COCSA Conference Call - June 28, 2006

Following is a transcript of a conference call held between members of the COCSA board of directors and the CCGPP’s executive committee. This transcript has been edited for clarity and brevity but none of the pertinent discussions regarding COCSA questions and CCGPP answers has been removed or changed.

CONFERENCE CALL PARTICIPANTS

CCGPP Board Members
Dr. Ron Farabough, Secretary
Dr. Gene Lewis, Past Chairman
Dr. Jonathan Griffiths, Treasurer
Dr. Mark Dehen, Vice Chair
Dr. Jay Triano, Commission Chair

COCSA Board Members
Dr. Jerry DeGrado, First Vice President
Dr. Jeff Fedorko, Second Vice President
Dr. David Kassmeier, District Four Director
Dr. Steve Simonetti, President
Dr. Kevin Donovan, Past President
Dr. Walt Engle, Treasurer
Dr. Kurt von Rice, District Five Director
Kathy Chittom, At Large Director
Dr. Len Suiter, CCGPP At Large Rep – joined the call in progress

BACKGROUND

COCSA sent out a request via email to all the state leaders asking them to provide questions for tonight’s call. We received 37 from various organizations and formatted the questions into four different categories: (1) questions about the process; (2) questions about the process of the commentary period; (3) legal questions; and (4) questions about the document itself. We will go through the first three or four questions in each category so that we don’t focus only on one category, one topic, or one state’s concerns. The rest of the questions will be forwarded to the CCGPP and for written response. The call is recorded so we can make the information available to everyone who has questions and concerns. It is COCSA’s experience that the only way to get real buy-in is to get people to own something and for them to feel comfortable with it and to be involved in the process.

QUESTIONS ABOUT THE PROCESS

Dr. Simonetti: How is the consensus process going to work and who is involved in the decision making?

Dr. Triano: The consensus process is a secondary level occurrence after the literature was collected by the team. The team evaluated the literature and if they felt there was a topic matter that was not adequately addressed by the literature that they were going to address on this round, because remember this is an iterative process, then the team pulled together and went through a Delphi process in order to address the issue and come to some conclusion with respect to whatever the topic was. Those involved in the consensus process are the team, which is made up of the experts on the team that were preset two to three years ago when this whole process began and any content experts that they would have pulled in. The team would call on content experts to get background information. Then they debated about the issues from the information that they had and came to a conclusion.

Dr. Simonetti: What is the grading system?

Dr. Triano: One is looking at the literature and what is the available literature. The topic matters were put forward to the committee in terms of the sequence of ICD numbers that were judged by the (CCGPP) Council as being appropriate and relevant to the chiropractic practice and most commonly used. The team was asked to go through the literature, particularly the National Board of Chiropractic Examiners Job Task Analysis, and other sources in the literature that described the practice of the chiropractic in terms of the most common conditions seen, the most common types of treatment used, and the most common diagnostic procedures relatively novel or unique to the profession but not exclusively so. They were asked to identify the most common things and then to carve off what they could chew in the first round and leave the rest for the next round. This is the first round. If there was a necessity to go to a consensus process on any of the topics selected, then they did so. If not, then they used the standardized instruments for evaluating the literature as has been published.

Dr. Simonetti: How is the doctor’s clinical judgment and the patient values weighed - the other parts of the triangle - and is that protocol printed and how does that get reviewed?

Dr. Triano: That is up to the doctor. That is not part of the document. The CCGPP commission has sought to create a basis to reinforce the argument that has been lost in evidence based care in the way some people have written things like guidelines. And again, we have not written a guideline. Some people have written guidelines and other people have gone to use those guidelines in a way that has progressively narrowed the notion of evidence base to eliminate doctor judgment. The initial chapter in the lumbar section, which we call the introductory chapter, was written to emphasize the fact that good practice requires not only the best available information from the literature but also the integration of the doctor’s judgment and experience and the circumstances of the case. Moreover, the authors even extended themselves to seek literature and to lift that literature as to write what might be exceptional circumstances that would justify a case being considered more complicated than the average and to list those in tables and to make them readily available for all to see. It is up to the doctor to read the information and have it available and to integrate the information from the document as he moves forward in his practice to either help him to decide what to do in a case or to defend what he has chosen to do. It is not the purview of the document or the Commission to integrate experience, but it is the judgment of the Commission and the Council that experience is very important, and we sought to create an evidentiary basis for the doctor to use it and to reintroduce that concept back into the way practice is evaluated on a day-to-day basis.

Dr. Lewis: What we are trying to do is anticipatea trend that is coming up Value Based Care, which is an emphasis on what the patient feels is important. This document helps to begin to provide that emphasis. If any of you want any references in regards to Value Based Care, let me know and I can send you information.

Dr. Simonetti: When do you anticipate the completed document will be released? Will state organization input for all chapters be allowed and considered prior to the release of the document? Will any of the chapters be released to stake holders prior to the completion of the entire document?

