Most IRBs have procedures for expedited review for specific types of research involving no more than minimal risk. These include procedures that follow, adapted from the Code of Federal regulations (45 CFR 46).
Prospective collection of:
1. Biological specimens for research purposes by noninvasive means such as: hair and nail clippings in a non-disfiguring manner; deciduous teeth at time of exfoliation; permanent or deciduous teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated manner or stimulated by chewing gum base or wax or by applying a dilute citric acid solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; supra- and subgingival dental placque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization.
2. Blood samples by finger stick, heel stick, ear stick or venipuncture collected no more than twice weekly from health, nonpregnant adults who weight at least 110 pounds in amounts not to exceed 550ml in an 8-week period, or from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected, but the amount drawn may not exceed the lesser of of 50ml or 3ml per kg in an 8-week period.
3. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
4. Data obtained through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Any medical devices must be already approved for marketing and not currently being tested for safety and effectiveness. Examples: physical sensors that are applied to the either the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow and echocardiography; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
5. Data from voice, video, digital, or image recordings made for research purposes.
6. Data on individual or group characteristics or behavior (such as research on perception, cognition, motivation, identity language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Decisions on exemption at Palmer College initially start with consideration by the Human Protections Administrator. If exempt, you are free to conduct your research; if not, the IRB will review the project proposal.
Tuesday, February 24, 2009
Monday, February 16, 2009
Using Television Shows to Teach Communication
An interesting new paper by Wong and colleagues (1) discusses how they used excerpts from two television shows to help teach their internal medicine residents better communication skills. As has long been understood, good communication skills are a necessary part of patient care; these skills help build trust, help communicate information at a level the patient can understand, and therefore also help to increase patient satisfaction. While communication skills are now a core competency within the medical profession, I am not certain that this is the case within chiropractic. Certainly, within Palmer College, attention is given in practice management courses to better communication, and there is also our SPEAK organization, which is designed to provide opportunity and training to our students in public speaking. This is but another form of communication, of course. However, a standardized curriculum or teaching approach does not exist.
In 1999, medical educators met in Kalamazoo, Michigan to develop such guidelines (2).There model had seven essential elements: building a relationship, opening the discussion, gathering information, understanding the patient’s perspective, sharing information, reaching agreement on problems and plans, and providing closure. As Wong et al note, no formal teaching method for this model exists in the literature. There therefore tried to develop such a model based on what is know as cinemeducation, or the use of clips from popular television and movie clips.
Their project used clips from the programs House, MD and Grey’s Anatomy. Episodes were carefully selected to demonstrate important and/or sensitive situations in doctor-patient relationships. The scenarios helped to demonstrate the importance of the seven competencies provided by the Kalamazoo model. Here, the scenarios looked at end-of-life issues, psychosocial aspects of illness, and disclosure of medical errors. After watching, residents were asked to answer questions related to the seven aspects of the Kalamazoo model, and to have interactive reflection about what they experienced while watching.
While it is true that television programs have a heightened sense of reality, and are drama driven, their use as a teaching tool may not be used as effectively, or even as much, as possible. Within my field of bioethics, House, MD provides significant grounds for discussion. I have even posted an earlier blog post using one of its episodes as grounds for discussion. I’d like to suggest that some consideration be given to using this mode of teaching, which will engage our students at a cultural, as well as an educational, level.
References
1. Wong RY, Saber SS, Ma I, Roberts JM. Using television shows to teach communication skills in internal medicine residency. BMC Med Educ 2009;9:9 doi:10.1186/1472-6920-9-9
2. Makoul G. Essential elements of communication in medical encounters: the Kalamazoo consensus statement. Acad Med 2001;277:390-393
In 1999, medical educators met in Kalamazoo, Michigan to develop such guidelines (2).There model had seven essential elements: building a relationship, opening the discussion, gathering information, understanding the patient’s perspective, sharing information, reaching agreement on problems and plans, and providing closure. As Wong et al note, no formal teaching method for this model exists in the literature. There therefore tried to develop such a model based on what is know as cinemeducation, or the use of clips from popular television and movie clips.
