[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.

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.

[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.

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.

The Role of End-of-Life Issues in the Design and Reporting of Cancer Clinical Trials: A Structured Literature Review.

BACKGROUND: Randomized controlled trials (RCTs) are important sources of information on the benefits and harms patients may expect from treatment options. The aim of this structured literature review by the German Institute for Quality and Efficiency in Health Care was to explore whether and how the end-of-life (EoL) situation of patients with advanced cancer is considered in RCTs investigating anti-cancer treatments. METHODS: Our journal pool comprised 19 medical journals, namely five preselected key general medical journals as well as 14 specialist journals (mainly cancer) identified via a scoping search. We systematically searched these journals in MEDLINE to identify RCTs investigating anti-cancer treatments for the following four cancer types: glioblastoma, lung cancer (stage IIIb-IV), malignant melanoma (stage IV), and pancreatic cancer (search via OVID; November 2012). We selected a representative sample of 100 publications, that is, the 25 most recent publications for each cancer type. EoL was defined as a life expectancy of ≤ two years. We assessed the information provided on (1) the descriptions of the terminal stage of the disease, (2) the therapeutic goal (i.e. the intended therapeutic benefit of the intervention studied), (3) the study endpoints assessed, (4) the authors' concluding appraisal of the intervention's effects, and (5) the terminology referring to the patients' EoL situation. RESULTS: Median survival was ≤ one year for each of the four cancer types. Descriptions of the terminal stage of the disease were ambiguous or lacking in 29/100 publications. One or more therapeutic goals were mentioned in 51/100 publications; these goals were patient-relevant in 38 publications (survival alone: 30/38; health-related quality of life (HRQoL) or HRQoL and survival: 6/38; symptom control or symptom control and survival: 2/38). Primary endpoints included survival (50%), surrogates (44%), and safety (3%). Patient-reported outcomes (PROs) were assessed in 36/100 RCTs. The implications of treatment-related harms for the patients were discussed in 22/100 appraisals. Terminology referring to the patients' EoL situation (e.g. "terminal") was scarce, whereas terms suggesting control of the disease (e.g. "cancer control") were common. CONCLUSIONS: The EoL situation of patients with advanced cancer should be more carefully considered in clinical trials. Although the investigation and robust reporting of PROs is a prerequisite for informed decision-making in healthcare, they are rarely defined as endpoints and HRQoL is rarely mentioned as a therapeutic goal. Suggestions for improving standards for study design and reporting are presented.

[Different name, same meaning? Comparative effectiveness research and patient-centered outcomes research in the USA]. / Anderer Name, gleicher Inhalt? Comparative Effectiveness Research und Patient-Centered Outcomes Research in den USA.

In 2009 the Congress of the USA commissioned a program on "Comparative Effectiveness Research" (CER) for two years. The program was funded with 1.1 billion USD and aims at projects that are directly relevant for the care of patients, investigate research questions and populations where research gaps are considerable, and which compare at least two interventions. Three years later it seems that in the USA CER has been replaced by "Patient-Centered Outcomes Research" (PCOR). This article summarizes the conceptual and empirical development of CER since 2009 and looks at the similarities and differences between CER and PCOR.

[Evidence-based public health. Prevention and health promotion in the context of science, values and (vested) interests]. / Evidence-based Public Health. Prävention und Gesundheitsförderung im Kontext von Wissenschaft, Werten und Interessen.

BACKGROUND AND PURPOSE: Public health aims at prevention and health promotion at the level of populations. Like in medicine, public health interventions should be based on the best available evidence. A coherent model for evidence-based public health (EBPH) is missing so far. This paper aims at developing a conceptual as well as operational model for EBPH. METHODS AND RESULTS: Based on the concept of evidence-based medicine (EBM) a model of EBPH was developed that takes the specific situation of public health into account: (1) nonmedical aspects, e.g. ethical, sociocultural, or organizational aspects, are often more relevant in EBPH than in EBM. 2) Criteria for decision-making at population level are often different from those employed at the individual level. (3) Values and (vested) interests affect not only the decision itself but the whole process of decision-making, including the generation of the evidence. CONCLUSION: A comprehensive model of EBPH that takes the aspects described above into account allows for the analysis of the interplay between decision-making and evidence in the complex reality of public health. This is illustrated using the introduction of the vaccination against human papillomavirus as an example.

Diagnostic accuracy of methods for the detection of BRCA1 and BRCA2 mutations: a systematic review.

As sequence analysis for BRCA1 and BRCA2 mutations is both time- and cost-intensive, current strategies often include scanning techniques to identify fragments containing genetic sequence alterations. However, a systematic assessment of the diagnostic accuracy has been lacking so far. Here, we report on a systematic review to assess the internal and external validity of current scanning techniques. Inclusion criteria were: controlled design, investigators blinded, and tests suitable as a scanning tool for the whole genes BRCA1 and BRCA2. Outcome parameters were sensitivity, specificity, and positive and negative predictive values compared to direct sequencing. Out of 3816 publications, 10 studies reporting on 12 methods met our inclusion criteria. The internal and external validity of most of these studies was limited. Sensitivities were reported to be 100% for enzymatic mutation detection (EMD), multiple-dye cleavase fragment length polymorphism (MD-CFLP), fluorescence-based conformation-sensitive gel electrophoresis (F-CSGE), RNA-based sequencing, restriction endonuclease fingerprinting-single strand conformation polymorphism (REF-SSCP), stop codon (SC) assay, and denaturing high-performance liquid chromatography (DHPLC). Sensitivity was 50-96% for SSCP, 88-91% for two-dimensional gene scanning (TDGS), 76% for conformation-sensitive gel electrophoresis (CSGE), 75% for protein truncation test (PTT), and 58% for micronucleus test (MNT). Specificities close to 100% were reported, except for MNT. PTT and SC assay are only able to detect truncating mutations. Most studies were designed to introduce new experimental approaches or modifications of established methods and require further evaluation. F-CSGE, REF-SSCP, RNA-based sequencing, EMD, and MD-CFLP will need further evaluation before their use in a routine setting can be considered. SSCP, MNT, PTT, CSGE, and TDGS cannot be recommended because of their low sensitivity. DHPLC outperforms all other methods studied. However, none of the four studies evaluating DHPLC was performed on BRCA2.