Non-therapeutic Interventions Research Articles

Preserving children's fertility: two tales about children's right to an open future and the margins of parental obligations.

The sources, extent and margins of parental obligations in taking decisions regarding their children's medical care are subjects of ongoing debates. Balancing children's immediate welfare with keeping their future open is a delicate task. In this paper, we briefly present two examples of situations in which parents may be confronted with the choice of whether to authorise or demand non-therapeutic interventions on their children for the purpose of fertility preservation. The first example is that of children facing cancer treatment, and the second of children with Klinefelter syndrome. We argue that, whereas decisions of whether to preserve fertility may be prima facie within the limits of parental discretion, the right to an open future does not straightforwardly put parents under an obligation to take actions that would detect or relieve future infertility in their children-and indeed in some cases taking such actions is problematic.

Value of Diagnostic and Therapeutic Laparoscopy for Abdominal Stab Wounds: Reply

The purpose of the present study was to evaluate the use of laparoscopy for the diagnosis and treatment for hemodynamically stable patients with abdominal stab wounds. We conducted a retrospective cohort study to compare the outcomes of 86 hemodynamically stable patients with suspected intra-abdominal injuries from abdominal stab wounds who underwent either exploratory laparotomy or diagnostic laparoscopy. Thirty-eight patients (group A) were treated before the adoption of laparoscopy as a diagnostic and therapeutic tool for abdominal stabbing injuries at our hospital, and 48 patients (group B) were treated after. Demographic information, injury severity, operative findings, rates of nontherapeutic interventions, operation time, length of hospital stay, and morbidity of the two groups were evaluated. There was no difference in the demographics and injury severity between the two groups. Laparoscopy decreased the nontherapeutic laparotomy rate from 57.9% in group A to 0% in group B (P < 0.001). The accuracy of diagnostic laparoscopy was 100% in group B. Patients in group B had a significantly shorter hospital stay (5.0 days versus 9.9 days; P < 0.001) and shorter operation time (90.7 min vs. 118.7 min; P = 0.019) than group A. For patients in group B with significant intra-abdominal injuries, therapeutic laparoscopy was successfully performed in 16 of 17 patients (94.1%), treating a total of 22 intra-abdominal injuries. Laparoscopy is feasible and safe for the diagnosis and treatment of hemodynamically stable patients with abdominal stab wounds. It can reduce the nontherapeutic laparotomy rate and shorten the length of hospital stay.

What should be the blood pressure target for patients with chronic kidney disease?

Persons with chronic kidney disease (CKD) exhibit a disproportionate burden of elevated blood pressure (BP) with a high prevalence of premature end-stage renal disease and cardiovascular events. Results of recent randomized controlled clinical trials suggest that most patients with reduced estimated glomerular filtration rate (eGFR) and hypertension experience optimal clinical outcomes when SBP is less than 140 mmHg and DBP is less than 90 mmHg. The benefit of additional lowering of SBP to less than 130 mmHg and DBP to less than 80 mmHg remains controversial, and appears to be of most benefit to the subset of CKD patients with proteinuria (>300 mg/day). The combination of a diuretic and an angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI) has demonstrated particular promise in patients with reduced eGFR and proteinuria. A practical approach in clinical practice for the treatment of elevated BP in persons with CKD is to achieve a BP less than 140/90 mmHg with a combination of diuretic and an ARB or ACEI. Consideration for a lower BP goal and other therapeutic and nontherapeutic interventions can be made based on the cause of CKD, presence of proteinuria, or other coexisting medical conditions.

