Participation of adolescents with and without physical disabilities and chronic diseases: A comprehensive conceptualization.

BACKGROUND: In 2001, the International Classification of Functioning and Disability (ICF) introduced participation as a main goal of rehabilitation processes. However, to date, a comprehensive concept of participation in the rehabilitative context is missing, particularly in German-speaking countries. We thus aimed to refine and extend the existing concepts of participation in this brief communication. METHODS: In preceding studies, we conducted semi-structured interviews with adolescents who either had chronic diseases and/or physical disabilities or had no impairments and focus groups with parents and experts. Based on these diverse perspectives and findings, we refine the term participation. RESULTS: Participation is a construct that is embedded in a social context and consists of objective (i.e., attendance) and subjective (i.e., satisfaction and involvement) dimensions. These dimensions are reflected in different domains and areas that are relevant to adolescents' lives. In addition, the subjective relevance of respective areas in life needs to be regarded as a weighing component when evaluating participation. CONCLUSION: Our results reflect international models on participation, refine the existing concept, and underline the multidimensional character of participation. These findings are urgently needed to develop appropriate instruments, for example, for assessing whether rehabilitative processes are effective regarding the goal of participation.

Nutritional interventions for preventing and treating pressure ulcers.

BACKGROUND: Pressure ulcers are localized injuries to the skin or the underlying tissue, or both, and are common in older and immobile people, people with diabetes, vascular disease, or malnutrition, as well as those who require intensive or palliative care. People with pressure ulcers often suffer from severe pain and exhibit social avoidance behaviours. The prevention and treatment of pressure ulcers involves strategies to optimize hydration, circulation, and nutrition. Adequate nutrient intake can reduce the risk factor of malnutrition and promote wound healing in existing pressure ulcers. However, it is unclear which nutrients help prevent and treat pressure ulcers. This is an update of an earlier Cochrane Review. OBJECTIVES: To evaluate the benefits and harms of nutritional interventions (special diets, supplements) for preventing and treating pressure ulcers in people with or without existing pressure ulcers compared to standard diet or other nutritional interventions. SEARCH METHODS: We used extensive Cochrane search methods. The latest search was in May 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) in people with or without existing pressure ulcers, that compared nutritional interventions aimed at preventing or treating pressure ulcers with standard diet or other types of nutritional interventions. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcome for prevention studies was the proportion of participants who developed new (incident) pressure ulcers. For treatment studies, our primary outcomes were time to complete pressure ulcer healing, number of people with healed pressure ulcers, size and depth of pressure ulcers, and rate of pressure ulcer healing. Secondary outcomes were side effects, costs, health-related quality of life and acceptability. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included 33 RCTs with 7920 participants. Data for meta-analysis were available from 6993 participants. Pressure ulcer prevention Eleven studies (with 12 arms) compared six types of nutritional interventions for the prevention of pressure ulcers. Compared to standard diet, energy, protein and micronutrient supplements may result in little to no difference in the proportion of participants developing a pressure ulcer (energy, protein and micronutrient supplements 248 per 1000, standard diet 269 per 1000; RR 0.92, 95% CI 0.71 to 1.19; 3 studies, 1634 participants; low-certainty evidence). Compared to standard diet, protein supplements may result in little to no difference in pressure ulcer incidence (protein 21 per 1000, standard diet 28 per 1000; RR 0.75, 95% CI 0.49 to 1.14; 4 studies, 4264 participants; low-certainty evidence). The evidence is very uncertain about the gastrointestinal side effects of these supplements (protein 109 per 1000, standard diet 155 per 1000; RR 0.70, 95% CI 0.06 to 7.96; 2 studies, 140 participants, very low-certainty evidence). The evidence is very uncertain about the effects of protein, arginine, zinc and antioxidants; L-carnitine, L-leucine, calcium, magnesium and vitamin D; EPA, GLA and antioxidants; disease-specific supplements on pressure ulcer incidence when compared to standard diet (1 study each; very low-certainty evidence for all comparisons). Pressure ulcer treatment Twenty-four studies (with 27 arms) compared 10 types of nutritional interventions or supplements for treatment of pressure ulcers. Compared to standard diet, energy, protein and micronutrient supplements may slightly increase the number of healed pressure ulcers (energy, protein and micronutrients 366 per 1000, standard diet 253 per 1000; RR 1.45, 95% CI 1.14 to 1.85; 3 studies, 577 participants, low-certainty evidence). The evidence is very uncertain about the effect of these supplements on gastrointestinal side effects. Compared to standard diet, the evidence is very uncertain about the effect of protein, arginine, zinc and antioxidant supplements on pressure ulcer healing (pressure ulcer area: mean difference (MD) 2 cm² smaller, 95% CI 4.54 smaller to 0.53 larger; 2 studies, 71 participants, very low-certainty evidence). The evidence on side effects of these supplements is very uncertain. Compared to standard diet, supplements with arginine and micronutrients may not increase the number of healed pressure ulcers, but the evidence suggests a slight reduction in pressure ulcer area (MD 15.8% lower, 95% CI 25.11 lower to 6.48 lower; 2 studies, 231 participants, low-certainty evidence). The evidence is very uncertain about changes in pressure ulcer scores, acceptability, and side effects of these supplements. Compared to placebo, collagen supplements probably improve the mean change in pressure ulcer area (MD 1.81 cm² smaller, 95% CI 3.36 smaller to 0.26 smaller; 1 study, 74 participants, moderate-certainty evidence). The evidence is very uncertain about the effect of these supplements on side effects. The evidence is very uncertain about the effects of vitamin C, different doses of arginine; EPA, GLA (special dietary fatty acids) and antioxidants; protein; a specialized amino acid mixture; ornithine alpha-ketoglutarate and zinc supplements on pressure ulcer healing (1 or 2 studies each; very low-certainty evidence). AUTHORS' CONCLUSIONS: The benefits of nutritional interventions with various compositions for pressure ulcer prevention and treatment are uncertain. There may be little or no difference compared to standard nutrition or placebo. Nutritional supplements may not increase gastrointestinal side effects, but the evidence is very uncertain. Larger studies with similar nutrient compositions would reduce these uncertainties. No study investigated the effects of special diets (e.g. protein-enriched diet, vegetarian diet) on pressure ulcer incidence and healing.

