Background: Hematopoietic stem cell transplantation is a potential cure for a range of life-threatening diseases, but is also associated with a high mortality rate. Nurses encounter a variety of situations wherein they are faced with discussing bad news with hematopoietic stem cell transplantation patients. Research objective: The aim of this study was to explore the experiences and strategies used by Iranian nurses related to truth-telling and communicating bad news to hematopoietic stem cell transplantation patients. (...) Research design: A qualitative approach using content analysis of interview data was conducted. Participants and research context: A total of 18 nurses from the main hematopoietic stem cell transplantation center in Iran participated in semi-structured interviews. Ethical considerations: The Institutional Review Board of the Tabriz University of Medical Sciences and the Hematology-Oncology and Stem Cell Transplantation Research Center affiliated with the Tehran University of Medical Sciences approved the study. Findings: In the first main category, not talking about the disease and potential negative outcomes, the nurses described the strategies of not naming the disease, talking about the truth in indirect ways and telling gradually. In the second main category, not disclosing the sad truth, the nurses described the strategies of protecting patients from upsetting information, secrecy, denying the truth and minimizing the importance of the problem. The nurses used these strategies to minimize psychological harm, avoid patient demoralization, and improve the patient’s likelihood of a fast and full recovery. Discussion: The priority for Iranian hematopoietic stem cell transplantation nurses is to first do no harm and to help patients maintain hope. This reflects the Iranian healthcare environment wherein communicating the truth to hematopoietic stem cell transplantation patients is commonly considered inappropriate and avoided. Conclusion: Iranian nurses require education and support to engage in therapeutic, culturally appropriate communication that emphasizes effective techniques for telling the truth and breaking bad news, thereby potentially improving patient outcomes and protecting patient rights. (shrink)

The informed consent process is the legal embodiment of the fundamental right of the individual to make decisions affecting his or her health., and the patient’s permission is a crucial form of respect of freedom and dignity, it becomes extremely important to enhance the patient’s understanding and recall of the information given by the physician. This statement acquires additional weight when the medical treatment proposed can potentially be detrimental or even fatal. This is the case of thalassemia (...) patients pertaining to class 3 of the Pesaro classification where Allogenic hematopoietic stem cell transplantation remains the only potentially curative treatment. Unfortunately, this kind of intervention is burdened by an elevated transplantation-related mortality risk , equal to 30% according to published reports. In thalassemia, the role of the patient in the informed consent process leading up to HSCT has not been fully investigated. This study investigated the hypothesis that information provided by physicians in the medical scenario of HSCT is not fully understood by patients and that misunderstanding and communication biases may affect the clinical decision-making process. (shrink)

This clinical ethics case examines a complex situation involving a 17-month-old child with multiple serious medical conditions who requires mechanical heart support. The ethics committee grappled with several key issues: whether to relist the child for heart transplant given his poor prognosis and severe neurological impairment, how long to continue mechanical heart support knowing it cannot be a long-term solution, and how to communicate with parents who want "everything done" for their child. The committee recommended against relisting for transplant given (...) the child's poor prognosis and need to fairly allocate scarce organs. However, they advised continuing mechanical support temporarily while working with the parents to establish clear criteria for eventual withdrawal of support and transition to palliative care. They emphasized the need for compassionate, frank discussions with the parents about quality of life and preparing for their child's death, while acknowledging how difficult these conversations will be following their previous loss of a child to similar conditions. (shrink)

An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed (...) and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature. (shrink)

Terminal kidney patients are faced with lower quality of life, restricted diets and higher morbidity and mortality rates while waiting for deceased donor kidney transplantation. Fortunately, living kidney donation has proven to be a better treatment alternative (e.g. in terms of waiting time and graft survival rates). We observed an inequality in the number of living kidney transplantations performed between the non-European and the European patients in our center. Such inequality has been also observed elsewhere in this field and (...) it has been suggested that this inequality relates to, among other things, attitude differences towards donation based on religious beliefs. In this qualitative research we investigated whether religion might indeed (partly) be the explanation of the inequalities in living donor kidney transplants (LDKT) among non-European patients. Fifty patients participated in focus group discussions and in-depth interviews. The interviews were conducted following the focus group method and analyzed in line with Grounded Theory. The qualitative data analyses were performed in Atlas.ti. We found that religion is not perceived as an obstacle to living donation and that religion actually promotes helping and saving the life of a person. Issues such as integrity of the body were not seen as barriers to LDKT. We observed also that there are still uncertainties and a lack of awareness about the position of religion regarding living organ donation within communities, confusion due to varying interpretations of Holy Scriptures and misconceptions regarding the process of donation. Faith leaders play an important educational role and their opinion is influential. This study has identified modifiable factors which may contribute to the ethnic disparity in our living donation program. We argue that we need to strive for more clarity and awareness regarding the stance of religion on the issue of living donation in the local community. Faith leaders could be key figures in increasing awareness and alleviating uncertainty regarding living donation and transplantation. (shrink)

BackgroundBeta thalassemia major is a severe inherited form of hemolytic anemia that results from ineffective erythropoiesis. Allogenic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative therapy. Unfortunately, the subgroup of adult thalassemia patients with hepatomegaly, portal fibrosis and a history of irregular iron chelation have an elevated risk for transplantation-related mortality that is currently estimated to be about 29 percent.DiscussionThalassemia patients may be faced with a difficult choice: they can either continue conventional transfusion and iron chelation (...) therapy or accept the high mortality risk of HSCT in the hope of obtaining complete recovery.Throughout the decision making process, every effort should be made to sustain and enhance autonomous choice. The concept of conscious consent becomes particularly important. The patient must be made fully aware of the favourable and adverse outcomes of HSCT. Although it is the physician's duty to illustrate the possibility of completely restoring health, considerable emphasis should be put on the adverse effects of the procedure. The physician also needs to decide whether the patient is eligible for HSCT according to the "rule of descending order". The patient must be given full details on self-care and fundamental lifestyle changes and be fully aware that he/she will be partly responsible for the outcome.SummaryOnly if all the aforesaid conditions are satisfied can it be considered reasonable to propose unrelated HSCT as a potential cure for high risk thalassemia patients. (shrink)