From Therapy and Enhancement to Assistive Technologies: An Attempt to Clarify the Role of the Sports Physician

Sports physicians are continuously confronted with new biotechnological innovations. This applies not only to doping in sports, but to all kinds of so-called enhancement methods. One fundamental problem regarding the sports physician's self-image consists in a blurred distinction between therapeutic treatment and non-therapeutic performance enhancement. After a brief inventory of the sports physician's work environment I reject as insufficient the attempts to resolve the conflict of the sports physician by making it a classificatory problem. Followed by a critical assessment of some ideas from the US President's Council on Bioethics, the formulation of ethical codes and attempts regarding a moral topography, it is argued that the sports physician's conflict cannot be resolved by the distinction between therapy and enhancement. Instead, we also have to consider the possibility that the therapy-based paradigm of medicine cannot do justice to the challenges of the continuously increasing technical manipulability of the human body and even our cognitive functions as well. At the same time we should not adhere to transhumanist ideas, because non-therapeutic interventions require clear criteria. Based on assistive technologies an alternative framework can be sketched that allows for the integration of therapeutic and non-therapeutic purposes. After a thorough definition of standards and criteria, the role of the sports physician might be defined as that of an assistant for enhancement. Yet the process of defining such an alternative framework is a societal and political task that cannot be accomplished by the sports physicians themselves. Until these questions are answered sports physicians continue to find themselves in a structural dilemma that they partially can come to terms with through personal integrity.

Placebo or intervention? Is it all a sham?

Placebo or intervention? Is it all a sham?

755 Non-Therapeutic Interventional Research in Paediatric Trauma: What Do Parents Think?

Background: Emergency research in children in general is limited due to lack of robust informed consenting at such an emotional time for parents and families. These issues get even more magnified should such research involve non-therapeutic interventions particularly in the context of paediatric trauma. Aim: To survey the voluntary opinion of parents about consenting for non-therapeutic interventional research in paediatric trauma. Materials and Methods: We approached the parents of children seeking children's services at Barts and the London Children's Hospital, London to give voluntary opinion for retrospective consent for emergency blood tests studying early coagulation defects in children following trauma via a questionnaire. Results: 66 parents agreed to give voluntary opinion and answered the questionnaire. 63 (95%) parents were extremely supportive of the research project. Majority of the parents wondered why a research project to study these issues was not done yet. A few parents opined that they would support the research as long as essential emergency treatment is not compromised and consent is sought at the earliest suitable opportunity. Three (5%) parents were unable to support the delayed consent issues since they felt it is too emotional a time to consider research. Conclusions: Majority of the parents are willing for their children to take part in non-therapeutic interventional study despite the limitations of retrospective consenting in paediatric trauma.

Value of Diagnostic and Therapeutic Laparoscopy for Abdominal Stab Wounds

The purpose of the present study was to evaluate the use of laparoscopy for the diagnosis and treatment for hemodynamically stable patients with abdominal stab wounds. We conducted a retrospective cohort study to compare the outcomes of 86 hemodynamically stable patients with suspected intra-abdominal injuries from abdominal stab wounds who underwent either exploratory laparotomy or diagnostic laparoscopy. Thirty-eight patients (group A) were treated before the adoption of laparoscopy as a diagnostic and therapeutic tool for abdominal stabbing injuries at our hospital, and 48 patients (group B) were treated after. Demographic information, injury severity, operative findings, rates of nontherapeutic interventions, operation time, length of hospital stay, and morbidity of the two groups were evaluated. There was no difference in the demographics and injury severity between the two groups. Laparoscopy decreased the nontherapeutic laparotomy rate from 57.9% in group A to 0% in group B (P < 0.001). The accuracy of diagnostic laparoscopy was 100% in group B. Patients in group B had a significantly shorter hospital stay (5.0 days versus 9.9 days; P < 0.001) and shorter operation time (90.7 min vs. 118.7 min; P = 0.019) than group A. For patients in group B with significant intra-abdominal injuries, therapeutic laparoscopy was successfully performed in 16 of 17 patients (94.1%), treating a total of 22 intra-abdominal injuries. Laparoscopy is feasible and safe for the diagnosis and treatment of hemodynamically stable patients with abdominal stab wounds. It can reduce the nontherapeutic laparotomy rate and shorten the length of hospital stay.