A pilot study to develop a participation self-assessment tool for adolescents: The Social Participation Inventory (SPI).

OBJECTIVE: Participation is one of the key goals of re/habilitative processes. Since participation impacts adolescents' social-emotional development and overall health, this goal is particularly important for them. However, to date, no German-speaking self-assessment tool for participation among adolescents is available. This study sought therefore to develop such a tool and to test its psychometric properties. METHODS: Based on a preliminary qualitative study, we developed 133 items for a pilot version of the Social Participation Inventory (SPI). The SPI assesses the objective dimension (i.e., attendance) and the subjective dimension (i.e., involvement and satisfaction) of participation. To test the psychometric properties of the SPI, we conducted a quantitative cross-sectional survey and applied the SPI to n = 151 adolescents with and without disabilities and/or chronic diseases. RESULTS: By using principal component analyses, we examined the SPI's consistency and verified the theoretical considerations regarding the two components of participation (i.e., objective and subjective dimensions). Items that did not load sufficiently on components were removed after careful theoretical-based consideration. The condensed version of the SPI consists of 39 items that assess participation and 18 items to assess the perceived importance of respective areas of life. The SPI shows very good overall reliability (Cronbach's α = .920) and good validity. CONCLUSION: This study provides a new psychometrically tested participation self-assessment scale for adolescence with and without disabilities and/or chronic diseases. Further research is needed to re-evaluate its psychometric properties and to evaluate the application of the SPI in clinical and scientific contexts.

What does social participation mean? A qualitative study exploring the concept of participation from the perspectives of experts and parents.

OBJECTIVES: This study aimed to assess the theoretical framework regarding social participation from the perspectives of experts and parents of youth aged between 10 and 17 years, and therefore, provides new insights into the concept of social participation. DESIGN: A qualitative study was conducted to understand the construct of social participation in more detail. Eight focus groups were held with experts (n=21) and parents (n=24) and analysed based on content analysis. PARTICIPANTS: We used purposive and snowball sampling to obtain a comprehensive sample of (A) parents of adolescents with and without chronic and/or physical-motor impairments and (B) experts involved in participatory research and/or treatment of adolescents with chronic and/or physical-motor impairments. The final sample consisted of 3 focus groups with a total of 21 experts and 5 focus groups with 24 parents. This included 10 parents who had disabled children. RESULTS: The concept of social participation consists of subjective and objective components. The focus from the experts' perspective is clearly on the subjective level; that is, revolving around the question 'Does the adolescent feel involved?' In contrast, the parents' focus is more on normative expectations. The possibility of participation in all areas of life through the adjustment of environmental factors was identified as a central factor. CONCLUSIONS: The results underline the importance of the subjective feelings of adolescents, as well as the significance of normative requirements. To capture the subjective component of participation, suitable measurements are needed. TRIAL REGISTRATION NUMBER: DRKS00014739.

[Mixed Methods Studies in Health Services Research: Requirements, Challenges and the Question of Integration - a Discussion Paper from the Perspective of Qualitative Researchers]. / Mixed Methods-Studien in der Versorgungsforschung: Anforderungen, Herausforderungen und die Frage der Integration ­ ein Diskussionspapier aus der Perspektive qualitativ Forschender.

With this discussion paper, the subgroup Mixed Methods of the working group Qualitative Research Methods in the non-profit organization German Network Health Services Research (DNVF) is taking up the topic of three previous discussion papers on the significance and potentials of qualitative research methods in health services research. Mixed methods are being increasingly used and demanded in health services research. However, there are also areas of conflict in the planning and implementation of mixed methods studies, and these are addressed in this paper from the perspective of qualitative research. Special attention is given to the aspect of integration as the fundamental signature of mixed methods research. With this discussion paper, our aim was to stimulate critical as well as constructive exchange of ideas on what constitutes high-quality health services research characterised by a diversity of methods and the framework conditions under which this can succeed.

Prenatal exposure to opioids and neurodevelopment in infancy and childhood: A systematic review.

