AJOB primary research最新文献

{"title":"Animal Origins of Surfactant: A Survey of Neonatologists’ Perceptions and Practices Regarding Parent Information Sharing","authors":"Sean M. Bailey, K. Hendricks-Muñoz, P. Mally","doi":"10.1080/21507716.2011.566597","DOIUrl":"https://doi.org/10.1080/21507716.2011.566597","url":null,"abstract":"Exogenous surfactants commonly used to treat a variety of neonatal respiratory diseases are derived from either bovine or porcine sources. The extent to which parents are aware of this fact is currently unclear, as is the impact that this may have on familial cultural or religious belief systems. Our primary aims were to assess U.S. neonatologists’ utilization of bovine and porcine surfactant preparations, their views on parent disclosure pertaining to the particular animal origins of exogenous surfactant therapy, and their willingness to provide alternative surfactant preparations based on parental religious preferences. An anonymous Web-based survey was provided to 2,137 neonatologists. There was a 46.9% response rate. We found that 63.4% of respondents used only bovine-derived surfactants, 14.9% exclusively used porcine-based surfactants, and 21.7% used combinations. While 74.3% of neonatologists discussed surfactant use with parents, only 2.2% always discussed its animal origins. When asked, 47.9% of neonatologists believed parental preference for religious reasons would not impact their surfactant choice, 19.4% reported it would affect their choice, and 32.7% said it maybe would. Access to only one surfactant was a major barrier to communication. Results showed that many neonatologists may be open to being inclusive of parents regarding surfactant therapy. Carrying different surfactant types on hospital pharmacy formularies and encouraging physician–parent communication may achieve a more family-centered approach to neonatal care.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"155 1","pages":"26 - 33"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81725979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Physician Opinions Regarding Informed Consent for a “Cutting-Edge” Intervention for Critically Ill Neonates","authors":"C. Wusthoff, C. Feudtner","doi":"10.1080/21507716.2011.567368","DOIUrl":"https://doi.org/10.1080/21507716.2011.567368","url":null,"abstract":"New “cutting-edge” medical interventions generally transition from research to the clinical realm after initial studies resolve short-term equipoise, demonstrating greater benefit than harm. During this transition, new interventions’ potential long-term consequences remain uncertain, which is problematic for physicians attempting to obtain appropriately informed consent. In this study, physicians were interviewed regarding their perspectives on the informed consent process for a particular intervention (neonatal therapeutic hypothermia) at a particular historical moment after short-term equipoise had been resolved but before a definitive understanding of this therapy's long-term consequences existed. Thirty neonatologists and pediatric neurologists at the Children's Hospital of Philadelphia were interviewed using a structured tool that quantified agreement with general statements regarding neonatal therapeutic hypothermia and perceptions of different consent processes. Of these, 33% of physicians agreed that neonatal therapeutic hypothermia should only be initiated after obtaining signed informed consent, whereas 37% felt that hypothermia should be initiated as standard emergent treatment. Preference for a more stringent consent process did not correlate with concerns regarding the strength of evidence supporting the intervention, but rather with placing a high value on parental counseling and with believing that children who receive the intervention may be less likely to die but more likely to survive in a severely disabled state. Thus, physicians conceptualized how to obtain consent for a transitional intervention with uncertain long-term consequences based less on strength of evidence and more on concerns regarding their duty to counsel and the potential for long-term disability. We discuss possible solutions for clinicians approaching these challenges.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"146 1","pages":"18 - 25"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86086052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects.","authors":"James Dubois, Holly Bante, Whitney B Hadley","doi":"10.1080/21507716.2011.631514","DOIUrl":"10.1080/21507716.2011.631514","url":null,"abstract":"<p><p>BACKGROUND: This paper reviews the past 25 years of empirical research funded by the National Institutes of Health (NIH) on matters of ethics in psychiatric research. METHODS: Using the NIH RePORTER and Medline databases, we identified 43 grants and 77 publications that involved the empirical study of a matter of ethics in research involving mental health service users. RESULTS: These articles provide original and useful information on important topics, most especially the capacity to consent and the voluntariness of consent. For example, participants who share a diagnosis vary widely in levels of cognitive impairment that correlate with decisional capacity, and capacity to consent can be enhanced easily using iterative consent processes. Few articles address matters of justice or benefits in research, particularly from the perspectives of participants. No articles address matters of privacy, confidentiality, or researcher professionalism. CONCLUSIONS: Despite the usefulness of data from the studies conducted to date, current research on research ethics in psychiatry does not adequately address the concerns of service users as expressed in recent publications.