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Methodology Used by Task Forces Clearly stating the questions and methods Using comprehensive searoh methods to locate relevant studies Using explicit methods to determine which articles to include Carefully assessing the validity of the primary studies with methods that are reproducible and free from bias Analyzing the variation between the findings of relevant studies Appropriately combining the findings of the primary studies Ensuring that the conclusions are supportable from the data cited The Infernotianai Journol of Periodontics & Resforative Denfisfry

Methodology Used by Task Forces - Perio Health …...117 Evidence-Based Periodontal Treatment, ii. Predictabie Regeneration Treatment TASK FORCE GOALS Michael G. Newman ' Michael K

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Page 1: Methodology Used by Task Forces - Perio Health …...117 Evidence-Based Periodontal Treatment, ii. Predictabie Regeneration Treatment TASK FORCE GOALS Michael G. Newman ' Michael K

Methodology Used by Task Forces

Clearly stating the questions and methods

Using comprehensive searoh methods to locaterelevant studies

Using explicit methods to determine which articles toinclude

Carefully assessing the validity of the primary studies

with methods that are reproducible and free from bias

Analyzing the variation between the findings of relevantstudies

Appropriately combining the findings of the primarystudies

Ensuring that the conclusions are supportable from thedata cited

The Infernotianai Journol of Periodontics & Resforative Denfisfry

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Evidence-Based PeriodontalTreatment, ii. PredictabieRegeneration Treatment

TASKFORCE

GOALSMichael G. Newman 'Michael K. McGuire"

Ciinical experience, technrcai ability, and intuition are indispensable but ore nolonger sufficient as the sole clinical skiits necessary fa provide fhe best outcomesfrom periodontal and peri-implanf regeneratian treafment. This article describes acomprehensive and rigorous méthodologie framework fo assess fhe ovaiiable evi-dence cantained within the literature. This assessment tooi is referred to as the evi-dence-based mefhod. The methodoiogy was used by a series of fask forces con-vened to evaiuate fhree common areas of clinical regenerative treatment Themajor goals of these task torces were: (1 ) to increase the sfrengfh of the inferencethat practitianers can derive fram the base af knowiedge contained within the liter-ature, (2) fo develop aigorithms fo improve the predictability of regeneration treat-ment, and (3) to determine methods that can be used to predictably transfer thevoiueo/ffieropj'foffiepQf/enr, (Int J Petiodont Rest Dent 1995:15:116-127.)

'Ptivote Ptootice, Beverly Hüls. Caiifotnia: Adjunct Professot,Univetsity of Caiifotnia, Los Angeles. School ot Dentistry, LasAngeles, Caiifotnia: Medical Science Systems, Newport Beach,ColifoiniQ.

**Private Ptactice, Houston, Texas: Assistont Ctinicol Ptofessor,University of Texas, Dental Branch, Houston, Texas: Assisfont CiinicaiPtotessot, Univetsity of Texas, Dentai Branch. San Antonio. Texas,

Reptint requests: Dt Michael G. Newman. 809 Alma Reoi Dr,Pacific Palisades, California 90272.

In the last 10 yeats, technologicand biologic advarices have has-tened the extensive use of regen-erative treatmetit fot periodontal,peri-implant, and bone augmenta-tion applications.' The body of lit-erature on clinical regenetativetteatment documents one of themost important therapeuticapproaches in dentisfty. Despitereports of clinical success withguided tissue regeneration (GTR),the maiti dilemma for a majority ofpractitioners is determining its pre-dictability on on individual patientbasis. The systematic incorporationof new knowiedge (evidence),together with clinical Judgmentand personal experience, canimprove treatment results.Scientifically valid information catireduce the variation in outcomesand improve the overall effective-ness of clinical practice,^

Regenetation of fhe periodon-fium has been described in the lit-erature^ for almosf 30 years, but itwas not until the development ofGTR that its widespread applica-tion was incorpotdted into routinepractice. Some of the previouslyconducted research, significantwhen published, did not conform

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to current méthodologie require-ments. Currently there is a greatopportunity to establish a baselineot evidence, evaluated for occu-racy and validity, trom which futureciinioal guidelines, clinical deci-sioris, and research can be devel-oped. At a time when individualpatients and third parties requiremare predictability fram therapy,improvements in "traditional" ciini-oal deoision-making processes canerihance the opportunity for a suc-cessful result."'" Patients' deoisionmaking about oost-benefit oonsid-erations is retined when they haveclear ohoices and relevant esti-mates of the prediciabi l i ty ofthe autcames (end points) fromtreatment.'"''