Dr. Triano: This has been a topic of discussion and the policy recommendations was set, and it had been envisioned from the beginning, that each chapter would be written as a stand alone and that when all chapters were completed they would be combined into a single document, as has been put out in several public releases. Each chapter will be provided to all of the stake holders for their comment. That is an appropriate and a necessary criteria for the credibility of the document itself according to the AGREE criteria which is a concern of a benchmark we are using to try to be sure that it has maximum credibility across all of the constituent groups that might try to access it. So every chapter will be presented for commentary, just as this one has been presented. Once a comment has been given, as has again been published several times, the commentary will be collected and will be grouped according to topic just as you have grouped your questions for tonight. Then the questions will be divided into two types: those that address strictly format or process questions and those that address content.

The process questions will be handled by the editors to try to explain process or to respond if someone has a suggestion on format or on the way the thing could be written to be more legible or what have you. If there is a change that they think would be useful, then the team will be consulted, and, unless there is a significant objection, we will make those changes and we will respond to that. Content issues will go to the team. The team will review the comments and any supporting documentation and evaluate it exactly the same way they did the previous evaluations. If new information is brought forward, or different information, or missed information then it will be evaluated and they will make a judgment as to whether to change their recommendations for the document or not. Then having completed those steps, each of the aggregate comments will be published in the final version of the chapter as will the responses giving rationale and justification for why the team did respond and change the document or why they did not respond to change the document based upon the input so that the process is totally transparent.

Dr. Simonetti: How is NACA’s input weighed?

Dr. Triano: The same as anyone else’s. They are another constitute and when they give us input, it will be put to the team if it is a content issue and to the editors if it is not a content issue. It will be responded to in the same way as previously outlined.

Dr. Lewis: Everything that comes in is sent to the teams, everything. I was down at Palmer, Florida a week and a half ago and somebody wrote something on what looks like a napkin and handed it to me. I scanned it and am forwarding it to Jay. We’ve gotten some interesting suggestions from different groups. We’ve spoken to a lot of groups and it has been interesting food for thought. So everything is considered.

Dr. Simonetti: Will the CCGPP post all of the comments it receives on its website along with responses to each comment?

Dr. Triano: All comments that come in will be grouped. If I get 17 comments that say “you are an idiot,” I am going to say that you had 17 comments that say you are an idiot and will respond to that accordingly, etc. It will all be published and be available for people to see.

QUESTIONS ABOUT THE COMMENTARY PERIOD

Dr. Simonetti: In the event that there is little or no consensus or in the event of adamant disagreement to passage of the document or chapter as presented [concerns being presented by state associations/member groups/valid stakeholders], will that portion or chapter be withheld or is there a process in place to address this beyond the commentary period?

Dr. Triano: This is a process of rating and stratifying the literature. This is not a process of telling you how to practice, nor are you being asked to ratify it. You are being asked to comment on it to see whether or not we’ve missed anything or have misinterpreted anything. To that extent, I do not quite understand where the angst is about this process. It is simply saying there are 17 articles out there that say manipulation is a really good thing to do, and you got 2 that say that it is not. The strength of the evidence for the 17 is good and the strength of the evidence for the two is mediocre to bad. The document provides that kind of a commentary so that everybody has the same information in their hands rather than the current state of the art, which is some group in California may have guidelines that they’ve pulled together. They are not going to share it with anybody else buy are going to judge the practitioner based on it, and the practitioner does not have the information in his hands to rebut it. We are trying to provide that information to everyone all in one context. It is not a matter of ratification and never has been.

Dr. Lewis: We understand that sometimes a lot of the feedback that we get especially concerns and even negative comments are typically going to be appearing loud and the people that are in agreement or even ambivalent often do not say anything. They had exactly the same experience in Canada. There were loud comments but actually it turned out that it was an extremely small minority. The vast majority were fine with what they wrote in Canada or were ambivalent. We understand the context of this.

Dr. Simonetti: The fact is that COCSA has forever in its history listened to all the opinions and all the concerns and represented everybody. That is the process we’ve had forever. That is what we need to do here as well, because if a minority’s opinion is not expressed, it will be expressed in other ways.

Dr. Triano: Might I suggest that is exactly what we are trying to do. That is why we are doing a written commentary period with written responses and total transparencies so everybody’s view will be in there. We do have an opportunity in that process that if the team cannot come to a consensus on a minority approach, then the minority approach will also be expressed and its justification will be written down. So the people who read this can take a look at it and get their perspective that is presented by all of the constituent groups and the participants.

Dr. Farabaugh: I have a comment on this particular topic. If you step through the smoke and mirrors of that question and get to the real heart of this issue, what the question really stating is if the Commission does its work and comes up with a recommendation that we really don’t like and we think it is going to harm us as a profession, are you still going to recommend it? In nuts and bolts, that is what it really comes down to. If we think this is going to harm us, do we publish it anyway? And I think the only answer is, in an actually honest world, yes. The literature is what the literature is, and we cannot control what a third party is going to do with it. That is really what the issue is. They think it is going to hurt our profession. What do you say to that?

