Is this really Empowerment? Enhancing our understanding of empowerment in patient and public involvement within clinical research.

BACKGROUND: There has been a growing push to involve patients in clinical research, shifting from conducting research on, about, or for them to conducting it with them. Two arguments advocate for this approach, known as Patient and Public Involvement (PPI): to improve research quality, appropriateness, relevance, and credibility by including patients' diverse perspectives, and to use PPI to empower patients and democratize research for more equity in research and healthcare. However, while empowerment is a core objective, it is often not clear what is meant by empowerment in the context of PPI in clinical research. This vacancy can lead to insecurities for both patients and researchers and a disconnect between the rhetoric of empowerment in PPI and the reality of its practice in clinical trials. Thus, clarifying the understanding of empowerment within PPI in clinical research is essential to ensure that involvement does not become tokenistic and depletes patients' capacity to advocate for their rights and needs. METHODS: We explored the historical roots of empowerment, primarily emerging from mid-20th century social movements like feminism and civil rights and reflected the conceptual roots of empowerment from diverse fields to better understand the (potential) role of empowerment in PPI in clinical research including its possibilities and limitations. RESULTS: Common themes of empowerment in PPI and other fields are participation, challenging power structures, valuing diverse perspectives, and promoting collaboration. On the other hand, themes such as contextual differences in the empowerment objectives, the relationship between empowerment and scientific demands, research expertise, and power asymmetries mark a clear distinction from empowerment in other fields. CONCLUSION: PPI offers potential for patient empowerment in clinical trials, even when its primary goal may be research quality. Elements like participation, sharing opinions, and active engagement can contribute to patient empowerment. Nonetheless, some expectations tied to empowerment might not be met within the constraints of clinical research. To empower patients, stakeholders must be explicit about what empowerment means in their research, engage in transparent communication about its realistic scope, and continuously reflect on how empowerment can be fostered and sustained within the research process.

Theories used to develop or evaluate social prescribing in studies: a scoping review.

OBJECTIVE: This scoping review aims to provide an overview of how theories were used in the development or evaluation of social prescribing (SP) intervention studies. BACKGROUND: SP describes a patient pathway where general practitioners (GPs) connect patients with community activities through referrals to link workers. This review seeks to understand the explanations provided for the outcomes and implementation process of SP. INCLUSION CRITERIA: Studies using a defined theory to develop or evaluate a specific SP intervention in primary care and the community sector. METHODS: This scoping review was conducted in accordance with JBI methodology. The following databases were searched on 8th of July 2022: PubMed, ASSIA, Cochrane, Cinahl, PsycINFO, Social Care Online, Sociological Abstracts, Scopus, and Web of Science. The search only considered English language texts. Additional literature was identified by searching relevant web pages and by contacting experts. The selection of sources and the data extraction was done by two reviewers independently. RESULTS: The search resulted in 4240 reports, of which 18 were included in the scoping review. Of these, 16 were conducted in the UK, one in Canada and one in Australia. The majority of reports employed a qualitative approach (11/18). Three were study protocols. 11 distinct theories were applied to explain outcomes (4 theories), differences in outcomes (3 theories), and the implementation of the intervention (4 theories). In terms of practical application, the identified theories were predominantly used to explain and understand qualitative findings. Only one theory was used to define variables for hypothesis testing. All theories were used for the evaluation and none for the development of SP. CONCLUSION: The theories influenced which outcomes the evaluation assessed, which causal pathway was expected to generate these outcomes, and which methodological approaches were used. All three groups of theories that were identified focus on relevant aspects of SP: fostering positive patient/community outcomes, addressing inequalities by considering the context of someone's individual circumstances, and successfully implementing SP by collaboratively working across professions and institutional boundaries. Additional insight is required regarding the optimal use of theories in practical applications.

Developing and Evaluating Digital Public Health Interventions Using the Digital Public Health Framework DigiPHrame: A Framework Development Study.

