# The new Rome II



## ohnometo (Sep 20, 2001)

Am J Gastroenterol 2000 Nov;95(11):3176-83 Related Articles, Books, LinkOut Erratum in: Am J Gastroenterol 2001 Apr;96(4):1319 Irritable bowel syndrome according to varying diagnostic criteria: are the new Rome II criteria unnecessarily restrictive for research and practice?Boyce PM, Koloski NA, Talley NJ.Department of Psychological Medicine, University of Sydney, Nepean Hospital, Penrith, New South Wales, Australia.OBJECTIVES: It has been suggested that the variation in the prevalence of irritable bowel syndrome (IBS) may be due to the application of different diagnostic criteria. New criteria for IBS have been proposed (Rome II). It is unknown whether persons meeting different criteria for IBS have similar psychological and symptom features. The aim of this study was to measure the prevalence of IBS according to Manning and Rome definitions of IBS and to evaluate the clinical and psychological differences between diagnostic categories. METHODS: A total of 4500 randomly selected subjects, with equal numbers of male and female subjects aged > or = 18 yr and representative of the Australian population, took part in this study. Subjects were mailed a questionnaire (response rate, 72%). Characteristics measured were gastrointestinal symptoms over the past 12 months, neuroticism and extroversion (Eysenck Personality Questionnaire), anxiety and depression (Delusions-Symptoms-States Inventory), mental and physical functioning (SF-12), and somatic distress (Sphere). RESULTS: The prevalence for IBS according to Manning, Rome I, and Rome II was 13.6% (95% confidence interval [CI] = 3.5-5.1%), 4.4% (CI 6.0-7.8%), and 6.9% (CI 12.3-14.8%), respectively [corrected]. Only 12 persons with Rome I did not also meet Rome II criteria; 196 persons with Manning criteria did not meet Rome II cut-offs. Having IBS regardless of which criteria were used was significantly associated with psychological morbidity, but psychological factors were not important in discriminating between diagnostic categories. However, pain and bowel habit severity independently discriminated between diagnostic groups. CONCLUSIONS: IBS is a relatively common disorder in the community. The new Rome II criteria may be unnecessarily restrictive in practice.


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## ohnometo (Sep 20, 2001)

