porcine ATP1A4 gene was also identified. Investigation of the genetic variation in the porcine ATP1A4 gene revealed a missense A/G SNP in exon 18. This A/G polymorphism results in a substitution of a methionine to a glycine residue (M888G). A very high overall DNA methylation rate of the ATP1A4 gene, 70-80%, was observed in both brain and liver. Expression analysis demonstrated that the porcine ATP1A4 gene is predominantly expressed in testis. The sequence of the porcine ATP1A4 cDNA encoding the Na⁺/K⁺-ATPase α4 protein has been submitted to GenBank under the accession number GenBank Accession No. MG587082.

A-to-I RNA editing of the IGFBP7 transcript increases during aging in porcine brain tissues.

The IGFBP7 gene encodes insulin-like growth factor protein 7. IGFPB7 is involved in diverse biological functions including cell growth regulation, senescence and apoptosis, and also acts as a tumor suppressor in multiple cancers. The IGFBP7 mRNA is subject to A-to-I RNA editing mediated by adenosine deaminases acting on RNA 1 and 2 (ADAR1 and ADAR2). In the current study we have examined molecular characteristics of the porcine IGFBP7 gene, and determined the mRNA editing in different tissues. The A-to-I RNA editing of human IGFBP7 in positions Arg78 and Lys95 was shown to be conserved in the porcine homologue. In addition, a novel editing site was discovered in position Lys97 in the porcine IGFBP7 transcript. A differential editing was demonstrated at the three positions in the IGFBP7 transcript with very high degrees of editing in frontal cortex, cerebellum and lung. Interestingly, the degree of editing increased during aging in porcine frontal cortex and cerebellum. The IGFBP7 gene was mapped to pig chromosome 8. The porcine IGFBP7 gene was found to be ubiquitously expressed in examined organs and tissues. The methylation status of the IGFBP gene was examined in brain and liver by bisulfate sequencing and a high degree of methylation was found in the two tissues, 52% and 54%, respectively.