The goals of vascular composite allotransplantation for hand are to maximize functional status and psychosocial wellbeing and to improve quality of life. Candidates are carefully vetted by transplant programs through an extensive evaluation process to exclude those patients with contraindications and to select those that are most likely to attain functional or quality of life benefit from transplant. Patient choice for any treatment, however, requires that candidates be able to understand the risks, benefits, and alternatives before choosing (...) to proceed. This study aimed to understand patients’ knowledge and perceptions about treatment options for hand loss, including hand transplant. This study will be used to inform a standardized education approach and develop conversation aids for use by clinicians and patients throughout the treatment decision process. Ten individuals who had experienced hand amputation or had congenital limb loss were interviewed to better understand previous and current decisions about treatment, experiences in adjusting to their treatment, and perceptions about hand VCA. From this qualitative interview data, four findings emerged: knowledge and education around VCA as a treatment option; adaptation of individuals with limb loss; fear of risk associated with transplantation; issues of aging and overuse injuries to existing limbs. Results suggests that there is opportunity for expanding education about all treatment options for patients with new loss, long-term loss, and congenital limb loss. Establishing a baseline of knowledge about all options–prosthetics, rehabilitative strategies, and VCA—can help patients evaluate their values and goals of treatment. Issues associated with aging, including overuse and injury, and adaptability over the life course should be included in considerations about treatment choices. Data indicate the need for routinely assessing patient preferences about treatment choice so patients can plan for their future as they adapt and age and as technology for treatments change. To assure that thorough information is provided for current and future decision-making, education about treatment choices and selection procedures for VCA should be standardized. (shrink)

The sudden onset of severe traumatic brain injury (sTBI) is an event suffered by millions of individuals each year. Regardless of this frequency in occurrence, accurate prognostication remains difficult to achieve among physicians. There are many variables that affect this prognosis. Physicians are expected to assess the clinical indications of the brain injury while considering other factors such as patient quality of life, patient preferences, and environmental context. However, this lack of certainty in prognosis can ultimately affect (...) treatment recommendations and prompt clinical ethical issues at the bedside, as it leaves room for physician bias and interpretation. In this article, we introduce data on neurosurgeon values that may shed light on the process physicians and patients involved in sTBI undergo. In doing so, we highlight the many nuances in decision-making for patients suffering from sTBI and discuss potential solutions to better patient-physician or surrogate-physician interactions. (shrink)

The aim of this study was to investigate factors associated with seriously ill patients’ preferences for their family and physicians making resuscitation decisions on their behalf. Using SUPPORT II data, the study revealed that, among 362 seriously ill patients who were experiencing pain, 277 (77%) answered that they would want their family and physicians to make resuscitation decisions for them instead of their own wishes being followed if they were to lose decision-making capacity. Even after controlling for other variables, patients (...) who preferred the option of undergoing cardiopulmonary resuscitation (CPR) in the future were twice as likely, and those who had had ventilator treatment were four-fifths less likely, to rely on their family and physicians than those who did not want CPR (odds ratio (OR)-2.28; 95% confidence interval (CI) 1.18-4.38) or those who had not received ventilator treatment (OR-0.23; 95% CI 0.06-0.90). Psychological variables (anxiety, quality of life, and depression), symptomatic variables (severity of pain and activities of daily living) and the existence of surrogates were not significantly associated with patients’ preferences for having their family and physicians make resuscitation decisions for them. Age was not a significant factor for predicting the decision-making role after controlling for other variables. (shrink)

Patients rely on, benefit from, and are strongly influenced by physicians’ recommendations. In spite of the centrality and importance of physicians’ recommendations to clinical care, there is only a scant literature describing the conceptual process of forming a clinical recommendation, and no discrete professional standards for making individual clinical recommendations. Evidence-based medicine and shared decision making together are intended to improve medical decision making, but there has been limited attention to how a recommendation is discretely formulated from either of those (...) processes or how patients’ preferences ought to be considered and how much weight they should hold. Moreover, physicians’ bias has been reported to strongly influence how a recommendation is derived, thereby undermining the quality of healthcare decisions and patients’ trust. To demonstrate a potential for improving the quality of decisions, this article proposes a conceptual framework for how physicians should reach a clinical recommendation and apply the process in practice. For preference-sensitive clinical decisions—that is, clinical decisions when patients’ values and preferences are relevant—the process for reaching a recommendation should be transparent to patients and should be based solely on the medical evidence and patients’ values and preferences. When patients’ preferences for care do not prioritize health, physicians decide whether their recommendation will prioritize a welfare-enhancing versus an autonomy-enhancing approach. When there are gaps in understanding how physicians derive their clinical recommendations and how to further improve the quality of the decisions, the author calls for further empiric research. (shrink)

The aim of this study was to examine physicians' and nurses' preferences regarding the use of life-sustaining treatments for severely ill elderly patients, and the patient- and social-centered factors that influence them. Physicians and nurses working in Israeli general hospitals completed structured questionnaires referring to their preferences for using LST in three severe health conditions. The participants were also asked about factors influencing these preferences, including patients' wishes, quality of life, religiosity and the current law. Both physicians and (...) nurses indicated that they would use less LST for patients with metastatic cancer than with those suffering from the other two health conditions. Our findings indicate that the attitudes of professionals involved in these processes are influenced not only by the patient's condition but also by their professional orientations and personal values. Open communication among professionals for clarifying the various beliefs, as well as the antecedents of these beliefs, is important for the benefit of professional teams, patients and families. (shrink)

Background Decisions regarding Cardio-Pulmonary Resuscitation (CPR) and Do Not Attempt Resuscitation (DNAR) orders remain demanding, as does including patients in the process. Objectives To explore physicians’ justification for CPR/DNAR orders and decisions regarding patient inclusion, as well as their reports of how they initiated discussions with patients. Methods We administered a face-to-face survey to residents in charge of 206 patients including DNAR and CPR orders, with or without patient inclusion. Results Justifications were provided for 59% of DNAR orders (...) and included severe comorbidity, patients and families’ resuscitation preferences, patients’ age, or poor prognosis or quality of life. Reasons to include patients in CPR/DNAR decisions were provided in 96% and 84% of cases, and were based on respect for autonomy, clinical assessment of the situation as not too severe, and the view that such inclusion was required. Reasons for not including patients were offered in 84% of cases for CPR and in 70% for DNAR. They included absent decision-making capacity, a clinical situation viewed as good (CPR) or offering little hope of recovery (DNAR), barriers to communication, or concern that discussions could be emotionally difficult or superfluous. Decisions made earlier in the patient's management were infrequently viewed as requiring revision. Residents reported a variety of introductions to discussions with patients. Conclusions These results provide better understanding of reasons for CPR/DNAR decisions, reasons for patient inclusion or lack thereof, and ways in which such inclusion is initiated. They also point to potential side-effects of implementing CPR/DNAR recommendations without in-depth and practical training. This should be part of a regular audit and follow-up process for such recommendations. (shrink)

