[Participation in children's hospitals: approaches to participatory formats for paediatric patients]. / Teilhabe im Kinderkrankenhaus: Formate zur Verwirklichung des Rechts auf Partizipation von jungen Patientinnen und Patienten.

Based on the UN Convention on the Rights of the Child, children and young people have the right to participate in all matters and decisions that affect them. This applies in particular when they are patients in a children's hospital. In the international context, established formats for the participation of young patients regarding health issues already exist, for example "Children's Councils" or "Young Person's Advisory Groups". In Germany, such approaches are still mostly lacking. It thus remains important to develop suitable formats that enable meaningful and effective participation of young patients in the health system. These formats must be chosen in such a way that they can realistically be implemented in clinical settings as well as in pediatric research, and that they can be sustained in the long term. In order to strengthen the consideration of children's rights in the health system, the advancement of such participatory formats as well as their sustainable implementation and evaluation are desirable.

[Development of an Integrated Community-Based Prevention Strategy in Freiham (Munich) from the Perspective of the Steering Group: A Qualitative Interview Study with Social Network Analysis]. / Aufbau der Präventionskette Freiham aus Sicht des Steuerungsgremiums: Eine qualitative Interviewstudie mit Sozialer Netzwerkanalyse.

BACKGROUND: The City of Munich is planning and implementing a "Prevention Chain" as an integrated community-based prevention strategy in the new district of "Freiham" in Munich. This is taking place while the district is being built. The "Prevention Chain Freiham" aims to create an environment that enables a healthy upbringing of all children and adolescents right from the start. In order to guide this project, an interdepartmental working group was formed within the City of Munich's administration. This study analyses the working group's structures, processes and its collaboration with a variety of stakeholders. METHODS: We conducted a multimethod study comprising qualitative interviews and social network analysis. Between March and April 2018, we conducted semi-structured interviews with members of the working group. The study participants also generated ego-centred social network maps. The transcripts were analysed using qualitative content analysis as described by Schreier. The network maps were also analysed using qualitative content analysis and the results were visualized. Our preliminary findings were interpreted, discussed and validated in a workshop in June 2018 with study participants. RESULTS: Ten members of the working group participated in the study. The interdepartmental, multiprofessional collaboration in the working group was perceived as beneficial for the process of developing and implementing the Prevention Chain. The external coordination by MAGs and the scientific expertise provided by the LMU Munich were considered highly supportive. Barriers to the planning and implementation of the Prevention Chain were mainly located at administration level. Most facilitators were attributed to the collaborative processes within the working group. After having mapped all stakeholders currently involved in the Prevention Chain (mainly actors within the City of Munich's administration), additional relevant stakeholders were identified by the members of the working group. CONCLUSION: The organizational form of the working group as a formalized association of representatives of various departments that are jointly responsible for the Prevention Chain is considered beneficial for the success of the Prevention Chain. This is further supported by the external coordination and academic support. Advancing the development and implementation of the Prevention Chain will require support from all relevant departments across sectors and hierarchies.

Nutrition policies in Germany: a systematic assessment with the Food Environment Policy Index.

OBJECTIVE: To systematically assess Germany's nutrition policies, to benchmark them against international best practices and to identify priority policy actions to improve population-level nutrition in Germany. DESIGN: We applied the Food Environment Policy Index (Food-EPI), a methodological framework developed by the International Network for Food and Obesity/non-communicable Diseases Research, Monitoring and Action Support (INFORMAS) network. Qualitative content analysis of laws, directives and other documents formed the basis of a multistaged, structured consultation process. SETTING: Germany. PARTICIPANTS: The expert consultation process included fifty-five experts from academia, public administration and civil society. RESULTS: Germany lags behind international best practices in several key policy areas. For eighteen policy indicators, the degree of implementation compared with international best practices was rated as very low, for twenty-one as low, for eight as intermediate and for none as high. In particular, indicators on food taxation, regulation of food marketing as well as retail and food service sector policies were rated as very low to low. Identified priority actions included the binding implementation of nutrition standards for schools and kindergartens, a reform of the value added tax on foods and beverages, a sugar-sweetened beverage tax and stricter regulation of food marketing directed at children. CONCLUSIONS: The results show that Germany makes insufficient use of the potential of evidence-informed health-promoting nutrition policies. Adopting international best practices in key policy areas could help to reduce the burden of nutrition-related chronic disease and related inequalities in nutrition and health in Germany. Implementation of relevant policies requires political leadership, a broad societal dialogue and evidence-informed advocacy by civil society, including the scientific community.