Their project used clips from the programs House, MD and Grey’s Anatomy. Episodes were carefully selected to demonstrate important and/or sensitive situations in doctor-patient relationships. The scenarios helped to demonstrate the importance of the seven competencies provided by the Kalamazoo model. Here, the scenarios looked at end-of-life issues, psychosocial aspects of illness, and disclosure of medical errors. After watching, residents were asked to answer questions related to the seven aspects of the Kalamazoo model, and to have interactive reflection about what they experienced while watching.
While it is true that television programs have a heightened sense of reality, and are drama driven, their use as a teaching tool may not be used as effectively, or even as much, as possible. Within my field of bioethics, House, MD provides significant grounds for discussion. I have even posted an earlier blog post using one of its episodes as grounds for discussion. I’d like to suggest that some consideration be given to using this mode of teaching, which will engage our students at a cultural, as well as an educational, level.
References
1. Wong RY, Saber SS, Ma I, Roberts JM. Using television shows to teach communication skills in internal medicine residency. BMC Med Educ 2009;9:9 doi:10.1186/1472-6920-9-9
2. Makoul G. Essential elements of communication in medical encounters: the Kalamazoo consensus statement. Acad Med 2001;277:390-393
Monday, February 9, 2009
Social Capital
Social capital is a concept derived from sociological research which can be applied to the educational setting. It refers to the connections that exist with and between social networks as well as connections among individuals (1). The core idea of social capital is that social networks have value and may play a significant role in the productivity of faculty within an institution of higher learning. (2) Adler and Kwan define social capital as “the goodwill that is engendered in the social relations of social systems, and that can be mobilized to facilitate collective action.” (3)
Social capital as an idea has been useful in aiding our understanding of organizational behavior. In specific, it has been used to examine cooperation and trust. Notably, it exists only within its specific setting, and is seen by management researchers as an important source of competitive advantage. One of the great problems facing those looking at social capital is, how do we create it? A paper by Pastoriza and colleagues (4) argues that a critical component of social capital is the daily personal interaction of personnel at all levels of the organization. The issue becomes how to foster and facilitate trust, associability and identification as chief components of social capital.
We are not social scientists here at Palmer. Most of us do not consider management theory in our interactions with friends, colleagues, administration or academic leadership. Yet we all know that there are good ways to enter into discussion, and there are less effective ways to do so. Management theory looks at issues such as self-interest, opportunism and note that human agency may be an important driver in our interactions, i.e, what is in it for me? Entire disciplines are built around this, such as agency theory and transaction cost analysis, and therefore efforts need to occur to overcome the limitations of self-interest. Mind you, this should not be seen as a negative. We wish to see self-motivated faculty working to advance themselves while also working to hone their draft. But of course, all of us are mindful that we are doing so within an organizational system, in our case a chiropractic education institution.
Pastoriza notes that organizational social capital has two main components: associability (collective goal orientation) and shared trust. Associability is defined as “the willingness and ability of organizational members to subordinate their parochial interests to firm’s collective goals.” (5) Here, the idea is that we care for others’ well being. Shed trust refers to one individual fully internalizing the other’s preferences. Organizations with high levels of social capital have high levels of identification trust.
Social capital can be created, but it takes work. AS one can read from this short description, a main goal in creating social capital is to enhance trust and associability, both of which work to enhance human relations. Success in its creation works to the benefit of both the organization and the people working for it.
