Background:Caring for patients with serious illness may severely strain clinicians causing distress and probable poor patient outcomes. Unfortunately, clinician distress and its impact historically has received little attention.Research purpose:The purpose of this article was to investigate the nature of clinician distress.Research design:Qualitative inductive dimensional analysis.Participants and research context:After review of 577 articles from health sciences databases, a total of 33 articles were eligible for analysis.Ethical considerations:This study did not require ethical review and the authors adhered to appropriate academic standards in (...) their analysis.Findings:A narrative of clinician distress in the hospital clinician in the United States emerged from the analysis. This included clinicians’ perceptions and sense of should or the feeling that something is awry in the clinical situation. The explanatory matrix consequence of clinician distress occurred under conditions including: the recognition of conflict, the recognition of emotion, or the recognition of a mismatch; followed by a process of an inability to feel and act according to one’s values due to a precipitating event.Discussion:This study adds three unique contributions to the concept of clinician distress by (1) including the emotional aspects of caring for seriously ill patients, (2) providing a new framework for understanding clinician distress within the clinician’s own perceptions, and (3) looking at action outside of a purely moral lens by dimensionalizing data, thereby pulling apart what has been socially constructed.Conclusion:For clinicians, learning to recognize one’s perceptions and emotional reactions is the first step in mitigating distress. There is a critical need to understand the full scope of clinician distress and its impact on the quality of patient-centered care in serious illness. (shrink)

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the (...) informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

The purpose of this study was to evaluate recognition of pathologists and radiologists as coauthors in case reports in the field of surgical oncology. The MEDLINE database was searched for all full free text case reports involving human material published from April 1, 2011 until March 31, 2016, using search terms: “case report” + “tumors” + “surgery” + “malignant”. The search strategy identified a total of 1427 case reports of which 907 were included in this analysis. Of 807 articles (...) with histopathological images and/or descriptions, 352 did not acknowledge or include the pathologist as a coauthor. Of 662 case reports with radiographic images and/or their description, 537 did not list the radiologist as coauthor nor acknowledge them. In case reports containing histopathological images, significantly more pathologists were either listed as coauthors or acknowledged compared to those who were not. However, among case reports containing radiographic images, there were significantly less articles either listing radiologists as coauthors or acknowledging them compared to a larger proportion of articles in which radiologists were omitted. In conclusion, pathologists and radiologists are underrecognized as coauthors in surgical oncology case reports in spite of obvious proof of their contribution to manuscript preparation. When involved in research and publishing, all physicians should be aware of fair and honest collaboration with specialists in other clinical and non-clinical disciplines to better serve the scientific community. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

The accelerating adoption of electronic health record systems will have profound impacts on clinical care. It will also have far-reaching implications for public health research and surveillance, which in turn could lead to changes in public policy, statutes, and regulations. The public health benefits of EHR use can be significant. However, researchers and analysts who rely on EHR data must proceed with caution and understand the potential limitations of EHRs.Much has been written about the risk of EHR privacy breaches. This (...) paper focuses on a different set of concerns, those relating to data quality. Unlike clinical trial data, EHR data is not recorded primarily to meet the needs of researchers. Because of clinicians’ workloads, poor user-interface design, and other factors, EHR data is surprisingly likely to be erroneous, miscoded, fragmented, and incomplete. Although EHRs eliminate the problem of cryptic handwriting, other kinds of errors are more common with EHRs than with paper records. (shrink)

BackgroundThe aim of this survey was to determine the level of awareness and understanding of peer review and peer review models amongst junior hospital doctors and whether this influences clinical decision-making.MethodsA 30-question online anonymous survey was developed aimed at determining awareness of peer review models and the purpose of peer review, perceived trustworthiness of different peer review models and the role of peer review in clinical decision-making. It was sent to 800 trainee doctors in medical specialties on the University College (...) London Partners trainee database.ResultsThe response rate was (178/800) 22%. Most respondents were specialist registrars. Checking that research is conducted correctly (152/178, 85%) and the data interpreted correctly (148/178, 83%) were viewed as the most important purposes of peer review. Most respondents were aware of open (133/178, 75%), double-blind (125/178, 70%) and single-blind peer review (121/178, 68%). 101/178 (57%) had heard of collaborative, 87/178 (49%) of post publication and 29/178 (16%) of decoupled peer review. Of those who were aware of double-blind, single-blind open and collaborative peer review, 85 (68%), 82 (68%), 74 (56%) and 24 (24%), respectively, understood how they worked. The NEJM, Lancet and The BMJ were deemed to have most trustworthy peer review, 137/178 (77%), 129/178 (72%) and 115/178 (65%), respectively. That peer review had taken place was important for a journal content to be used for clinical decision-making 152/178 (85%), but the ability to see peer review reports was not as important 22/178 (12%). Most felt there was a need for peer review training and that this should be at the specialist registrar stage of training.ConclusionsJunior hospital doctors view peer review to be important as a means of quality control, but do not value the ability to scrutinize peer review themselves. The unquestioning acceptance of peer review as final validation in the field of medicine emphasises not only the responsibility held by medical journals to ensure peer review is done well but also the need to raise awareness amongst the medical community of the limitations of the current peer review process. (shrink)

The aim of this literature review was to compose a narrative review supported by a systematic approach to critically identify and examine concerns about accountability and the allocation of responsibility and legal liability as applied to the clinician and the technologist as applied the use of opaque AI-powered systems in clinical decision making. This review questions if it is permissible for a clinician to use an opaque AI system in clinical decision making and if a patient was harmed as a (...) result of using a clinician using an AIS’s suggestion, how would responsibility and legal liability be allocated? Literature was systematically searched, retrieved, and reviewed from nine databases, which also included items from three clinical professional regulators, as well as relevant grey literature from governmental and non-governmental organisations. This literature was subjected to inclusion/exclusion criteria; those items found relevant to this review underwent data extraction. This review found that there are multiple concerns about opacity, accountability, responsibility and liability when considering the stakeholders of technologists and clinicians in the creation and use of AIS in clinical decision making. Accountability is challenged when the AIS used is opaque, and allocation of responsibility is somewhat unclear. Legal analysis would help stakeholders to understand their obligations and prepare should an undesirable scenario of patient harm eventuate when AIS were used. (shrink)