Effectiveness of a specialised breathlessness service for patients with advanced disease in Germany: a pragmatic fast-track randomised controlled trial (BreathEase).

BACKGROUND: The effectiveness of the Munich Breathlessness Service (MBS), integrating palliative care, respiratory medicine and physiotherapy, was tested in the BreathEase trial in patients with chronic breathlessness in advanced disease and their carers. METHODS: BreathEase was a single-blinded randomised controlled fast-track trial. The MBS was attended for 5-6 weeks; the control group started the MBS after 8 weeks of standard care. Randomisation was stratified by cancer and the presence of a carer. Primary outcomes were patients' mastery of breathlessness (Chronic Respiratory Disease Questionnaire (CRQ) Mastery), quality of life (CRQ QoL), symptom burden (Integrated Palliative care Outcome Scale (IPOS)) and carer burden (Zarit Burden Interview (ZBI)). Intention-to-treat (ITT) analyses were conducted with hierarchical testing. Effectiveness was investigated by linear regression on change scores, adjusting for baseline scores and stratification variables. Missing values were handled with multiple imputation. RESULTS: 92 patients were randomised to the intervention group and 91 patients were randomised to the control group. Before the follow-up assessment after 8 weeks (T1), 17 and five patients dropped out from the intervention and control groups, respectively. Significant improvements in CRQ Mastery of 0.367 (95% CI 0.065-0.669) and CRQ QoL of 0.226 (95% CI 0.012-0.440) score units at T1 in favour of the intervention group were seen in the ITT analyses (n=183), but not in IPOS. Exploratory testing showed nonsignificant improvements in ZBI. CONCLUSIONS: These findings demonstrate positive effects of the MBS in reducing burden caused by chronic breathlessness in advanced illness across a wide range of patients. Further evaluation in subgroups of patients and with a longitudinal perspective is needed.

Where is the 'global' in the European Union's Health Research and Innovation Agenda?

Global Health has not featured as prominently in the European Union (EU) research agenda in recent years as it did in the first decade of the new millennium, and participation of low-income and middle-income countries (LMICs) in EU health research has declined substantially. The Horizon Europe Research and Innovation Framework adopted by the European Parliament in April 2019 for the period 2021-2027 will serve as an important funding instrument for health research, yet the proposed health research budget to be finalised towards the end of 2019 was reduced from 10% in the current framework, Horizon 2020, to 8% in Horizon Europe. Our analysis takes the evolvement of Horizon Europe from the initial framework of June 2018 to the framework agreed on in April 2019 into account. It shows that despite some improvements in terms of Global Health and reference to the Sustainable Development Goals, European industrial competitiveness continues to play a paramount role, with Global Health research needs and relevant health research for LMICs being only partially addressed. We argue that the globally interconnected nature of health and the transdisciplinary nature of health research need to be fully taken into account and acted on in the new European Research and Innovation Framework. A facilitated global research collaboration through Horizon Europe could ensure that Global Health innovations and solutions benefit all parts of the world including EU countries.

Considerations of complexity in rating certainty of evidence in systematic reviews: a primer on using the GRADE approach in global health.

Public health interventions and health technologies are commonly described as 'complex', as they involve multiple interacting components and outcomes, and their effects are largely influenced by contextual interactions and system-level processes. Systematic reviewers and guideline developers evaluating the effects of these complex interventions and technologies report difficulties in using existing methods and frameworks, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE). As part of a special series of papers on implications of complexity in the WHO guideline development, this paper serves as a primer on how to consider sources of complexity when using the GRADE approach to rate certainty of evidence. Relevant sources of complexity in systematic reviews, health technology assessments and guidelines of public health are outlined and mapped onto the reported difficulties in rating the estimates of the effect of these interventions. Recommendations on how to address these difficulties are further outlined, and the need for an integrated use of GRADE from the beginning of the review or guideline development is emphasised. The content of this paper is informed by the existing GRADE guidance, an ongoing research project on considering sources of complexity when applying the GRADE approach to rate certainty of evidence in systematic reviews and the review authors' own experiences with using GRADE.