References
1. Portes A. Social capital: its origins and applications in modern sociology. Ann Rev Soc 1998;24:1-24
2. Putnam R. Bowling alone: the collapse and revival of Americna community. New York, NY; Simon and Schuster, 2000
3. Adler PS, Kwan S. Social capital: prospects for a new concept. Acad Management Rev 2002;27:17-40
4. Pastoriza D, Arino MA, Ricart JE. Ethical management behaviour as an antecedent of organizational social capital. J Business Ethics 2008;78:329-341
5. Leana CR, Van Buren HJ. Organizational social capital and employment practices. Acad Management Rev 1999;24:538-555
Social capital as an idea has been useful in aiding our understanding of organizational behavior. In specific, it has been used to examine cooperation and trust. Notably, it exists only within its specific setting, and is seen by management researchers as an important source of competitive advantage. One of the great problems facing those looking at social capital is, how do we create it? A paper by Pastoriza and colleagues (4) argues that a critical component of social capital is the daily personal interaction of personnel at all levels of the organization. The issue becomes how to foster and facilitate trust, associability and identification as chief components of social capital.
We are not social scientists here at Palmer. Most of us do not consider management theory in our interactions with friends, colleagues, administration or academic leadership. Yet we all know that there are good ways to enter into discussion, and there are less effective ways to do so. Management theory looks at issues such as self-interest, opportunism and note that human agency may be an important driver in our interactions, i.e, what is in it for me? Entire disciplines are built around this, such as agency theory and transaction cost analysis, and therefore efforts need to occur to overcome the limitations of self-interest. Mind you, this should not be seen as a negative. We wish to see self-motivated faculty working to advance themselves while also working to hone their draft. But of course, all of us are mindful that we are doing so within an organizational system, in our case a chiropractic education institution.
Pastoriza notes that organizational social capital has two main components: associability (collective goal orientation) and shared trust. Associability is defined as “the willingness and ability of organizational members to subordinate their parochial interests to firm’s collective goals.” (5) Here, the idea is that we care for others’ well being. Shed trust refers to one individual fully internalizing the other’s preferences. Organizations with high levels of social capital have high levels of identification trust.
Social capital can be created, but it takes work. AS one can read from this short description, a main goal in creating social capital is to enhance trust and associability, both of which work to enhance human relations. Success in its creation works to the benefit of both the organization and the people working for it.
References
1. Portes A. Social capital: its origins and applications in modern sociology. Ann Rev Soc 1998;24:1-24
2. Putnam R. Bowling alone: the collapse and revival of Americna community. New York, NY; Simon and Schuster, 2000
3. Adler PS, Kwan S. Social capital: prospects for a new concept. Acad Management Rev 2002;27:17-40
4. Pastoriza D, Arino MA, Ricart JE. Ethical management behaviour as an antecedent of organizational social capital. J Business Ethics 2008;78:329-341
5. Leana CR, Van Buren HJ. Organizational social capital and employment practices. Acad Management Rev 1999;24:538-555
Monday, February 2, 2009
Small Group Learning
Small group learning is one effective method health care educators can use to enhance student learning. As noted by Crosby (1), it “recognizes a movement towards learner-centered, problem-based and self-directed learning.” Crosby notes that there is no definitive answer to what constitutes “small” in terms of number of students, but what is important is that a small group must exhibit three attributes: active participation, a specific task, and reflection. By this, she means that those involved must all actively engage in the interaction, must have a clearly defined task and must reflect so that deep learning is achieved.
There are a number of benefits to small group learning. They include:
– Actively learn. When one works alone, it is often difficult to be able to understand what you have learned, what you do not understand and what you need to understand. Using group discussions can aid in understanding and in determining what information a student is not comprehending. Further, it helps that each student brings to their discussions an individual knowledge base which can be shared.
– Encourages self-motivation. Being actively involved motivates persons to learn and to learn more effectively.
– Allows application and development of ideas. Ideas generated by the group can be applied and tested, and therefore also help understanding of the issues involved.
– Promotes deep learning. Surface learning is the learning of facts, which requires nothing more than memorization. Small group work has been found to be better able to achieve deep learning, a better sense and understanding of the material.
– Promotes an adult style of learning. Part of our goals in educating our students is to expose them to adult learning principles. Our students come in as a mix of both traditional students (such as those who have come straight from a traditional undergraduate background) and adult learners (those who may have had experience in a work setting for some time before entering chiropractic college). Once everyone graduates, adult learning styles become critically important; the newly minted doctors need to know how to locate, synthesize and apply information without being led there by an instructor. Small group learning works with these principles and encourages individual responsibility for learning.
