Once again we are moving toward the end of a term, and as a result, this will be the now-legendary end-of-term posting. I’ll return again in a couple of weeks or so, but please enjoy this last post for the Spring 2010 term.
1. Via Ferrata: The idea of Via Ferrata grew out of World War I and II; soldiers developed means to cross mountain passes using a series of bolts and iron wiring that allowed mountain soldiers to climb areas that otherwise were impassable. Today, these same routes are used for technical hikers, mainly in Austria, Italy and other European places, and they are not for the faint of heart. Here is just one clip of a young woman walking the Martinswand: http://www.youtube.com/watch?v=7AF8jW9vj3g&feature=related
2. The Dangerous Road: And again, well, you can do something similar on a mountain bike. Here are riders heading down the world’s most dangerous road, in Bolivia. There is no way I would even walk this, let alone ride at speed: http://www.youtube.com/watch?v=MtUaherTC50
3. Ping pong! Hey, who doesn’t love seeing a phenomenal table tennis point: http://www.youtube.com/watch?v=MtUaherTC50
4. Blue Cheer: well, bassist Dickie Peterson recently passed away, sad to say. I saw these guys back in 1969, with the MC5 and the Psychedelic Stooges, and it was by far the loudest concert I’ve ever attended. But you had to be there: http://www.youtube.com/watch?v=nU5uDozoSSM
5. Up: This is the trailer for a movie that is so good it hurts. It has one of the most poignant
beginnings you will ever see, and this is despite the fact it is a cartoon. There are no words at all in the first 10 minutes, but what happens is incredibly moving. I highly recommend this film: http://www.youtube.com/watch?v=pkqzFUhGPJg
6. Ponyo: Of course, the true master of animation is Hayao Miyazake, whose past films include the astonishing Spirited Away and Princess Mononoke, among others. His latest film is just as good, Ponyo: http://www.youtube.com/watch?v=bskgNOXbdiE
7. Knowing: Let’s face it; I’m a science nerd, and I loved this sleeper of a movie, which was far better than it had to be. Here is the trailer for Knowing: http://www.youtube.com/watch?v=uxPQhm_Aq-E
8. Dr. Horrible: During the writers’ strike last year, Joss Whedon, creator of Buffy the Vampire Slayer, Angel, Firefly and Dollhouse, used the time to fashion a new approach to marketing a program. He created Dr. Horrible’s Sing Along Blog, starring Neil Patrick Harris, Nathan Fillian and Felicia Day (who herself had created The Guild, from which Whedon got the idea for his program). It’s, to be sure, a real hoot, and here is the first act: http://www.youtube.com/watch?v=apEZpYnN_1g
9. Happy Trails for now, again: http://www.youtube.com/watch?v=XcYsO890YJY
Monday, June 7, 2010
Tuesday, June 1, 2010
Guiding Principles for Scientific Research
The National Research Council offers a set of six guiding principles for scientific research (1), and it bears reiterating them as an aid to those of you considering conducting educational research here at Palmer College.
Principle 1: Post significant questions that can be investigated empirically. That is, develop a question in which your observations guide your conclusions. This is actually quite hard to do; developing a research question is difficult, and often when a well-meaning faculty member discusses his or her idea for a project, and I ask them what the research question is, they get a bit confused. They think the question is what it is they wish to find out- “what my students’ perceptions of “X” are,” for example. Well, that is a question, just not the question, which is much more detailed. What we wish to do is expand on scientific knowledge from prior theory and research.
Principle 2: Link research to relevant theory. Theories are conceptual frameworks that guide research studies. They help provide the reason for a research design and provide context for interpreting findings.
Principle 3: Use methods that permit direct investigation of the question. That is, your research methods should be appropriate for the research question. You will need to provide a detailed description of your research method- and this can lead to some confusion. It is not enough to say, I am conducing a survey. Is it paper based, or is it online? If it is online, how do you recruit participants, and how to gain their consent? How to you collect data, and import to a program where you can analyze that data? A lot of thought has to go into this question. You need to consider the reliability and validity of your measurement instruments, and the proper statistical methods as well.
Principle 4: Provide a coherent and explicit chain of reasoning. Your conclusions are usually going to be based upon inferential reasoning. That is, you are making logical judgments based on the results you obtain, in the context in which you obtained them. You will also need to rule out rival explanations and other threats to the validity of your findings.
