Why Do I Choose an Animal Model or an Alternative Method in Basic and Preclinical Biomedical Research? A Spectrum of Ethically Relevant Reasons and Their Evaluation.

BACKGROUND: Research model selection decisions in basic and preclinical biomedical research have not yet been the subject of an ethical investigation. Therefore, this paper aims, (1) to identify a spectrum of reasons for choosing between animal and alternative research models (e.g., based on in vitro or in silico models) and (2) provides an ethical analysis of the selected reasons. METHODS: In total, 13 researchers were interviewed; the interviews were analyzed qualitatively. The ethical analysis was based on the principlism approach and a value judgement model. RESULTS: This paper presents 66 reasons underlying the choice of researchers using animal (27 reasons) or alternative models (39). Most of the reasons were assigned to the work environment (29) and scientific standards (22). Other reasons were assigned to personal attitudes (11) and animal welfare (4). Qualitative relevant normative differences are presented in the ethical analysis. Even if few reasons can be rejected outright from an ethical point of view, there are good reasons to give some more weight than others. CONCLUSIONS: The spectrum of reasons and their ethical assessment provide a framework for reflection for researchers who may have to choose between animal models and (investing in) alternatives. This can help to reflect on and ethically justify decisions.

Results dissemination from completed clinical trials conducted at German university medical centers remained delayed and incomplete. The 2014 -2017 cohort.

OBJECTIVE: Timely publication of clinical trial results is central for evidence-based medicine. In this follow-up study we benchmark the performance of German university medical centers (UMCs) regarding timely dissemination of clinical trial results in recent years. METHODS: Following the same search and tracking methods used in our previous study for the years 2009 - 2013, we identified trials led by German UMCs completed between 2014 and 2017 and tracked results dissemination for the identified trials. RESULTS: We identified 1,658 trials in the 2014 -2017 cohort. Of these trials, 43% published results as either journal publication or summary results within 24 months after completion date, which is an improvement of 3.8% percentage points compared to the previous study. At the UMC level, the proportion published after 24 months ranged from 14% to 71%. Five years after completion, 30% of the trials still remained unpublished. CONCLUSION: Despite minor improvements compared to the previously investigated cohort, the proportion of timely reported trials led by German UMCs remains low. German UMCs should take further steps to improve the proportion of timely reported trials.

"Same same but different"? On the questionable but crucial differentiation between ethical and social aspects in health technology assessment.

INTRODUCTION: In health technology assessment (HTA), the demarcation of ethical and social aspects in two separate domains is a given fact. While an overlapping of ethical and social aspects is possible, this also raises theoretical and methodological questions, such as why overlaps happen (on the basis of which understanding of ethical and social aspects), or whether they are legitimate from a methodological point of view. METHODS: We analyzed, on a basis of purposive sampling, a) two well-known HTA frameworks (HTA Core Model, INTEGRATE-HTA), b) methodological literature about ethical and/or social aspects in HTA, and c) published HTA reports from the German DAHTA database and the international CRD database regarding statements on the understanding (definition/characterization) and relationship between ethical and social aspects. RESULTS: The frameworks use identical definitions for ethical aspects but deviate when it comes to social aspects. Methodological papers do not always provide a definition of social and ethical aspects. In the context of ethical aspects, they often refer back to ethics as a base discipline that deals with the motives and consequences of good and bad actions for ethical aspects, while for social aspects, there is orientation towards already existing checklists and methods, without reference to a base discipline such as sociology. The analyzed HTA reports barely offered details on their understanding of ethical or social aspects (7% of n = 33). DISCUSSION: The problem of defining/characterizing and differentiating ethical and social aspects exists in both theory and practice. The impression is that little attention is paid to demarcations and overlaps, and that also the methodological literature has not yet thoroughly addressed the issue. While there are also pragmatic reasons for the possible ambiguity between the ethical and the social domains, deeper epistemological issues related to the multi-/interdisciplinarity nature of HTA will have to be considered, too, such as the danger of "disciplinary capture" (pressure on some domains and their basic disciplines, e.g., ethics, to adopt the concepts and standards of other domains that are more dominant in HTA, e.g., efficacy assessment/evidenced-based medicine). CONCLUSION: The domains in HTA reports should be better described epistemologically and brought into a coherent relationship with each other. This is important to avoid unreasonable overlapping and possible problematic redundancy. Further, this could help with questions of adequate expertise and methods for the processing of all relevant information for solid technology assessment.

