1. When educational needs are identified and verified by organizations that do not receive commercial support and are free of financial relationships with industry (eg, US Government agencies), and

2. If the CME addresses a professional practice gap of a particular group of learners that is corroborated by bona fide performance measurements (eg, National Quality Forum) of the learners’ own practice; and

3. When the CME content is from a continuing education curriculum specified by a bona fide organization, or entity, (eg, AMA, AHRQ, ABMS, FSMB), and

4. When the CME is verified as free of commercial bias.

Alternatively, these conditions could provide a basis for a mechanism to distribute commercial support derived from industry donated pooled funds.

These conditions are additive folks. All would have to be met in the eyes of ACCME for commercial support to be appropriate. If adopted every accredited provider would only be able to accept commercial support if all four conditions were present.

Ok. So the literature review commissioned by the ACCME suggests that no empiric data exits to support the contention that commercially supported CME is biased. It may be but there are no data to demonstrate that proposition. There is a 10% non-compliance rate. Why? Before new conditions are proposed shouldn’t we understand the causes of the non-compliance and try to address those? Simply piling on new rules and regulations seems to me to be a response driven by a “quality assurance” model not a “quality improvement” model. Perhaps ACCME does know the major causes of non-compliance and are not sharing the information. Their privilege I suppose.

I digressed. So what did I provide in response to the challenge issued by Dr. Kopelow?

Murray,

I appreciate that at least one person is reading “Conversations in CME”. You asked that I send you some resources from improvement science that I think might useful in efforts to improve the work of the ACCME. It would be presumptuous of me to take on a task that large. However, to the point I made in the Blog. There are tools on improvement science that can be used to look at systems and processes that are instructive of the performance of those systems and processes. The specific issue I was addressing was whether there is a need for additional conditions promulgated by the ACCME to “regulate” commercial support for CME. My underlying question was “Has ACCME looked at the issue of non-compliance with the ACCME Standards for Commercial Support ^SM to identify the major causes of non-compliance?”

I assume there are leaders at the ACCME who are familiar with the classic literature in Quality Improvement like that of Juran, Shewart, and Deming. Further I assume those same people are familiar with a the straightforward book on quality “The Improvement Guide: A Practical Guide to Enhancing Organizational Performance” by Langley et. al. Of course there is literature and resources available related to Six Sigma and LEAN that I find very helpful. You might find the websites www.qualityamerica.com, http://www.managementhelp.org/quality/quality.htm, and http://mot.vuse.vanderbilt.edu/mt322/library.htm#Module%202. I find the Vanderbilt “Quality Library very useful. There are some resources in the management help site related to Total Quality Management that I think provide thoughtful resources concerning the creation of an improvement culture as a management style.

One of the Seven Basic Quality Tools http://www.asq.org/learn-about-quality/seven-basic-quality-tools/overview/overview.html) is the Pareto Chart, a simple bar graph showing which factors are more significant than others. It is useful when:

• analyzing data about the frequency of problems or causes in a process.
• there are many problems or causes and you want to focus on the most significant.
• analyzing broad causes by looking at their specific components.
• communicating with others about your data

One way to look at the issue of non-compliance with the commercial support standards is with this useful tool. Based on the results of this analysis, decisions could be made about which factors to pursue as improvement opportunities. Other tools of quality like root cause analysis using a cause and effect diagram might also be useful as the improvement effort moves forward.

So this is what I meant when I said I thought there were tools on improvement science that could be useful to ACCME. These are tools that quality improvement efforts in the health care setting use all of the time. These are tools that CME providers need be conversant with if there are to be successful integrating some of their efforts onto quality improvement. These are the tools I encourage the ACCME to use in its efforts to continuously improve the accreditation system.

Floyd Pennington, PhD

President, CTL Associates, Inc.

Brain Explorer is a site put together by Lundbeck Institute. It has a wide range of information, but the bits I liked the most were the Brain Atlas section, and the gallery. Lots of great images, and relatively simple explanations.

Science Daily has a wealth of newsworthy links and posts. Headings of 'Health & Medicine', 'Mind & Brain', 'Plants & Animals', 'Earth & Climate' and more - videos, articles and images. Great reading, you can spend a long time on this site!

Zack Lynch blogs about Neurotechnology on Brain Waves. He lists a bunch of quite technical blogs that he regularly visits, as well as some links that are well worth browsing on Neuroresources. Latest blog entries include the Allen Spinal Cord Altas, What's your Brain Age?, and a great video by Jill Bolte Taylor. Worth a visit!