Principle 5: Replicate and generalize across studies. You need to provide sufficient detail in your methods so that an interested researcher could replicate what you did, and potentially obtain the same results you did. We need to examine whether your results can be found in other populations and contexts as well, in terms of generalizability.
Principle 6: Disclose research to encourage professional scrutiny and critique. Publish or present your work at conferences or in journals. Share your findings so that we all learn from what you did, and we all can find means to use your data in our specific settings. This is how science grows.
A few good rules here, but worth remembering.
I am pleased to note that this is the 100th entry into this blog- I hope you continue to find it useful and I look forward to posting many more entries.
References
1. National Research Council. Scientific research in education. Washington, DC, National Academy Press, 2002
Principle 1: Post significant questions that can be investigated empirically. That is, develop a question in which your observations guide your conclusions. This is actually quite hard to do; developing a research question is difficult, and often when a well-meaning faculty member discusses his or her idea for a project, and I ask them what the research question is, they get a bit confused. They think the question is what it is they wish to find out- “what my students’ perceptions of “X” are,” for example. Well, that is a question, just not the question, which is much more detailed. What we wish to do is expand on scientific knowledge from prior theory and research.
Principle 2: Link research to relevant theory. Theories are conceptual frameworks that guide research studies. They help provide the reason for a research design and provide context for interpreting findings.
Principle 3: Use methods that permit direct investigation of the question. That is, your research methods should be appropriate for the research question. You will need to provide a detailed description of your research method- and this can lead to some confusion. It is not enough to say, I am conducing a survey. Is it paper based, or is it online? If it is online, how do you recruit participants, and how to gain their consent? How to you collect data, and import to a program where you can analyze that data? A lot of thought has to go into this question. You need to consider the reliability and validity of your measurement instruments, and the proper statistical methods as well.
Principle 4: Provide a coherent and explicit chain of reasoning. Your conclusions are usually going to be based upon inferential reasoning. That is, you are making logical judgments based on the results you obtain, in the context in which you obtained them. You will also need to rule out rival explanations and other threats to the validity of your findings.
Principle 5: Replicate and generalize across studies. You need to provide sufficient detail in your methods so that an interested researcher could replicate what you did, and potentially obtain the same results you did. We need to examine whether your results can be found in other populations and contexts as well, in terms of generalizability.
Principle 6: Disclose research to encourage professional scrutiny and critique. Publish or present your work at conferences or in journals. Share your findings so that we all learn from what you did, and we all can find means to use your data in our specific settings. This is how science grows.
A few good rules here, but worth remembering.
I am pleased to note that this is the 100th entry into this blog- I hope you continue to find it useful and I look forward to posting many more entries.
References
1. National Research Council. Scientific research in education. Washington, DC, National Academy Press, 2002
Monday, May 24, 2010
More on What the Best College Teachers Do
In this entry I return to the work of Ken Bain, whose book on the best college teachers (1) was the basis of his presentation to Palmer Davenport faculty a couple of years ago. In his text, there is a chapter on how the best teachers prepare to teach. And in this chapter he discusses a set of questions he finds that the best teachers ask when involved in course planning.
1. What big questions will my course help students answer, or what skills, abilities or qualities will it help them develop, and how will I encourage my students’ interest in these questions and abilities?
What this means is, we start with the results we hope to foster and work backward. What is it we want out students to do- do we want them to reason, to recall or to comprehend? When we look at the questions we want to ask, do we delve behind that question to see if there are larger questions? Do we test our fundamental assumptions?
2. What reasoning abilities must students have or develop to answer the questions the course raises?
We want more than to ask students to memorize information. We want them to be able to reason out the answers, and we want to get them to do so both collaboratively and by themselves in problem-solving settings.
3. What mental models are students likely to bring with them that I will want them to challenge? How can I help them construct that intellectual challenge?
How do these models impact, either positively or negatively, the learning students need to undergo to answer the questions we have set before them? Can we then plan to use this knowledge to help them do just that?
4. What information will my students need to understand in order to answer the important questions of the course and challenge their assumptions? How will they best obtain that information?
This revolves around what students need to learn, and not what we might intend to do in the classroom or clinic. Our focus is on helping people learn to reason, to think. It moves us away from being purveyors of knowledge, dropping content into student heads and brains. It makes learning far more active, and engaging for the student.
5. How will I help students who have difficulty understanding the questions and using evidence and reason to answer them?
This is sort of a question of tactics; do we answer questions, provide explanations, develop exercises, or what? How do we then develop new skills in our students when challenges arise?
