Psychological distress, including depression and anxiety, and Type-D personality are prevalent in patients with coronary heart disease and associated with poor cardiovascular outcomes. Worry and rumination may be among the core features responsible for driving psychological distress in these patients. However, the nature of associations between these constructs remains to be delineated, yet they may have implications for the assessment and treatment of CHD patients. This study aimed to explore the factorial structure and potential overlap between measures (...) of depression, anxiety and the Type-D personality factors known as negative affectivity and social inhibition, and examine how these constructs relate to worry and rumination in a sample of 1,042 CHD outpatients who participated in the in the cross-sectional NORwegian CORonary Prevention study. We conducted confirmatory factor analyses and regression analyses within a structural equation modeling framework. Results showed all constructs to have acceptable factor structure and indicated an overlap between the constructs of depression and negative affectivity. Worry was most strongly associated with anxiety, whereas rumination was most strongly associated with depression and negative affectivity. The results suggest conceptual similarities across the measures of depression and negative affectivity. They further suggest that intervention efforts could benefit from targeting worry and/or rumination in the treatment of CHD outpatients presenting with symptoms of psychological distress. (shrink)

BackgroundCoronary heart disease is closely associated with cognitive impairment, especially in severe cases of heart failure. However, it is unclear whether cardiac systolic function plays a role in the relationship between pre-existing CHD and cognitive impairment in subjects without clinical heart failure.MethodsIn total, 208 subjects from the First Affiliated Hospital of Xi’an Jiaotong University were recruited from June 2014 to January 2015, and were divided into CHD and non-CHD groups according to the inclusion and exclusion criteria. (...) The global cognitive function of all subjects was assessed by the Mini-Mental State Examination and cognitive impairment was defined as the score lower than the cutoff value. Left ventricular ejection fraction was measured using transthoracic echocardiograms. The relationship among pre-existing CHD, LVEF, and cognitive impairment was analyzed by multivariate logistic regression.ResultsIn total, 34 subjects met the criteria of cognitive impairment. Univariate analysis showed that the cognitive impairment prevalence in the CHD group was significantly higher than that in the non-CHD group. Multivariate logistic analysis revealed that CHD was significantly associated with a higher risk of cognitive impairment after adjusting for confounds except for LVEF. However, the OR of CHD decreased when LVEF was further corrected as a continuous variable, and LVEF was negatively associated with the risk of cognitive impairment.ConclusionPre-existing CHD is associated with a higher risk of cognitive impairment, and such an association can be considerably explained by reduced LVEF. An impaired cardiac systolic function may play a key role in the relationship between CHD and cognitive impairment among patients with pre-heart failure conditions. (shrink)

The relationship between law and a population’s health is complex and poorly understood. To the extent that scholarship exists on the subject, it has usually focused on epidemics that are concentrated in relatively vulnerable, marginalized communities. Often, individual behaviors are assumed to play a major role in the epidemiology of these diseases. Perhaps, as a result, these illnesses become stigmatized and the object of coercive laws, which in turn become the subject of litigation, legal debate, and ultimately scholarly analysis. Thus, (...) to the extent that U.S. legal scholars have thought about public health in the last 30 years, they have generally done so in the context of tuberculosis, intravenous drug abuse, and a handful of similar conditions. Likewise, Jonathan Mann’s own appreciation of the importance of human rights to public health emerged in the wake of his work with HIV, which is perhaps the prototypical stigmatized disease. (shrink)

The relationship between law and a population’s health is complex and poorly understood. To the extent that scholarship exists on the subject, it has usually focused on epidemics that are concentrated in relatively vulnerable, marginalized communities. Often, individual behaviors are assumed to play a major role in the epidemiology of these diseases. Perhaps, as a result, these illnesses become stigmatized and the object of coercive laws, which in turn become the subject of litigation, legal debate, and ultimately scholarly analysis. Thus, (...) to the extent that U.S. legal scholars have thought about public health in the last 30 years, they have generally done so in the context of tuberculosis, intravenous drug abuse, and a handful of similar conditions. Likewise, Jonathan Mann’s own appreciation of the importance of human rights to public health emerged in the wake of his work with HIV, which is perhaps the prototypical stigmatized disease. (shrink)

