Ethics should guide the design of electronic health records (EHR), and recognized principles of b... more Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was recently adopted by a team of informaticists who are 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 nonmaleficence 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 ho...
Accounts of the concepts of function and dysfunction have not adequately explained what factors d... more 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.
International Journal of Medical Informatics, 2013
Objective: There are benefits and risks of giving patients more granular control of their persona... more 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 what is 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.
Two weeks ago, Mr. Smith caught a cold. His runny nose cleared up in a week, but the cough contin... more Two weeks ago, Mr. Smith caught a cold. His runny nose cleared up in a week, but the cough continued and a few days ago it got worse. Last night he couldn't sleep because he was coughing so much, and for the first time he developed a fever and chills. Today his temperature is 101 F, he is coughing up some brownish sputum, and he feels short of breath. He has pneumonia-confirmed by the physical exam and chest x-ray-and is admitted to the hospital for antibiotics, fluids, and observation.
Patient advocates and leaders in informatics have long proposed that patients should have greater... more Patient advocates and leaders in informatics have long proposed that patients should have greater ability to control the information in their electronic health record (EHR), including how it can be accessed by their health care providers. The value of such “granular” control, as it has been termed, has been supported prominently in an influential report by the President’s Council of Advisors on Science and Technology (PCAST). Recently, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) funded several projects to study key components of EHR systems, including exploring ways to allow granular control. This “Points to Consider” document provides an overview of the benefits, risks and challenges of granular control of EHRs; a review of the key ethical principles, values, and Fair Information Practices that ought to guide development of an EHR that accommodates granular control, and seven detailed Points to Co...
Highlights: First adequately powered, randomized, controlled trial of quantitative information ... more Highlights: First adequately powered, randomized, controlled trial of quantitative information in a decision aid. Viewing quantitative information did not reduce intention to be screened or uptake. Viewing quantitative information increased perceived risk of colorectal cancer. Viewing quantitative information increased selection of a non-invasive screening test.
Medical decision making : an international journal of the Society for Medical Decision Making, Aug 1, 2017
Guidelines recommend that patient decision aids should provide quantitative information about pro... more Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a "nudge" towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge. Primary care patients (n = 213) eligible for colorectal cancer screening viewed basic screening information and were randomized to view (a) quantitative information (quantitative module), (b) a nudge towards stool testing with the fecal immunochemical test (FIT) (nudge module), (c) neither a nor b, or (d) both a and b. Outcome measures were perceived colorectal cancer risk, screening intent, preferred test, and decision conflict, measured before and after viewing the decision aid, and screening behavior at 6 months. Patients viewing the quantitative modu...
Consider the following patient: a 40 year old man who has had back pain that radiates down his le... more Consider the following patient: a 40 year old man who has had back pain that radiates down his left leg, on and off for two months. He performs his normal activities and does not have any "red flag" symptoms like fever or weakness. He's using two commonly prescribed pain medications (ibuprofen and acetaminophen) as needed, and they help somewhat. The pain is slightly better than when it started but not much. He is frustrated and wants to feel better. What can the doctor do for him? First, she can reassure him that the duration of his symptoms is not uncommon for sciatica, a pinched nerve in the back, and there is no reason to believe that something more dangerous is going on. Second, she can advise against invasive steps, such as surgery, which research shows to be useless and potentially dangerous. Third, she can offer a medication that might help, such as a muscle relaxer, tricyclic antidepressant (TCA), or anticonvulsant. Each of these can reduce sciatic pain, though only in a minority of patients and usually by only a moderate amount. Each medication has risks, most commonly symptoms such as drowsiness, dry mouth, constipation, or dizziness, which resolve when the medication is stopped. These medications also have rare severe side effects, such as allergic reactions that could be life threatening. Let's say that the doctor is considering prescribing amitriptyline, a TCA. Should she utilize the techniques that Alfano suggests to improve the patient's chance of benefit and reduce the risk of side effects? As Alfano (2015) describes, research shows that mentioning a side effect, such as dry mouth, can increase the chance of its occurring, due to the "expectation-confirmation" mechanism. Recognizing this, the doctor could use the authorized concealment approach that Alfano describes, which builds on an earlier suggestion by Miller and Colloca (2011). Is this approach ethical? A critic might complain that authorized concealment blocks informed consent by eliminating discussion of an important issue. In fact, demonstration of the expectation-confirmation mechanism simply proves what doctors have long suspected and used to justify nondisclosure, as discussed and seminally critiqued by Jay Katz (1984). One can defend authorized concealment by arguing that the side effect has in fact been disclosed, just vaguely, and the doctor and patient are discussing what sort of discussion to have. The process that Alfano describes is a far cry from the complete lack of disclosure that Katz and others have fought against, where doctors don't even mention the possibility of