6. How will I confront my students with conflicting problems (maybe even conflicting claims about the truth) and encourage them to grapple (perhaps collaboratively) with the issues?
How true this is in chiropractic, where there are numerous and often contradictory fundamental approaches to chiropractic, to management, to concepts and constructs such as subluxation. What methods can we use to address conflicting information that may arise both inside the educational program and outside it? Addressing conflict in ideas needs to be built into the fabric of our coursework and our teaching methods.
7. How will I find out what they know already and what they expect from the course, and how will I reconcile any differences between my expectations and theirs?
We all understand this, but we still often teach in a way that controls the questions, sets the agenda and so on; we are, after all, the experts here. But how do we reconcile this with a need to provide more self-directed and active learning opportunities?
These are only some of the questions that Bain asks, and there are a good number more, but the point here is to open the teaching window and consider the students whom we teach- look to make this a more active and engaging process in which the student actively helps to construct learning. Our best teachers often do this, and may not even understand why. Bain helps to answer that question.
References
1. Bain K. What the best college teachers do. Cambridge, MA; hardvard University press, 2004:48-57
1. What big questions will my course help students answer, or what skills, abilities or qualities will it help them develop, and how will I encourage my students’ interest in these questions and abilities?
What this means is, we start with the results we hope to foster and work backward. What is it we want out students to do- do we want them to reason, to recall or to comprehend? When we look at the questions we want to ask, do we delve behind that question to see if there are larger questions? Do we test our fundamental assumptions?
2. What reasoning abilities must students have or develop to answer the questions the course raises?
We want more than to ask students to memorize information. We want them to be able to reason out the answers, and we want to get them to do so both collaboratively and by themselves in problem-solving settings.
3. What mental models are students likely to bring with them that I will want them to challenge? How can I help them construct that intellectual challenge?
How do these models impact, either positively or negatively, the learning students need to undergo to answer the questions we have set before them? Can we then plan to use this knowledge to help them do just that?
4. What information will my students need to understand in order to answer the important questions of the course and challenge their assumptions? How will they best obtain that information?
This revolves around what students need to learn, and not what we might intend to do in the classroom or clinic. Our focus is on helping people learn to reason, to think. It moves us away from being purveyors of knowledge, dropping content into student heads and brains. It makes learning far more active, and engaging for the student.
5. How will I help students who have difficulty understanding the questions and using evidence and reason to answer them?
This is sort of a question of tactics; do we answer questions, provide explanations, develop exercises, or what? How do we then develop new skills in our students when challenges arise?
6. How will I confront my students with conflicting problems (maybe even conflicting claims about the truth) and encourage them to grapple (perhaps collaboratively) with the issues?
How true this is in chiropractic, where there are numerous and often contradictory fundamental approaches to chiropractic, to management, to concepts and constructs such as subluxation. What methods can we use to address conflicting information that may arise both inside the educational program and outside it? Addressing conflict in ideas needs to be built into the fabric of our coursework and our teaching methods.
7. How will I find out what they know already and what they expect from the course, and how will I reconcile any differences between my expectations and theirs?
We all understand this, but we still often teach in a way that controls the questions, sets the agenda and so on; we are, after all, the experts here. But how do we reconcile this with a need to provide more self-directed and active learning opportunities?
These are only some of the questions that Bain asks, and there are a good number more, but the point here is to open the teaching window and consider the students whom we teach- look to make this a more active and engaging process in which the student actively helps to construct learning. Our best teachers often do this, and may not even understand why. Bain helps to answer that question.
References
1. Bain K. What the best college teachers do. Cambridge, MA; hardvard University press, 2004:48-57
Monday, May 17, 2010
Anatomy of a Scholarly Article
In general, scholarly research articles are divided into the following sections: Introduction; Methods; Results; Discussion; Conclusion (sometimes referred to as the IMRAD format), though each main heading might have subsections. There will also be an abstract, usually in a structured format, and a reference section; articles missing any of these pieces are likely flawed in some manner. Keep in mind that research reports have structures that differ from case reports or literature reviews, which themselves have unique structures.
Abstract: This is a brief summary of the article limited to a paragraph or 250 words, providing a synopsis of the article. Typically, this is what a reader views before making a decision to read the full article. Today, structured abstracts are most common; these have subheadings for each part of the paper. These are preferred because they do a better job than the traditional prose abstract did. The abstract should present the purpose of the study, and allow the reader to screen for possible bias.
