Accounts of the concepts of function and dysfunction have not adequately explained what factors determine the line between low‐normal function and dysfunction. I call the challenge of doing so the line‐drawing problem. Previous approaches emphasize facts involving the action of natural selection (Wakefield 1992a, 1999a, 1999b) or the statistical distribution of levels of functioning in the current population (Boorse 1977, 1997). I point out limitations of these two approaches and present a solution to the line‐drawing problem that builds on the (...) second one. (shrink)
Similarly to other accounts of disease, Christopher Boorse’s Biostatistical Theory (BST) is generally presented and considered as conceptual analysis, that is, as making claims about the meaning of currently used concepts. But conceptual analysis has been convincingly critiqued as relying on problematic assumptions about the existence, meaning, and use of concepts. Because of these problems, accounts of disease and health should be evaluated not as claims about current meaning, I argue, but instead as proposals about how to define and use (...) these terms in the future, a methodology suggested by Quine and Carnap. I begin this article by describing problems with conceptual analysis and advantages of “philosophical explication,” my favored approach. I then describe two attacks on the BST that also question the entire project of defining “disease.” Finally, I defend the BST as a philosophical explication by showing how it could define useful terms for medical science and ethics. (shrink)
The way that diseases such as high blood pressure (hypertension), high cholesterol, and diabetes are defined is closely tied to ideas about modifiable risk. In particular, the threshold for diagnosing each of these conditions is set at the level where future risk of disease can be reduced by lowering the relevant parameter (of blood pressure, low-density lipoprotein, or blood glucose, respectively). In this article, I make the case that these criteria, and those for diagnosing and treating other “risk-based diseases,” reflect (...) an unfortunate trend towards reclassifying risk as disease. I closely examine stage 1 hypertension and high cholesterol and argue that many patients diagnosed with these “diseases” do not actually have a pathological condition. In addition, though, I argue that the fact that they are risk factors, rather than diseases, does not diminish the importance of treating them, since there is good evidence that such treatment can reduce morbidity and mortality. For both philosophical and ethical reasons, however, the conditions should not be labeled as pathological.The tendency to reclassify risk factors as diseases is an important trend to examine and critique. (shrink)
Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. -/- Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points to (...) Consider” (P2C) document, and convened a national expert panel to review and critique the P2C. -/- Results: We developed the P2C to aid informaticists designing an advanced query tool for an electronic health record (EHR) system in Indianapolis. The P2C consists of six questions (“Points”) that frame important ethical issues, apply accepted principles of bioethics and Fair Information Practices, comment on how questions might be answered, and address implications for patient care. -/- Discussion: The P2C is intended to clarify whatis at stake when designers try to accommodate potentially competing ethical commitments and logistical realities. The P2C was developed to guide informaticists who were designing a query tool in an existing EHR that would permit patient granular control. While consideration of ethical issues is coming to the forefront of medical informatics design and development practices, more reflection is needed to facilitate optimal collaboration between designers and ethicists. This report contributes to that discussion. (shrink)
Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decisionmaking. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem (...) from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. (shrink)
Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was adopted recently by a team of informaticists designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially when (...) principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and non-maleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper we show how using ethical principles can help in the design of EHRs by first, explaining how ethical principles can and should be used generally, and then by, discuss how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting further ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest. (shrink)
Introduction: Previous studies have measured individuals’ willingness to share personal information stored in an electronic health record (EHR) with healthcare providers. But none have measured preferences when patients’ choices determine access by healthcare providers. -/- Methods: Patients were given the ability to control the access of doctors, nurses or other staff in a primary care clinic to personal information stored in an EHR. Patients could restrict access to all personal data or to specific types of sensitive information, and could restrict (...) access for a specific time period. Patients also completed a survey regarding their understanding and opinions regarding the process. -/- Results: Of 139 eligible patients who were approached, 105 (75.5%) were enrolled and preferences were collected from 105 of them (100%). Sixty patients (57%) did not restrict access by any providers. Of the 45 patients (43%) who chose to limit the access of at least 1 provider, 36 restricted access only to all personal information in the EHR, while 9 restricted access of some providers to a subset of the their personal information. Thirty-four (32.3%) patients blocked access to all personal information by all doctors, nurses, and/or other staff; 26 (24.8%) blocked access by all doctors and/or nurses, and 5 (4.8%) denied access to alldoctors, nurses, and staff. -/- Conclusions: A significant minority of patients chose to restrict access by their primary care providers to personal information contained in an EHR, and few chose to restrict access to specific types of information. More research is needed to identify patient goals and understanding when facing decisions of this sort, and to identify the impact of educating patients regarding information contained in the EHR and its use in clinical care. (shrink)
In order to receive controlled pain medications for chronic non-oncologic pain, patients often must sign a “narcotic contract” or “opioid treatment agreement” in which they promise not to give pills to others, use illegal drugs, or seek controlled medications from health care providers. In addition, they must agree to use the medication as prescribed and to come to the clinic for drug testing and pill counts. Patients acknowledge that if they violate the opioid treatment agreement, they may no longer receive (...) controlled medications. OTAs have been widely implemented since they were recommended by multiple national bodies to decrease misuse and diversion of narcotic medications. But critics argue that OTAs are ethically suspect, if not unethical, and should be used with extreme care if at all. We agree that OTAs pose real dangers and must be implemented carefully. But we also believe that the most serious criticisms stem from a mistaken understanding of OTAs’ purpose and ethical basis. (shrink)
While several tests and strategies are recommended for colorectal cancer (CRC) screening, studies suggest that primary care providers often recommend colonoscopy without providing information about its risks or alternatives. These observations raise concerns about the quality of informed consent for screening colonoscopy.