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision (...) of care. Molecular tumor boards are one response to these changes and are now providing better access to next-generation sequencing and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent documents at all academic medical centers and to introduce dynamic and electronic informed consent. (shrink)

Rationale, aims and objectives: Bioethics and professionalism are standard subjects in medical training programmes, and these curricula reflect particular representations of meaning and practice. It is important that these curricula cohere with the actual concerns of practicing clinicians so that students are prepared for real-world practice. We aimed to identify ethical and professional concerns that do not appear to be adequately addressed in standard curricula by comparing ethics curricula with themes that emerged from a qualitative study of medical practitioners. Method: (...) Curriculum analysis: Thirty-two prominent ethics and professionalism curricula were identified through a database search and were analysed thematically. Qualitative study: In-depth, semi-structured interviews were conducted with 20 medical practitioners. Participants were invited to reflect upon their perceptions of the ways in which values matter in their practices and their educational experiences. The themes emerging from the two studies were compared and contrasted. Results: While representations of meaning and value in ethics and professionalism curricula overlap with the preoccupations of practicing clinicians, there are significant aspects of ‘real-world’ clinical practice that are largely ignored. These fell into two broad domains: ‘sociological’ concerns about enculturation, bureaucracy, intra-professional relationships, and public perceptions of medicine; and epistemic concerns about making good decisions, balancing different kinds of knowledge, and practising within the bounds of professional protocols. Conclusions: Our findings support the view that philosophy and sociology should be included in medical school and specialty training curricula. Curricula should be reframed to introduce students to habits of thought that recognize the need for critical reflection on the social processes in which they are embedded, and on the philosophical assumptions that underpin their practice. (shrink)

Background:To better understand the kinds of ethical challenges that emerge when using coercion in mental healthcare, and the importance of these ethical challenges, this article presents a systematic review of scientific literature.Methods:A systematic search in the databases MEDLINE, PsychInfo, Cinahl, Sociologicals and Web of Knowledge was carried out. The search terms derived from the population, intervention, comparison/setting and outcome. A total of 22 studies were included.Ethical considerations:The review is conducted according to the Vancouver Protocol.Results:There are few studies that study ethical (...) challenges when using coercion in an explicit way. However, promoting the patient’s best interest is the most important justification for coercion. Patient autonomy is a fundamental challenge facing any use of coercion, and some kind of autonomy infringement is a key aspect of the concept of coercion. The concepts of coercion and autonomy and the relations between them are very complex. When coercion is used, a primary ethical challenge is to assess the balance between promoting good and inflicting harm. In the included studies, findings explicitly related to justice are few. Some studies focus on moral distress experienced by the healthcare professionals using coercion.Conclusion:There is a lack of literature explicitly addressing ethical challenges related to the use of coercion in mental healthcare. It is essential for healthcare personnel to develop a strong awareness of which ethical challenges they face in connection with the use of coercion, as well as challenges related to justice. How to address ethical challenges in ways that prevent illegitimate paternalism and strengthen beneficent treatment and care and trust in connection with the use of coercion is a ‘clinical must’. By developing a more refined and rich language describing ethical challenges, clinicians may be better equipped to prevent coercion and the accompanying moral distress. (shrink)

BackgroundInformed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in clinical studies.MethodsThe template was (...) based on a literature review including systematic reviews and guidelines searched on PubMed, Embase, Cochrane Library, NICE, SIGN, GIN, and Clearinghouse databases, and on comparison of templates gathered through an extensive search on the websites of research institutes, national and international agencies, and international initiatives. We discussed the draft versions step-by-step and then we referred to it as the “matrix” to underline its modular character and indicate that it allows adaptation to the context in which it will be used. The matrix was revised by representatives of two international patient groups.ResultsThe matrix covers the process of ensuring that the appropriate information, context and setting are provided so that the participant can give truly informed consent. It addresses the key topics and proposes wording on how to clarify the meaning of placebo and of non-inferiority studies, the importance of individual participants’ data sharing, and the impossibility of knowing in advance how the data might be used in future studies. Finally, it presents general suggestions on wording, format, and length of the information sheet.ConclusionsThe matrix underlines the importance of improving the process of communication, its proper conditions (space, time, setting), and addresses the participants’ lack of knowledge on how clinical research is conducted. It can be easily applied to a specific setting and could be a useful tool to identify the appropriate informed consent format for any study. The matrix is mainly intended to support multicentre interventional randomized clinical studies, but several suggestions also apply to non-interventional research. (shrink)

Background International electives are often considered a valuable learning opportunity for medical students. Yet, as travelling to lower and middle income countries (LMICs) becomes more common, ethical considerations of such practices emerge. We conducted a scoping review to assess the extent to which five ethical themes were addressed in existing literature about electives, with the aim of investigating the ethical impacts of medical student electives on local resources, patients and clinicians in LMICs. Methods We systematically searched PubMed, Global Health and (...) Embase databases using the search terms “(ethics) AND (medical electives)”. Thematic content analysis was undertaken using a combination of deductive and inductive themes. The deductive themes included: exceeding clinical competence, use of limited local resources, respect for patients and local culture, collaboration with local community/colleagues, and one-sided benefits in partnership. In addition, we also allowed for emerging themes within the data, and conducted a narrative synthesis of the results. Results A total of 37 papers discussed ethical issues relating to medical student international electives to LMICs. More publications were written from the medical student perspective (n = 14), than by the host-institution (n = 5), with nearly half written from third-party perspectives (n = 18). Negative impacts on local host students and impact upon patient care were identified as additional ethical considerations. Conclusions Our review demonstrated that while there is a degree of awareness in the existing literature of the potential negative impacts of medical electives to local LMIC students’ access to medical education and patient care, continued work is needed to ensure equitable partnerships. We recommend that these ethical themes should be further explored in pre-departure elective teaching courses and post-elective debriefs to increase medical students’ awareness of the impact of their presence on host communities. (shrink)