Introduction: This provides a rationale for the study and conveys the article’s purpose. It will usually provide a brief review of the literature, highlighting important research on the topic and giving context for the research. It should stimulate the reader’s interest. It should conclude with a clear statement of the study’s purpose- indicating the hypothesis to be tested or the question to be answered. Thus, an appraisal of the introduction should look to see if the purpose is presented and the context given.
Methods: This provides details about how the study was carried out. It will tell you how subjects were selected and assigned to groups, will describe the equipment used, and will thoroughly describe the procedures used. It will define its experimental design. A standard for the methods section is that it should give you enough information so that an interested researcher could repeat what was done. There should be a statement about the ethical safeguard used for both human and animal research. And there should be a statement about how the data will be analyzed. When you appraise the methods, ensure that the research design is appropriate for the study’s purpose and question, that the population and samples are identified, and that the methods of data collection are described in detail.
Results: This presents the findings of the study. Data is summarized, tables and graphs prepared and information is presented in a comprehensive and convincing manner. Ensure that you see that all data is presented; missing data may be a sign the author is ignoring data contradictory to the study’s hypothesis. All statements should be supported by the data. You should also look to see that all the demographic data is presented, and that statistical tests are described.
Discussion: This section points our new or important features of the study, and compares the study’s results with previous reports. It should help tell whether the data supports the hypothesis, note any limitations and provide alternate explanations for findings. The discussion should follow logically from the study data, leading to conclusions that support the study objectives.
Conclusion: This points out the importance of the study findings, and points to new directions for future research. This is not a place for any speculation.
References: Should be complete and accurate, mainly from peer-reviewed journals and only relevant citations used and cited. They should be up-to-date and from high-quality evidence sources.
Abstract: This is a brief summary of the article limited to a paragraph or 250 words, providing a synopsis of the article. Typically, this is what a reader views before making a decision to read the full article. Today, structured abstracts are most common; these have subheadings for each part of the paper. These are preferred because they do a better job than the traditional prose abstract did. The abstract should present the purpose of the study, and allow the reader to screen for possible bias.
Introduction: This provides a rationale for the study and conveys the article’s purpose. It will usually provide a brief review of the literature, highlighting important research on the topic and giving context for the research. It should stimulate the reader’s interest. It should conclude with a clear statement of the study’s purpose- indicating the hypothesis to be tested or the question to be answered. Thus, an appraisal of the introduction should look to see if the purpose is presented and the context given.
Methods: This provides details about how the study was carried out. It will tell you how subjects were selected and assigned to groups, will describe the equipment used, and will thoroughly describe the procedures used. It will define its experimental design. A standard for the methods section is that it should give you enough information so that an interested researcher could repeat what was done. There should be a statement about the ethical safeguard used for both human and animal research. And there should be a statement about how the data will be analyzed. When you appraise the methods, ensure that the research design is appropriate for the study’s purpose and question, that the population and samples are identified, and that the methods of data collection are described in detail.
Results: This presents the findings of the study. Data is summarized, tables and graphs prepared and information is presented in a comprehensive and convincing manner. Ensure that you see that all data is presented; missing data may be a sign the author is ignoring data contradictory to the study’s hypothesis. All statements should be supported by the data. You should also look to see that all the demographic data is presented, and that statistical tests are described.
Discussion: This section points our new or important features of the study, and compares the study’s results with previous reports. It should help tell whether the data supports the hypothesis, note any limitations and provide alternate explanations for findings. The discussion should follow logically from the study data, leading to conclusions that support the study objectives.
Conclusion: This points out the importance of the study findings, and points to new directions for future research. This is not a place for any speculation.
References: Should be complete and accurate, mainly from peer-reviewed journals and only relevant citations used and cited. They should be up-to-date and from high-quality evidence sources.
Monday, May 10, 2010
Reporting Statistics in Healthcare I
Tom Lang is seen by many as the dean of statistical reporting in healthcare. His book on statistical reporting (1) is a leading text to the guidelines used for this purpose, and for novice writers following his recommendations is de riguer. His book opens with a chapter that reviews the reporting of statistics in each part of a scientific research report. This bears your attention.