In 1992. the authors began alorge-scale independent evi-dence-based evaluation of the lit-erature that supports the validityand predictabi l i ty of olinioalregenerative treatment. The devel-opment of the projeot began withthe assistance of an independentmeeting organizer (Qi Enterprises)and a sponsor (WL Gore). The pro-ject consisted cf the tarmation andmeeting of four fask forcesassigned fo evaluafe the evidencein taur areas ot regenerative treat-ment. The results of their delibera-tioris were planned to be dis-seminated to communities ofinterest through an international

symposium and by publioation in apeer-reviewed Journal. Althoughthis project was supported by aneducational grant from industry,participants in the process under-staad that this was a scientific,educatianai projeot with no pre-determined ccnciusions. Theauthors were sclely respcnsible tarthe scientific oonfent ot the prc-Ject. Three at four task foroe meet-ings were Informally audited byindependent third-party observers.

Evaluation of the evidence

When scientific evidence andexpert guidance are availabie, thepractitioner is obligated ta incor-porate new intormation into his orher clinical practice. To perform anadequate assessment of the avail-able infarmatian, the evaluationmust use object ive and reprc-duoible methods. The process out-lined in this report has relied heav-ily orí the evidence-basedmedicine approach developed bythe Evidenoe-Bdsed MedicineWorking Group in Ontario,Canada'^- '" and the 1989 WorldWcrksfiop in Ciinioal Periodontios.'These methods underscore theimportance oi establishing anexplicit, repraducible tramework tcevaluate the literature. In general,systematic, unbiased, and objec-tive evaluations increase the litera-ture's oiinicai applicability.^ in theabsence of the evidence-basedapproach, the practitioner must becautious about the interpretationof information derived fram ciinicaiexperience and Intuition, becauseit can be misieading.

The rules of evidence thathave been develcped ta guidethe evoluation are based on thequality and significance ot the evi-dence and on the ability of theintormdtion to be applied fo oiini-cai periodontal and implant freat-ment. In general, the guidelinesdeveloped by the World Workshopin Clinical Periodonfics^ and theAgency for Health Care Policy andResearoh'^ were used to deter-mine the type of liferature thdtwould quality as evidence. Forexample, abstracts were not con-sidered to be accep tab lebecause there is offen na way fcadequately assess the methodsand materials used, and there isusually insutfioient detail to permitthe kind ot evaludtion that isneoessdry.

The establishment of standardobjectives was tundamental toachieving objectivity and consis-tency throughout the task forceprocess. The use of explicit ruiesrepresents one of the most signifi-cant differences between the evi-dence-based appraach and tradi-tionai reviews of the iiterature. Amajor goal of evidence-basedperiodontal treatment^ was todemonstrate the feasibility ofapplying fhe rules at evidence tothe literoture on regenerative treat-ment. Several objectives were usedtc guide task force proceedings.

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dearly stating the questionsand methods

A cleor statement ot the questior^focuses the target of the literaturesearch and permits clinicians touse appropriate guides to assessthe validity of the articles. Eaohtask force was provided with acomprehensive and deto i iedworkbook containing explicitinstructions. Tables, charts, anddecision trees (algorithms) foreach chosen focus area wereincluded by ttie organizers as astarting point for further develop-ment by the task torce.

Using explicit methods to deter-mine which articles to include

Articles that discussed the strategyrriethods, and background for evi-dence retrieval and onalysis wereprovided to the task torce portici-pants, with permission, trom theAgency for Health Care Policy andResearch,'^ the Division of HeaithCare Services of the Institute ofMedioine, '* and the NationalLibrary of Medicine Col lect ionAccess Sect ion, ' ' as well asindividual authors.