Dr. Feng had purposefully scheduled Ms. Reid to come into the office at 4:15 PM on a Friday. Desp... more Dr. Feng had purposefully scheduled Ms. Reid to come into the office at 4:15 PM on a Friday. Despite the fact that her office staff would be trying to make it home as soon as possible, Dr. Feng had imagined that Ms. Reid might need extra time to discuss her biopsy results: there was a chance that the lump on her neck that she'd felt when tying a scarf might be cancerous. Ms. Reid had been in the waiting room for an hour already by the time Dr. Feng called her in, trying to keep an eye on her two young sons, who were tipping over towers of cardboard blocks into the aisles between seats. "Well, Ms. Reid," Dr Feng started. "I'd hoped that we'd have a clearer answer for you today, but the pathology results from the aspiration of thyroid nodule are unclear. Some of the cells do look concerning for malignancy. We could repeat the aspiration, but I think that we should remove a piece of your thyroid at this point, to be safe." "Is this a big surgery? Do I have to stay in the hospital?" Ms. Reid asked. With her job as a teacher and her kids, an inpatient stay would be difficult. "No, no. It's a day surgery, and one I do routinely. The complications we might see are mainly bleeding and infection. We can control bleeding by cauterizing blood vessels or tying them off, and if there are signs of infection, for instance, if the wound becomes red or if you begin to have fever, we will start you on an antibiotic. There is always a slight risk of injuring a nerve to your vocal chord, but I've done this surgery many times and that's very rare. What questions do you have for me about the procedure?" Ms. Reid said, "I'm ready to have this lump gone. Let's go ahead with the surgery." "OK, then, visit with the scheduling nurse out front, and set up a time that works for both of us. You might want to schedule it before one of those occasions when your school has a 3-day weekend, like Easter or Memorial Day. The surgery isn't urgent." Mrs. Reid scheduled the surgery, and it went as planned. A few days after the surgery, Ms. Reid came in for an emergency appointment with Dr. Feng. It was obvious that she was irate, but her voice could barely be heard above the noise of the clinic.
The way that diseases such as high blood pressure (hypertension), high cholesterol, and diabetes ... more 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...
Clinical research ethics consultation services have been established across academic health cente... more Clinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.
Some experts have argued that patients should routinely be told the specific magnitude and absolu... more 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.
Patients should not always receive hard data about the risks and benefits of a medical interventi... more 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.
With the growing focus on prevention in medicine, studies of how to describe risk have become inc... more 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.
Ethics should guide the design of electronic health records (EHR), and recognized principles of b... more Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was recently adopted by a team of informaticists who are 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 nonmaleficence 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 ho...
Accounts of the concepts of function and dysfunction have not adequately explained what factors d... more 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.
International Journal of Medical Informatics, 2013
Objective: There are benefits and risks of giving patients more granular control of their persona... more 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 what is 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.
Two weeks ago, Mr. Smith caught a cold. His runny nose cleared up in a week, but the cough contin... more Two weeks ago, Mr. Smith caught a cold. His runny nose cleared up in a week, but the cough continued and a few days ago it got worse. Last night he couldn't sleep because he was coughing so much, and for the first time he developed a fever and chills. Today his temperature is 101 F, he is coughing up some brownish sputum, and he feels short of breath. He has pneumonia-confirmed by the physical exam and chest x-ray-and is admitted to the hospital for antibiotics, fluids, and observation.
Patient advocates and leaders in informatics have long proposed that patients should have greater... more Patient advocates and leaders in informatics have long proposed that patients should have greater ability to control the information in their electronic health record (EHR), including how it can be accessed by their health care providers. The value of such “granular” control, as it has been termed, has been supported prominently in an influential report by the President’s Council of Advisors on Science and Technology (PCAST). Recently, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) funded several projects to study key components of EHR systems, including exploring ways to allow granular control. This “Points to Consider” document provides an overview of the benefits, risks and challenges of granular control of EHRs; a review of the key ethical principles, values, and Fair Information Practices that ought to guide development of an EHR that accommodates granular control, and seven detailed Points to Co...
Highlights: First adequately powered, randomized, controlled trial of quantitative information ... more Highlights: First adequately powered, randomized, controlled trial of quantitative information in a decision aid. Viewing quantitative information did not reduce intention to be screened or uptake. Viewing quantitative information increased perceived risk of colorectal cancer. Viewing quantitative information increased selection of a non-invasive screening test.
Medical decision making : an international journal of the Society for Medical Decision Making, Aug 1, 2017
Guidelines recommend that patient decision aids should provide quantitative information about pro... more Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a "nudge" towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge. Primary care patients (n = 213) eligible for colorectal cancer screening viewed basic screening information and were randomized to view (a) quantitative information (quantitative module), (b) a nudge towards stool testing with the fecal immunochemical test (FIT) (nudge module), (c) neither a nor b, or (d) both a and b. Outcome measures were perceived colorectal cancer risk, screening intent, preferred test, and decision conflict, measured before and after viewing the decision aid, and screening behavior at 6 months. Patients viewing the quantitative modu...