FOR THE INTRODUCTION
1. State the purpose of the study. Identify the relationships that were studied and the reasons for studying them. All too often the purpose for the research is left unsaid. In clinical trials, it helps to know if the study is explanatory or pragmatic. Explanatory studies, also known as efficacy studies, are designed to help understand a disease or therapeutic process; as a result, they are best conducted under optimal conditions with extremely tight controls over what occurs during the course of the study. Pragmatic studies, also known as effectiveness studies, are designed to help answer or provide information about clinical decision making. Thus, these are conducted under what might be considered “real world” or normal conditions, representing the reality of working in a clinical environment. Thus, it helps to know the purpose of the study, and in general a study should be one or the other, but not both. Lang states that you will more typically see heterogenous samples in pragmatic studies, but more homogenous samples in explanatory studies, and this makes sense given the above definitions.
2. If the study was designed to test one or more a priori hypotheses, state the hypotheses. This is because good science requires a “clear statement of a testable question.” When we know this in advance, it is called an a priori hypothesis, and the results can then be interpreted in light of that question. When we develop the question after we collect the data, that is termed a post hoc analysis, and this is a more speculative form of analysis because the data was not originally collected to answer the questions being asked “after the fact.”
3. State how the original data may be obtained for reanalysis and the format in which the data are stored. It should be an industry standard that the data collected in scientific studies should be made available upon request. Indeed, several journals require authors to sign a statement that they will provide the data when the editor asks for it. This can help to provide a check on data analysis, as well as scientific misconduct. Authors should report the format in which the data are stored, so as to ensure that those interested will be able to work with that data.
This is an introduction to how we can use report data properly. I will later look at other parts of scientific papers to provide an overview of reporting research designs and activities. I note and recommend that for those interested in conducting research Lang’s book is a must have. Highly recommended.
References
1. Lang T, Sekic M. How to report statistics in medicine: annotated guidelines for authors, editors and reviewers. 2nd edition. Philadelphia, PA; American College of Physicians, 2006
FOR THE INTRODUCTION
1. State the purpose of the study. Identify the relationships that were studied and the reasons for studying them. All too often the purpose for the research is left unsaid. In clinical trials, it helps to know if the study is explanatory or pragmatic. Explanatory studies, also known as efficacy studies, are designed to help understand a disease or therapeutic process; as a result, they are best conducted under optimal conditions with extremely tight controls over what occurs during the course of the study. Pragmatic studies, also known as effectiveness studies, are designed to help answer or provide information about clinical decision making. Thus, these are conducted under what might be considered “real world” or normal conditions, representing the reality of working in a clinical environment. Thus, it helps to know the purpose of the study, and in general a study should be one or the other, but not both. Lang states that you will more typically see heterogenous samples in pragmatic studies, but more homogenous samples in explanatory studies, and this makes sense given the above definitions.
2. If the study was designed to test one or more a priori hypotheses, state the hypotheses. This is because good science requires a “clear statement of a testable question.” When we know this in advance, it is called an a priori hypothesis, and the results can then be interpreted in light of that question. When we develop the question after we collect the data, that is termed a post hoc analysis, and this is a more speculative form of analysis because the data was not originally collected to answer the questions being asked “after the fact.”
3. State how the original data may be obtained for reanalysis and the format in which the data are stored. It should be an industry standard that the data collected in scientific studies should be made available upon request. Indeed, several journals require authors to sign a statement that they will provide the data when the editor asks for it. This can help to provide a check on data analysis, as well as scientific misconduct. Authors should report the format in which the data are stored, so as to ensure that those interested will be able to work with that data.
This is an introduction to how we can use report data properly. I will later look at other parts of scientific papers to provide an overview of reporting research designs and activities. I note and recommend that for those interested in conducting research Lang’s book is a must have. Highly recommended.
References
1. Lang T, Sekic M. How to report statistics in medicine: annotated guidelines for authors, editors and reviewers. 2nd edition. Philadelphia, PA; American College of Physicians, 2006
Monday, May 3, 2010
The Challenges of International Research
Over the past few months, I’ve fielded a number of questions from faculty members interested in conducting scientific research while on a Clinic Abroad trip. In each case, I have had to discuss the challenges of doing so, because the conduct of human subject research in foreign settings is fraught with legal, moral and ethical issues. And as much as I truly hate being the bearer of bad news- for after all, my role is in part to enhance research scholarship- there are good reasons to raise those challenges. I thought I would use this entry to briefly discuss the ethics of international research.