In current mental health care psychiatric conditions are defined as compilations of symptoms. These symptom-based disease categories have been severely criticised as contingent and boundless, facilitating the rise to epidemic proportions of such conditions as depression. In this article we look beyond symptoms and stress the role of epidemiology in explaining the current situation. By analysing the parallel development of cardiovascular disease and depression management in Finland, we argue, firstly, that current mental health care shares with the medicine (...) of chronic somatic conditions an attachment to risk factor epidemiology, which accentuates risk and prevention in disease management. However, secondly, due to the symptom-based definitions of psychiatric conditions, depression management cannot differentiate properly between symptoms, signs and risk factors such as, for example, cardiovascular medicine, but treats symptoms as signs or risk factors in contexts of treatment and prevention. Consequently, minor at-risk conditions have become difficult to separate from proper cases of depression. (shrink)

BackgroundHealth-related quality of life is known to be impaired in individuals with coronary artery disease, especially in those after a recent acute coronary syndrome. Heart failure is a common burden in this population that significantly contributes to worsening HRQoL. To accurately measure the level of HRQoL in individuals with CAD after ACS, disease-specific scales, such as the Minnesota living with heart failure questionnaire, are recommended. Nevertheless, to date, there has not been a study that (...) would comprehensively evaluate the psychometric properties of the MLHFQ in a large sample of individuals with CAD after ACS. The debate regarding the internal structure of MLHFQ is also still present. Hence, this study aimed to translate the MLHFQ and evaluate its internal structure, reliability/precision, and validity in individuals with CAD following ACS in Lithuania.MethodsIn the cross-sectional study, 1,083 participants were evaluated for sociodemographic and clinical characteristics. HRQoL was measured using the MLHFQ and the Short Form-36 health survey. In addition, exercise capacity was also evaluated in the study patients, using a standardized computer-driven bicycle ergometer.ResultsThe internal consistency of the MLHFQ subscales was found to be good. Confirmatory factor analysis provided the support for the three-factor model of the MLHFQ and showed acceptable fit [comparative fit indices = 0.894; goodness-of-fit = 0.898; non-normal fit index = 0.879, and root mean square error of approximation = 0.073]. Regarding convergent evidence, significant associations were found between the MLHFQ domains and the SF-36 domains and EC.ConclusionThe current study completed cultural validation and provided further information on the psychometric characteristics of the MLHFQ in Lithuania, suggesting MLHFQ as a valid and reliable instrument to measure HRQoL. The Lithuanian version of MLHFQ is best described by a three-factor solution, measuring physical, social, and emotional dimensions of HRQoL among individuals with CAD following ACS. (shrink)

Coronary by-pass surgery has been performed in hundreds of thousands of patients in the last 15 years with a high standard of technical and surgical perfection. The indications for this kind of surgery, however, are still controversial because in spite of many retrospective and several prospective studies it cannot be proven convincingly that in a given patient this surgical procedure will prolong life or prevent myocardial infarction. The present attempt to analyze the causes for this controversy shows that the (...) main reasons for this uncertainty lie: (a) in the enigma of the underlying (ischemic heart) disease itself, which is supposed to lend itself to surgical therapy; (b) in the inadequate methods available up until now for characterizing the state of the disease, its probable course, and its pathogenesis; and (c) in the professional group interests which have a momentum of their own. (shrink)

