[Opportunities and Challenges Of The Ethics Review Of Qualitative Health Services Research: A Survey Of Qualitative Researchers]. / Chancen und Herausforderungen der Ethikbegutachtung qualitativer Versorgungsforschung ­ eine Befragung qualitativ Forschender.

Ethics committees ensure compliance with ethical principles in medical research. They are oriented towards clinical studies, but also review e. g., qualitative research. Using a semi-structured online survey, we collected data on experiences of qualitative researchers with the review by ethics committees and analysed them via content analysis. In July 2019, 73 researchers took part in the survey. Five main topics were derived from their statements regarding the ethics review of qualitative research: 1. relevance of qualitative research expertise; 2. cooperation between researchers and ethics committees; 3. transparency of review criteria; 4. dealing with formal review requirements; 5. evaluation of the review's significance for qualitative research. The results show the potential of ethics review for reflection on ethical questions in qualitative research. Prerequisites for this are the fit with the characteristics and quality criteria of qualitative research, the presence of qualitative research expertise in ethics committees, the transparency of the ethics review process as well as openness to different professional cultures and a constructive communication culture.

Patient-centered empirical research on ethically relevant psychosocial and cultural aspects of cochlear, glaucoma and cardiovascular implants - a scoping review.

BACKGROUND: The significance of medical implants goes beyond technical functioning and reaches into everyday life, with consequences for individuals as well as society. Ethical aspects associated with the everyday use of implants are relevant for individuals' lifeworlds and need to be considered in implant care and in the course of technical developments. METHODS: This scoping review aimed to provide a synthesis of the existing evidence regarding ethically relevant psychosocial and cultural aspects in cochlear, glaucoma and cardiovascular implants in patient-centered empirical research. Systematic literature searches were conducted in EBSCOhost, Philpapers, PsycNET, Pubmed, Web of Science and BELIT databases. Eligible studies were articles in German or English language published since 2000 dealing with ethically relevant aspects of cochlear, glaucoma and passive cardiovascular implants based on empirical findings from the perspective of (prospective) implant-wearers and their significant others. Following a descriptive-analytical approach, a data extraction form was developed and relevant data were extracted accordingly. We combined a basic numerical analysis of study characteristics with a thematically organized narrative synthesis of the data. RESULTS: Sixty-nine studies were included in the present analysis. Fifty were in the field of cochlear implants, sixteen in the field of passive cardiovascular implants and three in the field of glaucoma implants. Implant-related aspects were mainly found in connection with autonomy, freedom, identity, participation and justice, whereas little to no data was found with regards to ethical principles of privacy, safety or sustainability. CONCLUSIONS: Empirical research on ethical aspects of implant use in everyday life is highly relevant, but marked by ambiguity and unclarity in the operationalization of ethical terms and contextualization. A transparent orientation framework for the exploration and acknowledgment of ethical aspects in "lived experiences" may contribute to the improvement of individual care, healthcare programs and research quality in this area. Ethics-sensitive care requires creating awareness for cultural and identity-related issues, promoting health literacy to strengthen patient autonomy as well as adjusting healthcare programs accordingly. More consideration needs to be given to sustainability issues in implant development and care according to an approach of ethics-by-design.

Patient Preferences for Long-Term Implant Care in Cochlear, Glaucoma and Cardiovascular Diseases.

In the process of developing and implementing innovative implant technologies the consideration of patient preferences can be beneficial for patients, doctors and developers. Nevertheless, in existing literature, there is still scarce knowledge of patients' perspectives on long-term implant care. In this study, three discrete choice experiments (DCEs) were conducted in the context of cochlear implants (CI, n = 92), glaucoma implants (GI, n = 21) and cardiovascular implants (CVI, n = 23), examining the relative importance of attributes of long-term implant care from the patients' perspective. The participants chose between differently shaped options for implant-related care. The attributes of these care options were generated and selected based on previous literature reviews, group discussions and a diary study with patients. The choice data were analyzed via binary logit regression. In CI-DCE, the technological compatibility of the implant with newer implant models, accessories or devices from other manufacturers was highly valued by participants, whereas in GI-DCE the (in)dependency on glaucoma medication post-implantation had the greatest influence on participants' choice behavior. In CVI-DCE, the attribute with the highest relative importance related to the means of securing long-term treatment success. In all three DCE, shared decision making was relatively important for participants. Our results emphasized the importance of an adequate transfer of technological advancements in implant care for promoting patient benefits, such as the availability of comprehensible, understandable, high-quality information about current developments. Similarly, promoting technological health literacy and further pushing the technological compatibility, durability and safety of implants are directions for future implant development in accordance with patients' preferences. Therefore, the participation of implant wearers in the development process is encouraged.