– Develop transferable skills. These skills include leadership, teamwork, organization, collaboration, time management, etc. They are skills that can be used in many settings within health care.
Cosby also notes the challenges to small group learning:
– Students do not like small group work. They are not accustomed to it, particularly those who come in from traditional undergraduate programs. It is alien to their experience. They don’t see the value, have been acculturated to passive learning, can wreak havoc in group dynamics, and it can be difficult for the students to see how learning is occurring.
– Staff do not know how to teach in small groups. Most of us grew up as traditional teachers, content experts who know our discipline and have found means to effectively (we think) teach our craft. This experience requires a new role for an instructor, one that differs from our past experience.
– We do not have enough teachers for small group work. This is always a challenge, because it does require additional time involvement by the instructors.
– There are too few rooms. This is also a problem in many institutions, and could potentially be so here were we to use this form of teaching in more widespread fashion.
– It is a waste of time- students do not learn anything. We feel that because we did a lecture on a topic and because students were there to hear it, they have learned it. And there is solace in that. We cannot see the learning in small group like we do in lecture, because we cannot see “the lecture” in those sessions. Therefore we often may believe no learning has occurred.
There are certainly challenges in using small-groups, but there is also great opportunity as well.
References
1. Crosby J. Learning in small groups. Med Teacher 1997;19:189-202
There are a number of benefits to small group learning. They include:
– Actively learn. When one works alone, it is often difficult to be able to understand what you have learned, what you do not understand and what you need to understand. Using group discussions can aid in understanding and in determining what information a student is not comprehending. Further, it helps that each student brings to their discussions an individual knowledge base which can be shared.
– Encourages self-motivation. Being actively involved motivates persons to learn and to learn more effectively.
– Allows application and development of ideas. Ideas generated by the group can be applied and tested, and therefore also help understanding of the issues involved.
– Promotes deep learning. Surface learning is the learning of facts, which requires nothing more than memorization. Small group work has been found to be better able to achieve deep learning, a better sense and understanding of the material.
– Promotes an adult style of learning. Part of our goals in educating our students is to expose them to adult learning principles. Our students come in as a mix of both traditional students (such as those who have come straight from a traditional undergraduate background) and adult learners (those who may have had experience in a work setting for some time before entering chiropractic college). Once everyone graduates, adult learning styles become critically important; the newly minted doctors need to know how to locate, synthesize and apply information without being led there by an instructor. Small group learning works with these principles and encourages individual responsibility for learning.
– Develop transferable skills. These skills include leadership, teamwork, organization, collaboration, time management, etc. They are skills that can be used in many settings within health care.
Cosby also notes the challenges to small group learning:
– Students do not like small group work. They are not accustomed to it, particularly those who come in from traditional undergraduate programs. It is alien to their experience. They don’t see the value, have been acculturated to passive learning, can wreak havoc in group dynamics, and it can be difficult for the students to see how learning is occurring.
– Staff do not know how to teach in small groups. Most of us grew up as traditional teachers, content experts who know our discipline and have found means to effectively (we think) teach our craft. This experience requires a new role for an instructor, one that differs from our past experience.
– We do not have enough teachers for small group work. This is always a challenge, because it does require additional time involvement by the instructors.
– There are too few rooms. This is also a problem in many institutions, and could potentially be so here were we to use this form of teaching in more widespread fashion.
– It is a waste of time- students do not learn anything. We feel that because we did a lecture on a topic and because students were there to hear it, they have learned it. And there is solace in that. We cannot see the learning in small group like we do in lecture, because we cannot see “the lecture” in those sessions. Therefore we often may believe no learning has occurred.
There are certainly challenges in using small-groups, but there is also great opportunity as well.