Coronary by-pass surgery has been performed in hundreds of thousands of patients in the last 15 years with a high standard of technical and surgical perfection. The indications for this kind of surgery, however, are still controversial because in spite of many retrospective and several prospective studies it cannot be proven convincingly that in a given patient this surgical procedure will prolong life or prevent myocardial infarction. The present attempt to analyze the causes for this controversy shows that the (...) main reasons for this uncertainty lie: (a) in the enigma of the underlying (ischemic heart) disease itself, which is supposed to lend itself to surgical therapy; (b) in the inadequate methods available up until now for characterizing the state of the disease, its probable course, and its pathogenesis; and (c) in the professional group interests which have a momentum of their own. (shrink)

There has been a modern epidemic of heart attacks in the western world, and this paper is concerned with this ‘new’ medical condition and how it arose. Two competing theories are commonly proposed, relating either to conventional accounts of medical science, or to social construction. Whilst recognising that aspects of both theories have some validity, it is claimed that neither is wholly adequate. This issue has particular relevance for heart attacks and is explored in some detail, but it (...) also points to some more general conclusions. First that medical knowledge cannot be separated into ‘scientific’ and ‘social’ compartments but is united by its human aspect; and second that although medical knowledge has a special dimension, when understood in this way, it may also resonate with a more general re-examination of the relationship between scientific and human knowledge. (shrink)

Medical theory and practice in the second half of the 20th century were transformed by the idea of risk, and, in particular, by the concept of the "risk factor." Many historians have described how the concept of the risk factor emerged in the actuarial science of the life insurance industry in the early 20th century and entered medicine through the Framingham Heart Study, specifically with its July 1961 article, "Factors of Risk in the Development of Coronary Heart (...) Disease," in the Annals of Internal Medicine. This story, while plausible, is incorrect.New techniques of digital history enable a new kind of research: full-text searching of publications in medicine, public health, and other... (shrink)

Living things are often plastic during their early development and are moulded by the environment. Many human fetuses have to adapt to a limited supply of nutrients, and in doing so they permanently change their physiology and metabolism. These programmed changes may be the origins of a number of diseases in later life, including coronary heart disease, stroke, diabetes and hypertension.

Definition of the problem: In 1997, Percutaneous Transluminal Coronary Angioplasty (PTCA) was performed in 138.001 cases in Germany. The standard indications, single vessel disease and badly controlled angina, are more and more extended to multivessel disease with and without severe angina, unstable or preinfarction angina, and acute myocardial infarction (AMI) itself. Dilating asymptomatic stenoses of more than 70–80% is a widely used indication, intending prophylaxis of complete occlusion and AMI. Actually there is no generally accepted guideline for (...) the different new indications, conservative versus invasive treatment schedule. It is difficult for the patient to get appropriate information before his decision between mechanical procedures and conservative methods; authentic informed consent actually seems to be in a very bad position. In 1992 the working group called ”Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte (ALKK)” decided to start a registry of all PTCA procedures, in order to gain knowledge about the present status of PTCA in Germany. Up to March 1999, 198.608 PTCA are logged.Arguments: Each PTCA was included on an intention-to-treat basis. The registry succeeded in a nearly complete recording with 98,6% of all PTCA procedures complete on March 17th, 1999. 93,5% of stenosed and 72,2% of the total occluded vessels were successfully dilated. In 4.729 cases (2,63%) the PTCA caused severe complications. The overall in-hospital mortality was only 0,5%, if the procedures done for AMI were excluded (including AMI it was 1,1%). The calculation of complications should be an essential part of the patients informed consent.Conclusion: Complete recording of all PTCA procedures is feasible even on a nationwide basis. Some results of the registry, as the indication control and the complication rate may help to realize a better doctor-patient-conversation on risks and benefits of either concept. The trend of many CHD patients is ”modern”: It should be done what can be done (mechanically), with results at once. Although said somehow paternalistic, this point of view cannot be tolerated: Proper informed consent today includes the realistic alternative of modern medicaments, especially those with an aggressive cholesterol lowering potency. (shrink)