["This is Not at All Foreseeable from the Outset" - Research Ethics in Qualitative Health Services Research: A Survey of Researchers]. / "Das ist vorher gar nicht absehbar"? ­ Forschungsethische Fragen in der qualitativen Versorgungsforschung. Eine Befragungsstudie mit Forschenden.

BACKGROUND: Health services research is multidisciplinary and involves the use of a plurality of research methods. Medicine as a discipline serves as an important reference, also in terms of addressing ethics issues in research. At the same time, however, the highly formalized ethical reviews common in medicine, are controversial within the social sciences, especially among qualitative researchers. So far, little is known about which research ethics issues arise in qualitative health services research. METHODS: In summer 2019, an online survey was conducted among health services researchers on two main topics: a) research ethics issues in qualitative health services research and b) experiences with the ethics review procedures. The questionnaire contained ten open questions; the responses were analyzed for content. The first topic (ethical issues) is addressed within this article. RESULTS: A total of 73 researchers with heterogeneous professional background and an average of more than seven years of work experience in health services research participated in the survey. The following were reported as central research ethics issues: a) legitimacy and anticipation of ethical challenges in the planning of research, b) field access, consent and burdens during data collection, c) anonymization and data protection in data processing, d) data analysis, e) publication of results and data and f) general topics such as central principles and goals of research as well as the role of researchers. The main formats for dealing with these issues were exchange and consultation as well as referring to texts and regulations. CONCLUSIONS: On the one hand, the data documents typical central research ethics questions that researchers are confronted with in the context of qualitative health services research; on the other hand, they also point to gaps and less considered topics. A systematizing ethical reflection could take up these findings in order to develop health services research-specific principles and strategies for handling research ethics issues.

Health Literacy in the Context of Implant Care-Perspectives of (Prospective) Implant Wearers on Individual and Organisational Factors.

The continuous development of medical implants offers various benefits for persons with chronic conditions but also challenges an individual's, and the healthcare system's, ability to deal with technical innovation. Accessing and understanding new information, navigating healthcare, and appraising the role of the implant in body perceptions and everyday life requires health literacy (HL) of those affected as well as an HL-responsive healthcare system. The interconnectedness of these aspects to ethically relevant values such as health, dependence, responsibility and self-determination reinforces the need to address HL in implant care. Following a qualitative approach, we conducted group discussions and a diary study among wearers of a cochlear, glaucoma or cardiovascular implant (or their parents). Data were analysed using the documentary method and grounded theory. The data reveal the perceptions of implant wearers regarding the implant on (1) the ability to handle technical and ambiguous information; (2) dependence and responsibility within the healthcare system; and (3) the ethical aspects of HL. Knowing more about the experiences and values of implant wearers is highly beneficial to develop HL from an ethical perspective. Respective interventions need to initially address ethically relevant values in counselling processes and implant care.

[DNVF Memorandum Health Literacy (Part 2) - Operationalisation and Measuring of Health Literacy from a Health Services Research Perspective]. / DNVF Memorandum Gesundheitskompetenz (Teil II) ­ Operationalisierung und Messung von Gesundheitskompetenz aus Sicht der Versorgungsforschung.

The "DNVF Memorandum Health Literacy (Part 2): Operationalization and Measurement of Health Literacy from the Perspective of Health Services Research" of the German Network for Health Services Research represents the continuation of the memorandum "DNVF Memorandum Health Literacy (Part 1): Background, Subject and Issues in Health Services Research". In addition to the general requirements for the measurement of health literacy, this memorandum also deals with the specific requirements, such as the differentiation of health literacy from related constructs, the differences between performance-based and self-assessment methods, the differences between generic and specific instruments, the use of screening instruments, and the measurement of health literacy in special populations. Furthermore, special considerations about the measurement of digital health literacy, potentials of qualitative and participatory research approaches as well as research ethics in the measurement of health literacy will be elaborated on. A special emphasis is placed on practical relevance for health services researchers. Finally, the authors will give an outlook on challenges and research desiderata in connection with the measurement of health literacy in the context of health services research.

