Monday, March 30, 2009

Finding Evidence

The Users’ Guide to the Medical Literature states that “assessment of knowledge gaps, question formation, gathering and synthesis of evidence, and application of that evidence to the care of patients are among the foundations of informed care.” (1) At Palmer we are contextualizing evidence-based practice in terms of patient care; we have used the PICO model to derive meaningful clinical questions that can be effectively searched in order to be answered. Thus, in terms of process, we look initially at a clinical case scenario; a patient presents some sort of challenge to a physician, who then must develop a clinical question to search for evidence, assess the evidence and then apply the evidence and monitor results.

Key in this is finding evidence. We locate evidence through the judicious use of information sources. The Users’ Guides categorizes information sources into four categories:

Systems: These are textbook-like resources that provide regularly updated clinical evidence. This may or may not be integrated with other forms of health care information, and which typically will also provide guidelines for patient care. An example of a system would be UpToDate (

Synopses: These are sources which provide preappraised resources of recent journal articles and publications. One classic resource for synoptic evidence is the ACP Journal Club (

Summaries: This is where you would locate systematic reviews of health care interventions. The major source that we are familiar with is the Cochrane Collaboration ( It is also possible to locate systematic reviews using the clinical queries link on PubMed. These reviews examine individual studies which meet inclusion criteria and then provide recommendations based on analysis of effect sizes and other data.

Studies: Of course, we should not forget that another great resource are individual studies themselves, as published in clinical literature. The challenge for us in using individual studies is we need to be able to evaluate the study before use, and this requires a certain skill set to do so most effectively.

In order for you to do the most effective search, you need to know how best to choose the appropriate information resource. Once again, the Users’ Guides offer suggestions. They find four important criteria for choosing a resource.

Soundness of evidence-based approach: The resource should provide access to a proper sample of high-quality evidence for your question It will address validity and outcomes of interest.

Comprehensiveness and specificity: Different resources have different goals and strengths. For example, Cochrane is useful when looking at management, but is not useful if your interest is in diagnostic accuracy. You need to ensure that the tool you choose is best able to answer the question you are interested in.

Ease of use: Think about how hard it is to construct an effective search in PubMed. How you need to understand syntax, logic and organization in order to structure a search query that helps cut out dross and unnecessary information. Then, consider how easy it is to go to Cochrane and find topical information related to your needs. Ease of use can be a compelling reason to use one website over another.

Availability: Not all sources are free, and some are quite expensive. Within the confines of an academic institution, we might have access to a great deal of information, bur for our students they will lose that access upon their graduation. We should familiarize ourselves with the best free sources of information, of which there are many.

This is then an overview for a look at good resources. That will be covered in the next blog post.

1. Guyatt G, Rennie D, Meade MO, Cook DJ. Users’ guides to the medical literature. New York, NY; McGraw Hill, 2008:30

Monday, March 23, 2009

Curriculum Development in Brief

A curriculum is nothing more, but nothing less, than a planned education experience. Traditionally within chiropractic education new instructors who took over a course simply used pre-existing materials as a basis for putting their own stamp on the content of the course, and given that most of those who teach in health care education were not actually trained as educators but as either clinicians or academic scientists, little thought was given to how best to develop a curriculum. This was true whether writ small (such as single course or lecture) or large (such as a full curriculum or course series). A superb text by Kern et all provides a reasoned mechanism for developing the curriculum in medical education (1). I provide a short summary here of a text we should all have and read.

Kern starts with several underlying assumptions, including (1) educational programs have aims or goals, whether these are stated or not; (2) educators have an obligation to meet the needs of learners, patients and society; (3) educators need to be accountable for the outcomes of their interventions; and (4) a logical approach to curriculum development will help achieve these ends. They therefore offer a six-step approach to curriculum development. Much of the following will be recognizable in one form or another from efforts accomplished here at Palmer College.