Dr. Triano: What I say to that is if you think you are not being hurt by the literature right now then you are foolish. The literature is being used like hell out of the chiropractic profession and there is nobody in the chiropractic profession who is standing up and waving the literature back at them saying you are misrepresenting it. You are not using it properly, etc., etc. We just went through a guy in England, Ezard Ernst, to publish a review of reviews, of reviews. He says that there is no value in manipulation for any reason whatsoever, and we have to go chasing after him and pointing out that he’s used bad methodology, etc., etc., etc. The average practitioner does not have time to do all of that, and I do not have time to do it fourteen (14) times for the profession. Let’s do it once. Let’s get out to everybody what the information is, and let’s update it regularly so that everybody has the same information. If the profession does not have enough literature in one field, it is not the only profession. The most well documented discipline is cardiovascular, and it is, at best, 50% documented in the literature. We need to mature on this issue and move forward. If we don’t have literature, we ought to step up to the plate and provide the resources to be able to do the research and get the literature changed. But unless we know where it needs to be changed, what do we do?

Dr. Farabaugh: The criticism is been levied that the modality rating is really low because there is not much positive research on the modality and that we should not have rated it to begin with. But, if you look at the British Medical Journal, there are, in fact, 2,700 articles written on physical therapy with 800 released since 1997. I hope everybody realizes there is literature. We just cannot scoff at it because we do not like the rating.

Dr. Triano: We cannot make it up. That will lose credibility.

Dr. Farabaugh: We cannot spend another ten years, another billion dollars trying to prove modality’s work when in reality they do work on a lot of patients. It is just that the evidence is rating them really low. As every other document that I have ever seen, there is no document that I have seen that rates modalities high.

Dr. Triano: That’s right, and part of the problem is that some of the questions that were being asked by the literature, in my view are the wrong questions. So for example, we are asking questions like, “If we do a therapy no matter what the therapy, does it change the outcome in a year.” We now know that spine related disorders are chronic recurring disorders; they are not pneumonia. So it is the wrong question. But by surveying the literature and discovering what is the state-of-the-art now, we can start focusing on the right questions. And it may well be true, as is my personal belief. that certain modalities assist the doctor in being able to get the job done better. But nobody has asked that question in the science. The way you start is by discovering what the literature says now, and I do not like what the literature says but that is irrelevant. It is what it says. It is what is real, and it’s the basis from which we begin.

Dr. Simonetti: The next question is in reference to the survey of state associations being conducted by the Wisconsin Chiropractic Association. Of the states that have responded, which is considerably less than the majority at this point, but an overwhelming majority of those who responded would like the CCGPP withdrawn. Has CCGPP considered what it will do if the majority of states request that this document be withdrawn?

Dr. Griffiths: I think one of the answers to that is those who are taking a very close look at document have probably not yet submitted their answers and that is why the document or the pop quiz seems as weighted as it is from Wisconsin. I would respectfully submit to you that once all of the state associations have input, you will probably see a greater diversity of ideas and thoughts about it. And the aspect of withdrawing the document is not an issue.

Dr. Simonetti: CCGPP has extended the comment period for states but have not stated when this extension will end. If the extension does not encompass the date of COCSA’s special CCGPP meeting, of what use is the extension or the special meeting.

Dr. Triano: I just want to make a general comment. I think if one historically looks at this process that the chiropractic profession has been involved with, with respect to looking at literature and using the results of that, one will see that history proves it has profoundly benefited the profession. Most and first most noticeable with the Agency for Healthcare Policy and Research, where the literature was used to leverage the Federal Government for the first time in history to acknowledge the value of spinal manipulation. And, the Rand Corporation where the evidence and the consensus process was used, and it leveraged the benefit of the profession. It is not possible to have everything come out your way. There are going to be some things that are not the way you would like to see them. But by withdrawing from the process of looking at the literature, all you are doing is inviting anarchy that everyone else will interpret the literature without your input. People are losing site of that and some people with their various agendas are trying to push buttons and drive the profession even before the document was released for comment. Now we are asking for comment and input, and we are being told that it is not a fair process. I do not know how you do that.

Dr. Fedorko: A lot of the questions we are receiving are based on this document being used as a guideline. I think what you have witnessed is a lot of the questions are phrased in such a way that this document is going to be used as a guideline. So, can this document or will this document be used as a guideline? It is a really important question.

Dr. Triano: Well, how do you use the Bible? You can use the Bible anyway you would like to use the Bible. We see people using it to try to slaughter other people, and you see other people using it to prevent murder. Yet it is the same Bible. I cannot prevent someone from using the document incorrectly, but CCGPP has stepped forward from the beginning and said that they are prepared to go to war with people who misuse it and to defend people.