"Withstanding ambivalence is of particular importance"-Controversies among experts on dealing with desire to die in palliative care.

In order to investigate controversies surrounding the desire to die phenomenon in palliative care by analyzing expert opinions on the topic, we carried out a secondary qualitative data analysis of free text comments collected during a Delphi survey that was designed to develop a conversation aid for dealing with desire to die in everyday clinical practice. Between 01/2018 and 03/2018, a two-round Delphi survey was carried out with national (German) and international palliative care experts. Free text comments were reinvestigated to identify controversies surrounding the desire to die phenomenon. An additional in-depth analysis focused on statements expressing attitudes towards proactively addressing (potential) desires to die. Within the Delphi survey, 103 of 149 multi-professional participants (almost all of them with practical and only six with exclusively theoretical expertise in palliative care) generated 444 free text comments. Thereof, we identified three main categories related to dealing with desire to die: "outer framework", "extended care system" and "health-professional-patient-relationship". Ambivalences, taboos and uncertainties surrounding desire to die in palliative care became apparent. Experts are divided concerning the practice of proactively addressing desire to die. Even if these conversations-especially the proactive approach-are also viewed critically, we conclude that open-ended and respectful communication about desire to die between health professionals and patients can be understood as an eligible intervention in palliative care. Proactively addressing the topic is a possible way to open up such conversations.

Culture in the spotlight-cultural adaptation and content validity of the integrated palliative care outcome scale for dementia: A cognitive interview study.

BACKGROUND: Dementia is a life-limiting disease with high symptom burden. The Integrated Palliative Care Outcome Scale for Dementia (IPOS-Dem) is the first comprehensive person-centered measure to identify and measure palliative care needs of people with dementia. However, such a measure is missing in the German health care system. AIM: To develop a culturally adapted German version of the IPOS-Dem and determine its content validity as a foundation for comprehensive psychometric testing. DESIGN: Cognitive interview study with intermittent analysis and questionnaire adaptation. Interview guide and coding frame followed thematic analysis according to Willis complemented by Tourangeau's model of cognitive aspects of survey methodology: comprehension, retrieval, judgment, response. PARTICIPANTS: Purposive sample with professionals (n = 29) and family carers (n = 6) of people with advanced dementia in seven nursing homes and person's own home care in four interview rounds (n = 11; 10; 7; 7). RESULTS: IPOS-Dem was regarded as comprehensive and accessible. Cultural adaption pertained to issues of comprehension and judgment. Comprehension challenges referred to the person-centered concept of "being affected by" used in the POS-measures. Judgment problems related to persons with limited communication causing challenges in assessment. CONCLUSION: Most issues of cultural adaptation could be addressed by questionnaire modifications. However, interviews unveiled fundamental challenges for using proxy reported person-centered assessments. Continuous training on how to use the instrument is imperative to integrate the person-centered approach of palliative care into nursing homes as a key provider of generalist palliative care for people with dementia. The refined version is ready for psychometric testing.

The ticking time-bomb. Health literacy in the context of genetic risk prediction in familial breast-ovarian cancer; A qualitative study.

Personalised methods of predicting breast and ovarian cancer risk through genetic testing increasingly demand a person's understanding and critical appraisal of risk-related information, as well as decision-making and acting upon disclosure of a positive test result. The current study aims at understanding health literacy (HL) among persons at risk of developing familial breast-ovarian cancer (FBOC) from a bottom-up perspective-incorporating their viewpoints into the research process. Its qualitative design integrates an ethnographic-narrative approach and findings from 10 narrative interviews with women who have undergone genetic testing, analysed by using reflexive grounded theory. The collected data reveal the entanglement of the women's perceptions concerning the risk of getting ill, their identity, and their strategies of managing health. The analysis of this interplay provides an empirical basis for approaching HL in its communicative dimension, considering individuals' understandings of health and illness, and emphasizing the role of critical HL.

Cardiopulmonary resuscitation (CPR) during spaceflight - a guideline for CPR in microgravity from the German Society of Aerospace Medicine (DGLRM) and the European Society of Aerospace Medicine Space Medicine Group (ESAM-SMG).