Parental refusal of a recommended treatment is not an uncommon scenario in the neonatal intensive care unit. These refusals may be based upon the parents’ perceptions of their child’s projected quality of life. The inherent subjectivity of quality of life assessments, however, can exacerbate disagreement between parents and healthcare providers. We present a case of parental refusal of surgical intervention for necrotizing enterocolitis in an infant with Bartter syndrome and develop an ethical framework in which to consider the (...) appropriateness of parental refusal based upon an infant’s projected quality of life. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Lisa’s StoryLisa P. (wife of patient) and Jeanne KerwinMy husband suffered from sudden onset of heart failure with a very low ejection fraction and was on IV Milrinone at the age of 47. One of the most powerful things he told me was that he was not afraid to die and therefore did not want to move forward with Milrinone. He eventually “did it for the kids.” After (...) the Milrinone drip was no longer working, he was offered an LVAD (left ventricular assist device) to keep him alive. He refused, but the doctor again convinced him to “do it for your kids” and said, “we put these devices in 80-year-olds.” He did not have time to explore any other options and reluctantly accepted the LVAD. It was implanted in May of 2014 in a very long and complicated surgery with a long and difficult recovery. He was in the hospital for a long time, and then he refused to go to rehab upon discharge, making it difficult for our family to manage, as he was extremely weak and needed care of his wound dressing. He worried about the financial [End Page 7] impact of a heart transplant and the medications required, as we were already struggling with the medical bills. He refused to have more surgery with the potential complications and never agreed to get on the transplant waiting list.After the implanted LVAD, my husband was not able to do most of what he loved in life. He couldn’t work (he was a truck driver), he couldn’t go fishing or swimming in the ocean, he couldn’t go hunting and fishing, and his overall physical condition was so poor that he couldn’t cook, garden and, most aggravating to him, he could not take a regular hot shower. The LVAD had to be covered with plastic in order to avoid getting the drive-line area wet, so bathing was a complicated process. He had trouble with stairs, had neuropathic pain in his legs from diabetes, and because of the pain medications, he felt cloudy and dizzy and slept most of the day in his recliner. I took care of him, even after I had to go back to work, and at the same time, I managed our two children (ages 9 and 12 at the time of LVAD).After almost two years of living with the LVAD, multiple hospitalizations for GI bleeds then seizures, more medications, and weekly blood draws for INR1, my husband requested that the LVAD be de-activated and that he be allowed to die of his heart failure. He described his life as “miserable.” He watched as his misery impacted his children and me. He suffered daily and had none of the joys that made life worth living for him. When we approached the cardiac team that implanted and monitored his LVAD with his request, they said “no.” They would not de-activate the LVAD because it was working. It was keeping him alive and he had no other terminal illness. His palliative doctor, who was treating his pain, also heard his request and told us to call for an “ethics consult” to determine if he would be “allowed” to have the LVAD de-activated. We got the number and called on March 31, 2016.At the time of the call to Ethics, we had no idea what “Ethics” was, other than a general definition of the word ethics as in professional behaviors and such. We did not know what to expect but we called. We would never have known to call “Ethics” if the palliative doctor had not advised us to do so, and my husband might have suffered a longer, more painful life both mentally and physically prolonged by the LVAD.We explained the request to the ethics consultant. She listened to my husband describe his daily living and his dissatisfaction with the quality of his life, his physical and emotional suffering, and his wish to rid himself of the LVAD and allow nature to take its course. There was actually no decision to be made on his part. He had already made up... (shrink)

Kamm's approach to patient selection qualifies the notion that fairness makes need for scarce, transplantable organs inversely proportional to age. She defines need as how much adequate conscious life a person will have had before death. Length of adequate conscious life correlates highly with age. If so, then younger persons are usually needier than older ones. Since Kamm allows for past periods of non‐adequate conscious life, I argue that this correlation may be neither as close, nor as easy to (...) apply, as she wants it to be. Fairness should require assessment of experiential content in determining how long one's life has been adequately conscious. I argue that such assessments involve some of the goods of experience and quality of life judgements that Kamm thinks a reliance on adequate conscious life will avoid. (shrink)

Background Following passage of the Patient Self Determination Act in 1990, health care institutions that receive Medicare and Medicaid funding are required to inform patients of their right to make their health care preferences known through execution of a living will and/or to appoint a surrogate-decision maker. We evaluated the impact of external factors and perceived patient preferences on physicians’ decisions to honor or forgo previously established advance directives (ADs). In addition, physician views regarding legal risk, patients’ (...) ability to comprehend complexities involved with their care, and impact of medical costs related to end-of-life care decisions were explored. Methods Attendees of two Mayo Clinic continuing medical education courses were surveyed. Three scenarios based in part on previously court-litigated matters assessed impact of external factors and perceived patient preferences on physician compliance with patient-articulated wishes regarding resuscitation. General questions measured respondents’ perception of legal risk, concerns over patient knowledge of idiosyncrasies involved with their care, and impact medical costs may have on compliance with patient preferences. Responses indicating strength of agreement or disagreement with statements were treated as ordinal data and analyzed using the Cochran Armitage trend test. Results Three hundred eighty-eight of 951 surveys were completed (41% response rate). Eighty percent reported they were likely to honor a patient’s AD despite its 5 year age. Fewer than half (41%) would honor the AD of a patient in ventricular fibrillation who had expressed a desire to “pass away in peace.” Few (17%) would forgo an AD following a family’s request for continued resuscitative treatment. A majority (52%) considered risk of liability to be lower when maintaining someone alive against their wishes than mistakenly failing to provide resuscitative efforts. A large percentage (74%) disagreed that patients could not appreciate complexities surrounding their care while 69% agreed that costs should never impact a physician’s decision as to whether to comply with a patient’s AD. Conclusions Our findings highlight the impact, albeit small, external factors have on physician AD compliance. Most respondents based their decision on the clinical situation at hand and interpretation of the patient’s initial wishes and preferences expressed by the AD. (shrink)