References
1. Crosby J. Learning in small groups. Med Teacher 1997;19:189-202
Monday, January 26, 2009
House Redux
House, MD is a great program for discussion about medical ethics, or bioethics. And the scenario I presented in last week’s post is rife with interesting twists and turns. We can see the following: Foreman convinced Thirteen to enter a trial in which he was one of the co-investigators because he is falling in love with her and wants to give her a chance to live a longer life. To do so, he has to manipulate her emotionally, because she was initially not interested in being in the trial. To do so, he arranges to bring Thirteen into contact with a woman suffering a far more advanced case of Huntington’s, meaning he had to manipulate that patient’s schedule. Thirteen catches on to this, and because of bleed-over from a patient she is involved in treating, whose condition has taken its toll on his family, she decides to end her relationship with Foreman. When she returns for her next treatment, she finds the same woman patient she had seen before, but very much improved. She accuses Foreman of bringing her to manipulate her, but Foreman lies by telling her he did not know what drug the other woman was getting, was not in charge of scheduling, and did not do it- we later learn he did do all of this. House knows, but House also does nothing about it. And the nurse unblinds the treatment regimen that Thirteen is getting. So we see violations of medical ethics by Foreman, the nurse, and House. Foreman is now aware that Thirteen is not getting the active treatment, but is getting the placebo. This is not going to end well.
All research projects have protocols that dictate how they are to be conducted. And all trials are based on something called clinical equipoise, which is a foundational setting that says that we do not know which of the treatments will have better improvement. If we do not start with this at baseline, ethically we cannot do the trial, because if we know that one treatment is better than another we cannot knowingly enter people into the trial knowing that some will be given a less effective treatment. Part of this also involves ensuring that research participants have an equal chance to be in either groups, and in our informed consent documents, we will tell them what we believe to be the risks and benefits of participation. What we will not do is tell them that they will categorically receive personal benefit; we can’t. Often, the only benefit will be the knowledge that they contributed to scientific information that may benefit others.
When patients believes that their involvement in a trial will personally benefit them, and that the doctors involved are doing everything they can on their behalf, they are said to be suffering from the therapeutic misconception. That is because in a research project, the investigators cannot do everything that would be done were we seeing this person as a patient in our clinic; we are constrained by the project protocols. In Thirteen’s case, her intervention seems to be nothing but the drug, and I do not know what outcomes they are measuring since Thirteen has yet to have any choreaform movements. But certainly, she believes she is receiving help, which is what her smile indicated at the end of the scene.
We have seen coercion used in this scenario. Forman is using his knowledge of his new girlfriend to manipulate her, and to do so he is using a second patient to show her how effective the experimental drug is. He has knowingly broken the scheduling log, and was caught by House, who did nothing as yet about it. The nurse should be taken to task as well for breaking the blinding. And these are only some of the issues involved. When we conduct research here at our PCCR, these issues are discussed and resolved long before we ever begin entering patients into our trials. Princeton Plainsboro (House’s hospital) certainly should know better.
All research projects have protocols that dictate how they are to be conducted. And all trials are based on something called clinical equipoise, which is a foundational setting that says that we do not know which of the treatments will have better improvement. If we do not start with this at baseline, ethically we cannot do the trial, because if we know that one treatment is better than another we cannot knowingly enter people into the trial knowing that some will be given a less effective treatment. Part of this also involves ensuring that research participants have an equal chance to be in either groups, and in our informed consent documents, we will tell them what we believe to be the risks and benefits of participation. What we will not do is tell them that they will categorically receive personal benefit; we can’t. Often, the only benefit will be the knowledge that they contributed to scientific information that may benefit others.
When patients believes that their involvement in a trial will personally benefit them, and that the doctors involved are doing everything they can on their behalf, they are said to be suffering from the therapeutic misconception. That is because in a research project, the investigators cannot do everything that would be done were we seeing this person as a patient in our clinic; we are constrained by the project protocols. In Thirteen’s case, her intervention seems to be nothing but the drug, and I do not know what outcomes they are measuring since Thirteen has yet to have any choreaform movements. But certainly, she believes she is receiving help, which is what her smile indicated at the end of the scene.