Heart disease is a complex condition that is a leading cause of death worldwide. It is often seen as a disease of affluence, yet is strongly associated with a gradient in socio-economic status. Its highly complex causality means that many different facets of social and economic life are implicated in its aetiology, including factors such as workplace hierarchy and agricultural policy, together with other well-known factors such as what passes for individual 'lifestyle'. The very untangling of causes (...) for heart disease thus inevitably raises social, moral and political issues. These include the proper role of the individual and of larger social forces in its aetiology, prevention and treatment. The construction of risk factors for heart disease likewise is enmeshed with questions of distributive justice in the responsible targeting of those at risk for heart disease, a debate which has received much overt attention in the medical literature, but less attention within the ethical literature. Strategies for addressing a condition of such complex causality can be highly diverse, from pharmaceutical to social interventions, and value issues attach to the choice and presentation of such strategies. For example, prevention strategies may raise complex issues of responsibility and of judgements of what it is to 'live well'. Further ethical debate on this highly political disease would be welcome. (shrink)

Written by cardiac surgeons, cardiologists, and pediatric intensive care physicans and nurses, this text offers a multidisciplinary approach to the care of children with critical heart disease. Throughout, Dr. Nichols and colleagues provide practice-oriented guidance on: * scientific principles * diagnostic and therapeutic techniques * specialized equipment * managing congenital and acquired special conditions * anesthesia, CPR, and respiratory care...... all with more than 400 illustrations to help you visualize anatomy and techniques, numerous charts and tables to summarize (...) critical data, and much more. (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)

It is a paradox that medical experimentation on individuals, whether patients or healthy volunteers, is now controlled by strict ethical guidelines, while no such protection exists for whole populations which are subjected to medical interventions in the name of preventive medicine or health promotion. As many such interventions are either of dubious benefit or of uncertain harm-benefit balance, such as mass screening for cancers or for risk factors associated with coronary heart disease, there is no justification for (...) maintaining the ethical vacuum in which preventive medicine finds itself at present. (shrink)

: Nearly all of the literature on the ethical, legal, or social issues surrounding genetic tests has proceeded on the assumption that any particular test for a gene mutation yields information about only one disease condition. Even though the phenomenon of pleiotropy, where a single gene has multiple, apparently unrelated phenotypic effects, is widely recognized in genetics, it has not had much significance for genetic testing until recently. In this article, I examine a moral dilemma created by one sort (...) of pleiotropic testing, APOE genotyping, which can yield information about the risk of two different conditions--coronary heart disease and Alzheimer's disease. A physician administering APOE testing for the beneficial purpose of assessing the risk of heart disease may discover medically useless and socially harmful information about the patient's risk of Alzheimer's disease. I explore how much providers should disclose to patients about pleiotropic test results and whether patients are obligated to know as much about their genetic condition as possible. (shrink)

Slight absolute changes in the Shanghai Stock Exchange Index (SHSE) corresponded to the city’s immediate increases in coronary heart disease deaths and stroke deaths. Significant fluctuations in the Shenzhen Stock Exchange Index (SZSE) corresponded to the country’s minor, delayed death rates. Investors deal with money, greed, stock volatility, and risky decision-making. Happy people live longer and better. We ask the following question: Who are the investors with the highest and most sustainable stock happiness, and why? Monetary wisdom (...) asserts: Investors apply their deep-rooted values (avaricious love-of-money aspiration and locus of control, Level 2) as a lens to frame critical concerns in the proximal-immediate (Shanghai Stock Exchange Index changes, Level 1) and the omnibus-distal contexts (domicile: city vs. country, Level 2) to maximize expected utility (portfolio changes, Level 1) and ultimate serenity (stock happiness, Level 1). We collected multilevel data—the longitudinal SHSE and 227 private investors’ daily stock happiness and portfolio changes for 36 consecutive trading days in four regions of China. Investors had an average liquid asset of $76,747.41 and $54,660.85 in stocks. This study is not a “one-shot” game with “nothing at stake.” We classified Shanghai and Beijing as the city and Shenzhen and Chongqing as the country. Our cross-level 3-D visualization reveals that regardless of SHSE volatility, investors with low aspiration, external control, and country domicile enjoy the highest and most sustainable stock happiness with minimum fluctuations. Independently, investors with low aspiration, external control, and country domicile tend to make fewer portfolio changes than their counterparts. Behaviorally, less is more, debunking the myth—risky decisions excite stock happiness. Our longitudinal study expands prospect theory, incorporates attitude toward money, and makes robust contributions to behavioral economics and business ethics. We help investors and ordinary citizens make happy, healthy, and wealthy decisions. Most importantly, the life you save may be your own. (shrink)