Aim: This systematic review aims to estimate the relationship between prenatal exposure to opioids and neurodevelopmental outcomes and examines potential sources of heterogeneity between the studies. Methods: We searched four databases through May 21st, 2022: PubMed, Embase, PsycInfo and the Web of Science according to a specified search strings. Study inclusion criteria include: (1) cohort and case-control peer-reviewed studies published in English; (2) studies comparing neurodevelopmental outcomes among children with prenatal opioid-exposure (prescribed or used non-medically) vs. an unexposed group. Studies investigating fetal alcohol syndrome or a different primary prenatal exposure other than opioids were excluded. Two main performed data extraction using "Covidence" systematic review platform. This systematic review was conducted in accordance with PRISMA guidelines. The Newcastle-Ottawa-Scale was used for quality assessment of the studies. Studies were synthesized based on the type of neurodevelopmental outcome and the instrument used to assess neurodevelopment. Results: Data were extracted from 79 studies. We found significant heterogeneity between studies due to their use of different instruments to explore cognitive skills, motor, and behavioral outcomes among children of different ages. The other sources of heterogeneity included: procedures to assess prenatal exposure to opioids; period of pregnancy in which exposure was assessed; type of opioids assessed (non-medical, medication used for opioid use dis-order, prescribed by health professional), types of co-exposure; source of selection of prenatally exposed study participants and comparison groups; and methods to address lack of comparability between exposed and unexposed groups. Cognitive and motor skills as well as behavior were generally negatively affected by prenatal opioid exposure, but the significant heterogeneity precluded a meta-analysis. Conclusion: We explored sources of heterogeneity in the studies assessing the association between prenatal exposure to opioids and neurodevelopmental outcomes. Sources of heterogeneity included different approaches to participant recruitment as well as exposure and outcome ascertainment methods. Nonetheless, overall negative trends were observed between prenatal opioid exposure and neuro-developmental outcomes.

The Adolescent Concept of Social Participation-A Qualitative Study on the Concept of Social Participation from Adolescents with and without Physical Disabilities.

PURPOSE: The construct of social participation is still not clearly defined. To reach a better understanding of social participation, the perspectives of adolescents must be taken into account. This study explores the adolescent concept of social participation and expands knowledge of the meaning of subjective components of the term. METHODS: Thirty-four semi-structured interviews were conducted with adolescents with and without physical disabilities or chronic diseases between the ages of 12 and 17 and analyzed according to grounded theory. RESULTS: Adolescents describe social participation as involving reflexive interaction with their social environment. Furthermore, forming a social environment plays an important role. All components of the concept are embedded in a context that influences the ways adolescents participate. Adolescents differentiate between active and passive forms of social participation. The concept of reflexive interaction is situated within an interdependent structure of components such as the "feeling of belonging" and the feeling of "well-being" among adolescents. CONCLUSION: The results expand the current state of knowledge regarding the theoretical differentiation of social participation by exploring subjective components of the term. This offers the possibility of supplementing the theoretical frameworks of social participation and supports the understanding of the critical importance of social participation for adolescents.

[The importance of health-conscious nutrition education in schools : Results of an analysis of selected German framework curricula]. / Der Stellenwert gesundheitsbewusster Ernährungsbildung in der Schule : Ergebnisse einer Analyse ausgewählter deutscher Rahmenlehrpläne.

BACKGROUND: Obesity, including among children and adolescents, is a major problem both nationally and internationally and is strongly linked to nutrition. Eating habits are formed at an early age and can influence the development of disease. Schools as places of learning and living can promote balanced and sustainable eating habits. The aim of this study was therefore to analyze selected curricula on nutrition education in order to identify deficits and suggestions for improvement in school nutrition education. METHODS: The most recent version of the scientific and home economics framework curricula of secondary schools as of 2019 were examined by means of qualitative curriculum analysis. The focus was on nutrition topics as well as their possibilities for in-depth study, practical implementation, and timeframe. RESULTS AND DISCUSSION: According to this analysis, nutrition and human biology are taught mainly up to grade 8 in all curricula, while more complex topics tend to be taught from grade 9 onward. Concrete learning content relevant to everyday life on practical nutrition, food quality, and the role of nutrition in disease prevention can significantly improve students' nutritional literacy but currently receive too little attention in the curricula. Home economics subjects address consumer issues, among other topics, but are offered in only three out of six states. Electives and honors courses can supplement nutrition education, but are not part of the curriculum at all schools. The amount of time and the practical implementation of nutrition education are strongly dependent on internal school factors. In some cases, there are considerable deficits in nutrition education. CONCLUSION: It is considered useful to intensify nutrition education in higher grades, to introduce home economics subjects in all types of schools, and to standardize the curriculum content among the individual states.

Participation in structured diabetes self-management education programs and its associations with self-management behaviour - a nationwide population-based study.