BACKGROUND: With the "Artemis"-mission mankind will return to the Moon by 2024. Prolonged periods in space will not only present physical and psychological challenges to the astronauts, but also pose risks concerning the medical treatment capabilities of the crew. So far, no guideline exists for the treatment of severe medical emergencies in microgravity. We, as a international group of researchers related to the field of aerospace medicine and critical care, took on the challenge and developed a an evidence-based guideline for the arguably most severe medical emergency - cardiac arrest. METHODS: After the creation of said international group, PICO questions regarding the topic cardiopulmonary resuscitation in microgravity were developed to guide the systematic literature research. Afterwards a precise search strategy was compiled which was then applied to "MEDLINE". Four thousand one hundred sixty-five findings were retrieved and consecutively screened by at least 2 reviewers. This led to 88 original publications that were acquired in full-text version and then critically appraised using the GRADE methodology. Those studies formed to basis for the guideline recommendations that were designed by at least 2 experts on the given field. Afterwards those recommendations were subject to a consensus finding process according to the DELPHI-methodology. RESULTS: We recommend a differentiated approach to CPR in microgravity with a division into basic life support (BLS) and advanced life support (ALS) similar to the Earth-based guidelines. In immediate BLS, the chest compression method of choice is the Evetts-Russomano method (ER), whereas in an ALS scenario, with the patient being restrained on the Crew Medical Restraint System, the handstand method (HS) should be applied. Airway management should only be performed if at least two rescuers are present and the patient has been restrained. A supraglottic airway device should be used for airway management where crew members untrained in tracheal intubation (TI) are involved. DISCUSSION: CPR in microgravity is feasible and should be applied according to the Earth-based guidelines of the AHA/ERC in relation to fundamental statements, like urgent recognition and action, focus on high-quality chest compressions, compression depth and compression-ventilation ratio. However, the special circumstances presented by microgravity and spaceflight must be considered concerning central points such as rescuer position and methods for the performance of chest compressions, airway management and defibrillation.

The desire to die in palliative care: a sequential mixed methods study to develop a semi-structured clinical approach.

BACKGROUND: Although desire to die of varying intensity and permanence is frequent in patients receiving palliative care, uncertainty exists concerning appropriate therapeutic responses to it. To support health professionals in dealing with patients´ potential desire to die, a training program and a semi-structured clinical approach was developed. This study aimed for a revision of and consensus building on the clinical approach to support proactively addressing desire to die and routine exploration of death and dying distress. METHODS: Within a sequential mixed methods design, we invited 16 palliative patients to participate in semi-structured interviews and 377 (inter-)national experts to attend a two-round Delphi process. Interviews were analyzed using qualitative content analysis and an agreement consensus for the Delphi was determined according to predefined criteria. RESULTS: 11 (69%) patients from different settings participated in face-to-face interviews. As key issues for conversations on desire to die they pointed out the relationship between professionals and patients, the setting and support from external experts, if required. A set of 149 (40%) experts (132/89% from Germany, 17/11% from 9 other countries) evaluated ten domains of the semi-structured clinical approach. There was immediate consensus on nine domains concerning conversation design, suggestions for (self-)reflection, and further recommended action. The one domain in which consensus was not achieved until the second round was "proactively addressing desire to die". CONCLUSIONS: We have provided the first semi-structured clinical approach to identify and address desire to die and to respond therapeutically - based on evidence, patients' views and consensus among professional experts. TRIAL REGISTRATION: The study is registered in the German Clinical Trials Register (DRKS00012988; registration date: 27.9.2017) and in the Health Services Research Database (VfD_DEDIPOM_17_003889; registration date: 14.9.2017).

Health Literacy as Communicative Action-A Qualitative Study among Persons at Risk in the Context of Predictive and Preventive Medicine.

Predictive and preventive medicine play an increasingly important role in public debates on health, providing cutting-edge technologies with the potential to measure and predict individual risks of getting ill. This leads to an ever-expanding definitional space between being "healthy" and being "ill", challenging the individual's everyday life, attitudes and perceptions towards the self and the process of health-related decision-making. "How do the condition of 'being at risk' and individual health literacy interrelate?" is the leading question of the current contribution. Drawing on empirical qualitative data, collected by means of narrative interviews with persons at risk in four clinical fields, a bottom-up ethnographic and health sciences perspective on health literacy (with an emphasis on critical health literacy) is employed. The findings will be embedded within theoretical approaches dealing with power relations and communication in healthcare encounters, particularly Habermas' theory of communicative action. The core outcome of our study is a concept for an overarching model of health literacy in the context of health-related risk prediction across indications, based on empirical insights gained through interpretative analysis of the four clinical domains.