As human activity globalizes, there has been increasing concern about international research ethics since a significant amount of drug research now occurs in third-world and developing nations. Not all of this has been without controversy. In the United States, our research ethics has been guided by the Belmont Report (1), which itself was based on the Declaration of Helsinki (2) [which was itself based on the Nuremburg Code (3) that developed immediately after the end of World War II]. While these codes and accords began with the protection of subjects involved in non-therapeutic research (that is , research that provided no benefit to the subject), it has been universalized to those who also participate in therapeutic research ( where there is a potential for subject benefit, not a guarantee). Arising from this is the key bioethical precept of informed consent. Quoting my former instructor Dr. Erin Egan, “Informed consent in research is a complex issue even in the United States, and research in other countries adds several levels of complexity.”(4) Beyond that, other areas of concern include (a) Vulnerable populations issues, (b) Informed consent issues, and (c) Social justice and societal benefits issues.
Vulnerable Populations: Major pharmaceutical companies look to overseas regions because it is cheaper and they might be able to use study designs that would not be approved for use in the United States. Costs are lower because potential participants are likely to accept far less monies that subjects in the US would, and because poverty may ultimately override their normal caution in considering participation. If you obtain participants because of poverty and desperation, this can be problematic; it is not unethical in and of itself to simply offer lower costs and payments. And consider this: if you do an AIDS trial in, say, Mozambique because the design you are using is not ethical in the US, and you are not offering any care once the trial is done, and the people of Mozambique will not be able to use the drug under development because it will cost too much; you are taking advantage of the population since they will never benefit from the results, and you are then using them to help develop a drug to be sold in the US alone. I think we can see the problem here. The current standard is that all research participants are entitled to the worldwide best standard of care (as opposed to the standard of care as offered in that country, said standard of which may be no care at all).
Informed Consent: This is hard to address in the USA as it is; it is even harder when you factor in language and cultural issues, as well as lack of education. How can we translate our English language consent forms into another language and retain the nuances of the document, and ensure it is written at an appropriate level? How well do we understand the culture itself? Do we need to involve community leaders or tribal elders? How do ensure that women are not coerced, without our knowledge, into participating or not participating?
Social Justice and Societal Benefits: There now exists both national and international guidelines about what comprises acceptable research in foreign populations. These are designed to help limit the concerns we might have about using one population of subjects for the primary benefit of another more advantaged population. Thus, one stipulation of this consensus is that the research must benefit the population studied; it makes sense, for example, to study Malaria in a country where it is endemic, though it might be less ethical to study the effects of a new drug for obesity in such populations. A second issue is that of subsequent care- you should not come into an area, conduct research and then leave without considering providing some consideration of the subsequent health needs of the community. This may seem less critical for chiropractic care, since it is not generally addressing life-threatening diseases, but it is still no less true. In countries with poor infrastructure, how do ensure this happens?
There is also one other consideration, and that is ethics review. We have a Palmer IRB which reviews research conducted by Palmer faculty and researchers. When working in another country, we need to follow their laws as well as our own, and this means we need to have IRB review done by both the Palmer IRB and a local IRB in the country of interest. We need to be sensitive to the health ministry and its regulations as well. This needs to be studied, since it varies by country. The National Bioethics Advisory Committee has said this on this issue: “Recommendation 5.2: The U.S. government should not sponsor or conduct clinical trials in developing countries unless such trials have received prior approval by an ethics review committee in the host country and by a U.S. Institutional Review Board. However, if the human participants protection system of the host country or a particular host country institution has been determined by the U.S. government to achieve all the substantive ethical protections outlined in Recommendation 1.1, then review by a host country ethics review committee alone is sufficient.” (5)
Given all these considerations, I hope you can see why I have been so cautious about the development of foreign-based projects during Clinic Abroad trips. This is not to say we cannot consider such research, but it will take significant planning to be able to develop such a project successfully.
References
1. http://ohsr.od.nih.gov/guidelines/belmont.html, accessed April 27, 2010
2. http://www.wma.net/en/30publications/10policies/b3/index.html, accessed April 27, 2010
3. http://ohsr.od.nih.gov/guidelines/nuremberg.html, accessed April 27, 2010
4. Egan E. Course notes, week 11, Research Ethics. Loyola University, Nieswanger Institute of Ethics, 2009
5. National Bioethics Advisory Committee. Ethical and policy issues in international research: clinical trials in developing countries. Bethesda, MD, 2001
As human activity globalizes, there has been increasing concern about international research ethics since a significant amount of drug research now occurs in third-world and developing nations. Not all of this has been without controversy. In the United States, our research ethics has been guided by the Belmont Report (1), which itself was based on the Declaration of Helsinki (2) [which was itself based on the Nuremburg Code (3) that developed immediately after the end of World War II]. While these codes and accords began with the protection of subjects involved in non-therapeutic research (that is , research that provided no benefit to the subject), it has been universalized to those who also participate in therapeutic research ( where there is a potential for subject benefit, not a guarantee). Arising from this is the key bioethical precept of informed consent. Quoting my former instructor Dr. Erin Egan, “Informed consent in research is a complex issue even in the United States, and research in other countries adds several levels of complexity.”(4) Beyond that, other areas of concern include (a) Vulnerable populations issues, (b) Informed consent issues, and (c) Social justice and societal benefits issues.