Background: In the USA, the Food and Drug Administration waiver of informed consent permits certain emergency research only if community consultation occurs. However, uncertainty exists regarding how to define the community or their representatives.Objective: To collect data on the actual preferences and values of a group—those at risk for stroke—most directly affected by the waiver of informed consent for emergency research.Design: Face to face focused interviews were conducted with 12 patients who were hospitalised with a stroke diagnosis in the previous (...) year. The interviews were audiotaped and a transcript based method was used for their analysis.Results: All 12 participants felt “that it was important that new treatments for stroke be developed”, but they were initially confused about the distinction between “research for stroke” and “emergency research for stroke”. However, after explanation, most expressed willingness to participate in the latter. In the absence of a surrogate to give informed consent in a stroke emergency situation, the majority said they would want the physician to “go ahead and enrol them in the trial”.Conclusions: This study is the first to identify the values and concerns of individuals most directly affected by stroke emergency research. Further interviews and focus groups are needed to develop and test a validated questionnaire on the preferences and values surrounding emergency research for stroke. (shrink)

BackgroundSocial support plays an important role for health outcomes. Support for those living with chronic conditions may be particularly important for their health, and even for their survival. The role of support for the survival of cancer patients after receiving an allogeneic hematopoietic cell transplant is understudied. To better understand the link between survival and support, as well as different sources and functions of support, we conducted two studies in alloHCT patients. First, we examined whether social support is (...) related to survival. Second, we examined who provides which support and which specific support-related functions and tasks are fulfilled by lay caregivers and healthcare professionals.MethodsIn Study 1, we conducted a retrospective chart review of alloHCT patients and registered availability of a dedicated lay caregiver and survival. In Study 2, we prospectively followed patients after alloHCT from the same hospital, partly overlapping from Study 1, who shared their experiences of support from lay caregivers and healthcare providers in semi-structured in-depth interviews 3 to 6 months after their first hospital discharge.ResultsPatients with a dedicated caregiver had a higher probability of surviving to 100 days than patients without a caregiver, OR = 2.84, p = 0.042. Study 2 demonstrated the importance of post-transplant support due to patients’ emotional needs and complex self-care regimen. The role of lay caregivers extended to many areas of patients’ daily lives, including support for attending doctor’s appointments, managing medications and financial tasks, physical distancing, and maintaining strict dietary requirements. Healthcare providers mainly fulfilled medical needs and provided informational support, while lay caregivers were the main source of emotional and practical support.ConclusionThe findings highlight the importance of studying support from lay caregivers as well as healthcare providers, to better understand how they work together to support patients’ adherence to recommended self-care and survival. (shrink)

Although in certain contexts judged to be over-rated,1 consistency is generally held to be a virtue in arguments about medical ethics. In everyday life, to be told that you are acting hypocritically, in a manner that is inconsistent with values you profess, is at least embarrassing, and depending on the circumstances can have more serious consequences, not least for politicians. How far complete consistency in thought and action is humanly possible or even desirable is a more doubtful however. In terms (...) of inconsistency over time, certainly, the maxim ‘When the facts change, I change my mind’ can be a reasonable defence: but in order to avoid less defensible forms of inconsistency, changing your mind about one thing may require changing it about others also. To take seriously just such a possibility is the ethical challenge of this month’s feature article: ‘Moral Uncertainty and the Farming of Human-Pig Chimeras’ by Julian Koplin and Dominic Wilkinson (see page 440).2 In this case, the facts that have or could soon have changed surround the emerging possibility of generating, within human-pig chimeras, human organs for transplantation into patients who need them and (although as yet the theoretical possibility) of avoiding the need for immunosuppression by generating the organs using stem cells from the patients themselves. The potential benefits of this possible answer to the worldwide shortage of transplantable organs clearly are immense. But, Koplin and Wilkinson point out, there are also serious potential harms. If human-pig chimeras with ‘partly humanised brains’ were to ‘develop morally relevant cognitive capacities’, such as dawning self-awareness, their moral status would make farming and killing them ‘a serious moral wrong’. Yet having said that, the real difficulty is that we cannot be certain, philosophically, ‘precisely what capacities confer what …. (shrink)

We examined if cancer patients' health-related quality of life (HRQoL) scores on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 are affected by the specific time point, before or during treatment, at which the questionnaire is completed, and whether this could bias the overall treatment comparison analyses. A 'completion-time window' variable was created on three closed EORTC randomised control trials in lung (non-small cell lung cancer, NSCLC) and colorectal cancer (CRC) to indicate when the (...) QLQ-30 was completed relative to chemotherapy cycle dates, defined as 'before', 'on' and 'after'. HRQoL mean scores were calculated using a linear mixed model. Statistically significant differences (P < 0.05) were observed on 6 and 5 scales for 'on' and 'after' comparisons in the NSCLC and two-group CRC trial, respectively. As for the three-group CRC trial, several statistical differences were observed in the 'before' to 'on' and the 'on' to 'after' comparisons. For all three trials, including the 'completion-time window' variable in the model resulted in a better fit, but no substantial changes in the treatment effects were noted. We showed that considering the exact timing of completion within specified windows resulted in statistical and potentially clinically significant differences, but it did not alter the conclusions of treatment comparison in these studies. (shrink)

Hematopoietic stem cell transplantation is a widely accepted practice in the United Kingdom (UK). The relatively liberal UK law permits donation both within families and from strangers, and even allows the creation of “saviour siblings” who are brought into being with the specific intent of having them donate stem cells to save other members of their family. This chapter describes the regulation of HSCT in the UK and highlights some ethical issues related to discrimination against some categories of (...) potential donors, the accuracy of the information provided to potential donors, and the controversy concerning saviour siblings. (shrink)