[Group Discussions in Health Services Research - Part 2: Reflections on The Concept of Group, Moderation and Analysis of Group Discussions as well as Online Group Discussion]. / Gruppendiskussionen in der Versorgungsforschung ­ Teil 2: Überlegungen zum Begriff der Gruppe, zur Moderation und Auswertung von Gruppendiskussionen sowie zur Methode der Online-Gruppendiskussion.

This article is the second of 2 articles on group discussions in health services research, written by the Qualitative Methods Working Group of the German Network for Health Care Research (DNVF). It starts with theoretical considerations on the concept of groups, and provides specific knowledge about groups in general and the behaviour of individual group members in particular, which is relevant for the design and interpretation of interaction processes in the group context. The following sections deal with the processuality of group discussions, moderation styles and techniques as well as reflections on possible subjects and methods of analysis. Presentation of results and text passages which unveil the interaction structure of several discussion participants are also discussed here. Finally, insights into the special features, potentials and challenges of group discussions via online platforms are provided. Together, the two articles provide an overview of the most important aspects of the application of group discussions in the field of health services research.

Health literacy in persons at risk of and patients with coronary heart disease: A systematic review.

BACKGROUND: Health literacy (HL) plays a crucial role in the maintenance and improvement of individual health. Empirical findings highlight the relation between a person's HL-level and clinical outcomes. However, the role of HL in persons at risk for coronary heart disease (CHD) and patients with CHD has not been researched conclusively. OBJECTIVE: The aim of this study was to review systematically the current evidence on HL, its dimensions (access to, understanding, appraisal and apply of health-related information), and its important influencing factors, with regard to CHD risk. METHOD: We used a mixed-methods approach. Eligible articles needed to employ a validated tool for HL or mention the concept and at least one of its dimensions. After the screening process, 14 quantitative and 27 qualitative studies were included and referred to one or more dimensions of HL. Six observational studies measured HL with a validated tool. RESULTS: Findings suggest that patients with lower HL feel less capable to perform lifestyle changes, exhibit fewer proactive coping behaviors, are more likely to deny CHD, are generally older, are less often employed, have lower educational levels and lower socioeconomic status, experience faster physical decline, and use the healthcare system less, compared to patients with higher HL. Barriers to HL include inadequate provision of information by health providers, lack of awareness of the risk factors for CHD, perceived impairment of quality of life due to lifestyle changes, and negative experiences with the healthcare system. Facilitators include a good patient-physician relationship based on good communicative competences of health providers. CONCLUSIONS: The concept of HL yields a promising potential to understand the process from obtaining information to actual health behavior change, and the results clearly indicate the need for more systematic research on HL in CHD patients and persons at risk.

The perception of barriers concerning opioid medicines: A survey examining differences between policy makers, healthcare professionals and other stakeholders.

BACKGROUND: In many countries, the consumption of opioid medicines is too low to meet population needs. Discussions within the Access To Opioid Medication in Europe project indicated that there may be significant differences in the perception of barriers for their adequate use, depending on the stakeholders. AIM: The aim of this study was to examine the perception of barriers and their impact concerning opioid medicines, comparing policy makers, healthcare professionals working in the field of pain management, palliative care or harm reduction and other stakeholders. DESIGN: Data were collected using a questionnaire partially constructed from existing surveys, reviewed for content validity by four experts and pilot-tested in Latvia. SETTING/PARTICIPANTS: Participants of the Access to Opioid Medication in Europe national conferences were invited to complete the questionnaire. Stakeholder groups were compared using non-parametric rank-sum tests. RESULTS: In total, 199 participants (54%) in seven countries completed the questionnaire. Most frequently rated major barriers included lack of financial resources and inadequate knowledge, skills and training among policy makers (55%-66%). Overall, policy makers perceived issues less often as major barriers or having major impact (29% barrier, 32% impact) compared to other stakeholders (36%-42% barrier, 39%-51% impact). Significant differences were seen on several aspects. For example, excessive regulation or bureaucracy for prescribing was rated as having major impact by 55%-57% of healthcare professionals in contrast to only 20% of the policy makers (p = 0.002). CONCLUSION: Multiple barriers may play an important role, partly depending on the perspective of the stakeholder involved. Hence, when addressing perceived barriers, it is important to include all relevant stakeholder groups. Only then, effective and widely supported solutions can be implemented.

