Five Coffin Nails to Informed Consent: An Autoethnography of Suffering Complications in Breastfeeding.

This autoethnography describes an illness episode caused by breastfeeding complications. It focuses on informed consent processes accompanying this illness episode. Informed consent is a cornerstone of ethical medical practice and has to be obtained before a medical intervention can legally be implemented. It is therefore not trivial that in practice, informed consent processes often fail to achieve what they are set out to. With this autoethnography, I want to provide a review of how informed consent processes can fail in the context of breastfeeding, but also draw attention to what these situations can mean and feel like for those affected. I provide in-depth descriptions of five scenes from my illness episode each representing a different barrier to informed consent. The scenes were developed based on emotional recall and written to grant access to the emotional dimensions of my experience in the tradition of evocative autoethnography. As part of my story, I engage with various issues like practices of prescribing, communicative requirements in vulnerable situations to ensure understanding, the dual purpose of informed consent in the moral and legal realm, and the moralized breastfeeding discourse. Possible routes for change to abolish or reduce described barriers to informed consent are discussed.

Having a Break or Being Imprisoned: Influence of Subjective Interpretations of Quarantine and Isolation on Boredom.

Boredom has been identified as one of the greatest psychological challenges when staying at home during quarantine and isolation. However, this does not mean that the situation necessarily causes boredom. On the basis of 13 explorative interviews with bored and non-bored persons who have been under quarantine or in isolation, we explain why boredom is related to a subjective interpretation process rather than being a direct consequence of the objective situation. Specifically, we show that participants vary significantly in their interpretations of staying at home and, thus, also in their experience of boredom. While the non-bored participants interpret the situation as a relief or as irrelevant, the bored participants interpret it as a major restriction that only some are able to cope with.

Stakeholder engagement to ensure the sustainability of biobanks: a survey of potential users of biobank services.

Biobanks are important infrastructures facilitating biomedical research. After a decade of rolling out such infrastructures, a shift in attention to the sustainability of biobanks could be observed in recent years. In this regard, an increase in the as yet relatively low utilisation rates of biobanks has been formulated as a goal. Higher utilisation rates can only be achieved if the perspectives of potential users of biobanks-particularly researchers not yet collaborating with biobanks-are adequately considered. To better understand their perspectives, a survey was conducted at ten different research institutions in Germany hosting a centralised biobank. The survey targeted potential users of biobank services, i.e. researchers working with biosamples. It addressed the general demand for biosamples, strategies for biosample acquisition/storage and reasons for/against collaborating with biobanks. In total, 354 researchers filled out the survey. Most interestingly, only a minority of researchers (12%) acquired their biosamples via biobanks. Of the respondents not collaborating with biobanks on sample acquisition, around half were not aware of the (services of the) respective local biobank. Those who actively decided against acquiring biosamples via a biobank provided different reasons. Most commonly, respondents stated that the biosamples required were not available, the costs were too high and information about the available biosamples was not readily accessible. Biobanks can draw many lessons from the results of the survey. Particularly, external communication and outreach should be improved. Additionally, biobanks might have to reassess whether their particular collection strategies are adequately aligned with local researchers' needs.

Beyond Research Ethics: Novel Approaches of 3 Major Public Health Institutions to Provide Ethics Input on Public Health Practice Activities.

Public health institutions increasingly realize the importance of creating a culture in their organizations that values ethics. When developing strategies to strengthen ethics, institutions will have to take into account that while public health research projects typically undergo thorough ethics review, activities considered public health practice may not be subjected to similar oversight. This approach, based on a research-practice dichotomy, is increasingly being criticized as it does not adequately identify and manage ethically relevant risks to those affected by nonresearch activities. As a reaction, 3 major public health institutions (the World Health Organization, US Centers for Disease Control and Prevention, and Public Health Ontario) have implemented mechanisms for ethics review of public health practice activities. In this article, we describe and critically discuss the different modalities of the 3 approaches. We argue that although further evaluation is necessary to determine the effectiveness of the different approaches, public health institutions should strive to implement procedures to ensure that public health practice adheres to the highest ethical standards.