In recent years much research has been undertaken regarding the feasibility of the human uterine transplant as a treatment for absolute uterine factor infertility. Should it reach clinical application this procedure would allow such individuals what is often a much-desired opportunity to become not only social mothers, or genetic and social mothers but mothers in a social, genetic and gestational sense. Like many experimental transplantation procedures such as face, hand, corneal and larynx transplants, UTx as a therapeutic option falls firmly (...) into the camp of the quality of life transplant, undertaken with the aim, not to save a life, but to enrich one. However, unlike most of these novel procedures – where one would be unlikely to find a willing living donor or an ethics committee that would sanction such a donation – the organs to be transplanted in UTx are potentially available from both living and deceased donors. In this article, in the light of the recent nine-case research trial in Sweden which used uteri obtained from living donors, and the assertions on the part of a number of other research teams currently preparing trials that they will only be using deceased donors, I explore the question of whether, in the case of UTx, there exist compelling moral reasons to prefer the use of deceased donors despite the benefits that may be associated with the use of organs obtained from the living. (shrink)

Purpose: Explore public attitudes towards the trade-offs between justice and medical outcome inherent in organ allocation decisions.Background: The US Task Force on Organ Transplantation recommended that considerations of justice, autonomy and medical outcome be part of all organ allocation decisions. Justice in this context may be modeled as a function of three types of need, related to age, clinical urgency, and quality of life.Methods: A web-based survey was conducted in which respondents were asked to choose between two hypothetical patients (...) who differed in clinical urgency , age, pretransplant and post-transplant quality of life, and life expectancy.Results: A pool of 1600 people were notified via email about the survey; 623 responded. Respondents preferred giving organs to younger people up to an age difference of <15.4 years and more clinically urgent people up to a difference in urgency of <2.54 months . Priority varied with the quality of life of the worst-off patient and the relative status of the patients. If both had worse than average quality of life, respondents preferred the better-off patient. When both had better than average quality of life, they preferred the worse-off patient. In analysis according to age versus clinical urgency, the older the patient, the more urgency needed to receive priority. In quality of life versus clinical urgency, the better the control’s quality of life, the more urgency the competing patient required. The worse the patient’s post-transplant outcome, the more urgency needed to receive priority.Conclusions: It appears that clinical urgency is only one of many factors influencing attitudes about allocation decisions and that respondents may invoke different principles of fairness depending the relative clinical status of patients. (shrink)

The behavior of somatic stem cells is regulated by their niche. Interaction between hematopoietic stem cells (HSCs) and their niches are a representative model to understand stem cell‐niche interplay. Here, we provide an overview of crosstalk between HSCs and their niches in bone marrow and extramedullary organs following the life journey of HSCs from emergence, development, maturation until aging. We highlight the unique differences of HSC niches in different life stages within various organs focusing on recent literature to (...) propose new speculations and hypotheses. (shrink)

This article proposes a retrospective analysis of a compassionate use, using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program issue. The secondary goals are: a) (...) to promote a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP. The instruments for carrying out the analysis of the case study and the discussion are as follows: Analysis of the audio-recording of the EC meeting regarding the selected Case study. In-depth discussion of topics that emerged during the meeting by means of administration of 5 semi-structured interviews with 2 doctors involved in the case and with 3 components of the EC who played a major role in the EC internal discussion. In an exploration of emerging clinical and ethical issues, four primary themes arise: 1. efficacy, safety of the treatment and patient’s quality of life; 2. clear, realistic, adequate communication; 3. right to hope; 4. simultaneous Palliative Care approach. The results of ethical analysis carried out concern two areas: 1) ethical profiles relating to the use of CUP; 2) the role of the EC concerning the compassionate use of drugs and the need to provide recommendations on how to request CUP. With the aim of implementing these conclusions, the provincial EC of Reggio Emilia chose to steer the request for drugs for compassionate use through recommendations for good clinical and ethical practice based on the following assumptions: 1) the “simultaneous care” approach must be preferred. Secondly, 2) the EC’s assessment must be part of the decision-making process that the care team conducts before proposing compassionate use to the patient. (shrink)

BackgroundPrognostic uncertainty is a challenge for physicians in the neuro intensive care field. Questions about whether continued life-sustaining treatment is in a patient’s best interests arise in different phases after a severe traumatic brain injury. In-depth information about how physicians deal with ethical issues in different contexts is lacking. The purpose of this study was to seek insight into clinicians’ strategies concerning unresolved prognostic uncertainty and their ethical reasoning on the issue of limitation of life-sustaining treatment in patients with (...) minimal or no signs of neurological improvement after severe traumatic brain injury in the later trauma hospital phase.MethodsInterviews with 18 physicians working in a neurointensive care unit in a large Norwegian trauma hospital, followed by a qualitative thematic analysis focused on physicians’ strategies related to treatment-limiting decision-making.ResultsA divide between proactive and wait-and-see strategies emerged. Notwithstanding the hospital’s strong team culture, inter-physician variability with regard to ethical reasoning and preferred strategies was exposed. All the physicians emphasized the importance of team—family interactions. Nevertheless, their strategies differed: (1) The proactive physicians were open to consider limitations of life-sustaining treatment when the prognosis was grim. They initiated ethical discussions, took leadership in clarification and deliberation processes regarding goals and options, saw themselves as guides for the families and believed in the necessity to prepare families for both best-case and worst-case scenarios. (2) The “wait-and-see” physicians preferred open-ended treatment (no limitations). Neurologically injured patients need time to uncover their true recovery potential, they argued. They often avoided talking to the family about dying or other worst-case scenarios during this phase.ConclusionsDepending on the individual physician in charge, ethical issues may rest unresolved or not addressed in the later trauma hospital phase. Nevertheless, team collaboration serves to mitigate inter-physician variability. There are problems and pitfalls to be aware of related to both proactive and wait-and-see approaches. The timing of best-interest discussions and treatment-limiting decisions remain challenging after severe traumatic brain injury. Routines for timely and open discussions with families about the range of ethically reasonable options need to be strengthened. (shrink)