Understanding complexity - the palliative care situation as a complex adaptive system.

BACKGROUND: The concept of complexity is used in palliative care (PC) to describe the nature of patients' situations and the extent of resulting needs and care demands. However, the term or concept is not clearly defined and operationalised with respect to its particular application in PC. As a complex problem, a care situation in PC is characterized by reciprocal, nonlinear relations and uncertainties. Dealing with complex problems necessitates problem-solving methods tailored to specific situations. The theory of complex adaptive systems (CAS) provides a framework for locating problems and solutions. This study aims to describe criteria contributing to complexity of PC situations from the professionals' view and to develop a conceptual framework to improve understanding of the concept of "complexity" and related elements of a PC situation by locating the complex problem "PC situation" in a CAS. METHODS: Qualitative interview study with 42 semi-structured expert (clinical/economical/political) interviews. Data was analysed using the framework method. The thematic framework was developed inductively. Categories were reviewed, subsumed and connected considering CAS theory. RESULTS: The CAS of a PC situation consists of three subsystems: patient, social system, and team. Agents in the "system patient" are allocated to further subsystems on patient level: physical, psycho-spiritual, and socio-cultural. The "social system" and the "system team" are composed of social agents, who affect the CAS as carriers of characteristics, roles, and relationships. Environmental factors interact with the care situation from outside the system. Agents within subsystems and subsystems themselves interact on all hierarchical system levels and shape the system behaviour of a PC situation. CONCLUSIONS: This paper provides a conceptual framework and comprehensive understanding of complexity in PC. The systemic view can help to understand and shape situations and dynamics of individual care situations; on higher hierarchical level, it can support an understanding and framework for the development of care structures and concepts. The framework provides a foundation for the development of a model to differentiate PC situations by complexity of patients and care needs. To enable an operationalisation and classification of complexity, relevant outcome measures mirroring the identified system elements should be identified and implemented in clinical practice.

Health literacy in clinical-high-risk individuals for psychosis: A systematic mixed-methods review.

OBJECTIVE: Numerous studies suggest that health literacy (HL) plays a crucial role in maintaining and improving individual health. Empirical findings highlight the relation between levels of a person's HL and her/his clinical outcome. To date, the role of HL in persons at-risk for psychosis has not been systematically reviewed. METHODS: We conducted a systematic review using a mixed-methods approach to analyse a variety of study types. Peer-reviewed publications were systematically searched in PUBMED, Cochrane Library, PsycINFO and Web of Science. RESULTS: The search string returned 10587 publications. After screening, 15 quantitative, four qualitative studies and two reviews were included. Only one study assessed HL as primary outcome, assessing knowledge and beliefs about psychosis among the general population. In the other studies, sub-dimensions of HL were investigated. None of the publications operationalized HL or it's sub-dimensions with a validated measure. CONCLUSIONS: A lack of understanding of their condition, and fear of stigmatization, were associated with a delay in help-seeking among people with clinical-high-risk state for psychosis. Family members, school personnel, general practitioners and the internet play a crucial role in the HL process. Considerable barriers in obtaining adequate specialist support emphasize the urgent need of a "HL environment" for persons at risk for psychosis.

Access to Strong Opioid Analgesics in the Context of Legal and Regulatory Barriers in Eleven Central and Eastern European Countries.

BACKGROUND: In 2011-2013, >95% of the global opioid analgesics consumption occurred in three regions, accounting for 15% of the world population. Despite abundant literature on barriers to access, little is known on the correlation between actual access to opioid analgesics and barriers to access, including legal and regulatory barriers. OBJECTIVE: This study aimed to evaluate the correlation between access to strong opioid analgesics and barriers to access in national legislation and regulations in 11 central and eastern European countries that participated in the Access to Opioid Medication in Europe (ATOME) project. DESIGN: Two variables were contrasted to assess their correlation: the country level of access to strong opioid analgesics indicated by the Adequacy of Consumption Measure (ACM) and the number of potential legal and regulatory barriers identified by an external review of legislation and regulations. MEASUREMENTS: A linear correlation was evaluated using a squared linear correlation coefficient. RESULTS: Evaluation of the correlation between the ACM and the number of potential barriers produces an R2 value of 0.023 and a correlation plot trend line gradient of -0.075, indicating no correlation between access to strong opioid analgesics and the number of potential barriers in national legislation and regulations in the countries studied. CONCLUSIONS: No correlation was found, which indicates that other factors besides potential legal and regulatory barriers play a critical role in withholding prescribers and patients essential pain medication in the studied countries. More research is needed toward better understanding of the complex interplay of factors that determine access to strong opioid analgesics.