OBJECTIVE: To evaluate the relationship between participation in structured diabetes self-management education programs (DSME) and self-management behaviour (SMB) in routine care. METHODS: The study included 864 ever- and 515 never-DSME participants from the population-based survey German Health Update (GEDA) 2014/2015. SMB and clinical care variables were: Following a diet plan, keeping a diabetes diary, holding a diabetes pass, self-monitoring of blood glucose (SMBG), foot self-examination (FSE), retinopathy screening, haemoglobin A1c (HbA1c) measurement and examination of the feet by clinicians (FEC). We conducted logistic regression analyses for association of DSME-participation with SMB, adjusting for various variables. RESULTS: DSME-participation was significantly associated with SMB including following a diet plan (OR 1.88 [95% CI 1.21-2.92]), keeping a diabetes journal (OR 3.83 [2.74-5.36]), holding a diabetes health passport (OR 6.11 [4.40-8.48]), SMBG (OR 2.96 [2.20-3.98]) and FSE (OR 2.64 [2.01-3.47]) as well as retinopathy screening (OR 3.30 [2.31-4.70]), HbA1c measurement (OR 2.58 [1.88-3.52]), and FEC (OR 3.68 [2.76-4.89]) after adjusting for confounders. CONCLUSION: DSME-participation is associated with higher frequencies of various SMB and clinical care variables in routine care. Never-DSME attenders are more likely not to receive retinopathy screening, FEC and HbA1c measurements as recommended. PRACTICE IMPLICATIONS: Clinicians should refer diabetes patients to a DSME and ensure a regular follow up for never-DSME attenders.

Infants' prenatal exposure to opioids and the association with birth outcomes: A systematic review and meta-analysis.

BACKGROUND: Prenatal exposure to opioids (PEO) is a worldwide public health issue. Opioids cross the placental barrier and may affect the developing foetus and the birth outcomes. OBJECTIVES: This review aimed to explore newborns' weight, length and head circumference, preterm birth, and perinatal death as primary outcomes in relation to PEO. The secondary outcomes were gestational age at birth, Apgar scores and length of hospitalisation after delivery. DATA SOURCES: PubMed, Embase, PsycInfo and the Web of Science. STUDY SELECTION AND DATA EXTRACTION: Inclusion criteria were (i) cohort, case-control or cross-sectional peer-reviewed studies published in English through 1 March 2021; (ii) comparing outcomes between prenatal exposed and unexposed groups to opioids (prescribed or obtained illegally). Exclusion criteria were foetal alcohol syndrome and non-opioid primary exposure. SYNTHESIS: Data were extracted by two authors. The Newcastle-Ottawa Quality Assessment Scale was used for study quality assessment. Due to heterogeneity across studies, we used random effects models to obtain pooled standardised mean difference (SMD), pooled risk ratio (RR) and 95% confidence interval (CI). RESULTS: Data from 80 studies were extracted. In meta-analyses, opioid-exposed neonates had lower birthweight (SMD -0.77, 95% CI -0.90, -0.64, I2  = 82%), smaller head circumference (SMD -0.67, 95% CI -0.86, -0.48, I2  = 84%), shorter birth length (SMD -0.97, 95% CI -1.24, -0.70, I2  = 91%) and gestational age (SMD -0.45, 95% CI -0.60, -0.30, I2  = 80%) than unexposed neonates. Pooled risks of neonatal death and preterm birth were higher among opioid-exposed compared to unexposed neonates (RR 4.05, 95% CI 2.12, 7.72, I2  = 73%; and RR 1.92, 95% CI 1.57, 2.35, I2  = 99%). CONCLUSIONS: We found increased risks of adverse birth outcomes in relation to PEO. Caution should be used in interpreting the findings, as many studies were rated as poor quality, and with substantial inter-study heterogeneity. Future studies should ensure comparability of opioid-exposed and -unexposed group to strengthen internal validity.

Patterns and associated factors of diabetes self-management: Results of a latent class analysis in a German population-based study.

OBJECTIVE: Few studies on diabetes self-management considered the patterns and relationships of different self-management behaviours (SMB). The aims of the present study are 1) to identify patterns of SMB among persons with diabetes, 2) to identify sociodemographic and disease-related predictors of SMB among persons with diabetes. RESEARCH DESIGN AND METHODS: The present analysis includes data of 1,466 persons (age 18 to 99 years; 44.0% female; 56.0% male) with diabetes (type I and II) from the population-based study German Health Update 2014/2015 (GEDA 2014/2015-EHIS). We used latent class analysis in order to distinguish different patterns of self-management behaviours among persons with diabetes. The assessment of SMB was based on seven self-reported activities by respondents (dietary plan, diabetes-diary, diabetes health pass, self-assessment of blood glucose, self-examination of feet, retinopathy-screenings and assessment of HbA1c). Subsequent multinomial latent variable regressions identified factors that were associated with self-management behaviour. RESULTS: Latent class analysis suggested a distinction between three patterns of SMB. Based on modal posterior probabilities 42.8% of respondents showed an adherent pattern of diabetes self-management with above-average frequency in all seven indicators of SMB. 32.1% showed a nonadherent pattern with a below-average commitment in all seven forms of SMB. Another 25.1% were assigned to an ambivalent type, which showed to be adherent with regard to retinopathy screenings, foot examinations, and the assessment of HbA1c, yet nonadherent with regard to all other forms of SMB. In multivariable regression analyses, participation in Diabetes Self-Management Education programs (DSME) was the most important predictor of good self-management behaviour (marginal effect = 51.7 percentage points), followed by attentiveness towards one's personal health (31.0 percentage points). Respondents with a duration of illness of less than 10 years (19.5 percentage points), employed respondents (7.5 percentage points), as well as respondents with a high socioeconomic status (24.7 percentage points) were more likely to show suboptimal forms of diabetes self-management. DISCUSSION: In the present nationwide population-based study, a large proportion of persons with diabetes showed suboptimal self-management behaviour. Participation in a DSME program was the strongest predictor of good self-management. Results underline the need for continual and consistent health education for patients with diabetes.