The full spectrum of ethical issues in dementia research: findings of a systematic qualitative review.

BACKGROUND: When including participants with dementia in research, various ethical issues arise. At present, there are only a few existing dementia-specific research guidelines (Committee for Medicinal Products for Human Use in Clinical investigation of medicines for the treatment Alzheimer's disease (Internet). https://www.ema.europa.eu/en/clinical-investigation-medicines-treatment-alzheimers-disease ; Food and Drug Administration, Early Alzheimer's Disease: Developing Drugs for Treatment Guidance for Industry [Internet]. http://www.fda.gov/regulatory-information/search-fda-guidance-documents/alzheimers-disease-developing-drugs-treatment-guidance-industy ), necessitating a more systematic and comprehensive approach to this topic to help researchers and stakeholders address dementia-specific ethical issues in research. A systematic literature review provides information on the ethical issues in dementia-related research and might therefore serve as a basis to improve the ethical conduct of this research. This systematic review aims to provide a broad and unbiased overview of ethical issues in dementia research by reviewing, analysing, and coding the latest literature on the topic. METHODS: We conducted a systematic review in PubMed and Google Scholar (publications in English between 2007 and 2020, no restrictions on the type of publication) of literature on research ethics in dementia research. Ethical issues in research were identified by qualitative text analysis and normative analysis. RESULTS: The literature review retrieved 110 references that together mentioned 105 ethical issues in dementia research. This set of ethical issues was structured into a matrix based on the eight major principles from a pre-existing framework on biomedical ethics (Emanuel et al. An Ethical Framework for Biomedical Research. in The Oxford textbook of clinical research ethics, Oxford University Press, Oxford, 2008). Consequently, subcategories were created and further categorized into dementia stages and study phases. CONCLUSIONS: The systematically derived matrix helps raise awareness and understanding of the complex topic of ethical issues in dementia research. The matrix can be used as a basis for researchers, policy makers and other stakeholders when planning, conducting and monitoring research, making decisions on the legal background of the topic, and creating research practice guidelines.

Details of risk-benefit communication in informed consent documents for phase I/II trials.

BACKGROUND: Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk-benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated. METHOD: We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk-benefit communication. RESULTS: The risk-benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as "common" or "rare," and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards. CONCLUSION: Our study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk-benefit communication and to clarify ways to specify the likelihood of health benefits.

Systematic reviews of empirical literature on bioethical topics: Results from a meta-review.

BACKGROUND: In bioethics, especially nursing ethics, systematic reviews are increasingly popular. The overall aim of a systematic review is to provide an overview of the published discussions on a specific topic. While a meta-review on systematic reviews on normative bioethical literature has already been performed, there is no equivalent for systematic reviews of empirical literature on ethical topics. OBJECTIVE: This meta-review aims to present the general trends and characteristics of systematic reviews of empirical bioethical literature and to evaluate their reporting quality. RESEARCH DESIGN: Literature search was performed on PubMed and Google Scholar. Qualitative content analysis and quantitative approaches were used to evaluate the systematic reviews. Characteristics of systematic reviews were extracted and quantitatively analyzed. The reporting quality was measured using an adapted PRISMA checklist. FINDINGS: Seventy-six reviews were selected for analysis. Most reviews came from the field of nursing (next to bioethics and medicine). Selected systematic reviews investigated issues related to clinical ethics (50%), followed by research ethics (36%) and public health ethics or organizational ethics (14%). In all, 72% of the systematic reviews included authors' ethical reflections on the findings and 59% provided ethical recommendations. Despite the heterogeneous reporting of the reviews, reviews using PRISMA tended to score better regarding reporting quality. DISCUSSION: The heterogeneity currently observed is due both to the interdisciplinary nature of nursing ethics and bioethics, and to the emerging nature of systematic review methods in these fields. These results confirm the findings of our previous review of systematic reviews on normative literature, thereby highlighting a recurring methodological gap in systematic reviews of bioethical literature. This also indicates the need to develop more robust methodological standards. CONCLUSION: Through its extensive overview of the characteristics of systematic reviews of empirical literature on ethical topics, this meta-review is expected to inform further discussions on minimal standards and reporting guidelines.

Result dissemination from clinical trials conducted at German university medical centers was delayed and incomplete.