Most people do not know there are different kinds of medical studies; some are conducted on people who already have a disease or medical condition, and others are performed on healthy volunteers who want to help science find answers. No matter what sort of research you are invited to participate in, or whether you are a patient when you are asked, it’s entirely up to you whether or not to do it. This decision is important and may have many implications (...) for your health and well-being, as well as those of other patients now and in the future. Making a good decision – the right one for you – requires you to become educated about topics you may not have thought about before, some of which may be quite complicated. This chapter explains the key issues to help you make a good decision. (shrink)
Patients should not always receive hard data about the risks and benefits of a medical intervention. That information should always be available to patients who expressly ask for it, but it should be part of standard disclosure only sometimes, and only for some patients. And even then, we need to think about how to offer it.
Although there is a growing recognition that older adults and those with extensive comorbid conditions undergo cancer screening too frequently, there is little information about patients’ perceptions regarding cessation of cancer screening. Information on older adults’ views of screening cessation would be helpful both for clinicians and for those designing interventions to reduce overscreening.
"Modern History" versions of the etiological theory claim that in order for a trait X to have the proper function F, individuals with X must have been recently favored by natural selection for doing F (Godfrey-Smith 1994; Griffiths 1992, 1993). For many traits with prototypical proper functions, however, such recent selection may not have occurred: traits may have been maintained due to lack of variation or due to selection for other effects. I examine this flaw in Modern History accounts and (...) offer an alternative etiological theory, the Continuing Usefulness account, which appears to avoid such problems. (shrink)
'Modern History' views claim that in order for a trait X to have the proper function F, X must have been recently favored by natural selection for doing F (Griffiths 1992, 1993; Godfrey-Smith 1994). For many traits with prototypical proper functions, however, such recent selection may not have occurred, since traits may have been maintained owing to lack of variation or selection for other effects. I explore this flaw in Modern History accounts and offer an alternative etiological theory, which I (...) call the 'Continuing Usefulness' account. According to my view, a trait has the proper function F if and only if, first, the trait was favored by selection for doing F at some point (perhaps far in the past), and, secondly, the trait has recently contributed to survival and reproduction by doing F. This separates the requirement involving natural selection from the one involving the recent past, two issues that the Modern History account conflates. The clear separation allows a detailed analysis of the causal judgments and form of adaptationism that ground the etiological approach to function. (shrink)
With the growing focus on prevention in medicine, studies of how to describe risk have become increasing important. Recently, some researchers have argued against giving patients “comparative risk information,” such as data about whether their baseline risk of developing a particular disease is above or below average. The concern is that giving patients this information will interfere with their consideration of more relevant data, such as the specific chance of getting the disease (the “personal risk”), the risk reduction the treatment (...) provides, and any possible side effects. I explore this view and the theories of rationality that ground it, and I argue instead that comparative risk information can play a positive role in decision-making. The criticism of disclosing this sort of information to patients, I conclude, rests on a mistakenly narrow account of the goals of prevention and the nature of rational choice in medicine. (shrink)
Some experts have argued that patients facing certain types of choices should not be told whether their risk is above or below average, because this information may trigger a bias (Fagerlin et al. 2007). But careful consideration shows that the comparative risk heuristic can usefully guide decisions and improve their quality or rationality. Building on an earlier paper of mine (Schwartz 2009), I will argue here that doctors and decision aids should provide comparative risk information to patients, even while further (...) research is conducted. (shrink)
Imagine you fly home from vacation with your one-and-a-half-year-old son who is traveling for free as a “lap child.” In the airport parking lot, you put him into his forward-facing car seat, where he sits much more contentedly than he did in the rear-facing one that was mandatory until his first birthday. After he falls asleep on the way home, you transfer him to his crib without waking him, lowering the side rail so you can lift him in more easily. (...) -/- Many parts of this idyllic parenting picture are deemed unacceptably risky according to recent child safety proposals. While these proposals all aim to improve child safety, their possible impact is unclear because there has been little discussion of the absolute risk and risk reduction involved in each. And while precise figures are lacking, rough estimates indicate that the magnitudes are quite small. I will argue that this risk and benefit data raises important questions about the proposals, including whether parents might reasonably believe that the small absolute risk reduction offered by the proposed changes does not justify the attendant burdens. This possibility—termed the “prevention paradox” in other contexts—highlights ethical and theoretical challenges in this area of public health. (shrink)
I argue that ductal carcinoma in situ (DCIS), the tumor most commonly diagnosed by breast mammography, cannot be confidently classified as cancer, that is, as pathological. This is because there may not be dysfunction present in DCIS—as I argue based on its high prevalence and the small amount of risk it conveys—and thus DCIS may not count as a disease by dysfunction-requiring approaches, such as Boorse’s biostatistical theory and Wakefield’s harmful dysfunction account. Patients should decide about treatment for DCIS based (...) on the risks it poses and the risks and benefits of treatment, not on its disease status. (shrink)
The child shall have things better than his parents: he shall not be subject to the necessities which they have recognized as dominating life. Illness, death, renunciation of enjoyment, restrictions on his own will, shall not touch him; the laws of nature, like those of society, are to be abrogated in his favor; he is really to be the center and heart of creation, “His Majesty the Baby,” as we once fancied ourselves to be.... At the weakest point of all (...) in the narcissistic position, the immortality of the ego which is so relentlessly assailed by reality, security is achieved by fleeing to the child. Parental love, which is so touching and at bottom so childish, is nothing but parental narcissism born again.... Sigmund Freud, “On Narcissism”. (shrink)