Step 1: Problem identification and general needs assessment. The process begins with recognition and analysis of a health care problem or need. Perhaps it might be a need to increase coverage of public health issues in response to new requirements from the Council on Chiropractic Education, or a need to enhance evidence-based practice (EBP) arising from R25 grant funding. In order to properly analyze the issue, we need to look at what our current approach is; thus, needs assessment and analysis. We can then develop an ideal approach to the challenge, to address the need. Kern et al note that the difference between the ideal approach and the current approach is the general need assessment.

Step 2: Needs assessment of targeted learners. Here we assess the needs of our targeted group of learners, as distinct from the general needs of all learners or of all health care (chiropractic) institutions. We may find that we lack discrete coverage of evidence-based practice in our curriculum, but that some instructors do touch on various aspects of the discipline in their specific courses.

Step 3. Goals and objectives. After we identify the needs of our learners, we can begin writing goals and objectives. Kern recommends beginning with board or general goals and then moving toward specific and measurable objectives. We have all engaged in this activity. These goals and objectives are critical for determining content. They also communicate what our curriculum is about to the outside, including accrediting bodies.

Step 4. Educational strategies. At this point, we have goals, objectives and content. The next issue to be addressed regards which educational strategies we should use to achieve those objectives. Perhaps in the case of EBP, we should look at case-driven approaches, given the emphasis on placing context around individual patient cases, as noted by the use of a PICO question (Patient-Intervention-Comparison-Outcome). In clinic,, we might rely on small-group teaching or individual teaching.

Step 5. Implementation. Kern notes several important components necessary for implementation: administrative support for the curriculum; identification of resources; identification of barriers to implementation; introduction and piloting of the curriculum (roll-out); administration of the curriculum; assessment and refinement.

Step 6. Evaluation and feedback. Noted in the last step directly above is assessment. This occurs at both the individual and institutional (program) level, and it can be both formative and summative.

This is an ongoing process, and it is not one that is accomplished sequentially and step-by-step, even though the above would seem to suggest it is. Each step has affects on, and influences, each other step, in a cycle of continual assessment, refinement and improvement. We have seen significant change here as a result, and we can be equally sure that we will see more as time goes on.

1. Kern DE, Thomas PA, Howard DM, Bass EB. Curriculum development for medical education: a six-step approach. Baltimore, MD; Johns Hopkins Press, 1998

Tuesday, March 17, 2009

Challenges to Reading a Clinical Trial

While I think we typically believe the results of clinical trials to be objective, this is in reality not often the case; the interpretation of results will reflect the worldview of the investigator (1). There are numerous “threats” to the integrity of the data that we, as readers, need to be aware of. Some are obvious and banal: we are invested in our research and wish to present the best picture from what we have discovered; we wish to enhance our career prospects (for promotion or for grant funding) by publication. Others are more complex and deep-seated: we may have obtained our funds from the industry in which our study is positioned; we might have ceded control of publication to industry representatives. We have seen public accountings of problems arising from these challenges. But even if we are clear about all of these above issues, we can be misled by research findings. The Users Guides lists eight guides to avoid being so misled.

1. Read only methods and results; bypass the discussion section. It is possible that the discussion often may suggest inferences that differ from those a reader could draw simply be reading the methods and results alone. This arises because authors might demonstrate greater enthusiasm for the interpretation of the results when funded by for-profit organizations.

2. Read the abstract reported in pre-appraised resources. A number of secondary-source publications exists wherein experienced clinicians and methodologists prepare structured abstracts of new research for readers. These provide important data and outcomes as well as clinical interpretations of use to practicing physicians. A notable example here would be the ACP Journal Club.

3. Beware large treatment effects in trials with only a few events. Exercise caution when you see large treatment effects (such as relative risk reduction of 50% or more) from studies with few participants (such as 100 or less). Large effects are not common or plausible because therapy can usually only address one or two mechanisms in a multi-causal disease process. You should see a large number of studies or a large number of events before beginning a new therapy that may be costly or risky.

4. Beware faulty comparators. This is related to what is being compared to what. For example, a faulty comparison is to a placebo when an effective agent is available, or to a more toxic agent when a less toxic agent is available. Read how the agent under study is being compared to, for that choice could lead to results that are skewed to the study intervention.