Using comprehensive searchmethods to locate relevantstudies

A comprehensive eiectroniosearch of the worid literatureon a particular facet of regener-ot icn was conduc ted bv thereviewer.'^"" The Proceedings ofttie World Workshop in CiinicaiPeriodontics^ ond the UnitedStotes Air Force's review of the liter-ature on regeneration^ were pro-vided to all pcrticiponts as anodjunct to the review. Task torceparticipants also provided addi-tional references.

Carefully assessing the validityof the primary studies withmethods that are reproducibleand free from bias

Using the explicitly stated goal(s)of the study as a framework torevaluation, the task torce wasasked to determine if the mea-sures thiat were used to assess theoutcome were appropriate. A cita-tion evaluation form was used as aguide (Fig 1), For example, if ostudy used probing pocket depthOS the soie measure of success in otrial where connective tissue reat-tachment was the primary goai oftreatment, could the authors justifyclaims of successful regenerotion?Were the primary and secondarymeasurements of the study's out-oome accurate and complete,and were there adequate sofe-guards to ensure that study partici-pation itseif did not alter the endresults ot the study? '̂-22

Carefuliy analyzing the varia-tion between the findings ofthe relevant studies

To accurately evaiuate the vorio-tion ond/or differences betweendifferent studies of regenerotion,the ciinician must ensure thataccurate and appropriate onalyti-ocl tectiniques were used.'"•^^-^'^Differences between clinical andstotisticol significance must beexpiicitiv anaiyzed. it is here thatmany studies often confuse "prootof principle," cr abiiity to demon-strate success, with scientific evi-dence. MoGuire ond Newman'tiave Suggested that clinioai inter-pretation by gifted ciinicians con-not substitute for controiied, unbi-osed dato for the purpose oftreatment predictability. Ttie ran-domized clinical trial is the goldstondard of evidence, but thereare relatively few randomized ciini-ooi triais in the iiterature on regen-eration. Consecutive controlledcase studies are good evidencefcr demonstrating clinicai success(not predictobil i ty), and casereports estoblish proof of principlethat a tectinique has the potentiaito achieve the desired gool.Results from cose reports andreports on a series of patients, how-ever, do allow weak inferencesobout the treatment. In regenera-tive treatment, many variables,some of whioh are not a directport of the treatment itself, influ-ence the outcome. These con-founding variabies include bias,chonce events, systemic influ-ences, psychologicai factors, diet,materials, patient and site prepa-ration, ^^^'

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Citation Evaluation Form*

(Use for each citation)

Citation Rank'

Bibliograpiiy style: int J Periodont Rest Dent

'Relevant study

'Possibly relevant

'Irrelevant study

Classify by study design: The following iist is in rank order, witii the most important at thetop of the iist:

Randomized, bunded iongitudinai ciinicai trials with histoiogy

Randomized, blinded longitudinai ciinicai triais witiiout histology

Cohort or iongitudinai studies

Case-controiied studies

Noncontroiled case studies

Descriptive studies

indirect evidence—Animai studies

indirect evidence—Laboratory studies

identify design flaws and biases:

Sampie size Statisticai power sufficient

Patientydefect seiection bias Adequate inciusion criteria

Seiection of controi group Randomization methods

Clear acceptable definition of the outcome measures

Validity of conciusions Other

Determine the generalizabiiity of conclusions:

Representative study population Reproducibiiity in private

practice setting

Other evaluation criteria (use additionai pages as necessary):

Fig 1 Citation evaluation form for assessing fhe validity af the primary sfudies.

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Appropriafeiy combining thefindings of ftie primary studies

Results from many odequately per-formed and onalyzed studies werecombined by explicit semiquanti-fative methods (describod lafer). Inone tasi< force, meta-analysis wosused to evaluate the evidence.^^Throughouf the discussion aboutthe evidence, the part icipantsused the information contoined inttie evoluotion form (see Fig 1) as aguide fo group the citations intothree general categories: relevant,possibly relevant, or irreievont. Thisevoluation was used to developftie listing of supportive evidence.