Evaluating the German Biobank Node as Coordinating Institution of the German Biobank Alliance: Engaging with Stakeholders via Survey Research.

Background: The German Biobank Node (GBN) is the central hub for German biobank activities and coordinates the German Biobank Alliance (GBA) to which 11 biobank sites in Germany belong. GBN, in cooperation with designated members of GBA, has developed various services and products for the German biobank community. To ensure that services and products are well aligned with the needs and interests of relevant stakeholders, GBN actively engages with its diverse stakeholder groups through different methods. Important stakeholder groups are the members of GBA who are generally the first users of developed products and services. Methods and Materials: Members of GBA were surveyed anonymously through a web-based application. The survey was sent to all members registered with an internal communication platform. Participants were primarily asked about their experiences with GBN, developed products and services, their wishes for the future of GBN/GBA, and their attitudes toward intensified cooperation on the European level. Answers were analyzed using descriptive statistics and qualitative content analysis. Results: Overall 63 of 110 registered GBA members (response rate of 57%) finished the survey. Participants were overall satisfied with the work of GBN and developed products and services. They also pointed out room for improvement. Participants, for example, proposed to shorten the survey developed for biobanks to engage with their users. They also shared what additional support wishes they had, for example, uniform cost models or use and access policies for the GBA community. Discussion: The survey was helpful to get a good overview of the experiences and attitudes of GBA members before making services and products available to other actors in the German biobank community. GBN will use the feedback to improve its work and to guide future strategy development. Survey research has shown an adequate method to engage with this particular stakeholder group, but further research on choosing methods for stakeholder engagement might be helpful.

[Consulting or engaging? The role of stakeholders in health research. A conference report by the organizers]. / Befragen oder Beteiligen? Die Rolle von Stakeholdern in der Gesundheitsforschung. Ein Tagungsbericht der Organisatorinnen.

Increasingly, researchers are required to engage stakeholders in health-related research projects. "Stakeholder" in this context are those people who may be directly or indirectly affected by the planned research or the research object. This could be, for example, patients, relatives, and health personnel, but also political decision-makers. Those conducting stakeholder engagement are faced with many open questions like what activities are meant by engagement, for what purpose researchers should engage stakeholders, who should be involved, or how best to design engagement activities.From 28 to 29 March 2019 the interdisciplinary conference "Consulting or Engaging? The Role of Stakeholders in Health Research" took place at LMU Munich. The aim of the conference was to facilitate cross-disciplinary discourse on research engagement of various stakeholder groups. Different application contexts were examined, such as public health research, clinical research, health services research, and bioethical deliberation.This conference report structures and explains the main topics discussed during the conference from the perspective of the organizers. It thereby addresses the question of inclusivity and exclusivity of frequently used terms for stakeholder engagement, reflects on different strategies for justifying stakeholder engagement, and provides an overview of different approaches to stakeholder engagement as well as of methodological and practical challenges in implementing engagement activities.

Position Statement from the German Biobank Alliance on the Cooperation Between Academic Biobanks and Industry Partners.

Under the umbrella of the German Biobank Node (GBN), 11 biobanks and two IT development centers are funded by the Federal Ministry of Education and Research (BMBF) to work together in the German Biobank Alliance (GBA). Their common aim is to make existing biomaterials hosted by different biobanks nationally and internationally available for biomedical research. This position article reflects and summarizes contributions and comments made during a GBA workshop, on the cooperation between academic biobanks and pharmaceutical and diagnostics companies that took place in Leipzig on the 21st of June 2018. It documents key points agreed on by all participating biobanks during the workshop thereby addressing several of the challenges identified. Although there are various possibilities for cooperation between academic biobanks and industry, this position article focuses exclusively on projects where academic biobanks give access to their biosamples and related data to industry partners. In doing so it considers the general conditions/framework and procedures in the German biobanking environment and raises ethical, legal, and procedural issues to be addressed when initiating such collaborations. It intends to furnish a basis for further activities to foster cooperation with industry and to push an overarching national coordination process. The final aim is to develop GBN-recommendations. Of course, many hospitals already have clear regulations on collaboration(s) with industry partners. These naturally take precedence for the GBA biobanks. However, where interest exists, GBN/GBA recommendations could help to induce changes to existing local policies nonetheless.