5. Beware misleading claims of equivalence. With drug research, as example, often the new drug is compared to a widely used drug in order to claim the new drug has some non-therapeutic benefit, such as less frequent dosing. Here, you should be looking at how wide the 95% confidence interval is- wider is less good than narrower. Also, you might be comparing the new drug to an older drug that is only marginally better than a placebo.

6. Beware small treatment effects and extrapolation to low-risk patients. There are a number of strategies researchers may (knowingly or not) use to create the perception of a large treatment effect. A classic example is to report a relative risk reduction rather than an absolute risk reduction- a relative risk reduction of 50% might mean an absolute reduction from 2% to 1% or from 50% to 25%. Other strategies exist as well, such as focusing on statistical significance in lieu of clinical significance.

7. Beware uneven emphasis on benefits and harms. Many trials neglect any reporting of harm, and almost never report event rates in treatment groups and controls.

8. Wait for overall results to emerge; do not rush. Today, information moves at light speed, and once results are out may people jump in to adopt them. We get a huge publicity splash with the first large trial, and years later see radically different findings. Think Vioxx.

We should be cautious and canny in our readings of trials literature. The above is a guide to help interpret findings in light of potential biases that have been unconsciously or consciously introduced.

1. Montori V, Ionnidis J, Jaescheke R et al. Dealing with misleading presentations of clinical trial results. In: Guyatt G, Rennie D, Meade MO, Cook DJ. Users guides to the medical literature, 2nd edition. New York, NY; McGraw Hill Medical, 2008:301-315

Tuesday, March 10, 2009

Intellectual Property

As Francis Macrina (1) notes, “Intellectual property is a unique creation of the human mind. It has neither tangible form nor exists apart from the context of the applicable governmental jurisdiction.” As faculty members, all of us are engaged in creative activities over the course of our academic careers. And creating intellectual property is one of the ways in which we can influence our students, our profession, and our careers. However, we often do not have a clear understanding of how intellectual property is protected, and this short post here is designed to offer a few thoughts on this issue.

Intellectual property exists solely as a legal right of ownership; that is, is subject to law. In the United States, there are four forms of intellectual property: trade secrets, trademarks, copyright and patents. Let me briefly touch on each, with the trade secret and trademark getting less attention since they play a smaller role in academia.

Trade Secret: The legal definition of a trade secret is information, including a formula, pattern, compilation, device, method, technique or process that derives independent economic value from not being generally known and not being easily ascertainable, and is the subject of reasonable efforts to keep it secret. To put it in simpler terms, a trade secret is information not publicly known, but has economic value and whose owners take efforts to keep secret. An example of a trade secret would be the formula for Coca Cola. Trade secrets are covered by state law, not federal law, and are in force as long as the secret is kept. However, once the secret becomes public, it loses protection under Trade Secret laws. Trade secrets can be sold like any other commodity.

Trademark: As you might expect, a trademark encompasses pictures, sounds writings, devices or objects that allow an owner to identify an idea, concept, service or product from a competitor. They cover the goodwill of the company. An example of a trademark would be the golden arches of McDonalds Corporation or the Apple icon for Apple Corporation. Trademarks are protected at both the state and federal level and must be registered with the United States Patent and Trademark Office. Protection is granted for 10 years but can be renewed indefinitely.

Copyright: A copyright protects the fixed expression of an idea, not the idea itself. Copyright comes into existence the moment you put words down on paper (or record a few bars of music on a computer, etc.), and in most cases we need never worry about protection. However, for those who require protection, such as an author who has written a new book, registration is mandatory to protect the work. Current law protects a copyright for the life of an author plus 50 years, and in the case of a “work for hire,” for 75 years from the date of publication or 100 years from the date of creation. Copyright protects both original works and derivative works; this latter component is what requires an author who uses a table or figure from an already published work from doing so without permission. The copyright owner has exclusive rights to the sale or distribution of the work in question, and a copyright can be transferred or sold. This is typically the case when a faculty member writes a work for an outside publisher. You transfer the rights to the work to the publisher in lieu of them taking on the costs of sales and promotion. The Fair Use laws allow faculty to use some copyrighted material without permission but in a strictly controlled manner; the use must be related to criticism, news reporting, teaching or research and scholarship.