Souvenaid for Alzheimer's disease.

BACKGROUND: Souvenaid is a dietary supplement with a patented composition (Fortasyn Connect™)which is intended to be used by people with Alzheimer's disease (AD). It has been designed to support the formation and function of synapses in the brain, which are thought to be strongly correlated with cognitive function. If effective, it might improve symptoms of Alzheimer's disease and also prevent the progression from prodromal Alzheimer's disease to dementia. We sought in this review to examine the evidence for this proposition. OBJECTIVES: To assess the effects of Souvenaid on incidence of dementia, cognition, functional performance, and safety in people with Alzheimer's disease. SEARCH METHODS: We searched ALOIS, i.e. the specialised register of the Cochrane Dementia and Cognitive Improvement Group, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), Web of Science (ISI Web of Science), Cinahl (EBSCOhost), Lilacs (BIREME), and clinical trials registries up to 24 June 2020. We also reviewed citations of reference lists of landmark papers, reviews, and included studies for additional studies and assessed their suitability for inclusion in the review. SELECTION CRITERIA: We included randomised, placebo-controlled trials which evaluated Souvenaid in people diagnosed with mild cognitive impairment (MCI) due to AD (also termed prodromal AD) or with dementia due to AD, and with a treatment duration of at least 16 weeks. DATA COLLECTION AND ANALYSIS: Our primary outcome measures were incidence of dementia, global and specific cognitive function, functional performance, combined cognitive-functional outcomes and adverse events. We selected studies, extracted data, assessed the quality of trials and intended to conduct meta-analyses according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of the evidence using the GRADE approach. We present all outcomes grouped by stage of AD. MAIN RESULTS: We included three randomised, placebo-controlled trials investigating Souvenaid in 1097 community-dwelling participants with Alzheimer's disease. One study each included participants with prodromal AD, mild AD dementia and mild-to-moderate AD dementia. We rated the risks of bias of all trials as low. One study (in prodromal AD) was funded by European grants. The other two studies were funded by the manufacturer of Souvenaid. One trial investigated the incidence of dementia in people with prodromal AD at baseline, and found little to no difference between the Souvenaid group and the placebo group after 24 months (RR 1.09, 95% CI 0.82 to 1.43; 1 trial, 311 participants; moderate quality of evidence). In prodromal AD, and in mild and mild-to-moderate Alzheimer's disease dementia, Souvenaid probably results in little or no difference in global or specific cognitive functions (moderate quality of evidence). Everyday function, or the ability to perform activities of daily living, were measured in mild and mild-to-moderate AD dementia. Neither study found evidence of a difference between the groups after 24 weeks of treatment (moderate quality of evidence). Two studies investigated combined cognitive-functional outcomes with the Clinical Dementia Rating Sum of Boxes and observed conflicting results. Souvenaid probably results in slight improvement, which is below estimates of meaningful change, in participants with prodromal Alzheimer's disease after 24 months (moderate quality of evidence), but probably has little to no effect in mild-to-moderate Alzheimer's disease dementia after 24 weeks (moderate quality of evidence). Adverse effects observed were low in all trials, and the available data were insufficient to determine any connection with Souvenaid. AUTHORS' CONCLUSIONS: Two years of treatment with Souvenaid probably does not reduce the risk of progression to dementia in people with prodromal AD. There is no convincing evidence that Souvenaid affects other outcomes important to people with AD in the prodromal stage or mild-to-moderate stages of dementia. Conflicting evidence on combined cognitive-functional outcomes in prodromal AD and mild AD dementia warrants further investigation. Adverse effects of Souvenaid seem to be uncommon, but the evidence synthesised in this review does not permit us to make a definitive statement on the long-term tolerability of Souvenaid. The effects of Souvenaid in more severe AD dementia or in people with AD at risk of nutritional deficiencies remain unclear.

Participation in structured diabetes mellitus self-management education program and association with lifestyle behavior: results from a population-based study.