Editorial October 2000Volume 95, Number 10Pages 2679-2681 -------------------------------------------------------------------------------- Rome? Manning? Who Cares? Lars Agrï¿½us, M.D., Ph.D.a --------------------------------------------------------------------------------In this issue of the American Journal of Gastroenterology, Saito et al. (1) present an important report concerning the two most often used definitions of the irritable bowel syndrome (IBS): the older but still widely used Manning criteria (2), and the Rome I criteria from 1989 (3). The latter definition has recently been revised, called Rome II (4). Saito et al.'s publication is of crucial importance: IBS is very common (see Table 6 in Saito et al.'s article), and it is expensive to society (5); and, as researchers present data with either definition, it is important to be able to compare the results of different authors. The confusion with two definitions in the arena is made even worse by the fact that different cut-off levels can be used for both definitions, as discussed by Saito et al., with, of course, lower prevalence with higher cut-offs. Nobody knows which cut-off is clinically applicable in either definition. However, the prevalence of IBS with the Manning criteria is consistently higher than with the Rome criteria. Despite this, Saito et al. show an acceptable agreement in identifying subjects with IBS using either definition, with both statistics and "overall agreement". The same findings concerning both prevalence rates and diagnostic agreement have been reported from population-based surveys before (6, 7, 8). It can be argued that the Manning criteria are more sensitive in finding cases than the Rome I criteria. The lower sensitivity of the Rome I criteria has recently been focused on in an abstract at the Digestive Diseases Week 2000 (9), where Saito et al. also showed that the new Rome II criteria give even lower prevalence rates than Rome I in community-based samples (10). Also, Hahn et al. (6) postulated that both the Manning criteria and the Rome I definition of IBS underestimate the true number of sufferers. So, what is the truth? The Manning criteria (2) were originally created and validated in a secondary care patient population, and the results from Manning et al. have been confirmed (11), showing that the sensitivity is acceptable but the sensitivity is poor: this is the reason why clinicians must exclude organic disorders by including "alarm" symptoms and investigations based on their "intuition." The Rome criteria are based on factor analysis of population-based data (12) and have been shown to have reasonable accuracy when combined with alarm symptoms and signs in secondary care patients (13), except for lactose intolerance (14), in secondary care. To my knowledge, no investigator has tried to validate the accuracy of the two definitions, including intestinal investigations, in a primary care setting or in a population sample. This is necessary as secondary care IBS patients represent only a subset of all sufferers (15) and most probably are heavily biased by health care-seeking behavior (16). It is also a huge task! Who uses the current definitions? It is the researcher, in both epidemiological studies, trying to approach the unselected population by mailed questionnaires, and in face-to-face consultations with either patients or subjects in a study. In these situations, there is time to use extensive questionnaires with several pages of questions. What other sources of information concerning diseases are available? One increasingly used source is computerized medical records, which also can "force" the doctor to set diagnoses at each consultation or telephone contact. A vast majority of those people with IBS symptoms consult in general practice (15). In Sweden today, as in many other countries, most primary health care centers are computerized (17), and in hospitals this process is accelerating. This gives us access to very important information about the IBS patients, as clinical information can now easily be extracted from the medical records. However, how is the IBS diagnosis made in clinical practice? If data from research and everyday clinical work are to be compared, diagnoses in research and reality must be comparable or, ideally, identical. Thompson et al. (18) showed that only nine of 55 general practitioners under survey have heard of the Manning criteria, and just one of them had heard of the Rome definition. None of them used these criteria in their practice. Despite this they referred only 14% of the IBS patients for a second opinion. In another study from the same group (15), 48% of the patients that fulfilled the Rome I and/or Manning criteria were not classified as such by the general practitioners, although half of these received a related functional gastrointestinal diagnosis. When I was invited to write this editorial, I asked the 136 general practitioners in the County of Uppsala, Sweden, whether they had ever heard of the Rome definition or the Manning criteria, and whether they used them. The doctors are specialized in family medicine and most of them experienced. Thirty-six answered promptly; of those, two had heard of Manning's criteria but never used it, and one had heard of the Rome definition, and thought he used it! They were also asked how they diagnosed IBS. The overwhelming majority mentioned abdominal pain and concomitant "unspecified" bowel problems, taking alarm symptoms into consideration, and ordered investigations when needed. The response rate is low, but most probably the nonresponders are not more familiar with the terminology! So how come this lack of definition works in practice? Well, one reason is that the Rome definition and the Manning criteria are too complicated to use in the busy clinical workday. Most patients with functional abdominal disorders are treated in primary health care (15), where an individual doctor sees up to 150 patients per week (19), and gastrointestinal complaints constitute only about 5% of all cases in primary health care (20). Not only gastroenterologists but many other specialists have presented complicated and, thereby, unusable algorithms. Many of the conditions encountered are polysymptomatic, and thus diagnosis is often based on clinical impression rather than applying definitions developed for the purposes of research (18). The situation in most gastroenterologists' practices not engaged in research, where up to half of the patients present with functional disorders (21), is probably similar. Another reason might be that the definitions per se are not applicable in a general practice setting, as they are not validated in that setting, and that therefore the general practitioner has to treat the patients