Patent: A patent is a grant by a national government to an applicant for a specific period of time during which the grantee has a legal right to exclude others from making or selling the grantee’s invention or device, so long as the grantee provides a full description of how it words to that government. This allows for continued creativity in invention, so that inventors can profit from their work while society benefits. Another way of looking at this is to say that a patent is a reward for disclosing something of social value. Patents give the inventor exclusive right to use of their invention for 20 years from the time the patent is applied for. The fundamental principle behind the patentability of a product is that the inventor made some unique intellectual contribution to the creation of the product. Further, the inventor must make an improvement that is non-obvious and useful (2). With new developments in gene therapy and biotechnology, the world of patents is changing and in the Human Genome Project large ethical issues have arisen over the propriety of patenting human gene chains. This is a subject for another day.

The protection we faculty typically seek is with regard to copyright, but we should understand the general legal issues surrounding all forms of intellectual property. That is, after all, our stock in trade.

1. Macrina F. Scientific integrity: an introductory text with cases. Washington, DC; ASM Press, 2000:179-209
2. Egan E. Class notes, BEHP 405 Research ethics; Week 3 lecture. Loyola Medical School Bioethics Program

Monday, March 2, 2009

Higher Education’s Changing Context

The superb book Rethinking Faculty Work: Higher Education’s Strategic Imperative (1) provides a reasoned discussion of the changing context for faculty work and faculty workplaces. The authors note that there are challenges today that are growing in importance: maintaining technological infrastructure; addressing user needs and budget constraints; recruiting and retaining students; finding new sources of revenue; responding to increasing accountability requirements; enhancing the prestige of the institution. And they further note that it is the faculty who enable our institutions to meet these challenges, that faculty work is essential to achieving the excellence that institutional leaders envision. And they denote that the faculty’s intellectual capital is any institution’s chief asset, indeed, is its only appreciable asset because all the other assets (such as buildings, technology, classrooms) all depreciate the moment they are obtained, but faculty intellectual competence and knowledge only grows with time. Thus, an institution must invest in its faculty.

But because of changes in higher education, new challenges and forces are developing. Chief among them are:
1. Fiscal constraints and increased competition
2. Calls for accountability and shifts in control
3. Growing enrollments and the increasing diversity of students
4. The rise of the Information Age along with expanded use of new technologies to facilitate learning

These factors combine to create major changes in faculty. They can lead to:
1. Changing patterns in faculty appointments: generally speaking, there are fewer tenure track positions opening, and growing numbers of renewable contracts and fixer-term or temporary appointments.
2. Declines in faculty autonomy and control: this is mainly due to the need to raise revenue, and to address the growing use of new technologies in the classroom.
3. As escalating pace of work and expanded workloads: there is a feeling among faculty across the country that they are now being asked to do more and more, a situation known as “ratcheting.” They are turned in too many directions, are expected to be available online 24 hours a day 7 days a week, and who must also play roles now in the processes of accountability they face (ie, accreditation, etc.).
4. Increasing entrepreneurial and high-pressure environments that hinder community and institutional commitment: there is a sense of isolation among faculty, as they handle workloads and assignments at a departmental level that often fails to integrate with other departments. A sense of general community is lost.
5. A need for continuous, career-long professional development: Most importantly, this addresses the need to stay abreast of new technology, and how it can be used in educational settings: blogs, twitter, facebook, wikis, posting boards and threaded discussions, online meetings, various programs, and even educational technology such as our Crestron system, all require training for best use.

These are simply some of the challenges we all face, and much of the rest of this book is dedicated to looking at how we might resolve them. I highly recommend this text for all faculty interested in the future of their art and profession.

1. Gappa JM, Austin AE, Trice AG. Rethinking faculty work: higher education’s strategic imperative. San Francisco, CA; John Wiley and Sons, 2007