Validation of a prediction rule to maximize curative (R0) resection of early-stage pancreatic adenocarcinoma

BackgroundThe surgeon's contribution to patients with localized pancreatic adenocarcinoma (PAC) is a margin negative (R0) resection. We hypothesized that a prediction rule based on pre-operative imaging would maximize the R0 resection rate while reducing non-therapeutic intervention. MethodsThe prediction rule was developed using computed tomography (CT) and endoscopic ultrasound (EUS) data from 65 patients with biopsy-proven PAC who underwent attempted resection. The rule classified patients as low or high risk for non-R0 outcome and was validated in 78 subsequent patients. ResultsModel variables were: any evidence of vascular involvement on CT; EUS stage and EUS size dichotomized at 2.6cm. In the validation cohort, 77% underwent resection and 58% achieved R0 status. If only patients in the low-risk group underwent surgery, the prediction rule would have increased the resection rate to 92% and the R0 rate to 73%. The R0 rate was 40% higher in low-risk compared with high-risk patients (P < 0.001). High risk was associated with a 67% rate of non-curative surgery (unresectable disease and metastases). ConclusionThe prediction rule identified patients most likely to benefit from resection for PAC using pre-operative CT and EUS findings. Model predictions would have increased the R0 rate and reduced non-therapeutic interventions.

Israeli lay persons’ views on priority‐setting criteria for Alzheimer’s disease

The aim of this study was to assess Israeli lay persons' preferences for setting priorities for the care of Alzheimer's disease (AD). As the knowledge about AD accumulates, and especially as more therapeutic and non-therapeutic interventions for its early diagnosis and treatment are developed, health-care costs associated with the disease rise dramatically. Therefore, setting priorities for funding these therapies, as well as other costs associated with AD is becoming an increasingly complex need. A convenience sample of 624 community-dwelling men and women participated in the study (mean age = 49, range = 20-90). Participants were asked how strongly they agreed or disagreed with 18 criteria that would be used to set priorities for the allocation of resources in the area of AD. High-weight criteria included being a life-threatening condition and the benefit of treatment. Average-weight criteria included the severity of the disease, treatment costs and equity of access. The age of the patient also was highly rated. All other patient-related criteria were rated as low. Value orientations and education were the main variables associated with participants' preferences. The lay public seems to endorse a multi-criteria decision process for the allocation of resources in the area of AD. Similar to other diseases--disease-related criteria were highly preferred. These preferences should be compared with those of other stakeholders such as clinicians and policy makers.

Genetic Manipulation and the Body of Christ

Efforts to distinguish therapeutic from non-therapeutic genetic interventions in the human body have floundered on the assumption that the body should be understood as a psycho-physical corpus. This article argues by contrast that the body of Christ, that is the church, should be seen as the hermeneutical key to interpreting the body, and therefore that features of the corporate life of the church can provide criteria for distinguishing acceptable from unacceptable forms of genetic intervention. Formation of the bodies of Christians in the church is contrasted with the formation of the body by the reflexive project of modern self-identity.

The Living life Program strategy for training of community health agents as social educators to give community attention in mental health

The Living Life Program which established in the state of Maranhão - Brazil 2001-2003, had three key areas: the excluded as clients, the training of the professionals involved as action strategy, and ethics which was orientated on the premise that every human being is born to be free, healthy, educated and happy as guidelines. Through the mental health training program, it was intended that the community health agents should gain the required knowledge to do three tasks: to identify suffering people mental problems, acknowledge this suffering in the patient's home and thirdly, to send the patient for specialist care in the region when necessary. This should be done to avoid non-therapeutic interventions, such as that often provided by the police. The comprehension that Program studies pertinent questions relating to mental health, is necessary to consider what human resources are required, so as to redirect the model for providing care, remembering that success can only be achieved in psychiatric care if at every point of care there is acceptance, treatment and social inclusion.

The Clinical Investigator as Fiduciary: Discarding a Misguided Idea

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior.