according to his or her enormous experience combined with "unstructured" knowledge. Attempts have been made to simplify the IBS definition. Kruis et al. (22) designed a scoring system with only pain, flatulence, bowel irregularity, and alternating constipation and diarrhea as mandatory symptoms, combined with symptom duration and negative laboratory tests. The Kruis scoring system has been found to be equivalent to the Manning criteria in identifying IBS and excluding organic gastrointestinal disease (23). Also, our group has shown that a simple definition with only abdominal pain or discomfort combined with constipation or diarrhea, or alternating constipation or diarrhea, gives the same prevalence rates as the Rome I definition, and slightly lower than the Manning criteria. The general agreement between this simple definition and the Rome criteria was very good ( 0.85, general agreement 96%), and somewhat lower than that with the Manning criteria. This simple definition can be criticized for not separating symptoms of stool consistency and defecation frequency, and defecation problems. We (8, 24) and others (25) have shown, however, that these different stool and defecation entities in layman's terms are understood as constipation or diarrhea. The definition has been validated in a general population sample (26), but not with any control investigations! It also seems to be consistent with the way general practitioners think. So who cares about Rome and Manning? Certainly not those doctors looking after most of the patients! As new clinical data become available because of computerization and as new IBS drugs are introduced on the market, we need diagnostic criteria for IBS that are validated in all settings and are applicable not only in research but also in clinical practice. The most important statement in the paper by Saito et al. is, consequently, the last one in the paper: further studies are needed to delineate the optimal criteria needed to identify and diagnose individuals with IBS in the community! --------------------------------------------------------------------------------aFamily Medicine Stockholm, Karolinska Institutet, Stockholm, Sweden, Primary Health Care Centre, Hallstavik, Sweden --------------------------------------------------------------------------------References 1. Saito YA, Locke III GR, Talley NJ, et al. A comparison of the Rome and Manning criteria for case identification in epidermiological investigations of irritable bowel syndrome. Am J Gastroenterol 2000;95:2816-24. 2. Manning AP, Thompson WG, Heaton KW, et al. Towards positive diagnosis of the irritable bowel. Br Med J 1978;2:653-4. 3. Thompson WG, Dotevall G, Drossman DA, et al. Irritable bowel syndrome: Guidelines for the diagnoses. Gastroenterol Int 1989;2:92-5. 4. Thompson WG, Longstreth GF, Drossman DA, et al. Functional bowel disorders and functional abdominal pain. Gut 1999;45(suppl II):1143-7. 5. Talley NJ, Gabriel SE, Harmsen WS, et al. Medical costs in community subjects with irritable bowel syndrome. Gastroenterology 1995;109:1736-41. 6. Hahn BA, Saunders WB, Maier WC. Differences between individuals with self-reported irritable bowel syndrome (IBS) and IBS-like symptoms. Dig Dis Sci 1997;42:2585-90. 7. Kay L, Jï¿½rgensen T, Lanng C. Irritable bowel syndrome: Which definitions are consistent? J Intern Med 1998;244:489-94. 8. Agrï¿½us L, Talley N, Svï¿½rdsudd K, et al. Identifying dyspepsia and irritable bowel syndrome: The value of pain or discomfort, and bowel habit descriptors. Scand J Gastroenterol 2000;35:142-51. 9. Bommelaer G, Dorval E, Denis P, et al. Prevalence of irritable bowel syndrome according to the Rome criteria in the French population. Gastroenterology 2000;118 (suppl 2):A-760. 10. Saito A, Locke GR, Talley NJ, et al. The effect of new diagnostic criteria for irritable bowel syndrome on community prevalence estimates. Gastroenterology 2000;118(suppl 2):A-402. 11. Talley NJ, Phillips SF, Melton LJ, et al. Diagnostic value of the Manning criteria in irritable bowel syndrome. Gut 1990;31:77-81. 12. Whitehead WE. Patient subgroups in irritable bowel syndrome that can be defined by symptom evaluation and physical examination. Am J Med 1999;107:33S-40S. 13. Vanner SJ, Depew WT, Paterson WG, et al. Predictive value of the Rome criteria for diagnosing the irritable bowel syndrome [see comments]. Am J Gastroenterol 1999;94:2912-7. 14. Hamm LR, Sorrells SC, Harding JP, et al. Additional investigations fail to alter the diagnosis of irritable bowel syndrome in subjects fulfilling the Rome criteria. Am J Gastroenterol 1999;94:1279-82. 15. Thompson WG, Heaton KW, Smyth GT, et al. Irritable bowel syndrome in general practice: Prevalence, characteristics, and referral. Gut 2000;46:78-82. 16. Drossman DA, McKee DC, Sandler RS, et al. Psychosocial factors in the irritable bowel syndrome. A multivariate study of patients and nonpatients with irritable bowel syndrome. Gastroenterology 1988;95:701-8. 17. Berg L. Data on file. The Research Unit in Primary Care, Tibro, Sweden. 18. Thompson WG, Heaton KW, Smyth GT, et al. Irritable bowel syndrome: The view from general practice. Eur J Gastroenterol Hepatol 1997;9:689-92. 19. Britt H, Miles DA, Bridges-Webb C, et al. A comparison of country and metropolitan general practice. Aust Fam Physician 1994;23:1116-21, 24-5. 20. Jones R. Self-care and primary care of dyspepsia: A review. Fam Pract 1987;4:68-77. 21. Lï¿½ï¿½f L, Adami HO, Agenï¿½s I, et al. The Diagnosis and Therapy Survey October 1978-March 1983, health care consumption and current drug therapy in Sweden with respect to the clinical diagnosis of gastritis. Scand J Gastroenterol 1985;20(suppl 109):35-9. 22. Kruis W, Thieme C, Weinzierl M, et al. A diagnostic score for the irritable bowel syndrome. Its value in the exclusion of organic disease. Gastroenterology 1984;87:1-7. 23. Doggan UB, ï¿½nal S. Kruis scoring system and Manning's criteria in diagnosis of irritable bowel syndrome: Is it better to use combined? Acta Gastroenterol Belg 1996;59:225-8. 24. Agrï¿½us L. The abdominal symptom study. An epidemiological survey of gastrointestinal and other abdominal symptoms in the adult population of ï¿½sthammar, Sweden. Thesis, Uppsala University, Uppsala, Sweden 1993. 25. Ragnarsson G, Bodemar G. Pain is temporally related to eating but not to defecation in the irritable bowel syndrome (IBS). Patients' description of diarrhea, constipation and symptom variation during a prospective 6-week study. Eur J Gastroenterol Hepatol 1998;10:415-21. 26. Agrï¿½us L, Svï¿½rdsudd K, Nyrï¿½n O, et al. Reproducibility and validity of a postal questionnaire. The abdominal symptom study. Scand J Prim Health Care 1993;11:252-62.--------------------------------------------------------------------------------