We have seen coercion used in this scenario. Forman is using his knowledge of his new girlfriend to manipulate her, and to do so he is using a second patient to show her how effective the experimental drug is. He has knowingly broken the scheduling log, and was caught by House, who did nothing as yet about it. The nurse should be taken to task as well for breaking the blinding. And these are only some of the issues involved. When we conduct research here at our PCCR, these issues are discussed and resolved long before we ever begin entering patients into our trials. Princeton Plainsboro (House’s hospital) certainly should know better.
Tuesday, January 20, 2009
Bioethics on Television: The Case of House, M.D.
I am about half-way through a master’s degree in biomedical ethics and public health, and I have an abiding interest in how ethics issues are portrayed in media. One of television’s most popular programs is House, M.D. It features the misanthrope Dr. Gregory House, who is brilliant but who pays utterly no attention to social conventions or rules of human behavior in his zeal to solve the difficult medical cases that he sees each week. This includes the rules of medical ethics that all institutions have to live by. So each week House does what he thinks necessary in order to diagnose the condition; this may include breaking into a patient’s house, treating them against their will, bullying them into compliance or forcing his co-workers to do his dirty deeds.
Last night’s episode contained a number of issues that are illustrative, but in this case they do not actually involve House himself, but the people who work for him and who have been influenced by him whether they wish to admit it or not. To set the stage, let me note that House’s colleague Dr. Foreman has begun a new relation with House’s latest hire, Dr. Remy Hadley, better known by her nickname “Thirteen.” Recently, Thirteen was positively diagnosed with Huntington’s Chorea, which has not yet begun to manifest; however, she understands it is a death sentence and has begun acting badly as a result. With Foreman’s coaching and after facing death from a deranged patient, she has decided to live better. Thus, she accepts Foreman’s suggestion that she enter a trial of a new drug for her disease, which is being held at their hospital, and which Dr. Foreman is one of the doctors overseeing the trial. In the course of showing up for treatment, she has befriended a woman whose Huntington’s disease is much more advanced, though the constant reminder of what is to come troubles her. As a result, Foremen rescheduled the patient so that they did not have coincident visits.
Which sets the stage for yesterday’s developments. In the episode, Thirteen tells Foreman she cannot see him again. She does not wish, in her words, to bring him down with her as she worsens (the case they are seeing outside of the trial involves a man in constant pain and the effect it has on his family). When she returns for her own treatment in the trial, the patient who had been rescheduled is there again, but she is greatly improved. She is obviously getting the experimental drug and it is working. Thirteen therefore accuses Foreman of setting this up in attempt to get her to remain in the relation. Foreman points out that it is a double blind trial, he does not do the scheduling, and he could not know whether or not this patient is getting the active drug or placebo. Thirteen is mollified and even happy to hear this.
Finally, to the point. Thirteen is in treatment again, and Foreman is there helping to fix a small leak in her IV bottle. They agree to go out that night. When Foreman leaves the room, the nurse outside asks him how he can stand the smell. He notes that he does not smell anything at all. The nurse then states that, in that case the patient (Thirteen) must be getting the placebo because the active drug smells very bad. We see Thirteen sitting inside, alone, but smiling in the thought of a successful treatment and a date to come. And then we see House pull Foreman aside, and tell him that he looked over the treatment logs and saw that Foreman had indeed switched the scheduling and manipulated the other patient in order to maintain his new and growing relation with Thirteen. And now Foreman knows that the woman he is growing to love is getting the placebo. And he is involved with the trial.
So, what violations have occurred here? What is wrong in the picture I have painted? Please feel free to send comments in here if you would like. Next post I will provide some answers, but for now, have at it, please.