Background: Pediatric guidelines recommend that children and adolescents participate in a developmentally appropriate way in end-of-life decision making. Shared decision making in pediatrics is unique because of the triadic relationship of patient, parents, and physician. The involvement of the patient may vary on a continuum from no involvement to being the sole decision maker. However, the effects of child participation have not been thoroughly studied. The aims of this literature review are to identify studies on end-of-life decision making in pediatrics, (...) to explore patient participation, and to assess the effects of such participation. Methods: Five databases—PubMed, PsycInfo, Medline, CINAHL, and Sociological Abstract—were searched for empirical studies on end-of-life decision making in pediatrics. Selected articles fulfilling the criteria were assessed for type of decision, participants’ characteristics, reports on participation of the minor patient, and outcome. Results: Fifty-seven articles on end-of-life decision making in pediatrics were identified. The majority of papers (n = 43, 75%) investigated parents’ and clinicians’ perspectives, while only 14 articles (25%) included perspectives of children and adolescents. Twenty-two articles (39%) reported some details on various forms of children's participation (e.g., receive information, plan care details, consulted before or after a decision was made). Positive (e.g., respect for patient's preferences) and negative (e.g., conflict due to diverging opinions) effects of children's participation in end-of-life decision making were reported. Conclusions: This systematic review highlights the need for research to identify factors that contribute to a favorable participation of minors in decision-making processes, as well as strategies to solve possible conflicts. More research should take into account the dynamics in the triadic process of decision making and emphasize children and adolescents’ perspectives. A better understanding of how to meaningfully involve children and adolescents in end-of-life decision making could facilitate the practice of patient participation in pediatrics. (shrink)

Despite the entrenched acceptance of normal science in health care, it appears that authoritative, positivist, linear, risk averse, certainty-based thinking can only get us so far along the route of optimum health. This paper examines labor and childbirth as a paradigm case of a complex adaptive system (CAS) and offers the example of techniques used in a master-level course on normal childbirth to illustrate how maternity care clinicians can be introduced to complexity-based thinking through reflexive analysis of real life clinical (...) narratives. It suggests that these techniques might be used as a basis for answering the question, what is likely to work for this person, in this situation, given the range of evidence, and given their values and beliefs, my values and beliefs, and my clinical skills and knowledge? Topics discussed in this paper include complexity, pregnancy, and childbirth; mainstreaming complexity-focused decision making in maternity care; and using story in practice. In conclusion, complexity theory appears to offer a good explanatory model for pregnancy and childbirth, both in general, and for specific individuals. Future work in this area should examine the efficacy and limits to formal story telling in maternity care, with the aim of increasing optimal maternity care for mothers and babies, and for the staff and organizations that deliver the care. (PsycINFO Database Record (c) 2010 APA, all rights reserved). (shrink)

BackgroundClinical ethics consultations can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. ObjectiveThe primary (...) objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality, process factors, and clinical factors. The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC. (shrink)

BackgroundRecently, considerable research has been conducted to study the effects of traditional Chinese exercises on cognitive function in older adults with MCI. We completed a comprehensive systematic review and meta-analysis to assess the efficacy of TCEs on cognitive function in this population.MethodsA search strategy based on the PICOS principle was used to find the literatures in the databases of PubMed, Web of Science, MEDLINE, SPORT-Discus, PsycINFO, Cochrane Central Register of Controlled Trials, Ovid. The quality and risk of bias in the (...) studies were independently assessed by two researchers.ResultsNine trials with 1,290 participants were included. The effect size of TCEs on global cognitive function was small when compared to the active control and was moderate compared to the inactive control; statistically significant effects were also found for short-term memory, long-term memory, shifting, language ability, visuospatial perception.ConclusionThis meta-analysis provides clinicians with moderate evidence to recommend that TCEs hold potential to enhance both global cognitive function and multiple domains of cognitive function, which, however, needs to be confirmed and further examined in futures studies. The results of this work provide critical knowledge for the design of future studies implementing TCEs as well as its clinical practice. Future RCTs with rigorous designs are needed to help obtain more definitive conclusions on the effects of TCEs on cognitive function in older adults with MCI. (shrink)

BackgroundDecision-making in initiating life-sustaining health technology is complex and often conducted at time-critical junctures in clinical care. Many of these decisions have profound, often irreversible, consequences for the child and family, as well as potential benefits for functioning, health and quality of life. Yet little is known about what influences these decisions. A systematic review of reasoning identified the range of reasons clinicians give in the literature when initiating technology dependence in a child, and as a result helps determine the (...) range of influences on these decisions.MethodsMedline, EMBASE, CINAHL, PsychINFO, Web of Science, ASSIA and Global Health Library databases were searched to identify all reasons given for the initiation of technology dependence in a child. Each reason was coded as a broad and narrow reason type, and whether it supported or rejected technology dependence.Results53 relevant papers were retained from 1604 publications, containing 116 broad reason types and 383 narrow reason types. These were grouped into broad thematic categories: clinical factors, quality of life factors, moral imperatives and duty and personal values; and whether they supported, rejected or described the initiation of technology dependence. The majority were conceptual or discussion papers, less than a third were empirical studies. Most discussed neonates and focused on end-of-life care.ConclusionsThere is a lack of empirical studies on this topic, scant knowledge about the experience of older children and their families in particular; and little written on choices made outside ‘end-of-life’ care. This review provides a sound basis for empirical research into the important influences on a child’s potential technology dependence. (shrink)