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## eric (Jul 8, 1999)

FYIThis is two years newer.Gastroenterology 2002 May;122 6:1701-14 Related Articles, Books, LinkOut Diagnosis of irritable bowel syndrome. Olden KW. Department of Medicine, Division of Gastroenterology, Mayo Clinic Scottsdale, 13400 E. Shea Boulevard, Scottsdale, Arizona 85259, USA. olden.kevin###mayo.edu Irritable bowel syndrome IBS is the most common disorder seen in gastroenterology practice. It is also a large component of primary care practices. Although the classic IBS symptoms of lower abdominal pain, bloating, and alteration of bowel habits is easily recognizable to most physicians, diagnosing IBS remains a challenge. This is in part caused by the absence of anatomic or physiologic markers. For this reason, the diagnosis of IBS currently needs to be made on clinical grounds. A number of symptom-based diagnostic criteria have been proposed over the last 15 years. The most recent of these, the Rome II criteria, seem to show reasonable sensitivity and specificity in diagnosing IBS. However, the role of the Rome II criteria in clinical practice remains ill defined. A review of the literature shows that, in patients with no alarm symptoms, the Rome criteria have a positive predictive value of approximately 98%, and that additional diagnostic tests have a yield of 2% or less. Diagnostic evaluation should also include a psychosocial assessment specifically addressing any history of sexual or physical abuse because these issues significantly influence management strategies and treatment success. Publication Types: Review Review, Tutorial PMID: 12016433PS " However, the role of the Rome II criteria in clinical practice remains ill defined" in part because a lot of Doctors may not use it or are familar with it all.


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## ohnometo (Sep 20, 2001)

Thanks for the update Eric


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## Mike NoLomotil (Jun 6, 2000)

?? _________________________________________"IBS is a relatively common disorder in the community" _________________________________________I wonder how much it cost to figure that out. Next time just write the check send it here. I could have provided the info much more quickly and put the money to use looking for CAUSES or better TREATMENTS of IBS.