Last night’s episode contained a number of issues that are illustrative, but in this case they do not actually involve House himself, but the people who work for him and who have been influenced by him whether they wish to admit it or not. To set the stage, let me note that House’s colleague Dr. Foreman has begun a new relation with House’s latest hire, Dr. Remy Hadley, better known by her nickname “Thirteen.” Recently, Thirteen was positively diagnosed with Huntington’s Chorea, which has not yet begun to manifest; however, she understands it is a death sentence and has begun acting badly as a result. With Foreman’s coaching and after facing death from a deranged patient, she has decided to live better. Thus, she accepts Foreman’s suggestion that she enter a trial of a new drug for her disease, which is being held at their hospital, and which Dr. Foreman is one of the doctors overseeing the trial. In the course of showing up for treatment, she has befriended a woman whose Huntington’s disease is much more advanced, though the constant reminder of what is to come troubles her. As a result, Foremen rescheduled the patient so that they did not have coincident visits.
Which sets the stage for yesterday’s developments. In the episode, Thirteen tells Foreman she cannot see him again. She does not wish, in her words, to bring him down with her as she worsens (the case they are seeing outside of the trial involves a man in constant pain and the effect it has on his family). When she returns for her own treatment in the trial, the patient who had been rescheduled is there again, but she is greatly improved. She is obviously getting the experimental drug and it is working. Thirteen therefore accuses Foreman of setting this up in attempt to get her to remain in the relation. Foreman points out that it is a double blind trial, he does not do the scheduling, and he could not know whether or not this patient is getting the active drug or placebo. Thirteen is mollified and even happy to hear this.
Finally, to the point. Thirteen is in treatment again, and Foreman is there helping to fix a small leak in her IV bottle. They agree to go out that night. When Foreman leaves the room, the nurse outside asks him how he can stand the smell. He notes that he does not smell anything at all. The nurse then states that, in that case the patient (Thirteen) must be getting the placebo because the active drug smells very bad. We see Thirteen sitting inside, alone, but smiling in the thought of a successful treatment and a date to come. And then we see House pull Foreman aside, and tell him that he looked over the treatment logs and saw that Foreman had indeed switched the scheduling and manipulated the other patient in order to maintain his new and growing relation with Thirteen. And now Foreman knows that the woman he is growing to love is getting the placebo. And he is involved with the trial.
So, what violations have occurred here? What is wrong in the picture I have painted? Please feel free to send comments in here if you would like. Next post I will provide some answers, but for now, have at it, please.
Monday, January 12, 2009
Evidence-Based Chiropractic
Over the past few weeks, I’ve engaged in several discussion and meeting where the concept of evidence-based chiropractic (EBC) has been discussed. The administration at Palmer College has committed to the inclusion of EBC in our DC curriculum, and the ninth trimester research course is largely devoted to a thorough presentation of its concepts. Yet still some confusion remains, and I thought I would take time here to discuss some general concepts involved with EBC.
One the challenges members of the chiropractic profession face is how to respond to a patient that stands outside of the normal day-to-day patient management protocols. What do we do when a patient walks in, say, and says that they have a condition such as brucellosis? Certainly, we’ve likely received little training on the management of brucellosis in our clinical education, yet our patient hopes there is something we can do for him. Likely, we will attempt in some fashion to locate information about the chiropractic management of brucellosis, and using that information attempt to move forward with the treatment. But there is a great deal embodied in what I just said. First, we need to recognize that we are essentially trying to construct a clinical question. That is the first skill we need to develop. Once the question is developed, we need to locate information. That is a second skill. Once we have located good information, we need to appraise it to determine what literature, out of all that we find, is germane to answering our question, and that is yet another skill. We need to understand the data in the reports we read, which is still another skill. And then we need to apply the information and monitor what happens, potentially leading to a new question and a new cycle of information gathering, etc. In a nutshell, EBC is the means to do just that.
All too often, EBC is seen as nothing more than using the results of clinical trials to inform clinical practice. As a result, many people fear that doing so will lead to managed care corporations limiting what chiropractors can do in practice. There is, of course, some merit to this fear, but I would remind readers that chiropractic is not simply whatever 65,000 chiropractors say it is (some use crystal waving, for example, but I ask, is that really chiropractic?). And we are all aware that clinical guidelines are often developed using clinical trial results; that is, after all, the entire reason for the Cochrane Collaboration. But this is not what EBC is.