BACKGROUND: Digital public health (DiPH) interventions may help us tackle substantial public health challenges and reach historically underserved populations, in addition to presenting valuable opportunities to improve and complement existing services. However, DiPH interventions are often triggered through technological advancements and opportunities rather than public health needs. To develop and evaluate interventions designed to serve public health needs, a comprehensive framework is needed that systematically covers all aspects with relevance for public health. This includes considering the complexity of the technology, the context in which the technology is supposed to operate, its implementation, and its effects on public health, including ethical, legal, and social aspects. OBJECTIVE: We aimed to develop such a DiPH framework with a comprehensive list of core principles to be considered throughout the development and evaluation process of any DiPH intervention. METHODS: The resulting digital public health framework (DigiPHrame) was based on a scoping review of existing digital health and public health frameworks. After extracting all assessment criteria from these frameworks, we clustered the criteria. During a series of multidisciplinary meetings with experts from the Leibniz ScienceCampus Digital Public Health, we restructured each domain to represent the complexity of DiPH. In this paper, we used a COVID-19 contact-tracing app as a use case to illustrate how DigiPHrame may be applied to assess DiPH interventions. RESULTS: The current version of DigiPHrame consists of 182 questions nested under 12 domains. Domain 1 describes the current status of health needs and existing interventions; domains 2 and 3, the DiPH technology under assessment and aspects related to human-computer interaction, respectively; domains 4 and 5, structural and process aspects, respectively; and domains 6-12, contextual conditions and the outcomes of the DiPH intervention from broad perspectives. In the CWA use case, a number of questions relevant during its development but also important for assessors once the CWA was available were highlighted. CONCLUSIONS: DigiPHrame is a comprehensive framework for the development and assessment of digital technologies designed for public health purposes. It is a living framework and will, therefore, be updated regularly and as new public health needs and technological advancements emerge.

Priority setting to support a public health research agenda: a modified Delphi study with public health stakeholders in Germany.

BACKGROUND: Research priority setting (RPS) studies are necessary to close the significant gap between the scientific evidence produced and the evidence stakeholders need. Their findings can make resource allocation in research more efficient. However, no general framework for conducting an RPS study among public health stakeholders exists. RPS studies in public health are rare and no such study has been previously conducted and published in Germany. Therefore, we aimed to investigate which research topics in public health are prioritised by relevant stakeholders in Germany. METHODS: Our RPS study consisted of a scoping stage and a Delphi stage each split into two rounds. Firstly, we invited members of the German Public Health Association to gather expert insights during two initial workshops. Next, we defined the relevant stakeholder groups and recruited respondents. Thereafter, we collected research topics and assessment criteria with the respondents in the first Delphi round and aggregated the responses through content analysis. Finally, we asked the respondents to rate the research topics with the assessment criteria in the second Delphi round. RESULTS: In total, 94 out of the 140 invited public health organisations nominated 230 respondents for the Delphi study of whom almost 90% participated in both Delphi rounds. We compiled a comprehensive list of 76 research topics that were rated and ranked by several assessment criteria. We split the research topics into two types, substantive research topics and methodological-theoretical research topics respectively, to ensure the comparability among the research topics. In both types of research topics-substantive research topics and methodological-theoretical research topics-the respective top five ranked research topics hardly differed between public health researchers and public health practitioners. However, clear differences exist in the priority ranking of many (non-top priority) research topics between the stakeholder groups. CONCLUSIONS: This research demonstrates that it is possible, with limited resources, to prioritise research topics for public health at the national level involving a wide range of pertinent stakeholders. The results can be used by research funding institutions to initiate calls for research projects with an increased relevance for health and/or scientific progress.

Mapping the complexity of dementia: factors influencing cognitive function at the onset of dementia.