Whether due to simplicity or hypocrisy, the question of access to patient data for biomedical research is widely seen in the public discourse only from the angle of patient privacy. At the same time, the desire to live and to live without disability is of much higher value to the patients. This goal can only be achieved by extracting research insight from patient data in addition to working on model organisms, something that is well understood by many patients. Yet, most (...) biomedical researchers working outside of clinics and hospitals are denied access to patient records when, at the same time, clinicians who guard the patient data are not optimally prepared for the data’s analysis. Medical data collection is a time- and cost-intensive process that is most of all tedious, with few elements of intellectual and emotional satisfaction on its own. In this process, clinicians and bioinformaticians, each group with their own interests, have to join forces with the goal to generate medical data sets both from clinical trials and from routinely collected electronic health records that are, as much as possible, free from errors and obvious inconsistencies. The data cleansing effort as we have learned during curation of Singaporean clinical trial data is not a trivial task. The introduction of omics and sophisticated imaging modalities into clinical practice that are only partially interpreted in terms of diagnosis and therapy with today’s level of knowledge warrant the creation of clinical databases with full patient history. This opens up opportunities for re-analyses and cross-trial studies at future time points with more sophisticated analyses of the same data, the collection of which is very expensive. (shrink)

Remote monitoring of implantable cardioverter defibrillator (ICD) patients links patients wirelessly to the clinic via a box in their bedroom. The box transmits data from the ICD to a remote database accessible to clinicians without patient involvement. Data travel across time and space; clinicians can monitor patients from a distance and instantly know about cardiac events. Based on ethnographic fieldwork in two Danish hospitals, this article explores the configuration of the wireless ICD patient by following a number of patients (...) through hospitalisation, implantation, in-clinic follow-up, and remote monitoring. Wireless therapy, we argue, scripts the patient as data. In high-tech clinical encounters, data are enacted as extensions and copies of the patient, and even proxies that, in patients’ experiences, may turn into identity thieves. In illuminating the multiple positions that data take in such clinical encounters and in patients’ experiences we discuss the ambiguities that arise when patients go wireless. (shrink)

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision (...) of care. Molecular tumor boards are one response to these changes and are now providing better access to next-generation sequencing and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent documents at all academic medical centers and to introduce dynamic and electronic informed consent. (shrink)

BackgroundAlthough a large number of clinical trials on interventions demonstrating efficacy (or lack thereof) are conducted annually, much of this evidence is not accessible to scientists and clinicians.ObjectivesWe aimed to determine the publication rate of posttraumatic stress disorder (PTSD) trials that have been registered in clinical trial registries, and the factors associated with publication.MethodsTrials, completed on January 15, 2015, were identified via the US National Institutes of Health clinical trials registry, the European Union Clinical Trials Register and the WHO International (...) Clinical Trials Registry Platform. A systematic search for publications (published by the end of March 2018) related to each of the registered trials were then performed.ResultsFour hundred and thirty-eight of 1982 potentially eligible trials were included. Only 34% of interventional trials were registered prior to initiation, 9% were registered within 2 months of starting and 20% after trial completion. Of the 438 included trials, 72% had generated peer-reviewed publications, while an additional 7% had disseminated results in some other form (such as on the trial database), 26 months after trial completion. Randomisation of a trial was the only factor individually associated with publication, in logistic regression analysis (p < 0.001). Intervention type, university as sponsor and study registration prior to completion were factors that influenced the time to publication, using Cox regression (p < 0.001).ConclusionsThis study underscores the importance of timely and accurate publication and dissemination of trial results, in order to avoid the potential waste of resources and to ensure research integrity and patient safety. We suggest that authors and journal editors adhere to conditions set out by the International Committee of Medical Journal Editors and that more diligent data sharing is encouraged through prospective trial registration and trial reporting websites. (shrink)

Clinical work in Alcohol and Other Drugs has not generally been an area of focus for ethicists. Likewise, ethics is not usually part of Alcohol and Other Drugs training or practice. This means that resources available to Alcohol and Other Drugs clinicians navigating ethical challenges are not widely available. This paper describes a systematic review of literature at the intersection of ethics and clinical practice in Alcohol and Other Drugs. The review will potentially benefit Alcohol and Other Drug practitioners by (...) outlining what resources currently available and will also highlight potential directions for future research. The review searched for all published work in ethics at the intersection with Alcohol and Other Drugs. Searches within academic databases, the World Wide Web, and within journal Tables of Contents identified 18 relevant papers from 1985 onwards. An inductive process of categorisation produced two categories of this literature. The first was codes of ethics, further divided into rule-... (shrink)

Background: Professional ethical codes are an important part of healthcare. They are part of the professionalisation of an occupation, are used for regulation of the professions and are intended to guide ethical behaviour in healthcare. However, so far, little is known about the practical use of professional codes in healthcare, particularly in paramedicine. Objective: The aim of this scoping review was to determine what is known in the existing literature about health professionals’ knowledge, awareness and use of their professional codes. (...) Method: A scoping review was performed based on a six-stage framework as described by Levac et al. Six databases were searched: OVID Medline, EMBASE, EMCARE, CINAHL, ProQuest and Scopus, in September 2020. Google Scholar, Trove and Google using.gov and.org websites were also searched for grey literature. Two reviewers independently assessed study eligibility. Results: The search yielded 1162 results after duplicate removal. Thirty-nine studies remained after title and abstract review. Twenty-five articles were included after full-text review. Sixteen examined nursing, eight examined medicine and one examined both nursing and medicine. No studies were identified that examined paramedicine. Twenty-one studies were of a cross-sectional design and four studies were of a qualitative design. Conclusion: Most health professionals know the codes exist, but do not think they know the content. Despite valuing professional codes highly, healthcare professionals do not use them regularly in clinical practice. Further research is needed, and professional codes should be made useful for practice and consideration given to how codes can be written, communicated and implemented to increase their actualisation in healthcare. Research should also begin in paramedicine to identify clinician’s knowledge and use of codes in this profession. Review registration: Open Science Framework – doi:10.17605/OSF.IO/NKBY4 Ethics Statement: This article does not contain any studies involving human participants performed by any of the authors. The review followed good scientific conduct. (shrink)