tnsuring that fhe conclusionsare supportable from the datacited

This phase of evaluation of fhe evi-dence was clearly the mostdemanding and difticulf toachieve, in almost all cases,occeptance of an article os piv-ofai evidence required justifica-tion, acoord ing fo the rules ofevidence, by the individual partici-pant c i t ing the study. Debateabout the relevance of specificarticles was transformed into confi-dential vof ing via anonymouselectronic technoiogy (Option-Finder, described later).A compos-ite net value rating was entered asfhe ievei of evidence tor o parficu-iar fherapy fo achieve fhe desig-na fed ou tcome. The summaryreport from each fasi< force docu-menfed the final outcome of theevidence evaiuotion ^^^^

The evidence-basedprocess

Theropy should be based on repro-ducible scientific dota. Wheneverpossibie, the only variabilitv in suc-cess rafes should be offribufed toclinical judgment and experienceor known pat ient differencesScientists ond experienced clini-cians musf be oble fo tormulafeevidence-bo sed ciinicai guidelinesfhat can be used to predictablyimprove outcomes. For onoverview of the evidence-basedprocess in periodontal therapy, seefhe orticle by McGuire andNewman.^

Areas of evaluofion

Because there aie some foctorsfhaf are common to ail regenera-tive procedures ond ofher factorsthat might be significant only incertoin areas of regeneration, itwos decided that the problem ofpredicfabiiify wouid be best evalu-afed by focusing on fhree com-mon oppiicafions of GTR: Class IIfurcations, intrabony defecfs, andbone defecfs associated withimplants. A fourth area, critical tosuccesstui outcomes, was basedon the identificafion of those fac-tors ttiat couid enhance the trans-fer ot informotion to the pafient inways that wouid improve fhepatient's desire for, accepfonce ofmofivotion of, and compiioncewith regenerative fherapy.

General principles

The generoi guiding principles andsequence of tasks were similar tothose used for conflicf (esolufion:(I) the overall goal was dividedinfo specific relevont and man-ageable focus areas; (2) specificcomponents of voriability or uncer-fainty were idenfified: (3) consen-sus or disensus was reached oneach componenf by use of unbi-ased rules and anonymous expres-sion of opinion so fhat each voterhod on equal vote; (4) the influ-ence of the dominoht opinion onthe finoi outcome was minimized;and (S) the results of deliberationsand evaluations were piaced intoa specific frameworl<, and, for rea-sons ot accouhtabilify and dlssemi-nofion, the proceedings weredocumented.

Reaching consensus: Use ofOpfionFinder Technology

OptionFinder (OptionFinderTechnologies) is a computer basedaudience-input system that allowsgroups of participants to give theiropinions quickly and anonymouslyon specific questions posed fothem via a computer and dis-played on a screen (Fig 2).Questions sought fo defermine thesfrength ot agreement or disagree-ment abouf a variety of issues,including the efficacy, value, pre-dictability, and validity of infer-ences, statements, ond recom-mendations. Ali parf iciponfsoperoted a hand-held keypadfhaf permitted them to send fheir

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vote by pressing a numbet on thekeypad. The vote was transmittedvia radio signol to a receiver,where all responses were collated,tabulated, and displayed for thegrcup to intetptet and discuss,

OptionFinder techr^ology hosseveral advantoges over tradi-tional face-to-foce group decision-moking methods, because eachperson's response is anonymous,and traditional strong or dominantpersonalities and their opinions oremitigated. Because all votes areg'wen simultaneously, group pres-sure has no influerice. The quanti-tative tabulotion and disploy ofthe voting permits the group todetermine the nature and strengthof disensus and allows for dissent-ing opinions ond minority

Task force membership

To examine the evidence associ-ated with a particular focus area,the four task forces, or expert pan-els, were convened during operiod from March to June 1994.Each task force was madeup of 10 to 13 experts, a ptofes-sionol focilitatot familiar withOptionFinder technology, and asupport team. A chairperson and areviewer were chosen based ontheir internotional recognition asexperts.