BACKGROUND: Dementia is a multi-factorial condition rather than a natural and inevitable consequence of ageing. Some factors related to dementia have been studied much more extensively than others. To gain an overview of known or suspected influential factors is a prerequisite to design studies that aim to identify causal relationships and interactions between factors. This article aims to develop a visual model that a) identifies factors related to cognitive decline that signal the onset of dementia, b) structures them by different domains and c) reflects on and visualizes the possible causal links and interactions between these factors based on expert input using a causal loop diagram. METHOD: We used a mixed-method, step-wise approach: 1. A systematic literature review on factors related to cognitive decline; 2. A group model building (GMB) workshop with experts from different disciplines; 3. Structured discussions within the group of researchers. The results were continuously synthesized and graphically transformed into a causal loop diagram. RESULTS: The causal loop diagram comprises 73 factors that were structured into six domains: physical (medical) factors (23), social health factors (21), psychological factors (14), environmental factors (5), demographic factors (5) and lifestyle factors (3). 57 factors were identified in the systematic literature review, additionally 16 factors, mostly of the social health cluster, were identified during the GMB session and the feedback rounds. CONCLUSION: The causal loop diagram offers a comprehensive visualisation of factors related to cognitive decline and their interactions. It supports the generation of hypotheses on causal relationships and interactions of factors within and between domains.

Contacts with general practitioners, dentists, and medical specialists among nursing home residents: a cross-sectional study in 44 German nursing homes.

BACKGROUND: Nursing home residents have high medical care needs. Their medical care utilization is, however, lower compared to community-dwelling elderly and varies widely among nursing homes. This study quantified the utilization of general practitioners (GPs), dentists, and medical specialists among nursing homes and residents, and investigated whether dentist utilization is associated with individual and nursing home characteristics. METHODS: Forty-four nursing homes invited 2124 residents to participate in a cross-sectional study. For 10 medical specialties, data on contacts in nursing homes, practices, and by telephone in the last 12 months were assessed at individual and nursing home level. The proportion of nursing homes and residents with any form of contact, and the median number and interquartile range (IQR) of contacts among individuals with contact were determined. Using multilevel logistic regression, associations between the probability of individual dental care utilization and sex, age, LTC grade, years of residence, sponsorship, number of nursing home beds, and transport and medical escort services for consultations at a practice were investigated. RESULTS: The proportion of nursing homes with any form of contact with physicians ranged from 100% for GPs, dentists, and urologists to 76.7% for gynecologists and orthopedists. Among the nursing homes, 442 residents participated (20.8% response). The proportion of residents with any contact varied from 97.8% for GPs, 38.5% for neurologists/psychiatrists, and 32.3% for dentists to 3.0% for gynecologists. Only for GPs, neurologists/psychiatrists, dentists, otorhinolaryngologists, urologists, and dermatologists, the proportion was higher for nursing home contacts than for practice and telephone contacts. Among residents with any contact, the median number of contacts was highest for GPs (11.0 [IQR 7.0-16.0]), urologists (4.0 [IQR 2.0-7.0]), and neurologists/psychiatrists (3.0 [IQR 2.0-5.0]). Dentist utilization varied widely among nursing homes (median odds ratio 2.5) and was associated with higher age. CONCLUSIONS: Almost all residents had regular contact to GPs, but only one third had contact with dentists. Lower proportions with contact were found for medical specialists, except for neurologists/psychiatrists. Reasons for the large variations in dental care utilization among nursing homes should be identified. TRIAL REGISTRATION: DRKS00012383 [2017/12/06].

[Dealing with Ethical Aspects in Student Research Projects - Results of a Survey of Health Sciences Faculties in Germany]. / Umgang mit der ethischen Bewertung bei studentischen Forschungsarbeiten ­ Ergebnisse einer Befragung an gesundheitsbezogenen Fachbereichen in Deutschland.