OBJECTIVES: Timely and comprehensive reporting of clinical trial results builds the backbone of evidence-based medicine and responsible research. The proportion of timely disseminated trial results can inform alternative national and international benchmarking of university medical centers (UMCs). STUDY DESIGN AND SETTING: For all German UMCs, we tracked all registered trials completed between 2009 and 2013. The results and an interactive website benchmark German UMCs regarding their performance in result dissemination. RESULTS: We identified and tracked 2,132 clinical trials. For 1,509 trials, one of the German UMCs took the academic lead. Of these 1,509 "lead trials," 39% published their results (mostly via journal publications) in a timely manner (<24 months after completion). More than 6 years after study completion, 26% of all eligible lead trials still had not disseminated results. CONCLUSION: Despite substantial attention from many stakeholders to the topic, there is still a strong delay or even absence of result dissemination for many trials. German UMCs have several opportunities to improve this situation. Further research should evaluate whether and how a transparent benchmarking of UMC performance in result dissemination helps to increase value and reduce waste in medical research.

Why are so few patients rating their physicians on German physician rating websites? A qualitative study.

BACKGROUND: Physician rating websites (PRWs) allow patients to rate, comment and discuss physicians' quality online as a source of information for others searching for a physician. It is generally assumed that PRWs will only be helpful for users, and fair for the rated, if there are a high number of ratings. However, the number of ratings on PRWs remains low internationally and there is currently a lack of research examining the reasons why patients are not rating their physicians. The aim of this study is to therefore identify the spectrum of factors influencing people's willingness to rate their physician on PRWs. METHODS: A mailed cross-sectional survey sent to a random sample from 4 North German cities between April and July 2016. Fifty participants who had previously used PRWs but not rated a physician provided reasons for why that had not rated a physician in a free text response. Semi-structured qualitative telephone interviews were then conducted with 22 interested participants to explore factors influencing their willingness to rate their physician on PRWs in more detail. RESULTS: Participants identified a total of 21 distinct incentives and disincentives for rating physicians on PRWs, which could be further categorised under the headings: user-specific, PRW-specific and physician-specific. Two key overarching groups of factors emerged: (1) factors concerning the physician-patient relationship, and (2) factors issues regarding technical aspects of PRWs. CONCLUSION: These findings will be helpful in guiding future research and health policy initiatives to increase the usefulness and fairness of PRWs.

Current practices for access, compensation, and prioritization in biobanks. Results from an interview study.

Human biological materials and related data stored in biobanks are valuable resources for biomedical research. Transparent, effective, and efficient governance structures and procedures for access, compensation, and priority setting are needed, but recent debates indicate challenges in the practical application of such governance processes. This study aimed to assess the practical experiences and attitudes of biobank experts regarding the governance of biosample access, prioritization, and compensation. Qualitative, semi-structured telephone interviews were conducted with 20 biobank directors from eight countries. Respondents highlighted the need for sound governance structures in order to ensure acceptance by all stakeholders (patients/donors, researchers, research funders, public, and others). They stressed practical difficulties in trying to make best use of biomaterials. As biobanks often form part of larger academic and clinical settings, the different and sometimes conflicting interests of researchers, clinicians, patients, funders, and biobank staff currently affect the governance of access decisions. Investments such as intellectual input, financial, and human resources need to be compensated adequately. Biobanks thereby have a dual role stewarding the hosted biosamples and acting as a service provider for local researchers from universities or hospitals. In order to facilitate efficient use of human biological materials, greater harmonization of at least minimum standards for access and compensation are required at both a national and an international level.

The Public's Awareness of and Attitude Toward Research Biobanks - A Regional German Survey.

Background: Biobanks have become an increasingly important means of biomedical research and innovation. However, they entail a variety of ethical, social and legal challenges, which need to be publicly discussed and managed collectively. A certain level of public awareness of biobank research is an important prerequisite for the public to form an opinion on the issue at hand and to be willing to participate in public engagement activities. For many countries, including Germany, recent information on the public's awareness of and attitude toward biobanks is scarce. Methods: Therefore, by means of a postal survey in a German urban region, this study updates data from the 2010 Eurobarometer by analyzing (1) the public's awareness of biobanks, (2) their general attitude toward biobanks, and (3) their hypothetical willingness to donate their own biological samples and personal or medical data. Results: Overall, 204 (20.4%) of 998 delivered questionnaires were returned. The majority of survey respondents stated a positive attitude toward medical research (95.5%) and - to a somewhat lower degree - toward genetic research (61.3%). Attitudes toward biobanks were mixed but positive for the majority of respondents: in a question about their spontaneous assessment of biobanks as a means for medical research, 77% showed positive attitudes toward biobanks (36.6% "definitely" and 40.5% "somewhat positive"). This finding is also reflected in a high proportion of individuals willing to participate in biobank research: 70.4% of respondents would be willing to donate biomaterial to a biobank during a hypothetical stay in hospital. In spite of the high overall support respondents show for biobanks (e.g., positive general attitude and willingness to participate), only about one third (30.8%) had previously heard of biobanks. Discussion and Conclusion: The comparison of survey results with prior data from the 2010 Eurobarometer indicates that public awareness of biobanks remains low. A higher level of biobank awareness can be assumed to be one prerequisite for public engagement in future decisions on biobank governance. We therefore argue that to increase public awareness of biobanks and to enable public involvement in biobank governance, publicly available and understandable information must be provided and disseminated.