The feature article in this edition outlines and then critically examines the Nuffield Council of Bioethics’ Report, ‘Genome Editing and Human Reproduction: Social and Ethical issues’. While Christopher Gyngell, Hilary Bowman-Smart & Julian Savulescu, ‘support the approach taken by the Nuffield Council’,1 their findings are stronger than those in the Report, arguing that - beyond being permissible - many instances of heritable genome editing will be moral imperatives. A collection of engaging responses to this feature article are provided by Rachel (...) Horton & Anneke M Luccason, Pete Mills, and Sarah Chan. As a short-sighed introvert, I am going to leave aside my concerns about Gyngell’s and colleagues’ account of the weak and unhappy gene pool in which I swim, and instead focus on their talk of moral imperatives. Gyngell and colleagues construct their moral imperative argument by way of analogy. The most straightforward, and perhaps most compelling, claim concerns single gene disorders. I reconstruct the claim in the following way: 1. There is a moral imperative to screen newborns for phenylketonuria. 2. If it were possible, there would be a moral imperative to provide replacement enzyme therapy for PKU. 3. By analogy, if it were possible, there would be a moral imperative to make safe genome edits which prevent PKU. The same analogical interference is claimed in arguments in favour of: editing around 27 mutations associated with coronary heart disease, editing to shift individuals of low or …. (shrink)

Plasminogen activator inhibitor‐1 (PAI‐1) is a physiological inhibitor of urokinase (uPA), a serine protease known to promote cell migration and invasion. Intuitively, increased levels of PAI‐1 should be beneficial in downregulating uPA activity, particularly in cancer. By contrast, in vivo, increased levels of PAI‐1 are associated with a poor prognosis in breast cancer. This phenomenon is termed the “PAI‐1 paradox”. Many factors are responsible for the upregulation of PAI‐1 in the tumor microenvironment. We hypothesize that there is a breast cancer (...) predisposition to a more aggressive stage when PAI‐1 is upregulated as a consequence of Metabolic Syndrome (MetS). MetS exerts a detrimental effect on the breast tumor microenvironment that supports cancer invasion. People with MetS have an increased risk of coronary heart disease, stroke, peripheral vascular disease and hyperinsulinemia. Recently, MetS has also been identified as a risk factor for breast cancer. We hypothesize the existence of the “PAI‐1 cycle”. Sustained by MetS, adipocytokines alter PAI‐1 expression to promote angiogenesis, tumor‐cell migration and procoagulant microparticle formation from endothelial cells, which generates thrombin and further propagates PAI‐1 synthesis. All of these factors culminate in a chemotherapy‐resistant breast tumor microenvironment. The PAI‐1 cycle may partly explain the PAI‐1 paradox. In this hypothesis paper, we will discuss further how MetS upregulates PAI‐1 and how an increased level of PAI‐1 can be linked to a poor prognosis. BioEssays 29:1029–1038, 2007. © 2007 Wiley Periodicals, Inc. (shrink)

Suls provides a useful review of research interested in the contribution of chronic negative emotions to coronary heart disease. Despite widespread support for a link between negative emotions and the etiology of disease, it is largely unknown if discrete negative emotions, particularly anger, sadness, and anxiety contribute to the development of physical disease in different ways. In this comment, we argue that answering this question will require a more comprehensive analysis of the unique characteristics of (...) discrete emotions as well as conceptually refined assumptions about how discrete emotions develop and change across the adult lifespan. (shrink)