Implications of a complexity perspective for systematic reviews and guideline development in health decision making.

There is growing interest in the potential for complex systems perspectives in evaluation. This reflects a move away from interest in linear chains of cause-and-effect, towards considering health as an outcome of interlinked elements within a connected whole. Although systems-based approaches have a long history, their concrete implications for health decisions are still being assessed. Similarly, the implications of systems perspectives for the conduct of systematic reviews require further consideration. Such reviews underpin decisions about the implementation of effective interventions, and are a crucial part of the development of guidelines. Although they are tried and tested as a means of synthesising evidence on the effectiveness of interventions, their applicability to the synthesis of evidence about complex interventions and complex systems requires further investigation. This paper, one of a series of papers commissioned by the WHO, sets out the concrete methodological implications of a complexity perspective for the conduct of systematic reviews. It focuses on how review questions can be framed within a complexity perspective, and on the implications for the evidence that is reviewed. It proposes criteria which can be used to determine whether or not a complexity perspective will add value to a review or an evidence-based guideline, and describes how to operationalise key aspects of complexity as concrete research questions. Finally, it shows how these questions map onto specific types of evidence, with a focus on the role of qualitative and quantitative evidence, and other types of information.

Voluntary industry initiatives to promote healthy diets: a case study on a major European food retailer.

OBJECTIVE: To analyse the scope and content of the nutrition pledge announced by Lidl. DESIGN: We applied the approach recommended by the private-sector module of the INFORMAS (International Network for Food and Obesity Research, Monitoring and Action Support) food environment monitoring framework and qualitative content analysis to Lidl's nutrition pledge. SETTING: Global. SUBJECTS: The nutrition pledge of Lidl, Europe's largest food retailer. RESULTS: Lidl pledges to reduce the average sales-weighted content of added sugar and added salt in its own-brand products by 20 % until 2025, using 2015 as a baseline, starting in Germany. Moreover, it vows to reduce the saturated and trans-fatty acid contents of its own-brand products, without specifying targets or timelines. To achieve these targets, it pledges to apply a number of approaches, including reformulation, promotion of healthier products, reduction of package and portion sizes, and provision of nutrition information and education. Strengths of Lidl's pledge are its extensive scope, the quantification of some targets, and its partially evidence-based approach to the selection of targets and interventions. Key limitations include the vagueness of many targets, a lack of transparency and the absence of independent monitoring and evaluation. CONCLUSIONS: Lidl's pledge, while commendable for its scope, does not meet current best practice guidelines. Given their current limitations, industry initiatives of this kind are likely to fall short of what is needed to improve population-level nutrition.

Effectiveness of interventions to reduce exposure to lead through consumer products and drinking water: A systematic review.

OBJECTIVES: The objective of this systematic review is to assess the effectiveness of regulatory, environmental and educational interventions for reducing blood lead levels (BLLs) and associated health outcomes in children, pregnant women and the general population. METHODS: Searches were run in MEDLINE, EMBASE and the Global Health Library up until August 2015. Studies were eligible for inclusion if they assessed the impact of regulatory, environmental or educational interventions, stand-alone or in combination, on BLLs among children, pregnant women or the general population through randomized controlled trials (RCT), controlled before-after (CBA), interrupted time series (ITS), uncontrolled before-after (UBA) or repeated cross-sectional studies. Studies assessing the impact of interventions to reduce exposure to lead in paint or household dust as well as studies concerned exclusively with environmental concentrations of lead were not included. As documented in a detailed protocol, screening, data extraction and quality appraisal were largely undertaken according to Cochrane standards. Harvest plots were used to graphically summarize evidence of effectiveness. RESULTS: The searches yielded 6466 unique records, of which five met our eligibility criteria; two additional eligible studies were identified by experts. We did not find any studies regarding the effectiveness of regulatory, educational or environmental interventions targeting exposure to lead in consumer products. Evidence regarding the effectiveness of interventions in reducing BLLs from exposures through drinking water is limited in both quantity and quality. Stand-alone targeted educational interventions showed no statistically significant reductions in children's BLL (two RCT) when compared to general educational interventions. Likewise, instructing women to reduce or eliminate lead-contaminated drinking water showed no effect on BLL (one RCT). Stand-alone environmental interventions appeared more promising in reducing BLL (three UBA). Combining educational and environmental interventions and targeting multiple settings may be effective in reducing BLL, as suggested by one uncontrolled before-after study. No studies examining the effectiveness of regulatory interventions were found. CONCLUSIONS: The limited quantity and quality of the evidence measuring BLL and associated health outcomes points to an urgent need for more robust research into the effectiveness of interventions to reduce lead exposure from consumer products and drinking water, especially for regulatory interventions.