Vulnerable Populations: Major pharmaceutical companies look to overseas regions because it is cheaper and they might be able to use study designs that would not be approved for use in the United States. Costs are lower because potential participants are likely to accept far less monies that subjects in the US would, and because poverty may ultimately override their normal caution in considering participation. If you obtain participants because of poverty and desperation, this can be problematic; it is not unethical in and of itself to simply offer lower costs and payments. And consider this: if you do an AIDS trial in, say, Mozambique because the design you are using is not ethical in the US, and you are not offering any care once the trial is done, and the people of Mozambique will not be able to use the drug under development because it will cost too much; you are taking advantage of the population since they will never benefit from the results, and you are then using them to help develop a drug to be sold in the US alone. I think we can see the problem here. The current standard is that all research participants are entitled to the worldwide best standard of care (as opposed to the standard of care as offered in that country, said standard of which may be no care at all).
Informed Consent: This is hard to address in the USA as it is; it is even harder when you factor in language and cultural issues, as well as lack of education. How can we translate our English language consent forms into another language and retain the nuances of the document, and ensure it is written at an appropriate level? How well do we understand the culture itself? Do we need to involve community leaders or tribal elders? How do ensure that women are not coerced, without our knowledge, into participating or not participating?
Social Justice and Societal Benefits: There now exists both national and international guidelines about what comprises acceptable research in foreign populations. These are designed to help limit the concerns we might have about using one population of subjects for the primary benefit of another more advantaged population. Thus, one stipulation of this consensus is that the research must benefit the population studied; it makes sense, for example, to study Malaria in a country where it is endemic, though it might be less ethical to study the effects of a new drug for obesity in such populations. A second issue is that of subsequent care- you should not come into an area, conduct research and then leave without considering providing some consideration of the subsequent health needs of the community. This may seem less critical for chiropractic care, since it is not generally addressing life-threatening diseases, but it is still no less true. In countries with poor infrastructure, how do ensure this happens?
There is also one other consideration, and that is ethics review. We have a Palmer IRB which reviews research conducted by Palmer faculty and researchers. When working in another country, we need to follow their laws as well as our own, and this means we need to have IRB review done by both the Palmer IRB and a local IRB in the country of interest. We need to be sensitive to the health ministry and its regulations as well. This needs to be studied, since it varies by country. The National Bioethics Advisory Committee has said this on this issue: “Recommendation 5.2: The U.S. government should not sponsor or conduct clinical trials in developing countries unless such trials have received prior approval by an ethics review committee in the host country and by a U.S. Institutional Review Board. However, if the human participants protection system of the host country or a particular host country institution has been determined by the U.S. government to achieve all the substantive ethical protections outlined in Recommendation 1.1, then review by a host country ethics review committee alone is sufficient.” (5)
Given all these considerations, I hope you can see why I have been so cautious about the development of foreign-based projects during Clinic Abroad trips. This is not to say we cannot consider such research, but it will take significant planning to be able to develop such a project successfully.
References
1. http://ohsr.od.nih.gov/guidelines/belmont.html, accessed April 27, 2010
2. http://www.wma.net/en/30publications/10policies/b3/index.html, accessed April 27, 2010
3. http://ohsr.od.nih.gov/guidelines/nuremberg.html, accessed April 27, 2010
4. Egan E. Course notes, week 11, Research Ethics. Loyola University, Nieswanger Institute of Ethics, 2009
5. National Bioethics Advisory Committee. Ethical and policy issues in international research: clinical trials in developing countries. Bethesda, MD, 2001
Monday, April 26, 2010
Single Subject Time Series Designs
The single subject time series design (SSTSD) is a form of a case report that uses a more formal process to track the response of a single patient over time. One of the challenges physicians face is the knowledge that it is never really possible to know, for a given single patient, that what we have done to the patient has resulted in the response we see. There can be many reasons a patient responds after therapy, such as natural history, the intervention, placebo effect, and so on. However, the SSTSD provides us with a better window into the usefulness of our intervention, since it tracks a single person over time.