Background Genuine uncertainty on superiority of one intervention over the other is called equipoise. Physician-investigators in randomized controlled trials need equipoise at least in studies with more than minimal risks. Ideally, this equipoise is also present in patient-participants. In pediatrics, data on equipoise are lacking. We hypothesize that 1) lack of equipoise at enrolment among parents may reduce recruitment; 2) lack of equipoise during participation may reduce retention in patients assigned to a less favoured treatment-strategy. Methods We compared (...) preferences of parents/patients at enrolment, documented by a questionnaire, with preferences developed during follow-up by an interview-study to investigate equipoise of child-participants and parents in the BeSt-for-Kids-study. This trial in new-onset Juvenile Idiopathic Arthritis-patients consists of three strategies. One strategy comprises initial treatment with a biological disease-modifying-antirheumatic-drug, currently not standard-of-care. Semi-structured interviews were conducted with 23 parents and 7 patients, median 11 months after enrolment. Results Initially most parents and children were not in equipoise. Parents/patients who refused participation, regularly declined due to specific preferences. Many participating families preferred the biological-first-strategy. They participated to have a chance for this initial treatment, and would even consider stopping trial-participation when not randomized for it. Their conviction of superiority of the biological-first strategy was based on knowledge from internet and close relations. According to four parents, the physician-investigator preferred the biological-first-strategy, but the majority stated that she had no preferred strategy. In phase 2, preferences tended to change to the treatment actually received. Conclusions Lack of equipoise during enrolment did not reduce study recruitment, mainly due to the fact that preferred treatment was only available within the study. Still, when developing a trial it is important to evaluate whether the physicians’ research question is in line with preferences of the patient-group. By exploring so-called ‘informed patient-group’-equipoise, successful recruitment may be enhanced and bias avoided. In our study, lack of equipoise during trial-participation did not reduce retention in those assigned to a less favoured option. We observed a change for preference towards treatment actually received, possibly explained by comparable outcomes in all three arms. (shrink)

Fanconi anemia (FA) is generally classified as a DNA repair disorder, conferring a genetic predisposition to cancer and prominent bone marrow failure (BMF) in early childhood. Corroborative human and murine studies point to a fetal origin of hematopoietic stem cell (HSC) attrition under replicative stress. Along with intriguing recent insights into non‐canonical roles and domain‐specific functions of FA proteins, these studies have raised the possibility of a DNA repair‐independent BMF etiology. However, deeper mechanistic insight is critical as current (...) curative options of allogeneic stem cell transplantation and emerging gene therapy have limited eligibility, carry significant side effects, and involve complex procedures restricted to resource‐rich environments. To develop rational and broadly accessible therapies for FA patients, the field will need more faithful disease models that overcome the scarcity of patient samples, leverage technological advances, and adopt investigational clinical trial designs tailored for rare diseases. (shrink)

Acceptance of elderly or marginal health individuals as kidney donors is debated, with practices varying between centres. Transplant recipients, live kidney donors and health-care professionals caring for patients with renal failure were surveyed regarding their views on live donor kidney transplantation (LDKT) of marginal health (diabetes, hypertension, atherosclerosis, obesity, etc.) and elderly donors. Participants were recruited within a tertiary renal and transplant centre and invited to participate in focus groups and structured interviews. They also completed an anonymous questionnaire. Of 464 (...) participants who completed the questionnaire (36% health-care professionals and 64% patients), 49% and 64%, respectively, stated that marginal and elderly donors should be accepted for LDKT. In the structured interviews, emphasis was given to presenting to donor, recipient and their respective families a calculated risk regarding the effect that either a nephrectomy or transplant has on long-term quality of life. Participants stated that an independent third party in addition to the transplant team should discuss involved risks. Issues of ‘how desperate’ the recipient's situation is should also be considered. Health-care professionals stated that regardless of the strength of will of an individual to donate a kidney (despite age, health problems or personal risk), they should always have the right to say ‘no’ if performing a specific LDKT was against their professional and ethical values. About half of those surveyed considered that marginal health and elderly donors were acceptable for LDKT. Emphasis was given to the explanation to donors and recipients of the risks involved in such transplantation. (shrink)

Living donor kidney transplantation has increased significantly in the past 10 years. Currently it accounts for 41% of all kidney transplants in the USA.1 While the percentage is lower in the United Kingdom and other European countries, the number of living compared with cadaveric kidney donors will probably continue to increase globally. Mortality associated with surgery on live donors is low, thanks largely to the success of laparoscopic nephrectomy. Kidney transplantation from a living donor is preferable to that from a (...) cadaveric, or deceased, donor because of its superior graft and patient survival outcomes. It also preempts the need for or reduces the duration of dialysis for individuals with end-stage renal disease and therefore greatly improves their quality of life.Some who donate kidneys to anonymous recipients are motivated by altruism, with no direct benefit and only an indirect psychological benefit as a consequence of donating. Those who donate may be motivated by prudential reasons involving shared interests, or by a sense of obligation grounded in emotional relations. This includes donations between spouses, siblings, parents and children and may also include donations between intimate friends. Others may be motivated to donate by the prospect of financial gain. In a recent article on kidney markets, The Economist claimed that those who donate one of their healthy kidneys do so at “very little risk to their health”.2 Presumably, this provides support for these markets. In 2004, Zell Kravinsky, an American in his early 40s, gave away one of his healthy kidneys to a stranger as part of a utilitarian obligation to help other people and maximise the good by saving or improving the quality of their lives.3 He estimated that this entailed a statistically insignificant risk to his health. In a lecture to an ethics class at …. (shrink)

As patient autonomy expands, a highly controversial issue has emerged. Should the advance directives of refusing life-saving treatments or requesting euthanasia of persons with dementia who express changed minds or are often in a happy state be fulfilled? There are two autonomy-related positions. The mainstream position in philosophical discussions supports the priority of ADs based on precedent autonomy. Buchanan and Brock, and Dworkin represent this view. The other position supports the priority of PWDs’ current wishes based on minimal autonomy (...) represented by Jaworska. By rethinking the theoretical and practical challenges of the two positions and their arguments respectively, the paper concludes that in such a scenario, the priority of ADs is morally indefensible, and it is also challenging to establish minimal autonomy defend the moral priority of PWDs’ current wishes. For PWDs whose past values, beliefs, and preferences fade away but who retain apparent intrinsic sentience of well-being, a modified defined quality-of-life approach serves as another reasonable basis in their medical decision-making, and the ADs and the QoL should be further merged to reduce the uncertainty of the grey zone. (shrink)