</p>","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"2 4","pages":"5-17"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524581/pdf/nihms411837.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31140479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"International Guidelines and Ethical Context","authors":"Benjamin Chan, D. Wendler","doi":"10.1080/21507716.2010.538035","DOIUrl":"https://doi.org/10.1080/21507716.2010.538035","url":null,"abstract":"Clinical practice and clinical research are subject to numerous ethical principles and guidelines, both formal and informal. Protect and promote patients’ and subjects’ clinical interests. Respect autonomy. Avoid exploitation. Yet what is required to follow these principles depends on the context. Which principles and guidelines are relevant, and how they should be specified and applied, all depend to varying degrees on the context in question. This sensitivity to context influences both how individuals ought to act and how their actions ought to be evaluated. In this way, the interpretive challenge posed by empirical research—what ethical conclusions can be drawn from the data?—is heightened when the results are obtained in unfamiliar contexts. Failure to recognize the relevance of context can lead one to see appropriate behavior as involving an inappropriate ethical double standard. This happened in the evaluation of the Rotashield vaccine for rotavirus. The withdrawal of Rotashield from the U.S. market due to a risk of intussusception lead to the cancellation of trials of the vaccine in developing countries (Melton 2000; Shaw 2006). However, given the much greater risk that rotavirus disease poses in developing countries, it was incorrect to assume that conducting Rotashield trials in those contexts was unacceptable simply because it would have been unacceptable to do so in the United States. From the perspective of an outsider, evaluating three empirical studies in this volume—the ethics of Iranian surgical practice, Portuguese neonatal care, and Brazilian human subjects protection—while being sensitive to context is a daunting challenge. There is much that might be ethically relevant in the respective social/cultural/historical/political/economic settings of those practices and places. At the same time, as outsiders, our ignorance of the respective contexts is vast. How could researchers hope to provide us with the context needed to grasp the ethical significance of their data?","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"34 1","pages":"28 - 30"},"PeriodicalIF":0.0,"publicationDate":"2010-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81478907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medical Paternalism or Parental Autonomy in Decision Making: A Portuguese Study in Premature Newborns","authors":"E. Silva, W. Osswald","doi":"10.1080/21507716.2010.526171","DOIUrl":"https://doi.org/10.1080/21507716.2010.526171","url":null,"abstract":"Health care providers and parents may have distinctive roles in the decision-making process regarding the care and treatment of premature babies. In this paper, we explore the process of decision making among doctors, nurses, and parents in premature care units (neonatal intensive care unites, NICUs) located in the central region of Portugal. Forty-one semistructured interviews with doctors, nurses, and mothers were conducted and analyzed. There is evidence that the medical teams provide a considerable amount of information to parents of premature babies, although sometimes unfavorable prognostic data are omitted. Mothers showed a high degree of confidence in the skill and knowledge of the medical professionals and accepted the latter's role in making decisions regarding the care and treatment of their premature babies. Only when invasive procedures or surgery were serious possibilities was something resembling written informed consent obtained. Ethics committees were seldom consulted. The results show that in the region surveyed, parents neither are invited nor appear to demand a role in making medical decisions that affect their babies. No conflicts between medical providers and parents were detected, suggesting that informed consent and the participation of parents in medical decisions regarding the care and treatment of their babies are not considered necessary or useful in this particular area by the respective parties, in contrast with the tenets of autonomy-based ethics.