Dr. Lewis: Plus, we are trying to work with the carriers so that they know this is out there, this is how to use it, this is what it is intended for, this is the kind of information base that it is suppose to provide. We are using our own people to do this and we are using other organizations to do this. It is important, and again like we’ve said to many of you, the natural assumption is going to be that it will to be abused; it is not whether it will or not. So like Jay just said, we do have plans to react to this, and those plans are to go again back to the carriers, re-explain if necessary, go to their clients, if necessary to go to their regulators. We cannot predict how successful that will be, but we are an organization in perpetuity. We plan to continue this process. We are not going away and it is not like previous documents. We do intend to take action. We are not going to lay still while things like this happen.

Dr. Triano: You have to recognize again people are losing site. They are being beat up now by inappropriate use of literature and inappropriate judgments. Guidelines that are true guidelines that say in them that “these are just guidelines and are not designed to be cut-off points, etc., etc.” are being used as cut-off points, and we do not have a profession wide basis to respond. To me, this is a straw-man. It is a fear based straw-man that is being used for whatever reason to oppose looking at the literature. The fact of the matter is if you look at the literature and if chiropractors are involved in interpreting the literature, because that is appropriate, then you have something to fall back on to defend yourself. Otherwise, it’s everybody for themselves.

Dr. Kassmeier: I guess we have already seen this with ACN as a group; ACN apparently has already started to do it so. My question is “Have you guys started response to them? I know the document has not been officially released and that it is just a draft, but they are still taking what we found in the literature and running with it. Are you putting the anti-missiles in effect to go against them?”

Dr. Lewis: I think you are making an assumption that what they wrote is a reaction to what we released and that is not true. About a year and a half ago, they started doing their own work and came to us and asked us to do this work for them. We felt like we would not have editorial independence, and we refused so they went ahead and did their own thing. That was released in April which was a month before ours was released. So what you are seeing from ACN has nothing to do with us. They are on their own little journey and without the document that we are working on, we would not have any defense against that. That cart was not before that horse.

Dr. Simonetti: Will there be open forms where any interested DC can personally present evidence?

Dr. Triano: We have invited any DC to personally submit evidence which is written in the document, which is written in the release for people to look at. The invitation is out there. They need to read that information and act on it. I do not know how you get people to respond or to follow recommendations of how they can get information to us when they come with that kind of question. It has been invited, and we will welcome it.

Dr. Simonetti: I am assuming that it is mainly through the survey.

Dr. Triano: Well, the survey is the start point and in the survey it says if you have material you would like to submit for us to review, send it on. We want it.

Dr. Simonetti: In one of the COCSA conference calls, a representative of the CCGPP stated that comments will be divided into two piles: clinical and politica,l and only clinical comments would be addressed. If this is a completely fair and open process, why would CCGPP divide the comments into two groups? Who will make the decision between clinical, political or process arguments?

Dr. Triano: Well, I do not know who said that but no such decision on how to divide things up was made by me. The decision was made to divide into issues related to the format or process. Questions related to “format and process” and issues related to “substance.” Those are the two departments. I do not know where political came into it. If a political question was raised, I suspect it will fall into one of those two aspects. It will be either a question that will have substance of merit and will be reviewed under that pile or it will have format and merit and will be reviewed under that pile. But every single thing put in will be commented on.

Dr. Simonetti: And I guess the question is “Who determines what pile it goes into?”

Dr. Triano: The editor does and that is me. And it goes one way or the other, and it will receive a comment.

LEGAL QUESTIONS

Dr. Simonetti: What is the business relationship between CCGPP, the Research Commission and Work Loss Data Institute? Will copies of all contracts and/or the agreements be made available to the profession for review? Are there any consequences (financial) to the CCGPP for indefinitely postponing publication until such time that a more complete review of the literature, based upon all levels of evidence relating to the most common patient conditions seen by a chiropractor (subluxations) can be properly done?

Dr. Triano: Let me just comment on the last part first, and I will let someone from the Council comment on the other part. First of all, the statement or the question that speaks to reviewing all literature is naïve. It is an impossible task to delay until all literature is reviewed. Since we have turned out the document for review, at least three major pieces of literature have come out that have impact on what we are saying, and I am trying to find a way to get it in front of the committee so that we can include it because it is helpful stuff. So it is absolutely impossible to get all literature done, and people need to sit back and get real. This is an ongoing process, it will be cycling through and we will pick up stuff on the second go around, etc. So, that is just an irrelevant and unfortunately naïve commentary.

Dr. Lewis: Right and there is not going to be a delay. We are on a timetable and that’s it. As far as anything we have, any relationship that we have with Work Loss Data Institute…again transparency is important. Any contracts that we have with them are fine for anyone to examine. I think if you read the contract, you will be pretty bored. It is a pretty ordinary contract that says that they do a certain amount of work for us. They do some distribution task s for us. They have some administrative tasks. We split any profits with them; it’s an 80/20 split which Janet tells me is a pretty good deal. We did not put up any money up front, which is why we are doing it that way because basically we do not have any money. We keep 20% and that money gets plowed back into the next iteration of this document, which is mandated to occur by our contract, not longer than 24 months. So any new literature gets scooped up between now and then. The relationship between us and Work Loss Data Institute is purely business, but I think Jay would share with you that the President of Work Loss Data Institute was unhappy with some of the stuff that he saw that described chiropractic, and in particular on-the-job injuries, and discussed with us that there must certainly be something better out there. Can’t you guys come up with something that will make you happy and I will have a product to sell. I’ve got a very well-developed dissemination network, I can help you guys get this into the different carriers’ hands. Get it across the country. Hopefully, it will help everybody and that is the way it is. Am I missing anything Jay?