In an SSTSD, you would initially establish a baseline on your patient over a period of at least 3 visits. Here, you would collect data on the patient’s status. For example, perhaps we were working with a patient who has chronic low back pain, and our outcomes measures include an Oswestry Disability Index as well as a Visual Analogue Scale. Taking these three measures gives us a stable sense of the patient’s status. Then, we begin treatment, and during the period of treatment we continue to take these same outcome measurements. We do so for the same length of time as we did for the baseline period. We might see a change in scores when we do this, a reduction in both disability and pain. This can help establish a relation between our intervention and the patient response. Now, let’s add one more period of measurement, a follow-up period where we cease therapy again, and instead measure the outcomes over a similar period of time. If we see the scores rise or return to where they were before we started treatment, this is even better data demonstrating the impact that our therapy has. This is known as an ABA design for a SSTSD.
Conditions ripe for study as SSTSDs need to be stable and chronic; acute conditions vary too quickly for a physician or researcher to be able to establish a meaningful baseline for comparison, because as you can see, the patient acts as his or her own control during the treatment and follow-up time. These kinds of studies are useful for helping a patient to understand change over time, especially for conditions where change in made only incrementally and slowly (for example, frozen should or adhesive capsulitis).
Variations in this design exist. For example, an ABA design can be repeated over time as an ABAB design, also known as a withdrawal design since it withdraws and then restores therapy several times. There can be an ABAC design, where C represents a second, alternative intervention. We can also consider a multiple baseline design, in which at least 3 individuals are tracked like this, but with the caveat that we do not begin treatment on the second patient until after we see a response in the first, and we do not begin treatment on the third patient until we see a response in the second. The differing baselines here are a means to reduce effects of confounding influences. There is also a simultaneous baseline design in which we do the same as in a multiple baseline approach but gather all our patients at the same time; in a multiple baseline approach it is not necessary to do so.
This methodology can be useful in a practice setting, and can be a means for a chiropractor to collect data for future publication. It also is a means to strengthen the results drawn from case reports, which tend to fall lower on an evidence hierarchy. I do not neglect case reports, though; they are often the papers clinicians turn to first, and they can offer direction for challenging patients.
In an SSTSD, you would initially establish a baseline on your patient over a period of at least 3 visits. Here, you would collect data on the patient’s status. For example, perhaps we were working with a patient who has chronic low back pain, and our outcomes measures include an Oswestry Disability Index as well as a Visual Analogue Scale. Taking these three measures gives us a stable sense of the patient’s status. Then, we begin treatment, and during the period of treatment we continue to take these same outcome measurements. We do so for the same length of time as we did for the baseline period. We might see a change in scores when we do this, a reduction in both disability and pain. This can help establish a relation between our intervention and the patient response. Now, let’s add one more period of measurement, a follow-up period where we cease therapy again, and instead measure the outcomes over a similar period of time. If we see the scores rise or return to where they were before we started treatment, this is even better data demonstrating the impact that our therapy has. This is known as an ABA design for a SSTSD.
Conditions ripe for study as SSTSDs need to be stable and chronic; acute conditions vary too quickly for a physician or researcher to be able to establish a meaningful baseline for comparison, because as you can see, the patient acts as his or her own control during the treatment and follow-up time. These kinds of studies are useful for helping a patient to understand change over time, especially for conditions where change in made only incrementally and slowly (for example, frozen should or adhesive capsulitis).
Variations in this design exist. For example, an ABA design can be repeated over time as an ABAB design, also known as a withdrawal design since it withdraws and then restores therapy several times. There can be an ABAC design, where C represents a second, alternative intervention. We can also consider a multiple baseline design, in which at least 3 individuals are tracked like this, but with the caveat that we do not begin treatment on the second patient until after we see a response in the first, and we do not begin treatment on the third patient until we see a response in the second. The differing baselines here are a means to reduce effects of confounding influences. There is also a simultaneous baseline design in which we do the same as in a multiple baseline approach but gather all our patients at the same time; in a multiple baseline approach it is not necessary to do so.
This methodology can be useful in a practice setting, and can be a means for a chiropractor to collect data for future publication. It also is a means to strengthen the results drawn from case reports, which tend to fall lower on an evidence hierarchy. I do not neglect case reports, though; they are often the papers clinicians turn to first, and they can offer direction for challenging patients.
Subscribe to:
Posts (Atom)
Posts