And my final link for today - Changing Minds is a huge site with a whole bunch of information and links to factors that influence change. From Argument to Brand Management, Theories and Techniques, this site has plenty to keep you interested, especially if you're curious about how to help people change. Definitely one to bookmark.

I hope you have a moment or two to spend perusing the links - they're fun and you can spend lots of time just locating information, for the true information junkie like me!!

A ten percent non-compliance rate should be of concern. But does this suggest more restrictive regulations should be adopted at this time? If CME is to be a “Bridge to Quality” perhaps the ACCME should approach the issue utilizing quality improvement science. That would suggest first examining the system to see if it is in control. In that examination some variation will be found. Some of that variation will be special cause variation. Systems and processes should not be changed to address special cause variation. Changing systems by addressing only special cause variation is tampering not improving.

If there is only common causes of variation in the system then that is how the system works. It is a system that is operating the way it is currently designed to work. It is in control. Only systems in control can be systematically improved. One place to start improving this system is to address the part of the 10% non-compliance that is common cause -not special cause-variation. Which of the common causes of variation that, if minimized, will have the greatest potential for system improvement? Identify it. Improve it and reassess the system. Did the improvements in the common causes of variation decrease the 10% non-compliance rate? If so, there is less variation in the system. The system is still in control and it is operating at a higher level than before the improvements were made. Isn't that what we want

There are very robust tools available from improvement science to use in improving systems and the component processes that comprise the work of systems. If that important work has not been done any suggested changes as sweeping as that suggested by the ACCME has to be viewed as tampering and not improvement.

ACCME should use the science it touts. Approach this issue as an opportunity for system improvement. Use the tools offered by improvement science. Accreditation criteria encourage CME providers to find ways to engage in quality improvement. ACCME - Lead By Example.

Floyd Pennington

My question is this “Where are the leaders in the field on this important issue? Why haven’t organizations like the Alliance for CME, the Society of Academic CME, the North American Association of Medical Education and Communications Companies, etc. put their stake in the sand on this critical issue”. They simply have not.

So in comes the ACCME, a regulating organization not an organization representing practitioners in the field, to establish the only alternative position to that of completely ending funding from commercial interests for all CME activities. The problem is that the ACCME proposed position on this issue is so restrictive it will likely have serious unintended consequences damaging the field for years to come.

I contacted the major membership organizations representing the field of CME and asked if they had a position on commercial support for CME. No! No! No! Not one of the groups that responded (and that was all but NAAMECC) have taken a formal position on this issue. Why not? Well it is too controversial. Well, we are responding to the ACCME “Call for Comment: but there are too many variations and variables in our part of the CME enterprise so a one size fits all model does not work. On and on. Responses bound by the limitations of organizational exigencies. Not the way policy should be driven but an unsavory reality of many organizations.

Should the CME profession tolerate ACCME (the regulator) taking the only leadership position in the field on this issue? Absolutely not! The CME stakeholder organizations must find a way to provide leadership on this issue. Regardless of the position taken a position must be taken. In the absence of this leadership from the profession the regulators will continue to dominate the field and lead it in directions it can control. That is not the leadership CME needs at this time.

Floyd Pennington

]]> http://symbilawchronicle.wordpress.com/?p=5 Sat, 19 Jul 2008 11:06:43 +0000 kanekalkuppesh http://symbilawchronicle.wordpress.com/?p=5 Symbi Law's beloved senior, 'Justice' V. C. Mattews made a guest appearance in college today and truly lived up to his name as he adjudicated in one of the Moot Court Halls at the Central Mooting Elimination 2008. Also in attendance as a judge was Annirudh 'two-therty' Mukherjee.

Rather than droll on about the different surgical lectures (all of which at the moment I have trouble following due to my inferior medical knowledge), I have found a common thread that seems to catch the perview of all the experienced surgeons that attend. It is a simple one; new surgeons that are practicing now have been subject to advanced technology and are therefore losing "old school", yet critical surgical technique. Case in point, the ability to convert a percutaneous laparoscopic procedure to an open procedure when complications begin to arise.

Take for example a laparoscopic cholecystectomy. The stigma is that opening a laparoscopic procedure is a sign of an unskilled surgeon. However, the opinion and statistical data show that laparoscopic complications (i.e. bile leak) occur after the learning curve; it is the experienced surgeon that becomes a bit too comfortable, thus leading to a problem. Compound that fact with no training in open surgery, and we are left with the statistic that only 0.1% of open choly procedures have a post-op complication, versus the 0.6% complication rate of a lapcholy. How does such a stigma still survive when the "advanced technique" produces 6 times the complication rate of an open procedure?