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 technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol.

BACKGROUND: Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues. The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs. METHODS: We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way. DISCUSSION: Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.

Medical professionalism of foreign-born and foreign-trained physicians under close scrutiny: A qualitative study with stakeholders in Germany.

Hospitals in Germany employ increasing numbers of foreign-born and foreign-trained (FB&FT) physicians. Studies have investigated how FB&FT physicians experience their professional integration into the German healthcare system, however, the perspectives of stakeholders working with and shaping the work experiences of FB&FT physicians in German hospitals have so far been neglected. This study explores relevant stakeholders' opinions and attitudes towards FB&FT physicians-which likely influence how these physicians settle in-and how these opinions were formed. We conducted a qualitative interview study with 25 stakeholders working in hospitals or in health policy development. The interviews were analyzed within a constructivist research paradigm using methods derived from Grounded Theory (situational analysis as well as open, axial and selective coding). We found that stakeholders tended to focus on problems in FB&FT physicians' work performance. Participants criticized FB&FT physicians' work for deviating from presumably shared professional standards (skill or knowledge and behavioral standards). The professional standards invoked to justify problem-focused statements comprised the definition of an ideal behavior, attitude or ability and a tolerance range that was adapted in a dynamic process. Behavior falling outside the tolerance range was criticized as unacceptable, requiring action to prevent similar deviations in the future. Furthermore, we derived three strategies (minimization, homogenization and quality management) proposed by participants to manage deviations from assumed professional standards by FB&FT physicians. We critically reflect on the social processes of evaluation and problematization and question the legitimacy of professional standards invoked. We also discuss discriminatory tendencies visible in evaluative statements of some participants as well as in some of the strategies proposed. We suggest it will be key to develop and implement better support strategies for FB&FT physicians while also addressing problematic attitudes within the receiving system to further professional integration.

Rapid qualitative review of ethical issues surrounding healthcare for pregnant women or women of reproductive age in epidemic outbreaks.

This article describes, categorizes, and discusses the results of a rapid literature review aiming to provide an overview of the ethical issues and corresponding solutions surrounding pregnancies in epidemic outbreaks. The review was commissioned by the World Health Organization to inform responses to the Zika outbreak that began in 2015. Due to the urgency of the response efforts that needed to be informed by the literature search, a rapid qualitative review of the literature published in PubMed was conducted. The search and analysis were based on the operationalization of 3 key concepts: ethics, pregnancy, and epidemic outbreak. Ethical issues and solutions were interpreted within a principlist framework. The data were analyzed using qualitative content analysis. The search identified 259 publications, of which the full text of 23 papers was read. Of those, 20 papers contained a substantive part devoted to the topic of interest and were therefore analyzed further. We clustered the ethical issues and solutions around 4 themes: uncertainty, harms, autonomy/liberty, and effectiveness. Recognition of the identified ethical issues and corresponding solutions can inform and improve response efforts, public health planning, policies, and decision-making, as well as the activities of medical staff and counselors who practice before, during, or after an epidemic outbreak that affects pregnant women or those of reproductive age. The rapid review format proved to be useful despite its limited data basis and expedited review process.

Ethical issues in public health surveillance: a systematic qualitative review.

BACKGROUND: Public health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent. METHODS: Ethical issues were defined based on principlism. We assumed an ethical issue to arise in surveillance when a relevant normative principle is not adequately considered or two principles come into conflict. We searched Pubmed and Google Books for relevant publications. We analysed and synthesized the data using qualitative content analysis. RESULTS: Our search strategy retrieved 525 references of which 83 were included in the analysis. We identified 86 distinct ethical issues arising in the different phases of the surveillance life-cycle. We further identified 20 distinct conditions that make it more or less justifiable to forego informed consent procedures. CONCLUSIONS: This is the first systematic qualitative review of ethical issues in public health surveillance resulting in a comprehensive ethics matrix that can inform guidelines, reports, strategy papers, and educational material and raise awareness among practitioners.