David Sackett described evidence-based medicine as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence form systematic research.” (1) To this has been added the need to take into account patient values as well.
There are a number of points to note here: (1) Clinical expertise is an important part of EBC. In chiropractic, often what we have is significant clinical expertise, but little evidence from clinical trials. (2) Best evidence. This does not necessarily mean “clinical trials.” Often, such information does not exist, but other forms of information, perhaps from lower on the evidence hierarchy, exists. We can use that information in EBC. (3) Patient values come to the fore, and are respected. Why do patients seek chiropractic care and what do they expect from that care? This is taken into account in EBC.
All EBC really is, is a set of tools. These tools help a clinician develop a clinical question, perhaps using a PICO format (patient, intervention, comparison, outcome), develop a literature search, locate and appraise literature, and then apply the information. These tools can be sophisticated, but in the end, they can be easily be learned. As we move forward with implementing our R25 grant, we are working to help provide the skills necessary to use these tools.
References
1. Sackett DL Rosenburg WMC, Muir Gray JM, Haynes RB, Richardson WS. Evidence-based medicine: what it is and what it isn’t. Br Med J 1996;312:71-72
One the challenges members of the chiropractic profession face is how to respond to a patient that stands outside of the normal day-to-day patient management protocols. What do we do when a patient walks in, say, and says that they have a condition such as brucellosis? Certainly, we’ve likely received little training on the management of brucellosis in our clinical education, yet our patient hopes there is something we can do for him. Likely, we will attempt in some fashion to locate information about the chiropractic management of brucellosis, and using that information attempt to move forward with the treatment. But there is a great deal embodied in what I just said. First, we need to recognize that we are essentially trying to construct a clinical question. That is the first skill we need to develop. Once the question is developed, we need to locate information. That is a second skill. Once we have located good information, we need to appraise it to determine what literature, out of all that we find, is germane to answering our question, and that is yet another skill. We need to understand the data in the reports we read, which is still another skill. And then we need to apply the information and monitor what happens, potentially leading to a new question and a new cycle of information gathering, etc. In a nutshell, EBC is the means to do just that.
All too often, EBC is seen as nothing more than using the results of clinical trials to inform clinical practice. As a result, many people fear that doing so will lead to managed care corporations limiting what chiropractors can do in practice. There is, of course, some merit to this fear, but I would remind readers that chiropractic is not simply whatever 65,000 chiropractors say it is (some use crystal waving, for example, but I ask, is that really chiropractic?). And we are all aware that clinical guidelines are often developed using clinical trial results; that is, after all, the entire reason for the Cochrane Collaboration. But this is not what EBC is.
David Sackett described evidence-based medicine as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence form systematic research.” (1) To this has been added the need to take into account patient values as well.
There are a number of points to note here: (1) Clinical expertise is an important part of EBC. In chiropractic, often what we have is significant clinical expertise, but little evidence from clinical trials. (2) Best evidence. This does not necessarily mean “clinical trials.” Often, such information does not exist, but other forms of information, perhaps from lower on the evidence hierarchy, exists. We can use that information in EBC. (3) Patient values come to the fore, and are respected. Why do patients seek chiropractic care and what do they expect from that care? This is taken into account in EBC.
All EBC really is, is a set of tools. These tools help a clinician develop a clinical question, perhaps using a PICO format (patient, intervention, comparison, outcome), develop a literature search, locate and appraise literature, and then apply the information. These tools can be sophisticated, but in the end, they can be easily be learned. As we move forward with implementing our R25 grant, we are working to help provide the skills necessary to use these tools.
References
1. Sackett DL Rosenburg WMC, Muir Gray JM, Haynes RB, Richardson WS. Evidence-based medicine: what it is and what it isn’t. Br Med J 1996;312:71-72
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