The COVID-19 pandemic put a large burden on many healthcare systems, causing fears about resource scarcity and triage. Several COVID-19 guidelines included age as an explicit factor and practices of both triage and ‘anticipatory triage’ likely limited access to hospital care for elderly patients, especially those in care homes. To ensure the legitimacy of triage guidelines, which affect the public, it is important to engage the public’s moral intuitions. Our study aimed to explore general public views in the UK on (...) the role of age, and related factors like frailty and quality of life, in triage during the COVID-19 pandemic. We held online deliberative workshops with members of the general public. Participants were guided through a deliberative process to maximise eliciting informed and considered preferences. Participants generally accepted the need for triage but strongly rejected ‘fair innings’ and ‘life projects’ principles as justifications for age-based allocation. They were also wary of the ‘maximise life-years’ principle, preferring to maximise the number of lives rather than life years saved. Although they did not arrive at a unified recommendation of one principle, a concern for three core principles and values eventually emerged: equality, efficiency and vulnerability. While these remain difficult to fully respect at once, they captured a considered, multifaceted consensus: utilitarian considerations of efficiency should be tempered with a concern for equality and vulnerability. This ‘triad’ of ethical principles may be a useful structure to guide ethical deliberation as societies negotiate the conflicting ethical demands of triage. (shrink)

We live in an age of “high tech” medicine which affects both health care recipients and physicians who are taught its many wonders and uses. It is easy in this atmosphere of specialization for clinicians, professors and medical students to become isolated and to ignore social issues which affect health care in its broadest sense.Individuals who are committed to the “common good” are the ones historically who have been effective change agents. It would be tragic simply to stand back and (...) allow the cynical and greedy to dominate any profession which deals with the poor, the uninsured and the homeless.It is imperative for physicians to take a broad view of today's problems in health care delivery systems, for they can have an enormous impact on the kind of world our children will inherit. It is essential for physicians to become involved in social concerns, and in improving health care delivery, at all levels in their practice.Given their power and prestige, it is crucial for physicians and aspiring physicians to have positive role models. Dr. Julius B. Richmond provides an admirable example of a physician who cares about his profession, his patients and his nation. Through his research, his public service and his teaching, Dr. Richmond has demonstrated the difference a single individual can make in improving the quality of life for all Americans. (shrink)

Advance health care directives and informed consent remain the cornerstones of patients' right to self-determination regarding medical care and preferences at the end-of-life. However, the effectiveness and clinical applicability of advance health care directives to decision-making on the use of life support systems at the end-of-life is questionable. The Uniform Anatomical Gift Act (UAGA) has been revised in 2006 to permit the use of life support systems at or near death for the purpose of maximizing procurement opportunities of organs medically (...) suitable for transplantation. Some states have enacted the Revised UAGA (2006) and a few of those have included amendments while attempting to preserve the uniformity of the revised Act. Other states have introduced the Revised UAGA (2006) for legislation and remaining states are likely to follow soon. (shrink)

Robust clinical decision-making depends on valid reasoning and sound judgment and is essential for delivering quality healthcare. It is often susceptible, however, to a clinician’s biases such as towards a patient’s age, gender, race, or socioeconomic status. Gender bias in particular has a deleterious impact, which frequently results in cognitive myopia so that a clinician is unable to make an accurate diagnosis because of a patient’s gender—especially for female patients. Virtue epistemology provides a means for confronting (...) gender bias in clinical decision-making and for correcting or even preventing its impact. The medical literature on cardiovascular and coronary heart disease is used to illustrate the role intellectual virtues can play in redressing the deleterious impact of gender bias on clinical decision-making and practice. Finally, questions are considered surrounding the pedagogy of intellectual virtues for medical students and practicing clinicians in order to provide quality care for patients, regardless of gender. (shrink)

With the recent advent of facial transplant (FT) treatment, patients who live with facial disfigurement have a new hope of improved facial aesthetics and quality of life. However, FT has been the subject of intense ethical debate, and there are numerous important ethical considerations surrounding FT that require further in-depth exploration. In the present review, the numerous ethical issues surrounding FT are elucidated, especially the weighty psychosocial impacts of FT, issues surrounding patients’ consent, selection and donor matching, and current (...) challenges with postoperative complication management and the facial reconstruction of donors. These are discussed with a key focus on stakeholders’ perspectives including recipients, donors’ families, and the medical teams involved. This review found that a number of key ethical questions remain unanswered in the field of FT, and further consideration is needed for this novel surgical procedure to have the same evidence-based ethical backing as conventional surgical procedures. (shrink)

Implicit biases involve associations outside conscious awareness that lead to a negative evaluation of a person on the basis of irrelevant characteristics such as race or gender. This review examines the evidence that healthcare professionals display implicit biases towards patients. PubMed, PsychINFO, PsychARTICLE and CINAHL were searched for peer-reviewed articles published between 1st March 2003 and 31st March 2013. Two reviewers assessed the eligibility of the identified papers based on precise content and quality criteria. The references of eligible papers (...) were examined to identify further eligible studies. Forty two articles were identified as eligible. Seventeen used an implicit measure, to test the biases of healthcare professionals. Twenty five articles employed a between-subjects design, using vignettes to examine the influence of patient characteristics on healthcare professionals’ attitudes, diagnoses, and treatment decisions. The second method was included although it does not isolate implicit attitudes because it is recognised by psychologists who specialise in implicit cognition as a way of detecting the possible presence of implicit bias. Twenty seven studies examined racial/ethnic biases; ten other biases were investigated, including gender, age and weight. Thirty five articles found evidence of implicit bias in healthcare professionals; all the studies that investigated correlations found a significant positive relationship between level of implicit bias and lower quality of care. The evidence indicates that healthcare professionals exhibit the same levels of implicit bias as the wider population. The interactions between multiple patient characteristics and between healthcare professional and patient characteristics reveal the complexity of the phenomenon of implicit bias and its influence on clinician-patient interaction. The most convincing studies from our review are those that combine the IAT and a method measuring the quality of treatment in the actual world. Correlational evidence indicates that biases are likely to influence diagnosis and treatment decisions and levels of care in some circumstances and need to be further investigated. Our review also indicates that there may sometimes be a gap between the norm of impartiality and the extent to which it is embraced by healthcare professionals for some of the tested characteristics. Our findings highlight the need for the healthcare profession to address the role of implicit biases in disparities in healthcare. More research in actual care settings and a greater homogeneity in methods employed to test implicit biases in healthcare is needed. (shrink)