The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review.

PURPOSE: To determine systematically the spectrum of ethical issues that is raised for stakeholders in a 'Learning Health Care System' (LHCS). DATA SOURCES: The systematic review was conducted in PubMed and Google Books between the years 2007 and 2015. STUDY SELECTION: The literature search retrieved 1258 publications. Each publication was independently screened by two reviewers for eligibility for inclusion. Ethical issues were defined as arising when a relevant normative principle is not adequately considered or two principles come into conflict. DATA EXTRACTION: A total of 65 publications were included in the final analysis and were analysed using an adapted version of qualitative content analysis. A coding frame was developed inductively from the data, only the highest-level categories were generated deductively for a life-cycle perspective. RESULTS OF DATA SYNTHESIS: A total of 67 distinct ethical issues could be categorized under different phases of the LHCS life-cycle. An overarching theme that was repeatedly raised was the conflict between the current regulatory system and learning health care. CONCLUSION: The implementation of a LHCS can help realize the ethical imperative to continuously improve the quality of health care. However, the implementation of a LHCS can also raise a number of important ethical issues itself. This review highlights the importance for health care leaders and policy makers to balance the need to protect and respect individual participants involved in learning health care activities with the social value of improving health care.

What methods do reviews of normative ethics literature use for search, selection, analysis, and synthesis? In-depth results from a systematic review of reviews.

BACKGROUND: (Semi-)systematic approaches to finding, analysing, and synthesising ethics literature on medical topics are still in their infancy. However, our recent systematic review showed that the rate of publication of such (semi-)systematic reviews has increased in the last two decades. This is not only true for reviews of empirical ethics literature, but also for reviews of normative ethics literature. In the latter case, there is currently little in the way of standards and guidance available. Therefore, the methods and reporting strategies of such reviews vary greatly. The purpose of the follow-up study we present was to obtain deeper methodological insight into the ways reviews of normative literature are actually conducted and to analyse the methods used. METHOD: Our search in the PubMed, PhilPapers, and Google Scholar databases led to the identification of 183 reviews of ethics literature published between 1997 and 2015, of which 84 were identified as reviews of normative and mixed literature. Qualitative content analysis was used to extract and synthesise descriptions of search, selection, quality appraisal, analysis, and synthesis methods. We further assessed quantitatively how often certain methods (e.g. search strategies, data analysis procedures) were used by the reviews. RESULTS: The overall reporting quality varies among the analysed reviews and was generally poor even for major criteria regarding the search and selection of literature. For example, only 24 (29%) used a PRISMA flowchart. Also, only 55 (66%) reviews mentioned the information unit they sought to extract, and 12 (14%) stated an ethical approach as the theoretical basis for the analysis. Interpretable information on the synthesis method was given by 47 (60%); the most common methods applied were qualitative methods commonly used in social science research (83%). CONCLUSION: Reviews which fail to provide sufficient relevant information to readers have reduced methodological transparency regardless of actual methodological quality. In order to increase the internal validity (i.e. reproducibility) as well as the external validity (i.e. utility for the intended audience) of future reviews of normative literature, we suggest more accurate reporting regarding the goal of the review, the definition of the information unit, the ethical approach used, and technical aspects.

Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections.

BACKGROUND: For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers' understanding and reactions. METHODS: We tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with members from the documents' target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process. RESULTS: Focus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic. CONCLUSION: Our results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers' understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future.

Public Awareness and Use of German Physician Ratings Websites: Cross-Sectional Survey of Four North German Cities.