Systematic development and adjustment of the German version of the Supportive and Palliative Care Indicators Tool (SPICT-DE).

BACKGROUND: The Supportive and Palliative Care Indicators tool (SPICT) supports the identification of patients with potential palliative care (PC) needs. An Austrian-German expert group translated SPICT into German (SPICT-DE) in 2014. The aim of this study was the systematic development, refinement, and testing of SPICT-DE for its application in primary care (general practice). METHODS: SPICT-DE was developed by a multiprofessional research team according to the TRAPD model: translation, review, adjudication, pretesting and documentation. In a pretest, five general practitioners (GPs) rated four case vignettes of patients with different PC needs. GPs were asked to assess whether each patient might benefit from PC or not (I) based on their subjective appraisal ("usual practice") and (II) by using SPICT-DE. After further refinement, two focus groups with 28 GPs (68% with a further qualification in PC) were conducted to test SPICT-DE. Again, participants rated two selected case vignettes (I) based on their subjective appraisal and (II) by using SPICT-DE. Afterwards, participants reflected the suitability of SPICT-DE for use in their daily practice routine within the German primary care system. Quantitative data were analysed with descriptive statistics and non-parametric tests for small samples. Qualitative data were analysed by conventional content analysis. Focus group discussion was analysed combining formal and conventional content analysis. RESULTS: Compared to the spontaneous rating of the case vignettes based on subjective appraisal, participants in both the pretest and the focus groups considered PC more often as being beneficial for the patients described in the case vignettes when using SPICT-DE. Participants in the focus groups agreed that SPICT-DE includes all relevant indicators necessary for an adequate clinical identification of patients who might benefit from PC. CONCLUSIONS: SPICT-DE supports the identification of patients who might benefit from PC and seems suitable for routine application in general practice in Germany. The systematic development, refinement, and testing of SPICT-DE in this study was successfully completed by using a multiprofessional and participatory approach.

Primary palliative Care in General Practice - study protocol of a three-stage mixed-methods organizational health services research study.

BACKGROUND: The focus of this project is on improving the provision of primary palliative care (PC) by general practitioners (GPs). While approximately 10-15% of the incurable, seriously ill or dying people will be in need of specialist PC, the vast majority can be adequately treated within generalist care. The strengthening of the GP's role in PC, as well as ensuring close collaboration between specialist PC services and GPs have been identified as top priorities for the improvement of PC in Germany. Despite healthcare policy actions, diverse obstacles still exist to successful implementation of primary PC on a structural, process, and economic level. Therefore, this project aims at addressing barriers and facilitators to primary PC delivery in general practice in Germany. METHODS: The study follows a three-step approach; first, it aims at systematically analyzing barriers and facilitators to primary PC provision by GPs. Second, based on these outcomes, a tailored intervention package will be developed to enhance the provision of primary PC by GPs. Third, the intervention package will be implemented and evaluated in practice. The expected outcome will be an evidence-based model for successful implementation of primary PC delivery tailored to the German healthcare system, followed by a strategic action plan on how to improve current practice both on a local level and nationally. DISCUSSION: The first step of the project has been partly completed at the time of writing. The chosen methodologies of four sub-projects within this first step have opened up different advantages and disadvantages for the data collection. In sum of all sub-projects, the different methodologies and target groups contributed valuable information to the systematic analysis of barriers and facilitators to primary PC provision by GPs. TRIAL REGISTRATION: The study (BMBF-FK 01 GY 1610) was retrospectively registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien) (Registration N° DRKS00011821 ; date of registration: December 04th 2017) and at the German Register of health care research (Versorgungsforschung Deutschland - Datenbank) (Registration N° VfD_ALLPRAX_16_003817 ; date of registration: March 30th 2017).