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## Kathleen M. (Nov 16, 1999)

1. Probably didn't cost much. I suspect that comment comes from the phone survey type of studies that really don't cost much. A couple of grad students at slave labor wages, a few phone bills.Although you could also do the what % of people in a general practice over X time had IBS complaints. Also not much effort.2. Establishing that something is a common, widespread problem may have been a bit of data that was needed when applying for a grant to study causes and treatments.Something that effects 1 out of 5 or 10 people may get more notice than something that is quite uncommon, especially when considered a non-life threatening condition.If you can prove that it is a BIG problem (like the survey that showed that it is the second leading cause of work place absenses) that gives you much more leverage at getting a piece of the funding pie. I mean if it effect 1 or 2 out of a million and was considered merely annoying that isn't as big a priority as something that effects 15-20% of people and cuts substantially into the productivity of the workforce as a whole. But you have to have DATA to back that sort of assertion up. So you get a Master's student (who may have actually not even been paid as sometimes they don't get RA's for this kind of project) or two, give them a randomly generated phone list (heck if you do it all with local calls you can do it even more cheaply then if you did a nationwide or region wide survey). Give 'em a desk and a phone and in about a year they should have enough data for that sort of thing.A heck of a lot of good reseach is done very cheaply. You usually have to generate some data with no funding to get to the point you have a strong enough case to get funding. I know plenty of people who during the 1980's and 1990's when funding got cut, and cut, and cut...to where instead of being in the top 25-50% of applicants you got funded to where you had to be in the top 10% or less to even get money who find ways to do good work on the cheap so they got enough numbers to be able to get a grant to do a big project.Masters students are a good way to do this. They often do not get assistantships, so sometimes they are paying to be slave labor, or get a Ph.D student who likes to teach so teaching pays them to eat and sleep somewhere (and not much else, really) to do the work.Even if all you get is a poster presentation out of it at a conference it is usually enough ## to be able to get your foot in the door to get enough $$ to do the kind of causitive and treatment work you seem to imply no one wants to do.K.


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## Mike NoLomotil (Jun 6, 2000)

"A heck of a lot of good reseach is done very cheaply"Oh I do agree, especially when you (the collective not the personal) are operating within an institution or organization which has the kinds of resources you describe. When I was with the Cleveland Clinic and its university affiliations, or at University Hospitals in Cleveland (Case Western Reserve U affilaited) it was like a candy store.Ditto at Mt. Sinai in Miami Beach and University in jacksonville (Affiliate with Shands in Gainesville which is UF med school)...and my friends down at UM, the ones in the right place, have access to resources that I can only dream of.I think my reaction is more related to the fact that one more investigation into the frequency of occurrence in the population is indeed limited in usefulness to what you describe...a poster on a table top display at a conference....there has been so much already published on the subject that I wish whatever dollars spent could have been spent in a more direct way I guess...an in vivo investigation fo one of the puzzling aspects of an IBS subpoulation, for example, which might yiled something helpful directly to patient care.But on the other hand if indeed such an effoort leads to access to funding for a new in vivo investigation of some new and original aspect of IBS...some value...then indeed the expense would have been worth while.Like the drug industry, though, it is a fact that way too many resources are basically wasted on reduncancy, that is doing something already done...just like just trying to create a new variation on existing drugs for a problem already addressed so you can get a new patent and grab market share in a target population that is clearly there, clearly defined, and which you will get immediate sales just by being there. Me tooism...which of course is the basic point of free enterpise and profit and publicly held companies...the priority is shareholder return and the low risk project is safer than the high risk. Especially now (see Market Report Lou Dobbs







.Need more funding directed at 'IBS" which is NOT industry depenent, rather can be used at the total and sole discretion of the investigator to look at specific aspects of the condition which need amplification with NO quid pro quos of any kind. This is just plain not the nature of industry sourced funding, never has, never will.Like Bengtsson for one example...he has access to resources which allow him to go look at exactly whatever he thinks needs to be looked at with no quid pro quos to fulfill to be able to systain the funding flow. And it must be substantila since you must have to really provide $$ inducement to the subjects for some of the invasive work he has done the last few years