INTRODUCTION: Research projects in the health sciences often involve ethically sensitive areas. The rise in the number of empirically oriented theses and concepts such as research-based learning has led to an increasing need for ethics approvals also for student research projects. There is no standardised procedure for dealing with student research projects in Germany. This can lead to research projects being carried out without an ethics approval, even though this might have been necessary. This study aims to investigate how different universities deal with ethical aspects in students' research. In addition, we present examples of existing approaches. METHODS: An online-based questionnaire was sent to 132 departments offering degree programmes in public health, health and nursing science, and psychology at 112 universities. Additionally, telephone interviews were conducted with the coordinators of four such degree programmes. RESULTS: Coordinators of 55 such degree programmes participated in the survey; 84% of the participating of these offered support to students with ethical questions concerning their research. However, only 39% provided a structured procedure for dealing with ethical assessments of research projects led by students. Several approaches were presented in depth by the coordinators of four degree programmes, among them the use of checklists, the establishment of internal ethics committees, and ethics advisory services. All respondents agreed on a need to deal with ethics approvals related to students' research projects. CONCLUSION: Structured procedures exist at some but not all degree programmes, faculties, and universities. Some of these procedures can serve as models for other universities.

[Medical specialist undertreatment in nursing home residents-Prevalence and extrapolation]. / Fachärztliche Unterversorgung bei Heimbewohnern ­ Prävalenzstudie und Hochrechnung.

BACKGROUND: Nursing home residents tend to have lower medical specialist utilization than other groups of older people; however, as yet there is little evidence whether nursing home residents obtain adequate medical specialist care. This study investigated whether nursing home residents receive adequate oral health care, ophthalmological care, otorhinolaryngologist care and neurological care. The unmet needs of the nursing home population in Germany was extrapolated. MATERIAL AND METHODS: Audiometry, eye examinations and oral visual inspection were performed in 409 residents from 44 nursing homes. Medical care in the previous 12 months as well as existing diagnoses were retrieved from the nursing documentation. Teams of physicians evaluated for each resident based on all collected data if the resident obtained specialist care that was adequate to the needs. RESULTS: Between 15% and 45% of the residents with need for medical specialist care did not receive adequate specialist care. Of all residents 27% had unmet need of specialist care in at least one of the investigated medical specialties. It is projected that up to 205,000 nursing home residents in Germany do not receive adequate medical specialist care. CONCLUSION: Given a considerable proportion of nursing home residents with unmet need of specialist care, interventions should be developed that help reduce the level of unmet needs.

[Assessing the Benefit of Palliative Care in Germany - Perspective of Patients, Relatives and Professionals]. / Den Nutzen von Palliativversorgung bewerten ­ Was muss aus Patienten-, Angehörigen- und Versorgersicht beachtet werden?

BACKGROUND: The evaluation of complex interventions such as palliative care is challenging. Methods guidance such as the guidance documents of the Integrated Health Technology Assessment for the Evaluation of Complex Technologies (INTEGRATE-HTA) project help address specific challenges. The INTEGRATE-guidance was developed cooperatively by various international stakeholders and it was applied in a case study on palliative care. The presented study was part of the INTEGRATE-HTA project. ObjectivesThe objective was to identify important assessment aspects of palliative care in Germany from the perspective of patients, relatives and professional providers. METHODS: Applying the structured consensus method of the Improved Nominal Group Technique, we conducted interviews with two focus groups - one with relatives and one with professionals. Additionally, we conducted 4 interviews with patients. We used an open coding procedure to analyze the data and a dialogical approach to validate the results. RESULTS: 8 assessment aspects were found to be important. These are the definition and legitimacy of the term benefit, understanding of palliative care, patient-centered and holistic care approach, access to palliative care, continuity and flexibility of care, education of palliative care providers, and multidisciplinary approach. A central point was the need to address the intervention in its complexity and to include interactions between the different components. CONCLUSIONS: To be able to integrate various models and different perspectives of palliative care, it is important to have the involvement of different stakeholders. This also enhances the incorporation of important aspects during the development of assessment instruments.

[Contact-Tracing Apps in Contact Tracing of COVID-19]. / Contact-Tracing-Apps als unterstützende Maßnahme bei der Kontaktpersonennachverfolgung von COVID-19.