The temptation to use prospective observational studies (POS) instead of conducting difficult trials (RCTs) has always existed, but with the advent of powerful computers and large databases, it can become almost irresistible. We examine the potential consequences, were this to occur, by comparing two hypothetical studies of a new treatment: one RCT, and one POS. The POS inevitably submits more patients to inferior research methodology. In RCTs, patients are clearly informed of the research context, and 1:1 randomized allocation between experimental (...) and validated treatment balances risks for each patient. In POS, for each patient, the risks of receiving inferior treatment are impossible to estimate. The research context and the uncertainty are down-played, and patients and clinicians are at risk of becoming passive research subjects in studies performed from an outsider’s view, which potentially has extraneous objectives, and is conducted without their explicit, autonomous, and voluntary involvement and consent. (shrink)

Spirituality is a topic of recent interest. Mindfulness, for example, a concept derived from the Buddhist tradition, has captivated the imagination of clinicians who package it in convenient intervention programs for patients. Spirituality and religion have been researched with reference to potential health benefits. Spirituality can be conceptualised as the alignment of the individual with the whole, experientially, motivationally and in action. For spirituality to unfold its true potential it is necessary to align this new movement with the mainstream of (...) science, and vice versa. Hence, both a historical review, and a systematic attempt at integration is called for, which we are trying to give here. It is useful to go back to one of the roots: parapsychology. Parapsychology was founded as a counter movement to the rising materialist paradigm in the 19th century. Adopting the methods of the natural sciences, it tried to prove the direct influence of consciousness on matter. After 125 years this mission must be declared unaccomplished. Surveying the database of parapsychological research it is obvious that it will not convince sceptics: Although there are enough exceptional findings, it has in general not been possible to reproduce them in replication experiments. This is, however, a characteristic signature of a category of effects which we call effects of generalised entanglement, predicted by a theoretical model analogous to quantum theory. Using this perspective, parapsychological effects can be understood, and the original aim of the founding fathers can be recovered, as well as a new, systematic understanding of spirituality be gained. Generalised entanglement is a formal and scientific way of explaining spirituality as alignment of an individual with a whole, which, according to the model, inevitably leads to non-local correlations. (shrink)

BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the (...) remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated. (shrink)

Background: A significant concern for patients treated for cancer is fear of cancer recurrence. Although a common experience, some patients report high levels of FCR that are difficult to manage and result in over vigilant checking and high use of health services. There has been speculation about the relationship of FCR with gender with mixed reports from several systematic reviews.Aims: To determine the association of FCR with gender in previous reported studies and investigate the strength of this relationship with various (...) moderators including year of publication, type of cancer and measurement attributes of self-reported FCR instruments.Methods: A systematic review was conducted with searches of the literature from the MEDLINE, PubMed, Embase, and PsycINFO databases following PRISMA guidelines. All the included papers were divided into two groups, namely: “pure” that comprise only of patients with cancer types that both men and women can contract and “mixed” that report on patients with a variety of cancer types. The association between gender and FCR level was assessed by meta-analysis. A meta-regression was performed to investigate the moderating effects of factors including: the year of publication, cancer type, mean age of the sample and the length of the FCR scale measurement. This review was registered with PROSPERO, ID: CRD42020184812.Results: Finally, 29 studies were included. The N size of pooled participants was 33,339. The meta-analysis showed females to have an overall higher level of FCR than males. The meta-regression of moderating or control variables found little, if any, systematic variation in effect-sizes.Conclusion: This systematic review has clarified a potentially confused pattern of previous results in understanding the relationship between gender and FCR. Women report higher levels of FCR than men and this feature is one that clinicians and researchers can factor into their practice and future studies. The effect size is moderate, hence there is ample variation in FCR level, independent of gender, that requires further investigation. (shrink)

BackgroundWhile fertility preservation is recommended practice for paediatric oncology patients, it is increasingly being considered for transgender children and young people in paediatric care. This raises ethical issues for clinicians, particularly around consent and shared decision-making in this new area of healthcare.MethodsA systematic review of normative literature was conducted across four databases in June 2020 to capture ethical considerations related to fertility counselling and preservation in paediatric transgender healthcare. The text of included publications was analysed inductively, guided by the Qualitative (...) Analysis Guide of Leuven.ResultsTwenty-four publications were identified for inclusion. Four key ethical considerations emerged from this literature: access to fertility preservation, conscientious objection, decision-making capacity of children and young people, and shared decision-making.ConclusionIn the identified literature, there is consensus that transgender children and young people should not be refused access to fertility preservation services solely due to their gender identity, and that clinicians with conscientious objections to fertility preservation for this group have an obligation to refer on to willing providers. Factors that create ethical complexity in this area of paediatric care include the child’s age, mental health, and parents’ views. (shrink)

Spirituality is a topic of recent interest. Mindfulness, for example, a concept derived from the Buddhist tradition, has captivated the imagination of clinicians who package it in convenient intervention programs for patients. Spirituality and religion have been researched with reference to potential health benefits. Spirituality can be conceptualised as the alignment of the individual with the whole, experientially, motivationally and in action. For spirituality to unfold its true potential it is necessary to align this new movement with the mainstream of (...) science, and vice versa. Hence, both a historical review, and a systematic attempt at integration is called for, which we are trying to give here. It is useful to go back to one of the roots: parapsychology. Parapsychology was founded as a counter movement to the rising materialist paradigm in the 19th century. Adopting the methods of the natural sciences, it tried to prove the direct influence of consciousness on matter. After 125 years this mission must be declared unaccomplished. Surveying the database of parapsychological research it is obvious that it will not convince sceptics: Although there are enough exceptional findings, it has in general not been possible to reproduce them in replication experiments. This is, however, a characteristic signature of a category of effects which we call effects of generalised entanglement, predicted by a theoretical model analogous to quantum theory. Using this perspective, parapsychological effects can be understood, and the original aim of the founding fathers can be recovered, as well as a new, systematic understanding of spirituality be gained. Generalised entanglement is a formal and scientific way of explaining spirituality as alignment of an individual with a whole, which, according to the model, inevitably leads to non-local correlations. (shrink)