Cultural influences and diabetes health care

Cultural influences and diabetes health care

Ethics and eugenic enhancement

Suppose we accept prenatal diagnosis and the selective abortion of fetuses that test positive for severe genetic disorders to be both morally and socially acceptable. Should we consider prenatal diagnosis and selective abortion (or other genetic interventions such as preimplantation diagnosis, genetic therapy, cloning, etc.) for nontherapeutic purposes to be acceptable as well? On the one hand, the social aims to promote liberty in general, and reproductive liberty in particular, provide reason for thinking that individuals should be free to make their own decisions about whether or not to employ whatever genetic services might be developed and offered by private enterprise. On the other hand, interventions aimed at enhancement would (in many cases) presumably only be available to those who are financially fortunate. A worry is that unequal access to enhancements that provide competitive advantages to offspring will further and more permanently increase existing unjust disparities between the haves and have-nots. The aim to promote liberty might thus conflict with the social aim of equality. An additional worry is that the development and provision of nontherapeutic genetic interventions would drain limited medical resources away from therapeutic purposes which would ultimately be more fruitful. The promotion of liberty might also thus conflict with the aim to promote aggregate utility. Assuming there is no reason to think that the promotion of liberty should be given absolute priority over both equality and aggregate utility, we need to think more about how to make trade-offs between these three legitimate social aims.

Lessons from everyday lives: a moral justification for acute care research.

Progress in emergency and critical care requires that clinical research be performed on patients who are incapable of granting consent for research participation. Analyses of the ethics of such research have left some questions incompletely answered. Why should we be permitted to expose vulnerable patients to research risks without their consent? In particular, how do we justify research interventions that have no potential benefit for participants (nontherapeutic interventions)? This article presents a moral justification for nontherapeutic interventions in emergency research. By relying on a framework for assessing research risks, and by drawing on the example of pediatric research, this justification is founded in how institutional review boards, and society in general, analyze risk. Our justification for emergency research also suggests additional protections for emergency research participants, including a stringent threshold for research risk, that still permit important research to proceed.

The ethics of clinical trials: a child's view.

Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in the AIDS epidemic. These social forces have shifted the core ethical question fromwhetherchildren should be research subjects towhenchildren should be research subjects.The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration (FDA) that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults.

The ethics of using newly dead patients for teaching and practicing intubation techniques.

The clinical training of medical students, interns, and residents raises a number of ethical questions. A dilemma faced by all clinical educators is whether to permit a trainee to learn therapeutic and diagnostic procedures by practicing on patients.1 The dilemma lies in the choice between two obligations: to educate health care providers and to protect the physical and psychological integrity of patients.2 The issue of nontherapeutic interventions for training purposes or research in patients who have not given consent raises the most intriguing and controversial ethical questions.3 A common practice is the teaching and practicing of intubation skills on patients . . .

Support for the survivor

As nurses, we have come a long way in acknowledging our feelings about death. Today we are better able to open the emotional doors with the dying person, as the preceding article by Kennedy demonstrates. But many of us still have to sort out our feelings about loss in order to support that person's fami ly after his death. My concern for our responsibility toward the grieving survivor was provoked dramatically years ago by nurses' responses to a woman whose husband had just died. He was 39, she was 37. Most of the staff reacted with avoidance to her sorrowful outburst. Some nurses attempted to direct her from grieving by firmly suggesting that she think of her responsibilities to her children. Although the motivation of those advising this cognitive response was undoubtedly genuine concern for this widow, their advice was not in the least helpful. Surely she had the right to mourn, a right to wail and be disruptive, a need to grieve in her own way. I had no well-thought-out basis from which to pose logical arguments regarding therapeutic versus nontherapeutic interventions with the grieving woman, but I did feel that something was wrong with the stairs response. The husband had died in the evening; his wife was dead by morning, of a massive stroke. That day I vowed to learn more about helping the bereaved.

The design of controlled experiments in the evaluation of non-therapeutic interventions

Methodologic issues concerning the design of non-therapeutic trials are discussed. Topics include the issue of group vs individual randomization, the choice between one and two control groups, and the value of detecting Hawthorne effects. Also discussed are the problems of study drop-outs and substitutes for the double-blind features of the classical clinical trial.