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"12 1","pages":"4 - 8"},"PeriodicalIF":0.0,"publicationDate":"2010-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78667493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review of Doug Wojcieszak, James W. Saxton, Esq., and Maggie M. Finkelstein, Esq., Sorry Works!: Disclosure, Apology, and Relationships Prevent Medical Malpractice Claims","authors":"Court D. Lewis","doi":"10.1080/21507716.2010.542583","DOIUrl":"https://doi.org/10.1080/21507716.2010.542583","url":null,"abstract":"Doug Wojcieszak, James Saxton, and Maggie Finkelstein’s book Sorry Works!: Disclosure, Apology, and Relationships Prevent Medical Malpractice Claims is a handbook for healthcare professionals that offers evidenced-based information and strategies for ameliorating victims’ feeling of anger and mitigating litigation after cases of medical error. The authors do not offer much in the way of direct philosophical argument, but the book is a nice addition to an otherwise lacking area of research in bioethics. The book offers bioethicists, and readers in general, both a framework from which to understand the issues involved in the aftermath of medical error and a resource on which to base normative claims of what should occur after such cases. Wojcieszak’s personal experience with medical error and his professional experience with tort reform, public relations, and medical malpractice claims enable him to offer valuable insights into the issues of medical malpractice and error. As the founder of the Sorry Works! Coalition, he teaches healthcare professionals and insurance companies that full-disclosure methods work as a means to striking a middle-ground solution between healthcare and insurance professionals who want “[f]ewer lawsuits and better control over liability exposure” and victims who want “swift justice with no constitutional limits” (9). The book gains added legitimacy with the addition of Saxton and Finkelstein, who contribute their vast amounts of legal expertise and medical malpractice litigation experience. The combined forces of the authors make Sorry Works! a valuable tool for not only physicians, hospitals, insurance companies, tort lawyers, and victims (or surviving loved-ones), but also anyone else who is engaged with the issues and implications of medical error.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"79 1","pages":"38 - 39"},"PeriodicalIF":0.0,"publicationDate":"2010-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79074887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Language of Hope: Therapeutic Intent in Stem-Cell Clinical Trials","authors":"C. Scott, Mindy C. DeRouen, L. Crawley","doi":"10.1080/21507716.2010.505899","DOIUrl":"https://doi.org/10.1080/21507716.2010.505899","url":null,"abstract":"Electronic registries for clinical trials present an opportunity for miscommunication of benefits and risks to potential subjects. We explored early phase clinical trials registered on the National Library of Medicine's ClinicalTrials.gov for inappropriate language patterns (terms and statements) that could convey therapeutic intent. We sampled early-phase heart disease clinical trial records involving stem cells registered on Clincaltrials.gov between April 24, 2004, and September 18, 2008, and randomly selected heart disease drug trials from the same period for comparison. Trial sponsorship and location were coded. Textual data were extracted from titles, purpose, outcome measures, and detailed description statements and coded for readability and the presence of therapeutic language. Content and multiple correspondence analyses were employed to explore language patterns suggestive of therapeutic intent. We found statistically significant differences in therapeutic language use between stem cell (n = 72, median statement frequency 3.5, IQR 1–7) and drug trial (n = 72 median statement frequency 1, IQR 0–3.5) records; Mann–Whitney U = 1808.5, p = .001. A correspondence plot, accounting for 65% of data variability, suggests correspondences among patterns of therapeutic language, regional location, and type of sponsorship between the two record types. Individual-, institute-, and government-sponsored stem-cell trials showed a tendency toward high frequency use of therapeutic statements. This study, the first to explore the potential for therapeutic miscommunication in electronic registries, suggests the need for greater scrutiny of language used in registered trials. Recommendations are offered to improve the integrity of records submitted to ClinicalTrials.gov.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"1 1","pages":"11 - 4"},"PeriodicalIF":0.0,"publicationDate":"2010-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74402703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethics in Humanitarian Aid Work: Learning From the Narratives of Humanitarian Health Workers","authors":"L. Schwartz, C. Sinding, M. Hunt, L. Elit, L. Redwood-campbell, N. Adelson, L. Luther, J. Ranford, S. DeLaat","doi":"10.1080/21507716.2010.505898","DOIUrl":"https://doi.org/10.1080/21507716.2010.505898","url":null,"abstract":"Little analysis has been made of ethical challenges encountered by health care professionals (HCPs) participating in humanitarian aid work. This is a qualitative study drawing on Grounded Theory analysis of 20 interviews with health care professionals who have provided humanitarian assistance. We collected the stories of ethical challenges reported by expatriate HCPs who participated in humanitarian and development work. Analysis of the stories revealed that ethical challenges emerged from four main sources: (a) resource scarcity and the need to allocate them, (b) historical, political, social and commercial structures, (c) aid agency policies and agendas, and (d) perceived norms around health professionals’ roles and interactions. We discuss each of these sources, illustrating with quotes from the respondents the consequences of the ethical challenges for their personal and professional identities. The ethical challenges described by the respondents are both familiar and distinct for bioethics. The findings demonstrate a need to provide practical ethics support for humanitarian health care workers in the field.