Recreational Drugs European Network (ReDNet) project aims to use the Psychonaut Web Mapping Project database (Psychonaut Web Mapping Group, 2009) containing novel psychoactive compounds usually not mentioned in the scientific literature and thus unknown to clinicians as a unique source of information. The database will be used to develop an integrated ICT prevention approach targeted at vulnerable individuals and focused on novel synthetic and herbal compounds and combinations. Particular care will be taken in keeping the health professionals working (...) directly with young people showing problematic behaviors regularly updated in terms of novel compounds and combinations as well. A user-friendly project website will be developed aimed primarily at delivering the information/prevention approaches, but will also be a way of communicating with project partners and relevant stakeholders (e.g. thematic forum facilities, instant messages, blogs, video chat, wikiblog, newsletters distributed via mailing list). The website will support various ICT prevention tools, including an SMS alert service. Different areas and sections will be aimed specifically at the different target groups. -/- . (shrink)

Placebos are often used by clinicians, usually deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Is it possible to extend the effects of drug treatments by interspersing placebos? We reviewed a database of placebo studies, searching for studies that indicate that placebos given after repeated administration of active treatments acquire (...) medication-like effects. We found a total of 22studies in both animals and humans hinting of evidence that placebos may work as a sort of dose extender of active painkillers. Wherever effective in relieving clinical pain, such placebo use would offer several advantages. First, extending the effects of a painkiller through the use of placebos may reduce total drug intake and side effects. Second, dose-extending placebos may decrease patient dependence. Third, using placebos along with active medication, for part of the course of treatment, should limit dose escalation and lower costs. Importantly, provided that nondisclosure is pre-authorized in the informed consent process and that robust evidence indicates therapeutic benefit comparable to that of standard full-dose therapeutic regimens, introducing dose-extending placebos into the clinical arsenal should be considered. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated. (shrink)

The development of gene expression profiling and next-generation sequencing technologies have steered oncogenomics to the forefront of precision medicine. This created a need for harmonious cooperation between clinicians and researchers to increase access to precision oncology, despite multiple implementation challenges being encountered. The aim is to apply personalised treatment strategies early in cancer management, targeting tumour subtypes and actionable gene variants within the individual’s broader clinical risk profile and wellbeing. A knowledge-generating database linked to the South African Medical Research (...) Council’s Genomic Centre has been created for the application of personalised medicine, using an integrated service and research approach. Insights gained from patient experiences related to tumour heterogeneity, access to targeted therapies and incidental findings of pathogenic germline variants in tumour DNA, provided practice-changing evidence for the implementation of a cost-minimisation pathology-supported genetic testing strategy. Integrating clinical care with genomic research through data sharing advances personalised medicine and maximises precision oncology benefits. (shrink)

Introduction Current treatments for pain have limited benefits and worrying side effects. Some studies suggest that pain is reduced when clinicians deliver positive messages. However, the effects of positive messages are heterogeneous and have not been subject to meta-analysis. We aimed to estimate the efficacy of positive messages for pain reduction. -/- Methods We included randomized trials of the effects of positive messages in a subset of the studies included in a recent systematic review of context factors for treating pain. (...) Several electronic databases were searched. Reference lists of relevant studies were also searched. Two authors independently undertook study selection, data extraction, risk of bias assessment, and analyses. Our primary outcome measures were differences in patient- or observer-reported pain between groups who were given positive messages and those who were not. -/- Results Of the 16 randomized trials (1703 patients) that met the inclusion criteria, 12 trials had sufficient data for meta-analysis. The pooled standardized effect size was −0.31 (95% confidence interval [CI] −0.61 to −0.01, p = 0.04, I2 = 82%). The effect size remained positive but not statistically significant after we excluded studies considered to have a high risk of bias (standard effect size −0.17, 95% CI −0.54 to 0.19, P = 0.36, I2 = 84%). -/- Conclusion Care of patients with chronic or acute pain may be enhanced when clinicians deliver positive messages about possible clinical outcomes. However, we have identified several limitations of the present study that suggest caution when interpreting the results. We recommend further high-quality studies to confirm (or falsify) our result. -/- FUNDING -/- Alexander Mebius research has been funded through the ERC grant "Philosophy of Pharmacology: Safety, Statistical Standards, and Evidence Amalgamation" (GA: 639276). (shrink)

ObjectiveA high prevalence of authorship problems can have a severe impact on the integrity of the research process. We evaluated the authorship practices of clinicians from the same university hospital in 2019 to compare them with our 2003 data and to find out if the practices had changed.MethodsPractitioners were randomly selected from the hospital database. The telephone interviews were conducted by a single researcher using a simplified interview guide compared with the one used in 2003. The doctors were informed (...) that their answers would be aggregated without the possibility of identifying the respondents. During the interviews, the researcher ticked the boxes with the answers on a paper file.ResultsWe interviewed 26 clinicians from various medical specialties. They were unfamiliar with the ICMJE criteria for writing medical articles and felt that these criteria were not well met in general. With regard to ways of reducing the practice of honorary authors, the participants clearly felt that asking for a signature was hypocritical and of little use. The ghost authors were well known; this practice was considered as rather rare. The ‘publish or perish’ has always been cited as being responsible for bad practices. We compared these results with those observed in 2003 and no improvement has been observed in the past 15 years.ConclusionFor the second time in France, within a 15-year interval, we have shown that the ICMJE criteria were ignored and that honorary authorship was frequent. (shrink)

Advances in intracranial electroencephalography and neurophysiology have enabled the study of previously inaccessible brain regions with high fidelity temporal and spatial resolution. Studies of iEEG have revealed a rich neural code subserving healthy brain function and which fails in disease states. Machine learning, a form of artificial intelligence, is a modern tool that may be able to better decode complex neural signals and enhance interpretation of these data. To date, a number of publications have applied ML to iEEG, but clinician (...) awareness of these techniques and their relevance to neurosurgery, has been limited. The present work presents a review of existing applications of ML techniques in iEEG data, discusses the relative merits and limitations of the various approaches, and examines potential avenues for clinical translation in neurosurgery. One-hundred-seven articles examining artificial intelligence applications to iEEG were identified from 3 databases. Clinical applications of ML from these articles were categorized into 4 domains: i) seizure analysis, ii) motor tasks, iii) cognitive assessment, and iv) sleep staging. The review revealed that supervised algorithms were most commonly used across studies and often leveraged publicly available timeseries datasets. We conclude with recommendations for future work and potential clinical applications. (shrink)