Metabolic Syndrome is a cluster of risk factors (including obesity, hypertension and insulin resistance), which is associated with late‐onset diabetes and coronary heart disease. Elevated levels of the protease inhibitor PAI‐1 are well‐known molecular markers of the Metabolic Syndrome. Here, however, we present a hypothesis that PAI‐1 acts as a causative factor in the development of Metabolic Syndrome and its clinical sequelae. We propose that PAI‐1 inhibits the activity of members of the proprotein convertase (PC) class of (...) serine proteases and that this underlies, at a molecular level, many of the other features of the Metabolic Syndrome cluster. BioEssays 28: 629–641, 2006. © 2006 Wiley Periodicals, Inc. (shrink)

The aim of this paper is to characterize some personality traits of women with ischemic heart disease, in order to determine their relationship to activity and inactivity, and define the implications of that relationship for ways of coping with coronary pain. The study comprised N = 100 women aged 33 to 80 years, hospitalized in the Department of Cardiology, who underwent angiography for the assessment of coronary arteries. Psychological studies have been conducted using clinical interviews, involving (...) the IPAT Anxiety Scale Questionnaire, the Pain Coping Strategies Questionnaire and the NEO Five-Factor Personality Inventory. The results obtained indicate that where a group of one hundred women with ischemic heart disease was concerned, their level of anxiety and fear stood at an almost neurotic level. In the structure of anxiety and fear one may observe the predominance of a strong tendency towards self-blame, experiencing feelings of guilt, and exhibiting high levels of internal tension. Among the personality traits in question, the following clearly dominated: extroversion, agreeableness and conscientiousness. The principal strategies for dealing with pain on the part of women with IHD were “prayer and hope”, “declarations of coping” and “diverting attention”. In women with ischemic heart disease, it would thus be advisable to employ psychotherapeutic strategies aimed at lowering the tendency towards selfdestructive behaviour and reducing any elevated levels of internal tension. Psychotherapeutic activities conducted among women with IHD should focus on strengthening psychological resilience, and on working out ways to cope with the disease by undertaking tasks which give them a chance to enrich their own development. (shrink)

Consistent findings about the inverse association of social network level with coronary heart disease mortality and morbidity suggest the importance of investigating biological pathways of association. Differences in plasma fibrinogen level were investigated among middle-aged men with weak and strong structural and functional social network ties. Men with low scores in the adequacy of social participation variable (structural) had higher mean values of plasma fibrinogen than those with high scores. The difference remained after adjustment for age, smoking (...) and cardiovascular health status and after possible modifying factors were taken into account, but did not remain significant after allowing for physical fitness. Men with high scores in overall support (functional) had higher plasma fibrinogen levels compared to the men with low scores. This difference persisted after age and cardiovascular health status were taken into account but was explained by smoking. The data suggest that smoking and cardiorespiratory fitness are important mediating or modifying factors between structural and functional aspects of social network ties and plasma fibrinogen. (shrink)

Residual confounding is a common source of bias in observational studies. In this article, we build upon a series of sensitivity analyses methods for residual confounding developed by Brumback et al. and Chiba whose sensitivity parameters are constructed to quantify deviation from conditional exchangeability, given measured confounders. These sensitivity parameters are combined with the observed data to produce a “bias-corrected” estimate of the causal effect of interest. We provide important generalizations of these sensitivity analyses, by allowing for arbitrary exposures and (...) a wide range of different causal effect measures, through the specification of the target causal effect as a parameter in a generalized linear model with the arbitrary link function. We show how our generalized sensitivity analysis can be easily implemented with standard software, and how its sensitivity parameters can be calibrated against measured confounders. We demonstrate our sensitivity analysis with an application to publicly available data from a cohort study of behavior patterns and coronary heart disease. (shrink)