How should modern medicine's dramatic new powers to sustain life be employed? How should limited resources be used to extend and improve the quality of life? In this collection, Dan Brock, a distinguished philosopher and bioethicist and co-author of Deciding for Others (Cambridge, 1989), explores the moral issues raised by new ideals of shared decision making between physicians and patients. The book develops an ethical framework for decisions about life-sustaining treatment and euthanasia, and examines how these life and death (...) decisions are transformed in health policy when the focus shifts from what is best for a patient to what is just for all patients. Professor Brock combines acute philosophical analysis with a deep understanding of the realities of clinical health policy. This is a volume for philosophers concerned with medical ethics, health policy professionals, physicians interested in bioethics, and undergraduate courses in biomedical ethics. (shrink)

As innovations in the field of vascular composite allotransplantation (VCA) progress, whole-eye transplantation (WET) is poised to transition from non-human mammalian models to living human recipients. Present treatment options for vision loss are generally considered suboptimal, and attendant concerns ranging from aesthetics and prosthesis maintenance to social stigma may be mitigated by WET. Potential benefits to WET recipients may also include partial vision restoration, psychosocial benefits related to identity and social integration, improvements in physical comfort and function, and reduced surgical (...) risk associated with a biologic eye compared to a prosthesis. Perioperative and postoperative risks of WET are expected to be comparable to those of facial transplantation (FT), and may be similarly mitigated by immunosuppressive protocols, adequate psychosocial support, and a thorough selection process for both the recipient and donor. To minimize the risks associated with immunosuppressive medications, the first attempts in human recipients will likely be performed in conjunction with a FT. If first-in-human attempts at combined FT-WET prove successful and the biologic eye survives, this opens the door for further advancement in the field of vision restoration by means of a viable surgical option. This analysis integrates recent innovations in WET research with the existing discourse on the ethics of surgical innovation and offers preliminary guidance to VCA programs considering undertaking WET in human recipients. (shrink)

Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ transplants, it requires greater (...) justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved—the patient, the donor and the potential child—as well as discuss the regulatory implications as research on uterus transplantations moves forward. (shrink)

In 1968, the Harvard criteria equated irreversible coma and apnea with human death and later, the Uniform Determination of Death Act was enacted permitting organ procurement from heart-beating donors. Since then, clinical studies have defined a spectrum of states of impaired consciousness in human beings: coma, akinetic mutism, minimally conscious state, vegetative state and brain death. In this article, we argue against the validity of the Harvard criteria for equating brain death with human death. Brain death does not disrupt somatic (...) integrative unity and coordinated biological functioning of a living organism. Neurological criteria of human death fail to determine the precise moment of an organism’s death when death is established by circulatory criterion in other states of impaired consciousness for organ procurement with non-heart-beating donation protocols. The criterion of circulatory arrest 75 s to 5 min is too short for irreversible cessation of whole brain functions and respiration controlled by the brain stem. Brain -based criteria for determining death with a beating heart exclude relevant anthropologic, psychosocial, cultural, and religious aspects of death and dying in society. Clinical guidelines for determining brain death are not consistently validated by the presence of irreversible brain stem ischemic injury or necrosis on autopsy; therefore, they do not completely exclude reversible loss of integrated neurological functions in donors. The questionable reliability and varying compliance with these guidelines among institutions amplify the risk of determining reversible states of impaired consciousness as irreversible brain death. The scientific uncertainty of defining and determining states of impaired consciousness including brain death have been neither disclosed to the general public nor broadly debated by the medical community or by legal and religious scholars. Heart-beating or non-heart-beating organ procurement from patients with impaired consciousness is de facto a concealed practice of physician-assisted death, and therefore, violates both criminal law and the central tenet of medicine not to do harm to patients. Society must decide if physician-assisted death is permissible and desirable to resolve the conflict about procuring organs from patients with impaired consciousness within the context of the perceived need to enhance the supply of transplantable organs. (shrink)

When ethical decisions have to be taken in critical, complex medical situations, they often involve decisions that set the course for or against life-sustaining treatments. Therefore the decisions have far-reaching consequences for the patients, their relatives, and often for the clinical staff. Although the rich psychology literature provides evidence that reasoning may be affected by undesired influences that may undermine the quality of the decision outcome, not much attention has been given to this phenomenon in health care or ethics (...) consultation. In this paper, we aim to contribute to the sensitization of the problem of systematic reasoning biases by showing how exemplary individual and group biases can affect the quality of decision-making on an individual and group level. We are addressing clinical ethicists as well as clinicians who guide complex decision-making processes of ethical significance. Knowledge regarding exemplary group psychological biases (e.g. conformity bias), and individual biases (e.g. stereotypes), will be taken from the disciplines of social psychology and cognitive decision science and considered in the field of ethical decision-making. Finally we discuss the influence of intuitive versus analytical (systematical) reasoning on the validity of ethical decision-making. (shrink)

Stem cell science, using both embryonic and a variety of tissue-specific stem cells, is advancing rapidly and offers promise to improve medical care in the future. Yet, with the notable exception of hematopoietic stem cell transplantation, a long-established approach to treating certain cancers of the blood system, this promise is long term and most stem cell research focuses on basic scientific questions or the collection of pre-clinical data. Although some clinical trials are underway, most are focused (...) on safety, and novel effective therapy is likely a long way off. Despite the preliminary nature of most stem cell research, however, numerous clinics around the world offer stem cell “therapies” to patients today outside the context of a clinical trial. Although the number of patients who have received these stem cell-based interventions is unknown, anecdotal reports suggest a substantial population of patients is willing to try them, despite unresolved questions about their safety and efficacy. (shrink)

A quiet revolution is occurring in the field of transplantation. Traditionally, transplants have involved solid organs such as the kidney, heart and liver which are transplanted to prevent recipients from dying. Now transplants are being done of the face, hand, uterus, penis and larynx that aim at improving a recipient's quality of life. The shift away from saving lives to seeking to make them better requires a shift in the ethical thinking that has long formed the foundation of organ (...) transplantation. The addition of new forms of transplants requires doctors, patients, regulators and the public to rethink the risk and benefit ratio represented by trade-offs between saving life, extending life and risking the loss of life to achieve improvements in the quality of life. (shrink)