OBJECTIVE: Whether participation in structured diabetes self-management education programs (DSME) for participants with diabetes mellitus is associated with a healthy lifestyle in routine care apart from randomized-controlled studies remains unclear and is this studies' research question. RESEARCH DESIGN AND METHODS: We identified 1300 persons with diabetes mellitus drawn from the cross-sectional population-based analysis German Health Update 2014/2015 (GEDA 2014/2015), which integrated the modules of the European Health Interview Survey (EHIS) wave 2. Of those, 816 were ever-DSME participants and 484 never-participants. We conducted multivariable weighted logistic regression analyses for lifestyle differences comparing ever-DSME and never-DSME participants. Lifestyle was defined by physical activity (PA), current smoking, fruit/vegetable consumption and body mass index (BMI). Age, sex, socioeconomic status, living together, limitation due to health problems for at least for 6 months, self-efficacy and attention to one's health were included as confounders in the regression models. RESULTS: Ever-DSME participants engaged significantly more often in cycling at least 1 day per week (OR 1.62, 95% CI: 1.15-2.30) and performed significantly more often aerobic endurance training of 150 min per week (including walking: OR 1.42, 95% CI: 1.03-1.94, without walking: OR 1.48, 95% CI: 1.08-2.03) compared with never-DSME participants. Ever-DSME participants were significantly more often ex-smoker compared with never-DSME participants (OR 1.39, 95% CI: 1.03-1.88). DSME attendance was not significantly associated with current smoking, BMI and fruit or vegetable consumption. CONCLUSION: DSME participation is associated with a moderately healthier lifestyle particularly for PA even in routine healthcare. Study results emphasize the importance of a broadly dissemination of DSME access for nationwide diabetes healthcare. Future studies should adjust for DSME participation when investigating lifestyle in persons with diabetes.

Coping mechanisms for financial toxicity: a qualitative study of cancer patients' experiences in Germany.

PURPOSE: The coping mechanisms employed to deal with objective financial burden following a cancer diagnosis are considered mediators of financial toxicity, specifically for the relationship between increased costs and health outcomes. Using qualitative research, the aim of the study was to explore the financial adjustments experienced by cancer patients and identify key coping mechanisms. METHODS: Semistructured interviews with 39 cancer patients (aged from 40 to 86 years) were conducted between May 2017 and April 2018 in Germany. Narratives were transcribed verbatim and analysed via qualitative content analysis. RESULTS: In all, 28 participants reported that they made financial adjustments related to two major categories: (1) reducing expenditures related to basic needs, luxury needs, and health-related decisions, and (2) increasing financial resources by saving less, using savings, investing manpower, obtaining help from third parties, incurring bank debt, and making health-related decisions. Typically, cancer patients both reduced expenditures and increased financial resources, but no typical patterns of combinations of coping mechanisms could be identified. However, reducing spending on basic and luxury needs was found to occur more typically than increasing the available money through incurring bank debt, making health-related decisions, or investing manpower. CONCLUSIONS: This qualitative study provides a comprehensive understanding of the complexity of the coping mechanisms used by patients to address either higher costs or changed needs and priorities following a cancer diagnosis. With regard to understanding patients' experiences of subjective financial stress, both increasing financial resources and reducing expenditures, particularly those relating to basic needs and luxury needs as distinct categories, might be relevant and should be considered. The financial situation impacts the treatment of cancer patients since health-related decisions were reported to be made with the aim of increasing financial resources by maintaining an ability to work or reducing expenditures through non-adherence.

Learning types and learning success in a structured diabetes education programme for patients with type 2 diabetes: study protocol of a prospective, longitudinal study.

INTRODUCTION: Diabetes mellitus (DM) has had a wide-ranging impact on healthcare politics. Secondary diseases and complications caused by diabetes are relevant cost and utilisation factors in the healthcare system. For decades, diabetes self-management education (DSME) has played a major role in the treatment of patients with type 2 DM (T2DM). The aim of this training is to empower patients to actively influence their diabetes process by gaining knowledge about health-related behaviours, such as healthy nutrition and exercise, and cardiovascular risks. The aim of the project is to analyse the practice of structured diabetes education and the effects of different learning types of participants. This project focuses on the needs of socioeconomically deprived patients and aims to improve DSME for this group. This patient group has a higher prevalence of T2DM, more complications and worse therapy-relevant parameters. METHODS AND ANALYSIS: The study will be conducted as a prospective longitudinal study. Patients will be recruited in outpatient physician offices over a period of 12 months. Patients will be included if they are 18 years and older, have T2DM and are scheduled to participate in DSME for the first time. A pseudonymised, written survey with standardised questionnaires will be administered. The data will be analysed using inferential statistical methods, such as correlation analysis, regression models and variance analytical designs. ETHICS AND DISSEMINATION: The study will be carried out following the principles of the Declaration of Helsinki and good scientific standards. Ethical approval of the Ethics Review Committee of the Medical Faculty at Martin-Luther-University, Halle-Wittenberg, was obtained. All participants in the study will receive comprehensive information and will be included after written informed consent is obtained. The results will be published in international peer-reviewed journals and presented at several congresses. TRIAL REGISTRATION NUMBER: DRKS00016630.

Development and psychometric testing of an instrument for measuring social participation of adolescents: study protocol of a prospective mixed-methods study.