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"11 1","pages":"45 - 54"},"PeriodicalIF":0.0,"publicationDate":"2010-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84833586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"State Intervention in Couples’ Reproductive Decisions: Socioethical Reflections Based on the Practice of Preimplantation Genetic Diagnosis in France","authors":"C. Bouffard, Julie-Kim Godin, Bénédicte Bévière","doi":"10.1080/21507716.2010.505897","DOIUrl":"https://doi.org/10.1080/21507716.2010.505897","url":null,"abstract":"Adopting socioethical and anthropological perspectives, this article addresses the impact of state intervention in the reproductive life of couples who consult for preimplantation genetic diagnosis (PGD) in France. Our main objective is to identify and analyze the socioethical problems flowing from French legislation as related to PGD and from its implementation. Methods included review and analysis of the relevant literature, ethnographic research in the three centers accredited to perform PGD, and participant observation (990 hours), with 79 semistructured interviews. Ethical problems identified were: (1) discrimination based on sexual orientation and the requirement for adherence to a traditional model of the couple and the family; (2) inequities in access to PGD; (3) restrictions on couples’ autonomy; and (4) breaches of respect for private life. We conclude that the state could improve the ethical conditions in which PGD is practiced by: (1) establishing educational programs in ethics to support members of multidisciplinary centers for prenatal diagnosis; (2) conducting empirical studies on the social acceptability of PGD; and (3) conducting empirical studies on the extent of state intervention in the reproductive life of couples likely to have recourse to reprogenetic services.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"10 1","pages":"12 - 30"},"PeriodicalIF":0.0,"publicationDate":"2010-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78318215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding “Understanding”: An Important Step Toward Improving Informed Consent to Research","authors":"P. Appelbaum","doi":"10.1080/21507716.2010.499322","DOIUrl":"https://doi.org/10.1080/21507716.2010.499322","url":null,"abstract":"What is known about how well research subjects understand the information communicated to them during the informed consent process is not encouraging. Although there is some diversity in the literature, in general studies suggest that research subjects are unable to recall much—in many cases most—of the information that has been conveyed to them by researchers (Verheggen and Wijmen 1996). Subjects typically fail to grasp the purpose of research studies, the likelihood of benefit, and the range of risks (e.g., Daugherty et al. 2000). This has been found to be true for a broad array of research subjects suffering from a wide range of disorders. In addition to purely factual information about the study, which presents challenges of its own, subjects seem to have a particularly difficult time grasping some of the ways in which participation in a clinical trial differs from engaging in ordinary treatment (Appelbaum et al. 2004; Joffe et al. 2001). In this issue of AJOB Primary Research, Sand, Kassa, and Loge (2010) demonstrate the conceptual and methodological chaos of the literature on which these conclusions are based. Definitions of what is being measured are often imprecise and vary widely across studies. Subjects are interviewed at disparate time periods after passing through the consent process. Methods range from semi-structured interviews to structured questionnaires based on free response, yes/no, or multiple-choice approaches. Instruments are often developed ad hoc for each study, frequently with little effort at validation, and typically with questions specific to the context being assessed. Hence, few instruments are—or can be—used in more than a single study. Indeed, had Sand, Kassa, and Loge included a broader selection of studies in their review, including the large number that have involved what they term “vulnerable” and “normal” populations, it seems clear that even greater variation would have been apparent. That this is not a desirable situation seems indisputable. Although many questions come to mind, three force themselves to the front of the line: 1) What implications do these","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"2 1","pages":"1 - 3"},"PeriodicalIF":0.0,"publicationDate":"2010-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79512208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}