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Letters to the Editor

ACOEM Guideline Analysis

T o The e diTor :

The recent series of 3 articles published in PainPhysician regarding the ACOEM guidelines repre-sented a significant new approach to evidence analy-sis and guideline synthesis by the addition of guide-line criticism (1-3). The manner in which the articleswere written attempt to objectively and strictly applythe methods of analysis and synthesis as proposed byprominent agencies and medical societies, and to alsoapply strictly ACOEMs own method with the additionof overlooked literature. The results of such analysisare shocking.

New ApproachIt is unusual for medicine to see one medical soci-

ety publish a sweeping reanalysis of another societysguidelines regarding an entire discipline, such as Inter-ventional Pain Management, or to criticize the mannerso thoroughly, then reapply analytic criteria to reachdifferent conclusions. What is the purpose of this?

The ACOEM guidelines regarding spine interven-tions and surgery are exceedingly negative, therebythreatening the existence of the specialty of Inter-ventional Pain Management. Logically, a reactionwas drawn. Rather than a simple emotional criticismpointing out the flaws of the ACOEM publication, theauthors present the reader details of proper evidenceanalysis and guideline analysis that are generally ac-cepted. The authors then guide the reader in the cor-rect application of the method.

Objectivity and StandardsThe various standards of evidence analysis such

as the Agency for Healthcare Research and Quality(AHRQ) (4) and Cochrane (5), the grading of recom-mendations modified from Guyat et al (6) and those ofASIPP (7), and the formulation of guidelines all havesome logical appeal to physicians and payers. The va-

lidity of such standards may be questioned. One wouldhave to subject such analysis, recommendations, andguidelines themselves to 2 cohort prospective studieswith randomization. We might discover that our com-munitys perception of wellness is better following theASIPP guidelines (7) more so than a cohort followingthe ACOEM guidelines (8,9) that would not allow cov-erage of interventional techniques; or the opposite

may become apparent.The method of ACOEM is not validated either,

and excludes a couple of clinical variables that may beimportant. Manchikanti et al (3) stated, While thereis no universally accepted approach to developing andpresenting guidelines . . ., impling that we cannotplace 100% of faith in any of the methods. However,one should logically conclude that more rigor and in-clusion of more evidence would be additive to the reli-ability of conclusions. Patients deserve best efforts.

AHCPR funding has been stopped by congress be-cause the application of guidelines was found to becontroversial and too restricting on medical practice;the development of the 19 guidelines they issued wasat an expense of $750 million taxpayer dollars (10).The US may be better able to afford the continuationof controversial practices than to try to develop guide-lines that everyone can agree are valid.

The refusal to consider well designed observation-al studies is both without validity and does disserviceto the public by ignoring important developmentsand valuable evidence. The value of RCTs in the studyof comparative efficacy of 2 similar drugs has not beendemonstrated to be a valid or necessary method ofstudying procedures. The cost of RCTs and the ethicalissues involved when enrolling patients in such studiesfor procedures dictates more extensive literature eval-uation and the experience of experts in the specialty.

ResultsThe first article (1) detailed the proper methods

and rating systems accepted in medicine. The articlepointed out the conflicts of interest that could intro-duce bias into the ACOEM method and conclusions.

The second article (2) did assess the methods ap-plied in the ACOEM guidelines applying the AGREE in-strument. The scores received by the ACOEM guidelinesfor the low back and chronic pain chapters, including

interventional pain guidelines, were dismally poor, afailure by any academic standard: < 10% in 3 of 6 do-mains, < 20% in 1/6, > 30% in 1/6, and > 70% in only 1/6;the overall score was < 30%. The AGREE instrument dic-tates that one conclude, not recommended or suitablefor use in practice. The guidelines also disastrously failusing AMA and IOM criteria.The analysis used measure-ment tools as mentioned above.

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ACOEM response by Hegmann et al (10) to thefirst 2 articles was, in contrast, an emotional responselacking evidence, method, and objectivity. It was asophomoric attempt to dismiss a well crafted critique

that one would prefer they take very constructively.It failed to address a basic criticism such as inclusionof the Caragee article on discography that comparedisthmic spondylolisthesis surgical outcome to fusionoutcomes for painful degenerative discs. This articledid not meet their own inclusion criteria as therewas no rational randomization and comparabitlityof the 2 cohorts, yet was part of the basis of theirrecommendation.

In the third article (3), the negligent exclusionof articles that score highly by proper adherence tomethodology was revealed. Very different conclusionsare reached when rigor is applied, even utilizing theirown system, favoring diagnostic use of provocationdiscography, facet diagnostics, and therapeutics, lum-bar transforaminal epidural steroid injection, sacroili-ac injection, adhesiolysis, and spinal cord stimulationwhich are strong; for facet neurolysis moderate tostrong; for caudal epidural steroid injection moderateevidence with positive results short-term, limited long-term, but overall Level 1 by AHRQ standards; whileACOEM methodology finds interlaminar epidural ste-roid injection insufficiently documented, Guyatt styleanalysis is 1A or 1B for cervical, 2A or C for lumbar.

These results are shockingly different from thosepresented by ACOEM.

Ethical Questions Should guidelines in a specialty area be issued

by that specialty society only? Are members ofother societies expert enough to thoroughly un-derstand the nature and intricacies of a differentdiscipline?