Membership in eoch of thefour task fotces was bosed on twomajor factors: (1) familiarify with lit-erature in the specific area offocus, and (2) broad-based experi-ence to allow for reptesenfation ofopinion and insight ocross a widespectrum of periodonfal care.Individuals from France, GermanyIsrael, Italy, Sweden, and the UnitedStates provided diversity of opinionond experierice. The clinicians whoparticipated were primarily peri-odontists, except for the tosk forceon transloting ciinical outcomesto patient volue. In thot toskforce, multidisciplinary input wasreceived from general dentists,dental hygienists. and officeadministrators. Cliriicians expeti-eticed with regenerative treot-ment were chosen to givea grassroots 'reality check."Academicians participated be-cause they were familiar with codi-fying, standardizing, and blendingdtt arid science so that informotioncould be transferred in a mannerthof incorporated sound principlesof education. Researchers pro-vided a resource of knowledgeand familiarity with objective eval-uation of new techriology. The sup-port team consisted of a literoturesearch expert and staff,

Consensus development<Fig 2)

Sfep I: Review of fhe evidence

Prior to ccnvening the task force,the reviewer wos asked to criticallyevaluate fhe relevant evidenoeusing the methods describedabove, From this evoluotion, a sum-mary report was drafted. Togetherwith individual copies of all of themajor citdtiotis, the report was sentto each task force participant forhis or her own individuol reviewand evaluation. Each task forcechairperson and reviewer met withthe program cochairs prior to theactual review process to detet-mitie the scope of the review.

Sfep 2: Convening of task force

The four itidividuol task forces metfor opproximately 2 days each dur-ing the period from March to June1994 :i2-35 jf^g |Q3|̂ forces were sup-ported by a library of applicableliterature, on-line iitetature retrievolcapability, on electronic voting sys-tem, and audiovisual equipment.The structural layout of the meet-ing room maximized group interac-tion. Rules of conduct, confidential-ity, conflicts of iriterest, anddisclosure were made part of fheoperating procedures. Of impcr-tarice was the explicit opportunityfor "minority" or dissenfing reportsby anyorie at ony time during theproceedings.

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Reaching Consensus

OptionFinder

Facilitator h

Definitions' Therapy" Goals'

'Scale Used in Rating1 Outcome substantially worse3 No change5 Outcome substantially better

¡I

Evidence' Procedures*

"Scale Used in Rankingt Strong disagreement5 Neutral9 Strong agreement

Fig 2 Methodo!ogy for reachirig consensus.

Step 3: Definition of success

In dn etibrt to focus fhe task torceprocess, consensus was sought onexactly what constituted thedesired outcomes of freatment(success). Previously, some clini-cians referred tc this as endpointsaf therapy. Each task force wasasked tc clearly define (!) the clini-cal problem (ie. Class II furcationdetecf), (2) regenerafion, (3) treat-ment success, (4) the goals oftreatment, and (5) the methodsused to measure them.

Step 4: Development of out-comes tabies

The most important outcomes(results) of therapy from bath thepatient's and clinician's points otview were determined. For eaohoutcome, speoitio criteria tar mea-suring successtui attainment cf thegoals were listed,^^-'^ The basis forthis list was q combination ot evi-dence-based criteria, clinicdl judg-ment, and common sense. Forexample, gain in probing attach-ment level is a desired evidencebased outcome, while tooth reten-tion in health and ccmtcrt wauld

be derived trom oommon sense.Eaoh and every entry was votedon (with OptionFinder), based onthe strength ot the availableoPjective evidence. When direct,quotable references were notavailable, the basis for consensus(or d¡sensus) wds oledrly quantifiedand noted. Gaps in the ¡iterdturewere identitied and bridged withexpert Judgment and consensus.

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Step 5: Development of the evi-dence table

Armed with the goals of treatmentfar the specific oiinicol indicationbeing evaiuated, a list of therapiesttiat have Peen used tc treat thatclinicoi condition was proposed.For each therapy, the evidencethat supports its efficocy wasdebated, voted, and listed. Theagreed-upon therapies were thenevoluated (and voted on) as tohow predictably they couidachieve eoch outcome based onthQ evidence.^^'^^ The anaiyticaiprocess used in formuiating a con-clusion (or vote) based on the evi-dence attempted in aii cases tcfollow the objectivity described inttie instructions: however, becauseof the diversity of data, studiescouid not oiways be weightedconsistently. This vote related onlyto the therapy being evaluated.No comparisons between thera-pies were permitted ot this time.This was fhe most difficult and time-consuming phase of the task forceproceedings, because each out-come (goal of treatment) had tobe backed up by evidence. Whenevidence wqs not direct or of thequality needed to justify strongsupport, the rating for that therapy(as effective in accompiishing thegool) was lower than that of othertherapies for which evidence wasavaiiable. In some instances, thetqsk force decided not to vote onoutcome categories because of aiack of evidence. In other taskforces, votes were taken, but onatation wos made, indicating thatit was based on clinical experi-ence, not on evidence.