Dr. Triano: I think only two points. The first one is to emphasize that nobody, and I mean absolutely nobody, is getting paid out money with the relationship with WLDI. So there is no economic advantage to any individual secondary to that. It is all being plowed back into the work of the council. The second thing that needs to be emphasized with respect to this is the purpose of getting buy-in. Somebody like WLDI, which is a commercial sales and publishing operation, publishes these kinds of things and guidelines as well. The fact is we can interpret the literature and get rid of some of the misinterpretations, like acute low back pain should be treated for four weeks. That is not what the Agency for Health Care Policy and Research said. What they said was if you are not better within four weeks maybe you should do something else. But it got twisted around by various people for obvious reasons to be four weeks of care and we are going to cut you off. Well, I served on that commission and that pisses me off that they are doing that to our work. If we can get our interpretation and understanding of the natural history into these places and disseminate it so that it is coming through an organization like WLDI, which has a ton of clients that buys from them, then we’ve seeded the field with our interpretation rather than somebody else’s. And that’s what it’s all about.

Dr. Lewis: It is the imprimatur of WLDI on this , a sort of neutral imprimatur that really can make a difference here. Hoping that everybody understands that concept.

Dr. Simonetti: What does anyone believe the actual legal impact will be on the chiropractic professional, what legal impact is intended for the chiropractic profession if this document is implemented?

Dr. Griffiths: I would like to make a statement here. I think one of the more interesting statements that I’ve heard came from Mike Schroeder, I believe it was where in a meeting one day he was very concerned that this would somehow take the place of Mercy and they have found that Mercy has been extremely useful to the attorneys who are defending chiropractic over the years and their big concern was that this might take the place of some of the things that were said in mercy. And if you recall, when Mercy was published there were a lot of people that were complete naysayers and guys were saying it was not approved by our association, state association or whatever and the reality was it was being used and it was being used very effectively. And I think that this could do the same thing except it is not in the guideline format.

Dr. Lewis: If I can amplify that comment, you are correct Jonathan. It was made to me in Nashville in November of 2004 after I left COCSA and went up to Nashville to speak to the NACA attorneys. I was pretty surprised to hear their comment. They use it in front of the board s of examiners, they use it in malpractice defense and in particular one of the attorney’s concern that we write something that would upset Mercy, that was Bob Hirtle from Connecticut, who has defended 11 stroke cases for chiropractors. When he brought this up, I was pretty surprised. That is why I made the comment at FCLB that Don Harrison picked up and has published over and over again that this is going to be used by boards of examiners. But the context of that comment was that if you have a readily identified set of rules to go by and that chiropractor who is sitting in front of the board of examiners, who is sitting in some trial somewhere being tried for malpractice and they can show that they went by accepted standards, then they are home free. That is what Bob Hirtle said, that is what Mike Schroeder said, and that is what the rest of them said. And so when I made that comment, that is what I was referring to and of course Harrison took that and ran with that football. So it’s appeared over and over again, and I just saw the other day that Rondberg had quoted the very same thing. That was the context. There needs to be some kind of rules of the road. O therwise, they can use any rules that they want, and I think that also the lawyers will give us their comments too. We do not know what they feel about the implications, but they play a role in this just like you do. NACA is a founding member and they do have somebody sitting on CCGPP. They are going to give us feedback just like you are, and we will get their ideas so we will take that as we get it.

Dr. Triano: I think that it will be worth putting in context is that the people who are involved here are the very same people who are called on by the attorneys to be the expert witnesses to assist doctors of chiropractic out of trouble wherever possible. And so they are not naïve to the issues with respect to the medical/legal possibilities and while nobody’s perfect you can certainly write something that you do not intend to have an impact. But the attorneys will review it and I promise you that from the editorial side everything that gets written in there is being reviewed with an eye to the fact that the language reflects the literature but does not inappropriately taint the literature, or where it will harm an individual who was following good practice. You can look at, for example, the recent NCMIC publication on stroke which just was put out. I am the primary editor on that. Trust me, there was a hell of a lot of interest in being sure that everything was phrased so that the literature represented in there did not inordinately cause risk for the company that was sponsoring the document. We are in the same business you guys are in. My livelihood is dependent on the success of this profession and so is everybody else that is involved.

Dr. Simonetti: What is the source of CCGPP financing? Have the vendors who are supporting this make a single contribution or they make progress payments?