Will insurance companies and agencies reappraisethe validity of ACOEM guidelines and stop usingthem in favor of guidelines that strictly apply thecurrent standards of evidence analysis and guide-line synthesis. And score highly on the AGREE

assessment? How should society at large react if payers fail toadhere to the principles?

When an agency or company refuses patients ac-cess to justifiable services, are they negligent orguilty of a form of malpractice?

Are they endangering the well-being and produc-

tivity of our community in the interest of theirbalance sheets?

Will denial of coverage for our procedures widenthe gap in care between the rich who can affordto pay for elective procedures and those who aredependent on coverage for care?

Will the denial of coverage for pain interventionsresult in more people being shifted into disabilityand increase our social security burden?

Is there any financial relationship between theACOEM investigators and payers? If so, is thatokay or should that be disclosed in parcel with theACOEM guidelines?

In ClosingOne assumes that guidelines that will be used to

influence payer coverage would adhere to the high-est standard and methodology. When it does not, asit appears here to have failed, then one is truly disap-pointed and left feeling betrayed. Most importantly,payers have been citing these apparently unreliableguidelines as a basis to deny coverage for interven-tional techniques. Garbage in, garbage out is too sim-ple an excuse when patient well being is at stake. Gov-ernment agencies and the public should join multiplemedical societies in questioning the appropriatenessand responsibility of payers who follow guidelinesthat are scoring so poorly when the AGREE instru-ment is applied. Thus far multiple medical societiesand members of Congress have voiced their protest(11,12). The public and Legislators should be con-cerned about the expansion of Social Security burdenswhen citizens lack access to pain control due to denialof coverage in workers compensation, state agency,or private sectors.

Joseph Jasper, MDMedical Director

Advanced Pain Medicine PhysiciansTacoma, WAE-mail: apmedicine@qwest.net

r eferences

1. Manchikanti L, Singh V, Derby R, HelmS, Trescot AM, Staats PS, Prager JP,Hirsch JA. Review of occupational med-icine practice guidelines for interven-

tional pain management and poten-tial implications. Pain Physician 2008;11:271-289.

2. Manchikanti L, Singh V, Helm S, Trescot

AM, Hirsch JA. A critical appraisal of2007 American College of Occupation-al and Environmental Medicine (ACO-EM) practice guidelines for interven-

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Letters to the Editor

tional pain management: An indepen-dent review utilizing AGREE, AMA, IOM,and other criteria.Pain Physician 2008;11:291-310.

3. Manchikanti L, Singh V, Derby R, SchultzDM, Benyamin RM, Prager JP, Hirsch JA.

Reassessment of evidence synthesis ofoccupational medicine practice guide-lines for interventional pain manage-ment. Pain Physician 2008; 11:393-482.

4. West S, King V, Carey TS, Lohr KN, McK-oy N, Sutton SF, Lux L. Systems to Ratethe Strength of Scientific Evidence , Ev-idence Report, Technology Assess-ment No. 47. AHRQ Publication No. 02-E016. Rockville, MD: Agency for Health-care Research and Quality, 2002. www.thecre.com/pdf/ahrq-system-strength.pdf

5. Koes BW, Scholten RJ, Mens JMA, Bout-er LM. Epidural steroid injections forlow back pain and sciatica. An updatedsystematic review of randomized clini-cal trials.Pain Digest 1999; 9:241-247.

6. Guyatt G, Gutterman D, Baumann MH,

Addrizzo-Harris D, Hylek EM, PhillipsB, Raskob G, Lewis SZ, Schnemann H.Grading strength of recommendationsand quality of evidence in clinical guide-lines. Report from an American Collegeof Chest Physicians Task Force.Chest

2006; 129:174-181.7. Boswell MV, Shah RV, Everett CR, Se-hgal N, Mckenzie-Brown AM, Abdi S,Bowman RC, Deer TR, Datta S, Col-son JD, Spillane WF, Smith HS, Lucas-Levin LF, Burton AW, Chopra P, StaatsPS, Wasserman RA, Manchikanti L. In-terventional techniques in the manage-ment of chronic spinal pain: Evidence-based practice guidelines. Pain Physi-cian 2005; 8:1-47

8. American College of Occupational andEnvironmental Medicine (ACOEM) LowBack Disorders. InOccupational Medi-cine Practice Guidelines: Evaluation and Management of Common Health Prob-

lems and Functional Recovery of Work-ers, Second Edition . OEM Press, BeverlyFarms, 2007.

9. American College of Occupational

and Environmental Medicine (ACOEM)Chronic Pain. InOccupational MedicinePractice Guidelines: Evaluation and Management of Common Health Prob-lems and Functional Recovery of Work-ers, Second Edition . OEM Press, Beverly

Farms; awaiting publication.10. Hegmann KT, Talmaga JB, Genovese E.In Reference to Manchikanti et als Criti-cism of ACOEM Guidelines.Pain Physi-cian 2008; 11:567-568.

11. Letter to Robert K. McLellan, MD, Pres-ident of the American College of Oc-cupational & Environmental Medicine(ACOEM) from the American Academyof Pain Medicine, American Society ofInterventional Pain Physicians, Interna-tional Spine Intervention Society, andNorth American Neuromodulation Soci-ety. January 22, 2008.

12. Letter to Robert K. McLellan, MD, Presi-dent of the American College of Occupa-tional & Environmental Medicine (ACO-EM) from the Honorable Bart Stupakand Ed Whitfield, U.S. House of Repre-sentatives, January 25, 2008.