Difficulties experienced by migrant physicians working in German hospitals: a qualitative interview study.

BACKGROUND: With Germany facing a shortage of doctors, hospitals have been increasingly recruiting physicians from abroad. Studies in other countries have shown that migrant physicians experience various difficulties in their work, which might impact the quality of patient care, physician job satisfaction, and, accordingly, retention. The experiences of migrant doctors in Germany have not been systematically studied so far and will likely differ from experiences migrant physicians make in other contexts. A thorough understanding of challenges faced by this group, however, is needed to develop adequate support structures-as required by the WHO Global Code of Practice on the International Recruitment of Health Personnel. METHODS: A qualitative study was conducted to give an overview of the multifaceted difficulties migrant physicians might face in German hospitals. Twenty semi-structured interviews with foreign-born and foreign-trained physicians were conducted in German. Participants were recruited via the State Chambers of Physicians and snowballing based on a maximum variation sampling strategy varying purposefully by source country and medical specialty. The interviews were recorded, transcribed verbatim, and analysed using qualitative content analysis. RESULTS: Participants described difficulties relating to healthcare institutions, own competencies, and interpersonal interactions. Participants experienced certain legal norms, the regulation of licensure and application for work, and the organization of the hospital environment as inadequate. Most struggled with their lack of setting-specific (language, cultural, clinical, and system) knowledge. Furthermore, behaviour of patients and co-workers was perceived as discriminating or inadequate for other reasons. CONCLUSIONS: This is the first study to describe the broad range of issues migrant physicians experience in Germany. Based on this information, institutional actors should devise support structures to ensure quality of care, physician wellbeing, and retention. For example, training opportunities should be offered where needed to support acquisition of setting-specific knowledge. Discrimination experienced by participants calls for better diversity management as a leadership task in healthcare institutions. Misinformation practices in recruitment could be managed by a voluntary code of ethical conduct. Further research is necessary to identify strategies that adequately address diverging normative positions between migrant health personnel and their patients and colleagues.

Does facilitated Advance Care Planning reduce the costs of care near the end of life? Systematic review and ethical considerations.

BACKGROUND: While there is increasing evidence that Advance Care Planning has the potential to strengthen patient autonomy and improve quality of care near the end of life, it remains unclear whether it could also reduce net costs of care. AIM: This study aims to describe the cost implications of Advance Care Planning programmes and discusses ethical conflicts arising in this context. DESIGN: We conducted a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. DATA SOURCES: We systematically searched the databases PubMed, NHS EED, EURONHEED, Cochrane Library and EconLit. We included empirical studies (no limitation to study type) that investigated the cost implications of Advance Care Planning programmes involving professionally facilitated end-of-life discussions. RESULTS AND DISCUSSION: Seven studies met our inclusion criteria. Four of them used a randomised controlled design, one used a before-after design and two were observational studies. Six studies found reductions in costs of care ranging from USD1041 to USD64,827 per patient, depending on the study period and the cost measurement. One study detected no differences in costs. Studies varied considerably regarding the Advance Care Planning intervention, patient selection and costs measured which may explain some of the variations in findings. NORMATIVE APPRAISAL: Looking at the impact of Advance Care Planning on costs raises delicate ethical issues. Given the increasing pressure to reduce expenditures, there may be concerns that cost considerations could unduly influence the sensitive communication process, thus jeopardising patient autonomy. Safeguards are proposed to reduce these risks. CONCLUSION: The limited data indicate net cost savings may be realised with Advance Care Planning. Methodologically robust trials with clearly defined Advance Care Planning interventions are needed to make the costs and returns of Advance Care Planning transparent.

What is personalized medicine: sharpening a vague term based on a systematic literature review.