Dr. Griffiths: I think that from our prospective most of the funding that is obtained - and I don’t know too many vendors who have been involved - but most of the funding that has been obtained has gone through a process through FCER so that in no way does it affect the judgment or the feel of the commission relative to any one particular group. There has been funding from the ACA, there has been funding from the ACC, there has been funding from all over the place and what we are trying to do is get the funding basically if we can channel through FCER at all times to try to keep it at arms length - Any kind of problems that may exist with some vendor that might want to get involved or is interested in blowing their own horn or whatever - So that is basically the way it is being done.

Dr. Lewis: But we have alsoreceived funding directly and if you go to our site it lists everyone who has been a contributor. Funding directly has come to us from the Association of Chiropractic Colleges. They have given us the most; it’s been $50,000. They promised $50.000. Some associations, I think about 12 associations, have contributed anywhere from $1,000 to $2,000 up to about $30,000. California gave us $30,000. Vendors have given a little bit of money here and there. ChiroCode has given us directly $20,000, and Henry Leavitt, who is both a vendor and a vendor representative to CCGPP, has been very gracious in that. And, we have looked for grant money. We are working on that right now. We are trying to get money everywhere we can. This is an expensive process. How successful are we? We are not as successful in raising money as we want. There are a lot of states who have not contributed. We solicited to individual chiropractors and not gotten a big success right there, but we are still looking.

Dr. Simonetti: It sounds like most of the contributions are single contributions and not on a schedule.

Dr. Lewis: Correct

Dr. Simonetti: We have been told by CCGPP that there is a "demand" for guidelines for NMS conditions. Who demanded them? Can we name any agencies outside of the profession that have made such a demand?

Dr. Triano: Certainly. For example, the State of California made such a demand. Similarly, Texas made such a demand for the worker’s compensation changes in this law that this state just went through. They have gone off to identify somebody that would provide them guidelines, and interesting enough, they chose WLDI. And so there are lots of places that the demands are coming from. Insurance companies are asking for information to help them get understanding of what ought to be done rather than what they are doing. State associations have asked us for information on this. So one of the criticisms very recently, like within recent days, there is a concern that these best practices are not guidelines enough by a state association of chiropractic.

Dr. Lewis: So yeah, we can give you a list. Physicians and chiropractors at the VA medical centers have come to me directly and asked for this. At the VAMC’s, they’ve got completely different guides at every single base. The military bases, the same thing. Really different guides at different bases and at one base you can treat low back and at one base you can treat everything and another base it is something else.

Dr. Triano: They are bringing them because there is nothing out there yet. They are making their own and they are bringing them to us to review. Gee, is this kind of where things look like to you. And so far what they brought is pretty good.

Dr. Simonetti: Will these guidelines be used by state boards to attack DC’s or for services not included such as DRX900, MUA, wellness care, etc.?

Dr. Triano: Well, first of all, these are not guidelines. So if they abuse them as guidelines, sure somebody’s going to abuse them if the literature says that there is no basis for something but doctors choose to do it anyway. Trust me, the state association and everybody else can find that literature just like we can, and they are going to use it. It is not us; it is the literature. It is not about us, and it is not about chiropractic. It is about what does the literature say to support what we do, and what is missing to support what we do, and how do we get it.

Dr. Simonetti: Please describe the series of key questions used by the research team to address the issues of defining population, the intervention, the control, and the outcome measurements and describe how they relate to the majority of practicing chiropractors. Was a spinal manipulation performed by a PT or MD considered equivalent to a chiropractic adjustment by a chiropractor? Does the decision to include studies of treatment provided by non-chiropractors invalidate the application of these recommendations as chiropractic in nature?

Dr. Triano: Okay, the decisions I’ve described earlier how the process that was set up was the standardized process for all teams to seek out information and the nature of the disorders they would address and the treatments that they would address.

Dr. Lewis: I can actually email some information if you want it. That will describe it.

Dr. Triano: It is also in the document itself. The processes as I said: the ICD codes were reviewed by the CCGPP council and then the commission transmitted those codes, broke them up according to topic area, low back, neck, etc., and sent the codes to each team. The team was instructed to go to literature, specifically the National Board of Chiropractor Examiner Job Task Analysis as a primary source, but also to any literature that describes chiropractic practice. So we have literature by Cheryl Hawk, by Ian Colter, by Eric Hurwitz, etc. which describes practice where surveys of what chiropractors actually do in their office and what they actually see in their office are available in the literature. Teams were asked to make judgments based on high priorities in that literature as to what they are going to survey. As to the component of the question that relates to whether non-chiropractors where involved in any study….if you restrict your results looking at the literature to just those done by chiropractors, what you are going to do is create a clearly evident body of evidence that says chiropractic performed research using chiropractors is an extremely tiny component of the world literature on the treatments that chiropractors use when, in fact, there are a lot of other people out there that are doing research in these areas. That is one thing to keep in mind. I am not sure if you want to make that statement either directly or indirectly. Secondly, the rest of the world does not make the distinction that chiropractors do. I happen to be one researcher who believes and who is actively involved in research at trying to discern whether it makes a difference if it is done by a highly trained practitioner, i.e. a chiropractor or done by somebody else. Nobody else out there in the entire world is addressing that issue, and I have six papers on it right now in the literature and more research in the pipeline. The fact of the matter is that the rest of the world lumps the procedure and treatment into one unit and whoever does it, does it. And so yes, the literature that is out there speaks to the treatment that is being performed. I happen to believe that it makes a difference who does it, but we do not have enough literature yet to show that. What difference is it going to make? Well, if we can find literature that it says that it makes a difference who does it, it will make a big difference. But so far the literature does not say that.