AimIn case of extremely rare diseases, case reports are often the only experience to draw from for evidence-based management. Carmi syndrome is a rare, mostly lethal combination of junctional epidermolysis bullosa and pyloric atresia. During an ethical board, there were differences in perception of mortality rate. We tested the hypothesis that the cumulative mortality of single case reports is lower than that of multiple case series.CaseA baby girl was born at 33 weeks gestation with Carmi syndrome. The treatment options discussed (...) in an interdisciplinary ethics board were a palliative approach versus surgical gastrojejunostomy. Because about one third of operated children described in case reports survived, we opted for surgical treatment. The patient died a painful death 4 weeks later.MethodsThe PubMed database was systematically searched for reports of Carmi syndrome. Single case reports were compared to case series in terms of outcome.ResultsA total of 102 cases of Carmi syndrome were identified in the literature. Mortality of single case reports was 17 out of 27 patients (63%), while that of case series was higher at 62 out of 74 patients (84%,p = 0.036).ConclusionsSelection and publication bias may lead to inflation of survival rates in single case reports because successful cases are more likely to be published in the literature. These biases may lead to inappropriately aggressive treatment in futile cases. Clinicians should be cautious when discussing prognosis and making decisions based on the cumulative experience of case reports of extremely rare or novel diseases. (shrink)

The feasibility of posthumous reproduction when the surviving partner is female has brought to light many ethical, moral, social, and legal issues. This review aims to summarize these issues and to assist clinicians who may be faced with such requests. A question list, used for health technologies assessment, was utilized in a question-answer approach as the review methodology. Of the 1,208 publications identified through a comprehensive literature search in biomedical, psychological, and ethical databases, 31 articles included arguments related to one (...) or more questions from the predefined question set. Key stakeholders identified include the deceased, the requesting party, the resultant child, the physician, and society. Key ethical issues relevant to posthumous reproduction include the four traditional pillars of medical ethics—autonomy, beneficence, nonmaleficence, justice—as well as the stakeholders’ rights and sociocultural attitudes. The ethical framework formulated by these issues has been incorporated in a clinical ethics decision-making tool that could prove useful to clinicians and decision makers. (shrink)

Background: Today, many healthcare or dementia organizations, clinicians, and companies emphasize the importance of detection of Alzheimer’s disease in an early phase. This idea has gained considerable momentum due to the development of biomarkers, the recent FDA and EMA approval of three amyloid tracers, and the failure of a number of recent therapeutic trials conducted in the early dementia phase. On the one hand, an early etiological diagnosis can lead to early and more efficacious intervention. On the other hand, it (...) is questioned how early an etiological diagnosis is beneficial to the patient. Here we consider ethical issues related to the process of biomarker testing and the impact on the diagnostic disclosure to patients with mild cognitive impairment due to prodromal Alzheimer’s disease. Methods: A systematic review of the theoretical bioethics literature was performed by using electronic databases. The review was limited to articles published in English between 2003 and 2016. Results: A total of twenty articles were included in our effort to make an analysis of the ethical challenges. One of the biggest challenges was the uncertainty and the predictive value of the biomarker-based diagnosis where patients can be amyloid positive without full certainty whether or when they will develop symptomatic decline due to Alzheimer’s disease. Another challenge was the tension between the right to know versus the wish not to know, the limited efficacy of currently available treatment options, and the opportunities and consequences after receiving such an early diagnosis. Conclusion: Based on the results and the additional comments in the discussion, several unanswered questions emerged. Therefore, careful consideration of all these ethical issues is required before the disclosure of a biomarker-based diagnosis to the patient with mild cognitive impairment due to Alzheimer’s disease. (shrink)

Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must (...) justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician. (shrink)

Background Older patients are often vulnerable and highly dependent on healthcare professionals’ assessment in the event of acute illness. In the context of ambulance services, this poses challenges as the assessment is normally conducted with a focus on identifying life-threatening conditions. Such assessment is not fully satisfactory in a patient relationship that also aims to promote and protect patient autonomy. Aim To describe ambulance clinicians’ understanding of older patients’ self-determination when the patient’s decision-making ability is impaired. Research design A qualitative (...) design with an inductive approach, guided by descriptive phenomenology. Participants In total, 30 ambulance clinicians, comprised of 25 prehospital emergency nurses, 1 nurse and 4 emergency medical technicians participated in 15 dyadic interviews. Ethical considerations The research was conducted in accordance with the Declaration of Helsinki, and permission was granted by the Swedish Ethical Review Authority. Findings The findings are presented in two themes: (1) Movement between explicit and implicit will; and (2) Contradictions about the patient’s best interests. The clinicians’ interpretations are based on an understanding of the patient’s situation using substitute decision-making in emergency situations and conversations that reveal the patient’s explicit wishes. Sometimes the clinicians collaborate to validate the patient’s implicit will, while they at other times subordinate themselves to others’ opinions. The clinicians find themselves in conflict between personal values and organisational values as they try to protect the patient’s self-determination. Conclusion The results indicate that older patients with an impaired decision-making ability risk losing the right to self-determination in the context of ambulance services. The clinicians face challenges that significantly affect their ability to handle the older patient’s unique needs based on a holistic perspective and their ability to be autonomous. (shrink)

Recent discussions of genomics and international justice have adopted the concept of ‘global public goods’ to support both the view of genomics as a benefit and the sharing of genomics knowledge across nations. Such discussion relies on a particular interpretation of the global public goods argument, facilitated by the ambiguity of the concept itself. Our aim in this article is to demonstrate this by a close examination of the concept of global public goods with particular reference to its use in (...) the context of genomic databases. We contend that the argument for construing genomics as a global public good depends on seeing it as a natural good by focusing on features intrinsic to genomics knowledge. We shall argue that social and political arrangements are relevant and that recognising this opens the door to construing the use of global public goods language as a strategic one. (shrink)