Contact tracing is currently one of the most effective measures to contain the COVID-19 pandemic. In order to identify persons that would otherwise not be known or remembered and to keep the time delay when reporting an infection and when contacting people as short as possible, digital contact tracing using smartphones seems to be a reasonable measure additional to manual contact tracing. Although first modelling studies predicted a positive effect in terms of prompt contact tracing, no empirically reliable data are as yet available, neither on the population-wide benefit nor on the potential risks of contact tracing apps. Risk-benefit assessment of such an app includes investigating whether such an app fulfils its purpose, as also research on the effectiveness, risks and side effects, and implementation processes (e. g. planning and inclusion of different participants). The aim of this article was to give an overview of possible public health benefits as well as technical, social, legal and ethical aspects of a contact-tracing app in the context of the COVID-19 pandemic. Furthermore, conditions for the widest possible use of the app are presented.

Methods Assessing Sociocultural Aspects of Health Technologies: Results of a Literature Review.

OBJECTIVES: Social and cultural aspects are rarely assessed in health technology assessments (HTA), despite being part of most HTA definitions. One hypothesis for the reason why they are hardly considered in HTA is that we lack relevant assessment methods. Accordingly, this review aims at providing an overview of methodological approaches to address social and cultural aspects related to health technologies in HTA. METHODS: We conducted a comprehensive literature search by searching fourteen databases and a hand-search of two pertinent journals. Additionally, we sent a query to all member agencies of the International Network of Agencies for Health Technology Assessment (INAHTA) asking them for methods they use to assess social and cultural aspects. RESULTS: A total of 125 publications met our inclusion criteria. We grouped the methodological approaches into checklists for experts, literature reviews, stakeholder participatory approaches, primary data collection methods, and combinations of methodological approaches. CONCLUSIONS: There is a wide variety of methods available for assessing social and cultural aspects of health technologies, some of which have been applied in HTA. The presented overview of the different approaches and their merits can facilitate the assessment of these aspects, and improve the knowledge regarding (potential) success and failure of the implementation of a health technology.

Health Technology Assessment of Public Health Interventions Published 2012 to 2016: An Analysis of Characteristics and Comparison of Methods.

OBJECTIVES: The aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs). METHODS: We defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables. RESULTS: We included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process. CONCLUSIONS: Our analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.

[Health research funding in Germany]. / Finanzierung der Gesundheitsforschung in Deutschland.

BACKGROUND: In Germany, a great amount of money is spent annually on health research (HR). However, detailed quantitative data concerning funders and receivers of the financing is lacking. OBJECTIVE: The goal of this paper is to depict the scope to which funders finance HR and the amount of money research institutions receive for their research activities. MATERIALS AND METHODS: First, openly accessible sources were searched to identify the relevant data for 2013. Missing data was requested from the specific institutions. Where relevant data could not be identified, approximate results were determined or marked as missing. RESULTS: In 2013, approximately 10.14 billion EUR were spent on HR. The most important funders were business (58%) and public agencies (36%). Business mainly funded privately financed research institutions, while public agencies mainly funded universities and non-university research institutions. Overall, privately financed research institutions received 55% of the research money, universities 34%, non-university research institutions 9%, and 2% of the money went to federal institutions. CONCLUSION: In Germany, the biggest share of health research money is spent and consumed by the private sector. The pattern of financing health research in Germany is comparable to other countries where data are available.

The development of CHAMP: a checklist for the appraisal of moderators and predictors.