BACKGROUND: Physician rating websites (PRWs) allow patients to rate, comment, and discuss physicians' quality. The ability of PRWs to influence patient decision making and health care quality is dependent, in part, on sufficient awareness and usage of PRWs. However, previous studies have found relatively low levels of awareness and usage of PRWs, which has raised concerns about the representativeness and validity of information on PRWs. OBJECTIVE: The objectives of this study were to examine (1) participants' awareness, use, and contribution of ratings on PRWs and how this compares with other rating websites; (2) factors that predict awareness, use, and contribution of ratings on PRWs; and (3) participants' attitudes toward PRWs in relation to selecting a physician. METHODS: A mailed cross-sectional survey was sent to a random sample (N=1542) from four North German cities (Nordhorn, Hildesheim, Bremen, and Hamburg) between April and July 2016. Survey questions explored respondents' awareness, use, and contribution of ratings on rating websites for service (physicians, hospitals, and hotels and restaurants) and products (media and technical) in general and the role of PRWs when searching for a new physician. RESULTS: A total of 280 completed surveys were returned (280/1542, 18.16% response rate), with the following findings: (1) Overall, 72.5% (200/276) of respondents were aware of PRWs. Of the respondents who were aware of PRWs, 43.6% (86/197) had used PRWs. Of the respondents who had used PRWs, 23% (19/83) had rated physicians at least once. Awareness, use, and contribution of ratings on PRWs were significantly lower in comparison with all other rating websites, except for hospital rating websites. (2) Except for the impact of responders' gender and marital status on the awareness of PRWs and responders' age on the use of PRWs, no other predictors had a relevant impact. (3) Whereas 31.8% (85/267) of the respondents reported that PRWs were a very important or somewhat important information source when searching for a new physician, respondents significantly more often reported that family, friends and colleagues (259/277, 93.5%), other physicians (219/274, 79.9%), and practice websites (108/266, 40.6%) were important information sources. CONCLUSIONS: Whereas awareness of German PRWs appears to have substantially increased, the use of PRWs and contribution of ratings remains relatively low. Further research is needed to examine the reasons why only a few patients are rating physicians. However, given the information inequality between provider and consumer will always be higher for consumers using the services of physicians, it is possible that people will always rely more on interpersonal recommendations than impersonal public information before selecting a physician.

Ethical issues in obesity prevention for school children: a systematic qualitative review.

OBJECTIVES: Planning and conducting preventive measures against obesity for school children is beset with ethical issues which should be known to make well-informed decisions. The goal of this study was to provide a comprehensive spectrum of these ethical issues by means of a systematic review. In this context, the study also assesses the value of different search strategies for ethical literature in public health. METHODS: Literature was searched in Medline, EBSCO and others. Three different search strategies with varied scopes were applied and their output was compared. Qualitative content analysis was used for extracting and categorizing ethical issues. RESULTS: 109 publications (published from 1995 to 2015) were finally included. The qualitative analysis resulted in 60 potentially relevant ethical issues. The three search strategies showed substantial differences regarding their search results. CONCLUSIONS: The presented spectrum provides an initial evidence base for dealing with ethical issues adequately. The findings of the study further suggest that a broader scope is more fruitful for systematic reviews on ethical issues in the field of public health.

Access policies in biobank research: what criteria do they include and how publicly available are they? A cross-sectional study.

Access policies of biobanks specify the governance of sample and data sharing. Basic guidance on relevant access criteria exists, but so far little is known about their public availability and what criteria for access and prioritization they actually include. Access policies were gathered by hand searching the websites of biobanks identified via registries (eg, BBMRI and P3G), and by additional search strategies. Criteria for access and prioritization were synthesized by thematic analysis. Of 523 biobank websites screened, 9% included a publicly available access policy. With all applied search strategies, we finally retrieved 74 access policies. Thematic analysis resulted in 62 different access criteria in three main categories: (a) scientific quality, (b) value and (c) ethical soundness. 'Scientific quality' criteria were mentioned in 70% of all policies, 'value' criteria in 33% and 'ethical soundness' criteria in 73%. Criteria for prioritization were specified in 27% of all policies. Access policies differed broadly in number, specification and operationalization of the included access criteria. In order to make biobank research more effective, efficient and trustworthy, access policies should be more available to the public. Furthermore, access policies should aim for precise and more harmonized wording of access criteria. From a public and governance perspective, the issue of how to prioritize access to scarce samples should form part of access policies.

Current state of ethics literature synthesis: a systematic review of reviews.

BACKGROUND: Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed. METHODS: A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature. RESULTS: We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information. CONCLUSIONS: While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

BACKGROUND: When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. AIM: To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. METHOD: A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. RESULTS: The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. CONCLUSIONS: The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.