INTRODUCTION: Social participation is an important part of a young person's life. It influences the social experience, social-emotional development and dimensions of competence experience. This applies to people with or without physical disabilities or chronic diseases. Currently, there is no reliable assessment tool for measuring social participation of adolescents in Germany although social participation is a central goal of rehabilitation. The aim of this study is to develop, test and pilot an instrument that assesses social participation for adolescents between the ages of 12 and 17 years and to start a psychometric test. METHODS AND ANALYSIS: In a sequential mixed-methods study, adolescents with and without physical disabilities or chronic diseases are asked about their experiences with social participation as well as the individual significance of self-determination through semistructured interviews. The perspective of adolescents is supplemented by focus groups that will be conducted first with experts from social paediatric care and second with legal guardians. Based on this, an assessment instrument will be developed, evaluated and implemented in exemplary social paediatric centres (SPCs) and rehabilitation clinics and psychometrically tested in a pilot study. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the principles of the revised Helsinki Declaration. The study was approved by the Ethics Review Committee at the Martin-Luther-University Halle-Wittenberg. The developed assessment instrument can be used in science to identify disadvantaged groups and to compensate for the disadvantages that could impair development. For this purpose, the results will be presented at scientific conferences and published in international peer-reviewed journals. In practice, the instrument can be used to determine the goals of rehabilitation together with the adolescents and to evaluate the achievement of these goals. For this, implementation workshops and further training will be organised and carried out in children's rehabilitation clinics and SPCs. TRIAL REGISTRATION NUMBER: DRKS00014739; Pre-results.

'Learning to shape life' - a qualitative study on the challenges posed by a diagnosis of diabetes mellitus type 2.

BACKGROUND: Diabetes mellitus type 2 is a central challenge for health policy and healthcare in all advanced countries. For the affected persons, living with a diagnosis of type 2 diabetes is difficult because the disease and its treatment have a considerable effect on daily life. The aim of this study was to investigate the challenges associated with a diagnosis of type 2 diabetes for those affected and the range, depth and complexities of the subjective perspectives of the patients under the conditions of the German healthcare system. METHODS: A cross-sectional qualitative study was conducted using a sample of 19 adult patients with type 2 diabetes mellitus. Patients were recruited successively from two specialized diabetological practices, three general practitioner's offices, and two hospitals. The patients were interviewed once in person using semi-structured interviews. All interviews were recorded, transcribed, and analysed based on grounded theory. RESULTS: Persons affected by diabetes mellitus type 2 seem to feel responsible for managing their disease. Two strategies of action could be identified: 1) patients strictly followed the recommendations of the physicians, or 2) they showed that they are knowledgably managing their diabetes mellitus type 2. The action strategy to address the disease seemed to be influenced by patients' confidence in themselves, the effectiveness of the interventions, or the patients' locus of control. Minor differences in educational status could be discovered, and patients who were less educated tended to follow the recommendations of the physicians very strictly and seemed to place more emphasis on being compliant, which goes hand in hand with a life with prohibitions and restrictions. In contrast, being perceived as competent patients who make their own rules to manage the disease in daily life appeared to be more important for people with higher education levels. CONCLUSION: Patient education and self-management programmes for diabetes mellitus type 2 should take different types of learners into account. Giving less-educated patients specific recommendations for successful diabetes self-management is particularly important. TRIAL REGISTRATION: German clinical trial register (DRKS-ID: DRKS00007847 ).

Socioeconomic differences in experiences with treatment of coronary heart disease: a qualitative study from the perspective of elderly patients.

OBJECTIVES: This qualitative study aims to analyse socioeconomic differences in patients' experiences along the treatment pathway for coronary heart disease (CHD). DESIGN: A longitudinal qualitative study using in-depth semistructured interviews to explore patients' experiences with treatment was conducted. We analysed the transcripts of the records according to qualitative content analysis and identified differences between patients with lower and higher socioeconomic status (SES) by comparing and contrasting the narratives. SETTING: The University Hospital in Halle (Saale), Germany. PARTICIPANTS: 41 elderly patients (aged 59-80 years) who suffered from CHD. RESULTS: From various patient's experiences along the pathway of care which were found to differ according to SES we derived three major themes: (1) information: patients with higher SES had greater knowledge about treatment and could use medical records as sources of information; (2) illness perception: patients with lower SES focused on improving symptoms and survival, while patients with higher SES focused on physical performance and disease management; and (3) perceived role in healthcare: patients with lower SES tended to delegate responsibility to healthcare professionals. CONCLUSIONS: Differences in the patient's knowledge about treatment, their perceived role in healthcare and illness perception can be the factors and mechanisms that contribute to explain socioeconomic inequalities in the treatment of CHD. These factors should be considered in quantitative studies to better understand the disparities in treatment and mortality. We suggest that improving patient-physician communication and patient knowledge can change the patient's understanding of CHD and their perceived role in healthcare and reduce inequalities in CHD treatment. TRIAL REGISTRATION NUMBER: DRKS00007839.

Environmental and behavioural modifications for improving food and fluid intake in people with dementia.