Consider the following patient: a 40 year old man who has had back pain that radiates down his le... more Consider the following patient: a 40 year old man who has had back pain that radiates down his left leg, on and off for two months. He performs his normal activities and does not have any "red flag" symptoms like fever or weakness. He's using two commonly prescribed pain medications (ibuprofen and acetaminophen) as needed, and they help somewhat. The pain is slightly better than when it started but not much. He is frustrated and wants to feel better. What can the doctor do for him? First, she can reassure him that the duration of his symptoms is not uncommon for sciatica, a pinched nerve in the back, and there is no reason to believe that something more dangerous is going on. Second, she can advise against invasive steps, such as surgery, which research shows to be useless and potentially dangerous. Third, she can offer a medication that might help, such as a muscle relaxer, tricyclic antidepressant (TCA), or anticonvulsant. Each of these can reduce sciatic pain, though only in a minority of patients and usually by only a moderate amount. Each medication has risks, most commonly symptoms such as drowsiness, dry mouth, constipation, or dizziness, which resolve when the medication is stopped. These medications also have rare severe side effects, such as allergic reactions that could be life threatening. Let's say that the doctor is considering prescribing amitriptyline, a TCA. Should she utilize the techniques that Alfano suggests to improve the patient's chance of benefit and reduce the risk of side effects? As Alfano (2015) describes, research shows that mentioning a side effect, such as dry mouth, can increase the chance of its occurring, due to the "expectation-confirmation" mechanism. Recognizing this, the doctor could use the authorized concealment approach that Alfano describes, which builds on an earlier suggestion by Miller and Colloca (2011). Is this approach ethical? A critic might complain that authorized concealment blocks informed consent by eliminating discussion of an important issue. In fact, demonstration of the expectation-confirmation mechanism simply proves what doctors have long suspected and used to justify nondisclosure, as discussed and seminally critiqued by Jay Katz (1984). One can defend authorized concealment by arguing that the side effect has in fact been disclosed, just vaguely, and the doctor and patient are discussing what sort of discussion to have. The process that Alfano describes is a far cry from the complete lack of disclosure that Katz and others have fought against, where doctors don't even mention the possibility of
Dr. Feng had purposefully scheduled Ms. Reid to come into the office at 4:15 PM on a Friday. Desp... more Dr. Feng had purposefully scheduled Ms. Reid to come into the office at 4:15 PM on a Friday. Despite the fact that her office staff would be trying to make it home as soon as possible, Dr. Feng had imagined that Ms. Reid might need extra time to discuss her biopsy results: there was a chance that the lump on her neck that she'd felt when tying a scarf might be cancerous. Ms. Reid had been in the waiting room for an hour already by the time Dr. Feng called her in, trying to keep an eye on her two young sons, who were tipping over towers of cardboard blocks into the aisles between seats. "Well, Ms. Reid," Dr Feng started. "I'd hoped that we'd have a clearer answer for you today, but the pathology results from the aspiration of thyroid nodule are unclear. Some of the cells do look concerning for malignancy. We could repeat the aspiration, but I think that we should remove a piece of your thyroid at this point, to be safe." "Is this a big surgery? Do I have to stay in the hospital?" Ms. Reid asked. With her job as a teacher and her kids, an inpatient stay would be difficult. "No, no. It's a day surgery, and one I do routinely. The complications we might see are mainly bleeding and infection. We can control bleeding by cauterizing blood vessels or tying them off, and if there are signs of infection, for instance, if the wound becomes red or if you begin to have fever, we will start you on an antibiotic. There is always a slight risk of injuring a nerve to your vocal chord, but I've done this surgery many times and that's very rare. What questions do you have for me about the procedure?" Ms. Reid said, "I'm ready to have this lump gone. Let's go ahead with the surgery." "OK, then, visit with the scheduling nurse out front, and set up a time that works for both of us. You might want to schedule it before one of those occasions when your school has a 3-day weekend, like Easter or Memorial Day. The surgery isn't urgent." Mrs. Reid scheduled the surgery, and it went as planned. A few days after the surgery, Ms. Reid came in for an emergency appointment with Dr. Feng. It was obvious that she was irate, but her voice could barely be heard above the noise of the clinic.
The way that diseases such as high blood pressure (hypertension), high cholesterol, and diabetes ... more 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...
Clinical research ethics consultation services have been established across academic health cente... more Clinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.
Some experts have argued that patients should routinely be told the specific magnitude and absolu... more 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.
Patients should not always receive hard data about the risks and benefits of a medical interventi... more 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.
With the growing focus on prevention in medicine, studies of how to describe risk have become inc... more 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.
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Papers by Peter Schwartz