The roting of the evidencecontained within this toble wasbased on a discrete scaie of 1 fa 5(see Fig 2). The arithmetic mean ofthe voting was used os the finairating only after it wos determinedthat o consensus wos oohieved.This was contirmed by the toskforce participonts through an evai-uotion of the frequency distributionof votes in grophic form. After dis-cussion and some revoting, anyrating with a wide distribution ofvotes wos recorded. An opportu-nity tar recording a minority or dis-senting opinion was provided.in some cases, participantsabstained from vofing, and thiswos similorly noted.

Cnce the evidence table wascompleted with a rating for eochtherapy's obiiity to ochieve thegoal in question, a subjective ranJe-ing of the therapies was performedon q discrete scaie of 1 to 9 (seeFig 2). This provided on opportunityfor the participants to give a"globai" oilnioal judgment as towhich theropy or therapies wauidmast predictobly achieve the mostoutcomes. Ranking appropriateindications tor different procedureshave been used in medicine ih osimilar manner with generalacceptance.

Step 6: Development of algo-rithms (decision trees)

The findings trom the evaiuations ofttie evidence were ttansferred intooigorithms.^^"^^ The aigcrithm hosreceived general acceptance osa format for organizing a processof thinking regarding alternativeswhile providing visuai reinforce-

ment. The method used by the taskfoices wos derived by consideringseverai approaches,'•^^•25,36,37When possible, the algorithm wasonnotated to provide a iinkagebetween oiternative pqthwoysand the evidence that was usedto formulate the choices.

The therapy (or theropies) thotreceived the tiighest ranking fromthe evaluotion of the evidenceevaluation was (were) used as ttieframe of reference for the devei-opment of five algorithms: (I) thepretreatment patient seiectionalgorithm, (2) the defect selectionalgorithm, (3) the presurgicol olgo-rithm, (4) the surgery algorithm,and (5) the postoperative algo-rithm. The degree of detail and thestrength ot recommendations con-tained within eooh algorithm var-ied oonsiderably because of thevoriobility of the strength of theevidence that could be cited tosupport a specific detoii of a par-ticuiar recommendation. Wtien thisoccurred, the strength of the evi-dence, or lock of it, was noted anddiscussed in the narrative. Sometask forces aiso included a iist ofclinical guidelines based solely onexperience: these guidelines werenot considered to be evidence-bosed but ere important neverthe-less because they representcommon practice.

Where objective dato did notexist and clinical experience sug-gested an area of importonoe, alist of fopics was generated to pro-vide direction for new research.

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Step 7: Compilation af a refer-ence list

Affer the task force evaluated fheevidence, the individual citationswithin the bibiicgrophy wereranked occording fo their impor-tance and value. The ranking wosbosed on objective crlferia of eval-uation, OS discussed eoriier. Thisphase at the process aiiows clini-cians fhe opportunity fa personallyevaluate selected references andform fheir own opinions.

Step 8: Creotion af o summaryrepart for peer review and pub-iication

Following eoch fask force meefing,the leaders and reviewers took themodified fables and charts, alongwith the supporting evidence, anddeveloped a summary reporf tcsynfhesize fhe consensus and find-ings of the task force. These reportswere submitted far peer reviewand publicafion,^2-^^

Discussion

The process used to assess,debate, rate, and rank the evi-dence and clinioal judgment wassemiobjective. It was rigorouslyapplied in its attempt to follow therules of evidence as presented inthe task torce proceedings. Thisframework helped avoid fhe fradi-tional weaknesses of the narrativereview, which often includes lGci<ot objective criteria for determin-ing levels of evidence and poten-tial for bias in article selection. The

methods used fo weight the qual-ify of evidence in fhe overoil con-clusions were sef forth. The processalso helped fo identify gops inknowledge, the lack of sfrong evi-dence, and the existence ofdiverse opinions in many oreas.However it was clear tt^af sufficientevidenoe exists ta warrant andsupport ttie use of regenerdtivetherapies for the treatment of avoriety of indioafions. Now a basisexists for enhanoing the pre-diotobitity ot those treatmentsbased on critical evoiuotian of theevidence.