BACKGROUND: Personalized healthcare relies on the identification of factors explaining why individuals respond differently to the same intervention. Analyses identifying such factors, so called predictors and moderators, have their own set of assumptions and limitations which, when violated, can result in misleading claims, and incorrect actions. The aim of this study was to develop a checklist for critically appraising the results of predictor and moderator analyses by combining recommendations from published guidelines and experts in the field. METHODS: Candidate criteria for the checklist were retrieved through systematic searches of the literature. These criteria were evaluated for appropriateness using a Delphi procedure. Two Delphi rounds yielded a pilot checklist, which was tested on a set of papers included in a systematic review on reinforced home-based palliative care. The results of the pilot informed a third Delphi round, which served to finalize the checklist. RESULTS: Forty-nine appraisal criteria were identified in the literature. Feedback was obtained from fourteen experts from (bio)statistics, epidemiology and other associated fields elicited via three Delphi rounds. Additional feedback from other researchers was collected in a pilot test. The final version of our checklist included seventeen criteria, covering the design (e.g. a priori plausibility), analysis (e.g. use of interaction tests) and results (e.g. complete reporting) of moderator and predictor analysis, together with the transferability of the results (e.g. clinical importance). There are criteria both for individual papers and for bodies of evidence. CONCLUSIONS: The proposed checklist can be used for critical appraisal of reported moderator and predictor effects, as assessed in randomized or non-randomized studies using individual participant or aggregate data. This checklist is accompanied by a user's guide to facilitate implementation. Its future use across a wide variety of research domains and study types will provide insights about its usability and feasibility.

HOW TO AVOID GIVING THE RIGHT ANSWERS TO THE WRONG QUESTIONS: THE NEED FOR INTEGRATED ASSESSMENTS OF COMPLEX HEALTH TECHNOLOGIES.

Health technologies are becoming increasingly complex and contemporary health technology assessment (HTA) is only partly equipped to address this complexity. The project "Integrated assessments of complex health technologies" (INTEGRATE-HTA), funded by the European Commission, was initiated with the overall objective to develop concepts and methods to enable patient-centered, integrated assessments of the effectiveness, and the economic, social, cultural, and ethical issues of complex technologies that take context and implementation issues into account. The project resulted in a series of guidances that should support the work of HTA scientists and decision makers alike.

TOWARD INTEGRATION IN THE CONTEXT OF HEALTH TECHNOLOGY ASSESSMENT: THE NEED FOR EVALUATIVE FRAMEWORKS.

OBJECTIVES: A comprehensive health technology assessment (HTA) enables a patient-centered assessment of the effectiveness, economic, ethical, socio-cultural, and legal issues of health technologies that takes context and implementation into account. A question is whether these various pieces of evidence need to be integrated, and if so, how that might be achieved. The objective of our study is to discuss the meaning of integration in the context of HTA and suggest how it may be achieved in a more structured way. METHODS: An analysis of the concept of integration in the context of HTA and a review of approaches that were adopted in the INTEGRATE-HTA project that may support integration. RESULTS: Current approaches to integration in HTA are mainly methods of commensuration, which are not optimally geared to support public deliberation. In contrast, articulating evaluative frameworks could be an important means of integration which allows for exploring how facts and values can be brought to bear on each other. CONCLUSIONS: Integration is not something that only needs to be addressed at the end, but rather throughout an HTA, right from the start. Integration can be conceived as a matter of accounting for the relevance of empirical evidence in view of a commitment to a set of potentially conflicting values. Various elements of the INTEGRATE-HTA project, such as scoping and the development of logic models, can help to achieve integration in HTA.

A CONSULTATION GUIDE FOR ASSESSING THE APPLICABILITY OF HEALTH TECHNOLOGIES:A CASE STUDY.

OBJECTIVES: The translation of research findings into policy and practice is crucially dependent on the applicability of such findings in a given decision-making context. We explored in a case study whether a generic consultation guide to assess the applicability of a health technology could be rapidly deployed and deliver useful insights. METHODS: A consultation guide based on the context and implementation for complex interventions (CICI) framework was developed and piloted to assess the applicability of reinforced home-based palliative care in three European countries. Individual consultations in England and Germany and a panel discussion in Poland were completed. RESULTS: Various barriers may hinder successful implementation of reinforced home-based palliative care in the three countries. Whilst the experts across all countries emphasized the lack of funding along with organization and structure as major barriers, information varied by country for many of the other identified barriers and facilitators. Participants in the pilot study provided positive feedback in terms of understanding the topic and purpose of the consultation, and both individual and panel consultations could be easily implemented. CONCLUSIONS: In this case study, the consultation guide presented a pragmatic, ready-to-use tool to assess the applicability of a health technology. As shown here, it can be used in a generic manner without discrete empirical information on the technology in question or, ideally, makes use of specific information collected as part of a HTA. Further studies are needed to validate this guide and apply it to other types of health technologies and more diverse decision-making contexts.