I guess the point is that yes modern technology helps in tremendous ways. Yet, we lose the art of surgery; the feel for the anatomy is lost to the secondary interaction via cold steel, the surgeon is now working in two dimensions on a tv screen, rather than three. I think the take home message is frugality with technology, and therefore one should not abandon the classic procedures, but cultivate such skills.

Marx talks about this phenomena. He describes man as "an appendage to the machine". I'd like to think that what I will be doing in the future evades such a benign fate. I think that I am fortunate to have such a glimpse into the minds of the experienced, and I plan on taking their concerns to heart when doing my surgical training. To some, technology is God, but to others, I hope some of us find it scary when surgical procedures are no longer the outcome of a surgeon's dexterity, but an outcome of the maturity of the technology being utilized. The newest and best thing in the technical world always has a built in expiration date, but refined skill and practice remains constant.

Thoughts?

Here are some tips for prevention of diabetic foot ulcers.

Have your blood sugar level,blood pressure & cholesterol checked regularly.
Do not self medicate.
Eat your meals regularly.They should have a healthy mix of fruit and
vegetables which are low calorie and hi-fiber.
Give up smoking.
Get your feet eyes and kidneys checked once a year.
Meet your dentist twice a year.
Wash and check your feet every day.Keep the skin soft.If you use gentle
skin lotion do not apply between the toes.
Do not walk bare foot in the grass or any where else.
Always wear form fitting cotton and woolen socks with loose elastic bands
and sturdy and comfortable shoes in consultation with your doctor.
Do not leave sharp edges when you cut your nails.
Do not cut corns or use corn plaster.They may wound the skin.
Wear shoes when you walk on a warm or hot surface.
Do not use Hot water bottle or cold compress ,heating pad or electric
blanket.Your skin may burn.
If your feet feel cold at night wear socks.
When you sit in a chair keep your feet up.Twice or thrice a day rotate your
toes and flex your ankle.
Do not sit cross legged for any length of time.
Walking,dancing and cycling are good exercise.But do not jump or run.

PRASANNAM Diabetic Foot Clinic is the first of its kind in Rajasthan.It has been estlabished by Dr.Archana Sogani.MS Gen. Surgery (1991 )MBBS (1987) from SMS Medical College,Jaipur.She is also a life member of Diabetic Foot Society of India and has been working on diabetic foot lesions since 1996.She is actively involved in conducting patient education programmes and continuous medical education on diabetic foot care.
PRASANNAM Diabetic Foot Clinic,
'Aashirwad'
79,Dhuleshwar Garden,
Jaipur 302001
(M)9829053173
email:archanasogani(at)yahoo.com

A hotly-debated ban on drug companies providing gifts and meals to physicians was stripped out of proposed legislation a House committee approved late yesterday.

The panel also removed requirements that drug and medical device companies report payments they make to doctors for consulting and speaking to other physicians and that the Department of Public Health post that information on its website. A proposed $5,000 fine per violation was also dropped from the bill, which is expected to be voted on by the full House today.

The last section of this report beginning on page 23 should be read very carefully, especially the last paragraph of the document. ACCME is stating that it believes due consideration be given to the elimination of commercial support for CME. I agree. Is this a signal about what the position of ACCME is going to be? I guess we will have to wait and see. Without data tio support that position I certainly hope not.

Could you blame any commercial interest from withdrawing support for CME? The Senate is investigating ties between commercial interests and CME providers. Major national organizations are calling for the elimination of commercial support for CME. Commercial interests spend increasingly large amounts of money just to administer a unit to support CME that is "firewalled" from the marketing and sales interest of the company. They have a huge expense in operating a compliance effort related to the support they provide to the CME enterprise. Do they think it is worth it? Some are saying NO.

The relationship between the medical profession and the industries that provide the tools of their trade is unique among the professions. There is an interdependency between physicians and the industries that provide them what they need to do their jobs. That relationship needs to be one of concern especially if it leads to poor clinical decisions and bad patient outcomes. But the data don't support the contention that, in general, commercial influence in CME is a wide spread problem. What all of the organizations expressing opinions that suggest an undo influence of commercial interests in CME are doing is making the exceptions the rule. In quality management that is called tampering. STOP IT. Until there is evidence to suggest that the system is out of control work to reduce the variability in the system. Don't make the "tampering" mistake. Deal with exceptions. Don't let the exceptions set the course for all of CME.

One last thing. If you have not responded to the ACCME call for comment distributed recently there are also some very important directions under consideration by the ACCME that could have a significant impact on the field.

Get engaged in this fray. It is critical.