The volidify of the evidence-based approach for periodonfaland implanf fheropy has yet to bedefermined, Validify requires ofleast three characferisfics: repro-ducibiiity, appropriafeness of fhequesfion, ond measurement of fheinfended voriable,-*^-"^ The evi-dence-bosed mefhod presenfedin fhis reporf meets fhese fhree cri-feria. The overaii quality of fheinfcrmafion currenfiy available infhe peer-reviewed iiterafure onGTR does nof readily permit fhedefermination of quantifafive esfi-mates of freafmenf effecf such asfhe poinf esfimate, oolculation ofconfidence infervols, odds rafios,cbsolufe ond relafive risk reduc-tion, and other dofo dependentmeasures,"'•'^•''ä-'"' On fhe ofherhand, quontitative statisfical con-clusions such as cost-ufilifyanalysis,^'* regression analysis,probabllify values, and ofhers, donot subsfitute for clinical relevancyqnd the powerful influence of indi-vidual pofient preferences,'''^'''''''*Success for one pafient mqy notbe the same as success toranather patient,'''-^'

To furfher val idate the evi-dence-based approoch, long-ferm randomized ciinicai triols willbe required; their findings can beused by clinicians to make betterquality decisions,̂ -̂ '̂̂ ^ ^ number ofshorf-term studies hove confirmedthat the evidence-based systemcon be tought to medical stu-denfs. These sfudenfs are more upfo date regarding currenf literatureguidelines ot medical freatmentthon ore traditionally taught stu-dents,'O'^'^ j^Q sfgpj outlined inthis report ore not the only woy inwhich to evaluate the evidence. Infhe context of this clinical subjectarea, however, it represents themost objecfive opproaoh to datebecause if emphosizes a compre-hensive evoluation of fhe availableempirical and quanti tat iveevidence.

Tradeoffs between the specificbenefifs of regenerative treatmenfand fhe ccsf of alternative freot-ments, including nonsurgical treot-menfs, ore being explored bypafienfs ond payers,^'^ This isanother area in which the evi-dence-bosed approach is soimportant, because it can enhancefhe clinician's ability fo validate fhechoice of fherapy,*•*•'*•''* * ^ "

Professionol compefency andcompefifiveness depend in parton fhe abilify to provide high qual-ity technologic service. To do thispredictably, the clinician mustknow what factors have beenassociated with reproducibiiity andpredictability and then determinethe best ways to controi, use, orintegrate them into the actualprocedure, as opposed to merelyfollowing recommendations basedon the unconfrol led clinical

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experience of pracfifioners whichmay perpetuate the widespreadapplication of treofments thothove not been validated.^^s'Quaiify-orlented clinicians will ben-efit from o more precise estimateaf predicfabiiify. For mosf practi-tioners, the magnitude of the ben-eficial effect from a specific treat-ment must not oniy be sufficient towarrant its use but also mustprovide value based on reason-able expectations of treatmentoutcomes.

This opproach may provide asource of empowerment, ollowingproctifioners to independentlyevaluate conflicting recommen-dations regarding patienf care byusing evidence as fhe basis fordecisions.'̂ •̂ ° The results thot canbe derived from incorporating thissysfem info pracfice must be otsufficient value fa overcome coun-teractive forces, such as informo-fion overload, habifual practicepatterns, and economic factors.'*

Is the evidence-basedapproach better?

The evidence-based approochrequires o strong commitment offime and resources, and a detailedimplementation and disseminationplan to produce informafion that istruly of value fo the constituenciesof interest. Evidence-based peri-odonfai treatment complementsand supplements a fast-growingbody of Iiterofure focused on therecognition of risk, prognosis, andtreotment predicfobiiity fac-tors,?.2S.37.2e.«.ûo |f,e fin

be whether or not the predictabil-ity of regenerative proceduresimproves aver the current levels.The application of the evidence-based approach fo regenerofiveand other denfoi treatments hasthe potential to substontiallyimprove the quality ond efficiencyof care.

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