Dr. Lewis: When the Canadians went through their process, they found the exact same issue…that there was not enough literature to support the kind of document they wanted to do.

Dr. Triano: I think I need to say one more thing about it. The other issue is this: as long as chiropractors continue to insist on doing things like acupuncture, modalities and physical therapy, there is an argument to say it would be hypocritical for them to selectively say only chiropractic based literature for certain things, but oh yes, go ahead and let us raid other disciplines to use what they use.

Dr. Simonetti: Does the decision of the research team to focus its literature search on the symptom “low back pain”, rather than the various patient conditions most frequently seen by chiropractors (subluxation) introduce a “publication BIAS” which will invalidate the document as representative of the practice of the majority of chiropractors? Does the medical community usually select literature search strategies based upon symptoms rather than patient conditions? Does the medical community develop guidelines/best practices without including a review of all relevant evidence including all LEVELS of evidence? Why has the CCGPP Research Committee chosen to do so? Doesn’t this decision invalidate the application of this document/data base for general use rather than special use?

Dr. Triano: Well, in that question, there are several incorrect assumptions. First, the general medical community establishes its review of the literature almost exclusively on randomized control clinical trials. That is not what CCGPP did. It selected the top evidence available which included RCTs and guidelines and gets down into cohort studies, etc. where they could. So the assertion that needed to include other literature is just flat wrong. Secondly, I will say that where the best literature was available and it was adequate to make a conclusion that the evidence was strongly in favor, there was no reason to go any deeper because that’s the best evidence. Why bother. Where there was no evidence, they started down into the layers the best they could until they got to the point where it was more than they could chew in their first iteration. The second iteration will go deeper if the evidence is there.

If you relied upon individual conditions for the chiropractic literature, you would not have any evidence because none of the literature or almost none of the literature speaks to specific diagnoses. It is only, for example, within the last three months that the very first randomized controlled clinical trial using spinal manipulation by chiropractors for disc with sciatica has appeared. It is favorable, and we are working to get that into the document since the article came out after we released it. So, if you want to do it that way, you are going to have nothing to do. Secondly, even the medical community as of 1990 with the President of the North America Spine Society standing up and giving what became his published annual presidential speech has said that the classical medical model for diagnosis has failed when it comes to spine related problems. The literature, specifically the literature such as the work done out of Quebec and the Quebec task force for the lower back and for the neck and other sources, shows that you can predict outcomes better if you could move away from pathoanatomical diagnosis and you look at description - that is symptoms. The third issue of subluxation was included. Wherever we looked, we looked for subluxation as being a specific topic. The evidence is pretty dismal, not that we say that we don’t treat it, but we don’t have a good means of identifying it so how do we define if it got better. The outcomes are hard to use. The literature is in poor quality, etc. But we specifically sought subluxation, so there is rationale based in the literature based on the existing practices in medicine and in chiropractic for the choices that were made in our process.

Dr. Simonetti: Please explain what specific steps where taken by research teams to integrate a patient’s prospective into the development of best practices of chiropractic care of low back pain, lower back conditions, pain. What steps were taken to ensure that recommendations were not totally dependent on just a limited review of the literature? Could the absence of patient involvement skew recommendations towards only those that are deemed scientifically valid by the researcher?

Dr. Triano: Well, we have a process but you have to understand the question again is based on an incorrect assumption. First of all, the fact of the matter is that as we speak we have opened up the comment period to the public so that the public can give its input as well. No. 2: It isn’t the superficial review of the literature. The literature was reviewed using standardized techniques and processes worldwide accepted. Consequently, and by the way, it takes a fair amount of time to review any single piece of literature in order to fill out the standardized form to show that you’ve gone through all of the issues related to that, that are important - considered by whoever - as important. So (a) it is not superficial and (b) the public has been invited to give their input. Their comments and their input will be shared in the same manner as everybody else’s.

Dr. Lewis: If I can inject something else right here because this has been brought up also. Why involve the public right now? Why involve insurance companies? Why involve other healthcare professionals? We wrote an article about this. It is a component of the AGREE process, the international evaluation tool. If we don’t have input even at these stages, the document is judged to be invalid and that was partly why the ACOEM guidelines in California were judged to be not up to snuff. That is all part of the process and if we expect credibility, we have to satisfy those very same requirements that everybody else has to. Otherwise, they just dismiss us. But that is an important component to this, and we hope that people will understand that we have repeated it a number of times. I think there is a certain paranoia that we should not include anyone else but us at this point. It is just not possible.