AN INTEGRATED PERSPECTIVE ON THE ASSESSMENT OF TECHNOLOGIES: INTEGRATE-HTA.

OBJECTIVES: Current health technology assessment (HTA) is not well equipped to assess complex technologies as insufficient attention is being paid to the diversity in patient characteristics and preferences, context, and implementation. Strategies to integrate these and several other aspects, such as ethical considerations, in a comprehensive assessment are missing. The aim of the European research project INTEGRATE-HTA was to develop a model for an integrated HTA of complex technologies. METHODS: A multi-method, four-stage approach guided the development of the INTEGRATE-HTA Model: (i) definition of the different dimensions of information to be integrated, (ii) literature review of existing methods for integration, (iii) adjustment of concepts and methods for assessing distinct aspects of complex technologies in the frame of an integrated process, and (iv) application of the model in a case study and subsequent revisions. RESULTS: The INTEGRATE-HTA Model consists of five steps, each involving stakeholders: (i) definition of the technology and the objective of the HTA; (ii) development of a logic model to provide a structured overview of the technology and the system in which it is embedded; (iii) evidence assessment on effectiveness, economic, ethical, legal, and socio-cultural aspects, taking variability of participants, context, implementation issues, and their interactions into account; (iv) populating the logic model with the data generated in step 3; (v) structured process of decision-making. CONCLUSIONS: The INTEGRATE-HTA Model provides a structured process for integrated HTAs of complex technologies. Stakeholder involvement in all steps is essential as a means of ensuring relevance and meaningful interpretation of the evidence.

TAKING PATIENT HETEROGENEITY AND PREFERENCES INTO ACCOUNT IN HEALTH TECHNOLOGY ASSESSMENTS.

OBJECTIVES: The INTEGRATE-HTA project provided methodology to evaluate complex technologies. This study provides guidance on how to retrieve and critically appraise available evidence on moderators and predictors of treatment effects and on patient preferences for treatment outcomes as a source of complexity. METHODS: Search filters for PubMed were developed by hand-searching a large volume of articles reporting on relevant aspects. Search terms were retrieved from selected papers and algorithmically combined to find the optimal combination of search terms. For the development of the appraisal checklists literature was searched in PubMed and Google Scholar together with citation chasing. For the CHecklist for the Appraisal of Moderators and Predictors (CHAMP) a Delphi procedure was used to value a set of eligible appraisal criteria retrieved from the literature. RESULTS: Search filters were developed optimized for different accuracy measures. The final version of CHAMP consists of a seventeen questions covering the design, analysis, results and transferability of results of moderator and predictor analysis. The final checklist for appraisal of literature on patient preferences for treatment outcomes consist of six questions meant to help the user to identify relevant quality issues together with a guidance toward existing tools concerning the appraisal of specific preference elicitation methods. CONCLUSIONS: Incorporating knowledge on subgroups for whom a specific treatment will produce more benefit holds the promise of better targeting and, ultimately, enhancing overall effectiveness and efficiency of healthcare technology. Finally, incorporating information on preferences for treatment outcomes will foster health technology assessment that addresses outcomes that are important to patients.

[Education and Training in Public Health - Results of the Working Group 9 of the Forum Future Public Health, Berlin 2016]. / Lehre, Fort- und Weiterbildung in Public Health.

The need for a qualified public health workforce can only be met by appropriate provision of a wide spectrum of basic, advanced and continuing education and training programs on public health that meet international standards. At the same time, efforts must be made to offer young academics attractive career opportunities. Training in public health competences must also be provided for allied professionals in health care and for professions with influence on the determinants of health such as urban planning or agricultural science. This report from a working group meeting at the 'Public Health Zukunftsforum 2016' in Berlin presents ideas for the further development of training in public health in Germany.