Staff Reporters

Pfizer Inc., hoping to temper criticism that it is improperly influencing doctors, is eliminating direct financial support for continuing medical education [CME] courses that are offered by third-party companies.

The Reaction

Pfizer will continue to fund CME courses at academic institutions, teaching hospitals and those supported by medical societies, but will no longer directly support CME courses offered by for-profit medical-education and communication companies; according to a new report in the Wall Street Journal on July 3, 2008

Assessment

Pfizer said it is ending the payments to avoid the appearance of any conflicts of interest, as critics have charged that industry-supported CME courses for doctors are not purely educational; but rather are designed to promote use of specific medicines.

Conclusion

Is this an appropriate action, or an “over-reaction”; please opine and comment.

Related Information Sources:

Practice Management: http://www.springerpub.com/prod.aspx?prod_id=23759

Physician Financial Planning: http://www.jbpub.com/catalog/0763745790

Medical Risk Management: http://www.jbpub.com/catalog/9780763733421

Healthcare Organizations: www.HealthcareFinancials.com

Health Administration Terms: www.HealthDictionarySeries.com

Physician Advisors: www.CertifiedMedicalPlanner.com

Speaker: If you need a moderator or speaker for an upcoming event, Dr. David E. Marcinko; MBA - Publisher-in-Chief of the Executive-Post - is available for seminar or speaking engagements. Contact: MarcinkoAdvisors@msn.com  or Bio: www.stpub.com/pubs/authors/MARCINKO.htm

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I needed a controller, preferably with 76 keys as I like to stretch out from time to time and it would also allow for the possibility to play other styles of music outside of my usual electronic and ambient work that I do, should the need arise.

After some research I decided to pick up a CME UF70.

And the other cool little toy I decided to purchase was BleepLabs Thingamagoop. At it's core it's pretty much just a noise maker. It's essentially a very basic analog style synth with some interesting controls, including a photosensor and some knobs and switches that allow it to emit some truly unique and mostly unpredictable sonic strangeness. With all this wrapped up in a silly (but oddly appropriate) package, I just had to have one. You can read more about them at http://bleeplabs.com/thingamagoop/.

ACCME accredited providers have been operating under a set of Standards of Commercial Support for some time. I have heard from a number of people in industry that they support these standards. It is the responsibility of the accredited CME provider to address the issue of real or perceived bias in an approved CME activity and to take necessary actions to see that the content provided in the activity is not biased or unduly influenced by any narrow commercial interest. The current ACCME guidelines preclude any interference by a commercial interest in the content of a funded activity. So, if there is bias in an activity approved for CME credit, the responsibility for that bias creeping into an approved CME activity lays at the feet of the CME provider not the commercial supporter.

Accredited providers of CME activities need to step up to the plate and take part of the responsibility for the current situation that has government agencies, education organizations, and the consumer concerned about bias in the continuing professional development of physicians in this country. We were given the responsibility to see that it didn't happen. Most of us are diligent in our responsibility. Some are not. Those who are not need to be censored by the ACCME or banned from the CME enterprise.

You might find the podcast I did with Ron Cervero (the author of the literature review) discussing the findings related to the empirical evidence supporting the contention of bias in commercially supported CME.

We need an answer to the question of the presence of bias in commercially supported CME. Pharma is not the group to fund the studies to determine the answer.  Nor should the ACCME be the source of funding for the necessary studies. Accredited providers need to band together and figure out how to get these studies done and we need to do this quickly.

See original Pfizer press release

See comment and responses from Pharmalot Blog

See comment and responses from the Wall Street Journal Blog

What do you think? What might this mean for eg European CME?

This post found on MindHacks (see my 'blogroll' for the link!) leads to several helpful readings about what fMRI actually measures, how it does so, and more importantly, says 'our understanding of what brain scanning data tells us evolves over time. A study conducted ten years ago might mean something different now.'

People who are sceptical of science will possibly sieze on this as confirmation that 'you can't trust science, it could be wrong' - but for me, it shows how open science is to revision in the light of new information.

Anyway, that was an aside: head on over to the post, and check out some of the supporting readings, I think it's helpful, albeit needing a little time to digest!

ACCME reports that: "As part of their responsibility for the oversight of any program or industry affecting seniors, the U.S. Senate Special Committee on Aging has requested that the ACCME provide information on “the accreditation process for CME courses; any criteria the ACCME uses, as part of the accreditation process, regarding the scientific validity of course content; any mechanisms the ACCME has in place to ensure that no undue influence by any industry is being exerted through CME courses; and any further plans the ACCME may have in place to develop such mechanisms.”