Dr. Triano: You remember that the RAND Corporation consensus process developed that process, and they mandate that it will be multi-disciplinary. In the AHCPR process, there were 23 partners. Only one was a chiropractor, the second one was a chiropractor MD, and the rest of them not chiropractors. Yet it still came out favorable for us.

Dr. Simonetti: Is the CCGPP developing a computer based “database” which will be accessible by interested parties to “arrive at guidelines for frequency and duration of care”? If so, how has this “database” been constructed? What is its structure and design? And, how will it be queried? Will it be accessible to the profession for “pilot testing” and validation prior to its release to the broader health care community for access and use?

Dr. Triano: Well, that one came off the wall and the answer is “no”. We are not making such a development and consequently it can’t be offered to anybody to see in advance.

Dr. Lewis: Nothing about frequency and duration.

Dr. Triano: That’s not true. On the low back paper in the section that we described as being “literature is not yet reviewed,” there were three papers that were reported…one by Harrison, one by Western State’s Haas, and one out of Quebec…which spoke to the issue about better care, better results if the patient was seen “x” number of times. Other than that, there is nothing in the entire document about frequency.

Dr. Simonetti: Mercy is the first reference listed by CCGPP and it was based on consensus (opinion).   How can CCGPP use opinion as a substitute for factual data in a Best Practices document?

Dr. Triano: Because the entire standard for establishing best practices involves using the best available information with respect to a topic. If the best available information is not anything but opinion and that is what you use. However, if the person or the group that is asking this question is portraying that Mercy is only opinion, then they have not read and understood Mercy. Mercy also used the best available information at the time, which is now out of date, and used the literature as its basis.

CONFERENCE CALL PARTICIPANT QUESTIONS

Dr. Griffiths: Did the commission err when it was going through the consensus process on the side of strictness for a particular purpose rather than the laxity if there was a dearth of evidence in the literature or randomized control trials or anything like that then the consensus had to be reached. Did the commission in this first iteration possibly err on the side of being too strict because this was going to be a benchmark for the profession?

Dr. Triano: First of all, that’s a judgment call. Secondly, there was never a conversation in which I was involved where those issues were raised. The question was “What does the literature say and if there is evidence is it good evidence or bad evidence? And if there is no evidence and it is a high priority issue that the team is able and willing to take on right now, let’s do a consensus process for that. And I would say that the only time that I got involved…because remember, I am not a member of the team. I am an editor. I became aware that there was something that might be not apparent, not that I felt was needed, but many people were asking for and I asked the team to specifically address it. The evidence was not very good, and I watched the team work its butt off to try to give some kind of foundation for the doctor to use his judgment rather than to create a statement that would be used totally against him. So to answer your question, it is a judgment call as to whether anybody thinks that we erred one way or another, but none of the issues you are asking were part of any conversation that I was a part of.

Dr. Simonetti: Jonathan, I think that it is a judgment call and the profession is going to judge that and it’s not just in Alabama. That is one thing I commonly heard. We are holding ourselves to a gold standard and the question is “Do others hold themselves to the same RCT level of research?” I am not arguing the point. I am just saying that this is an issue.

Dr. Triano: If that is the question, then let us answer that question. People need to go and look at what other people are doing. And the fact of the matter is, we did not use only RCTs.

Dr. Griffiths: The question that I asked was of a rhetorical question because I believe that there is very good reason if we did err on the side of strictness. Because this is going to be such a benchmark piece, I really think that was the way to go if we where perhaps too strict rather than too loose on the consensus opinions.

Dr. Triano: Okay, that is your view but like me, you also were not a part of that conversation. But let me just finish on the other. It is very important if that is the question people are asking that they look at what other people are doing. They will find that, yes, everybody else is using randomized controlled trials almost to exclusion. So if were not holding ourselves for the higher level, in fact, we are banging on the side of the container, this little black box saying guys you are missing the boat by holding to only randomized trials because they do not always apply and all of the reasons that are in Chapter 1.

Dr. Simonetti: I want to thank everybody again on behalf of the Board of COCSA and our members.Janet can forward the questions that we did not get to, as well as the questions we asked to CCGPP. Realize we went through the first five in each of category. There are not more than six or seven maximum in each category after the first five, and I think they are little bit more easily answered as well. The call was again recorded, so that it is available for any and all, and the answers to the questions will be posted on the COCSA website. We are also posting any comments from the states that are forwarded to Janet.

Dr. Triano: From a prospective of the commission, all inputs whether its these questions that you forward on or anybody else’s questions that come in, we will respond to all input and publish the results in the final literature document. It will be extremely difficult for the team to be asked to respond to questions along the way but rather we need to follow process so that beyond this venue we will take everything and it will be published and the result will be published.

Dr. Simonetti: Very good. Everybody, okay?

End of call.