Context and implementation: A concept analysis towards conceptual maturity.

Context and implementation of health interventions have received increasing attention over the past decade, in particular with respect to their influence on the effectiveness and reach of complex interventions. The underlying concepts are both considered partially mature, limiting their operationalization in research and practice. We conducted systematic literature searches and pragmatic utility (PU) concept analyses to provide a state-of-the-art assessment of the concepts of "context" and "implementation" in the health sciences to create a common understanding for their use within systematic reviews and HTA. We performed two separate searches, one for context (EMBASE, MEDLINE) and the other for implementation (Google Scholar) to identify relevant models, theories and frameworks. 17 publications on context and 35 articles on implementation met our inclusion criteria. PU concept analysis comprises three guiding principles: selection of the literature, organization and structuring of the literature, and asking analytic questions of the literature. Both concepts were analyzed according to four features of conceptual maturity, i.e., consensual definitions, clear characteristics, fully described preconditions and outcomes, and delineated boundaries. Context and implementation are highly intertwined, with both concepts influencing and interacting with each other. Context is defined as a set of characteristics and circumstances that surround the implementation effort. Implementation is conceptualized as a planned and deliberately initiated effort with the intention to put an intervention into practice. The concept of implementation presents largely consensual definitions and relatively well-defined boundaries, while distinguishing features, preconditions and outcomes are not yet fully articulated. In contrast, definitions of context vary widely, and boundaries with neighbouring concepts, such as setting and environment, are blurred; characteristics, preconditions and outcomes are ill-defined. Therefore, the maturity of both concepts should be further improved to facilitate operationalization in systematic reviews and HTAs.

A protocol for a systematic review of the effectiveness of interventions to reduce exposure to lead through consumer products and drinking water.

BACKGROUND: The toxic heavy metal lead continues to be a leading environmental risk factor, with the number of attributable deaths having doubled between 1990 and 2010. Although major sources of lead exposure, in particular lead in petrol, have been significantly reduced in recent decades, lead is still used in a wide range of processes and objects, with developing countries disproportionally affected. The objective of this systematic review is to assess the effectiveness of regulatory, environmental and educational interventions for reducing blood lead levels and associated health outcomes in children, pregnant women and the general population. METHODS/DESIGN: The databases MEDLINE, Embase and the Global Health Library (GHL) will be searched using a sensitive search strategy. Studies in English, German, French, Spanish, Italian or Afrikaans will be screened according to predefined inclusion and exclusion criteria. We will consider randomized and non-randomized studies accepted by the Cochrane Effective Practice and Organization of Care (EPOC) Group, as well as additional non-randomized studies. Screening of titles and abstracts will be performed by one author. Full texts of potentially relevant studies will be independently assessed for eligibility by two authors. A single author will extract data, with a second reviewer checking the extraction form. Risk of bias will be assessed by two researchers using the Graphical Appraisal Tool for Epidemiological studies, as modified by the Centre for Public Health at the UK National Institute for Health and Care Excellence. Any inconsistencies in the assessment of eligibility, data extraction or quality appraisal will be resolved through discussion. Where two or more studies report the primary outcome blood lead levels within the same population group, intervention category and source of lead exposure, data will be pooled using random effects meta-analysis. In parallel, harvest plots as a graphical method of evidence synthesis will be used to present findings for blood lead levels and secondary outcomes. DISCUSSION: This systematic review will fill an important evidence gap with respect to the effectiveness of interventions to reduce lead in consumer products and drinking water in the context of new WHO guidelines for the prevention and management of lead poisoning. It will also contribute to setting a future research agenda.