BACKGROUND: Recently, individualized or personalized medicine (PM) has become a buzz word in the academic as well as public debate surrounding health care. However, PM lacks a clear definition and is open to interpretation. This conceptual vagueness complicates public discourse on chances, risks and limits of PM. Furthermore, stakeholders might use it to further their respective interests and preferences. For these reasons it is important to have a shared understanding of PM. In this paper, we present a sufficiently precise as well as adequate definition of PM with the potential of wide acceptance. METHODS: For this purpose, in a first step a systematic literature review was conducted to understand how PM is actually used in scientific practice. PubMed was searched using the keywords "individualized medicine", "individualised medicine", "personalized medicine" and "personalised medicine" connected by the Boolean operator OR. A data extraction tabloid was developed putting forward a means/ends-division. Full-texts of articles containing the search terms in title or abstract were screened for definitions. Definitions were extracted; according to the means/ends distinction their elements were assigned to the corresponding category. To reduce complexity of the resulting list, summary categories were developed inductively from the data using thematic analysis. In a second step, six well-known criteria for adequate definitions were applied to these categories to derive a so-called precising definition. RESULTS: We identified 2457 articles containing the terms PM in title or abstract. Of those 683 contained a definition of PM and were thus included in our review. 1459 ends and 1025 means were found in the definitions. From these we derived the precising definition: PM seeks to improve stratification and timing of health care by utilizing biological information and biomarkers on the level of molecular disease pathways, genetics, proteomics as well as metabolomics. CONCLUSIONS: Our definition includes the aspects that are specific for developments labeled as PM while, on the other hand, recognizing the limits of these developments. Furthermore, it is supported by the quantitative analysis of PM definitions in the literature, which suggests that it it is widely acceptable and thus has the potential to avoid the above mentioned issues.

Regulatory space and the contextual mediation of common functional pressures: analyzing the factors that led to the German Efficiency Frontier approach.

There are no automatic links between the functional advantages and pressures associated with delegation to independent agencies for Health Technology Assessment (HTA) and their emergence in national regulatory spaces. We argue that the rise of these organizations is mediated by contextual factors, which must be explained. Accordingly, we analyze the German 'regulatory space' for health policy decision-making, identifying contextual factors relevant to the adoption of the Efficiency Frontier approach. Based on qualitative interviews with key stakeholders, we argue that the development of the Efficiency Frontier can be associated with cultural reluctance to frame healthcare prioritization decisions around cost based valuations of human health and related doubts about the validity of metrics for human health gain. Based on this finding, we conclude that the delegation of authority to independent HTA agencies follows a broadly evolutionary pattern, in which contextual factors allow for significant variation in institutional and methodological responses to the functional pressures and advantages leading to their establishment.

Cost-effectiveness analysis of an additional birth dose of Hepatitis B vaccine to prevent perinatal transmission in a medical setting in Mozambique.

This study is the first to assess the cost-effectiveness of an additional birth dose of Hepatitis B (HBV) vaccine administered by professional birth attendants in medical settings in a sub-Saharan country (Mozambique). The WHO has recommended the birth dose to prevent perinatal transmission of HBV. A Markov model was constructed to analyse the costs and effects associated with avoiding perinatal transmission of HBV through a birth dose vaccination in addition to the existing vaccination schedule in Mozambique. The comparator intervention is the existing vaccination schedule administered at 6-10-14 weeks. The analysis was conducted for the birth cohort of 2008. As the context is a low-income setting our main outcome measure was disability-adjusted life years (DALYs) averted. Transition probabilities, costs and effects were estimated based on a thorough literature review. One- to three-way sensitivity analyses were conducted to account for uncertainty in the data. We found an incremental cost-effectiveness ratio (ICER) for the additional birth dose of 250.95 US$ per DALY averted. Assuming a willingness-to-pay threshold of 441 US$, which was the GDP per capita for Mozambique in 2008, the findings show the additional birth dose to be highly cost-effective. However, one-way sensitivity analysis reveals that the outcome changes with parameter variation. To give unambiguous recommendations on introducing the birth dose in Mozambique, more information on the parameters that render the birth dose cost-ineffective in sensitivity analysis is needed. Those parameters are 'vaccine effectiveness', 'prevalence of HBV among mothers', 'the transition probability from chronic HBV to liver cancer' and 'the risk of perinatal transmission for mothers negative for the Hepatitis B "e" antigen (HBeAg)'. Parameter variation (one-way) showed the ICER to lie between 72 US$/DALY averted and 683 US$/DALY averted.