Achtung, you are meandering again MNL and the road is calling...gotta be in Hot 'lanta for lunch!MNLOH PS...this might help clarify where I am coming from in a good natured wayRe: _________________________________________"...the kind of causitive and treatment work you seem to imply no one wants to do" ________________________________________Heck no I am not implying it I am stating flat out that in this sector nobody will now fund any direct-research $$ to the project. Period. It is NOW literally impossible to get done what would be considered acceptable to the mainstream vis a vis study design by accessing some funding directly. What was there for the original technology development and beta clinic funding I was able to secure between 1993 and 1999 (over $5,000,000 of investment capital) has evaporated. VC's lost almost 30% of the value of their managed assets last year. It is evaporetd so badly in the VC markets and angel markets that if you have something that is not already generating a 20% EBITDA you can just take your proposal and your buisness plan and skip the submission desk and carry it straight to the circular file as this is where it goes..period. In fact some ex Anderson employees will work cheap to just shred it up for you.EVEN with the HUGE market we all know the IBS population represents. It is not sexy, which is the one redeeming virtue in the private sector that can save yer bacon in the buck hunt if you ain't got the EBITDA already...sexy sells. Not in the "sex sense"...sexy in the investment sense. There is no adventure capital without it...and research $$$ outside your own resources which you can generate is all AD-venture capital now not Venture capital.Example? Lets just say people are literally falling all over themselves from major universities down to individual physicians and angel investors over this new low frequency pulsed elctromagnetic therapy bed we brought over from Europe. Why? NFL players with broken bones and torn up knees whose careers were deemed over or who were deemed lost for the season by their trainers and doctors slept in it and ended up starting and playing all damn season. Eureka!!! Even though the same venue (both NFL and NCAA) has been using MRT testing and diietary management based upon it for years to quietly optimize the diet and eliminate physical symptoms of players....BIG NAME players...Hall of Fame players even!







Now THAT magnetic bed thing...rapid healing, rapid recovery, rejuvenated masses of bone crushing muscle lifted from the trainers table and deposited back into the starting lineup...THAT is "sexy".In fact so sexy and so exciting when "they" think it through that the damn manufacturing plant is already building them, docs are lining up to buy them, and a group of NFL trainers and players put up scratch to do it and out us in the training room of every NFL tean we want by making that key phone call "you guys need to look at this".Further, doctors I know from my years at the Cleveland Clinic and elsewhere, some within 24 hours of seeing the project, were in contact with at least (3) major universities who immediately responded with exrpess interest to get them in and to use their own money to do the research and publish it!!! Same world of doors that have been closed any time some possible solution from our sector is shown for poor people who cannot control their bowels was concerned unless "how much cash do you have to pay us" could be answered with six figures.THIS took less than 2 weeks to make happen.Sexy. Damn I wish uncontrollable diarrhea were sexy.







But this is the length we will go to to get $$ to advance work further on our core subject...Disease Mangement enhancement for people with these weird reactions to things which then make them clinically ill.I will bootstrap it myself. If this is what it takes to be able to do it...well I am a determined d-type I'll tell ya that







Gotta go..really...wearing out the highway and the bandwidthMNL


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## Kathleen M. (Nov 16, 1999)

I've been involved in a little clinical trial (both ends researcher and guinea pig).And the more invasive the testing the bigger $$ you gotta give to get subjects. Survey work is pretty cheap as it goes, but stick a tube in someone and you gotta be able to pay people for the trouble.K.


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## ohnometo (Sep 20, 2001)

KPlease dont give Mike any ideas







He might start looking for subjects







*******************************************but stick a tube in someone and you gotta be able to pay people for the trouble.


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## Mike NoLomotil (Jun 6, 2000)

Don't worry...Prof. Bengtsson and Brostoff together will work with us on it so we can get the in vitro and in vivo tetsing doen concurrently on the same subjects...the problem is that Prof. Bengt. already had and has a pile of things to do before he can even look at a protocol and start planning it and has asked us to "defer" until he finishes what is on his full plate







and he is the guy with the people who will "take the hose" and who are known reactive. They have a good sized clinic so they have been able to isolate a susbtantial population over time who fit the selection criteria.I also do have a respected center here that will put it together (they do preclinical drug trials for a living) but there is this specific sum of $$$ that must be acquired to pay the costs...so we wait unless Santa Claus opens a big GI clinic for us







We could spend the time and $$$ to keep putting toegther reports like Dr. Pardell did....but it has been done, speaks for itself, and takes just as much effort to get published (he is still tap dancing with the journal editors with it). Then the skeptics will merely hold forth all their reasons that it should be ignored. When you know you need a specific type of ice skates to get in the game on an exclusive rink, and if you do not have them you will be immediatley kicked off the ice, then get a that set of skates before you go play. Do it right and you only have to do it once.Meanwhile there are lots of other people who will play with you off that exclusive rink.MNLMNL


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