When scientists consider the interaction of science and value judgments, debates often occur. When public policy grows out of science, disagreements between scientists can become even more spirited. This paper examines the case of nutrition policy in the United States, which has been both at the interface between agriculture and medicine and the object of serious discord concerned with the strength and validity of the scientific evidence and the responsibility for action. The development of indirect intervention policies, designed to educate (...) and inform the public on diet and health, is traced as a practical demonstration of the effects of involvements of nutritional scientists of different disciplines and philosophic bents. Controversies centered mainly on the issues of diet and coronary heart disease and of diet and cancer in nutritional guidelines for Americans and the recommended dietary allowances. But the arguments turned on a complex web of values and interests as well as scientific questions. A remarkable turnaround by animal agriculture and its scientific support occurred, changing from a defensive, rightist stance to one that appears to recognize a moral responsibility to the public health. The convincing point was likely the changing market. Nutritional scientists, however, remained divided on the issue of whether a public health strategy keyed to public education should replace a strategy to identify persons of high risk and modify the risk by treatment. Our analysis suggests that the tension between libertarian and utilitarian social values of scientists is at least as important as disagreements relative to validity and strengths of the scientific evidence. (shrink)

A number of arguments have shown that randomization is not essential in experimental design. Scientific conclusions can be drawn on data from experimental designs that do not involve randomization. John Worrall has recently taken proponents of randomized studies to task for suggesting otherwise. In doing so, however, Worrall makes an additional claim: randomized interventional studies are epistemologically equivalent to observational studies, providing the experimental groups are comparable according to background knowledge. I argue against this claim. In the context of testing (...) the efficacy of drug therapies, well-designed interventional studies are epistemologically superior to well-designed observational studies because they have the capacity to avoid a type of selection bias. Although arguments for interventional studies are present in the medical literature, these arguments are too often presented as an argument for randomization. Randomization in interventional studies is defended on Bayesian grounds. (shrink)

Critical congenital heart disease screening is rapidly becoming the standard of care in the United States after being added to the Recommended Uniform Screening Panel in 2011. Newborn screens typically do not require affirmative parental consent. In fact, most states allow parents to exempt their baby from receiving the required screen on the basis of religious or personally held beliefs. There are many ethical considerations implicated with allowing parents to exempt their child from newborn screening for CCHD. Considerations (...) include the treatment of religious exemptions in our current legal system, as well as medical and ethical principles in relation to the rights of infants. Although there are significant benefits to screening newborns for CCHD, when a parent refuses for religious or personal beliefs, in the case of CCHD screening, the parental decision should stand. (shrink)

Phenomenology has contributed to healthcare by providing resources for understanding the lived experience of the patient and their situation. But within a burgeoning literature on the characteristic features of illness, there has not yet been an account appropriate to describe congenital illnesses: conditions which are present from birth and cause suffering or medical threat to their bearers. Congenital illness sits uncomfortably with standard accounts in phenomenology of illness, in which concepts such as loss, doubt, alienation and unhomelikeness presuppose prior health. (...) These accounts reflect, in different ways, Maurice Merleau-Ponty’s assumption that the ways of living of the ill contain allusions to fundamental, healthy functions. The originality of congenital illness complicates this assumption and demands its own original phenomenology. In this paper, I sketch my personal experience living with a single-ventricle heart condition. While some of this story may reflect my own idiosyncratic experience, I hope that much of it will resonate with the congenital illness experience. I argue that the phenomenological literature on illness, grounded in the notion of loss, does not describe the congenital illness experience. I show how a number of other patient-centred theories of health and illness which have been influential on phenomenology can and cannot elucidate congenital illness. In particular, I consider Georges Canguilhem’s account of the normal and the pathological; debates in disability; and the notion of illness as biographical disruption. I show that congenital illness results in the preadmission of its patients to a paradoxical logic of medical palliation, one product of which is existential maturity. (shrink)

ABSTRACT The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were (...) conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use. (shrink)

ABSTRACT The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were (...) conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use. (shrink)

The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were conducted with RHDGen participants, (...) study staff and with individuals who refused to participate. In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use. (shrink)