BACKGROUND: Weight loss, malnutrition and dehydration are common problems for people with dementia. Environmental modifications such as, change of routine, context or ambience at mealtimes, or behavioural modifications, such as education or training of people with dementia or caregivers, may be considered to try to improve food and fluid intake and nutritional status of people with dementia. OBJECTIVES: Primary: To assess the effects of environmental or behavioural modifications on food and fluid intake and nutritional status in people with dementia. Secondary: To assess the effects of environmental or behavioural modifications in connection with nutrition on mealtime behaviour, cognitive and functional outcomes and quality of life, in specific settings (i.e. home care, residential care and nursing home care) for different stages of dementia. To assess the adverse consequences or effects of the included interventions. SEARCH METHODS: We searched the Specialized Register of Cochrane Dementia and Cognitive Improvement (ALOIS), MEDLINE, Eembase, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 17 January 2018. We scanned reference lists of other reviews and of included articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) investigating interventions designed to modify the mealtime environment of people with dementia, to modify the mealtime behaviour of people with dementia or their caregivers, or both, with the intention of improving food and fluid intake. We included people with any common dementia subtype. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data and assessed the risk of bias of included trials. We assessed the quality of evidence for each outcome using the GRADE approach. MAIN RESULTS: We included nine studies, investigating 1502 people. Three studies explicitly investigated participants with Alzheimer's disease; six did not specify the type of dementia. Five studies provided clear measures to identify the severity of dementia at baseline, and overall very mild to severe stages were covered. The interventions and outcome measures were diverse. The overall quality of evidence was mainly low to very low.One study implemented environmental as well as behavioural modifications by providing additional food items between meals and personal encouragement to consume them. The control group received no intervention. Differences between groups were very small and the quality of the evidence from this study was very low, so we are very uncertain of any effect of this intervention.The remaining eight studies implemented behavioural modifications.Three studies provided nutritional education and nutrition promotion programmes. Control groups did not receive these programmes. After 12 months, the intervention group showed slightly higher protein intake per day (mean difference (MD) 0.11 g/kg, 95% confidence interval (CI) -0.01 to 0.23; n = 78, 1 study; low-quality evidence), but there was no clear evidence of a difference in nutritional status assessed with body mass index (BMI) (MD -0.26 kg/m² favouring control, 95% CI -0.70 to 0.19; n = 734, 2 studies; moderate-quality evidence), body weight (MD -1.60 kg favouring control, 95% CI -3.47 to 0.27; n = 656, 1 study; moderate-quality evidence), or score on Mini Nutritional Assessment (MNA) (MD -0.10 favouring control, 95% CI -0.67 to 0.47; n = 656, 1 study; low-quality evidence). After six months, the intervention group in one study had slightly lower BMI (MD -1.79 kg/m² favouring control, 95% CI -1.28 to -2.30; n = 52, 1 study; moderate-quality evidence) and body weight (MD -8.11 kg favouring control, 95% CI -2.06 to -12.56; n = 52, 1 study; moderate-quality evidence). This type of intervention may have a small positive effect on food intake, but little or no effect, or a negative effect, on nutritional status.Two studies compared self-feeding skills training programmes. In one study, the control group received no training and in the other study the control group received a different self-feeding skills training programme. For both comparisons the quality of the evidence was very low and we are very uncertain whether these interventions have any effect.One study investigated general training of nurses to impart knowledge on how to feed people with dementia and improve attitudes towards people with dementia. Again, the quality of the evidence was very low so that we cannot be certain of any effect.Two studies investigated vocal or tactile positive feedback provided by caregivers while feeding participants. After three weeks, the intervention group showed an increase in calories consumed per meal (MD 200 kcal, 95% CI 119.81 to 280.19; n = 42, 1 study; low-quality evidence) and protein consumed per meal (MD 15g, 95% CI 7.74 to 22.26; n = 42, 1 study; low-quality evidence). This intervention may increase the intake of food and liquids slightly; nutritional status was not assessed. AUTHORS' CONCLUSIONS: Due to the quantity and quality of the evidence currently available, we cannot identify any specific environmental or behavioural modifications for improving food and fluid intake in people with dementia.

Socioeconomic differences in the pathways to diagnosis of coronary heart disease: a qualitative study.

Background: Socioeconomic inequalities in coronary heart disease (CHD)-related morbidity and mortality are well explored. However, less is known about the causes of inequalities in CHD treatment. In this qualitative study, we explored socioeconomic differences in the pathways to diagnosis of CHD. Methods: The data originated from 38 semi-structured interviews with older CHD patients, aged 59-80 years, conducted at the university hospital in Halle, Germany, between November 2014 and April 2015. We analysed the narratives related to the time before CHD was confirmed by coronary angiography electively or urgently. Transcripts were analysed following inductive qualitative content analysis and we identified socioeconomic differences by comparing and contrasting patients' narratives. Results: The patients interpreted their symptoms based on expectations, normalization, relief and obtaining help from third parties. For those experiencing chronic CHD symptoms, only patients with low socioeconomic status (SES) waited to seek healthcare until they suffered myocardial infarction. Mainly low-SES patients procrastinated in undergoing diagnostic procedures. We found no socioeconomic differences in the urgent pathway. However, along the elective pathway, only low-SES patients reported receiving assistance from a general practitioner in accessing a cardiologist. Conclusions: Socioeconomic differences in CHD diagnosis were mainly apparent before patients sought healthcare. These differences were more pronounced when CHD was electively diagnosed due to chronic symptoms rather than urgently diagnosed due to acute symptoms. To address socioeconomic differences, general practitioners should focus on any indication of symptoms and interpretation mentioned by low-SES patients, and coordinate these patients' pathways to diagnosis while emphasizing the seriousness of CHD.