There are many ways in which biases can enter processes of scientific reasoning. One of these is what Ludwik Fleck has called a “harmony of illusions”. In this paper, Fleck’s ideas on the relevance of social mechanisms in epistemic processes and his detailed description of publication processes in science will be used as a starting point to investigate the connection between cognitive processes, social dynamics, and biases in this context. Despite its usefulness as a first step towards a more detailed (...) analysis, Fleck’s account needs to be updated in order to take the developments of digital communication technologies of the 21st century into account. Taking a closer look at today’s practices of science communication shows that information and communication technologies (ICTs) play a major role here. By presenting a detailed case study concerning the database SCOPUS, the question will be investigated how such ICTs can influence the division of epistemic labour. The result will be that they potentially undermine the epistemic benefits of social dynamics in science communication due to their inherent tendency to reduce the diversity of scientific hypotheses and ideas. (shrink)

In business and government, databases contain large quantities of digital transactional data (purchases made, services used, finances transferred, benefits received, licences acquired, borders crossed, tickets purchased). The data can be understood as ongoing and dynamic measurements of the activities and doings of people. In government, numerous database devices have been developed to connect such data across services to discover patterns and identify and evaluate the performance of individuals and populations. Under the UK’s New Labour government, the development of such (...) devices was part of a broader policy known as ‘joined-up thinking and government’. Analyses of this policy have typically understood joining up as an operation of adding together distributed data about subjects, which can then be used in the service of government surveillance, the database state or informational capitalism. But rather than such technical or managerialist analytics, I argue that topological analytics capture what these database devices enact and do: they materialize the ‘individuality’ of subjects in intensified, distributed and fluctuating ways and materialize and intensify a logic of what Deleuze describes as modulating controls. Through examples of UK New Labour social policy initiatives over the past decade, I argue that topological analytics can account for these as immanent rather than exceptional properties of database devices and, as such, part and parcel of a governmental logic and ontology of subjects. (shrink)

Nurse clinician‐scientists are increasingly expected to show leadership aimed at transforming healthcare. However, research on nurse clinician‐scientists' leadership (integrating researcher and practitioner roles) is scarce and hardly embedded in sociohistorical contexts. This study introduces leadership moments, that is, concrete events in practices that are perceived as acts of empowerment, in order to understand leadership in the daily work of newly appointed nurse clinician‐scientists. Following the learning history method we gathered data using multiple (qualitative) methods to get close to their daily (...) practices. A document analysis provided us with insight into the history of nursing science to illustrate how leadership moments in the everyday work of nurse clinician‐scientists in the “here and now” can be related to the particular histories from which they emerged. A qualitative analysis led to three acts of empowerment: (1) becoming visible, (2) building networks, and (3) getting wired in. These acts are illustrated with three series of events in which nurse clinician‐scientists' leadership becomes visible. This study contributes to a more socially embedded understanding of nursing leadership, enables us to get a grip on crucial leadership moments, and provides academic and practical starting points for strengthening nurse clinician‐scientists' leadership practices. Transformations in healthcare call for transformed notions of leadership. (shrink)

As a gynecologic surgeon with a focus on infertility, I frequently hold complex discussions with patients, exploring with them the risks and benefits of surgical options. In the past, we physicians may have expected our patients to simply defer to our expertise and choose from the options we presented. In our contemporary era, however, patients frequently request options not favored by their physicians and even some they've found themselves online. In reproductive endocrinology and infertility, the range of options that may (...) be offered or that patients may themselves seek out is continuously widening. Physicians certainly seek to find the option that will result in the best outcome for their patients, but the information to guide us in achieving the best outcome can be vague or conflicting. Add to this the financial and emotional pressures bearing on patients seeking assisted reproduction. In this essay, I explore the extent to which clinicians in reproductive medicine should follow patient requests with which they disagree or instead try to persuade the patient to do something else or simply refuse outright to meet the request. And if persuasion is to be used, what would be legitimate methods? Clearly, coercion is unacceptable, but the line between persuasion and coercion can be elusive. At what point can or should clinicians resist such requests—and to what degree? (shrink)

After the novel, and subsequently cinema privileged narrative as the key form of cultural expression of the modern age, the computer age introduces its correlate — database. Why does new media favour database form over others? Can we explain ist popularity by analysing the specificity of the digital medium and of computer programming? What is the relationship between database and another form, which has traditionally dominated human culture — narrative? In addressing these questions, I discuss the connection (...) between computer's ontology — the way software represents the world — and the new cultural forms privileged by computer culture such as database. I propose that computerisation of culture involves projection of two fundamental parts of computer software — data structures and algorithms — onto the cultural sphere. Thus CD-ROMs and Web databases are cultural manifestations of one half of this ontology — data structures; while new media narratives are manifestations of the second part — algorithms. I conclude by proposing that in computer culture database and narrative do not have the same status. Given that on the level of data organisation most new media objects are databases, it is not surprising that on the level of form database also dominates new media culture. (shrink)

Some 30 years ago the role of the clinical ethics consultant (CEC) was formalized. At the time, the perception of the role differed between two groups serving in that capacity, clinicians and nonclinicians. Differences in their roles reflected their training and experience.These divergent views were resolved semantically by designating the role of the CEC as “ethics facilitation.” In practice the different perspectives have remained. However, the subsequent published literature on clinical ethics consultation has not adequately reflected the activity of the (...) clinician as a CEC.There have been recurring unanswered calls for the acquisition of empirical data on the nature of the problems that prompt ethics consultation requests and the functions required to address them. The authors introduce a template that provides a means to acquire such data for clinician ethicists. A similar instrument could be constructed to reflect the role of the nonclinician ethicist serving in that capacity. (shrink)