This is another in a series of information seeking activities directed to the ACCME related to industry involvement in CME. We should all monitor the response made by the ACCME. Those of us in the the CME enterprise need to be more aggressive in communicating our positions on these issues to these investigative committees.

We all understand the concerns expressed by Congress related to the influence of industry in CME. But does Congress really understand what is being done by many in the CME enterprise, including industry, to assure that the CME offered by the quality accredited CME provider is based on the best evidence available and not unduly influenced by any special interest?

If you haven't read the review of literature by Ron Cervero on the relationship between commercial support and bias do it. The research does not support the "urban myth" that industry involvement in CME automatically means the content will be biased. More careful research is needed to demonstrate the validity (or lack of it) related to that belief. As CME providers we need to use the best evidence available to support our contentions. Cervero provides some evidence we should pay heed to.

I'm pleased to report that the bid on November 2012 contracts has risen to 132 from the 130 where I was able to buy my last contracts and - get this- the ask is up to 155. Lord knows if anyone at this point is going to be dumb enough to sell contracts at these low prices. I'm going to keep buying them, though. You can follow the action at http://housingrdc.cme.com/

I started buying at 161, and have had to pony up for margin calls as the price fell. Yesterday, I bought 3 more contracts at 130, and today, the bid is at 130.4. Another turning point, I suspect. I intend to buy more as the market slowly heads back up.

Notice also that Las Vegas is the only contract that is up today. I'll be the first to admit that 40 cents is not much delta, but if there's any one motto that underlies Frothing Developer, it's that today's trends are much more important than yesterday's results.

Among the 'alternative' options, one woman I'm seeing at the moment is wearing copper bracelets, several hematite pieces of jewellery, drinks no carbonated drinks 'because it excites the nerves', has regular healing touch massage with aromatherapy, and ingests a variety of homeopathic concoctions. She was horrified to hear that the magnetic underlay she bought has no known effectiveness, but was still considering whether she should ask a health agency if they would buy her a massage chair...

The amount of money that is spent by people desperate to find something to fix their pain is incredible!

Which leads me to a book I'm thoroughly enjoying at the moment. It's called 'Trick or Treatment' and is written by Professor Edzard Ernest, Professor of complementary medicine and Dr Simon Singh, science writer, and is published by Bantam Press.

It's a very readable book, and the chapter I'm loving the most is actually the first - a wander through the history of the double blind, placebo-controlled, randomised clinical trial - and includes blood-letting, Florence Nightingale, scurvy and early research into smoking! The authors argue that the most significant contribution to modern medicine is evidence-based medicine (although some of my colleagues still argue that it's all very well, but there just isn't enough evidence yet...). One quote from Hippocrates stays in my mind "There are, in fact, two things, science and opinion; the former begets knowledge, the latter ignorance." Oh if only more basic scientific principles were taught in schools, we would have so much less opinionated nonsense!!

Other chapters cover the evidence for acupuncture, homoeopathy, chiropractic, herbal medicine - and the final chapter 'Does the truth matter?'. I haven't got there yet (I'm still half-way through acupuncture!), but a quick flick right to the end Appendix 'Rapid Guide to Alternative Therapies' shows a long list of locally popular remedies including colonic irrigation (why would you?!), magnet therapy, orthomolecular therapy (wha..????), Reiki - well you've probably got the idea now!!

Recommended reading for all of us who work with patients who are likely to have thought about or tried at least some of these approaches, this book is well-written, somewhat simplistic but having said that, is attempting to summarise hundreds of studies into lay language. Enjoy.

Most of us who have been in CME for some time know a few physicians who are "in the pocket" of drugmakers. One way to help eliminate the very negative impact we are seeing from the unhealthy partnership of a few physicians with industry is to refuse to let them participate in any way in CME activities we approve for CME credit. If we address theses exceptions we might be able to avoid the inevitability of federal regulations on CME that will have a significant impact on our efforts.

Fibromyalgia: A Label for Chronic, Widespread Pain, available on Medscape asks a number of multiple choice questions. With the correct answers are given the percentage of replies for each answer and an in-depth explanation providing information about Fibromyalgia Syndrome.

Here is the FibroAction article on it.

This reference guide provides access to clinically relevant information and specialized educational resources for practicing physicians in several major areas of increasing importance and growing concern among those responsible for protecting public health and water safety, including basics of water safety and protection, evaluation and management of disease resulting from waterborne pathogens, evaluation and management of disease resulting from chemical contaminants, and evaluation and management of water-related disease in susceptible populations and risk communication. CME credit is available through the publisher beginning in August 2008.

A module on "Physician Preparedness for Acts of Water Terrorism" is also available.